Our Daily Barrage: Melody Petersen Explains
174 CommentsBy Ed Silverman // March 20th, 2008 // 10:43 am
For several years, Melody Petersen covered the pharmaceutical industry for The New York Times. As she explains in her new book, ‘Our Daily Meds,’ she was, at first, instructed to find stories about the new drugs that pharma’s scientists were researching. She wound up becoming fascinated with the ‘medicine merchants,’ as she now calls them - the people who transformed the industry into a big marketing machine “selling dangerous medicines as if they were Coca-Cola or Cadillacs…and have become experts at promoting fear of disease.” Her book details numerous examples in which drugmakers used a plethora of controversial tactics - manipulating clinical trial data; seducing doctors with freebies; promotional stunts that obscured side effects - to drive sales. She does not paint a pretty picture.
Pharmalot: I’m wondering whether you were aghast at all of the marketing pitches and ploys back when you were still working at the Times. And if so, how’d that affect your view of the industry?
Petersen: When I began covering the industry in early 2000, I believed the drug companies were all about science. But after following the industry and talking to executives, I saw that my early impression was wrong. For example, that year, some of the most talked-about drugs were products like Nexium, Advair, and Clarinex. The companies said these were “new” drugs. They weren’t. They were little more than old drugs, tweaked a little in the lab and then heavily promoted to make the public believe they were new. I realized that it wasn’t science that drove these companies. It was marketing.
Pharmalot: What do/did you say to people who complain the media is too critical of big pharma and harps on negatives - such as marketing gaffes or side effect reports - and overlooks the positive contributions made by research?
Petersen: I know the pharmaceutical industry likes to blame the media for its problems. Unfortunately, the industry gives journalists a lot to write about. The industry sells products that can help people and save lives, but that hardly gives it the right to hurt other people through aggressive marketing.
Pharmalot: Now, to the book: You describe a system that, basically, ran amok and is rigged. How did we get to this point?
Petersen: The simple answer comes down to the piles of cash the industry has to spend. Our medical system once had many safeguards to protect patients from drugs they didn’t need. Academics and universities once helped keep the industry’s clinical trials objective and honest. Physicians once were independent from the industry and acted as gatekeepers who put patients first. The FDA once did not require fees from the industry to fund its operations; it’s only client was the public. But all these groups are now dependent on the industry’s cash handouts and patients have suffered. The safeguards have disappeared. The drug companies have learned they can sell just about any pill by spending heavily on promotion. There are relatively few independent experts left who are willing to point out how the system has gone wildly wrong.
Pharmalot: Is there any going back? How can pharma survive without heavily relying on the marketing machine?
Petersen: The industry needs to get back to the hard work of using science to discover genuinely new medicines that help the sick and ease suffering. In fact, it’s hard to see a need for companies that don’t do that.
Pharmalot: You suggest several changes in behavior and regulation, such as rolling back DTC advertising to pre-97 constraints. Basically, you’re saying DTC hasn’t worked. Isn’t that like throwing the baby out with the bath water? Some people insist they’re more aware of their health because of those ads.
Petersen: The television ads have made people believe that all they have to do is swallow a pill and life will be grand. They’ve warped the public’s view about health. I have a lot of gripes with the ads. That said, I actually think the ads are less damaging than all the other promotion the industry does from behind the scenes. I’m talking about the promotion that is disguised to look like its coming from an independent source. Things like the hiring of celebrities and doctors to talk up the benefits of drugs and the creation of medical journal articles that have been ghostwritten by marketers. That is the stuff that is especially dangerous because people don’t have their guard up like they do with advertising. I wrote the book because I wanted people to be able to see through this covert promotion.
Pharmalot: Another suggestion involves requiring docs to provide patients with lists of their interactions with, and ties to, drugmakers. Why is that realistic?
Petersen: I actually want a law that bans companies from giving cash or gifts to physicians, while also making it illegal for physicians to take anything from the industry. That’s what we really need. At a minimum, doctors should be required to keep track of everything they receive from the industry and give this list to every patient checking in with the receptionist. By law, political candidates must keep track of all donations and gifts. If doctors want to take corporate handouts, they should have to do the same type of recordkeeping and disclose the list to their patients.
Pharmalot: Do you see any differences now in big pharma’s collective behavior than you did while researching the book? If so, how?
Petersen: You’re kidding, right? If anything, the marketing has become more aggressive as some of the industry’s big-selling blockbuster drugs have lost their patent protection.
Pharmalot: Drugmakers have a new mantra - transparency - such as posting clinical trials. In your view, is this for real or is it just talk?
Petersen: Last year, President Bush signed a law aimed at increasing penalties for companies that don’t quickly disclose clinical data. I hope that will help. But even if the companies now began disclosing all information, we will never learn about the results of an untold number of older clinical studies that have never been published even though they involve drugs still being prescribed.
Pharmalot: Of the various anecdotes about people you wrote about in your book, which moved you the most, and why?
Petersen: All the stories in my book about patients who died or were hurt by prescription drugs are heartbreaking.
Pharmalot: Which anecdote involving a drugmaker angered you the most, and why?
Petersen: It’s hard not to be angry about any case where aggressive marketing harms patients and takes lives. I write about so many of these needless tragedies. It’s impossible to say that one of these cases was somehow more or less egregious than another.
Former pharma Marketing Exec
She is right, if the Pharma industry thinks media is being too harsh, they (we) have ourselves to blame.
Unfortunately many patients still find it hard to believe that they are being essentially “sold out” by the very people who are supposed to be helping them - their doctors.
We’ve done much harm to humanity and we really need to fix it.
Melody
Brent Hoadley, author of “Too Profitable to Cure,” pointed out many of the same things. Because it was framed from the viewpoint of a T1 diabetic, it appeared to be only about diabetes. NOT! I have not yet read Melody Petersen’s book . . . but if it achieves notoriety and effectively disseminates the message that ‘profits above patients’ is the ruling paradigm, she should be heartily commended.
Outside the Box
Could Melody be persuaded to also take a look at the other parts of the health care industry in the US? I am no defender of the excessive practices of the pharma industry, but devices, diagnostics, hospitals are all in the business of maximizing profit through practices that are not well publicized and result in substantial increases in the cost of the system. Pharma is the very public end of a health care funding system that has the patient firmly at the bottom of the list of priorities.
Dan
Melody’s book is now added to about a dozen others written by pharma critics. And they are all worth reading, for educational purposes, if nothing else.
WBP
Great interview. I’m glad that you brought this book to our attention. I wonder if there is a Top 10 List for Big Pharma books worth reading. This one sounds like it would be quite good. I’m sure she’s not the first and she probably won’t be the last, but she is absolute spot-on with her assessments and suggestions. I applaud the elimination of DTC - let the doctors decide. I’m in favor of cutting the ties between physicians and Big Pharma - the large amount of money that changes hands for the purpose of influencing prescribing is obscene. The opinion leaders also need to become objective in their positions - not heavily subjective because one company is lining their pockets more than the others. Also, eliminate PhARMA - nothing but a bunch of overpaid lobbyists run by a bunch of over-zealous marketers. If Big Pharma doesn’t change on its’ own, it will be changed by the government. The graft can’t continue unabated. It has gone on fro way too long. It’s time to put patients first!
RTW
Well - I have to say that the VAST majority of those of us that worked in Drug discovery hated marketing.
RTW
Oops - wasn’t finished there… At any rate - They determined what projects we worked on as well as what technologies we sometimes invested in. It has always been about return on investment to shareholders in the industry. Nothing different about it compared to building cars or making pizza’s. To expect that management is going to be altruistic when faced with shareholder expectations is laughable. There was once a rumored scathing memo written by a PD VP in R&D about the fact that since the company wouldn’t invest in biotechnology at the time, perhaps they should start making pizza’s and compete with another notable company up the street. This was over 18 years ago I think.
Lauren
I don’t know if I can bear to read her book, as through several years of work and study following the killing of my son by Zyprexa, I’ve learned most everything. I have also made close friends with others who lost their children or their spouses through the antipsychotics or SSRIs. Seldom do our stories hit the papers or books due to confidentiality constraints or feelings on the family’s part that the painful death is family business; private. I know these people and their stories, and greatly value their friendship. I’m not sure I want to know any more. Most news articles and blogs talk about share prices or government suits, not death.
Outside the Box
Here-in lies the biggest paradox in the industry - the desire to research and develop meaningful products, and the legal responsibility that management has to make a profit. Yes, it is a legal responsibility in public companies that they make profit unless the share holders have given them permission not to. The same is true of the insurance companies (although they don’t have the R&D justification that pharma and biotech have).
A core argument in support of this approach has always been that Government is very bad at managing innovation and that the innovation coming from the pharma industry will be aimed at diseases that require treatment and for which a commercial price can be paid. The big problems appear to have arisen in recent years when pharma is perceived to be gouging prices, promoting clinically less relevant “lifestyle” drugs, failing to develop real innovation (and lying about safety when they do). There are many examples of fabulous innovation, reasonable pricing, social awareness and the like. Unfortunately the examples of the “bad” have shifted perceptions too far for the “good” to provide a balance.
James
Same tune, different singer. She and her ilk who rip the pharma industry would be screaming to the high heavens if they couldn’t get the latest and greatest in meds. RTW, you and I agree–the pharma industry is no different than pizza delivery in that they are both in it to make a profit. As it should be–I don’t want a non-profit or the gov’t developing my medications.
It is ridiculous that she wants the same restrictions on doctors that are on elected officials. Doctors are private practitioners, not politicians. They should be bound by the same rules as lawyers, office workers, and fast food employees are. If I get a gift basket from a vendor, or sports tickets from a potential partner, should I be required to document it, or worse, return it?
Why do we expect doctors and healthcare companies to act like charities? Not only is it unrealistic, it would be counter-productive. The profit motive is excellent for stimulating new developments, increasing efficiency, and boosting customer service.
Melody is proof that a little knowledge is a dangerous thing.
Lisa Van S
James,
“Doctors are practicing Physicians, not Politicians”
Maybe not,.. But they sure enjoy the perks that come along with Lobbying our Politicians on behalf of Industry..
James
So what? So does every other company and individual who has a special interest in Washington.
Gun owners, gun control proponents, realtors, retirees, lawyers, small businesses, bird lovers and their brothers lobby politicians and gain benefits from it.
I’m pretty sure you’ve been on Capitol Hill a time or two, if what I’ve read on here is true. Care to tell us what you received for Christmas the last five years, and document it down to the exact dollar value?
Pharma Giles
James: I have no idea if you regularly shill for Big Pharma and I don’t really care. But why would you not want your medicines to be developed by non-profit making companies? All that matters is that they are efficacious and safe. I can recall a time when most people in the industry, sales reps included, took a genuine pride in their products and the benefits they provided. That motivational pride has been replaced by profit and greed, and we are seeing the results.
“Big Pharma” simply can’t be trusted to do what is best for its customers any more.
Melody’s views are not new but they are correct. Her “little knowledge” is only dangerous to the racketeers who have hijacked the pharmaceutical industry. Your apparent ignorance of this reality is either breathtaking or disingenuous, James, and I suspect it can only be funded by the pharmaceutical industry itself.
Lisa Van S
James,
Never accepted a dime, or a gift from anyone. My husband and I did rcve condolence cards and flowers when my mother-in-law passed away in 2005 (Does That Count)other than that Im not interested in being beholden to anyone.
Melody (not Petersen)
Outside the box, you state: . . .the legal responsibility that management has to make a profit. Yes, it is a legal responsibility in public companies that they make profit unless the share holders have given them permission not to.
Many health-related blogs reveal a multitude of culprits; perhaps you’ve hit the nail on the head. I don’t see ‘capitalism’ as the problem, but rather unbridled capitalism . . . which has given rise to pharma’s need/demand for blockbuster drugs and record-breaking profits. Perhaps corporations (and their shareholders) should be challenged to shift priorities away from exorbitant executive salaries/perks and shareholder demand for ever-escalating ROI. If employees (the backbone of any corporation) and consumers (without which a corporation would cease to function) were given the same value as management and shareholders, wouldn’t EVERYONE benefit?
Justice in Michigan
I have appreciated MP’s reporting for several years. Glad to see that she has put it together in this book.
Re: other generally accessible works, I am personally most positive about Phil Hilts’ _Protecting America’s Health_ (history of the FDA from a center-left perspective, also former NYT reporter); Howard Brody’s _Hooked_ (mostly on rel between medicine and industry by a guy who is both a distinguished physican and ethicist); and - not easy to find anymore - John Braithwaite’s book on Corruption and the Pharm Industry (not remembering exact title, but it is a far more subtle work than that may suggest). To me, these are not simply “exposes” - of which there is now no shortage - but include serious policy reflections.
_Dark Remedy_ - a study of thalidomide - is still very much worth reading. So is Thomas Moore’s _Deadly Medicine_ about the anti-arrhytmics.
Doc
She is right on, but doesn’t even know the worst of marketing aggression. Been there done that, it is much worse than she thinks.
CV MD
Big Pharma should be held to a higher standard. Medications impact aptients health and lives! I’m not sure what planet James is from, but his views are out of this world. Perhaps another marketer or salesman from the Imperial Deathstar?
Alan
Has anyone looked at the intersection of the pressure of insurance companies and aggressive marketing? Is it any coincidence that at the same time the aggressive marketing ramped up, insurance companies began to treat physicians as mindless sheep and require stricter formularies? My point is that one group, in isolation, doesn’t paint the whole picture. The larger question of increasing marketing, costs, etc. has to be put in the same context as the rest of the players within the healthcare space. The need to paint one villain is very tempting, but there are many forces at work here.
James
Giles, I have no idea if you regularly jump to conclusions about a person’s point of view and frankly I don’t care. I don’t want a non-profit developing drugs because they rarely get actual results. What is the last disease a non-profit cured? What was the last social ill a non-profit resolved?
I want for-profit companies creating my drugs because the profit motive is the best way to ensure responsiveness to me, the customer.
You also wrote: “Big Pharma” simply can’t be trusted to do what is best for its customers any more.
Of course they can’t. No company can, or ever should be. Companies aren’t in business to do what is best for its customers. Companies are in business to make profit. Further, non-profits can’t be “trusted” to do what is right for their stakeholders, and gov’t can’t be “trusted” to do what it right for constituents.
If you trust anyone to do what is right for you, rather than doing research for yourself and *choosing* what is best for you, you deserve what you get.
Your apparent ignorance of this reality is either breathtaking or disingenuous, Giles, and I find it quite sad.
And CV MD, you argue that big pharma should be held to a higher standard. Why? Because medications impact health? So? Maybe people should be held to a higher standard, to make decisions about what they put into their own body.
I wouldn’t trust you to make decisions about what goes into my body. I don’t trust pharma companies, either. And I don’t trust doctors to tell me the truth about that advantage of one statin over another. It’s called research.
Now, if a company demonstrably lies about their product, sue their executives into a life of fast food (I think Justice in Michigan and I agree on that one–I even support easily piercing the corporate veil). But giving doctors CME in Costa Rica has absolutely nothing to do with patient safety.
Patients unwilling to do some work themselves before they put a drug in their body, however, does have a lot to do w/ patient safety. That’s as true on Earth as it is on the Death Star.
Grieving
There is only one group of villains for me; Lilly execs who lied, thus allowing many people to die (all down in black and white on the blog furious seasons). There was justice in the case of the Enron execs and some are in prison. Why has there been no justice in the pharmaceutical world when the crime resulted in innocent people being killed?
Pharma Giles
Ah, “James”. I could use a talent like yours to help me write my own blog, you really are so funny. So you want people to knock up their own medicines in their bathtubs? Or maybe chew strange-looking herbs from their backyards if they get sick? People used to be able to trust drug companies to provide them with safe medicines - not the sort of work Joe Public can “research” on his own, really. So your message to the families affected by, say, Vioxx, is “serves you right for making a bad consumer choice”? How interesting. Ah, such is the thinking in George Bush’s America. So glad I don’t live there…
Grieving
Pharma Giles, I can’t tell you the number of lectures I have gotten about “doing research” before my son took Zyprexa. First of all, he was pushed into it when he took Medicaid, no doubt by a drug rep who sold the overworked psychiatrist the party line. Secondly, we had never been “tricked” and lied to before; my son having been on lithium for years - there was no profit in lying about a generic. Plus, my son had a real, ethical doctor who exhaustively explained everything. Third, in 2001, there was next to nothing the literature anyway. It was all tucked away in Lilly’s vault, and in the FDA’s Medwatch statistics, which are not revealed. Ut has been a cruel criticism to be told I should have “done research”. Though, dear God, I wish I’d known about hyperglycemia and what it looks like - if this had been the case,my son might have made it.
James
Giles, I don’t know whether to respond to your comments as though they were actually sincere, or to roll my eyes and move on. For whatever reason, I will opt for the former:
1. “Joe Public” can’t read up on what drugs do? Funny, I have no problem finding all kinds of info on what drugs actually do, from legit sources, and I have no special access.
2. Clearly I’m not advocating people manufacture their own drugs. That’s not even a good straw man.
3. I wrote in the same post that if companies lie about their drugs, they should be sued to the hilt. That answers your Vioxx claim. By the way, your beloved gov’t regulators concluded a few years ago that Vioxx has an acceptable risk/benefit profile for certain patients. Further proof you can’t trust the gov’t to protect you, perhaps.
4. You wrote “People used to be able to trust drug companies to provide them with safe medicines”. Really? When was this? Was it Tylenol in the 1980s? Was it the Dalkon Shield in the 1970s? How about Thalidomide in the 1950s? Elixir Sulfanilamide in the 1930s?
Please enlighten me as to when this golden age of trustworthy companies was.
AAU
I think James is either brainwashed or has his head in the sand. Companies that are in the business of healthcare need to care about the health of patients. When they stop caring, they deserve to be called out on the carpet for their misdeeds. Should everyone forgive and forget about Purdue, merck, lilly, Schering-plough, Pfizer and all the other companies that have been called into court and fined for their defrauding of the governement and the public. Absolutely not! Where in the world are you coming from? The business of pharma should be way diffeent than soda pop or cereal!
robert
Didn’t Bush sign a law last year, which makes all drug companies publish phase 11-1V study results. Ted Kennedy et al. introduced the bill. I know that DTC was a compromise. Isn’t this a positive move? When it comes down to it, the science matters, clinical trial results. I know that clinical trial design is manipulated by design and shady statisticians guided by some shady MDs (this applies very much to the medical device industry the most corrupt and still under the radar). But scientists are smart enough to pick out the statistical problems with trials if they are independent, but that is the question of the moment. Who is independent? Am I wrong?
HorusCat
Funny how trendy it is to attack pharma. Big evil Satan. Of course, when pharma comes up with that cure for Alzheimer’s, I bet Melody and Giles will be in line.
Of course pharmaceutical companies are in the business of making money. Duh. And they will make what they are incentivized to make. At this time, Wall Street incentivizes me-too, make-profit-and-make-it-quick drugs like the new SNRI Wyeth is coming out with. But guess what? Any consumer out there can say, “No thanks, Doc, I’ll take that generic Effexor XR that’s available.” And any doctor worth his/her salt can look at the efficacy/safety/tolerability profile of a new med and an old med and make a prescribing decision based on that. What magicians we pharma reps must be to persuade a doctor to write only our products?
Marketing is an important tool in any industry, including pharma. Most doctors will not willingly do the research necessary to learn about new drugs on the market, especially if the drug is a new class of drugs. When Prozac came out, it took a huge marketing effort by Lilly to convince doctors to try it instead of relying on the old stand-bys, the tri-cyclics and the MAOIs. Prozac CLEARLY had safety benefits (tricyclics are fatal in overdose and hello, depressed people OD on their meds!) and tolerability benefits (weight gain, drowsiness, orthostatic hypotension, to name a few). Despite these clear benefits, physicians had to be SOLD on the benefits of the SSRIs. Now, do we need a dozen SSRIs? Probably not. But again, this is a matter of getting Wall Street to incentivize different behavior on the part of pharma.
What about these vaunted non-profit organizations doing all our pharma research for us? Where would that money come from? There are not enough tax dollars in the world to fund that effort. There is too much risk, too much liability and too much failure in pharma development to take it out of the private sector. And those occasional blockbuster drugs like Paxil or Cialis fund less successful, less profitable medications for less glamorous diseases.
And drug companies haven’t necessarily “defrauded” anyone, despite these large lawsuits won by the government against companies like Pfizer or Lilly. Doctors use drugs off-label all the time. Getting indications is expensive–if a drug works for neuropathic pain of one kind, chances are very good it will work for neuropathic pain of another kind. Pfizer paid a huge fine for Neurontin–but guess what? The drug worked for all kinds of pain, not just the indication it had. That’s not fraud–it’s the government raping a company because it can in an effort to fill its coffers.
As for bad outcomes–every thing in life has risks and benefits. Corporations should be punished for knowingly selling products without revealing the dangers. If Merck knew about the cardiac risks with Vioxx and did not reveal those to the public, then sue them for everything they’ve got. But don’t forget that side effects from drugs often take years and years to show up–if we did enough clinical trials to show up those side effects, a drug would never get to market. You pays your money and you takes your chances with just about everything in life. No one is forcing pills down your throat. Everyone of those Vioxx patients had the choice of living with their pain.
And by the way, America, take a little responsibility. You want to super-size everything, sit on the couch and watch American Idol, smoke two packs a day…then you want a pill to make it all better. Then you complain when the pill is expensive and has side effects. You are obese and putting incredible strain on your joints, causing all sorts of chronic pain, then you want a pill to make the pain go away. But make it free and no side effects!
And Zyprexa lady? I am really, really sorry your son died. But I can’t tell you how many psychiatrists I had tell me, for years, that their patients’ weight, blood sugar, blood pressure and cholesterol were not their concern. Everyone on the psychiatric planet knew that Zyprexa caused weight gain. Perhaps your son’s physician made the best decision he could to treat your son’s symptoms. Perhaps he was really comfortable with Zyprexa and unwilling to try anything new, despite other pharma reps best efforts. Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds. I have seen all of these things. Despite what happened to your son, Zyprexa is a good medicine and has helped millions of people. It’s always a matter of risk vs. benefit, and sometimes bad things happen.
Go ahead and flame me, all of you who love to pretend that big pharma is the most evil thing on earth. When you get cancer and want chemo, I want to see you shun pharma. When you or your friend gets MS, I want to see you shun pharma. When your mom has a stroke and needs a clot-buster, I want to see you shun pharma. And that Alzheimer’s lurking in the future for 1 of 8 Americans? Just so you know, pharma is throwing billions at that problem. But I expect you aren’t interested, because God forbid, pharma might make a profit on it.
HorusCat
And by the way, I expect that all of you who post scathing remarks on the fact that pharma turns a profit are working for free. Melody won’t make any money on this book; Giles, whatever you do, you receive minimal compensation? CV doc, don’t even get me started–what are you pulling down, $500,000 a year? The guy who built my house is doing pretty well–how dare he? Housing is a RIGHT–no one should make a profit on it. I and my kids would die in a northern winter without a house–contractors should be held to a higher standard. And food!! All these people making money on food (except the illegal immigrants, who make bupkis)–and sometimes the food is bad!! and kills people!! I have to have a car–can’t work without one. UAW members? How dare you demand pensions and health benefits and no co-pay for your meds? You are driving the price of my car up, and I think it should be less expensive, because after all, a car is a necessity.
Ah, America and the entitlement mentality. Go after pharma and kill it. Don’t laugh, docs, you’re next. The only industries that are safe are the lawyers and any industry that relies on union labor.
Justice in Michigan
The great thing about this blog is that people from across the spectrum of opinions have a chance for thoughtful and respectful reflection. Usually, people don’t flame. They try to listen to each other, even when they disagree. From time to time, they even learn from each other. Very few people use it for same old, same old tirades.
anonomiss
Very true Justice. Except for the two comments immediately before yours :-|
Horus-Cat: Egyptology. That versus science? No contest.
anonomiss
Satan: Religion-Belief. That versus Science? No contest. Awaiting pharma coming up with a CURE for alzheimers. They’ve tried passing cures off, they aren’t scientific, they don’t work. Won’t happen.
anonomiss
Pharma Turns A Profit and You Don’t: Myth. Get Paid? Most of us pay for our websites and so are LOSING money, not MAKING a profit.
anonomiss
“Prozac CLEARLY had safety benefits (tricyclics are fatal in overdose and hello, depressed people OD on their meds!) and tolerability benefits (weight gain, drowsiness, orthostatic hypotension, to name a few). Despite these clear benefits, physicians had to be SOLD on the benefits of the SSRIs.”
Wow. So they were. The clear benefits of Prozac included homicidal and suicidal ideation. So they shot and hanged themselves instead. But great you managed to sell prozac on those CLEAR benefits.
anonomiss
It has to be a great benefit that mentally healthy trial volunteers killed themselves on Prozac and its cousins. Great selling to doctors, congratulations from the dead.
anonomiss
“The guy who built my house is doing pretty well–how dare he? Housing is a RIGHT–no one should make a profit on it. I and my kids would die in a northern winter without a house–contractors should be held to a higher standard.”
Your HOUSE Horus, has not killed you and, short of an earthquake, is not likely to. Therefore your house contractors have done nothing other than give you shelter and so are entitled to make a profit.
Drugs that kill people, Horus, do the opposite.
anonomiss
“And Zyprexa lady? I am really, really sorry your son died. But I can’t tell you how many psychiatrists I had tell me, for years, that their patients’ weight, blood sugar, blood pressure and cholesterol were not their concern. Everyone on the psychiatric planet knew that Zyprexa caused weight gain. Perhaps your son’s physician made the best decision he could to treat your son’s symptoms. Perhaps he was really comfortable with Zyprexa and unwilling to try anything new, despite other pharma reps best efforts. Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds. I have seen all of these things. Despite what happened to your son, Zyprexa is a good medicine and has helped millions of people. It’s always a matter of risk vs. benefit, and sometimes bad things happen.”
HORUS, fantastical comment. Sometimes bad things happen? Zyprexa has helped millions of people? Please give evidence of your statement.
“Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds.”???
WOW. ARE YOU A PSYCHIARIST who never listens to his patients telling him how bad they feel on the drugs you give him? If you are, change jobs, you’re no good at psychiatry.
anonomiss
In fact, Horus, you’re no good at whatever you’re doing on the drug front. Give it up. Find something that benefits human life, something that benefits your own living. Leave what you’re doing. At the moment you die, you will have no choice but to look back at what you did, what you caused, who you killed.
CHANGE YOUR VOCATION before its too late for YOU.
anonomiss
Evem Egyptologists can repent. REPENT!
REPENT!
anonomiss
And if that didn’t answer your soul’s problem then what the END of it here:
REPENT !
anonomiss
You, HORUS, will not triumph over the human spirit. Don’t even try because those who do will have a bad end.
Robyn Clothier
Justice in Michigan, John Braithwaite’s excellent books include:
Braithwaite J.
Restorative Justice and Responsive Regulation
Oxford: Oxford University Press; 2002
http://www.oup.co.uk/isbn/0-19-515839-3
Braithwaite J, Drahos P.
Global business regulation.
Cambridge: Cambridge University Press; 2000
http://www.cambridge.org/uk/catalogue/catalogue.asp?isbn=0521784999
Braithwaite J.
Corporate crime in the pharmaceutical industry.
London: Routledge & Kegan Paul; 1984
http://www.amazon.com/exec/obidos/tg/detail/-/0710200498/qid=1124498017/sr=1-1/ref=sr_1_1/002-4340062-2313626?v=glance&s=books
These and many others relating to pharmaceutical marketing are listed in Healthy Skepticism’s library:
http://healthyskepticism.org/library/search.php
Melody (not Petersen)
HorusCat, you state: “Go ahead and flame me, all of you who love to pretend that big pharma is the most evil thing on earth.”
May I point out that this site is PHARMALOT . . . not CafePharma. Obviously, you got your ‘training’ and ‘expectations’(of flaming) on the site run for ‘professional’ drug reps.
Observer
Dear HorusCat,
Wow! You’ve got some serious issues! Behavior modification may be of assistance. Temper conrol is certainly needed. This blog started with Ed writing up an interview with the author of a boob on the industry. Calm down, look around, and take in th world around you.
Former pharma Marketing Exec
Phew! Have all the “professional” (and I use the term very loosely) Sales Reps finished posting here yet?
Do us a favor and copy this over to cafe pharma and finish your diatribe over there…Geesh, maybe we should give a bonus to Doctors just for listening to you, because I sure find it annoying.
Lisa Van S
Former Pharma,
Im sure the diatribe can be cured with a good night’s sleep.
harpy
Hmm. I don’t see how being upset about “numerous examples in which drugmakers used a plethora of controversial tactics - manipulating clinical trial data; seducing doctors with freebies; promotional stunts that obscured side effects - to drive sales” equates with thinking drugs are evil and that the companies that make drugs are evil. Are we supposed to just roll over when megacorporations lie to us about how safe their products are? Business ethics hasn’t always been an oxymoron.
How did this - “manipulating clinical trial data; seducing doctors with freebies; promotional stunts that obscured side effects - to drive sales” - become good business practice, HorusCat? Your conclusions don’t make any sense. Of course we want the latest and greatest pharmaceuticals. We don’t want shit painted yellow and sold to us as gold. Now why is that hard to understand?
Justice in Michigan
Cute, Harpy.
Against my own better judgement, just this add-on re: Neurontin as an example. Absolutely true that it is effective for all kinds of off-label applications (and some that it was pushed for, but not). WL knew that and deliberately decided not to seek approval so they could do so for Lyrica (”son of Neurontin,” below). Have cake, eat it too.
Here is FDA’s summary of the case. The FDA is not known for seeing the industry as Great Satan, for knee-jerk responses, nor for tirades.
The point is, to have a real discussion about what is and isn’t fraud, you can’t pick out a small bit and ignore all the rest - the context in which the small bit occurred.
*************************
Drug Maker to Pay $430 Million in Fines, Civil Damages
Pharmaceutical manufacturer Warner-Lambert has agreed to plead guilty and paymore than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of unapproved uses for the drug Neurontin (gabapentin). The drug was approved by the Food and Drug Administration in December 1993 solely for use with other drugs to control seizures in people with epilepsy.
Under the provisions of the Federal Food, Drug, and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses–any use not specified in an application and approved by the FDA.
Warner-Lambert’s strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved, according to a recent press statement from the U.S. Department of Justice. The company promoted Neurontin for the treatment of:
bipolar mental disorder
various pain disorders
amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease
attention-deficit disorder
migraine
drug and alcohol withdrawal seizures
restless leg syndrome.
The company also promoted the drug as a first-line monotherapy treatment for epilepsy–using Neurontin alone, rather than in addition to another drug.
Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective. For example, the company promoted Neurontin as effective for use as the sole drug for epileptic seizures, even after solo use had been specifically rejected by the FDA. Similarly, the pharmaceutical company falsely promoted Neurontin as effective for treating bipolar disorder, even when a scientific study demonstrated that a placebo worked as well or better than the drug.
“This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk,” says U.S. Attorney Michael Sullivan. “This scheme deprived federally-funded Medicaid programs across the country of the informed, impartial judgment of medical professionals–judgment on which the program relies to allocate scarce financial resources to provide necessary and appropriate care to the poor. The pharmaceutical industry will not be allowed to profit from such conduct nor subject the poor, the elderly, and other persons insured by state and federal health care programs to experimental drug uses which have not been determined to be safe and effective.”
As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully informed medical judgment or whether the doctor was instead influenced by misleading statements or inducements from Warner-Lambert. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen problems because the drug was not studied in the type of patient it is being used for off-label, and the appropriate dosage and course of treatment have not been established.
Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. The company’s agents also made false or misleading statements to health care professionals regarding Neurontin’s efficacy and whether it had been approved by the FDA for the off-label uses. Warner-Lambert also used “medical liaisons,” who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.
Warner-Lambert paid doctors to attend so-called “consultants’ meetings” in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics, and Hawaii. There was little or no significant consulting provided by the physicians.
The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a prearranged number where they would listen to a doctor or Warner-Lambert employee speak about off-label use of Neurontin. The company also sponsored purportedly “independent medical education” events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.
Warner-Lambert misled the medical community beforehand about the content, as well as the lack of independence from the company’s influence, of many of these educational events. In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by “planting” people in the audience to ask questions highlighting the benefits of the drug.
Warner-Lambert paid physicians to allow a sales representative to accompany the physician while he or she saw patients, with the representative offering advice regarding the patient’s treatment that was biased toward the use of Neurontin.
These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin to compete with a “son of Neurontin” drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.
Neurontin was put on the market in February of 1994. From mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert’s illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses.
The investigation began in the District of Massachusetts when a former medical liaison for Warner-Lambert, David Franklin, M.D., filed suit on behalf of the U.S. government. Private individuals are allowed to file whistleblower suits under the federal False Claims Act to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower’s claims, the whistleblower may share part of the recovery. As a part of the resolution, Franklin will receive about $24.6 million of the civil recovery.
The Federal Bureau of Investigation, the Department of Veterans Affairs’ Office of Criminal Investigations, the FDA’s Office of Criminal Investigations, and the Office of Inspector General for the Department of Health and Human Services conducted the investigation.
Terms of the agreement include:
Warner-Lambert has agreed to plead guilty to two counts of violating the Federal Food, Drug, and Cosmetic Act with regard to its misbranding of Neurontin by failing to provide adequate directions for use and by introduction into interstate commerce of an unapproved new drug. Warner-Lambert has, as punishment for these offenses, agreed to pay a $240 million criminal fine, the second-largest criminal fine ever imposed in a health care fraud prosecution.
Warner-Lambert has agreed to settle its federal civil False Claims Act liabilities and to pay the United States $83.6 million, plus interest, in civil damages for losses suffered by the federal portion of the Medicaid program as a result of Warner-Lambert’s fraudulent drug promotion and marketing misconduct.
Warner-Lambert has agreed to settle its civil liabilities to the 50 states and the District of Columbia in an amount of $38 million, plus interest, for harm caused to consumers and to fund a remediation program to address the effects of Warner-Lambert’s improper marketing scheme.
Pfizer Inc., Warner-Lambert’s parent company, has agreed to comply with the terms of a corporate compliance program, which will ensure that the changes Pfizer Inc. made after acquiring Warner-Lambert in June 2000 are effective in training and supervising its marketing and sales staff.
Grieving
RE the comments of “Horus” to me, “Zyprexa Lady”. As someone else stated, I hope that you can save your soul (if you have one left) by leaving working where you do , Walk a mile in my moccasins and imagine that your only son, who did fine on lithium for nine years, was suddenly and with no notice killed by Zyprexa. Imagine his last word in the ER, a scream…”Mom”. Then think twice the next time you utter the inhumane words to anyone that you did to me. I have friends who lost their sons to Zyprexa WITH NO WARNING. One is filled with anger and despair as well and is WRITING A BOOK. The other couple are also angry and full of despair. In each case, their sons were their only children. ONLY CHILDREN.
I feel very sorry for you and for your family. Imagine equating this “industry” with others. Houses, shoes, sodas, don’t KILL WITHOUT WARNING; the company does not hide the killing effects of its product. No, it’s only Pharma that does this.
Justice in Michigan
HC - What is your view of FDA’s summary of the Neurontin case?
Lisa Van S
HorusCat,
Hmmm, gonna go out on a limb here and assume that your Mother is not a child or adolescent for which psychotropic drugs carry Black Box Warnings. Your story of your mother’s success on an antidepressant, is simply anecdotel.
Shit yellow,…. How about Blood Red
Justice in Michigan
HC - Thanks for taking the time to recreate a lost post.
As you know, FDA went out of its way to say that this was not about a few reps or managers, but a company-wide strategy. Thus:
“These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin to compete with a “son of Neurontin” drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.”
The wider discussion of off-label is interesting, but my point was the importance of looking at specific instances, in detail and context. FDA/DOJ make the effort prosecute companies (or individuals, for that matter) extremely rarely. In this instance, they were more or less forced to because of the whistleblower law.
Melody (not Petersen)
HorusCat, you state: Am I emotional about all of this? You bet. I am proud of what I do and of what the medications that I detail can do in people’s lives
I imagine Ashley Dupre, who earns at rates I’ve seen ranging from $2,500 to $5,000 per hour, believes she is benevolently providing a needed service. And I would bet that she, too, is proud of what she does, and truly believes the ‘product’ she delivers makes a difference in peoples’ lives.
Such is the nature of ‘perspective.’
No longer optimistic
Wow. You spent 8 years digging into this and you’re nowhere near the bottom.
1- Which is the next area that will work… antisense or rnai? When/what patent decision will unleash additional investment into this burgeoning space? Has MaB hit a wall like organic chemistry of the late 90s? I mean, you’re saying drug co’s are only into marketing tactics. You really should spend some attention on the reasons why the ROI of the R&D investment is lower than that of marketing. If you’re a profit-driven enterprise, shouldn’t you invest till your marginal cost of investment is equal to all other options?
2- Reps do what ‘family doctors’ don’t do… they bring attention to NEW treatment protocols. I was one of those clueless reps. I saw doctors that were motivated by their interest in medicine, patients, independence of what constitutes appropriate care. However, the stacks of unread medical journals, questions about what were the key ingredients in the combo’s they were using, etc, showed me that they were profit-seeking, legal-conscious but rationale 99% of the time. They did not have or take the time to do anymore CME than was required. Sorry, but the reprints coming from the Taurus trunks were read more than the unopened JAMAs. I can’t see that changing.
3- TV ads: What % of Americans with treatable conditions are adequately controlled with available, affordable treatments? Sadly, despite the billions spent, we’re at 25-40% for most conditions. DTC ads have edged this 5-10% higher over the past decade. Congratulations on talking like an Aetna spokesperson. They owe you big.
4- International trade. A tax on our relative profits has been increased as other countries have not and will not pay for the R&D required to produce improved medications. Until this is addressed… I am not optimistic that the like-minded drivel like this book will do anything but beat down the solution-minded minority out there.
Lisa Van S
HorusCat,
“And the Black Box Warning which the SSRI’s received is bogus. Talk to any child Psych about it. Look at the Data behind the decision”
You and I have debated this issue in the past,.. You may have changed your name,..But the rant in your writing gives you away.
Use the “F” word towards me again and I will expose who you are, and the Company you work for…
Grieving
I would appreciate it if you exposed it now, Lisa. He has vented his personal spleen on me, the mother of my only son- dead from Zyprexa with no warning. I don’t really know or care who he is, but I find him dispicable. He must be afraid of losing his job, or his company. Or have a whopping guilty conscience. Or all of the above. Thanks.
HorusCat
Justice in Michigan,
I think you are more informed on the Neurontin debacle than I am. That was before I got into pharma. Such prosecutions aren’t rare anymore, though. Astra-Zeneca, Lilly, GSK–they’ve all been hit. There was a good post on another one of Pharmalot’s topics; I can’t remember the exact wording, but it had to do with slippery slope you are going down when the government starts regulating business speech too closely. I think the burgeoning talk of preventing doctors from prescribing off-label is a natural outgrowth of the hoopla with the pharmaceutical industry. Already, insurance companies stifle physician prescribing by refusing to approve medications for off-label use or dosing (while at the same time REQUIRING off-label use of other meds). The red herring here is pretending that such regulation is about anything other than money.
Justice in Michigan
All I was doing was quoting FDA’s own summary of the Neurontin story. As that summary makes clear, the “promotion” went far beyond “speech.”
In fact, such prosecutions do remain extremely rare and virtually always involve acts that go beyond speech. These include: paying docs (in cash or gifts) to use the drug off-label, fraudulent studies that suggest efficacy where none has been demonstrated, invasion of the consulting room or patient files, targeting particularly vulnerable patient groups (e.g., children and elderly), etc..
It is true that it requires corrupt docs to facilitate this kind of behavior. But to suggest this is mainly about freedom of commercial speech is, to my mind, yet more disinformation.
Lisa Van S
Grieving,
I suggest you ignore Horus, here, and refrain from engaging him further. The more you engage, the nastier he gets.
Lisa Van S
HorusCat,
Sometimes,..Somethings,.. are just better left unsaid, especially, when it comes to the loss of someone’s child. Unless of course you have no self-respect.
pg
What evidence are you referring to, Horus, when you say
“The evidence is overwhelming that anti-depressants work for children and adults.” ?
The evidence shows that antidepressants are little different than that of a placebo. There is one difference however: antidepressants have a plethora of physical, neuorological and psychological side effects, some which can prove fatal, and a placebo does not.
pg
You say somewhere above (Horus) that there were no suicides in prozac clinical trials. Have you seen the ‘Fentress Confidential’ paper which contains complete data on suicide and suicide attempts from trials of Prozac?
You can read it HERE.
The issues are quite simple really. They’re about things like cheating and fraud in clinical trials at the beginning, followed up by equally unscientific claims based on that fraud which is something that can and does lead to the deaths of a considerable number of people.
How does a perfectly understandable and reasonable concern about the risks to health and life when fraudulent research flies under the banner of science equate with “scientology”?
So “Tom Cruise” shares that concern and happens to be a scientologist. So what? Fraud and corruption in the clinical research and marketing of drugs leads to death and has nothing to do with scientology.
pg
Anonymous, perhaps you, or of course Horus, should read further. Try the other documents and then its possible you might see the point.
THE OTHER DOCUMENTS.
Its equally possible you might not, but I’m sure many people will.
pg
There are plenty more links I can give and will if you (or should I say Horus) keep ignoring the issue:
That fraud in science kills.
You can deny it, you can argue it, you can defend the fraud.
You can maintain that the population should know better, that they aren’t entitled to expect qualified doctors to know what they are prescribing.
You can put forward the ridiculous theory that everyone should become researchers in medicine before taking a medicine.
You could say the same about all manner of disciplines, ie, perhaps the public should become electrical experts before hiring someone to wire their living place, or learn every aspect of car building before purchasing a vehicle, or learn every detail about house building before buying a home.
The people who are not trained in medicine all have their own skills and trust physicians to know the skill THEY learned as they expect others to trust them on their own skills.
Unfortunately the average physician also has to trust those in charge of the research and the ‘experts’ who publish studies. They too are dependant but the public are not told that and aren’t magicians so they rightly expect that a doctor who studies medicine is an expert in medicine and can be trusted, just as they trust that a housebuilder is skilled in building and so can be trusted, and that vehicle manufacturers know what they are doing and so its safe to buy a new car.
Did you ever buy a new car? Did you assume that the new car is likely to be safe, or do you take years out to study mechanics and engineering and its relevance to car manufacture before purchasing?
It is the JOB of the VERY WELL PAID DRUG INDUSTRY and its Industry Experts to do their work correctly and to expose fraudulent science. Its sad and in other disciplines considered criminal that they do not do so.
To blame the non-medically trained population for the results of drug fraud is a blatantly weak, particularly dishonorable, and exceptionally despicable attempt to defend scientific fraud by blaming people who have no knowledge or control over research.
I hope at least you can understand THAT sentiment.
pg
Please don’t come back with ‘I took the precautions of doing a survey’. Many patients do actually do a ’survey’ if they have access to the internet and they find masses of publications written by Industry Doctors, Industry Psychiatrists’, such as some found in pubmed and other journals, many of which are written by well paid ‘experts’ to author what many know are untruths and others who are don’t want to upset their own applecart by pointing out that they have never seen the data, have no idea whether the publication is accurate…etc.
So those patients do a survey and are told that drugs that have actually been approved by using scientific fraud are perfectly beneficial. They are told so by people who have betrayed the hippocratic oath and have betrayed science.
Just as if you had a survey done on your new home, or new car, unaware that the surveyor was getting well paid by the building company or the vehicle manufacturer to just say its a great building/vehicle - and then you find your brand new home collapses killing a member of your family, or that the brakes on your new car fails with the same result.
Is that YOUR fault? According to fraud defenders: Yes of course it is. You should have done with your car or home what you believe people taking medicines should do. Before ever taking a medicine you should spend years becoming as educated as your physician, and even then you’d have to learn - as physicians need to - that much of the negative information/data you can’t get hold of anyway because its hidden, by courts, under Trade Secrets - thats if you happen on a site that actually has got hold of the information in the first instance.
Why not leave it out with the ‘ya’ll think pharma and/or drugs are evil’, ‘are you scientologists?’ rubbish. It should be of concern to anyone where fraud in medical or psychological drugs is concerned, and its very strange indeed trying to understand what kind of mentality it is that works to defends that fraud at the risk of lives.
I hope that sentiment too is clear enough to understand.
pg
Finally, Horus, re your attack on ‘Grieving’. You are the one trying to stifle scientific debate. Utter shame on you for the way you have tried to do so in your comment to Grieving.
Lisa Van S
Former Pharma Marketing Exec,
Since you appear to be the wisest here, I would appreciate it if you can give me your personal,..Professional Opinion on these documents
http://paxilharmschildren.com/doc/GSK.gif.pdf
Lisa Van S
HorusCat,
Nice description,.. a description that is only used by a man. As a Woman,.. Im qualified to make that statement!
Hmmm,… PHD in Neuropharmacology,.. neither I or any other Drug Rep… “If you listen long enough people will tell you everything you need to know”,.. a qoute from a Psychiatrist.
Former pharma Marketing Exec
To Lisa Van S,
About those documents - typical examples of marketing driven “clinical” trials.
It does show two major things:
1.) The study does not show at all that Paxil is effective in adolescent depression. This fact has obviously raised concern with the “Paxil Team” and the medical writers were given instructions to “spin” it another way.
2.) The SAE’s information was repressed or diminished.
What is really disturbing is the Dr’s willingness to go along with this. The problem is that we in pharma have created such a “co-dependency” of doctors having to rely on us to help them continue to “publish or perish” papers like these. There needs to be more publicly funded research that is not driven by for profit industry…
We know now that Paxil and other similar drugs do show some effect but only in major cases of depression. In those cases, then careful close monitoring for the SAE is warranted. A doctor would be doing the right thing for the patient to properly diagnose the type of depression and carefully closely monitor the adolescent along with the full support of fully informed parents. That would be the ideal win-win situation. If the “Paxil team” wanted to do the right thing, this is exactly the approach they should have used. They would have gained so much credibility. What is wrong with saying something like: “Paxil isn’t for everyone, if you suffer from mild depression do A B, C (team paxil could have even worked with a child psychologist and write a nice little information book on life style management, nutrition etc. Maybe even something educational for the parents). Yes, sales would be a bit slower, but the public would have been better served and team Paxil wouldn’t be in the mess they are now.
The over marketing of this drug on this scant and adulterated information allowing it to be widely used for mild cases of depression without a full team of support comprised of the parents and the health care team is nothing less than negligent behavior.
Thanks for your kind words, I am not sure I am the wisest here, but I do not have a commercial motivation of any kind. This allows me to bring much more objectivity to this discussion.
Lisa Van S
Former Pharma Marketing Exec,
In May of 2004, GSK sent out Dear Health Care Provider letters telling doctors not to prescribe Paxil to patients under 18 because clinical trials determined their was no efficacy in the Pediatric Population. My Question is this,..wouldnt it be appropiate for the Health Care Provider to share this info with parents before prescribing it to their child?
Your objectivity is quite refreshing!
horuscat
Lisa,
Now I am curious. Just who do you think I am? My husband would be interested in knowing he has been married to a man for the past 14 years. And I sure would like to avoid all the little inconveniences of being a woman of a certain age, like peering in my pants when I sneeze.
horuscat
oops, peeing, not peering.
horuscat
You people are all just bizarre. I hope you don’t vote.
horuscat
lisa,
Do you believe that President Bush knew about 9/11 before it happened?
horuscat
Well, Lisa, it has been fun baiting you, but I have to go play with my son now. Please do drop me a line and tell me who you think I am.
Former pharma Marketing Exec
Lisa,
So, the “Dear Health Care Provider” letter went out several years after the study, results of which we now know were subjectively tampered with, and after which time adolescents were already on the drug?
Yes, in my opinion, the health care provider should share this information. This is what is supposed to be meant by informed consent. Likewise, if parents ask doctors to prescribe these drugs, doctors have an absolute duty, in my opinion, to tell them no and why. The health care provider cannot assume that the parent will not understand and then continue to with hold important information from the parents based on their skewed opinion. I do not know why Doctors and other members of the health care team do not feel comfortable with just telling patients that there is nothing minor about these illnesses and they need to learn as much as they can about them. That being said, however, one reason we often hear is that it takes too much of “their” time. At the very least they need to provide parents and the children with some direction of where they can go to learn more about the illness.
On the other side of the coin though, I can’t help but tell you that when these very same busy/overworked doctors are approached by marketing from Pharma they have all the time in the world to go on junkets, attend CME events (fully paid for) and in short, allow us to dominate their agenda…Hmm, maybe seein gthe patient doesn’t pay enough?
I am not familiar at all with this case, but was the product monograph ever changed? Did they every receive an indication for adolescent use from the FDA? Does the package monograph clearly state that the drug should not be administered or prescribed to children under 18?
Additionally, GSK should/could have gone farther by making sure they placed ads to this effect in family medicine journals and in family practice/pediatricians clinics.
Team Paxil missed a golden opportunity to carefully plan the long term success of this product by ensuring that it was used in the appropriate manner. Sales targets/commissions and incentive rewards programs along with “publish or Perish” fully sponsored CME’s took precedence over the health and welfare of minors. The patients lost the battle, but thanks to you Lisa and others like you, the war is not over yet.
Lisa Van S
Former Pharma Marketing Exexec,
To this day,.. with the exception of prozac.. no antidepressant has been FDA approved for the use of antidepressants to treat pediatric depression.
On Aug 22,2003 Wyeth sent our a Dear Health Care Provider Letter…….. I QUOTE,..”In Clinical Studies of Pediatric Patients (ages6 to 17) efficacy was not established for mdd or GAD and there were increased reports among those patients on Effer vs placebo of hostility and suicide-related events such as suicidal ideation and self harm. Effexor and Effexorcr have not been and are not now recommended for use in pediatric patients”
GSK 1998 Paxil Memo No Efficacy
http://www.paxilharmschildren.com/13.html
I suggest you take a look at other GSK Marketing Documents in this link
Pharma News 3_22 « Impactiviti blog
[...] Our Daily Meds - the latest book to take a critical look at the pharmaceutical industry. Pharmalot (blog) has an interview with the author. [...]
pg
Horus: “If you are for real, then you know that pharma can not pay for a doctor to go to a CME event.”
“Skiing in Aspen in December and cruising the Bahamas in June, ahhh, the life of a physician on vacation. But these trips aren’t all fun and games. There’s work to be done, too—like learning the latest advancements for treating sleep disorders or getting an update on geriatric medicine.
Continuing Medical Education (CME) conferences, which take place at fantastic locations around the globe, in medical school classrooms nationwide and on the Internet in physicians’ homes, provide physicians the education credits many need to maintain their state medical licenses.
Furthering one’s education and staying abreast of the newest medical techniques appear worthy activities, but in recent years, CMEs have garnered negative attention. The criticism focuses mainly on the seminars’ commercial sponsorship. By funding the events, pharmaceutical companies and other for-profit enterprises have become the educators of sorts, critics charge, and this leads to biased instruction.…”
“…Then perhaps it’s time to end the lavish dinners and excursions, critics respond. Physicians should focus on the instruction, not the treat. “But the fact of the matter is that most doctors, most practicing physicians are spoiled. They think they are entitled to be wined and dined and entertained and charged the most minimal fee for…education as long as they are willing to listen to what the drug companies want them to hear.”
Unfortunately, Relman says, even with all the new attention to commercial sponsorship, he doesn’t foresee any drastic changes to the CME landscape. “And that’s because big money and the pharmaceutical industry talks, and nobody in the medical establishment is willing to walk away from that money and alienate the pharmaceutical industry,” he says.”
http://www.amsa.org/tnp/articles/article.cfx?id=61
pg
http://www.aafp.org/afp/20070515/letters.html
May 15, 2007
“Medicine and the Pharmaceutical Industry: A Call to Action
TO THE EDITOR: At our practice, we continue to regularly receive a barrage of invitations to free dinners, offers to attend professional athletic venues, and all-expenses-paid consultant meetings at five-star hotels. These events are sponsored by pharmaceutical companies under the umbrella of medical education and research. Why is this still occurring? In the late 1980s and early 1990s, the major medical organizations and medical journals established guidelines to address the relationship between the pharmaceutical industry and medicine. Studies and literature reviews show that gifts to physicians from the pharmaceutical industry influence prescribing patterns of residents and physicians, and the formulary requests of physicians.1
Despite this, the amount of money pharmaceutical companies spend on direct marketing to physicians continues to rise at a rapid pace. According to the U.S. General Accountability Office, drug companies spent $16 billion on direct marketing to physicians in the United States in 2001, more than $19,000 per physician. Promotions to physicians accounted for more than 80 percent of all marketing spending by drug companies in 2001. Direct-to-consumer spending by pharmaceutical companies was $2.7 billion in 2001, up 145 percent since 1997.2
The amount of money spent on promotional activities affects prescribing habits and the cost of medications. Systematic reviews have confirmed that prescribing patterns of physicians differ depending on the frequency of contacts with pharmaceutical representatives. Physicians who have more frequent contact with the pharmaceutical industry are less likely to prescribe generic drugs and more likely to prescribe new drugs.3
The pharmaceutical industry may be influencing clinical practice guidelines and are beginning to fund postgraduate education. Major medical journals require authors to disclose any potential conflicts of interest with pharmaceutical companies; however, there is no similar requirement for clinical practice guideline panel members. In a cross-sectional survey of 192 authors of 44 clinical practice guidelines published between 1991 and 1999, 87 percent had some tie with the pharmaceutical industry, and 58 percent had received financial support to perform the research. Another concerning trend is that residency and fellowship programs are using pharmaceutical monies to fund residency activities.4,5
Where are the major medical associations on these issues? Major journals are dominated by pharmaceutical advertisements, and continuing medical education (CME) is increasingly being underwritten by pharmaceutical companies. At major medical meetings, physicians are enveloped in the embrace of the pharmaceutical industry from registration to the exhibition hall to “breakfast and dinner lectures.” It is time for our major associations to step forward and address the effect the pharmaceutical industry has on rising drug costs and rational prescribing patterns. Our leaders need to address the industry influence on publication bias, clinical practice guidelines, CME, and medical education. If we continue to slip backward, every facet of our profession is in danger of being dominated by pharmaceutical industry agendas…”
pg
Horus, I would LIKE to think you were simply naive. But unfortunately I just don’t believe you are.
pg
http://well.blogs.nytimes.com/2008/02/27/guess-whos-educating-your-doctor/
February 27, 2008
Guess Who’s Educating Your Doctor?
It’s no secret that drug companies sponsor medical conferences and seminars. But a new report by Australian broadcasters shows how drug companies also help select the speakers at those events.
The reason it matters is that conferences are often where doctors go for continuing medical education. “It seems that invisible influence may be flowing through these sponsored seminars — even those accredited by august associations — far more often than many of us realize,‘’ writes Ray Moynihan, a lecturer at the University of Newcastle in Australia and a visiting editor at the British Medical Journal, where the article appeared. “It is not uncommon for drug company sponsors to suggest speakers at sessions that are assumed by the thousands of general practitioners who attend them to be totally independent.’’
The article describes the “invisible” influence of drug companies in doctor education. It cites e-mails between conference organizers and drug firms in which the drugmakers suggest specific speakers for the education programs.
One example, outlined in a background briefing report by the Australian Broadcasting Corporation, highlights a talk given by a doctor at a continuing education program at the University of New South Wales. The doctor makes several casual references to the diet drug Duromine, which is the Australian brand name for the weight-loss drug phentermine.
“While the weight loss drug was mentioned more than half a dozen times, what was not mentioned to the doctors present was the fact that the company marketing Duromine, called 3M, as part of its sponsorship package, had paid for the right to suggest speakers for the session,’’ the report explained.
The broadcasters go on to cite e-mails showing that the drug firm was directly involved in helping the doctor prepare his educational talk.
None of this is shocking, but the Australian report provides an interesting glimpse into the vast reach drug firms have in the training of doctors around the world. And while doctors often are blamed for having relationships with drug firms, the report shows how many doctors who believe they are receiving independent information are unwittingly being educated by drug company representatives.
To read a transcript or listen to an audio file of the report, click here…”
pg
Horus, are you wasting your life working to harm the public?Or are you really SO naive?
http://www.talk.pharma-mkting.com/show023.htm
About Pharma Marketing Talk | List of Shows | Schedule and Archives | FAQs
Welcome to the CME Laundromat!
Is Pharma-sponsored Physician Education Biased?
Guest: Daniel Carlat, M.D., Assistant Clinical Professor of Psychiatry at Tufts University School of Medicine and Editor-in-Chief of The Carlat Psychiatry Report
Live Podcast Date: Tuesday, July 10, 2007, 2 PM Eastern US time
Duration: Approx. 35 minutes
Go to the Pharma Marketing Talk Channel Page to listen LIVE at the designated time or afterward to listen to the audio archive on the Web with your browser. After the live podcast you can also click on a button below to listen to the streaming audio archive on your computer or to download the show for playback on your iPod or other portal audio player.
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Background
In a New York Times Op-Ed piece, Daniel Carlat, a professor at Tufts Medical School and editor in chief of The Carlat Psychiatry Report, characterizes pharma-sponsored Continuing Medical education (CME) as “a new twist on that well-known instrument of corruption, money laundering.”
“[CME] content,” says Carlat, “is rarely developed by the identified experts. Instead, it is developed by the undisclosed communication company, which is paid by the sponsoring pharmaceutical company.” (see “Diagnosis: Conflict of Interest”).
“Everybody who stands to gain is complicit in this enterprise,” says Carlat. “The companies get a uniquely effective marketing vehicle, the medical education communication companies (MECCs) get millions in educational grants, the ACCME gets funding to continue its mission, hired-gun physician speakers get cash, prestige, networking opportunities, impact, etc…., and the doctors who attend the programs get free education. Who in their right mind would want to spoil the party?
Our patients, for one. Industry-supported CME always downplays the dangers of any product being sponsored. Sometimes, these dangers are trivial, as in the case of SSRIs. Other times, these dangers include diabetes, obesity, and high cholesterol, as in the case of Zyprexa.
The point is that we can never trust commercial CME, because of its inherent conflict of interest: it is education designed to encourage the audience to use more of the sponsor’s product.”
Daniel J. Carlat, M.D., is Assistant Clinical Professor of Psychiatry at Tufts University School of Medicine and maintains a private practice in Newburyport, Massachusetts. He graduated from the psychiatric residency at Massachusetts General Hospital in 1995, has written The Psychiatric Interview, and Drug Metabolism in Psychiatry, and is founding editor of The Practical Guide Series in Psychiatry, published by Lippincott Williams & Wilkins.
Dr. Carlat is the founder and editor of The Carlat Psychiatry Report, a monthly CME newsletter. He recently started The Carlat Psychiatry Blog to follow up on some buzz generated by a recent New York Times op-ed in which he recommended that industry-sponsored CME activities no longer receive accreditation from the ACCME.
Some questions:
Can you describe how pharma companies sponsor phsyician continuing medical education (CME) and why?
You say the pharma-sponsored CME is biased. Aren’t there regulations and guidelines in place that prevent that? Are pharmaceutical marketers involved? What is the role of ACCME?
Why don’t physicians pay their own way?
What are the signs that a pharma-sponsored CME program may be biased? “
pg
Horus, which are you? Stupid or just rotten to the core when you state:
“HorusCat
Marketing Exec,
If you are for real, then you know that pharma can not pay for a doctor to go to a CME event. “
Lisa Van S
pg,
You are good!
pg
Thanks Lisa :-) We’re all fighting for the same thing, just using different ways of doing so.
Lisa Van S
pg,
Horuscat believes that he is the best Marketing/Sales Rep the world has ever seen
Ed Silverman
Hi PG,
Just thought you may want to know that Pharmalot covered the issue in Australia a few days before the NY Times blog you cited…
http://www.pharmalot.com/2008/02/in-australia-pharma-sponsors-independent-cme/
Cheers
ed
pg
Ed: Great :-) I’m really glad you did that and also sorry I didn’t catch that one, but relied on Google search and just took the ones that ‘intantly’ took my eye at that moment. You do a great job all round!
pg
sorry: ‘instantly’ …not ‘intantly :-)
pg
Lisa, lets hope Horus is what he believes. That makes our work much easier lol.
pg
The thing is, that because the drug makers are now exposed regarding scientific fraud THEY DO NOT have any science anymore to fall back on. So Horus is very likely one of the best they have under the circumstances.
The drug companies CANNOT anymore state their distorted, fraululent version of scientific evidence in the world of the internet where people are searching for the real scientific evidence. So they have to rely on people like Horus. People who will do anything to protect scientific fraud.
It might still take a few decades of bringing the fraud to the forefront and the end of it all, but it will eventually happen and it WILL happen at some point that the people in general, the population, will realize and start to demand SCIENCE without fraud.
They’ve had their profitable day, it might last a while, but they know its going to end soon.
Horus is typical of the drug fronts they send out in desperation right now. Soon they will have to conform to SCIENCE in the making of medicines.
Keep fighting Lisa et al - each and every way you can.
Fraudsters in drug makers have a limited time now and they know it. Eventually history will look back on drug company fraud with utter disbelief on how they got away with it.
Nite.
Chris
I’ve been away for a few days and just returned from visiting my son’s future college (in US). One of the things we learned on the tour was to forget the myth that when kids leave high school the nonsense that exists there disappears and that suddenly students mature and lose the teenage bickering, posturing, in-crowd (you’re in! you’re out!) mentality. And so I log onto Pharmalot and remember it doesn’t stop even then. Oh boy, some of the posts launched around the admittedly prolific and previously unkown Horus are so sophomoric that I wonder really what point is trying to break through. There is a clique mentality here that reminds me very much of the ‘I’n in with the in-crowd’ days - never particularly inclusive and all the poorer for it - that is a distinct turn off. Surely when we mature a little we should accept that others might just have an opinion worth considering, regardless of the strength of individual conviction, and that a polite conversation may just help. After a decent Easter away from work, stepping back into the tee-hee aren’t we cool exchanges I saw here, shot me back far too many years into junior high school and made me wonder, for a while, what to expect in future. There are too many smart people on here and so many insightful comments to get spitballed by those who live to titter and insult the majority with something useful to say.
pg
Chris, I’m not quite sure who you are getting at. But…
The easily simple issue here is:
We are talking about cheating and fraud in clinical trials.
There isn’t any excuse for that. Its FRAUD. SCIENTIFIC FRAUD.
There’s no excuse for FRAUD and there’s no excuse for trying to excuse it.
Or do you think there is?
pg
When we mature, we should now by by then what is clearly wrong and clearly right.
SCIENTIFIC FRAUD is ALWAYS WRONG. It kill people.
But, if you have an opinion which believes it right to defend scientific fraud, then that is your opinion, but as a MATURE adult, surely you should know the difference between right and wrong?
pg
We happen to adults, not students. You as the parent of a student must also be an adult.
Right and wrong should be clearer to you than you son. Your job as a faher should be to guide him futher.
So what are you going to tell you son? Do the right thing and reject fraudulent science..or
I’m you dad and I don’t care, you protect fraud if you feel its OK?
If so, you’re no adult and you’re no good father. TAKE RESPONSIBILTY for your offspring and teach him to be a GOOD man.
Disgusted
There are some very interesting polarizing views on this post. I’ve been with Pharma for over 10 years and I can categorically state that I’ve never seen a decision made that was clearly the right one for the patients. Everything was about driving the business, gaining influence, selling more drug, making mor money, raising prices, making more monet. Greed drove everything. Human compassion and understanding was totally absent in the minds of the top executives. They deserve everything they get for their misdeeds.
Former pharma Marketing Exec
PG, I have to side with Lisa, you’ve done an excellent job in presenting the facts.
This has been an interesting thread to say the least.
HorusCat
pg,
Just because you find it on the internet doesn’t make it true. Yes, pharmaceutical companies fund CME events. They give the money and walk away, at least the company for which I work does. But I suspect you’ve never been to one of the CME events, have you? Because you’re neither a physician nor a pharmaceutical company employee nor a CME-vendor employee. In fact, you’re probably a stay-at-home soccer mom with nothing better to do than rant about big coorporations on blogs on the internet. What have you contributed to society lately?
If a physician wants a grant from my company to do a CME program, the CME folks at his university have to go on-line and ask for a grant. I have nothing to do with it, and once the money is given, neither does my company.
As for what doctors do at CME programs, that is really up to them, isn’t it? Of course the programs are at nice locales–who wants to go to a conference in Des Moines, Iowa? The doctors pay for the trip themselves–and if they choose to pay for golf and nice meals while they are there, what’s it to you? The drug companies aren’t paying for it.
Drug companies that adhere to pharma guidelines cannot take doctors to sporting events or provide any kind of entertainment at their programs, so any doctor who claims he is getting such treatment is either lying or doing business with non-pharma associated companies.
This site is just a clique of people who engage in self-congratulation. You just chase your tails around in circles of solipsism–big pharma bad–doctors listen to big pharma–doctors bad–and on and on. The fact is that medications save lives and decrease utilization costs in the healthcare system. All of your bluster and sputtering and internet “fact-finding” won’t change that.
Ironically, while you accuse big pharma of spin and doctors of buying into it, you do the same with books you read and the reporters you listen to. It obviously never occurs to you, or you conveniently choose to overlook it, that these reporters and authors have an ax to grind, too. Oh, but because they agree with you, they are obviously unbiased. Of course, a book about how medication saves lives and reduces costs wouldn’t make the NYT bestseller list, would it?
As for you, pg and Lisa, I sincerely hope that you never need what pharma has to offer. You would probably die from having to choke down the crow.
And Lisa, would you like me to describe my clitoris for you? You are all talk, but no action.
Oops, gotta go make some money so that you guys can suck off the taxpayers’ teat!!
HorusCat
pg and Lisa,
When you aren’t here, are you on the global warming blogs complaining about the oil companies or on the conspiracy sites moaning about how Bush knew about 9/11?
And pg, you obviously resent that physicians have the money to play golf and eat at nice restaurants when they PAY FOR THEIR OWN cme trips. Go to school, get a degree, find a job that pays you well, and you, too, can enjoy golf and a nice meal.
Get Lost
Wow!
Just when you think sanity has returned, Horuscat is back. She uses words that aren’t exactly appropriate for this site, attacks others, rants and raves, and continues to spew Big Pharma drool. Either she’s been operating with her head in the sand or has drunk from the Big Pharma bottle once too often. I suggest you migrate back to CafePharma, where your methods of communication fit right in with the rest of the unhappy ‘woe is me’ sales crew. Pharmalot doesn’t need you.
Lisa Van S
Get Lost,
She,.. is really,.. a He. I guess he thinks he’s back in the High School’s Boy’s Locker Room. Hmmm and they call Mr. Bigley unstable…
Chris
Pharmalot justifiably won an award as a top new business blog site (Times). It’s a pity that some of the comments on here can’t match the tone of the posts. I’m not being elitist but surely some of our more frequent commenters can abandon the sophomoric comments and try to see there is more than one side to a discussion. It’s a great site but some of the dogma in comments is a real turn off.
Lisa Van S
Chris,
My Sister’s Vehicle dons a Bumper Sticker,.. It says,…
My Son is in Iraq
Enjoy your Freedom
I will enjoy my “Freedom”,.. to speak freely,.. ThankYou
Ed Silverman
Okay, folks…
We all need to take a time out. Unfortunately, the tone and substance of this thread has gotten off the subject.
I know the topic - which originally was the troubles with the pharma biz as articulated by Petersen - can yield some polarizing reactions in some people.
But the comments have increasingly veered off into remarks about others. I understand everyone enjoys being able to sound off, but I need to treat this site as a living room in which people can circulate and participate in different discussions. But when one discussion gets too edgy - to put it mildly - it can sour the atmosphere for others.
So I’m going to ask very nicely if you would all please circle back to pharma and its issues, and avoid carping at others. I am not singling out any one individual. It is the collective tone and direction this thread has taken that prompts me write this note.
I hope you all take this in the spirit in which I make this request. If you have an issue, please feel free to write me privately at ed@pharmalot.com
Thanks for your understanding
ed
Former pharma Marketing Exec
HorusCat,
You claim to be original, yet you are a guy posing as a female “I could be your kid’s soccer coach. ” Kind of gives you away. Now if you would have said “Brownie Den Mother” or something, well that would be different..
People here do not have the same commercial interest as you. The evidence of the past few weeks on SSRIs speaks pretty clearly. The Paxil documents that Lisa shared certainly strengthen my conviction that there was serious negligent behavior that resulted in harm to innocent individuals.
I have worked in Pharma for over 18 years. There are some good things, but as we see in the press, there has been some pretty fraudulent behavior. If you think we like bashing Pharma, you are wrong. However, we have ample reason to be outraged and in my opinion we are being way too quiet!
We are talking about the abuse of power and the erosion of trust that shakes many of us to our very core. Look around you, we are all we have. If we cannot have faith in our doctors, healthcare system, government and the pharmaceutical companies that are supposed to be providing quality service within a tightly regulated system to the most vulnerable fellow human beings of our population than what does that say about society in general?
SSRIs and all drugs need to be carefully administered and carefully monitored. We need to put more emphasis on R&D and improving our clinical safety profiles. It is time for full disclosures and non commercialized CME and patient educational programs that empower all key decision makers, patients included, with the right information to improve communication and enjoy the right to fuly informed consent decision making.
It is time for marketing and sales to step down.
Don’t waste time telling me and everyone else to dig up studies that have been adulterated by marketing managers disguised as medical affairs. Been there - done that and I am tired of hearing people claim that it doesn’t exist. It does, deal with it, we are.
The system is seriously broken and it seriously needs to be fixed.
Now, the question is - are you part of the problem or part of the solution?
Former pharma Marketing Exec
Sorry Ed,
My post must have crossed yours….
Lisa Van S
Former Pharma Marketing Exec
Again,.. Very Eloquently stated,.. Thank You
Chris
OK - to get back to the original thread.
1 - she thought the drug industries were about science. Only science? That’s what universities do with private funds and without the responsibility to make enough money to keep the research going. How would any business (not a foundation) manage without some commercial involvement?
2 - would a book sell if written about the good things that happen because the pharma and biotech industries have (sometimes) enough money to see through their developments?
3 - I understand that auditors and accountants look for deviations and exceptions from the norm before investigating. Is this what some journalists do? I’m guessing there wouldn’t be a story if she couldn’t find something to write about - and one can always find that anywhere
4 - It is absolutely heartbreaking to hear about patients and families who lost lives due to prescription drugs. I would be interested to know how many are covered in the book who benefited from prescription drugs
5 - In referencing ‘the industry’ I wonder if Ms Petersen means the global industry or that of the US
6 - good that physicians disclose donations from pharma provided they notate for what purpose they were given
7 - marketing has become more aggressive as companies have lost patents on blockbusters. of course it has, but does that negate the other activities that have continued such as continuing to develop treatments for niche, underserved conditions?
Ms Petersen and others focus too much on megapharma and their blockbusters and asume that represents the industry whem in fact many more companies, employees, researchers, marketers et al work in less glamorous circumstances trying to apply whatever skills they have to develop drus which may eventually help somebody with a condition or disease which most of us have never heard of. Doesn’t mean they are all good, but writing about them would probably not sell too many books.
HorusCat
FME,
I am really amazed that you think I am a man. I suppose I shouldn’t focus on that, but it amuses me. I almost got back on and posted, “Not soccer coach, because I hate soccer.” There are soccer moms, you know. I couldn’t be a Brownie den mother; I have three sons. I must confess that I am really curious as to who you think I am. Whoever he is, he obviously made quite an impression! It is possible, you know, for more than one person who dissents to find this blog!
As for the rest of what you have to say. You have some good points, but I think you overstate the case. For instance, with the SSRIs: Paxil was never marketed for kids. I used to sell Zoloft, and we never marketed it for childhood depression. Heck, we never marketed it to child psychs at all–we didn’t need to. I talked to my child psychs extensively when the Paxil warning came out. The data truly had to be stretched to include anxiety and agitated behavior in order for the “suicidal behavior” warning to have statistical significance. And statistical and clinical significance are not the same things. That fact is borne out by the truth that childhood suicide did not increase with the use of SSRIs.
Does that mean they should be prescribed willy-nilly for kids? Of course not. Childhood depression is such an anomaly that it needs to be handled very carefully–there are always psychosocial issues going on that speak to the need for more than medication therapy. And the warning was good in that it reminded doctors that SSRIs are anxiogenic in the early days of treatment. Patients who are deemed depressed enough to be treated with medication certainly need to be followed more closely than your average hypertensive.
What you and others seem to be overlooking is that Melody Petersen and others who make a living in journalism have to make a story juicy and exciting. Who would want to buy a book that depicted the pharmaceutical industry in all its ambiguity? Who would want to read about an industry filled with people who both want to treat illness and make money? Who wants to read a book that deals with the issues of the economics of drug development, continuing medical education, clinical research and sales/marketing of medication? Much better to read a tale of bad guys poisoning America’s children.
What you also leave out is the industry response to all of this criticism. Yes, we sponsor CME. No one else has the money to do so. And don’t suggest our tax dollars going to pay for it. Nowhere in the Constitution does it suggest that one of the responsibilities of government is the continuing education of the medical profession. But you should know how it works. Just like this, a true story from my own experience: a university doctor wants to do a day-long continuing education seminar on her specialty. She asked me for a grant of $5,000. I told her that her CME people must get on line and go the medical education grants website of my company. From there, it is out of my hands. They write the brief proposal (brief because it is, after all, only $5,000). All they have to say is they want to have a continuing education seminar on such and such a day covering so and so topics. They got the money. They are, in fact, using it for a speaker who will speak on a topic unrelated to the drug I sell. I will not be at the seminar. Now, are you going to argue that just the fact that the money comes from pharma makes it tainted? I think you will have trouble pushing that one very far.
Companies complying with pharma guidelines may not pay for a doctor to attend a CME event. They may not pay for airfare, hotel, event fees…nothing. Are the events fun for doctors? I guess so; I have never been. Having conferences in nice locales with golf and such is one of the perks of having gone to school for 2 decades. Are they really there for the CME? Who knows? What does that have to do with the drug companies?
As for speaker programs. A speaker can only present data that can be found in the package insert or that is approved by the FDA. They can speak from their own experience about a disease state, but they may not cite case studies of their own experience. They may answer off-label questions, but they must clearly cite that it is off-label and terminate the discussion as quickly as possible. My company has outside auditors that randomly attend evening programs to measure compliance. Dinner programs are really boring and no one comes, anyway.
Speaker training programs. These used to be pretty nice, I must admit. Speakers had plenty of free time and they could bring their spouses, although they had to buy the plane ticket and meals for their spouse. Now it is pretty brutal, at least for my company. In late on Friday night, start bright and early, plane ticket home within 2 hours of the program’s end. Some speakers do make a lot of money off speaking fees. Ironically, these are the doctors you don’t want in your territory, because they are never in the office to prescribe any drugs. The average speaker probably makes a couple of grand a year–they’re not good enough to travel extensively, and how many times can docs come hear the same speaker speak?
Part of what seems to bother people is the fact that drugs are, well, sold. But that is the free-market system. Why does it bother people that drugs are sold, but not that politicians are sold? The profit motive, properly harnessed, has produced all the wonderful things that we enjoy in society, including medication. And drugs do have to be sold: the average doctor will not educate himself and experiment with new drugs. They just won’t. SSRIs had to be sold to physicians, despite clear evidence that they were safer than tricyclics, if only because overdose on them isn’t fatal. Older doctors use the drugs they learned in residency–maybe that is fine for a diuretic, but it is not as fine for an anti-epileptic. The profits that are made off drugs go to fund more research and development.
Should the industry be looking in other directions for R&D? Of course. Hopefully, Wall Street will come to incentivize long-term thinking and innovative medicines, instead of me-too SNRIs and bladder control products. (Although anybody who says overactive bladder is a made-up disease has never peed down their legs as they run for the bathroom stall in the locker room.) You don’t know the frustration in the field when it seems that management is focusing on the safe target of another me-too drug. But what can they do when Wall Street wants a 15% profit and they want it in 6 months? We want to see pharma focus on diseases for which treatment is eluding us: MS, ALS, various cancers, etc. That means biologics and probably pharmacogenomics. That means even fewer successes and even more money. That means educating the American investor that pharma isn’t going to be a big profit deal in their 401k anymore.
As for clinical trials, I am not with you that companies are willy-nilly falsifying data and covering up adverse events. The FDA is pretty careful about approving drugs, despite what Melody thinks. They are also under pressure from patient advocacy groups to get drugs to market faster. Get them here faster, but safer, too is kind of a catch-22 don’t you think?
And the American public needs to accept that medication is not risk-free. Tylenol can kill you, for God’s sake–if you drink it with a little alcohol. vioxx may have cardiac risks, but Advil will rot out your kidneys (and also carries a cardiac risk, by the way). Should a company be punished if it discovers a safety signal and covers it up (as Merck apparently did)? Of course. And the courts are taking care of that, aren’t they? But that really doesn’t happen very often, and you can’t argue that it should never happen. This is a free-market and these are corporations made up of people. Some are going to be dishonest. That is the price we pay for living in a free society. That may sound cavalier, but it’s not. It’s a real freedom we enjoy, and it sometimes carries a real price.
Americans also need to be educated that some side effects of medication take time to come out. They may take years and years and millions of patients. If a pharma company tested a drug on millions of patients, well…it can’t be done, and you know that. So they test on several thousand, and they extrapolate safety data from there. With things like Vytorin and ENHANCE, you know that endpoint data takes a long time to develop. The company brings the product to market while mortality studies are going on. Too bad for Schering that Vytorin didn’t prove to be better than Zocor alone for this particular endpoint. Doesn’t mean Vytorin is dangerous or bad–but that is what I am reading in the press. It wasn’t fraud–pharma had good reason to believe that the extra cholesterol lowering provided by Vytorin would prove to be beneficial. Now we may have to rethink that idea–maybe it matters how you get rid of the cholesterol? Or maybe the study was a fluke.
I’ve been going on and on, but you get the idea. Just because I’m in pharma doesn’t mean I’m an idiot. But if you read my previous posts, despite my caustic banter, I am the ONLY one on the thread who admits there are two sides to this story. For Lisa or anyone else to say that the SSRIs kill people is not sustainable by the evidence, and it directly contradicts the life experience of literally millions of people and physicians. What could be a learning moment, as my sister says, that sometimes, even when you treat people with medicine, bad things happen, turns into an hysterical screed that accomlishes nothing.
As for creating fear of disease…I am thinking of fibromyalgia. A big topic now, because Pfizer has a med for it, as will Lilly and Forest here soon. But you know, I had a friend who claimed to have fibro 15 years ago. There is an underground of people who say they have fibro (I’m not judging one way or the other)…and they have been saying it for years. I think it is only smart business for a drug company to address the disease state, if that is what it is. And the American public must not be too scared of things like cardiovascular disease and diabetes, because they continue to be obese, sedentary smokers who only fill their Lipitor prescriptions 3 times on average. If that’s scared, I’d hate to see apathetic.
I happen to be proud of the pharma industry. Not of everything they do. But every day–every single day–somebody tells me that one of my medications has changed their lives for the better. Not very many people can say that about their jobs.
Thanks for the dialogue, FME. You are the only one who actually engaged.
HorusCat
And by the way, I medicate my autistic son with Wellbutrin and Abilify. I had to think long and hard about that, because he IS young and life is long…but I weighed the possible, unknown adverse effects against the clear adverse effect of being ostracized socially for behavior he can’t control…and I decided to medicate him. Now he has friends. The girls in his class mother him. The teachers find they can work with him. He is able to be mainstreamed. He has a fairly normal life. I have hopes that he may live independently one day, find an equally quirky girl to marry, have his own kids…Will I regret medicating him in 15 years? Maybe. But I would definitely regret having to put him in a home or in a restricted school situation where the only people he interacted with were other kids equally handicapped.
Do I think medication is the only answer for my son? Of course not. We go to counseling, we get tutoring, we work every night on schoolwork and social interactions. Medication is only a piece of the puzzle. But it is an integral piece, and one that I don’t think people like Lisa should be able to take away from my son. His prescriptions are completely off-label. I don’t know if the Abilify reps are out there selling the drug for kids like my son. I do know that I’m glad his doctor had the guts to get some experience with it, and I think other doctors would benefit from him sharing that experience. And right now, that is something the government won’t let happen. And I don’t think that’s good for medicine, either.
HorusCat
And FME,
You claim that marketing adulterates studies…if you go to pubmed and search a topic such as “SSRIs and suicide” you get a wide variety of abstracts. These were not drug-company funded analyses; they were independent researchers doing their own footwork, including calling the original investigators and asking them about suicide and adverse events. No matter how powerful you think pharma is, do you really think they could cover something like this up? That’s just absurd. When a Cymbalta trial participant hanged herself in the hospital while taking the drug, it was front-page news. Why? Because it doesn’t happen all the time. It would be ungodly easy to catch the pharma companies out–suicides here in the states would have to be reported to the FDA. Anyone can write to the FDA, and for a hundred bucks or so, have pages and pages and pages of adverse events sent to them that have to do with any particular drug. I know because I have done it for Zyprexa. Pages of events from hiccoughs to death. So I don’t think an outbreak of suicide would fly by the FDA’s radar screen, even if an enterprising and omnipotent drug company managed to talk the investigators out of publishing it. What kind of cynical do you have to be to think that an investigator in a major clinical trial would fail to mention that a patient in said trial committed suicide? That’s just not thinking clearly. So yeah, I believe the analysts in pubmed who say that there is no indication of increased risk of suicide with SSRIs.
I think a much more interesting and fruitful question would be to ask why there is no clear signal of DECREASED risk of suicide with SSRIs, tricyclics and MAOIs. Only Clozarel and lithium have been shown to decrease the risk of suicide, and neither one of those in depression. Why?
And what about stimulating debate about an important related question: what do we do when a drug has clear benefits, but also definite risks? For instance, Tysabri, a drug for MS. CLEARLY superior efficacy, but gee, it killed a few people. The FDA and the company pulled it from the market, but guess what? Patients demanded its return. Many physicians feel that the risks associated with such tremendous immunosuppression may well be even greater than we appreciate right now. Only time will tell. The discussion is quite heated about whether patients should be allowed to make the decision to use the drug. Can it really be informed consent? What are all the ethical ramifications here? If the risks turn out to be greater than we thought, are we going to see people like Melody writing books about the evil pharmaceutical company that marketed Tysabri? I think the picture is much more complicated than you, Lisa and Melody paint it to be, and I think the debate goes on within pharmaceutical companies and between pharma and the doctors much more than you think it does.
Reasonable people can disagree. I for one am on the side of erring in favor of discovery and experimentation, because I think the other side, that of extreme regulation and knee-jerk constriction of the market means that the fount of discovery will be shut off. And I for one, am still hoping for that cure for Alzheimers…
Nathan
Thanks for posting HorusCat. There are a few regular posters on this site (like myself) who are involved in pharma R&D. But no one from marketing seems to post on this site. Marketing definately gets a bad rap on this site — but then again, so does the entire industry.
FPME, I’m not quite sure what to make of your statement: “You claim to be original, yet you are a guy posing as a female”. Are you critisizing HorusCat because of her gender? I always knew your comments bordered on the edge of sanity, but this is off-the-edge.
HorusCat
Nathan,
Thanks for the post. What is really funny is I am a woman!! Whoever this mysterious poster is with whom they are confusing me, he must have been memorable! They are parsing every word I say (soccer coach) to prove I am a man…it just makes me laugh.
No, I can see why marketing would stay away from this site. The level of venom is astonishing. It is good to hear from R&D, too–I hope that we can move away from the me-too mentality into some really exciting areas of research. I think the low-hanging fruit of R&D has been picked: the anti-hypertensives, the statins, the diabetes drugs…the future is wide open, though, for genetically-targeted therapy in not just cancer, but also mental illness. Keep up the good work!!
Louise (my real, middle, name)
HorusCat
Nathan,
I will repost a comment I tried to post earlier. For some reason, the spam filter on this site thinks I am spam. I am trying not to get paranoid about it!
FME and Lisa are pretty funny, thinking I am a man. I don’t know why they seem so fixated on that; whomever this other poster was, he seems to have made an indelible impression! Perhaps they are trying to coerce me into revealing my real name.
I can see why sales/marketing folks do not post on this site. Countervailing views are not welcomed. Nonetheless, I am glad that you posted. I hope that as pharma moves forward, it will focus on new disease states and innovative pharmaceutical solutions to old disease states. Biologics and genetically-targeted medications are going to be the wave of the future, if upper management can get past the easy-money, me-too mentality. Perhaps, as we work in sync with basic researchers out there, we will find out why some people respond to drugs like SSRIs and others don’t–and even why some people become depressed or bipolar in response to environmental stressors, and others don’t.
Keep up the good work! Maybe we should join hands and sing, “We Shall Overcome!”
Louise (my real middle name)
pg
Horus cat - I don’t know, and don’t care, whether you’re a male or female. What you ARE is a human being. I don’t ever intend to lose the point by getting lost in that argument as to who you are.
I DO care that whether male of female you ARE working for pharma and not for the health and safety of other people.
AND THAT is what counts for me. You KNOW what you are doing and you KNOW what happens as a result. You help pharma kill children.
That is who you are. Male? Female? Who cares?
What does it matter what gender a traiter to other humans is?
HorusCat
pg,
Take a Valium; it can only help. I don’t need to defend pharma. The medications developed by pharma over the past 100 years have saved millions of lives and made millions more infinitely better. Hysterical blathering about “pharma kills children” is just nonsense. Produce your evidence, not just anecdotal terror stories about this child or that child. Show data that reaches clinical significance that pharmaceuticals kill children when they are used in the manner in which they are intended. In the meantime, I suggest you expend your energy talking to the parents who refuse to parent and the teachers who want to teach zombies.
So stow your sanctimonious glowerings. What have you done that’s good for the planet lately?
pg
Horus says: “So stow your sanctimonious glowerings. What have you done that’s good for the planet lately?”
A great deal more than you have, thats for sure! You’ve been shown the data but are either too stupid or are just fighting because you just don’t want to know.
But hey guy/madam, you keep fighting to keep your job for as long as you can, we understand - YOU and YOUR personal interests are more important than the lives of “anecdotal” kids who have died.
pg
You take valium? I guess you need to. I don’t.
pg
Editing: HORUSCAT: YOU just must surely need that valium to drown your conscience to sleep at night. I do not, because I do not promote scientific fraud that kills children.
Justice in Michigan
“Show data that reaches clinical significance that pharmaceuticals kill children when they are used in the manner in which they are intended”
Thalidomide?
Chris
Thalidomide was used up until the early 60s by women in pregnancy, I think for morning sickness. The terrible effects on their children born later were major deformities. I believe this was the issue, not death. Thalidomide was given to women, not children, and the practice ended over 40 years ago. I believe the question above was quite different.
pg
“Show data that reaches clinical significance that pharmaceuticals kill children when they are used in the manner in which they are intended”
Its always “significant” in my view when children die of pharmaceuticals, particularly when fraud takes place in the manufacture and/or marketing of those drugs.
Heres just a few of very many deaths of children. This is a FEW of the ones reported in children on Strattera. Taken from http://patientsville.com/ then simply pick on a drug from the initials along the top.
“…STRATTERA problem was reported by a Physician from PUERTO RICO on Mar 09, 2007. Male patient, child 9 years of age, weighting 74.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: injury asphyxiation. STRATTERA dosage: 18 MG, UNK. Patient died on 12/05/2005.
STRATTERA problem was reported by a Physician from UNITED STATES on Feb 20, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. STRATTERA dosage: 80 MG, UNK. Patient was hospitalized. Patient died.
Physician from UNITED STATES reported STRATTERA problem on May 09, 2007. Male patient, 14 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. STRATTERA dosage: 18 MG, DAILY (1/D). During the same period patient was treated with FLUOXETINE HYDROCHLORIDE. Patient died on 05/06/2007.
Consumer or non-health professional from SOUTH AFRICA reported STRATTERA problem on May 18, 2007. Male patient, child 11 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. STRATTERA dosage: 40 MG, DAILY (1/D). Patient died.
STRATTERA problem was reported by a Consumer or non-health professional from UNITED STATES on May 18, 2007. Female patient, 16 years of age, was diagnosed with disturbance in attention and was treated with STRATTERA. STRATTERA dosage: unknown. Patient died on 10/03/2004.
STRATTERA problem was reported by a Consumer or non-health professional from AUSTRALIA on May 23, 2007. Female patient, child 7 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with STRATTERA. After drug was administered, patient experienced the following problems/side effects: agitation, attention-seeking behaviour, depressive symptom. STRATTERA dosage: unknown. Patient died…”
pg
I don’t know how many of these 252 deaths on paxil were children - I don’t have time to go through the very many pages of reports.
http://patientsville.com [On it's PAXIL page]
“PAXIL Safety Reports
Total PAXIL reports: 2436.
PAXIL FDA safety alerts: 2004 2005 2006 .
Reported deaths: 252…”
Justice in Michigan
Chris,
Not correct. A great many infants were stillborn or died shortly after birth because of the extent of malformations - including absence of major organs, etc.. Horrific injuries. The company was fully aware of these deaths and directly covered them up, continually lying until they were forced otherwise. The estimate is 5,000 to 7,000 infants “died of their deformities before birth” (Hilts, Protecting America’s Health, p. 158). That’s about the same number of infants who survived their deformity.
The drug was promoted for several conditions, and different conditions in different countries, all without evidence of efficacy or safety. Severe neuropathies, sometimes fatal were covered up. Indeed, deliberate destruction and suppression of safety data was the hallmark of the story.
I will reconform it, but I believe the drug was, in some contexts, promoted for use directly in children - as a “babysitter” sedative. But if you know your product is killing infants in the womb or just after birth, I’m not sure the “route of administration” is the critical variable. HC’s challenge was to show evidence “that pharmaceuticals kill children when they are used in the manner in which they are intended.” Thalidomide killed children when it was used in the manner that it was intended. And we know definitively that its manufacturer and distributors knew it, and continued to promote and continued to lie.
BTW, even after the drug was withdrawn in Europe and the U.S., it continued to be promoted in Africa under the label, “completely harmless.”
(Many here will know the drug has had an afterlife as a therapy for very serious conditions. No one imagined that at the time.)
pg
Ditto re how many child deaths in the Zyprexa section:
http://patientsville.com/medication/zyprexa_side_effects.htm
“ZYPREXA Safety Reports
Total ZYPREXA reports: 3431.
ZYPREXA FDA safety alerts: 2002 2004 2005 .
Reported deaths: 377…”
Justice in Michigan
Confirmation. In Germany, thalidomide was actually marketed under the name “babysitter” as a sedative to be given to children.
Justice in Michigan
BTW, for those who will claim that the thalidomide saga is irrelevant to today, here is Howard Brody’s conclusion. Brody is an M.D., Ph.D., Chaired Professor, and Direct of the Institute of Medical Humanities, University of Texas Medical Branch, Galveston:
“Almost all of the practices in the research, development, and marketing of drugs that we find problematic today had appeared before the MER-29 and thalidomide cases became widely known. What is surprising is not how much, but rather how little has changed since 1962.”
Brody does not mean such cases are typical. They are obviously not. He is saying that when things go very wrong, they tend to go very wrong today in much the same way today as they did fifty years ago.
pg
Justice, re the issue of children dying due to thalidomide taken by parents - in this document:
http://www.teratology.org/updates/60pg306.pdf
it refers to Sweden.
“…Thalidomide was available in Sweden between January
1959 and December 1961. An estimated 150 Swedish
infants were affected, of which approximately one third
died in the neonatal period or early infancy
(Stro¨mland and Miller, ’93)…”
Assuming that the ‘one third’ referred to in Sweden would be reflected as an average across the world, then you’re certainly right that a huge number of children died in early infancy.
HorusCat
pg,
You haven’t proven anything. The report of a death while taking a drug does not prove causality. I am sure many of those people ate carrots; are you suggesting that perhaps carrots are to blame for their deaths?
You people have been blathering about SSRIs and deaths for the past decade. The FDA investigated and found no credible link between SSRIs and suicide. In fact, evidence exists that when SSRI use goes up, suicide decreases.
SSRIs and other medications are a necessary tool in the medical professionals toolbox. While I would agree that children are way overmedicated, I would place much of the blame at the feet of parents who want an easy answer to behavioral problems and teachers who want docile zombies to teach. No matter how hard a pharmaceutical representative pushes a medication, it takes a willing doctor and a willing parent to administer the medication.
Deaths of patients occur with every single medication on the market, including over-the-counter meds. You are far more likely to kill your child with Tylenol than with Prozac.
You are not logically-driven, you are emotionally-driven. You don’t assemble data of risk vs benefit, you just take a case history, about which you know nothing, since you are not privy to the patient’s medical records, and you make an assumption.
Then, in your venom and hysteria, you call people names like traitor, which BTW is spelled with an “o” and not an “e.”
I read your posts for their entertainment value.
Jane
Mr.HC, Are you suggesting you have access to patients medical records?
pg
Another interesting book covering drugs, research, manipulation of trial data, controversial tactics, promotional stunts, regulation, risks & benefits, etc. “America Fooled”
Large sections of it are available at the link and can be read online.
HorusCat
Jane,
I think even Lisa now believes that I am female, so you can call me Mrs. HC. No, of course I don’t have access to patient records. That’s the point. Unless you have knowledge of a patient’s entire medical history, you can’t really draw a conclusion from a short blurb such as those listed on the paxil site. The FDA receives what are called post-marketing reports from all sorts of sources, including doctors, reps, patients. (For instance, if a neighbor mentions to me that she took one of my company’s products, even if it is one I don’t sell, and she got a headache, I have to report that to the company, who then passes it on to the FDA. Did the product cause the headache? Who knows? It still gets reported.)
If a patient dies while taking a drug, it usually gets reported to the FDA and the company. The FDA and the company investigate the death. I am not sure at that point whether the FDA has access to the medical records or how that works. They do find out what concurrent medications the patient was taking; they talk to the doctors involved. I don’t know if they talk to family members. That would be an interesting thing to ask the FDA.
An example from my own experience was a patient who died while taking one of the drugs I sell. At first, the doctor thought it was the drug. I reported it, and after that, it was out of my hands. The doctor later told me that the patient was a heroin addict in a methadone program. He had OD’d on methadone, while also using cocaine. The report you might find on a website such as the paxil one, though, is simply that the patient, age 29, died while taking such-and-such drug.
I am suggesting that it is not productive to get agitated and hysterical about anecdotal reports of deaths in patients who were taking a drug. I think the FDA for the most part does a good job of investigating adverse events and determining causality.
The thalidomide disaster could happen today in the sense of patients being given a medicine with an unsuspected horrible side effect that only comes out in post-marketing use. Not with pregnant women any more, because we are so much more careful, but say like the Fen-phen situation. What would be harder would be for the company to cover it up the way they evidently did with the thalidomide thing, because we have so much more open media access than was true 50 years ago. Back then, there was no internet, there were only 3 TV channels…people did not communicate instantly and globally the way we do now.
I think this kind of communication is a good thing for all of industry, not just pharmaceuticals, because it holds them more accountable. What I object to is when an investigation is made and a conclusion reached, people like pg continue to slander people like me. Despite credible and overwhelming evidence that SSRIs do not increase suicidality or homicidality (is that a word?), they continue to lash out indiscriminately. It’s illogical.
Jane
Hc, Im curious what you think of this interview? Is the drug rep lieing” http://carlatpsychiatry.blogspot.com/2008/03/drug-rep-tells-all.html
Former pharma Marketing Exec
I would like to make a few corrections to HC’s post above:
1.) Yes if your neighbor mentions to you the headache while on one of the drugs even if you do not sell it, you report it. But then you also have to give the information about your neighbor. Medical Affairs contacts them and there is a full report they fill out - trust me on this one, I have done it often enough. Point is, it is not at all as haphazard as you make it sound.
2.) The doctor will not tell you, the sales rep the entire story, regardless of what relationship you think you have. Your Medical affairs and regulatory people know more and precisely what they need to know.
3.) Have you ever participated in a clinical trial for example? They record everything.
When something goes wrong they do verify, they have to verify exactly everything the patient was taking in order to determine the drug-to-drug relationship (if there is a need).
No one is slandering you. Try not to take what is going on here personally. We are making comments about the facts that are known and what Ed has reported. Many of us are adding our experiences.
Many of the people posting on this sight are bringing forward much needed information that allows us to improve our knowledge of the situation that will eventually lead to improved systems. Hopefully, by candidly discussing the problems we can find the solutions to reduce the harm to patients.
I believe that is the major focus of this site.
pg
A few more good reads on manipulation and fraud in the manufacture of medicines.
http://www.healyprozac.com/default.htm
“Considering the benefit and the risk, we think this preparation totally unsuitable for the treatment of depression.’ — May 25th 1984 communication to Lilly US from Lilly Bad Homburg by B v.Keitz containing a translation of an unofficially received medical comment on the Fluoxetine application to the German regulators.”
“‘I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation.’ — Memo from Bouchy C to L Thompson Re: Adverse Drug Event Reporting – Suicide Fluoxetine. November 13th 1990. Exhibit 117 in Forsyth vs Eli Lilly.”
“‘I am concerned about reports I get re UK attitude toward Prozac’s safety. Leber suggested a few minutes ago we use CSM database to compare Prozac aggression, suicidal ideation with other antidepressants in the UK. Although he is a fan of Prozac and believes a lot of this is garbage, he is clearly a political creature and will have to respond to pressures. I hope Patrick realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that.’ — Memo from Leigh Thompson February 7th 1990. Exhibit 98 in Forsyth Vs Eli Lilly.”
“‘All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector.’ — Editorial (2000). Resisting smoke and spin. Lancet 355, 1197.”
and
http://www.socialaudit.org.uk
“This website began as an investigation of problems with antidepressant drugs – not only their adverse effects on many users, but also what the problem signalled about the conduct of the competent authorities, and the adequacy of their institutions and process. As the problem unfolded, notably between 1997 and 2003, it revealed a glimpse of pharmageddon - a world of sickness created and sustained by exploitation of the fear of disease, indifference to real health needs, dependence on authority, and misplaced trust in the triumph of drug benefits over harm. These are the main themes in Medicines out of Control? …”
Justice in Michigan
HC writes: “The thalidomide disaster could happen today in the sense of patients being given a medicine with an unsuspected horrible side effect that only comes out in post-marketing use.”
Just so we’re clear (I think we are), there was nothing “unsuspected” about the problems with thalidomide early on. The company there were very serious problems in animal studies - both mice and dogs - the results of which they hid, as we now know.
From the perspective of most people here, I don’t think the issue is when a problem emerges in any event. It is what a company does, or doesn’t do, once it does.
Anyway, I take it we are now in agreement (if not about particular cases) that there are instances of companies knowingly continuing to market a drug even while also knowing it is killing children in significant numbers.
I do _not_ think such instances are representative of the industry. But I do think that denying it happens is, well, denial.
HorusCat
Justice,
You are absolutely correct, and obviously know more about the thalidomide issue than I. It does seem rather incredible doesn’t it, a drug used to treat pregnancy symptoms that causes problems in pregnant animals still making it to market? When something like that happens, criminal charges need to be brought.
Former,
You were making my points for me. I was simply making the point that adverse events get reported and investigated, although I have never given enough information about a random report from a neighbor for them to be able to contact the neighbor. Of course, there is a difference between someone telling you that they got GI upset from an SSRI and someone dying.
pg
Suicide decreases when SSRI use goes up?
http://www.pharmalot.com/2007/09/suicides-rise-as-antidepressant-use-falls/
“…That’s the conclusion of yet another study in the American Journal of Psychiatry, which finds that teenage suicides rose 14 percent from 2003 to 2004, a year in which the debate that antidepressants actually cause suicide gained widespread publicity…”
“FDA Panel Finds Evidence of Link Between Antidepressants and Youth Suicidality, Calls for a “Black Box” Warning…
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
…Senior FDA officials acknowledged that the results of the new analysis were substantially the same as the conclusions reached a year ago by FDA drug safety analyst Andrew D. Mosholder. At a hearing in March 2004, the agency declined to make Mosholder’s conclusions public, citing a lack of confidence in his results. The March hearing resulted in FDA’s requiring manufacturers to change the drug labeling for medications used to treat pediatric depression to include a statement recommending close observation for the emergence of suicidality.
In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling.
After the March hearing, FDA hired a group of suicidality experts at Columbia University to reanalyze the data. That analysis, which was the centerpiece of the September hearing, reached conclusions nearly identical to Mosholder’s. It found that 2 to 3 percent of children treated with antidepressants had suicidal thoughts or behaviors that were NOT a result of underlying depression but were CAUSED by the medications themselves…”
Justice in Michigan
Thanks or the word, HC. Originally, thalidomide was mainly marketed as a sedative. The focus on women came later, and pregnant women even later. In a kind of horrific way, it prefigured the abuse of diazepam (which I am not against; it has saved my back, literally, many times).
For a variety of reasons - plea bargaining of one kind of other - criminal charges were avoided. Civil settlements were also very late and very limited.
BTW, there were also companies (as I recall, Squibb and Lederle) who recognized that thalidomide had no science to back its claims, distrusted it, and refused to have anything to do with it. Once again, important to see all the relevant lessons.
HorusCat
Jane,
Crap. I had a long response to your question about Lilly rep at Tufts, and I don’t know where it went. It probably appeared on someone’s computer in Malaysia.
I don’t think this guy is lying; I do think he has an agenda and was playing to an audience. I also think that he is representative of a certain kind of person that you find everywhere: he is only in it for himself. No matter what he did, he wouldn’t care about the people with whom he interacted. There are drug reps out there like that, just as I know doctors like that and lawyers like that. Drug reps like that don’t last very long, because the doctors see through them. I am in this job for the long haul–I will be seeing these doctors day in and day out for years, even decades. There is no percentage in it for me to lie and manipulate.
As for some of the things he says:
1. Our computers. He is grossly overestimating the information we get about a doctor’s prescribing habits. It is a matter of much amusement among drug reps about what our computers say. The smart rep only uses the computer to give her a general idea of what med a doc prefers, and heck, most docs will tell you if you just ask them.
2. Buying lunch for doctors. Well my attitude always is, if you eat, I eat! Otherwise, I tend to rely on pretzels for lunch. (caution: humor) Really, with every rep from every company buying a doctor lunch, how much influence is my sandwich going to have over another rep’s sandwich? Yes, if a doctor perceives two drugs to be equal, he may pick the one from the rep he likes better, or whom he saw last…or he may pick the one he has the right dose of samples for, or the one on the formulary, or he may tell his nurse to go get what’s handy out of the sample closet…
3. Samples. Evidently, Lilly is much more sophisticated in their sample analysis than my company is. I have no idea how many samples to leave a doctor in order to optimize prescribing. I just ask them how many they want. I do try to limit the samples I leave in an office where I know the patients have good insurance.
4. Being friends with a doctor. Of course we’re not friends with our doctors. They know it’s a business relationship.
Ultimately, what struck me about this guy is his cynicism and selfishness. I do care about the patients who get my drugs and the doctors I see. These are human beings we are talking about. I have told my docs before when I don’t think my drug is right for a patient–although ultimately, they may disagree with me because they know particulars about the patient I don’t know. What I try to communicate is what the drug does, what side effects other doctors are seeing, what doses seem to be working best and what kind of formulary access it has. I also try to be a conduit from the doctor BACK to the company. A clinical trial may show one thing, but clinical experience turns out to be another. When the company hears from 200 reps that drug A isn’t working or is making people grow tails or whatever, they have to figure out what is going on.
All in all, people seem to get upset when they discover that the pharmaceutical industry is in it to make money. Of course they are! I think that is a good thing, because when people think they can make money, they come up with new ideas. What I have said time and again on this site is the industry needs to turn toward truly innovative therapies, and get out of the me-too business. And what we also need is the balance of having policies in place to prevent fraud and to spot problems and correct them.
HorusCat
Jane,
Of course, this guy may have one all sorts of awards and contests, while I never win anything. There is that to consider. Maybe he is a much better salesperson that I am.
I always try to approach it this way:
I know a LOT about my drugs, the competitor drugs and the disease state being treated. Our training is incredibly extensive, and I do tons of reading on my own because I am a geek. I ask myself: if this were I or one of my kids or my mother or my sister…what drug would I want? Sometimes, more often than you might think, it is not the drug I sell. And I tell my doctors that. I guess it is a good thing I don’t sell drugs for something like the prostate, because I would have trouble relating.
Although, on a side note on the disease-mongering thing…I keep hearing these men talking about overactive bladder being a made-up disease…ha! They’ve obviously never peed their pants on the way to the bathroom.
HorusCat
Justice,
Aren’t they using thalidomide for something again? Emesis in cancer patients maybe?
Justice in Michigan
HC - Yes, that’s referred to in one of the posts above. As I recall, it has had applications in multiple myeloma, leprosy, and some other cancers where benefits outweight risks (of neuropathies). And, of course, no pregnant women.
In the credit-where-credit’s-due dept., re: thalidomide’s manufacturer (Grunethal) looking for distributors, Brody summarizes: “Smith, Kline, and French had a competent research staff and quickly determined that the Grunenthal data on efficacy and safety were full of holes. Lederle also turned them down.”
Nathan
HorusCat,
Thalidomide has been used as a very effective leprosy treatment for decades. (nothing to do with nausea — completely different mechanism of action) It’s being investigated as a potential cancer treatment. (not emesis for cancer patients — actually using it as an anticancer or chemotherpeutic) It’s quite promising from what I understand. Obviously it is not prescribed to women of childbearing age. See this link:
http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Thalidomide_Makes_News_Again.asp
HorusCat
Nathan,
Did you know that leprosy has a genetic component? Very interesting disease.
Bob Freeman
FPME, to your point about the data collected on clinical trial patients, I would add only one caveat: While that’s true for patients completing the protocol, it is not necessarily true to those patients who drop out of the study and are lost to follow-up. While the CRO does due diligence to locate them, some will be lost. This is a problem in the intention-to-treat cohort. Now, if a patient drops out due to side-effects that’s a different case and adequate follow-up is usually included.
HorusCat
pg,
“We may have inadvertently created a problem by putting a ‘black box’ warning on medications that were useful,” says Tom Insel, director of the National Institute of Mental Health. “If the drugs were doing more harm than good, then the reduction in prescription rates should mean the risk of suicide should go way down, and it hasn’t gone down at all - it has gone up.”
I’m not sure what your point is–the site you linked me to notes that as SSRI use decreased, suicides rose.
pg
Apologies to most people for what apparently needs to be repeated, at least in part, of a former comment:
http://www.pharmalot.com/2007/09/suicides-rise-as-antidepressant-use-falls/
“…That’s the conclusion of yet another study in the American Journal of Psychiatry, which finds that teenage suicides rose 14 percent from 2003 to 2004, a year in which the debate that antidepressants actually cause suicide gained widespread publicity…”
“FDA Panel Finds Evidence of Link Between Antidepressants and Youth Suicidality, Calls for a “Black Box” Warning…
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
“…In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling.
…It found that 2 to 3 percent of children treated with antidepressants had suicidal thoughts or behaviors that were NOT a result of underlying depression but were CAUSED by the medications themselves…”
Explanation. When it was being put about by the Journal of Psychiatry that an increase in suicides during 2003 and 2004 was due to a reduction in SSRI prescriptions, in fact SSRI prescriptions WERE INCREASING to under 18’s during 2003 and 2004, despite the warnings. Drugs to kids were increasing at the same time that suicides were also increasing, ie - the Journal of Psychiatry were trying to do a manipulation job and it was based on false information which would seem to be an attempt to get the warnings OFF the SSRIs - which after all bring in $$$ billions annually.
Thank goodness for whistleblower reps such as Melody Petersen, Shahram Ahari, Slattery-Moschkau, Jamie Reidy, Elena Ferrante, Gwen Olsen and many others who have had the courage it takes to speak out as individuals against some extremely powerful and wealthy drug companies. Its amazing how each one of those individuals can make more difference across the world than thousands of reps who choose to stick with the pharma rhetoric.
Pharma has no options than to try to discredit them, because they know the whistleblowers are stating truths about misconduct that they can’t refute.
pg
Thank goodness for people like this also:
http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=259
“NIMH [National Institute of Mental Health]Funded Prozac Trial Report Concealed Suicide Attempts by Teens
“…Recent revelations indicate that pharmaceutical companies have selectively reported partial (favorable) clinical trial results from pediatric antidepressant trials and concealed evidence of harm from physicians, other healthcare professionals, and the public.
It is universally agreed in the literature that failure to disclose all trial results compromises physicians’ ability to provide professional care - thereby increasing the likelihood of causing preventable harm. More generally, failure to disclose trial results in scientific publications taints the scientific literature (by rendering it not credible) and, as New York State Attorney General Elliot Spitzer charged recently, constitutes plain and simple fraud…”
pg
Corruption and fraud goes on now as much as it did in the days of thalidomide. Thank goodness individuals have the courage to risk everything by letting us know these things.
http://ahrp.blogspot.com/2007/11/us-psycho-pharmaceutical-industrial.html
“…To the delight of Big Pharma, NIMH uses taxpayer monies to fund researchers who are financially connected to pharmaceutical companies. One important example is the “Sequential Treatment Alternatives to Relieve Depression (STAR*D),” a $35 million U.S. taxpayer-funded study that proclaimed the effectiveness of antidepressant treatment. The results of STAR*D were widely reported by the corporate media. Unfortunately, the NIMH press release about STAR*D excluded the fact that STAR*D researchers received consulting and speaker fees from the pharmaceutical companies that manufacture the antidepressants studied in STAR*D–and this fact went unreported by the corporate media. Also not in the press release and unreported is the fact that STAR*D researchers failed to include a placebo control and failed to incorporate relapse rates in the overall results. So in reality, STAR*D antidepressant results were no better than the customary placebo results or the results of no treatment at all–this also unreported by the corporate media….”
“…By the early 1970s, all of psychiatry was in the process of being transformed by the influence of drug money. Pill-oriented shrinks could earn much more than those who relied primarily on psychotherapy (prescribing a pill takes a lot less time than talk therapy); drug-company sales representatives who came to their offices often plied them with little gifts (dinners, tickets to entertainment, and the like); and their trade organization, the APA, had become ever more fiscally dependent on drug companies. 30 percent of the APA’s annual budget came from drug advertisements to its journals.…”
“…Drug companies have also been successful hijacking university psychiatry departments. In 2005 the Boston Globe reported that Harvard Medical School’s psychiatry department at Massachusetts General Hospital received $6.5 million from four drug companies. Marcia Angell, physician and former editor-in-chief of the New England Journal of Medicine and author of The Truth About the Drug Companies (2004), reported that the head of the psychiatry department at Brown University Medical School made over $500,000 in one year consulting for drug companies that make antidepressants. Angell remarked, “When the New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an antidepressant agent, there wasn’t enough room to print all the authors’ conflict-of-interest disclosures. The full list had to be put on the website.”
Jane
Hc,
Let’s see if I understand what you are telling me.
1) you don’t need a computer to tell you a doctors prescribing habits.
2) You don’t need to buy your doctors lunches.
3) You tell the doctors when not to prescribe drugs to patients.
4) You tell the doctors about all the side effects your drugs cause based on information you have obtained from other doctors.
5) You have never won an award.
I am having a hard time with the fact you believe you are going to stay in the business for decades based upon your this kind of behavior. I guess I just don’t understand why companies spend so much money on in obtaining doctors prescribing habits, lunches and other gifts, research identfing side effects, and bonuses to sells rep.
You must be one hell of a sellsperson.
pg
Letter to TOM INSEL, director of the National Institute of Mental Health
I should have pointed this out in a comment a little further up.
http://www.ahrp.org/infomail/04/06/23.php
“To: Thomas Insel MD; Tommy Thompson
Re: Published NIMH Prozac Trial Report Concealed Suicide Attempts by Teens…”
“…In light of the above information, AHRP kindly requests that the NIMH answer the following questions underlying our concerns:
1. How many children receiving Prozac in the NIMH-sponsored study attempted suicide?
2. Was the NIMH informed about suicide attempts and other adverse events in the NIMH-sponsored study?
3. How does the NIMH explain that suicide attempts by children treated with a psychotropic drug in an NIMH-sponsored study were not duly reported in a publication resulting from that study?
4. How do NIMH officials explain that in the announcement posted by the NIMH on its website on April 23, 2004, specifically addressing parental concern about the possible link between antidepressants and suicidality, suicide attempts by children treated with Prozac in an NIMH-sponsored study are not disclosed?
AHRP is also concerned about the NIMH’s role in funding a study with taxpayer money that was subsequently used by Eli Lilly to extend its Prozac patent exclusivity and to obtain FDA approval for treating depression in children - while apparently failing to ensure that all relevant data from that study be fully disclosed. AHRP is also concerned that conflicts of interest may undermine the credibility of taxpayer funded research findings and support. The following is the basis for our concerns.
In the FDA review of Eli Lilly’s submission for the approval of Prozac for pediatric depression, Dr. Russell Katz, Director of Neuropsychopharmacological Drug Products, refers to “Study X-658″ as “the Emslie study,” noting:
Eli Lilly was not involved with the conduct of this study, but obtained the primary data and performed their own analysis. (FDA, 2001b)
Dr. Andrew Mosholder, FDA expert reviewer, notes:
Lilly arranged to acquire the data from Dr. Emslie and colleagues in 1997, as part of their pediatric development program for fluoxetine (FDA, 2001a, p. 16)
In light of the above information, AHRP kindly requests that the NIMH answer the following questions:
5. How much did NIMH pay for this study?
6. If the study was “part of [Eli Lilly's] pediatric development program for fluoxetine,” did Eli Lilly pay for the data, and did Lilly reimburse the NIMH for the funds disbursed to Dr. Emslie, his colleagues, and their institution to conduct the study?
7. How much did the investigators receive in total from Eli Lilly in the past 10 years?
In sum, you will recognize that our concerns raise important questions about preventable harm to children who are prescribed antidepressants without their physician’s knowledge about the risks.
Indeed, they also raise questions about the credibility of the most recent announced findings of an NIMH-funded Prozac trial in adolescents. New positive findings from this trial were announced on June 2, 2004, by the NIMH and by the principal investigators, Drs. Emslie and John March. Though the announcement was reported on the front page of the New York Times and in numerous other media outlets, no data were released for independent review, nor was any publication date announced…”
Thank goodness not only for these people who risk all by speaking out, but ALSO for the internet so that people genuinely concerned about FRAUD in science that can kill children (and adults) and want HONESTY and SAFETY in medicines are able to find the information!
HorusCat
Jane,
If you are interested in a two-way conversation, then by all means, let’s have one. If you come at me with an agenda, and when I reply to you sincerely you respond with sarcasm and incredulity, then F*** you.
1. No I don’t need a computer; I ask the doctor and we have a conversation.
2. I didn’t say I don’t need to buy lunches. Oftentimes, lunch is the only time a doc has for a 5-10 minute conversation. What I said was if you look at it logically, doctors are getting lunch from every pharma company. What makes my lunch special? Nothing, except the relationship he may or may not have with me.
3. Doctors often bring up specific patients (no names) or a type of patient. Or, a certain type of patient is the obvious one for a drug. (For example, an overweight, non-exercising smoker may be a candidate for a statin.) We have frank conversations about which drugs might work for which patients. Do you really find that hard to believe? The fact that I am conversant with most of the doctors’ choices means that I can engage in meaningful conversation with them. In addition, I often ask questions about what they see with different drugs in different patients because I am interested in what they have to say.
4. I tell my doctors about the side effects they can expect to see based on what other doctors tell me, yes. One, I am legally responsible for reminding them of the three most common side effects of my drug. Two, if I failed to acknowledge side effects, what kind of credibility would I have? It’s not like my failure to acknowledge side effects is going to magically make them not happen. Doctors want medications to succeed in their patients. They know there are going to be side effects. In the case of nuisance side effects, such as sleepiness, a doctor can prepare a patient for the side effect and get better compliance. Doctors frequently trouble-shoot side effects with their reps. What about that is so hard to believe, except that it blows away your absolute certainty that we are all money-grubbing liars?
5. I have won awards–usually when the territory I am in has a windfall, like a drug suddenly going on formulary. Or as in one case, when I inherited a part of a territory that had a really lousy rep that never worked. I actually found doctors that had never heard of my drug. When you get one scrip out of a doctor who has never written your drug, that is 100% growth.
And what is wrong with bonuses for sales reps? Except that you somehow think that no one in the pharma business should actually MAKE money. Do you make money? Or does your husband? Why should I not make a living?
Maybe I won’t be in this business for decades. I don’t blow my numbers out every year, so maybe they will have to get rid of me eventually.
But it just amazes me that you can look at the pharma talking about itself and cry, “Bias!!” yet look at someone like this Lilly rep out there “telling all” and NOT see that he has an agenda, too. What that tells me is that you don’t really have an open mind. You have a fixed opinion, and you only want to listen to people who support that opinion.
HorusCat
pg,
What I see when I check out your links is an organization with an agenda as clear as that of which you accuse pharma of having. They have a clear bias toward psychology, versus psychiatry, so one should not be surprised that their efforts are geared to skew away from medication and toward other means of healing. Thus, I think you have to take what they say with a grain of salt. They will “spin” things to fit their agenda just as much as any other interest group will. For instance, the NIMH response alludes to differing descriptions on the part of researchers of adverse events. You have to be familiar with clinical trials for this to make sense. A clinician in one city may define agitation quite differently from a clinical in another city. Yet both get reported as agitation. One would have to have access to far more original documentation that we do to get a clear sense of what is going on.
I don’t find anything wrong with the group’s bias, by the way. I think psychiatry has devolved into medication-dispensing, not so much because of the “pharmaco-industrial complex,” as because doctors are not reimbursed adequately for providing other services. It doesn’t pay for them to do therapy. But I think good doctors know that psychotherapy and alternative methods are essential to good mental health and will make use of providers of these other services. I think that psychiatric patients benefit as much from psychotherapy, CBT, talk groups, etc., as they do from drugs (with the exception of some diseases such as schizophrenia). I am currently taking my youngest to a psychiatrist because he has been coming home from school and crying while he does homework. He complains he can’t concentrate or focus and that everything distracts him. Now, I don’t know how I feel about the whole ADD thing and I totally can’t relate to not just loving every minute of school, so I decided to get medical consultation. The psychiatrist to whom I am taking him will only see patients when they are also receiving counseling, so we are talking to a counselor as well. I find this reassuring, and hope that we will come up with strategies to help Solomon focus and concentrate without using drugs. I am in close contact with his teacher and we are brain-storming ideas, as well. In my opinion, this is what a good child psychiatrist does. The mental health centers here in town (which service the Medicaid and low-income populations) also have a counseling requirement built in to their medical treatment, so low income children, ironically, may be forced to receive better services than children whose parents have insurance and can go to providers who don’t offer counseling.
Beyond the influence of pharma companies on psychiatry, the increasing trend of scientists to see the human body and brain as nothing more than chemical processes means an inevitable trend toward pharmacological manipulation of those processes. I think there is a mystery to the human brain that chemicals and electricity cannot explain. Many scientists disagree. I have had psychiatrists tell me that nothing we do is a result of free will, that we really make no choices in life, that everything is dictated by our genes and by the chemical processes in our brains. I don’t happen to think this is due to the evil influence of pharma as much as I think it is to due with the loss of faith and undue belief in the concrete. But the increasing use of chemicals to control behavior is a natural outgrowth of this belief in a sort of chemical soup upstairs in our skulls.
I think you and the group you cite focus on pharma to the detriment of your cause, because pharma, while they may be encouraging psychiatrists to medicate patients, is not out there on the street recruiting parents to bring their children in to see doctors. Nor is there direct to consumer marketing for children’s drugs. Our society is less and less tolerant of what I would call normal childhood behavior. Parents seem less willing to undertake disciplinary processes and work with their kids and more willing to use drugs. Schools are not capable of tailoring classrooms to fit under- and over-achievers, and so those kids may get labelled as having behavior problems, when really they just need a different classroom setting.
pg, I don’t disagree with you at all about the over-medication of our children. Nor do I hold pharma faultless, as you seem to think I do. But I do think that medication is a tool that we need to have in our toolbox, and I get the idea from you that you think it should never be used.
pg
How we earn money MATTERS.
http://www.bmj.com/cgi/content/full/330/7496/911?ehom
REVIEWS
FILM
Confessions of a drug rep
A forthcoming movie claims to spill the beans on Big Pharma
Think big. Think money. Think drugs. And then think of all the sly, silly, ethically impaired things that people will do to sell drugs, and you’ll have a taste of Kathleen Slattery-Moschkau’s film, Side Effects.
Slattery-Moschkau (pronounced Moscow, “like the city”) sold drugs for a living for Bristol-Myers Squibb and Johnson & Johnson, until she found it increasingly difficult to “look myself in the mirror,” and left her job after 10 years in the industry…”
pg
“pg What I see when I check out your links is an organization with an agenda as clear as that of which you accuse pharma of having. They have a clear bias toward psychology, versus psychiatry, so one should not be surprised that their efforts are geared to skew away from medication and toward other means of healing…”
Reply: I’ve quoted a number of sources - which sites are you referring to in particular?
Would it be that of a recognised expert on psychopharmacology and an eminent PSYCHIATRIST (not psychologist) who used to be a consultant for drug companies but exposed the fraud, yet despite his honesty remains a university professor and still, as it happens, believes that the drugs can help SOME people?
Or would it be the quote from the FDA?
I’m sorry I don’t understand your ‘logic’ in your statement. You seem to be prone to clumping things together from various sources then making a broad statement in the hope that doing so will suit your cause, but I’m afraid it doesn’t actually work that way - not outside of the world within which drug reps work at least.
Good night.
HorusCat
pg,
I have no problem with the way I make money. And I would hazard a guess that this young lady uses more than little hyperbole to make her point. Either that, or BMS is a whole different culture than my company, which I doubt.
Having a background in science is certainly helpful when it comes to pharma sales, and the oldsters like me in pharma moan about the type of new hires we see. But the truth is, what is required for pharma is an intelligent person who can learn and understand a huge amount of information in a fairly short period of time. Why shouldn’t a history major be a drug rep? If she can read and understand about a disease state and the drugs used to treat it, she can talk about the drugs to a doctor. No one expects her to diagnose and treat the disease. Over a period of years, a rep acquires a huge wealth of information about medications and disease states. One of the problems the industry faces now is the turnover of reps, mostly in primary care, so that reps never develop that database of knowledge.
I never tell my doctor my drug is “the best thing ever” for his patients. Why would he believe that? He’s going to use it and find out how it works for himself. Especially with psych drugs. Everyone knows they all work about the same as far as efficacy goes. It’s all a matter of side effects, cost, formulary access and individual patient response. One schizophrenic patient does fabulously on Seroquel, but failed miserably on Risperdal. The next patient does great on Risperdal. The next one doesn’t respond to anything. The researcher who figures out why that is is going to win a Nobel prize.
And just like the Lilly rep Jane alludes to, Kathleen is way overstating the power of the computer. The computer only captures about 30% of a doctor’s scrips, and it misses many important sources of data. So what a rep has is a rough idea of which drugs a doctor prefers. Like I told Jane, I can ask a doctor that. What’s the big secret? How does knowing a doctor prefers a certain drug give me an “edge” over the doctor? It’s not a competition between me and the doctor, where I need an “edge” in order to fool him into writing my product. It’s a conversation where I find out how a doctor makes a prescribing decision and try to show him our my medication suits his needs. That’s why I don’t use my computer. I ask the doctor what he likes and why. Then I present a case for my drug fitting his needs. That is why, as I told Jane, I sometimes tell a doctor my drug doesn’t fit his needs. What good is it going to do me to lie? He’s going to find out when he writes the drug.
And the whole business about flying him to corporate. If every doctor with decent writing potential got flown to corporate every time some manager flipped out about his market share, the airline industry wouldn’t be in the shape it is in. First of all, they don’t go to corporate. What they may do is go to an advisory board meeting, of which there are very few anymore. And only a very, very few doctors get to do that. But the hype and hyperbole in her movie should sell tickets.
You seem like a fairly intelligent person, pg. Yet you have a powerful set of blinders to the agenda that may drive the people who tell you what you want to hear.
Because of that blind spot, you come across as sanctimonious and self-righteous. Unless you are out there feeding the poor, living in a hovel and eschewing the use and purchase of anything that might result from human exploitation (illegal immigrants, anyone?), then you are really out of line censuring someone else for their choice of profession.
pg
I’m truly not sure which “young lady” you are referring to.
I don’t fall for the twists and turns of reps who know that corruption goes on but continue to defend it, albeit by a rather obvious change of direction when things aren’t going so well on any given website. Oh how I wish I had those blinders you try to imply I have. The reality without blinders is quite horrific. So many people are dying due to fraud in clinical trials and one of the reasons why is that physicians have been hoodwinked by reps ‘just doing their job’. That is what you do. Try reading more carefully the EXPERTS who have seen the evidence. Experts who have putting everything on the line to protect the lives of others. THEN try to justify the work you do.
I’m off to bed. Good night.
HorusCat
pg,
Our posts crossed, and reading yours leads me to reiterate what I said in the last few paragraphs. You are a sanctimonious prig who is incapable of self-awareness. You cite your expert and note his credentials, and then what? Expect that to be the end of it?
Why is it you have such a hard-on for the drug industry? Except that is probably the wrong image, because I would lay money on you being a woman. The depth of your animosity is mind-boggling and truly fascinating. I just can’t imagine what drives someone like you. But I am done conversing with you because you don’t listen and respond, you just repeat yourself endlessly.
pg
PS, for someone who only reads my comments due to their amusement value, you sure do put some effort into trying to discredit the links I post. Whatever.
pg
“Why is it you have such a hard-on for the drug industry? Except that is probably the wrong image, because I would lay money on you being a woman. The depth of your animosity is mind-boggling and truly fascinating. I just can’t imagine what drives someone like you. But I am done conversing with you because you don’t listen and respond, you just repeat yourself endlessly”
So on that rather sily statement you just made, then Lisa is right, you’re a man?
You truly have little understanding. I’m posting information from people far more knowledgeable than you are, or I am.
So, when you criticise me - you’re simply trying to shoot a simple messenger and it has no effect on the information that I or anyone else here posts that comes from the people that exposed the information. Feel free to carry on, because thats about all you, as a drug rep, can do.
GOOD NIGHT!!
PS: Sorry Ed :-|
HorusCat
pg,
You really don’t read for comprehension, do you. I spent several paragraphs agreeing with you about the need for more non-pharmacologic approaches to mental health care. Did you not read that?
I didn’t try to discredit your sources. In fact, I AGREED WITH THEM TO A LARGE EXTENT. I capitalized that so you may comprehend it differently than you seem to comprehend anything else I write. I just pointed out to you that they also have an agenda and a bias. They are going to select data and information that serves their purpose. Therefore, in arriving at a conclusion about the available data, one must take into consideration’s each party’s biases. Is there a nuance to that point that I am failing to get across to you, or are you denying that your sources, too, have an agenda?
And just because I use a certain image, why does that mean I’m a man? If you read the totality of my posts on this site, you would come to no other conclusion than that I am a woman. Not that it matters. Could be I’m transgender, and therefore think like both a man and a woman. The point I was making to Lisa is that I am not a previous poster with whom she had apparently had contact, and whom she thought was a man.
pg
GOOD NIGHT. I don’t care about your opinion Horus. The man thing should be obvious from what you said earler. Personally., as I said before, I don’t give a toss if you are or not.
You made it your views very clear a lot further up this particular board. I’m not sure whether anyone else cares what you think, but I know I don’t.
I still wonder why someone that feels I’m simply an “amusement” value needs so badly to keep on and on trying to discredit the LINKS to EXPERTS etc that I’ve left.
It kind of gives your agenda away don’t you think?
Your mind games don’t impress me. You’re attitude change doesn’t either. What I CAN see is that you’re a good pharma rep, but pharma actually can’t fight fraud in science that they’ve involved themselves in, and thats why you behave like you do.
Sleep well.
PS AGAIN. Sorry Ed lol.
pg
WHOOPS you like to use any old thing like typos to discredit. Please excuse the “you’re” when I mean “your”. I’m tired. OK?
HorusCat
pg,
You are a sad and bitter person who has no desire to engage another as a human being. You must be filled with hatred and rage. Still, people like you are necessary checks and balances on the pharmaceutical industry, because yes, as I’ve said before, the industry is made up of people and people behave in ways both good and bad.
The industry is under pressure to provide stockholders a return on investment. We have seen many examples lately of what that pressure leads to in the lack of proper policing. Perhaps people like you will provide the necessary tension to force the industry to be more transparent and honest. Everyone will benefit from that.
Lisa Van S
Jane,
He has won an award, if he told you what award it was it would give away his identity
HorusCat
Lisa,
Actually, many companies call their awards the same thing. And I have changed companies.
What I find interesting is that while I post messages to you engaging you as human beings with thoughts and feelings, good points and bad points, you continue to talk ABOUT me as though I were some sort of insect you are disecting.
You had been responding to my recent posts as if I merited your sincere engagement, but perhaps that was an aberration on your part.
Evidently, your prejudices prevent you from taking me as an individual, rather than as a faceless member of a group you dislike. If someone behaved in that manner toward a recognized minority group, you would probably be quick to shout “****ism.” Because I am not a member of such a group, you feel free to treat me as beneath your contempt.
I am biased, of course, but given the choice between interacting with a person such as I, who engages at an individual level and responds genuinely and sincerely to arguments raised, and interacting with a person such as you and Jane, who default to snide remarks and sarcastic misinterpretations of what a person says….I’d take me any day. And I have a far better sense of humor.
HorusCat
See Lisa and Jane,
If you engaged with me as a human being, you would find that I am funny, intelligent, well-meaning, genuine, curious and conscientious. I relentlessly question management decisions and am something of a pain in the butt to them. It was the complaining and questioning of reps like me that led my company to cease marketing to certain subsets of physicians–because WE, the reps, persuaded management it was off-label and unproductive.
I am also stubborn, caustic, argumentative, sometimes judgemental and I leave my clothes lying around the bedroom, which drives my husband crazy.
You MIGHT find that engaging sincerely with people like me stimulates us to work for change in our organizations. Such interactions and the resulting efforts to change pharma might accomplish far more than what your knee-jerk condemnations of every single person involved in the industry achieves. IMHO.
HorusCat
Today, I vow to pick up all the clothes lying on the floor and put them away in drawers. Furthermore, I will organize my closet and take all the clothes out of the dry cleaning bags so that I don’t end up wearing the same thing every day of the week.
Jane
Lisa, I only said he didn’t win any awards because he had said he didn’t.
HorusCat
Jane,
Yoo-hoo!! Hey!! I’m over here!! Psst!!
pg
No rage and bitterness for you Horus. ANGER, SADNESS and DESPAIR at people who engage in or defend misconduct in science that kills, and I can’t see how anyone can justify that as being ’sad and bitter’. Sad, yes. Its a normal human emotion to feel sadness for casualties that suffer and children that die. It’s also probably also normal to feel bitterness about the people involved in causing that if the loss if, for instance, your OWN child, or wife, husband, sister, brother, father, mother. But you’re wrong, I’m not bitter. Just extremely sad for the casualties, and sadder and angry the extent of the damage corruption has done to so many people and at those who knowingly work so hard to keep it that way.
pg
Horus said:”You MIGHT find that engaging sincerely with people like me stimulates us to work for change in our organizations.”
I think we HAVE found that people like Melody Petersen who are the insiders are the ones that do something to change the organisations.
People like her do not say
“HorusCat
Funny how trendy it is to attack pharma. Big evil Satan. Of course, when pharma comes up with that cure for Alzheimer’s, I bet Melody and Giles will be in line…
…”And drug companies haven’t necessarily “defrauded” anyone…” [Horus, have you never read the once 'confidential documents' showing how they HAVE defrauded people?]…
“…And Zyprexa lady? I am really, really sorry your son died. But I can’t tell you how many psychiatrists I had tell me, for years, that their patients’ weight, blood sugar, blood pressure and cholesterol were not their concern. Everyone on the psychiatric planet knew that Zyprexa caused weight gain…
…Perhaps your son liked the way he felt on Zyprexa and asked your doctor not to change the meds…”
SAD, and angry. Thats how I feel, Horus.
Your above comments I believe were near the beginning of this particular page… March 20th or thereabouts.
Carpet lover
Carpet lover…
…