New Jersey AG Is The Latest To Probe Vytorin
53 CommentsBy Ed Silverman // April 21st, 2008 // 8:53 am
The line is growing ever longer. First, the House Energy and Commerce Committee and the Senate Finance Committee opened investigations into the controversial Vytorin trial, known as Enhance. Then, the New York and Connecticut Attorneys General begin their own probes into the handling of study data and the marketing of the expensive cholesterol med. Earlier this month, New Jersey’s Anne Milgram, issued her own subpoenas to Merck and Schering-Plough, according to the Merck earnings statement that was released this morning. The subpoenas were dated April 4.
The Vytorin study has attracted enormous attention because the drugmakers delayed results for nearly two years; briefly changed the primary endpoint without consulting their lead investigator; named an independent panel to review data without releasing names and three panel members were later learned to have financial ties; and some Schering-Plough execs sold lots of stock during all this time.
There’s another aspect to Milgram’s move that some may find interesting. For decades, New Jersey has been home to much of the world’s pharmaceutical industry. And for that reason, drugmakers have often been handled with kid gloves - when other states launched investigations into questionable marketing, for example, the Garden State usually wasn’t on the list of participants.
So it came as a surprise last fall when the recently appointed Milgram announced a new task force to study recommendations for handling conflicts of interest between docs and drug and device makers. At the time, she told Pharmalot that “there are no sacred cows.” Since then, she has also issued a subpoena to Amgen over its marketing of the Enbrel treatment.
Ecstatic
Bravo for Ann Milgram. Now there’s at least one elected official in Nj who is looking out for the best interests of the public rather than Big Pharma. It’s about time, especially after these companies have been living off of huge tax breaks for years as big employers and now are laying off thousands of NJ workers!
Insider
She’s hot!
Jack2
And for that reason, drugmakers have often been handled with kid gloves - when other states launched investigations into questionable marketing, for example, the Garden State usually wasn’t on the list of participants.
-I haven’t seen that.
Also, I agree with Insider.
Atlex
Ecstatic, not that it’s a big deal, but she’s not an elected official; she’s was appointed by the governor.
Ed Silverman
Hi Jack,
Having followed the pharma biz for the Ledger since 1995, I covered various stories - no, I’m sorry, I can’t remember which ones, specifically, anymore - that involved lawsuits brought by various states against drugmakers and NJ was rarely among them, although NJ would still get a share of a settlement.
Once in awhile, I’d be on the phone with an asst or deputy AG from another state and ask “Where’s NJ?” and the usual reply would come back about the issue with industry. Those multi-state efforts, by the way, were usually coordinated through a committee that’s part of the National Association of Attorneys General.
I’m sorry I can’t be more specific right now, but it’s been out there awhile, which is a key reason Milgram’s idea for a task force caught many by surprise.
And to Ecstatic, as Atlex noted and I wrote earlier, Milgram is appointed. NJ doesn’t elect its AG.
Regards
ed
Sam
The trouble with these investigations is that they only attack the tip of the
iceberg(an individual drug). The major problem is PHARMA ability to market
drugs and not cure illnesses. The FDA approves drugs if PHARMA show the drug is more effective than a sugar pill. Don’t any of you feel that something
is wrong when PHARMA spends $57 Billion a year to market a drug and only
$31 Billion on research and development.
Gifts to physicians and researchers on PHARMA payroll and ghost written
positive reports are allowed to occur without any regard to the harm these
drugs cause patients.
Sam
May I suggest you read a new book by Melody Petersen called “OUR DAILY MED”. It really exposes how PHARMA develops a disease and then markets
the drug to cure a made-up disease.
Sam
Lisa Van S
Hey Guys,.. You may think she’s hot,…and that Could be the reason why Corzine appointed her. She lacks tenacity and backbone to do her job and protect NJ’s most vulnerable citizens,.. children and Seniors from dangerous antipsychotics that are being heavily promoted for off-label use.
Nathan
Sam says: “Don’t any of you feel that something
is wrong when PHARMA spends $57 Billion a year to market a drug and only $31 Billion on research and development.”
Only $31 billion? The numbers I’ve seen are $55 billion for 2007. Can you name another industry that spends EVEN CLOSE to that amount on R&D? I think most people on this site (even insiders like myself) think that we likely spend too much on marketing. However, say you take $10 billion from marketing and shift it over to R&D. (assuming your numbers are correct) Then R&D would be about equal, right? That would only be true if sales remained constant. They likely would not.
As an industry, we reinvest about 1/3 of our income into R&D. To borrow an analogy from Derek Lowe, we could easily make R&D a bigger “piece of the pie”. However, as marketing expenses decline, the size of the pie is likely to shrink. Therefore, R&D output really may not change much by shifting money from marketing to R&D.
Many here would argue that decreasing the size of the “pharmaceutical pie” is a GOOD thing. They may well be right unfortunately for my career…
James
Sam said “May I suggest you read a new book by Melody Petersen called “OUR DAILY MED”. It really exposes how PHARMA develops a disease and then markets the drug to cure a made-up disease.”
I love when people write things like this. It reminds me of when I would debate w/ leftists in high school and college and they would retort “Just read Kafka and you’ll get it,” or when conservatives back in the day would proudly proclaim to be “ditto heads.”
It’s sad when people do nothing more than parrot the unverified claims of someone in popular media–but at least you know where that person stands, and what their “ideas” will be, long before they say another word.
Sam
It seems that Nathan represents PHARMA. My numbers came from an
article in the NY Times a few weeks ago.
Sam
Sam
James said
It’s sad when people do nothing more than parrot the unverified claims of someone in popular media–but at least you know where that person stands, and what their “ideas” will be, long before they say another word.
It is interesting that you use the word “parrot”. That is what PHARMA reps do
to sell a drug to a physician. They repeat what the company tells them to say
to convince physicians that their ghost-written reports and studies are truful.
Sam
Nathan
Sam,
Thanks for telling me (sortof) where your numbers came from. Mine came from the PHRMA website. They get their numbers from SEC filings.
You can “accuse” me of representing pharma. In fact, I do. I feed my family by working as a researcher at a big pharma company. I’m certainly biased in my opinions. However, what I stated in my previous post was really just some economics. As marketing decreases, sales are likely to decrease. As sales decrease, revenue decreases. As revenue decreases, less money is available to spend on R&D. It seems quite simple to me. If you disagree, please explain. (once again: I’m NOT arguing that this is good or bad — I’m only arguing that it is reality).
Justice in Michigan
Given legal liability, the fact that Melody P. was a very successful investigative reporter for several years at the NYT, and the fact that Farrar, Straus, Giroux is the most careful and respected press in publishing, describing her work as “unverified claims of someone in the popular media” is a little slip-shod.
But let’s test it. If anyone is aware of a false or unverified claim in the book, name it.
James
Dear Justice,
Well, I haven’t read her book, and won’t (unless someone wants to loan it to me) because I don’t want her to get a royalty from me. However, I will quote several of her comments from the interview she did with Pharmalot in March, and I will respond to some of her unverified/incorrect claims:
Petersen: but that hardly gives it (the pharma industry) the right to hurt other people through aggressive marketing.
I’ve yet to see anyone harmed by marketing. Even the most aggressive of sidewalk vendors has never assaulted me, and I’ve yet to see Nexium hawked on the streets. Why do I mention this? Because her use of loaded words shows her bias, no different than a pro-pharma doctor who accepts money from the industry.
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. …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.
Really? When was this blissfully safe time? The 1930’s (sulfanilamide)? The 1950’s (Cutter polio vaccine)? The 1970’s (Dalkon Shield)?
It is important we recognize, the FDA has not made us safe. Not before GMPs, not before PDUFA, not now. They have the potential to make us safer*, but not safe. Money from taxpayers, money from industry, doesn’t matter.
Her decision to ignore the past allows her to draw conclusions that just aren’t true.
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.
What evidence does she have to cite that the ads have “warped” the public view about health? A study I saw cited here on Pharmalot (if you want, I can dig for it) indicates that the ads make us more inclined to talk to our doctor. How is that warping us?
Petersen: 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.
That’s actually not true–politicians can accept $0 from corporations, and don’t need to disclose donations up to a certain $ amount (I believe it is $100, but I can research the exact figure if need be) from individuals. So she’s just plain wrong on her facts. Of course, to compare those privately employed to those seeking to make laws that affect us all…well, we can debate the speciousness of that argument later.
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.
Last numbers I saw are that, at least in some segments (e.g. sleep meds) companies are reducing DTC ads.
Is that enough, Justice?
Sam
Nathan, I hope you have a long and successful career as a researcher for
PHARMA. My complaint has to do with the extreme and costly efforts of
marketing drugs. My complaint is also with the profit layer of health care
insurances. Between the cost of drugs and co-pays, I find that people are now refusing to take the prescriptions after I just filled it. This has never happened before! Some insurance co-pays are just discounts on what the insurance says
is the price. For an example: The Rx insurance says the price for the Rx is
$150 and the co-pay is $100! New drugs are rare, companies are coming
out with combination of older drugs - gives it a new name (Vytorin), the FDA
gives the company a new patent and the cost of the drug increases.
If I warn Docs about a drug interactions, they don’t care! Seniors get so
many drugs the chances of interactions increases. The direct to consumer
ads gives the consumer the idea that a pill will resolve all their problems.
Sam
Kevin
“…the FDA gives the company a new patent…”
Can you cite to the statute that gave the FDA the ability to grant patents? Last I heard, that power was vested in the US Patent and Trademark Office. All the FDA can do is grant a limited (3 or 5 year) marketing exclusivity on new drugs.
Jack2
Just two points to add, and I don’t really disagree with Sam or Nathan.
1. First, Pharma companies are companies. They need to sell products and they invest a huge amount of money into R&D. Find another industry that spends more on R&D, either as a %, or in total. They also invest a huge amount of money into selling those products. Likely, they’ve reached this balance based on what best keeps the business going. Economics 101.
Also, people who read about the industry on this blog tend to see money spent on sales/marketing as wasted money thrown down the drain. I don’t see it that way. You’re looking at an industry where <1% of it’s tested products reach the market. Once that happens you need to tell people about it. Some doctors keep up with the literature, others are more lax. Doctors aren’t paid to read the literature, they’re paid to see and treat patients. At the very least, without sales/marketing uptake would be slower. FYI, I don’t work in sales or marketing, but I do work in the industry.
2. I think people notice the cost of drugs more as their insurance company shelters them from that cost less. While I think insurance companies shelter patients from all healthcare costs less and less, I think it is most pronounced with prescriptions. People don’t actually care how much their surgery/hospital visit/check-up/rehab/root canal/eyeglasses/prescription cost. They care how much it cost them. Increases in the price of drugs have been some of the slowest growing costs in healthcare. People just think it’s been super-rapid because of changes in health insurance.
Why else would people care more about gas tax that costs them $0.18 a gallon than a war that costs them $4.5k/household. It’s all about the cost that the individual sees. High gas prices are visible. Where money that comes out of your payroll check goes - invisible. Sorry to get political.
LILLI
September of 2007 State Attorney General, Anne Milgram started a Task Force concerning Doctors receiving gifts from Pharmaceutical Companies.. Her office has not yet published a report on the task force. . New Jersey is not really interested in patient safety. Sen. Joseph Vitale in 2004 organized the Patient Safety Act, not for the citizens safety, but directed, by then, president Gary Carter of the hospital
Assoc. AND ALSO THE PRESIDENT OF The New Jersey Medical Society of which is part OF AMA.. .
. New Jersey residents must take action and make the elected and appointed RESPONSIBLE FOR THEIR ACTIONS.
LILLI
I am beginning to think that pharmalot is just for people to sound off. Since the creation of this web site what has been accomplished for the quality of healthcare and patient safety? Did Anne Milgram,state attorney general issue a report on the task force on gifts doctors receive from drug companies? The people of New Jersey should make elected and appointed officials responsible and accountable, if not they should be disciplined.
Bob Freeman
Nathan, I don’t have the link to the source of this estimate but I’ll report the relationship between sales and lagged R & D spend; for every 1% decrease in the rate of sales growthe, there’s a l.04% decrease in lagged R & D spend. The source is Mike Dickson at the Univesity of S. Carolina and his analysis did not receive industry support. The data are somewhat dated and I can’t remember the period for the estimate.
Nathan
Lili,
Maybe Ed can state it better — but I don’t think the purpose of Pharmalot is to accomplish ANYTHING in particular. It’s only purpose is to inform people (in the industry and just interested in the industry) of things relevant to the pharma buisness.
Chris
Lilli is asking whether a report was issued by Milgram on the gifts received by doctors from drug companies: I suppose this might be important at some level, but as a long-time resident of New Jersey I would hope that more pressing matters might occupy her agenda. Aside from the questionable effect of a free ballpoint pen on a trained professional’s prescribing habits (and I include PAs and NPs here) I sincerely hope that NJ’s resources are more imminently directed at finding ways to pay for much needed education and healthcare services to those desperately in need (as well as to VA and their patrons) than to another political jamboree.
We have enough of that already in JAMA-land without distracting NJ’s officials down the same path.
Lisa Van S
Lilli
I wouldnt expect Senator Vitale to display any type of integrity when it comes to Patient Safety. He has blocked a Parental Informed consent bill,. S1512 from being heard in his committee since January 2007. He’s to busy attending award ceremonies that are sponsored by Pharma.
Paul
Now NJ can truly capitalize on the very strong economy of Newark, which employs such a high number of highly-educated, well-employed, high-tax-paying people.
Talk about biting the hand that feeds you
Lisa Van S
Chris,
So,…. you are a long time resident of New Jersey,…. hmm, so am I. So,.. are you ok with NJ tax payers paying 76 Million dollars for unapproved, unsafe, no efficacy drugs that will maime and kill children?
Lisa Van S
Paul,
Those of us residing in Hunterdon County are expected to pick up the tab. No surprise there!
LILLI
To Chris:
It has nothing to with the gifts but the promises made by Milgram. Most doctors do not report medical errors, it is not only pens, it more than that. Doctors receive vacations, money toward cars and what about our corrupt elected officials allowing to be influenced by the medical profession, healthcare industries, hospitals and pharmaceuticals?
FDA issues warning labels on medications, the label says tell your doctor if you have these problems, what does the doctors do, give you another medication to make your condition worse. Medication are causing many healthy people to have serious side effects that are leading to unexpected death. New Jersey ELECTED OFFICIALS WRITE PATIENT SAFETY LAWS THAT ARE IN NAME ONLY. NEW JERSEY SHOULD MAKE THEIR ELECTED AND APPOINTED OFFICIALS RESPONSIBLE FOR THEIR ACTIONS. What HAS HAPPENED WITH THE SCANDALS WITH THE University of Medicine and Dentistry of New Jersey—NOTHING —AND I AM SURE THE SCANDALS CONTINUE ! WE MUST HAVE ETHICAL HEALTHCARE! AND PUNISH THE GUILTILY! THE INNOCENT SHOULD NOT BE MADE TO SUFFER FOR THE GREED OF POWER AND MONEY!
LILLI
ALL CHOLESTEROL MEDICATIONS SHOULD BE INVESTIGATED! there must a method where doctors must report side effects from all medications. But of course elected officals will not allow this because the pharmaceuticals will not allow this. There are serious very serious side effects not reported from cholesterol medications and doctors are covering up for their mistakes to protect the pharmaceuticals.
Lisa Van S
Lilli,
When you have Elected Oficials like “Viatale” who are more interested in Posh Award Dinners, then patienty Safety,. You will be guarunteed nothing will change. Im not even sure that his Constintuants realise that this man has no problem jeopardizing their safety for politiacal,.. financial gain.
LILLI
To Nathan
You do not seem to be interested in the truth and the corruptiion that exists in New Jersey health care. PLEASE EXPLAIN WHAT IS THE TRUE PURPOSE OF PHARMALOT IF NOT TO PROTECT THE HEALTH OF THE PEOPLE. I write from horrible heartbreaking difficult experiences all becuse of the unethical medical practices and laws in New Jesery and the federal government. I hope no one has to expierence what my family did. What game are you playing?
LILLI
To Lisa
I am glad you agree with me. I am constantly writng to our elected officials and I am planing on meeting with many of them—hoping they grant me an appointment.
Chris
Lisa
Not only am I a long time resident of NJ,I’m also old enough (just…) to remember 45 RPM singles and what happens when the needle gets stuck. So, in all fairness I don’t want to enter into the old discussion.
And Lilli - whatever your personal issue is I really do sympathize but I can’t see quite where your argument is beyond doctors receiving unspecified money and gifts, UMDNJ corruption (totally agree), and cholesterol medications, which we can discuss ad nauseam.
Respectfully,
Chris
Chris
Paul,
Your characterisation of Newark sounds familiar, if a bit outdated.
It’s actually coming along quite well, not before time of course, but slowly becoming better.
Justice in Michigan
Chris - Just getting back to this now, and the thread has taken another direction. But I appreciate your taking the time to respond.
I do think that taking a few bits from an interview, which I assume was itself edited, is a different thing than reading a book which includes notes, citation, etc.. But I also respect your not wanting to hand MP more royalties in the process. I guess that’s why we have libraries. But my guess is that you won’t want to give her your time either.
So just one point because I think it can stand for the rest. You take issue with the idea that people can be hurt by aggressive marketing. Hou have never seen anyone hurt by marketing.
Isn’t that essentially the “guns don’t hurt people, people hurt people” argument? Everything depends on the specific examples one uses. FDA called Merck’s Vioxx marketing “false and misleading” repeatedly. The sagas of fen-phen promotion, the off-label Neurontin scam (as for bi-polar), or high-dose Baycol are well known. A number of industry folks on this list have talked about the ways marketing has overriden science in blockbuster contexts, with terrible consequences for some people.
This is not rocket science. Some drugs have been over-promoted or promoted in misleading, even fraudulent ways - to physicians (mot important) and to pts. And, as a result, some number of pts were killed and injured in the process
Is there really a dispute about that?
Justice in Michigan
This point too. In the really excellent thread we had a few days ago, you (assuming you are the same Chris) wrote in the opening entry:
“I have been in PhRMA for 20 years and the conduct of Schering never surprises me. But Merck was a scientific vanguard. It’s so disappointing to see how far Merck has fallen. Shameful.”
Others in industry commented - candidly and generously - on the changes they have seen in the past 15-20 years, many associated with more aggressive marketing, and the pivotal role that ad companies have come to play, “from test tube to boob tube.”
So I agree that there was never a “perfectly safe time” (I don’t think MP thinks so either) or that PDUFDA is the main problem.
But do you not agree with the implication of your own comment - that even companies like Merck have “fallen” relative to what was once normative behavior? And do you see Merck alone in that regard?
Insider
So was she appointed by Spitzer?
James
Justice, you wrote: So I agree that there was never a “perfectly safe time” (I don’t think MP thinks so either) or that PDUFDA is the main problem.
I disagree completely in re: MP–she is quite clear in her opinion that money, and specifically included in that, PDUFA, is the problem. Again, I quote:
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. 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 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.
That’s very clear to me that she blames the money, and specifically, PDUFA. And, I would gather by your reply (and your many other posts), that you don’t have such a simplistic view of the system as MP does.
So you wanted examples of her misstatements. I noticed you did not reply to many of the others I’ve cited. So I hope you will agree that she is, at the very least, a questionable “expert” to be citing.
Now, to respond to another statement of yours:
“This is not rocket science. Some drugs have been over-promoted or promoted in misleading, even fraudulent ways - to physicians (mot important) and to pts. And, as a result, some number of pts were killed and injured in the process
Is there really a dispute about that?”
Yes. I dispute the simplicity of the chain you cited. You left out the patients that, in haste to heal their pain or illness, embraced a drug without learning about the risk/benefit profile. You left out the doctors who attempted to educate their patient about same. You left out the other risk factors that patients had, and didn’t tell their doctors about. You left out the comprehensive health plans that doctors gave their patients, and they chose to ignore (e.g., “Okay, take Vioxx. But you also need to stop smoking and lose weight, because you are already at risk for a heart attack.” “Sure doc. Whatever.”) You left out a food chain that makes bad for you foods cheap and easy to obtain, and fresh, healthy foods expensive. You left out the healthcare system we have in the U.S. that doesn’t value and provide reimbursement for many preventative measures, because they are difficult to measure.
ALL of these, and more, factor into the deaths of patients. None of us live in a test tube. But it is much easier to say “He took Vioxx. He had a heart attack. Bad pharma company!”
Now, the simple view, no doubt, plays better in media reports, Congressional testimony, and trials by jury. But there’s so much more to many patient deaths than a “bad” drug company.
Now,with that said, if there is evidence of a company promoting false or misleading information about their products, they should be punished. I, personally, favor piercing the corporate veil in these cases and holding specific people responsible, but that is a Utopian argument for another time.
Lisa Van S
Chris,
Its never an old discussion when it comes to money, especially,.. since taxes were due on April 15th. Maybe you wouldnt mind paying more, I dont, especially when it will cause potential harm to a child. Id like to see Ann Milgram do her job,.. thats what she’s being payed for,.. again through taxpayer dollars.
Chris
JiM - Different Chris to the one making the opening comment. I think you may have been addressing someone else’s comments anyway.
Lisa - stet.
Justice in Michigan
Whoops. First, yes, I was responding to James and wrote “Chris”…sorry for that.
So James - you are right that I do think the PFDUFA argument is more complex than is often suggested. My own analysis would focus less on a “culture of approval” and more on the resources that CDER had to take from other projects - especially those relasted to post-marketing surveillance - and put them into coming up with their half of the OND budget. That was Gardiner Harris’s initial analysis as well, and I think it holds up.
Re: your other series of points, you are also right that I don’t see the issue as mono-factorial. Of course, there are all kinds of reasons that people are killed or injured by drugs besides marketing, etc. The list, of course, could be much longer than the one you provided. For example, social class and social position are much greater risk factors (independent of diet and access to care) for bad health outcomes.
I guess I don’t read MP, or most people here, as blaming everything on “big bad pharma” and leaving out all the other factors that may be in play in any particular situation. There _may_ be a difference in ways we apportion the relative signficance of other factors in the cases of particular drugs (especially “blockbusters”).
Take an extreme example - one end of the spectrum. Those who were injured or killed by thalidomide - heavily promoted - were certainly not given information on “risk factors” (which were suppressed by company), had any discussions with their docs (other than some version of “take this, honey,”; etc. There may have been genetic predispositions for some pts - I doubt we know. Certainly we didn’t then. In any case, this was a clear instance of sustained and criminal fraud.
The Vioxx case is much more complicated, in my view. But if we accept some version of the estimated excess deaths - 30,000 would be the low end - it comes down to how much of those deaths could be associated in significant ways with the factors you cite and how many to Vioxx per se (obviously, in conjunction). And then how many rx’s would have been written for Vioxx had Merck made known all it knew - and pursued what it suspected - early on. And then how many of the rx’s written could be indepndently associated with the marketing blitz (largest in history) that accompanied the launch and what followed.
Understandably, the first things companies do - when they start getting bad Medwatch reports or other signs of trouble - is to look for _other_ reasons. Sometimes there are other reasons. Sometimes there aren’t. Sometimes there are, but - in the scheme of things - they are not the significant issue if maximizing benefit and minimizing risk - on a population level - is the main priority.
Anyway, I think we may look at relative weight of factors somewhat differently (not even sure of that), but I don’t think we see the core issue differently. (I’m leaving out MP, who is less important!).
Re: the “corporate veil,” I agree with you 100%. Nothing would make more difference, and I have appreciated nothing more than those who have “been there” who have spoken here both candidly and fairly about how things are.
That is, indeed, the ballgame. Melody P. spoke mostly to docs and some ‘insiders.’ But there is a much richer tale to be told - more complex, more interesting, and with much more compelling implications (about human strengths and frailties, and the sometimes unexpected fate of good intentions).
Justice in Michigan
p.s. for what it’s worth (not much), I thought Melody P’s discussion of the thalidomide case was bungled badly. She left out the entire history of MER-29, which is key, and was either vague or mute on a range of other key issues on the way it unfolded and its signficance. The impact on Kefauver-Harris, and _its_ signfiicance, was also missing. Terrible.
I’m assuming this had something to do with her/publisher saying that others have told that tale. True. But then better not to go there at all then do it so poorly.
DeWaarheid
Regrettably, as an “adopted” employee of SP I have to read weekly “missives” from our (insert myriad adjectives for incompetent, ignorant, greedy, etc) leaders. They are misguided, and purely business driven with a strongly worded message that is only a veiled concern for patients overall well-being (both physical and financial health). Does Vytorin work as labeled? Well, yes. Does it harm patients? Medically, no, but if its medical effects don’t translate to true health benefits that can be had elsewhere cheaper than the economic answer is a resounding YES. THAT IS WHAT NJ AG MILGRAM IS TALKING ABOUT. As a rep for almost 15 years I have been proud to sell many drugs that worked well and did what they were expected to do. It is with some chagrin that I am sad to recently find out that I have sold a drug that was something other than what I sold it to my customers as, the best and fastest solution w/o a hint of an SAE/ADR, etc. We as reps can only sell on the PI and in the manner that our company dictates to us. Unfortunately, many of our leaders have shown themselves to be greedy, unscrupulous SOBs. The present leadership at SP has left a trail of unscrupulous activity in their wakes in the off label promotion of Gentropin, the cover-ups regarding fen-phen and most recent the extreme delays and data manipulation with ENHANCE/Vytorin. Were these things done with the patients health in mind? Maybe with Gentropin and Vytorin, absolutely not with fen-phen. Were they done with PROFITS in MIND? ABSOLUTELY.
Earlier posters are correct. Pharma, PHRMA and the FDA have gotten out of hand. Yes this is a democratic, capitalistic society, but if a profit motive is your only angle, join the rest of the sc*&bags manipulating the energy markets now. Medicine should not be an emotional choice like a Coke or a choice between a brownie or apple pie for dessert. Don’t deliver another analog or isomer that twaeks your blockbuster for another decade of monster profits, put your minds to it and invest in R&D for better solutions or maladies that are not treated at all. Drug manufacturers have done a magnificent job of having their indications chopped into little pieces of DSMIV to carve out market share. If you are going to create new diseases, then you best be able to show that there is a dramatic mis-diagnosis of anther disease state and that by viewing it in this light, you have truly cured it. Although the cholesterol market is a bit controversial right now, I find it interesting that the “pleitropic” effects that have been proposed as being the reason for the statins efficacy was initially viewed as the benefits of cholesterol redutction. ANd some diabetes drugs seem to have cardio benefits not first viewed. DTC is a huge problem because it infers a benefit that maynot be there but once the patient gets the thought that that little blue or purple pill is the panacea the have been seeking, many drs are hard pressed to convince them otherwards.
Chris
Bravo! Finally, it appears that someone from Schering-Plough is willing to be open and honest about the executives.
Justice in Michigan
fen-phen was Wyeth/American Home Products, yes? Was Schering involved?
Chris
Chris
I’m sure S-P is not a happy camp at all just now but a handful of comments and opinions may not be representative of the whole. And Pharmalot commentators are not usually the most positive champions of their companies for some reason…
Chris
Chris
JiM - yes, and no
Lisa Van S
Chris,… Lisa Stet., Care to elaborate? Or are you a NJ Wimp who lives on the other side of the tracks?….
Justice in Michigan
If anyone does happen to know the Schering/fen-phen connection, would be interested in learning it. Thanks.
Chris
Dear Lisa
Stet = “let it stand”, as in my earlier comment about getting into a discussion with you. So much for trying to be brief.
Your question about my living on the other side of the track is a good one though; I just don’t understand it.
Have a nice day - really.
Chris
DeWaarheid
JiM:
To answer your question, my allegation was not that SP was involved with fen-phen of Genotropin but that the present SP leadership has a history of shady dealings in their past. Carrie Cox was the marketing manager for fen-phen and it has been revelaed in court documents that she was informed of and aware of the issues with fen-phen before they came to light in the public. I honestly think the managers of this company have the same programmed sallow attitude that you see in the “wives and mothers” on that Mormon ranch in Texas. They are scared shitless to say anything negative. SP has this dictate that it is against company policy to post on blogs, etc. Many of us “adoptees” are bugged by the “holier than thou preachy bs” that has come from SP execs that does not seem to be upheld by them.
I am just waiting for their day in court so we can get some new leadership into this place. Yeah, I may be alittle jaded, but this place is nothing like “the pictures we were shown.” As the punch line to the joke goes, “coffee breaks over, everyone back on their heads.”
Lisa Van S
Chris,
I guess you have to be a Dunnelenite to understand..
Justice in Michigan
Got it. Yes, I was aware of the connection through individual senior managers.
SP 2
And the connection to Human Growth Hormone was the same group plus a few others. Only Pfizer found out and had to pay the off-label fine for anti-aging after Fred, Carrie and cronies ran off!