Harvard Psychiatrist Didn’t Report Pharma Income
162 CommentsBy Ed Silverman // June 7th, 2008 // 9:31 pm
A Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given Congressional investigators, The New York Times reports.
By failing to report income, the psychiatrist, Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Timothy Wilens, may have violated federal and university research rules governing conflicts of interest, US Senator Chuck Grassley, an Iowa Republican tells the Times, since some of their research is financed by government grants.
Grassley has been investigating the interplay between academics who receive grant money from both pharma and the NIH. Another recent example he uncovered involved a University of Cincinnati professor who received funds from AstraZeneca while studying one of their drugs, but allegedly failed to report the outside income to the university while also receiving NIH grants.
Like Biederman, Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Thomas Spencer, reported earning at least $1 million after being pressed by Senate investigators. But even these amended disclosures may understate their outside income because some entries contradict payment info from drugmakers, the investigators told the Times.
In one example, Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But J&J told Grassley that Biederman was paid $58,169 in 2001. The Harvard group’s consulting arrangements were already controversial because of their advocacy of unapproved uses of psychiatric meds in children.
“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money,” according to Grassley’s statement in the Congressional Record. Want to see Biederman’s lack of disclosure? How about Grassley’s letters to the NIH and Harvard? Look at the Congressional Record (just search for ‘Biederman‘ once you open the link).
In an e-mail to the paper, Biederman wrote: “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Wilens and Spencer wrote e-mails saying they thought they had complied with conflict-of-interest rules.
John Burklow, a spokesman for the National Institutes of Health, told the Times: “If there have been violations of NIH policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and NIH will not tolerate it.”
The federal grants received by Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants, the Times writes, adding that the health institutes could place restrictions on the hospital’s grants or even suspend them altogether.
Alyssa Kneller, a Harvard spokeswoman, e-mailed the Times this statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.” She added that the docs had been referred to a university conflict committee for review.
The NIH last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, officials have insisted, the Times notes, so the government relies on universities. Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.
“It’s really been an honor system thing,” Robert Alpern, dean of Yale School of Medicine, tells the Times. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”
Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients, the Times writes. Although many of his studies are small and often financed by pharma, his work helped fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotics in children, the Times writes, adding that the Senate investigation did not address research quality.
In the past decade, Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults, the Times writes. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotics, which were invented to treat schizophrenia.
Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic use in children have soared, the Times notes and then cites data from Medco, the pharmacy benefits manager, showing about 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 younger than 6 years old.
Henry
I like Senator Grassley.
Laurie
So do I Henry! Biederman and his “team” are responsible for the most aggregious use of antipsychotics in children. Even their colleagues question their methods.
http://www.boston.com/news/globe/editorial_opinion/oped/articles/2007/06/19/misguided_standards_of_care/
If left to their own devices this “team” would being drugging every aspect of childhood. It was Biederman who polydrugged Rebecca Riley until her death.
It’s time that Harvard took away this mans “distingished” Harvard title, for the sake of his patients.
Laurie
Correction it was Biedermans research and recommendations, that Rebecca’s psychiatrist followed.
Matthew Holford
Biederman’s a very confused guy, I think. I came to the conclusion, long ago, that the people who work in the field of mental health are actually trying to repair themselves (but do so in secret, whilst pretending to be experts in repairing others). As I understand Biederman’s conduct, he’s been trying to crush certain kinds of apparently normal childhood behaviour.
I imagine that that is how he was treated, when he was a child, and that’s how he’s been programmed to behave. Which would be fine, except that, given his position, if his methods are incorrect (and I think they are), he will likely do a great deal of damage to his patients, when he is not treating them, but merely imposing his own reality.
Matt
ol cranky
I wonder if these folks who didn’t accurately report this income to university officials accurately reported it on their taxes. . .
Melody
You gotta love the concept of ’self-regulation’ and medical ‘ethics.’ Where are his outspoken ‘brethren’? Do they not recognize that they get smeared with the same broad paintbrush of contempt when misdeeds come to light? Do doctors endorse an unacknowledged code of silence when they enter the medical brotherhood? That code has served another organization quite well, hasn’t it?
Thom
Here’s some good footage of Biederman on 60 Minutes. The title of the program is “What killed Rebecca Riley?”
http://www.cbsnews.com/stories/2007/09/28/60minutes/main3308525_page2.shtml
HorusCat
ol cranky,
I think the pharma companies send in tax forms on what they pay docs, so the individuals concerned better have reported accurately to the IRS!
JC
Just another whore for Big Pharma. Harvard should be ashamed. I, as a physician, am ashamed.
Atlex
HC is correct. All consultants, speakers, researcher, etc. receiving payment from pharma companies receive a Form 1099 with income information. This information is also sent to the IRS.
Not wanting to make excuses for not reporting income to the University or in other places, it is important to put this in context to the era. For much of the era, there was not much emphasis on reporting this and reporting was very lax. It has only become a hot topic in the past 2 or 3 years. This is still not an excuse for not reporting, but does put it into context.
One final note…whether this was reported or not, anyone involved in this issue was very aware of Biederman’s support from pharma in terms of research grants and consulting fees. It doesn’t excuse his lack of transparency, but let’s not act as though this is “new” news.
Atlex
Laurie
While this may not be “news” to those who are well aware of funding, this is huge news when put together with the controversial nature of Biedermans “research” and influence.
If Biederman claims that the money had no influence over his research, then comes the question….why not be completely honest and open about those sources of funding?
This line in the article is especially disturbing:
” Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.”
This statement highlights how it wasn’t about the financial gain(4000 dollars isn’t going to make someone rich), yet he purposely lowered that amount to conceal the violation of the disclosure rules. If he was willing to do that over $4000, what else was he willing to cover up? It comes down to integrity, which IMO he has none.
Rodney Wilson
This happens all the time, I’m afraid. Check out Side Effects: A Prosecutor, A Whistleblower, and a Bestselling Antidepressant on Trial, a new book by Alison Bass:
http://www.amazon.com/Side-Effects-Whistleblower-Bestselling-Antidepressant/dp/1565125533/ref=pd_bbs_5?ie=UTF8&s=books&qid=1212946585&sr=8-5
johnd
I have never voted Republican, but this guy Grassley is getting a big “thank you” email from me today. Not only is he uncovering Harvard’s and others criminal behavior, but he also found out UCLA has been doing liver transplants for Japanese gangsters while poor folk are dying. From this mornings NY Times:
http://www.nytimes.com/2008/06/08/washington/08transplant.html?th&emc=th
I have been going crazy, and now have taken my ex to court because my 7 year old doctors have been feeding here amphetamines, antidepressants, anti-anxiety meds and things to help her sleep. They have just started her on Respirdal, an atypical anti-psychotic!! They started these constantly-changing drug cocktails when she was 6 years old! This medication of masses of our children can clearly be blamed on big pharma and the unscrupulous doctors that take their money. They should all be put in jail.
Hooray for Sen. Grassley!!!
johnd
Doc
Sen. Grassley rocks!
Anne
Senator Grassley DOES rock. I am especially proud that he exposed the unscrupulous Biederman, busy disease-mongering and harming thousands upon thousands of children with a made-up illness and giving them lethal drugs. Grassley is Mr. Drug Safety in the Senate - not many more like him there.
Marilyn Mann
Ed’s link for the Congressional Record isn’t working. Try this:
http://frwebgate3.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=96306823720+0+1+0&WAISaction=retrieve
or
http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=96319827735+0+0+0&WAISaction=retrieve
or go to http://www.gpoaccess.gov/crecord/index.html
and search for “Biederman”
Brian
Biederman has been one of the worst Big Pharma Hos ever… but what makes him and his ilk particulalry evil is that they take money and destroy innocent, helpless children. Sen. Grassley should have these guys tax returns audited; hopefully they can be prosecuted for tax evasion. At the very least NIH should strip Biederman and Harvard of its grants.
Anonymous
Dr. Biederman obviously didn’t want to disclose the degree to which he is enriched by pharma, even though such disclosure is required. It is more than an oversight, it is a deliberate effort to conceal material facts related to his work. If Dr. Biederman is so ethically challenged that he can’t or won’t disclose his compensation from pharmaceutical manufacturers, how honest is his work?
If Dr. Biederman won’t tell the truth to NIH and Harvard, how can he be trusted to conduct ANY research or to practice medicine? He should have his license revoked.
Lili
Henry,
You may like Chuck Grassley, but why do have so much corruption in our government? Maybe it is time Chuck Grassley and Congress, Federal and state elected should be honest and truthful, especially when it it is our health. I speak erience and when it happens to you and member of your dies because of our corruptive health system you
will feel differently.
Lisa Van S
Atlex,
I agree,.. Bierderman isnt news. His ties to Industry are well known to those who follow this issue. In other words this guy is a bum,.. no doubt about it!!!!!!
HorusCat
johnd,
Sounds like you have more of a problem than “pharma drugging your child.” No pharma company has ever taken a child to a doctor or written a prescription–your ex has something weird going on, if you think your child is perfectly fine and she thinks she needs medication. Child docs rely a lot on what parents report about behavior, so strange stuff is going on with your ex for her to be telling the doctor anything to get your daughter medicated.
Sounds like you and your ex need to hash some things out–no way should she be taking your child to a psychiatrist without your knowledge and input. Obviously, you already know that, because you are taking her to court. I am sorry it has to come to that–that is so damaging to you and to your child. I hope you already have joint legal custody and can put a stop to this–do you have visitation? I guess you can’t steal her while you get it hashed out in court, that would damage your standing. I hope you get it taken care of; in the meantime, don’t stop the meds suddenly. Get that court order and take your daughter to another psych with the explicit intention of tapering her off the drugs. Good luck!
johnd
HorusCat - thanks for the support. I’m looking for a psych in the SF Bay Area I can have my daughter see, and as well maybe provide expert testimony in support of therapy and parent training instead of this insanity of using antipsychotics on children who are not mentally ill. The whole thing seems pretty unreal.
Matthew Holford
Laurie wrote:
“…It comes down to integrity, which IMO he has none.”
I agree with that, wholeheartedly: it points to a bigger issue than a few grand.
It’s a different field, but in the UK, when one is licensed as an “competent person” within the financial services regulatory environment, one is required to disclose any criminal convictions. A traffic offence means absolutely nothing, and won’t impact on one’s application for Approval, but not reporting a traffic offence most certainly will…
Matt
Laurie
That $4000 difference not reported was a blatant attempt to circumvent the mandatory $10,000 limit for reporting. That’s what’s so disturbing about this whole situation. While some will argue that full disclosure of funding sources isn’t a true indicator of corruption of research….I think this situation highlights the fact that if an individual is willing to go to these lengths to decieve, then their ethical practices are in question.
HorusCat
johnd,
This will sound crazy, but if you know any reps in the area, ask them. Reps know who the good, thoughtful docs are–even though they often aren’t the ones prescribing our drugs! My middle son is autistic, and I recently wanted to change doctors. Sadly, the list was very short of psychiatrists who would also spend the time I wanted them to just talking to my son. Fortunately, I found one–she spends at least 45 minutes with him every time we see her. Additionally, we found a psychologist who specializes in kids on the spectrum, and she spends weekly time with us helping to problem-solve social situations and anger/impulsivity issues (like why you can only ask a person to explain a decision once, and after that they get annoyed!).
Another resource might be a local autism society–not that your daughter is autistic, but because those folks are really plugged in to the counseling community. They may have a list of psychologists who do behavioral/family counseling, much like I do with my son. They may also have insight into the legal situation. Hang in there!
AV
For an SF Area child psych, I would recommend you do some research on Kiki Chang, MD. A very progressive and highly respected doc.
Jane
I believe Kiki Chang is also part of the Biederman gang that believes in medicating children as young as possible.
Sam
In some legal circles there is a belief that if someone entices someone
to do something not legal or not ethical, the enticer is just as guilty as
the person who did something wrong.
All consultants, speakers, researcher, etc. receiving payment from pharma companies receive a Form 1099 with income information. This information is also sent to the IRS, but this latest news report clearly
shows that PHARMA is the enticer.
The money given to these so-called respected, highly regarded physicians is not as important as the motive for giving these physicians the money. It has been reported that these new psychotropic drugs accounted for $10 Billion in 2006.
Even more important is the fact that parents of young children and other adults were prescribed these drugs unnecessarily in many cases for FDA approved use and off label uses. How many patients suffered
from side effects of these drugs - in some cases age restricted was ignored. A couple of years ago, it was reported tha Zyprexa reps
did not tell physicians that the use of the drug caused patient to
gain from 20 to 100 pounds, in many cases causing patients to
become diabetic.
If PHARMa funded these research physicians in a honest and ethical manner and not as a marketing tool, every one would gain. But one
has wonder, how many more unethical situations is still not known?
observer
kiki chang is indeed part of the biederman mafia and has spoken for them on pbs when biederman refused to answer questions.
docf
Just sent the following letter to Harvard Medical School. Made me feel a bit better. Maybe if they get swamped with mail and calls they won’t languish in their decisions.
“I am a psychiatrist who trained at NYU. There I was taught that honesty was integral to the practice of good medicine. I’m sure that’s what you teach at your institution as well.
Please do not just discipline but fire Biederman et al. as quickly and publicly as possible. Their moronic greed is going to have hideous ramifications in medicine for some time but the quicker that we all publicly denounce what they did and begin to take steps to correct our imperfect system, the sooner we will begin to earn our patient’s trust back.
That is of course, unless we just want to go back to a laying of the hands and stop prescribing drugs altogether.”
P.S. I also think that their licenses should come under review for revocation for unethical conduct.
Jane
Bravo docf! Every Psychiatrist and the APA should be sending letters just like the one you wrote instead of trying to justify these doctors behavior by stating they may not have known it was drug money such as Danny Carlat.
docf
Thanks Jane. I’m rather shocked there’s not more discussion going on about it in the medical community. It really puts a lot of off label research we depend on for prescribing (especially in psychiatry) at risk. I know if I have to wait for the the FDA to approve a use a drug for a particular indication, usually I’m doing my patients a tremendous disservice. I do hope more docs get upset by this.
Nathan
Sam,
As far as I can tell from the NY Times article, it appears that the pharma industry acted entirely within ethical and legal guidelines. This appears to be a failure on the part of the medical establishment at Harvard. Disagree?
CV MD
If the academic docs reported all of the income from pharma, the sheer amounts would shock the country. Research amounts are relatively small compared with consultant and speaking fees. I’ve worked in the cardiovascular area for years and can tell you that millions have gone to Harvard and Duke physicians who carry the label “Key Opinion Leader.” Yes, millions! Did all of this get reported? Highly doubtful. These large university centers all have their own research groups whose physicians are very well rewarded. Not only that, the amounts thrown around in cardiovascualr dwarf what is spent in psychiatry.
Former Big Pharma
CV MD is right on target. Grassley is just seeing the very tip of an extremely large iceberg. If he started to look at cardiologists who work for drug companies at the major academic institutions, he would find much, much more. I also agree that harvard and Duke have been extrtemely active for years.
More power to Sen. Grassley. he’s one of the few that is trying to do something about the corruptness that is Big Pharma.
Sam Kerr
I think that the research should be closely scrutinized. There will be an inquiry, but I’m not sure it will involve reviewing all the studies in detail. That would take a long time.
Nathan
CV MD,
Do you mean that pharma pays these KOLs money for *personal* use or are you talking about research sponsorships & unrestricted grants? Unrestricted grants are a great way that pharma is funneling money into research institutions. It provides very necessary money at a time when federal funding is drying up. At my level, I’m completely unaware that pharma is personally funding the bank accounts of these KOLs. I always thought we were primarily funding their research groups.
alan milner
I find it interesting - and disturbing - that I cannot find any references in the reporting on this story to the specific drugs which may have benefited from Biederman’s suborned endorsements. It would seem to me that the public should be informed about which drugs, or drug regimens, that Biederman endorsed are manufactured by companies that subsidized Biederman’s research activities.
The failure to “name names” with respect to the specific medications involved raises questions about the mendacity of the news media itself. My guess is that the management of the New York Times saw a potential law suit emerging if they were to identify the medications in question, and simply steered clear of the question.
Imagine how much more potent this story would be if it were connected to the specific drugs that Biederman has recommended. It would also have been a better service to the community to let the public know which drugs fall into this category so that they can reconsider any treatment regimen that includes these medications.
alan milner
Ah ha! There was a reference to a specific drug, all the way down on page two of the Times article, but there was a reference to only one drug out of the unknown number of drugs in question. I reiterate my concern about the inadequate reporting, and the absence - still - of a full disclosure about which drugs may have been recommended by doctors receiving compensation from the companies that manufacture those drugs.
truthman30
This kind of thing is rampant in the industry…
It’s corrupt to the core..
truthman30
“At my level, I’m completely unaware that pharma is personally funding the bank accounts of these KOLs. I always thought we were primarily funding their research groups”
You should read up on “Martin Keller” of Brown university Nathan and “Study 329″ …
If corruption, abortion of ethics and pharma whoring is the accepted status quo at the top of the psychiatric profession, you can only imagine what happens further down..
harpy
Not wanting to make excuses for not reporting income to the University or in other places, it is important to put this in context to the era. For much of the era, there was not much emphasis on reporting this and reporting was very lax. It has only become a hot topic in the past 2 or 3 years. This is still not an excuse for not reporting, but does put it into context.
You raise a good point, Atlex, but don’t you wonder if the lax reporting is what has led to it becoming a hot topic?
CV MD
Nathan,
You’re kidding, right? Advising, Consulting and Speaking fees have gone through the roof over the past few years, with some “KOLs” commanding up to $5000/day! Many speak several times a month and consult for multiple companies. Not only that, they sit on a number of advisory boards at the same time. And then there’s the research, where they charge outrageous amounts for their own personal time! How do you think these guys live in the most extravagant houses and drive the most incredible wheels? It’s not from their day job at an academic institution. They don’t get paid that much! If the government starts to look at who pays who what and who didn’t report side income, then the lid will be blown off of Pandora’s Box.
Nathan
CV MD,
Sure - speaking fees. We generally pay $1000-$2000 for academic speakers to come in for a day. That is “pay for work” — not just “pay for hell of it”. These guys won’t speak for free!
You said in your prior message that “millions have gone to Harvard and Duke physicians who carry the label Key Opinion Leader.” If it is all in <$5000 increments, for speaking, consulting, etc, so what? We need academic speakers and consultants in order to keep up with advances in technology. These guys don’t offer thier services (speaking and consulting) for free!
M Helm, MD
Nathan, your “academic” speakers charge you for speaking services because they understand that in those situations (where they are using the corporate written presentations) they are promoting a product.
I know a fellow (more senior) academic who was always delighted to give talks around the state. For one product, he expected $1,500 per talk, and would only do local area events not more than an hour away. He also liked to be picked up at the office, driven there and back. Lots of times he was “speaking” to two or three other physicians. I think he did around a dozen of these, but it might have been more. The really odd thing was although he is a pediatric subspecialist, the product he was speaking for products had no approved use (or studies) in children. About a year later, the product was pulled due to safety issues (which were signalled in the original studies).
I’m an academic, and I speak often locally on a variety of topics. I’ve given talks to family medicine meetings, pediatrics and psychiatry grand rounds, a state respiratory therapy meeting, as well numerous meetings for our Medicare/Medicaid quality improvement organization. I make my own presentations - which is a great deal more difficult and time consuming than attending a speaker training session (followed by golf). I don’t take honoraria. Academicians will speak for free. It is called teaching.
CV, MD is absolutely correct on this point. The KOL’s (who are usually deemed such by PhRMA)are simply leveraging their academic positions to get supplemental income.
The “advisory boards” are especially absurd. There is just no way that an “advisory board” member can provide any useful direction to a company on how to research or market any product. The research folks, and the marketing teams have a much more intimate understanding of the strengths, weaknesses, opportunities and threats for their product group than any outside “advisor.” These boards exist (I believe) to buy some goodwill from the attendees, and to plant some off-label use seeds. Having worked in PhRMA marketing, I know exactly why we had “advisory boards,” and the degree to which anyone internally paid any attention to them. Payments to “advisors” are little more than bribes and ego-stroking.
CV, MD - Can I get an AMEN?
Nathan
CV MD and M Helm,
I guess I’m in a different area of research. What you say may be true in clinical R&D. I’m in pre-clinical R&D. We bring in academic consultants (”advisors”) and speakers several times a year and pay them $1000/day for their services. They provide useful information to our project teams. They also bring an “outside the box” perspective. Sometimes we get “tunnel vission” from looking at the same project for so long. Often an academic might see something totally obvious, but because we’ve been so intimately involved in the day-to-day research, we’ve missed something obvious to someone with a fresh perspective.
My only point is that not ALL payments by pharma to academics are made with bad intentions. We fund basic research (with unrestricted grants) and we bring in speakers/consultants to educate our scientists about new work going on in academia. Just like physicians, we (in the lab) don’t always pay as much attention to primary literature as we should. Academic speakers and consultants are an important part of continuing education for pharmaceutical researchers.
HorusCat
M Helm and CV,
You are a little behind the times. No more golf, at least not with my company. Speaker training programs are a real pain in the patootey now; no free time whatsoever. We do most of the training over the internet, anyway. Ad boards are few and far between with the big companies; the smaller companies still get away with them. (Biogen comes to mind, as a matter of fact.)
Most speakers are not divas and don’t command fees of $5,000 per day. In fact, I am having one in a couple of days. He is driving himself–even using MapQuest! He did ask for two talks for the day, which will pay him about $2,500, but since he is driving four hours and giving up a day’s work in his office, I don’t think that’s unreasonable. His speaking cap for us is not very high–$20,000 or so total for all speaking for the year. He’s not a huge KOL, but he uses my drug and is passionate about the disease state. To me, that kind of speaker is more valuable than some big name from Duke–often those guys are out of the office so much they don’t have any real clinical experience to offer. My docs want someone who actually treats patients and uses different medications.
Another speaker I’ve used a bit is local; he speaks not just because he is passionate about the disease state and uses my drug, but because he can draw attention to current research, network with local doctors and talk about interventions that can occur if medications fail. I think that benefits all concerned.
The vast majority of speakers for pharma are local or regional level docs who do maybe ten or so talks a year. They don’t have the reputation or desire to do national tours. The Duke, Harvard, Cleveland Clinic types get lots of press, but they are a small minority of speakers. We don’t do a lot of dinner talks anymore, because no one wants to come out at night. That’s why we do talks with a few doctors–we can do lunch or breakfast. It’s a lot cheaper, food-wise, too. And reps have kids and lives, too. The worst thing in the world is to have one of those big names in and get no one at your program!
My point is that you get in high dudgeon over what is a small part of the speaker process. What goes on most of the time is pretty small potatoes.
HorusCat
Also–some academic centers require that physicians turn over speaking fees to the university.
Perks
Three (3) men make between them ‘at least’
$4.2 million dollars from drug companies in return for persuading physicians that children should be prescribed drugs with known toxic properties.
That should be considered criminal activity on both sides, bribers and takers.
CV MD
Amen to M. Helm! Nathan - you are sheltered in pre-clinical and have no idea what goes on in the commercial side of the Big Pharma companies. The business bozos are the ones throwing around the money, not the research groups! Trsut me - many are paid $5000 per day and bill door to door! many KOLs are on “retainers” to pharma for $50,000 - 100,00 per year!! Advisors and consultants are paid ridiculous sums for very little work. It happens all the time! Horuscat - perhaps your company follows the rules, but most don’t. just look at all the bad press lately. It’s at least once or twice a week that Big Pharma is in the news for another stupid move. Wait until the democrats get elected in November - then Pharma will not know what hit them. They will be royally toasted. Please wake up!
M Helm, MD
Nathan, You are correct that we are talking apples and oranges. The preclinical consultants are the reason the internal folks know all there really is to know before the late clinical and post launch phases. That’s really a different ball game.
HCat I think you do know the score for the majority of speaker bureau situations. The challenge is that while your company limits speaker bureau fees to a $20K cap, nothing stops the doc from being on multiple speakers programs. The problem I still is that the speakers are trained to present only the side of the story the Marketing department wants heard. The speakers, unlike the internal experts (such as Nathan will be if he is not already), don’t know where are all the warts and pitfalls.
You may be right that the “advisory boards” are a phenomenon relegated to the smaller players, but I certainly know a few MDs who are proud to say that they are on advisory boards for some pretty big products. I know one company that seems to specialize in a behavioral condition which affects children predominantly which still does it “old-style.” They aren’t that small.
The meds themselves aren’t the problem. Neither is the well-designed and well-executed research which is produced (sadly that doesn’t describe the majority of industry funded post-marketing research). The problem is the marketing tom-foolery and the greed and ego beyond all reason that seem always to go with the supposed KOLs. It is a problem and it makes PhRMA and physicians and everyone around them look bad.
I think PhRMA as a whole would do well to dump them, but there is a certain economic inter-relatedness that makes that hard to do. Biederman and Co generated billions in off-label sales of atypicals for many kids who may have done as well with behavioral interventions. (Watch a few “SuperNanny” episodes, you’ll see what I mean.)
Finally, to CV. MD - Preach it, brother!
Perks
When three (3) guys get to make ‘at least’ $4.2 million between them from drug companies in return for persuading physicians to prescribe drugs with known toxic properties to children, then the credibility of the meds and the quality of the studies surely comes into question.
Children would certainly have done better with behavioural interventions if that had excluded drugs, as without those drugs their health would not have been compromised by drug toxicity.
In any event, as in the usual business surrounding drug wars, it should be considered criminal activity on both sides, that of the bribers and of the takers.
Doug Bremner MD
Not as much profit in behavioral therapy as prescription medications.
CV MD– “I’ve worked in the cardiovascular area for years and can tell you that millions have gone to Harvard and Duke physicians who carry the label “Key Opinion Leader.”
Why is that if we followed the cholesterol guidelines written the expert consensus panel in cardiology that half of males over the age of 35 would be on a statin? Why is it that KOLs in cardiology say that statins should be put in the drinking water? Why is it that KOLs in cardiology say that we should develop a “polypill” that combines aspirin and a statin that the entire population should take? Why is it that the expert guidelines state that women without heart disease should take statins when the literature shows no reduction in heart attack, let alone mortality. Why is it that the US guidelines would have double the number of people on statins as any other country in the world? Could it be that 8/9 on the expert panel had major COIs?
Expert guidelines are a great tool because if you don’t follow them you feel like you aren’t practising the “standard of care”.
HorusCat
M Helm and CV,
We are talking at cross-purposes here. I don’t disagree with you about KOLs milking the system. Or that KOLs should be sanctioned for talking/promoting drugs off-label (i.e., for kids). I’m just pointing out that they are the ones who get all the press–the majority of speakers aren’t KOLs and don’t receive the attention and perks that KOLs do.
The company does strictly control what a speaker can say–or is supposed to do so. The speaker basically doesn’t have anything that I don’t have in my marketing pieces, at least when it comes to data about the drug. They have some epidemiological stuff and disease state material. As I pointed out, most of their value comes from their experience actually treating patients.
They also are required to present all the fair balance stuff: side effects, any warnings, etc.
After a speaker gives a talk for me, I have to sign a statement to be submitted to the company that affirms that he didn’t go off-label. And we have random compliance checks from a 3rd party company–they just show up at the program and report whether the speaker stayed on-label.
All in all, I think the average speaker program is a far cry from what goes on with the KOLs.
Nathan
Doug,
It’s fine for you to write in and criticize the standard cardiology guidelines for statins. You correctly point out that “Key Opinion Leaders” in this field have conflicts of interest. However, you left out some key pieces of information about yourself that are important to people reading your post.
1) In spite of the “MD” after your name, you are not a cardiologist. You are a psychiatrist, correct?
2) You just wrote a book entitled “Before You Take That Pill: Why the Drug Industry May Be Bad For Your Health”.
3) You receive royalties on sales of that book.
Don’t you think it’s a little hypocritical to point out conflicts-of-interests in others while not mentioning your OWN conflicts-of-interest?
BDM
Nathan - What drug company do you work for that creates your own conflict of interest? Pfizer? Schering-Plough? Merck? Astra Zeneca? Other?
Nathan
BDM,
Doug was the one critisizing conflicts-of-interest. I was not. If you critisize someone else’s COI’s, I think you should also point out your own COI’s. Doug didn’t take this step, so I did it for him.
Anyway, for what it’s worth I’ve been very clear on this site about my own conflicts-of-interest: I work for a top-10 drug company - I’d rather not specify which one. I could list my other (personal) conflicts, but no one seems interested… The only interest on this site seems to be in financial ties to the pharma industry.
Perks
Biederman and co are key opinion leaders with conflicts of interest which strongly appear to be the main motives behind why they have used their influence to create health risks for children on a wide scale, where they should have used them to improve the health of children.
HorusCat
Nathan,
The only important conflict on this site is that which anyone who works for or with pharma might have. Fortunately, and something I lose sight of if I spend too much time here, most physicians understand the value of pharma, appreciate the work we do to educate patients and support advocacy groups, know that drugs don’t sell themselves and that profits from drugs drive further research, and are capable of listening to a drug detail without swallowing the spin hook, line and sinker.
I had a great example of this today: I took a speaker to an office. Before he started to share his experience with my med (and the whole class of these meds), I said–the goal here is for you to choose XXX for all your patients. We all started laughing–and my speaker said, “That’s the sell. Here’s the science.” And we went on from there. At the end, the physicians there thanked me and the speaker–they got a new perspective on the disease state, they got all sorts of prescribing tips that didn’t have anything to do with my drug, they learned about new research (not all of it medication-related), and they confirmed what my company already knows: most doctors don’t think of my drug for this particular indication, because it has not been marketed for the indication. So the assumption that physicians already know everything they need to about every drug out there–and that they will do all the necessary research on-line and through networking is clearly a mistaken assumption.
You are doing good work, Nathan. I desperately want you to solve the Alzheimer’s dilemma before I get any older. My husband is absolutely convinced he is getting AD (he is 47)–and he is more than 80% serious when he says he will kill himself if he develops the disease.
Perks
Biederman, Wilens and Spencer failed to disclose their consulting fees from the drug industry which were ‘at least’ $4.2 million between them.
Biederman, Wilens and Spencer and Harvard Mass General have been highly influential advocates of children being prescribed unapproved drugs with well known toxicity levels.
Furthermore, Biederman & colleagues have attempted to counteract future criticism and consequences to themselves of advocating off label unapproved use of these drugs in children, by aggressively promoting the idea that young children suffer from bipolar disorder. As a result there has been a rapid rise in diagnosis and prescriptions to children. Rebecca Riley was diagnosed at the age of 2 by a psychiatrist who stated she was following Harvard-recommended guidelines. Rebecca Riley died from drug toxicity age 4.
The drugs with serious risks attached advocated for use in children are made by the drug industry from whom Biederman, Wilens and Spencer received the $4.2 million.
The $4.2 million they dishonestly, and in violation of federal law, failed to disclose.
Doug Bremner MD
Nathan said “Doug, It’s fine for you to write in and criticize the standard cardiology guidelines for statins. You correctly point out that “Key Opinion Leaders” in this field have conflicts of interest. However, you left out some key pieces of information about yourself that are important to people reading your post…”
1. I post my conflicts of interest on my website which can be accessed simply by clicking on my name associated with this post or by going to the bio at dougbremner.com.
2. Yes I did write the book you mentioned (thanks for the plug) and yes I do receive royalties although probably not as much as you think
3. I made a lot more money in my days giving talks for pharma but that quit by mutual agreement because I didn’t feel comfortable/didn’t think it was ethical to give talks where I had no say over the slide content, something that was claimed to be due to the need to have slides ‘vetted by the FDA’ which I don’t really believe, but maybe someone could comment on that).
4. The book probably isn’t as radical or dangerous as you might think but my guess is that you haven’t read it and just go by the title, but we have argued about this before and so be it. Again, people who read it don’t think it is such a big deal.
5. Yes I am a psychiatrist but also board certified nuclear medicine physician and read nuclear cardiology scans and do research in cardiology and therefore have some expertise.
6. I don’t think you need to be in a specialty to comment on a drug. That is the problem, the KOLs are the only ones that the media runs to and they are conflicted not just by pharma money but because their careers are often tied up in advocating for, e.g. screening for heart disease. Sometimes it helps to have an ‘outside perspective’, you know?
7. Fact is that US guidelines have twice as many people on meds as any other country. Why is that?
BAC
Nathan
If you work for Big Pharma, you automatically have a conflict of interest. The company pays your salary and it is in your best interest for it to do well. your livlihood depends on them.
Nathan
Doug writes:
“Fact is that US guidelines have twice as many people on meds as any other country. Why is that?”
While, it could be because the drugs work! Heart attack death rates have dropped dramatically over the last decade. Why? Most doctors attribute the drop to the use of cholesterol controlling drugs. What do you attribute the drop to? I don’t think Americans are any more healthy, fit, and less stressed than they were 10 years ago. Do you?
Nathan
BAC - of course I have a conflict of interest! Does that make my opinions irrelevant? I’ve been entirely open about what conflicts of interest I have. Whenever I point out other people’s conflicts of interest (like Doug’s), I also point out my own.
Doug Bremner MD
A lot of the reduction in mortality from heart attack is due to improved emergency responses
http://www.emaxhealth.com/93/22672.html
also blood clot dissolving drugs that can be given in the ER.
And half as many people smoke now as they did 30 years ago, an important risk factor for heart disease.
http://www.washingtonpost.com/wp-dyn/content/article/2007/11/08/AR2007110801094.html
And there has been a change in the American diet over time with less consumption of foods high in cholesterol. Sure, obesity has increased, but blood pressure and cholesterol levels have fallen.
http://www.cdc.gov/mmwR/preview/mmwrhtml/mm4830a1.htm
Also the decline in heart disease mortality began in the 1950s, before statins came on the market.
If you give 100 men a statin for five years, only one of them will be saved by a heart attack. So it isn’t possible that a 56% decline in heart disease mortality is attributable soley to statins. Not saying that statins had no contribution to make, but other changes should be put in perspective.
Doug Bremner MD
The fact is that declines in mortality from heart disease are related to a halving of smoking rates, decreased blood pressure and lower cholesterol, and improved emergency responding to heart attack over the past 30 years, as noted by the CDC.
http://www.cdc.gov/mmwR/preview/mmwrhtml/mm4830a1.htm
Since only one out of 100 men will be saved from a heart attack with a statin over 5 years (while three will have one even though they on a med) statins can’t account for the 56% reduction in cardiac mortality. Also the reduction in cardiac mortality began in the 1950s before statins came on the market.
Nathan
The study you pointed to was looking at rates through only 1999. Here’s a study that looks specifically at 1995-2004.
http://www.nlm.nih.gov/medlineplus/news/fullstory_62555.html
They found that 3% year-by-year reduction in death rate was largely attributable to drug therapy.
Here’s a quote: “After adjusting for various factors that could cloud the results, the study authors found that the prescription of drugs such as beta blockers, cholesterol-lowering statins, ACE inhibitors and the like may have been the primary reason for the improvement.”
(BTW, the study was NOT supported by the pharma industry)
Justice in Michigan
Nathan and Doug - I think you guys are talking about apples and oranges, or at least quite different kinds of apples.
The study Nathan cites was of secondary prevention - mortality in those who already had heard attacks. “The long-term survival of older Americans who have heart attacks,” says the article.
I think there are very few who question the value of a range of meds in secondary prevention/post MI mortality.
Atlex
Doug,
A couple of responses to your email. First, those of us who read your comments on this site are aware of your self-reported COIs. I think Nathan is trying to make a point by his comment. We are regularly seeing KOLs and others lambasted by the media for making a public comment (eg, an Op-Ed) or publishing a paper and not listing every possible COI; of course in most instances their COIs are easily found on the web. There seems to be a double standard; if you say something pro-pharma or make a positive statement about a drug, you are expected to list every possible COI every single time even if they are publicly available. If you make an anti-pharma statement or a negative statement against a drug, there seems to be no expectation for a listing of COIs.
The second point concerns your point regarding speaker program decks. At my company, there are very strict requirements that forbid speakers from making changes to slides. Certainly there are concerns about the FDA, but of equal concern are the possibilities that the speak may discuss off-label uses for the drug. From an OIG perspective, the speaker is considered an extension of the company, thus an off-label discussion could lead to Neurontin-like situations where the company is fined hundred of millions of dollars. I can understand your ethical concerns, but it is important to note the company has legitimate reasons for its approach.
Atlex
Jon
Most of you are idiots. You have judged and executed Biederman et al without due process. The NY Times article was yellow journalism at best and also attempted to turn innuendo into fact.
There is consensus, across the research community, in psychiatry, genetics, neurology, etc. that Biederman and his teams’ work is of the most professional and unbiased quality. His team has published as many papers identifying meds that have not worked as those that do.
This kind of witch hunting will only distract Biederman, and peers across this research community, and take them away from the important work they are doing.
I don’t claim that the pharmaceutical companies are not pushing meds or that doctors are not over prescribing but this is certainly not Biederman’s fault.
Personally, the real conflict of interest is between the FDA and the pharmaceutical companies.
You people are being irrational. How would like to be burned at the stake based upon unfounded accusations?
Laurie
“This kind of witch hunting will only distract Biederman, and peers across this research community, and take them away from the important work they are doing. ”
We can only hope! Biederman research is questioned by MANY in the psychiatric community. Drugging a two year old for two year old behavior is not “important work”.
BPW
Altex,
Unfortunately, there’s very little to be said about Big Pharma these days. Hence, the shortage of pro-pharma comments. They have dug themselves an “image” hole and it will take them a long time to crawl out. About the only people saying anything good are the highly-paid prostitutes called KOLs or persistently naive pharma employees.
As for slide decks, most companies have decks that need to be approved, but the problem is they don’t stick to them. They let speakers slip in new slides on recent research, use slides to answer questions. if that won’t work, they’ll direct the ‘unrestricted” educational grants or stick their noses in CME where they don’t belong. Face it,the industry is hopelessly corrupt and will remain so until it gets rid of all the MBAs who are running or controlling the companies.
BTW, Jon is a complete idiot. Probably works for s drug company pushing atypical anti-psychotics for every CNS condition known to man, and creating a lot of metabolic problems in the meantime.
Atlex
BPW,
You obviously don’t work for a pharma company, so how can you possibly know how most companies handle slide decks?
Atlex
Doug Bremner
Yes I was talking about primary prevention (meaning preventing the first heart attack in people at risk). I have no problem with giving statins with aspirin and beta blockers to those with a heart attack, although I will remind people that it won’t necessarily prevent another heart attack (although granted there is a statistically significant reduction in mortality). Also note that in these patients adopting Mediterranean diet and exercise work twice as good as statins (Trichopolou et al) for preventing heart attack recurrance.
My point was that for “primary prevention” the evidence for statins benefit is… meager. And the studies were done on people with multiple risk factors while the standard of practice in the US is to give statins to people with elevated cholesterol, no history of familial hypercholesterolemia, and no risk factors (no study has been done on this group, for good reason).
As for KOLs (we used to call them shining lights) we should ask, who are they? There is a mutually beneficial relationship between pharma and KOLs. Walk into a major medical meeting and there are posterboards advertising pharma sponsored talks by KOLs. Pharma can promote your career by putting into the minds of regular practitioners that you are a KOL. It is called promotion, marketing, public relations, what you will. At the risk of seeming self righteous, sour grapes, inviting ad hominem attacks, or whatever, I will say what are the objective criteria for a KOL? Usually in academia they use how many times your papers have been cited by others as measured by services like ISI. Are all the academics who meet these criteria equally called upon to consult to pharma? If not, why not?
As for giving talks with slides approved by the company, if OGI considers academics to be extensions of the company, what does this mean? That they accept that academics are mere pitchmen for pharma? Can’t pharma fund lectures in the interest of education and let them talk about what they want? I am confused. In any case I am not going to give any more lectures where the content of the slides is dictated by a pharmaceutical company, period. I don’t care what the rationale or justification is.
Perks
‘Can’t pharma fund lectures in the interest of education and let them [academics] talk about what they want?’
Apparently not. That in itself should give a clue as to why academic freedom is under threat.
HorusCat
Hi Doug,
“Can’t pharma fund lectures in the interest of education and let them talk about what they want?”
The answer is simple: it depends. If the talk is promotional in any way, NO. If the talk is educational, YES.
You are not the only one frustrated by the rigidity of promotional talks–our speakers are strictly bound to use only company-approved slides for DATA. They can use their own slides about disease state stuff, epidemiology, etc., but if they make any product claims, they have to use company slides. This is indeed to avoid the Neurontin-type debacle–any product claim has to be approved by legal, with an eye to not irritating the FDA. Whatever the speaker says about my product, it has to be within labeling guidelines. If a speaker deviates from the PI, I have to speak up and say “that was off-label and we do not advocate using our product in that way.” Then I have to report the speaker to legal. Two violations and he’s out. As I mentioned in an earlier post, we have random audits by 3rd parties. It does make the talks kind of boring; I think the pendulum has swung too far in the anti-Neurontin direction.
It used to be that we could sponsor particular speakers for educational talks–CME, Grand Rounds (which are usually CME), etc. We could pay a speaker’s honorarium or provide a grant. Now there is a strong Chinese firewall between sales and grant-funding, no matter what no-nothings like BPW say. A university can request a grant for grand rounds from a company, and the speaker can talk about the weather, if he wants. Of course, they usually ask for funding for a speaker in the area of interest of the company (i.e., asking UCB for funding for an epilepsy GR). We have absolutely no say in the content of the talk. And actually, most med centers go out of their way to keep the talks as non-medication oriented as possible. Another avenue some med centers take is to allow displays outside the GR auditorium. The display fees cover the cost of all the speakers throughout the year.
HorusCat
BPW,
Atlex is right. You don’t know what you’re talking about. Speakers can’t use any slides with data about the drug being promoted that aren’t provided by the company–and therefore approved by legal and on-label. This is part of PhRMA guidelines.
There are smaller companies playing the Neurontin game, but that’s because they can get away with it. The FDA doesn’t care about the Biogens pushing Tysabri first-line; they want Pfizer and Merck and Lilly. Better headlines and deeper pockets.
Perks
‘Can’t pharma fund lectures in the interest of education and let them [academics] talk about what they want?’
Not if the academic wishes to bring up relevant issues pharma do not want on the agenda.
HorusCat
Perks,
You don’t know what you are talking about. If my company provides grant funding for a grand rounds speaker, we have no control whatsoever over who is chosen or what he/she says. It’s not like anyone other than a rep is going to be there to watch over them. No one from the company is playing Big Brother, making sure the speaker doesn’t dis a drug.
Perks
‘Can’t pharma fund lectures in the interest of education and let them [academics] talk about what they want?’
Free speech or academic freedom is limited. For instance, pharma companies promoting lipitor would not welcome an academic speaker who wished to point out that ‘the evidence for statins benefit is… meager.’
Or that ‘patients adopting Mediterranean diet and exercise work twice as good as statins (Trichopolou et al) for preventing heart attack recurrance’.
Science must adhere to the aims and objectives of pharma regardless of its credibility.
HorusCat
Perks,
You’re just wrong. If Duke asks Pfizer for a grant to fund a GR on heart disease and cholesterol, they don’t have any restrictions on who the speaker is or what he can say. Like I said, he could get up and talk about NASCAR or global warming. He could say that he thinks Crestor is the cat’s meow and Lipitor is crap. He could say that cholesterol is a myth and prayer is the answer. No one at Pfizer gets to hear his talk or see his slides in advance. No one from Pfizer attends the talk and reports back to anyone on what he says. Hell, the reps probably don’t even go.
It’s ludicrous to think that a noted scientist would even talk about basic stuff like statins’ effects on cholesterol and heart disease. These ARE already trained physicians attending GR. They want to hear about new research and odd disease states. I funded many a GR before the firewall went up, and the speaker usually went off on tangents totally unrelated to my drug.
I know from my time with Pfizer selling Zoloft that we and other companies funded all the GR at my med center–and 75% of the talks weren’t about meds. They were given by psychologists, social workers, therapists and basic scientists, covering things like genetics, cognitive behavioral therapy, dialectic therapy, you name it. The doctors already know how the drugs work–they don’t need a primer in the action of SSRIs or cholinesterase inhibitors. I funded a GR speaker who touted CBT for OCD–and Zoloft was/is indicated for OCD. The speaker presented data showing that well-administered and slightly modified CBT is the most effective way to treat OCD in kids. No one from Pfizer asked me what the guy said.
If you are going to make assertions of fact, make sure you have the facts. Otherwise, you’re just engaging in polemics.
HorusCat
Perks,
BTW, what exactly are your credentials for expounding so knowledgeably on the industry? You work for the industry? Have worked for the industry recently, since PhRMA guidelines were put in place? Do CME for a university? Organize grand rounds? Apply for grants from companies? Are an academic who has been told he isn’t welcome to talk about the Mediterranean diet if Pfizer is paying his freight? Or just a pharma-basher eager to join in to a politically-correct orgy?
Odd how the pharma folks and those interested in actual conversation (such as Justice, Just A Thought, Jaynesday, CMC guy, M Helm MD) on the site are so up-front about their interests and motivations, while all the bloviating (how about that Justice?) anti-pharma wankers almost never reveal themselves–and never actually engage in dialogue, just sarcastic remarks and unsupported assertions.
BPW
Altex and HorusCat,
I actually do know what I’m talking about. I’ve worked as an MD in pharma for over 15 years. You are talking about what pharma should do and I’m speaking about what pharma does. They are supposed to follow rules, but many think that they’re meant to be broken. I’ve worked in medical Affairs and it is the biggest nightmare. The commercial crooks always want the MDs to sign off on illegal and unethical activities. It;s a constant battle. I don’t think that you know what really goes on inside.
The business people are impossible to deal with. That’s why i’ve switched back to R & D - it’s much more pleasant.
HorusCat
BPW,
Perhaps you need to change companies. I am good friends with a medical liaison (an MD) and she adheres rigorously to guidelines–as does every other liaison with whom I’ve worked.
I’ve seen funding for GR and CME speakers in action–and watched speakers talk about whatever they want. I have also seen that med centers refuse to use speakers who seem in any way to be promotional.
I just attended an all-day CME event funded by 5 companies with a dog in the fight, so to speak. The talks had nothing to do with the medications, except for one about pregnancy and medication use. So where was the big pay-off for the companies?
I’m not arguing that there are those on the commercial side who want to break the rules. You’re always going to have that, in every industry (look at good Sen Dodd and Countrywide). But as we shine a bright light on the instances where rule-breaking occurs, let’s not tar the entire industry with the same brush. The vast majority of us go about our jobs with integrity and sincerity. And let’s not assume that every person connected with the industry, whether as an employee or an outside researcher or KOL, is automatically corrupt when they advocate the use of medications. That’s what gets me about this: all the COI hoopla seems to suggest that anyone who advocates the use of a medicine is corrupt and can’t be believed–and yet we rely on these medications to treat disease. The logical conclusion of all this assumption of conspiracy and corruption is that we shouldn’t have medications and we certainly shouldn’t talk about how to use them.
I locate the root of the problem in the assumption that health care is a right that should be paid for by someone else–the obscurance of what health care costs and who is actually paying for it allows the waste and over-utilization to occur rampantly. Pharma, insurers, physicians, hospitals and patients take advantage of this shell game, because very few actually take the money out of their wallets to pay for their care. Make a patient pay for his Lipitor directly, and he may decide he’ll take the risk of an MI instead. Make him responsible for most of the cost when he does have an MI (probably due to overeating, not exercising and smoking), and maybe he’ll pay for the statin, eat a Mediterranean diet and stop smoking.
And let’s not lose sight of the fact that the vast majority of our health care dollars aren’t spent on drugs, anyway. They are spent on end-of-life care and over-utilization of testing and provider services. Pharma is an easy target–much easier than telling a family that grandpa is a vegetable and isn’t going to get heroic measures to keep him alive for another week so that family members can fly in from all over the country to see him lie there like a rutabaga before he finally is allowed to pass on. Or telling a young girl’s family that she isn’t going to get an organ transplant to keep her alive for 2 more months (Sen Edwards!).
Atlex
BPW,
I agree with HC, change companies or do something about what your company does. Frankly, outlier companies like yours hurt all of us. I know that in my company, noncompliance to these rules means automatic dismissal. Moreover, I’ve seen such dismissals happen.
Atlex
Justice in MI
For Atlex and HC - Is it conceivable that compliance (and consequences for noncompliance) varies within different teams within the same company, depending on a range of factors (importance of product in portfolio, who happens to be in charge at that level, etc.)?
Genuine question, tied into other thread about company structure.
Atlex
Justice,
Anything is possible; however, at my company the processes have been standardized, making it very difficult to abuse the system for very long. The grants system for CME and other similar activities has been completely divorced from the speaker’s programs. Each speaker’s programs is standardized with approved slides that cannot vary. Speakers are allowed to answer questions that arise from the audience, but are required to note that the answer comes from their own experience. They then must return to the approved slides. If the speaker does not follow “the script”, a company representative is expected to file a report. Moreover, 3rd parties regularly audit these programs to ensure compliance.
Do abuses happen? On occasion I guess. But they are likely rare because of the consequences. I’m pretty confident that most of the majors have similarly rigorous programs that will become more rigorous following the release of the forthcoming revision of the industry’s Code of Conduct.
Atlex
Perks
On the topic of conflicts of interest, there is an interesting audio interview with Melody Petersen that was aired on June 12 that can be listened to at onpointradio http://www.onpointradio.org/shows/2008/06/20080612_a_main.asp
Its called ‘This hour, On Point: Our daily meds, and a nation hooked on prescription drugs.’
Melody found ’shocking conflicts of interest. Medical professionals co-opted by drug companies for shady research and non-stop marketing. It looks like a scandal of pushers.’
Atlex
Perks,
Did Melody mention her COI? She has one you know–she wants to sell books! That is as much a COI as a KOL working with a pharma company. It doesn’t make her right or wrong, but it would be hypocritical for her not to admit it and self-serving if she doesn’t mention it as a precursor to her statements. I’d also be interested to know if she has other nonfinancial COIs.
Atlex
Perks
Atlex, as you most likely saw from my comment, it is made perfectly clear that she is the author of Our Daily Meds on the webpage the audio link is on.
Dr Carlat is also a guest and discusses talks, a drug rep brings up issues they do here including the topic of golf trips not taking place and much more. There is a mention of how one person every 5 minutes dies due to taking a prescribed drug.
You may like the interview, it is fairly long and there is a lot to it.
Perks
Melody Petersen’s book is also mentioned at length at the beginning of the audio, there is no non-disclosure here. http://www.onpointradio.org/shows/2008/06/20080612_a_main.asp
Jon
First of all. Biederman has never drugged a 2 year old for 2 year old behavior. This an outright lie.
Secondly, I have nothing to do with pharmaceutical companies, or medicine, or government, etc. I am much more qualified than that. I have a bipolar daughter who was initially diagnosed at age 6 and we received 2nd and 3rd opinions at Stanford (Steiner) and USF. We then read all of the available research (which 12 years ago was maybe 2 inches thick) and learned about all the meds that existed and as new ones as they became available.
At age 8, after all other less drastic options had been exhausted, and our daughter was still suffering terribly (at age 6 she would write notes to us begging us to kill her so she wouldn’t be in pain anymore) we began trying medications. After about 4 years, and 2 hospitalizations, we found a combination of meds that nearly eliminated her manic and aggressive behaviors. She was not subdued or a zombie. She was relieved.
If we had not opted to take the risks associated with these meds we are sure our daughter would be dead today. Suicide rates for untreated BP are the highest of all severe mental illness (around 18%).
Dr Biederman and the other dozens of researchers across the country, who also get funding and consulting fees from pharmaceutical firms, enabled my daughter to have this medical option.
I have read his and all the other BP pediatric researcher’s work and his team is clearly one of the most significant contributors to the field.
Most of the subjects in his longitudinal studies are not his patients. Many of the subjects are taking no medications at all. The research is just starting to include genetic correlations in conjunction with the Broad Institute. This will certainly lead to much better diagnostics and treatment that is clearly very subjective at this point.
I have never disagreed about the conflict of interest that exists because the pharmaceutical companies providing so much research funding. Given the NIH’s reluctance or inability to provide the necessary funding there no better option.
Finally, why is Biederman responsible for the explosion of BP diagnoses and treatment? He didn’t train these doctors? He didn’t treat these children?
If some researcher publishes findings about a new diabetes treatment and some doctor reads it and prescribes these new meds why is the original researcher responsible for the outcome? The researcher doesn’t approve medications. This is the job of the FDA.
If someone wants to prescribe something off label they better know more than just reading an article or talking to a drug rep. Also, the patient should be asking questions like, “What is your experience level with this medication? How many people have you diagnosed and treated with this medication?” etc.
Unfortunately, in today’s world of medicine, the patient needs to be a strong advocate for their children and themselves. Just because someone has a MD stuck at the end of their doesn’t make them necessarily the best resource for every kind of disease or treatment.
truthman30
Hi Jon..
While I do sympathise with your situation..
you should be aware that it was not too long ago that psychiatrists were adamant in their view that “depression” could not exist in children… I am sure it was the same with Bipolar disorder…
This was before the psychiatric drug cartels though…
Why the xplosion in diagnosis of “bipolar in kids”.. Follow the money trail and find out..
These “labels” are used now as a convenient “catch all” diagnosis for a range of different behaviors in children..
What ever happned to children just being sensitive or over sensitive or shy or just different?…
You should research psychiatry a bit more..
You would be horrified if you did…
Maybe you should start with reading this letter of resignation from Loren Mosher, a well known psychiatrist who resigned in disgust…
http://www.critpsynet.freeuk.com/Mosher.htm
Loren R. Mosher M. D.
2616 Angell Ave
San Diego, CA 92122
December 4 1998
Rodrigo Munoz, M.D., President
American Psychiatric Association
1400 94 Street N. W.
Washington, D.C. 20005
Dear Rod;
After nearly three decades as a member it is with a mixture of pleasure and disappointment that I submit this letter of resignation from the American Psychiatric Association. The major reason for this action is my belief that I am actually resigning from the American Psychopharmacological Association. Luckily, the organization’s true identity requires no change in the acronym.
Unfortunately, APA reflects, and reinforces, in word and deed, our drug dependent society. Yet, it helps wage war on drugs. Dual Diagnosis clients are a major problem for the field but not because of the good drugs we prescribe. Bad ones are those that are obtained mostly without a prescription. A Marxist would observe that being a good capitalist organization, APA likes only those drugs from which it can derive a profit - directly or indirectly.
This is not a group for me. At this point in history, in my view, psychiatry has been almost completely bought out by the drug companies. The APA could not continue without the pharmaceutical company support of meetings, symposia, workshops, journal advertising, grand rounds luncheons, unrestricted educational grants etc. etc. Psychiatrists have become the minions of drug company promotions. APA, of course, maintains that its independence and autonomy are not compromised in this enmeshed situation.
Anyone with the least bit of common sense attending the annual meeting would observe how the drug company exhibits and industry sponsored symposia draw crowds with their various enticements while the serious scientific sessions are barely attended. Psychiatric training reflects their influence as well; i.e., the most important part of a resident curriculum is the art and quasi-science of dealing drugs, i.e., prescription writing.
These psychopharmacological limitations on our abilities to be complete physicians also limit our intellectual horizons. No longer do we seek to understand whole persons in their social contexts rather we are there to realign our patients’ neurotransmitters. The problem is that it is very difficult to have a relationship with a neurotransmitter whatever its configuration.
So, our guild organization provides a rationale, by its neurobiological tunnel vision, for keeping our distance from the molecule conglomerates we have come to define as patients. We condone and promote the widespread overuse and misuse of toxic chemicals that we know have serious long term effects: tardive dyskinesia, tardive dementia and serious withdrawal syndromes. So, do I want to be a drug company patsy who treats molecules with their formulary? No, thank you very much. It saddens me that after 35 years as a psychiatrist I look forward to being dissociated from such an organization. In no way does it represent my interests. It is not within my capacities to buy into the current biomedical-reductionistic model heralded by the psychiatric leadership as once again marrying us to somatic medicine. This is a matter of fashion, politics and, like the pharmaceutical house connection, money.
In addition, APA has entered into an unholy alliance with NAMI (I don’t remember the members being asked if they supported such an organization) such that the two organizations have adopted similar public belief systems about the nature of madness. While professing itself the champion of their clients the APA is supporting non-clients, the parents, in their wishes to be in control, via legally enforced dependency, of their mad/bad offspring. NAMI, with tacit APA approval, has set out a pro-neuroleptic drug and easy commitment-institutionalization agenda that violates the civil rights of their offspring. For the most part we stand by and allow this fascistic agenda to move forward. Their psychiatric god, Dr. E. Fuller Torrey, is allowed to diagnose and recommend treatment to those in the NAMI organization with whom he disagrees. Clearly, a violation of medical ethics. Does APA protest? Of course not, because he is speaking what APA agrees with but can’t explicitly espouse. He is allowed to be a foil; after all he is no longer a member of APA. (Slick work APA!)
The shortsightedness of this marriage of convenience between APA, NAMI and the drug companies (who gleefully support both groups because of their shared pro-drug stance) is an abomination. I want no part of a psychiatry of oppression and social control.
Biologically based brain diseases are convenient for families and practitioners alike. It is no fault insurance against personal responsibility. We are just helplessly caught up in a swirl of brain pathology for which no one, except DNA, is responsible. Now, to begin with, anything that has an anatomically defined specific brain pathology becomes the province of neurology (syphilis is an excellent example). So, to be consistent with this “brain disease” view all the major psychiatric disorders would become the territory of our neurologic colleagues. Without having surveyed them
I believe they would eschew responsibility for these problematic individuals. However, consistency would demand our giving over “biologic brain diseases” to them. The fact that there is no evidence confirming the brain disease attribution is, at this point, irrelevant. What we are dealing with here is fashion, politics and money. This level of intellectual/scientific dishonesty is just too egregious for me to continue to support by my membership.
I view with no surprise that psychiatric training is being systemically disavowed by American medical school graduates. This must give us cause for concern about the state of today’s psychiatry. It must mean, at least in part, that they view psychiatry as being very limited and unchallenging. To me it seems clear that we are headed toward a situation in which, except for academics, most psychiatric practitioners will have no real relationships, so vital to the healing process, with the disturbed and disturbing persons they treat. Their sole role will be that of prescription writers, ciphers in the guise of being “helpers”.
Finally, why must the APA pretend to know more than it does? DSM IV is the fabrication upon which psychiatry seeks acceptance by medicine in general. Insiders know it is more a political than scientific document. To its credit it says so, although its brief apologia is rarely noted. DSM IV has become a bible and a money making best seller - its major failings notwithstanding. It confines and defines practice, some take it seriously, others more realistically. It is the way to get paid. Diagnostic reliability is easy to attain for research projects. The issue is what do the categories tell us? Do they in fact accurately represent the person with a problem? They don’t, and can’t, because there are no external validating criteria for psychiatric diagnoses. There is neither a blood test nor specific anatomic lesions for any major psychiatric disorder. So, where are we? APA as an organization has implicitly (sometimes explicitly as well) bought into a theoretical hoax. Is psychiatry a hoax, as practiced today?
What do I recommend to the organization upon leaving after experiencing three decades of its history?
1.. To begin with, let us be ourselves. Stop taking on unholy alliances without the members’ permission.
2.. Get real about science, politics and money. Label each for what it is - that is, be honest.
3.. Get out of bed with NAMI and the drug companies.