… should really stop, writes the editorial board of the Milwaukee Journal Sentinel.
Especially since the grubber in question is the University of Wisconsin’s medical school, which got a million dollars from a drug company to put UW’s good name behind the company’s synthetic testosterone.
Said testosterone is not only of uncertain benefit to men older than 45; it might actually be dangerous. But its maker, Solvay, touted it on a continuing medical education website which offered CME credit to doctors who read articles on the site about it. And, since a real live university sponsored the deal, the medicine looked legit.
Industry funding of continuing medical education should be phased out to avoid conflicts, and Congress should require full disclosure of all industry payments for continuing medical education.
Phasing out industry funding of CME means phasing out CME, at least as we’ve come to know it.
From UD‘s friend Bill at The Periodic Table — a link to an editorial in the Minnesota Star-Tribune excoriating the University of Minnesota for ineptitude and indifference in regard to conflict of interest among its professors.
How is it possible to assess a conflict of interest, much less manage it, if [university] officials don’t know how much money is involved?
Grassley’s letter about COI to the university was “embarrassing,” writes the Strib.
Things at UM are going to get worse before they get better. UD thinks they should start stockpiling anti-embarrassment pills.
*******************
Oh. The quotation in my headline, taken from the Strib editorial, is from Arthur Caplan, the country’s best-known medical ethicist.
… is well-known. But it’s a sort of background fact until forced resignations and conflict of interest scandals break through to the daily papers.
That’s what’s happening today, as its head of medical device regulation resigns (way industry-friendly, he approved all sorts of quackery) at the same time as its head of drug approval gets investigated for conflict of interest.
In the COI case, Janet Woodcock appears to have been been friends – and a collaborator on scientific papers and articles – with MIT Professor Ram Sasisekharan.
They wrote one of those thirty-author, ten-page thingies you see in the New England Journal of Medicine. Here’s the thing itself:
Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K, Lansing JC, Sriranganathan N, Zhao G, Galcheva-Gargova Z, Al-Hakim A, Bailey GS, Fraser B, Roy S, Rogers-Cotrone T, Buhse L, Whary M, Fox J, Nasr M, Dal Pan GJ, Shriver Z, Langer RS, Venkataraman G, Austen KF, Woodcock J, and Sasisekharan R. “Contaminaed Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” N Engl J Med 2008 Jun 5;358(23):2457-67
And of course the MIT guy’s really an entrepreneur with his own company and that company appears to have been unfairly favored by the FDA in a recent competition for approval for a blood thinner; and the competing company filed an ethics complaint against Woodcock, which is now being investigated by the Inspector General.
In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta’s FDA connection as a “game-changer,” and Momenta’s stock jumped 17% in a day.
Ten little pages, and look what happened! Talk about significant research results…
***********************
Update: Roy Poses, at Health Care Renewal, provides crucial background and analysis on the heparin scandal.
… lurks in the unlikeliest places.
Found this toward the end of the comment thread for a New York Times debate on whether direct to consumer television commercials for prescription drugs is a good idea.
(Answer, according to virtually all debaters and commenters:
Are you effing kidding?):
An erection pill called Ta Da? Ta Da! I’m now a vacuous, bourgeois, self-entitled cretin chasing his menopausal, morbidly obese spouse around our stucco McMansion with a raging erection – Ta Da! the American Dream!
There’s more where that came from. The whole thing’s worth reading.
***************
Results of the debate here.
David Healy describes
… the astonishing marketing power of pharmaceutical companies, which can now effect huge changes in medical culture within months. [To take one] case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company-written. Firms of medical writers are contracted to pharmaceutical companies to place in academic journals articles attributed to, but not actually authored by, university researchers.
Because of this, guideline makers like Nice, which can only go by the published literature, are trapped. Regulators, like the FDA and MHRA, which reflect a professional consensus rather than lead on issues like this, are likewise stuck. Doctors who believe their role is to follow Nice, the MHRA and the scientific evidence are in the same bind.
The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians with no links to industry that will sound a note of caution about prescribing antidepressants to women of child-bearing years. This is a problem that increasingly applies across all of medicine – from the use of HRT, to drugs for osteoporosis, respiratory or gut problems, pain-relief, as well as all psychotropic drugs.
Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good. Where once farmers knew to keep their cattle out of fields growing the serotonin reuptake inhibiting weed, St John’s Wort, as it caused miscarriages, under industry influence women have been herded by doctors in exactly the opposite direction.
These are quotations from a BBC special on the next edition (it will come out in 2012) of the psychiatric DSM.
The catch-all mental disorder category NOT OTHERWISE SPECIFIED — which will apparently be abundantly featured in the forthcoming edition — allows UD (and you too) to anticipate lifelong toxic drug treatment for something or other.
*********************
“The relationship between the pharmaceutical industry and the American Psychiatric Association” is at the heart of Diagnostic and Statistical Manual.
“Each edition doubles the number of diagnoses.”
“A seemingly small change in adding diagnostic criteria can create a whole other population to prescribe a medication for… Most of the categories have a not-otherwise-specified diagnosis…. A person is exhibiting some mood symptoms but those symptoms are not that severe. When you have that kind of (NOS) prescription, you are inadvertently pathologizing what could be a normal part of [life].”
“If you create a criteria, and people appear to meet the criteria… well, many kids appear to have the criteria for bipolar pediatric disorder… This leads to treatment with a group of medicines that are among the most toxic in medicine…. Children of one, two, three, are put on these drugs…”
“There are barely short-term studies, let along long-term studies, on childhood bipolar disorder.”
“The majority of DSM panel members have financial ties to the industry. In the panels on mood disorders and schizophrenia, one hundred percent do… These are THE categories for which drugs are the standard treatment.”
“Psychiatry is undergoing a crisis of credibility… Senator Grassley has asked the APA leadership for their financial records…”
“The APA must develop more rigorous COI policies… Unrestricted research grants, for instance, are currently excluded in their COI policy…”
“The DSM decisions are worth $25 billion to the drug industry.”
“This whole business of sub-clinical disorders… will interest the drug industry enormously…”
“This could cause the rates of mental disorder to sky-rocket. … The pharmaceutical industry will be thrilled with broader, more open descriptions of disorders…”
Now UD, let’s calm you down.
**********************************
UD thanks Daniel Carlat.
Professor Gloria Bachmann was
paid to put her name
on an article other people wrote.
*******************
Nice Work
Holding hands with Wyeth
‘Neath a sunny sky
Nice work if you can get it
And you can get it if you try
Ghosting for big pharma
Lying lie after lie
Nice work if you can get it
And you can get it if you try
Just imagine women
Trusting that you did the work
And prescribing doctors
What a bunch of ignorant jerks
Showing rank indifference
Then collecting your fee
Nice work if you can get it
And if you get it — how sick will that make me?
UD thanks a reader for alerting her to the latest Grassley letter, this one sent to the Naval Medical Center, just a hop, skip, and a jump from UD‘s house.
Once again, Senator Grassley wants to know about any “failure to report outside income by a physician at your institution.”
How do you think he’ll do? He’s sent out dozens of these letters, and so far he’s batting a thousand. Let’s keep backing a winner.
… of the Senate hearing on Continuing Medical Education. It should be starting about now…
Oh. Here it is!
Senator Kohl, specs low on nose, summarizes the problem — “Crux of today’s hearing… Do they instead market the industry’s latest products? Greater transparency, stronger firewalls, need to be considered… I’m disappointed that the AMA has not yet updated their ethical guidelines on this… “
Martinez: “Accounts of ethical lapses on the part of some doctors and pharmaceutical companies are troubling… Sometimes the line between promotion and education can be blurred… ”
Franken: “How are patients affected by COI? … Unlimited and far from impartial interactions between industry and providers… This often has a negative influence on outcomes… Drives up prices to patients… Medical schools are over-reliant on industry funds… CME is another example of the same thing… ”
HHS/Inspector General guy: A little stiff, nervous. “An honest tale speaks best being plainly told – Shakespeare.” As opposed to glitzy biased CME tales. Wants full prohibition of industry support of CME. Wants firewalls – money yes, but independent grant organizations to disperse the money. Or doctors can pay for their own education. This might make for higher quality if they’re doing the paying. Growing concern about the quality of CME — shift cost to physicians.
Steven Nissen: “CME has grown into an enormous industry with extraordinary influence on the practice of medicine… CME has become an insidious vehicle for the aggressive promotion of drugs and devices. This now dominates the education of physicians. Marketing cleverly disguised as education…. With a wink and a nod the communication company selects speakers they know will please the industry. I can almost always guess who the speakers will be… Who is guarding the integrity of the process? I’ve written to the CME certifying agency with many complaints about bias – my letters were never even acknowledged.”
Next speaker: “It is impossible to find any aspect of medicine in which industry does not have significant control… Industry funding creates bias… Need to be free of industry influence… Stronger measures are required… Current situation unacceptable.”
Jack Rusley, med student, AMSA: He’s wearing his white doctor suit! “Medical research must serve the public and not physician lifestyles… Why do students care so much about these issues? … Not yet tinged with the streak of cynicism… My computer’s shutting down… Sorry… I’ll continue speaking off the cuff… Med students used to be docile in regard to authority… Not anymore… After pressure from Senator Grassley, the press, and students, Harvard has reviewed its COI policy and now has a passing grade on the AMSA scorecard.”
********************
Question session. Martinez, a lawyer, is shocked because continuing ed in the law is not sponsored by any industry. No money involved.
The bias was so terrible at a recent CME session Nissen wandered into that “I had to walk out.”
Another speaker: “Physicians are accruing the education capital here — They should pay for it themselves.”
Franken asks about the accreditation organization for CME. Nissen: “I can assure you that a considerable amount of CME … is marketing. It is not restricted in any way. It is highly biased. We therefore need a new system of certification. We need this organization to go away altogether. There’s no will to police this.”
[I’m sure I’m getting some names wrong, etc. Will correct later. This is live-blogging.]
Franken: “Is there anything good to say about CME, besides better hotels and shrimp?”
Nissen: “There are a few good CMEs. But most are subtly or not so subtly organized to get people to buy a product.”
Another speaker: “CME hugely drives high costs in health care in this country. We spend ninety billion dollars a year more than we should be spending. This machine for getting doctors to prescribe the most expensive medications is one of the big reasons for the problem…. It drives me crazy to hear all this talk that we can’t afford health care reform! We can. We need to make these changes.”
Enough. The second panel’s here. They’re the pro-COI guys. I’ll let one of their fans live-blog that.
Tell it to Richard Joel, the president of your university.
He still hasn’t faced the fact that Bernard Madoff and Ezra Merkin held among the highest positions of authority at your university for years, and that no one ever questioned that. Only when criminal investigations proceeded against these men did your university respond, and it responded by erasing them from its web pages and pretending they didn’t exist.
Nor has Joel faced the fact that a number of the remaining Yeshiva trustees — all male, of course, wouldn’t want to pollute things with a woman (see the post directly below this one)– at your university seem still to be involved in financial conflicts of interest with one another.
Really, Professor Asch. Begin at home. Start by looking around you.
A recent issue of Nature attempts to summarize the latest embarrassment from America’s psychiatrists — their revision of what everyone calls their bible, the Diagnostic and Statistical Manual of Mental Disorders.
This bound bohemoth – its anal insistence on stuffing everything in the world into itself stronger proof of mental disorder than most of the diagnostic descriptions within it – has always attracted ridicule and condemnation, and the next edition will attract even more.
Because this time around the anal fixates of the APA are adding secrecy, hyperactivity, and self-delusion to their practices.
[C]ritics have alleged that the process has been too secretive, and that working groups have been pushed to meet an unrealistic 2012 publication date. Some, including the architects behind the last two editions of the DSM, also complain that project leaders are pushing for the premature inclusion of changes meant to incorporate recent genetic and neurobiological advances, before they are ready for the clinic.
The problem facing the revision
committees is that the manual
is not a bible; it has become a
tower of babel. Picture the
situation in this way and it
begins to make sense:
See how there isn’t any foundation,
and how you’ve got a lot of frenetic
people running around trying to
decide what to do? Only they
can’t decide what to do, because
they’re not living, as Madonna sings,
in a material world:
Rather than relying strictly on categorical diagnoses — one either has depression or does not, for example — they have pushed to add ‘dimensional’ criteria to ascertain to what extent a person is depressed. Such criteria could also address similarities among different disorders, reflecting, for example, neuroimaging studies that suggest multiple anxiety disorders can affect the same region of the brain.
… [A]larmed critics … say the science behind such dimensional assessments is not yet ready to be incorporated into clinical assessments. In March, Duke University psychologist and epidemiologist Jane Costello resigned from the working group on child and adolescent disorders … Adding these assessments would require a great deal of extra research, she says, at a time when working groups were already behind schedule for their 2012 publication deadline. “There just hasn’t been time to do this in an organized way,” she says. “This is a huge job.”
Yes, real science does take time, but psychiatry has never let empirical unreadiness impede it, and the drug companies are getting impatient.
The latest revisions come as financial ties between prominent psychiatrists and pharmaceutical companies are being closely scrutinized. A 2006 analysis of potential conflicts of interest among those who participated in the last revision showed that 56% of panel members had financial links to the pharmaceutical industry.
Chop-chop!
Australian medical students launch Pharma Phacts:
Fed up with the barrage of drug company marketing designed to mould their future prescribing habits, a group of Australian medical students has decided to fight back.
Pharma Phacts, a national campaign that is officially launched today, aims to educate students on the effects and unconscious influence of pharmaceutical marketing. And it will come with an optional online pledge, in which students can vow to never accept a drug company freebie.
… After a “soft launch” including a Facebook group in March, Pharma Phacts gained about 450 members at 19 universities around the country.
… “[M]ore than doctors, we are ill-equipped to differentiate marketing from education [said one student]. With the free books, free stethoscopes — by the time you are prescribing you are totally involved in the machine. I think the Vioxx case has been an eye-opener about pharmaceutical tactics: a lot more medical students are coming off the fence. We want to be the generation that says no.”
A former psychiatrist, alarmed by what the profession’s become, reviews the latest farcical use of psychiatrists in a high-profile trial, and then considers the larger situation:
… These days, psychiatric diagnoses are based on the “Diagnostic and Statistical Manual of Mental Disorders,’’ published by the American Psychiatric Association. This hefty volume is a main money-maker for the association, upward of a million dollars in annual sales.
… It is … tarnished by many of the specialists being paid to be involved in studies of drugs to treat the illnesses they list as their expertise. The temptation for them to find a drug that will treat a diagnosis they can specify and in which they are the expert is significant.
The current conflict-of-interest investigations – including by Congress – into psychiatrists getting paid to do research that might prove the efficacy of the drugs they use to treat their patients are well documented. If a drug company can link a particular drug to a particular diagnosis, bingo – a blockbuster drug can earn over a billion dollars a year. The lucrative link between a diagnosis and a drug to treat it, when diagnosis itself is culture-bound and often subjective, pollutes the impartiality of the “Diagnostic and Statistical Manual,’’ and opens the courtroom door to the psycho-battles that demean and confuse…
The corruption not only of examining rooms and courtrooms, but also of universities, by ghost-writers, shills, and mercenaries, emerges more and more clearly. University Diaries looks forward, as always, to chronicling it.
Arnold Relman, in the New York Review of Books:
Nearly a half-century ago, Stanford economics professor Kenneth Arrow, later a Nobel laureate, convincingly argued that medical care cannot conform to market laws because patients are not ordinary consumers and doctors are not ordinary vendors. He said that sick or injured patients must rely on physicians in ways fundamentally different from the price-driven relation between buyers and sellers in an ordinary market. This argument implied that, contrary to the assumptions of antitrust law, market competition among physicians cannot be expected to lower medical prices. And since physicians influence decisions to use medical services far more than patients do, the volume and types of services provided to patients—and hence total health costs—need to be controlled by forces other than the market, such as professional standards and government regulation. But Arrow’s argument was largely ignored in the rush to exploit health care for commercial purposes that ensued after the passage of Medicare and Medicaid in 1965.
When the organizations that set professional standards — the whorish American Psychiatric Association, for instance — are themselves market law conformists, what hope for change? That organization, speaking of excess volume and types of services, is even now revising the profession’s diagnostic manual to medicalize more and more non-medical human behaviors. There’s money in it.
*********************
Update: Recall Marcia Angell in the New York Review of Books:
Since there are no objective tests for mental illness and the boundaries between normal and abnormal are often uncertain, psychiatry is a particularly fertile field for creating new diagnoses or broadening old ones. Diagnostic criteria are pretty much the exclusive province of the current edition of the Diagnostic and Statistical Manual of Mental Disorders, which is the product of a panel of psychiatrists, most of whom, as I mentioned earlier, had financial ties to the pharmaceutical industry. [Christopher] Lane, a research professor of literature at Northwestern University, traces the evolution of the DSM from its modest beginnings in 1952 as a small, spiral-bound handbook (DSM-I) to its current 943-page incarnation (the revised version of DSM-IV) as the undisputed “bible” of psychiatry—the standard reference for courts, prisons, schools, insurance companies, emergency rooms, doctors’ offices, and medical facilities of all kinds.
Given its importance, you might think that the DSM represents the authoritative distillation of a large body of scientific evidence. But Lane, using unpublished records from the archives of the American Psychiatric Association and interviews with the principals, shows that it is instead the product of a complex of academic politics, personal ambition, ideology, and, perhaps most important, the influence of the pharmaceutical industry. What the DSM lacks is evidence. Lane quotes one contributor to the DSM-III task force:
There was very little systematic research, and much of the research that existed was really a hodgepodge—scattered, inconsistent, and ambiguous. I think the majority of us recognized that the amount of good, solid science upon which we were making our decisions was pretty modest.
Lane uses shyness as his case study of disease-mongering in psychiatry. Shyness as a psychiatric illness made its debut as “social phobia” in DSM-III in 1980, but was said to be rare. By 1994, when DSM-IV was published, it had become “social anxiety disorder,” now said to be extremely common. According to Lane, GlaxoSmithKline, hoping to boost sales for its antidepressant, Paxil, decided to promote social anxiety disorder as “a severe medical condition.” In 1999, the company received FDA approval to market the drug for social anxiety disorder. It launched an extensive media campaign to do it, including posters in bus shelters across the country showing forlorn individuals and the words “Imagine being allergic to people…,” and sales soared. Barry Brand, Paxil’s product director, was quoted as saying, “Every marketer’s dream is to find an unidentified or unknown market and develop it. That’s what we were able to do with social anxiety disorder.”
Some of the biggest blockbusters are psychoactive drugs. The theory that psychiatric conditions stem from a biochemical imbalance is used as a justification for their widespread use, even though the theory has yet to be proved. Children are particularly vulnerable targets. What parents dare say “No” when a physician says their difficult child is sick and recommends drug treatment? We are now in the midst of an apparent epidemic of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity disorder as the most publicized condition in childhood), with a forty-fold increase in the diagnosis between 1994 and 2003.[18] These children are often treated with multiple drugs off-label, many of which, whatever their other properties, are sedating, and nearly all of which have potentially serious side effects.
Continuing Medical Education, a great American tradition described here, is under attack by the government, and by universities.
Daniel Carlat’s on the case; he’s reproduced on his blog an ad — no, not an ad! A call to arms! — running in medical journals and magazines that alerts fellow Americans to the chilling effect of efforts to transform CME from free vacations paid for by drug firms that want you to prescribe their pills and use their devices, to evidence-based, serious seminars run by independent scientists. (Here’s another description of the ad.)
If CME junkets, which after all make everyone happy — the doctor who gets a free vacation, the salesperson who gets a captive audience — are undermined, the very foundations of this nation will begin to tremble.