Monday, January 30, 2012

Celebrity Shills for Pharma

I was kindly asked by The Scientist to submit an opinion for their blog regarding recent news that Paula Deen, who I gather is a celebrity chef sort of person who has tended to advocate high-fat diets, has acknowledged having Type 2 diabetes and has shown up as a celebrity spokesperson for a diabetic drug for Novo Nordisk. So I figured why write two blog posts when I can write one:

Sunday, January 29, 2012

Ritalin: Is Drug Shortage or Drug Excess the Problem?

Today's New York Times features an opinion piece by Dr. J. Alan Sroufe, emeritus professor of psychology at the University of Minnesota and expert on child development:

Dr. Sroufe starts by noting that the news has lately been full of reports of serious drug shortages, leaving frantic parents and teachers worried that kids with attention deficit disorder will be unable to get their Ritalin (methylphenidate). Dr. Sroufe then offers the argument that instead of worrying that these kids might not be able to get their meds, we should be worried that far too many kids are getting medicated for ADD despite good evidence that any benefit from drugs is probably limited and short-term.

The piece basically falls into two parts. One addresses the actual evidence about the benefits of stimulant drugs like Ritalin in ADD. The other discusses the likelihood that ADD is not an inborn chemical imbalance and may be at least partly environmentally triggered, suggesting that a more complex approach is needed rather than just prescribing drugs. (Since psychiatrists tend to prescribe drugs for behavioral problems and psychologists tend to downplay the value of drugs and suggest various other forms of therapy and prevention, I fully expect to read angry psychiatrists attacking Sroufe's article in coming days.) And Dr. Sroufe defends his bona fides by noting that early in his career, he did research on Ritalin and helped show that it seemed to have benefit. Anyway, the first part of the article is what I choose to focus on as most pertinent to this blog's agenda.

Basically Dr. Sroufe disputes the initial claims that ADD kids have messed up brain chemistry because of an inborn problem, so that stimulant drugs have a paradoxical effect on them and settle them down instead of revving them up. There's no paradox, he says--anyone given stimulants, and then assigned to do boring, repetitive tasks (presumably like much schoolwork is) will be able to do the tasks better. The real issue is whether in the long run ADD kids improve on Ritalin, in terms of learning or life adjustment, and he claims that long-term studies show no difference and that any presumed benefit to stimulants disappears after a few years as the body develops tolerance. Because the body develops tolerance, kids do worse when the drug is stopped, so studies showing worsening of ADD symptoms on drug withdrawal hardly support the actual benefits of the drugs.

What these assertions have to do with our concerns is:

  • Stimulants, like many drugs used in mental health, look very good so long as you do your study for a 4-8 week period, and never look at long term outcomes. For this reason it is increasingly worrisome that so many studies of psychoactive drugs are roughly 4-12 weeks' duration. From an industry viewpoint this is good for two reasons--such studies are cheap and quick, and as noted their outcomes are much more likely to be positive. The rest of the world (the FDA included) needs to take note that such studies are also virtually uninformative about any drug intended to be used chronically.

  • To repeat a basic theme, drug marketing does not simply try to sell us drugs. Marketing tries to sell both physicians and the general public a way to think about drugs. We have recently discussed the popularity as well as the scientific defects of the low-serotonin theory of depression ( Telling guilty and frazzled parents and teachers that the child has an inborn brain disease is reassuring, while saying that something in the environment may be making them act that way just ramps up the guilt. So the public (and the physicians trying to reassure them) readily grab for a biochemical story to tell about ADD. So long as that story sells pills, Pharma wants to be sure we keep believing it, even if the science refuses to accommodate them.

  • We are also seeing here more signs of the worries raised in Robert Whitaker's controversial but probably mostly-on-target book, Anatomy of an Epidemic ( Whitaker paints a bleak picture of modern psychopharmacology, while admitting that for the small population of people with really severe psychiatric symptoms, drugs are far better than no drugs. He claims as a general point about psychoactive drugs that the human body seeks to restore homeostatis, a fancy way of saying that if you give a drug that (say) raises your serotonin, the body thinks this is making things go out of kilter and sooner or later tries to lower its own serotonin production in response. If you then go off the drug for a while, you are left with a brain that is producing serotonin at even lower levels than normal, and you might well see withdrawal effects, which psychiatrists interpret as more evidence that you really need the drug and dare not stop it. So the bottom line is that we've gone way overboard in prescribing drugs that have dangerous and often unknown long-term consequences for people who have such mild symptoms that they would be much better off with no drug treatment--Sroufe notes that we now prescribe 20 times more stimulants for ADD than we did 30 years ago.

Tuesday, January 24, 2012

Another Planet Heard From: Sunshine Law is Useless

I had not heard recently from Dr. Thomas Stossel of ACRE fame (see for example However, the redoubtable Dr. Stossel now appears on the op-ed page of the Wall Street Journal ("Who Paid for Your Doctor's Bagel?" January 23, p. A17; subscription required), to inform us that the Sunshine Act provisions included in the Affordable Care Act, due to take effect later this year, are "toxic" and "inverts reality."

I have felt for some time that Dr. Stossel lives on another planet. On his planet everything is just fine between medicine and Pharma, at least so long as the evil government, and goody two-shoes folks like me, don't interfere. Docs get paid big bucks by Pharma. As a result they think fine thoughts and invent great new drugs. These great new drugs then make us all live longer and better. Eeveryone wins, and there's no downside. Dr. Stossel reports that medicine can today do wonderful things that we could not do when he graduated from med school in 1967--I didn't realize he was that old, I graduated in 1976 and feel pretty much fossilized myself--an assessment of progress with which I totally concur. He believes that all of it is due to the free enterprise business model that he advocates.

So what doesn't happen on Dr. Stossel's planet, that in my humble opinion happens on this one? First, drugs only help people and never hurt them, and companies never market potentially dangerous drugs to people who don't need them. Revelations such as Dr. Don Light's about the harm caused by prescription drugs apparently are irrelevant there:

But perhaps the most fascinating difference between the two planets is Dr. Stossel's claim, "Having failed to detect substantive corruption due to physician-industry relationships over a quarter century, [critics] will spend taxpayer-provided grant money" to keep searching for the supposedly non-existent corruption.

There's no "substantive" corruption because when the industry pays docs, it is always strictly on the up and up. Physicians are "compensated by royalties from useful inventions that they license to companies, or ...were paid consulting fees for advice concerning the optimal use of products, or for educating other physicians about products." On that other planet, docs are never paid bribes by industry to prescribe their drug or device, or to persuade their fellow physicians to do likewise. Funny how on this planet seldom a week goes by that I'm not blogging about some such corruption at the medicine-industry interface.

But then again, I suppose that the corruption that I have been blogging about all these years is not "substantive" enough. So just who "inverts reality"?

The Over-the-Top Prices for Cancer Drugs

Our pal Merrill Goozner of GoozNews blog just posted this article in the Fiscal Times:

Gooz goes into the current problems caused by the high cost of new cancer drugs, relating facts such as:

  • 84% of oncologists report that treatment recommmendations are modified due to the patient's out-of-pocket costs

  • Despite decreasing incidence of cancer, the National Cancer Institute projects a 27% rise in the cost of treating the 29 most common cancers by 2020
Typical price tags:

  • Johnson & Johnson's Zytiga extends life in advanced prostate cancer by 5-16 months, costing $44,000 per year

  • Bristol-Myers Squibb's Yervoy improves 1-year survival rate in metastatic melanoma from 25% to 46%, costing $120,000 for a 4-month treatment course
Gooz notes that neither the Republican nor the Democratic proposals for health care system changes address in any serious way what to do about this problem.

Back in HOOKED, I discussed the high price of some cancer drugs, noting that these prices were determined by one factor only--what the company figures it can squeeze out of the market. The price has nothing to do with either manufacturing costs or research costs--in this area, the bulk of the research on breakthrough molecules continues to be done in academic and not industry labs.

Until now, the industry has figured that a patient with advanced cancer would pay any amount for even a few more months of life, especially if newer drugs, as many promise, are much less burdened with side effects than old-style chemotherapy. Gooz's account shows that even if the patient has good insurance, the out-of-pocket copays may be so high that the patient and family decide that it's just not worth it. So as much as people want to sound off about "government death panels," here we have rationing of cancer care based on the private marketplace.

You could make the claim that when a new cancer drug might extend life by only a few months, and a patient decides they'd rather leave that much money to their grandkids rather than buy the medicine, it's a perfectly rational choice, and a good system that allows it to be made. I worry however that when the drug offers more substantial benefits than that, it seems less fair that the luck of the draw that is today's health insurance system might determine whether the drug is affordable. On the other hand, I have steadfastly proclaimed in this blog that there's no good, solid "ethical" answer to how much drugs should cost.

One point to note in pasing that as Gooz interviewed industry experts about why these drugs cost so much, one answer that came back is that the companies are trying to recoup their losses from so many blockbuster drugs like Lipitor all going off patent at about the same time, and that if you want to get this money back from cancer patients (there are reportedly about 887 new cancer drugs in some state of development), then you have to get as much of it as you can up front, because unlike patients taking Lipitor, these folks won't be around for that long. So the longer-term solution is likely to be refining the drugs and identifying the really promising compounds that truly keep these patients alive for a long time.

Monday, January 23, 2012

NPR: Forget the Serotonin Theory of Depression

Alix Spiegel of NPR did a very nice story this morning on the serotonin theory of depression:

She quoted a number of notable psychiatric experts, but sadly not our friends Jeffrey Lacasse and Jon Leo, whom we have cited here previously:

Anyway the news report covered most of the bases--that scientists believe that attributing depression to a deficiency of serotonin is at best overly simplistic and at worst flat wrong; that the low-serotonin narrative for depression caught on with the public (and physicians) because it's simple, and no equally simple narrative is available to take its place; distressed patients really like simple narratives that promise to fix the problem, rather than complex narratives that may be scientifically more accurate; and the serotonin narrative has had both pluses and minuses--the plus being that many no longer see depression as something to be ashamed of or hidden, the minuses being that everyone now seeks a pill for depression despite the fact that pills work badly and have major safety issues, and many non-pill therapies work very well for mild to moderate depression.

Ms. Spiegel left out only one factor--what was the role of pharmaceutical marketing in selling all of us on the nice, simple serotonin narrative? And in making sure we still believe it even after it's debunked?

Tuesday, January 17, 2012

From Kalman Applbaum: How Pharma Does Business

Thanks to my esteemed colleague Daniel Goldberg for alerting to to this post--
--by our old friend anthropologist Kalman Applbaum, for example as summarized here:

Dr. Applbaum, showing us once again that academic research is far from glamorous, is apparently camped out in a courtroom watching the unfolding of the whistle-blower case regarding the antipsychotic drug Risperdol, Janssen/J&J, and the various state Medicaid agencies, primarily Texas and Pennsylvania, that the drug firms attempted to influence (or more bluntly, to bribe) to assure that their own drugs were promoted to physicians by getting written into the official treatment guidelines. To get a full sense of the case see the earlier posts in this series by Dr. Applbaum.

This particular post may not mean much if you've not been following the case closely, so I cut to the chase by appending his final comments. Dr. Applbaum refers here both to his extensive experience in interviewing pharmaceutical executives, and also the recently settled case regarding another antipsychotic, Seroquel:

While the scale of the organization of deceit revealed in the Seroquel documents astonishes, what should strike us the most in the depiction of the implemented marketing plans is how routine they appear to be. The spectacle of the court trial is in this sense a distraction, since it focuses our attention on violation, on breach. But while the actions under investigation may be legal contraventions, they are not managerial ones. On the contrary, the marketing practices conform to business and organizational norms that are positively embraced as sound managerial principles.

Because of this, the most florid violations lie on a simple continuum with all pharmaceutical marketing practices. The prosecuted cases are distinguished, if at all, by degree and not kind with other examples. If for no other reason than that competitive pressures drive companies to behave in similar ways, one can guarantee that the marketing strategies and tactics for drugs of a single class will resemble each other. When Vioxx blew, industry watchers knew that the other Cox-2 inhibitors (Celebrex and Bextra) were potentially not far behind. When Zyprexa [Lilly’s SGA] was called to account, informed observers knew that the other manufacturers of atypical antipsychotics (of which Seroquel is one) were guilty of similar crimes, which would become visible if the opportunity arose for opening up their marketing records.

Dr. Applbaum heads this post "The Banality of Corporate Corruption" which probably says it all.

Friday, January 6, 2012

Peddling Useless Drugs: Paying Journals to Publish

I reprint the following from my post of November 21, 2011:

I've previously mentioned the Primary Care Medical Abstracts program run by my friends Rick Bukata and Jerry Hoffman, in which subscribers receive a CD each month with commentary on 30 recently published papers from medical journals. Since both Rick and Jerry are concerned about the impact of Pharma marketing on medical science and practice, it's not uncommon for several of the papers each month to address topics of interest to this blog. The October, 2011 issue had an especially impressive bumper crop. Here are capsule summaries of some of the papers.

Who's Marketing the Heck Out of Useless Cholesterol Drugs?

Before statins came along, an older class of drugs, the fibrates, was employed in attempts to lower cholesterol. Recent research has documented thoroughly that these drugs have no place in the medical armamentarium. Yet these authors noted a 117% increase in fibrate prescriptions between 2002 and 2009. Was this because physicians all on their own decided to go back to this old class of drugs? Hardly; the data show that newer brand-name fibrates are selling much better than older generics. So it seems that creative drug marketing has resurrected a class of drugs that should have been sent to the retirement home long ago.

Jackevicius CA, Tu JV, Ross JS, et al. Use of fibrates in the United States and Canada. JAMA 305:1217-1224, March 23/30, 2011

Okay, so you might ask, just how is Pharma going about twisting docs' arms to get them to prescibe more and more of these useless drugs?

Enter Marilyn Mann, who except for the fact that she reads this blog regularly is an eminently sane person. She posted a clue to this puzzle on her blog, which is called, for some strange reason, Marilyn Mann's Blog:

Marilyn, tipped off by Dr. Harlan Krumholz at Yale, provides links to a so-called review article on fibrate drugs. The fine print at the end of the article says that Abbott Laboratories, which by the merest coincidence manufactures two fibrates, paid the publisher to print this article. The disclaimer goes on to note that Abbott did not directly pay the authors. But the lead author is "medical editor" of the journal. I rather doubt that he does this out of the goodness of his heart, so I assume that the publisher pays him. So Abbott pays the publisher and the publisher pays the author, but Abbott does not pay the author. Okay, now it's all clear.

The tried and true tricks that the article trots out for our edification (hitting the high points only) are, first, including really glitzy graphics to illustrate what fibrates do at the chemical and cellular levels (a sure tipoff of generous Pharma funding; the average medical journal, unless they are high rollers like New England Journal, simply cannot afford cute color graphics)--thereby increasing the scientific panache of the paper without really saying anything important for clinical medicine; second, stressing surrogate endpoints--in this case, how much fibrates reduce blood levels of triglycerides, without mentioning that there's no correlation between making your lab numbers look better and your living any longer; and finally, omitting the key take home message, which is that all studies of actual patient outcomes in fibrates show that they reduce the rate of some cardiovascular events, some of the time, but don't budge the mortality rate. In other words, if you don't want to die of a heart attack, but would rather die just as quickly of something else instead, take fibrates. (In fairness, this point is mentioned, though effectively buried, in the text of the article, but is completely absent from the abstract--which is the only part of the article many, if not most, busy practitioners read.)

Marilyn wants to know why any physician would bother to read such drek, and why a state chapter of the American College of Cardiology would reveal its bottom-feeding tendencies by allowing its name to be attached to such a publication. She might as well ask why 85% of US docs see drug reps and use the industry as a source of information about pharmaceuticals. You can bet that Abbott did not merely pay the journal to print the article, they also bought a ton of reprints. Those reprints are handed to docs by the reps peddling the fibrates, and the docs have no time to read the reprint (except maybe the abstract as noted), but the reps point out the pretty pictures as evidence that the sales pitch they're delivering is "scientific."

(Hat tip also to Jerry Hoffman for helpful e-mail comments.)

Thursday, January 5, 2012

A Voice from France on Device Scandals

Most of you are aware of the current scandal in France over flawed breast implants (for example:

Don't be surprised that this happened, says Dr. Alain Braillon, referring back to a commentary he wrote on how cozy the French device regulators are with the industry they supposedly regulate:

Braillon, an MD/PhD, was fired from his post at the University Hospital of Amiens in 2009, despite strong peer support, as a result of his whistleblowing activities that angered the French Department of Health (see:

The French debate is of concern as the US medical device industry struggles hard to fight the latest efforts of the FDA to regulate them more stringently, playing the "jobs" card in Congress as aggressively as they can with both parties:

Wednesday, January 4, 2012

From Health Care Renewal: Egregious Behavior of the APA

Once again I am just the scounting party or the warmup act, whichever you prefer, for the Health Care Renewal blog, in this case Dr. Bernard Carroll:

Dr. Carroll submits evidence that the American Psychiatric Association, currently under fire for the way that it is setting about revising its Diagnostic and Statistical Manual 5th edition (DSM-5)--see for example earlier posting:
--has now shut down a UK blog that was serving as a discussion forum for criticisms of the DSM-5 proposed revisions. APA threatened legal action based on copyright infringement if the blog did not close down its discussion of DSM-5. (Hey APA-- I just said "DSM-5" in this blog post--come and sue me too.)

Dr. Carroll makes a number of on-target observations in his post. He notes that this action by the APA amounts to what's called "SLAPP," which as I discussed in HOOKED means "strategic lawsuit against public participation." In this case it would be a threatened SLAPP rather than a true SLAPP, as no lawsuit was filed, but the fear of having to go up individually against the deep legal pockets of the APA forced the UK blogger to knuckle under promptly. A SLAPP is not a lawsuit that has merit that could win in a court of law--it's a power play in which the disproportionate ability of one party to pay for legal expenses without going broke is used to make the other party cease public criticism of the other party.

He also notes the divergence between appropriate professional standards and the behavior of the APA. Does the APA own psychiatric diagnosis? The organization makes huge bucks off selling the DSM which is effectively the Bible of psychiatric diagnostic labelling, whether your interest is clinical or financial in terms of billing for services. Dr. Carroll asks--why have we entrusted the APA with this publication? It can only be because society has confidence that an organization of physicians will carry out its mission with scientific integrity. Scientific integrity demands that if there's controversy, it is conducted openly and that what in the end gets published has withstood the most searching scientific criticism possible.

To try to shut down and stifle criticism because one hopes to make money off one's product is commercialism and not professionalism. That the APA appears to be acting in this crassly commercial manner would seem a severe indictment of what sorts of people are allowed to manage so-called "professional" medical societies in these times.

Previously I have taken off after my own professional society, the American Academy of Family Physicians, for behavior suggestive of commercialism and conflicts of interest:
I would ordinarily not want to commit myself as to which society has sunk lower in the area of professional integrity, but I think the award has to go to APA-- at least if people disagree with what the AAFP is up to, the AAFP has not stepped in threatening legal action against their right to express their views.