Tuesday, September 28, 2010

Looking For an Effective Presentation for Physicians about Pharma? PharmedOut Can Help

We know that (according to Campbell's 2007 survey) 94% of US physicians interact in some way with the pharmaceutical industry. We also know, from many sources reviewed in HOOKED and in this blog, that many physicians resist any suggestion that their prescribing behavior might be influenced through that contact. Finally, previous studies of educational interventions aimed at residents and practitioners have not been very encouraging.

But help is on the way. Adriane Fugh-Berman and her colleagues at PharmedOut have both put together a nice slide show suitable for a medical grand rounds or similar hospital conference, and also have reported (subscription required) on the evaluations from 14 presentations to some 373 physicians in multiple specialties. (You can find the slide show at http://www.pharmedout.org/type.htm#slideshows, though if I understand the article and a related communication from PharmedOut, there may be a new, revised version that is not yet up on the Web.)

The authors report fairly substantial shifts in attitudes based on pre-and-posttest data from these educational presentations, according to which physicians became considerably more skeptical of drug company gifts and information, and more inclined to refuse to accept gifts or to speak with drug reps. While this does not address what real behavior change followed over time, it is rather more encouraging than was the case with previous educational efforts. So if any physicians are looking for an easy-to-borrow slide show to educate their colleagues, check this one out.

Fugh-Berman AJ, Scialli AR, Bell AM. Why lunch matters: assessing physicians' perceptions about industry relationships. Journal of Continuing Education in the Health Professions 30(3):197-204, 2010.

Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. New England Journal of Medicine 356:1742-50, 2007.

Sunday, September 26, 2010

Tilting the Pinball Table, for Fun and Profit

Thanks to faithful reader Marilyn Mann once again for word of this posting on the blog conducted by an anonymous neuroscientist from the UK:

Background: My colleague Dan Moerman, a medical anthropologist at U Michigan-Flint, published a classic paper on the placebo effect nearly 30 years ago. He looked at about 35 published studies of the then-new-miracle drug, cimetidine (Tagamet) for healing peptic ulcers, all of which had almost identical methods--the patient was endoscoped at the start of therapy and then a month later to see whether the ulcer had healed and what size it was. (They didn't have the term back then, as I recall, but Moerman did an early meta-analysis.) He showed a number of surprising things:
  • According to his meta-analysis, cimetidine was actually no better than placebo.
  • Cimetidine, however, was quite consistent in its effects across studies. No matter where the study was done (a wide range of international sites were represented), the healing rate in the cimetidine-treated group at one month was about 70-75%.
  • If you looked at the individual studies, about half showed that cimetidine was superior to placebo, and half showed it wasn't.
  • Since cimetidine was so consistent, the only variable to explain this inconsistency had to be the placebo response rate. And indeed that varied from a low of 10 percent to a high of 80 percent.
  • So whether cimetidine was shown in any individual study to be better than placebo had virtually nothing to do with the cimetidine response rate and everything to do with the placebo response rate.
  • The placebo response rate in these studies is not the same as the "placebo effect." Studies of this sort cannot distinguish between healing of ulcers caused by administering a placebo, vs. healing of ulcers due to other causes (primarily, spontaneous remission). Most ulcers, given time, heal. However, it would be contrary to most of what we think about peptic ulcers to imagine that the spontaneous healing rate of these ulcers differ so widely among study centers in different countries. So it is more plausible to imagine that the rates of placebo effect differed among study sites to primarily account for the large differences.

Now, let me make two points about Moerman's (subsequently replicated) research. First, it reveals a real problem in using the typical double-armed, placebo controlled, double-blind randomized trial to assess drug effects. It reveals that the placebo arm of the trial can be a source of "noise" that might obscure a presumably real drug effect. Second, I take Moerman's work to be real science. Moerman was not trying to sell Tagamet. (Nor, so far as I know, did he own stocks in a placebo company.) Moerman was trying to understand what various factors determine the outcome of placebo-controlled studies and quantitatively, how much of a result can be attributed to each factor.

Fast-forward to the article reviewed by Neuroskeptic in his blog. It's one of a series of studies funded by drug companies either directly or indirectly, and differs from earlier entries into the series (according to Neuroskeptic at least) only in its brazenness. If you are trying to sell drugs, then you really want to take what Moerman observed and work it to your advantage. What that usually means is to try to manipulate the placebo arm of the trial so as to reduce, as much as possible, the response rate among subjects randomized to that arm--thereby assuring that the subjects taking your drug have the best possible chance of doing better than their placebo counterparts.

Hence, in the name of "accuracy" or more usually, "efficiency," we get a variety of proposals that all amount to various ways to ignore or toss out data when the placebo effect is inconveniently high. These efforts fall (in my view) along a spectrum. At one end we have relatively innocent and well-reasoned alterations of study design that try to correct for extreme and obvious distortions that lead to underestimating the true drug effect. At the other end of the spectrum are blatant efforts to wipe out unfavorable data and replace them with good-looking data, science be damned. You can read the post about this most recent proposal from GlaxoSmithKline and you be the judge. (Neuroskeptic thinks it's an extreme case of tilting the pinball table by eliminating all study sites that have an "abnormally" high placebo response rate, thereby assuring that your drug will emerge the winner.)

My own view is that most efforts, at most points along the spectrum, run afoul of one basic consideration. In the real world of medical practice, the placebo effect is omnipresent. Further, while in a study setting, one might have a legitimate reason to try to minimize placebo effects (in both arms of the trial equally), in the world of clinical medicine, practitioners do everything possible most of the time to augment the placebo effect, quite appropriately as this makes more patients get better faster. So any study that tries to get "better" data by minimizing the placebo effect is likely not to inform us of how this drug will perform in actual practice settings.

Merlo-Pich E, Alexander RC, Fava M, & Gomeni R. A New Population-Enrichment Strategy to Improve Efficiency of Placebo-Controlled Clinical Trials of Antidepressant Drugs. Clinical Pharmacology and Therapeutics PMID: 20861834 (published on line 22 Sept. 2010).

Saturday, September 25, 2010

Catching Up: Pharma Settlements in Criminal Cases

A while back I noted that it was a lot easier to simply do these items as a fill-in-the-blank form. So I started to complete the latest announcement as follows:

Drug Company: Forest Laboratories
Drug: Celexa and Lexapro
Amount of settlement: $313M
The settlement equals what percentage of one year's sales of the drug?: 13.6% (Lexapro only)
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage: http://www.nytimes.com/2010/09/16/health/16drug.html?scp=1&sq=natasha%20singer%20forest%20celexa&st=cse

It was only in the process of reading about this settlement, that I came to realize that I had missed the news of a settlement two weeks earlier:

Drug Company: Allergan
Drug: Botox
Amount of settlement: $600M
The settlement equals what percentage of one year's sales of the drug?: 46%
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage:

Taking the earlier case first, Allergan was accused of pushing Botox for headache, pain, and spasticity associated with cerebral palsy, all unapproved indications according to the FDA. The marketing methods included kickbacks to doctors for off-label uses and helping physicians to get insurers to reimburse for off-label uses by falsely putting in the billing code for an approved indication. (In partial defense of Allergan, British regulators recently accepted company research showing that Botox might be useful in the treatment of chronic migraines, suggesting that the current FDA label for the drug might be too restrictive--though of course legally, the company is supposed to expand its label first and market the drug for those indications second, not the other way around.) The Botox settlement may set a new record, not for the total amount--Pfizer's $2.3B Bextra settlement still holds pride of place--but for the substantial percentage of 1 year's sale of the drug in question. Still, it means that in about 6 months, Allergan will make enough revenue off the drug to pay off the total cost of the settlement.

Now to Forest. They had already pulled off a huge coup by marketing Lexapro, a minor tweak of the Celexa molecule, as a brand-new antidepressant just in time to "evergreen" Celexa as its patent was running out. The major off-label use they were promoting was the use of the drugs for children and adolescents when the FDA had approved adults-only usage. The major methods of marketing alleged by the Feds were huge bribes to docs--examples noted between 1998 and 2005 were tickets to Cardinals and Red Sox games and Broadway shows, a $1000 gift certificate for the gourmet French restaurant Alain Ducasse, and a deep-sea fishing trip off Cape Cod for a doctor and his 3 sons. What is most striking about this list is the suggestion of the effects of the 2002 PhRMA code of conduct. While less stringent than the code that went into effect in January, 2009, the 2002 code was supposed to have done away with such extreme items as sports tickets and leisure junkets (as I wrote about in HOOKED). We don't know the exact dates on the allegations in the Federal suit against Forest, but it would appear at least possible that Forest reps were handing out bribes of a sort that the PhRMA code had supposedly banned, in years after the PhRMA code was supposed to be in effect--perhaps another suggestion on how effective these voluntary codes of conduct within the industry really are.

Final note: Defenders of industry will point out, correctly, that the companies have admitted to none of these charges. The suits against the companies were all based on whistleblower disclosures, which generally lead to the discovery of extensive files of in-house company documents. So we can assume that the Federal allegations are based on the review of those company files.

What Disclosure? Failure of Present Journal Policies in Orthopedics

Again, apologies for being behind the times in just getting to last week's news. Duff Wilson in the New York Times--
--nicely summarized a new study published on-line in the Archives of Internal Medicine (subscription required) by our friends over at the Institute on Medicine as a Profession at Columbia University.

Susan Chimonas, Zachary Frosch, and David Rothman started out with the information sprung loose in 2007 by a court settlement involving 5 device manufacturers. From those data the authors identified 41 orthopedic surgeons who had been paid at least $1M by these companies. They figured quite resonably that while somebody could quibble about how big a deal it is if a doc fails to disclose (say) $5000 in consulting fees, it's hard to dismiss more than a million smackers as chicken feed. They then tracked all the journal articles published by those 41 folks in the subsequent year. Overall, 25 of 32 who published articles in 2008 (I suppose the rest were too busy counting their money to publish anything) failed to disclose this income in at least one of the articles they published. The exact rate of disclosure varied a good deal but at best it was about half. The existence of a strong editorial policy at that journal on disclosure of conflicts had no relationship to whether these conflicts were actually disclosed.

The authors suggest that the present system of disclosure in medical journals (assuming orthopedic journals to be representative) is clearly not working. They point out that by 2013, the new health reform law will require that pharmaceutical and device companies post relevant physician payments to a standard online national database. It will then be much easier for journals independently to confirm whether an author has a conflict and how much money is involved. The authors also recommend that the "how much" be part of the disclosure, again suggesting that the doc who rakes off a cool million might be in a somewhat different position with regard to potential bias than the guy who runs off with $10K 0r $20K.

Chimonas S. Frosch Z, Rothman DJ. From disclosure to transparency: the use of company payment data. Archives of Internal Medicine, DOI 10.1001/archinternmed.2010.341, published online 13 Sept. 2010.

It's Published: Some Cholesterol Calculators Spur Extra Drug Sales

A while back I blogged about some important work being done by Dr. Jesse Polansky and colleagues:

I'm pleased to report that their work has now been published in the Journal of General Internal Medicine--that's the good news. The bad news is that most people reading the JGIM paper would miss the important connections between their findings and drug industry marketing. (My guess is that the editorial review process might have toned down some of the more pointed comments in the original text.) You might be able to find the article at http://www.springerlink.com/content/x266735764406234/fulltext.html-- but I suspect it is available to journal subscribers only.

Anyhow, here's a brief reminder summary plus the missing piece. There are two versions of the Framingham risk calculator that is recommended by most guidelines for physicians to use to decide how high-risk a patient is for coronary disease, which then leads to the decision to prescribe a statin, and what target cholesterol level to aim for. One directly calculates risk and the other assigns points. So long as you are doing paper-pencil calculations, the point system is much easier to manage; but if you're computerized, it's just as easy to use the one as the other.

The point system turns out to be less accurate than the full calculator, and the errors are not random. About twice as many people will be classified by the point system erroneously as needing more statins, compared to those misidentified as needing less.

What got this whole thing going was the observation that when drug company money was somewhere in the neighborhood (for instance, Epocrates, an educational medical-reference website that is heavily supported by industry advertising), the on-line risk calculator was much more likely to be based on the inaccurate point system, rather than the more accurate "full" calculator. But there is no way for the average doc to be aware that this bias is present when she's rushing to calculate a patient's risk score so that she can get that patient out of the office and get on to the next patient.

The published article goes into all the details about why the two calculators are different and just how many patients in each general category are likely to be erroneously classified when using the point-based model. Sadly, it soft-pedals all the links to industry funding and marketing. So docs now know that there's two models of the Framingham calculator out there and that using one of them is more likely to lead to error. What they don't know from this article is that drug industry funding is a fairly good predictor of whether they'll run into the less accurate (but more profitable for statin sales) calculator.

Gordon WG, Polansky JM, Boscardin WJ, Fung KZ, Steinman MA. Coronary risk assessment by point-based vs. equation-based Framingham models: significant implications for clinical care. Journal of General Internal Medicine, DOI 10.1007/s11606-101-1454-2; published online 8 Sept. 2010

Friday, September 24, 2010

When Drug Makers Pay for Reporters to Attend Conferences...

As I 'fessed up in a previous post, I made the mistake of leaving the country for a week, meaning I have spent the past week digging out and not having any time to post about a number of issues that have arisen. So back to work.

See Alison Fairbrother's nicely comprehensive article--
--on the practice of pharmaceutical companies sponsoring educational conferences for journalists and underwriting their attendance.

You'll quickly see the same arguments trotted out as we have been used to reading in the medicine/CME debate. On the one hand we hear that the companies give the money but do not dictate the content, and that with serious cutbacks in media budgets reporters could otherwise not get funding to attend these valuable and informative conferences. On the other side we encounter worries about integrity and conflict of interest and a fear that this is the entering edge of the wedge.

I see only one major difference between this controversy around journalism ethics and medical CME. We know what is happening around the country as investigative reporting seems to be going the way of the dodo and as bankrupt major newspapers rush to lay off staff. The claim that the profession of journalism could not, in house, afford these sorts of teaching venues without the influx of outside money, rings a bit truer than the claim that physicians are somehow too poverty-striken to manage to arrange their own CME without industry largesse. But that observation does not make the ethical concerns go away.

Thursday, September 16, 2010

A Brief Postcard from Lebanon

I am appearing this week at conferences sponsored by the new Salim El-Hoss Bioethics and Professionalism Program of the American University of Beirut Faculty of Medicine, under the capable leadership of Thalia Arawi, PhD. Today I spoke at an internal medicine conference (before an audience of perhaps 30-40) on "Ethics, Medicine, and the Pharmaceutical Industry: Current Controversies." I was able to leave about 25 minutes for questions and comments and hoped thereby to learn about the status of the issues of interest to this blog among Lebanese physicians.

I found myself preaching to the choir as virtually no one took any issue with my call for significant reforms. (Dr. Arawi informs me that AUB is developing new policies on conflicts of interest on US and European models just this year, and that while there was initially some physician opposition, it was soon superseded by general support and a sense that something needed to be done.)

The first comments that I received were to the effect that the problem was generally worse here than in the US, and even worse yet in the developing world. "More and more physicians are on the drug companies' monthly payroll" was how one comment put it (sadly I was not able to follow up to ask just what that meant). Lebanese patients seem to resemble many Americans in believing that if they do not leave the physician's office with a prescription in hand, the physician provided them with no service. Another academic commented on the vast amount of research money spent by companies merely to "evergreen" profitable drugs rather than to discover truly innovative drugs. I received a startled question about my description of the practice of ghostwriting from a professor of philosophy, who obviously could not believe that such things went on. Another question dealt with the FDA and why its regulatory authority had not set matters right. Perhaps the most challenging question came from a neurologist who wanted nto know why I did not support remaking drug firms into non-profit institutions--as he said, we understand that universities are supposted to be non-profit; why not the companies that discover and manufacture drugs for the public health? (I didn't want to mention that the emergence of for-profit universities seems to be the latest fad in US higher education.)

Wednesday, September 15, 2010

New Study Demonstrates Power of Rationalization in Justifying Gifts

Sunita Sah and George Loewenstein of Carnegie Mellon in Pittsburgh authored a paper in this week's JAMA that nicely fills in a gap in our knowledge. (Subscription required to access paper; several popular press accounts are circulating)

They surveyed around 300 pediatrics and family medicine residents, using survey forms that differed in the degree to which they 1) suggested personal sacrifice as a possible rationale/rationalization for accepting gifts (aka bribes) from the pharmaceutical industry, and 2) reminded the residents of their high debts, low pay, and sleepless nights. As we might have expected, by substantial margins, residents who were either reminded more forcefully of poor working conditions, or who had the rationalization suggested to them, were more likely to view accepting gifts as appropriate.

One perhaps unexpected finding was the relatively low rate of acceptance of the rationalization when it was baldly presented to the residents. A majority of the residents rejected the argument that just because they had made various personal sacrifices, therefore accepting gifts was justified. The authors suggested that the rationalization works better at the subconscious level. But at any rate it does seem as if more recent surveys are showing us a decreased level of acceptance of the old habits of profligate bribe-taking among recent trainees.

Readers of HOOKED know that I have always been persuaded that rationalization plays a huge role in this area and is a prime subverter of ethical reflection. We have known for a long time that drug reps are carefully trained to provide their physician targets/dupes, not only with various gifts, but with a steady stream of rationalizations designed to make accepting the gifts seem the right thing to do. And we docs have (at least till recently) generally proven very accepting of both of the diets being fed to us.

Sah S, Loewenstein G. Effect of reminders of personal sacrifice and suggested rationalizations on residents' self-reported willingness to accept gifts. JAMA 304:1204-11, Sept. 15, 2010.

Friday, September 10, 2010

More on EHRs and Safety

At intervals, I've posted about the dangers associated with electronic health records (EHRs), due not to the basic concept which most agree is excellent, but to the too-often slipshod implementation, especially as the software industry moves in to capitalize on the promised bonanza. I have just read (thanks to my colleague Dr. Scott Monteith) one of the best brief articles summarizing the problem that I have yet seen, by Elizabeth Gardner in Health Data Management:

A couple of pearls... The article notes that EHRs are, by most any definition of the term, medical devices. That justifies the FDA in regulating them. But the FDA had a bad experience trying to do pre-market approval of blood-bank software in the 1990s. The general sense at the time was that the demand for pre-approval put such a damper on potential profits that major vendors pulled out of that line of business, creating a huge lag in technological innovation. Thus the FDA is really gun-shy about getting into the business of regulating EHRs. Just to show how primitive it all is, the article states, "The Agency for Healthcare Research and Quality is currently working with the FDA, VA and other federal agencies to develop a common format for reporting I.T.-related patient safety events and unsafe conditions." In other words, a bunch of Federal agencies are going through a big-deal negotiation simply to develop a form that the rest of us can use to report problems--nothing being said yet about fixing the problems!

Another quote: "When Geisinger Health System first installed its EHR, the I.T. staff was dismayed to find that there was no safe way to link it with a state-of-the-art pharmacy system from another vendor. ... To the pharmacy's chagrin, its lovely system had to go, to be replaced by the EHR vendor's pharmacy offering. Chief health information officer James Walker, M.D., later learned of research showing that at least 62 other institutions had found the same problem, no matter which EHR or pharmacy vendors they were using." Now, sorry to be so cynical, but you are going to have to talk for a long time to convince me that this was not basically about increasing the market for each firm's own software products, and not about insuring the quality of patient care by maximizing the interchangeability and interfacing of the EHR.

Final quote: "'It's inevitable that some new errors will be introduced [with EHRs],' says David Bates, M.D., chief of general medicine at Brigham and Women's Hospital, Boston, a patient safety expert, and a member of the information technology executive committee of Partners HealthCare, Brigham's parent. 'The key thing is to devote enough resources and attention to fixing them after they happen. Your EHR may prevent 10 errors for every new one it causes, but you have to have an approach for dealing with the new ones.'" Now, to the best of my knowledge, Dr. Bates is basically correct, though some would quarrel about the 1-10 ratio. My only wish is that the cheerleaders, including those in the Obama administration, that are currently waving the pom-poms and urging all hospitals and docs to adopt an EHR (any EHR) and to do it yesterday, would be as frank in their own descriptions of the state of the art.

Thursday, September 9, 2010

New Review of Ghostwriting for Selling HRT

My e-mail has been jumping with people praising the new article in PLoS Medicine by PharmedOut leader Adriane J. Fugh-Berman at Georgetown:

My own reading of the paper has a few qualifications, however.

Generally the paper is based, yet again, on secret drug company documents released through litigation--in this case, people who developed breast cancer while on Wyeth's Prempro and later sued. Dr. Fugh-Berman notes that while Prempro for menopausal symptoms and/or prevention was touted at the time as "hormone replacement therapy" or HRT, that presumes that menopause is a disease of hormone deficiency, which is itself a disputed model of menopause that favors drug treatment; so a better label would be HT.

The focus of the study is the role of DesignWrite, a medical education and communications company (MECC), in managing a portfolio of articles to be placed in medical journals touting the virtues of Prempro, including trying to extend its use to off-label indications such as preventing Alzheimer's and Parkinson's disease and macular degeneration, and producing younger looking skin. Fugh-Berman was able to track about 50 papers that DesignWrite produced that were eventually published. I wish she would have addressed the question, as David Healy did in a similar article about psychiatry and ghostwriting, as to just what proportion of the total literature this represents. I did a quick PubMed search on English language articles on conjugated estrogen-progestin therapy published between 1997 and 2003, Fugh-Berman's target period, and came up with 253 cites; which suggests that as many as 1 out of 5 papers on the topic were ghostwritten by marketers.

The procedure was that DesignWrite's writer produced a draft and then Wyeth reviewed and kibbitzed about the draft. Only then was the draft sent to an academic physician who was asked to appear as the supposed author. Fugh-Berman did not discover among her documents what was paid to the academic physicians; for major papers DesignWrite received $25,000. She gives examples of academic docs meekly signing off on "their" articles, but the occasional old-fashioned physician actually taking the role of author seriously and insisting on editing and changing the text--which DesignWrite, to mollify the doc, tried to permit so long as Wyeth's main marketing message was retained. (One recalcitrant academic even tried to acknowledge the role of DesignWrite's hired ghostwriter in print, but that effort was firmly squelched.)

It's certainly valuable to have this information in the public record, and to know that "HRT" was yet another area manipulated by ghostwriting. My qualifications come from having followed this discussion fairly closely at the time, and conferring with some of my evidence-based colleagues on what advice to give to our patients when the RCT's were announced showing that "HRT" increased both cardiovascular and breast cancer risks. My worry is that we are engaged in some revisionist history right now on the "HRT" question. A few points to recall:
  • Fugh-Berman mentions only in passing that one clear-cut benefit of HT, which I don't believe has ever been denied, is prevention of osteoporosis. As we proceed today to vilify HT, with the benefit of 20-20 hindsight, we tend to forget the plight of the 80-year-old woman with a broken hip, who was in danger of dying or being stuck for life in a nursing home as a result, and the strong desire to prevent such an occurrence if possible.
  • Also minimized today is the reality of severe hot flashes and the fact that many patients, when we tried to stop their HT, came back complaining bitterly of the lowered quality of life, and in some cases even frank incapacitation this caused.
  • Then, consider the actual "number needed to harm" as revealed, not in industry-sponsored commentaries, but in the raw numbers contained in the supposedly reliable RCTs that first revealed the true risks. As best as I can recall, for conditions like breast cancer and other cancers, the number of patients who would have to take HT for a year for 1 to end up with a cancer was in the range of 500 to 1200. That is a real risk, but it's within a numerical range that a woman with severe hot flashes, or at high risk for osteoporosis, might rationally decide to continue HT even knowing the risk.
In hindsight, we know now that HT was oversold as a preventive for cardiovascular disease, and this seems mainly the result of relying on observational studies before RCT results were available. The RCTs clearly showed increased, not decreased cardiac risk. It's good to now know that this misimpression was not completely accidental but was aided and abetted by ghostwritten marketing articles. The complete picture is a bit more nuanced than this one article conveys, IMHO.

Post on Meridia Dangers

Brandon Yu is a Managing Editor of AllTreatment.com. AllTreatment is an online rehab center directory and substance abuse information resource. He thought our readers would be interested in this brief post about the safety of diet drugs:

My long post on Donald Light's study of the safety and benefits of new drugs:

--prompted a rebuttal from Thomas Sullivan on the "Policy and Medicine" blogsite:

Now, if I can say this without sounding patronizing, if Mr. Sullivan (who's CEO of a medical communications/education company) were a student in one of my ethics courses and turned in this essay for a grade, I'd give him high marks. A skill that's all too rare among students is that of being able to characterize your opponent's case fairly and cogently before you start to argue against it. I think this post by Mr. Sullivan is exemplary for a good faith efort to summarize both my and Light's arguments before launching any counter-attack.

That said, Mr. Sullivan still finds reasons to negate my main point--that whereas the burden of proof has previously been placed on us pharmascolds to prove that the current way the industry markets new drugs/devices causes more harm than benefit, really the pharmapologists ought to have the burden placed on their shoulders to prove that new drugs are really all they are cracked up to be. Since he had presumably only my summary of Light's paper and not the voluminous citations Light provides, I don't see how he can be confident that Light's case is poorly supported. His own case seems to be based on the self-evident wonderfulness of new medical "breakthroughs" such that no argument or facts are needed, we just feel warm and fuzzy all over when these are mentioned. Only an extreme viewpoint, according to Sullivan, would argue, as Light does, that since the R&D budget of the US drug industry rose from $19B to $47B between 1998-2008, that it's disappointing that fewer than 10-15 % of new drugs are properly categorized as therapeutic advances over existing drugs(for example).

My reactions to Sullivan's criticism can be summarized by highlighting a few of his concluding comments:

"The theories proposed by Dr. Light, while interesting, completely ignore the fact that all drugs and treatments inherently have risks and benefits, the weight of which are decided during the approval process, and subsequently when a doctor and patient choose. " The "weight" of risks and benefits is all too often not addressed by the FDA approval process. The typical new drug is approved by being shown to be superior to placebo, not the currently available drugs for that condition. The safety data on which approval relies usually comes from short-term follow-up of a few thousand subjects, when many drug adverse reactions require long-term follow-up of 10,000-20,000 people to detect. When a doctor chooses for a patient, that presumes that the physician has access to a scientifically valid body of literature (unless, of course, the doc simply asks the handy detail rep for advice). See just about every other post on this blog for examples of how the drug industry works to distort the available literature to assure that marketing and not science is best served.

"To suggest that industry is preying on the elderly and exposing populations to risks because industry wants to make profits is misguided. The goal of industry in working with patients and collaborating with doctors is to improve patient outcomes." Dr. Light is a sociologist and so is in the business of describing the world, not passing moral judgments about who's "preying" on whom. He describes a set of financial incentives and argues that drug companies naturally pursue the lines of behavior that maximize their profits under those incentives. According to Dr. Light's analysis, these incentives are such that trying to improve patient outcomes commonly means losing revenue, and he suggests you don't usually see companies acting that way. Let's turn the incentives issue around. Mr. Sullivan presumably is all in favor not merely of collaboration between medicine and industry (the point of his blog), but the sort of collaboration that puts money into docs' pockets. Now, the conflict-of-interest rules that he finds so onerous would all go away instantly if only docs were happy to collaborate with industry simply for the knowledge that they were "improving patient outcomes" and not so as to profit personally. But presumably Mr. Sullivan would argue to keep the money flowing, out of concern that physicians wouldn't have enough incentive to be truly innovative in their discoveries if they were not paid generously. So why imagine that physicians are slaves to financial inducements, but drug companies can ignore financial incentives and put the patient first?

Tuesday, September 7, 2010

Reward Drug Companies for Restrained Use of New Antibiotics?

The following announcement comes by way of a website of the Robert Wood Johnson Foundation:

The news release refers to an article in the new issue of Health Affairs:

The article, by Aaron S. Kesselheim (medicine-Harvard) and Kevin Outterson (law-BU), proposes a novel way to pay drug companies for new antibiotics. They note that the present payment system encourages the misuse (wide overuse) of new antibiotics as a way to increase revenue before the drug goes off patent. The too-wide use of new antibiotics speeds the development of resistance to the antibiotic among bacteria, making the antibiotic ineffective more quickly. Restrained use of the new antibiotic would slow development of resistance but cost the company in terms of revenue.

Their proposed solution is to pay rewards to drug companies based on data that the drug continues to demonstrate a low level of resistance among targeted bacteria. This would (presumably) give drug companies a financial incentive to work in tandem with hospitals and physicians to use newer antibiotics in a targeted, restrained, scientifically thoughtful fashion.