Lee begins correctly noting abuses in the pharmaceutical industry and runs down some of the well known examples of unethical and even criminal corporate behavior. Predictably he trots out Vioxx, citing questionable promotions and implying illegal activity. Granted, drug companies could stand to clean up their marketing act. That would earn them more credibility with doctors. When they go outside legal boundaries of promotion they should be prosecuted. But Dr. Lee is wrong in his interpretation of the Vioxx example:
The most notable case illustrating how direct marketing to doctors can lead to serious harm was the rofecoxib scandal.
In the VIGOR trial Vioxx was compared with naproxen, a non steroidal anti-inflammatory drug singular in its cardiovascular safety. In that trial it was associated with an increased risk of myocardial infarction. But in the real world of promotion Vioxx was competing with a variety of older generation NSAIDs most of which have been found to carry similar or even greater cardiovascular risk!     Moreover, in its promotion as a pain medication Vioxx may have been competing with narcotic analgesics, a class of drugs associated with a rising body count over the past decade. My point is that neither the VIGOR trial nor any corporate improprieties surrounding it constitute evidence that pharmaceutical industry marketing has had a net harmful effect on patient outcomes. In fact, as I argued in a recent Medscape Roundtable piece, there’s not a shred of evidence that this is true of promotions in general.
The naysayers appeal to another body of evidence, and the argument goes like this: Promotions are associated with increased use of the sponsor’s product. Doctors believe they are immune form influence while multiple surveys show they are not. Indeed there is a large body of such evidence but it’s all soft science. None of that research comes close to addressing patient outcomes. Although there is evidence that promotions sometimes lead doctors away from evidence based practice such reports are biased and unbalanced, as I pointed out in that same Roundtable:
Drug detailing sways doctors away from evidence-based practice. Studies in support of this argument do not give a balanced view. Surveys of the effects of drug detailing on doctors' prescribing have focused selectively on areas of overuse, such as antibiotics in the ambulatory setting and new expensive drugs compared with equally effective generics. Although some promotions undermine evidence-based practice, others may enhance it. Because promotional literature is a mix of good and bad information, the net effect on patient care is not known. Many heavily promoted treatments are evidence-based and known to be underutilized by doctors. A good example is the inadequate use of low-molecular-weight heparin for thromboembolism prophylaxis. The promotion of statin drugs and angiotensin-converting enzyme inhibitors for appropriate patients is another example. Such a promotion toward best practice has been ignored in published studies. Research in a broader range of clinical situations is needed before conclusions can be made about the overall effect on evidence-based practice.
The soft evidence, recited faithfully by Dr. Lee, is insufficient to justify the unintended consequences of harsh policy measures such as bans on industry supported CME or putting the government in charge of all clinical research.
Finally, I find Dr. Lee’s concern about conflict of interest to be curiously and inappropriately selective. If we are to address conflict of interest in a realistic and credible manner we must not overlook the pervasive conflicts and abuse that occur outside the arena of industry ties. That’s one of the points Dr. Stossel makes in his counterpoint. In the opening paragraph he notes (my bold):
Their sermons, echoed by medical journals and the news media, warn that medical practitioners, educators, or researchers accepting gifts from or payments for services to companies producing medical products compromise their scientific objectivity and professionalism. Strangely, financial transactions between patients, insurance companies, hospitals, and doctors, encompassing 85% of the medical marketplace, do not count as conflicts of interest.
Stossel goes on to note the lack of evidence of harm attributable to drug industry ties (again, my bold):
Conflict of interest ideology purports to promote scientific rigour yet is far from rigorous itself. Adverse outcomes objectively ascribable to financial conflicts of interest are almost non-existent, especially in the context of overwhelmingly positive commercially driven medical advances. Conversely, purely academic research and education are hardly more reliable than their corporate or corporate sponsored counterparts--arguably less so, because they are not, for example, subject to stringent Federal Drug Administration reporting requirements. Misconduct fells a single academic miscreant but can bring down an entire company.
Stossel may seem like a lone dissenting voice among the academics in this debate. However, surveys and polls indicate that only a very small minority of doctors favor the ongoing purge against physician-industry relations.
Note: Since publication of Stossel’s commentary and our Medscape piece there has been evidence reported---the first ever---documenting the effect of an industry promotion on patient outcomes, and the evidence was positive. You can read about it here.