A recent article in the International Journal of Clinical Practice provides a unique and welcomed voice to balance the debate surrounding financial conflicts of interest. The authors provide a well-organized argument against the one-sided conflict of interest discussion, which is spiraling out of control.
"After more than 20 years of impugning the motives of industry and demeaning the professional judgment of physicians," the article states, the conflict of interest "instigators" have failed to substantiate their "central claim that interactions between physicians, researchers and the medical products industry cause physicians to make clinical decisions that are adverse to the best interests of patients."
What the conflict of interest campaign has done, however, is "divert resources away from worthwhile pursuits, such as basic and applied medical research, clinical care and medical education towards onerous compliance exercises and obtrusive laws and regulations."
The authors argue that the narrative surrounding the conflicts of interest movement dodges the central issue of patient outcomes in favor of three "proxies."
The first is the high cost of medical products, which the article states is a very unproductive way to pigeonhole the benefits improved therapy offer. Newer drugs, the authors argue, not only may be cost-effective long term, but definitely add value to patient's health and wellbeing.
Absent evidence of negative patient outcomes, industry critics have also questioned the degree of novelty of new drugs and argue that industry, in a sense, creates diseases. The authors rebut these points by stating that innovation, especially in highly scientific fields, is necessarily an incremental process. Critics also often cite the fact that more diagnoses are made for obscure conditions following the availability of treatment for those conditions. "However, this rise in diagnoses is because of doctors having a new way to treat dysfunction and distress, and thus have a reason to diagnose, rather than companies creating illusory conditions."
Third, conﬂict of interest instigators often criticize the use of new medications because of unknown risks. Of FDA approved drugs, however, only 8.2% acquire black box warnings and 2.9% are withdrawn. The low rate of unforeseen risks "hardly justifies arbitrarily avoiding recently approved therapies."
Industry Critics' Main Points of Contention
The authors methodically go through the industry critics' most common examples of "conflicts of interest," and point out the flaws behind a blind dismissal of each industry-physician interaction.
Detailing: Drug rep visits to physicians in order to provide "details" of their products has been condemned by COI instigators. The authors argue that doctors actually find these visits useful. Detailing provides "patient-care doctors convenient access to FDA regulated information about new products and product-updates through expedient face to face encounters." The authors note that "[t]here is no evidence that these visits harm patients. In the absence of such evidence, the debate boils down to an ideological squabble."
- "Gifts": Critics often focus on small "reminder items" used by drug reps used to get doctors' attention during detailing encounters These items formerly included pens, notepads, and free meals. While companies still provide meals, the PhRMA and AdvaMed ethics codes of 2008 banned reminder items. "The bans were intended as a public relations manoeuver to improve industry's image, but were spun by critics into an admission of guilt."
- Advertising: The authors aruge that "[w]hile it is true that direct to consumer advertisements increase requests for particular products," this serves the public good by increasing awareness in the public that treatments exist for various health conditions. Advertising aimed at physicians also plays an important role in public health. It too raises physician awareness of the existence of new therapies in a concise format. "The fact that these advertisements are sometimes presented in a lowbrow or even misleading manner or fail to support all claims with high level evidence, while disappointing to purists, is largely besides the points." Ads are "attention-getters and should not be mistaken for scientific evidence."
- Peer-to-Peer Speaking: Companies pay physicians to speak to other physicians about new indications and new products. The authors note that "[t]he content of these speeches is regulated by FDA as a form of marketing, meaning that speakers may only discuss products' on label indications, and must spend equal time on positive and negative aspects of the products." Thus, the regulations make physician peer-to-peer speaking "among the most heavily regulated forms of speech in the United States." Doctors want to learn about new products and find it useful to obtain such information from physicians. These events are certainly educational, but should not be confused with continuing medical education. "Physicians should always consult other resources before prescribing a new product," the authors state.
- CME Funding: Industry provides 28% of ACCME-accredited CME funding in the US, the authors note. This commercial interest is "only allowed to manifest itself in a limited number of ways." The main route is through the selection of a general area of medicine which the CME event will focus on. Commercial funders are not permitted to select speakers or to fund CME activities that focus on particular products. The authors state that several large surveys of CME participants indicate commercially sponsored CME is not perceived to be biased. "Despite such evidence, the instigators routinely attack commercially sponsored CME on the mistaken ground that such education is biased." Unfortunately, these attacks on industry funding reduce the overall rate of CME activities produced, with "disproportionate impact on providers outside of major cities." Thus, these attacks don't help patients, but "are in fact undermining them by depriving providers of high quality educational content."
The authors conclude their argument by dissecting the focus of conflict of interest research: off-label settlements and publication biases. Neither, the authors note, demonstrate that industry-physician collaboration has detracted from patient care.
Newspaper headlines around huge settlements for off-label promotions often describe the government as catching companies red-handed committing illegal acts. "The real story is more complicated," the authors argue. The cases, brought under the False Claims Act by whistleblowers with a large financial stake in the outcome, are negotiated by the government under very harsh terms. To actually win at trial, the government would have to prove that the pharmaceutical industry caused physicians to prescribe off label, in the scientiﬁc 'but-for' causal sense. This would be very difficult. However, when threatened with exclusion from government reimbursement, many companies accept huge settlements to avoid the "death sentence."
The stories surrounding the huge settlements "mislead the public into believing that the medical products industry is exerting a toxic influence on physician prescribing decisions through mechanisms such as detailing and advertisements." Despite the press, "there is little evidence that these lawsuits reveal physicians making decisions that conflict with patients' best interests."
The authors also confront "publication bias," COI instigators have spent a lot of time evaluating whether industry funded randomized clinical trials differ from RCTs funded by not for proﬁts in their rate of positive outcomes, rate of adverse event reporting, or the quality of the trial. However, the article argues that the proper question should be: "Are industry funded studies scientifically unsound?" The authors state that "[i]n the absence of the assumption that industry results are more likely to be positive because of some sort of misconduct, no reason exists to consider this ﬁnding relevant to the integrity of industry sponsored medical science." In fact, it "might simply indicate that industry is selecting therapies which are efficacious."
The critics have "neither shown that the scientific evidence presented in industry funded studies is faulty or that it improperly leads physicians to make erroneous prescribing decisions."
A lot is at stake:
"Nearly every major medical advance over the past century has involved industry and most have involved physician-industry collaboration," the authors state. "These collaborations are the lifeblood of medical innovation. We should not restrict or eliminate them based on vague feelings of unease or ideological arguments."