Elucidation: The Medical Products Industry Must Resist the Pharmaphobes

I often ask people: “Do you think medical practice is better, worse, or the same compared with what it was when I graduated from medical school nearly 50 years ago?” The most common answer is “I guess it’s somewhat better,” although some say “Worse!” I explain that the unequivocal right answer is “hugely better!” For example, our average lifespan is now a decade longer, and we suffer far less from incapacitating diseases such as arthritis. Then I ask, “Why are things so much improved? Is it because of doctors, medical school research, or government?” The usual reply is “I guess it’s all those things.” And I ask, “Is anything missing from that list?” Silence ensues. “What about the medical products industry?” I reply. Responses range from “I guess it produces some new technology” to “Don’t even get me started about pharma!”

I imagine BPI readers believe that they work for a fundamentally honorable industry, that they create value for society, and that they might find it strange and sad that public opinion often judges the medical products enterprise dismissively at best and, at worst, as greedy and even harmful.

What accounts for that discrepancy? I address the answer in my recently published book, Phamaphobia: How the Conflict of Interest Myth Undermines American Medical Innovation. After reviewing the facts about industry’s contributions to medical value and some nuts and bolts concerning how innovation works in practice, Pharmaphobia describes the emergence, perpetrators, and stunning success of what I call “the pharmaphobe narrative.” That narrative promotes the myths that industry doesn’t really innovate — it just profiteers — and that it is fundamentally corrupt and corrupts the physicians and academic researchers who partner with it. The pharmaphobes’ catchall phrase for that alleged corruption is conflict of interest. The pharmaphobe narrative’s perpetrators are academics who achieve attention and promotion, an inadequately discerning media, and (especially) attorneys who profit whether they sue or defend industry. Other perpetrators include those who sell compliance training for the myriad conflict-of-interest regulations that have arisen in health centers, professional organizations, government, and the industry itself.

What are those regulations? To name a few, universities have restricted what researchers can study and payments they can receive based on the theory that industry payments encourage research misconduct. Health centers and medical practices have restricted corporate marketing access to their physicians, based on the theory that marketing of FDA-approved products is misinformation and that physicians can’t resist acting on it. Activist physicians have relentlessly attacked industry’s pricing of recently FDA-approved “specialty drugs,” based on the theory that companies exaggerate the difficulty and cost of drug development. They allege that if companies cut back their marketing expenses, they could divert more resources to innovation. They want the United States to impose price controls that are universal abroad. The 2.3% tax on medical devices imposed by the Affordable Care Act is a manifestation of that theory.

Pharmaphobia explains how those theories are false. To deny the fact that profitability from current drug pricing is the only antidote to a documented high failure rate of drug development is economic illiteracy. And to claim that innovation could persist under price controls is intellectual dishonesty. The price controls of other nations enable them to parasitize our hard-won innovation.

To restrict from physicians corporate information intensely analyzed by the FDA results in less-informed doctors. Indeed, these professionals are immolated with far less rigorously vetted data published in medical journals and totally unregulated medical advertising propaganda. Pharmaphobia reviews how the allegations of corruption are also misleading. Nearly all scientific misconduct has no commercial relationship, and adverse outcomes attributed to corporate malfeasance are few and misrepresented. The book also explains how the huge fines companies have paid for off-label marketing and kickback settlements are really a prosecutorial extortion racket based on the distortion of “false-claims” litigation. Conviction in one indictment of a false claims suit, however improbably, results in a draconian penalty called “debarment.” Debarment — never mentioned by the media in its reporting of these settlements — potentially puts companies out of business.

Unfortunately, the industry has done a poor job of defending itself. Simply reiterating that it creates value doesn’t overcome the strident denials of that value by ill-informed academic pharmaphobes. An overly deferential attitude by industry toward its physician (especially academic) customers made some sense when medical-school–based research and clinical trials dominated medical innovation. This circumstance reversed itself a long time ago, and industry has become the dominant engine of medical progress. If industry employees want to achieve the recognition they deserve for their good work, they need to understand the errors of the conflict-of-interest movement and the damage its regulations impose. Pharmaphobia spells it all out, but unless the industry workforce mobilizes and actively rebuts its tormentors, nothing will change.

Thomas P. Stossel, MD, is the American Cancer Society Professor of Medicine at Harvard Medical School and a Visiting Scholar of The American Enterprise Institute; [email protected]. Pharmaphobia is published by Rowman and Littlefield.