Q: Your recent book “Pharmaphobia:—–” about conflict of interest “Myths” drew great attention to what you and David Shaywitz earlier called the “Pharmascolds” hazard. How do you see that phenomenon impacting the current national movement toward “Precision Oncology”?
A: The public’s dread of cancer engenders electric excitement every time something new comes along to combat the disease. The latest example of such a development is “precision oncology:” using the specific genetic makeup of a patient’s malignancy to target therapy against it or else engineering a subject’s immune system to recognize and destroy tumors based on their unique composition.
Over my five decades in health care new anti-cancer strategies have, for the most part, incrementally brought cancer mortality to its all-time low. Therefore, in theory the public’s enthusiasm for these novel approaches ought to be justifiable.
But one serious impediment threatens to squelch such optimism. I call this obstacle “pharmaphobia”: demonization of the industries that produce medications and medical devices. The current political fallout of this attitude is to demand drug price controls.
Underlying pharmaphobia is profound ignorance of fundamental facts. One is that the maligned industry is responsible for healthcare — including cancer treatment — being far better today than in the past.
Another is that developing new drugs is incredibly difficult and expensive. An FDA drug approval costs eighty times more today compared to 50 years ago. It’s because even small increases in testing stringency the FDA imposes on drug development disproportionately exacerbate a high disappointment rate: nine out of ten drugs that seem promising in test tubes and animal studies crash in clinical trials. Therefore, every drug brought to market has to pay for the nine that fail. In no other enterprise does the cost of developing a product bear so little relationship to its present value or production costs. Only profitability addresses the long odds by enabling taking more chances.
What motivates pharmaphobes? Academics gain promotions by attacking industry. Lawyers profit by teaching regulatory compliance – so the more regulations the better. The media attracts readership by ginning up faux scandals, and demagogue politicians garner attention. Medical journals demonize industry marketing to brand themselves as fonts of “trustworthy” information. But the truth is practicing physicians get far more accurate practical information from FDA-regulated company marketing than from unregulated medical journal articles or health center propaganda.
But what about those huge fines medical products’ companies pay for alleged misconduct? These penalties are not smoking guns for corruption but rather manifestations of a federal extortion racket. Physicians often and rightly prescribe FDA approved products “off-label” for unapproved indications. Prosecutors twist the definition of a “false claim” — billing the government for unperformed services – to allege that devious corporate marketing that physicians can’t resist coerced them to prescribe off-label. These cases never go to trial, because conviction for one indictment confers a penalty called “debarment.” A debarred company cannot sell to the government, the major purchaser of its products. To avoid this draconian punishment, companies always settle.
Pharmaphobia has slowed or prevented research relationships, limited or eliminated worthwhile activities (such as providing product samples to patients) and compromised medical training. Most importantly, it diverts scarce resources from medical innovation and education. Unchecked, pharmaphobia will sabotage the promise of precision oncology.
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