During my 25-year-career in drug discovery research, when I told people what I did for a living, I ran into the same response over and over: "How can you work for such an evil industry?" Yet, after even brief discussions of what the jobs in profession were really like— that being, a fierce devotion to finding treatments for the worst diseases in the face of an overwhelming array of nearly impossible obstacles—virtually everyone I spoke with changed their opinions.
This especially held true in universities, where the anti-pharmaceutical sentiment is quite strong. Over the course of my career, I was invited to give lectures at dozens of schools, where I spoke about various aspects of drug discovery. The change of attitude in the room following a one-hour seminar was palpable, especially when I talked about AIDS. Students and faculty quickly understood why HIV infection ceased to be an automatic death sentence. It was not magic. In reality, it took 20 years of unparalleled research, during which time the pharmaceutical industry did most of the heavy lifting. Prior to the seminar, virtually none of the attendees had any idea of what really happened. Indeed, it is widely accepted by the public that drugs simply appear, or are discovered by the "government"—two assumptions that are dead wrong.
The mentality I have just described, and the driving force behind it, is the essence of Dr. Tom Stossel's fascinating new book, "Pharmaphobia- How the Conflict of Interest Myth Undermines American Medical Innovation, " (Rowan & New York, 2015).
Stossel examines what he calls the "conflict-of interest-movement," and how it shapes public opinion, which, in turn, stifles innovation and progress in the medical field. This misguided mindset arises from a widely-held misconception that collaborative efforts between industry, academia and government are inherently corrupt. Instead of focusing on the many life-saving products and technologies that have arisen from these collaborations, the conflict of interest movement emphasizes any faults, real or imagined, in the method by which innovation is attained rather than the innovation itself.
He is certainly the right person to challenge this mindset, since during his 50-year career as a physician and medical researcher has he has participated in more than his share of innovation, examples of which, are sprinkled throughout the book. Readers will have their memories jarred as Stossel recounts case after case of miraculous medical advances that have had a profound impact on their health and lifespan.
Yet, despite the book's extraordinary well-documented and indisputable examples of real progress, the negative impact of the "anti-innovation" industry—which has used every trick in the book to slow progress—becomes just as clear. By far, the most potent weapon in the arsenal of the conflict-of interest-movement is the fabrication of the myth that the process that leads to innovation is inherently dishonest and corrupt.
The propagators of this movement are just who you would expect them to be: biased reporters, politicians looking to score cheap points, bureaucrats seeking job security, and predatory lawyers— all of whom stand to gain by painting a one-sided view of the world of medical innovation. The rest of us suffer as they routinely toss out a variety of phony, obfuscative roadblocks that make an already-difficult job even more so.
Stossel pulls no punches, defining the conflict-of-interest movement as "a mixture of moralistic bullying, opinion unsupported by empiric evidence, speculation, simplistic and distorted interpretations of complicated and nuanced information, superficially and incompletely framed anecdotes, inappropriately extrapolated, or irrelevant psychological results, and emotionally-laden human interest stories."
Speaking from experience, I think It is fair to say that the conflict-of-interest movement is simply one component of the noxious anti-science movement that thoroughly pervades much of the developed world. This takes the form of the anti-vaccine movement, the anti-GMO movement, and perhaps the most harmful of all, the alternative medicine "consortium," which fools people into having their colons cleansed to remove toxins that do not exist, inhaling ozone to treat their cancers, and taking useless supplements instead of real medicine when it is needed.
Among the misconceptions that Stossel debunks is the commonly held perception that industry's primary role in medical innovation is simply to sell drugs, medical devices and other technology that was developed in academia, while offering little in the way of innovative research. This could not be further from the truth.
He backs up this assertion with data that show what anyone in pharmaceutical research already knows—that since about 1950 getting a drug or medical device approved has become vastly more difficult, time consuming and expensive. Stossel demonstrates this by a comparing the medical and electronics industries.
For example, a phenomenon known as Moore's Law is directly applicable to the latter. As electronic components became exponentially more powerful, their cost became exponentially lower, but in the pharmaceutical world, the exact opposite is true. The difference between industries is so profound that the corresponding pharmaceutical experience has been dishearteningly dubbed "Eroom's Law."
This is, of course, largely a function of increasingly stringent FDA requirements for new drug approvals, which put an extra burden even on large companies that already have enormous research and development budgets. Additionally, excessive stringency can only serve to increase the already sky-high failure rate of drugs in trials, which is guaranteed to result in even higher development costs, especially for drugs in the latter stages of the approval process.
So, in light of these already-enormous and continuously exploding costs, how can universities possibly provide the resources required to even begin, let alone finish the myriad of tests and trials that are required to introduce a new product? They can't. This is the "Catch 22" facing medical innovation, at least in the world of the conflict-of interest-movement. Academia does not have anything remotely close to the resources or multiple skillsets required to develop a new drug or product, yet when they team up with industry, the effort is automatically tainted by financial considerations.
This is reflected by the estimate that 85 percent of the pipeline of medical products come from industry, and is also consistent with my own views that are based on many years of infectious disease research. By definition, inventors are those who are listed on patents. Even a brief perusal of patent records reveals that the vast majority of patents of antiviral drugs (HIV and hepatitis C especially) are held by companies rather than universities. So, in reality, the view that the pharmaceutical industry is merely a money-making machine that exploits noble institutions where the "real" innovation lies is a giant lie itself.
Yet, drug companies do not get a free pass either. Stossel points out a flaw that is nearly universal within the industry: poor decisions that are driven either by misread financial considerations, or more importantly, risk-averse behavior by corporate management. Anyone who has ever worked for a drug company has seen this time after time.
There is, in fact, a disincentive for people making decisions to promote the development of a drug. I call it "pharmaceutical ass-covering." Stossel explains: "The high and expensive failure rate of medical product development puts these individuals at greater risk if they the recommend projects that fail than if they reject them, because nobody knows whether they might have succeeded."
As an example, he documents the fate of a drug that was mismanaged in this way. In 1970, there was little that could be done (with the exception of antacids) to treat or prevent ulcers, which left untreated can cause serious gastrointestinal problems. Scientists at Astra—one of the companies which would later become AstraZeneca—were researching mechanisms that would reduce the production of stomach acid, but their drug omeprazole was shot down by the company's scientific advisory board, which decided that antacids were good enough, and that the drug wouldn't be profitable. With funding from the Swedish government, Astra kept up its development program. It paid off. Omeprazole would later become Prilosec—the first proton pump inhibitor—and would earn the company more than $2 billion during the 1990s alone. Ulcers are now preventable or treatable.
The essence of Stossel's book is found in the chapter entitled "The Gift Smoke Screen." It is here where he debunks some common myths about conflicts of interest, especially regarding physicians and drug companies.
Are gifts to doctors bribery? A 2011 article in The Journal of Law, Medicine and Ethics concluded that there are three types of financial relationships between drug companies and doctors: kickbacks, gifts, and financial support for professional activities, which the authors claim can all "compromise physicians' independent judgement and rational prescribing."
Stossel isn't having any of this: "The author of these comments seamlessly equates gift, defined as reminder items, meals, and 'financial support for professional activities,' with 'kickbacks." Kickbacks are quid pro quo transactions, which are illegal. In addition to this already inaccurate assertion, "[The] article is unencumbered by any quantitative evidence and devotes not a word to the possibility that the gift menu might actually add some value to medical care."
He likewise tackles similar misconceptions, questioning (and backing up with evidence) the following:
- Are gifts bribery?
- Do gifts increase medical costs?
- Do gifts necessarily result in the expectation of reciprocity?
- Do gifts to physicians alter their prescribing practices?
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