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September 08, 2010

Debate on Industry Research – Critic Admits to Mealy Mouthed Evidence

Analog-palm-pilot Pile of papers
Critics Medical Researchers


Two groups—the "pharmapologists" and the “pharmascolds”—have long debated the proper role of the pharmaceutical industry, and what responsibility they have to the public.

As Howard Brody, MD, recently pointed out, the "pharmapologists" argue that the pharmaceutical industry produces life-saving drugs and fantastic innovations in health, and when physicians get paid handsomely for working closely with this industry, the result is more innovation and more lives saved. And the huge social benefits created by today's pharmaceutical industry are obvious: medical devices, longer lives, better health, less pain, vaccines, reduction in death rates for serious diseases like heart disease, and improved prevention, treatment and diagnosis of numerous conditions.

Since working with the pharmaceutical industry provides such progress and promising results, pharmapologists argue that “it is against the public interest to derail” the industry-physician collaboration by imposing strict conflict-of-interest policies, which essentially criminalize and ban these relationships.

So with all the positive outcomes that come from physician-industry collaboration, Brody admits, that the burden of proof, to show that some kind of “harm” comes from this relationship, is on the shoulders of the pharmasclods. He even admits, that what Pharmascolds offer as evidence “is often pretty mealy-mouthed.” In other words, Pharmascolds lack an evidence base because they cannot prove that there is anything about the marketing of drugs that causes bad patient outcomes.

Consequently, in an attempt to bolster the Pharmascolds position, Brody uses a recent paper by his “esteemed colleague Dr. Donald Light, a medical sociologist and health policy expert based at University of Medicine and Dentistry of New Jersey. Dr. Light recently delivered the content of his paper at the American Sociological Association’s annual meeting in Atlanta, entitled, "Pharmaceuticals: A Two-Tiered Market for Producing 'Lemons' and Serious Harm."

According to Brody’s summary, Dr. Light builds his paper around an economist's idea, Akerlof's theory of "a market for lemons." Essentially, Dr. Light argues that the pharmaceutical industry develops and produces lemon-drugs with hidden dangers, and that this practice is widespread and results from the systematic exploitation of monopoly rights and the production of partial, biased information about the efficacy and safety of new drugs. Basically, Dr. Light believes that the pharmaceutical industry is capitalizing on an imbalance of information that is available to the buyer, and so the industry is taking advantage by pushing inferior products off on buyers.

What makes it possible for industry to produce lemons, according to Dr. Light, is the relationship between the drug companies and the government regulators. He feels that because the FDA now relies heavily on industry user fees to fund their own operations, FDA has little power to impede the "market for lemons" and instead becomes a sort of enabler, providing additional cover for the companies because they can always point to FDA approval in their own defense.
As a result, he asserts that “this kind of system allows companies to design and run their clinical trials to minimize evidence that their drugs cause adverse reactions and maximize evidence that they are not inferior to or [are] better than a placebo for the target indication.”

Dr. Light also believes that another effect of the exchange between industry and government is that “companies will learn from the regulatory body how to game accelerated approvals and condition[al] approvals.” They do this with post-market studies by cutting corners and submitting partial evidence in order to get drugs on the market faster and put the regulator under pressure to approve and not to later rescind.

To support his claims that the pharmaceutical industry is using the FDA regulatory system to “produce lemons,” Dr. Light offered evidence, such as the fact that only 10-15 percent of so-called “new drugs” put onto the market annually are significant advances. He added that only a few are actually novel chemical structures, and of those, only a handful is real advances over existing drugs. Using this data, he asserts that since 85-90 percent of drugs aren’t “new, company R&D goes largely to a marketing strategy that does not meet societal needs or the needs of patients."

As a result, Dr. Light feels that the increase in R&D in the US drug industry from $18.9B in 1998 and to $47 billion in 2008, was a huge waste as so few real drug innovations resulted as noted above.   Why don’t we tell that to all the scientists and researchers at pharmaceutical companies who devoted their lives work in developing cures.  

He also adds that had the R&D been significant, we would have seen fewer deaths from adverse drug reactions. But adverse drug reactions were the 4th leading cause of death, and lead to about 1.5 million hospitalizations per year. Despite these numbers, Brody and Light do not acknowledge the impact that drugs have had on preventing deaths for numerous other causes such as heart disease, cancer, and so on. In other words, they only choose the negative effects of drugs, and not the positive benefits and costs savings they provide.

Dr. Light also claims that the lemons (drugs) industry produces, which offer no real advantage over existing drugs, are also putting patients at risk. But if FDA approves them, to what extent do they offer no real advantage? Despite what Dr. Light believes is industry doing everything possible to speed up FDA approvals of new drugs and to slow down any threatened FDA action to remove an unsafe drug from the market or to restrict its use, this reflects a regulatory issue, not an issue from industry.

Moreover, the premise that the drug industry is turning medicine into a commercial enterprise at the service of industry profits through this regulatory arrangement is problematic. The reality is, companies are making new discoveries and innovations each day that improve our health and lives. These breakthroughs cost money, and because insurance companies and health care providers do not want to cover them, the industry is taking the blame for the risks they took.

Ultimately, Brody and Light do not support their claim by this recent paper or any of the sources used. The burden of proof is still on the Pharmascolds to prove the harm that working with industry causes to patients, if any. The theories proposed by Dr. Light, while interesting, completely ignore the fact that all drugs and treatments inherently have risks and benefits, the weight of which are decided during the approval process, and subsequently when a doctor and patient choose.

To suggest that industry is preying on the elderly and exposing populations to risks because industry wants to make profits is misguided. The goal of industry in working with patients and collaborating with doctors is to improve patient outcomes. While it may take some trial and error, like all science, to find the best and most effective approach, the current strategies in place have led to numerous breakthroughs that produce life-saving drugs and fantastic innovations in health.

We should not let the extreme viewpoints of some derail what’s in the public’s best interest, and that is to continue progress in medicine by collaborating with industry and physicians.

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