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Commercial and Patent Incentives Reduce Study of Drugs that Prevent Disease

2015-12-28

An article in the New York Times (NYT) describes the perverse incentives that make it more profitable for private drug companies to produce drugs that improve survival marginally in late-stage cancers than to produce drugs that prevent cancer in the first place.

It is a medical axiom that the best way to cure a disease is to prevent it from occurring in the first place (“an ounce of prevention is worth a pound of cure.”)  However, when we survey the medical literature, we find very few studies of drugs that prevent disease, especially cancers.  The reason for this is the perverse incentives of patent exclusivity.

The developers of a drug are given 20 years to exclusively produce (or license others to produce) that drug.  On average, after clinical studies are complete, there are 12.5 years left of exclusivity for the company to profitably sell a drug.  This incentive works against clinical studies that take many years to complete.  By definition, a drug that prevents disease will take much longer to show significant results than a drug which treats the disease after it has already appeared.  In many cases, prevention lasts a lifetime: 70 years or more, much longer than the patent exclusivity period.

The article refers to research done by Eric Budish, Benjamin N. Roin, and Heidi Williams that shows how this works for cancer drugs.  The abstract of the study concludes:

… we document several sources of evidence that together show private research investments are distorted away from long-term projects. The value of life-years at stake appears large. We analyze three potential policy responses: surrogate (non-mortality) clinical-trial endpoints, targeted R&D subsidies, and patent design.

A good example (in a non-cancer context) is the case of Lipitor, formerly a widely advertised and popular drug that had patent exclusivity for Pfizer and made them a great deal of money.  It took many years for a study to appear that had adequate statistical strength to prove that it lengthened lives.  By the time this information was available and accepted by a preponderance of medical doctors, the patent had expired and there was no longer any financial incentive for Pfizer to advertise it or to sponsor studies of its use.

Despite the loss of patent protection, atorvastatin has come to be used for many other things than hyperlipidemia (high cholesterol and high fats in the blood): for example, atorvastatin has been used for progeria, polycystic ovary syndrome, transient ischemic attacks (mini-strokes), type 2 diabetes (the most common type), coronary artery disease (obstruction of the arteries that supply the heart muscle with blood, that leads to heart attacks), peripheral artery disease (obstruction of peripheral arteries), arteriosclerosis and atherosclerosis generally, after a heart attack to prevent further damage, and so on.  Most of these diseases are directly related to hyperlipidemia, but polycystic ovaries and progeria are not.

Studies of high doses of atorvastatin given to patients with severe coronary artery disease, especially after heart attacks, have already shown that it lengthens the life span of people who take it.  The main side effects, muscle pain and weakness, may require a patient to discontinue the drug, but most patients tolerate it extremely well with no side effects.  It will take many more years to prove that atorvastatin lengthens the lives of people who merely have high cholesterol; some studies already suggest that administration of the drug to otherwise normal individuals has advantages.

One approach that reduces this problem is to look for “surrogate end points”, a method that has helped in the development of drugs for AIDS.  In this approach, blood tests or other tests, even symptoms and signs, are used to determine if the drug shows any indications that it may improve survival in the long run.  For AIDS, the surrogate end points are such things as the number of T cells in the blood.  Very low numbers are associated with severe, end-stage AIDS, and drugs that can increase the number of T cells will usually improve survival, despite unpleasant side effects.  Drugs that improve the patient’s weight, strength, and other outward signs of illness can also be used as surrogate markers.

The article discusses other approaches that may improve the incentives to produce drugs that prevent cancer, but it concludes:

Drug patents incentivize innovation, and F.D.A. approval is a check regarding drug safety and efficacy. The way they work together affects the incentives for research and could reduce something many would view as highly valuable: cancer prevention.

The approach that is not discussed in the article is the only one that is certain to improve incentives: government sponsorship of drug development for specific long term purposes.  If the federal government were to set up a program that looked for and developed drugs that improve long term survival and well-being, the problem of perverse incentives would be overcome with a single stroke.

This idea is sure to be controversial because it sets up the government in competition with private drug companies; if it can be made clear that development will proceed in parallel and that the government will only develop drugs with long term benefit, drugs in which the private companies have no financial interest, it may be possible to further proceed in this direction.

The only alternative, the condition that exists today, is for naturopaths and other “quacks” to produce and sell drugs that have anecdotal evidence for benefits, hardly a productive state of affairs.

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