The Marketplace Can't Give Us the Drug Safety Data We Need


drug safetyby Jerry Avorn, MD

It has become fashionable to argue that if we just let the marketplace do its thing in healthcare, quality will rise, costs will plummet, and our patients -- I mean our customers -- will prosper. But this is a bad way to organize medical care delivery, and it's an even worse way to generate information about the medications we use.

The Food and Drug Administration does not test drugs itself, instead relying on manufacturers to design and conduct the clinical trials that determine whether their products are approved or not. The companies even pay the salaries of the FDA employees who make those approval decisions. The FDA has hardly any resources to conduct its own postmarketing safety studies of drugs. Instead, it asks the manufacturers to do them -- and most of the studies it requests are not done.[1,2]

With growing federal deficits, it might seem hopeless to call for a stronger public sector role in evaluating drugs.

But consider this: Before Vioxx was taken off the market in 2004, the nation spent about $2.5 billion a year to pay for a drug that we later learned doubles a patient's risk of heart attack or stroke. About a billion of those were public dollars, paid through government programs like Medicaid. A tiny fraction of those misspent public funds could have paid for the studies we needed to learn about that risk years sooner.

Why can we find the funds to pay for expensive drugs, but not to evaluate them properly? Our marketplace-based system of drug evaluation is actually costing us more than it would cost to do things right.[3]

In his First Inaugural, President Reagan said, "Government is not the solution to our problem; government is the problem." When it comes to drug safety, as in many other matters, President Reagan was wrong.

  1. Baciu A, Stratton K, Burke SP, eds. The Future of Drug Safety: Protecting the Health of the Public. Washington, DC: Institute of Medicine, National Academies Press; 2006.
  2. Government Accountability Office. Drug Safety: Improvement Needed in FDA's Post-Market Decision-Making and Oversight Process. GAO Report 06-402. Washington, DC: Government Accountability Office; 2006.
  3. Avorn J. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. New York: Knopf; 2005.
Jerry Avorn, MD, Professor of Medicine, Harvard Medical School, Boston, Massachusetts; Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts