Serious Risks from New Prescription Drugs

by Donald W. Light

Based on http://www.ethics.harvard.edu/lab/blog/436-new-prescription-drugs-a-major-health-risk

Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

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Introducing New Contributor Donald Light

Donald Light is a medical and economic sociologist who does policy research on institutional and global bioethics concerning access and quality of medical services and drugs. Recent research analyzes the epidemic of harmful side effects from drugs (The Risks of Prescription Drugs [Columbia UP, 2010]); institutional barriers to more effective, safer drugs; and global vaccine policy. Light is a founding fellow of the Center for Bioethics at the University of Pennsylvania. From 2009-2011, he was the Lokey Visiting Professor at Stanford University, and he is a professor of comparative health policy at the Rowan University School of Osteopathic Medicine.  From 2012-2014 he is a visiting fellow at the Edmond J. Safra Center for Ethics at Harvard University. Light received his BA from Stanford, his MA from the University of Chicago, and his PhD from Brandeis.

Selected Publications:

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