Risky Drugs: Why the FDA Cannot Be Trusted/ Safra Center for Ethics, Harvard

A forthcoming
article for the special issue of the Journal of Law, Medicine and Ethics (JLME),
edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics,
presents evidence that about 90 percent of all new drugs approved by the FDA
over the past 30 years are little or no more effective for patients than existing drugs.  

All of them may be better than indirect measures or
placebos, but most are no better for patients than previous drugs approved as
better against these measures. The few superior drugs make important
contributions to the growing medicine chest of effective drugs.  The bar for “safe” is equally low, and over the past 30
years, approved drugs have caused an epidemic of harmful side effects, even
when properly prescribed. 

Every week, about 53,000 excess hospitalizations and
about 2400 excess deaths occur in the United States among people taking
properly prescribed drugs to be healthier. One in every five drugs approved
ends up causing serious harm,1 while one in ten provide substantial
benefit compared to existing, established drugs. This is the opposite of what
people want or expect from the FDA.   

Prescription drugs are the 4th leading cause of death.
Deaths and hospitalizations from over-dosing, errors, or recreational drug use
would increase this total. American patients also suffer from about 80 million
mild side effects a year, such as aches and pains, digestive discomforts,
sleepiness or mild dizziness.  The forthcoming article in JLME also presents systematic,
quantitative evidence that since the industry started making large
contributions to the FDA for reviewing its drugs, as it makes large
contributions to Congressmen who have promoted this substitution for publicly
funded regulation, the FDA has sped up the review process with the result that
drugs approved are significantly more likely to cause serious harm,
hospitalizations, and deaths. 

New FDA policies are likely to increase the
epidemic of harms. This will increase costs for insurers but increase revenues
for providers.  This evidence indicates why we can no longer trust the FDA
to carry out its historic mission to protect the public from harmful and
ineffective drugs. Strong public demand that government “do something” about
periodic drug disasters has played a central role in developing the FDA.2Yet close, constant contact by companies with
FDA staff and officials has contributed to vague, minimal criteria of what
“safe” and “effective” mean. 

The FDA routinely approves scores of new minor
variations each year, with minimal evidence about risks of harm. Then very
effective mass marketing takes over, and the FDA devotes only a small percent
of its budget to protect physicians or patients from receiving biased or
untruthful information.34 The further corruption of medical
knowledge through company-funded teams that craft the published literature to
overstate benefits and understate harms, unmonitored by the FDA, leaves good
physicians with corrupted knowledge.5 6 Patients are the innocent victims…