Friday, August 23, 2013

90% Of New Drugs Are No More Effective Than The Old Ones

Do you know that drug companies spend 25% of their revenues on marketing but only 1.3% on finding new molecules. 9 out of 10 new drugs approved by Food and Drug Administration (FDA), U.S.A., provides no significant benefit over existing remedies.

According to a recent paper in the Journal of Law, Medicine and Ethics, led by Donald Light, from Harvard's Edmond J Safra Center for Ethics, drug companies are not nearly as "innovative" as they claim to be. They do produce a lot of new drugs, but mostly just iterations, rather than new recipes.

The paper points out that, "Companies are using patents and other protections from market competition primarily to develop drugs with few if any new therapeutic benefits and to charge inflated prices protected by their strong IP rights."

The FDA may be at least partly to blame. For one, drug companies are allowed to test new drugs against a placebo but aren't required to compare them to effective treatments already on the market. The FDA also allows companies to design trials "in ways that minimize detection and reporting of harms and maximize evidence of benefits"--for example, by excluding people from the trial who might react badly to the drug.

The paper is also particularly critical on "user fees" that pay FDA salaries. The authors charge FDA has become "institutionally corrupted" by lobbying in Congress and industry-funded “user fees”. The "fees" may allow FDA to approve drugs more quickly, and also let through more drugs of dubious benefit, including many with serious side effects. "Industry fees have not increased innovation as measured by clinically superior drugs," the paper says.

In the paper, the authors demand:
(1) fundamental reform of the FDA.
(2) create a new independent testing body
(3) end the industry "user fees"

They also recommend consumers be more cautious about new drugs. Don't take anything that hasn't been on the market for at least seven years, unless you have to.


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