What is the proper stance of the FDA in ensuring that new and innovative drugs are available as soon as possible, while also ensuring that those drugs are reasonably safe and effective? This is the subject of much controversy these days, and the FDA may have some answering to do.
The advocacy group Public Citizen has sued the FDA over its release of the high-dose (23 mg) form of Aricept (donepazil), asking the court to compel the FDA to respond to their original May 2011 petition to withdraw the drug.
A 2009 study of the new 23 mg dose showed it to be no more effective than lower doses and to have a higher risk of side effects, some potentially life-threatening. The new drug dose was created in anticipation of the lower doses going generic, in order for the company to obtain a new patent for the higher (and more expensive) dose for an additional three years.
It is a common practice of drug companies to come up with slightly different forms of their drugs that are about to turn generic, in order to create new patents for higher-cost drugs, and maximize their profits. Past examples of this strategy include Lexapro (a form of Celexa) and Nexium (a form of Prilosec).
The FDA’s own medical reviewer recommended against release of the high-dose Aricept, but was overruled by a senior director at the agency.
If you think something smells fishy here, you are not alone.
The latest issue of the Journal of the American Medical Association also contains an article about expedited release of medications that questions whether enough due diligence is being followed to protect the public. The article describes three recently-approved drugs (for cancer, multiple sclerosis, and prevention of strokes) that were subsequently found to have serious side effects and inadequate information about the best and safest dosages before they were released for use by the general public.
The US Senate is currently considering a bill that would give the FDA even greater authority to expedite release of such new medications. Clearly these decisions are being guided by politics, public pressure for new treatments (and probably pharmaceutical dollars as well), rather than good science, causing us to lose sight of our primary directive to “first, do no harm!”