1/3 of New Drugs Often Approved and Marketed Ahead of Crucial Data

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medication bottlePharmaceutical companies have been accused of profiting from deceptive claims while American’s always thought that they were fervently working to come up with medication that would prevent and cure diseases that are plaguing the human race. Investigations carried out by experts have, over time, revealed false claims made by the pharmaceutical industry or just hiding critical information in order to get the approval of having their drugs in the market.

FDA Comparative Data Study

A recent study has found that nearly one third of new approvals for drugs done by the FDA did not have data on how the medications compared to existing alternatives. A pharmacist at the Boston based Harvard Medical School, Joshua Gagne, said that even when such data was available, going through it would be very time consuming. Healthcare providers and insurers find it difficult to find inexpensive, but effective drugs for patients, according to Gagne, who led the work done on the new drug approvals.

The major drawback is in the gap between the release of comparison research and the release of new medicines. Gagne said that information on new medicines is released years later despite $1.1 billion set aside in 2009 by Congress to support comparison research aimed at helping doctors to select the best drugs.

Related Read: Drug Companies Fake Thousands of Drug Documents

The Study

Gagne and his colleagues went through FDA information on 197 drugs that were approved from 2000-2010. Medicines for diseases that have no alternative medications were excluded. 70% of the packages approved had data on comparisons with existing medications. The study was published Tuesday in the Journal of the American Medical Association and elicited mixed reactions form experts.

Dr. Alec B. O’Connor, who had done an earlier study, said that a third of these drug approvals had no comparative information. The University of Rochester School of Medicine and Dentistry in New York researcher said that it’s sad that this is the case and believed that all new drugs should undergo testing against existing medications.

Some however, were surprised that the drug makers provided the comparative data though they were not required to. Dr. Robert Temple is one such expert. He heads the FDA office of Medical Policy.

O’Connor said that the risk of not having comparative data is that using new drugs is done based on guessing that it is better. However, with comparative data patients and doctors win and societal costs are saved.

Meanwhile, Gagne and his team say the comparative FDA data, when it exists, should be made more accessible.

Reuters

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