Many Drugs Approved on Incomplete Data

We’ve long written about medical devices hitting the market via a legal process that involves fast-tracking, a process which has been roundly criticized by many nonindustry advocates concerned with potentially defective devices making their way into patients’ bodies. Now, Reuters is drawing attention to the issue of <"http://www.yourlawyer.com/practice_areas/defective_drugs">medications being approved on incomplete data.

For instance, said Reuters, comparative data could reduce costs and better enable physicians in treatment planning, but is not always available when a new drug is approved, according to a new study conducted at the Harvard Medical School in Boston.

The study was published in the Journal of the American Medical Association and was released this week. The team found that about one-third of all new drugs released with approval by the U.S. Food and Drug Administration did not include data on how the new drugs fared when compared to existing and similar medications, said Reuters. “Even when these things are accessible, it’s hugely time-consuming to go through it,” said Joshua Gagne, a pharmacist at Harvard Medical School in Boston, quoted Reuters.

Gange pointed out to Reuters Health, that this issue creates a gap for insurers and healthcare providers who are seeking an efficacious and economic medication for their patients. Gange led the study.

In 2009, Congress allowed $1.1 billion for the support of such drug comparison research, a move that would better enable physicians to choose prescriptions for patients from a range of drugs, explained Reuters. The information from this research, however, will most probably take years for release in all cases when new medications are made available to consumers because drug manufacturers—under current regulations—are only required to prove products are superior to placebos (sugar pills), not how they work in comparison with existing medications, said Reuters.

“There is a gap between the time the drug hits the market and the time this information is generated,” Gagne said, quoted Reuters. Gange and his team reviewed public FDA data for 197 drugs that received approved between 2000 and 2010.

“A third of new drugs that are approved have no comparative data at all,” said Dr. Alec B. O’Connor of the University of Rochester School of Medicine and Dentistry in New York. “I think we’d all say that is sad,” quoted Reuters Health. Other experts disagreed noting that most medications do have some comparative data available with the FDA.

In a prior study in which O’Connor was involved, the research attempted to look at the cost efficacy of various painkillers and found that the task proved nearly impossible because most researchers never conducted drug-to-drug testing, said Reuters Health. “When a new drug becomes available, if it’s not compared with a drug we already use, we don’t know if it is better or worse—we’re just guessing. If you’re a patient, I don’t think you would want your doctor to be guessing,” he told Reuters Health. “You could save a lot of money if you had better comparative data at the time of approval,” he noted. “It’s a win-win for patients, for doctors, and for societal costs.”

Gagne and his team conclude that, when available, comparative FDA data should be accessible.

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