hey, hey, FDA how many kids did you kill today?

by Jon Chun

Published: May 3, 2008

Drug manufacturer Cephalon Inc.’s shares fell 4.4% yesterday when news leaked that Fentora, a drug used to alleviate pain in cancer patients, is facing increased scrutiny by the FDA. The company is seeking to make the drug available on a more general basis to people who suffer from chronic pain, not necessarily related to cancer. However, the FDA is concerned that the opiates contained in the drug could lead to widespread abuse by the general public.

In a note to investors analyst Eric Schmidt stated, “Our initial read of the documents suggest the FDA has set a high bar for approval…”

An appropriate response, one may assume, given the risks inherent in a drug of that nature. Cephalon reacted by excluding Fentora sales from it’s financial projections for the foreseeable future. The case is pretty much closed; chalk up one more victory for the FDA in their ongoing battle to keep the pharmaceutical industry from pushing harmful drugs on the public.

But before we rush to pat the FDA on the back I would like to introduce 2 words into the discussion: false negatives. In the FDA’s case, a false negative occurs when they ban a drug that could have alleviated pain, healed a disease or saved a life.

False negatives don’t get much press because it’s impossible to print the following headline:

“FDA bans Such-And-Such Drug. 50,000 people unnecessarily suffer from chronic pain.”

There’s no way to track the impact that a drug could have had on society. Lives lost because a certain drug was not available will always go unaccounted for. On the flipside, this headline sells lots of newspapers:

“Popular weight loss drug Fen Phen linked to heart problems.”

Thus, the FDA’s obsession with false positives. If you work at the FDA and it turns out that an FDA- approved drug does irreversible damage to the heart, that could cost you your job. At the very least it makes life very uncomfortable. But the “Such-And-Such Drug” headline is never printed and consequently gets ignored.

Although the headline goes unwritten, it is still real. The FDA saves lives and takes lives. They prevent bad products from reaching the market and they prevent good products from reaching the market. (In case you feel tempted to question the premise that the FDA keeps good products off of the shelf.)

If the FDA has proven itself incapable of correctly screening out harmful drugs, then it should not take a stretch of logic to assume that they are also capable of screening out harmless drugs. Mix in the fact that little to no backlash occurs when good drugs are banned and it’s safe to assume that the latter scenario is far more common than the former.

Also remember that when you finally do get to purchase that medicine for your arthritis, it’s price includes the costs of the R & D associated with your arthritis pill AND many of the other drugs that the company developed but was never able to sell. The odds of any given drug making it through the development stage and onto the shelf are slim to say the least. Therefore, when a drug finally does get approved the manufacturer needs to recoup costs that are entirely unrelated to that specific drug. You can blame drug companies for the high price of medication if you’d like, but by far the greatest costs are associated with government hurdles and not CEOs paychecks.

The FDA’s stated mission is to protect “the public health by assuring the safety, efficacy, and security of human and veterinary drugs” and so on. Personally, I think their supposed success is the result of a tremendous “false positive.”

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