Could it now be easier than ever to get a new drug approved by the FDA?

Uh oh. We might have just gotten a revealing look at the new FDA. And if we have, it appears there may be a very drug-company-friendly rubber-stamp attitude when it comes to the drug approval process.

A new drug company pal in town

A recent Reuters Health report (which quotes two financial analysts but no medical professionals – what’s up with THAT?) notes the FDA approval of Fanapt, a powerful atypical antipsychotic drug that treats schizophrenia.

Nothing unusual about that. The FDA approves new drugs all the time. But this approval “stunned Wall Street,” according to Reuters. (Again – why the sharp focus on the financial side from Reuters HEALTH?)

Here’s the Fanapt story in a nutshell: In July 2008 the FDA sent a “not-approvable” letter to executives for Vanda (maker of Fanapt), informing them their marketing application had been denied. But Vanda resubmitted their drug for consideration in November, and six months later Fanapt was approved.

But something’s fishy here.

According to the Washington Business Journal, the FDA initially rejected Fanapt because it “too closely resembled rival drugs already on shelves and needed more clinical tests.”

But one of those financial analysts Reuters Health spoke to expressed surprise at the Fanapt approval, because it was “based on the same data set submitted earlier with no additional trials conducted.”

Fishy.

That other financial analyst told Reuters: “Perhaps the presence of a new commissioner is already having an effect.”

Yeah – a big, sweetheart rubber-stamp effect!

Heart unfriendly

Vanda CEO Mihael Polymeropoulos told Reuters Health that about 75 percent of the nearly 2.5 million schizophrenia patients in the U.S. change their medication every 18 months.

So a new atypical antipsychotic drug like Fanapt will be welcomed by some – even though it closely resembles rival drugs and, like those other drugs, may affect heart rhythm parameters, according to Reuters Health. Put another way: Sudden cardiac death is a risk with this class of drugs, as revealed by a 2009 study in the New England Journal of Medicine.

Mr. Polymeropoulos told Reuters Health: “There is a tremendous pool of patients who are dissatisfied with their current treatments and willing to try the next drug.”

Too bad their doctors are so focused on the next drug, and the next, and the next…

In the e-Alert “Getting Played” (1/2/07), I told you how patients with schizophrenia are typically deficient in vitamin B-3 (also known as niacin). In some cases, patients respond quite favorably to high doses of the vitamin.

Here’s what HSI Panelist Allan Spreen, M.D., has to say about this issue: “The link between B-3 and schizophrenia is not well known except for those in complementary medicine. The response, however, can be remarkable, though it can take as much as 30,000 milligrams (30 grams) of B-3 in difficult cases.”

Abram Hoffer, M.D., Ph.D., was the first to recognize the B-3/schizophrenia link. And for Dr. Spreen the connection with Dr. Hoffer is personal.

Dr. Spreen: “Hoffer later treated my sister, a schizophrenic who had been written off and permanently institutionalized. My parents were told she’d never be a useful, productive member of society. She ended up graduating law school and passing the bar.”

Dr. Hoffer’s book “Vitamin B-3 and Schizophrenia: Discovery, Recovery, Controversy” can be found on amazon.com.

Sources:
“Vanda Shares Soar 8-Fold on Surprise Drug Approval” Esha Dey, Reuters Health, 5/8/09, reutershealth.com
“Still Courting FDA, Vanda Pharmaceuticals Waits Again for Approval” Vandana Sinha, Washington Business Journal, 5/1/09, bizjournals.com