May 8

Has the Obama administration already cowered to the demands of Big Pharma?

The unexpected approval of a "me too" dangerous antipsychotic drug that the agency itself had deemed "NOT APPROVABLE" in July 2008, raises serious questions about the Obama administration talk about applying comparative efficacy research (CER) standards to medical treatments–in order to improve care and rein in expenditure for worthless, ineffective treatments.
See Douglas Bremner MD blog, Before You Take That Pill, Vested Interests Move Against Putting Logic in Medical Decision Making

Forbes reports that even Jeffrey Lieberman, MD an influential schizophrenia researcher who, until the horrific findings of harm produced by the new antipsychotics, had been a prominent promoter of these drugs, said he was "amazed" that the FDA approved Vanda Pharmaceuticals’ bid to market iloperidone (Fanapt).

"The inference was that the FDA may be changing its policy and requiring superiority or distinctiveness for new drugs coming to a market that is already crowded. But the Fanapt approval would suggest the agency is still doing business as usual."

The decision, Forbes notes, sends the signal that industry can look forward to dealing with "an easier FDA."

posted by Vera Sharav
Is The FDA Easing Up?
Matthew Herper, 05.08.09

After the Food and Drug Administration told Vanda Pharmaceuticals that the company’s schizophrenia drug was "not approvable" last July, Wall Street marked the tiny biotech for dead.

The FDA asked for a new clinical trial; Vanda insisted it could change the agency’s mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.

Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That’s the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.

But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth, which is being bought by Pfizer, and Schering-Plough, which is being bought by Merck, were rebuffed last year by the FDA after submitting data for schizophrenia drugs.

Together with the July rejection of Fanapt, it seemed the FDA was setting a higher bar for new antipsychotics, demanding they must not only beat placebo results but also be at least as effective as existing drugs like Seroquel, from AstraZeneca, and Zyprexa, from Eli Lilly.

"The inference was that the FDA may be changing its policy and requiring superiority or distinctiveness for new drugs coming to a market that is already crowded," says Jeffrey Lieberman, chairman of psychiatry at Columbia University Medical Center. But the Fanapt approval "would suggest the agency is still doing business as usual."

Lieberman says he is "amazed" the FDA approved the drug. He says the approval is "probably a testament to persistence" on Vanda’s part. "There’s no harm in having it," he says. "It gives clinicians another option to choose from, but it doesn’t really add anything in terms of any substantial advance in efficacy or safety."

Lieberman was the primary investigator for a government-funded clinical trial that showed there was little difference in how long patients stuck with the new class of antipsychotics, like Zyprexa and Risperdal, vs. the older, cheaper variety, such as Haldol. That study, called CATIE, led to soul searching by psychiatrists over how big the advantages of the new drugs were. These antipsychotics are now the best-selling drugs in the U.S., according to IMS Health, a consulting firm.

One of the main problems with the newer drugs is their side effects. A selling point of drugs like Zyprexa was supposed to be that they spared patients the tremors, stiffening and other neurological side effects of older meds like Haldol. But many come with new side effects, including weight gain and the potential for increased cholesterol levels and potentially increased cardiovascular risk.

Fanapt was initially pitched as a medicine that might be slightly less effective, based on a study that compared it to Risperdal, a Johnson & Johnson antipsychotic that is now generic. But it also had a benign side-effect profile, not causing as much weight gain or heightened cholesterol. Although Abilify, from Otsuka Pharmaceuticals and Bristol-Myers Squibb, and Geodon, from Pfizer, both make similar claims, that could lead to "a modest niche" for Fanapt, says John Newcomer, a psychiatrist at Washington University in St. Louis.

That could bode well for Wyeth’s antipsychotic, bifeprunox, which likewise had a good safety profile but subpar efficacy. Schering-Plough has only said that the FDA wants new analyses for its antipsychotic Saphris.

Mihales Polymeropoulos, Vanda’s chief executive, says that the FDA did not actually have to lower its hurdle to approve Fanapt; instead, his company did a statistical analysis that convinced the agency that the medicine’s underperformance compared to Risperdal was caused by design flaws in the study.

"Vanda provided the FDA with additional data and arguments that led us to reinterpret results of several of their studies, thus convincing the agency that there was sufficient data to support an approval action based on the existing clinical trials," says Sandy Walsh, an FDA spokeswoman. A full accounting of the FDA’s decision will come when memos explaining it are released on the agency’s Web site.

But there are other signs that what seemed a climate of virtual paralysis at the agency is abating. The blood thinners Effient and Xarelto were highly controversial, but expert panels convened to evaluate the drugs turned out to be cakewalks. One of Effient’s biggest critics was excluded from the panel just days before it happened.

Margaret Hamburg is likely to be confirmed soon as FDA commissioner. Joshua Sharfstein, an associate commissioner who is expected to be closely involved with the agency’s drug division, has already started. That may be removing some of the political pressure that has helped paralyze the agency. The Obama administration has also budgeted more money for the agency.

Not that the controversy is ending. Next month, the agency will consider another hot-button topic: the overuse of antipsychotic drugs like Risperdal and Zyprexa in children.

"In children and adolescents, the medicines should not be banned, and they should not be restricted," says Lieberman. But he cautions that doctors need to "think twice, and even three times" before prescribing the drugs in kids, for whom the long-term efficacy, as well as the long-term risk, is unknown.



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