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As costs, legal scrutiny rise, more prescription drugs may disappear

San Diego — As drug costs and medicolegal scrutiny increase, the future of many drugs appears murky, said Stephen E. Wolverton, M.D., at the 70th annual meeting of the American Academy of Dermatology.

In recent years, Dr. Wolverton says, pharmaceutical manufacturers appear increasingly willing to pull the plug on underperforming drugs and those whose risks may outweigh their benefits. He is the Theodore Arlook Professor of Clinical Dermatology at Indiana University School of Medicine, Indianapolis.

"When drugs come and go and we hear about chemotherapy shortages, the fact is that drugs — now more than before — are unavailable for prescription at least temporarily," he says. This creates long-term back orders that can prove problematic for doctors and patients. "Or some drugs just aren't profitable, so the companies quit making them. And I have the feeling, though I couldn't prove it, that this will happen increasingly in the future. We will see more either temporary or permanent withdrawals of drugs that aren't selling."

The disappearance of the insulin sensitizer Rezulin (troglitazone, Pfizer) about five years ago exemplifies the trend, he says. "It has to do in part with whether there are any comparable drugs available that carry fewer risks such as, in the case of troglitazone, liver toxicity. In my opinion, once it was clear that Actos (pioglitazone, Takeda) and Avandia (rosiglitazone, GlaxoSmithKline) were available, then Rezulin was taken off the market."

Conversely, "The whole story of isotretinoin — all the way back to 1982 — is that multiple times, withdrawal was a possibility from a regulatory standpoint. But it's never been taken off the market, at least in part because there's no comparable drug."

In recent years, "There have been multiple articles that did not show a correlation with isotretinoin and the different types of inflammatory bowel disease (IBD) on a population level," Dr. Wolverton says. However, "Lawyers were filing successful lawsuits before there was even one article showing a borderline level of risk" of IBD in patients on isotretinoin.

Recently, he adds, such an article — written by researchers who previously found no link between isotretinoin and IBD (Crockett SD, Gulati A, Sandler RS, Kappelman MD. Am J Gastroenterol. 2009;104(10):2387-2393. Review) — showed a possible link with ulcerative colitis (UC; Crockett SD, Porter CQ, Martin CF, et al. Am J Gastroenterol. 2010;105(9):1986-1993. Epub 2010 Mar 30).

Since then, "Lawyers are taking almost any gastrointestinal symptom and trying to make it a successful lawsuit," with advertisements that suggest a connection between isotretinoin and IBD but don't mention that the article showing a possible connection pertains only to UC specifically, Dr. Wolverton says.

In this climate, he tells patients that one study shows there may be increased risk for a subtype of IBD, "But the majority of studies say there isn't. Until we know for sure, if you get the following symptoms — painful diarrhea, cramps and blood in the stool — stop isotretinoin immediately. Call me, and we'll discuss the options."

All for business

Other drugs disappear as the result of what Dr. Wolverton calls "business decisions." Examples include Oxsoralen-Ultra (methoxsalen, Valeant), which has historically been on and off the market, he says. Similarly, "For about 15 years, nitrogen mustard, it seems, would go off the market for awhile, then resurface."

Recently, Dr. Wolverton says, he tried to prescribe tetracycline for a few patients and learned from pharmacists that "It's gone, perhaps for good." Again, he emphasizes, this is merely speculation. "I just know that you currently can't get the drug. I don't know if that's permanent or not. The pharmacies say, 'Our supplier can't get it for us now.' I'd have to say at the gut level, the odds are more than 50-50 that tetracycline is gone for good, likely for business reasons."

Disclosures: Dr. Wolverton is a principal investigator for Abbott and Janssen.

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