Pharma Company Sends Letters to Docs Who Criticized Drug Online

[Pharma Newshound]

Source: WSJ

URL Pharma Under Fire for Letters to Doctors Who Criticized Drug

By JONATHAN D. ROCKOFF

When a prescription drug called Colcrys came on the market last fall to treat gout, a number of physicians voiced their displeasure on an online message board for rheumatologists.

Now, those doctors are embroiled in a dispute with the drug's maker, URL Pharma Inc., over their postings. Some doctors had advocated use of a cheaper version of the drug, whose generic name is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions.

URL Pharma didn't threaten to sue the doctors, but warned that their comments expose them to liability lawsuits from injured patients.

"These are shake-down letters to silence" critics, said John Goldman, an Atlanta rheumatologist. In his postings, he had criticized URL Pharma for conducting limited research and for its pricing of Colcrys. URL Pharma says it reached out to physicians to educate them about its clinical trials and help them prescribe the drug appropriately, not to quash criticism. The company says it wasn't targeting the message-board members in particular, but had sent letters to a total of 150 doctors who had "mischaracterized unapproved colchicine as being safe or legal" in opinion pieces and other venues.

"We were trying to alert this small group of misinformed physicians to the fact that they were being led into medical malpractice liability," the company said in a statement.

Gout is a painful form of arthritis caused by high levels of uric acid in the blood. There were 3.5 million prescriptions of colchicine and $6.4 million in sales in 2008, according to IMS Health, a drug-data firm.

Colchicine has been around for centuries—so long that its use predated the Food and Drug Administration and therefore didn't require the agency's vetting. The FDA has encouraged companies to put such unapproved medicines through clinical testing. URL Pharma went through such steps, and last summer received approval to exclusively market its colchicine product, which it dubbed Colcrys, for gout attacks for three years. Last fall, the FDA approved the drug's use to prevent such attacks, but did not give URL Pharma exclusive marketing rights for that use.

URL Pharma priced Colcrys much higher than the pennies a tablet that patients had been paying for the older colchicine saying it was costly to conduct the clinical testing and the price was in line with other approved gout treatments. Colcrys retails for more than $5 a pill. The Philadelphia company also sued rival colchicine manufacturers, including Excellium Pharmaceutical Inc., Vision Pharma LLC, Watson Pharmaceuticals Inc. and West-Ward Pharmaceutical Corp., for illegal marketing. The four companies have said they are fighting the lawsuits.

URL's moves drew the ire of many doctors. On the online discussion group, sponsored by the American College of Rheumatology, critics posted numerous comments with their names attached. Doctors criticized the FDA, in addition to URL Pharma.

Edward Herzig, a Cincinnati-area rheumatologist, wrote that one of his patients had just learned that a 90-day supply of Colcrys would cost $550. "What chutzpah!" he said. Paul Rochmis, who practices in suburban Washington, expressed concern that URL Pharma was taking advantage of the FDA's unapproved drugs initiative at the expense of patient welfare. Edward Fudman in Austin, Texas, encouraged doctors to urge the FDA to allow unapproved colchicine to remain on sale.

The company says many insurers will cover the higher cost of its drug. Some people may qualify for a URL program that covers all or some of the cost of the drug. The company says it wanted to educate doctors that there is now on the market an approved drug, which means regulators have concluded it is safe and manufactured according to government standards.

Write to Jonathan D. Rockoff at jonathan.rockoff@wsj.com