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FDA says Vertex promotional material overstates benefits of hepatitis C drug

Federal regulators have asked Vertex Pharmaceuticals Inc. not to disseminate promotional material they say overstates the benefits of the company’s hepatitis C drug.

In a letter sent last Friday, officials from the Food and Drug Administration's Office of Prescription Drug Promotion said a Vertex-submitted “branded story” from a patient treated with the drug Incivek “is misleading because it overstates the efficacy, omits material facts, and minimizes important risk information about the drug product.”

The letter marked the second setback for the Cambridge biotechnology company in the past week. It was issued the same day Vertex officials said they learned that encouraging clinical trial data they published earlier in the month about the company’s experimental cystic fibrosis treatment had been overstated because of a statistical vendor’s mistake.

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That error boosted Vertex shares by more than 55 percent on May 7, enabling five senior executives and two directors to exercise stock options and sell shares worth millions of dollars. After Vertex stock tumbled Tuesday — when the company said the cystic fibrosis data was not as positive as initially reported — shares rallied Wednesday, climbing $2.38, or 4.1 percent, to $60.18 on the Nasdaq stock exchange.

Vertex spokeswoman Nikki Levy said Wednesday that the branded story prepared by the company for the hepatitis C drug, Incivek, has never been distributed, and the company is now reevaluating the material in light of the FDA’s letter, which fell short of a formal warning.

Biopharmaceutical companies are required to submit proposed promotional material to the FDA office for review.

“We take the FDA’s feedback very seriously,” Levy said. “The material they’re referencing hadn’t been used publicly. And it won’t be until we’ve addressed the FDA’s concerns.”

The story, which identifies the patient only as “James ‘J.P.’ M, Hepatitis C Mentor,” was planned as part of a promotional event that is common practice at Vertex and other drug companies.

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During such events, patients share their experiences with a treatment, appearing with nurses who also discuss the therapy with prospective new patients.

The patient speakers are paid travel expenses and a modest honorarium by the drug company, Levy said.

In the Vertex patient’s story, which is posted on the FDA’s website, he says: “Six months after the treatment ended, I found out I’d cleared the virus. That made me feel so good. I was happy to know I’d be around a little longer to see my son grow up.”

FDA regulatory review officials Sheetal Patel and Michael Sauers wrote that, while such claims may accurately reflect the patient’s experience, “this branded story misleadingly implies that most or all [patients] infected with hepatitis C will successfully achieve sustained virologic response” on Incivek.

They also said the word “cleared” wrongly implies the removal of the virus from the body.


Robert Weisman can be reached at weisman@globe.com.