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Patients, Doctors Taken In By Off-Label "Buzz"

Drug Hyped as Pulmonary Fibrosis Cure Found Ineffective

By Truman Lewis
ConsumerAffairs.com

March 20, 2007
For years, desperate pulmonary fibrosis patients -- including World Trade Center rescue workers -- have poured money into a drug called Actimmune, hoping it would save them from an early death, even though the drug had never been approved for treatment of the disease.

The patients and, in many cases, their physicians were taken in by a "buzz" created by executives of the drug's manufacturer, InterMune. But now, clinical trials have found the drug does not prolong the lives of pulmonary fibrosis patients.

InterMune recently stopped an 826-patient trial after an interim analysis found that 14.5 percent of patients taking Actimmune had died, compared with 12.7 percent who were on a placebo and said it would abandon further efforts to develop the product as a federally-approved treatment for idiopathic pulmonary fibrosis.

"Clearly, the manufacturer hoped the research would either support the off-label uses, or could be tweaked to look like it did," said a trial attorney familiar with the case. "Consumers and insurance companies got ripped off."

The company's stock plummted when the clinical trial was ended. The company gets all of its sales, about $90 million annually, from Actimmune, also known as interferon gamma. Most of those sales have been for off-label use by pulmonary fibrosis patients.

InterMune last week asked the Securities and Exchange Commission for an extension to file its annual financial report. It said it needed extra time to complete its review of "certain additional disclosures and financial implications" regarding its decision to discontinue its Actimmune trials.

Company Promoted Off-Label Use

It's not as though InterMune was unaware the drug was being promoted for unapproved uses.

Last year, InterMune agreed to pay $37 million to settle charges it promoted Actimmune to treat pulmonary fibrosis even though it was not approved for that condition and its own studies didn't show it was effective.

It is not illegal for doctors to prescribe drugs for off-label use, as long as they are already approved for other uses, but it is against federal regulations for companies to actively promote drugs for unapproved uses.

"It is vital to public health and safety that pharmaceutical companies are deterred from improperly marketing their drugs to doctors and patients to treat illnesses that these drugs are not approved to treat," said Peter Keisler, an assistant U.S. attorney general.

Testimony in the case indicated that the company characterized the study as reducing mortality rates by 70 percent of patients with mild or moderate symptoms and encouraged Actimmune salesmen to tell physicians that the drug worked for pulmonary fibrosis.

Pam Lord, an InterMune spokeswoman, said any off-label promotion was done by executives no longer at the company.

Under the settlement, the company agreed to alter its promotion tactics and maintain written records documenting its sales efforts. The settlement did not provide any reimbursement for patients who wasted dollars and time taking Actimmune.

Big Disappointment for Patients

The clinical trial findings are a major setback for the 80,000 Americans suffering from the disease, for which there are no approved medications.

A lung transplant is the only hope for most patients with advanced pulmonary fibrosis. Patient advocates say some patients probably waited too long to get on the waiting list for a transplant because of their belief that Actimmune would help slow the progress of disease.

Pulmonary fibrosis, which scars and inflames the lungs, has been blamed for the deaths of numerous firefighters, police officers and other emergency workers who responded to the September 11, 2001 World Trade Center disaster.

Among the recent victims was Mark DeBiase, 41, a utility repairman who restored essential cellphone service at Ground Zero and later was stricken with pulmonary fibrosis. He died late last year. Other victims include New York City Police Detective James Zadroga and Police Officer Cesar Borja.

In a lawsuit DeBiase's widow charged that the city failed to provide DeBiase with protective gear to keep him from breathing in toxic air and dust while toiling for weeks operating cellphone service at Ground Zero and the Fresh Kills landfill. It's thought to be the first wrongful-death cases filed by a World Trade Center responder specifically linking the rare lung disease to Ground Zero exposure.

The only approved uses for Actimmune are for the treatment of two extremely rare diseases -- chronic granulomatous disease and severe malignant osteopetrosis. There are thought to be only 800 people in the United States with those diseases.

"It's unfortunate that there was so much hype about the drug and that physicians were willing to accept the results of a preliminary study that resulted in many patients being placed on this drug at a very high cost without obvious benefit,'' said Dr. Jonathan B. Orens, the associate director of pulmonary and critical care medicine at Johns Hopkins Hospital in Baltimore, according to The New York Times.

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