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Stryker Biotech: Tootsie Rolls, Oatmeal, and Fraud

November 4, 2009

Last week, a federal grand jury indicted drug and medical device maker Stryker Biotech on fraud charges relating to the company’s promotion of off-label uses of a bone strengthening product that has been linked to potentially fatal complications. Stryker’s implants, designed to promote bone growth, were FDA-approved for narrow uses only, but the indictment alleges that top Stryker executives and sales staff encouraged doctors to combine the products for unapproved uses with a bone filler that is not FDA approved and has never been tested in humans.

According to the U.S. Attorney’s office, Stryker’s implants, called OP-1 Implant and OP-1 Putty, could not alone compete with other safe, legal products. So Stryker promoted molding their implants with Calstrux, an untested bone void filler. The company provided doctors with recipes recommending doctors combine the products into “cigars,” “tootsie rolls” or “vienna sausages” to implant into patients. The recipes were inconsistent, callying for varying levels of Calstrux and other ingredients. In some cases where adverse effects occurred, doctors reported the mixture resembled “oatmeal,” “grits,” or “white sesame seeds.”

FDA’s approval of the Stryker devices was an “humanitarian device exemption” that allowed for use of the products only in patients with slow healing broken shin or thigh bones, and for no more than 4,000 patients annually. Such exemptions can be granted even for drugs that have yet to prove fully effective. But in 2006, FDA issued a class 2 recall of Calstrux, warning of serious health hazards when mixed with other bone growth products, and also that year, a physician recruited by Stryker to assess the products reported that the combination was ineffective. Last year, FDA warned Stryker of potentially fatal swelling of the neck and throat in patients given its OP-1 implants, but Stryker continued to promote the combination through February 2009.

Other bone growth implant makers have also recently faced controversy about their products. Earlier this year, a study of Medtronics bone growth implant Infuse was retracted by a leading medical journal after it was revealed that the clinical trial reported in the study was a complete fraud. The study’s author, Dr. Timothy Kuklo, purportedly tested Infuse on injured Iraq soldiers, but an army investigation found that some study participants were created out of thin air and the reported 92% success rate of treatments was fabricated. Two months after the company received the Army report on the fraud, Medtronic paid Dr. Kuklo to give a presentation on Infuse at a doctor’s junket in Las Vegas.

Interestingly, a recent GAO report on fraud in clinical trials and FDA’s delayed response in sanctioning researchers responsible for breaches (see “Failing the Drug Test: Fraud and Misconduct in Corporate Clinical Trials”) noted a frightening quirk in FDA’s disciplinary authority: a researcher disciplined by FDA for violations in drug testing trials is free to work in drug device testing, and a researcher found guilty of violations in drug device testing is free to go test experimental drugs.

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