The Food and Drug Administration (FDA) has been around for over 100 years. It is “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation,” among other things. The FDA approval process for products varies. For example, “new drugs and complex medical devices . . . must be proven safe and effective before companies can put them on the market.” By contrast, products like “cosmetics and dietary supplements . . . can generally be marketed with no prior approval.” The length of time for the approval process also varies For example, the FDA states that the “average review time for an innovative new drug is now only 6 months.”
FDA regulations are not to be taken lightly. Skirting the rules can land companies and those that work for them in hot water. Desiring to fill what they saw as a gap in the market two companies, Synthes and Norian, did not follow proper protocol to get their new product approved and are still facing the consequences for their choices today. Some sixteen years ago, “spinal surgeons had few options if they wanted to use a cement-type product to treat vertebral-compression fractures to reduce pain.” Norian “had developed bone cements used in skull and arm-bone surgeries” and the company was subsequently bought by Synthes. Synthes “planned to alter Norian’s product so it could be used in spinal surgeries.” In order to do this, the company would need FDA approval.
The company, however, chose to start testing the product without first getting the required approval for spinal surgeries. One doctor who was recruited to test the product was Dr. Jens Chapman. He and another doctor conducted an experiment with the bone cement using the product on pigs, as well as human blood. They found that the cement caused clotting in the pigs, killing them. In addition, they found that the cement caused clotting in the human blood samples. But even with these results, warning from the FDA not to use the cement on spinal surgeries, and a warning from a medical consultant for Synthes “in 2002 that unauthorized clinical trials amounted to ‘human experimentation,'” the company pushed forward and the product was used in spinal surgeries anyway.
There were significant consequences for ignoring the rules for the company and unsuspecting patients. Three people died after the bone cement was used during a spinal operation between 2003 and 2004, according to the Wall Street Journal, another died in 2007, and another in 2009. The FDA did give marketing approval to a Norian bone cement product several years later in 2006, but the product had to be labelled that it could not be used on the spine and “Synthes sent a 2007 letter to surgeons announcing that restriction.” Even so, Chapman still continued to use the bone cement after the letter had been sent.
Both Norian and Synthes were later brought up on charges by the Justice Department for conducting trials without FDA approval. In 2010, the companies plead guilty and were fined. Four Synthes executives were criminally charged in connection with the illegal testing. In addition, civil lawsuits are still going to court over the use of the bone cement on patients.
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