Research Concerning Victoza Cancer Risks Under FDA Review

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Certain Type 2 diabetes medications continue to be associated with risks for pancreatic side effects that include pancreatic cancer. Drugs such as Victoza (liraglutidefrom), which are used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes, are known as icretin mimetics and are being evaluated by the U.S. Food and Drug Administration (FDA).

Icretin mimetics, including Victoza, have been the subject of research, specifically unpublished findings under evaluation by the FDA. This emerging research was conducted by a group of academic researchers whose findings suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes—pancreatic duct metaplasia—in Type 2 diabetic patients treated with incretin mimetics. Pancreatitis is a known risk cancer for pancreatic cancer.

The findings were based on a review of a small number of pancreatic tissue specimens taken from patients who died from a number of causes. The agency has requested the researchers to provide the methodology they used to collect and study these specimens, and have also requested the tissue samples utilized so that the agency may continue investigating possible pancreatic toxicity associated with Victoza and other incretin mimetics. These drugs imitate the body’s incretin hormones, which are meant to stimulate insulin release following a meal.

Victoza Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

Although the FDA said it has not reached new conclusions on the safety risks associated with Victoza and other drugs in its class, the FDA did inform the public and the health care community that it intends to secure and evaluate the new information that reveals links between Victoza and similar Type 2 mediations and increased risks for diseases of the pancreas, such as pancreatic cancer.

The FDA previously issued a warning concerning post-marketing reports of acute pancreatitis—fatal and nonfatal—associated with Victoza and other drugs in its class, but has not advised the public about the pre-cancerous cell changes seen with these drugs, The Associated Press (AP) noted. On the FDA website, the FDA did indicate that this is the first time the agency has communicated a possible pre-cancerous link to incretin mimetics, said Reuters.

Watchdog group, Public Citizen, petitioned the FDA to remove diabetes injection drug, Victoza, from the market because it likely increases the risk a patient will suffer thyroid cancer or pancreas and kidney failure. The group told the FDA that Victoza’s risks outweigh its benefits and the agency’s own review panel had reservations before Victoza was ultimately approved for use in 2010. Three scientists on an FDA advisory panel reviewing Victoza for approval made recommendations against its approval over reports the agency had collected concerning Victoza’s link to thyroid tumors. The FDA acted against that advice, voting to approve the drug. Public Citizen also cited evidence that Victoza was also associated with other side effects in addition to its likelihood to cause thyroid tumors. Currently, the FDA only warns people with a family history of thyroid diseases to avoid taking Victoza.

The False Claims Act allows for private persons to file lawsuits that provide the government with information about wrongdoing. If a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government may recover treble damages and $5,500-$11,000 per statute violation under the Act. If the claim is successfully resolved or litigated, the whistleblower can receive 15-25 percent of the monies recovered. Should the government decline to join the case, the lawsuit may proceed privately; the whistleblower will be entitled to a 25-30 percent recovery reward in this case.

Companies are prohibited from retaliating against a whistleblower under the False Claims Act. In fact, an employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with his/her seniority restored, recovery of double back pay with interest, and other compensatory damages. Whistleblowers may initially and anonymously report fraud by filing a claim through an attorney and the whistleblower’s identity remains under seal while the Justice Department is conducting its investigation. Should the government choose not to pursue the case, the firm will never know the whistleblower’s identity, unless the claim is privately pursued.