New Report Highlights FDA Drug Approval System’s Failings, Diabetes Drug Risks

Thousands of patients may have been injured or killed due to unknown side effects of Januvia, Byetta, Victoza and other similar diabetes drugs, thanks to the failings of the FDA’s drug approval process, according to the findings of a new report. 

An investigation into drug approvals at the FDA by the Milwaukee Journal Sentinel and MedPage Today claims to have turned up systemic failings in how new drugs get through the FDA’s approval process and on pharmacy shelves. The investigators found specific concerns in how the agency treats diabetes drugs.

The MedPage Today/Milwaukee Journal Sentinel report found that before the drugs go to the market, the FDA relies heavily on what are known as surrogate measures, instead of proof that users of drugs actually live longer. For example, they often look at a diabetes drug’s effects on glucose levels, as opposed to whether the person taking the drug lives a longer life.

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Critics say this means that, like in the case of diabetes drugs such as Byetta, they might see that the drug lowers blood sugar levels or positively affects insulin production, but miss that a number of patients later were diagnosed with pancreatic cancer and died.

Investigators conducted an analysis of case reports from 2004 to 2014 submitted to the FDA’s Adverse Events Reporting System. They found that diabetes drugs, particularly the side effects of Januvia, Byetta, and Victoza, were linked to about 3,300 deaths and 20,000 hospitalizations.

They found the most deaths, 964, had been linked to Januvia side effects, which also hospitalized 4,425, according to the reports. However, while the competing diabetes drug Byetta logged second with 880 deaths, it was linked to far more hospitalizations; 7,115. Victoza, a version of which was just approved as a weight loss drug, was linked to 319 deaths and 2,827 hospitalizations.

Even though, combined, the three drugs only make up 7% of diabetes drug prescriptions in the U.S., they accounted for more than half the deaths and hospitalizations linked to diabetes drugs last year.

Byetta, Januvia, Janumet and Victoza are all part of the same incretin mimetic class of diabetes drugs, which work by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal. A number of other studies have suggested a strong association between the drugs and pancreatitis and pancreatic cancer.

Many health experts say only a small percentage of adverse events are reported, so the actual number of deaths and hospitalizations linked to the drugs could be as high as tenfold the number reported. An investigation in 2000 by the Government Accounting Office (GAO) indicated that only 10% of all drug adverse events are submitted to the FDA.

The system is supposed to help the FDA discover problems with drugs after they’ve hit the market, but many critics say that is often too late for victims of drug side effects, and the GAO has found that even when signals indicate a dangerous drug side effect, the FDA does not appear to have the will or resources to actually do anything in many cases. Only the most egregious and deadly drug side effects appear to trigger reactions from the agency, according to a 2009 GAO report, which blamed the problems on an anorexic FDA budget.

Diabetes Drug Lawsuits

The report found that, in many cases, drug side effects are not brought to light until lawsuits are filed against drug companies.

There are currently more than 500 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits pending in the federal court system, which all involve allegations that the drug makers failed to adequately warn about the risk of pancreatic cancer associated with the class of diabetes drugs known as incretin mimetics.

The cases are centralized before U.S. District Judge Anthony Battaglia in the Southern District of California, as part of an MDL or multidistrict litigation, to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Ultimately, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different diabetes drugs, known as bellwether trials. While the outcomes of these trials will not be binding in other cases, they are designed to help the parties gauge the relative strengths and weaknesses of their cases, and may lead to Byetta and Januvia settlement agreements.


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