Publication Date: January 13, 2014
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On this episode of Drugwatch Podcast, I am joined by Dr. Michael Carome, director of the Health Research Group (HG) at the public advocacy group Public Citizen. Public Citizen is a voice for the people in the nation’s capital and has been fighting for the interests of the American people since 1971.

The nonprofit watchdog group’s main goal: “To ensure that all citizens are represented in the halls of power.”

One of the areas Public Citizen is very active in is challenging the abusive practices of Big Pharma. The group fights to get dangerous drugs off the market and challenges the U.S. Food and Drug Administration’s process for approving drugs and medical devices. Over the years, the group has been successful at getting Washington and corporations to pay attention and make choices that would benefit the people.

As patient advocates ourselves, we at Drugwatch salute and appreciate Public Citizen’s great work to make drugs and devices safer for the public.

On Part I of this two-part episode, Dr. Carome joins us to discuss dangerous diabetes drugs and hip implants, as well as the policies and regulations of the U.S. Food and Drug Administration (FDA).

Public Citizen Calls for a Ban on Diabetes Drug Victoza

With the number of Americans diagnosed with type 2 diabetes increasing, the need for effective treatments is also increasing. The most popular way to treat type 2 diabetes is by prescribing medications.

However, often, it seems as if the race to create the latest and greatest drug may come at the cost of safety. Many of the new drugs released in recent years have not always been the safest.

One of the newer drugs on the market is Victoza (liraglutide). Public Citizen petitioned the FDA to ban the drug in 2012, pointing to studies conducted in animals that showed a risk of thyroid cancer.

“Because of this signal of cancer, the FDA’s own pharmacology reviewers concluded that it should not be approved,” Carome said.

However, the FDA approved the drug anyway, ignoring the recommendations of its own reviewers.

There is also evidence that the drug causes pancreatitis, as well as the possibility for pancreatic cancer. According to Carome, the entire class of drugs called incretins may carry the same risks. Other drugs in this class include Byetta and Januvia.

The Long Fight Against Avandia

Another one of the drugs Public Citizen has been fighting to get off the market for years is Avandia. Since the drug became available in 1999, it has faced scrutiny for safety issues.

According to Carome, clinical trials and studies simply don’t support that the drug is more effective than others on the market. Some of these studies even showed that Avandia was inferior in efficacy.

The drug was linked to serious heart problems, and Public Citizen urged people not to use it.

“We thought it was too dangerous, and its benefits do not outweigh the risk. When you compare Avandia head to head with other oral medications for type 2 diabetes, Avandia was not as effective at reducing blood sugar levels as the other drugs,” Carome said.

Other drugs in the same class as Avandia include Actos, a drug that is linked to bladder cancer in studies.

Public Citizen testified at FDA hearings, presenting the agency with this evidence in an effort to get the drug banned. The FDA unfortunately denied the organization’s petition. So far, the FDA has not made a final decision on the drug’s safety.

Medical Devices Not Properly Tested

While Public Citizen spearheads the fight against bad drugs, it also gets involved in policing medical devices.

Most recently, they have been concerned with metal hip implants such as DePuy’s ASR, Stryker’s Rejuvenate and ABG II and Biomet’s M2a Magnum. In addition, they see many problems with transvaginal mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.

Metal and transvaginal mesh implants have spurred tens of thousands of lawsuits after patients who received them were seriously injured.

According to Carome, one of the biggest problems is that many of these devices are classified as Class II devices. The FDA’s 510(k) premarket clearance process allows medical device companies to release devices as long as there is already a substantially equivalent device on the market. This means they do not need clinical trials or proof of safety or efficacy before they are sold.

Carome calls this practice an “uncontrolled experiment” on the public.

“We don’t think that devices that are intended to be permanently implanted or life-supporting or life-sustaining should ever come to market through this process … and [should] undergo appropriate testing before they come to market,” Carome said.

He went on to say that the Institute of Medicine (IOM) was asked by the FDA to evaluate the 510(k) process in 2011. Not surprisingly, the IOM committee concluded that the 510(k) was inadequate to show that devices were safe.

Unfortunately, the FDA ignored this conclusion.

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