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Suspicious Link Between Actos and Doctor Raises Safety Concerns

Dr. Steven Nissen

Dr. Steven Nissen - Cardiologist

When Dr. Steve Nissen, one of the top cardiologists in the country, heralded the death knell for Avandia by finding the diabetes drug increased the risk of heart attack and found that its competitor Actos lowered the risk, the good doctor was hailed as the unsung hero to diabetes patients worldwide.

But today, suspicion lingers over Nissen’s questionable relationship with Actos manufacturer Takeda Pharmaceuticals and the financial gains made from its meteoric rise in sales.

In a whistleblower lawsuit filed in federal court recently, a former Takeda safety consultant said that Nissen organized the downfall of Avandia, which was the top selling type 2 diabetes drug of the time, while generating $13 million for his institution by promoting Actos.

In 2007, Nissen, an outspoken drug-industry critic and chair of cardiovascular medicine at the Cleveland Clinic, co-authored a study that ran in the New England Journal of Medicine that lambasted Avandia and led to its demise.

Nissen’s study found that Avandia (rosiglitazone) increased heart attack risks by more than 40 percent and doubled the rates of heart failure. At the same time, his study also found that Actos (pioglitazone) decreases heart attacks, strokes and death by 18 percent, though it increased heart failure.

In her lawsuit, whistleblower Dr. Helen Ge, who worked for Takeda in its pharmacovigilance division, said that Nissen was a principal investigator in Actos clinical trials while he was working on the Avandia study.

“The payment Dr. Nissen received from Takeda through Cleveland Clinic Foundation was estimated to be $8-10 million for this study,” Ge said in the lawsuit.

Clinical Trials Prove Actos is Less Safe Than Avandia

Ge said in 2005, Actos clinical trials revealed that the drug had 115 more congestive heart failures and 16 more bladder cancers than the placebo group. As a result, Takeda was required to include bladder cancer risks on the drug’s label.

“These negative factors placed Actos at risk for further loss of market share,” she said.

She said Nissen downloaded data from 42 Avandia studies that had not been made public and a month later, in May 2007, he came out with his damning research on the drug.

“This was at a time when Dr. Nissen was also serving as the principal investigator for Takeda’s (clinical) trial designed to show Actos lowers cholesterol,” she said.

Other studies also question Nissen’s findings. In August 2007, Dr. Sanjay Kaul, an American Heart Association fellow, found that Nissen’s findings were questionable.

“The data that was analyzed does not allow us to conclude definitively whether the risk of heart attack with (Avandia) is increased or decreased,” he said.

Ge said that scientific proof shows that Actos is actually less safe than Avandia.

“Takeda has not only taken advantage of Avandia’s downfall to the detriment of patient safety and government funds, but Dr. Ge is convinced Takeda orchestrated this outcome,” the lawsuit said.

Nissen has vehemently denied any financial gain or “personal income” from his ties to Takeda. The funding goes to Cleveland Clinic, he has stated.

Even with this, the evidence presented in the whistleblower lawsuit provides some interesting food for thought. It raises questions: Did Takeda orchestra the downfall of its competitor? How much of a roll did Nissen play in this? Did a pharmaceutical company dupe the American public?

For the thousands of patients who have suffered because of taking Actos, these are questions that need to be answered.  Perhaps Actos never belonged on the market in the first place.