UCSF Heart Doctor Wary of Amgen-Paid Repatha Study

UCSF Heart Doctor Wary of Amgen-Paid Repatha Study March 22, 2017
By Alex Keown, BioSpace.com Breaking News Staff

THOUSAND OAKS, Calif. – How much should the public trust Amgen ’s latest data regarding Repatha and its ability to lower cholesterol and reduce the chance of death from cardiovascular-related events? That’s a question posed by Dr. Rita Redberg, a cardiologist at the University of California, San Francisco.

Redberg told The New York Times that she had some concerns about the results Amgen announced last week at the American College of Cardiology meeting. In her interview with the Times, she said there was a potential for bias in the data because “Amgen paid for the study, helped design it, collected the data and helped write the paper.” The Times did not report any other concerns raised by Redberg, but did note that the data analysis was conducted by an independent team of academic researchers led by Dr. Marc S. Sabatine, “chairman of a cardiovascular research group called TIMI at Brigham and Women's Hospital, a teaching hospital at Harvard Medical School.” In Sabatine’s comments to the Times, he said reducing the risk of heart attack or stroke by 20 percent is “a pretty big reduction.”

Amgen’s latest data showed Repatha, a PCSK9 inhibitor, in combination with a statin led to more cuts in major cardiovascular events, including heart attacks, strokes and coronary revascularizations. Repatha was initially approved by the U.S. Food and Drug Administration in 2015 to lower cholesterol. However, the results were not as promising as researchers were hoping. The study involved 27,564 patients with cardiovascular disease. About 80 percent of the patients involved had already suffered a heart attack. There was a hope that Repatha used alongside statins would cut the risk of cardiovascular events by as much as 30 percent. However, when the data was in, the results showed that the drug combination reduced risks by an average 15 percent. However, when looking at heart attacks and strokes, the numbers were better. The combination cut the rate of heart attacks by 27 percent and strokes by 21 percent. It also reduced stents and heart bypass procedures by 22 percent.

While not the homerun Amgen and analysts were hoping for, the results are certainly a solid hit. Still, for Redberg and others certainly, there is a doubt about the science produced by the pharmaceutical industry. The doubters think that the company is only concerned about its bottom line and not about developing a therapy that is beneficial to patients. In some ways, the doubts raised by Redberg go hand-in-hand with comments made by President Donald Trump who has criticized the industry, particularly over pricing. During a press conference, Trump said the pharmaceutical companies were “getting away with murder.”

But, ForbesJohn LaMattina suggested Redberg’s fears are “absurd.” He said Amgen designed Repatha’s FOURIER trial in collaboration with cardiologists and the U.S. Food and Drug Administration. He said the study was carried out by investigators at teaching hospitals. While Amgen did collect the data, the analysis was performed by the independent team helmed by Sabatine. LaMattina noted that Amgen did pay for the study, he estimated about $500 million, which he said was a figure beyond the means of publicly funded institutions.

Spending half-a-billion dollars on the trial was a risk carried by Amgen, LaMattina said. And that’s a risk that has failed for other companies. He pointed to rival Pfizer , which halted a PCSK9 inhibitor trial last year because the drug’s benefits faded over time.

“Because of the risks, these studies are undertaken with great care and with the advice and oversight of many outside of the company that is footing the bill for the study. Foolish comments like those by Dr. Redberg are of little use as the industry works to advance medical science,” LaMattina said.

Back to news