Actemra Falsely Promoted?

Treatments for an estimated 1.5 million Americans afflicted with arthritis can have terrible side effects. Therefore, doctors and patients were understandably excited when Actemra hit the U.S. market in 2010. Actemra was promoted as not being linked with heart attacks, heart failure, or life-threatening lung complications, unlike competing arthritis drugs.  Was Actemra falsely promoted?

Hundreds Dead after taking Actemra
Despite the promises that it was safer than competitors’ similar drugs, hundreds of people who took Actemra died from the very same problems.  Many others have suffered harm. STAT (statnews.com) analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs. It found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking competing drugs.

No Warning for Actemra
Most of those other arthritis medications warn about those risks on their labels. Actemra does not warn about those risks.

What is Actemra?
Taken by injection or intravenously, Actemra is primarily used to treat rheumatoid arthritis, an autoimmune disease that causes pain, swelling, and stiffness in joints. Doctors also prescribe Actemra “off-label” for about 60 other conditions for which it has not completed testing for safety and efficacy. Actemra has been given to more than 760,000 patients worldwide. It generated sales of $1.7 billion in 2016 for Roche, becoming the company’s fifth highest-grossing drug.

1,128 Deaths Follow Actemra Use
People are peppered every day with drug ads tailed by laundry lists of so-called “side effects.” (They’re REAL effects all right, despite the euphemism.) Nevertheless, STAT’s investigation shows that risks to patients may be greater than they are led to believe. The FDA has received reports on 1,128 people who died after taking Actemra. Considering that it is a well-known fact that just 1-10% of adverse events are ever reported to FDA, the real Actemra death toll could easily top 10,000. Curiously, FDA has reviewed Actemra’s safety profile several times since the drug was approved, and has never proposed a label change. Sadly, the agency doesn’t have the tools to determine whether Actemra was the cause of, or a mere coincidence in, all those (reported) deaths.

FDA Limitations
The FDA is charged with monitoring the safety of prescription drugs, but the agency does not verify the side-effects’ reports it receives. The documents often lack crucial information. In the case of Actemra, they don’t prove the drug caused the deaths. But close inspection of some reports can allow one to reasonably determine the cause of a death or injury.

Two Deaths Causally Linked with Actemra
In one striking example – found through a Freedom of Information Act (FOIA) request from Charles Piller for STAT – the reporting doctor said, “[N]o factor other than the drug could have explained a 73-year-old man’s fatal brain bleed two days after he received an intravenous Actemra treatment.”  Another reported on a 62-year-old German woman’s heart attack in 2014: “The company assessed fatal myocardial infarction as related to (Actemra).”  That company was Roche, Actemra’s maker.

Despite these and other reports, neither Roche nor the FDA has ascted to change Actemra’s label to alert patients and doctors that potential risks have turned up, along with clinical studies completed after Actemra hit the market in 2010.

Actemra and Heart Failure, Pancreatitis
Experts who examined the data at STAT’s request said the FDA should immediately consider warnings for heart failure and pancreatitis – an inflammation of the pancreas that in its acute form can kill up to half of patients. They said the evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease – a potentially fatal scarring of lung tissue – is less convincing, but it warrants further review.

The failure to warn the public, experts say, highlights the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved, and to act promptly when potential danger signs appear.

“The system is broken, and all the financial incentives are linked up to keep it broken.”   – Dr. Vinay Prasad, Oncologist, Medical Ethicist.

Actemra Deaths, Injuries Unreported

“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” said Dr. Vinay Prasad.  The  oncologist and medical ethicist at the Oregon Health and Science University added:  “The system is broken, and all the financial incentives are lined up to keep it broken.”

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by Matthews & Associates