Merck stops production of osteoporosis drug over stroke concerns, has yet to stop vaccine production

Thursday, September 08, 2016 by: David Gutierrez, staff writer
Tags: Merck, osteoporosis drug, stroke risk

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(NaturalNews) Pharmaceutical giant Merck announced on September 2 that it is abandoning plans for a new osteoporosis drug known as odanacatib, after the latest phase of safety trials showed that the drug significantly raised patients' risk of stroke. The findings of that trial will be presented at the conference of the American Society for Bone Mineral Research.

"We have learned that odanacatib treatment reduces the risk of osteoporotic fractures," said Roger Perlmutter, president of Merck Research Laboratories. "At the same time, we believe that the increased risk of stroke in our Phase 3 trial does not support further development."

While Merck may be abandoning plans for this drug due to its unacceptably high risk of side effects, it has of course announced no plans to end production of its controversial MMR vaccine – even though the mumps portion of that vaccine does not actually protect against the disease.

Drug class riddled with failures

Odanacatib had been predicted to be a major blockbuster for Merck, potentially raking in profits of 3 billion dollars a year. But the drug's path to approval had been rocky for some time. In 2014, Merck announced that it was delaying filing for FDA approval, after preliminary results came back from Phase III trials showing an increased risk of stroke and atrial fibrillation. At that time, the company said it still hoped to gain approval by 2015. But now that delay has turned permanent, and Merck is no longer continuing drug development.

"The company has decided to discontinue development after an independent adjudication and analysis of major adverse cardiovascular events confirmed an increased risk of stroke," Merck said in a statement.

"We are disappointed that the overall benefit-risk profile for odanacatib does not support filing or further development," Perlmutter added.

Odanacatib inhibits the action of the enzyme cathepsin K, which plays a role in the part of bone maintenance that involves breaking down old tissue (bone resorption). It is the third cathepsin K inhibitor to fail to reach the market in recent years. In 2006, Novartis dropped its application for a cathepsin K inhibitor that was found to cause skin lesions. Medivir pulled an application without explanation in 2009, as did Onon Pharmaceutical in 2012.

The string of failures has some observers asking if elevated stroke risk or other severe side effects might be intrinsic to the drug class.

The news is expected to bolster the fortunes of rival Pharma companies UCB and Amgen, who are in late-stage trials on new osteoporosis drugs. The effectiveness results of these trials are mixed, however.

But vaccine fraud marches on

While it's good news that Merck's dangerous osteoporosis drug won't be hitting pharmacy shelves, don't expect this to start a trend. After all, it's been six years since two Merck scientists filed a False Claims Act complaint with the federal government, outing the company as having doctored the results of its mumps vaccine trials.

According to the complaint, the company artificially introduced animal antibodies into its samples in order to bolster its false claim that the vaccine was 95 percent effective at preventing mumps.

The complaint noted that this placed the health of children at risk, and actually contributed to the ongoing persistence of mumps in the United States. It also allowed Merck to maintain a monopoly, as no other companies could achieve the (perhaps impossible) falsely inflated "95 percent efficacy" of the Merck drug.

The scientists said that the fraud stretched back as far as the late 1990s, and that all senior management were well aware of it. The vaccine was never tested against real-world mumps viruses.

The complaint was not made public until 2012. To date, neither Merck nor the federal government has taken any action in response.

Sources for this article include:

MarketWatch.com

NaturalNews.com

FierceBiotech.com

PMLive.com

Yahoo.com

Science.NaturalNews.com