Osteoporosis News: FDA Regulators Look Out for Merck, Pharmaceutical Giant Loses Lawsuit, and the FDA Makes You the Guinea Pig
It seems there’s always news in the osteoporosis community. And it’s going to stay that way for quite some time, courtesy of Big Pharma. Today, the spotlight is (yet again) on Merck and its popular osteoporosis drug, Fosamax.
“Dear Merck: Please make a safer drug than Fosamax! – signed, the FDA”
While that’s a fictional quote, it sums up what’s going on between pharmaceutical giant Merck and the FDA. Documents from a recent legal battle have revealed that the FDA has asked Merck repeatedly for a safer osteoporosis drug than Fosamax.
Of course, Save Our Bones readers (a.k.a “Savers”) are already aware of the harmful side effects of this bisphosphonate, particularly the link between Fosamax and osteonecrosis of the jaw.
And notice the disturbingly cozy relationship between the regulators and Merck. Instead of stopping the sales of Merck’s blockbuster drug, the FDA was actually pleading with Merck to discover a “safer” drug that would replace Fosamax. The inevitable question is, who’s really in control of drug “safety”?
So watch out – now that Fosamax’s patent has expired, Merck is finally “making good” on the FDA’s request with odanacatib, which belongs to a new class of drugs known as “cathespin-K inhibitors.”
“Merck has stated that odancatib will present fewer long-term safety issues than the bisphosphonate drugs due to the drug’s unique mechanism of action on bone turnover, which is slightly different than Fosamax’s mechanism.
In an April 2012 earning conference call, when asked about the commercial viability of odancatib in an already-crowded osteoporosis drug market, Merck Chairman and CEO Kenneth C. Frazier noted that there exists ‘declining use of bisphosphonate [drugs] due to some concerns that have been raised around long term safety’. Merck expected to file for odancatib’s approval in 2013, however, Merck recently disclosed that it will delay filing the formal application for odancatib marketing approval until 2014. At its peak, Fosamax generated $3.5 billion per year in annual sales for Merck. In the United States, Merck has already stopped selling the 35 mg dose of Fosamax. It is anticipated that Merck will discontinue marketing Fosamax in the United States once it receives marketing approval for odancatib.” 1
Win Some, Lose Some: Merck’s in Trouble
Over 4,000 state and federal lawsuits have been brought against this massive pharmaceutical corporation. Seven of these cases have gone to trial, and incredibly, Merck has won five of them. But Merck has recently lost two cases, and the most recent one – Scheinberg vs. Merck – puts Merck on the hot seat.
Scheinberg is a resident of New York who contends that Fosamax caused her immense suffering in the form of bone disease in her jaw following a tooth extraction. The jury ruled that Merck failed to give proper warning of the risks of Fosamax.
“Lawyers for Scheinberg, a 69-year-old New York resident, contended Fosamax caused her to suffer delayed healing and a bone disease of the jaw after a tooth extraction. The jury found that Merck’s failure to warn of the drug’s risks was a cause of her injury.
‘With this victory, this litigation has a renewed purpose and a renewed focus,’ Tim O’Brien, a lawyer for Scheinberg who also represents other plaintiffs in Fosamax lawsuits, said in a statement.
The lawsuit, filed in 2008, was one of 975 pending before U.S. District Judge John Keenan in New York after a judicial panel consolidated Fosamax cases alleging jaw-related injuries.
Another 842 lawsuits alleging femur injuries are pending in the U.S. District Court in New Jersey. Other lawsuits are pending in state courts.
The only other Fosamax case that Merck has lost at trial resulted in a $8 million verdict by a federal jury in Manhattan in June 2010 for Shirley Boles, a Florida woman who alleged she developed osteonecrosis of the jaw after taking the drug.”2
Conflict of interest? Big Pharma Bankrolling Almost Half of FDA’s Annual Budget
Back in 1992, Congress gave in to the pressure the drug companies were putting on the FDA for faster approval times, and passed the Prescription Drug User Fee Act. As part of the deal, the pharmaceutical industry agreed to pay additional user fees, effectively becoming a major contributor to the FDA’s ever-growing budget.
“In the 1990s, industry dollars began rolling in to the world’s pharmaceutical companies, nicknamed “Big Pharma.” Drug companies, in turn, discovered they were able to take money to influence doctors as they peddled new drugs and devices to patients.
As promised, FDA approved drugs much more quickly. And in 1997, the Food and Drug Administration Modernization Act directed the FDA to create a “Fast Track” mechanism whereby important new drugs could get to patients even sooner.
The same year, user Big Pharma fees added $87.5 million to the FDA’s annual $1.0 billion budget. To wit:
- In 2009, the agency’s budget request was just under $2.4 billion, with $628 million of that total coming from the Big Pharma.
- By 2012, user fees amounted to $1.33 billion, and they are projected to grow to $1.97 billion in 2013.
That means that by 2012, if approved by Congress, 44 percent of the FDA’s $2.5 billion allocation will come from Big Pharma, the very companies whose products the FDA is charged with regulating.” 3
Why let Big Pharma toy with your health and wellbeing?
You don’t have to be Big Pharma’s guinea pig, because you have a choice. With the Save Our Bones Program by your side, you have full control of your bone health without having to worry about dangerous side-effects; there’s only a healthy change for the better!
Till next time,
1 Cousins, Farron. “FDA To Merck: Make a Safer Osteoporosis Medication Than Fosamax.” Ring of Fire. February 11, 2013. Web. http://www.ringoffireradio.com/2013/02/11/fda-to-merck-make-a-safer-osteoporosis-medication-than-fosamax/
2 Raymond, Nate. “Merck hit with $285,000 verdict in Fosamax trial.” Reuters. February 5, 2013. Web. http://www.reuters.com/article/2013/02/05/us-merck-fosamax-idUSBRE91416H20130205
3 “FDA Fast-Track Programs for Drugs and Medical Devices.” Drugwatch. February 27, 2013. Web. http://www.drugwatch.com/fda/