6/22/2016 by Share Your Story

The Daily Rise: Wednesday, June 22


Halt! NIH Declines March-In Rights Request

Score a victory for innovation.

This week, the National Institutes of Health halted a backdoor effort to impose price controls through the use of new “march-in rights.” On Monday, the NIH declined a request that would have undermined the patent rights on Astellas Pharma’s prostate cancer drug Xtandi.

What exactly are “march-in” rights? Included in the 1980 Bayh-Dole Act, march-in rights grant the government the power to seize control of intellectual property. The controversial provision has never been used, but now, some are proposing the provision be implemented as a way to forcibly lower drug prices.

Today, many of our medical breakthroughs are funded from collaborative research, which can be funded in part by federal research grants. When Congress passed the Bayh-Dole Act in 1980, it was intended as a way to ensure that the government’s involvement in research didn’t obstruct innovation. As we’ve written previously, government research prioritizes publishing achievements for researchers — not treatment gains for patients.

“Prior to the enactment of Bayh-Dole, the government owned approximately 26,000 patents, only 5 percent of which had been used in the private sector,” Peter Rheinstein, the president of Severn Health Solutions and a former president of the Academy of Physicians in Clinical Research, wrote earlier this year. “Taxpayers were funding groundbreaking research. But since so few inventions were being licensed for drug development, Americans weren’t seeing the full benefits.”

ICER Watch: Avoiding the Public Relations Hit

Is the Institute for Clinical and Economic Review merely a public relations front for insurance companies?

Gregg Keller, principal of Atlas Strategy Group and a former national executive director of the American Conservative Union and the Faith & Freedom Coalition, says that ICER’s research is helping insurance companies avoid “the public relations hit” for enforcing policies that limit access to care and undermine patients.

“In the wake of ridiculous Obamacare mandates, the insurance industry is under tremendous cost pressure to deny its customers access to expensive lifesaving drugs,” Keller writes in a piece published at the Daily Signal. “But those insurance companies don’t want to take the public relations hit for denial of these drugs that cost billions in research and development to get to market, hence the Institute for Clinical and Economic Review. The institute helpfully steps into the breach and, with funding directly from the insurance industry and its allies, produces “research” that even liberals acknowledge vastly limits patients’ access to lifesaving drugs.”

He adds, “What this denial of service leads to is exactly the kind of drug rationing that free market conservatives have been warning about for years, usually to vocal derision from the left.”

Quote of the Day: Okon on Medicare Part B

“It’s totally mandatory. In fact, patients don’t even know. They’re not given what you would call informed consent in the research process and they’re not monitoring any of the adverse events.” — Ted Okon, executive director of the Community Oncology Alliance

Okon joined Politico’s Pulse Check podcast to discuss Medicare Part B’s pilot project to slash drug reimbursement rates. Jump to the 25-minute mark to hear extensive background on the Medicare reimbursement policy, cancer treatment prices and why the proposal violates the basic principles of clinical research.

State Spotlight: California’s Advance Notice to Aid Gray Market

California could see an expansion in the number of wholesalers and distributors operating in the “gray market” for prescription medicines under one legislative proposal.

Sara Radcliffe, president and CEO of the California Life Sciences Association, warns that a state level drug price transparency measure would cause prices for treatments to rise.

“SB 1010’s “advance notice” provisions would, however unintentionally, aid the prescription medicine “gray market” of shady wholesalers and distributors,” Radcliffe writes in an opinion piece published at the Sacramento Bee. “A 2012 report by Congress found that the gray market took advantage of the national drug shortage to “charge exorbitant prices for drugs used to treat cancer and other life-threatening conditions.”

In addition to the 2012 congressional report that revealed price spikes for cancer drugs, Radcliffe points to evidence that the proposal will compromise patient health and safety.

“A 2009 FDA investigation determined that improper handling by gray marketers had caused diabetes medicines to lose their potency,” she added. “There have also been reports of vendors selling adulterated or diluted medicines.”

We’ll keep saying it: Yes, cost is important. But, it’s only one of many factors important to patients. Patients should demand more than cheap and ineffective treatments that jeopardize patient safety.


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