Latest Drugwonks' Blog
Hamburg opposes separate safety reviews
FDA Commissioner Margaret Hamburg told BioCentury she opposes separating postmarket safety oversight from new drug reviews, a policy Rep. Rosa DeLauro (D-Conn.) and Sen. Chuck Grassley (R-Iowa) are promoting. DeLauro recently announced plans to attach a report instructing FDA to create an independent postmarket drug safety office to an appropriations bill.
"We need to strengthen the integration of safety and efficacy throughout the lifecycle of medical products," Hamburg said. "It would be a mistake to further separate and stovepipe safety and efficacy." Hamburg said she is considering organizational changes to better integrate safety and efficacy oversight. In addition, she said FDA needs to "strengthen safety science, and that's why I've asked the Institute of Medicine to do a report [on postmarket safety studies], and our Science Board will be undertaking a study about safety science at FDA"
Hamburg supports releasing complete response letters
Releasing information about negative decisions on drug applications could benefit drug developers and advance scientific progress, FDA Commissioner Margaret Hamburg said Tuesday at a conference on drug development. An FDA transparency working group's draft proposals include publicizing redacted versions of complete response and refuse to file letter.
"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," Hamburg said at the meeting, sponsored by Friends of Cancer Research, Ewing Marion Kauffman Foundation, Council for American Medical Innovation and others. Companies might oppose public release of information about rejection of their application, but "those same companies can recognize there are benefits if everyone opens up and does the same,” she said.
Hamburg told BioCentury that disclosures would describe the reasons for a rejection. They also "would obviously speak to the adequacy of data in certain instances, but more significantly, that certain approaches might not be effective or certain kinds of molecular entities have certain toxicities, and that could have relevance beyond a particular application." FDA would not release commercial confidential information "without industry's explicit permission," she said.
Robert Butler MD died this week of leukemia at the age of 83, full of projects and brimming with new constructs for future research. I was a junior at SUNY Buffalo when I read "Why Survive? Being Old in America.” What I found striking about the book what Butler’s ability to deconstruct aging as a product of disease, not of getting old, which he argued was society’s convenient way of not investing time and money into understanding the biological processes that characterized “getting old.”
An excellent tribute to Dr. Butler can be found here: tinyurl.com/26ph5s9
There has to be a solution short of a total ban, because with the CME industry a billion dollar business, there’s simply too much money at stake.
But one of the physician comments to Dr. Pho’s blog caught my eye:
"It's private insurers who often are telling their clients that, "No, you can't get this recommended treatment that the doctor has made"; "No, you can't get this drug"; "No, you're not going to be able to stay in the hospital an extra day"; "No, you're not going to get this because we're concerned about costs."
HHS solution to the fact that Congress has underbudgeted money for temporary insurance coverage for people with pre-existing conditions in state run high risk pools:
Health law risks turning away sick
The Obama administration has not ruled out turning sick people away from an insurance program created by the new healthcare law to provide coverage for the uninsured.
Administration officials insist they can make changes to the program to ensure it lasts until 2014, and that it may not have to turn away sick people. Officials said the administration could also consider reducing benefits under the program, or redistributing funds between state pools. But they acknowledged turning some people away was also a possibility.“There’s a certain amount of money authorized in the statute, and we will do our best to make sure that that amount of money insures as many people as possible and does as much good as possible,” said Jay Angoff, director of the Office of Consumer Information and Insurance Oversight at the Department of Health and Human Services (HHS). “I think it’s premature to say [what happens] when it’s gone.”
Read more here
Sounds like rationing to me, at least according to the definition used by Sec. Sebelius: "We will not allow these companies to insure only the healthy and leave the sick to suffer."
instead, the government will make that happen.
California is the front line in the war over patient-centric care and cost-based controls. And the present battle engagement is over Assembly Bill 1826 and “fail first/step therapy”
According to a report in the Sacramento Bee, insurance interests are lobbying state senators to reject the proposal.
“In letters, insurance associations and companies also contend that step therapy is a good idea because employees of health plans are often in a better position than patients' doctors to know the risks of drug interaction.”
Blue Shield of California also wrote, "step-therapy protocols also act as a check-and-balance to the cozy relationship that exists between many physicians and drug companies."
This from the industry that spiffs physicians with monetary incentives when they switch patients from innovator to generic medicines.
The group's letter says plans consult "expert opinion" and federal research, while many doctors lack a procedure to get "the latest information" about proper drug dosages.
All those in favor of disempowering physicians in favor of insurance companies signify by saying “Oy!”
The complete Sacramento Bee story can be found here.
LETTERS
July 1, 2010
Finger-Pointing Doesn't Provide Care
The financial disaster that will befall doctors and the corresponding lack of access to care that will befall seniors if Congress fails to address scheduled cuts in Medicare ("Doctors Chafe as Medicare Cuts Loom," U.S. News, June 16) isn't a new problem. In fact, the president was only able to claim that his health-reform plan didn't add "one dime to our deficit" by ignoring $371 billion in spending needed to fix Medicare reimbursement rates.
Congressional Democrats claimed that the cost of fixing the Medicare payment formula shouldn't count as part of their health-care reform package because it was a problem they inherited. But now isn't the time to assign blame. Now is the time to solve the problem, for which we all will have to pay.
Peter Pitts
President
Center for Medicine in the Public Interest
New York City
(Mr. Pitts is a former associate commissioner for the Food and Drug Administration.)
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
