Latest Drugwonks' Blog
A study to look at whether drinking rice milk and strapping autistic kids down and filling them with dimercaptosuccinic acid cures their disease compared to playing wiwth gluten free Play-do...?
Read more here
Studies that seek to squeeze down the cost of using drugs and technologies for cancer and arthritis in Medicare without regard to variations in genetics, age, race, comorbidity and all the other things comparative effectiveness was supposed to take into account... or as Kaiser Health "News" reports:
Comp. Effectiveness Promises Better, Cheaper Health Care But Critics Link It To Rationing
Read story hereDon't know how I even got the two confused. Sorry. How stupid of me... Won't happen again....
AHRQ supports many important health care services research activities. However it's comparative effectiveness program is second rate, anti-innovation and is now being politicized by those in Congress and in the Obama administration who want to find money to pay for a government takeover of health care. Add to that, "stakeholders" are skewing the agenda and the science, allowing federal dollars to be devoted to study junk science about autism "cures" and vaccine dangers ...
HR 3200 would formalize a comparative effectiveness research center within AHRQ (the Agency for Healthcare Research and Quality). An independent CER commission would be formed to oversee the center, recommend research priorities and conduct stakeholder outreach.
Our friend and colleague (and House Energy & Commerce Committee member) Congressman Mike Rogers (R, MI) sponsored an amendment that says "in no case may any research conducted, supported or developed by the Center for Comparative Effectiveness Research, the Comparative Effectiveness Research Commission, or the Federal Coordinating Council for Comparative Effectiveness Research be used by the federal government to deny or ration care."
Pleased to report that the amendment passed, despite a “nay” from Mr. Waxman.
Part I
Part II
Part III
The Eshoo version of protecting patients and data exclusivity for new biotech drugs sailed through the Waxman controlled Energy and Commerce Committee...
"One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March. In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed. The amendment was passed by the Committee by a comfortable 41-11 margin. Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA). The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors)."
The bad news....
House Compromise Would Let Medicare Negotiate Drug Prices
"The government would be authorized to negotiate prices in Medicare’s prescription drug program under an agreement Energy and Commerce Committee Democrats struck Friday on its health overhaul bill.
The panel, rushing to finish its part of the huge bill before leaving later in the day for the August recess, was expected to vote on the drug pricing provision as part of a package of amendments aimed at satisfying the competing demands of liberal and conservative Democrats...." .....The second amendment, according to a summary of the agreement, would make a number of less controversial changes to the bill, including requiring that the public plan use a formulary to control its drug cost. The third amendment would authorize HHS to negotiate drug prices paid by Medicare — something long fought by the pharmaceutical industry. The amendment also would require insurance plans selling policies through a new “exchange” created by the bill to request permission from the government before increasing their premiums faster than the rate of medical inflation, one lawmaker said.
Read article here.
Price controls. Not controversial?
Meanwhile in an announcement that was striking for it's coincidence....
Agencies Seek to Use Stimulus Funds to Find Cheaper Health Care
By JANE ZHANG
"Federal health agencies, seeking to hand out stimulus funds to research the effectiveness of various medical treatments, said they will include projects that look in part at the cost of drugs and other treatments.
The approach -- which was unveiled in a report to Congress this week by the Agency for Healthcare Research and Quality and the National Institutes of Health, both agencies under the Department of Health and Human Services -- could provide more fodder to conservatives worried that the government might use the results of such studies to limit health care to consumers.
Administration officials have said they want to use stimulus funds to help doctors and patients choose more-effective treatments and ultimately, help rein in rising health-care costs. Democrats are considering including measures that would support such research as part of health-care legislation making its way through Congress."
".... Nicholas Papas, an HHS spokesman, said under the stimulus law, Medicare can't use the research to deny coverage to patients."
Of course not! But what about delaying access to new treatments or, requiring prior authorization or paying less for covered treatments which, as research shows, leads to reduced use?
Read more here
FDA NEWS RELEASE
For Immediate Release: August 3, 2009
Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA, European Medicines Agency Launch Good Clinical Practices Initiative
Collaborative effort aims to ensure appropriate conduct of clinical trials
The U.S. Food and Drug Administration and the European Medicines Agency (EMEA) today announced an agreement to launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly, appropriately and ethically. The initiative will begin with an 18-month pilot phase on September 1, 2009 and will focus on collaborative efforts to inspect clinical trial sites and studies. Products regulated by the FDA’s Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union will be the focus of the initiative.
“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.”
Key objectives of the FDA-EMEA GCP initiative will be:
--To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
--To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
--To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.
“The clinical development of medicines is a global undertaking,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “With limited resources available to address the global nature of clinical research, this is an outstanding opportunity for the FDA and the EMEA to work together to carry out inspections and share information.”
At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed.
"This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA," said Murray M. Lumpkin, M.D, Deputy Commissioner for International Programs. "This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality."
According to Bloomberg, Novartis AG’s two-year effort to revive its Prexige pain pill after it was rejected by
Novartis may re-submit a marketing application for Prexige to the Food and Drug Administration this year along with a genetic test that can detect who may suffer the liver damage that arises in some patients, said Michael Nohaile, the head of Novartis’s new molecular diagnostics unit. The test would be obligatory for patients to obtain a prescription, a first for the drug industry, he said.
“This is a very real opportunity now,” Nohaile said in an interview at the company’s
While a growing number of treatments are marketed as personalized medicine, with genetic tests to allow doctors to determine which patients will benefit, Prexige would be the first with a test to ensure safety. Drugmakers see testing as a way to persuade regulators and insurers to approve and pay for the medicines by showing that they’re effective.
Novartis is counting on the test to reassure doctors and patients. With a test showing that a certain drug will be safe, Nohaile said, “We can go to doctors and say it moves it out of the realm of choice into the realm of malpractice if you don’t use this drug.”
Click here for the entire Bloomberg article.
What do you call a medical home without a physician? Well, for starters, you can call it HR 3200.
HOUSE HEALTH-CARE BILL WOULD ESTABLISH 'MEDICAL HOME' FOR THE ELDERLY AND DISABLED
By Marie Magleby
(CNSNews.com) - The House health-care reform bill proposes to decrease hospital visits by establishing a “medical home pilot program” for elderly and disabled Americans.
Such a medical home would not require a physician to be on the staff, and therefore could be run solely by nurse practitioners and physician assistants. Medical homes also would practice “evidence-based” medicine, which advocates only the use of medical treatments that are supported by effectiveness research.
But physicians’ groups say the legislation could lead to restrictions on which treatments may be used for certain conditions, despite the fact that some patients might require a unique or unconventional approach. It also may lead to dumping Medicare/Medicaid patients in facilities that are not required to have physicians on staff.
The Center for Medicine in the Public Interest (CMPI) expressed its concerns in a report that explains why statistical evidence does not always reflect reality of effective medicine.
“‘One size fits all’ rarely does,” the report said. “From clothes to shoes to hats, few people find that items carrying that label work with their individual bodies. So why do we entrust the health of our bodies -- one of the most important assets we have -- to a one-size-fits-all mentality?”
With so many articulate, high-powered brains talking about healthcare reform these days, it’s refreshing to debate someone like the former Boy Mayor from Cleveland. He’s so deeply entrenched in Kumbaya fantasyland that it’s really the next best thing to the Daily Show. Except that it’s not funny.
Mr. Kucinich tried to convey his message of a healthcare system that was paid and provided for by the federal government – but wasn’t run by the government. Um, right.
He also wanted to make it very clear that he wasn’t for “socialism,” but rather for a national healthcare system that ran like a “non-profit. Welcome to Kucinichcare via “non-profitism.”
It’s an interesting rhetorical finesse – but isn’t a system that’s run by the government minus any free-market incentives well, socialism?
Maybe Mr. Kucinich should introduce a bill called “the Non-Profitism Manifesto?”
Video shortly.
How to Encourage Biotech Innovation
There's no evidence to suggest that granting makers of biologic drugs 12 years of market monopoly "would drive costs even higher" for these drugs. In fact, shortening the monopoly period is likely to raise the price of biologics.
Academic research shows that a biologic producer needs more than 12 years of exclusive sales to break even on the development costs of a new drug. If a firm faces competition from biosimilars any earlier, it would probably raise prices for its innovator biologics, as it must recoup its initial investment within a much smaller monopoly window. As a result, cutting-edge medicines would become even less affordable.
Peter Pitts
President
Center for Medicine in the Public Interest
New York
Read more here.
Meanwhile, the increasingly anti-pharma fiercepharma can't say enough about how horrible it is that CER can't be used to deny people access to new drugs and devices... Because if people die in the pursuit of denying drug companies profits, that's just the cost of advancing one's ideology... My advice, to the fierce proponents of public options and government guided decisions... why not enroll in Medicaid and tell the rest of us lesser mortals what it's like? Put your lives where your mouthpieces are (or is??)
Read here
Meanwhile, I will move to Mr. Rogers' neighborhood.
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.
