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CMPI's Peter Pitts on CNN's Lou Dobbs Tonight from Psyclone WMS on Vimeo.
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FDA NEWS RELEASE
FDA Commissioner Sets Out Vision on Enforcement to Support Public Health
Commissioner of Food and Drugs Margaret A. Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.
“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Commissioner Hamburg told a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C. “We must get the word out that the FDA is on the job.”
Commissioner Hamburg said that some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” She added that the pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”
Commissioner Hamburg highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory and enforcement system:
– Set post-inspection deadlines. The FDA will establish a clear timeline for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.
– Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
– Work more closely with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
– Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
– Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.
– Develop and implement a formal warning letter “close-out” process.” If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.
By taking these steps, Commissioner Hamburg said, the FDA will ensure that “violative inspection results are taken seriously, that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”
Wow. Busy day what with the front page article in the New York Times and some very savvy reporting in the Wall Street Journal. Who said August was going to be slow? Talk about a food fight at recess!
All that to say that the window seems to be somewhat open to actually discussing the … facts! I know, who would ever have thunk it.
Taking advantage of this new opportunity, I’ve penned a new op-ed on the Reuters “Great Debate” site. Here’s a taste:
“In SiCKO, Michael Moore portrayed the British National Health Service and the Canadian health system as particular exemplars of excellence. He backed it up with a lot of statistics, but statistics, as the saying goes, are like a bathing suit. What they show you is interesting, but what they conceal is essential.
And what SiCKO concealed was that systems such as those in the
Citizens of countries with government-run health care systems experience long wait times, a lack of access to certain treatments and, in many instances, substandard medical care. For example:
• The five-year survival rate for early diagnosed breast cancer patients in
• A typical Canadian seeking surgical or other therapeutic treatment had to wait 18.3 weeks in 2007, an all-time high, according to The Fraser Institute.
• The average wait time for bypass surgery in
• More than half of Canadian adults (56 percent) sought routine or ongoing care in 2005. Of these, one in six said they have trouble getting routine care.
• Eighty-five percent of doctors in Canada agree private insurance for health services already covered under Medicare would result in shorter wait times.
• Approximately 875,000 Canadians are on waiting lists for medical treatment.
If we’re going to look to other healthcare models for solutions, we must uncover and study their problems. Health care is too important to allow reform by sound bite. “Drugs from
The complete op-ed can be found here.
Here it is...
Well, ok...
So how about Obama vs. Obama. Is that fishy disinformation?
Here is the President's response -- captured in the clip provided by The Disinformation Czarina -- to a question posed by Jake Tapper about whether people will have to change plans or not:
"Well, all right- when I say if you have your plan and you like it, and your doctor has a plan- or you have a doctor and you like your doctor, that you don't have to change plans, what I'm saying is the government is not going to make you change plans under health reform. Now, are there going to be employers right now, assuming we don't do anything- let's say that we take the advice of some folks who are out there and say, "Oh, this is not the time to do health care. We can't afford it. It's too complicated. So, let's take our time," et cetera. So let's assume that nothing happened. I can guarantee you that there's the possibility for a whole lot of Americans out there that they're not going to end up having the same health care they have. Because what's going to happen is, as costs keep on going up, employers are going to start making decisions. We've got to raise premiums on our employees. In some cases, we can't provide health insurance at all. And so there are going to be a whole set of changes out there. That's exactly why health reform is so important."
Left unsaid in all this is whether the government will try to keep you from changing plans if you want (which happens in all bills) or using Medicaid as a dumping ground for people. And the President pretty cheery about the possibilities of a government run plan being lots cheaper than a private plans:
"So there are going to be some ground rules that are going to apply to all insurance companies. Because I think the American people understand that, too often, insurance companies have been spending more time thinking about how to take premiums and then avoid providing people coverage than they have been thinking about how can we make sure that insurance is there; health care is there when families need it. But, I'm confident that, if- you know, I take those advocates of the free market to heart when they say that, you know, the free market is innovative and is going to compete on service and is going to compete on, you know, their ability to deliver good care to families. And if that's the case, then this just becomes one more option. If it's not the case, then I think that that's something that the American people should know."
Is that because he knows government can set prices and low-ball private companies who are forced to charge young and healthy people higher premiums to subsidize sick and health people.
That's also in all the bills.
Is Obama vs the actual legislation fishy?
Want more? Go to www.handsoffmyhealth.org Get knee deep in disinformation. As Orwell said, “In a time of universal deceit, telling the truth becomes a revolutionary act.”
It must be nice to believe that Uncle Sam, MD can be the reincarnation of Marcus Welby. Similarly, it must be nice to believe that veganism is the answer to our national healthcare woes. And it must be nice to believe that a national healthcare system run by the government minus any free-market incentives isn’t socialism. Therefore, it must be nice to be Congressman Dennis Kucinich. He believes all of the above.
As already mentioned, (http://www.drugwonks.com/blog_post/show/6904) the former Boy Mayor and I spent the better part of an hour Saturday debating healthcare reform on Fox Business Channel. My favorite bit (and its right up front, so have look) was when he said that, just because the government would pay the bills and specify the treatments, doesn’t mean the government would be “in control.”
To which I replied (and with all due respect) that he was “living in fantasyland.”
The complete debate can be found here.
http://drugwonks.com/podcasts/peter-pitts-on-fox-business/
Kucinichcare. What a concept.
In the meantime, the gloves are off elsewhere too. Got this e-mail yesterday and it’s worth passing along:
FISHY CLAIMS
We Answer The White House's Call For "Disinformation" On Government-Run Health Care
THE WHITE HOUSE'S BLOG: "There is a lot of disinformation about health insurance reform out there, spa nning from control of personal finances to end of life care ... Since we can't keep track of all of them here at the White House, we're asking for your help. If you get an email or see something on the web about health insurance reform that seems fishy, send it to flag@whitehouse.gov." (
WE FOUND FISHY CLAIMS ABOUT KEEPING YOUR DOCTOR AND YOUR INSURANCE PLAN ...
"If you have insurance that you like, then you will be able to keep that insurance. If you've got a doctor that you like, you will be able to keep your doctor." http://tinyurl.com/mj5od2
"If you like your doctor, you will be able to keep your doctor. Period. If you like your health care plan, you will be able to keep your health care plan. Period. No one will take it away. No matter what." http://tinyurl.com/mzkrz9
AND FISHY CLAIMS ABOUT SO-CALLED "PUBLIC PLAN" AND CONSUMER CHOICE ...
"Now, the public plan I think is a important tool to discipline insurance companies. What we've said is, under our proposal, let's have a system the same way that federal employees do, same way that members of Congress do, where -- we call it an 'exchange,' or you can call it a 'marketplace' -- where essentially you've got a whole bunch of different plans." http://tinyurl.com/krmgqn
"That's why I've said that I think a public option would make sense. What that then does is, it gives people a choice ... You don't have to do anything. But if you don't have health insurance, then you have an option available to you." http://tinyurl.com/moq36h
AND A FISHY CLAIM ABOUT KEEPING HEALTH CARE COSTS DOWN ...
"What I've said is our top priority has to be to control costs... And I've said very clearly: If any bill arrives from Congress that is not controlling costs, that's not a bill I can support. It's going to have to control costs. It's going to have to be paid for." http://tinyurl.com/krmgqn
AND A FISHY CLAIM ABOUT TAXING MIDDLE CLASS
"And while they're [Congress] currently working through proposals to finance the remaining costs, I continue to insist that health care reform not be paid for on the backs of middle-class families." http://tinyurl.com/lkvgsp
So to help the surely inundated White House, we've already debunked these "fishy" statements at BarackObamaExperiment.com
Was anyone really ever wearing gloves in the first place? Hard to act polite when that "seat at the table" had a trap door beneath it.
Meanwhile, on the topic of when “cost” means “co-pay,” a new op-ed in today’s edition of Speaker Pelosi’s hometown newspaper, the San Francisco Chronicle. It begins as follows:
Higher co-pay, fewer prescriptions filled
Peter Pitts
“One of the major threats to patient health hasn't received nearly enough attention during the recent negotiations in
According to a recent study by Wolters Kluwer Health, fewer Americans are filling their drug prescriptions. In the fourth quarter of 2008,
Why? Drug prices. It's not that the cost of prescription drugs is rising - it's patients' out-of-pocket costs, or co-pays. One of the reasons for this is that insurance companies, reluctant to foot the bill for brand-name medications, have been refusing to cover more brand-name prescriptions.
In the fourth quarter of 2008, in fact, health insurers denied coverage for 10.8 percent of brand-name drugs - a jump of 21 percent from the first quarter of 2007.
And it's not because the medicines themselves are becoming more expensive. Between 1998 and 2003, prescription drug costs increased by $22.48 per person. Meanwhile during that same period, the average health insurance premium went up by $104.62 per person.”
For the rest of the story, see here.
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/04/EDP0193SR1.DTL
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."
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.
