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CMPI president Peter J. Pitts

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In what he referred to as a “note on the desk” to the next Secretary of Health and Human Services, Mike Leavitt, the current inhabitant of that seat released “The Personalized Health Care Initiative.” Personalized health care should be an "explicit goal of health care reform,'' Leavitt said.
Oh well, better late than never. (The complete report can be found here.)
Hopefully there is a longer memo (perhaps with the keys to the backdoor and the security code to the secretarial washroom) on the urgent need to fund the Reagan/Udall Foundation.
Read More & Comment...
But what I’d like to share with you is a comment that was posted in response to my discussion of NICE and its implications for US healthcare reform.
Here it is:
“Pitts cannot hope to cover all of the NHS's sins in a short piece. They also instruct doctors to lie to patients, informing them that life-saving treatments do not exist, when the NHS has merely decided the procedures are too pricey. It is better, in the view of the NHS, that people die rather than complain. Also, thousands die in their hospitals each year because staff cannot be bothered to wash their filthy hands. A trip to the NHS is often a death sentence, pure and simple."
And to that all I can add is, “Happy 60th Birthday, Prince Charles.”
Read More & Comment...
Read CBS Article Here
July 17 (HealthDay News) -- Access to health care in the United States continues to elude more and more Americans, a new survey shows.
Read Full Forbes Article Here
Americans Want Overhaul of Health System
Read More
Leaders in health care and health care policy feel strongly that the way we pay for health care in the U.S. must be fundamentally reformed.
Tuesday, 4-Nov-2008
US trails other nations in chronic illness care
Read More
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And it’s been ambiguity all the way down the line.
So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process. And is there anyone out there who feels improvement is not required?
The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.
At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies.
Topics include:
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;
* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;
* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;
* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.
For more details, contact the HHS press office at (202) 690-6343.
And tell them Drugwonks sent you.
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C-Path Expands Partnerships to Speed Development of Critical New Drug Therapies
Dear Friend of C-Path:
Thanks to Arizona supporters, C-Path was created in Tucson four short years ago and we have been very successful in bringing drastic improvements to the methods used to evaluate new drugs and diagnostic tests; changes that are advancing personalized medicine. In addition, Arizona’s Governor, The Honorable Janet Napolitano, along with our state and federal legislators, have been very supportive of our work and our mission.
One of the state’s truly innovative new programs is Science Foundation Arizona (SFAz) which provides highly competitive grants to support meritorious collaborations between scientists and businesses in Arizona. Last year we were fortunate to receive one of the first of these highly competitive awards.
And again, I am extremely pleased to tell you that we have just been awarded a four year SFAz grant for $9 million. With this award, we will be able to expand our work and form additional industry-FDA consortia. These new consortia will improve our understanding of major diseases such as Alzheimer’s and Parkinson’s so that, when effective treatments are discovered, they can be developed in less than three years and with a 95% chance of success; not the current situation, 15 years and a 5% chance of success.
Thank you for your friendship and interest in C-Path.
Best wishes,
Ray Woosley
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Senator Max Baucus, (chairman of the Senate Finance Committee) is proposing legislation to “cover the 47 million uninsured.”
Or what about government-paid care for the 10 million uninsured illegal aliens. Every politician calling for “universal care” has been silent on this topic – except to include them in the count.
(2) “By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.”
(3) “Health coverage is a shared responsibility and all should contribute.”
Note: These three quotes come directly from Senator Baucus' website.
The one thing we should all be able to agree upon is that there are no easy solutions …
Read more here
But.
What's with the "Steve Nissen isn't so bad" and "would be good for industry" rationalization en route to claming he has the inside track because he's been "vetted" by the Obama campaign to be FDA commissioner?
Sorry for all the quotation marks. Let's go to the RPM post and deconstruct.
"We have no idea if Nissen will end up at FDA—but as an Obama advisor he has already been vetted in case he is picked for some kind of government post. "
Nissen was not an Obama advisor. He was an Obama surrogate and contributed to the Obama campaign and might have sent some materials in as part of a cast of thousands. But "vetted" like a nominee would be vetted? Hardly.
Here's more:
"First, as commissioner, Nissen can’t just lob grenades as products the way he has been in recent years. Sure, he might pull Avandia outright, rather than cripple it commercially—but as commissioner he also has to set some constructive public health agenda that doesn’t simply involve taking potshots at individual products."
Pull Avandia? Can we say conflict of interest? If I am at his confirmation hearing that would be the first question I ask. Would he recuse himself in every drug he has worked on, commented on or is working on?
"Second, Nissen is not a drug safety gadfly at heart. Believe it or not, he wants to see industry succeed at developing innovative products. After all, he does drug development himself, and has spoken out in favor of products like Lilly’s prasugrel. As commissioner, you can bet Nissen would work just as hard to encourage the types of products and studies he likes as he would to discourage those he doesn’t."
Ah yes Lilly's prasugrel. Which is a good drug. But so is Plavix. But Plavix was developed by BMS. And BMS made Pravachol which was trashed by Nissen in the REVERSAL study. BMS also was the target of Niissen's wrath with respect to Pargluva. The question is: Did Nissen first offer to use his ultrasound study to cast Pravachol in a good light only to be rejected? That's happened before according industry and academic insiders. And the REVERSAL study? It gave credence to Nissen's research for Esperion Therapeutics ("a mere 47 patients showed that the company's injectable drug, ETC-216, decreased artery plaque by a statistically significant 4%, ten times the decrease seen with Lipitor." ) http://www.forbes.com/2003/11/12/cx_mh_1112pfe.html On the basis of that study, Nissen peddled the sale of Esperion to.....Pfizer! ETC-216, like many other drug development programs Nissen has participated in, have gone nowhere. But to assert "that you can bet Nissen would work just as hard to encourage the types of products and studies he likes as he would to discourage those he doesn’t" is inconsistent with how Nissen has used his research as a protection racket.
"Last but not least, there is the Kessler effect: the last time a commissioner was appointed who defined himself by making enemies in industry, he also gave the agency the credibility it needed to establish accelerated approval and the user fee program. Kessler was never popular with industry, and drug companies celebrated his departure. But drug approvals have been in steady decline ever since. Coincidence or not, those were the good old days."
User fees were a Dan Quayle and David McIntosh idea. Accelerated approval under Kessler? He was forced to it under pressure by AIDS activists and the Gingrich-led Congress in 1994. The Clinton administration couldn't re-invent the drug approval process fast enough. He didn't give the industry any credibility. And to suggest that Nissen's demand for mandatory safety trials prior to approval for cardiovascular risks for all drugs and the elimination of surrogate endpoints (except for those he has developed) would somehow advance the public health is absurd.
There are many other individuals outside of the FDA who could be superior stewards of the public health, who would regard the reforms and post market safety activities as a platform for effective leadership and not for the self-promotion and self-dealing that is the hallmark of Nissen's career.
This is -- and should not be -- a "fight" between industry and some annointed enemy of the companies.
Read More & Comment...
For the record, Nissen was rejected to conduct the athero measures for ENHANCE and is now doing a study to compare Crestor, the subject of JUPITER with Lipitor, two drugs made by two companies he has done work for in the past. And this is the man who would be FDA Commissioner.
http://www.forbes.com/healthcare/forbes/2008/1117/036.html
So what are scientists saying about JUPITER?
According to Eric Topol, JUPITER shows that people with ver high C-Reactive Protein levels get a very strong benefit from Crestor. People in this study were considered to be "healthy" but in fact 40 percent had metabolic disorder, smoked or were overweight. Topol asks: Is this a CRP or a metabolic story? The JUPITER study gives doctors something new and important to discuss with patients and something that can be used to tailor treatments to the individual.
Which is why Topol raises another important issue. While the relative risk of all cause of death declined by 25 percent the absolute absolute risk was cut by 1 in 120 treated for two year period. Meanwhile 1 in 200 developed diabetes.
Topol's point is not that Crestor use or use of statins should not be expanded. Rather his take is twofold. First, we should continue our search to tailor the use and development of statins to the right pathway and markers rather than pursue a one size or one mechanism fits all approach. Second, and more subtle, it is interesting how people flip out on the relative RISKs of medicines generated by meta-analyses of people like Nissen without looking at the absolute risk relative to the benefit generated or the cost of not taking the medicine.
http://blogs.theheart.org/topolog
Similarly, attacks Sid Wolfe launched against Crestor when it was first approved about liver damage, which proved to be bogus, has probably caused more deaths due to heart disease than high LDL levels have generated since that time. That is particularly the case with African Americans who seem to have responded particularly well to Crestor. Alicia Mundy and others in the media hail Wolfe as some sort of hero. Yet it is drug companies who by spending hundreds of millions of dollars on several large clinical trials have advanced clinical practice and provided researchers with more data that can be used to personalize the treatment of heart disease.
Who are the real heroes?
http://content.nejm.org/cgi/content/full/NEJMoa0807646
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Earlier this month a news story ran that discussed the issue of children and medications. The story focused on the fact that American children are taking more medicines than ever before – with specific attention being given to childhood obesity, one of the most crucial public health problems facing our nation.
November 9, 2008
But the fact that kids today have access to a range of prescription medications is a good thing. When I was a boy, the only remedy for the medical conditions associated with excessive weight was diet and exercise.
To increase access to these cutting-edge medicines, we must expand access to health insurance coverage.
That's why the new Obama administration should make it a priority to enroll qualifying children in Medicaid and the State Children's Health Insurance Program.
And here’s something that’s worse – we’re now playing catch up when it comes to advancing down the Critical Path. While the Reagan/Udall Foundation remains an unfunded and inactive shell, the European Union is making exciting and important progress.
The new program, funded by the French government, is called the Advanced Diagnostics for new therapeutic Approaches (ADNA) is a nine-year initiative aimed at developing personalized medicine for infectious diseases, cancer and rare genetic diseases by combining new diagnostic and therapeutic approaches.
That’s how you make drugs “safer.” That’s how you reduce costs. By getting the right medicine to the right patient in the right dose at the right time. All this at a time when many are arguing that the way to make drugs "safer" is to empower people to sue pharmaceutical companies. Sound familiar?
Funded by the French state-owned bank for small and medium-sized enterprises (OSEO), The ADNA program is funded to the tune €89.5 million. That is, at least in theory, what the Reagan/Udall Foundation is supposed to do. (And the ADNA program just part of the European Union’s bigger investment of almost €400 million in R&D over the 2008-2017 period.)
According to the partner companies (bioMérieux, Généthon, Transgene, GenoSafe), the ADNA will seek to identify and develop biomarkers that will allow new therapies to be targeted to patients who are most likely to benefit from them. Biomarkers can also help in making an early diagnosis, improving understanding of the progress of a disease, tracking a patient's response to treatment, and developing new diagnostic tests, they note. Sound familiar?
The €89.5 million in aid is broken down into €50.8 million in subsidies and €38.7 million in loans repayable in the event of success. Good model. Government and industry working together. Government as both regulator and colleague. Sound familiar?
Good for them. It will benefit us all. But shame on us for sitting on the sidelines and allowing political dithering to make us merely observers.
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Kennedy has earned a reputation over the years for his phony (but media friendly) attacks on the drug industry.
EPA calls for sound science. Kennedy is best know for pseudoscience.
For example, RFK, Jr. once claimed that the CDC and big pharma supposedly "covered up" a link between mercury in vaccines and autism, all the while misrepresenting the science.
Read more here
As a result of this policy shift, patients are now lining up and demanding the government reimburse them for the out-of-pocket expenses they incurred buying these drugs privately.
Quite frankly, these patients have been grossly wronged by the NHS and they deserve to be compensated.
While NICE has reversed its policy on top-up payment, do bear in mind that Britons are obligated to sustain the expenses "associated with the extra drugs they buy." That includes scans, tests, use of NHS staff time, etc. In other words, patients are still being kicked while they're down by the NHS.
The more things change, more they remain the same.
November 5, 2008
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Apart from the fact that he will be a dart board for the stunts and ethical questions dogging him that we already know about, there are even more serious problems -- even legal problems -- that could be raised at or before his confirmation hearing, problems that his lapdogs in the MSM have eagerly ignored. I can assure those who went after Scott Gottlieb for his "conflicts" and quoted Nissen approvingly in trashing Scott, the good doctor from Cleveland has a lot of, uh, adverse events he has failed to report.
2. Following the advice of the health care experts at the Hamilton Projects
I wrote about this before: The bright idea of Harvard's Joe Newhouse and Richard Frank: "To address the stresses on the federal budget, prices paid for drugs purchased on behalf of beneficiaries previously covered by Medicaid should be reduced to near their former Medicaid levels. To limit the ability of manufacturers to name their prices of therapeutically unique drugs, a standby mechanism for establishing temporary administered prices should be developed."
Meanwhile, this from the WSJ:
Cash-Poor Biotech Firms Cut Research, Seek Aid
By JEANNE WHALEN AND RON WINSLOW
http://online.wsj.com/article/SB122523819921178005.html?mod=googlenews_wsjRead More & Comment...
Volume 359:1977-1981 November 6, 2008 Number 19
The timing of an announcement will, IMHO, demonstrate how seriously the new administration views the FDA's role in both protecting and advancing the public health.
One prediction I will hazard to offer is that the next FDA Commissioner will not be Steve Nissen. He is widely disliked within the agency and is, as those in the know know, quite conflicted.
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