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The U. S. Food and Drug Administration prides itself on being, first and foremost, all about science. So, how did the agency that regulates upwards of 30 percent of the
When one considers the mission of FDA—to independently protect and advance the public health—it is not at all clear whether the Commissioner should be a Senate-confirmed political appointee “serving at the pleasure of the President.” I think that the American people would prefer he or she be nominated by the President for a fixed 6-year term—similar to that of the Director of the FBI. Think about it—why should the safety of food additives, the integrity of the blood and vaccine supply, and decisions on drug labeling indications (to name only a few FDA responsibilities) be considered Democratic or Republican issues? The boss of the FDA Commissioner is and should continue to be the Secretary of Health and Human Services—a politically appointed, Senate-confirmed cabinet officer. This is enough. More politics just leads to regulatory paralysis and discord—neither which protects or advances
Having had the honor to serve our country as an FDA Associate Commissioner, I can unequivocally state that the unwelcome infusion of politics into science makes an already difficult job virtually impossible. To have the job of Commissioner open and only partially filled for extended lengths of time grinds progress to a halt. Low morale, lengthy delays, and even postponements often characterize an open Commissionership. This is not acceptable.
Who becomes the next FDA Commissioner is important. But an important indication of the seriousness with which President-Elect Obama takes that post is how soon in his administration a nomination is made. Let’s hope it’s done swiftly and smartly.
For more on this, have a look at the Journal of Life Sciences.
The Times writes:
"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias."
“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments."Here are the facts:
Goodwin consistently studied the effects of lithium a drug that lost it's patent nearly a half century ago and continues to lecture about it's benefits as a front line treatment for manic depression.
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Goodwin also pioneered the use of light therapy to treat season affect disorder.
Meanwhile the Grassley witch hunt continues apace, now "investigating" Goodwin's private consulting business for promoting "off-label" use of lithium. Translation: Publishing an article in JAMA comparing the effect of lithium in reducing suicide among manic depressive patients to marketed products - in partnership with managed care plans and other research organizations -- is now a reason to investigate. And of course just being investigated by Grassley is a crime because taking money from any drug company for any reason at any time makes all of one's research suspect and you a criminal.
Got that?
I can hear the hatchets being sharpened. Shannon Brownlee and Jeanne Lenzer must not be far behind.
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Here are (only) some of Dr. Goodwin's particulars:
* Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society;
* Former Director of the National Institute of Mental Health
This was not relevant to the story, why?
Looks like that "all the news that's fit to print" window is getting narrower all the time. Talk about a lack of fair balance and adequate provision.
Time to contact the Ombusdman.
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He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism.
Goodwin will continue to publish, lecture and research, adding value and knowledge to patients lives.
Here's the difference between Goodwin and his attackers:
Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them.
They have to live with their legacy. I am sure Fred will be content with his.
Read New York Times article
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Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.
* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”
* “We must build a system that promotes universal access, not by mandate but through free-market solutions that maximize coverage and improve access.”
* “In 2007 — for the first time — we offered
* “This year, roughly two-thirds of enrolled employees — including moi — and dependents chose one of these options. By 2010, our company will offer only consumer-driven options for our active employees.”
Lechleiter’s full remarks can be found here.
In his keynote address, IFPMA President Fred Hassan (whose day job is Chairman and President of Schering-Plough), shared that
Bravo.
Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in
Rich Bagger (SVP, Worldwide Public Affairs & Policy, Pfizer) was the only speaker to consistently refer to his company as being in the “life sciences” business. Why is this so hard for everyone else to remember ?
One of Rich’s themes was “new roads to access.” And he offered a very early yet tantalizing example – Pfizer’s partnership with the Grameen Bank of
Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.
Tom Daschle is a terrific choice for HHS for many reasons. Most importantly, he’s a grown-up.
Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.
His other role in the Obama White House, that of Health “Czar,” poses some interesting questions. Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?
Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott. Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.
I am not as phlegmatic.
And to that point, a few things worthy of consideration:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
Specifically, drug importation.
It’s worth restating the facts.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).
Shameful.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
We’re all in deep enough fiscal trouble. We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.
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Some highlights:
The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?
The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.
Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)
Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.
More from the IFPMA Assembly tomorrow.
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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.
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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.”
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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
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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
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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.
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