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August 30, 2007
The Hanging Chad of Health Care
by Peter Pitts
Guarantees are hard to come by. Even with medicine, doctors would be hard-pressed to tell patients that the drug they're prescribing is certain to work. After all, thanks to different medical histories, personal biochemistries, and physiologies, everyone is different. There's no such thing as a "me-too" patient.
That's why patients and their doctors often try a variety of different drugs before finding one that works - because there's no such thing as a "me-too" medicine. But in the interest of saving a few bucks, such personalized treatments may soon become a thing of the past.
This fundamental misunderstanding is being advanced by politicians grasping for answers to questions on health care. For an example, look no further than Reps. Tom Allen, D-ME, and Jo Ann Emerson, R-MO, whose Enhanced Health Care Value for All Act would increase spending on one-size-fits-all, top-down solutions.
The bill would authorize $3 billion of investment on new research "on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions." Senator Hillary Clinton also has advocated a similar program.
Here's the rest of the story, courtesy of the Tampa Tribune ...
Comparative Effectiveness -- the Hanging Chad of Health Care.
Posted by peterpitts at 12:15 PM
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August 27, 2007
Wuthering Cites
by Peter Pitts
Last Thursday I had the privilege to attend and participate in the third annual FDA Regulatory & Compliance Symposium held at Harvard University. (Or as we Martlets call it, "The McGill University of the South.)
My panel focused on federal preemption and DTC advertising issues. The title of my presentation was "FDA: Advancing the Public Health or Being Led by Political Whims." Needless to say, it was hard to limit my remarks to the requisite 45 minutes.
Two of the other panelists were Alex Sugerman-Brozan (of the Prescription Access Litigation Project) and Lauren Guth Barnes of the law firm Hagens Berman Sobol Shapiro. Perhaps the most polite way to put it is that we didn't agree on most issues.
And that's okay. A feisty, robust -- and respectful debate is always worthwhile. And this panel was certainly all of those things.
Of the many differences, I'm sure you can fill in the blanks vis-à-vis our divergent views on both federal preemption and DTC issues. But what I found most disturbing was that both Alex and Lauren relied, almost exclusively, on partial research data, one-sided anecdotes, and rather selective legal citations.
Their presentations were as one-sided as they were narrow and they lacked any perspective as to the unintended consequences of (what I viewed as) simplistic alternatives. They spoke of solutions driven by adjudication and legislation -- with nary a nod to science.
(Although we did find some common ground on the need for better and more disease awareness advertising and the banishment of reminder ads.)
But (and here's the good news) while their ideas are wrong -- their hearts are in the right place. I really believe that. I hope that, with more conversation (both face-to-face and otherwise) we can all work to help advance the public health through a strong and better funded FDA.
Posted by peterpitts at 08:30 AM
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August 20, 2007
Abigail Force Winds
by Peter Pitts
The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.
Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.
But over-heated rhetoric generally means that each side demonizes the other and neither is listening.
Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.
But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.
The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.
In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.
The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.
Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.
Posted by peterpitts at 08:48 AM
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August 16, 2007
What WOULD Elaine Say?
by Stephanie Koze
It’s back…the TODAY SPONGE that is. Considering the limited number of efficient, non-hormonal birth control options available to women, I’m betting that Elaine and many other women might cheer.
While the sponge is not 100 percent effective in preventing pregnancies -- is abstinence really an option?? -- it does provide women with another form of contraception. That’s good news for ladies not concerned about STDs who can’t or don’t want to use hormonal birth control. It’s also good news for those couples who feel other traditional methods, such as condoms, diaphragms, creams and gels, are uncomfortable or affect spontaneity.
Whether you are for or against the reintroduction of the sponge, you have to admit it provides an alternative to existing contraception. And, choice is a good thing.
Posted by stephanie_koze at 08:31 AM
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August 14, 2007
Commonwealth of Nations
by Peter Pitts
On Sunday the New York Times ran a 1292 word jihad against the American healthcare system. The thesis of the editorial is that “Many Americans are under the delusion that we have the best health care system in the world” because, in the words of the Gray Lady, we lag "well behind other advanced nations in delivering timely and effective care.”
For its facts and figures, the Times largely relies on “the highly regarded Commonwealth Fund” that has “pioneered” comparative studies with other advanced nations.
Let’s pause for a moment and shed a little light on the Commonwealth Fund and their most recent (heavily touted) comparative study of national healthcare systems.
The “highly regarded” Commonwealth Fund is also the same “highly Liberal” Commonwealth Fund that has been consistently lobbying for a U.S. single-payor healthcare system. It’s also important to note that the “pioneering” comparative study the Times refers to failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care.
Why didn’t the Times mention this? At over 1290 words it certainly wasn’t because of space constraints. It’s worth repeating the old maxim that “research is like a bikini – what it shows you is interesting, but what it conceals is essential.”
There are so many variables when it comes to healthcare. The Times mentions only the ones that fits its thesis. For our national newspaper of record (and on a Sunday, no less) it’s amazingly simplistic. According to the editorial, our system is bad and single payor systems are good. Almost like a print version of SiCKO penned by Paul Krugman on an off-day.
One point of discussion, conspicuous by its absence, is that Americans are the ones paying for global medical innovation. Indeed, what would survival rates for any number of diseases look like if a nation could only use medicines they helped pay to develop? This "disparity" is unfair to the American consumer and not sustainable. The rest of the world must accept its fair share of the burden for healthcarer R&D. Zero discussion of this by Andy Rosenthal and his associates.
Another issue absent from the Times editorial is the general state of healthcare record keeping from country to country. Perhaps the most polite way to address this issue is to say that it is uneven. And to allow the findings of the Commonwealth Foundation to drive the debate, while ignoring other, more detailed European-based research findings (such as those by Populus and the pan-European Stockholm Network) which point to significant dissatisfaction among EU citizens of single-payor nations on a wide swath of healthcare delivery issues is, well, curious.
But, most importantly, it’s crucial that we not allow slanted studies by folks at the Commonwealth Foundation or ill-considered propaganda like SiCKO to sucker us into believing that there is some universal “best” model for the delivery of healthcare – when what we really need to be debating is how to construct a healthcare system that provides the right care for the right patient at the right time. “Comparing” various national healthcare systems through poor research is as dangerous and fruitless as “comparing” the relative effectiveness of medicines using large scale population studies that weren’t designed for that purpose.
Unless, of course, you only want to use research that tells you what you want to hear.
Posted by peterpitts at 10:21 AM
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August 13, 2007
Duck and Cover
by Peter Pitts
Senator Grassley is proposing legislation that would have pharmaceutical companies disclose payments made to physicians for just about eveything. The Senator wants "transparency."
And transparency is a good thing.
Should Big Pharma be disclosing payments or should the burden of transparency be on the physician? Good debate. But here's a bigger question -- if transparency is a good thing when it comes to Big Pharma's payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits?
Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?
It's not in the Grassley bill.
Or what about transparency regarding how some state governments are leveraging a physician's prescribing habits via state regulations?
Also not in the Grassley bill.
It seems the Grassley is always greener when it comes to slamming Big Pharma -- but that everyone else with an open wallet (or a tight wallet in the case of state governments) gets a free pass.
If transparency is good for the goose then it's good for the gander.
Posted by peterpitts at 07:52 AM
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August 09, 2007
Raj Rage
by Peter Pitts
This week's ruling by the Supreme Court of India institutionalizes that incremental innovation in pharmaceuticals isn't important on the sub-continent -- at least when it comes to patent protection..
Many of the usual suspects (Jamie Love, et al.) applaud this decision. But, in reality, it's a horrible blow to global public health -- and particularly to the Third Word, because economically-driven, short-term decisions have deadly unintended consequences.
As Trevor Jones ( a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out relative to treatments for HIV-AIDS:
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
The Indian ruling is only the most recent example of how healthcare technology assessment (HTA) aka: evidence-based medicine (EBM) being used to deny not only appropriate patient care, but now case patent protection.
And this is an important link, because minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
(But large Indian generic manufacturers can make a bundle.)
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits – and members of the Indian Supreme Court.
Posted by peterpitts at 05:25 PM
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August 06, 2007
Phoning it in
by Peter Pitts
Here's how the Journal of Life Sciences introduces its story on FDA reform:
The FDA needs to rethink the way it communicates in an age of empowered patients.
MUCH HAS CHANGED over the past 25 years, but one of the immutables has been that FDA tries to communicate important health messages without the resources or attitude necessary to do it well on a consistent basis, according to Peter J. Pitts. A big part of the problem is that not only have communications tools changed, but so have people and society. He says the FDA needs to change as well.
Here's the rest of the story:
http://www.tjols.com/commentary/aug1_fda.jsp
And the good news is that Commissioner von Eschenbach believes in strident and robust constituency outreach.
Posted by Peter Pitts on August 2, 2007 9:42 AM | Permalink
Posted by peterpitts at 09:08 AM
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