Latest Drugwonks' Blog
The NY Times rejoinder to Elliot Fisher is devastating and could have been even more complete if Reed Abelson and Gardiner Harris had not pulled their punches on such aspects of the Dartmouth empire as it's deep involvement in and financial dependency on Health Dialog...
It also raises the stakes on the Berwick nomination since Berwick's love and faith in Dartmouth is well known and has been reciprocated. From an earlier NPR report"
ROVNER: So at first glance, the person President Obama has chosen, Donald Berwick, seems an unlikely candidate. He's a mild-mannered pediatrician and Harvard Medical School professor. But Dartmouth health policy researcher Elliot Fisher, who's worked with Berwick for years, says he's the perfect choice to implement some of the most sweeping changes to the nation's health care system in generations.
Dr. ELLIOT FISHER (Researcher, Dartmouth Health Policy): Don Berwick is a visionary leader who not only understands health care, but also understands and has shown that he can help physicians, nurses and hospital leaders work together to improve the care that patients receive.
www.npr.org/templates/story/story.php
I smell hypocrisy and an unwillingess to respond to this important question.
Congressman Todd Tiahrt (R,KS) from CMPI on Vimeo.
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Senator John Barrasso (R,WY) on Health Care Reform from CMPI on Vimeo.
Once you get past the wonk talk about Markov estimates and parametric projection models the key considerations were the following:
"no data for the stable disease subgroup were provided to allow separate consideration of the use of erlotinib in squamous and non-squamous disease. Furthermore, no evidence was provided comparing erlotinib with pemetrexed in patients with non-squamous disease who have stable disease after first-line treatment."
And,
"The Committee discussed whether the SATURN study could be generalised to UK clinical practice and noted that there were few UK patients and a high proportion of patients from Southeast Asia in the study. The Committee noted a comment from the ERG that Asian people are known to respond better to lung cancer treatments than other races. The Committee heard from the clinical specialists that there are no significant reasons why the relative benefit of erlotinib in the SATURN trial would not also be seen in the UK population."
And
"It also heard from clinical specialists that patients with EGFR mutations have a longer natural history of disease and a better prognosis than other patients with non-small-cell lung cancer. The clinical specialists also commented that the small proportion of patients with EGFR mutations in the SATURN trial would be similar to the UK population. The Committee noted that no one in the SATURN trial had received first-line treatment with pemetrexed and cisplatin, which is now becoming a commonly used combination chemotherapy regimen for patients with non-squamous disease. It therefore concluded that there was uncertainty about the clinical benefit of erlotinib in patients who had previously received pemetrexed and cisplatin."
Do I think Tarceva should not have been approved. No. Because it would make more sense to allow reimbursement, encourage biomarker development and contribute to personalized medicine.
But the NICE consultation process reveals a deeper appreciation of the role of biomarkers in evaluating treatment effectiveness than the current bone headed approach being funded by AHRQ.
www.nice.org.uk/guidance/index.jsp
effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/
Once more into the abyss.
But transparency is no longer good enough for the ACCME – now they want purity – whatever that means.
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
In the February 7th edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
The new dictate by the ACCME is the COI polloi out of control. Consider the comments of healthcare icon and NIH director Francis Collins:
"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector.”
Big Pharma hires the best. And now America’s physicians are being denied their counsel.
Do we really want to build the foundation of 21st century CME on the second best and the almost brightest?
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Interesting story in yesterday’s edition of the St. Louis Post-Dispatch about Express Scripts and its president, George Paz (who is referred to in the article as a “former accountant").
Mr. Paz -- “The cheapest drugs is (sic) where we make our profits.” To that end, the article points out that in 2008, “Express Scripts agreed to pay $9.3 million to 28 states and $200,000 in reimbursement to consumers to settle lawsuits that accused the company of deceptive business practices in allegedly overstating the economic benefits to consumers of switching to certain drugs.”
And yet:
“Express Scripts would like to extend its influence further. Plans are in the works to put information kiosks in doctor's offices to advise patients about cheaper alternatives to brand-name drugs.”
Not “better.” Not “more effective.” Not “safer.” “Cheaper.” Can you imagine what would happen if a pharmaceutical company wanted to try something like this? Can you say “congressional investigation?”
And just who is “cheaper” better for?
"Our whole model is switching people to lower-cost drugs," Paz said. "The more money my shareholders make, the more money I make."
(According to the Post-Dispatch article, Mr. Paz’s compensation, including bonuses and other incentives, totaled $10.6 million in 2009.)
This is sadly reminiscent of the Blue Care Network of Michigan program (now discontinued) that sent letters out to their participating primary care physicians offering a $100 payment “for each member in their panel with a BCN pharmacy benefit who fills a prescription for a generic lipid lowering agent.”
Per an ABC News investigative report, “Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.” In other words, we’ll pay you $100 to switch your patient to a generic statin that isn’t even a generic version of what they are currently taking.
When asked by the ABC reporter if patients knew their doctors were receiving payments from the insurance company in return for a service that helps to increase the profits of the insurance company, the response from BCN was “not specifically.”
A study fielded by the National Consumers League demonstrated that switching a patient to a generic medicine doesn’t always result in positive outcomes:
- 15% of general Rx users saying that they or a family member experienced therapeutic substitution
– Nearly half of Rx users (47%) were dissatisfied (or their family was) with how the process occurred and report that this substitution did not result in lower pocket costs.
– More than a third (40%) said that the new medication was not as effective as the original one, and nearly a third (30%) experienced more side-effects following the substitution.
– Large majorities of Rx users think that the potential side effects of the new medication, the patient’s medical history, how well the drug works and the prescribing physician's opinion are factors that are absolutely essential when decisions are made about therapeutic substitution.
Just as no two patients have the same biochemistry, no two medicines are exactly equivalent. But if your primary goal is to reduce short-term costs, that's an inconvenient truth.
The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.
http://content.nejm.org/cgi/content/full/NEJMp1006304?query=OF
The key paragraph is:
"The challenge is to deliver the benefits of this work to patients. As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time."
Sadly not everyone shares their commitment. There are those in the agencies both of them lead who oppose their vision. I know since I have met and heard them speak. One of them -- from the NIH -- called the ALLHAT study the "gold standard" of evidence-based medicine. Must have received his MD from the Rosa Delauro School of Biomarker Science (Merrill Goozner, Dean of Academic Research).
At the same time, personalized medicine does not automatically translate into faster approvals. It would be easy to chalk this up to agency risk aversion across the board. Rather, I think it is more a matter of over time that the regulatory system has been able to become bloated and expensive because the way health care technologies have been paid for allowed both industry and government to pass the cost of oversight on to consumers, inefficiencies and all. Is the process of developing new medicines risky and expensive? You bet it is. But could it be less so and could industry made or demanded more efficiencies in product cycles and manufacturing? Absolutely. And will more of the fate and future of a produce be determined in the market rather than in the clinical period. That will be true as well. Especially when in comes to finding new uses based on the same pathways in different diseases or disease sites.
So faster approvals will still matter, but faster adoption or approvals for new uses will likely matter more. Which means getting to "no" faster in the early stages of development and finding multiple uses in the real world. And both will depend on personalized medicine as defined by Drs. Hamburg and Collins.
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.
