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Here’s what Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had to say in response to the proposed $40 billion tax on medical devices and diagnostics that is included in a draft health care reform proposal from Senator Max Baucus, chairman of the Senate Finance Committee:
“This tax will raise the cost of care for all patients, especially those in greatest need of advanced treatments and diagnostics. It is a form of double taxation, since a portion of the hundreds of billions in cuts aimed at our customers, including hospitals, nursing homes, and home health care agencies will be passed on to us. Moreover, the tax will fall most heavily on the small and emerging companies that are the backbone of our industry, often driving development of cutting-edge treatments and cures, and are least able to pay new taxes. Additionally, the fee imposed on clinical labs raises serious concerns in view of other cuts to payments for lab services.”
“While AdvaMed supports broad-based health care reform and has been working to achieve that important goal, we cannot support a proposal that unfairly singles out the medical technology industry for a tax on innovation on top of the billions in cuts that the industry would already have to absorb within the health care reform proposal. We will continue to work with congressional leaders and the White House to further real health reform and to eliminate this counterproductive proposal from any reform package considered by the Congress.”
Real reform doesn't pay for itself by standing on the throat of innovation.
FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting.
ODAC was convinced that clofarabine is active in getting elderly AML patients into remission, but ultimately voted 9-3 that the additional trial did need to be conducted prior to its approval - regardless of the enormous disease and patient population challenges that have stood in the way of conducting such trials thus far.
Hmm.
Jenkins blamed the lapses on "long-standing limitations in staffing and information technology resources," saying that "competing workload priorities prevented us from the level of oversight and review of the entire portfolio of [postmarketing requirements] and [postmarketing commitments] that we would have desired …With new resources and congressional directives, FDA is committed to ensuring proper drafting and review of the entire portfolio going forward.”
Among the changes, each Center for Drug Evaluation and Research division now has a designated postmarketing study coordinator and a postmarketing study tracking coordinator.
In general, the deputy division director for safety - a position established under the agency's Safety First initiative - has assumed the postmarketing study coordinator job, and the safety regulatory manager will handle postmarketing study tracking. "These people as their full-time job are managing the safety and postmarketing study portfolio for their division," Jenkins said.
According to Jenkins, new policies and procedures are in place to "improve consistency in developing" postmarket requirements and commitments and lead to "better designed studies and trials with effective and realistic time frames for initial completion.” He added that other changes have been made to improved tracking and reviewing, including standardizing policies and procedures across CDER review divisions and offices.
According to the AP:
THOUSAND OAKS, Calif. — California authorities say a clash between opponents and supporters of health care reform ended with one man biting off another man's finger.
Ventura County Sheriff's Capt. Frank O'Hanlon says about 100 people demonstrating in favor of health care reforms rallied Wednesday night on a street corner. One protester walked across the street to confront about 25 counter-demonstrators.
O'Hanlon says the man got into an argument and fist fight, during which he bit off the left pinky of a 65-year-old man who opposed health care reform.
A hospital spokeswoman says the man lost half the finger, but doctors reattached it and he was sent home the same night.
She says he had Medicare.
O'Hanlon says the attacker fled but authorities have a good description.
No doubt there will be much pontificating and punditry surrounding the Pfizer settlement. That the matters at hand happened in the past and under different management will be largely ignored. (And the fact that they did certainly doesn’t make any past malfeasance less serious.) That being said, a few personal observations.
The people I know at Pfizer are honest and honestly dedicated to advancing both the business aims of their company and (even more importantly), the public health. These are not mutually exclusive objectives. They are proud of what they do – and rightfully so.
Don’t give up the ship.
Comparative Effectiveness of Lipid-Modifying Agents
"Due to these limitations in the available data, we present first our results based on the available evidence for the group requiring intensive lipid lowering when combination treatment is compared to a higher dose of a statin, and then provide a broader perspective using available data in all risk groups comparing combination therapy to any monotherapy statin dose."
Translation into humanspeak: the less than 100 randomized trials we review only gave us a one-size fits all conclusion, which is lousy but we are going to give it to you anyway.
Media translation: "Researchers analyzed 102 published studies on the topic and found no benefit of combination therapy at reducing the risk of death, heart attack, stroke, or the need for bypass surgery over using high doses of statins alone."
Statins May Perform Better as a Solo Act
Combination Therapy for Lowering Cholesterol Not Yet Proven to Be Superior to Statins Alone
By Jennifer Warner
WebMD Health News
Policy translation: Gee, one pill -- especially the cheaper red bill -- is even cheaper than two pills. So let's start everyone on the cheapest pill.
Recommendation:
"Pragmatic trials are required in order to provide relevant guidance to practitioners and patients. In trials of this type, oversampling of populations of interest, including women, ethnic groups, elderly Americans, and persons with diabetes,would help define the relative applicability"
Humanspeak: "We need to spend more money to come up with the same conclusions about needing more research years from now. In the meantime we will tell the press that one cheap pill is just fine."
"...the benefits of additional therapies need to be clearly defined along with attendant risks and costs before advocating widespread use of combination treatment,” writes researcher Mukul Sharma, MD, MSc, of the Canadian Stroke Network in the Annals of Internal Medicine.
http://www.webmd.com/cholesterol-management/news/20090831/statins-may-perform-better-as-a-solo-act
So glad the $1.1 billion in CER money is being put to such good use....
Mixed news from the 2009 European Society of Cardiology Congress in Barcelona on a new post hoc sub-analysis of patients treated with Lipitor (atorvastatin calcium) in the five-year Treating to New Targets (TNT) study. For patients with established heart disease who were treated with a statin, 18 novel biomarkers including C-reactive protein (CRP) did not predict future cardiovascular events such as heart attack and stroke. By contrast, traditional lipid risk factors were strong predictors of cardiovascular events.
The 18 novel biomarkers were not predictive of risk for future cardiovascular events in patients with stable coronary heart disease already on statin therapy. Higher levels of LDL cholesterol and triglycerides and lower levels of HDL cholesterol, however, were each strongly and significantly predictive of risk for future events.
The complete report can be found here.
Consider value-based insurance design, and then consider Section 224 (c) of HR3200, "Encouraging the Use of High Value Services." The public health insurance option may modify cost sharing and payment rates to encourage the use of services that promote health and value."
The Pink Sheet points out a recent paper sponsored by the National Pharmaceutical Council as "adjust[ing] out-of-pocket costs based on an assessment of the clinical benefit value - not simply the cost - to a specific patient population." The overall goal is "getting more health out of every health care dollar."
And they continue:
“A shift to value-based insurance would provide some interesting opportunities for drug manufacturers to develop and present evidence of their products' value. A permanent comparative effectiveness research program, which is being considered as part of health care reform legislation, also could become an important source of information on value.”
ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)
and his main point is that the devil is in the details.
Lichtenberg believes that incorrect estimates of some or all of these key inputs are often used:
ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated
And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.
Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.
Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:
Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States
Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.
and
Murphy and Topel: The value of a life year is $373,000.
Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.
Attention must be paid. Hello Senator Baucus.
Uninsured Americans
And while obviously the recession that hit the US beginning last year has worsened the picture, a Gallup poll in June 2009 put the number currently uninsured at around 16 percent of adults. That is higher than in previous years, yes, but not shockingly or dangerously so. It also represents only those uninsured at one point in time and leaves out people under 18, who tend to have a higher rate of being insured, especially with the extension this year of programs like SCHIP.
I’m hardly going to argue that “only” 14-16 percent uninsured is a reason to leave the US health care system as is. However, both honesty and well-researched information have been lacking, on all sides, of the health care debate. The myth of the rising uninsured is yet another example of this.
In Sunday's edition of the New York Times, Robert Pear reported that:
“Medicare beneficiaries would often have to pay higher premiums for prescription drug coverage, but many would see their total drug spending decline, so they would save money as a result of health legislation moving through the House, the Congressional Budget Office said in a recent report.”
The "but" is at the very end of the article:
“But, Mr. Elmendorf said, the averages conceal the fact that beneficiaries would be affected in different ways.”
(That’s Doug Elmendorf, director of the CBO.)
And when you consider the, um, facts …
“Those who use a relatively small amount of prescription drugs would pay more in additional premiums than they would save, he said, while those who use a large amount of drugs would gain more from lower cost-sharing than they would pay in higher premiums.”
The CBO study was undertaken at the request of Representative Dave Camp (R, MI), the senior Republican on the
Mr. Pear ends by reporting that, “The budget office did not estimate how many Medicare beneficiaries might see an increase in their spending for prescription drugs and drug coverage, and how many would see a reduction, under the House bill. Mr. Camp said “the vast majority of seniors” would pay more, and he said House Democrats should scrap their bill and “start over with open, bipartisan talks.”
The complete New York Times article can be found here.
What’s the problem with higher co-pays? They reduce usage and compliance. Great if you’re trying to save money in the short-term. Not so great if you’re trying to enhance patient outcomes over the long-term. Short-term-savings (a political objective) vs. long-term patient health (which is also much more cost-effective in the long-term).
Short-term (political) thinking delivers long-term (public health) problems.
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.
When co-pays go up, more people see the need to abandon their prescription drug regimen. At least that's what a study from
As health care costs continue to rise, it's understandable that insurance companies (including the nation’s biggest payer – Uncle Sam) are looking to save money wherever possible. Passing off the cost of prescription drugs to patients, however, will only drive up overall costs while resulting in dramatically poorer health for more Americans.
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.
