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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.


Bextra Credit

  • 09.03.2009

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.

The latest contribution to our understanding of "what works" -- guaranteed to save money according to CER kool-aid drinkers -- from AHRQ:

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....


Not so dynamite?

  • 09.02.2009
Nobody said it was going to be easy.

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.

Δ House

  • 09.01.2009

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.”

It’s important to consider VBID in the broader conversation of clinical effectiveness and more specifically HTA modeling a la QALY – because that brings you into the direct path of VSLY – the value of a statistical life year.  According to Dr. Frank Lichtenberg of Columbia University, for a healthcare technology assessment scheme (such as the NICE model) to yield valid decisions in practice, it is necessary to have reliable estimates of:

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.
One of the presumptions behind calls for wider access to health insurance is that over the last ten years more and more Americans have found themselves uninsured. But it turns out that this isn’t quite true. Sure, the number of uninsured Americans is higher now than it was a decade ago but the change has a lot to do with population growth. A far better measure is the percentage without insurance, which despite fluctuations, has not changed a lot since even the early 1990s. In fact, between 2006 and 2007, the last years for which there is good data, both the number and the percentage of Americans who are uninsured went down.

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.

Camp Counseling

  • 08.31.2009

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 House Ways and Means Committee.

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, U.S. patients neglected to fill 6.8 percent of on-patent prescriptions - a 22 percent increase compared to the first quarter of 2007. (On-patent prescriptions are those for which there is no generic alternative to the brand-name drug.)

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 Oregon Health & Science University found. In 2003, researchers looked at what happened when a small $2 to $3 co-payment was introduced for Oregon Medicaid patients. After examining data on 117,000 patients, the researchers found that prescription drug use dropped by 17 percent.

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.

The Week in Quotes

  • 08.28.2009
Economist Thomas Sowell on life expectancy rates and the health care debate:
 
“No small part of the current confusion between ‘health care’ and medical care comes from failing to recognize that Americans can have the best medical care in the world without having the best health or longevity because so many people choose to live in ways that shorten their lives.”
 
Howard Dean on the reason tort reform is omitted from the current House proposals:
 
“Here is why tort reform is not in the bill. When you go to pass a really enormous bill like that the more stuff you put in, the more enemies you make, right? And the reason why tort reform is not in the bill is because the people who wrote it did not want to take on the trial lawyers in addition to everybody else they were taking on, and that is the plain and simple truth. Now, that’s the truth.”
 
Chairman of the House Energy and Commerce Committee Henry Waxman on Medicare Part D:
 
“We want it back. We want to make sure the windfall for the drug companies does not continue, and we want to recover the money that has been a windfall.”
 
Henry Waxman on the deal between PhRMA and the White House:
 
“We don’t have any deal with them, and the whole enterprise of doing health insurance for all Americans isn’t to make the drug companies happy, or wealthier.”
 
PhRMA CEO Bill Tauzin’s response to Waxman’s efforts to recover a so-called windfall for drug companies as a result of Medicare Part D:
 
“You not only break the deal, but you break the bank for us.”
 
Senator Joe Lieberman (I-CT) on the ambitious health care proposals currently under consideration:
 
 
“We’ve got to think about putting a lot of that off until the economy’s out of recession. There’s no reason we have to do it all now, but we do have to get started. And I think the place to start is cost, health delivery reform and insurance market reforms.”
 
Senator Mary Landrieu (D-LA) on how to proceed with health care reform:
 
“I'd prefer a private market-based approach to any health care reform that would extend coverage. I'd like to cover everyone -- that would be the moral thing to do -- but it would be immoral to bankrupt the country while doing so.”
 
 

Reading responses to a recent piece on ideas for increasing transparency in industry support for continuing medical education, this particular comment stuck out to me:
 
All industries use corporate support to further continuing education. There should not be a ban on that. If we are going to cut the communication between the industry and professionals, then how on earth the new technologies can be introduced to professionals. The fight to prevent influencing the minds of physicians is going too far. Now we want the industry and physicians not to even see each other??? Does it not sound like the Taliban… too orthodox? I am a physician and I want to know what is going on in the healthcare industry. I want someone to tell me what new medicines are coming out of pipeline into the market. I do not have time to research it myself. Just because a physician saw it in a seminar does not mean they will not use it judiciously. Even ACP and other conferences have sections where they allow healthcare industry to show case what they got. Those who do not want to know the latest technology are actually doing a disservice to their patient. For example a recent drug was introduced in the market as an alternative to allopurinol for gout. I would not have known about it for many months, unless a drug rep had not come in and told me about it. I still write allopurinol, but in the back of my mind I know I have a second medicine to help my patients, if they need it.

Industry and Professional communication is very important for overall development of technology. The users have to be told what tools they have. Once we are out of school those opportunities are limited. There is just too much to do than just browse every single medical journal to see what’s new out there.

Every single day the fast food companies advertise on television and ask our children to eat cholesterol laden food which will make them obese. Every single day marketeers are ruthlessly selling a lot more harmful stuff to everyone including us. We should focus on that, rather than just be trapped in our own world of medicine and to cut communications inside it.
 
Senator Grassley and gang; Read it, print it, frame it, and hang it up on your office walls.
 
To learn more about the indispensable role industry plays in CME, read our paper on the topic here.

According to SCRIP Pharmaceutical News, Great Britain, once a popular destination for European Union parallel traded drugs – is fast becoming a major EU source country, leading to shortages of some major drugs there.

Last year, the British Association of Pharmaceutical Wholesalers (BAPW) warned about a risk of severe drug shortages over the winter as wholesalers ran down stocks in advance of price cuts on January 1st, 2009. It also noted that the problem could be made worse by parallel trading from the
UK caused by the weakness of sterling against the euro and other currencies.

In July this year, the problem of shortages was raised again, with claims that they were being caused by changes in
UK supply arrangements (many manufacturers had adopted the direct-to-pharmacy model), and that parallel exports could also be a contributing factor.

While it is wholesalers that are responsible for most parallel trade, it appears that in the
UK many pharmacies and even some doctors are plying their own mini-trade too. The ABPI says that the pricing discrepancies and the exchange rate factor have "created a financial incentive for either wholesalers, pharmacies or dispensing doctors to order extra medicines and sell them overseas for a quick profit.”

The industry is not alone in drawing attention to this situation.
UK health authorities and pharmacy bodies have issued strong warnings to the effect that pharmacists indulging in this kind of trade are acting "unethically,” particularly given the disruption the pandemic could cause in the coming flu season.

Keith Ridge, chief pharmaceutical officer at the Department of Health (DH), has written to NHS chief pharmacists noting that some NHS hospitals are "considering entering into agreements to export, or result in the export of, medicines for short-term financial gain". This, says Mr Ridge, is "wholly unacceptable" and "contrary to acceptable professional behaviour". Pharmacists who enter into such agreements at a time of pandemic "are acting particularly irresponsibly.”

So, if you think Her Majesty’s Government is going to sit passively by while American politicos ponder drug importation from their island kingdom – think again.

CMPI

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.

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