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“I Aim at the Stars,” was a 1960 B-movie biopic about Wernher von Braun. Many felt that it should have been subtitled, “But sometimes I hit London.

In keeping with that metaphor, comes news that Germany’s IQWiG (the Institute for Quality and Efficiency in Healthcare) is preparing to test a new cost-benefit methodology towards the end of this month. The test will last for about four months.

To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year and drew many comments (not all laudatory) from stakeholders. Some were critical of the proposed "efficiency frontier analysis" the institute plans to use as the basis of cost-benefit assessments. IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives.”

“Flexible” is in the eyes of the beholder.

IQWiG´s new methodology will help determine an “appropriate ceiling” price for drugs that are reimbursed by the statutory health insurers but cannot be included in a reference price group. IQWiG’s assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the health care system as a whole.

The cross-channel (and potential cross-Atlantic) implications are especially timely coming on the heels of the Baucus/Conrad bill and while experts are predicting a meltdown of Britain’s NHS.

The answer? According to Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), draconian rationing. As he said earlier this week, "Rationing is a necessary evil. We have to do it. There will be losers and winners." That's "universal" health care in its true guise of cost-based "government" health care.

As Tom Lehrer sang, “Once the rocket goes up who cares where it comes down. That’s not my department says Wernher von Braun.”


Today the NY Times, in a house editorial, tells the truth about vaccines and autism. 

But where are the front page stories?  Where's the outrage? 

Where's the justice?

Here's the complete editorial:

Debunking an Autism Theory

Ten years ago, a clinical research paper triggered widespread and persistent fears that a combined vaccine that prevents measles, mumps and rubella — the so-called MMR vaccine — causes autism in young children. That theory has been soundly refuted by a variety of other research over the years, and now a new study that tried to replicate the original study has provided further evidence that it was a false alarm.

The initial paper, published in The Lancet, the prestigious British medical journal, drew an inferential link between the vaccine, the gastrointestinal problems found in many autistic children and autism. In later papers, researchers theorized that the measles part of the vaccine caused inflammation in the gastrointestinal tract that allowed toxins to enter the body and damage the central nervous system, causing autism.

Now, a team of researchers from Columbia University, Massachusetts General Hospital and the Centers for Disease Control and Prevention has tried and failed to replicate the earlier findings.

These researchers studied a group of 38 children with gastrointestinal problems, of whom 25 were autistic and 13 were not. All had received the vaccine for measles, mumps and rubella. The scientists found no evidence that it had caused harm. Only 5 of the 25 autistic children had been vaccinated before they developed gastrointestinal problems — and subsequently autism. Genetic tests found remnants of the measles virus in only two children, one of whom was autistic, the other not.

The new study adds weight to a growing body of epidemiological studies and reviews that have debunked the notion that childhood vaccines cause autism. The Institute of Medicine of the National Academy of Sciences, the C.D.C. and the World Health Organization have found no evidence of a causal link between vaccines and autism.

Meanwhile, the original paper’s publisher — The Lancet — complained in 2004 that the lead author had concealed a conflict of interest. Ten of his co-authors retracted the paper’s implication that the vaccine might be linked to autism. Three of the authors are now defending themselves before a fitness-to-practice panel in London on charges related to their autism research.

Sadly, even after all of this, many parents of autistic children still blame the vaccine. The big losers in this debate are the children who are not being vaccinated because of parental fears and are at risk of contracting serious — sometimes fatal — diseases.


The headline of the AP story says it all, “Congress likely to delay health care overhaul.”

“As Congress returns from summer recess, lawmakers are expected to continue needling pharmaceutical makers and health insurers with investigations, while holding off on major health care reform until next year.”

That’s what this country needs – more needling!

But isn’t health care reform the driving domestic policy issue?  

“Health care has fallen in importance as an issue to voters and that would make one question how aggressive action is going to be next year," said Lehman Brothers analyst Tony Clapsis.

Guess not.

“… analysts are not holding their breath for universal health care coverage, despite some recent rhetoric from the campaign trail.”

"Some" rhetoric? That's generous.

How about less needling, less rhetoric – and more focus on dealing with the problem.  Which aspirant to the White House will have the courage to call for bringing all parties (drug companies, insurance companies, physicians, patients, hospitals, etc.) together to really begin addressing ways to provide access to excellence?

Reform by soundbite is insulting and dangerous.

Donut Hole Defined

  • 09.08.2008
 A new Kaiser Foundation sponsored study uses an IMS data set to look at how many seniors hit the donut hole and what happens when they do.  It turns about about 14 percent go through the point where seniors have to spend up to $3850 of their own money on drugs.  That's about the same as in 2006 according an independent study conducted by IMS itself if you take away seniors who did not spend anyting on prescription.  Adding in seniors that spent nothing you get about 6 percent hitting the donut hole. 

The Kaiser folks wiped out the seniors who spent nothing to plump up the bottom line figure.   Why is one level of spending any less or more important than any other.  Indeed, when doing weighing of distributions you have to add those folks in so that decision was a political one to say the least, not a methodological imperative.  Six percent is still 3 million people.  And it doesn't take away from the fact that both studies found people who hit the hole -- up to one in 10 -- stopped taking their meds for diabetes, depression, Alzheimer's, hypertension and that more than half did not restart after getting catastrophic coverage.  

The biggest problem with the Kaiser study is that it does not compare the behavior of seniors with and without gap coverage indeed the authors admit:

"The IMS database does not provide sufficient information about Part D plans (in particular, it does not distinguish among the multiple plan offerings of a single sponsor) to allow for identification of the small share of enrollees in plans with gap coverage, which prevents us from excluding them from the analysis." 

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/08/21/hscout618675.html

Small share?  Actually over 60 percent are enrolled in plans in gap coverage. 

The interesting policy question is what aren't more seniors choosing plans with gap coverage over the lowball premium plans? 

A further policy question is whether encouraging seniors to switch from an existing medicine in a class -- generic or not -- to another drug is wise.   Gail Shearer of Consumer Union sent a letter to the NY Times arguing that "taking the cholesterol-lowering drug simvastatin (the generic of Zocor) instead of Lipitor saves about $60 to $70 a month. Likewise, many people with acid reflux disease can save $150 to $200 a month by taking nonprescription omeprazole (the generic of former best-selling Prilosec) instead of the much-advertised Nexium.
People should raise the issue of drug prices with their doctors to make sure they get prescriptions for medicines they can afford."

http://www.nytimes.com/2008/09/07/opinion/l07Medicare.html?scp=1&sq=gail%20shearer&st=cse

I am glad she urged people to raise the issue with doctors because switching drugs is something people should not do on their own.  Direct to consumer information -- from any source -- should start with patient VALUE in the long term and work from there.   Off the cuff money saving comments can be dangerously expensive otherwise.
 


Here's the WSJ's June Kronholz looking into the soul of Sarah Palin and concluding that her newborn Trig is, well, just a cynical political prop:

"Little Trig Palin prompted more than delegate coos when he joined his mother on stage at the Republican convention. He also raised new questions among parents whose children have disabilities.

Was Alaska Gov. Sarah Palin simply including her 5-month-old son, who has Down syndrome, in a big family moment, or was she exploiting him in a tight presidential campaign? Would he help break down social barriers facing children with Down syndrome, or would those children now be drawn into the right-to-life debate?"

Wasn't it the media and the left wing blogosphere who raised all these questions and invaded her family's privacy?  Of course it was and that's where Krumholz went for her "sources."

"Among bloggers' top concerns is a Bush administration measure that would trim Medicaid funding for community services for people with disabilities. Democrats have so far stalled the cuts, which advocates for the disabled said would force the disabled back into institutions.

Blogs also were filled with questions about Gov. Palin's record on services to the disabled during her two years in state office. This spring, Alaska agreed to almost triple its spending on special-needs children, to $73,840 each beginning in 2011. But Gov. Palin didn't help draft the legislation."

She didn't help draft the legislation??  Obviously a sign of neglect!!

..http://online.wsj.com/article/SB122083992345509015.html

A new article in NewsWeek is titled, “We Fought Cancer…And Cancer Won.”

According to the article, “In 2008, cancer will take the lives of about 230,000 more Americans—69 percent more—than it did in 1971.”

That’s true.

The article continues, “Of course, since the population is older and 50 percent larger, that raw number is misleading. A fairer way to examine progress is to look at age-adjusted rates. Those statistics are hardly more encouraging. In 1975, the first year for which the National Cancer Institute has solid age-adjusted data, 199 of every 100,000 Americans died of cancer. That rate, mercifully, topped out at 215 in 1991. In 2005 the mortality rate fell to 184 per 100,000, seemingly a real improvement over 1975."

Also accurate.

Further, “Perhaps the most sobering statistic has nothing to do with cancer, but with the nation's leading killer, cardiovascular disease. Thanks to a decline in smoking, better ways to control hypertension and cholesterol and better acute care, its age-adjusted mortality has fallen 70 percent in the same period when the overall mortality rate from cancer has fallen 7.5 percent.  No wonder cancer "is commonly viewed as, at best, minimally controlled by modern medicine, especially when compared with other major diseases," wrote Harold Varmus, former director of NCI and now president of MemorialSloan-KetteringCancerCenter in New York, in 2006."

Yep.  But what's implicit in what Dr. Varmus says is -- since we're not dying of heart attacks and strokes (thanks largely to pharmaceutical interventions) -- we're living long enough to get cancer.  (Also -- NewsWeek fact-checkers please note --  Varmus wasn't the "former director of NCI," he was the former director of the NIH.)

So, are more people getting cancer?  Yes.  Are more people dying of cancer?  Yes.  Does that mean that we are "losing" the war on cancer?  Not necessarily.

“The meager progress,” according to NewsWeek, “has not been for lack of trying. Since 1971, the federal government, private foundations and companies have spent roughly $200 billion on the quest for cures."

Meager?  Really?

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.

Is cancer close to being “cured?”  No.  Is cancer close to becoming a chronic disease?  It depends.  Is there much work to be done?  Certainly.  Is there need for even more financial investment on the part of both public and private sectors?  Of course.

Is there cause for hope?  Absolutely. And no better reason to embrace and fund the Critical Path program.

The really, really early warning requirement for new drugs has prompted the predictable response from the usual suspects. The goal of course is to focus post market detective work on which groups of people respond best to which drugs.  But that's not how it's playing out. PhRMA fears people will worry unnecessarily and safety-uber-alles zealots like Diane Zuckerman, president of the National Research Center for Women and Families, worries "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."  

Oh.  And just how high a body count would Diane like?  I have a clue.

Diane, has also said that  anti-depressants don't work and that she knew better than I did because she is an epidemiologist,  When I told her that certain members of my family had responded well to SSRIs she said, "Well, good for you. "   I could feel the love. 

http://ap.google.com/article/ALeqM5jLeef2T5nlybcAAzF3Fe1qqDEaqgD930MUEG0

Like I said, predictable.

AERS Apparent II

  • 09.05.2008
Per the earlier question, "Will the FDA advise a pharmaceutical company in advance if one of their products is to be be included in a quarterly AERS report?" -- the answer is "yes."

According to my source inside the agency, "For all our communications we endeavored to communicate 24-48 hours in advance."

As far as today's inaugural report, sponsors were notified yesterday.

Question:  why not sooner?

AERS Apparent

  • 09.05.2008

The FDA announced today that it will post, quarterly, a report of drugs that are being evaluated for potential safety problems.  The FDA will base this list on adverse events reported through the agency’s Adverse Event Reporting System (AERS). The first report will be posted today.

This reporting mechanism is a requirement of FDAAA.

Ultimately, based on these evaluations, the FDA can require next steps ranging from (1) nothing – if the adverse events are determined not to be drug-related, (2) a risk management plan (REMS), (3) a label change, up to and including (4) a Phase IV clinical trial. It's important to note that all of these options can now, per FDAAA, be mandated by the agency.

This news was presented by Paul Seligman, MD (Associate Director of Safety Policy and Communication, CDER) and Gerald Dal Pan, MD (Director, Office of Surveillance and Epidemiology).  Both commented on the need to keep these warnings in perspective and both spoke to the issue of unintended consequences and that the agency would strive to communicate the information in the manner designed to avoid misinterpretation by patients and overreaction by the media.

(If you disagree that the media overreacts, let's see what happens tomorrow.)

One way to help modulate the unintended consequences (aka, "general hysteria") these things tend to generate is to make sure drug companies have some advance warning of these postings so they can be prepared to communicate their perspectives to patients, physicians and payers.  Will the FDA be advising companies that a given product will be included in the report?  It wasn't discussed during the press briefing.

Inquiring minds want to know (1) if "yes," how far in advance will a company be notified and, (2) if "no," why not?

More as more develops.


Center for Medicine in the Public Interest presents:

"Industry Support for Continuing Education of Healthcare Professionals"
Monday September 22, 2008
8:00am-12:00pm
121 Cannon House Office Building, Washington, DC


CLICK HERE to view the Capitol Hill event invitation


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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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