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From the pages of BioCentury:

Republican bill seeks to ban comparative effectiveness

 

Sens. Jon Kyl (R-Ariz.) and Mitch McConnell (R-Ky.) introduced a bill that would prohibit the U.S. government from using comparative effectiveness research to deny or delay coverage of healthcare treatment to a patient based on cost. The Preserving Access to Targeted, Individualized, and Effective New Treatments and Services (PATIENTS) Act of 2011 (S. 660) was referred to the Committee on Health, Education, Labor and Pensions. The bill was co-sponsored by Sens. John Barrasso (R-Wyo.), Tom Coburn (R-Okla.), Mike Crapo (R-Idaho) and Pat Roberts (R-Kan.).

 


And from the “
I'm shocked, shocked to find that gambling is going on in here” department:

WASHINGTON (AP) -- AARP lobbied for the new health care law and now it stands to profit, Republican lawmakers charged Wednesday as they called for the IRS to investigate whether the powerful interest group representing millions of older Americans should be stripped of its federal tax exemption.

Three veteran GOP representatives released a report that estimates the seniors lobby could make an additional $1 billion over 10 years on health insurance plans whose sales are expected to pick up under the new law. They also questioned seven-figure compensation for some AARP executives.

The report found that insurance sales are AARP's single largest source of revenue. AARP-brand offerings are the market leaders for Medicare prescription coverage, private Medicare Advantage insurance plans, and Medigap coverage that fills in benefit gaps for people with traditional Medicare.

UnitedHealthcare, which operates the AARP plans, paid the organization $427 million in 2009, according to the report.

The Ways and Means Committee has scheduled a hearing Friday on AARP's structure and finances.

CMPI president Peter Pitts recently sat down for an interview with New Jersey Congressman Jon Runyan on health care reform.
 
Runyan was elected to Congress in November 2010 and represents the 3rd Congressional District of New Jersey. He is the former offensive lineman with the Philadelphia Eagles. Congressman Runyan is only the fourth NFL player to be elected to the United States Congress.
 
Watch the interview here:


Dr. Tevi Troy, host of New Books In Public Policy, recently did an audio interview with CMPI’s Robert Goldberg to discuss his book “Tabloid Medicine.”
 
Here’s more on the interview from Dr. Troy:
 
This week New Books in Public Policy interviews Bob Goldberg about his new book Tabloid Medicine: How the Internet Is Being Used to Hijack Medical Science for Fear and Profit (Simon & Schuster, 2010). The book is a look at the way medical science is discussed and played out over the Internet. As Goldberg says on his website, tabloid medicine is “medical reporting or information based on or consisting of Internet material that sensationalizes and exaggerate the dangers of medical technology without describing the benefits.”

In the interview, Goldberg talks about both this problem and its implications, from parents refusing to vaccinate their children to suicidal people avoiding antidepressants for fear of overhyped side effects. He also discusses the role of those who seek to foment fear, as well as discredit their opponents, using new media and innuendo regarding inappropriate conflicts of interest.

Finally, Bob takes on the New Books in Public Policy signature question, “What policies would you initiate if you were king for a day?” and gives his policy prescriptions for addressing the problem of Tabloid Medicine.


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According to a report in the Washington Post, “Medicaid, the joint federal-state health program for the poor, spent $329 million extra in 2009 purchasing 20 brand-name drugs instead of available generic copies, according to an American Enterprise Institute report.”

 

The spending numbers are iffy.  The word “extra” is wrong.  And words matter.  A lot.

 

The Post writes, “The study included contraceptives, respiratory medicines and antibiotics. Risperdal, New Brunswick, N.J.-based Johnson & Johnson’s antipsychotic, prescribed in generic form exclusively would have saved $60 million in 2009, the report released Monday found.” It’s important to note (and is mentioned in the Post story) that Teva (the world’s largest generic drugs company) makes a generic version of the drug.

 

Two things for starters.  First, nowhere in the Post story (or, even more surprisingly, in the AEI paper) does it mention that the report’s author receives monetary support from Teva.  Whatever happened to the urgency of transparency?  That’s a big oops.

 

Secondly, and more importantly from a therapeutic perspective, generic substitution, while a good way to save payers money in the short term (including our nation’s largest payer – Uncle Sam), often has quite deleterious impact on patient care -- an issue that is well researched and quantified and entirely absent from both the AEI report and the Washington Post reportage.

 

And this is even more important when it comes to medicines that have a narrow therapeutic index – such as Risperdal.

 

According to the FDA, narrow therapeutic index means that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions."  The AEI paper not only ignores this issue, but openly shills for more aggressive therapeutic substitution (as a way to save money) without ever once mentioning the very real such a policy would have on patient care.


(Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.)

 

In fact, this is such an important issue, that at recent meeting of the Generic Pharmaceutical Association, CDER Director Janet Woodcock said that the FDA is discussing tightening the equivalence limits of generic medicines "so there is less variability. And the agency’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index drugs.

 

Mention of this in the AEI report? Zero.  Mention of “millions of dollars in potential savings? Multiple. Mention of author’s financial relationship with the world’s largest generics manufacturer? None.

 

The Post reports that, “the top-20 list of drugs Medicaid overspent on in 2009 includes five anticonvulsants.” And that the “estimated waste” cited by the report on the five treatments totals $169 million. The Post finally admits that these medicines “are under Food and Drug Administration scrutiny because of patient and provider concerns that generic versions don’t work as well to treat epilepsy as their brand-name counterparts.”

 

Thank you. On a personal note, my eldest son has epilepsy – so this issue is both professional and personal for me. 

How’s that for transparency?

 

The report’s author, per the Post, “said he couldn’t comment on whether generics should be substituted for anticonvulsants. “We have to leave it to the FDA to determine what’s interchangeable.”


Alas – that too is lacking from the pages of the report. 

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I attended an excellent conference at The New York Academy of Sciences Monday entitled Vaccines Under the Gun. The participants were Paul Offit, MD, Dan Thomasch (who argued the Supreme Court case limiting vaccine maker liability) and Trine Tsouderos, Chicago Tribune science and health reporter who spent a year investigating alternative treatments for autism, leading to a series of stories that deemed them risky and unproven and Perri Klass, a pediatrician and author of many books and articles on health, medicine and children.

The major point of discussion was: Why did the media fail so miserably in covering the vaccine-autism link and why was it willing to give junk and pseudo science a platform?

No one answer was provided. However it is clear that the motivations and approach of journalists that perpetuated this false narrative is alive and well. The participants made the following points:

1. Health care journalists limit their focus on conflicts to specific industries and give those ‘experts’ who raise questions about the integrity of companies, who claim links between chemicals and disease and who identify the profit motive as inherently evil are free pass. Here are one recent example: 
FDA Probes Link Between Food Dyes, Kids' Behavior

‎2. Health care journalists ignore all ‘conflicts of interest’ except when it comes to medical product companies. For instance, a story in Reuters claiming if doctors prescribed more generic drugs there would be more compliance and less spent on medications. It was based on a study conducted by CVS and Harvard professors who claimed no financial interest. The authors are: an executive of CVSCaremark, a doctor running CVS Caremark Harvard Partnership for Improving Medication Adherence and another making money doing academic detailing. The authors did not disclose this association or were not required to. Even health care journalists are guilty of this deliberate oversight: Joanne Kenen’s
bio on the Health Journalism blog leaves out her long affiliation with the left-leaning New America Foundation.

3. Health care journalists continue to ignore the body of science in covering a study. The Reuters article is a case in point: The totality of evidence regarding the impact of generic drugs in improving adherence is unclear at best because most studies do not measure the impact of switching to a generic on compliance. Such studies, with rare exception, fail to look at total treatment costs in specific therapeutic areas. Finally, there is a body of evidence demonstrating that “allowing people to use only generic drugs would increase total treatment costs, not reduce them, and would lead to worse outcomes.”

More here.

Similarly, coverage of the food color-ADHD ‘connection’ has ignored several large studies and a European Food Safety Agency review harshly criticizing the small ‘studies’ for the same reasons Wakefield’s MMR-autism ‘research’ was trashed.

More here.

The
following blog post shows how an unbiased journalist would critically cover this story.

All of which leads me to conclude that health care journalists need to be more vigilant in correcting those in the field. There is nothing wrong and indeed much to admire in reporting or coverage with a strong point of view or bias. I don’t think journalists should be penalized for having a particular bent or expressing opinions on most subjects. At the same time it is wrong to apply a double standard on conflicts, (which will be the subject of another post) fail to do a 5 minute search of well-designed studies that have clear endpoints or subject a medical or scientific claims about risks to the scrutiny of clear, replicable evidence. Finally, journalists and headline writers have to stop framing possible associations as causation.  
CMPI Vice President Robert Goldberg was recently interviewed by Jennifer Byde Myers of the Thinking Person's Guide To Autism blog about his new book "Tabloid Medicine."

 
I got a chance to talk with Dr. Robert Goldberg PhD about his new book “Tabloid Medicine.” In it he breaks apart the formula for Tabloid Medicine: change the terminology to fit your agenda, create an instant expert, play the little guy against the big guy, proliferate bad information, then find a celebrity to lead the charge. Voila! Your very own epidemic-I make light, but this book doesn't, since it's not really a funny topic. We spoke of how he came to the topic as a parent, when his own daughter struggled with misinformation in the media, but continued, fueled by the tragedy that with so much good the internet could be doing, it was being “hijacked” by the likes of Andrew Wakefield, Jenny McCarthy, David Healy, Sidney Wolfe MD, and Barbara Loe Fisher. Passionate about the subject, and well-grounded by facts, Dr. Goldberg answered a few questions for me.

 
 

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Dr. Emily Gibson has written an excellent piece explaining the obstacles she has faced in persuading parents to have their children vaccinated:

As a physician, I help enforce vaccination requirements for a state university.  A day doesn’t go by without my having a discussion with a prospective student (or more likely the student’s parent) about the necessity for our requirement for proof of  mumps, measles, rubella vaccination immunity.  I have been labeled a Nazi, a Communist, a pawn of the pharmaceutical industry and many more unprintable names because I happen to believe in the efficacy of modern vaccine to help keep a community free of infectious disease outbreaks that will kill people.

We have forgotten these are honest to goodness killers of healthy human beings.  We forget that unvaccinated children continue to die in developing countries for lack of access to vaccine.   Yet educated and well-meaning American parents make the decision daily to leave their children unvaccinated, believing they are doing the best thing for their children by protecting them from potentially rare and often unproven vaccine side effects.

I’ve had caring loving parents tell me that God will provide the needed immunity if their child gets sick so taking the risk of a vaccine is unnecessary.    Actually they are banking that everyone else will be vaccinated.  The problem is:  guess again.  There are now too many deciding that they are the ones who can remain vaccine-free.   Babies died in California this past year from becoming infected with whooping cough–in the year 2010– when this is a completely preventable illness.

I tell these parents God does provide immunity — after suffering through a life threatening disease which threatens those who are unfortunately exposed.  He also provides immunity in the form of a vial of vaccine, a needle and syringe.  I don’t think any one of these parents would deny the life saving miracle of injectable insulin for their child diagnosed with diabetes, nor would they fail to strap their child into a car seat.  Vaccines are miracles and instruments of prevention too, but the rub is that we have to give them to healthy youngsters in order to keep them healthy.

As a society, or as clinicians, we simply don’t think about immunizations in the same way as we did in the fifties.  When I received my first DPT vaccination at the age of 4 months, my mother wrote in my baby book:

“Up most of the night with fever 104.5 degrees, considered a good ‘take’ for the vaccine.”  She truly was relieved that it had made me sick, as it meant that I would be safe if exposed to those killer diseases that were so common in the 1950s.  Now a febrile reaction like that would almost be considered grounds for a law suit.

Read the full piece here.
 

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Congressman Henry Waxman (D-CA) is still harping on one of the few positive provisions in the Affordable Care Act: The 12-yr exclusivity time for biosimilars.
 
Waxman said this week that he is still working to change this aspect of the law, “I hope we can change that provision and we’ll do the best that we can.”
 
His reasoning?
 
“I think the existing law is a real barrier to consumers holding down the costs.”
 
Now that Congressman Waxman is no longer Chairman of the Energy & Commerce Committee, perhaps he has some time to watch the video of CMPI’s Capitol Hill briefing a couple years ago on this issue. Both Congresswoman Anna Eshoo (D-CA) and Congressman Mike Rogers (R-MI) discussed the importance of the 12-yr exclusivity for biosimilars.
 
See video here and here.

Quotes of the week

  • 03.25.2011
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“Happy first anniversary, ObamaCare. May you not survive long enough to see your second.”
 
- Editors, Las Vegas Review-Journal
 
"When Senator Barack Obama was running for president, he repeatedly promised that he was going to reduce 'every family's premiums by as much as $2,500.' ... Average premiums for individual plans, according to the nonpartisan Congressional Budget Office, are predicted to increase by $2,100 per family over the next five years under the law."
 
- Senator John Thune (R-SD)
 
"If I were president, on Day One I would issue an executive order paving the way for Obamacare waivers to all 50 states."
 
- Mitt Romney

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www.philly.com/philly/opinion/20110324_A_losing_battle_against_disease_and_ignorance.html

PEDRO MOLINA
 
PEDRO MOLINA
READER FEEDBACK



A losing battle against disease and ignorance

The government surrenders to anti-vaccine zealots.

By Robert Goldberg

Last month, a 27-year-old woman with a case of measles she picked up in London exposed hundreds as she flew into the Washington area and then on to Denver and Albuquerque, N.M. She had never been vaccinated for the disease.

The woman who spread the measles isn't an outlier. Rather, she's the product of a zealous and largely unchecked movement to convince parents that vaccinations can harm their children.

"Virtually every single empirical claim of vaccine rejectionism is factually false," notes Dr. Amy Tuteur, an obstetrician-gynecologist and blogger, "but parents who lack even the most basic understanding of immunology are often incapable of evaluating those empirical claims. Indeed, those parents most likely to proclaim themselves 'educated' on the topic are generally the most ignorant."

But many parents - most of them white, affluent mothers - believe otherwise, and not by accident. Making vaccines sound scarier than measles and the other infectious diseases they prevent took a village of anti-vaccine organizations fomenting fear.

One prominent proponent of the idea that vaccines cause autism and brain damage is Andrew Wakefield, who began using the Web and other media to promote his "research" on the subject in the 1990s. Wakefield's findings were discredited, but not before they sparked a growing anti-vaccination movement. Its members theorize that the government, the pharmaceutical industry, and the medical community have conspired to hide the dangers of vaccines in an effort to protect corporate profits.

The media have been part of the problem. Rather than exposing fraudulent claims, sympathetic reporters have fueled anti-vaccine groups, spread panic, and crowned celebrities such as Jenny McCarthy as immunization experts. Meanwhile, they have depicted true leaders in the field, such as Dr. Paul Offit of the Children's Hospital of Philadelphia, as less reliable because of their connections to commercially successful vaccines.

As they plug their books, diets, and supplements, McCarthy and others have flogged the message that the best defenses against childhood disease are conspicuously "natural" - including prolonged breast-feeding and exposure to other sick children at measles and chicken pox "parties." That's right: The supposedly enlightened anti-vaccine parent protects her kids by exposing them to diseases that have killed millions.

It would be nice if our public officials stood up to these fearmongers instead of treating them as just another interest group. But apparently that's too much to ask of the Obama administration, which seems to have gone out of its way to legitimize the belief that vaccines cause autism.

In 2009, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices postponed the release of the swine-flu vaccine because of safety concerns raised by McCarthy's group, Generation Rescue. Now the CDC committee - which makes far-reaching recommendations about what vaccinations America's children should receive - appears to be backing away from a lifesaving infant vaccine to prevent meningococcal disease, a leading cause of bacterial meningitis.

That's despite the fact that in 1999, meningococcal disease was on the CDC's list of 10 conditions targeted for elimination. And the CDC voiced its support for an infant meningococcal vaccine in 2008, citing data that demonstrated its safety and potential to greatly reduce harm caused by the disease.

Last year, however, Obama's CDC showed signs of backing down from that position. The immunization committee indicated that it might not recommend the vaccine for infants. Among the reasons it cited was the potential for a "rare adverse event."

Last month, the Obama administration released its long-awaited National Vaccine Plan, which devoted a lot of attention to overcoming cultural and economic barriers to immunization. But it didn't include a word about bogus claims that vaccines are dangerous. And then Environmental Protection Agency chief Lisa Jackson joined the panic parade by suggesting that contaminated drinking water causes autism.

Wakefield helped launch a powerful movement against immunizations. Sadly, the Obama administration has been unable or unwilling to generate a strong provaccine response.

If measles and other diseases continue to surge, we can't just blame those who spread them. We can also thank the politicians and health officials who fail to protect us from deadly diseases and lethal stupidity.

 


Dr. Robert Goldberg is vice president of the Center for Medicine in the Public Interest and the author of "Tabloid Medicine: How the Internet is Being Used to Hijack Medical Science for Fear and Profit" (Kaplan, 2010). He can be reached at robert.goldberg@cmpi.org.

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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