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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.

 
 

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.
 

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
“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

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.

The big news in Moscow this morning is that Russian President Dmitry Medvedev hosted the band Deep Purple (according to the official Kremlin report), “at his luxurious residence near Moscow.”

Soldier of Fortune
indeed.  Rock on Dmitry!


Perhaps the reason the Kremlin chose to comment on President Medvedev getting in touch with his internal groupie was to send the message that Russia (from the top down) is more Western than we in the West give it credit for. The news item on Deep Purple, after all, wasn’t in the mainstream Russian press but rather in the English language Moscow Times.

Fascination with rock stars notwithstanding, Russia is not the West. But neither is it dancing bears and balalaikas. It’s Russia.  And in 2011 that’s a complicated proposition -- even more so when it comes to healthcare issues.

One of the major problems is that its regulatory framework is still quite nascent. With senior government officials entering and departing public service at an alarming pace (and rarely of their own volition), there is a lack of continuity and predictability that makes working with the FDA look like predicting the tides.

Case in point is the Russian government’s recent decision to demand that, prior to licensing any new medicine, the sponsor company must conduct clinical trials in the Rodina. Nobody’s clear whether that means Phase III trials (which is probably the case), but the practical reality is that this edict prevents over 400 new medicines (both NMEs and dosage forms) from being introduced onto the market.

Is the government concerned about safety?  If so, what new safety information will additional clinical trials provide?  How large must these Russia-only trials be?  The government edict is unclear and nobody inside the Kremlin is willing to clarify. My sources tell me that multinational pharma wants to talk and wants to do the right thing – if they could only find someone to talk to and negotiate with.  Can this new regulation be prospective – allowing the pending drugs (that are all currently on the market in both the US and the EU) be given the green light and then have all future drugs incorporate domestic trials? Seems fair and logical – but there’s no one to sit in the chair opposite industry to discuss it.  Can a panel of Russian experts be asked to review the clinical trial results of these 400 pending products and offer their expert opinion as to their design and findings? That would be a good conversation – except that there’s no one to have the conversation with.

Everybody's shuffling on keeping a place in the line
Don't you think we're gonna make it
We've got a place in line
We're gonna make it some time
Somehow


From the Deep Purple song, Place in Line.

It’s also important to understand wither this new proto-regulation came from – it came directly from Vladimir Putin.  Nobody knows if the Russian Prime Minister is a Deep Purple aficionado, but no one has ever accused him of being a creature of the West.  His preferred methods and recent public remarks certainly do not reflect such attitudes. At the one meeting where representatives of the international pharmaceutical industry were able to discuss the clinical trial issue, the senior government official present said that industry “had made some good points.”

 

And the next day he was fired.  So much for constructive dialogue.

 

As Joseph Stalin commented after a particularly brutal purge, “Life is more joyous, comrades.” Translation – you could be next, so watch your step.

 

At dinner with a senior member of the Russian healthcare firmament, I was told that the most significant advance Russia has made in adopting a more science-based regulatory standard was that there are now “reasonable bureaucrats.” When I asked what that meant he responded, “It means people who have been in their jobs for more than five years.” Something to think about for FDA watchers who complain that too many people at the agency have been in their jobs for too long.  Be careful what you wish for.

 

One of the things the Russian government is wishing for is a more developed and robust domestic pharmaceutical industry.  To this end they developed a plan called “Pharma 2020” – except that it was developed without any real input from industry.  In other words, with (to be polite) limited expertise in this area, the government put a plan in place that prioritizes domestic pharmaceutical manufacturing over research and development.  Central planning of this sort proved less than successful when it came to tractors, it will be a disaster when it comes to sowing successful seeds for it’s own domestic “большая фармацевтическая продукция” (Big Pharma). The future for Russia is too important for it’s biotech future to be a gulag archipelago.

 

Industry was ignored – but why did they wait to be asked? Why didn’t all of the smart and savvy representatives of multinational Big Pharma sit down and design a model program and then share it with the government?  This time, alas, the problem cannot be blamed on the Kremlin’s lack of access.  Rather the problem is that there is no real industry body akin to PhRMA in Russia.  Best estimates are that, for all non-sales activities inside Russia, all the mutinational pharmaceutical companies spend under three million dollars combined.

 

For a nation with the potential of Russia and considering how much verbiage is regularly directed at the importance of this market, this is not a serious number. When it comes to Russia, industry efforts have not been nearly, um, Gudunov.

 

Stepping outside of Russia, the story, relative to international pharmaceutical industry engagement is just as bad if not worse. In Egypt, for example, last year non-sales spending was about $40,000 for the industry. Yes, combined.

 

Clearly there needs to be much better focus on organic chemistry.

 

In Russia and elsewhere, if industry wants to reinvent the process, they must actively and aggressively become a more important part of the process.  Current lack of funding for such efforts does not match up with the rhetoric of true globalization.

 

Feel it coming
It's knocking at the door
You know it's no good running
It's not against the law
The point of no return
And now you know the score
And now you're learning
What's knockin' at your back door

 

From the Deep Purple song, Knocking on Your Back Door.

 

Please pass the kvass.

  •  
Paul Offit at the NYAS!
  • Vaccines Under the Gun: Politics, Science, Media and the Law

    Monday, March 28, 2011 | 1:00 PM - 5:00 PM
    The New York Academy of Sciences

    Presented by the Vaccine Science Discussion Group

    Recent outbreaks of vaccine-preventable diseases (measles, 2008; mumps, 2009, meningitis, 2009; pertussis, 2010) have shown that as more children remain unvaccinated, community immunity has broken down. Several recent legal cases (CHOP vs Health Care Workers Union 1199, AFL-CIO; Bruesewitz vs Wyeth) have underlined the battle between the rights of the individual vs. the good of society. This half-day symposium examines historical approaches to vaccination, the evolution and use of the National Childhood Vaccine Injury Act, community-wide and personal safety considerations, social implications of these decisions, and the impact of recent arbitration, in this fast-evolving field, from a scientific, legal and social perspective.

    Networking reception to follow.

http://spectator.org/archives/2011/03/23/an-obamacare-anniversary-bridg

The Right Prescription

An Obamacare Anniversary Bridge

Last week Health and Human Services Secretary Kathleen Sebelius wrote an op-ed on the first anniversary of the ramming through -- I mean passage -- of Obamacare, proclaiming "Everyone prospers under health law." Unfortunately it appears that the real and immediate benefits only flow to those who play ball with unconfirmed Medicare/Medicaid administrator Donald Berwick to enact Obamacare before the 2012 election.

In that article Sebelius claims: "Just 12 months after the Patient Protection and Affordable Care Act became law, the American people are enjoying new protections, greater freedoms and lower costs."

Did anyone else miss all that, because I sure did. The new protections -- as we have heard ten million times from Obamacare supporters -- is that kids can stay on their parents' plans until they are 26 and no one can be dumped for pre-existing conditions. These are generally agreed to be good changes. But most adult children in America are already covered under existing state laws. That leaves less than 1 million people. As for pre-existing conditions? Queen Katherine claimed 129 million would be protected because that's how many people have pre-existing conditions (ranging from cancer to dandruff).

The real number? Closer to 650,000 according to House Democrats. Meanwhile only 280,000 people have signed up for coverage in federally funded insurance plans run by states for people with pre-existing conditions. The Grande Dame of HHS claimed 4-6 million Americans would prosper under this plan.

Sebelius claims "insurers are being held accountable for the way they spend consumer premiums. New rules require insurers to pay out 80 percent to 85 percent of premium dollars on health care and quality improvement efforts -- rather than marketing and executive bonuses."

The accountability is certainly there. It's just that the new rules have been -- what's the word -- waived so that millions of Americans won't lose coverage. And it's not just companies and unions seeking such "accountability." Maine got an exemption because Queen Kathy determined "the new federal spending requirement could hurt Maine's health insurance market." Now several other states with less than a dozen health insurers are following suit.

Halfway through her editorial, Sebelius exhausts her list of earth-shaking benefits (a new interactive website!) and looks into the future:

A family of four, making $55,000, could save more than $6,000 a year on health insurance in 2014. For a family making $33,000, those savings will be nearly $10,000 annually. For many American families, this means that health insurance will be within reach for the first time.

Not really. Only people who get a subsidy will see "savings" relative to the cost of insurance under Obamacare. That's about 7 percent of Americans -- about 13 million individuals, families, and single parents, many of whom already have insurance. Much of the subsidy goes to sicker and older people with the same income as healthier and younger heads of households. And as Keith Hennessey observes, 8 million Americans who make more than $44,000 a year would have to pay higher taxes, higher premiums, and receive no subsidy.

Which means that "within reach" boils down to pushing most of the uninsured into Medicaid. Sebelius promises she is willing to work with anyone to improve the law and fix what needs fixing, especially to control government spending on health care. But not when it comes to Medicaid. Many governors have asked the administration for a fixed amount of money for Medicaid in exchange for more of the "freedom" flowing like a mighty river under Obamacare. Instead, with months to go before he is forced to resign, Donald Berwick is working hard to expand Medicaid and he's spending money to do it.

Berwick won't say why money-saving block grants are off the table. Chances are he will be no more transparent about the deal he cut with California to fund its "Bridges to Reform" waiver (not to be confused with the "towering bridge" Berwick adores, otherwise known as the British health system). The waiver allows California to add 2 million people to the Medicaid program before 2014 -- and just in time for the 2012 presidential election.

Under this waiver, California gets an additional $10 billion over five years. Of that amount, $3.8 billion goes to hospitals under something called the Delivery System Reform Incentive Pool (longhand for slush fund). Another $3.3 billion goes to California' s uncompensated care fund (something that was supposed to disappear under Obamacare). Medicaid waivers are not supposed to add to federal Medicaid spending. But in this case, funding to expand coverage under the California waiver is uncapped.

Berwick will be sticking around long enough to turn on that federal spigot in addition to the $10 billion California gets for being first. Before he leaves it might be interesting to ask him and his soon-to-be ex-boss if Bridges to Reform -- an outright bribe on the order of the Cornhusker Kickback -- is an example of the kind of "anniversary gifts" Americans can expect under Obamacare.

Comrades!

 

I come to you live from the sixth annual Moscow International Congress on Biotechnology, where I have just given my presentation titled, “Biosimilars:  Safety or Savings?”

 

Here is a sampler:

 

The age of the blockbuster is over. Cost concerns are more challenging than ever. And we are struggling with what “personalized medicine” really means.

 

We are now in the era of post-patent medicine where advances in manufacturing and molecular diagnostics are as important as new molecular entities, and safety is as important (and as improvable) as efficacy.

 

The era of post-patent medicine is also the epoch of biosimilars.  But will biosimilars really be as important an element of change as many believe.  Will it be, as we like to say in the United States, a game changer?

 

I believe the answer is “yes,” but I am not sure whether or not all the changes will positively affect the advancement of the public health.  I fear the expectations that biosimilars will radically reduce costs are overstated. I fear that safety concerns are being understated and that the risks to innovation are real.

 

As Eli Lilly & Co. CEO John Leichleiter said, "Creating and maintaining the conditions for innovation to flourish is challenging and complicated work - work that is never finished.”

 

What is the place for Russia in all this?  Russia will certainly offer an attractive market for biosimilars and biobetters.   With millions of people, and tremendous unmet medical need, we can expect the uptake of quality biosimilar and biobetter products to be substantial, particularly if those products are available at a substantial cost savings, or offer additional therapeutic benefits.

 

But beyond the market potential, what about the role of Russia as a center for biosimilar and biobetter research and manufacture? 

 

I believe that Russia’s strong tradition in science and medicine offers a platform to both develop and produce these medicines – and potentially not only for its domestic market, but also for export.

 

Such a proposition is not without risks and it will be a complicated decision depending on a variety of local factors. One critical element will be an evolving regulatory framework.

 

To protect the health and safety of Russian patients and, moreover, if Russia hopes to export these medicines, a 21st century, state of the art, internationally recognized and harmonized regulatory system will be a fundamental requirement. 

 

No patient, whether in the USA, Europe or Russia, should be exposed to low quality, unreliable biosimilars or unproven biobetters. And no payor -- whether private or government -- should spend one kopek on uncertain products.

 

I understand that the Russian Health Ministry is looking at revising Russia’s biosimilar regulations to meet the highest international standards and I can think of few things that would be more in the interest of Russian patients or more firmly guarantee Russia’s investments and economic aspirations in this area.

 

Simply put, a good regulatory system is good for the public health and good for business.

 

There’s much more to share from my mission to Moscow (which runs through the end of this week). Stay tuned as I delve further into the state of healthcare in Russia – truly a riddle wrapped in a mystery inside an enigma.

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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