Latest Drugwonks' Blog
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 SciencesPresented 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.
Philip Stevens, CMPI Senior Fellow, responds to an Oxfam report on dealing with the growing problem of counterfeit drugs in developing countries:
Read the full article here.
Oxfam's trademark confusion
Philip Stevens
10-Feb-2011
Counterfeit and substandard medicines in developing countries are becoming a critical problem. A report released by Oxfam earlier this month(1) claims to have the answers: stop treating fake medicines as an intellectual property problem, and do whatever it takes to bolster local regulation. Oxfam's diagnosis is only half-correct. Unfortunately, the same can't be said for its prescriptions.
Oxfam's main beef with current approaches to the problem the conflation in certain pieces of legislation of intellectual property issues such as patents with trademarks. Exhibit A is Kenya's 2008 Anti Counterfeiting Act, which was designed to protect Kenyan citizens from the increasingly ubiquitous counterfeit products that are flooding the local market, from fake tyres to dodgy toothbrushes.
While such products are not without their dangers and economic costs, a more pressing concern is the staggering proportion of counterfeit and substandard medicines circulating in the country, which recent studies have put as high as 38 per cent(2).
Proponents of the 2008 Act hoped it would finally put a floor under the plummeting quality of the country's medicine supply; as most physicians know, medicines that contain therapeutically sub-optimal levels of active ingredient can promote drug resistance and lead to clinical failure.
Oxfam's criticism of Kenya's anti counterfeiting bill is not without grounds: from a legal perspective, it is a badly drafted law that attempts to achieve too much. The bill defines counterfeiting as an intellectual property breach of a protected good, which can include "the manufacture, production, packaging, re-packaging, labelling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods."
In theory, this could outlaw well-made generic copies of drugs that are on-patent anywhere overseas. Seeing that the vast majority of drug patents are not registered in developing countries like Kenya, this could suddenly reduce the range of generic medicines available to physicians, undermining competition while doing little to address drug quality.
Oxfam's main beef with current approaches to the problem the conflation in certain pieces of legislation of intellectual property issues such as patents with trademarks. Exhibit A is Kenya's 2008 Anti Counterfeiting Act, which was designed to protect Kenyan citizens from the increasingly ubiquitous counterfeit products that are flooding the local market, from fake tyres to dodgy toothbrushes.
While such products are not without their dangers and economic costs, a more pressing concern is the staggering proportion of counterfeit and substandard medicines circulating in the country, which recent studies have put as high as 38 per cent(2).
Proponents of the 2008 Act hoped it would finally put a floor under the plummeting quality of the country's medicine supply; as most physicians know, medicines that contain therapeutically sub-optimal levels of active ingredient can promote drug resistance and lead to clinical failure.
Oxfam's criticism of Kenya's anti counterfeiting bill is not without grounds: from a legal perspective, it is a badly drafted law that attempts to achieve too much. The bill defines counterfeiting as an intellectual property breach of a protected good, which can include "the manufacture, production, packaging, re-packaging, labelling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such a degree that those other goods are identical or substantially similar copies of the protected goods."
In theory, this could outlaw well-made generic copies of drugs that are on-patent anywhere overseas. Seeing that the vast majority of drug patents are not registered in developing countries like Kenya, this could suddenly reduce the range of generic medicines available to physicians, undermining competition while doing little to address drug quality.
Read the full article here.
The spread of fear in advance of an evaluation of measuable and observable events colors health and science policy. It shapes what we fear and how we measure risk. In a perfect world, government agencies would provide a corrective to simply confirming the fear de jour or reinforcing a false narrative and of what causes illness.
Not so.
The article by Trevor Butterworth (see below) demonstrates how a presidential panel to evaluate cancer risks tries to re-direct research away from predicting and controlling cancer through gene-based and individualized treatment to research that reconfirms claims that all cancer flows from "toxins" in the environment include BPA. As Butterworth shows, what we fear is a collective and political choice that can run roughshod over facts.
www.thedaily.com/page/2011/03/21/032111-opinions-column-professors-butterworth-1-2/
The conflict over cancer
The best angle on the disease? Depends on whom you ask
“When I saw this new report,” said Sir Richard Peto, “I thought, ‘Poor President Obama, he deserves better advice.’” Peto is professor of medical statistics and epidemiology at the University of Oxford, and earned his knighthood for, among other achievements, calculating the incidence of cancer. The report in question was provided last April by the President’s Cancer Panel, an advisory body of experts which had concluded that the incidence of cancer caused by exposure to chemicals in the environment had been “grossly underestimated” by none other than Sir Richard Peto.
Even with its terrifying take-home message — a “come-hither” look to journalists if ever there was one — the Cancer Panel report sank faster than the Titanic, largely because the American Cancer Society agreed with Peto and ripped the panel for treating a shopworn hypothesis as a startling new fact. For all the bluster, the president’s would-be counselors couldn’t provide any statistical data to support their claims.
None of this has stopped the current issue of the New England Journal of Medicine from weighing in with a “perspective” piece on the whole affair by David Christiani, M.D., MPH, who holds positions at both Harvard’s School of Public Health (in the environmental health department) and at its medical school. Christiani disagrees with Peto and takes the report very seriously indeed, believing it warrants an entire rethink of America’s cancer prevention strategy, which — bottom line — means we should spend more researching the environmental causes of cancer.
Every dispute about our health is now a game of “Rock ’Em Sock ’Em Professors,” so let’s rate our fighters’ form:
Back in 1971, plain old Richard Peto joined Sir Richard Doll at Britain’s Medical Research Center, one of the world’s pre-eminent independent scientific institutions, where Doll had conclusively demonstrated a link between smoking and lung cancer. Both men went on to set up Oxford University’s Clinical Trials Unit, a research colossus for epidemiology and statistical analysis. In the early 1980s, they calculated the leading causes of avoidable cancers in the United States, estimating that occupational and environmental exposures accounted for just 4 to 6 percent of all cancer cases.
How good was Doll? He contributed a staggering amount to medicine, including fundamental work in assessing the risk from asbestos, radiation, and the benefits of taking aspirin to ward off heart attack.
How good was (and is) Peto? As Doll’s obituary in The British Journal of Cancer noted, “Although recognized as a good statistician himself, he placed great importance on working with the best available in the field.” Eugene Braunwald, Hersey professor of medicine at Harvard, who is widely considered the pre-eminent cardiologist of our time, has described Peto as “the best statistician in the universe.”
The genius of Doll, plus Peto squared to the power of Braunwald, is not a guarantee of truth, of course. But it presents a powerful warrant: The probability that their calculations on environmental cancer are wrong would have to be justified by, at the very least, a comparable deployment of statistical genius.
And this is where the President’s Cancer Panel simply didn’t bother showing up. Far from being “the Mount Everest of the medical mainstream,” as New York Times columnist Nick Kristoff claimed, it appeared to rely on those who peck in the molehills of conspiracy, including Devra Davis, author of “The Secret History of the War on Cancer,” which was pilloried in The Lancet by the director of the International Agency for Cancer Research, Peter Boyle: “with so many important factual inconsistencies in dealing with areas with which I have some familiarity, I start to have concerns about the factual accuracy in the areas I do not know so well.” (The panel, by the way, did not invite anyone from the International Agency on Cancer Research to participate in its meetings.)
It’s hard not to give the two Sir Richards victory by default.
“The particular reasons they gave for dismissing our work were ridiculously incorrect,” said Peto, after I emailed him for his thoughts. “As far as I’m concerned, the only estimates I’d change much from what we wrote 30 years ago is that instead of attributing 30% of 1978 US cancer deaths to smoking, I’d attribute 33% of 2005 US cancer deaths to smoking, I’d approximately double the risk we attributed to ionizing radiation (to reflect the improved understanding of the hazards of domestic exposure to radon … and I’d be even more definite about the importance of chronic infection than we were in 1981.”
By establishing the leading causes of cancer, Doll and Peto have, in effect, guided the world’s research priorities and spending on cancer. It is little wonder, then, that those who want more money to research environmental causes have to contend with the problem that what they do just isn’t very important in the grand scheme of disease priorities. And not being important, at a time of government cutbacks in research, means less money, not more.
Sunshine? More like dense clouds.
HHS/CMS is holding a conference call on the implementation and potential expansion of the Physician Payment Sunshine Provision of the Affordable Care Act, entitled “Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.” As CMS noted, “It is seeking stakeholder input on a number of topics defined in the statute.” Those include:
- Comments on additional forms and natures of payment and transfer of value to be considered by HHS.
- Accessibility to and usability of the reported data by consumers.
- Mechanisms for accurate, efficient, and cost-effective reporting of data. 
Here are the details for the call:
Date: Thursday, March 24, 2011
Time: 2:00PM - 4:00PM EST
Number:
Conference ID: 51513526
** Capacity is limited so dial in early. You may begin dialing into this forum as early as 1:45PM EST. **
Submit additional thoughts or feedback following the session to an email address established for this purpose: physiciansunshine@cms.hhs.gov.
Be there or be square – as in squarely in the crosshairs of the COI Polloi. (COI = Conflict of Interest).
According to the HHS/CMS announcement, “The Physician Payment Sunshine Act has the potential to bring about a systemic shift in the health care industry, with government taking a larger role in care of patients.”
Just what everyone (and by “everyone,” I mean “the American public”) fears – “government taking a larger role in care of patients.”
If you go back and look at all the rhetoric surrounding this particular piece of legislation, you will not find a call for “government taking a larger role in the care of patients.”
But, per the good folks in the Humphrey Building, this law certainly does have the potential for significant and severe mission creep. And that’s where it’ll be headed unless we all start paying attention.
And the first person to be queried on this is Senator “Sunshine Charles” Grassley. Is this what he intended? Here’s what he said, “"Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships."
Nothing there about “government taking a larger role in the care of patients.”
Further, since this conference call is being advertised as an “open door,” perhaps it’s time to open the door to a discussion about the incentives physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?
If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
Who’s pure and who isn’t? Here’s the answer – nobody is 100% pure. Not even Ivory Soap is 100% pure – and it floats!
In the February 7, 2009 edition of The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research and the pharmaceutical industry are artificial at best -- and dangerous at worst. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
His main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism." It's what's in the best interest of the patient.
The thought of expanding the Sunshine Act to faciliate "government taking a larger role in the care of patients" is an unsunny proposition indeed.
Not to mention an inappropriate one.
Once again, life expectancy in the United States climbed from one year to the next. With 2-3 sobering exceptions, age adjusted death rates for the 10 leading causes of diseases declined for all Americans, regardless of sex, race or age. As the population grew, the number of people dying fell.
At the same time, the number of people being diagnosed and treated for such illnesses as diabetes, cancer, heart disease, respiratory conditions increased. All this has happened even as the number of people without health insurance has declined
The math is simple. More diagnosis and treatment -- largely medicines -- leads to less death and increased life expectancy.
There are some disturbing exceptions. The number of people dying from Alzheimer's continues to climb. The death rate for male African Americans between the ages of 30-45 actually rose. And the number of suicides and the suicide rate among teens increased, even as the rate of diagnosis remained the same.
The difference? Anti-depressant use among male teens declined. Medication use among African-american males between the ages of 18-44 has hardly budged from 1988-2008.
Better health depends on increasing the number of people diagnosed with illness who take medications regularly.
At the same time, the number of people being diagnosed and treated for such illnesses as diabetes, cancer, heart disease, respiratory conditions increased. All this has happened even as the number of people without health insurance has declined
The math is simple. More diagnosis and treatment -- largely medicines -- leads to less death and increased life expectancy.
There are some disturbing exceptions. The number of people dying from Alzheimer's continues to climb. The death rate for male African Americans between the ages of 30-45 actually rose. And the number of suicides and the suicide rate among teens increased, even as the rate of diagnosis remained the same.
The difference? Anti-depressant use among male teens declined. Medication use among African-american males between the ages of 18-44 has hardly budged from 1988-2008.
Better health depends on increasing the number of people diagnosed with illness who take medications regularly.
---FOR IMMEDIATE RELEASE---
What if . . .
Iron Lung Foundation Launches "Just Say No To Vaccines" Campaign
New PSA Communicates "Let Nature Take Its Course" Message
NEW YORK (March 17) -- The Iron Lung Foundation is encouraging parents to "Just Say No To Vaccines" with a PSA launched on its YouTube channel.
"Parents should know they are not alone in not immunizing their kids against measles, whooping cough, polio and other illnesses and that living a natural lifestyle in the long run is the best way to keep children healthy," said Eleanor Delano, the Foundation's director of new media.
The PSA features a Manhattan mom with her proudly unimmunized child sitting on her lap . . . with a cough strangely reminiscent of whooping cough.
According to Ms. Delano, "Everyone can see that the child has pertussis and the sky didn't fall. We produced this PSA to show everyone that 'natural' immunity to infectious disease is nature's way. It's part of living a life in harmony with the planet."
To view the Iron Lung Foundation's new PSA, click here:
http://www.youtube.com/watch?v=73oCFzZr8Tg.
###
But honestly -- for more information on the danger of denying the safety and value of vaccines, please contact the Center for Medicine in the Public Interest (www.cmpi.org). President Peter Pitts can be reached at peter.pitts@cmpi.org or (212) 417-9169. Vice President Bob Goldberg can be reached at robert.goldberg@cmpi.org or (212) 417-9169.
BioCentury reports:
Part D negotiation bill introduced
Here we go again.
Remember black and white television? Remember when “cable” meant “telegram” and “fax” meant the opposite of “fiction?” Remember when watching a Fox network might get you slapped in polite company and you wore white gloves to a tea party?
“Back in the day” (as my wonderful children would say), “earned media” meant ink (as in “coverage”). And success was measured by “impressions.”
Today, “earned” means “trusted.” And it’s complicated.
In the good old days there were three ways to communicate a brand message: (1) Bought (as in purchased advertising in its various and sundry forms), (2) Owned (annual reports, brochures, sales materials, inter-office communications, etc.), and Earned (that traditional deliverable of the public relations professional), largely done by talking with journalists, by “pitching” them on a story.
Today, bought still means bought. Owned still means owned. But earned means something different. Today “earned” must be considered largely in the context of interactive, real time, opinionated, snarky, and hugely influential social media.
Today earned media is only partially about attracting the attention of the Fifth Estate and mustn’t be primarily measured by “gross impressions.” Today the “New Earned” is measured by its utility for and impact on multiple levels of influencers. Much more difficult to achieve and measure but, when done right, with far more important implications.
And the only way to engage with influencers credibly is to have something interesting to say that adds to their body of knowledge. Contact for the sake of "face time" is deleterious as it defines you as unimportant. Impact with influencers happens when what you have to share is to their benefit -- not yours. And that requires a level of focus, acumen and honesty that is always hard and often lacking.
That denizen of Twitter, Ashton Kutcher, opined that, “Social media is for entertaining. So be entertaining.” While this may be true in his demimonde, the truth is different for health care where the rule of thumb should be that “Social media is for educating. So become a trusted source.
How? Add value. Participate in social media to achieve marketing goals? Sure. But primarily to advance the public health. Or don't bother. The "New Earned" presents regulated industry with a powerful (albeit uncomfortable) opportunity to be First Among Equals. But that position must be, well, earned through active, lively and regular participation.
How to corral and conquer the New Earned? Become a 21st century NEJM -- The New Earned Journal of Medicine. Or find yourself a cozy little corner on the communications dust heap of history.
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.
