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.
Drugwonks
Drugwonks.com is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.
CMPI Second Annual Odyssey Award Gala
Date and Location:
Thursday, February 25, 2010
Cocktails: 6:00 pm
Hyatt Regency in Morristown, NJ
Dinner: 7:00 pm
Honoring:
Dinner Chairman:
New Jersey Governor Chris Christie
John F. Crowley, CEO, Amicus Therapeutics
BioInnovation Institute CEO Frank Douglas
Note: John Crowley’s life is the subject of the major motion picture "Extraordinary Measures", featuring actors Harrison Ford and Brendan Fraser.
To learn more or purchase tickets to the dinner, CLICK HERE
CMPI In the News
CMPI’s Robert Goldberg on America's Nightly Scoreboard Click Here
Peter Pitts Discusses economic
incentives for healthy living on Fox Click Here
CMPI’s Peter Pitts Talks with
Pixels and Pills at the FDA Hearings Click Here
Over a billion dollars for CER @ AHRQ ... but only $25 million to advance FDA's regulatory science.
The Pink Sheet Reports:
Gaining the expertise and infrastructure needed to assess products of the future - such as biosimilars and those based on stem cells and nanotechnology - is the goal of a $25 million scientific modernization effort proposed in the fiscal 2011 FDA budget.
The Advancing Regulatory Science Initiative (ARSI) is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.
The agency bills the initiative as the first major effort to address a 2007 FDA Science Board report that cited FDA's inability to keep up with scientific advances, such as those in biology and bioinformatics.
The Center for Drug Evaluation and Research plans to "establish regulatory guidance to provide a scientifically sound and safe pathway to better characterize and develop biosimilars," the agency says in supporting documentation for its budget.
ARSI, which FDA characterizes as a new program and an increase in budget authority, provides $2 million for the biosimilar effort. Another $3.7 million in carry-over balances from user fees will be used for the program.
As part of a $15.55 million increase for infrastructure, workforce and collaboration, ARSI includes money to prepare for reviewing products that utilize stem cells and nanotechnology.
With the removal in 2009 of the ban on federal funding for embryonic stem cell research, FDA "anticipates a significant increase in investigational new drug applications and biologics license applications for stem cell products during the next few years," the agency says.
In anticipation of that, ARSI gives the Center for Biologics Evaluation and Research $950,000 and five full-time equivalents to prepare for reviewing stem cell products (i.e., a therapy comprised of, or derived from, human cells, tissues or cellular or tissue-based products, and gene therapy products) as novel biologic therapies.
The FY '11 funds will allow CBER to develop and communicate guidance that provides agency expectations for pre-clinical studies, clinical trial design and regulatory policy. CBER also will work with the scientific community to develop analytic tests for characterizing stem cell products.
The largest chunk of ARSI is $7.3 million for nanotechnology regulatory science across the agency. CBER and CDER each will receive $475,000 and one FTE to participate in the effort.
The intent is to build laboratory testing capacity, develop and train staff in nanotechnology and conduct research into the character and safety of products. The latter will help FDA scientists as they review the benefits and risks of products, such as drugs delivered by nanoparticles to cancer cells.
Included in ARSI is a $4.45 million increase in funding for the Critical Path Initiative. The money will enable FDA to launch new projects for validating biomarkers, modernize and increase the efficiency of clinical trials; improve tools to predict product safety and effectiveness, including the use of information technology; and modernize toxicology studies.
FDA's documents do not provide a baseline figure for CPI, but includes it under the Office of the Chief Scientist (OCS), which is budgeted at a total of $29.59 million. Funding for CPI in the current fiscal year is $16 million.
The money also will enable OCS to staff the Office of Science and Innovation, which is being set up to serve as a core resource of scientific expertise in emerging areas. OSI was created in a reorganization implemented by Commissioner Margaret Hamburg in mid-2009 to improve the agency's scientific capabilities.
No, not the movie about our courageous friend John Crowley – the case of Amphastar v. Woodcock.
Back in August Amphastar was so unsatisfied with the way the FDA was dealing with their file for generic Lovenox, they decided to claim unfair treatment at the hands of CDER Director Dr. Janet Woodcock.
Amphastar claimed that its rival, Momenta, had a "leg up" and was getting "special access." And yet both companies were in the same place in the regulatory process and both companies are being asked for the same data sets. And this is unfair why?
According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.
Well, to nobody’s surprise, the inspector general of the Department of Health and Human Services has cleared Janet of all allegations of conflict of interest.
Not satisfied to acknowledge a boner of monumental proportions, Amphastar's general counsel, Jason Shandell, said that the FDA narrowly tailored its review to legal issues. "We never asserted she got any money—that would be illegal. Our focus was on the appearance of impropriety and its impact on the approval system.”
This week the British medical journal Lancet officially retracted an already discredited article it published by Andrew Wakefield which falsely claimed vaccines caused autism. (See how the journal was shamed into doing the right thing here.)
At the same time, President Obama increased the budget of the Agency for Healthcare Research and Quality (AHRQ) -- charged with developing information about what are the best and most cost-effective medical treatments --by $640 million, including money for anti-vaccine groups who regard Wakefield as a hero and push studies examining the effectiveness of treatments and diets based on Wakefield's study for reversing or curing autism.
AHRQ is the same agency that provided the United States Preventive Services Task Force (USPSTF) the data for recommending women under the age of 50 not get a regular mammogram. Before every major health group rejected the decision, the administration said the guideline was based on the "best available science."
Mentioned twelve times in the health bill, AHRQ states itsgoal is "translating research into improved health care practice and policy. " In fact, AHRQ was and is the administration's go-to agency for "bending the healthcare cost curve." Hence, in 2009 AHRQ's budget increased from $300 million to $1 billion for "comparative effectiveness research" (CER): studies looking at two or more treatments or a diagnostic for the same disease to see if one delivers equal or better results for the same amount of money. The studies would be used to create government guidelines for hundreds of medical treatments like the mammogram decision.
Proponents claim that CER helps doctors make better "patient-centered" decisions instead of one-size fits all recommendations. But AHRQ spends all its money making comparisons based on research -- as it did in producing the study recommending against routine mammography for women under 50 -- that ignores individual differences in patients.
So, for instance, in reviewing the "science" of mammography, AHRQ ignored "differences in outcomes among certain risk subgroups, such as women with BRCA1 or BRCA2 genetic susceptibility mutations, women who are healthier or sicker than average, or black women who seem to have more disease at younger ages than white women." As a result, the study only provided "estimates of the average benefits and harms."
That's why Nobel Prize winner and NIH Director Francis Collins who helped map the human genome worries that CERstudies are a step backwards because they consider "everybody equivalent, which we know they are not." Collins says that CER -- and AHRQ by extension -- fails to use "all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies."
Meanwhile AHRQ allows CER researchers to hand out money to each other.
For instance, Dr. Alan M. Garber of Stanford University has received millions of dollars of AHRQ grants over the years and is a member of member of AHRQ's panel for determining what evidence should be packaged into guidelines. Garber also advises Congress on what AHRQ should spend money on. HMO's also happen to operate CER research centers that get much of AHRQ's funding.
Dr. Mark Helfand -- who contributed research to the mammogram decision -- runs the Oregon Health & Science University Drug Effectiveness Review Project that receives millions from AHRQ each year. Helfand also directs AHRQ's "science" board for its CER program.
Sean Tunis, another AHRQ consultant also advised Congress on the AHRQ agenda. Tunis once said he never saw adequate evidence to justify paying for new medical technology.
AHRQ's involvement with anti-vaccine groups is also longstanding. It has given millions a year toConsumers United for Evidence Based Care (CUE) an organization that "advocates for local and federal legislative changes," in favor of CER. CUE includes groups like the Center for Science in the Public Interest and the National Center for Trangender Health. The anti-vaccine groups SAFEMINDS and the National Vaccine Information Center are also active parts of CUE.
CUE participants use CER to push their own political agenda with AHRQ help. In 2005 CUE coordinator Dr. Kay Dickersin (another AHRQ grant recipient) and transgender advocacy groups challenged Washington State's Medicaid program decision not to cover sex change operations. SAFEMindsused CER to claim that you couldn't rule out vaccines "causing" autism.
And now AHRQ is funding the NVIC/SAFEMINDS pet project that looks at the effectiveness of controversial and dangerous autism treatments such as chelation therapy, which have killed several children.
Given the deficit, AHRQ's budget should be cut, starting with is funding of outdated science, transgender advocacy and anti-vaccine movements. That would insure CER actually improved the public health.
You’ve certainly heard the old business saw, “Only half of my advertising works – now if I only knew which half.”
Now consider something of infinitely greater importance – government spending on healthcare.
Next year government programs will account for more than half of all dollars spent on U.S. healthcare spending. By 2020 about one in five dollars spent in the U.S. will go to health care.
Public funds accounted for 47% of the $2.34 trillion of national health spending in 2008, the last year for which figures are available. CMS estimates, in a paper to be published Thursday in the journal Health Affairs, that the proportion will rise to 50.4% by 2011.
Are we spending too much – or are we not spending it in the right way?
Much debate over what “too much” is – but very little argument that we need to spend more smartly. What does “smartly” mean? There’s the rub. Well, for starters, it must mean getting patients (aka “people”) on the best, most effective therapies as quickly as possible. It doesn’t mean forcing physicians to “fail first” on less expensive options. That’s not only contrary to the public health, it’s pernicious to the public purse. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
When it comes to healthcare spending and healthcare reform, we’d do well to remember the words of Winston Churchill:
“There are a terrible lot of lies going around the world, and the worst of it is half of them are true.”
Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, enthusiastic comments about a yet-to-be-approved anti-wrinkle injectable.
At first blush this seems like regulatory creep and cause for First Amendment agita. But it isn’t. This is not a case of the FDA trying to stifle unregulated speech by an individual without “interest.” Dr. Bauman is a clinical investigator for the product she’s been touting. That’s “interest” whether the trial sponsor paid her to do so or not. (In this instance, there was no “pay for play.”) In any case, it’s an unambiguous regulatory no-no.
According to FDA regulation (at 21 CFR 312.7(a)), "A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug."
No ambiguity there. No regulatory creep. Just good enforcement in an area of medicine that is all too frequently prone to hyperbole. This is not (IMHO) about the free and fair dissemination of scientific data -- or even an "interested" discussion thereof.
Alas, just as too many medical marketers misinterpreted the agency’s April 2009 letters on sponsored Google links to mean “we can’t use social media,” so too will many pharmaceutical MLR departments ( the “nabobs of no”) point to the Bauman letter as a reason to question the appropriate use of medical spokespeople. And the New York Times certainly does stoke the flames of such paranoia in its reportage. (See New York Times story here.)
My advice, read the letter before you get your panties in a twist about “doctors are being muzzled” or overly agitated that the FDA is getting ready to launch a full-frontal assault on physicians-as-spokespeople. Just read the regs – and stay away from the gray zone.
http://vaccineawakening.blogspot.com/ January 29, 2010 Statement by the National Vaccine Information Center on Dr. Andrew Wakefield and his research
The National Vaccine Information Center (NVIC) supports the past, present and future scientific research into the reported association between inflammatory bowel disease, developmental delays and vaccination in young children conducted by Dr. Andrew Wakefield and other physician scientists. Dr. Wakefield’s work to define the pathogenesis and etiology of chronic inflammation in the body that can affect brain and immune function is commendable. His work has led to biomedical interventions for children, who have become chronically ill and disabled after vaccination, to ease their suffering.
Research to better define the association between vaccination and chronic inflammatory disorders that affect brain and immune function should be given a much higher priority by government, industry and academia. Understanding the biological mechanisms for vaccine induced chronic inflammation in children and adults can help identify those at high risk for suffering vaccine reactions, injury and death and lead to adoption of safer vaccine policies.
http://www.the-scientist.com/community/posts/list/0/846.page "The Lancet today retracted a 1998 study by Andrew Wakefield and colleagues that, based on a sample of 12 children, claimed to have found a link between autism and the widely used MMR (measles, mumps, and rubella) vaccination. The paper induced a long string of correspondences published in the journal and stirred major controversy surrounding the vaccination.
10 of the paper's 13 authors had already acknowledged some of the problems with the paper, publishing a "retraction of an interpretation" in 2004. But the official retraction didn't occur until today, as a result of the Britain's General Medical Council's finding against Wakefield and two of his colleagues, who are at risk of losing their rights to practice medicine in Britain for their "unethical" methodology, and for describing the research in a "dishonest" and "irresponsible" way.
Given the fallout of the paper's claims, including a drop in vaccinations and a resurgence of measles, what measures must now be taken? Is a simple retraction enough, or is a published re-analysis of the data with a more accurate interpretation of the results necessary? Is losing their medical licenses in Britain a harsh enough punishment for Wakefield and his colleagues, or are more severe actions required?"
--Jef Akst, Associate Editor, The Scientist
Consumers United for Evidence-based Healthcare (CUE) is a national coalition of health and consumer advocacy organizations committed to empowering consumers to make the best use of evidence-based healthcare (EBHC). CUE, organized in 2003 when the USCC invited advocacy groups to join a consumer advocate-scientist partnership, is a pioneering effort to improve consumers’ ability to engage in and demand high quality healthcare.
Currently, the 27 member organizations represent: cancer, geriatrics, temporomandibular joint disorders, minority health, addiction, environmental health, lesbian, gay, bisexual, and transgender health, mental health, women’s health, and disabilities. The Coalition is committed to a representative membership that addresses the needs of AHRQ’s priority populations. As a result, CUE is an educated, diverse, and committed advocacy network.
CUE is a consumer advocate-scientist partnership. Initial funding from the Agency for Healthcare Research and Quality (AHRQ) has enabled the USCC to nurture CUE’s development and to provide a secretariat and staff. CUE is guided by an elected Steering Committee providing overall direction and policy and program development.
N.L. Premier Williams set to have heart surgery in U.S.
Kenyon Wallace, National Post
Keith Gosse
ST. JOHN'S, N.L. -- Newfoundland Premier Danny Williams will undergo heart surgery later this week in the United States.
Deputy premier Kathy Dunderdale confirmed the treatment at a news conference Tuesday, but would not reveal the location of the operation or how it would be paid for.
"He has gone to a renowned expert in the procedure that he needs to have done," said Ms. Dunderdale, who will become acting premier while Mr. Williams is away for three to 12 weeks.
"In consultation with his own doctors, he's decided to go that route."
Mr. Williams' decision to leave Canada for the surgery has raised eyebrows over his apparent shunning of Canada's health-care system.
"It was never an option offered to him to have this procedure done in this province," said Ms. Dunderdale, refusing to answer whether the procedure could be done elsewhere in Canada.
Mr. Williams, 59, has said nothing of his health in the media.
"The premier has made a commitment that once he's through this procedure and he's well enough, he's going to talk about the whole process and share as much detail with you as he's comfortable to do at that time," she said.
Ms. Dunderdale wouldn't say where in the U.S. Mr. Williams is seeking treatment.
A popular Progressive Conservative premier, Mr. Williams has also seen his share of controversy. During the 2008 federal election, Mr. Williams vehemently opposed the Conservative government, launching his "Anything But Conservative" -- which has been credited with keeping the Tories from winning any seats in the province.
He's also drawn criticism for his support of the seal hunt.
In his State of the Union address, the President implored Congress not to "walk away" from healthcare reform. With Scott Brown's victory in Massachusetts, and growing skepticism among Americans, passage of a "comprehensive" healthcare bill is looking less and less likely every day.
And for good reason. The House and Senate versions of healthcare reform are nearly 2,000 pages long. Some of the most expensive provisions in the bills are effectively unfunded and will indeed exacerbate our federal fiscal catastrophe.
The most egregious example of this reckless spending is the infamous "Doc Fix" provision, which determines how and how much the government will reimburse physicians for services provided to patients on Medicare and Medicaid. This provision is only a one-year patch -- with the cost offset by taxes and reduced spending elsewhere. What about the other nine years? That, it seems, is the purview of S.1776 and, according to a recent New York Times piece, "Congressional Democrats have no plans to offset the cost of S. 1776, which is why they are eager to keep it separate from the broader health care legislation and avoid breaking the president's promise."
Remember President Obama's promise? "I will not sign a plan that adds one dime to our deficits -- either now or in the future. Period." Well, it seems that many in Congress are looking at the "period" and seeing an ellipsis. The Times continues, "Congressional Democrats insist that fixing the doctor payment formula should not count toward the cost of the big health care legislation, because it is a problem they inherited." Unlike the problem of the uninsured? Unlike the problem of preexisting conditions? Unlike the problem of the donut hole? Unlike the problem of (FILL IN THE BLANK)? And from whom exactly did they inherit the problem? LBJ? Sounds like a total ellipsis of the sum.
Honestly -- a healthcare bill that doesn't include Medicare payments to physicians? As my kids would say: "Word." And to quote Representative Charlie Rangel, supporters of the pending legislation "have a serious problem." The Quinnipiac poll has only 34% of respondents approving the bill. Americans smell something fishy. And they're right. Americans are wondering just how healthcare reform is going to impact them. And now that the voting public is paying attention, they don't like what they see. Because what they're seeing is whose going to pay.
The most high profile debate is about the 40% excise tax on "Cadillac" health plans. But consider just two of the ways Democrats are suggesting the public "pay" for healthcare reform:
• 2.35% increase in Medicare payroll tax on incomes over $200,000 for individuals and $250,000 for couples.
• $471 billion in cuts to Medicaid.
You're not hearing a lot about either of these because they tax the middle class and gut healthcare options for senior citizens. Not core Democratic Party talking points. You're not hearing about it is because Democratic lawmakers are horse trading behind closed doors. And in case you've forgotten, during the presidential campaign candidate Obama pledged that any negotiations on healthcare legislation would be broadcast on C-SPAN, "so the American people can see what the choices are," and "not conducted behind closed doors." "Such public negotiations," he said, were "the antidote" to "overcoming the special interests and the lobbyists who… will resist anything that we try to do." To quote another American media icon, Madonna -- "Not." Americans aren't stupid -- and Americans are paying attention.
Can history repeat itself? When it comes to healthcare reform, let’s hope so.
The parallels are striking. A young, charismatic president. A “special address to Congress.” A time of national uncertainty.
Barack Obama on healthcare reform? No. John Kennedy on the space race. On May 25th, 1961, JFK intoned:
“Let it be clear--and this is a judgment which the Members of the Congress must finally make--let it be clear that I am asking the Congress and the country to accept a firm commitment to a new course of action--a course which will last for many years and carry very heavy costs”
Sound familiar?
“I believe that this nation should commit itself to achieving the goal, before this decade is out, of landing a man on the Moon and returning him safely to the Earth.”
And we did it. Even though the science and the engineering didn’t exist and the costs seemed prohibitive. We did it.
Can we do it again? Can we reform our healthcare system “before this decade is out? – even though it will certainly “last for many years and carry very heavy costs.” Do we have the national fortitude?
Yes we can. If we learn nothing from the current stalemate, it’s that healthcare reform is not going to emerge, fully formed from the head of Zeus (or Nancy Pelosi or Harry Reid or Peter Orszag – or Barack Obama).
Rather healthcare reform must be a thoughtful, iterative process. That’s not as sexy a political soundbite as “universal coverage” or “drug importation” – but it is reality. And those who ignore reality do so at their own peril. Hello Massachusetts.
In 1961, nobody in that joint session of Congress disagreed that we should put a man on the moon. Nobody shouted “liar” when the president presented his goals along with a detailed budgetary request – a behemoth $531 million in fiscal 1962 and an estimated $7-9 billion more over the next five years.
And there lies the biggest asymmetry between JFK’s challenge and President Obama’s September 9, 2009 Joint Session speech on healthcare reform – personal ownership and a detailed plan. Kennedy’s remarks followed a thorough investigation by an appointed Space Council chaired by Vice President Lyndon Johnson.
Just as with the issue of putting a man on the moon, healthcare reform is as much about vision as it is about engineering. In 1961 the pledge was made before the mechanics existed to make it happen. But that’s what challenges are all about. Reach. Stretch. Delta.
Similarly with healthcare reform, the promise must be made – all Americans must have access to quality and affordable healthcare. Healthcare reform is no different. The challenge is big and many of the tools are nascent (i.e., molecular diagnostics).
And, like the space race, the solution must be “elegant engineering” – a term that could hardly be applied to the current legislative packages passed by the House and Senate. Legislative sausage didn’t put a man on the moon. Neither will it deliver long-term healthcare reform.
Putting a man on the moon wasn’t about “good guys” (Democrats) wanting it and “bad guys” (Republicans) in opposition. And that’s not the case with healthcare reform either. The cynical politics of healthcare reform must end. All the more reason not to think about Scott Brown as the 41st vote against healthcare reform, but rather the first vote towards a new, more thoughtful approach.
Just a sampling of the desperation and self-confessionial screeds coming from liberal health policy "experts"
Ezra (Moment of the Mind) Klein:
That said, many are hoping that the State of the Union was the start, not the end, of Obama's renewed sales pitch. As I write, the president is in Tampa, making many of the same arguments, in much the same way, as he did last night. He sounds like he did on the campaign. He has more events scheduled in the next few weeks. It was a good beginning, say some on the Hill, but that's not enough.
Jonathan Cohn (giving it the " we just need to explain it more and better excuse")
Fortunately, Obama seems to grasp this too. He acknowledged, explicitly and with a sense of humor, his administration's failure to explain the plan--and noted that few people understand exactly what it would do. He also reminded people, in simple terms, of the reasons he took up the challenge. He talked about people suffering because they had no insurance or their insurance was inadequate--and he talked about the economic importance of controlling health care costs.
While Israel is making an effort to save life in Haiti, the never-happy-with-Israel crowd is trying this new line of over-sophisticated counter-intuitive argument: Haiti is easy, but what about Gaza.
Here's Derfner saying: "the Haiti side of Israel that makes the Gaza side so inexpressibly tragic. And more and more, the Haiti part of the national character has been dwarfed by the Gaza part". Here's the Electronic Intifada criticizing the media for its positive spin of this humanitarian effort: "A few media outlets have pointed out the discrepancies in Zionist self-congratulation". And the estimable NYT showing very little understanding of Israel's true feelings by claiming that "Israelis have been watching with a range of emotions, as if the Haitian relief effort were a Rorschach test through which the nation examines itself. The left has complained that there is no reason to travel thousands of miles to help those in need - Gaza is an hour away".
"Range of emotions" meaning what? that 99% support the effort and 1% complaining about Gaza? That 99% feel proud about this humanitarian effort and 1% feel the need to politicize even the simplest act of compassion and demonstrate, yet again, that they've lost their collective minds?
Anyway. Since this the why-Haiti-but-not-Gaza nonsense is gaining traction, maybe some reminders are necessary. Here we go:
1. Because Haitians never bombed Israeli towns.
2. Because the government of Haiti never declared that it wanted Israel to be eliminated.
3. Because no Haitian suicide bomber was caught trying to reach an Israel bus stop of cafe.
4. Because while Gazans' suffering should not be belittled, I don't remember any report claiming that 100,000 Gazans are dead because of Israeli blockade. Not even the Goldstone report.
5. Because it's easier sending rescue workers and doctors in uniform into a place in which Israelis in uniform are well received.
6. Because no Israeli soldier is being kept hostage in Haiti, and there's no standing Haitian demand for the release of hundreds of terrorists from Israeli jails.
7. Because Haiti had no way of stopping the earth-quake and the government of Gaza can easily make life better for its people by changing course.
If you're smarter than a fifth grader, I'm sure you can add many more such points. If you're smarter than a fifth grader you know that sometimes being too-smart is being stupid.
With the AFL-CIO opposing passage of the Senate health bill on account of the “Cadillac tax” and House members increasingly skittish in the wake of Scott Brown’s victory in Massachusetts, it appears unlikely the House of Representatives will pass the bill.
That said, it’s worth exploring the motivation behind the so-called Cadillac tax, which is one of the main obstacles to the health bill’s passage in the House.
Rep. Jerrold Nadler acknowledged the obvious absurdity of this Cadillac tax concept a couple weeks prior to the deal struck with Big Labor. Nadler said “The fact that premiums are higher does not mean that benefits are better.”
Duh.
Something far more sinister is at work here.
Patricia Murphy at Politics Dailynails it in just two paragraphs:
Despite the politically powerful unions that oppose it, the tax is enormously attractive to government economists because it both raises revenue -- $149 billion over 10 years -- and should depress the rate of health care inflation by discouraging companies from offering more generous health plans. The Joint Committee on Taxation and the CBO credit the tax as the largest factor in "bending the cost curve" and cutting the federal deficit, as Senate Democrats say the bill will do.
Christina Romer, a senior economic adviser to the president, predicted in October that the tax would encourage "both employers and employees to be more watchful health care consumers." But research released last week by Mercer, an employee benefits consulting firm, showed that in addition to considering lower-cost plans, two-thirds of companies polled said they would also raise health care costs for workers through higher co-pays and deductibles, regardless of whether the employee is a CEO or a line worker at a factory.
This is odd as we have been told to the point of exhaustion that insurance companies are shamelessly denying people health care as a matter of course all in the name of profit.
But that’s the dirty little secret – these so-called health reformers believe Americans consume far too much medical care. Of course they won’t come right out and say that for political reasons. Instead, they simply rail against insurance companies, the drug companies, and whatever other bogeymen they have created to pollute this debate.
This tax on “Cadillac” plans would create the groundwork for a situation whereby we all end up paying substantially more for health care but get appreciably less in services than that which we are accustomed.
It’s eerily similar to the Japanese health model. Insurance companies are heavily regulated. The Japanese pay unusually high co-pays, a large chunk of their insurance premiums (employers picking up the rest) and out-of-pocket health expenses for services not covered by the modest insurance plans.
This works to ensure more equality of medical treatment – but it’s sub-par treatment.
In this blog last year, I cited this 2007 Wall Street Journal excerpt:
While Japanese patients want American-style treatment, their policymakers are alarmed. With a huge national debt and corporations worried about higher taxes, they say Japan can't afford to pour money into treatments that can't extend life span by very much.
"America did too much of this and that's why their medical costs have grown," said Masaharu Nakajima, a surgeon and former director of the Health Bureau at the Ministry of Health, Labor and Welfare.
Since Japan enacted universal health insurance in the early 1960s, the emphasis has been on a minimum standard of care for all. People must pay a monthly health-insurance fee, and large companies pay also. Coverage decisions, doctors' pay, and other rules are set by the central government.
Japanese doctors complain that they have no time to spend with patients. The experience of seeing a doctor is summarized as "a three-hour wait for a three-minute visit."
“Minimum standard of care for all.” Those are the key words.
The commitment to "social justice" is driving this idea and not any commitment to sound health policy.
It’s hard to believe Americans in 2010 are prepared to give up their Cadillacs in exchange for Pintos.
The Washington Postreportson the deaths of 26 mentally-ill patients from hypothermia at one of Cuba’s largest hospitals.
The cause? Faulty windows and substandard care.
The Post notes:
“Communist Cuba provides free health care to all its citizens but, though the quality of its medical system is celebrated in leftist circles around Latin America, it is also plagued by shortages. Patients are expected to bring their own sheets and towels and sometimes their own food during hospital stays.”
Not to worry, the benevolent Cuban government has its priorities in order.
Cuba revealed last week that it has been lining up folks for sex-change operations at the government’s expense.
While Nebraska has been the target of much criticism and the central focus of the special deals that tainted the process of securing Senate passage of a health care bill, there are other states that received equally insidious protections.
A Drugwonks reader recently emailed me in an uproar about President Obama’s home state of Hawaii being on the receiving end of a special deal as well in the Senate bill.
Not giving the claim much credence initially, I looked into it and, lo and behold, she was right.
The Hawaii Reporterexplains the specific exemption in the bill:
“H.R. 3590 also includes a provision requested by Senator Akaka which preserves Hawaii’s system of employer-mandated health care. A large percentage of Hawaii residents have health insurance because of the state’s employer-mandated health care system which depends on a long-standing exemption from the Employee Retirement Income Security Act (ERISA). The Patient Protection and Affordable Care Act includes a provision that is intended to preserve Hawaii’s unique ERISA exemption and the employer-mandated insurance that the exemption enables.”
Hawaii has a law that mandates employers provide robust health plans to employees who work at least 20 hours a week. It is a law that has been on the books since 1974.
The Senate health bill has no such employer mandate.
This comment from Honolulu arbitrator and labor lawyer Michael Nauyokas stands out:
“We don’t need the feds to go in and mess up our system.”
One might argue the state of Massachusetts sent Congress that exact same message last week on behalf of the other 49 states.
Something that was ignored throughout the long ponderous, hollow debate over healthcare reform is clearly articulated by Jim Pinkerton:
"Healthcare is a great driver for the economy. It's the biggest employer, and medicine--not "health insurance"--is a product that people want to consume, sometimes desperately, ravenously. And not just Americans, but people around the world. So if that's not an economic engine, what is? Isn't that what we want?
But the argument has to be made. And alas, since, 98 percent of the discussion over healthcare has been over controlling costs--that is, shrinking the healthcare sector, perhaps provoking a recession in one of the few vibrant sectors of the economy--then it's little wonder that the country doesn't think of healthcare and medicine as an economic driver.
Serious Medicine Strategy has always been an economic strategy--now is the time to make that case."
The movie Extraordinary Measures chronicles the story and struggle of John and Aileen Crowley to find a treatment to save the lives of their two children, both of whom have Pompe Disease, an irreversible and rare disorder that prevents the body from breaking down glycogen (a form of sugar). Glycogen accumulates around the heart and skeletal muscles leaving children unable to walk or breathe on their own. I won't provide a movie review here since information about this new release is available everywhere, except to say that Extraordinary Measures is a family movie in two important ways.
First, it is a movie that parents and kids (13 and up in my opinion) can and should see together. It demonstrates the power of love and the determination parents have, even under the most dire circumstances, to provide children with hope and happiness each moment of their life. It shows that you can go up against and use the system to make a difference and that the "system" will invest in that risk and reward it. However the movie shows that making a miracle involves going against the grain, which is why meaningful change or advances take time. And the movie does the best job of explaining the interesection of capital, science, passion and faith the constitutes the process of biomedical innovation. A thoughtful, impactful movie about biotech and drug development? Extraordinary Measures is that and more because it ties the process of innovation to the ultimate purpose and people who benefit.
Second, the movie itself is the culmination of a process that has created a family of relatives, friends, supporters around the Crowleys. I was fortunate to have attended a post-movie reception that Geeta Anand, the gifted and gracious author of The Cure held in NYC yesterday. The group that gathered (including the Crowleys) -- including people involved in the movie, Geeta's literary agent (and mine) Joelle Delbourgo, former associates, etc. shared not only in the success of her book but in the spirit the book, the movie and the release of both have created: A sense that while anything may not be possible, nothing great happens without passionate intensity, friendship and cooperation and support of those you love. Such is the recurring source of hope.
Seeing the movie and reading The Cure will allow you to share in that experience. Few movies have been made to convey such a message. You read more about Extraodinary Measures and The Cure at the link below.
Let the big government types defend comparative effectiveness generated decisions that exclude and undermine the health of minorities... We are supporting a different, more compassionate and equitable approach...
Prospective Health Consortium: Development and Assessment of Predictive Tools in Disease Prevention and Wellness Promotion
A core mission of the Center for Medicine in the Public Interest is to spur approaches to the problem of chronic illness in medically underserved communities that are not “one size fits all” or based on studies that ignore clinical, behavioral and genetic variations in disease progression and treatment response. Our efforts build on the leadership and pioneering work of the National Minority Quality Forum in using data to map and identify these variations.
We are proud to support the launch of a consortium that would develop and evaluate a tool for health risk assessment and treatment selection based on predictive information relatively unique to that individual that can be used to reduce disease and promote wellness in medically underserved communities.
The idea of a consortium is based on discussions held in May at Brookings Institution at a meeting entitled “A Critical Path for Personalized Medicine”. That meeting -- chaired by Dr. Mark McClellan and Sir Michael Rawlins -- discussed ways to demonstrate how predictive or personalized medicine could be used to improve the quality of care and health outcomes. In particular, Ralph Snyderman MD, Chancellor Emeritus of Duke University Medical Center and CEO of Proventys, called for an evaluation of an tools bringing together the latest technologies to predict events and enable intervention before damage occurs. Combining personalized risk prediction and strategic health-care planning will facilitate what Snyderman calls ‘prospective health care’.
Maggie Mahar -- another liberal health care "expert" -- on why a bipartisan healthcare effort should not be pursued:
"Conservatives blame the sick for being sick, and they fault the poor for being poor. Health care reform must be compassionate, and it must be equitable."
