Desperate Measures

• 02.06.2010

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.”

Yeah, right. 

Talk about desperate measures.

Woe is AHRQ

• 02.05.2010

http://spectator.org/archives/2010/02/05/woe-is-ahrq


The Right Prescription

Woe Is AHRQ

By Robert M. Goldberg on 2.5.10 @ 6:07AM

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 its goal 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 CER studies 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 to Consumers 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. SAFEMinds used 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.

Half Nots

• 02.04.2010

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.”

Which “half” indeed?

Wrinkle, Wrinkle Little Star

• 02.03.2010

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.

Good catch DDMAC.

Disgraceful Support of Disgraced "Doctor"

• 02.02.2010

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. 
 

CUE Member Organizations:

• Annie Appleseed Project http://www.annieappleseedproject.org/
• Black Women’s Health Imperative http://www.blackwomenshealth.org/ 
• Center for Medical Consumers http://www.medicalconsumers.org/
• Center for Science in the Public Interest http://www.cspinet.org/
• Cherab Foundation http://www.cherab.org/
• Childbirth Connection http://www.childbirthconnection.org/
• Citizens for Health http://www.citizens.org/
• Citizens Health Alliance for Truth http://www.chatdc.org/
• Consumers Union http://www.consumersunion.org/
• Faces and Voices of Recovery http://www.facesandvoicesofrecovery.org/ 
• Lamaze International http://www.lamaze.org/
• Mautner Project, the National Lesbian Health Organization http://www.mautnerproject.org
• National Breast Cancer Coalition http://www.natlbcc.org/
• National Center for Transgender Equality http://www.nctequality.org/
• National Coalition for Lesbian, Gay, Bisexual and Transgender Health http://www.lgbthealth.net/
• National Consumers League http://www.nclnet.org/
• National Council on Aging http://www.ncoa.org/
• National Environmental Education & Training Foundation www.neetf.org/
• National Mental Health Consumers’ Self-Help Clearinghouse www.mhselfhelp.org/
• National Partnership for Women & Families www.nationalpartnership.org/
• National Vaccine Information Center www.909shot.com/

 

National Vaccine Information Center www.909shot.com/

Health Care You Can Always Count On

• 02.02.2010

Promises, Promises

• 02.02.2010

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.

Moon for the Misbegotten

• 02.01.2010

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 25^th, 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.

Liberal Healthcare Despair Watch

• 01.28.2010

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.

http://voices.washingtonpost.com/ezra-klein/2010/01/what_obama_did_and_didnt_say_o.html

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.


http://www.tnr.com/blogs/the-treatment

And my favorite from Senator Baucus

“We’re not going to put it down,” Baucus said. “We’re moving expeditiously. And expeditiously means quickly, solidly, thoughtfully.”

http://news.yahoo.com/s/politico/32191

Haiti Relief: Israel's Good Deeds Are Punished

• 01.27.2010

Rosner's Domain: The why-Haiti-but-not-Gaza nonsense

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.