Mitt Happens

03/27/2009 12:08 PM |

From today's Wall Street Journal:

Praise Mitt Romney. Three years ago, the former Massachusetts Governor had the inadvertent good sense to create the "universal" health-care program that the White House and Congress now want to inflict on the entire country. It is proving to be instructive, as Mr. Romney's foresight previews what President Obama, Max Baucus, Ted Kennedy and Pete Stark are cooking up for everyone else.

In Massachusetts's latest crisis, Governor Deval Patrick and his Democratic colleagues are starting to move down the path that government health plans always follow when spending collides with reality -- i.e., price controls. As costs continue to rise, the inevitable results are coverage restrictions and waiting periods. It was only a matter of time.

They're trying to manage the huge costs of the subsidized middle-class insurance program that is gradually swallowing the state budget. The program provides low- or no-cost coverage to about 165,000 residents, or three-fifths of the newly insured, and is budgeted at $880 million for 2010, a 7.3% single-year increase that is likely to be optimistic. The state's overall costs on health programs have increased by 42% (!) since 2006.

Like gamblers doubling down on their losses, Democrats have already hiked the fines for people who don't obtain insurance under the "individual mandate," already increased business penalties, taxed insurers and hospitals, raised premiums, and pumped up the state tobacco levy. That's still not enough money.

So earlier this year, Mr. Patrick appointed a state commission to figure out how to control costs and preserve "this grand experiment." One objective is to change the incentives for preventative care and treatments for chronic disease, but everyone says that. It sometimes results in better health but always more spending. So-called "pay for performance" financing models, on the other hand, would do away with fee for service -- but they also tend to reward process, not the better results implied.

What are the alternatives? If health planners won't accept the prices set by the marketplace -- thus putting themselves out of work -- the only other choice is limiting care via politics, much as Canada and most of Europe do today. The Patrick panel is considering one option to "exclude coverage of services of low priority/low value." Another would "limit coverage to services that produce the highest value when considering both clinical effectiveness and cost." (Guess who would determine what is high or low value? Not patients or doctors.) Yet another is "a limitation on the total amount of money available for health care services," i.e., an overall spending cap.

The Institute for America's Future -- which is providing the intellectual horsepower (we use the term loosely) for reforms like those in Massachusetts -- argues that the cost overruns prove the state must cap how much insurers are allowed to charge consumers and regulate their profits. If Mr. Patrick doesn't get there first, that is. He reportedly told insurers and hospitals at a closed meeting this month that if they didn't take steps to hold down the rate of medical inflation, he would.

Even the single-payer cheerleaders at the New York Times have caught on to this rolling catastrophe. In a page-one story this month, the paper reported on the "expedient choice" that Mr. Romney and Democrats made to defer "until another day any serious effort to control the state's runaway health costs. . . . Those who led the 2006 effort said it would not have been feasible to enact universal coverage if the legislation had required heavy cost controls. The very stakeholders who were coaxed into the tent -- doctors, hospitals, insurers and consumer groups -- would probably have been driven into opposition by efforts to reduce their revenues and constrain their medical practices, they said."

Now they tell us. What really whipped along RomneyCare were claims that health care would be less expensive if everyone were covered. But reducing costs while increasing access are irreconcilable issues. Mr. Romney should have known better before signing on to this not-so-grand experiment, especially since the state's "free market" reforms that he boasts about have proven to be irrelevant when not fictional. Only 21,000 people have used the "connector" that was supposed to link individuals to private insurers.

Which brings us to Washington, where Mr. Obama and Congressional Democrats are about to try their own Bay State bait and switch: First create vast new entitlements that can never be repealed, then later take the less popular step of rationing care when it's their last hope to save the federal fisc.

The consequences of that deception will be far worse than those in Massachusetts, however, given that prior to 2006 the state already had a far smaller percentage of its population uninsured than the national average. The real lesson of Massachusetts is that reform proponents won't tell Americans the truth about what "universal" coverage really means: Runaway costs followed by price controls and bureaucratic rationing.

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Physician Empowerment: No Good Deed Goes Unpunished

03/27/2009 02:37 AM |

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Fighting Wolverines Fight Prostate Cancer

03/26/2009 02:01 PM |

With all the brouhaha over the relative efficacy of prostate cancer screenings, you'd think the media would be watching for some really important news -- like a biomarker that could change the whole paradigm.  Alas, the MSM seems to have missed the story entirely.  Not shocking, but nevertheless disappointing considering the play they gave to the cost-effectiveness angle just last week.

But drugwonks won't let that happen

According to researchers from the University of Michigan, a newly identified marker for prostate cancer progression may also offer a new target for treatment. Previous research has found that decreased levels of the marker galectin-3 are linked with neoplastic progression in prostate cancer. However, increased levels of galectin-3 are believed to be associated with tumorigenicity in a number of other tumor types.

The University of Michigan team believed this difference was due to the fact that galectin-3 was cleaved during prostate cancer progression. Their study found that cleaved galectin-3 is present in a late-stage prostate cancer and that reducing levels of galectin-3 inhibited development of metastatic prostate cancer.The findings suggest that cleaved galectin-3 may serve as a diagnostic marker and treatment target for prostate cancer progression.

The study shows "that galectin-3 is cleaved during the progression of prostate cancer and might be associated with metastasis, cell growth and tumorigenicity. Expression of intact versus cleaved galectin-3 thus might be used as a marker for prognosis of prostate cancer and a therapeutic target for the treatment of prostate cancer," wrote study author Avraham Raz and colleagues.

Go Wolverines!

The study appears in the April issue of The American Journal of Pathology.

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BIGT Changes for Nice?

03/25/2009 07:45 PM |

Our Congress is confiscating bonuses and the administration is set to limit executive pay. It is launching a Medicare Part D benefit that limits access to new medicines based on price and one size fits all comparative effectiveness...

Meanwhile in the UK, the government seems to be finding a way to keep it's biotech industry and the patients who depend on it alive before it's too late:

Click Here to Read More
 
Grim Outlook For UK Biotech Industry
Mar 11, 2009
By: Sarah Houlton

One-third of publicly owned UK biotechs have less than six months’ money left in the bank, and just 0.2 percent of the London Stock Exchange is now made up of biotech companies. “A new approach to funding is needed to fill the gaps left by investors,” claims Aisling Burnand, chief executive of the BioIndustry Association.

“We are faced with a very different world than we were a few years ago,” says Bioscience Innovation and Growth Team chairman Sir David Cooksey. The BIGT just released Bioscience 2015, an industry report designed to map out the market for the next six years.

First released in 2003, the report had been written to look forward 12 years and forecast where industry would be. In this revised and refined report BIGT has have lowered its sights.

The main problem, Cooksey claimed, is that investors simply do not see enough reward to justify the risk in putting their money into the sector. “There are hurdles in the way such as NICE and the EU clinical trials directive, which has been more stringently applied in the UK than in other countries,” he says. “We have to change the balance.”

This drying up of finance for biotechs is a real problem. “Biotech companies have not given good enough returns to investors to make them want to come back. Private sector angels, venture capitalists, and public markets have all turned away. We need to make it more attractive, and then I have no doubt that as the extra funding is rolled out we will get the situation where there is more participation in terms of the public sector.”

However, Cooksey does not believe that a large investment by government is the right way ahead, in contrast to the demands made by Sir Chris Evans and a group of his fellow venture capitalists at the end of last year. “We’ve not said, ‘Let’s have $1 billion in [government] funding,’” he claims. “If you look at history, governments putting a lot of money into technology development with civil servants picking the winners has not had much success.” Rather, they are looking for regulatory help and enhancements to the existing R&D tax credit scheme to encourage pharma companies to invest in biotech.

He believes that if Big Pharma were given more confidence in the biotech sector and had a more collaborative involvement at an earlier stage, it should give investors more confidence, too. “We are looking for real support from government to put a regulatory environment in place that will be effective in the longer term,” he adds. “We need to look at how to change the drug development pathway, use modern techniques to make it cheaper, faster and safer—it’s currently unnecessarily expensive. We are in danger of it no longer being worth a company’s while [to get into drug discovery] as they will never get to be able to sell a product at the price they need and which is also acceptable [to the payers].”

However, he says, this cannot be done by the UK on its own—it will have to involve the EU and the FDA, too. “Changes in the global regulatory system will take time and effort,” says serial entrepreneur and former BIA chairman Simon Best. “In the past four or five years, the sector has fallen out of favour. If we can do more work using modern tools such as genetics and genomics, and run smaller, better focused trials, it will be a reduced ask for investors.”

There is also the suggestion of allowing patients to receive drugs for life-threatening diseases after Phase II trials on a conditional licensing basis. “Hopefully safety issues would be flagged up more quickly, and the poor uptake of innovative drugs could be addressed,” Best said. “We want to see more pivotal trials carried out in the EU, maybe allowing conditional licenses while still doing Phase III trials in the US. This would allow us to address safety issues much earlier, and identify which patient populations could most benefit—or would most likely to have problems. I’m not convinced that post-marketing surveillance is the way ahead.   Read More & Comment...

The Other Sweet 16

03/25/2009 12:20 PM |

We’re all used to state AGs suing drug companies for inappropriate promotion of off-label indications (Neurontin comes to mind – among others).  Now there’s an interesting new wrinkle.

16 state Attorneys General (Oklahoma, Alaska, Utah, Iowa, Colorado, Kansas, Maine, Missouri, Nebraska, New Mexico, North Carolina, Rhode Island, South Dakota, Texas, West Virginia, and Wyoming) have written to Abby Black (Director, Center for Drug and Health Plan Choice at CMS) to complain that Part D participating insurance companies are requiring that their customers fail on a variety of off-label therapies before they will be reimbursed for medicines that have the more appropriate, on-label indication relevant to their particular conditions.

The AGs write, “Just as it is inappropriate for pharmaceutical companies to market drugs for off-label uses, it is equally inappropriate for health insurance companies to refuse to reimburse for physician-prescribed medications unless a patient first undergoes treatment with drugs that are off-label. … This practice of requiring treatment with an off-label drug before reimbursing a patient for using a drug approved by the FDA for that specific condition subverts the legislatively mandated approval process for drug indications by substituting the judgment of health insurance companies for that of the FDA. It undermines the doctor-patient relationship by empowering health insurance companies to make broadly applicable medical decisions best left to a physician considering the needs of a specific patient. This “one-size-fits-all” insurance-company mandate is inappropriate and dangerous.”

 

Many issues here – particularly the validity of the FDA label for anything post Wyeth v. Levine – but an equally important question is when is off-label not off-label? At present, the answer seems to be; when it's on-formulary and off-patent.

 

Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).

Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia.  In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin.  None of these three agents are approved by the FDA for the treatment of fibromyalgia.

But they are less expensive than the on-patent, on-indication product.  So what we've got here is step-therapy based on off-label usage.  Not unheard of, certainly, but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances.  (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)

The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.

So here's where we stand:  Off-label use of on-patent medications is bad, but off-label use for generics is good.  Translation:  off-label use is good when it saves the payer money.

Here’s how the Sweet 16 end their letter to CMS:

“Insurance company requirements that patients utilize off-label treatments before being reimbursed for FDA-approved treatments are dangerous and should not be permitted.  The same policy considerations that support a ban on off-label marketing by pharmaceutical companies support the prohibition of this insurance company practice.”

 

Here is the complete letter to CMS.

 

Are you paying attention Mr. Waxman?

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Drug Spending Slows and Cost Sharing Climbs. Is There A Connection?

03/25/2009 02:15 AM |

Patient Cost-Sharing on the Rise: Results from the
Benefit Design Index
By Melinda C. Haren, RN; Kirk McConnell

The cost of employee health coverage continues to grow faster than inflation,1 putting additional economic pressure on employers ...

American Health and Drug Benefits

Cost sharing of Rx is climbing faster than premiums AND inflation....drug spending is falling.  We know that compliance falls and disease burdern increases as a result.  

Meanwhile insurers diddle about reimbursing for personalized medicine which is very cost effective and product ...

The Economic Impact of Personalized Medicine: Genetic Testing in Metastatic Colon Cancer May Save $604 Million Annually
By Caroline Helwick

So much for controlling health care costs.
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To Sir, with Love

03/23/2009 03:35 PM |

Well, if not love then at least respect.  Significant respect.

I had lunch today with Sir Michael Rawlins (Chairman, National Institute for Health and Clinical Excellence) in his office today.  Finger sandwiches were served – but the conversation was meaty.

Rather than sharing any particulars of a private conversation (Chatham House rules, you know), I will say that we were of a mind on many things -- not the least of which is the need for better tools for clinical effectiveness research.

My only “ask” was for Sir Michael to consider traveling to the U.S. to speak at a Center for Medicine in the Public Interest conference on the future of clinical effectiveness.  He readily agreed.

Watch this space for more details.

While waiting in the NICE lobby, I picked up a brochure entitled, “How to Change Practice.”  There is much in it to debate, but one thing must be stipulated – the quote at the bottom of page 4:

“Change is not made without inconvenience, even from worse to better.”

The words (via theologian Richard Hooker, 1554-1600) are right, but it’s frightening that NICE should choose to quote from Hooker, who is (arguably) best known for his belief in the doctrine of “Justification by Faith.”

But I digress.

In the meantime, have a look at this new op-ed (from the Newark Star-Ledger), "President Obama, health care and "comparative effectiveness research."

Here are the concluding paragraphs to whet your wonkish appetite:

“Another way to make sure comparative effectiveness research is used properly is to follow the Food and Drug Administration's lead in creating a Critical Path Initiative for CER. The FDA's current Critical Path Initiative aims at using the latest scientific advancements to modernize the process through which treatments are turned from laboratory discoveries into useable medical technologies.”

“This model would be just as helpful in creating a modernized comparative effectiveness research program. By utilizing the most up-to-date scientific knowledge, treatment potency could be assessed in a manner that gives the utmost attention to the genetic, clinical, and demographic factors that affect how different patients react to different treatments.”

“President Obama is right to see the potential benefits associated with comparative effectiveness research. As he moves forward with his plan, however, it's imperative that he also be aware of the serious risks that this research poses.”

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Blumenthal's Soros Connection

03/20/2009 06:07 PM |

Why did all the press releases about David Blumenthal, who will run the health IT shop over at HHS, ignore the following:

Blumenthal is also head of an organization called The Institute on Medicine as a Profession (IMAP) which according to it's website "aims to set forth a vision for professionalism in the 21st century and to promote that vision through research and policy initiatives. "

IMAP received a $7.5 million grant from George Soros who made his money in part from wrecking currencies. IMAP is part of a new venture called The Prescription Project, which is funded by Community Catylst, which in turn is funded by the same group that funds the liberal Families USA which also receives money from Soros. The Prescription Project is being funded by the Pew Charitable Trust to the tune of $6 million but is also linked to the Prescription Access Litigation Project through its affiliation with Community Catalyst. That project is comprised of the largest tort lawyers suing drug companies for a variety of reasons.

The Prescription Project is designed to end companies from having any contact with doctors or patients whatsoever. As the project notes: "Public and private payers spend billions of dollars a year on prescription drugs. When these payers rely on information from industry marketing campaigns rather than unbiased scientific studies, the result is higher cost and poorer quality."

Maybe we will only connect to doctors by computer using messages screened for commercial content and judge consistent with materials produced by the Federal Comparative Effectiveness Coordinating Council.
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Run Jesse Run!

03/20/2009 12:48 PM |

Jesse Goodman, the well-respected CBER director is getting a new job.  Actually, two new jobs.  He’s been promoted to be FDA’s Chief Medical Officer and will also serve (as the agency’s only representative) on the Federal Coordinating Committee on Comparative Effectiveness – where his ability to think big, think smart, and think fast will be a tremendous asset.

Jesse is a smart guy, a nice guy, a key player in the FDA’s Critical Path Initiative – and a heck of a tennis player.

It's good news for Dr. Goodman -- and better news for the public health.

Congratulations Jesse. 

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The Sharfstein Shudder

03/19/2009 12:26 PM |

Unnamed "lobbyists" say one thing -- I say, let's give the guy a chance.

Here's what CongressDaily has to say:

Drug industry is wary of Obama's pick for FDA deputy

By Anna Edney, CongressDaily

Food, pharmaceutical and medical device groups have lauded President Obama's pick to lead the Food and Drug Administration, but his selection for second in command is giving the drug industry heartburn.

Industry insiders describe their colleagues as cautiously optimistic about FDA Administrator-nominee Margaret Hamburg, a former New York City health commissioner who works at a nuclear nonproliferation think tank, and nervous in varying degrees about Baltimore City Health Commissioner Joshua Sharfstein.

"Hamburg will be focused on the food supply and creating regulation of tobacco, and to some degree it's expected Sharfstein will have a certain amount of autonomy on pharmaceuticals and medical devices," one lobbyist said.

"Companies are clearly going to get more scrutiny."

The drug industry is viewing the dual picks, as one FDA lawyer put it, as a "power-sharing agreement."

Obama emphasized food safety when he announced the selections of Hamburg and Sharfstein, likely keeping in mind the string of deadly foodborne illness outbreaks in recent years. Hamburg's public health and bioterrorism background make food safety a natural fit. She is a senior scientist at the Nuclear Threat Initiative, which publishes Global Security Newswire, a National Journal Group affiliate.

Sharfstein, on the other hand, has a long and sometimes contentious history with the pharmaceutical industry.

"Anyone who spent their career under Henry Waxman ...," said one lobbyist, trailing off with a shudder.

Sharfstein worked under the now-House Energy and Commerce chairman from July 2001 to December 2005, a Waxman spokeswoman said.

Waxman has been tough on drug companies, particularly given several scandals involving contaminated drugs or unheeded warnings in the recent years. Sharfstein has carried the torch on many of his former boss' public health priorities, ranging from cracking down on medication use for illnesses not approved by FDA to criticizing pharmaceutical companies for gifts handed out to physicians.

Sharfstein led the Obama transition team's FDA evaluation and was thought by many to be a shoo-in for the top post at the agency. He raised warning bells as well that led the agency to re-evaluate the safety of cough and cold medicine use for children.

The pediatrician could play a key role implementing 2007 FDA legislation that set up a system for pharmaceutical companies to assess risks associated with their products and come up with a plan to mitigate those risks -- hence the term risk evaluation and mitigation strategy, or REMS. The law affords FDA the discretion to determine how stringent a product's REMS should be, and the drug world fears potentially burdensome REMS could become the norm.

"I think companies are really nervous based on his track record," an industry insider said.

Peter Pitts, co-founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, argued the drug lobby's fears are unfounded.

"I don't think you'll see more strident regulations," Pitts said. "I think you'll see a more effective way to use existing regulations."

He anticipates FDA will experience an influx of resources this year that will have the underfunded agency running smoother and more efficiently.

One lobbyist called the new funding on the horizon "a blessing and a curse," adding, "With that money, the question is: What type of additional oversight or regulatory burden [is] not going to be put on just pharma-companies but biotech and medical device companies as well?"

Waxman is a leader in trying to move legislation that would grant FDA the authority to oversee tobacco, a bill Sharfstein worked on with the chairman, as well as his most recent legislation that would allow FDA to approve generic versions of biologic drugs.

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Comparative Ignorance on Prostate Cancer Screening

03/19/2009 03:29 AM |

In case you missed it, here is what the Fritz Schroder who ran the European Randomized Study of Screening for Prostate Cancer said about the results of the study published today in the New England Journal of Medicine:

By initially screening men 55 to 69 years with the PSA marker and offering regular follow up, this led to an increase in early detection. Deaths due to metastasized disease were then reduced. Exact data showedthat on average for every 1,408 men screened, 48 had cancer diagnosed and received treatment, resulting in saving one life. Screening took place on average every four years with a mean follow-up over nine years. The cut-off value was a PSA level of 3.0 ng/ml or more. Men with this reading were then offered a biopsy.

The study shows that PSA screening delivers a 20% reduction in mortality from prostate cancer. This provides decision makers on screening policies with important new data on the effectiveness of PSA testing in preventing deaths.

Did you miss that? I sure did. I am sure you did too. Know why? Because the New England Journal of Medicine, the New York Times, USA Today, etc, all ignored the findings and ran with this:

"The PSA blood test, used to screen for prostate cancer, saves few lives and leads to risky and unnecessary treatments for large numbers of men, two large studies have found."

Mortality Results from a Randomized Prostate-Cancer Screening Trial  (The New England Journal of Medicine)

"The findings, the first based on rigorous, randomized studies, confirm some longstanding concerns about the wisdom of widespread prostate cancer screening. Although the studies are continuing, results so far are considered significant and the most definitive to date ..."

Continued Here

"What the European study tells us is that, if you are a man who chooses screening, you are 47 times more likely to be harmed by screening than to have your life saved," said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society.

Where to begin?

Unnecessary and harmed by screening?

What is Brawley thinking? Does the ACS really pay him to say things to reduce prostate cancer survival rates? Does he realize that urological oncology has learned how to segment and stage prostate cancers based on risk and PSA velocity? That the number of cancers detected that undergo watchful waiting have increased even as the more dangerous tumors can be removed successfully to increase overall life expectancy at ever age and that this is possible because of the increase in early and widespread detection in combination of better treatment?

Oh, and did he read the methodology section of the study which controlled for mortality caused by treatment? Guess not.

Read More

Now let's turn to Kolata who's article is as balanced as the Dreyfus Affair. The American study likely understates the impact of screening because the design is biased against minorities who would have higher detection rates of cancers that progress faster and have an oversampling of asymptomatic patients whose slow growing tumors are likely to have a a good prognosis. This bias was further compounded in the American study because the treatment rates in the untreated group were about the same as those in the treatment group:

The other half of the men on the trial were offered “usual care” - meaning ‘whatever their health insurers considered appropriate’. Crucially, this meant that the control group for the study contained men who could also potentially be screened for prostate cancer.

"According to this analysis, over half of men in the ‘unscreened’ group actually received some form of prostate cancer screening (compared to over eight-out-of-ten men in the ’screened’ group)."

In the US trial, some men who were in the unscreened group actually ended up having a PSA test - probably as part of their health insurance or because of suspected prostate cancer symptoms.This may have significantly affected the results, by cutting deaths from prostate cancer in this group, and reducing any differences the trial was designed to show."

Finally, both studies took a one size fits all approach to screening and to PSA levels. In fact, PSA use and levels in the real world are tailored to family history, age and race. Increasingly, algorithms that combine clinical data, PSA levels and other markers such as fusion genes and sarcosine, a metabolite found in urine can be used to more precisely determine whether prostate cancers were benign, localized or agressive.

Read More

Here is info on the PSA Test

So the take away is this: to make policy or impose reimbursement from one clinical trial or even several is fool hardy. To dictate clinical practice and ration screening based on press releases or sound bites is irresponsible.

Then again both the NY TImes and the American Cancer Society are desperately seeking to show the flag on comparative effectiveness. They have done the job well on prostate cancer screening. At the expense of cancer patients and medical progress.
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My Daughter's Battle With AHRQ

03/18/2009 06:55 PM |

The folly of comparative effectiveness reviews
By Robert M. Goldberg

Comparative effectiveness—which is supposedly the “science” of comparing two treatments for the same illness and determining which one provides the best outcome for the least amount of money—is something that at least on the surface should be a process we can all agree on.   Who wouldn’t want to use baking soda in warm water for an upset stomach instead of a four-dollar pill?  
 
But these homely comparisons are not why a collection of interests—including insurance companies, managed care plans, government bureaucrats, advocates of single-payer health plans and experts from government-run health systems from Canada, Britain and Australia—have spent millions lobbying for the inclusion of $1.1 billion to create a government run agency to conduct comparative effectiveness studies.  And it is not because, as the advocates for this mega-agency promise ( with a budget  exceeding  the Food and Drug Administration’s allocation on regulating new drugs, vaccines and devices) any decisions would be legally binding on doctors, Medicare, Medicaid or any health plan that would be regulated under Obamacare.   In fact,  Britain’s  National Institute for Health and Clinical Excellence (NICE) has no authority to control what doctors do or what its National Health Service (NHS) pays for.    (The managed care lobby, America’s Health Insurance Plans or AHIP, supports giving a comparative effectiveness agency such authority.)
 
Yet, the NHS now obliges itself to follow NICE comparative effectiveness decisions.  And so doctors and patients have to wait years for NICE judgments or more accurately for NICE to say that paying for drugs for osteoporosis, Alzheimer’s, arthritis and cancer just isn’t worth it.  Even worse, the whole comparative effectiveness decision-making process now overshadows everything.   Any evidence, biological or otherwise that does not go through the government comparison mill lacks “kosher certification” and is regarded as not authoritative.   To express pain, pose scientific questions, challenge questionable or sloppy assertions, one must become part of the bureaucratic apparatus or the parasitic lobbying necessary to obtain a “seat at the table.” The establishment of such an agency is dangerous if not done with great humility and humanity. My opposition is based not only on this concern but my experience on how it grinds human life into dust. 
 
Several years ago my daughter battled bulimia.  She was hospitalized three times for one month or less.   Her discharge had nothing to do with treatment success.  It had everything to do with her managed behavioral health plan following the logic of the comparative effectiveness review of the Agency for Healthcare Research and Quality (AHRQ) which will be responsible for turning the $1.1 billion into more reports.  Or rather, it was how such reports are written and used that gave the insurer the running room to toss Sara and others like her out of the inpatient setting irrespective of whether they were clinically ready.  
 
For instance, an AHRQ technology assessment, “Management of Eating Disorders,” published in 2006 concluded that the evidence for the effectiveness of combination of treatments for bulimia remains “weak.”   It also went on to note that “few factors were found to be consistently related to outcomes.”
 
It was the process of taking the opinion of a group of health care consultants that evidence was “weak” and giving it the imprimatur of government authority that allowed health plans to limit coverage for eating disorders, claiming they are psychological instead of biological or truly measurable.   This happened even without a law linking reimbursement to an explicit recommendation.  

In fact, the reasons that “factors” are not “related to outcomes” have nothing to do with the implication that longer treatment is ineffective.  The “technology assessment” never states what is well known: that the disease is still not well understood.  Worse, it never acknowledges that the 30 day or less discharge contributes to the problem.  When Sara was discharged she found herself fighting the urge to binge or purge the sense of shame and drive to perfection common among people with bulimia was amplified and was, sadly, reinforced by parents anxious to avoid a relapse or doing anything wrong.  
 
Sara was discharged the first time after she did not binge or purge in a controlled setting for a few days in a row.  Twice more she was discharged not because she was able to get control of her illness but because her blood pressure had been stabilized. Similarly, one of her friends at her eating disorders program had a perforated stomach from so much vomiting. Against the medical advice of her doctor, her insurance company kicked her out after a week because her heart rate was “normal.”   
 
In 2007, Magellan, Aetna and Blue Cross and Blue Shield, three groups leading the push to expand AHRQ’s reach (and whose comparative effectiveness centers would do much of AHRQ's work) were sued.  Susan Pisano, the spokeswoman for AHIP, said “there is no research that shows that longer treatment produces better results. In today's environment, the real question has to be: What does the evidence show?" I wonder where she got that excuse. 
 
Advocates of comparative effectiveness claim that studies will be used differently here than in Britain.  That’s a lie.  In every other setting in the United States, comparative effectiveness reviews have been used to restrict access to new drugs or deny coverage to life-saving treatment more often than not.  Comparative effectiveness research as currently construed is not about what’s best for people.  It’s about saving money for political purposes.  Don’t take my word for it.  Ask my daughter.  Read More & Comment...

Healthcare Reform Quote of the Week

03/18/2009 12:25 PM |

Here's what Representative Henry Waxman (D, CA) told the American Medical Association the other day: "We all know that we have to get costs under control, but the way to do that is not to tell physicians what they can and cannot do or put them in a position where they cannot put the needs of their patients first.”

 

Mr. Waxman said this publicly at the AMA’s National Advocacy Conference.

 

Further:

 

“Don’t let anyone tell you that what I’m interested in is socialized medicine.  I flatly tell you that is not the case … I am not interested in trying to put a public plan in place that would drive out competition.”

 

Thanks for that – but just what does Mr. Waxman define as “socialized medicine?”

 

We’ll see soon enough.

 

Good quotes from Mr. Waxman – but the winner of the drugwonks healthcare reform quote of the week (yes, even though it's only Wednesday) goes to Senator Ron Wyden (D, OR):

 

"Nobody disputes the fact that there's going to be some startup costs."

 

Thank you Senator Wyden.

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Is Comparative Effectiveness Comparison Shopping?

03/17/2009 05:21 PM |

A nice piece on comparative effectiveness by Ceci Connolly of the Washington Post.  No pun intended.  Nice in that it underscores the limits of comparative effectiveness and it's link to consumer choice rather than top down directives. 

However, there are limits that Connolly's piece did not discuss and which likely will be silence by the IOM panel which is stacked with people who believe that the one size fits all, literature review, take it or leave approach of comparative effectiveness is the key to  universal coverage.  This (with some rare and sensible exceptions) is a panel of patronage appointees intended to suppress responsible, science based alternatives to evaluating treatment effects.  I will have much, much more on this subject in a forthcoming post.  But for instance, don't expect the IOM panel, which is stacked to simply implement an AHRQ agenda that they have developed and receive millions from to address the following issues:

Which drug or treatment works best for an individual based on a variety of factors including genetic variation, co-morbidity, life style preference, stage of life? 

Moreover, will comparative effectiveness force additional studies before a product is paid for?  If so, that will inevitably delay access, raise prices or reduce rates of innovation.  And if trials have to be randomized for each subpopulation the cost goes higher still. 

The drug effectiveness review studies conducted by DERP fail to control for subpopulations and the literature they look at themselves exclude adjustments for severity of illness, genetic variation, etc.   So most "studies" show no difference in drugs for a particular illness when in fact there are substantial variations, particularly in the areas of depression, schizophrenia, hypertension. 

Therefore, shouldn't money be spent on tools for personalized medicine instead of one-size fits all guidelines?  Read More & Comment...

Career Advice

03/17/2009 11:48 AM |

Sources inside the Obama administration assure me that they have no plans to bifurcate food/tobacco from drugs/devices.  In other words, Commissioner-designate Hamburg and proposed Principal Deputy Commissioner Sharfstein will act as a team in addressing the direction of the FDA as a totality.

That being said, the issue of whether or not food safety and security remains inside the FDA or becomes its own agency within HHS remains as contentious as ever, with Representative Waxman and Representative DeLauro agreeing to disagree.

Mr. Waxman (D-CA) believes that the "first step on the legislative path" should be shoring up food safety and finding ways to prevent further incidents. According to the Pink Sheet, “Waxman did suggest that he would entertain the concept of a bifurcated agency in the future. Once reforms are passed and implemented, he suggested Congress could consider "whether a reorganization is necessary" for food safety enforcement.”

But Representative Rosa DeLauro, (D-CT), the chair of the House Agricultural Appropriations Subcommittee which oversees FDA's budget, has introduced the Food Safety Modernization Act, which would move some divisions out of FDA and form a Department of Health and Human Services agency for food safety. The bill, H.R. 875, has 40 co-sponsors.

That being said, a dangerous bifurcation that must be avoided at all costs is a differentiation in the vision for the future of the FDA between appointees and career staff.  Drs. Hamburg and Sharfstein should listen and learn from the agency’s senior staff – most specifically as to how the agency can be both regulator and colleague with the industries it regulates.  A fine line to walk -- but a journey worth the effort.

Exhibit A:  The Reagan/Udall Foundation and the Critical Path Initiative.

After all, the FDA must work to both protect and advance the public health.

A shared vision, crafted together will succeed. 

Unity, yes.  Bifurcation, no.

Yes we can.
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Stark Mad

03/17/2009 04:35 AM |

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Taxing Benefits

03/16/2009 10:48 AM |

During the election, candidate Obama called candidate McCain’s proposal to tax employer-provided health benefits “the largest middle-class tax increase in history.” Today President Obama is sending signals that he would support the same idea.

Representative Pete Stark (D, CA) says it's a "stupid idea."

According to the New York Times, such a tax could raise $3.6 trillion over a decade to help “expand coverage to the 46 million uninsured Americans.”

(The complete New York Times article – worth a read – can be found here.)

Except when you take an honest look at who is being inappropriately included in that 46 million (4.1 million now eligible for government benefits via expanded SCHIP + 12 million already eligible for government programs but not signed up + 10 million illegal aliens, + 10 million Americans “opting out” = 32 million) it really comes out to about 14 million uninsured Americans.

$3.6 billion (over 10 years) + the President’s proposed $634 billion “down payment” (over 10 years) divided by 14 million uninsured.  Talk about healthcare inflation!

(And this isn't counting the dollars allocated via the stimulus package that provides unemployment insurance-eligible Americans and their families with government health insurance as part of their benefits.)

For more on miscounting the uninsured, see “Sasquatch Care.”

Another thing the candidate Obama was against but now supports seems to be drug importation.  Can support of government price controls be far behind?
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Uncle Sam, MD? Not So Fast.

03/13/2009 01:36 PM |

According to Douglas Schoen (formerly a pollster for President Bill Clinton) and Scott Rasmussen (president of Rasmussen Reports, an independent national polling company), “It is simply wrong for commentators to continue to focus on President Barack Obama's high levels of popularity, and to conclude that these are indicative of high levels of public confidence in the work of his administration”

Relative to healthcare reform, they find that a majority of Americans aren’t so keen after all to have their Uncle Sam become Uncle Sam, MD:

“There is no real appetite for increasing taxes to pay for an expanded health-insurance program. Less than half would support such an idea, which is 17% less than the percentage that supported government health insurance when Bill Clinton first considered it in March of 1993.”

(Their complete opinion piece in today’s edition of the Wall Street Journal can be found here.)

The conclusions reached by Schoen and Rasmussen are completely in line with a poll fielded by the Center for Medicine in the Public Interest last October.

The CMPI survey was of “Millennial” voters (18-28 years old) -- often portrayed as the new “driving force” in American politics.  When millennial voters were engaged on the issue of health care reform they had some very strong – and often contradictory – opinions a -- particularly when it comes to issue of “universal care.”

The national public opinion poll of young voters (the result of 1001completed interviews with adults 18-28 years of age who are registered to vote) shows limited acceptance for the potential consequences of greater government control over health care.

While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.

Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.

Some germane findings:

* A majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden;

* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,

* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.

(For further details on the CMPI poll, see “The Young and the Restless.”)

The CMPI poll and the findings of Schoen and Rasmussen demonstrate that all sides of the debate need to do a better job educating Americans about how various reform plans will impact the future of our healthcare system.

Nobody said it was going to be easy. 

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Conflict of Interest For Thee But Not For Me

03/12/2009 07:27 PM |

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Pawlenty of Advice on Healthcare Reform

03/12/2009 06:26 PM |

To watch CMPI’s interview with Governor Pawlenty, click here.
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