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Rationing to save money without regard to health or value is dumb. Doing so without the consent of the doctor or patient and the use of population based information as Reinhardt has relentlessly proposed for a decade is inefficient and does not contain costs or improve improve health.
Further, Reinhardt stumbles en route his leap to logic, as do other single payer supporters, in assuming that administrative controls can tamp down costs. They do not and cannot. All they do -- take note Dr. Krugman -- is ration more completely and destroy innovation.
Then again, Reinhardt who believes America is NOT a democracy but an aristocracy, also believes in massive redistribution of income.
Which is why he continues to charge and take nicely sums from corporate and investor groups to talk about health care.
I wonder if Reinhardt will also pledge to enroll in Medicaid to help drive down health care costs and create social solidarity? Will Krugman?
More details to follow (on).
CMPI TO HOST HILL BRIEFING ON FOLLOW-ON BIOLOGICS WITH REP'S ESHOO AND ROGERS
Event Focused on Ensuring “Patient Safety” is Top Priority of Follow-on Biologic Legislation Being Debated on Capitol Hill
Grassley said his inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals.
The text of the letter (sent to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, The Journal of the American Medical Association, and The New England Journal of Medicine) can be found here.
But inquiring minds want to know … who drafted the letter onto which Senator Grassley affixed his signature?
The bill states that "the [HHS] Secretary shall negotiate rates for the reimbursement of health care providers for benefits covered under a community health insurance option."
Direct negotiations? Some things to consider:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School's Alain Enthoven and Kyna Fong
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. Consider:
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
By revoking the Non-Interference clause, Uncle Sam will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
“Direct negotiations” means price controls. And price controls = choice controls.
The HELP committee will resume markup of the health reform bill on July 7th.
For the best recap, have a look at what Tobin Harshaw wrote in the New York Times' “Opinionater” column:
“It was a bit like planning the dream wedding only to have a hurricane rip away the chapel roof as you make your way down the aisle.”
He also offers useful links to what other reformacenti had to say:
Jeff Poor of the Business and Media Institute gives a “thoughtful, respectful and probing” analysis:
“Call this a teachable moment, but even with ABC’s best-laid plans to kickstart the debate about health care reform and not allow the “Prescription for America” special to become an “infomercial,” as many have complained – the president spent more than twice as much time as his questioners vaguely answering or not answering the questions asked of him. But the network consistently presented the event as part of the need to fix a “broken system.” When asked, every one of the 164 hand-picked audience members said they felt that health care needed to be changed.”
And further …
“While Obama had to field some difficult questions — from the audience and ABC — he faced no Republican critics of his proposals. The network also allowed him to dominate the program with long-winded and vague answers. Out of the 75 minutes the network dedicated over the two programs (commercials excluded), the president managed to take 60 percent of that time: 45 minutes to give 19 vague responses – not exactly the “dialogue” advertised by ABC …”
Scarecrow at FireDogLake’s Oxdown Gazette, however, thinks the network lured the president into a devilish trap:
“For its part, ABC insisted on having Charles Gibson and Diane Sawyer, instead of informed, qualified health care experts, guide the conversation. That was a mistake, but not the worst of ABC’s offensive conduct. Sawyer’s main contribution was to introduce her own uninformed biases/opinions in framing issues and introducing questioners. Gibson’s primary role was to reveal his own misconceptions and then literally read talking points from a Republican letter — an obvious ransom extracted after days of Republican whining about giving the President air time on a critical public issue.”
And as far as trading "Good Morning America" for "Healthcare at Night" ...
“Gibson’s other role was to interrupt the President every few minutes to announce a commercial break. The all too frequent commercial interruptions served as an apt metaphor for how private commercial interests demand our attention and extract their profits while limiting our ability to discuss critical public policy issues.”
Harshaw’s full column can be found here.
Cost-Effectiveness of Cancer Drugs Is Question
Read Wall Street Journal article here"The widespread use of expensive cancer drugs to prolong patients’ lives by just weeks or months was called into question by an article published Monday in the Journal of the National Cancer Institute.
Crunching data from published studies, the authors found that treating a lung-cancer patient with Erbitux, a drug that costs $80,000 for an 18-week regimen, prolongs survival by only 1.2 months.
Based on that estimate, extending the lives of the 550,000 Americans who die of cancer annually by one year would then cost $440 billion, they extrapolated."
Let it be noted that the authors Tito Fojo and Christine Grady work at the National Cancer Institute where, we hope, they are nowhere near patients or even lab rats. This is multiplication by morons... Most cancer drugs don't cost that much, extend life by more, often add to quality of life even if they don't add to length, and by doing so add value and wealth to the economy. And then there is the obvious -- one would hope -- shift in cancer care towards personalized treatment, providing medicines to those who can benefit, which brings the 1.2 survival way up.
"How to control escalating spending on end-of-life care is one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system.
Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S."
Here's how Tito and Company -- trained bioethicists as well as having advanced degrees in multiplication - deal with these sensitive issues...
“Many Americans would not regard a 1.2-month survival advantage as ‘significant’ progress,” the authors wrote. “But would an individual patient disagree? Although we lack the answer to that question, we would suggest that the death of a mother of four at age 37 years would be no less painful were it to occur at age 37 years and 1 month, nor would the passing of a 67-year-old who planned to travel after retiring be any less difficult for the spouse were it to have occurred one month later.”
How does one respond to such wisdom and compassion? Perhaps by suggesting that the authors follow their own sagacious advice when faced with a similar situation and voluntarily refuse treatments that -- on average -- increase survival by 1.2 months but could also do so by 4 years or more.
They would be making such a contribution to science and humanity.
From the IOM report:
"This focus of CER reflects the growing potential for individualized and predictive medicine—based on advances in genomics, systems biology, and other biomedical sciences—through the analysis of subgroups with demographic, ethnic, physiologic, and genetic characteristics that could be useful factors in clinical decisions."
Then there is this:
"A common misapprehension is that CER will lead to uniform, “one-size-fits-all” care that ignores the ways that patients differ. In fact, CER done well should give providers the means to tailor the choice of treatment to the individual patient’s characteristics and preferences. Better comparative effectiveness studies will make it possible to measure the implications of individual differences in disease severity and the presence of comorbidities, to identify predictors of response to treatment, and to incorporate other aspects of a person’s health and preferences. For example, CER might assess the added value of using genomic information in addition to traditional clinical predictors to determine the best treatment for a cancer in a particular patient."
There is no misapprehension. The fact is CER has used data from medical claims and randomized trials to compare drug A to drug B to figure out -- on average -- which one provides the most "benefit" for the least amount of money. And CMS is stil proposing such studies today. Moreover, CER is still framed as head to head comparisons conducted largely through randomized clinical trials that take forever and are biased by the cost contaiment goals of government and by definition exclude patient variation as opposed to continuous feedback loop for improving clinical practice.
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My letter to the editor of The Hill is a start....
The fact that there have been fewer patent challenges to biologics than for pharmaceuticals is not a rationale for weakening patent protection for biologics..... Is that the new standard for economic and science policy for the Obama administration? Or is it all about cost?
Eshoo drug legislation better than Waxman alternative bill
By Robert Goldberg, Ph.D., co-founder, Center for Medicine in the Public Interest
Posted: 06/30/09
An important part of the healthcare debate is the two competing pieces of House legislation that give the Food and Drug Administration the authority to create modernized pathways for the creation of generic forms of biologic medicine drugs.
Known as follow-on biologics, or biosimilars, the FDA currently cannot approve these important medicines because of safety concerns over the difficulty in replicating these types of drugs.
House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.) believes the language in his follow-on biologic bill should be included in the broader healthcare legislation in order to reduce the cost of one of President Obama’s top policy agenda items.
On the other hand, Rep. Anna Eshoo (D-Calif.) believes her legislation should go through the standard process of committee markup and onto the House floor on its own, allowing for full vetting and debate on one of the key healthcare reforms of this generation.
Both pieces of legislation have their merits and both members should be commended for their willingness to take a lead on this important issue, but Eshoo’s bill has the right prescription for getting follow-on biologics to the market.
First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.
Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.
Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.
Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.
Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.
Consider what Steve Usdin of BioCentury has to say on the subject of biosimilars in the wake of the recent Federal Trade Commission (FTC) report.
“A Federal Trade Commission (FTC) report released last week, and the responses to it from members of Congress and industry, demonstrate that the prolonged debate has not diminished the controversy over the best ways to balance incentives for biomedical innovation with the economic benefits to patients and payers that could be produced by a robust biosimilars market.
The FTC flatly rejected arguments the Biotechnology Industry Organization (BIO) has made to justify its contention that a 14-year exclusivity period for pioneer biologic products is essential to ensure the future ability of companies to attract capital and to invest in new product development.
Indeed, all four FTC commissioners signed off on the report, “Emerging Health Care Issues: Follow-on Biologic Drug Competition,” which argues there is no need for any market exclusivity for pioneer biologics beyond that provided by patents, save for products for Orphan diseases and unpatentable drugs.”
Ouch.
According to the FTC, “There is no evidence that patents claiming a biologic drug product have been designed around more frequently than those claiming small molecule products.”
Double ouch.
Usdin’s complete article is worth a careful read.
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.
