Latest Drugwonks' Blog

Democrats are touting the fact that the AMA has signed on to their health care reform effort. But is the AMA really representing the views of its members, or are they playing a Washington game: currying favor with the Democrat majority, in the hopes that when negotiators decide who’ll pay for national health care, they’re not left holding the bill? Here’s one suggestion that the AMA leadership may be getting ahead of its rank and file:

Concerned that the American Medical Association has taken too tepid a position on Democratic healthcare reform plans, a coalition of state medical associations and specialty organizations is breaking from the country’s largest physicians’ group to mount its own push against the inclusion of a public insurance option in any overhaul bill.

Seventeen state medical associations and three specialty physicians’ groups planned a conference call late Wednesday to discuss a draft letter that would go much further than the AMA’s more measured responses to the public option.

The AMA has made clear it is not opposed to a public plan, but would resist a Medicare-like program that mandates physician participation and pays less than their costs..

The draft letter, written by members of the Medical Association of Georgia, says flatly that the physicians’ groups unequivocally oppose a government-administered insurance plan, as well as use of government-funded effectiveness tests, or “comparative effectiveness research,” to dictate which medical procedures should be eligible for coverage…

A Republican aide familiar with the coalition’s concerns said the physicians’ groups especially worry that AMA’s position on public option language in the House’s developing legislation has been “too squishy…”

“Physicians have been offered a seat at the table so long as we sit still with our hands folded in our laps and keep our mouths shut,” wrote John Black president of the South Carolina association, and Gary Delaney, the group’s chairman. “The muzzle that the Feds placed on us must be removed and the decibel level of our voices must be raised so that we are unmistakably heard.”

In addition to Georgia and South Carolina, state medical associations from New Jersey, Florida, Arkansas, Virginia and 10 other states and the District of Columbia planned to discuss the letter and consider signing it.

The Triological Society and the American Academy of Facial Plastic and Reconstructive Surgery were also invited to participate in Wednesday’s discussion, said a spokeswoman for the Georgia group.

Seventeen state associations are considering separating themselves from the national AMA to make clear that they oppose a government-run plan. That doesn’t completely devalue the AMA’s position, but it certainly makes you wonder what could have caused such a sudden and dramatic reversal. Given the threats Democrats have been leveling against groups that refuse to cooperate with their agenda, it would be no surprise if the AMA’s leadership simply calculated that it would be more dangerous to fight than to give in.

We’ll know in the next few days how many state associations are willing to buck their leadership and sign on to this letter. I wonder how much attention that will receive.


The Wall Street Journal reports that:

"Top Senate Democrats were critical Thursday of comments made by the director of the nonpartisan Congressional Budget Office that existing reform plans wouldn't curb federal spending on health care. CBO Director Douglas Elmendorf told lawmakers on the Senate Budget Committee earlier Thursday morning that legislation approved this week by a Senate panel wouldn't reduce the federal government's spending on health care. "And on the contrary, the legislation significantly expands the federal responsibility for health care costs," Mr. Elmendorf said. Mr. Elmendorf went on to say that there is widespread support among health analysts for taxing health care benefits as a way to reduce federal outgoings on health care. Taxing individuals' health care benefits is extremely unpopular among many Democratic lawmakers. Asked about the assessment, Senate Majority Leader Harry Reid (D., Nev.), quipped that Mr. Elmendorf should consider running for Congress."


Senator Reid, what do you mean by that remark?

That healthcare reform bill just released by Democratic House leaders calls for a public insurance option which would negotiate rates directly with providers, including drug firms.

It's in Subtitle B Section 224, which says: "The Secretary also has authority to negotiate prescription drug prices for the public option."

Direct negotiations? For some things to consider, see today’s edition of the Washington Examiner.

"Direct negotiations" means price controls. And price controls = choice controls.

Pharmaceutical marketers are in a tough spot when it comes to social media. On the one hand, they understand the importance and opportunity of it. On the other, they are restrained and frustrated by a number of barriers, including actual and implied ones from the FDA, and self-imposed ones from the nabobs of “no” (aka MLR – medical legal review). Anti-depressants anyone?

Social media is a social movement, and using the excuse that pharma can’t engage because, “We’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special differences” that pharmaceutical companies must engage actively and creatively in social media. And that difference is the responsibility of advancing the public health.

Don’t pin all the blame on MLR. They’re on board. As the head of one large pharma’s MLR department commented to me, “We have to talk to our customers where they are – and they are in social media.”

MLR looks at risk, but is marketing presenting the benefits? And what about the FDA?  The agency is certainly sending mixed messages. Yet, a senior Center for Drug Evaluation and Research (CDER) official said at the Drug Information Association (DIA) meeting last month: “The FDA does not want to stifle the use of social media.” Good news? We’ll see.

This, in the preamble of section about the public plan in the House Dem bill....

"the Secretary’s primary responsibility is to create a low-cost plan without comprimising quality or access to care. "

So, not only do members not have to read the bill (per Mr. Hoyer) -- spelling no longer counts.

Perhaps the IOM should commission a study on the correlation between spelling errors and medical errors.

It may come as a surprise to many Americans to here that not only are all European health care systems not socialized but some are arguably less socialized and more market-based than the US and yet achieve universal coverage. The best example is Switzerland, which has dispensed with providing coverage through work, instead all Swiss purchase insurance directly from the companies. This means that consumers have freedom to pick whatever plan or company they want. Those who cannot afford to buy insurance are given subsidies to help them do so.
 
Further, since 2002, Switzerland allows insurance companies to be for-profit, unlike those in other European systems. Insurers operate on the canton (state) level, just as most US insurers do, and Switzerland tries to maintain robust competition between insurers over members by allowing them to offer difference prices or plans that cover different types of treatments.
 
As in the Netherlands, Swiss insurers must also make available a basic plan that is open to everyone, regardless of preexisting conditions or health risk, and the components are comprehensive and perpetually increasing. The price for this basic package is set based on location and age only. They are also forbidden from making money on this package. On all other plans, companies are allowed to discriminate based on age, risk, health status, etc. Rationing and waiting lists are nowhere in evidence.
 
This is possible in part because Switzerland mandates that everyone buy insurance and imposes stiff fines on those who do not comply. As a result, virtually 100 percent of the population has health coverage.
 
However, despite giving a lot of market freedom to companies and customers, Switzerland’s health care is not a total free market. Prices for services are negotiated between insurers and doctors/medical facilities but the government in each canton has to approve them. Drug prices are free – up to a ceiling.
 
Further, the Swiss system is expensive, if significantly cheaper than the US. Switzerland spent 11.3 percent of GDP on health care in 2006, ahead of every other country in Europe, and that percentage is rising much faster than in other countries, 2.4 percent vs. an OECD average of 1.5 percent. Premiums are costly too, and going up “twice as fast as costs.” Families spend approximately $680 per month or around $8,167 annually for four people on the basic plan. Keep in mind that this is all paid directly by consumers, the employer doesn’t contribute as in the US.
 
Prices for services are also high and paid on a fee for service basis. There is little payoff to doctors or hospitals for bringing them down, in fact they benefit from overuse of tests and procedures, exactly what the US has struggled with in its own system. In general, cost is the most common complaint among the Swiss about their health care. However, Switzerland is one of the few countries that is not currently facing urgent concerns about the financial sustainability of the system.
 
Switzerland has been conspicuously out of evidence recently but in the past politicians of both American political parties have seen it as a potential model, including a visit there in 2007 by Health and Human Services Secretary Michael Leavitt. Perhaps it is time to bring Switzerland back into the American debate so that we can understand the gamut of health care systems that exist elsewhere in the world and what they tell us about what works, what doesn’t, and the choices you make along the way.

Bend This!

  • 07.14.2009
Peter Orzsag is more responsible than anyone for peddling the nonsense that comparative effectiveness research can save $700 billion over ten years and asserting that slowing health care costs are key to economic prosperity... 

I bring this up again, because...


New tests may help spot early-stage Alzheimer's

Tue Jul 14, 2009 2:32am EDT
 
[-] Text [+]

By Julie Steenhuysen

CHICAGO (Reuters) - New tests assessing brain changes and body chemistry are showing promise at diagnosing Alzheimer's disease in its earliest stages, aiding the search for new drugs, researchers said on Tuesday.

In one study, Irish researchers found scans measuring brain volume and a combination of memory tests accurately identified nearly 95 percent of people who had progressed from mild cognitive impairment to early Alzheimer's disease.

In another study, U.S. researchers found that a type of brain scan that measures glucose combined with low scores on memory tests was a strong predictor of disease progression.

The findings, presented at an Alzheimer's Association meeting in Vienna, Austria, are some of the first from a five-year, $60 million study aimed at identifying brain changes that signal the advance of Alzheimer's disease.

"The idea is if there could be biological markers identified that tracked what was going on in the brain, this would give you a better idea of whether a drug was having a biological effect," Neil Buckholtz, who heads the U.S. National Institute on Aging's Alzheimer's Disease Neuroimaging Initiative, or ADNI, said in a telephone interview.

The study, which is funded with U.S. government and industry funds, involves more than 800 people looking at brain structure and biological changes such as in spinal fluids that could signal disease progression.

Despite decades of research, doctors still have few effective treatments for Alzheimer's disease, a mind-robbing form of dementia that affects more than 26 million people globally and is expected to reach 100 million by 2050.

CHEAPER TRIALS

Only an autopsy revealing the disease's hallmark plaques and tangles in the brain can offer a definitive Alzheimer's diagnosis. Short of that, doctors use neurological and memory tests. Because they are subjective, drug companies must run large, costly trials to show their drugs work.

Biomarkers may lead to cheaper trials, Buckholtz said...."

Newer tests.  Earlier intervention.  More drugs that are targeted.. More costs upfront.  People living longer, healthier lives. 

Not good in the Orszagian Universe...


Jim who?

  • 07.14.2009

BioCentury reports:

 

“Proponents of six separate bills seeking to create a pathway for approval of biosimilars are trying to line up enough support to prevail in a vote that could come as early as Friday in the Senate Health, Education, Pensions and Labor (HELP) Committee. The bills have been introduced as amendments to healthcare reform legislation.

 

The Biotechnology Industry Organization is strongly backing an amendment introduced on Thursday by Sens. Kay Hagan (D-N.C.), Michael Enzi (R-Wyo.) and Orrin Hatch (R-Utah) that would provide 12 years of exclusivity for pioneer biologics. BIO is opposing an amendment introduced on Tuesday by committee Chairman Sen. Edward Kennedy (D-Mass.), arguing that the amendment's nine year period of guaranteed exclusivity is too short. BIO also opposes language that seeks to limit exclusivity to a "major new substance" that would exclude many biologics, as well as the amendment's limited exclusivity for products approved before enactment of the legislation.

 

Sen. Sherrod Brown (D-Ohio) has introduced two biosimilars amendments, which would provide for seven and nine years of exclusivity. Two other pending amendments, filed by Sens. Barbara Mikulski (D-Md.) and John McCain (R-Ariz.), would provide 10 years of basic exclusivity. If the HELP Committee fails to agree on one of the amendments, it may send healthcare reform to the Senate floor without biosimilars provisions. This could put the creation of a biosimilars pathway in the hands of the House of Representatives.”

 

On a related note, it seems that BIO needs to hire a new publicist for Jim Greenwood.  In her Wall Street Journal article, reporter Alicia Mundy refers to him simply as an “industry lobbyist.” I guess the fact that he’s the president of BIO and a former United States Congressman isn’t relevant.  It’s also interesting that she describes the Kennedy bill as a “victory” for biotech. 

 

Ms. Mundy should probably put Steve Usdin on speed dial.

No-Part Harmony

  • 07.13.2009
It’s not surprising that physicians serving in Congress are as conflicted as their peers outside the Beltway when it comes to how best to achieve healthcare reform (“For Doctors, Little Harmony on Health Care,” New York Times, July 12, 2009). 

What is surprising is how ignorant some physician/representatives are when it comes to existing options for their patients/constituents who are without health insurance.  Representative Steve Kagen (D, WI) is upset that a patient cannot afford the medicines he prescribes, but seems ignorant or unwilling to recommend the many patient assistance programs available to those who earn too much to receive government assistance but too little to afford private insurance.  Such programs are valuable options, providing free or low cost medicines to millions of Americans. The Partnership for Prescription Assistance (toll-free, 1-888-4PPANOW; www.pparx.org) is a single point of access to the more than 475 patient assistance programs, which include more than 180 programs offered by the pharmaceutical industry. 

Dr. Kagen, the other physicians in Congress and every member of Congress should be aware of private sector healthcare access success programs before opting for a government-run public option.

Obama invoked Lincoln and read Roosevelt as he prepared to become president and provide the American people an image to shape our vision of his leadership... Here, given the recent roilings of the health care debate, are graphic scenes of yesteryear that may be a more appropriate metaphor:


CMPI

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.

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