Gruber trouble

01/11/2010 03:20 PM |

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Anti-Pharma Extremists

01/11/2010 09:39 AM |

Pfizer gives Standford Medical School an unrestricted grant to develop continuing medical education...just as critics have wanted.

What is the response?

Let Arnold Relman and David Rothman (he who receives his dollars from George Soros) render judgment:

Relman:  “But it’s just not a good idea for a profession that says it wants to be independent and trusted, a reliable source of information to the profession and the public about drugs, to take money from the drug company under any conditions.”

Rothman: I will also confess I am surprised Pfizer is doing it,” he added, “and I don’t know how many more times they will give money with no strings attached.” (As opposed to the tight strings attached to everything Soros gives to his sock puppets?) 

So doctors who take unrestricted money for any reason under conditions from any company are inherently corrupt? 

Too bad the NY TImes continues to give these extremists a platform -- without ask them to disclose their funding sources... as if that mattered.

www.nytimes.com/2010/01/11/business/11drug.html
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Howdy Pilgrim

01/11/2010 07:57 AM |

Harvard Pilgrim Health Care Inc. has won a major grant from the Food and Drug Administration to build a system to monitor the safety of drugs and medical devices after they have gone on the market.

Pilgrim will use a five-year, $72 million grant to coordinate the efforts of 28 health care organizations around the country as they design ways to make use of information they already gather, in electronic medical records or claims data, to provide early warning of potential harm.

“The goal is to be able to do active surveillance, to look for signals that might indicate there is a safety problem and then to be able to follow up to determine whether there is a problem or not,’’ said Dr. Richard Platt, who will lead the effort. He is chairman of population medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. “This is part of a major shift on FDA’s part from being reactive, waiting for physicians and patients to tell them about problems, rather than to be looking actively for problems.’’

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Strike up the Rand

01/11/2010 07:48 AM |

"We do not support approaches, such as those suggested in the Senate's proposed Independent Payment Advisory Board, that rely too heavily on the Medicare program to achieve cost-containment objectives."  So said AARP CEO Barry Rand in a letter sent to Senate Majority Leader Harry Reid and Speaker of the House Nancy Pelosi.

The provisions in the Senate bill task the 15-member board with reducing excess cost growth by recommending cuts in Part D premium subsidies paid by Medicare. Those recommendations mandate fast-track congressional action, required within two-and-a-half months unless the Senate has a three-fifths vote to repeal the board recommendations or any of the savings targets.

Rand continues, "Congress should not abdicate its role of determining benefits and cost-sharing for Medicare.”

Mr. Rand is right.  One of the most frightening unintended consequences of such an advisory board is that they will make decisions based on cost rather than care.  And it’s an inevitable consequence.  Those who owe their jobs to the American voter must always be held ultimately responsible for government reimbursement decisions. And if you don't think this really makes a difference -- just ask the folks at NICE about Sutent.

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Bridges to Health Reform

01/08/2010 08:27 AM |

A new op-ed by CMPI senior fellow John Bridges (appearing today in the Baltimore Sun):

Make patients' needs a higher priority

The Senate's vision for health care reform - the "Patient Protection and Affordable Care Act" - would create a "Patient-Centered Outcomes Research Institute." This institute would aim to compare the effectiveness of different treatments to "assist patients, clinicians, purchasers, and policy-makers in making informed health decisions." ("Purchasers" refers to public, private and employer-sponsored health insurance.)

As the founding editor of "The Patient - Patient-Centered Outcomes Research" - the first medical journal devoted exclusively to informing the health care system about patients' needs and wants - I have several reservations.

It is unclear how the institute will define, let alone meet, the often-competing interests of patients, clinicians, purchasers and policymakers. While clinicians, purchasers and policymakers have adequate means and resources for advancing their interests, it is questionable whether the patient's voice will be adequately represented in this process. Despite the many patient organizations representing specific diseases, only a few are active in research, and these may be tarnished through funding by pharmaceutical companies. Furthermore, unlike clinicians and purchasers who are bound together by their commercial and professional interests, representing the range of patient perspectives is difficult and expensive.

"Patient-Centered Outcomes Research Institute" sounds like a more politically palatable name for an "Institute for Comparative Effectiveness Research." Like other such agencies internationally, the bill gives the institute the power to determine the "appropriateness of medical treatments." International experience demonstrates that "appropriate" is defined as cost-effective or budget minimizing (although our senators have carefully avoided such terms). Also like its international counterparts, the institute would be placed at arm's reach from government, to ensure lawmakers have plausible deniability with regards to health care rationing.

Finally, similar institutes internationally have been criticized for promoting "one-size-fits-all" medicine by ignoring variations in needs and wants across patient populations. While the institute will consider "variations in patient subpopulations," it is unclear what characteristics will define such subpopulations.

A centralist and paternalistic approach is found throughout bill's description of the institute. Already a number of professional organizations have expressed concern that the institute would control the health care system by controlling the flow of information. Internationally, this occurs explicitly through limitations on the advertising of pharmaceuticals and implicitly by restricting funding of research. While the new institute will have a role in "the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments," a truly patient-centered approach would also focus on the patient's perspective.

There is little federally funded research focused on the patient's perspective. Knowing more about what patients think might have resulted in less of an uproar over the recent changes to breast cancer screening recommendations, for example.

It is unclear how the findings of the institute will we implemented. Similar institutes overseas cannot have their decisions challenged in court. In trying to be everything to everybody, the institute will need to make trade-offs that will most likely promote clinician-centered or payer-centered outcomes research - ignoring the disparate needs of patients.

House and Senate negotiators should create a separate institute for the scientific study of the patient's perspective, an "Institute of Patients' Needs and Wants," to conduct and fund real patient-centered outcomes research. Such an institute would not only provide necessary oversight, but more importantly, the input of the patient's perspective and participation in health care decisions, from start to finish.

John F. P. Bridges is an assistant professor in the Department of Health Policy and Research at the Johns Hopkins Bloomberg School of Public Health and a senior fellow at the Center for Medicine in the Public Interest.   Read More & Comment...

Part D Line

01/07/2010 01:07 PM |

From today's Wall Street Journal:

The Lessons of Medicare Part D
By DAVID WESSEL

Four years ago, the U.S. government offered subsidized prescription-drug insurance to 43 million elderly and disabled, the biggest expansion of government-backed health care in decades. Today, the program is working better than many expected. Now academics are drawing lessons that are acutely relevant to heath-care legislation pending in Congress.

Medicare Part D did lead the elderly to use more drugs. (That's unsurprising, but pleases economists because it confirms their predictions that when government subsidizes something, people use more of it.) More important is the conclusion from Nobel laureate Daniel McFadden of the University of California at Berkeley: "Medicare Part D … has achieved its primary political goal of providing near-universal coverage in a viable private market." (Link for paper)

Some early lessons:

Markets do work, but...

In Medicare doctor and hospital insurance, the government generally chooses benefits and sets prices. In Part D, there is no government plan; the typical elderly person has a choice of 40 plans, all sponsored by private insurers whose offerings are supervised by the government. Few elderly pick really lousy plans; the government makes sure no really lousy plans are offered, an important lesson for the "exchanges" at which many Americans would shop for private health insurance under the pending bill. Jonathan Gruber and Jason Abaluck of the Massachusetts Institute of Technology, with data on 2.7 million Part D enrollees, find that 70% could have chosen a lower-cost plan, and the typical enrollee could have saved about 25%. (Link for paper.) Consumers focused too much on premiums, not enough on out-of-pocket spending. It's a reminder that elaborate cost-sharing formulas don't guide consumers well if they're too complicated for consumers to understand.

"Markets definitely work," says John Hsu, a physician-MBA at Harvard Medical School. "However, they don't always work according to original assumptions. It's very important to examine each step very carefully to look for unintended consequences."

Prices don't always do the predictable.

The early fear was that arming the elderly with subsidized drug insurance would increase demand and thus drug prices, especially since Congress barred the government from negotiating drug prices directly. That task was left to the private insurers.

Insurers had strong incentive to bargain hard. Mark Duggan of the University of Maryland and Fiona Scott Morton of the Yale School of Management conclude, "Moving consumers into Medicare Part D plans significantly reduced the per-dose price paid to manufacturers." (Link for paper.) Average price cut: 12%. Why? "An individual consumer typically does not have the knowledge of which drugs are acceptable [cheaper] therapeutic substitutes; the consumer's physician typically has poor knowledge of [drug] prices and any one consumer is too small...to negotiate with a pharmaceutical company."

That strengthens the case for harnessing private insurers to restrain health costs, but doesn't mean drug prices couldn't be lower still. The Medicaid program for the poor and the Veterans Administration get even lower drug prices. That matters particularly to the elderly poor who may pay more for drugs because they were switched to Medicare Part D from Medicaid.

One countervailing force: an uptick in drug-company ads aimed at elderly consumers. In unpublished work presented at the American Economic Association this week, Darius Lakdawalla of the University of Southern California compared direct-to-consumer ad spending on drugs with no Medicare use with ad spending on drugs typically used by Medicare patients. After Part D kicked in, spending on the latter rose 60% above spending on drugs with no Medicare users.

Programs never cost what the experts predict.

Economy-wide growth in drug spending slowed surprisingly sharply. "This sharp deceleration in growth rates was unexpected by us, CBO, and most industry experts," CMS chief actuary Richard Foster said in an email to Slate's Tim Noah. "It occurred largely as a result of effective efforts by health-insurance plans to induce people to use generic equivalents and a slowdown in the number of new "blockbuster" drugs coming into the market." Projections are always wrong, he notes, but still essential to wise policy making.

Health care is never simple, though. Higher drug spending pulled down hospitalization of the elderly for diseases treatable by medicine, such as diabetes. "It did make them healthier and keep them out of the hospital," Michael Chernew of Harvard Medical School said at an AEA presentation.

Of course, Congress is often happy to spend those savings and more. Douglas Holtz-Eakin, CBO chief when the drug bill passed, notes that Congress now is contemplating filling "the doughnut hole" -- out-of-pocket spending on drugs that wasn't covered by the original plan. "Every entitlement program gets richer over time," he says.

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And that's Terry Vermillion on Line 2

01/06/2010 03:20 PM |

FDA Warns Public of Continued Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment.”

FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.

Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA’s Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.

The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA’s concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.

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Not Slower But More Expensive

01/06/2010 01:15 PM |

Left unsaid in Matt Perrone's article (one of the best FDA reporters around) is that it is becoming more expensive to launch new products.  Fewer new products requiring more studies with more human subjects, not fewer, more post market followup...and now pressure to extend randomized trials to devices..  How long before China becomes the home for first launch of new products in the world??

Push for Drug Safety Did Not Slow FDA Drug Approvals Last Year
Wednesday, January 06, 2010
By Matthew Perrone, Associated Press
(Copyright 2008 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)

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The Frosting on the Healthcare Cake

01/06/2010 08:06 AM |

Personalized medicine means the “Four Rights” – the right medicine for the right patient, in the right dose at the right time.  We’ve made some significant strides forward via (among other things) molecular diagnostics – but we’ve only scratched the surface.

Consider two recent studies on how we’re diagnosing and treating depression.

According to the Wall Street Journal, “More Americans are being prescribed multiple psychiatric medications for use at the same time, but most people diagnosed with recent depression don't get adequate treatment, according to two independent studies published Monday.”

Advancing the tools and techniques of personalized medicine is real healthcare reform.  And there’s no better place to start than with the FDA’s Critical Path Program and its Reagan Udall Foundation.

To paraphrase – we have promises to keep. And miles to go before we sleep.

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Depressing Anti-Depressant Coverage

01/05/2010 10:49 PM |

Get a load of the first sentence of this article which skews what this meta-analysis -- yet another study of studies -- shows:

Drugs May Aid Only Severe Depression

By BENEDICT CAREY

Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.

The findings could help settle a longstanding debate about antidepressants.

NOW WATCH AS CAREY DUMPS ON MEDS IN A BACKHAND WAY..

While the study does not imply that the drugs are worthless for anyone with moderate to serious depression — many such people do seem to benefit — it does provide one likely explanation for the sharp disagreement among experts about the drugs’ overall effectiveness.

Taken together, previous studies have painted a confusing picture. On one hand, industry-supported trials have generally found that the drugs sharply reduce symptoms. On the other, many studies that were not initially published, or were buried, showed no significant benefits compared with placebos.

THE LAST GRAF IS NONSENSE.  NO TRIALS -- INDUSTRY OR OTHERWISE HAVE EVER SHOWN THAT ANTIDEPRESSANTS SHARPLY REDUCE SYMPTOMS. THEY ARE HARD TO DESIGN AND ENDPOINTS HARD TO MEASURE.  MANY ARE TO0 SMALL.   WHICH IS WHY MANY ANTIDEPRESSANT STUDIES ARE NOT PUBLISHED.  RATHER IT HAS BEEN THE CUMULATIVE CLINICAL EXPERIENCE THAT HAS DEMONSTRATED BENEFIT IN LARGE PART BECAUSE TESTING AGAINST PLACEBO DO NOT TAKE INTO ACCOUNT THAT 60 PERCENT OF ALL PEOPLE WHO START ON ONE ANTIDEPRESSANT SWITCH.   THUS THE STAR-D TRIAL,  A GOVERNMENT FUNDING STUDY THAT USE A  CROSSOVER DESIGN MIMICING CLINICAL PRACTICE FOUND SIGNIFICANT BENEFITS THROUGH THE INDIVIDUALIZATION OF TREATMENT.  WHEREAS...

The new report, appearing in The Journal of the American Medical Association, reviews data from previous trials on two types of drugs and finds that their effectiveness varies according to the severity of the depression being treated.

Previous analyses had found a similar pattern. But the new study is the first to analyze responses from hundreds of people being treated for more moderate symptoms, as are most people who seek care.

AGAIN, UNTRUE..  SEE THE STAR-D TRIAL 

“I think the study could dampen enthusiasm for antidepressant medications a bit, and that may be a good thing,” said Dr. Erick H. Turner, a psychiatrist at Oregon Health and Science University. “People’s expectations for the drugs won’t be so high, and doctors won’t be surprised if they’re not curing every patient they see with medications.”

But Dr. Turner added, “The findings shouldn’t dampen expectations so much that people refuse to even try medication.”

A team of researchers, including psychologists who favor talk therapy and doctors who consult widely with drug makers, performed the new analysis, using government grants. The group evaluated six large drug trials, including 728 men and women, about half of them with severe depression and half with more moderate symptoms.

Three of the trials were of Paxil, from GlaxoSmithKline, a so-called S.S.R.I., and the other three were of imipramine, an older generic drug from the class known as tricyclics. The team, led by Jay C. Fournier and Robert J. DeRubeis of the University of Pennsylvania, found that compared with placebos, the drugs caused a much steeper reduction in symptoms of severe depression (cases scoring 25 or higher on a standard scale of severity, putting them in the top quarter of the sample). Patients with scores of less than 25 got little or no added benefit from the medications.

“We were able to give an overall estimate of effectiveness for the first time in this more moderate severity range, from 14 to 20 on the scale, in which there’s no question that doctors would likely consider prescribing medication,” Dr. DeRubeis said.

His co-authors included Steven D. Hollon and Dr. Richard C. Shelton of Vanderbilt University, Sona Dimidjian of the University of Colorado, Dr. Jan Fawcett of the University of New Mexico and Dr. Jay D. Amsterdam of Penn.

The effects of other popular S.S.R.I.’s like Lexapro and Prozac are not likely to be much different than those of Paxil, experts said.

Dr. DeRubeis and others said antidepressants’ inability to outperform placebos against moderate symptoms stemmed partly from the sustained attention that patients in drug trials received from top doctors — which itself can help relieve symptoms, drug or no drug. For some people, too, the drugs’ side effects may cancel any benefit.

HOW ABOUT THE USE OF GENETIC TESTS TO INDIVIDUALIZE AND OPTIMIZE DRUG SELECTION TO REDUCE SIDE EFFECTS? 

THIS IS A POOR STUDY RECAST AS A SLAM AGAINST MEDICATIONS BY THE NYTIMES

FOR THOSE INTERESTED IN THE STAR-D RESULTS AND IMPORT.

www.nimh.nih.gov/health/trials/practical/stard/backgroundstudy.shtml
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Political Lifetimes and Healthcare Lifelines

01/05/2010 03:03 PM |

Bloomberg reports that “Democrats will likely drop the idea of setting up a new government-run insurance program as they try to quickly resolve differences between House and Senate health-care bills, party members in both chambers said.”

Illinois Senator Dick Durbin, the No. 2 Senate Democrat said, “The Senate has pushed this to the limit of 60 votes. We have to be careful that whatever we change doesn’t jeopardize that 60-vote margin.”

“We’ll never have another chance like this in my political lifetime,” Durbin said. “This is it.”

Healthcare reform is too important to tie it to Senator Durbin’s political lifetime. The American public is not concerned about Senator Durbin’s political lifetime. 

The goal, according to Bloomberg, is to have a bills signed by the State of the Union.

Shouldn’t the goal be to pass healthcare reform legislation that advances the public health in smart and progressive ways? Why the artificial deadline? 

Should we accept legislation that compromises the public health?

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Are you listening, PhRMA?

01/04/2010 11:47 PM |

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Ex officio rationing and Medicare

01/04/2010 11:39 PM |

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The Coming Medical Meltdown

01/04/2010 08:23 PM |

Can't wait when we all get to use our "affordability credits" to wait a year to see a doctor at a federal health clinic...

Article published Jun 28, 2009
Doctor shortage proves painful to state
By BRENT CURTIS Staff Writer

Much of the state is short on primary care providers at a time when the nation as a whole is searching the same pool of doctors.

Since the start of the year, Rutland County, for example, has lost three primary care doctors and three more are over age 60 and planning to retire within the next few years, said Rutland Regional Medical Center President Thomas Huebner.

"We have the biggest shortage of primary care doctors in the state," Huebner said, pointing to a 2008 state Department of Health report that indicated that all but a tiny portion of the county faced a "severe need" for primary care physicians.

And that study was conducted before the departure of three primary care doctors earlier this year.

The loss of those doctors is more than just an inconvenience for their patients. With the demand for primary care in Rutland County exceeding the supply – which Huebner said is short by about four doctors – patients are forced to wait longer to see doctors who are overburdened. Also, many doctors in the region aren't accepting new Medicare or Medicaid patients – most physicians can only accept so many state-insured patients due to low government reimbursement rates – which compels many patients to put off doctor visits until their needs are acute and they end up in the hospital.

It's a fallback practice for those who can't find primary care doctors that Huebner and other health care professionals say ends up costing hospitals, insurance companies and ultimately those paying for insurance more.

And the primary care problem hardly is unique to Rutland or to Vermont for that matter.

Elsewhere in the state and nation, primary care physicians are in short supply.

Dr. Ted Epperly, president of the American Academy of Family physicians, said the United States is about 15,000 primary care doctors short of demand — a 30 percent shortfall across the board for all 50 states.

If current trends persist, the AAFP predicts the deficit will grow to 40,000 over the next 10 years.

That estimate is no surprise given that only 17 percent of U.S. medical school graduates in 2008 expressed a preference for family medicine. The AAFP said the small percentage of primary care-minded graduates represented an "all-time low" among emerging students.

Even in Vermont, where the University of Vermont prides itself on ranking in the top 5 percent of all medical schools for primary care, access to family medicine is spotty.

In addition to Rutland County, large swaths of the Northeast Kingdom along with large portions of Grand Isle, Franklin, Lamoille, Addison, Orange, Washington and Windham counties were labeled "severe need" areas by the Department of Health. Many other areas of the state were listed as "limited need" areas.

In fact, the only sizeable areas with adequate supplies of primary care, according to the most recent state study that compares full-time equivalent hours with regional populations, were portions of Chittenden, northernmost Orleans, southern Addison, much of Windsor, central Windham and most of Bennington counties.

The reasons for the doctor shortage, which has been gradually worsening over the years, are well documented. Much of the problem boils down to money. Medical students who opt to specialize rather than enter primary care practices stand to make significantly more because specific procedures earn higher reimbursements than generalized care and diagnoses. For medical students leaving school with debt loads often topping $150,000, the decision to enter primary care practice often means a degree of financial hardship, according to survey-based research conducted in Vermont and nationwide.

Those same surveys show that primary care physicians tend to work longer hours than specialized doctors and must juggle larger caseloads with the reams of paperwork that accompany most procedures in modern medicine.

In Rutland, Huebner said those symptoms are particularly acute due to high ratios of Medicaid and Medicare patients in the community. Reimbursements from the two government programs are well below the cost of medical procedures.

Vermont can be a tough place to recruit new doctors who can often find higher wages in other states, according to the Vermont Medical Society.

"What Vermont has going for it is quality of life," said Paul Harrington, executive vice president of VMS. "Nothing trumps a desire to be here because there are other places where doctors do earn more."

On top of that, Harrington said Vermont has a higher ratio of Medicaid patients and an ever increasing number of Medicare patients due to a graying population.

The pay scale puts Vermont at a disadvantage when it comes to recruiting new doctors – and it makes keeping them here a challenge, as well.

Since the primary care shortage is a national problem, other states constantly are trying to lure doctors away from Vermont.

To keep physicians here, hospitals around the state utilize their own recruiters who not only try to bring doctors to their facilities but work toward a balance of doctors in private practice in the surrounding communities as well.

Hospitals have an interest in the medical community beyond their own walls because a shortage of primary care doctors means more patients arriving in the emergency room suffering from ailments that a family physician could have detected and dealt with at a less acute and less expensive stage.

"We're all in this together," said Donna Izor, vice president of physician services at Central Vermont Medical Center.

Izor, and other recruiters around the state, offer incentives such as electronic medical records, startup loans and hospitallist services – hospital employed doctors who oversee a primary care physician's patients during hospital stays – to ease the financial, paperwork and time burden that family physicians shoulder.

But all acknowledge that the real answer to the problem lies at the state and federal level, where Medicaid and Medicare reimbursement levels are set – and all too often are cut.

During the last legislative session, budget realities prompted legislators to cut Medicaid reimbursements by 2 percent.

In the Legislature's defense, Rep. Steve Maier, D-Middlebury, said legislators exempted a number of procedures common to primary care physicians from those cuts and he said the Legislature increased Medicaid reimbursements for some primary care procedures.

"We know there's a shortage and we know that quality primary care saves money for the system in the long term," said Maier, who is chairman of the House Health Care Committee.

The Vermont medical community is also looking at changing the way that primary care is delivered. Through a blueprint model originally developed to handle chronic care for patients, three pilot programs are underway in Burlington, Bennington and St. Albans that will provide a small supplemental sum for each primary care provider in the pilot. More importantly, the blueprint pilot establishes a team approach that would surround primary care doctors with physician assistants and specialists, who the pilot's drafters hope will assist family physicians and relieve some of their time and caseload burden.

Huebner said he is seeking to make Rutland the fourth pilot site for the blueprint.

In the meantime, the RRMC president said he's looking ahead to the opening of a federally qualified health care center at 69 Allen St. later this summer.

The center, which will serve as a satellite for the main FQHC center in Castleton, is starting small with just a single doctor, but Huebner said he has applied for funding to expand the practice by building a center on land owned by the hospital.

There are eight other FQHC centers in the state – the one in Springfield is the newest – and 34 satellite offices. The centers' greatest asset is something of a commentary on the underlying problem confronting other primary care doctors – they are paid a much higher reimbursement for Medicaid and Medicare patients.

The FQHC facilities operating in the state cover a majority of the state's 14 counties.

But independent U.S. Sen. Bernard Sanders, who has advocated for additional centers for years, said he won't be satisfied until two more centers are added in Addison and Bennington counties.

Sanders said this week that he has had recent success expanding the FQHC program, which will create 126 new health centers nationwide this year.

"We have 60 million people out there with no doctor of their own," he said. "What we need to do and work on is making sure that every person in the nation has access to a doctor."

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The Dumbing Down of Academic Medicine

01/04/2010 11:38 AM |

From the NY Times..Partners Healthcare is the first to walk the plank on political correctness when it comes to undermining industry-academic partnerships.   Just more money will flow overseas and to other less guilt-ridden institutions.  

Harvard Teaching Hospitals Cap Outside Pay

By DUFF WILSON

The owner of two research hospitals affiliated with the Harvard Medical School has imposed restrictions on outside pay for two dozen senior officials who also sit on the boards of pharmaceutical or biotechnology companies. The limits come in the wake of growing criticism of the ties between industry and academia.

Medical experts say they believe the conflict-of-interest rules at the institution, Partners HealthCare, go further than those of any other academic medical center in restricting outside pay from drug companies. The rules, which became effective on Friday, impose limits specifically on outside directors who guide some of the nation’s biggest companies.

http://www.nytimes.com/2010/01/03/health/research/03hospital.html?pagewanted=print

Will someone please explain to me what the downside of such ties are as long as all relationships are transparent and the research conducted is done so at arms length? Should academia receive no industry support of any kind?

However, it's okay for business professors who criticize pharma ties to academia to disgorge huge consulting fees from said corporations... 

"Thomas Donaldson, a professor of business ethics at the Wharton School of the University of Pennsylvania, said: “It strikes me as a breath of fresh air in a room that’s getting progressively more stale. I hope this will set a standard for others — hospitals, medical schools.”

Professor Donaldson, who advises large companies on corporate governance, said dual roles in a hospital and at a drug maker were “dicey at best” because a director’s duty is to look out for the corporation’s financial interests.

The irony or hypocrisy is not even noted because, well, only pharma dough is evil.  Meanwhile, I have obtained a photo of the new Partners RNAi antibodies facility... paid for from medical students actvitivy fees


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The Golden Clipboard

01/04/2010 08:35 AM |

As we flip the calendar to a new year, it’s time again for our drugwonks.com annual Golden Clipboard Awards.

 
Why a golden clipboard? Well, commenting on the current state of 21st century bioinformatics, CDER chief Dr. Janet Woodcock quipped that, "Today the major tool of modern medicine seems to the clipboard."

 

 

In the past, we’ve given out awards to those who impede (unwittingly or otherwise) the advance of medical progress. For 2009, in the spirit of non-partisanship, we hand out honors based on those who helped move the needle towards real healthcare reform in a more positive direction.

 

 

Herewith our 2009 honorees …

 

Honorable Mention: The FDA for telling Senator Dorgan et al. to park their idea for drug importation in a tamper proof location.

 

Honorable Mention: Richard "Buzz" Cooper of the Leonard David School of Public Health at University of Pennsylvania and Gary Puckrein of the National Minority Quality Forum for respectfully challenging the outdated Dartmouth methodology and forcing policymakers to examine the impact of poverty,

 

behavior and severity of illness on differences in health expenditures.  Equally dead is not a baseline.

 

Honorable Mention: Representatives Mike Rogers (R) and Anna Eshoo (D) for working together to promote a safe and savvy pathway for follow-on biologics.

 

Honorable Mention: Billy Tauzin for cutting “the deal” that protects the Non-Interference Clause, thus preventing a slippery slide towards broader government price controls for pharmaceuticals.  Price controls = choice controls.

 

The Bronze Clipboard: We are pleased to award the 2009 Bronze Clipboard to Paul Offit for bravely and publicly standing up to those (including CBS News) who slandered him and threatened the lives of his children for simply saying vaccines have benefits far outweighing the risks.

 

The Silver Clipboard: And the winner is NIH Director Francis Collins for telling it like it is about comparative effectiveness when he points out that it ignores individual differences that we know exist at the clinical and genetic level.

 

 

And the 2009 Golden Clipboard winner is … DRUMROLL PLEASE …

 

 

The Golden Clipboard Winner for 2009 is FDA Commissioner Peggy Hamburg for saying “yes” to science and personalized medicine and “no” to political interference at the Food & Drug Administration. She calls it like she sees it and that’s just the attitude required to help the FDA advance the public health by being both regulator and colleague to the industries the agency oversees. It’s a tightrope to be sure – but Dr. Hamburg has the requisite smarts and finesse.

 

And so, Golden Clipboards awarded, let us march forward together into 2010 with high hopes and in a spirit of cooperation to advance the public health.

 

(But we’re keeping our athletic supporters on just in case.)

 

Happy New Year.

 

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Healthcare Appendix

12/31/2009 11:04 AM |

In the debate over healthcare reform, I’ve often considered the old saw that “the plural of anecdote isn’t data.”  Sure, but what is it?  Having just had an up-close-and-personal interface with the American healthcare system – I have a suggestion:  the plural of anecdote is … reality.

This end-of-year revelation comes after my wife’s emergency appendectomy. Here’s the briefest chronology:

2AM: Horrible stomach pain and other relevant symptoms.
5:45AM:  911 call
5:50AM: EMTs arrive
6:00AM:  Arrive at emergency room
6:07AM: Wife in emergency room bed
6:15AM: Nurse takes blood
6:20AM: Initial physician consultation
6:25AM: Wife on saline and anti-nausea drip
7:00AM: Wife gets some morphine
7:00AM – 11:00:  Wife rests comfortably waiting for CT scan
11:00AM:  CT scan (One machine was out of service, hence the long wait.)
11:10AM:  Resident confirms diagnosis of appendicitis
11:15: Initial consultation with surgery resident
1:00PM: Surgery prep
2:00PM: Surgery
3:30PM: Recovery Room
5:00PM: Admitted to empty room
9:30AM (the following day): Released

To use a pain intensity scale analogy – the entire experience was only “moderately painful.”

Which brings me back to the plural of anecdote being reality.  As a good resident of the 21st century, I used Facebook to let my friends and family know about my wife’s condition. The Americans were all appropriately sympathetic. The Europeans were mostly amazed.  Amazed that we didn’t wait hours for an emergency room bed. Amazed that we saw a doctor in fewer than 5-8 hours. Amazed that we weren’t told to go home and come back at a later date (since her white blood cell count was only slightly elevated and the appendix wasn’t in danger of bursting) and not amazed but astounded that the surgery was done immediately. That there was actually a room available and that it was vacant – at a large urban hospital – they couldn’t even fathom.

Here is one verbatim comment from one continental comrade:

“I waited three days in London to see a GP and 20 hours at ER for an "exploratory op." It burst and I nearly died (to say nothing of the two life-threatening incidents whilst I was being "cared" for). But hey! The public option is better than letting people choose, right?”

So, while the plural of anecdote isn’t data – it is reality.  And, in the immortal words of George Santayana, “Those who do not learn from history are doomed to repeat it.”

Speaking of General Santayana, here’s one of his less famous observations – keenly apropos of the current debate on American healthcare reform, “Fanaticism consists in redoubling your efforts when you have forgotten your aim.”

And the occasional anecdote goes a long way to reminding us of that, um, reality.

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Shuren-uff

12/31/2009 06:30 AM |

According to a story in the New York Times:

“The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.

Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, said in a telephone interview on Monday that the F.D.A. most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added.

The F.D.A.-sponsored study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study. In addition, that study also found that about 25 percent of trials had failed to adequately follow the outcomes of a sufficient number of patients, a level the review defined as 90 percent or more of patients initially enrolled in a trial.”

The full New York Times story can be found here.

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"Med-Ops" for Pops

12/29/2009 07:26 AM |

Welcome a new phrase to the health policy lexicon, ““med-ops."

According to a new report just issued by the Center for Technology and Aging, medical optimization (“med-ops”) via information technology is an important element to improving medication-related errors and improving medication adherence among older adults.

The report says "widespread use" of technology aimed at this population could save thousands of lives and billions of dollars.

"More widespread use of technologies that reduce the cost and burden of medication-related illness among older adults is urgently needed," said David Lindeman, the center's director.

The Institute of Medicine reports that more than 2 million serious adverse drug events and about 100,000 deaths occur annually due to medication use problems. The New England Healthcare Institute estimates that $290 billion in healthcare expenditures could be avoided if medication adherence were improved.

"Medication non-adherence is responsible for up to 33 percent to 69 percent of medication-related hospital admissions and 23 percent of all nursing home admissions," said Lindeman. "As Congress debates ways to improve our healthcare system and lower costs, it will be critical to put in place incentives that encourage providers to accelerate the use of available 'med-op' technologies."

The report addresses three areas of opportunity for medication optimization: reconciliation, adherence and monitoring. It describes the technologies being used or under development within the three areas along with an assessment of their pros, cons, market stage and economics.

Some of the technologies described include:

    * Medication kiosks, such as those piloted at the Veterans Health Administration;
    * Walgreen's online medication history tool for consumers;
    * Cognitive assessment tests like the Mini-Mental State Exam (MMSE);
    * "Rex," a talking pill bottle designed by Pittsbugh-based MedivoxRx that assists visually or cognitively impaired patients;
    * The Med-eMonitor System, a portable electronic medication-dispensing device from Rockville, Md.-based InforMedix;
    * Mobile phone apps with medication management, reporting and trending features; and
    * Wireless point-of-care testing devices to monitor medication use.

According to the report, of the 3 billion medication prescriptions issued each year in the United States, 12 percent are never picked up by the patient and 40 percent are not taken correctly.

"And yet, effective tools and technologies already exist to greatly reduce these problems," said Lindeman. "Ultimately, medication optimization technologies can lead to significant improvements in the cost and quality of care for older adults."

Number of words devoted to such concepts in both the House and Senate health reform bills?  Zero.

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Hospice Patients First Victims of Health "Reform"

12/27/2009 12:03 PM |

Except in Chicago, dead people can’t vote. Perhaps that explains why Senate Democrats are financing the votebuying required to pass healthcare legislation with cuts to hospice care. Let me frame this Solomonic tradeoff more precisely: To buy the votes of specific Senators – a hospital here, a tax exemption there, the protection of a program (read: re-election) elsewhere needed about $2 billion.   The money comes from somewhere. Tax increases don’t kick in for a year a two, but Medicare cuts start next year.  And the deepest and most immediate cuts are in programs to help dying people. It’s estimated that next year hospice care programs will lose $2 billion nearly $10 billion overall over ten years. 

The best that can be said about this cynical exploitation of people and families in hospice settings is that at least there is no Death Panel making coverage decisions.   The cut is across the board, one size fits all and designed not to save lives or save Medicare as Senator Reid claims, but to win the support of specific Senators and special interests. Connecticut’s Chris Dodd gets a hospital,  New York and Florida get to keep Medicare Advantage, a program that allows poor seniors to get additional services (like hospice) without paying more premiums while millions of other seniors will be tossed from the program. (They will be able, once again, to buy expensive supplemental insurance from AARP, which coincidentally supported the health care bill.) There are very special Medicaid payments for Ben Nelson’s Nebraska, which already gets more dollars per person and a higher federal share of payments than the programs average. 

Liberals excuse this behavior by claiming it is the one-time cost of getting a deal done that benefits the nation as a whole.  However,  such horsetrading – cutting benefits to free up cash for universal healthcare is a central feature of both the House and Senate bills and of government run systems in general.  

Healthcare policy and deal making is already a big business. 

It is easier to get cuts by force than through regulatory “reform.” 

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