Latest Drugwonks' Blog

With the amount of misinformation and deliberate distortion that characterizes the American discussion of health care reform, it is no surprise that it has tended to devolve into little more than a shouting match. In the process, both extremes seem to have lost any grip they ever had on reality. This is especially true when many American commentators invoke the failings and successes of health care systems in other countries.
 
Perhaps the greatest and most prevalent fallacy about health care overseas is the enduring myth of the ‘European health care system’ where treatment is free. First, Europe is a continent with more than two dozen countries – and just as many health care systems. Second, single-payer, government-run systems are only one end of a continuum that runs all the way to systems that are highly market based systems, arguably more so than that of the US.
 
Countries with government single-payer health care include: the UK, Portugal, Spain, Italy, and the Scandinavian countries. The Republic of Ireland is single-payer but with a substantial private sector. The UK is actually somewhat unusual in that the government owns the public providers as well as paying for care, in many single payer systems doctors and hospitals are at least partially private.
 
France is often labeled a single-payer country but in fact it has a two-tier mixed system. The French are charged a payroll tax that funds basic coverage for everyone that is administered through quasi-private insurers, not through a government bureaucracy. Most people also buy separate supplementary coverage. Doctors and hospitals are private and patients have full choice. Belgium is similar.
 
Germany administers health care through private (but nonprofit) insurance companies and is paid for through premiums deducted from payroll. There is also a private insurance system in which about 10 percent of Germans participate. Recent reforms, however, are introducing more of a role for government. Austria has a similar system.
 
The Netherlands and Switzerland have market driven systems which use a philosophy called ‘managed competition.’ Coverage is purchased from primarily nonprofit insurance companies, via work in the Netherlands and by individuals in Switzerland.
 
The rampant confusion about what these systems look like seems to stem from a tendency to elide universal coverage and single-payer. It makes sense to look to other countries, especially when most any strategy Americans are considering has been tried somewhere, but if policy wonks and politicos, never mind the population, cannot do the most cursory of research, than they squander those lessons.
 
The ‘European healthcare system’ may be imaginary, but the consequences of believing in it aren’t.

How about a tax break for staying healthy?

Senators Max Baucus, D-MT, and Tom Harkin, D-IA, are drafting legislation to use tax incentives as an incentive for businesses to develop a healthier workforce through employer-sponsored wellness programs.

“Prevention and wellness should be a centerpiece of healthcare reform,” said Harkin, who regularly climbs the stairs to his seventh-floor office on Capitol Hill.

Certainly seems like a common sense approach, as employees with elevated cholesterol and blood pressure, poor blood glucose control and excess weight are more likely to get sick, develop chronic disease, experience absence and disability and over utilize their fair share of expensive healthcare resources, making U.S. firms less competitive and makes the tax incentive concept seem like a no-brainer.

Maybe. But there’s a more efficient and practical alternative without enacting yet another undue burden on business: Personal tax incentives to adults and their dependents for achieving and maintaining healthy body weight. See
here to see how.

To facilitate public participation, a grass-roots social marketing campaign should be undertaken. One of President Obama’s eight principles for health legislation is that it must “invest in prevention and wellness. Yes we can.


Check Out CMPI's New Book:


Physician Disempowerment: A Transatlantic Malaise

Download the E-Book Version Here

Few relationships are more personal, private and important than the one between doctor and patient. Yet, today, one both sides of the Atlantic, physicians are increasingly having there decisions second-guessed by distant third parties. “Physician Disempowerment:  A Transatlantic Malaise,” a new book from the Center for Medicine in the Public Interest (CMPI) chronicles the recent -- and pronounced -- intrusion by government and other disinterested third parties into the private medical relationships patients have with their doctors.


While this insidious “adverse event” has been an issue in Europe and Canada for many years, it is just now emerging as the hidden third rail of American healthcare reform. The book also includes essays by physicians and policy makers who work in the oft-vaunted socialized healthcare systems of our neighbor to the North and Western Europe.

 

Dr. François Sarkozy, a pediatrician (and also the brother of the French President) shared his impressions of the state of the French medical profession. "There’s a relative loss of status in being a physician. There’s a malaise with the French physicians," he says. "We’ve seen that independent private practice has become less attractive in France than it was before.


The book is based on a conference recently held by CMPI in Washington, DC, that brought together a dozen doctors, policymakers, and health scholars. We hope that readers will take note of the dire realities of a healthcare system laden with government interference -- and take heart in the fledgling efforts to restore the doctor-patient relationship to its rightful place.

An electronic copy of Physician Disempowerment: A Transatlantic Malaise can be downloaded at by clicking here.  Hard copies can be obtained by contacting CMPI at (212) 417-9169.


21 and Legal

  • 05.19.2009
Dr. Margaret Hamburg will be sworn in as the 21st commissioner of the Food and Drug Administration. The Senate confirmed her nomination by voice vote.

All in favor, say "yea."
Comparative effectiveness is alive and well....

Here is the entire decision from CMS on CTC for colorectal

Click Here to View the Decision

And note the key word that runs throughout... AVERAGE as in one size fits all.   The key to disallowing advances is to insure that the benefit has to be shown to fit everyone in a large scale randomized trial...  Or as CMS says (and you better get used to this phraseology...    the evidence is not sufficient to conclude that screening CT colonography improves health benefits for asymptomatic, average risk Medicare beneficiaries. While it is a promising technology, many questions on the use of CT colonography need to be answered with well designed clinical studies that focus on health outcomes for the Medicare population.”

Why not try getting evidence of cold fusion?

May 19, 2008
CMS initiates this national coverage analysis for the use of screening CTC for colorectal cancer.  The public has 30 days to submit comments on this topic.  CMS considers all public comments, and is particularly interested in clinical studies and other scientific information related to the technology under review.  We are especially interested as to the types of studies needed if the evidence is determined to be premature for coverage or if the appropriate frequency interval is uncertain.

November 19, 2008
CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to review the available evidence on the use of CTC as a screening test for colorectal cancer for average risk individuals, including test characteristics, screening frequency, cost effectiveness, safety and training requirements.

February 11, 2009
CMS posts a proposed decision memorandum and the 30 day public comment period begins.

March 3, 2009   
CMS met with representatives of the American Cancer Society, the American College of Radiology, and the American Gastroenterological Association and listened to their concerns regarding the proposed decision memorandum and asked them to reflect those concerns in the written comments they submit during the public comment period.

March 10, 2009
CMS met with representatives of the Medical Imaging and Technology Alliance and listened to their concerns regarding the proposed decision  memorandum and asked them to reflect those concerns in the written comments they submit during the public comment period.



The value-based design legislation proposed by Senator Hutchinson and Senator Stabenow could be a great platform for promoting personalized medicine...

Bill Would Test Value-Based Insurance in Medicare
Les Masterson, for HealthLeaders Media, May 15, 2009

Legislation filed yesterday would create a demonstration project to test whether value-based insurance design can work in the Medicare population.

Trumpeted by employers and health plans as a way to both improve patient outcomes and lower long-term health costs, VBID lowers or eliminates copays for high-value prescriptions and treatments, such as medication for diabetes, asthma, and heart disease. The concept follows the logic that removing cost barriers will help at-risk patients follow their prescription regimens and not postpone doctors' appointments because they can't afford the care.

The bipartisan legislation was filed by Sen. Kay Bailey Hutchinson (R-TX) and Sen. Debbie Stabenow (D-MI). Hutchinson says the federal government has lagged behind the private sector in adopting VBID strategies.

"Value-based insurance design has the power to truly bend the healthcare cost curve in the right direction. By taking practical steps to lower healthcare costs and improve health, we can make insurance more affordable for all Americans. Ultimately, that is the single most important goal of healthcare reform," says Hutchinson.

VBID pilot programs have been successful in the commercial population. Pioneers in the VBID movement, Marriott and Pitney Bowes, eliminated cost sharing associated with diabetes medications and achieved positive cost and quality outcomes.
While many health insurers and employers have increased copays and created high-deductible plans as a way to lower their healthcare costs, VBID supporters say the concept is a more forward-thinking way to tackle spiraling costs.

One of the creators of VBID, A. Mark Fendrick, MD, who is co-director at the University of Michigan's Center for Value Based Insurance Design, says, "Cost containment efforts should not lead to preventable decreases in quality of care. The inclusion of value based design into the Medicare program will show that an approach that encourages the increased use of high-value medical services will produce more health for every taxpayer dollar spent."

Could VBID work in Medicare?

A recent white paper by Avalere Health and the Center for Value-Based Insurance Design suggested that the government could implement VBID in Medicare. VBID addresses both the objectives of cost containment and quality improvement by promoting fiscally responsible, clinically sensitive cost sharing, according to the white paper.

VBID advocates and policymakers think the concept could be a winner in the Medicare population. Twenty-three percent of Medicare's 26 million beneficiaries have five or more chronic conditions and account for nearly 70% of the program's spending.

Medicare beneficiaries are more likely to have chronic illness than the commercial population and more apt to take multiple medications.

Costs can create a barrier to medication compliance for beneficiaries. In fact, the Medicare Part D population takes five prescription drugs per day on average and nearly 20% of them are not able to fill a prescription or delay filling a prescription because of cost, according to the white paper.

"You have the potential to have an even greater impact [in the Medicare population] because the sicker the beneficiary is and the more you can target a value-based insurance design, the better the outcomes are likely to be," says Lisa Murphy, manager at Avalere Health in Washington, DC, and coauthor of the paper.

The researchers reviewed five options for Medicare and found that three of them can be implemented immediately with minor operational changes:

Reduce cost sharing for specific drug or drug classes

Exempt specific drugs or drug classes from 100% cost sharing in the coverage gap

Reduce cost sharing for chronic special needs plan enrollees based on the plan's target condition

The other two options that were reviewed would require policy changes, such as CMS revising its non-discrimination clause to allow for reduced cost sharing for enrollees with chronic conditions or reducing cost sharing for enrollees in Medication Therapy Management Programs.

Tanisha Carino, PhD, vice president at Avalere Health in Washington, DC, and co-author of the paper, says her research shows VBID's potential in the Medicare population. She says VBID has the potential to help make Medicare a "more prudent purchaser of healthcare that meets patient needs. These tools need to be considered in the context of health reform as they map directly into the administration's goals of improving quality and preventing complications of illness."

Click Here to View the Full Article

Legend has it that the great Bauhaus guru Walter Gropius coined the phrase, “Less is More.”  But it was Ludwig Mies van der Rohe (the visionary behind such edifices as the Seagram’s Building in New York) who quipped, “but more tastes better.”

And indeed it does.

So, in the spirit of “more tastes better,” please welcome the newest pharma blog “More than Medicine.”  It’s sponsored by GSK and can be found at

http://www.morethanmedicine.us.gsk.com/blog/

Here’s the “More than Medicine” credo:

“Too often the U.S. pharmaceutical industry's communications to the outside world are seen as a bit stuffy and formulaic.  Not to be too defensive, but there is a pretty good reason: we're under greater scrutiny than many other industries--and rightly so.  We're in the healthcare business, and what could be more important than the health of our child, parent, spouse, or partner?  Healthcare is an incredibly personal and emotional issue, and we ask doctors and patients to put a great deal of faith in what we say and the products we make. But healthcare is about more than medicine.  It's about trying to make sure that patients have access to the best care, treatment and medicines available. It's about doctors and other prescribers being able to match the right patient with the right medicine.  It's about each of us doing our very best to lead healthy lifestyles. Healthcare is about preventing people from becoming ill; managing diseases when they become sick; and continuing the search for better treatments and cures. That's why GSK started the More Than Medicine blog.  Our goal is to encourage an open, productive discussion about a range of topics related to the US healthcare system and how it can be improved.  And we're going to try and do our best to provide a GSK perspective that doesn't sound like it's written in legalese." 

So, for those of you who embrace legalese – sorry.  For everyone else – hooray!

There are a series of “legacy” posts (posts that predate the official launch) and they’re worth reading.  I served as a beta tester of this site and found it interesting (a must) and timely (unusual, but pleasantly surprising from the Brethren of Big Pharma).

Have a look. Regularly. 

And congrats to GSK for their effort.  Welcome to the neighborhood.

From today’s Financial Times:

Advisory body faces critics on drug payments

By Andrew Jack, Pharmaceutical Correspondent

The government's medicines advisory body meets critics today to debate changes to the way it decides whether the National Health Service pays for costly new drugs.

Professor Sir Ian Kennedy, who is chairing a review triggered by attacks on the National Institute for Health and Clinical Excellence, will hear complaints from the pharmaceutical industry, patients and academics that it it does not take sufficient account of innovation.

The hearings, drawing on more than 40 organisations, follow worries that Nice risks slowing research into new medicines by rejecting those with promise but which are seen as too expensive for the benefit that they provide.

His study follows last year's attacks on Nice when it advised against the NHS paying for costly cancer drugs. Topics set for discussion in the two-day consultation include whether the government should become more involved in funding clinical trials as a way to share the risks of costly new drug development with the pharmaceutical industry.

Patient groups argue that assessments for drugs such as those for Alzheimer's disease fail to take into account the relief they provide in terms of broader social care costs outside the health system, which is beyond Nice's authority. Others criticise the way in which Nice calculates the quality-adjusted life years by which it judges the value of a medicine, and questions whether it adequately assesses the severity of some conditions.

However, the Commons health committee last week warned that a move to allow Nice to approve more costly drugs of limited benefit risked taking away scarce resources from other medicines with greater demonstrable benefit.

More as more develops.

Ripples of Hope

  • 05.17.2009
It has been a while since I posted.  I was busy putting together the launch event held Wed. May 14 for CMPI's Odyssey Project on Entrepreneurial Capitalism and Biomedical Innovation.   Innovation has hardly been mentioned by anyone who is covering or involved in what is a non-debate about health care reform.   And yet without innovation, the ability to commercialize discoveries, we can forget about improving care, increasing access or reducing the cost of treating disease, assuming we are not willing to allow government to kill people to save money. 

I think inside the Beltway there is this belief that if the executives of each patient group can be called in and massaged/threatened by pols that innovation will be protected silence can be bought.  Perhaps it can for a while.  But obvious discomfort of comparative effectiveness supporters have in even talking about the process -- they would rather try to silence those who have legitimte questions by attacking them as reactionaries -- suggests that their motives are less than pure.   And in any event the measure of process will be the extent to which it targets new technologies instead of trying to develop tools for selecting treatment options that encourage preventive and prospective care.

Which brings me to the event itself.    Mike Ferguson, the former Congressman and CMPI fellow moderated the event which included three of his friends and colleagues, Congresswoman Anna Eshoo D-CA,  Mike Rogers, R- MI and John Crowley, CEO of Amicus Therapeutics.    Unfortunately Elijah Alexander, the former NFL linebacker who has battled multiple myeloma could not join us because early that week he was admitted to the ICU with an infection and low blood cell count. 

I can't do justice to the eloquence and passion of our speakers.  Eshoo spoke of the importance of encouraging future biotech investment.  Mike Rogers talked about how comparative effectiveness guidelines would have "guided" his doctor away from tests that flagged his cancer when he was a teenager. And John Crowley, who's search for a cure to treat his twins rare disease is now the subject of movie with Harrison Ford talked movingly about  how government regulation could have made his investment imposslbe.   There was bi-partisan agreement that we shouldn't give an inch on any effort to limit incentives or access to innovation for the sake of cost control. Second guessing at any point could easily stifle or discourage research or technologies deemed a waste of money that years in the future could or have culiminated n transformational cures. It is not just a matter of the inability and ineptness of government planners in determining what thousands of patients, scientists and physicians can decide. It is also because innovation generates it's own excitement and inspiration that can be undermined by centralized planning. 

As the absence of Elijah and John’s comments underscored, innovation is incremental but also inspirational. To paraphrase Robert F. Kennedy, it is numberless diverse acts of freedom, inspiration and belief that sustains innovation. Each time someone pursues an idea, or acts to improve the lot of others, or seeks to  battle a disease that has no cure, that individual sends forth a tiny ripple of hope. Those ripples cross each other from a million different centers of energy and daring and build a current which sweeps away the most daunting afflictions, to energize yet another wave of innovation. Only the impatient hand of government possessed with the arrogant sense it has absolute knowledge can fully stop this process. 

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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