Latest Drugwonks' Blog
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
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,
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.
All in favor, say "yea."
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.
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
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
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.
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.
In
After President Obama’s “historic” meeting with six major health care organizations, Robert Pear reports that, “confusion swirled in
For those of you who missed the details or were otherwise caught up in the NHL and NBA playoffs, the President announced that, from 2010 to 2019, the major players in American healthcare pledged to cut the rate of growth of national health care spending by 1.5 percentage points each year or about $2 trillion over all.
However, Pear writes, “Health care leaders who attended the meeting have a different interpretation. They say they agreed to slow health spending in a more gradual way and did not pledge specific year-by-year cuts.”
And here’s the fun part:
“Nancy-Ann DeParle, director of the White House Office of Health Reform, said “the president misspoke” on Monday and again on Wednesday when he described the industry’s commitment in similar terms. After providing that account, Ms. DeParle called back about an hour later on Thursday and said: “I don’t think the president misspoke. His remarks correctly and accurately described the industry’s commitment.”
Thanks for the clarification,
According to those who were at the meeting, there was some misspeaking by the President.
The
In the bulletin, Richard J. Pollack, the executive vice president of the hospital association, said: “The A.H.A. did not commit to support the ‘Obama health plan’ or budget. No such reform plan exists at this time.”
Moreover, Mr. Pollack wrote, “The groups did not support reducing the rate of health spending by 1.5 percentage points annually.”
Two other lobbyists who attended the White House meeting confirmed Mr. Pollack’s account.
One of the lobbyists, Karen M. Ignagni, president of
David H. Nexon, senior executive vice president of the Advanced Medical Technology Association, a trade group for makers of medical devices, said “there was no specific understanding” of when the lower growth rate would be achieved.
Maybe it was a typo on the teleprompter.
CMPI: Health Reform Must Support Rather than Impede Medical Innovation
Health Leaders Launch "The Odyssey Project" to Foster Continued Medical Progress
Washington, DC (May 15) -- Yesterday, the Center for Medicine in the Public Interest (CMPI) launched The Odyssey Project, a new initiative to ensure that support for medical innovation remains a top priority in any healthcare reform effort.
"The Odyssey Project will provide a forum for discussing medical progress over the past half century," said Peter Pitts, President of CMPI. "It will create a roadmap for ensuring that public policy continues to offer patient-centered prescriptions for
The Odyssey Project is a multiyear effort focused on bringing comprehensive information into the reform debate to educate the public and national policymakers about how biomedical innovation, far from being a major source of rising health care costs, has been and will continue to be the most important source of solutions to the challenges facing our healthcare system. The Project will propose fundamental changes in attitudes, regulations, health policies and healthcare financing that focuses on the near-term potential of new technologies and services that advance personalized medicine and allow individuals to save money while improving their health.
Rep. Mike Rogers (R-Mich.), a member of the House Energy and Commerce Subcommittee on Health and a leading advocate for high-quality, accessible health care said that The Odyssey Project is about improving health care.
"The Odyssey Project is exciting because it is ultimately about saving lives and improving health care for American families,"
CMPI Vice President Robert Goldberg highlighted the importance of technology to saving lives. "Medical technology is not a costly burden to be contained, but the solution to humanity's greater challenges," Goldberg said. "It's counterproductive to reduce health spending by diminishing access to innovative new therapies. Indeed, over the past 50 years, the commercialization of medical discoveries and the development of more effective ways of integrating the use of these products to sustain individual health has produced enormous economic benefit to our nation and added to the health status of countless Americans. Policy changes that impede innovation will not save money or provide for better health."
Elijah Alexander, a former NFL star who is currently the president of the Tackle Myeloma Foundation, spoke of the importance of medical innovation in his own life, as a cancer patient. "Drugs come from private companies, and that requires years of trial and error by dedicated researchers," Alexander said. "Profits drive investment, and investment supports research. If I had been diagnosed with multiple myeloma 10 years ago -- before the drug that has saved my life, Revlimid, was developed -- I would probably not be here today."
Mark Thornton, the President of the Sarcoma Foundation of America, called on policymakers to protect
According to the Pink Sheet, “Senate Finance Committee Chairman Max Baucus, D-Mont., plans to propose patient protections for federal comparative effectiveness research that draw a clear line separating information gathering and coverage decisions. The "pro-patient safeguards," as they're being called, would take the next step after previous Baucus statements that seek to distance comparative effectiveness from insurance coverage decisions, according to Finance Committee staffer Shawn Bishop.”
Further, “One provision would bar CMS from having ‘automatic links to a study’ in a coverage decision, Bishop said. Creating safeguards via legislation suggests Baucus is taking seriously opposition to comparative effectiveness research and is sensitive to criticism that comparative studies could lead to a "one-size-fits-all" health care system.”
This news from an event sponsored by our good friend the very smart Ellen Sigal of Friends of Cancer Research.
Friends of Cancer Research makes four key recommendations:
1) A comprehensive comparative effectiveness research program should be developed to identify the most effective health options.
2) The program should link data from public and private entities.
3) CER studies should support the development of personalized medicine.
4) Processes should be developed to ensure information from CER is incorporated into clinical practice.
Ellen's not the only Sigal who knows how to build from the ground up.
Another of our smart friends,
"I have a lot of experience in this," Woodcock said. "A clinical trial network needs to be set up" in order to increase the number of trial investigators participating in CER studies.
"We need to lower those barriers in order to get more participants," Woodcock said, adding that a "first-time investigator is also a last-time investigator" due to the red tape involved in conducting a clinical study in the
Okay – it’s a start. And the more people calling for a Critical Path for Comparative Effectiveness the better.
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.
