Latest Drugwonks' Blog
"A limited body of evidence informs gene expression profiling tests to inform cancer therapy decisions. It is unclear if the widespread addition of such testing to the evaluation of patients with would result in a meaningful change in disease management and improved health outcomes."
Yes, and it was unclear if the widespread addition of taxol to breast cancer patients would result in a meaningful change either. But it did. But only after we had a widespread addition through clinical use.
The larger issue is how CMS sticks approaches to evaluation that are outdated and fail to incorporate the same science used to develop the technologies they want to measure. This includes biological m markers of disease, disease progression, differences in treatment response and effects. This was and is the rate limiting factor that led the FDA to launch the Critical Path.
The Personalized Medicine Coalition has offered to meet with CMS to encourage a more patient-centered approach in evaluation, which is a great first step. But we need a Critical Path for Personalized Medicine to insure that the old tools and methods of evaluation are not used to exclude and delay access to innovations but instead help guide appropriate use from the outset and learn from how clinicians optimize care.
Here's a laundry list of some of the new technologies (and a few old ones) that CMS wants to apply outdated comparative effectiveness evaluation as NICE does in the UK
http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=19
Contact PMC for a copy of the letter it sent to CMS. It lays out a set of common sense set of patient-centered principles for evaluating new medical technologies.
http://www.personalizedmedicinecoalition.org/
Well, "conflict-free" is in the eye of the beholder. And conflict-free many academic medical centers are not.
To this point, consider the remarks that Roger Meyer, MD (Clinical Professor of Psychiatry, Georgetown University, Adjunct Professor of Psychiatry, University of Pennsylvania) offered at the recent conference held on the subject of industry-sponsored CME by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com). Dr. Meyer points out that the same accusations of conflict being leveled at industry are equally true for academic medical centers.
To view Dr. Meyer's slides (particularly slide #9, "The Impact of Commerce") along with other presentations from the CMPI event, click here.
Attention must be paid -- particularly by those who deem "health care like in England," as the "universal" solution to health care reform in the United States.
Starting next year, Eli Lilly and Co. will reveal how much money it pays physicians for speeches and consulting. According to a report in the Indianapolis Star, Lilly president and chairman, John Lechleiter, will announce the new policy in an address to the Economic Club of Indiana today.
"Lilly is striving to be a leader in improving transparency across our industry," Lechleiter said in a statement. "As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."
Under Lilly's registry of physician payments, they will list fees to physicians who serve the company as speakers and advisers. That information, which likely will include physicians' names and hometowns, will be posted starting in the second half of 2009 on a publicly accessible Internet database, Lilly said.
In 2011, Lilly plans to expand the database to include payments, updated annually, for clinical research and other provisions called for in the Physician Payments Sunshine Act pending in Congress.
For a big drug company to be the first to disclose its payments to doctors "takes a lot of courage," said Sen. Herbert Kohl, D-Wis., a co-sponsor with U.S. Sen. Charles Grassley, R-Iowa, of the Sunshine Act.
In 2004, Lilly became the first drug maker to voluntarily make public data on its clinical trials of new drugs. Last year it began publicly reporting its educational grants and charitable contributions, becoming the first in its industry to do so.
The complete story can be found here.
I have amended the blog and will now head out for a lunch of grits and crow.
Damn Yankees.
In the case of the Mass Health Connector for instance, it's insurance coverage without access to primary care. And by the way, the Commonwealth of MA refuses to allow retail clinics into the state. The result, newly enrolled folks are waiting a 100 days to see a doctor at Medicaid rates. And the plan is already $1 billion over budget.
http://www.boston.com/news/health/articles/2008/09/22/across_mass_wait_to_see_doctors_grows/
Obama's "plan" to extend coverage to 210,000 people in Illinois was accompanied by regs to force doctors and health plans to accept patients regardless of condition and reimburse at 30 percent lower rates than private plans. Years later people are still waiting to see doctors and the state of Illinois owes physicians nearly $2 billion in Medicaid payments.
Government financed and run healthcare is looking more and more like Fannie Mae and Freddie Mac backed mortgages, owners without assets, homes without homeowner as more and more people flood into a zone where they are encourage -- free of normal risk and responsibility and market controls -- to purchase and consume a good at an artificially reduced price in order to hit a hollow target. In the case of Freddie Mac it was home ownership. Government subsidized solutions to increasing health care coverage are largely focused on getting as many people covered as possible, burying the costs and paperwork and worrying about the impact on people and providers later. The result, over the past 15 years and as state efforts to create single payer systems have shown, has been a run up in costs and a decrease in access to care, particularly among minorities, children and the mentally ill.
Yesterday’s CMPI conference on the current state of continuing medical education addressed the single most important issue relative to industry-sponsorship of CME – it works.
William Mayo, MD
We made no bones about the fact that the briefing would make the case for CME and thanks to our panelists, we did not fail in this task. George Lundberg, the Editor in Chief of Medscape, made the point that most doctors like CME because they learn things from it that allow them to be better doctors, a theme restated by other participants.
Moreover, it became clear that the charges of bias-because-of-commercialism were being leveled by interests who themselves are mired in commercialism and stand to gain from and elimination of the commercial provision of CME. Further, the assaults on industry support of CME has discouraged investment according those in the trenches (Marissa Seligman Chief of Clinical Regulatory Affairs for Pri-Med, the largest commercial provider of CME for primary care physicians, Jack Lewin, president of the American College of Cardiology). Also discussed are the risk of undermining primary care and underserved populations. Data was presented by Dr. Leonard Bielory, Tom Sullivan of Rockpointe, and Jeff Drezner, CEO of Clinical Care Options in support of the claim that CME does improve clinical practice. Dr. Lundberg referenced a JAMA study showing that online CME is highly effective compared to CME workshops. And more data is widely available in medical journals underscoring this point.
CME should be part of an overall approach to making medicine more patient-centered, increasing access to health care in medically underserved communities and improving health outcomes. None of this achievable by banning or discouraging industry support for CME. On the contrary we need more CME, not less.
That was (and is) our message.
It’s a fair, honest – and personal account and it’s called:
A tale of 2 sickbeds: Health care in UK vs. US: A journalist's treatment for same condition in two countries is worlds apart
Here is a link to the complete story.
And here are some sample paragraphs to whet your appetite:
"LONDON - A few weeks ago I found myself curled up in a hospital here in London, my feverish body shaking violently back and forth. The pain in my side and back made it hard to straighten my torso, and I’d thrown up in a friend’s car on the way to the hospital.
"The hospital couldn’t find an extra hospital bed, so I spent my first night hooked up to an IV on a gurney in the middle of a row of men and women, my sweaty skin sticking to the plastic. A shriveled woman in the bed to my right issued loud and largely unintelligible commands to nobody in particular. A steady flow of patients visited the bathroom right in front of my bed. A shouting match broke out between some of the nurses and nurses aides until a man at the other end of the room yelled, “Could you please take it outside? I’m trying to rest.”
Sometime in the midst of this I was diagnosed with pyelonephritis, a severe urinary tract infection that had spread to a kidney, and ended up in the hospital for three nights. I had already been on two courses of antibiotics, but that hadn’t cleared up the initial infection. Finding myself sick and alone thousands of miles away from my mom was bad enough, but scarier still was just how familiar the illness felt.
I’d been sick with the same thing almost 10 years ago when I was in my 20s and still living in the United States, where I’m from. In both cases, my side and back hurt and fever shot up. And each time, I recovered after serious doses of antibiotics and lots of bed rest. But apart from that, my experiences were a world apart.
The biggest difference: Money. Getting sick in New York City decimated my bank account. In London, I didn’t pay a penny. I should note, however, that a full 9 percent of my gross pay goes towards the equivalent of a health tax. (For comparison’s sake, according to the Commonwealth Fund, in 2007 about half of working-age Americans spent 5 percent or more of their income on out-of-pocket medical costs and premiums.)
And while I recovered fully in both cases, the care I received felt quite different. In New York, I never feared that I would be overlooked. At my doctor’s office in upscale Gramercy Park, he and his nurses took their time seeing me, and were always at pains to reassure me. On my first visit, the receptionist let me sit in an empty consulting room so that I wouldn’t have to weep in the waiting room. She checked in on me and brought me water.
But unlike the personal care I received in the US, in London, I felt like I was on a vast and often creaking conveyor belt, and there was a big risk of falling through the cracks. British care is socialized — and feels that way."
Alas, there are no simple solutions to America’s health care woes. But there is significant danger in those who promise an “EU-style” panacea.
We look forward to the forthcoming debate between Senator McCain and Senator Obama (the one on October 15th at Hofstra) to see how they address the tough, perplexing – and crucial issue of American health care reform.
In the meantime, please visit www.biggovhealth.org to learn more about the problems inherent in government-run health care.
Now maybe people will start listenng.
Both campaigns, it seems, have come to their senses. The issue is safety.
And:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
The important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
The next canard, that of "universal" care is even more dangerous. It's government care -- and it ain't free.
"Universal" care is the new importation.
But we'll bask in the demise of importation until Monday.
(And, hopefully, reports of its death have not been greatly exaggerated.)
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.
