Latest Drugwonks' Blog
Here’s an excellent article by Dick Gephardt. Remember Dick Gephardt? Smart guy with an important message. Buzz is that he may be sharing this message from a more prominent perch in the near future. But buzz, as you know, often turns out to be just that.
In any case, enjoy this article (from Politico):
Medical innovation is economic key
By: Dick Gephardt
As Washington searches for solutions to continue our nation’s economic recovery, it’s time to cultivate new growth strategies.
Medical innovation should be key. It can create millions of high-paying jobs, increase our global competitiveness and help reduce our nation’s growing deficit.
Experts project that the health care sector will generate 3 million jobs from 2006 to 2016, with significant growth due to medical innovation. From lab coats to hard hats, medical innovation creates an array of high-paying positions across academic disciplines, management fields, health services and skilled trades.
Much of the promise from medical discoveries, new technologies and cutting-edge procedures is a direct result of America’s longtime leadership in medical innovation. Yet global leadership is now ours to lose unless we make a national commitment to needed strategic and sustained investments and partnerships to keep the U.S. competitive.
For medical and life sciences, research can transform local economies. Even in Michigan, which has seen serious job losses in many sectors, the number of people working in life sciences increased by more than 10 percent between 1999 and 2006. Average wages jumped 29 percent.
In Iowa, medical schools and teaching hospitals have a combined economic impact of $4.1 billion, according to the Association of American Medical Colleges. In Virginia, the economic impact is $9.9 billion. In Ohio and California, it is $27.2 billion and $41.6 billion, respectively.
One need only look to the Cleveland Clinic to see what’s possible. In addition to its world-renowned health care, the Cleveland Clinic has helped launch more than 200 cutting-edge inventions per year . It has spun off 24 separate companies in the past decade.
Cultivating this sort of activity on a national scale can spur new businesses and establish a truly 21st-century work force, fueled by the skilled workers and increased productivity that are byproducts of continued innovation.
Today, many experts suggest that we could forfeit our leadership if we do not address the challenges that have emerged. We are plagued with a shortage of capital and arbitrary limits on private investment. The U.S. Food and Drug Administration’s approval process is lengthy, costly and presents more uncertainty for struggling entrepreneurs.
Worst of all, our talent pool is shrinking. The U.S. ranked 16 out of 29 Organization for Economic Cooperation and Development countries in science literacy, according to the latest scorecard from the National Center for Education Statistics, and 24 out of 29 OECD countries in mathematics.
We must do more to produce the next generation of highly educated scientific innovators. And we must train and retrain students and adults for jobs to support medical innovation.
With high unemployment and skyrocketing deficits, we need a national strategy that will help us innovate our way out of our current economic crisis and create a path that ensures long-term opportunities.
This strategy could draw on the best of what we’ve learned from public and private sectors. It would create incentives for sustained public and private investment in medical research, education and training.
It would encourage public policies that spur technology transfer, appropriately protect intellectual property and help attract venture financing at all stages of research and development. It also would establish a tax and regulatory climate that encourages private enterprises — large and small — to participate in medical innovation.
For more than a century, the U.S. has been synonymous with medical discovery and achievement. This excellence has dramatically improved our quality of life, driven our ability to compete globally and created countless new domestic employment and economic opportunities.
Let’s make the decisions and investments necessary to continue to reap the enormous economic and human benefits made possible through medical innovation.
Dick Gephardt, former House majority leader, is now president and chief executive officer of Gephardt Government Affairs and serves as chairman of the Council for American Medical Innovation.
Samuel Goldwyn
A recent article in Health Affairs tries to prove what we all knew: there were cheaper, better ways to reform healthcare but political realities got in the way. The article:
"Could We Have Covered More People At Less Cost? Technically, Yes; Politically, Probably Not", concludes using a mathematical model believe it or not that shows only a few different approaches would produce both more newly insured people and a lower cost to the government. However, these are characterized by design options that seemed political untenable, such as higher penalties, lower subsidies, or less generous Medicaid expansion.
A few means more than two, so let's say five different aproaches. What made them politically untenable was not the burden it would place on taxpayers but the fact that politicians wanted to increase government control to the fullest extent possible.
Now what if the November elections become a vote on Obamacare and a new Congress reforms the current law to reduce the cost and government control?
You can read the abstract of the article here: content.healthaffairs.org/cgi/content/abstract/29/6/1142
Meanwhile the Health IT community is still trying to convince doctors that spending billions on new systems will improve quality and reduce costs even as physician payment under Medicaid will be slashed and reporting requirements will multiply. It seems to me that the only valuable contribution health IT can really make is to allow doctors and patients to improve health by the development of personaized and predictive approaches to care and paying for that approach. The rest is simply like remodeling a restaurant to look trendy and assuming it will increase the chef's ability to produce five star meals for twice as many customers even as his salary and food budget are cut in half. So much of health It is not only beside the point but created to establish new approaches to delivering care that have nothing to do with how medicine is practiced, or should be.
My recent op-ed on the new Independent Payment Advisory Board (IPAB) generated a lot of comments – and a lot of corrections. And so, in the spirit of transparency and disclosure and (most of all) thanks, here are some important emendations
1. In the article’s fourth paragraph, the last sentence reads, "And the IPAB's policy recommendation automatically will be institute unless Congress overrides them." Technically, it will be implemented automatically unless Congress comes up with its own proposal that meets the same spending cut targets. Congress can also (with 3/5 majority in both houses) pass a resolution rejecting the IPAB proposal, but that can be vetoed by the President and would then be subject to a 2/3 override. I oversimplified. Mea culpa.
2. Sixth paragraph, second sentence reads, "For one, it doesn't have any authority over the biggest cost-drivers in Medicare." I stand corrected. IPAB cannot make recommendations (before 2019) that would "reduce payment rates" to Medicare Part A providers or Part B suppliers. However, IPAB could nevertheless make recommendations with respect to those entities that would have the effect of implementing policies that would be viewed as unfavorable or harmful by those entities (or beneficiaries that rely on Parts A and B.) For example, IPAB could utilize the LCA policy for Part B drugs, establish a Part B national formulary, etc.
3. Ninth paragraph, first sentence reads, "Yet the IPAB has no power over Part A or Part B." While the IPAB cannot make recommendations to cut provider payments in Part A or B before 2019, but that does not mean they have no power over providers in Part A and B and in fact that there are lots of recommendations they could come up with that impacts these providers without cutting their payment.
4. Eleventh paragraph, first sentence, "The IPAB can make drastic changes to Medicare plans, including raising premiums, cutting benefits, and restricting eligibility requirements." Let me clarify. There is a prohibition on recommendations that would increase Medicare beneficiary cost-sharing (including deductibles, coinsurance and copayments) or otherwise restrict benefits or modify eligibility criteria – but the prohibition on raising premiums does not apply to Part D - but these other prohibitions do (rationing, cutting benefits and restricting eligibility.
As George Bernard Shaw wrote, “A life spent making mistakes is not only more honorable, but more useful than a life spent doing nothing."
And many thanks to all you drugwonks out there for the smart and savvy corrections. The devil is in the details.
These two articles demonstrate the importance of commercialization in addressing the clinical and logistical barriers to personalized medicine.
Medco, CVS Caremark Gear Up to Expand Genetic Testing Management Services
www.aishealth.com/Bnow/hbd060710.html
23andMe Partner to Provide Genetic Counseling
www.genomeweb.com//node/942414
This movement will be the counterweight to one size fits all comparative effectiveness...
Former Senate Democratic leader Tom Daschle and Victoria Kennedy, the late senator’s wife, are expected to be named co-chairs this week of a $125 million campaign White House allies are rolling out to defend health reform amid growing signs the party is failing to get political traction on the issue.
The extraordinary campaign, which could provide an unprecedented amount of cover for a White House in a policy debate, reflects urgency among Democrats to explain, defend and depoliticize health reform now that people are beginning to feel the new law's effects.
The Health Information Center is being started by Andrew Grossman, a veteran Democratic operative who founded Wal-Mart Watch, a labor-backed group to challenge the world’s largest retailer.
Even without issuing one press release, this "Health Information Center" misleads by ripping off the name of a "National Health Information Center" which is run by the federal government.
Here is the link to the site www.health.gov/nhic/. According to the site NHIC puts health professionals and consumers who have health questions in touch with those organizations that are best able to provide answers. NHIC was established in 1979 by the Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Office of the Secretary, U.S. Department of Health and Human Services.
NHIC also provides key support for the healthfinder.gov Web site, your gateway to reliable consumer health information.
And what does the new Health Information Center funded by cash raised by the Democrats claim to do:
The center’s rollout is part of a Democratic Party-wide effort to bolster support for health reform as the provisions begin kicking in.
Democrats and the White House will hold more than 100 simultaneous events nationwide as President Obama plunges back into health reform, selling the historic plan all over again as its provisions kick in. More than 10,000 people will be on the phone with the president as he holds a “national tele-town hall” meeting, 22 minutes from the White House at the Holiday Park Multipurpose Senior Center in Wheaton, Md.
This is, as noted above, an effort to "depoliticize" the implementation of the new health care law.
Which is why you want to call the propaganda effort THE HEALTH INFORMATION CENTER and not the Campaign to Neutralize Healthcare As An Issue In The Midterms Center
Calling it the Health Information Center reminds me of the restaurant Eddie Murphy worked at in "Coming to America" named McDowells. Cleo McDowell who runs the restaurant explains why McDonalds might have a problem with the name:
"Me and the McDonald's people got this little misunderstanding. See, they're McDonald's... I'm McDowell's. They got the Golden Arches, mine is the Golden Arcs. They got the Big Mac, I got the Big Mick. We both got two all-beef patties, special sauce, lettuce, cheese, pickles and onions, but their buns have sesame seeds. My buns have no seeds."
(I couldn't find the clip of this scene on youtube but here's another slice www.youtube.com/watch)
McDonald's. McDowell's. National Health Information Center. Health Information Center. What's the difference, right?
Oh, and there is also a Health Information Center on the web. www.healthinfocenter.org
If you have to hide what you really are and what your real goals are, how can the NATIONAL HEALTH INFORMATION be trusted?
Read more: http://www.politico.com/news/stories/0610/38199.html#ixzz0qC8awJUU
The buzz at ASCO is about more (and more expensive) personalized treatments – but the word on everyone’s lips is “diagnostics.”
And the question is whether FDA is going to be part of the problem or of the solution?
As the science of biologics necessitated the agency’s invention of CBER, so too does the promise of "personalized medicine" demand a new FDA bureau to further the development of 21st century diagnostics.
As CDER begat CBER so too must CDRH bring forth a new progeny. Let’s call it the Center for Diagnostics Advancement.
And let’s end the unfortunate ambiguity over the regulatory pathway for diagnostics.
FDA and NIH have launched a new website for reporting safety data.
The hope is that the Safety Reporting Portal (SRP) will streamline the process of reporting product safety issues to the FDA and NIH, with manufacturers, healthcare professionals, researchers, public health officials and consumers all able to submit an online safety report.
Currently, the site can be used to report safety problems relating to food (both human and animal), animal drugs as well as adverse events occurring on clinical trials involving human gene transfer.
Consumers can also report problems regarding pet foods and pet treats.
The website will eventually allow for safety problems with other clinical trials to be reported, as well as encompassing safety issues from products regulated by a broad array of federal agencies, such as the Environmental Protection Agency (EPA).
The FDA said it sees the site as the "first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event."
Organizations and individuals in certain professional roles, including drug manufacturers, researchers and food manufacturers, may be required by law to submit safety reports.
"The portal will be a key detection tool in improving the country's nationwide surveillance system and will strengthen our ability to protect the nation's health," said FDA commissioner, Margaret A Hamburg. "We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public."
From today's edition of Britain's Daily Mail:
NHS 'preparing to cut millions of operations': Patients will lose out to ensure £20bn savings
Millions of patients face losing NHS care as bosses prepare to axe treatments to make £20billion of savings by 2014, a top doctor has warned. Among procedures being targeted by health trusts are hernias, joint replacements, ear and nose procedures, varicose veins and cataract surgery.
Dr Mark Porter, chairman of the British Medical Association's consultants committee, warned NHS bosses wanted 'wholesale reductions in budgets'.
He said primary care trusts - which commission care - are already compiling lists of 'low value' operations that would no longer be provided.
These include hip replacements for obese patients and some operations for hernias and gallstones. Procedures for varicose veins, ear and nose problems including grommets in children are also not funded in some areas.
Dr Porter said it was wrong to impose blanket bans on such procedures when some patients might benefit.
Although the Government has pledged to defend spending, trusts are preparing for a period of 'unprecedented retrenchment' to make the £20billion savings within four years, he said.
'Already NHS commissioners are drawing up lists of health interventions that must be decommissioned. Cut. Stopped. Not done any more.
'These lists are clothed in the language of evidence but they represent target reductions based on cost and volume, sometimes ignoring the potential benefit to individual patients.
'Instead, in the quest for wholesale reductions in budgets, lists of banned treatments are being compiled. This is wrong.'
Dr Porter told the BMA's annual consultants conference that hospital doctors would stand up for patients.
Earlier this year the Government's rationing body said more cuts in medical treatments are planned to save the NHS at least £600million.
Patients could find it harder to get into hospital under plans from the National Institute for health and Clinical Excellence, which advises on drugs and procedures to be funded.
Chief executive Andrew Dillon said a review of clinical guidelines will be finished by the end of the year, which will include 'evidence of overuse' of treatments to 'see what the prospects (for savings) might be'.
Nice will also push through 150 changes to medical practice aimed at saving money, from reducing prescribing of antibiotics by GPs to delaying some prostate cancer tests.
A Department of Health spokesman said: 'Savings will be implemented in a way that does not affect the quality of services and all savings will be reinvested back in the NHS.'
www.nytimes.com/2010/06/03/business/03dartmouth.html
Now the question is, what role does Don Berwick have in enabling the perpetuating the Dartmouth machine? Has he consulted for Dartmouth or any of it's holdings? Have they paid him any honoraria, covered his expenses for any event. Has he used his connections to open doors for them and did he get anything in return? We know he is close to the Wennbergs and others in the Dartmouth empire. The vice president of his own group, the Institute for Healthcare Improvement serves on the board of the Health Dialog funded Foundation for Informed Medical Decisionmaking.
The conflict of interest game is played both ways...
Those who call for FDA to adopt comparative effectiveness as a regulatory third leg are laser-beam focused on cost effectiveness. What's important is to understand the unintended consequences of such rhetoric on pharmaceutical innovation.
For a brief lesson on the environment in which innovation operates, see here.
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.
