Latest Drugwonks' Blog
http://www.economics21.org/commentary/incredible-lowering-medicare-drug-benefit-baseline
June 2003, "I happen to be a proponent of a single-payer universal health care program." -- Barack Obama
Calling for the revocation of the Kennedy/Daschle Non-Interference Clause is the Drug Importation canard of the Obama Administration. – a faux policy that pretends to offer an easy solution to a complex problem. Populism may "sell" but it doesn't solve – and it may be a stalking horse for something more ominous.
During Tuesday’s State of the Union the President said, “We’ll reduce taxpayer subsidies to prescription drug companies.”
And on Thursday (and right on cue), a “coalition of liberal groups” (according to an article in Politico), launched a campaign to allow Uncle Sam to negotiate Medicare drug prices, claiming it will “save billions of federal dollars every year.”
Senator Amy Klobuchar (D/MN) recently introduced a bill (S. 117) to empower the Health and Human Services Department to negotiate for lower drug prices. "This is a matter of fairness for our seniors, who deserve affordable prices for their prescription drugs, and it is a matter of fairness for America's taxpayers, who deserve less waste in our system," she said.
Senator Klobuchar should pay closer attention to the numbers.
The non-partisan Congressional Budget Office (CBO) has found that Part D plans “have secured rebates somewhat larger than the average rebates observed in commercial health plans.”
And the Medicare Trustees report that “many brand-name prescription drugs carry substantial rebates, often as much as 20-30 percent and that on average, across all program spending, rebate levels have increased in each year of the program.
Is the argument that Uncle Sam could do better?
According to the CBO (in 2004), revoking the Kennedy/Dascle Non-Interference Clause, “would have a negligible effect on federal spending because CBO estimates that substantial savings will be obtained by the private plans and that the Secretary would not be able to negotiate prices that further reduce federal spending to a significant degree. Because they will be at substantial financial risk, private plans will have strong incentives to negotiate price discounts, both to control their own costs in providing the drug benefit and to attract enrollees with low premiums and cost-sharing requirements.”
In 2007 after two years of experience with bids in the program, the CBO found that striking noninterference “would have a negligible effect on federal spending because … the Secretary would be unable to negotiate prices across the broad range of covered Part D drugs that are more favorable than those obtained by PDPs under current law.”
In 2009 after even further program experience, the CBO reiterated its previous views, stating that they, “still believe that granting the Secretary of HHS additional authority to negotiate for lower drug prices would have little, if any, effect on prices for the same reason that my predecessors have explained, which is that…private drug plans are already negotiating drug prices.”
Importantly, the CBO says that no further savings are possible unless the government restricts beneficiary access to medicines or establishes market-distorting price interventions.
In the words of USA Today (America’s vox populi) “Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan … With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
Is revoking the Kennedy/Daschle Non-Interference Clause the President’s next move towards what he has previously said is his preferred policy solution – a single payer system? It’s a question worth asking.
Just in time for Valentine’s Day comes the Institute of Medicine’s new report, Countering the Problem of Falsified and Substandard Drugs.
Some relevant findings include:
· Congress should fund the FDA to do a national track and trace system, possibly using California as a model.
· The 50 states should adopt NABP's standards for wholesaler licensing (and revocation of license).
· The FDA should publish a list of wholesalers who have lost their licenses from states to, in effect, create a de facto national wholesaler blacklist.
· NIST should setup a repository of counterfeit detection technologies.
Lots of good information.
More good information (and insights) will be at hand at the February 28th conference, The Danger of False Profits: The Threat of Counterfeits to the Public Health. Jointly presented by the Center for Medicine in the Public Interest and the Institute for Policy Innovation, this event will feature speakers iSenior Counselor to the FDA Commissioner John Taylor, Jeff Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce, John Clark, Vice President & Chief Security Officer, Pfizer, Michael Maves of Project Hope, Former Executive Vice President and CEO, American Medical Association, Gaurvika Nayyar Research Fellow and Analyst, National Institute of Health, among others.
Event Details:
Thursday, February 28, 2013
9:00 am - 2:00 pm
Reserve Officers Association Headquarters, 5th Floor
One Constitution Ave NE, Washington DC
*Complimentary lunch will be provided
Questions? Please contact Erin Humiston at (972) 874-5139, or erin@ipi.org
President Obama on Medicare,
“We’ll reduce taxpayer subsidies to prescription drug companies and ask more from the wealthiest seniors.”
Does that mean another ill-considered assault on the Kennedy/Daschle Non-Interference Clause and a call for Medicare means-testing? Stay tuned.
“Our government shouldn’t make promises we cannot keep.”
Like "If you like your health care plan, you can keep your health care plan.”
Hm.
“But we must keep the promises we’ve already made.”
Like 12 years of data exclusivity for biologics?
Just asking.
He that promises most will perform least.
-- Gaelic Proverb
I am pleased to announce that Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., a nationally recognized expert in clinical research and development, has been selected as deputy center director for science operations.
With CDER now over 4,000 employees, Dr. Moscicki, in his newly established role, will join Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in providing leadership and overall direction to Center activities to ensure that we accomplish our mission most effectively.
Dr. Moscicki currently serves as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011.
Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He is known to be inclusive in his management style and is credited with implementing solid business practices to sustain the company’s long-term operations.
As deputy director for science operations, Dr. Moscicki will share in executive direction of Center operations and provide leadership in overseeing the development, implementation, and direction of our programs.
Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.
His medical, academic, clinical, and regulatory knowledge and expertise – coupled with his strong leadership and organizational management qualifications – make him the ideal candidate for this important position.
Please join me in welcoming Dr. Moscicki. He respects the work that we do and is looking forward to bringing his skills and experience to our Center to assist us in advancing the Agency’s mission.
Janet Woodcock
Less is more.
The CBO report outlining its 2013-2023 projections is not pretty reading -- but there is one exception:
“The largest downward revision in the current baseline is for spending for Medicare’s Part D.” (This citation appears on page 57 of the report.)
The actual data table can be found here.
The ever-accumulating evidence shows that Part D is succeeding beyond all expectations, delivering needed prescription drugs to Medicare beneficiaries for less money than anyone expected—driven by strong competition among plans.
Note to President Obama, if it ain’t broke, don’t fix it.
Smart partnership between government and the free market works.
3D bioprinter and “virus traps” take top startup honors at FutureMed pitch contest
As you’d expect at an event called FutureMed, disruption ruled this week’s event, and Saturday’s startup pitch contest was no exception.
Of the 27 companies that participated, the two that wowed the panel of investor judges the most were seriously outside-of-the-box ideas.
For their “startup to watch” award, the judges chose a company that made a splash in the tech world last fall when Peter Thiel’s foundation put $350,000 behind its novel idea to make more sustainable meat by 3D printing it. That company is ModernMeadow, co-founded and pitched by Andras Forgacs, who’s also one of the co-founders behind the human tissue-focused 3D bioprinting company Organovo.
It was a compelling presentation with some mind-blowing statistics and visuals depicting theresources required to produce a quarter-pound burger. ModernMeadow’s business model also includes a cultured leather product.
The overall startup winner, Vecoy Nanomedicines (Vecoy standing for virus + decoy), is focused on creating a new way to address one of the biggest unmet needs in medicine by outwitting viruses that cause infection.
The Israeli-based company is working on a therapy that uses tailor-made “virus traps” that mimic human cells and cause viruses to attack them. When they attack, the viruses get locked into the decoys and annihilate themselves before they can reach the real human cells, CEO Erez Livneh said. He noted that this new approach to fighting viruses may have the potential to lower the viral load in patients with HIV/AIDS, hepatitis B and C and other infections.
[Disrupt image from BigStock Photos]
“So far, most new (cancer) drugs offer only marginal extensions of life and few cures. “
Now a look at the facts and where Pomalyst fits in the progress we are making against MM. Pomalyst was studied in people with MM who had no other options. As in, their MM was no longer responding to other drugs and they were going to die.
Clinical trials showed that median overall survival for people getting Pomalyst was 13.7 months.
Another study looked at response of patients who were no longer responding to other drugs and whose MM had already come back:
Clinical trials showed halfway into the study that nearly 50 percent of people receiving Pomalyst responded rapidly (as in the MM stopped progressing) and 78 percent had a median surival time of between 3-6 months. Patients receiving Pomalyst were seven times more likely to respond (and live) then those who received an old MM drug.
Now overall survival is the average time half of all patients in a study will live after treatment. So a median survival of 13.7 months means that after 13.7 months, 50% of people with that condition would be alive, and 50% would have passed away. Which also means that many people in the trials are living much longer than 13.7. Or in the other study, 3-6 months.
Several studies have shown that the median survival of people diagnosed with MM has gone from 3 years in 1997 to up to 20 years. The first MM drug was introduced in 1998. Two others were introduced in 2003 (Velcade) and Revlimid (2005) thereafter. W hen age is controlled for, that means an increasing number of people with MM can expect to have the same life expectancy as people who do not have the disease. And we can't measure the full impact of these drugs let alone Pomalyst in a precise manner.
But we can say that MM drugs have increased average life expectancy more rapidly among MM patients than it has average LE in the population as a whole.
And we can say that just as a few HIV drugs introduced over a 5 year period dramatically saved lives, so too have a handful of drugs for MM turned an incurable disease into a controllable condition in less than a decade. And these drugs work because they target specific disease mechanisms in patients for whom they work the best and offer the most hope. The averages are indicators of profound and rapid gains among more and more people.
If we had bought the story about marginal benefits 10 years ago and delayed and dragged out approval and use of other cancer drugs, where would we be today? If we accepted the arrogant assertion that "most new (cancer) drugs offer only marginal extensions of life and few cures.“ how may more people would be dead? Let me go out on a limb and say that while not all new products are useful and effective, the current effort to control health care costs is biased and shaped by this naysaying approach to innovation, an approach delays access to new medicines -- indeed an approach that subsidizes a industry of underachieving social scientists to study average cost effectiveness in an era of personalized medicine -- assures more people will die who did not have to or want to. Recently, the National Pharmaceuetical Council held a conference on The Myth of the Average Patient.. All well and good. But how about a conference on what CER will cost people seeking better medicines for cancer and Alzheimer's in terms of lives saved. My late colleague John Vernon and I did a lot of work in this area but somehow the "stakeholders" always ignore the impact of adding CER to the rate of innovation and the number of lives saved. Why is industry and patient groups silent about the impact of CER on medical progress? What gives?
Finally, why does it take so long to conduct clinical studies. In both of the trials mentioned above, response was immediate and highly effective. (Less than 6 months in most cases). Can't we find other ways to confirm what works and what doesn't? Here's Eric Topol on this important topic..
We have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that's great if one can do that, but often we're talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials. And things are changing so fast with respect to medicine and, for example, genomically guided interventions that it's going to become increasingly difficult to justify these very large clinical trials.
We are not just standing in the way of medical progress, we are putting up obstacles based on outdated science and sanctimony.
Herding Katz.
The departure of Rusty Katz as FDA’s Director of the Neurology Products Division is an inflection point in the agency’s 21st century direction. Will his replacement continue his philosophy that the FDA must be a partner in innovation – or will political considerations turn back the clock?
Following Katz at FDA is an important analysis of the situation.
Pleased and proud to report that, according to the Healthcare 100 ranking of the world’s top blogs on health and medicine, Drugwonks is tied for #5. That puts us ahead of the health blog of both the New York Times and the Wall Street Journal.
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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.
