Latest Drugwonks' Blog
Contraception, who cares?
By: Peter J. Pitts
During an episode of “Mad Men,” someone asks (apropos of an advertising campaign for pantyhose), “What do women want?” Strolling by, agency principal Roger Sterling quips, “Who cares?”
Who cares, indeed?
There’s been a lot of news lately about pharmacists not wanting to be forced to dispense medicines about which they have moral objections, specifically Plan B, “the morning after pill.” A thorny topic, to say the least. Yet, despite all the hoopla from the usual suspects, there has been total silence from an important voice in the debate – the pharmaceutical industry.
On the one hand, that’s not surprising. Why, after all, would anyone want to interject themself into such a no-win, high stakes, high profile battle? But doesn’t a manufacturer who makes a product have a responsibility to stand up and be counted when their product is under attack?
(And, let’s face it, contraceptives are under attack. No value judgment here – just a fact.)
What? Pharma take a stand? Not only is this not unheard of, it is regular and accepted practice when scientific questions are raised. It is regular and accepted practice when safety and efficacy are debated. It is regular and accepted practice when legislative questions arise.
Here’s a relevant example – pseudoephedrine. When many state and federal legislators wanted to ban (or severely restrict) the availability of many OTC products in order to address the scourge of methamphetamine (pseudoephedrine is a common ingredient, or “precursor,” in the manufacture of methamphetamine) both manufacturers and their trade association (the Consumer Health Products Association) went on the offensive.
But, then again, there’s no pro-meth lobby.
When it comes to pharmacists not wanting to dispense Plan B – there’s nothing but silence from the manufacturer. Has Planned Parenthood approached Teva (the maker of Plan B) to enlist its support? If so, what explains the company’s silence? And, if not – why not? Doesn’t Teva have the courage to speak out in favor of its own product? When the initial Rx-to-OTC switch debate was raging, Barr Labs (subsequently purchased by Teva) was quite vocal in its support of Plan B as an avatar for reproductive rights. Today – silence. Qui tacet consentire videtur? Not likely. So why is mums the word?
Could it be that leveraging reproductive rights at FDA was in Barr’s financial interest but that debating it “in the streets” isn’t? Is Teva afraid (should they side with Planned Parenthood and other such organizations) that there might be a boycott against many of its other products?
Mums the word? Consider this couplet from Piers Plowman:
Thou mightiest beter meten the myst on Malverne hulles
Then geten a mom of heore mouth til moneye weore schewed!
That translates as, “You may as well try to measure the mist on the Malvern Hills as to try and get her to speak without first offering payment,” or, in more modern parlance, “Show me the money.”
Why the silence from Teva?
It’s a shame and a sham that a principled stand on reproductive rights was silenced when it became associated with potential commercial risk – just as Secretary Sebelius’ recent reversal of FDA on further Plan B access was done to mitigate potential political repercussions. When politics and profit come before the public health – bad things happen.
As my father used to say, “A principle doesn’t count until it hurts.”
Ouch.
And the generic industy says that as a result drug companies are costing consumers and taxpayers billions.
That's the spin. It's not about the samples. It's about getting around REMS. Generic companies never guarantee that they will replicate the REMS system that an innovator comany uses. Anyone who has seen the citizen's petitions of the generic companies knows that. So does the FDA. Take the the case of Accutane (the acne drug that goes by the generic name of isotretinoin): Despite a program designed to limit fetal damage from the drug called iPLEDGE there were 122 pregnancies just in its first year. And that was with just one program.
By allowing "samples" the provision would force FDA to approval countless versions of REMS programs that were designed for a single drug for a single use for a specific group of patients. And now, because the Supreme ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug (Wyeth v. Levine) any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be ground for suing an innovator.
Finally, it's not just giving samples. Especially when it comes to the little things, like say, permanent birth defects, maybe we want to be a bit more careful. Perhaps we want to be extra cautious about passing around samples without having a good reason to go outside a tightly controlled method of distributing and administering a specific group of drugs that has protected infants from damage up till now? REMS are not one size fits all to be sure. But take a look at this video about the effects of thalidomide before assuming that there's no risk in giving generic companies every sample of every drug they want. I find it ironic that the same interests who demand more regulation of innovator companies for the sake of safety are willing to let safety slide for the sake of generic industry profits...
http://www.youtube.com/watch?v=FK-RuOqdZ1M
Let’s give credit where credit is due – Mayor Bloomberg’s heart is in the right place. Obesity (especially of the childhood variety) is an epidemic that is going to sink us all unless we can address it immediately and aggressively.
But we have to address it smartly.
The media circus surrounding the Mayor’s call to ban large sodas is just silly. It reeks of nanny statism and diverts attention away from the issue. Plainly speaking, it trivializes the problem.
Prohibition doesn’t work. How many times do we have to learn this lesson? What works is personal responsibility and adherence to the Aristotelian Mean (aka – moderation).
In the immortal words of Nucky Thompson, “First rule of politics, kiddo: Never let the truth get in the way of a good story.”
It’s time to put headlines behind us and move on to addressing the real story.
And we start right here with a short video -- “Big Gulp Empire.” Have a look and pass it on.
Not content to stop at keeping people from 20 oz bottles of Mountain Dew (but unlimited refills are fine) the Board of Health started coming up with other food items that it should portion control:
“The popcorn isn’t a whole lot better than the soda,” said Bruce Vladeck, a senior adviser at Nexera Consulting and one of the mayor’s appointees to the 11-member board. The board yesterday agreed to put Bloomberg’s big-soda ban up for a public hearing July 24, but also talked about the merits of limiting other high-calorie treats. A large tub of movie-theater popcorn has up to 1,650 calories.
Bruce Vladeck (center in photo)
But why stop at regulating popcorn?
“There are certainly milkshakes and milk-coffee beverages that have monstrous amounts of calories . . . and I’m not so sure what the rationale is not to include those,” said member Dr. Joel Forman, a pediatrics professor at Mount Sinai. (Milkshakes have calories? Coffee coolattas too? Shocking.)
So wait.. I thought the enemy was sugar. Or is it calories? Or is it portions? Or is it food?
Perhaps we should just wait until the Board of Health comes out with a government approved menu that we all have to buy from. Scary thing is, as this poll shows, there are enough social control freaks out there who would agree the government should regulate what we eat and drink:
And here's an enthusiastic defense of the nutritional police state by someone that calls herself "the portion teller." (Oy)
http://portionteller.com/size-matters-at-least-in-nyc/
Rosa Nervosa and Full Speed Ahead
BioCentury reports that the Reagan-Udall Foundation received $900,000 from FDA to support FY12 operations and infrastructure. The funds are the first from FDA since Congress created the foundation in 2007 as a public-private partnership to oversee and fund precompetitive research to advance drug development and regulation. FDA funding was previously blocked by the U.S. House of Representatives, led by Rep. Rosa DeLauro (D-Conn.), who claimed that the foundation could prompt FDA to lower its approval standards.
The FDA Amendments Act of 2007 authorized $500,000-$1.3 million annually from FDA to support the foundation, and also gave Reagan-Udall authority to accept private sector funding. The specific amount from FDA is determined annually between the foundation and the agency, but the foundation's Executive Director Jane Reese-Coulbourne said she does not expect further funding roadblocks.
Reagan-Udall has received $1.3 million in grants and donations to fund research, including a $60,000 grant last year from Susan G. Komen for the Cure to support a project on cardiotoxicity associated with tyrosine kinase inhibitors. By year end, the foundation expects to have a publicly-accessible database of genes and pathways associated with cardiotoxicity. Last May, the foundation also received a $1 million grant from the Bill & Melinda Gates Foundation to serve as a facilitator among global tuberculosis stakeholders in the Critical Path to TB Multidrug Regimens Project (CPTR), an initiative to test and seek approval for combinations of individual investigational TB drug candidates.
Huzzah!
Part D that is.
On Tuesday Governor Romney discussed an alternative to the ACA (aka, “ObamaCare”) that would make the health insurance system more like a “consumer market” -- applying free-enterprise principles to the nation’s health-care system (letting competition drive down prices and increase choice and quality) rather than operate it like a “government-managed utility.”
In other words, precisely the model that has made Medicare Part D such a resounding success among seniors (as measured by participant satisfaction pushing 90%), below budget costs (the price of Part D over the next decade is expected to be nearly $120 billion less than originally estimated) and lower than expected premiums (in August 2011, HHS announced that premiums would be slightly lower in the drug program in 2012).
Smart partnership between government and the free market works.
It works at keeping costs low and – most importantly – improving care. As JAMA reported, “Implementation of Medicare Part D was followed by increased use of prescription medications, reduced out-of-pocket costs, and improved medication adherence.” And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
It’s time for many on the left to address their PDDD (Part D Deficit Disorder) and embrace a free market solution to health care reform.
Governor Romney also wants to divert federal Medicaid money and other federal funding to state governments, making them responsible for covering the uninsured. He correctly recognizes that states are the laboratories of invention. (And that some labs are more successful than others – witness the success of “Healthy Indiana” vs. the albatross of the Bay State’s “Commonwealth Care.” The Governor speaks from personal experience.)
If the Supreme Court doesn’t entirely repeal the ACA, Governor Romney said he would work to repeal whatever remains of it on his first day as president by granting a waiver to all 50 states to opt out of the legislation’s restrictions.
“We can get health care to act more like a consumer market, and if we do that and we stop making it like a big government-managed utility, we’re going to see better prices, lower costs and better care,” Romney said. “It’s happened everywhere we’ve applied consumer-market principles. Free enterprise is the way America works. We need to apply that to health care.”
Amen.
New report calls for value-driven collaboration for design
and reimbursement of personalized medicine
New York, NY (June 13, 2012)
A new report calls for greater collaboration and replacing comparative effectiveness research with value-driven design of new products in order to preserve American leadership in medical innovation and personalized medicine.
“From Promise to Performance: Commercializing Personalized Medicine” was produced by The Personalized Medicine Acceleration Working Group. The working group is a project of The Center For Medicine In The Public Interest and was established to recommend new pathways for the faster commercialization of tools and technologies that deliver personalized medicine. The report and the working group were supported with a grant from the Ewing Marion Kauffman Foundation (www.Kauffman.org).
Robert M. Goldberg, PhD, a working group member and author of the report notes: “Medical progress has been a source of economic growth and prosperity for the United States. Personalized medicine, because of its capacity to extend life and prevent illness, will be a source of future value and wealth. However, the nation’s ability to commercialize such products has declined even as the capacity to do so has grown in countries such as China, India, and Brazil.”
The working group focused on how to design and reimburse new products that reflect increased value to consumers.
The working group recommends adopting a value-driven approach to the design and development of personalized medicine. Simply put, that means investing in design elements that make medicine easier and more effective for consumers or end-users and ensuring that proof-of-concepts and prototypes achieve that goal.
To do so, it recommends the refinement and use of a value-driven equation to measure improved patient-centricity and reduced complexity relative to the cost of using a new technology. Such an equation can take into account the preferences of health plans, consumers, and doctors prior to both FDA review and adoption. It is, therefore, an approach to measuring value for reimbursement purposes built into the design of products.
It also recommends that two institutions involved in the working group – The Scripps Translational Research Institute and the Austen Bioinnovation Institute of Akron – collaborate to create a usability lab that would use the value-driven equation and help entrepreneurs engage in value-driven design and engineering.
The working group recommends replacing the current approach government and health plans use to decide whether to pay for personalized medicine. Reimbursement processes come after FDA approval and do not measure the value of new personalized technologies to add to the value of health and increase simplicity. Value-driven design would build the needs and preferences of patients, health plans and physicians into the design of products.
A separate paper developed for the working group estimates that comparative effectiveness research (“CER”) may reduce the number of new medicines by 57 over the next 10 years and cause the United States to forgo nearly $10 trillion in health value.
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The report – “From Promise To Performance: Commercializing Personalized Medicine” – can be downloaded here: http://cmpi.org/reports-newsletters/reports/from-promise-to-performance
The second report -- "Uncertain Innovation: The Effect of Comparative Effectiveness Research (CER) On Personalized Medicine" -- can be downloaded here: http://cmpi.org/reports-newsletters/reports/uncertain-innovation
Reporters interested in scheduling an interview with the authors of the report should contact CMPI Vice President Bob Goldberg at rgoldberg@cmpi.org or 212-417-9169.
About CMPI
The Center for Medicine in the Public Interest, a non-profit public policy group dedicated to research-based free market reforms for the health care industry.
It's do-it-yourself detailing!
Total Therapeutic Management (TTM) is the company chosen by AHRQ to develop the agency’s so-called “academic detailing” program.
(“Academic” in quotations since the majority of detailers are pharmacists. It’s really government detailing – in every sense of the word.)
Barry Patel, TTM’s CEO, has made available the materials that his reps are using to re-educate America’s doctors (particularly the high prescribing ones).
Those non-FDA reviewed detail aids can be found here.
Slides cover the therapeutic areas of Breathing Conditions, Cancer, Developmental Delays, ADHD, Autism, Diabetes, Digestive System Conditions, Gynecology, Health and Blood Vessel Conditions, Infectious Diseases, HIV/AIDS, Mental Health, Muscle, Bone, and Joint Conditions. And there’s the promise of more to come!
For a more, um, detailed discussion of government detailing and TTM’s remunerative involvement therein, see this new paper from the May edition of the Drug Information Journal.
CMPI says requirements under federal health care reform would deprive Americans of medical innovation worth trillions over 10 years
New York, NY (June 12, 2012) --- Personalized medicine – treatments targeting individual risk of disease -- can increase life expectancy and generate $13 trillion in health value – but comparative effectiveness research would reduce investment in such innovations according to a report released today by the Center for Medicine in the Public Interest (CMPI), entitled: “Promoting Innovation and Health: Personalized Medicine or Comparative Effectiveness Research?”
"Our analysis shows that personalized medicine can increase life, well-being and the social value of health but also demonstrates that CER increases the cost and uncertainty of investing in such innovation," said John A. Vernon, Ph.D., a professor at the Purdue University, Krannert School of Management and co-author of the study. "CER will deny our nation better health and much needed biomedical investment."
The federal health reform law requires government-run comparative-effectiveness research, which will purport to evaluate the costs and benefits of different treatment options -- and use these studies to decide what medical innovations government and health plans should pay for and to limit what technologies doctors and patients can choose.
Proponents of CER claim it can increase investment in personalized medicine. But the CMPI study, conducted for its Personalized Medicine Acceleration Working Group, found that CER will reduce the level of investment in biomedical research by $75 billion over 10 years. There would be 60 fewer new personalized medicines available over the next decade if CER is required before marketing.
“We need to build upon the promise of personalized medicine,” said Robert Goldberg, Ph.D., Vice President of CMPI and co-author of the study. “Commercialization of innovations that reduce cost and extend life contribute to our nation’s prosperity and our global competitiveness. Policymakers should find ways accelerate the adoption of personalized medicine rather than adding regulatory requirements that increase the cost and risk of innovation.”
The study was conducted for The Personalized Medicine Acceleration Working Group, a CMPI project focusing on actionable steps that can be taken to speed up the commercialization and adoption of personalized medicine. The study and the working group were supported with a grant from the Ewing Marion Kauffman Foundation (www.Kauffman.org)
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The report -- "Uncertain Innovation: The Effect of Comparative Effectiveness Research (CER) On Personalized Medicine" -- can be downloaded here: http://cmpi.org/reports-newsletters/reports/uncertain-innovation
Reporters interested in scheduling an interview with the authors of the report should contact CMPI Vice President Bob Goldberg at rgoldberg@cmpi.org at 212-417-9169.
About CMPI
The Center for Medicine in the Public Interest, a non-profit public policy group dedicated to research-based free market reforms for the health care industry.
To support congressional work on user fee authorizing legislation and other FDA-related drug, device, and biological product provisions, Congressional Research Service analysts have prepared tables comparing provisions in the Senate passed bill that originated in the Senate Committee on Health, Education, Labor, and Pensions and the House suspension document that originated in the House Committee on Energy and Commerce.
• S. 3187, the Food and Drug Administration Safety and Innovation Act, passed by the Senate on May 24, 2012; and
• H.R. 5651, the Food and Drug Administration Reform Act of 2012, revised and dated May 24, 2012, as posted on the websites of the House Committee on Energy and Commerce and the House Committee on Rules.1
CRS has also provided brief summaries of relevant provisions in current law, mostly the Federal Food, Drug, and Cosmetic Act (FFDCA), but also the Public Health Service Act (PHSA), the Controlled Substances Act (CSA), and several others as noted.
The complete report can be found 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.
