Latest Drugwonks' Blog
As our current financial meltdown forces state governments to consider ugly budget cutbacks, some foolish ideas often get undeserved airtime.
Specifically, drug importation.
It’s worth restating the facts.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ 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.
And what of Minnesota’s RxConnect? 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 what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).
Shameful.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources 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.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation 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.
We’re all in deep enough fiscal trouble. We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.
Specifically, drug importation.
It’s worth restating the facts.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ 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.
And what of Minnesota’s RxConnect? 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 what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).
Shameful.
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources 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.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation 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.
We’re all in deep enough fiscal trouble. We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.
Sorry for the late evening post, but I've been at 24th IFPMA Assembly in Washington, DC. all day.
Some highlights:
The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?
The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.
Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)
Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.
More from the IFPMA Assembly tomorrow.
Some highlights:
The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?
The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.
Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)
Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.
More from the IFPMA Assembly tomorrow.
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Amidst the current fiscal climate, certain words evoke visceral reactions ... as one example - a margin call, ie the process of an authority such as a lender making a demand of a account holding client to make good on a shrinking collateral (margin) balance, by demanding payment pronto (which may have dire consequences for a party with a diminishing account "coming due" because of taking a calculated risk, based on prior assumptions that subsequently changed). In like spirit, the review of noninferiority margin by the FDA's Anti-Infective Drugs Advisory Committee this week will recommend changes that may be viewed as precedent setting, and which are likely to have similar impact on "pharma portfolio managers" who are subject to the decisions of the agency and its advisors - with potential dramatic impact for sponsors across all therapeutic areas.
For those of us who are not statistical wizards, the concept of noninferiority margins refers to an issue of "assay sensitivity" involving the setting of expectations for the ranges of outcomes in clinical trials comparing two agents which are deemed acceptable to declare the two competing chemicals as "equivalent" (ie calculations to rule out that the test intervention is no worse than the control intervention by a chosen amount). In turn, the margin set will drive the size (and cost/duration) of such trials ... the smaller the margin set (ie 10% vs. 15%) the more patients needed in the study to prove noninferiority. Past US anti-infective trials had been constructed with margins around 15% as being a reasonable rule of thumb (as in FDA's 1998 Points to Consider document), until a 2001 expert review (and subsequent FDA communications) suggested a reduction of the acceptable margin below 15% was indicated, which in some cases did compel sponsors to extend ongoing studies to meet the expectations of the change in standards. Clearly, setting margins for any trial requires thoughtful and individual review based on disease severity, range of comparator/historical control outcomes and like considerations. In the Advisory Committee this week, the discussion will focus on margins for complicated skin and skin structure infections ... many speculate that margin call will be 10%, and that the recommendations will be used as a reference point in other therapeutic groups (a la the "Ten" Commandments), which will, in turn, create some very challenging circumstances for those considering development programs for new antimicrobials and perhaps other agents. In some cases, it is possible that larger companies faced with portfolio decisions on selecting which compounds to advance (or terminate) given limited funds (and those smaller companies which have projected their capital burn for development based on prior margin rules) may be compelled to delay or exit these areas of study. Might the law of unintended consequences be invoked here, in that making margins more rigid could force pharma's anti-infective developers to reconsider their chances of successful, timely development (and instead provoke them to polish their burger flipping skills from college years)? Or will the modifications in margins be accompanied by more creative design features (a la the Critical Path programs, which might consider modifications such as single tail statistical designs for noninferiority analyses in selected conditions, or conversely to encourage superiority trials in a "bet the ranch" approach?). Whatever the outcomes, it is hoped that those deliberating on the margin call give due consideration to long term factors which their recommendation may influence ... to paraphrase HF Emerson "when you pick up one end of a stick, the other end comes along" and this stick could impose quite a beating ... or be a framing timber of new trial constructs ... depending on what and how this discussion plays out. In a worst case scenario, the margin of noninferiority and the margin of company development budgets could become an inverse relationship for sponsors - with a chilling effect on innovation, and thus no marginal gain for patients in the end result ... which would be an unfortunate & unintended margin of error in judgement.
In what he referred to as a “note on the desk” to the next Secretary of Health and Human Services, Mike Leavitt, the current inhabitant of that seat released “The Personalized Health Care Initiative.” Personalized health care should be an "explicit goal of health care reform,'' Leavitt said.
Oh well, better late than never. (The complete report can be found here.)
Hopefully there is a longer memo (perhaps with the keys to the backdoor and the security code to the secretarial washroom) on the urgent need to fund the Reagan/Udall Foundation.
The great Lewis Black expounds on why politics is a renewable resource for comedians...
Yesterday I had an op-ed in the Washington Examiner, “Obama, Congress Should Learn from Britain’s Healthcare Failings,” where I make the point that “NICE’s failings indicate that government is liable to misuse drug approval power, and they should arouse suspicion about the merits of additional government intervention in the healthcare market. The British government is finally giving patients and physicians the freedom they need to best combat disease. American lawmakers should follow their lead.”
But what I’d like to share with you is a comment that was posted in response to my discussion of NICE and its implications for US healthcare reform.
Here it is:
“Pitts cannot hope to cover all of the NHS's sins in a short piece. They also instruct doctors to lie to patients, informing them that life-saving treatments do not exist, when the NHS has merely decided the procedures are too pricey. It is better, in the view of the NHS, that people die rather than complain. Also, thousands die in their hospitals each year because staff cannot be bothered to wash their filthy hands. A trip to the NHS is often a death sentence, pure and simple."
And to that all I can add is, “Happy 60th Birthday, Prince Charles.”
But what I’d like to share with you is a comment that was posted in response to my discussion of NICE and its implications for US healthcare reform.
Here it is:
“Pitts cannot hope to cover all of the NHS's sins in a short piece. They also instruct doctors to lie to patients, informing them that life-saving treatments do not exist, when the NHS has merely decided the procedures are too pricey. It is better, in the view of the NHS, that people die rather than complain. Also, thousands die in their hospitals each year because staff cannot be bothered to wash their filthy hands. A trip to the NHS is often a death sentence, pure and simple."
And to that all I can add is, “Happy 60th Birthday, Prince Charles.”
Does it only seem like the 50th time this year that the Commonwealth Fund has put out a study or survey to make the case that compared to government run health systems elsewhere the American way of medicine is horrible?
France best, U.S. worst in preventable death ranking
Reuters, January 8, 2008
U.S. Health System Facing Senior “Crisis’
Study Says 78 Million Baby Boomers Will Enter A System Unprepared To Meet Their Needs
Washington, April 14, 2008
Read CBS Article Here
Read CBS Article Here
July 17 (HealthDay News) -- Access to health care in the United States continues to elude more and more Americans, a new survey shows.
Read Full Forbes Article Here
Americans Want Overhaul of Health System
Chicago AUG 07, 2008 (Reuters)
By Julie Steenhuysen
Read More
Leaders in health care and health care policy feel strongly that the way we pay for health care in the U.S. must be fundamentally reformed.
Read More
Leaders in health care and health care policy feel strongly that the way we pay for health care in the U.S. must be fundamentally reformed.
Tuesday, 4-Nov-2008
US trails other nations in chronic illness care
Nov. 13, 2008
By Will Dunham
Read More
Read More
Congratulations. You’ve survived the “valley of death,” emerged from the “tar pit of safety," successfully forged the Critical Path and received FDA approval. Mazel tov. Now you’ve earned the privilege of fighting with CMS and a potential AHRQ comparative effectiveness review.
And it’s been ambiguity all the way down the line.
So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process. And is there anyone out there who feels improvement is not required?
The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.
At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies.
Topics include:
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;
* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;
* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;
* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.
For more details, contact the HHS press office at (202) 690-6343.
And tell them Drugwonks sent you.
And it’s been ambiguity all the way down the line.
So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process. And is there anyone out there who feels improvement is not required?
The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.
At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies.
Topics include:
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;
* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;
* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;
* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.
For more details, contact the HHS press office at (202) 690-6343.
And tell them Drugwonks sent you.
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.
