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Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.

John Lechleiter (President and CEO, Eli Lilly & Company) spoke on the urgency of making healthcare more personal. A few points from his remarks:

* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”

* “With critics of the U.S. system pointing to Europe and other countries for reform guidance — in the past decade, nearly every European country has introduced market-oriented reforms — and has turned to the private sector in their efforts to reduce the health costs of treatments.”

* “We need to build a consumer-driven system — one that instills a sense of personal ownership … and puts the individual consumer in charge of how health care dollars are spent — through such mechanisms as health savings accounts.”

* “Transparency is the lubrication that makes consumer-driven healthcare work.”

* "We need to restructure the system so it is patient-centered … where health care providers, payers, regulators, and innovators work together to answer a single question: What is best for the individual patient?”

* “In a patient-centered system, individuals bear primary responsibility for their own health. And physicians help patients recognize incentives for healthier living … and act as agents on their behalf. In this system, providers compete on value and are measured on quality.”

* “We must build a system that promotes universal access, not by mandate but through free-market solutions that maximize coverage and improve access.”

* “In 2007 — for the first time — we offered U.S. employees consumer-driven options: HSA/HRA. About one-third of employees opted for a health savings account or a health reimbursement account.”

* “This year, roughly two-thirds of enrolled employees — including moi — and dependents chose one of these options. By 2010, our company will offer only consumer-driven options for our active employees.”

Lechleiter’s full remarks can be found here.

In his keynote address, IFPMA President Fred Hassan (whose day job is Chairman and President of Schering-Plough), shared that the IFPMA will commence a global communications effort on the value of IP. And while he didn’t say that IP is a human right, he came very close – pointing out all of the good that solid intellectual property right protection affords civil society. He also quoted Abraham Lincoln (a popular thing in Washington, DC these days), saying that intellectual property rights “add the fuel of interest to the passion of genius.”

Bravo.

Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in Geneva. (Note to Fred: If you have to ask …)

Rich Bagger (SVP, Worldwide Public Affairs & Policy, Pfizer) was the only speaker to consistently refer to his company as being in the “life sciences” business. Why is this so hard for everyone else to remember ?

One of Rich’s themes was “new roads to access.” And he offered a very early yet tantalizing example – Pfizer’s partnership with the Grameen Bank of Bangladesh (yes – the one run by Nobel Laureate Muhammad Yunus). Pfizer and Grameen are developing a “micro health insurance model” along the lines of Grameen’s well-known micro-credit programs. According to Bagger, a policy might cost $20/month of which $3 would go towards pharmaceutical coverage. That’s consumer-driven healthcare LDC style – and a program that the world’s largest life sciences company should talk about publicly, proudly and often.

Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.

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  • 11.20.2008

Tom Daschle is a terrific choice for HHS for many reasons.  Most importantly, he’s a grown-up. 

Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.

His other role in the Obama White House, that of Health “Czar,” poses some interesting questions.  Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?

Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott.  Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.

I am not as phlegmatic.

And to that point, a few things worthy of consideration:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. 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."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause.  Consider:

* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.

Why?  Marketplace competition.

* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.


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.

Sachs Appeal

  • 11.19.2008
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.

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  • 11.18.2008


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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.

According to the HHS website, “The Personalized Health Care Initiative will improve the safety, quality and effectiveness of healthcare for every patient in the US.  By using “genomics”, or the identification of genes and how they relate to drug treatment, personalized health care will enable medicine to be tailored to each person’s needs. Healthcare that is proactive, instead of reactive, gives the patient the opportunity to become more involved in their own wellness.”

HHS seeks to advance this Initiative through two guiding principles:

(1) Provide federal leadership supporting research addressing individual aspects of disease and disease prevention with the ultimate goal of shaping preventive and diagnostic care to match each person’s unique genetic characteristics.

(2) Create a “network of networks” to aggregate anonymous health care data to help researchers establish patterns and identify genetic “definitions” to existing diseases.

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...

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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.

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