A Baucus Caucus

• 11.13.2008

Senator Baucus, in his white paper, "A Call to Action," says that "his door is open."  That's good news -- because when it comes to something as crucial and complicated as healthcare reform, a welcome mat beats a baseball bat.  To view the Senator's document, click here.  There's not a lot of detail -- more of a conceptual blueprint.  And that's the right way to begin.

A Ray of Hope

• 11.12.2008

My candidate for FDA commissioner, Ray Woosley, (I said that to ensure he stays right where he is!) once again demonstrates that productive public-private partnerships are critical to promoting a new era of personalized medicine. Ray's leadership and dedication has sustained the Critical Path Intiative and supported the vision of Mark McClellan, Janet Woodcock and others at th FDA who launched it nearly 4 years ago.

 

C-Path Expands Partnerships to Speed Development of Critical New Drug Therapies

 

Dear Friend of C-Path:

Thanks to Arizona supporters, C-Path was created in Tucson four short years ago and we have been very successful in bringing drastic improvements to the methods used to evaluate new drugs and diagnostic tests; changes that are advancing personalized medicine. In addition, Arizona’s Governor, The Honorable Janet Napolitano, along with our state and federal legislators, have been very supportive of our work and our mission.

One of the state’s truly innovative new programs is Science Foundation Arizona (SFAz) which provides highly competitive grants to support meritorious collaborations between scientists and businesses in Arizona. Last year we were fortunate to receive one of the first of these highly competitive awards.

And again, I am extremely pleased to tell you that we have just been awarded a four year SFAz grant for $9 million. With this award, we will be able to expand our work and form additional industry-FDA consortia. These new consortia will improve our understanding of major diseases such as Alzheimer’s and Parkinson’s so that, when effective treatments are discovered, they can be developed in less than three years and with a 95% chance of success; not the current situation, 15 years and a 5% chance of success.

Thank you for your friendship and interest in C-Path.

Best wishes,

 

Ray Woosley

Kaiser Builds the Case for Part D Price Controls

• 11.12.2008

Healthcare to the Max

• 11.12.2008

Senator Max Baucus, (chairman of the Senate Finance Committee) is proposing legislation to “cover the 47 million uninsured.” 

But …

Neither he nor his staff are offering any cost estimates. The plan proposed by President-Elect Obama during the campaign was estimated to cost about $100 billion a year.  Any savings from healthcare IT (another urgent need) or follow-on biologics (the price differentials from which will look nothing like small molecule generics) are but a glimmer of future hope in the eyes of the OMB.  How are we going to pay for this?  Stock options?

One of Senator Baucus’ recommendations is to reduce healthcare costs is via comparative effectiveness.  In global health policy circles this is generally referred to as “HTA” – Healthcare Technology Assessment.  To physicians and patients in Canada, Great Britain and elsewhere it is generally referred to as “rationing.”  According to Sir Michael Rawlins, chairman of Great Britain’s National Institute for Health and Clinical Excellence (NICE), "Rationing is a necessary evil. We have to do it. There will be losers and winners." Ouch.

In the last session of Congress, Senator Baucus and Senator Conrad introduced the “The Comparative Effectiveness Research Act of 2008 (CERA).” This legislation would create a Health Care Comparative Effectiveness Research Institute.  Comparative effectiveness centralizes clinical decision-making, and replaces the judgment, variation and response of doctors and patients with a handful of Beltway-appointed elites who, despite transparent procedures, impose standards and use methods that are cost-based rather than patient-centric.

It is urgently important to engage early and in a robust manner in this debate.  The philosophy behind comparative effectiveness (using the current blunt, short-term, price-centric tools used in Europe and Canada) is a giant first step towards healthcare rationing and, ultimately, price controls.  This would spell an end to pharmaceutical innovation as we know it – and to what end?

The most likely immediate result of 20^th century cost-effectiveness in a 21^st century world would be the reduction of on-patent reimbursement and, ergo, a physician’s ability to practice medicine according to her patient’s individual therapeutic needs.  That’s the trade-off -- a short-term decrease in a line item (on-patent medications) that represents only 7% of the entire American healthcare spend for the future of healthcare innovation.  It’s a bad choice – a Hobson’s Choice.

It’s a particularly bad choice for the severely ill, commercially-insured population. A recent study published in Health Affairs found that the costs of medical services to this population account for more than 75% of health plan costs. Hospitalization costs accounted for half of this amount. In contrast, medications accounted for just over 20% of health spending for this group, whose annual costs are more than nine times higher than the overall plan population. The authors concluded that medication costs “do not seem to be the driver of health care costs for these members.” And among the 2.5% of members with the highest spending, specialty medicines (defined in this study as "biologic-derived agents that target specific immune processes and proteins”) were used by 45% and accounted for 32% of spending on medicines and just 6.6% of total plan spending.

Que CERA sera. Or as Aldous Huxley said, “Facts do not cease to exist because they are ignored.”

We often talk about “first principles.”  According to Senator Baucus’ website, “The first principle is universal coverage.”  Rhetoric is important here.  “Universal” healthcare means “Government” healthcare. And that certainly doesn’t mean “Free” healthcare. 

And that “47 million uninsured” number really has be addressed honestly. 

What is Senator Baucus’ position on the scores of healthy young people — close to 20 million, by some accounts — who elect not to buy health insurance even though they can afford it? They voluntarily choose not to have health insurance — which is quite different from not being able to get health insurance.  Would they have to pay a penalty to electing not to have health insurance?  President-Elect Obama was asked if his healthcare plan would penalize the decision not to be insured.  He was asked it directly.  And he said “no.”  You can look t up.

Or what about government-paid care for the 10 million uninsured illegal aliens. Every politician calling for “universal care” has been silent on this topic – except to include them in the count.

And what about the 12 million people (half of whom are children) who currently qualify for SCHIP but are not signed up?

These are facts and must be part of the debate.

The good news is that Senator Baucus is a smart and savvy guy, a terrific legislator. – and he really understands healthcare. According to his office, the Senator wants to begin meetings next week with the members (of both parties) of the Finance Committee and the Senate Health, Education, Labor and Pensions Committee – where Senator Kennedy (chairman of the HELP Committee) is expected to play a major role.

There are some things we can all agree on and use as valuable and non-partisan points of departure:

(1) “We cannot address the health care system, and leave a growing portion of the country behind. Though this must be a public and private sector mix.”

(2) “By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.”

(3) “Health coverage is a shared responsibility and all should contribute.”

Note: These three quotes come directly from Senator Baucus' website.

The one thing we should all be able to agree upon is that there are no easy solutions … America’s SiCKO apologists notwithstanding.

Is the RPM Blog on the Nissen Commissioner Bandwagon?

• 11.11.2008

I love the RPM eletter.

Read more here

But.

What's with the "Steve Nissen isn't so bad" and "would be good for industry" rationalization en route to claming he has the inside track because he's been "vetted" by the Obama campaign to be FDA commissioner?

Sorry for all the quotation marks. Let's go to the RPM post and deconstruct.

"We have no idea if Nissen will end up at FDA—but as an Obama advisor he has already been vetted in case he is picked for some kind of government post. "

Nissen was not an Obama advisor. He was an Obama surrogate and contributed to the Obama campaign and might have sent some materials in as part of a cast of thousands. But "vetted" like a nominee would be vetted? Hardly.

Here's more:

"First, as commissioner, Nissen can’t just lob grenades as products the way he has been in recent years. Sure, he might pull Avandia outright, rather than cripple it commercially—but as commissioner he also has to set some constructive public health agenda that doesn’t simply involve taking potshots at individual products."

Pull Avandia? Can we say conflict of interest? If I am at his confirmation hearing that would be the first question I ask. Would he recuse himself in every drug he has worked on, commented on or is working on?

"Second, Nissen is not a drug safety gadfly at heart. Believe it or not, he wants to see industry succeed at developing innovative products. After all, he does drug development himself, and has spoken out in favor of products like Lilly’s prasugrel. As commissioner, you can bet Nissen would work just as hard to encourage the types of products and studies he likes as he would to discourage those he doesn’t."

Ah yes Lilly's prasugrel. Which is a good drug. But so is Plavix. But Plavix was developed by BMS. And BMS made Pravachol which was trashed by Nissen in the REVERSAL study. BMS also was the target of Niissen's wrath with respect to Pargluva. The question is: Did Nissen first offer to use his ultrasound study to cast Pravachol in a good light only to be rejected? That's happened before according industry and academic insiders. And the REVERSAL study? It gave credence to Nissen's research for Esperion Therapeutics ("a mere 47 patients showed that the company's injectable drug, ETC-216, decreased artery plaque by a statistically significant 4%, ten times the decrease seen with Lipitor." ) http://www.forbes.com/2003/11/12/cx_mh_1112pfe.html On the basis of that study, Nissen peddled the sale of Esperion to.....Pfizer! ETC-216, like many other drug development programs Nissen has participated in, have gone nowhere. But to assert "that you can bet Nissen would work just as hard to encourage the types of products and studies he likes as he would to discourage those he doesn’t" is inconsistent with how Nissen has used his research as a protection racket.

"Last but not least, there is the Kessler effect: the last time a commissioner was appointed who defined himself by making enemies in industry, he also gave the agency the credibility it needed to establish accelerated approval and the user fee program. Kessler was never popular with industry, and drug companies celebrated his departure. But drug approvals have been in steady decline ever since. Coincidence or not, those were the good old days."

User fees were a Dan Quayle and David McIntosh idea. Accelerated approval under Kessler? He was forced to it under pressure by AIDS activists and the Gingrich-led Congress in 1994. The Clinton administration couldn't re-invent the drug approval process fast enough. He didn't give the industry any credibility. And to suggest that Nissen's demand for mandatory safety trials prior to approval for cardiovascular risks for all drugs and the elimination of surrogate endpoints (except for those he has developed) would somehow advance the public health is absurd.

There are many other individuals outside of the FDA who could be superior stewards of the public health, who would regard the reforms and post market safety activities as a platform for effective leadership and not for the self-promotion and self-dealing that is the hallmark of Nissen's career.

This is -- and should not be -- a "fight" between industry and some annointed enemy of the companies.

Greetings from JUPITER

• 11.10.2008

The JUPITER study puts a whole different spin on statins in the wake of all the trash talk that went on with regard to Vytorin. But just as the media went overboard attacking the ENHANCE results, lead by Steve Nissen who called for a "moratorium" on it's use in the wake of that study, it has gone overboard in claming that the same statins they were dissing are now to be used in nearly everyone, led again by, Steve Nissen who told his Boswell, Forbes' Matt Herper, that JUPITER is “potentially a game-changer. There could be a much larger population of patients that may benefit than are currently treated."

For the record, Nissen was rejected to conduct the athero measures for ENHANCE and is now doing a study to compare Crestor, the subject of JUPITER with Lipitor, two drugs made by two companies he has done work for in the past. And this is the man who would be FDA Commissioner.

http://www.forbes.com/healthcare/forbes/2008/1117/036.html

So what are scientists saying about JUPITER?

According to Eric Topol, JUPITER shows that people with ver high C-Reactive Protein levels get a very strong benefit from Crestor. People in this study were considered to be "healthy" but in fact 40 percent had metabolic disorder, smoked or were overweight. Topol asks: Is this a CRP or a metabolic story? The JUPITER study gives doctors something new and important to discuss with patients and something that can be used to tailor treatments to the individual.

Which is why Topol raises another important issue. While the relative risk of all cause of death declined by 25 percent the absolute absolute risk was cut by 1 in 120 treated for two year period. Meanwhile 1 in 200 developed diabetes.

Topol's point is not that Crestor use or use of statins should not be expanded. Rather his take is twofold. First, we should continue our search to tailor the use and development of statins to the right pathway and markers rather than pursue a one size or one mechanism fits all approach. Second, and more subtle, it is interesting how people flip out on the relative RISKs of medicines generated by meta-analyses of people like Nissen without looking at the absolute risk relative to the benefit generated or the cost of not taking the medicine.
http://blogs.theheart.org/topolog
Similarly, attacks Sid Wolfe launched against Crestor when it was first approved about liver damage, which proved to be bogus, has probably caused more deaths due to heart disease than high LDL levels have generated since that time. That is particularly the case with African Americans who seem to have responded particularly well to Crestor. Alicia Mundy and others in the media hail Wolfe as some sort of hero. Yet it is drug companies who by spending hundreds of millions of dollars on several large clinical trials have advanced clinical practice and provided researchers with more data that can be used to personalize the treatment of heart disease.

Who are the real heroes?


http://content.nejm.org/cgi/content/full/NEJMoa0807646

SCHIP, Puppy Love, and the First Family

• 11.10.2008

Earlier this month a news story ran that discussed the issue of children and medications.  The story focused on the fact that American children are taking more medicines than ever before – with specific attention being given to childhood obesity, one of the most crucial public health problems facing our nation.

We will soon have a new First Family who can play an important role in communicating about this very important issue.  With young children in the White House the difficult conversation about childhood obesity, diet, exercise and parental responsibility can be addressed in a new and powerful way.  It’s a tremendous opportunity.  

This is also an important issue relative to SCHIP – certainly to be one of the first healthcare initiatives to be taken up by the new Congress.  And to that end, I wanted to share my letter that appeared in yesterday’s edition of the Baltimore Sun:

Give more children access to medicines
November 9, 2008

It's a shame that so many young Americans are struggling with obesity ("Many more children on medication, study says," Nov. 3).

But the fact that kids today have access to a range of prescription medications is a good thing. When I was a boy, the only remedy for the medical conditions associated with excessive weight was diet and exercise.

To increase access to these cutting-edge medicines, we must expand access to health insurance coverage.

That's why the new Obama administration should make it a priority to enroll qualifying children in Medicaid and the State Children's Health Insurance Program.

According to a recent Kaiser Family Foundation study, 75 percent of children without health insurance are eligible for these programs.

Peter Pitts, New York

There are a lot of contentious issues about SCHIP reauthorization – but one problem that is rarely discussed is that over six million children who currently qualify for the program have not signed up.  Achieving that goal should be a priority of our new President and Congress.  

And having two children on the White House lawn chasing a puppy might just be a good way to start.

Soup Nazis in America

• 11.09.2008

Honoring Change We Need

• 11.07.2008

The Critical Path a toute vitesse

• 11.07.2008

Remember back in the day when there was a transatlantic “drug gap?” At the time it meant new therapies were approved first in the US and later on in Europe. That’s changed. It's reversed. And that’s unfortunate.

And here’s something that’s worse – we’re now playing catch up when it comes to advancing down the Critical Path. While the Reagan/Udall Foundation remains an unfunded and inactive shell, the European Union is making exciting and important progress.

The new program, funded by the French government, is called the Advanced Diagnostics for new therapeutic Approaches (ADNA) is a nine-year initiative aimed at developing personalized medicine for infectious diseases, cancer and rare genetic diseases by combining new diagnostic and therapeutic approaches.

That’s how you make drugs “safer.” That’s how you reduce costs. By getting the right medicine to the right patient in the right dose at the right time. All this at a time when many are arguing that the way to make drugs "safer" is to empower people to sue pharmaceutical companies. Sound familiar?

Funded by the French state-owned bank for small and medium-sized enterprises (OSEO), The ADNA program is funded to the tune €89.5 million. That is, at least in theory, what the Reagan/Udall Foundation is supposed to do. (And the ADNA program just part of the European Union’s bigger investment of almost €400 million in R&D over the 2008-2017 period.)

According to the partner companies (bioMérieux, Généthon, Transgene, GenoSafe), the ADNA will seek to identify and develop biomarkers that will allow new therapies to be targeted to patients who are most likely to benefit from them. Biomarkers can also help in making an early diagnosis, improving understanding of the progress of a disease, tracking a patient's response to treatment, and developing new diagnostic tests, they note. Sound familiar?

The €89.5 million in aid is broken down into €50.8 million in subsidies and €38.7 million in loans repayable in the event of success. Good model. Government and industry working together. Government as both regulator and colleague. Sound familiar?

Good for them. It will benefit us all. But shame on us for sitting on the sidelines and allowing political dithering to make us merely observers.