The Next Administration: Obama’s Top Health Positions

Earlier, we put out the short lists of possible McCain health people. Now, again, the lists are by no means scientific. These are names that have been circulated, brought up in discussions with sources, or individuals we think could end up being candidates based on their experience. Remember, this is just for fun. Here we go:

Obama Administration

HHS Secretary:

Former Senator Tom Daschle: The former Senate Majority leader is a favorite for Obama’s chief of staff along with Rep. Rahm Emanuel. If Obama goes with Emanuel, HHS Secretary would be an obvious spot for Daschle. He wrote a book on health care and he was a supporter of President Clinton’s health care proposal, and universal health care is Daschle’s pet issue.

Kansas Governor Kathleen Sebelius: The Kansas Governor made a name for herself in Kansas as an insurance reformer (she wouldn’t accept campaign contributions from insurance companies) and stopped Blue Cross Blue Shield from merging with another out of state firm. She is very close to the Obama campaign as a key surrogate and was supposedly in the top 3 for VP. Sebelius makes a lot of sense here.

Former Vermont Governor Howard Dean: The DNC chairman is an obvious possibility here with his MD, plus he oversaw expansion of health care in Vermont. But Dean is such a lightning rod for the Republican party, we just don’t know that he would be the right choice here considering how fragile a coalition it will take to advance Obama’s health plan.

Massachusetts Governor Deval Patrick: No governor, it seems, has been more active in the health care discussion as Patrick. Whether its universal health care, the state’s $1 billion life sciences/biotech plan to bring more companies into the state, or the Mass. law on pharma marketing restrictions, Patrick has been in the middle. We think Patrick is perfect for the position, but we think he’s more likely to get a nod for the next Supreme Court opening. Otherwise, it could be Patrick.

FDA Commissioner:

Bruce Psaty (U of Washington): We think Psaty’s drug safety work probably make him a possibility but also may take him out of serious consideration. His focus on drug safety issues may be too extreme to appease both reformers and more moderate FDA stakeholders. Still, he warrants mention.

Steve Nissen (Cleveland Clinic): Avandia. Need we say more? However, Nissen also works closely with drug manufacturers on large, important clinical trials (Pfizer’s HDL-raising drug torcetrapib, for example). He’s recently changed his messaging somewhat from one focusing on drug safety to one more rooted in pro-innovation themes (witness his endorsement of Lilly’s anticlotting drug prasugrel). If Obama goes with a real reformer in the mold of David Kessler, Nissen has to be at the top of the list. He’s also an official adviser to campaign now, an important development.

Robert Califf (Duke): The Duke researcher has close ties to FDA through the Critical Path Initiative, and advisory committee process and has both Republican and Democratic supporters. In September 2006, Duke entered into an agreement with FDA to serve as a warehouse for electrocardiograms to serve as tools for drug safety research. If Obama goes with a big name, but one less associated with major reforms, Califf could easily be the pick. One thing that may serve as roadblock is his close ties to drug manufacturers (a Kennedy pet peeve).

Mary Pendergast (consultant): The former associate commissioner under Kessler and independent consultant is a dark horse candidate for the job. It’s understood she was previously vetted by Kennedy for commissioner (and did well) after Kessler left. She’s not an MD but that may not matter if Obama chooses an MD to head up HHS (Howard Dean, for example).

David Blumenthal (Harvard): A Harvard professor and director of Massachusetts General Hospital’s Institute for Health Policy, Blumenthal is a major contributor to the Obama health plan. He will be a strong candidate for a number of important positions either in the White House as a special assistant to the President or as head of one the key health agencies. Blumenthal, a physician, got his start in politics as a professional staff member on Senator Ted Kennedy’s Subcommittee on Health and Scientific Research during the 1970s.

Susan Wood (GWU): The former head of women’s health at FDA resigned in protest from the agency due to the delay in switching the morning-after pill over-the-counter. She now represents the Union of Concerned Scientists in a public capacity and is a research professor at the George Washington University for Public Policy. Wood campaigned vigorously for Hillary Clinton during the primary, and if Clinton takes over the Senate HELP Committee in the case that Kennedy becomes less involved, the former FDAer would have an outside shot. Still, the odds are against her.

Dora Hughes (Obama Senate FDA advisor): Hughes, an internal medicine physician, is Obama’s Senate health advisor. If Obama picked her, she would be the first African-American woman commissioner. It’s more likely she will be highly involved in making the pick. She previously served as deputy director for health for Senator Ted Kennedy on the HELP Committee.

CMS Administrator

CBO director Peter Orszag: The head of the Congressional Budget Office has been everywhere making public speeches on skyrocketing healthcare costs, regional disparities in how care is paid for, the Medicare program, and strategies on how to find costs savings without compromising quality of care.

Harvard Economist David Cutler: The health economist and Institute of Medicine member is a top health adviser to Obama and is considered a major architect of Obama’s health care reform plan. Cutler has co-authored health economics papers with McClellan and shares some of McClellan’s views on finding significant cost savings by correcting and reforming the inefficiencies in the system. Cutler could end up in any number of positions, probably at the White House council of economic advisors, but we think this isn’t such a bad one, is it? Blumenthal could also be a candidate here.

Avalere Health founder Dan Mendelson: Before starting Avalere, Mendelson served as associate director for health under the Clinton Administration from 1998-2000 at the Office of Management and Budget. Mendelson’s ties to people involved in the campaign make him an intriguing candidate for a position at CMS or possibly another health role in the next administration.

Harvard’s Steven Pearson: The comparative effectiveness guru is a senior fellow at the insurer’s trade association the America’s Health Insurance Plans and runs Harvard’s Institute for Clinical and Economic Review. Pearson has published research on how to use a standardized scoring system when it comes to comparative effectiveness research. Interesting. If not CMS, Pearson would be at the top of any list to head up a national center on comparative research.

This list is just a start and we'll be adding to it and subtracting from it after the election depending on who wins. We'll give you our picks next, but what do you think? Show us your picks and we'll post them.

Heroes, Prophets and Presidential Candidates

Add candidates Obama and McCain to the national autism discussion. And, with that, add an unsettling note for vaccines during the next four years.

Earlier this month, we wrote about praise from an unusual quarter for Congressman Henry Waxman (D-CA). An American Enterprise Institute scholar called the Democrat a “hero” in the effort to reassure the country about the safety of childhood vaccines. Waxman was praised at a book review event for a new work tracing the history and misdirected arguments from the evangelists of a perceived new epidemic of autism (“Autism’s False Prophets,” Paul Offit).

Then, as a perfect example of how politically potent the subject of autism has become, the subject was raised by both candidates in the final presidential debate on Oct. 15.

Republican candidate McCain, who has previously suggested support for those arguing that a link exists between vaccines and autism, raised the issue first in the Oct. 15 debate. McCain discussed autism in relation to his choice of Sarah Palin as a running mate.

Palin “understands special-needs families,” McCain declared. “She understands that autism is on the rise, that we’ve got to find out what’s causing it, and we have to reach out to these families, and help them, and give them the help that they need as they raise these very special needs children.” [Note: Perceptive fact-checkers quickly clarified Palin’s familial relationship to the issue: she has a nephew who has autism.]

Not to cede the issue of caring about autism to his opponent, Obama jumped in when asked for a response on Palin’s qualifications: “I think it’s very commendable the work she’s done on behalf of special needs. I agree with that.”

But Obama said that McCain’s stated plan to freeze federal spending would make it impossible to conduct further work on autism research. “I do want to just point out that autism, for example, or other special needs will require some additional funding, if we’re going to get serious in terms of research.”

McCain returned to the subject of autism forty minutes later in the debate in a section on funding for education. He said again that vice-presidential candidate Palin “knows about” special educational needs and autism “better than most.” The Republican candidate promised that “we’ll find and we’ll spend the money, research, to find the cause of autism.”

As sensitive barometers of the hot political/social issues, the candidates confirm the potency of attention to autism. Both candidates are primed to pay attention to the disease from the White House. But because of the lingering public misperception of a link between vaccines, the political statements represent a discordant note for the public health effort and for the vaccine community from the upcoming election.

The “further research” approach to autism in the third debate, however, is an improvement, from the vaccine community’s point of view, over earlier references to concern about a relationship between the condition and vaccinations.

One current legislative push, under the sponsorship, of Manhattan Democrat Carolyn Maloney would require the National Institutes of Health to conduct comparative trials of vaccinated versus unvaccinated populations “to study and resolve the question of the possible link between thimerosal in vaccines and autism.”

A definite answer from a controlled clinical trial: that sounds like the best way to put lingering questions about the safety of vaccines to rest. But it is not as easy as it sounds.

George Washington University anthropologist and international affairs professor Roy Richard Grinker has devoted close attention to the issues of prevalence and incidence rates of autism. A father of an autistic daughter, in 2007, he wrote “Unstrange Minds: Remapping the World of Autism.”

Grinker questions the fundamental assumption that there is an epidemic of autism. He maintains that the perceived change in prevalence rates in autism that is driving the public attention is not really a change in rates but stems from changes in diagnostic criteria and methods and an increase in the numbers of childhood psychologists doctors. He told an American Enterprise Institute event on autism on October 11 that comparing historic prevalence rates of autism to current rates is not comparing “apples to oranges,” it is more like comparing “apples to automobiles.”

Grinker also says that it will be very difficult, if not ethically impossible, to compare vaccinated versus unvaccinated populations. Some of the groups suggested as the unvaccinated arms are not unvaccinated.

“There is a myth out there that the Amish are unvaccinated,” Grinker says. “That is not the case: the Amish are vaccinated, probably at a rate similar to African-American communities in urban areas.” He noted that the population of unvaccinated children tends to be children with other issues (such as compromised immune systems) which will make them difficult to study.

The promise of more studies sounds good in a political campaign. Autism studies may even develop into a health priority during the next budget-strapped years. If Grinker is correct, however, the practical issues surrounding those studies will make them much harder to perform than to promise.

Why Big Pharma Should Vote Democratic

This Super Tuesday, pharmaceutical CEOs should ask themselves one question before they decide which way they will vote in 2008 if they are indeed single-issue voters:

Are you in favor of an expansion of the government subsidy to almost 50 million Americans to buy your products or would you prefer a drastic curtailing of the government subsidy under the popular Medicare Part D drug benefit?

If you’re in favor of the former, you should punch the Democratic ticket in November. If the latter is your desired outcome, then hop on the McCain Straight Talk Express.

The prospect of a Democratic administration with a Democratic-controlled House and a split Senate has a number of drug industry stakeholders nervous about the next four years. After all, the centerpieces of Senators Hillary Clinton’s (NY) and Barack Obama’s (IL) domestic policy agendas are universal health care proposals. And when Big Pharma hears “universal health care” it tends to be synonymous with national, government-run, single-payor system aka price controls.

But here’s something Big Pharma should keep in mind: neither Clinton nor Obama are proposing a single-formulary system. What they are proposing, though, is providing health care coverage for the 47 million and counting Americans without it.

In case you missed it, here was my first take on the Clinton and Obama health care proposals. Clinton has explicitly stated that buying coverage would be mandatory under her plan; Obama says he will wait to analyze affordability of a coverage proposal before mandating that individuals buy insurance.

“This should not be scary,” Clinton senior health policy advisor Chris Jennings told Wall Street investors at the Stanford Group health care conference in January. “This should be viewed as an incredible opportunity.” Obama health advisor Gregg Bloche echoed Jennings’ remarks at the meeting saying, “companies that innovate are going to thrive in the environment under the Democratic plans.”

There’s little doubt that under a universal, government-administered coverage system, there will be downward pressure on pricing, whether it’s through market competition or government “tinkering.” But Jennings and Bloche say whatever drug companies give up in margin, they’ll more than make up for in a jump in market share.

It would be hard to argue that the drug industry hasn’t reaped a windfall from providing roughly 40 million seniors with drug coverage under the Part D program. A universal coverage program would roughly double the number of Americans receiving some form of a drug benefit who previously were not.

Some senior company executives clearly see the advantages of working together with Democrats—should they win the White House—on health reforms. “It is really going to take a bipartisan view to be able to accomplish [universal health care],” Merck CEO Richard Clark said during the Morgan Stanley Pharmaceutical CEOs Unplugged conference in January. “I hope we are able to provide some recommendations, particularly around the uninsured and how that should be solved, just as we provided recommendations around Medicare” and the creation of the prescription drug benefit.

Eli Lilly SVP for corporate affairs and communications Alex Azar is urging the biopharmaceutical leadership to rally around a united position that preserves core industry business principles under more direct involvement by the government in health care. “We have to show that we’re willing to engage and to propose constructive alternatives,” the former HHS deputy secretary told attendees at The RPM Report’s FDA/CMS Summit in December. “Our industry brings some credibility to this discussion.”

For the most part, Republicans are looking at incremental improvements in health care that go hand-in-hand with the free-market principles underlying Part D ie. competitive insurance plans and allowing individuals to cross state lines to buy insurance from different providers if they don’t like the deal they’re getting locally.

Not too scary.

But under a Republican administration, the odds of a Medicare reform bill would be a near-certainty as the government looks for savings to fix the looming physician reimbursement cuts. In that climate, drug prices under Part D would be a tempting target for savings.

Moreover, the presumptive Republican nominee, Senator John McCain (AZ) does not look eager to become best friends with the pharmaceutical industry. During a New Hampshire debate before the primary in January, for example, McCain cast the industry in a not-so-flattering light while discussing why Americans can’t import drug from Canada. Former Massachusetts Governor and Presidential candidate Mitt Romney jumped in, “Don't turn the pharmaceutical companies into the big bad guys.” McCain responded: “They are.”

The drug industry is clearly reading the bi-partisan tea leaves. The pharmaceutical industry has given $4.6 million to Democrats thus far in 2008 compared to $4.5 million for Republicans, a 51-49 split, according to the Center for Responsive Politics. During the last election cycle in 2006, donations to Democrats totaled $6.1 million compared to $13.2 million, a 31% to 67% difference (independent donations make up the remaining 2%). The last Presidential election in 2004 saw the pharmaceutical industry give two-thirds of their donations to Republicans ($12 million) compared to one-third ($6.1 million) to Democrats.

You get the picture.

For all of the undecided In Vivo Blog readers, maybe the HealthCentral.com political PoliGraph will help you choose where you stand. Try it, it’s fun.