A new president, a look at the future, but the world goes on

November 7, 2008 – 3:51 am

Yes, Barack Hussein Obama will be the 44th president of the United States, once he is sworn into office in January. Now that the election is over and Mr. Obama is already starting to pick staff members, we can all go back to our daily lives. Other things did happen this week: The Supreme Court heard the first oral arguments in the Wyeth vs. Levine preemption case; GlaxoSmithKline is cutting 1,000 people from its salesforce and is consolidating its U.S. headquarters; Sanofi-Aventis and Pfizer have ended research on their obesity drugs; and drug companies apparently hid millions of dollars in payments to physicians in Vermont and Minnesota by designating them as “trade secrets.” There’s all sorts of other news out there as well, so I’ll get to it.

What’s next?

The pharmaceutical industry and expert pundits were quick to react to the news that Mr. Obama had won the election against Republican Sen. John McCain. Into my e-mail box came a missive from the Generic Pharmaceutical Association, congratulating Mr. Obama on his win and pledging to work with him on increasing access to generic medicines, especially biogenerics. His campaign stated that, as President, he would support legislation to create a biogenerics approval pathway with as short an exclusivity period as possible to ensure timely consumer access,” GPhA executives said. “That’s welcome news to the countless Americans who are struggling to afford to the extremely high costs of brand biopharmaceutical medicines.”

PhRMA also had its own congratulations to Mr. Obama. “As our nation’s leaders look ahead and begin to shape their agendas for next year, America’s pharmaceutical research and biotechnology companies — which lead the world in discovering new cures and treatments for patients — welcome the opportunity to help address the difficult healthcare challenges facing America,” said Billy Tauzin, PhRMA president and CEO and a former senator. “As always, we will work with lawmakers on both sides of the aisle and will continue to support policies that encourage and strengthen innovation, improve patient access to medicines and expand healthcare coverage for all Americans.”

PhRMA was quick to issue a statement on the new FDA commissioner to be appointed by the administration. “Due to the vital nature of the FDA’s public health oversight, identifying a strong, independent FDA Commissioner should be among the first accomplishments of the new Administration,” Mr. Tauzin said. “The ideal candidate should embrace the need to advocate for an empowered FDA that is adequately resourced to carry out its crucial mission. The individual also must have strong managerial skills that are essential for directing science-based activities at an Agency that has just expanded its ranks with thousands of new employees.”

As Dr. Robert Goldberg at DrugWonks said here, “Let’s stop thumb sucking and get down to business.”

FDA has a lot of problems to address, and the new commissioner will have to grapple with many issues, the most recent of which is mismanagement of employee benefits and pay, according to a letter that Sen. Chuck Grassley sent to current FDA Commissioner Andrew von Eschenbach. ““Based on the reports that have come to me, it looks like there is more than isolated incidents of mismanagement, and it could have significant repercussions for the quality workforce that the public deserves to have at the Food and Drug Administration,” Mr. Grassley said. “The leadership of the department and the agency needs to address these issues promptly.”

Over at Pharmalot, Ed Silverman polled readers to see if Dr. Steve Nissen, who has been a huge thorn in the side of the pharma industry, could possibly be tapped as FDA commissioner under an Obama administration. About three-quarters of the readers said no. Mr. Silverman points to other candidates here, following the lead of the InVivo Blog, where Ramsey Baghdadi named suggestions not only for FDA commissioner but head of Center for Medicare and Medicaid Services and Health and Human Services secretary as well. Some of Mr. Baghdadi’s picks include former Vermont governor Howard Dean, Kansas Governor Katherine Sebelius, and Masschusetts Governor Deval Patrick as Health and Human Services secretary; Dr. Nissen, Dr. Bruce Psaty at the University of Washington, Dr. Robert Califf of Duke (who commenters on the Nissen poll seemed to favor), consultant Dr. Mary Pendergrast, and Dr. David Blumenthal of Harvard as FDA commissioner; and Harvard economist David Cutler and Harvard’s comparative effectiveness expert, Steven Pearson, as CMS head.

Alicia Mundy at the Wall Street Journal Health Blog names some other candidates, including former South Dakota Sen. Tom Daschle as head of HHS; and as FDA commissioner, Mike Taylor, former FDA commissioner under President Clinton, and Dr. Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research.

At the Wall Street Journal Health Blog, Jacob Goldstein was told by readers that another potential candidate by be Dr. Joshua Sharfstein, commissioner of the Baltimore City Health Department. “Before he landed the Baltimore gig, he worked as a health policy adviser to Rep. Henry Waxman (D., Calif.), who chairs the House Committee on Oversight and Government Reform,” Mr. Goldstein says. “And we’ve heard Waxman would like to see Sharfstein running FDA in an Obama administration.”

Peter Pitts at DrugWonks says he’s been asked who’ll be the next FDA commissioner. “It’s an interesting question — but there’s an equally important question people are not asking — that of timing,” Mr. Niseen says. “When will a nomination will be made.” He’s right, Mr. Obama cannot dilly-dally in picking a new commissioner. It took quite a long time before President Bush nominated Dr. Mark McClellan as FDA commissioner, and it took even longer for Dr. von Eschenbach to be put into the position.

Mr. Pitts agrees with the commenters on Mr. Silverman’s poll that Dr. Nissen would not be a good choice. “He is widely disliked within the agency and is, as those in the know know, quite conflicted,” Mr. Pitts says.

Mark Senak at Eye on FDA also had some things to say about who the future FDA commissioner will be. Mr. Senak said Washington, D.C., was “an amazing place” to be on Wednesday, with “everyone walking around with a goofy and dazed expression on their face, myself included,” but, “The haze will lift quickly — times demand it.”

“There is no question of Dr. von Eschenbach staying,” Mr. Senak says. “He’s going to be out. It is less interesting who the person is over what he or she can bring to the table in terms of a unique mix of strengths, because there is a long list of needs on the part of the agency — an agency that has experienced a virtual vacuum of leadership for nearly the entire Bush presidency occurring exactly at a time when the agency was experiencing unprecedented challenge in overseeing the regulation of one-quarter of the nation’s economy.”

Mr. Senak lists several qualifications for the new FDA commissioner, such as having “a solid grasp of the pharmaceutical industry without being associated with it”; being able to “balance the policy maker hunger for safety while assuring that the pipeline produces”; and having “the credibility and gravitas to tell policy makers on the Hill to stop using the agency as a political means to gain headlines and bash.

He also emphasizes that the new commissioner must be “an incredible visionary and communicator.”

“The agency is in trouble not only from a functional point of view, but has done very little to proactively address the descent of its image and to communicate and assure the public and policy makers that there is a vision,” Mr. Senak says. “In fact, the agency does not seem to acknowledge much of a problem, much less a plan for solving it. The new commissioner needs to understand this, act upon it, and seize leadership. Pronto.”

Merrill Goozner at GoozNews disagrees with the pundits who say healthcare reform will be put on the backburner for at least the first half of Mr. Obama’s presidency. “Curbing the growth of health care spending will reassert itself as an issue next year because it is key to restoring this nation to economic competitiveness,” he says. “American businesses are at a competitive disadvantage when they must pay twice what companies in other countries pay (whether premiums or taxes) to provide their workers health coverage.”

Niko Karvounis at Health Beat looks at the bipartisan merits of a public competitor in health care. He contends that Mr. Obama’s plan for a National Health Insurance Exchange would actually strengthen the competitive market for health insurance. “Today, insofar as there is competition amongst health insurers, it’s all about minimizing risk — that is, scrambling to pick up only the healthiest, and thus most cheaply insurable, customers while rejecting the sick,” Mr. Karvounis says. “This is not competition centered on customer satisfaction. The goal seems to be: provide as little coverage as possible to the fewest number of people who need it least. But the public and NHIE affiliated plans wouldn’t discriminate on these grounds. They would set a new standard of expectations and services in health care, redefining competition in terms of quality and efficiency. Those insurers who can’t keep up would go out of business.”

Any of the healthcare reforms proposed by Mr. Obama will live or die in the Senate, Mr. Goldstein says. “Long before Election Day, the senators were crafting a game plan that may feature some aggressive procedural moves to push legislation past any Republican objections,” he says. “Staffers from the key Senate committees have been meeting for months to map out a strategy for expanding insurance coverage and improving how the health-care system functions. And perhaps most importantly, they’ve been busy trying to figure out how to pay for the whole thing.”

One person who may have some influence in a new FDA is Sidney Wolfe of Public Citizen, who became a member of FDA’s Drug Safety and Risk Management Advisory Committee; Mr. Silverman at Pharmalot has an interview.

Another area that might shift under the Obama administration is the U.S. patent office, says Stephen Albainy-Jenei of Patent Baristas. “Most likely, any changes will come slowly,” he says, but does believe that Jon Dudas, the undersecretary of Commerce for Intellectual Property and a Bush appointee, would be leaving.

Mr. Albainy-Jenei details more benefits of an Obama administration on patents and technology here, such as the promotion of American businesses abroad, doubling the federal funding for basic science research, expanding research at American colleges and universities, and restoring scientific integrity to the White House.

Preemption battle at high court

Overshadowed somewhat by the Election Day hoopla this week was the beginning of oral arguments in the Wyeth vs. Levine case at the Supreme Court. Ed Silverman at Pharmalot sourced Dow Jones, giving us the play-by-play. Mr. Silverman also provided the official transcript of the court proceedings.

Other bloggers weighed in on the preemption case, such as Val Jones at Science-Based Medicine. “It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case,” she says. “I’ve been watching the media frenzy about the lawsuit with interest — mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one — and that most journalists (and even medical journal editors) have missed the salient points.”

Both Mr. Silverman and Sarah Rubenstein at the Wall Street Journal Health Blog picked up a story from the Law Times, which stated that if Mr. Obama was elected, preemption would be history.

Around and about …

Daniel Carlat at the Carlat Psychiatry Blog comments on the hidden payments for Vermont physicians. “By far the majority of trade secret payments were for promotional speaking (43.2%) and for ‘educational’ activities — presumably CME (41.7%),” he says. “Most such gigs are well-publicized by mailings to doctors’ offices, and they are typically for products that are already FDA-approved. Calling promotional speeches and CME events ‘trade secrets’ is Orwellian double-speak at its finest.” I am far from surprised that so many payments were designated as “trade secrets.” Just try and get someone at a pharma company to confirm or deny which agency holds one of their brands as an account. Practically everything in their marketing plans is a “trade secret,” “competitive information,” etc.

And speaking of payments to physicians, Philip Dawdy at Furious Seasons and Ed Silverman at Pharmalot look at stories that Sen. Chuck Grassley, R-Iowa, and Sen. Herb Kohl, D-Calif., are probing Johnson & Johnson over payments possibly related to the antipsychotic Risperdal.

Dr. Derek Lowe at In the Pipeline looks at the death of the CB-1 antagonists as obesity drugs. “I don’t see much work going on in this area for some time to come, unless the pharmacology gets untangled to the point that someone can see a safe way through,” he says. “There may well not be one. And before we all try to forget that this all happened, let’s spare a thought for the huge amounts of time, effort, brainpower and money that went into this area over the last eight or ten years. Three of the biggest research organizations in the industry have now flamed out trying to develop these drugs, and plenty of smaller players were trying, too, as a glance at the patent literature will make clear. The end result is that we have paid a gigantic amount of money to learn that the biology is more complicated than we thought, and it needed no ghost come from the grave to tell us this. If you think that drug development is a sure road to riches — if anyone still thinks that — then come survey this wreckage and think again.”

Jim Edwards at Bnet also looks at the obesity drug failures, noting that there is something odd about Pfizer’s statement. “It said there was nothing wrong with the compound, but they were booting it from the pipeline because they couldn’t be bothered to navigate the bureaucracy required to bring it to market … Really? The company has an effective drug but won’t attempt to sell it — clearly we’re lacking some important details,” Mr. Edwards says.

Mr. Edwards writes about what GlaxoSmithKline employees are saying about the layoffs. Like just about all of us who cover the industry, Mr. Edwards was able to glean some useful insights from Cafe Pharma, or as he put it, “GSK’s internal human resources intranet.” Mr. Edwards says this poster, who started this thread a year ago, “seems to be some sort of GSK-based Nostradamus.”

At the Wall Street Journal Health Blog, Jeanne Whalen had predicted the cuts, saying two weeks ago, CEO Andrew Witty was “scrutinizing the U.S. staff to ensure it reflects the increasingly difficult market conditions there. He added that the current model of sales teams bombarding doctors with visits isn’t ‘a sustainable way forward,’ and said Glaxo needs to focus more on insurers and other payers that increasingly decide which drugs doctors can prescribe.” She updated the news when the axe fell.

A hat tip to Fierce Biotech, which picked up the story from the Minneapolis-St. Paul Business Journal; apparently the Mayo Clinic is cutting its clinical trials unit.

Sarah Rubenstein at the Wall Street Journal Health Blog and Ed Silverman at Pharmalot both had the news about an extortion threat to Express Scripts over breached patient data. The pharmacy benefit manager is refusing to pay up to the hacker and had informed the FBI right away.

From the really strange if it’s really true file: According to Ed Silverman at Pharmalot, an AstraZeneca regional sales manager allegedly directed reps to use Winnie the Pooh’s friends Tigger and Eeyore to promote Seroquel. It’s not the first time a regional sales manager at AstraZeneca has gotten over into trouble for suggestions to sales reps; who can forget the infamous “a big bucket of money” incident? Or the pink cupcakes? But neither of those incidents involved copyright characters. Disney lawyers tend to very humorless when it comes to use of its characters in other companies’ marketing campaigns …

John Mack at the Pharma Marketing Blog was more salty about the use of the Disney characters, saying the use of Eeyore was “a jackass marketing gimmick.” He turned to the AstraZeneca discussion board on Cafe Pharma for some insight.

Mr. Dawdy at Furious Seasons was disturbed that Bristol-Myers Squibb is marketing Abilify for depression (I saw the same ad, and all I could think was, “Uh, there’s going to be a lawsuit in the making.”). “We have reached avery pretty pass in our culture and in depression treatment when a pharma company pimps an antipsychotic on TV as a treatment for depression,” he says. “I’ll leave it at that.”

From the Med 2.0 blog comes the news that Bristol-Myers Squibb and Novartist have provided unrestricted grants for social media initiatives, aimed at cancer patients. (Hat tip to Steve Woodruff of Impactiviti.) About the Bristol-Myers Squibb grant, Shwen Gwee says, “I think it’s a really good sign that pharmaceutical companies are starting to recognize the value and importance that online communities and other social media efforts can have in supporting patients, caregivers, and even healthcare professionals.”

And speaking of social media, Johnson & Johnson keeps posting more videos to its YouTube Health Channel, says Marc Monseau at JNJBTW; the most recent one is about living with bipolar disorder.

This is an example of the pitfalls of social media for pharma: Ed Silverman at Pharmalot chronicles how Marianne Skolek, whose daughter died from OxyContin, is dogging Purdue Pharma on Wikipedia. “Of course, Purdue can arrange to have this deleted, but meanwhile, her message is getting out there,” Mr. Silverman says. UPDATE: Ms. Skolek’s edits were removed within 24 hours, but Chris MacDonald at the Business Ethics Blog has a screen capture of the original entry.

It’s a good thing some companies are willing to take some steps into social media, because there are more than 60 million U.S. adults engaged in 2.0 health initiatives, says Rich Meyer at World of DTC Marketing, picking up the most recent survey by Manhattan Research. However, spending next year on Web 2.0 initiatives for consumers is likely to slow down because of the economy.