Amidst all the merrymaking of the past weeks, here’s what PostScript was reading…

FDA: a fixer-upper?

Obama and the FDA – will he fix it, and when? Those are the questions Tribune reporter Noam Levey asks about the troubled agency and where its reforms may fall on the growing list of the President-Elect’s priorities.

And Merrill Goozner at Gooznews talks about the consumer voice in discussions about the next FDA commissioner. Goozner says Obama’s FDA transition team has worked to bring all voices to the table, and is confident the consumer perspective has been heard.  We liked his credo of sorts at the end:

“Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner,” Goozner writes.  “That’s not faster cures. That’s smarter cures, even as the new commissioner insists that they still meet the agency’s statutory hurdles for safety and efficacy.”

Northern Disclosure

And in the snowy Midwest this week, there were two very different stories swirling around conflicts of interest at two major academic medical centers.

The University of Wisconsin-Madison announced it will post signs at its health clinics indicating that doctors may take drug company money for research and consulting beginning in January. Earlier this year, the UW School of Medicine and Public Health revised its conflict of interest policies, tightening restrictions on industry-sponsored meals and establishing a strong samples program that would provide pharmacy vouchers to clinic patients, eliminating the freebies-bias toward newer and often more expensive drugs.

The Wisconsin State Journal reports that despite this move toward greater transparency with patients, who will be able to ask for details about their doctor’s industry relationships, the University will not be publishing physicians’ corporate receipts in a public way anytime soon.

“It would take a lot of time and effort to have an updated database,” the dean of the medical school, Dr. Robert Golden, told the Journal. “We believe it will be only a handful of patients requesting this.”

Meanwhile, the Minnesota Star-Tribune revealed that the head of the committee charged with developing a new set of conflict of interest policies for the University of Minnesota Medical School, Dr. Leon Furcht, was censured in 2004 by the Dean that appointed him for diverting $500,000 in industry research dollars to his own stem cell company.  Furcht, who just emerged from a three-year sanction period that banned him from involvement with any commercially-backed research, is now co-chair of the committee convened to write the University’s policies regulating faculty and student interaction with industry.

This Star-Tribune editorial praises the COI policy process at the med school but says the choice of Furcht to head the committee undermines the credibility of any policies it will produce.

Diagnose This

And the Los Angeles Times looks at the kerfuffle developing around the nondisclosure agreement the American Psychiatric Association had the writers of the DSM-V sign. The Diagnostic and Statistical Manual of Mental Disorders, which was last updated in 2000, has major influence on and implications for psychiatric diagnoses and treatment, insurance reimbursement, and social concepts of what it means to be well or disordered.

One of the new authors, Dr. Robert Spitzer of Columbia, has broken rank and has openly opposed the mandated secrecy as something neither his profession nor the field of medicine can afford. Reading about “chronic complaint disorder” from published working papers of an earlier DSM committee, we understand why they might not want to let the diagnostic dogs out just yet.

An excellent piece on the DSM in the New York Times, as well.

Angell Reviews Rx Books of 2008

Along literary lines, former New England Journal of Medicine editor Dr. Marcia Angell writes in the New York Review of Books about three books on Big Pharma’s influence on medicine: Our Daily Meds, Side Effects, and Shyness: How Normal Behavior Became a Sickness.  Without the space limitations of other publications that tackle this complex web of problems around industry involvement with medical decision-making, Angell is free here to connect the dots: from the systemic bias of company-sponsored clinical trials, to the cultural secrecy and acceptance of corporate support by academic researchers who write treatment guidelines, prescribe, and advise the FDA, to the growth of off-label prescribing and industry’s subtle and multi-front campaign to promote it – Angell brings these texts together with her own experience as editor in what makes for an eloquent problem statement about the state of industry influence on academic medicine.

“The mission of medical schools and teaching hospitals—and what justifies their tax-exempt status—is to educate the next generation of physicians, carry out scientifically important research, and care for the sickest members of society,” Angell writes. “It is not to enter into lucrative commercial alliances with the pharmaceutical industry. As reprehensible as many industry practices are, I believe the behavior of much of the medical profession is even more culpable.”

Well, we’re back on the Reader wagon just in time for the holidays. So if you’re still in front of your monitor like us, here are a few things that caught our eye.

First, the Physician Payments Sunshine Act won major support this week when a  Congressional Budget Office (CBO) report released Thursday supported industry disclosure of relationships with physicians in a volume of health-related budget options.

CBO made a very positive assessment of the Sunshine provision, saying it “believes that, over time, disclosure has the potential to reduce spending.” Among its considerations:

• Hospitals and health plans can use this information to safeguard the integrity of formulary decisions
• Disclosure might encourage physicians to monitor or modify their behavior
• The data collected could help inform further regulations to reduce cost
• CMS could use the data in combination with claims data to better understand trends in physician practices and utilization of drugs, and
• Medicare beneficiaries could be informed to a greater degree when selecting a doctor.

Pharmaceutical leaflet quality subpar, says FDA study

The FDA has found that the quality of prescription drug safety and use pamphlets wanting, according to a new evaluation conducted by the agency. As reported by the Wall Street Journal, a quarter of the leaflets, called consumer medication information or CMI, failed to meet minimum standards set by the agency,  including two-thirds that “lacked general dosing information”  and two-fifths that “failed to give dosing instructions specific to the patient.”

Stiglitz writes on drug safety, efficacy

And the WSJ’s quicker, freer sidekick, the Healthblog looks a Health Affairs piece by Nobel Laureate Joseph Stiglitz that says one way to better drug safety and efficacy is to use comparative effectiveness tools that would require drugs to be tested in ‘head-to-head’ clinical trials, and to conduct those trials with public funding and public transparency, which Stiglitz argues would unclog the pipeline of endless me-too drugs.

“CME-like”

Unlike pretty much all of the economy, Sen. Grassley’s conflict of interest charge hasn’t slowed. This week, he called out Emory University’s semantic defense of Nemeroff’s jillions being non-disclosable because they were for ‘CME-like’ activities.

In a letter sent to Emory’s president, Grassley wrote: “Neither anyone on my staff, nor any medical expert that they have contacted, have ever heard of the term ‘CME-like…It appears to be a new term created at Emory University.” Then he attached the laws pertaining to false statements made before Congress.

Grassley’s investigators have also revealed evidence that Wyeth engaged in extensive ghost-writing around hormone replacement therapy beginning in the late 1990s.

For all you ever wanted to know and more, check out the Health Care Renewal blog.

Florida changes Medicaid rule, allows reimbursement for some off-label prescribing in kids

Pharmalot reports this week that Florida Medicaid department has reversed a rule that prohibited reimbursement for prescriptions to children under a certain age. Pharmalot’s Ed Silverman points out that that this includes atypical antipsychotics, which are not approved for use in children under 10 – in other words, Florida prescribers can now be reimbursed for off-label use of psych drugs in kids, a combination that Silverman says has been shown to have some worrisome side effects in recent studies.

Who’s it gonna be?

And the bets are still rolling in on who will be the next FDA commissioner, though the speculative field is narrowing, according to the New York Times and Wall Street Journal. This week, we found out it won’t be Andrew Von Eschenbach again.

Happy holidays, peace, and travel.

We’re at the Carnegie Endowment for Peace Conference Center in Washington DC today for the first Prescription Project Conference, Righting the Script, Improving Pharmaceutical Policy in an Era of Health Reform, and Congressman Henry Waxman (D-CA) is delivering the keynote address in a few minutes. We’ll be live-blogging his address.

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“Chairman Waxman has been a hero to all of us in the health access area,” said RxP Executive Director Rob Restuccia as he introduced Rep. Waxman.

“Next January, I’ll assume the Chair of Energy and Commerce, ” Rep. Waxman began, but turned nearly immediately to his previous role as Chair of the Committee on Oversight and Government Reform, where he said he used oversight to try to “shine a spotlight” on the fraud and abuse in government, or “what happens when our regulatory agencies become politicized, and when politics replaces science.”

Waxman talked about the legislation he worked on as 16-year chair of the Commerce committee’s Subcommittee on Health & Environment, including:

-Hatch-Waxman Act

-Medicaid price advantage

-national nutrition labeling system

-a childhood vaccine compensation system

-orphan drug legislation

-Ryan White Act, which offer services to AIDS patients

-”now-famous” tobacco hearings

“I’ve been amused of late, when a lot of people started to speculate about how I would be in legislating,” Rep. Waxman said. “I think if people want to know how I’m going to act as Chairman, they should look back to what I did back then as Chair of the Health & Environment subcommittee.”

Of his new chairmanship, Rep. Waxman said he’d not move away from oversight: “But that doesn’t mean we’re not going to look at oversight,” he said. “Oversight informs the legislative process.”

He said he wants to work with President-elect Obama to pass “affordable, accessible health care coverage for all Americans.”

“The opportunity we have now to change this system is the greatest we’ve ever had,” the incoming Chairman said, and mentioned HHS Secretary-appointee Tom Daschle and “a legend” in Sen. Edward Kennedy to help move health reform efforts.

“There are some that say with the economy the way it is, we have to put this goal off,” he said. “Well, I look at it completely differently,” saying he believes that health reform is even more critical in the current economic climate.

“And to me, the best approach is what we can pass,” he said, indicating that President-elect Obama has laid out a “workable blueprint.”

He mentioned Congress’ immediate health care priorities are to re-enact and expand SCHIP, and offer states Medicaid help. In addition:

-generic biologics

-wants to give FDA authority to regulate tobacco

-offer “support” and “constructive criticism” of public health agencies, who’ve “too often had their scientific judgment interfered with.”

“Americans must face an inconvenient truth about drug safety,” he said, and acknowledge that in an effort to get therapies to people, we have to let drugs on the market whose full safety profiles aren’t known.

But because companies do such heavy marketing in those first years, Waxman said that dangerous effects can go undetected and spread in wide prescribing, and said he supported legislation that would grant FDA authority to put a moratorium on direct-to-consumer advertising on certain drugs in the first two years on a case-by-case basis.

Rep. Waxman went on to say Congress needs to address physician marketing, because the “most persuasive, effective advertising” really goes on in the doctor’s office. He discussed industry’s attempts to conduct off-label marketing, cherry-picked industry information, and his support of Kohl’s academic detailing initiative, the Independent Drug Education and Outreach Act.

Dr. Daniel Carlat (Carlat Psychiatry Report) asked about support of Physician Payments Sunshine Act, which would require companies to disclose payments to physicians, health care organizations, and other prescribers.

“I was going to ask how you felt about it, as a psychiatrist,” Rep. Waxman quipped, and then said he hadn’t had a chance to review the legislation, but would take Carlat’s recommendation to support it into consideration .

When asked about the “broken agency” reputation of the FDA, Rep. Waxman said he would prefer totally independently funded FDA, instead of reliance on industry user fees, but not if that means an under-funded agency.

Asked what level he hoped to fund the FDA at, Rep. Waxman didn’t give a number, but listed authority, funding, and organizational structure as his three strategies for fixing the agency.

Ever since RxP submitted citizen petitions to the FDA Wednesday, asking that 6 medical device ads without proper risk information be pulled from YouTube and that the FDA clarify its rules around internet marketing, the web has been abuzz with questions about whether the three devicemakers just missed this, or were trying to push the envelope around social media marketing rules and regs.   As of this writing, all three companies – Abbott, Stryker and Medtronic — have removed the YouTube videos referenced in the petition. On Wednesday, Abbott announced it will “embed safety and risk information in the videos moving forward.”

It seems that experts from all corners think that drug and device companies ought to be held to the same rules in the brave new world of social media as they are in more established broadcast forms.

Peter Pitts at DrugWonks put it this way:

“After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances.  This is not rocket science and pharmaceutical and medical device companies should know this without having to be told…

The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don’t contain required warnings and disclosures.  And they’re right…

Just follow the rules.   Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.”

It may not happen often, but we agree with Pitts.

Today the Prescription Project filed a series of citizen petitions with the FDA asking that six YouTube videos be removed immediately from the self-broadcast internet supersite because they appear to have been posted by medical device manufacturers, but do not contain the federally-mandated warnings or provisions required of medical device advertisements.

The videos include four posted by Abbott Laboratories about its XIENCE-V drug eluting stent, one for Medtronic’s Prestige® Cervical Disc, and one for Stryker’s Cormet™ Hip Resurfacing Technology. Here they are.

The Project is petitioning the FDA, which is charged with regulating the marketing of approved medical devices as well as prescription drugs, to require the makers to remove the ads from YouTube immediately and to post “curative” ads that contain the proper risk information. In addition, the Project calls on the FDA to:

• Advise all major prescription drug manufacturers and medical device manufacturers that online/Internet drug and device advertisements and promotions are subject to the same requirements as drug and device promotions in other media, and recommend that they review their online advertisements for compliance.

• Issue a Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet to clarify how federal law and FDA regulations apply to online drug and device promotions.

But who watches YouTube for info about health, anyway?  Well, it seems that number is growing rapidly. According to a 2007 survey conducted by the Pew Internet and American Life Project, somewhere between 75% and 80% of internet users have looked online for health information. And a Manhattan Research poll about physician online habits released just last month found that 83% of physicians watch video clips online, as compared with 34% of all US adults.

So statistically, these ads are being seen by both patients and doctors.  And without the proper risk information that’s required in other broadcast drug device advertising, that’s a problem.

In fact, we think it’s an even bigger problem because consumers injured by medical devices can no longer sue device manufacturers for failing to warn them about known but undisclosed risks, a result of the February 2008 Supreme Court decision in Riegel v. Medtronic. And consumers injured by prescription drugs may well lose that same right if the Supreme Court issues a similar ruling in Wyeth v. Levine, a case argued before the Court last month.

To read the petitions and view the videos, go to: http://www.prescriptionproject.org/citizen_petition