The president of American Academy of Family Physicians, Dr. Ted Epperly, has misdiagnosed the Physician Payments Sunshine Act, claiming it would place “onerous” and “undue burdens” on physicians.

“It gets into every little detail,” Epperly tells AAFP News Now, and calls for reporting only payments above $500. That won’t do. Data collected in Vermont and Minnesota show that a whole lot of influencing happens before Epperly’s preferred $500 is ever reached, including meals, entertainment, and gifts.

The Sunshine Act would not burden physicians with paperwork: In fact, it would place the burden of compliance on companies. And Sen. Charles Grassley’s investigations have showed that interesting things happen when companies do report. The bill would not require any proprietary information to be revealed other than that which is already mandated and available on clinicaltrials.gov; the only additional data beyond that already in the clinical trials registry would be the amounts paid to investigators.

Epperly complains that physicians would be unable to correct misreported payments once they were published. Again, not correct. The 2009 version of the Sunshine Act allows physicians to correct erroneous information on the site. The bill, reintroduced by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI), is a stronger version than one circulated last spring.

The uniform, public database that the Sunshine Act offers is the right medicine at the right time. The transparency and trust-building that the Sunshine Act offers is good for patients, and, all things being equal, that should be more than enough to win the AAFP’s support.

Family physicians play a crucial – and often under-appreciated – role in our health system. And they have been at the fore in acknowledging the problem of influence of industry marketing; state chapters in Oregon and Washington have taken steps to be pharm-free. We hope the AAFP will give this bill another look.

Pfizer announced today that it will begin to disclose payments made to physicians in a public online database beginning in the first half of 2010. Not only does this signal another Big (+ Wyeth = Bigger!) Pharma player hopping on the voluntary disclosure train, it would be the first company to post such information including payments to PIs of clinical trials.

Even though Pfizer is proposing a higher reporting threshold of $500, which would miss out on a healthy portion of payments like meals, the move takes more wind out of the already drooping sail of an argument the industry is hammering Massachusetts regulators with: that disclosure of clinical trial payments is Fatal to Business (especially, to hear them tell it, the Massachusetts Convention Industry).

It’s worth remembering Eli Lilly already discloses consulting and advisory payments on its website, and had pledged to widen that disclosure to match the Physician Payments Sunshine Act by 2011 (go here to read about other company promises) – so it could be said that Pfizer’s announcement is a case of the Great One-Up. But coming now – as Massachusetts Dept. of Public Health continues to come under industry fire for drafting regs that would require companies to do as Pfizer is doing – the move is significant.

As Newton’s First Law of News requires, the wires also brought this not-so-great report out of Minnesota indicating that the ethics chair and outgoing dean of the University of Minnesota Medical School, Dr. Deborah Powell, has significantly weakened recommendations by her own conflict of interest reform committee, which handed in a bold and comprehensive draft COI policy earlier this academic year.

According to the Minnesota Daily, which received a copy of the unreleased draft, “key elements of the task force’s recommendations, believed by some to be among the most needed changes, are notably absent from Powell’s draft, among them a recommendation to sever financial ties between industry and continuing medical education programs.”

Among those nips and tucks Dean Powell made to the committee’s recommendations? Yep, research:  “The task force recommended that faculty fully disclose the source of research funding as well, particularly those with clinical trials funded by industry,” but such disclosure didn’t make it into the new draft, either.

“They gutted it,” Center for Bioethics professor Carl Elliott told the Daily. Another Minnesota faculty member, Gary Schwitzer, a health journalist who has been a strong voice in calling for the separation of pharma money and faculty, told the paper he had not seen the latest draft at all, and American Medical Student Association Scorecard Director Gabriel Silverman said that the draft changes would take his read on the policies from strong to “borderline.”

Dean Powell, whose leadership of the task force was already marred by reports that the co-chair she named, Dr. Leo Furcht, was sanctioned for violating the university’s old conflict of interest policies, will step down as medical school dean but continue to chair the ethics reform committee, according to the Daily.

An amendment put forward today by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) as part of the Senate’s economic recovery bill would better illuminate conflicts in federal biomedical grants by requiring the National Institutes of Health to enforce its conflict of interest policies and respond to violators in a timely manner.

The Grassley-Kohl amendment would address systemic problems in the way grantees’ conflicts get reported – or don’t – problems that turned up in a series of recent investigations by Sen. Grassley.

The amendment also would require the following information to be given to the NIH by grantees receiving NIH in excess of $250,000:

a.   The amount of the primary investigator’s significant financial interest, estimated to the nearest one thousand dollars
b.   A detailed report on how the grantee institution will manage the primary investigator’s conflict of interest.

“It’s become clear that the federal rules in place to manage conflicts of interest in research aren’t enforced as they ought to be, and there’s an opportunity to strengthen them here, as well,” Grassley said in a statement.

“NIH grants are highly competitive,” Kohl said in a statement. “The government has a right to know whether the scientists it funds have a financial stake in the outcome of their research.”

The two senators also introduced the Physician Payments Sunshine Act earlier this session, and are resisting attempts by industry to weaken the bill, according to Inside Health Policy (subscription required). A Senate aide told the IHP that strengthened provisions – including a preёmption clause that allows states to collect other information, stronger penalties, and a lower reporting threshold — are not up for major negotiations, but the sponsors need to hear from supporters of the new, strong bill. To send a letter online, go here.

It’s Monday, which means the Arizona Cardinals’ championship dreams go back into hibernation* for at least another year, and it’s six more weeks of winter for the rest of us, at least if you believe the groundhog.

In the pocket: States introduce bills to protect patients, promote transparency

Vermont legislators have proposed a new law that would build on the state’s existing gifts disclosure law. The new version, if enacted, would ban gifts, meals, and certain types of payments from drug and device companies to prescribers, and require all others to be disclosed on a website with the names of the individual physicians. Moreover, the new bill does not include a trade secret clause that some say weakens the existing statute.

Here’s more at the Barre-Montpelier Times-Argus, and an interview with Senate President Pro tem and bill sponsor Peter Shumlin on Vermont Public Radio.

And on the other coast, a bipartisan group of Washington state legislators have introduced a bill that would shore up patient privacy law around notices about prescription drugs, reports the Seattle Post-Intelligencer. Right now, a loophole in federal HIPAA regulations allows patient’s prescription data to be sold to drug companies and PBMs, who then contact patients directly, urging them to refill their prescription with a prescription-switch in mind.

“(The letters and e-mails) are couched as being of service to the patient, but in reality they’re marketing newer, more expensive drugs — without the patient’s doctor having any idea that this marketing pitch is being done,” Rupin Thakkar, a pediatrician in Edmonds and co-chairman of the Washington Coalition for Prescribing Integrity told the Post-Intelligencer.

In other privacy news, Massachusetts State Rep. Stephen Kulik discusses why he introduced a pharmaceutical data-mining ban in the pages of the Worcester Business Journal.

Glory days: Gone at the FDA

The latest GAO report on FDA medical device approval found that the agency has been whisking through of the riskiest class of devices through an abbreviated process, and in a letter we wrote about here, agency scientists indicated device approvals had been mishandled by political appointees. These are just two more signs, the New York Times editorial board says, that indicate the agency is in deep need of repair.

“The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over,” writes the Times. “Officials will also have to make clear that the Bush administration’s practice of distorting science and weakening regulation to favor industry also is over.

But a new bill reintroduced last week may provide some answers for the troubled agency. The Food and Drug Administration Globalization Act (FDAGA), introduced by Energy and Commerce heavyweights Reps. John Dingell (D-MI), Bart Stupak (D-MI), and Frank Pallone (D-NJ), would establish a dedicated foreign inspectorate, and would give FDA funds to increase foreign GMP (good manufacturing practices) and pre-approval inspections. Producers of drugs and APIs (active pharmaceutical ingredients) would be inspected every two years and in some cases, four.

FDAGA also recognizes that while oversight is critical, the ultimate responsibility of ensuring quality rests with the manufacturer. The FDA cannot battle tainted drugs with inspections alone; industry must be accountable for their manufacturing supply chains.

The bill requires that manufacturers have a plan in place to formally assess their suppliers before contracting and to conduct ongoing monitoring and evaluation. The Act also requires that manufacturers be able to produce on request an electronic statement documenting every step in the supply chain of a drug, clearly establishing that each element, be it drug, ingredient, or other material, was processed and conveyed under appropriate conditions.

Here’s more at Reuters.

Offensive lines: U.S. attorney talks Lilly off-label marketing

Acting U.S. attorney for Pennsylvania’s Eastern District Laurie Magid paints a damning portrait of Eli Lilly’s marketing strategy to increase geriatric off-label use for dementia, depression and anxiety on the op-ed page of the Philadelphia Inquirer. Magid cites the “5 at 5” slogan reps were given, meaning “5 milligrams of Zyprexa at 5 p.m. would keep elderly patients quiet all night, not bothering the doctors or nursing staff in a long-term-care facility.” Such information was revealed in the course of the $1.4 billion settlement Lilly made around its off-labeling marketing of Zyprexa. Off-label is any use of a prescription drug not approved by the FDA, and it is illegal for companies to market drugs for off-label use.

“Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer,” she writes. “Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.”

And in other off-label news, a Medicare rule change would make more off-label cancer drug prescriptions eligible for payments.  The rule change expands the list of ‘guides’ used to determine coverage from one to four. Off-label prescribing, already a complex and controversial issue, is further complicated by the fact that three of the four guides that now trigger Medicare coverage are funded by pharmaceutical interests or groups that received industry funding, says the Wall Street Journal.

*In Phoenix right now: Sunny. Highs 69-74 degrees.