A new report out by the Institute of Medicine recommends that Congress pass a law like the Physician Payments Sunshine Act to disclose industry payments to doctors, and that continuing medical education for doctors be completely decoupled from industry funding and replaced by a new funding mechanism within two years.  The report from the highly-regarded, nonpartisan Institute offers an unambiguous critique of the current coziness between the pharmaceutical industry and medical profession.

The IOM recommendations are consistent with those that RxP has made for academic medical centers, physician groups, and policymakers. On the heels of a recent series of Senate investigations into undisclosed consulting payments to doctors, and strong recommendations to end or limit industry support of CME from the Macy Foundation and the Association of American Medical Colleges, the IOM’s bold report is likely to quicken the pace of the reforms we’ve already begun to see.

And as the IOM points out, if medical schools, professional societies and individual doctors don’t take these steps, change will likely be imposed on them from outside the profession – Congress and the National Institutes of Health, to name two.

For more, here’s the AP coverage, the New York Times, and the report brief.

Yesterday, the Vermont District Court upheld a 2007 law banning the use of prescriber-identifiable information to market prescription drugs. In his opinion, Judge J. Garvan Murtha affirmed the Vermont Legislature’s findings that the use of data-mining as a pharmaceutical sales tactic promotes the overuse of more expensive, less-tested drugs, and that banning the practice for marketing purposes protects public health and contains costs.  Importantly, the decision explicitly deferred to the legislature to decide how to rein in rising health care costs.

The Court’s decision supports a unanimous November 2008 ruling by the U.S. First Circuit Court of Appeals to uphold a similar law in New Hampshire that bans the use of prescriber-identifiable information for marketing purposes, and is a strong signal for other states that are currently considering data-mining restriction laws, including Connecticut and Massachusetts.

A Healthy Blog, part of the coalition supporting the Massachusetts data-mining bill, found inspiration in Vermont Attorney General William Sorrell’s response to the decision: “It is a testament to our Legislature and to the courage of this small state that we continue to lead the way on important public health issues,” he said.

Here’s the full decision.

Vermont docs got $2.9 million from drugmakers in ’08

Drug companies spent $2.9 million on payments to health care professionals, hospitals, universities and clinics in Vermont last year, according to a report released by the Vermont Attorney General’s office Wednesday. Payments related to drugs to treat depression and ADHD fell off as a proportion of total marketing payments, while those to promote diabetes and hypertension drugs increased.

The state law that requires companies to disclose payments to health care providers allows the companies to designate payments as trade secrets, effectively hiding the details of those payments from the public.  Payments designated as trade secrets jumped from 72% to 83% of the value of all reported payments between FY 2007 and FY 2008.  However, the proportion of all disclosed information fields declared trade secrets – the details of which may not be shared with the public – jumped from 41% to 74% between FY 2007 and FY 2008. A bill pending in the Vermont Legislature would eliminate the trade secret exemption, similar to laws in Minnesota and Massachusetts.

More from the Associated Press and the WSJ Health Blog.

Googleable compliance

And today the New York Times has this follow-up about how drug companies are changing tack to respond to FDA warning letters that charged companies were not providing sufficient risk-disclosure information on Google search ads, and that the ads were to be pulled down.

The companies say that the 95-word limit on the ads makes it impossible to disclosure the info the FDA says that they must, and are now using generic-sounding links with redirects to the brand-name page. According to the Times, Google “will not let any advertiser except for pharmaceutical companies use this kind of redirecting link.”

NYC detailers pound pavement for public health causes

Earlier this week, the Times reported that New York City is using academic detailing to get out the word on six different public health campaigns, from everything to domestic violence prevention to flu vaccines. A growing number of states and regions have started to use the method, which sends trained health professionals into doctors’ offices with unbiased information about drugs in the same way pharma reps make office calls.  Congress is considering a bill now, the Independent Drug Education and Outreach Act, that would provide resources for states and medical centers to start academic detailing programs of their own.

Psaty on COI, clinical trial bias

And from way back last weekend, a good how-can-you-tell story in The Macon Daily on medical conflicts of interest. Drug safety expert Dr. Bruce Psaty, who takes no money from the pharmaceutical industry, told the paper that in the absence of a clinical trials system funded entirely by the public, there are some flags people can look for in trials that may point to clinical bias.

“Was the question a good question? Did they set the study up right? Did they use the weakest possible comparator to make a drug look good in a trial?” he said. Psaty spoke about the FDA at the Prescription Project conference last year.

Hopkins bans gifts, drug samples

Johns Hopkins has banned some types of gifts, meals and drug samples from pharmaceutical companies, says the WSJ HealthBlog. The policy, which extends not only to the University’s medical school but also to its affiliated hospital and clinics, also prevents consulting payments without legitimate research aims and keeps sales reps out of patient-care areas.

But wait a second, says fellow blogger Dr. Daniel Carlat, PhRMA already bans its own reps from giving the pens and tchotchkes Hopkins put on the do-not-accept list — it’s in the industry’s new voluntary code on Interaction with Healthcare Professionals. And on closer inspection, the meal limits still allow Hopkins faculty members to eat quite well on a drug rep’s dime (and maybe have a sip of his martini), Carlat says.

FDA calls for safety, efficacy tests of risky medical devices

The FDA announced this week that it will require makers of the riskiest class of medical devices, called Class III devices, to prove their products are safe and effective, though a grandfathering system established before 1976 allowed many of them to be marketed and sold without establishing such evidence. The New York Times has more here.

According to the Times, “The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.”

Sen. Grassley looks into pharma ties of mental health advocacy group

And Sen. Charles Grassley (R-IA) has asked the National Alliance on Mental Illness for information on all funding it receives from pharmaceutical companies or pharma-funded foundations. According to Bloomberg, the group, which calls itself the largest national grassroots organization for those with mental illness, came under fire after 1999 report that it received $11.7 million over 3 years from 18 drug companies, and still has a host of support from high-octane drug makers.

“Destroy them where they live”: email in Vioxx lawsuit reveals company plans to discredit critics

An email from Merck employees released in a federal court in Melbourne, Australia this week reveals a hit list of doctors and researchers who raised questions about the painkiller Vioxx. According to a report in the Australian, the email uses the words “neutralize” and discredit” in reference to those who criticized the blockbuster drug before it was pulled from the market in 2004 for lethal cardiac side effects.

“We may need to seek them out and destroy them where they live,” the email said, according to an excerpt read in court by plaintiff’s attorney.

The email was released as part of a class action lawsuit brought by 1000 Australians who allege they were injured by taking Vioxx between 1999 and 2004.

What DTC, drug labeling does and doesn’t say

The average American watches 16 hours of drug ads on TV each year, reports the Boston Globe in this in-depth look at direct-to-consumer drug ads. The story explores not only the persuasiveness and dangers of the marketing strategy, but a series of proposals from researchers on how to make drug risks and facts clearer in ads and in labeling.

Iowa biotech attacks data-mining bill

The Iowa Biotechnology Association argues in this Des Moines Register column that an Iowa Senate bill to end commercial data-mining would stifle innovation in the state. But the only kind of data-mining that the bill (SF 389) would prevent is marketing: in other words, the use of prescribing records by drug companies to target their sales pitches to doctors – often without the doctor’s knowledge.  For more on prescription data-mining, check out our fact sheet.

One click is too far to go for risk information, according to a series of warning letters the FDA sent to drug manufacturers last Friday. The fourteen letters pointed out violations in online search engine ads for over 45 drugs made by some of the nation’s biggest drug manufacturers, including Glaxo-Smith-Kline, Merck, Eli Lilly, and Pfizer.

The FDA warning letters are consistent with the Pew Prescription Project’s request for the agency to articulate the rules regulating online advertising, which was made in a series of citizen petitions filed with the FDA last December. While three petitions dealt with online ads promoting three medical devices, a fourth petition urged FDA to take a strong public position advising all drug and device manufacturers on how close risk information and side effects, called “disclosures,” must appear to an internet ad.

Marking a significant shift in current industry standards, the FDA rejected the ‘one-click’ rule of thumb currently used by manufacturers, which often puts access to the product websites and full risk information one click away from these sponsored links.  Though the FDA requires all prescription drug ads to include “disclosures,” a list of side effects, risk information, and indications for a drug, the ‘one-click’ standard has allowed drug companies to post YouTube videos and short ads such as ones that appear during a Google search without these disclosures, but with a link to the company website where the disclosures are posted. In its petitions, the Prescription Project argued that internet ads that failed to provide these disclosure direcly should be considered illegal by FDA.

FDA repeated consistently to all these manufacturers that merely providing a link to the drug’s website “is insufficient to mitigate the misleading omission of risk information from these promotional materials.” The letters ask that the companies remove the ads in violation and respond to the agency by April 9.

And in another good move for consumers swamped by DTC ads in every media, the FDA also advised these fourteen drugmakers to broadly review  all their internet promotions for other drugs to ensure compliance with the advertising regulations, a move urged by the Project’s petition, as well.

Stanford will put researchers’ industry payments online

Stanford has announced it will disclose the names of researchers and faculty members who receive drug and device company consulting payments on a public website beginning later this year. The move makes Stanford the second major academic medical center, following the Cleveland Clinic, to make public such disclosures, and comes as the Physician Payments Sunshine Act gathers steam in Congress.

“Access to information about physicians’ interactions with industry is key to fostering strong doctor-patient relationships, as well as increasing public confidence in the medical community,” Dean of the College of Medicine Phillip Pizzo said in a news release.

Stanford says it plans to publish the names of all researchers and physicians who make more than $5,000 from industry consulting or speaking in a year, but not the specific payment amounts.  The list will be located here beginning later in the year: http://med.stanford.edu/profiles/.

“IDEA” academic detailing bill introduced in Senate, House

The Senate and House have reintroduced a bill that would send pharmacists and nurses head to head with pharma’s nearly 100,000 sales reps to give doctors unbiased information about prescription drugs.

The Independent Drug Education and Outreach Act of 2009 would provide grants to create unbiased educational materials for doctors, and grants to train pharmacists and nurses to make educational office visits to doctors with that information, combating the biased commercial information brought by drug reps.
Since last year when the bill was first filed, academic detailing programs have picked up steam in the states, with Massachusetts, New York, Washington D.C. and Maine all implementing state-wide programs this year. Other states that have proposed academic detailing bills this year include California, Minnesota, and Iowa.  IDEA, if passed, could offer these states – as well as other payors and non-profits who accept no pharmaceutical funding – grants to fund their academic detailing programs.

“Academic detailing,” a concept which relies on the pharmaceutical industry’s own tactic of office visits to share unbiased drug information with physicians and other prescribers, has demonstrated cost savings at the national level in Australia, and in Pennsylvania’s PACE program. The bill, if passed, could have important effects as Congress looks to introduce a health reform proposal in a tight fiscal climate.

IDEA is being sponsored in the Senate by Sen. Herb Kohl (D-WI), Sen. Edward Kennedy (D-MA), Sen. Richard Durbin (D-IL) and Sen. Robert Casey (D-PA), and in the House by Rep. Henry Waxman (D-CA), Rep Frank Pallone (D-NJ), Rep. Pete Stark (D-CA), and Rep. Charles Rangel (D-NY).

For more information, check out the Prescription Project’s fact sheet and academic detailing cost analysis here.

PMA leaders in JAMA: drop industry funding

And a group of current and former heads of professional medical associations says groups should work toward a $0 reliance on industry funding, according to a paper published in today’s issue of JAMA. The recommendation is one of ten proposed by the PMA group, which was convened with the support of the Pew Charitable Trusts and spent two years developing the recommendations. The pervasive dependence on industry funding for operating budgets, “inevitably creates the perception and reality of conflicts of interest and jeopardizes public trust,” write the authors.

The authors also recommend that PMA officers be free of financial conflict with industry when they are elected, that practice guidelines be composed without industry support, that industry not have any say in the educational content of conferences, and that PMAs never endorse a commercial product or service.

For more, read the Wall Street Journal, Modern Healthcare, or visit the Institute on Medicine as a Profession website.