A new survey of physicians published in the JAMA Archives of Surgery this week suggests that across specialties, the majority of physicians still hold a positive attitude about gifts and meals from pharmaceutical and medical device companies.

Confirming what previous studies on marketing influence have found, cognitive dissonance was at work here: the majority of the 590 respondents (52.2 percent), who worked at Mount Sinai School of Medicine and its affiliated hospitals, believed that receiving industry gifts and meals influenced other physicians’ prescribing, but just about one-third believed that they themselves were influenced by gifts and meals. Earlier studies quantifying physician attitudes have suggested an even greater differential.

And though the majority of respondents thought that industry funding of medical education was acceptable, more than two-thirds of them perceived bias in such sponsored lectures.

The researchers hypothesized that surgeons, whose journals had published little of the literature to date on gifts’ prescribing influence, would have more favorable views of industry gifts and involvement in medical education. The results bore this out, with surgeons significantly more amenable to certain types of gifts, and industry funding of medical school programs (82.8 percent compared to 71.1 percent overall). Recent news stories in Bloomberg and the New York Times have revealed the unique coziness between some high-profile surgeons and makers of implants and devices that failed their patients.

In an interesting aside, the specialty most likely to say that its institution should prohibit residents, students and attendings from interacting with pharma and device reps were psychiatrists, who have been the focus of a series of headlining Congressional investigations in recent years and have consequently done a lot of work to clean their house.

So where is education and awareness in all this? In many cases, the more familiar a physician was with her institution’s guidelines, the less likely she was to rate gifts and meals as appropriate or very appropriate, and the less likely she was to say that samples improve patient care.

But just over half of the respondents surveyed said they were familiar with their institution’s guidelines–guidelines, we note, that received an “A” on the American Medical Student Association 2009 Scorecard. One question then is: How are the many institutions that have strengthened or developed new policies communicating them to their clinicians – or are they?

The authors suggest that despite such policy changes, the medical practice environment still fosters a “hidden curriculum” that approves of industry gifts, meals and relationships–a curriculum that has left physicians behind the public and regulatory movement toward trimming marketing’s influence on medicine.

Despite this sea change in public and governmental attitudes during the last several years, the physicians we surveyed retain generally positive attitudes toward many industry gifts, and more than two-thirds still find gifts and lunches from industry acceptable. In fact, our findings are remarkably similar to results of other studies of physician attitudes toward industry from as early as 2001….

The positive attitudes of physicians we surveyed are likely to reflect the continuing acceptability of industry interactions and gifts within the culture of medicine despite changing guidelines. Physicians in practice continue to speak frequently with industry representatives, and academic physicians enjoy food and other industry gifts when they attend continuing medical educational events and national specialty meetings. Although other groups have found that education about the effect of industry contact may have a modest effect on physician attitudes, physician attitudes are not likely to align with those of the public until the culture of medicine rejects industry marketing interactions more fully.

–Kate Petersen, PostScript blogger

The FDA will introduce stronger rules on safety and quality assurance for drug makers who outsource production, an agency official told an industry conference this week. According to the Wall Street Journal, the agency said it will likely soon “require companies to conduct on-site audits at outside contract manufacturing facilities,” whether domestic or foreign.

Right now, current good manufacturing practices (cGMPs) do not require companies to conduct on-site supplier inspections, and companies may rely instead on Certificates of Analysis – documentation submitted by a supplier containing safety, purity and quality data. This normally paper-based documentation can—and has been—easily falsified. Companies should be required to thoroughly assess ingredient suppliers before contracting (they’re not now) and conduct on-site audits of contracted suppliers (along the lines of FDA’s announced proposal). FDA should look at closing all these gaps, especially since the agency is currently unable to inspect all domestic and foreign manufacture sites.

The number of drug recalls related to manufacturing quality has spiked in recent years as more manufacturers struggle to guarantee the safety and quality of their products–a task made only harder by an increasingly splintered drug supply chain. The origin of the contaminated raw ingredients that FDA found at the McNeil plant in April has still not been revealed, nor has McNeil or Johnson & Johnson indicated they are investigating the raw material supplier.

“Outsourcing by drugmakers and the increased reliance on contractors, especially those based in developing nations, clearly puts consumers at risk of contaminated or substandard drugs,” Pew Prescription Project director Allan Coukell told the Journal. “Requiring companies to physically audit their suppliers and ensure the quality of drug ingredients would improve safety.”

For more, go to the Pew Prescription Project’s page on securing a safe drug supply.

–Kate Petersen, PostScript blogger

Though much attention was focused on national reforms this spring, several states made moves toward greater transparency in the pharmaceutical industry, and toward curbing the industry’s marketing influence on prescribing. Connecticut passed a law requiring companies to create codes of ethics at least as strong as the PhRMA code, and Vermont and Colorado expanded transparency efforts.

This week, Connecticut Governor Jodi Rell signed a bill into law that requires all pharmaceutical and medical device companies that do business in Connecticut to write a code of ethics that meets, at minimum, the PhRMA code and submit it to the state.

“After four years, Connecticut passed important pharmaceutical provisions into law,” advocate Jean Rexford said. She heads the Connecticut Center for Patient Safety, which pushed for passage of the law and similar bills in the past. “Pharmaceutical companies will be required to write a code of ethics, submit it to our Attorney General’s office and if that code is not followed, there will be a $5,000 fine under our Unfair Trade Practices Act.  We had a great coalition working on this—Connecticut AARP and Consumers Union activists generated thousands of emails.  But it’s our Attorney General’s office and Representative Ritter and Senator Harris who deserve the most credit.  It took years but we finally got there.  Over those four years I have seen a change: accountability and transparency are now understood to be an important part of health care reform.”

In May, the Colorado legislature sent a bill to the governor that would require Colorado to post payments disclosed through the federal Sunshine Act on its state website. Gov. Ritter indicated this week that he intends to sign the bill.

“The availability of information to consumers on pharmaceutical payments to physicians allows consumers to have conversations with their doctors and to draw their own conclusions on conflicts of interest,” said Lynn Parry, a physician who heads the Colorado Prescription Coalition, which supported the bill. “These conversations have to include any person who can be affected by industry relationships.”

Vermont also clarified and expanded its existing transparency and gift restriction law, explaining that small food and drink given at a conference is permitted, and requiring that drug samples, including their recipient and amount, be disclosed in 2012. This disclosure mimics the provision that samples be disclosed to the federal government beginning in 2012 recently passed as part of the Patient Protection and Affordable Care Act. Read more about some drugmakers’ recent samples reporting to Congress at the Wall Street Journal.

–Kate Petersen, PostScript blogger

Α new study in the Archives of Internal Medicine suggests that academic detailing may improve physicians’ adherence to clinical guidelines, findings that boost AHRQ’s recent announcement to back 9000 academic detailing visits over the next three years.

Using the not-so-memorably-named ALLHAT/JNC7 Dissemination Project, researchers looked at office-based academic detailing visits to more than 18,000 physicians in 41 states between 2004-2007 and correlated data from a national pharmacy database. The ALLHAT clinical trial, published in 2002, found that the use of thiazide-type diuretic, an antihypertensive, lowered risk of heart attack. Prescribing of thiazide-type diuretic during 2004-2007 in counties that received academic detailing visits rose 8.7 percent, but only 3.9 percent in those without academic detailing programs.

This study was conducted using county level data, so causal associations between educational interactions and prescribing at the individual physician level could not be established. Still, this paper supplements a body of evidence suggesting that academic detailing visits can improve physicians’ awareness of and reliance on evidence-based clinical guidelines.

Academic detailing sends physicians, pharmacists, nurses and other clinical professionals into practice settings to give unbiased, balanced, evidenced-based information to prescribers on the safety and efficacy of certain drugs. I wrote about academic detailing as one piece of the evidence-based prescribing policy puzzle here.

–Kate Petersen, PostScript blogger

Another drug recall occurred this week as the FDA has told providers to stop using contaminated IV medications made by Claris Lifesciences in a factory in India. Providers have been warned not to use the company’s intravenous metronidazole, ondansetron, and ciprofloxacin.

Following on the heels of the much-publicized McNeil recalls last month, this latest FDA advisory hit the same week as a Gold Sheet report that the number of US drug recalls rose sharply in 2009. The record 1,742 drug recalls the FDA listed last year is due mainly to a spike in good manufacturing practice (GMP) violations, which may signal a breakdown of quality control but also increased regulatory vigilance on the part of the FDA.

At least one of the Claris IV bags analyzed by FDA contained Cladosporium mold that can cause human infection, especially in immuno-compromised individuals.

Thought the recent McNeil recalls of pediatric meds has received the most headlines, the biggest recall last year was by a Shreveport-based repackager called Advantage Dosing, which issued 1016 recalls at the end of 2008. Drug companies Apotex, Caraco and Teva were also among the top recallers.

The report indicates that recalls of drugs made overseas more than doubled from 2008. Though still up a small proportion of total recalls – 10 percent this year – the Gold Sheet says that number is likely to grow further as FDA increases its foreign inspection capacity.

As Congress contemplates giving FDA mandatory recall authority (an authority the deputy commissioner asked for at a hearing this spring), the agency has recently taken steps to shore up its enforcement. Even quicker reporting—it takes the agency one-third the time to post recalls in its weekly enforcement bulletin that it did before the Obama Administration took office—suggests a stepped-up vigilance, the Gold Sheet says.

To learn more about steps toward securing a safe drug supply, visit the Pew Prescription Project.

–Kate Petersen, PostScript blogger