The FDA has delayed announcing its new pediatric cough and cold medicine dosing guidelines, according to the Tan Sheet. The guidelines were due to be released in June 2010, but have been pushed to December 2010.

The chief catalyst for the revised guidelines was a citizen petition filed in 2007 by then-Baltimore Health Commissioner Joshua Sharfstein and other pediatricians, demanding that the FDA visit the safety requirements and standards for over-the-counter (OTC) pediatric cough and cold medication. Such medications, marketed for children, are not subject to any required efficacy standards and have been linked to infant deaths.

The agency responded by recommending that children under 2 not be given OTC cough and cold meds and formally reviewing its standards. In 2008, makers of those products voluntarily changed labeling to suggest such drugs not be administered to children under 4. Last year, Sharfstein was named Principal Deputy Commissioner for the FDA, where he has led drug safety efforts.

Though the process is a slow one, Sharfstein told the Washington Post in 2008 that this is how change is made. From the PostScript archives:

…the agency has scheduled a meeting on Oct. 2 to consider questions about whether the products should be proven effective or safe to remain on the market, and if so, how. Baby steps? Maybe. But experts say this is how it gets done.

“This is how the agency can take these products off the market,” Baltimore Commissioner Joshua Sharfstein told the Post.  “I think this signals the agency is going to apply a modern standard of safety and efficacy to these products, and that is a standard these products cannot pass.”

Sharfstein knew, then and now, that regulation of a sprawling and complex industry like drugs is a deliberate process that takes time to get right. The agency’s recent steps toward increased transparency, boosting and upgrading its capacity at the Office of Regulatory Affairs, and a willingness to request additional authorities to better protect Americans’ food and prescription drugs all suggest that the rules on pediatric cough and cold meds, when they come out, will line up with the FDA’s renewed focus on making drugs safer.

–Kate Petersen, PostScript blogger

We read with interest Merrill Goozner’s blog, “Putting Academic Detailing in Perspective.” See, the Agency for Healthcare Research and Quality recently distributed $30 million of stimulus funds to 9000 locations around the country to get doctors unbiased patient-centered outcome research through academic detailing, also sometimes called prescriber education. (Community Catalyst and the Pew Prescription Project have supported federal and state academic detailing efforts–more here and here.)  Goozner seems to suggest that, while nice,  such grants cannot hope to match “the combined might of the marketing arms of Big Pharma, Big Bio and Big Device.” With a little guess-timation, he says the number of academic detailers that such grants could deploy is a drop in the bucket compared to pharma sales reps: “Do the math,” Goozner writes. “50,000 for the drug industry; 300 for the truth squad. Henry V had better odds at Agincourt.”

Well, sort of. Yes, in numbers, the (shrinking) army of company detailers far outstrips the number of academic detailers currently in the field, or that would be deployed as part of AHRQ grants. But there are other questions of public policy and public health at work here, and it’s worth looking at what those are.

Academic detailing, to refresh, sends trained clinicians such as pharmacists and nurses into the field to talk to doctors. Versed in the body of research on a condition or drug class, the academic detailers talk with doctors about what the science shows to be the safest, most effective treatment out there. They are employed by a nonprofit or a public agency—and therefore not working on a sales commission or motivated by profit to promote one product over another.

Though some doctors may be looking for perks or samples, many say they talk to drug reps because they can’t always find the information they need elsewhere. But it’s more useful for a busy doctor to meet with one academic detailer who knows about all therapies for a given condition and how they’ve faired in trials, than to meet with several commercial detailers, who rarely have clinical backgrounds and are interested, in every case, in talking up one product: theirs.

And there’s the big difference: sales reps are there to sell drugs. Academic detailers are there to talk about what drugs and therapies are out there, and what the science shows works best.

Goozner’s shrug of a post also ignores the bigger picture: Academic detailing isn’t happening in a vacuum. The deployment of prescriber education at local, state and regional levels in the last five years—and now at the federal level—is part of a growing awareness that pharmaceutical marketing has the potential to interfere with safe prescribing and patient care—and a broader effort to make sure it doesn’t.  Medical schools, trade organizations, and a range of medical specialty societies have adopted policies to clarify the relationship between pharmaceutical companies and their members and faculty. Companies have begun to disclose their payments to doctors, and the Physician Payment Sunshine Act passed, establishing a new national transparency standard.

Goozner (and PhRMA President Ken Johnson, in recent comments), seem to suggest that academic detailing is a purely counter-industry tactic, designed to take on—or take down—Big Pharma.  But it isn’t, and to suggest so obscures academic detailing’s real, and very common, mission: to improve clinical care.

There are thousands of investments made daily at local and system-wide levels to improve patient care, and this is one of them. Academic detailing is, at bottom, an effort to improve patient outcomes through rational, evidence-based prescribing. Just as one hospital’s efforts to reduce its infection rates should not be dismissed for not reversing the national trend of hospital-acquired infections, so attempts to get the best science into the hands of doctors who want it should not be dismissed as insignificant or trifling. Good medicine matters, at every level.

UPDATE: I originally wrote 9000 groups will receive the dissemination grants. I have corrected it to read: 9000 locations.

–Kate Petersen, PostScript blogger

A new report (pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China.

According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs. For instance, 94 percent of all tetracycline antibiotics imported into the U.S. come from China, as do three-quarters of the ingredients used to make another important class of antibiotics, the aminoglycosides, which are administered intravenously and in eye drops.

And the report makes clear that China has neither the will nor the systems in place to monitor its exports. Though domestic regulation in China has improved, the SFDA, China’s main regulatory agency for drugs, provides limited oversight of exported pharmaceutical products. For example, Chinese regulation assigns total responsibility for product quality to oversight responsibilities on the importing party. And as the proportion of U.S .drugs made overseas has exploded in recent years, the FDA has been unable to keep up. We saw the risks most dramatically when heparin, a common blood thinner, was contaminated during its manufacture in China, causing a number of U.S. deaths. From the report:

Many reports, publications, and public testimonies assert that China’s health and safety regime for export products is fragmented and ineffective. The impediments are many: poorly enforced regulations, lack of inspections and ineffective penalties for code violators, underfunded and understaffed regulatory agencies and suspect interagency cooperation, the proliferation of fake goods and ingredients, the existence of numerous unlicensed producers, falsified export documents, intense business competition that often induces firms to cut corners, failure by Chinese companies to closely monitor the quality of their suppliers’ products, government corruption and lack of accountability, especially at the local level.

The report includes a series of recommendations, including more and better-targeted FDA inspections of Chinese plants, and ensuring FDA databases contain accurate and integrated registration and inspection information.

Indeed, the report is an alarming but needed reminder that we need to take steps to shore up the inspectorate, resources and systems to ensure foreign drugs are safe before they reach American medicine cabinets. At a recent hearing on drug safety, a spirited dialogue between Rep. John Dingell (D-MI) and FDA Deputy Commissioner Joshua Sharfstein made clear that a system-wide remedy for imported drug safety is sorely needed.

–Kate Petersen, PostScript blogger

The launch of drug giant Pfizer’s database of payments to doctors and medical groups this week has shone some more light on the Physician Payments Sunshine Act, which passed last week with the comprehensive health reform bill. The company website, mandated in a court order as part of an illegal marketing settlement last year, showed that the company paid doctors $35 million in the last half of 2009–$20 million of it for consulting and promotional speaking.

The Sunshine act, as you recall, requires drug companies to report payments over $10 to physicians and teaching hospitals into a national public website. Such reports will begin in 2013. Allan Coukell, director of the Pew Prescription project, a key backer of the Sunshine Act over the last three years, talked to news organizations about the importance of transparency and the limited usefulness of company websites such as Pfizer’s to the public’s understanding of to the public.

“Separate company databases, while welcome, are still short of what we need, which is a single national database,” Coukell told the Wall Street Journal.

We wrote earlier on PostScript about the pros and cons of current company databases.

And University of Miami announced this week its own searchable database of drug company payments to faculty, joining a handful of other academic medical centers that have set up voluntary disclosure sites over the last several years.

“This is a growing trend,” Coukell told the Miami Herald. “I know of four other schools that are doing this. With the passage of the Sunshine Act, there’s going to be a lot, lot more.”

It’s in all the news that’s fit to print, and then some.

Read more in:

Associated Press

The New York Times

The Wall Street Journal

PBS Nightly Business Report

Science (subscription required)

–Kate Petersen, PostScript blogger