In this week’s New England Journal of Medicine (subscription required), the office of the Inspector General of Health and Human Services suggests that pooled industry funding for Continuing Medical Education could provide a midterm solution to what the Inspectors hope will be the medical profession’s ultimate decision, to “eschew commercial support for CME.”

Authors Lewis Morris and Julie Taitsman, both counsel to the HHS OIG, ask “what is the best way to ensure that CME serves a bona fide educational purpose, is not co-opted as a marketing tool, and does not violate laws against fraud and abuse?” Their suggestion: a pooled-funding mechanism, whereby drug and device companies would contribute to unrestricted pools of funding controlled by independent grant organizations, who, through a transparent and unbiased process, would “award funding based on the educational merit of the CME programs, without allowing the donors to specify which programs their donations will fund.”

Of course, the authors admit that early signs suggest this is a hard sell to pharmaceutical and medical device companies, whose support for CME has grown 300 percent, and who currently develop and tailor their CME programming to align closely with their product marketing interests. An attempt by the American Academy of Orthopedic Surgeons to create such an independent pool won little company interest.

Still, the authors write, shoring up the independence of CME should be a top concern to the medical profession. “Since the marketing goals of pharmaceutical and device companies can influence CME funding,” they write, “preservation of the academic integrity of CME requires clear boundaries separating education and marketing.”

The HHS Inspector’s office has expressed concern before about the influence of commercial CME funding, and testified in July before a Senate committee on the commercial influence of CME on prescribing and medical practice.

Though the fall of Sen. Byron Dorgan’s drug re-importation bill in the health reform debate earlier this week isn’t news, yesterday’s NPR health blog “Shots” pointed to an analysis of pharma contributions and votes on the re-importation bill by Maplight, a national watchdog group that uses technology to highlight the relationship between financial support and political action. According to the NPR health blog, the Senators “voting nay have averaged 66 percent more in campaign contributions from Big Pharma than senators who voted yea.” Legalizing drug re-importation, which is illegal in the U.S. now, would lower drug costs dramatically – Dorgan estimated $100 billion in consumer savings over the next decade.

Despite the political drama around President Obama’s reversal on the issue of re-importation (he and some Democratic senators took high-visibility stands against the amendment this week, citing issues of drug safety), we hope the commitment the President and these Senators demonstrated to preventing unsafe products from reaching U.S. patients will extend to all the drugs, devices, and ingredients we currently legally import, many coming from countries such as India and China, where regulatory scrutiny is low.

PostScript takes a holiday

Happy tidings, and we’ll see you in 2010!

According to the New York Times, the deal PhRMA struck with the White House and Senate Finance committee this summer in exchange for its support of health reform is now apparently holding up a vote that would allow drugs to be reimported from Canada. The bill, sponsored by North Dakota Sen. Byron Dorgan, has enough votes to make it into the health reform bill. The CBO has said that the bill could save the U.S. $19.4 billion over the next 10 years, though industry and the FDA have voiced concerns that reimported drugs might be susceptible to adulteration.

But Sen. Dorgan says that his bill addresses those concerns.

“U.S. consumers are charged the highest prices in the world for drugs that sell for a fraction of the price in most other countries,” Mr. Dorgan said. “My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk. It applies only to F.D.A.-approved prescription drugs produced in F.D.A.-approved plants from countries with comparable safety standards.”

And two Senators have filed an amendment to the health reform legislation moving through Congress that would prevent drug companies from mining prescriber-identifiable data for marketing purposes, according to the Associated Press. Companies buy physician prescribing data and sell it to pharmaceutical companies, which use it to target their sales pitches. By filing the amendment, sponsors Sens. Kohl (D-WI) and Durbin (D-IL) have raised the national profile of this problematic marketing tactic, which some states have been grappling with for years.

“I think at both  federal and state levels you’ll see continued momentum because it’s clear the issue of drug marketing influence hasn’t been addressed yet,” Community Catalyst’s Marcia Hams told the AP.

In other Senate news, Big Pharma’s epistolary thorn-in-side Sen. Grassley was at it again this week, writing to 33 patient and professional medical groups to ask for details about the industry funding they receive.  Among them, the American Medical Association, the American Cancer Society, and the American Academy of Family Physicians.

Apparently, it’s all how you define industry. AMA spokesman Mike Lynch told the Times that “industry funding comprised less than 2 percent of the organization’s budget,” though last year the organization made a handy $47.6 million licensing physicians’ data, which is then bought by  pharmaceutical companies for data-mining.

“These organizations have a lot of influence over public policy, and people rely on their leadership,” Mr. Grassley told the Times. “There’s a strong case for disclosure and the accountability that results.”

And the St. Louis Post-Dispatch reported earlier this week on how Congress, FDA and consumer groups are looking at ways to curb TV and online direct-to-consumer advertising for patient safety.  Some members of Congress are considering putting a moratorium on ads for new drugs, or lifting the tax break pharma companies currently get on consumer ads. And recently, the FDA requested public comment on how to regulate pharma and medical device companies’ online marketing. At the hearing, the Pew Prescription Project’s Allan Coukell told agency officials that marketing regulations should protect the public health first, and not be loosened for online ads before there is evidence that the public health is being protected by such ads.

“Before the FDA provides a pathway for companies to do a whole new kind of marketing,” he told the Post-Dispatch,” I think they should be looking for evidence of health benefits,” he said.

–by Kate Petersen, PostScript blogger

–by Jonas Hines

The New York Times reported this weekend about a newly-approved cancer drug, Folotyn, for a deadly blood cancer. The catch? It costs about $30,000 per month. Per month. Oh, and it did not prolong life expectancy for patients (though it did shrink tumor size) in the trial that led to its FDA approval in September.

And, as the Times reported last month, the cost of drugs is on the rise—nine percent last year, the highest rate of inflation since 1992. Big Pharma says, predictably, such hikes are necessary for the research of novel drugs (such as Folotyn?). Interestingly, last time major legislation that could impact the cost of drugs was on the table –in 2006 with Medicare Part D– the cost of drugs went up, too.  Is this ramp up simply in anticipation of health care reform legislation? One thing is for sure: The cost of health care is only going up as long as we are using $30,000-a-month drugs to shrink tumors.

As for the drug maker’s take on the cost of its drug? The Times reports: “Mr. Caruso [CEO of Allos Therapeutics, who makes Folotyn] also said the price of Folotyn was not out of line with that of other drugs for rare cancers. Patients, moreover, are likely to use the drug for only a couple of months because the tumor worsens so quickly, he said.”

In other words, because the drug doesn’t prolong life, the exorbitant cost is self-limited.

Jonas Hines is a medical student in New Mexico and a member of the American Medical Student Association. Previously, he held a fellowship at Public Citizen in Washington D.C.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.

by Ann Woloson, Executive Director, Prescription Policy Choices

Who’s lurking in the shadows of our kid’s computer screen? Marketers, that’s who, including drug companies offering free gifts in exchange for personal information, which in turn, is used for marketing purposes.

Many adults might be surprised and offended to know their personal information, which most assume is private, is frequently being used in such ways.  Now young teens and older children are being targeted via the internet by a whole host of marketers, including pharmaceutical companies.

As a policy maker and a parent, I’m concerned about drug companies reaching out to kids over the internet under the guise of providing information.  Free gifts are offered in exchange for names, addresses, date of birth, and other personal information; which is unknowingly used, shared or sold for marketing purposes.

My concern is not about limiting access to information, especially information kids want about health care they may need.  My concern is over what drug companies do with information they collect from teens. It will be used to market specific drugs to kids–products that might not be necessary or not as safe or effective as others on the market.

While federal law offers some protection to kids under age 13, older children are not protected. A law to help prevent predatory marketing was passed unanimously in Maine last spring.  Its intent was to prevent the retrieval of personal health care-related information from kids that would in turn be used for marketing purposes.  Testimony regarding the proposed law described drug company pop-ups and other ads that lure kids to websites offering free gifts (music downloads, backpacks, coolers, art supplies, lunch boxes, etc), coupons and free samples, in exchange for their personal information.

The law was challenged in court by a number of plaintiffs, including web companies, universities, and newspapers, who were concerned about free speech rights. Colleges were concerned they wouldn’t be able to market programs to students. Newspapers worried they could not report on sports events or kids who make the honor roll.  While drug companies are not named in the challenge, they were represented and provided comment at a legislative committee meeting in Maine where the law was reviewed.

Previous legal cases have established that public speech and commercial speech are provided different protections, especially when states have an interest in protecting the health, safety and welfare of children.

However, it appears, that Maine’s final predatory marketing law may pose unintended problems even though it was amended to address real privacy concerns. For that reason, it’s likely to be repealed and reintroduced with changes allowing legitimate activity, while providing privacy protections teens need to prevent the use of their personal information for unintended purposes.  There needs to be a balance between the right to access information for legitimate purposes, and the right to safeguard and protect the privacy of our children’s personal information.

PostScript is a group blog, and a forum for many different opinions on prescription drug issues. The views expressed do not necessarily reflect those of Community Catalyst or of other PostScript authors.

New Jersey is responding to widely-shared concerns about physician-industry financial relationships with a mix of both tested and newer reforms, and its move toward greater transparency is consistent with national trends.

In a report this week, the state’s Division of Consumer Affairs calls on state agencies to ban pharma meals to physicians, require physicians to disclose industry payments totaling more than $200, and restrict the use of commercial data-mining of prescriber data, one of the main tools in the pharma industry’s marketing arsenal.

New Jersey’s Board of Medical Examiners has been exploring these issues seriously and comprehensively for some time, holding public hearings on pharma issues like gifting, conflict of interest policies at academic medical centers, and industry-backed continuing medical education. (The Prescription Project testified before the Board on industry marketing in Nov. 2007.)

In general, we favor measures that put the compliance requirements on the industry, rather than on physicians. Because New Jersey puts the onus on doctors, it is possible that its approach will do more than existing laws in other states to discourage certain problematic relationships. However, it may also be more difficult to ensure compliance. In the main, though, New Jersey is to be congratulated for these innovative efforts to curb inappropriate influence on prescribers.

We’re going group!

After two years, PostScript is graduating to a group blog. There’s more about Rx policy than we can say ourselves, so from time to time—starting next week—we’ll open this space to other voices on pharmaceutical issues.

Stay tuned…

–Kate Petersen, PostScript blogger