The state of Vermont’s annual report on industry payments to doctors shows that payments in that state have gone down significantly: total number of expenditures went down 80 percent from 2008 levels, when manufacturers reported the most payments. In 2009, the state strengthened its law to ban meals and most gifts (including gifts that PhRMA swore off in its own 2008 Code). This year’s report suggests those restrictions had a big effect on how drug companies spent their money in Vermont.

This report—and proposed amendments to the law to accommodate industry requests—has got people talking again about how disclosure and gift bans can work together, and whether the downturn in payments to Vermont docs suggests the problem is going away.

It’s like that Jake Gyllenhaal movie, right: All that pharma-rep coziness was way back in the 90s?

Well, no. Far from having gone away, there’s evidence that the problem of pharma conflicts of interest and their impact on clinical care may be getting bigger. Pharma now tops all industries, including defense, in total fraud payments paid under the False Claims Acts. And of the 150+ pharmaceutical company settlements—that’s $19.8 billion in penalties between 1991 and 2010—three quarters of both the settlements and penalties have occurred since 2006. (Check out Public Citizen’s great report on this.)

More? The two largest criminal fines in U.S. history were imposed on two drug companies in 2009 for off-label promotion, and in 2010 alone, at least five companies paid settlements of at least $100M due to marketing a product off label, paying illegal kickbacks or making misleading claims about a product. Eight of the ten largest settlements with the federal government in FY2010 were over drugs.

And despite recently endorsing conflict-free guideline writing committees, more than half of those writing clinical guidelines for the American College of Cardiology through 2008 reported financial ties to the drug industry, a 2011 study found.

But isn’t all that money for innovation and research collaboration?

Vermont’s data suggests it’s not. Before the state asked for the proverbial check on drug company wine-and-dines, meals were in some sense the main course in industry-MD relationships in VT, representing about 30 percent of the total spent by companies on docs in  2009 and accounting for 87 percent of payments that year.

Some industry voices suggest that the updates and modifications Vermont has made to the law since 2008 signal vacillation—one blog even went so far as to say it showed that lawmakers “had little idea of what they were doing when they first created the law” and weren’t accounting for stakeholders.

That’s not true, or fair. Especially since some of this year’s proposed updates grow directly from industry asks, including an exemption for market-research payments.

The legislative process is built to flex and accommodate changing realities and lessons learned, and Vermont’s gifts and disclosure laws is a great example of that, and how public disclosure can signal gaps and needs in the law.Seeing that the majority of payments were going to feeding MDs and prescribers – costs with dubious patient benefits but that get passed onto patients – helped Vermont target its law while protecting the legitimate sort of academic-industry relationships that are critical to good medical innovation. The number of companies disclosing to Vermont went down in tandem with the meals ban, and if companies left because the best thing they had to offer in Vermont was lunch, well, from a public health standpoint, that’s okay.

With the industry’s “market and let’s see what works” approach of off-label marketing alive and well, Vermont and academic medical centers across the country have provided a sensible counter-approach of evolving regulation that seeks to protect patients.

Such responsiveness makes for good lawmaking in the interest of the public health, and transparency paved the way for that lesson-based learning.  We don’t know what lessons we’ll learn from Sunshine, and that’s exactly why we need it.

–Kate Petersen, PostScript blogger

Sunshine’s getting closer, and we’re not talking sandals and patio seating.

With complete rules scheduled to be out this October, the Centers for Medicare and Medicaid (CMS) are spending the summer writing the whos, whats and whens of the Physician Payment Sunshine provisions, which will require drug and device companies to publicly report payments to doctors and teaching hospitals. And since the devil’s in the details, consumers and industry are weighing in with CMS on how to make Sunshine a source of light, not just heat.

On a recent open door call with the agency, industry and consumers weighed in on aspects they think are important to consider as it builds the Sunshine regulations and system. Representatives from Community Catalyst, Health Care for All (Massachusetts), Minnesota Prescription Coalition and the National Physicians Alliance joined representatives of BIO and PhRMA on the call.

Here are some of the key issues we heard (and were underscored by follow-up letters PhRMA and BIO published this week.)

Payment categories
Categories of reported payments should be adequately detailed, clearly defined and discrete: payment for meals, travel, gifts and entertainment should be reported in separate categories, rather than lumped into broader catch all categories, or collapsed into research or education. This will prevent double-counting, make data comparable across companies and provide more accurate and comprehensive info for researchers and consumers.

In its letter, PhRMA proposes collapsing some payment categories: “some meals and travel could be reported as expenses associated with consulting activities, rather than individual line items.” But CMS should be careful, as collapsing categories could make the data less useful and might assign marketing-based payments –dinner at a nice restaurant, sports tickets—the false legitimacy of bona fide research payments.

Other things it’s important to define:

• Payments reported as “research” should meet the standards, in existing federal law, for systematic investigations, which does not include, for instance, marketing research;
• Payments reported as ‘education’ should refer to participation in an accredited CME program;
• “Consulting” should hew to the definition of bona fide services established in a number of widely accepted industry codes (AdvaMed, PhRMA) and include a written contract, deliverables and clinical research protocol;
• Community Catalyst emphasized that the name of the drug associated with each payment should include both the common name (in addition to the technical name) so consumers will recognize drugs they may be taking.

The Vermont disclosure database and Massachusetts’ databases, though not perfect, provide useful examples for CMS in structuring these definitions and categories.

Accuracy
All parties on the call agreed that industry and CMS should work together to make sure the data is as accurate as possible. Establishing detailed unambiguous guidelines and reporting forms as well as opportunities to correct data will help with that. So would coming up with a list of all potential recipients and assigning unique identifiers, industry and consumers said. Consumer groups also want to see aggressive enforcement to ensure accuracy and full participation by companies.

Speaking of all potential recipients, we’re baffled by a number that keeps coming up. Both on the call and in its letter to CMS, PhRMA cited a mid-size company that estimated it would have to report more than 1 million transactions with 300,000 physicians in the first year of Sunshine. Considering that there are a total of about 660,000 in the whole US (BLS), we are both impressed by the reach of that mid-size company and wide-eyed at its marketing budget. Unless they’re going pen by pen (which the law precludes), that’s a lot of dinners. Or research.

The point they’re making is—we think—is the burden of all this data. A million anything is hard to keep track of! But Vermont’s disclosure law provides some evidence that companies are already managing these data well, because though it is a small state, the Attorney General’s office in Vermont manages to collect comprehensive data from 141 manufacturers of pharmaceuticals, biologics and medical devices. And unless they aren’t complying, this means the companies are managing to get it to them. All that’s good news.

Background info
So why do we need Sunshine? That’s an important question to answer on the Sunshine website, we think, so that consumers and other visitors have both context and rationale to frame what – let’s face it—is going to be a lot of numbers.

The risks associated with financial conflicts of interest are inherent in academic-industry relations, but gone unacknowledged, such COIs have the potential to bias patient care and prescribing. The Institute of Medicine has done excellent work framing the rationale for financial transparency.

Both PhRMA and BIO made a point of asking that the Sunshine website describe the benefits of academic-industry collaboration to patient care; we think such commentary, if included, must be counterweighed with evidence of the risks of financial marketing relationships on clinical care.  Both aspects of the relationship are explored in the IOM research, and its process has included all stakeholders.

So what’s next?

CMS has an open comment period this spring and summer with a goal of having completed regulations up by October 1, 2011 so that companies can begin collecting data in 2012.  The first year data is set to be published by CMS September 30, 2013.

More about Sunshine? Check out the Sunshine Act Guide.

–Kate Petersen, PostScript blogger

Later this month, the Supreme Court will hear IMS v. Sorrell, about the right of Vermont and other states to restrict a practice called data-mining – the collection and sale of doctors’ prescribing histories that drug companies then buy and use in marketing to MDs and other prescribers. Vermont’s law banning this practice was struck down in the Second Circuit Court of Appeals, after the First Circuit upheld similar laws. (Both New Hampshire and Maine have standing laws, and Massachusetts is considering a bill this year supported by consumers and the state medical society that would do the same.)

Prescription data-mining is a multi-million dollar business for companies that buy prescription records from pharmacies and physician lists from the American Medical Association, and then match these to produce profiles that they sell to drug companies.  The companies then arm their drug reps with this information to market their drugs to individual prescribers. (Way more about that in the PostScript archives)

Why did the court strike the law? The drug industry trade group PhRMA and the ‘data-mining’ companies, like IMS, who sell this information argued that it was ‘speech’ protected by the First Amendment.

Speech? Are your purchases on Netflix speech?  This seems like a stretch.

The First Amendment protects some kinds of speech more than others, based on the whether the speech has political or cultural value, whether it relates to business and commerce, or whether its part of an otherwise criminal act. The most protected speech is the set of public exchanges that create a thriving free marketplace of ideas – political, social, and economic – which are essential to a vibrant democracy. For instance, the government cannot pass laws preventing the news media from lying. The answer to any lies or untruths in this are is the free flow of opposing ideas – more speech.

However, in the commercial sphere, the government has broader authority to protect people from being deceived or misled. So consumer protections laws can ensure that when a company runs an ad, they have to honor that ad, and not use it to lure customers in for other deals. But since 1976, the Supreme Court ruled that the First Amendment also protects truthful commercial speech from excessive government regulation, because the vibrancy of the marketplace of ideas in a democracy is affected by the free flow of information in the marketplace of goods and services.

That means the First Amendment allows someone affected by a government regulation to ask a court to make the government prove that the government’s regulation of commercial speech ‘directly advances’ a ‘substantial’ state interest, and that the government restriction of speech is not more extensive than necessary to achieve the government’s interest. Lawyers call this “intermediate scrutiny.”

Despite the fact that the First Court of Appeals upheld similar laws in New Hampshire and Maine, the Second Circuit was not convinced that the law banning the use of this data directly advanced the substantial interest of the state (which it acknowledged) in promoting public health and reducing health care costs.

But in its appeal, Vermont maintains that banning the non-consensual sale and use of these doctors prescribing records is “a modest step that protects the traditional confidentiality of the doctor-patient relationship.” Indeed, the state says, it’s not a pharmacy’s free speech right to sell a prescriber’s info that it obtained solely because federal law requires pharmacies to collect that prescriber data in order to dispense prescriptions. (DOJ concurs with this position.) These are undeniably private medical records, the state appealed, and their privacy should be protected as the Court has for other medical records and information.

We have long supported the efforts of Vermont and other states to ban or restrict the sale and use of prescriber data for marketing purposes, since it violates the privacy of the prescriber-patient relationship without conferring any medical (or other) benefit on either party. (The legislation only bans use of this data for marketing, not for legitimate research or quality improvement planning.)  Indeed, in all the hearings and subsequent court cases since New Hampshire passed its first-in-nation data-mining law, no benefit has been established other than that conferred on companies’ marketing campaigns, which are much more effective when a rep knows how much of a competitor’s cholesterol med a doc prescribed last week.

In preparation for the case, Community Catalyst and its Prescription Access Litigation (PAL) project along with more than 32 groups and 35 states (plus DC!) filed amici curiae in support of Vermont’s law. The U.S. Dept. of Justice also weighed in to back the state law.

Drawing on PAL’s experience from several lawsuits, Community Catalyst joined with Health Care for All and AFSCME District Council 37 to highlight how this data-mined prescriber information was used to perpetuate illegal industry promotion. Numerous documents from several lawsuits have shown that data-mined information is an integral part of the drug industry success in its illegal promotion of unapproved uses of prescription drugs like Neurontin, Zyprexa, and Bextra. This illegal promotion not only put consumers at greater risk, it also cost consumers and insurers billions of dollars for ineffective and inappropriate drug treatments.

Don’t want to wade through all those other legal briefs yourself? Don’t worry, we did! In the next week we will be blogging a sort of viewer’s guide that summarizes key points and quotes from other amici, including state medical societies, lawmakers, the New England Journal of Medicine, and major consumer groups. Check back in next week for those.

–Wells Wilkinson, Community Catalyst and Kate Petersen, PostScript blogger

Can current safeguards in our medicine supply prevent another heparin crisis, and how do we confront quality problems so extensive that the government must seize factories because of the risk to public health? On Monday and Tuesday Mar. 14-15, the Pew Health Group will bring together members of industry, policymakers, regulators and consumers to tackle these and other key questions about overseas drug manufacture, distribution and safety.

“After Heparin” comes at a critical moment. Since adulterated batches of the blood-thinner heparin from China were linked to more than 100 American deaths in 2007 and 2008, a spike in drug recalls and manufacturing violations signal breakdowns in internal quality and oversight systems. Just yesterday, the FDA took over three Johnson & Johnson plants after endemic quality problems that led to near-weekly recalls went unfixed.

The FDA and Justice Department’s seizure, known as a consent decree, “is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” Director of FDA’s Office of Compliance Deborah Autor told CNN. Autor will speak Monday at the “After Heparin” conference.

And on this Sunday’s 60 Minutes (7 ET on CBS Mar. 13), Dr. Sanjay Gupta will look at the problem and proliferation of counterfeit medicines, and how they can make their way back into the legitimate U.S. drug supply. (Here’s a preview). Experts believe the cost-incentive of using adulterated materials was a driving factor in the tainted heparin from China.

As the number of raw materials and ingredient suppliers in low-cost economies mushrooms, knowing where our drugs come from has gotten harder to determine. Eighty percent of all ingredients in medicines brought into the U.S. are now made overseas, and though FDA foreign inspections have increased, an inspectorate designed for a much smaller domestic market has not been able to keep pace.  Congress has proposed legislative solutions to address these safety gaps, and Americans—nine of ten—overwhelmingly support such fixes.

FDA acting Deputy Commissioner John Taylor and U.S. Senator Michael Bennet from Colorado will deliver keynote addresses at “After Heparin,” and roundtables made up of major industry associations, consumer groups – including Community Catalyst – regulators and scientists will look at the major questions and potential policy solutions around quality systems, inspections, and counterfeit detection and deterrence.

For a conference agenda and more information, visit the Pew conference page.

Check back at PostScript Monday and Tuesday for conference exclusives, watch the live webcast here starting Monday at 8:30 am Eastern, and follow SafeRxWatch on Twitter for live updates from the conference.

–Kate Petersen, PostScript blogger

Three headlines that caught our eye over the weekend:

FDA report suggests it’s not quite time for J&J to cut the ribbon on its brand-recovery campaign. The New York Times looks at the most recent inspection report the agency filed on J&J’s troubled Puerto Rico plant, which documents “distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.” The report goes through early November; earlier this month, more manufacturing problems led the company to make another huge wholesale recall of more than 9 million bottles of liquid Tylenol, 4 million packages of Benadryl, as well as Motrin and Rolaids products.

As concerns of nationwide counterfeiting problems grow, India commissions a feasibility study on a federal computerized distribution system to better track drugs through the supply chain. In addition to this survey of stakeholders, India’s drug regulatory agency, DCGI, is also encouraging smaller drug companies to use national subsidies to help with set-up costs of a barcoding system. “Both developments tie in with recent initiatives by the Indian government to try to improve the transparency of India’s pharmaceutical sector – a critical supplier of essential generic medicines for countries around the world – and shake off its image as a hub for counterfeit and substandard drugs,” Securing Pharma writes.

And American Medical News, the online news arm of the American Medical Association, sees a significant drop in doctors’ financial ties to drugmakers. Using follow-up survey data on commercial CME, meals, and samples in a recent Annals of Internal Medicine article, the AMN suggests the last five years have seen a sea-change in the way industry markets to doctors (or conversely, the way doctors accept industry’s advances.)

But though there may be a trend here, recent payment data from Massachusetts’ disclosure law and aggregators like PharmaShine and ProPublica suggest that hundreds of millions of dollars are still going from industry marketing budgets to physicians’ pockets each year.

The future federal sunshine law, as well as state and other AMC public disclosure regs (which barely got a paragraph here) are key: not only as potential driving factors in the trends that AMN is pointing to, but as sources of data that suggest the drop off of physician-industry coziness may not be quite as simple as the AMN suggests.

The article also gives a lot of space to the voluntary PhRMA conduct code and AMA’s own code, both of which are relatively weak and unenforceable compared to many academic medical center policies, and which were, chronologically, responses to pressure for system reform rather than drivers of such change, as the AMN article implies.

–Kate Petersen, PostScript blogger

Yesterday we blogged about comments Prescription Access Litigation and others made to the FDA in support of proposed rules on presenting risk information in broadcast drug ads.

Numerous other consumer and public health groups have commented, and overall offered resounding support for these proposed regs. The Patient, Consumer and Public Health Coalition offered their support for these regulations and stressed that “the goal of DTC ads is to persuade, not to educate, and so DTC ads emphasize the benefits but not the risks of prescription drugs.”

Consumer groups, including the National Consumers League, additionally offered support for the proposed fifth requirement of dual-modality, simultaneous audio and textual presentation. Consumers Union voiced the importance of dual-modality in their comment stating that “[p]roviding an audio warning with other things happening in the background is, no matter how hard one tries, distracting” and, “[p]roviding a text warning while talking about other things is distracting;” “Providing the same, simultaneous audio and visual warning is the single best way to make a lasting impression that will be helpful to patient-consumers.”

Some consumer groups also argued that pre-review of ads should be required. Here’s Public Citizen: “to obtain approval of DTC advertising on broadcast media, a party shall present market research demonstrating that information concerning side effects, contraindications and warnings is comprehensible to the target audience.” A pharmacists group and pharmaceutical powerhouse Eli Lilly also supported the use of focus groups to review and “pre-approve” ads and to pilot test that elements (e.g. font size, color, placement) of an ad.

In addition to these shared themes, AARP also suggested that the FDA rule should specify where in the ad the “major statement” should appear” and that the major statement should not be allowed to be placed in the middle of the ad “where it can be bookended by conveyance of benefit information and is least likely to be retained by consumers.”

The two pharmacist organizations that commented–the American Society of Health-System Pharmacists and the Academy of Managed Care Pharmacy (AMCP)—supported the new proposed rules, as well as dual modality in ads and pre-dissemination review whether by the FDA or by consumer test groups.

Industry against dual modality, for delays
Industry was relatively quiet on these new proposed regulations:  only the Pharmaceutical Research and Manufacturers of America (PhRMA) and four pharmaceutical companies submitted comments so far. Though industry all stressed the public health benefits of DTCA and generally offer their support for the FDA’s action to further clarify the standards, a few common themes of opposition are apparent in all industry comments.

On the whole, industry seems very opposed to the proposed fifth standard of requiring dual modality. Sepracor argues that dual modality “could prove to complicate the presentation for consumers.” PhRMA seconded this argument and said that “dual modality might produce presentations that actually overemphasize risk information.”

Merck further stated that dual modality “does not improve consumer recall or understanding of important risks information.” Though Merck supported this argument with one 2005 study, it went on to mention the limitations of this study and none of the other industry commenters provided any support for their arguments against dual modality, and all of industry’s comments against dual modality ignore the numerous studies that have shown that the technique enhances clarity and recall of information (and which the FDA cited in its proposed rule).

The second overarching theme of the industry comments seems to be an attempt to delay the implementation of these rules. Sepracor, Merck and Eli Lilly all suggest that the FDA do further research and analysis on these standards before implementation. Sepracor argued that the rule should not be made effective until the results of FDA’s study on the impact of distraction can be published and commented on.

This argument reads largely as a delay tactic employed by Sepracor to postpone the inevitable implementation of this rule. Though there is no doubt that the FDA’s study may help them to further understand what elements of broadcast media can be distracting, there’s little debate that the impact of distraction on consumer understanding… is to distract, and that’s hardly a reason for FDA to delay implementing these rules when the public’s health is at stake.

In one of the more head-scratching unsupported assertions, Sepracor stated that up to 70 percent of the time slot of an ad is used to convey safety information for the drug. Anyone who’s ever viewed one of the numerous DTC ads currently on TV knows that this statistic has little foundation in reality.

–Emily Cutrell, Prescription Access Litigation

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

MedPac approves disclosure recs

Last week, the Medicare Payment Advisory Commission approved recommendations that would require pharmaceutical and medical device companies to disclose payments to clinicians, academic medical centers, continuing medical education programs, and other health care entities in a public database.

We discussed the recommendations and their potential influence on the next Congress last week here.

Medical school mashup

Conflicts of interest in academic-industry relations were the hot topic at the annual meeting of Association of American Medical Colleges last week, said Stanford School of Medicine Dean Phillip Pizzo in his Dean’s newsletter last week.

Speaking of academic-industry relations, Emory University has announced that it has formed an ethics panel to look into its management of researcher conflicts of interest. The move comes after a Senate Finance Committee investigation into the extra-curricular and undisclosed industry payments of Dr. Charles Nemeroff led to his stepping down as chair of Emory’s psychiatry department last month.

Check out RxP director Rob Restuccia’s op-ed on why greater transparency like the kind the Finance Committee is seeking is essential for good medicine, and find out more about the new Emory ethics panel here.

Hunting caps

Based on the GlaxoSmithKline’s recent comment that it will be capping industry payments at $150,000 per doctor per year in line with the industry’s current standards, Ed Silverman at Pharmalot went on an epistolary hunt to see exactly what those industry norms were. Many of the responses he received from companies suggested they were looking at current practices, and referenced compliance with the revised PhRMA code which, incidentally, is silent on caps on payments to doctors.

Papers weigh in on pre-emption

And thought it seems forever ago, it was just last week: Before there was Election Hubbub, there were opening arguments in the Supreme Court’s hearing of Wyeth v. Levine, the preemption case that will determine whether consumers can file suits over FDA-approved drugs in state courts. Here are opposing editorials from the Boston Globe and Wall Street Journal – we’re sure they won’t be the last – and the Kaiser Daily Health Policy Report provides a good soup-to-nuts.

Subcommittee refutes FDA safety finding

In a follow-up to a story we touched on last month, Integrity in Science Watch reported that the FDA subcommittee assigned to look at the FDA’s prior ruling on bisphenol-A “blasted the agency for declaring the plasticizer safe, saying the agency used unacceptable criteria for selecting studies to inform its deliberations.” Some groups had been concerned with a possible conflict of the subcommittee chair, who received a large undisclosed gift for his University of Michigan research lab from a Michigan-based plastic maker.

Despite the subcommittee report, the FDA issued a statement saying it stands behind its position that BPA is still safe for water bottles everywhere.

Does “a wealth of data from independent studies,” show that direct-to-consumer advertising of prescription medications “has a positive impact on public health”? That’s the claim from Pfizer in its recent submission to the FDA. But their evidence ain’t much.

Our own submission, filed jointly with Prescription Access Litigation, cites a systematic review by Gilbody et al. The authors evaluated 2800 DTCA-related publications, finding only four that met strict criteria for quality of study design (most available DTCA data comes in the form of consumer and physician surveys). And none of the four studies demonstrate a public health benefit from DTCA; they in fact raise some concerns.

Pfizer references eight citations in its submission. But it turns out that four of those were consumer surveys focused mainly on awareness and perception, and two others were earlier testimony from Pfizer and PhRMA to the FDA. One was a General Accounting Office report warning (Pfizer neglected to mention this) that “DTC advertising prompts millions of consumers to ask their doctors for prescriptions for specific brand-name drugs. As a result, it is important that FDA act effectively to minimize the public’s exposure to misleading DTC advertisements.”

In the one study put forth by Pfizer from a peer-reviewed journal, patients were asked what had happened when an advertisement prompted them to ask their doctor a question.  It turns that about a quarter of these patients ended up with new diagnoses (a substantial minority of which were for “high priority” conditions). There were some methodological limitations, but the bottom line is that not even the study’s authors concluded that DTCA produces public health benefits.

There may or may not be free speech grounds for allowing DTCA. Based on this evidence, there surely isn’t a public health case.

To view the full docket, follow this link.

We heard the Early Reader gets the Bookworm, but whether that’s fact or fable, the Reader gets an early start this week with news that Stanford University School of Medicine will be decoupling pharmaceutical industry funding from its continuing medical education programs, effective Monday. The move comes in the wake of Congressional inquiries into a Stanford psychiatrist’s financial interests and research post earlier this year, as well as growing calls for limits on industry involvement with doctors’ continuing education.

According to the San Jose Mercury-News, the new policy mandates that “companies will no longer be able to designate that their contributions be used for specific types of medical training, to limit the companies’ ability to tailor those sessions around their products.”  These restrictions make Stanford’s CME policy among the strongest in the nation.

“It’s a good plan, and it’s a big deal that a place like Stanford has adopted it,” Dr. Murray Kopelow told the New York Times.  Kopelow heads the Accreditation Council for Continuing Medical Education. “When this is all over, medical education will not be the same as what it’s been.”

All-you-ever-wanted-to-know at:

Wall Street Journal Health Blog

San Francisco Chronicle

Chronicle of Higher Education

Speaking of CME, this historical look at industry involvement in continuing medical education in last week’s Journal of the American Medical Association demonstrates just what a ‘therapeutic jungle’ it is out there. According to authors Scott Podolsky and Jeremy Greene, concerns about industry involvement in medical education are much the same now as they were 50 years ago, though they argue the stakes are higher now.

“Technological and regulatory solutions intended to defend professional control over knowledge circulation—such as CME—have instead provided novel sites of intersection between pharmaceutical marketing and physician education,” they write.

Label liability?

And now to Washington, where this week the FDA finalized a rule that will make it tougher to update a drug label to reflect warnings and side effects.

According to the BNA Health Care Daily Report:

“The final rule published in the Aug. 22 Federal Register (73 Fed. Reg. 49603) allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the product.

‘Expressly requiring that a CBE supplement reflect newly acquired information and be based on sufficient evidence of a causal association will help to ensure that scientifically accurate information appears in the approved labeling for such products,’ the FDA said.

Critics are saying that the rule adds up to immunity for drug makers, who would no longer have to warn consumers about drug risks or new side effects without proof of causation and newly acquired information. The American Association for Justice, which holds the new rule protects drug manufacturers, told the BNA the FDA’s decision “leaves the drug and device companies too much discretion in determining when to include safety hazards on warning labels.”

Baby steps

In other FDA news, the agency signaled it would be revising rules on over-the-counter cough and cold medications for children, according to the Washington Post. Last fall, an advisory panel convened to look at the safety and efficacy of the drugs, which have been linked to children’s deaths and have not been put to effectiveness tests.

Now, a year on, 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 organized the citizens’ petition filed in March 2007 requesting that the FDA review the safety of these drugs.

And the midyear update from the National Conference of State Legislatures says that prescription drugs continue to be a hot topic in state houses everywhere; 540 pharmaceutical-related bills have been filed this year, to date.

If you don’t already know about it, these topical legislative reports on the NCSL website are a dynamite resource: You can read description of all prescription drug bills filed so far this year by state, topic, or status of bill.  Find clusters of states where similar legislation has been introduced, or just see things that make you go ‘Hmm.’  Like how earlier this year Florida House members passed H.9065, a non-binding resolution honoring PhRMA on the anniversary of its program…honoring pharma.