The American Medical Student Association released its 2013 PharmFree Scorecard this month, continuing to pressure and encourage medical schools to improve their policies on conflicts of interest and interactions with industry. These policies have impacts on students’ medical education, the future of the medical profession and the care physicians provide. As patients we should be able to trust that decisions about our care are based on science and our best interests, not the marketing strategies of the pharmaceutical industry.

Now in its sixth year, the AMSA Scorecard rates U.S. Medical Schools on 11 key model polices that institutions should implement to reduce inappropriate interactions between the industry and medical school faculty and students. In the 2013 Scorecard, fully 115 (73 percent) of the 158 U.S. medical schools now receive an aggregate grade of A or B for their policies, compared with 102 last year and just 45 in 2009.

Dr. Elizabeth Wiley, AMSA national president, praised the progress made: “The PharmFree Scorecard is a successful, evolving tool which assesses the policies of academic medical centers and medical schools… With all of the compelling data about how marketing influences even the best-intentioned physicians, it is gratifying to see that medical schools are taking the necessary steps toward practicing evidence-based medicine, which translates into better patient care.”

The Scorecard analyzes and scores gifts and meals from industry to doctors, paid promotional speaking for industry, acceptance of free drug samples, interaction with sales representatives and industry-funded education. Ninety-seven percent of all eligible medical institutions sent their policies to AMSA for analysis this year, up from 92 percent in 2009, a striking confirmation of its significance for medical school leadership.

Dr. Maurice Clifton, Sr. Associate Dean for Academic Affairs at the new Commonwealth Medical School in Scranton, PA, told Community Catalyst that “The scorecard was an essential tool that helped us develop a comprehensive policy to ensure appropriate interactions between students, faculty and industry in the academic clinical setting.”

Commonwealth Medical School, which welcomed its first class in the 2009-2010 academic year, received an aggregate “A” grade, with the highest scores possible on 10 of the 11 model policies. In March, Commonwealth MS joined other Pennsylvania medical schools and academic medical centers in a meeting convened by Community Catalyst to discuss best practices and strategies to implement the policies that the Scorecard measures.

Highlights of the 2013 AMSA Scorecard:

• 93 schools (59 percent) now have model polices prohibiting all gifts and on-site meals, up from 19 (12 percent).
• 79 schools (50 percent) have a curriculum on conflicts of interest, up from 12 (8 percent) in 2008.
• Schools with model policies on speaking arrangements have grown tremendously; 44 (28 percent) schools ban or severely restrict participation in speaker bureaus compared to 31 (20 percent) in 2011-2 and only 4 (2.5 percent) in 2008.
• Only 41 schools (26 percent) have a model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
• Policies restricting industry support for Continuing Medical Education are now in place in only 28 schools (18 percent), but this is nearly double the number of schools in 2010.
• Access by pharmaceutical sales representatives remains a major challenge, with only four schools (2.5 percent) prohibiting sales reps from meeting with faculty and trainees regardless of location, or prohibiting sales reps from marketing their products.

A webcast of a live discussion of the AMSA Scorecard release can be found here. This National Grand Rounds was organized by the National Physicians Alliance, and includes a description of the updated methodology for the 2014 Scorecard for medical schools, as well as the new Scorecard for teaching hospitals, which were designed by AMSA and the Pew Charitable Trusts.

Community Catalyst is also producing “A Policy Manual for Academic Medical Centers and Medical Schools,” with Toolkits on the policies rated by the AMSA Scorecard – you can download the the first one, on medical school curricula on conflict of interest, here.

The 2013 AMSA PharmFree Scorecard, the NPA National Grand Rounds and the Community Catalyst Policy Manual are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin. Partners in the PACME project are AMSA, Community Catalyst, the National Physician’s Alliance, and the Pew Charitable Trusts. For more information, contact Marcia Hams, at mhams (at) communitycatalyst (dot) org.

Marcia Hams, Director of Prescription Access and Quality, Community Catalyst

When it comes to pharma meals, MA medical centers have already spoken

In its aggressive push to repeal the state’s gifts and meal ban, the Massachusetts restaurant industry (and pharma, the presumptive cooks in the kitchen behind this lobbying blitz) are hoping legislators will think the issue of doctors and drug companies is still, well, on the table. Since Bay State restaurant numbers don’t seem to have suffered from the law, these groups are betting that lawmakers will be willing to open the old and fundamental question: Should prescribers who are responsible for their patients’ best interests be letting pharma pay their way for meals, liquor and other perks?

But the question’s closed: Academic medical centers in Massachusetts have spoken loudly, and they’ve said that physicians and drug companies should work together at the lab bench, not the dinner table (or the bar). They’ve done this by developing and strengthening policies around industry marketing over the last four years, many of which set the bar nationally for rethinking conflicts of interest in the clinical setting, while protecting innovation.

UMass, Boston Medical Center, Tufts and Harvard Medical School have all demonstrated national leadership and done big work in setting ground rules to keep pharma’s marketing dollars out of doctors’ training, practice, and professional development. The American Medical Student Association scorecard, which evaluated conflict policies at all U.S. medical schools, recognized this leadership with top grades.   Specifically, all of these institutions received perfect “3s” on gifts and meals, meaning that “all gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”

So, if Massachusetts’ flagship medical centers have done this, why all this hubbub over at the State House?

In 2008, lawmakers heard the message from these clinical centers about keeping medicine separate from marketing, and they realized that what’s good for patients and providers at UMass or Harvard is good for patients and providers outside the academic medical centers—on the Cape, or in Waltham, or Deerfield. Tchotchke-free waiting rooms and unbiased clinical care should be the norm everywhere in the state, and that could only be addressed by a state law. And so they passed a law limiting the kinds of gifts and meals drug and device companies could give docs—including the ‘educational’ wine-and-dines at some of the state’s priciest restaurants.

This wasn’t radical: This was the next step on ground cleared by AMCs and the industry itself (whose own code of conduct Massachusetts used as a template for its law).

The drive to preserve this law will be decided in the next few weeks.  The House voted to repeal the gift ban, but the Senate Ways and Means budget, released yesterday, does not include mention of repeal. Senate President Therese Murray championed passage originally as part of the effort to eliminate unnecessary health care spending, including that driven by drug company marketing.  And as for that claim that these meals are necessary educational opportunities for docs: What caliber of education do we really believe happens in the function rooms of Boston’s finest restaurants over a $40 cut of Kobe sirloin and a few bottles of a nice reserve cab?  (Dr. Carlat talks menus here.) Remember, the law doesn’t prevent companies from catering a legitimate program in the hospital, but that wouldn’t include liquor and elaborate meals.

So as the debate heats up again, let’s remember that we’ve already had this one—and physician leaders have said clearly that gifts, food and booze don’t have a place in the medicine being practiced our prestigious academic institutions.  We hope these leaders will take the opportunity to remind the public in the coming weeks why they took a stand for reforming the relationships between the industry and physicians, and why their new institutional policies and the Massachusetts gifts and disclosure law are important to upholding the state’s reputation for clinical excellence and medical education.

–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

The 2010 American Medical Student Association (AMSA) Scorecard is out today, and for the first time since the student group began assessing conflict-of-interest policies four years ago, one half of all U.S. medical schools received an A or B (78 out 152).

That’s up from approximately one in three schools last year, and just 20 percent in that range just two years ago, suggesting that we really are engaged in a nationwide project to figure out what the proper role of the industry in  medical education should be.

About one-fifth of medical schools improved their scores over last year, the same improvement rate as we saw in 2009 over the previous year’s Scorecard. We think that’s really good. Let’s remember that these are giant, slow-moving academic institutions – not exactly the hares of the system-change race. That makes such steady and significant shifts even more impressive.

As for “most improved” candidates for the we-wish-it-existed AMSA Scorecard Yearbook, Tufts University would have to be up there, moving from D to an A and to the top of the class this year among medical schools in Massachusetts, as would University of South Dakota Sanford School of Medicine and Des Moines College of Osteopathic Medicine, who also jumped from Ds to As in a year.

We should point out here that the room between A and B is somewhat complex. The scorecard is composed of 11 domains:
-acceptance of gifts and meals from industry;
-consulting relationships;
-speaking relationships;
-disclosure of financial conflicts;
-pharmaceutical samples;
-individuals with financial conflicts participating in university purchasing decisions;
-financial support for educational events (on- and off-campus);
-industry support for scholarships and trainee funds;
-access of industry sales personnel to medical school or hospital personnel;
-and inclusion of education about conflict of interest within the academic curriculum.

Each year, AMSA asks all medical schools, early and often, for their policies in each of these domains and then using methodology developed with the help of the Pew Prescription Project, independent blinded assessors evaluate the policy out of a possible three points.

The needle’s been harder to move in certain domains than in others.

Unsurprisingly, very few—10 percent of schools—got a perfect score on their on-campus continuing medical education policy. Drug company sponsorship of grand rounds and other on campus co-hosted educational activities is a big money maker for medical schools, and can give a company talk the imprimatur it craves. The Accreditation Council for Continuing Medical Education gets this, and its policy recommendations have lagged behind many rule-making bodies and medical groups on decoupling industry-physician marketing relationships.

More surprisingly, perhaps, even fewer schools – just two – got a perfect score on limiting access to sales reps. A score of “3″ on industry access, according to AMSA’s scorecard site, is given to policies in which “pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

Schools that limit faculty and student interaction with sales reps, or where sales reps can go, but do not ban them, received a 2.

Still, the fact that no more than two schools banned sales reps outright is surprising to us because:

A) allowing sales reps on campus seems like the easiest, clearest example of letting industry inappropriately infiltrate your medical school. It’s in the name: they are there to sell stuff. Cutting out sales reps doesn’t get into questions of patient access to drugs or doctor access to education programs.

B)There are just less of them than two years ago. The last half of this decade hasn’t been a good one for sales reps, as pharma companies with trickling pipelines have slashed traditional marketing budgets in favor of … well, doctor-to-doctor CME, for one, and online campaigns. It seems that this would make it even easier for schools to put together great policies to keep the sales reps at bay. Maybe people need pens more than we thought.

For more, visit the 2010 scorecard at http://amsascorecard.org or check out the Pew Prescription Project resources on marketing and conflicts of interest.

–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

Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

(This is the first in a two-part blog. Read tomorrow when we look at how industry and other stakeholders weighed in.)

How clear does risk information need to be in direct-to-consumer drug ads? That’s the question the FDA is getting closer to answering as stakeholders weighed in this week on the agency’s proposed rules for presenting risk in broadcast ads.

Twenty-two members (see end of the blog for a complete list) of Community Catalyst’s Prescription Access Litigation Coalition and other supporting groups joined PAL in submitting comments that support the agency’s new proposal to make risk information clear, conspicuous, and neutral in TV ads. The groups also suggested the FDA require that risks be quantified in ads and that the overly-scientific talk be toned down to match the comprehension of the viewer who would have the most trouble understanding the ad.

Many of the provisions in this year’s proposed rule do reinforce the handling of risk information that FDA proposed in last year’s draft guidance. But they are clearer and more concrete, and would go further than the agency’s current standard of “fair balance,” in which drugmakers are only required to present risk as clearly as they present benefits. Specifically, the proposed rules would require that ads use everyday language that is easily readable when in writing and is presented slow enough and prominent enough, whether in writing or audio form, to be easily understood by a consumer viewing the ad. The FDA also proposed a rule that would ban any distracting sounds or images in broadcast prescription drug advertisements.

A step back on why all this matters: remember that the U.S. is one of only two countries that allows drugs to be advertised on TV at all (New Zealand is the other).  And it’s a relatively recent allowance—only in 1997 did the loosening of an FDA regulation about how the major statement about a drug is presented open the floodgates to the sleep butterflies, allergy bees, and PMS symptom balloons.

As was shown by the PAL cases on Vytorin-Zetia, Nexium, Vioxx and Ketek, those changes came with controversy and human costs. Rofecoxib, or Vioxx, was heavily advertised to consumers and physicians in its first year before it was pulled from market after being linked to between 35,200 to 52,800 deaths and 88,000 to 140,000 heart attacks in the US. This caused the Institute of Medicine and other experts to call for an end to DTCA for new drugs, whose side effects are often not known (or in Vioxx’s case, suppressed) until years after they appear on the market.

The link between DTCA and increased prescribing of newer, less-tested drugs has been well-documented, and policymakers, regulators and academics have all expressed concern that the FDA’s inability to regulate and oversee broadcast ads has put the public’s health at unnecessary risk.

But despite this concern and growing evidence that drug ads carry risks beyond the speed-read ones, drug companies came up short on proving public health benefits to their current ad style or offering new evidence-based ideas for presenting risk info in a clear and neutral way. We’ll take a look at what they said tomorrow. Short of all out banning DTCA, the FDA must determine the appropriate standards to best protect the public.

What else could the FDA do?
In addition to offering support to the proposed rules, PAL suggested additional steps that could further enhance the clarity of ads and thus further protect consumers. PAL urged the FDA to address the widely-held myths that the FDA approves all TV ads, and that the government only lets drugs that are “really safe” be advertised on TV, by requiring a disclaimer that “FDA has not approved this ad” for all ads that have not been pre-approved, and including the adverse event hot-line “Medwatch” number in all TV ads.

Though PAL fully supports FDA’s increased vigilance in regulating prescription drug ads, we noted in our comments that there are far more new ads being produced than there are FDA staff members to review these ads. It’s a big imbalance, and though increased funding and staffing of the FDA would help, delayed warning letters that appear long after an ad-buy—such as this Lunesta one–will probably still happen.

To address this issue, the FDA should start using their authority to fine drug companies for ads that violate FDA regulations. Though fining will not increase the speed at which the FDA is able to review ads, it could potentially increase pharma’s compliance with these regulations and exact a price from noncompliant companies, even if the ad in question is no longer being aired.

Those joining Community Catalyst’s and PAL’s comments were:

The Alliance for Retired Americans
The American Federation of State, County and Municipal Employees (AFSCME)
The American Medical Student Association (AMSA)
Breast Cancer Action
California Alliance for Retired Americans (CARA)
CALPIRG
The Coalition of Wisconsin Aging Groups
Connecticut Center for Patient Safety
Connecticut Citizen Action Group
Consumers Advancing Patient Safety (CAPS)
Health Care for All
IUOE Local 4 Funds
Long Island Health Access Monitoring Project
MASSPIRG
New England Carpenters Health Fund
National Legislative Association on Prescription Drug Prices (NLARx)VPIRG
National Women’s Health Network
Oregon Health Action Campaign
Prescription Policy Choices
TeamstersCare
US PIRG

–Emily Cutrell, Prescription Access Litigation

It’s been 927 days (back of our envelope, anyways) since Senators Charles Grassley and Herb Kohl first introduced the Physician Payments Sunshine Act, a bill that would require drug and device companies to disclose on a public, searchable website the gifts and payments they make to physicians and teaching hospitals. (Postscript is younger by a few weeks.)

Today, the Sunshine Act became law, as a provision in the national health care reform bill signed by President Obama. You can read the final provisions here.

Though it has not captured headlines like the coverage provisions and insurance regulations in the reform bill have, today’s passage of the Sunshine act is itself a dramatic answer to years of growing questions about how to balance the need for industry to work with academic researchers and the need to keep patients safe with good prescribing that is free from the influence of marketing. In recent years, that line has often proved a blurry one, as a series of investigations and media reports revealed that physicians have received millions of undisclosed dollars in speaking and advisory roles for drug companies, even as they conducted research on drugs made by those companies. PostScript has been along for much of that ride (as the archives in the right rail attest).

The momentum for Sunshine has come from a lot of corners – the investigations and hearings, led by Sens. Kohl and Grassley, that brought to light some of the most dramatic conflicts-of-interest between marketing and medicine.

It has come from many Members of Congress, who co-sponsored, worked on and advocated for Sunshine over the years.

It has come from academic medical centers and professional medical associations, who took a look at their own relationships with industry and developed policies to clarify those relationships.

It has come from the AMSA Scorecard, a joint project of the American Medical Student Association, Community Catalyst and the Pew Prescription Project  to rank the conflict-of-interest policies at every medical school in the nation.

It has come from state lawmakers and regulators, who brought bills and rules aimed to better safeguard prescribing from the influence of marketing dollars.

It has come from the efforts of numerous groups, including ours here at Community Catalyst and at the Pew Prescription Project.

It has come from the broad-based National Coalition for Appropriate Prescribing, which helped remind Congress why transparency is so important for consumers.

And it has come from pharmaceutical and medical device companies, many of whom acknowledged, in revised conduct codes and voluntary disclosure measures, that gifts don’t have a place in the doctor’s office.

We are proud of this collective effort, and all the work that went into getting Sunshine on the books. Thank you.

–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.