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

(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

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.

In a week where spending your taxpayer dollars on bad investments suddenly sounds like a ‘rescue plan,’ read this: the FDA spent a chunk of their not-so-spare change  (OK, so $300,000 is a lot less than $700 B) to hire a PR firm to “create and foster a lasting positive public image of the agency for the American public,” the Washington Post revealed this week. Instead of issuing the request for bids required for federal government work, a former public affairs executive for a medical-device firm now working for the FDA orchestrated a no-bid contact through Alaska Newspapers, Inc, which isn’t subject to government bidding requirements because of its special status. 

So are we more enraged at the fact the agency went the good ol’ boys route and circumvented the rules process to find the best and lowest-cost bidder, or that even as the chronically under-funded agency was asking Congress for more dollars to shore up its crumbling safety and oversight divisions, it was working this hard and shelling out this much to shine up the story in tomorrow’s social studies books? Right now, we’d say it’s a coin toss.

Putting ADHD drug ads in timeout

The FDA has warned five drugmakers about false or misleading advertisements of five ADHD drugs, according to the Bureau of National Affairs Health Care Daily Report. “The FDA sent letters to Eli Lilly and Co., Mallinckrodt Inc., Novartis Pharmaceuticals, Johnson & Johnson, and Shire Development.” One of them was a video testimonial by Extreme Celebrity Home-giver Ty Pennington for Shire’s Adderall XR, an unapproved ad the FDA says overstates efficacy but which company officials claim was never supposed to leave the Shire website, where the side effects, dosage and indications were plain for all to see.

The pre-emption question

As the Supreme Court’s November date with pre-emption case Wyeth v. Levine nears, this Boston Globe editorial argues the evidence has shown that the FDA approval process requires “insufficient proof” of drugs’ safety “and then does not recognize their harmful effects quickly enough.” The Globe continues: “the Supreme Court has no business depriving patients of their recourse to courts.”

Pharmalot’s Ed Silverman has made his site the one-stop shop for all things pre-emption. Check out his syllabus here.

Media matters

And in this week’s Journal of the American Medical Association, researchers from Harvard Medical School and Cambridge Health Alliance look at news reports on industry-funded pharmaceutical studies in the mainstream media and found that about 40% of 300 major news stories failed to mention the source of the study’s funding. 

Of course, reporters aren’t alone – recently, major medical journals have been discovered to have missing disclosure statements from industry-funded authors, and Congressional queries have found giant gaps in payment disclosures by university researchers. When it comes to disclosure, these researchers seem to be asking that the fourth estate go first.

UMN ponders new stronger COI policy

Minnesota Public Radio revealed leaked recommendations by a University of Minnesota medical school task force on new conflict of interest policies. The recommendations called for health care providers to disclose to patients any interest they have in companies whose products they prescribe them, developing a conflict of interest website, a complete phaseout of industry funding for continuing medical education, and a requirement that all physician-industry relationships be disclosed (currently, only payments above $10,000 are required to be reported). The University received a D on the American Medical Student Association scorecard for its current policies earlier this year. Here’s the AP follow-up.

Cephalon settlement calls for disclosure

As part of $444 million in settlements of whistleblower lawsuits related to illegal off-label marketing, Cephalon is the first drugmaker to enter into a corporate integrity agreement that will require it to disclose prominently payments to physicians and amounts on its website; the move comes a week after Eli Lilly and Merck announced they will voluntary disclose such payments beginning next year; two years ago, five medical device makers began to disclose such payments under a similar settlement agreement to Cephalon’s.

Find out more at Marketwatch and Wall Street Journal Healthblog.

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.

Who is behind a new FDA website aimed at helping consumers understand and interpret direct-to-consumer (DTC) advertising?

The FDA unveiled the “Be Smart about Prescription Drug Advertising” website this week and a press release notes that it was developed in collaboration with EthicAd, “a nonprofit organization devoted to improving public health through consumer education.”

EthicAd executive director Michael Shaw tells the Prescription Project that the website has been five years in the making. He says his organization was created in 1999 by a group of academics concerned about the direction of DTCA. EthicAd receives no funding from any company and is supported “mostly by contributions of individual academics.”

But we couldn’t help noticing that when we phoned EthicAd, we ended up in the voicemail system for Shaw Science Partners, founded by the same Michael Shaw and identified on its website as a “pharmaceutical marketing agency” that has been behind “30 major pharmaceutical product launches,” including Viagra, Celebrex, Zoloft and Cymbalta.   

EthicAd is open about its ties to the pharmaceutical and marketing industries. Indeed, its website says:

“If you are a part of the pharmaceutical or advertising industry and would like to work in collaboration with us in the development and adoption of DTC ethical standards, we would like to hear from you.”

According to an Advertising Age report on EthicAd from May 2000, “[w]hile the group’s primary function is to serve as a consumer advocate, it also sees its role as a supporter of pharmaceutical companies and their marketing efforts.”

An assistant to Dr. Shaw promised to provide us with a list of EthicAd members – those academics who support the organization, without even the benefit of a tax deduction (EthicAd does not have federal tax-exempt status). Two days later, we’re still waiting.

Meanwhile, we find ourselves asking just what sort of expertise is the FDA gaining with this collaboration? 

The unconventional thank you note: GSK exec demonstrates

Yesterday Chris Viehbacher, head of GlaxoSmithKline’s U.S. Division, sent a wouldn’t-it-be-a-shame note to legislators considering a Massachusetts bill that would ban pharmaceutical vendors from giving gifts to physicians.  In the letter, Viehbacher expressed his displeasure at the prospective law and reminded them of Glaxo’s recent job creation in the Bay State. Considering that the same legislators have proposed $1B to help boost the state’s biotech cluster, we wonder just how much Viehbacher wants before he’d be content ditching the bribes to physicians and sticking to the science.

Here’s the original story in the Boston Herald, and today’s follow-up, which includes interviews with two legislators who weren’t amused. We were, though, to read that state Sen. Mark Montigny (D-New Bedford) called the letter ‘baloney.’

Speaking of the Boston broadsheets, Pharmalot says supporters of physician/industry relations have enjoyed some column inches lately on the op-ed pages of the Herald and Globe. Chief of medicine at Mass General Hospital Dennis Ausiello, M.D. coauthored both, in which he calls for “more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.”

When last we checked, that engagement was happening at every stage of the process – and look how good Vytorin turned out.

We’d like to hear from you

Today, Big Pharma goes to the Hill, but not for lobbying (ok, well maybe for that too.) The House and Energy Oversight and Investigations subcommittee will be hearing from Pfizer, Johnson & Johnson, Merck, and Schering-Plough about direct-to-consumer advertising.

The baby in the bathwater, and Texaco treats at school:

A doc–off over AAMC recommendations

Over at MSNBC, Art Caplan Ph.D., a renowned bioethicist at University of Pennsylvania squares off against Cornell surgeon Edward Craig M.D. M.P.H.  about why the new AAMC recommendations are a good thing – or not.

Caplan writes:

Business has no business selling or promoting in the middle of classrooms or other academic settings. Academic medical centers, if they want to teach their students how best to think about the medicines they prescribe and to retain the trust of the American people about evaluating them objectively, should do everything they can to keep the marketing, sales pitches, promotions and bribes — large and small — away from campus.

Craig, however, says that the prescribed ban, which includes things as big as foreign travel and as small as pens, lacks subtlety, and insults hungry doctors.  “When was the last time you were bribed by a piece of pizza or a logo pen with five days worth of ink?” Craig writes.

Ah, the old if-it-were-you argument.  More than a few fables and aphorisms have been written to warn us against that reasoning, but perhaps Jane Austen did it best in her novel, Persuasion: “How quick come the reasons for approving what we like!”

(And we like the pens a lot.)

Airing on the side of secrecy

Slate.com reported on some undisclosed industry relationships on the airwaves.  Neither the hosts nor the medical experts interviewed during a program on the depression meds SSRIs announced the experts’ consultant and advisory capacities for makers of the drugs.  More here.

A few weeks ago, we posted on the curious persistence – and size — of propaganda for Vytorin, the combo cholesterol drug that’s efficacy went the way of its clinical trial results – into thin air – after a panel of cardiologists rendered its cholesterol-lowering powers null and void at the American College of Cardiologists meeting in March.

But Gary Giorgio, MD, a doctor of emergency medicine in Akron, Ohio, said it better than we could have in this letter to the editor of the Akron Beacon-Journal, which ran two full-page Vytorin ads like the ones we saw in the Globe.

“The ads follow fast and furious on the heels of a study published in the New England Journal of Medicine that showed no benefit of the combination drug in reducing plaque,” Giorgio wrote.

“Given these facts, why would any intelligent physician prescribe this medication? Is it because industry-tainted guidelines keep pushing for lower and lower cholesterol targets despite a lack of evidence that this is beneficial? Is it because pharmaceutical giants Merck and Schering-Plough, which stand to make billions more dollars if patients are switched to or kept on Vytorin, have duped physicians and their patients? You be the judge.

“If you’re taking Vytorin, maybe, as the ad suggests, you should be talking more to your physician.”

PostScript was delighted to discover DTC-In-Perspective, a blog by the CEO of the company of the same name. DTC is one of those publishing, conference/training, and consulting companies that specializes in soaking pharma for pricey analysis of its own behavior — in this case direct to consumer advertising.  Bob Ehrlich, the aforementioned CEO, ought to know whereof he speaks. Bob is the guy who brought us Lipitor. That is, he advertised the heck out of it when he was VP Consumer Marketing for Parke-Davis. For that, Advertising Age named Bob one of the top 50 marketers in the US.

But all that marketing was strictly educational, right? Not really. Here’s Bob this week: “Drug marketing is designed to sell drugs. Ok, I said it. It is not usually to educate objectively… Does all this drug marketing create demand for products that may have cheaper equally effective alternatives? I am sure it does.”

Thanks for confirming, Bob. We couldn’t have said it better.

…but landed the folks behind “Money Talks: Profits over Patient Safety” on the list of ”2008 Notable Video for Adults” by the American Library Association Video Roundtable Committee.   

Among the stars of the Kathleen Slattery-Moschkau’s documentary on pharmaceutical marketing, Prescription Access Litigation’s own Alex Sugerman-Brozan.  We’ve got an ear out for the Oscar buzz. 

You can find out more about the award and the documentary at Prescription Access blog.