Pre-pre-emption report shows divide in FDA over labeling regs

Several top FDA officials objected to the agency’s rewrite of labeling rules in 2006 and 2008, which have made it harder for drug companies to include new safety risks on drug labels and thus be held liable for missing information, says a report released this week by the House Committee of Government Oversight and Reform. The rewrites under the Bush administration attempt to strip away drugmakers’ liability for safety issues not included in the labeling of approved drugs – plus a ‘preamble’ that argues that the new rules preempt state lawsuits.

The report, which comes a week before the Supreme Court will hear the watershed preemption case, Wyeth v. Levine, shows strong intra-agency disagreement and evidence of a push from the Bush administration to secure the language of regulatory preemption.

For more, see the Wall Street Journal, Pharmalot and FiercePharma posts.

Would you like generics with that?

The AP looks at the incentives on offer from some insurance companies to doctors who switch patients to generic drugs (steak and ale, in this case), a practice frowned upon by those in the medical community who say the prescribing pad should be the sole purview of the doctor.

“On either side you’ve got corporate bottom-line interests putting pressure on physicians who should be putting patients first,” Dr. Jean Silver-Isenstadt told the AP. Silver-Isenstadt is the executive director of the National Physicians Alliance, a partner group of RxP that encourages physicians to unbrand themselves from both industry and insurers. Check out their Unbranded Doctor campaign here.

Merck says Rosetta will swap coasts

The Scientist blog and Forbes Science Business blog mull the announcement that Merck biotech subsidiary Rosetta Inpharmatics in Seattle will be closing its doors – both bloggers, it seems, grew a bit nostalgic for brighter days at Rosetta, and worried for scientists they knew there. But wait! Hold the flowers, Merck tells The Scientist blog: The division is merely being incorporated into the parent company’s Boston labs – that is, if Merck can convince the researchers who work there to trade their homes in Starbucks City for the Land of Dunkin’.

…And speaking of Boston (since it’s a light news week), we were amused to catch a recent episode of Boston Legal that  got at some issues we here at RxP are pretty well-acquainted with.  In a court room, in a world not so very different from this one, TV-lawyer Candace Bergen went on a serious riff about conflicts of interest in academic medicine.

Maybe, just maybe, show creator (and Boston native) David E. Kelley penned Bergen’s jury speech after soaking up the news in our own Weekly Reader. Then again, perhaps we’re trying too hard to make the RxP-Hollywood connection.

BREAKING NEWS: Sandusky farmer says pumpkins have regrouped along party lines.

This month, the Wisconsin Medical Society adopted a no-gifts, no-exceptions policy for its 12,000 plus members, stating that a “complete ban eases the burdens of compliance, biased decision making, and patient distrust.”  In addition, the policy prevents members from joining industry speakers bureaus, and recommends changes to drug sample practices that act as marketing tools for pharmaceutical companies.

In a statement, the society’s president Dr. Steven Bergin said, “This policy is strong and clear. It leaves no doubt that the society’s physicians want to prevent even the impression that a gift–no matter how small–could get in the way of a physician’s decision-making.” Hat tip to Pharmalot.

GlaxoSmithKline joined other pharmaceutical companies this week in agreeing to voluntarily disclose advisory payments to physicians and researchers, and an extra step, pledging to cap them at $150,000 per year, according to the Financial Times. The London-based drugmaker has been making the other kind of headlines lately, one of them being how busy it kept former Emory psychiatry chair Charles Nemeroff on its speaking circuit.  Ed Silverman at Pharmalot wonders why $150,000 is the magic threshold – a question that seems, these days, straight off the presidential campaign trail.

The New York Times reports this week that we may be seeing the inklings of a trend, as IMS health numbers show Americans bought less prescription drugs in the third quarter of this year for the first time in a long time – an admittedly small reversal (down less than one percent) of a decade-worth of chart-scaling growth. 

And the new conflict of interest policy being considered for adoption at the University of Minnesota Medical School is officially Out There, after being leaked last month to the Minnesota Daily. The policy would ban all gifts to faculty, students, and residents, and phase out industry support of continuing medical education.  Read the Minneapolis Star-Tribune for more.

And the FDA’s conflict of interest problem isn’t just Rx-related, says The Pump Handle blog. Quick review: the FDA convened an advisory committee this summer that decided, after reviewing new evidence, that the current recommendations for human exposure to bisphenol A are just fine, relying mainly on studies done by the plastics industry.  Now, a subcommittee is reviewing that draft decision – and reporters from the Milwaukee Journal-Sentinel discovered that the chair of the subcommittee, Martin Philbert, recently received a handy $5 million toward his research center in Michigan.  From whom? None other than retired medical supply-maker Charles Gelman. 

From the Journal-Sentinel, we know that Philbert didn’t report the donation to the FDA, but we sure hope he wrote a thank you note – before the donation, the University of Michigan Risk Science Center had an annual budget of just $210,000.

The American Gastroenterological Association has issued guidelines on the management of Gastroesophageal Reflux Disease (GERD), which can be loosely described as persistent and troublesome heartburn or asymptomatic reflux that causes esophageal injury. The guidelines recommend a proton-pump inhibitor treatment (e.g. Astra Zeneca’s Nexium or TAP Pharmaceuticals’ Prevacid) — once a day, twice if necessary.

What the guidelines do not recommend is routine lifestyle changes, such as weight loss or reducing intake of coffee or alcohol. “The problem,” the authors write, is that there are “simply too many recommendations … to enforce the whole set on every patient.”

That may indeed be the case – an absence of evidence to support lifestyle changes. Do these things work? As long as the research enterprise is dominated by pharmaceutical studies, we may never know. But as long as the treatment guidelines are written by people who have financial ties to the companies selling the drugs, the public is likely to suspect their recommendations.  All three authors of the AGA guidelines are consultants to, speakers for, and/or receive research support from Astra Zeneca and TAP Pharmaceuticals, among other companies. The AGA itself receives funding from more than a dozen of the companies whose products it recommends.

This week, House Energy and Commerce Committee Chair John Dingell (D-Mich) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) sent a letter to the FDA asking about just how and why the agency chose non-profit EthicAd to partner on the creation of the “Be Smart About Prescription Drugs” website, launched last month to help consumers navigate drug ads.

In September, we had some questions of our own about EthicAd’s mysterious funding sources and close ties to Shaw Science Partners, a pharmaceutical marketing company with a long list of Big Pharma clients.  We broke news of Shaw Science Partners and EthicAd’s office- and phone-sharing arrangement here on Postscript, and look forward to hearing of the agency’s reply. 

And the latest joint probe of the Senate Finance Committee and the Special Committee on Aging, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments received by Columbia University cardiologist and stent entrepreneur Martin Leon and other Columbia researchers at the Cardiovascular Research Foundation.  The probe seems to center around the CRF’s industry–sponsored device conference, Transcatheter Cardiovascular Therapeutics, and Leon’s ties to the sponsoring companies.

Here’s more at Bloomberg.

But it’s only the latest investigation, and if history’s any guide, won’t be the last. With the troubling discovery of piles of undisclosed industry payments an Emory University psychiatrist took from a company whose drug he was testing on the government’s dime, and new revelations about the wag-the-dog marketing tactics used to push Neurontin, editors of the New York Times and Atlanta Journal-Constitution write this week that all this coziness between drug companies and doctors “underscores the need for Congress to pass a bipartisan bill, sponsored by Senators Chuck Grassley and Herb Kohl, that would require drug companies and other medical manufacturers to publicly disclose payments to physicians that exceed $500 a year.” (10/11, New York Times).

The Journal-Constitution went further in its recommendation, saying passage of the disclosure bill – also known as the Physician Payments Sunshine Act – is a “bare minimum,” and that the “culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing,” including a “temporary reduction in the amount of money going into research and continuing physician education.”(10/12, Atlanta Journal-Constitution)

And another editorial in the Arizona Republic this week takes a puzzling non-stand on the PPSA: First they were against, then they were for it? In the end, we’re not really sure. Just like the writers don’t seem very sure whether or not doctors are influenced by pharmaceutical marketing. The verdict?  “Probably not.” Sure, we’d heard the West is a place of fewer words, but this is taking it too far.

The first two editorials were no doubt spurred by the controversy around Dr. Nemeroff’s busy speaking schedule. News came this week that he’s about to get a little less busy – the National Institutes of Health have hit pause on the 5-year, $9.3 depression grant that Nemeroff was heading up at Emory. The AJC says despite his freed up schedule, Nemeroff is still turning down interviews.

And over at A Healthy Blog, RxP’s Kathy Melley looks ahead at what we’ve all been waiting for. Our 401Ks back? Ok, the other thing we’ve been waiting for – the decision from the U.S. Court of Appeals on prescription data-mining bellwether case, Ayotte v. IMS Health.

“The court ruling could have the effect of ratcheting up or down state legislative activity on data mining,” Melley writes, but that “regardless of where the court comes down, there’s a good chance the U.S. Supreme Court may be the final arbiter on this issue.”

Medical students and local physicians will rally at the Harvard Medical School campus today, urging their adminstrators to create better conflict-of-interest policies around pharmaceutical marketing.  According to a press release from the American Medical Student Association, which is capping its National PharmFree Week at the Longwood medical campus in Boston, “Students are asking for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.”

Check out the AMSA scorecard rating medical school COI policies here.

A conversation with Michael Hochman, MD

A study this month in the Journal of the American Medical Association found the mainstream news media isn’t passing muster when it comes to sussing out industry bias in pharmaceutical research. Investigators looked at more than 300 articles in the mainstream print media about major medical studies and found that 42% of the articles neglected to indicate when the research being reported was funded by pharmaceutical company, and that two-thirds of news articles refer to medications by their brand names, rather than the generic ones, the majority of the time.

We talked with lead author Dr. Michael Hochman, an internal medicine resident at Cambridge Health Alliance, who says that both the fourth estate and the medical community need to be asking more questions about why and how industry funds the research of its own drugs, and what that could mean for our health.

RxP: Why did you do this study?

MH: From numerous recent studies, we know that company funded research is more likely to generate positive results than non-company funded research. We also know that company funded research frequently uses “soft endpoints,” such as improvement in cholesterol levels rather than more meaningful endpoints like all-cause mortality. Because of the important impact company funding can have on the reliability of research results, readers of the lay media need to be aware when a study has been company-funded so that they can interpret the results appropriately. We found that the news media do not always do a great job of this.

Based on our findings, here’s what I think needs to be done:

1. News organizations must adopt and enforce formal, written policies stating that all articles about medical research must indicate how the research was funded and must refer to medications predominately by their generic names.

2. Doctors need to be aware of the biases inherent in company funded research, and view the results in that light.

3. We need to consider alternative funding sources for clinical research, such as the National Institutes of Health, that do not have direct financial interests in the results.

RxP: You say journalists should use a drug’s generic name instead of the widely-used brand-names owned by the companies that sponsor the studies. If journalists did use generic names more often, would it change a doctor’s choice of drug?

MH: I think it could. Patients often come to their doctor requesting specific medications that they see in advertisements or read about in news articles, and if they read about generic medications in news articles then I think they will be more likely to ask their doctors about generic medications, and doctors will be more likely to prescribe generic drugs.

RxP: You’ve said: “We in the medical community realize that research funded by pharmaceutical companies can’t always be trusted…” Has the press played a role in telling that story?

MH: Yes, but not as well as they could. We have had several prominent recent examples in which company funded proved to be biased. The most widely known is the rofecoxib (Vioxx) scandal in which company researchers were not forthcoming about the adverse cardiovascular effects of the drug. Company researchers were also not particularly forthcoming about cardiovascular side effects associated with rosiglitazone (Avandia).

I think these are all very important news stories, and the news media has covered them, but they haven’t driven home the point.

RxP: How could the press done better by the public around Vioxx?

MH: I think they did a good job of identifying the problem, but they didn’t do a good enough job of emphasizing that the same problems that led to the rofecoxib scandal are probably at work in many other company funded studies. It’s probably a much more widespread problem than this one isolated case. The media didn’t ask us to reexamine the fundamental way we do research in this country, or question that maybe having Merck research its own drug isn’t the best way to get meaningful results.

RxP: Do you think physicians have fully acknowledged the influence of their relationships with industry?

MH: Unfortunately, no. If we had, we would be actively seeking alternative funding sources for medical research – the National Institutes of Health, for example. To be quite frank, I am much more skeptical of company funded research than I am of other research, and I try to rely on non-company funded research as much as possible when making decisions about my patients. I think some of my colleagues feel similarly, but not the majority.

RxP: How will the current economic crisis affect our ability to consider seriously restructuring research funding through the NIH?

MH: At one level, sure, bailing out Wall Street means the government will have less money to support the NIH, but keep in mind, we’ve seen a pretty significant cutback in NIH research funding in the eight years prior. That said, I think this economic fallout has made all Americans more skeptical of corporate practices, and perhaps that skepticism will spill over to the pharmaceutical industry.

RxP: You point out in a Boston Globe op-ed that journalists get promotional press releases from the industry and interact with pharmaceutical representatives at medical conventions. But we expect and need journalists to hear from all stakeholders for any story. Where’s the evidence that coverage has somehow been biased?

MH: A number of previous studies have shown that medical coverage by the news media overstates medication benefits and underplays their side effects. There are a number of reasons why this may be the case. I think the main reason is that journalists want to write interesting stories that will keep readers engaged.

However, pharmaceutical promotions may also play a role. I can’t site specific evidence that the news media are influenced by company promotions, except to say that if the advertising didn’t work, the companies wouldn’t do it.

RxP: But do you find petitions by drug companies to the press corps more harmful to health care than gifts from detailers to physicians or the interactions clinicians have with pharma reps at conventions and CME courses?

MH: All are problems. I believe that we doctors should not accept any gifts from pharmaceutical representatives of any value. Medical decision making should be based on evidence, not advertising. And we have strong research that shows physicians who accept gifts are more susceptible to advertising.

RxP: So you seem to say there’s an absence of skepticism around company-funded trials the larger medical community, not just in the news. If that’s the case, are you asking the press to go first?

MH: I wish I could place all the blame on the media, but medical journals and doctors – who have bought into our current system – probably deserve the lion’s share of the blame. It is the medical community – not journalists – that has allowed a system to develop in which companies fund the vast majority of clinical research. However, I think both the medical community and the news media can play an important role in counteracting corporate influences in medicine.

We in medicine have a long way to go on this – we have the power to keep reps out of our hospitals and out of our clinical decision-making, and many medical schools and some hospitals have begun to ban gifts to doctors, but a lot more work needs to be done.

In terms of the news media, they sometimes get carried away in reporting exciting new medical developments before they’re ready for prime time. But patients’ lives are at stake, and we really need to be more vigilant in weeding out the junk, and determining how good these treatments really are, and what the risks are.

RxP: Do you think physicians should be required to disclose their own financial relationships with industry to patients?

MH: I think patients absolutely should be aware of any company funding that their doctors have received, however the best way to transmit this information is unclear. Perhaps physicians should be required to disclose financial relationships on publicly available websites.

RxP: Reporting on the source of funding doesn’t really tell patients or doctors whether a study is biased or well-designed. Are there more substantive changes you’d like to see in how journalists report medical studies?

MH: Again, this is challenging, because in order to really understand medical research, you need a medical background and some training in epidemiology, and you can’t expect this of most journalists — and perhaps not even of all doctors. I think the responsibility for fleshing out the details of studies and exposing their shortcomings must come from non-biased medical journal reviewers who carefully go through the study methods. The FDA must also do a better job of critically analyzing medical research when making decisions about drug approvals.

The Association of Healthcare Journalists has published an excellent set of guidelines about the appropriate way to cover medical research, and I think journalists should focus on abiding by these principles (http://www.healthjournalism.org/secondarypage-details.php?id=56).

Also, the Health News Review (http://www.healthnewsreview.org/) evaluates the quality and fairness of medical stories in the popular press, and I think the standards by which they grade articles are very appropriate and should be followed by journalists.

Thanks to co-authors: Steven Hochman, Pomona College; Dr. David Bor, Chief of Medicine, Cambridge Health Alliance, associate professor of medicine, Harvard Medical School; Dr. Danny McCormick, Cambridge Health Alliance, assistant professor of medicine, Harvard Medical School.

Cold season cautions

On Tuesday, the Consumer Healthcare Products Association announced it would label its combined cough and cold products so as not to be used in children under four, citing health risks from improper use and dosage, reports the Star-Tribune. The move comes a week after the FDA held a hearing and chose not to demand such products be pulled from shelves entirely, citing the need for more review.

Last October, the CHPA voluntarily pulled products labeled for children under two after the filing of a citizen’s petition with the FDA cited a lack of safety and efficacy evidence for such products in children under 12, and a rash of child fatalities and hospitalizations tied to the drugs’ use.

New Neurontin reports paint picture of data spin

This week, new documents in a class action suit around the off-label marketing of Warner-Lambert’s infamous epilepsy drug Neurontin show company officials suppressed studies that found the drug to be ineffective and doctored other data, strengthening the case that when it came to Neurontin, Warner-Lambert’s marketing department was running the show and the science.

The Prescription Access Litigation blog has all the goods – including the full reports by experts – on the latest revelations to come out of the pending class action lawsuit in the U.S. District Court in Massachusetts. In 2004, Pfizer (which acquired Warner-Lambert in 2000) paid $430 million to settle civil and criminal allegations around off-label promotion of Neurontin in the 1990s.

According the PAL blog, “The documents that were recently released were part of “expert reports” submitted by the lawyers for the plaintiffs in the case. The reports both contain and analyze documents from Pfizer about its alleged illegal off-label promotion of Neurontin.”

MedPAC to vote on disclosure recommendations

This month, the Medicare Payment Advisory Commission discussed recommendations that include a federal disclosure law that would require pharmaceutical and device manufacturers to report payments to health care providers, continuing medical education companies, and the like in a publicly accessible database, according to Modern Healthcare.  Many of the recommendations being considered mirror the Physician Payments Sunshine Act proposed last year in Congress. MedPAC will vote on the recommendations at its November meeting.

Virtue and Device

Sen. Charles Grassley (R-IA) is pressing Medtronic for more information about its consulting agreements with physicians around a bone graft device called Infuse. According to the Bureau of National Affairs Health Care Daily Report, a letter sent by the Senator to the Minneapolis-based devicemaker recently “asked the company to provide the names of all doctors with whom Medtronic has consulting agreements for the Infuse product, as well as the copy of all consulting agreements and the total amount of the payments.”

Sen. Grassley is also still petitioning the Department of Justice to give him more dirt on two qui tam cases filed against Medtronic in 2002; though the cases were dismissed in 2006 as part of a separate kickback settlement agreement, one is still sealed, and the other’s dismissal has been appealed by the whistleblower.  For a taste of the juicy kickback allegations in the sealed complaint, obtained by the Wall Street Journal last month, check out our earlier blog post.

And former U.S. Attorney General John Ashcroft is one of the five appointed compliance monitors working with medical devicemakers to undertake corporate reforms mandated in a deferred prosecution agreement with the federal government in 2007 for (more) settlements over kickbacks to doctors.  According to the BNA Health Care Daily Report, Ashcroft told attendees at a health care fraud and compliance forum in Baltimore this week that one of his challenges is “ensuring the plans are not at odds with sales goals.”

“Surely you remember”

The Atlanta Journal-Constitution has a good follow-up story here on exactly how hard officials at Emory tried to get Dr. Charles Nemeroff to disclose his multitudinous industry ties.  Last week, Dr. Nemeroff stepped down as chair of Emory’s psychiatry department after a Senate Finance Committee investigation revealed he’d received some $900,000 in undisclosed payments and expense reimbursement by GlaxoSmithKline for giving talks on its psychiatric drugs between 2000 and 2007, even as he was a principal investigator on a National Institutes of Health trial on a GSK drug.

The end of doodads

The Kansas City Star looks this week at the state of industry-physician relations on the eve of PhRMA’s new voluntary code, which will ban its salespeople from bringing docs on their circuit doodads or making dinner reservations for them after January 2009.

“Generally, the pharmaceutical representatives are very good,” AMA trustee Rebecca Patchin told the Star, defending the AMA’s voluntary guidelines of accepting gifts, which are weaker than the industry’s code and many academic medical centers.  “They know their products and they provide good information,” Patchin said. “They know their role and physicians know their role.”

See above on Neurontin, Nemeroff, and Medtronic, and assorted devicemakers for proof otherwise.

When is writing a memo fun? When the sender is you, the recipient is you, and its purpose is to authorize payment - to you.  We’re pretty sure Dr. Charles Nemeroff enjoyed getting that memo (from himself) authorizing $3000 to be paid (to himself) for writing a medical journal supplement, as much as we would enjoy a similar return-address windfall.

But what about that journal supplement itself? These ‘special sections’ in medical journals – often sponsored and usually focused around a related topic, like a disease group or drug class – tend to be less editorially rigorous, amounting to nothing more than glossy chances for companies to buy extra ad space.  In this Journal of the American Medical Association study, blinded reviewers found that the quality of the medical articles – in study design, sample size, and analysis — was inferior in the supplements to those published in the parent journals. And other scholars and clinicians have wondered openly whether they are worth the paper they’re printed on – much less $3000.

Yet, that self-payment was just one of the more trifling findings of the Senate Finance Committee into the large undeclared industry payments to Dr. Charles Nemeroff, former head (and by former, we mean Friday) of the Emory University Department of Psychiatry and principal investigator on an NIH grant to study a GlaxoSmithKline drug there. And by industry payments, we mean GlaxoSmithKline.

While the Committee has been hot on the trail of 30 academic psychiatrists and their disclosure sheets that don’t match up to company records, the case around Dr. Nemeroff – depicted in this letter from Committee Chair Sen. Charles Grassley to Emory and obtained by Pharmalot — is singular in the repeating and bald-faced quality to Nemeroff’s bucking of the NIH rules, which require universities to ‘manage’ conflicts caused by investigators’ significant conflicts of interest (defined as $10,000 per year).

For instance, in August 2004, Nemeroff wrote to Emory’s conflict-of-interest committee to say he was in compliance with the $10,000 limit — and in that month alone Nemeroff took in excess of that yearly maximum in speaking gigs and “non-product” phone calls alone.

After Emory’s COI committee raised questions about his failure to follow approval protocol of his consulting agreements and discrepancies on his disclosure sheets, Nemeroff wrote another memo, this one not as fun, about his future compliance, which read: “I will follow the management plans for my conflicts of interest”… and “I shall limit my consulting to GSK to under $10,000/year and I have informed GSK of this policy.”

Grassley’s letter goes on:

Barely a week after this promise, on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave regarding Paxil at the Larkspur Restaurant and Grill in Las Vegas, Nevada. The following day, Dr. Nemeroff gave two more talks in exchange for $7,000 from GSK ($3,500 per talk).

Maybe the maxim, What happens in Vegas, stays in Vegas, just hasn’t made it to the Beltway yet.

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.