This week, I talked by email with physician and researcher Dr. Joseph Ross about the importance of using unique identifiers in pharma disclosure data, and other ways to take the guess work out of the Physician Payments Sunshine database.

PS: Last week, a commentary in JAMA (Carpenter/Joffe) suggested that unique investigator identifiers should be used in the Physician Payments Sunshine database to make the data most usable, accurate, and suitable for cross-reference with other databases.

You’ve spent a lot of time with data collected under similar disclosure laws in Minnesota and Vermont. From your point of view as a researcher, what aspects of an identifier are important or helpful to looking at these data?

JR: From our experience examining the data in Minnesota and Vermont, I can only say that some unique identifier is necessary. Neither the Minnesota or Vermont data that we used included a unique identifier, just the name of a physician, clinician, or hospital/clinic that accepted the payment from the pharmaceutical company.

We found that trying to determine exactly who accepted which payment was virtually impossible, because one could not be sure whether a “Dan Smith” in Minneapolis was the same or a different “Dan Smith” in St. Paul, for example. Without a unique identifier, doing research to examine which physicians or clinicians are accepting payments can only be done in the aggregate, not at the individual level.

However, what is most interesting about Carpenter and Joffe’s proposal is not the unique identifier in itself, but the development of an identifier that could be used across databases, linking payment disclosure data, to grant applicants, to manuscript submissions and publications, to service on NIH or FDA committees. I could imagine this identifier being an expanded use of the NPI (national provider identifier), or another number, but it would certainly make identifying potential conflicts of interest far simpler.

PS: One of the reasons these authors suggest a unique identifier is to capture payments made to non-physician investigators. Did you deal with this issue in your work with the Minnesota and Vermont data?

JR: Yes, examining the data in Minnesota and Vermont, there were a substantial number of payments made to non-physicians, although these clinicians were not necessarily investigators. I agree that if the PPSA is broadened to include payments made to non-physicians, an alternative identifier to the NPI might be necessary. NPIs are required by all health care providers, including non-physicians who bill insurance companies or write prescriptions. But some non-physicians who receive payments from industry may not fall into this category.

However, to me, the real issue is a shortcoming of the PPSA, which requires companies to include physicians’ NPIs in their annual submissions, but prevents these numbers from being made publicly available.

PS: Why is that a problem?

JR: This is a problem because, as it stands, the payment disclosure data cannot be confidently attributed to an individual without using the NPI as a unique identifier. Our prior experience suggests that individual physicians will appear in the disclosure data multiple times, potentially with different spellings of their names, different practice addresses and so forth. It becomes a bit of guess work to determine if a payment to Daniel Smith from Lilly in September should be combined with the payment to Dan Smith from Lilly in April.

PS: In your 2007 JAMA article, you wrote about difficulty you had obtaining the Vermont/Minnesota data, and the poor quality of the information once you received it. Out of this experience, what should some of the priorities be in developing Sunshine systems and payment categories to produce a meaningful public disclosure scheme?

JR: Well, we’re still more than two years away from seeing how the PPSA plays out in practice. The legislation was fairly specific in terms of what information is to be collected.

Of all the categories pre-specified, the “nature” of the payment is most subject to interpretation.

My hope is that they interpret it as specifically as possible, so that, for instance, its disclosed when a payment is for a) speaking at a ACCME accredited educational event, b) speaking at a non-ACCME accredited educational event, c) attending a ACCME accredited educational event, or d) attending a non-ACCME accredited educational event. If the “nature” of a payment is disclosed vaguely, all four of those activities could be listed under the umbrella of “education.”

Otherwise, I agree with the Carpenter/Joffe commentary: Something needs to be done to ensure that a unique identifier is required for disclosure by companies and made available to the public. Without this, these payments may be misattributed, particularly within larger markets, limiting the effectiveness of this law within those communities.

Joseph S. Ross, MD, MHS, is an Assistant Professor in the Section of General Internal Medicine at the Yale University School of Medicine in New Haven, CT. He holds a medical degree from the Albert Einstein College of Medicine, Bronx, NY, and completed his post-graduate training in primary care internal medicine at Montefiore Medical Center in Bronx. As a fellow in the Robert Wood Johnson Clinical Scholars program at Yale University, Dr. Ross earned a Master’s degree in health sciences research. Using health services research methods, Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations, evaluating the impact of state and federal policies on the delivery of appropriate and higher quality care, and issues related to conflicts of interest, medical professionalism, and drug safety.

Interviewed by Kate Petersen, PostScript blogger

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

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

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

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

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

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

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

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

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

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

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

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

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

–Kate Petersen, PostScript blogger

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

Despite a heightened awareness of the need for transparency of financial relationships in clinical medicine and research, a new review of meta-analyses in JAMA found that among a sample of high-impact publications, very few of the reviews acknowledged industry-backing of the source trials.

According to the review, only two of 29 of the meta-analyses selected from recent editions of influential journals identified industry-backed trials as such, even though nearly two-thirds of the trials with declared funding sources were sponsored by drug companies.

A considerable body of research suggests that industry-backed trials tend to portray the drug more positively, favor the drug over placebo, and downplay side effects more often than in non-industry trials (see the JAMA bibliography). This 2006 BMJ article found industry support tended to lower the rigor of meta-analyses.  It seems, then, a matter of some import to have an understanding of trials’ funding sources, both in their original publication and when they are aggregated in reviews.

Of course, blame for this dearth of financial disclosure doesn’t rest solely with the reviewers of the trials – the lack of standard documentation of industry funding and relationships in trials published in major medical journals is a complex and compound problem. For instance, among the Randomized Control Trials (RCT) included in the 29 meta-analyses, only a quarter included financial disclosures for authors, and only two-thirds listed sources of trial backing. In such a landscape, then, it’s tricky–if not impossible–for a meta-analysis to accurately or completely describe the shape and scope of the funding behind the findings.

The researchers call for a standard policy:

The results of the present study highlight a major gap in the reporting of COIs and suggest that, without a formal reporting policy, COIs from RCTs are unlikely to be reported when results are synthesized in meta-analyses. The PRISMA statement should be updated to require authors of meta-analyses to report funding sources of included RCTs or report that funding sources were not disclosed.

There’s much agreement that transparency of potential COIs is important in clinical care and prescriber settings. But progress toward transparency in the clinic may be diluted, if not undermined, without a more unanimous foundation of disclosure in the medical literature, which serves to set the therapeutic standards and practice guidelines used there.

–Kate Petersen, PostScript blogger

While physicians may be more wary of marketing relationships with industry, a new national survey of nurse practitioners shows that the group, who outnumber family docs, still has extensive ties with the industry and holds favorable views toward marketing tactics such as drug samples, sponsored lunches and dinners, and industry-backed continuing medical education. Considering nurses’ expanding role as primary prescribers in the U.S. health care system and the way the Sunshine provisions in the health reform law require reporting of only physician payments, these data may presage a turn in the industry’s promotional efforts away from physicians and toward nurses.

In the survey of nurse practitioners, “Under the Radar,” conducted in 2007-2008 by Elissa Ladd et al and published in the latest issue of the American Journal of Managed Care, 96 percent of respondents reported having regular interaction with the pharmaceutical industry, and the same number attended an industry-sponsored CME program over the prior five years. Forty-nine percent of nurse practitioners reported that they regularly attended pharma-backed lunches or dinners in the previous six months, and 48 percent said they’d be more likely to prescribe a drug that was highlighted at such a lunch or dinner event.

While the nurses’ survey does not give us trends, it does suggest an openness to industry marketing that may be waning, if slightly, among physicians. In a widely-cited 2004 survey by Eric Campbell et al in the New England Journal of Medicine, 94 percent of physicians reported having a relationship with the pharmaceutical industry. According to a November 2010 follow-up survey in the Archives of Internal Medicine by the same authors, fewer physicians (about 84 percent) reported relationships with pharmaceutical companies and involvement in all domains—samples, gifts, payments, and reimbursement—had decreased over the previous five years. Still lots of ties, but less of them.

Take samples. The number of physicians accepting samples went from 78 percent in 2004 to 64 percent in 2009; that reduced percentage nearly matches the proportion of nurses—66 percent—who reported taking samples between 2007-2008. So while we can’t see trends in the nursing data, we can surmise that policies around physician-industry relationships, coupled with nursing’s favorable attitudes toward promotional activities and its growing prominence (there are now more prescribing nurses in the U.S. than family physicians) could push both exposure and marketing attention toward the nurses’ corner.

If there is a salt-grain alert, it could be that the nurse survey represented a much smaller pool of respondents (263) than the 2009 AIM physician follow-up (1,891). And as they were independently designed and conducted, the surveys are necessarily snapshots, and not designed for perfect comparison.

Still, a few general lessons are worth noting here. While the spotlight has been trained on physician-industry relations in the last six years, the fact that prescribing nurses still hold a very positive attitude toward and active engagement with pharma marketing is an important signal for the nursing profession and those concerned with the influence of marketing to look more closely at the industry’s interaction with prescribing nurses.

State and federal policymakers moving to curb the influence of marketing on prescribing should keep in mind the implications of a group of prescribers whose numbers and prescribing power in the health care industry is growing, but whose involvement with the industry has largely flown “under the radar,” and make sure that policies don’t make a loophole of the nursing profession, and undercut the regulations that seek to protect the integrity of the patient-prescriber relationship.

–Kate Petersen, PostScript blogger

Newly-released court documents gathered as part of a court case against Wyeth (now part of Pfizer) brought by patients who developed breast cancer while taking its Prempro hormone replacement therapy (HT) illustrate how ghostwriting was used to distort or hide scientific evidence and lend clinical credibility to company marketing aims in medical journals and presentations. In “The Haunting of Medical Journals” in this week’s PLoS Medicine, Georgetown physician, researcher and expert witness Adriane Fugh-Berman examined the documents. She found that where company-funded trials and clinical findings are concerned, the marketing tail is still vigorously wagging the dog.

DesignWrite, a medical education and communication company (MECC) was hired by Wyeth to produce large quantities of “authored” papers that touted unproven benefits and later downplayed risks of HT proven in large randomized control trial (RCT) studies. Between 1997 and 2003, Wyeth hired DesignWrite to produce drafts of more than 50 peer-reviewed publications, including at least four primary publications on a Wyeth-funded Prempro trial.

DesignWrite’s ghostwriters also helped “manage” clinicians and thought leaders, ensuring marketing messages remained front and center in published papers, and planned CME events and journal supplements.

“Even though a 1997 DesignWrite proposal admitted that ‘HRT continues to be a drug in search of a disease’” Fugh-Berman writes, “my examination of the available documents indicates that the lack of evidence regarding the prevention and treatment of cardiovascular disease, dementia, and other diseases proved no deterrent to Wyeth/DesignWrite’s promulgation of numerous marketing messages positioning HT as a panacea.”

While this lines up with mounds of other evidence that show companies’ marketing goals running the scientific show, the casualness of the counter-science that was done to keep physicians prescribing HT is newly shocking.

When in 2002 the Women’s Health Initiative, a large RCT, disproved purported cardiovascular benefits previously associated with HT and showed increased risk of breast cancer and stroke, Wyeth commissioned the ghostwriters at DesignWrite to write papers casting doubt on hormone therapy’s role in breast cancer. One Wyeth employee suggested that a journal supplement falsely state that breast cancer associated with the treatment was less virulent. That year, Wyeth management “charged the Publication Committee with increasing the number of positive HRT/Premarin-related publications. They have asked us to publish at least 1 study per month.” The company also flooded medical publications with mini-reviews, editorials, comment, and other booster pieces that did not have to be peer-reviewed, but still packed a clinical punch with physicians.

Physicians, it’s clear from the documents, were only as valuable to Wyeth and DesignWrite as their prescribing pen and their generic credibility. As “authors” who lent their names to ghostwritten pieces, the companies saw them as interchangeable: “I moved Dr. Creasman as an author to the patient ed piece (with Blackwood, Weiss, & Speroff) and left Horwitz and Boman on the basic science manuscript,” one document stated.

This should be insulting to physicians. As a marketing tool, ghostwriting has been implicated in the physician recruitment campaigns around Vioxx, Neurontin and other high-profile drugs stripped of their mystique and safety profiles by sound science.  But as Fugh-Berman and these documents illustrate, the use–and manipulation–of medical journals and clinical evidence to support marketing aims may have become so routine that in some cases, the most reaction Wyeth’s antics stirred was confusion on the part of the token author:

“From what you have written, I would be more of an ‘editor’ rather than the major writer—that is, you guys would be writing the versions—with me ‘altering, editing, etc.? Is that correct?’”

And if this is an outrage to physicians, so should it be to the rest of us. The following is a response from Wyeth’s Gerald Burr to a ghostwriter about whether manuscripts could be reused.

“‘You can’t just put another name on the article, but you can plagiarize the way we did when we wrote papers in college. What you need to do is give your potential authors Karen’s version of the article before the author modified it. Then have your authors modify it for publication under their name. Wyeth owns Karen’s draft, not the final publication.’ Burr supplied five drafts but asked that [a DesignWrite supervisor] Karen Mittleman be notified of the plans for reuse ‘so she can advise if we are going to piss off any of the U.S. authors.’”

Read the full article here.

–Kate Petersen, PostScript blogger

A new survey of physicians published in the JAMA Archives of Surgery this week suggests that across specialties, the majority of physicians still hold a positive attitude about gifts and meals from pharmaceutical and medical device companies.

Confirming what previous studies on marketing influence have found, cognitive dissonance was at work here: the majority of the 590 respondents (52.2 percent), who worked at Mount Sinai School of Medicine and its affiliated hospitals, believed that receiving industry gifts and meals influenced other physicians’ prescribing, but just about one-third believed that they themselves were influenced by gifts and meals. Earlier studies quantifying physician attitudes have suggested an even greater differential.

And though the majority of respondents thought that industry funding of medical education was acceptable, more than two-thirds of them perceived bias in such sponsored lectures.

The researchers hypothesized that surgeons, whose journals had published little of the literature to date on gifts’ prescribing influence, would have more favorable views of industry gifts and involvement in medical education. The results bore this out, with surgeons significantly more amenable to certain types of gifts, and industry funding of medical school programs (82.8 percent compared to 71.1 percent overall). Recent news stories in Bloomberg and the New York Times have revealed the unique coziness between some high-profile surgeons and makers of implants and devices that failed their patients.

In an interesting aside, the specialty most likely to say that its institution should prohibit residents, students and attendings from interacting with pharma and device reps were psychiatrists, who have been the focus of a series of headlining Congressional investigations in recent years and have consequently done a lot of work to clean their house.

So where is education and awareness in all this? In many cases, the more familiar a physician was with her institution’s guidelines, the less likely she was to rate gifts and meals as appropriate or very appropriate, and the less likely she was to say that samples improve patient care.

But just over half of the respondents surveyed said they were familiar with their institution’s guidelines–guidelines, we note, that received an “A” on the American Medical Student Association 2009 Scorecard. One question then is: How are the many institutions that have strengthened or developed new policies communicating them to their clinicians – or are they?

The authors suggest that despite such policy changes, the medical practice environment still fosters a “hidden curriculum” that approves of industry gifts, meals and relationships–a curriculum that has left physicians behind the public and regulatory movement toward trimming marketing’s influence on medicine.

Despite this sea change in public and governmental attitudes during the last several years, the physicians we surveyed retain generally positive attitudes toward many industry gifts, and more than two-thirds still find gifts and lunches from industry acceptable. In fact, our findings are remarkably similar to results of other studies of physician attitudes toward industry from as early as 2001….

The positive attitudes of physicians we surveyed are likely to reflect the continuing acceptability of industry interactions and gifts within the culture of medicine despite changing guidelines. Physicians in practice continue to speak frequently with industry representatives, and academic physicians enjoy food and other industry gifts when they attend continuing medical educational events and national specialty meetings. Although other groups have found that education about the effect of industry contact may have a modest effect on physician attitudes, physician attitudes are not likely to align with those of the public until the culture of medicine rejects industry marketing interactions more fully.

–Kate Petersen, PostScript blogger

A review by the Sunlight Foundation found that important safety and other clinical data on more than one-third of the top-prescribed drugs in the U.S. is  not readily available to prescribers, researchers and patients. The transparency watchdog group found that nine of the 25 top-prescribed drugs, including Lipitor, Effexor, and Plavix, lack this online information–meaning most prescribers have an incomplete picture of safety and efficacy on commonly-written scrips.

The data, required by the FDA for approval but often left unpublished in medical journals and other venues, is only online for drugs approved after 1998. Even then, Sunlight reports, the online info may be heavily redacted and is published in manually-created PDFs that “are not hyper-linked or text searchable, and therefore are hard to navigate.” Information on drugs approved before 1998 has to be obtained by the characteristically slow and cumbersome Freedom of Information Act request, a process most physicians don’t use to inform prescribing decisions.

The Foundation says its unclear whether such data will be included as part of the Obama administration’s Open Government Directive, a plan to have each government agency publish previously undisclosed data sets to the public, but drug safety advocates like Dr. Steven Nissen of the Cleveland Clinic say that such drug info should “absolutely” be included.

For more on the review, including a list of the top-prescribed drugs and which data remains inaccessible, read the story here.

–Kate Petersen, PostScript blogger

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.

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.