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“Best” practices

November 24th, 2008

On Friday, Sen. Charles Grassley (R-IA) wrote to a pharmaceutical consulting company asking it to clarify the service it offered clients on its (recently changed) website.

On that now-extinct webpage, Best Practices LLC described itself as “a network of distinguished clinical investigators and opinion leaders serving as a bridge between drug companies’ preclinical scientists, clinical scientists, and marketing specialists.”

One of Best Practices’ founding consultants is Dr. Frederick Goodwin, a psychiatrist and host of an NPR radio show, “The Infinite Mind,” under investigation by Sen. Grassley for not disclosing $1.3 million in drug company pay between 2000-2007 to the producers or listeners of his show, on which he discussed often the safety and efficacy of psychiatric drugs.

Under the heading Evaluating Regulatory Environment, the Best Practices website listed assistance in dissemination of new “off label” information.

In his letter to the Bethesda-based group, Sen. Grassley points out that marketing, or “information dissemination,” of drugs for indications not approved by the FDA – known as off-label – is illegal. Doctors can prescribe drugs off-label, but companies can’t peddle them that way, a margin that some marketing teams have mined for profit at their peril [see Neurontin]. But Best Practices did not seem to be particularly covert about its helpfulness around off-label marketing, unless you count scare quotes as covert.

Of course, those “scare quotes” around off-label may be important, and not fall into the growing collection of “unnecessary quotation marks” popping up on web pages, restaurant menus, and advertisements everywhere.  But not even proper quotes can change the meaning of a word.  And if “off-label” is anything like the off-label we know of, then an explanation from Best Practices is more than necessary.

U.S. First Circuit Court of Appeals upholds New Hampshire data-mining law

November 18th, 2008

Today the First Circuit Court of Appeals unanimously upheld New Hampshire’s Prescription Confidentiality Act, which prohibits the commercial use of prescriber data, including for pharmaceutical detailing.

The practice, commonly known as “data-mining,” is a key tactic used by prescription drug companies to tailor their marketing campaigns to individual doctors. The New Hampshire first-in-nation law was struck down by a district court in April 2007 on the grounds that the use of that data by health information companies, pharmacies, and drug companies constitutes commercial speech. The state appealed, and IMS Health v. Ayotte was heard by the First Circuit Court of Appeals in Boston in January of this year.

In its 148-page decision upholding the law, the Court said “the portions of the law at issue here regulate conduct, not speech” and even if they qualified as protected speech (the Court held they did not), New Hampshire’s restrictions on the use of prescription data would pass “constitutional muster” in regulating that speech.

“This is an important decision for data privacy advocates,” said Sean Fiil-Flynn, Counsel for the public interest amici in the case, and with whom the Prescription Project filed a friend of the court brief. “The ramifications of giving companies a First Amendment right to sell data on all of our purchases, travel and activities would be staggering.

“The First Circuit ruled on the side of consumer privacy, admonishing that the First Amendment does not protect every exchange of information from traditional social and economic regulation. It refused to apply the First Amendment to the trading of prescription records for marketing purposes where ‘information itself has become a commodity.’ The court explained that applying the First Amendment to such trade in prescription data ’stretches the fabric of the First Amendment beyond any rational measure.’”

Flynn is the Associate Director of the Program on Information Justice and Intellectual Property at the Washington College of Law, American University.

The Court wrote: “We believe that in moving to combat the novel problems presented by detailing in the information age, New Hampshire has adopted a form of conduct-focused economic regulation that does not come within the First Amendment’s scope.”

To read the decision for yourself, go here.

Rx Futures

November 18th, 2008

In the afterglow (or for some, aftermath) of the election, PostScript thought it was worth scanning the federal policy horizon for any Rx out there.

And it’s hard to say anything about prescription drug policy in the next Congress without first talking about health reform.

With an early break from the gate, Senate Finance Committee Chair Max Baucus (D-MT) released a white paper last week entitled “Call to Action: Health Reform 2009.” The paper was the first look at an issue that lawmakers and President-elect Obama have both named as a priority when Congress reconvenes. It included provisions for comparative effectiveness, coverage-guarantee for those with pre-existing conditions, and would allow people age 55-64 to buy into Medicare early.

While passing health care reform is going to take broad consensus, and others such as Sen. Edward Kennedy (D-MA) and President-elect Obama are working on comprehensive plans of their own, we were encouraged to see that the Baucus paper recommends public disclosure of the financial relationships between industry and the medical profession. The paper referenced the recommendations MedPAC approved last week (see our earlier post) as well as S.2029, the Physician Payments Sunshine Act, though it doesn’t recommend specific reporting thresholds as MedPAC and PPSA have.

And right after Who Will Be the Next Commish, a little game being played at all the right blogs and Beltway dinner parties this season, we see two major FDA questions facing the Congress in its next term:

Q: With drugs coming from everywhere on the planet, how do we make sure they are safe enough to go into American medicine cabinets?

(Probable) A: The FDA Globalization Act. Ever since the heparin-from-China scare of 2008, interest in having a better handle on where our drugs are coming from and a bill that would shore up oversight, require new country-of-origin labeling, provide more resources for inspections of foreign manufacturing plants, and grant the agency subpoena power many other federal agencies charged with protecting the public already have. Both a House and Senate version were introduced in 2008.

Q: What happens to biotech drugs after the patent runs out?

(Right now) A: Nothing, and that’s an expensive answer both for consumers and the future of the drug pipeline, as R&D turns more and more to biologic therapies. Currently, four draft bills on the creating a pathway for biogenerics (also called “follow on biologics”) are circulating. The version introduced by Rep. Henry Waxman (D-CA) is widely considered to be the most consumer-friendly.

Only 64 days till the 111th is sworn in, so stay tuned – we sure will.

RxP Weekly Reader

November 10th, 2008

MedPac approves disclosure recs

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

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

Medical school mashup

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

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

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

Hunting caps

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

Papers weigh in on pre-emption

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

Subcommittee refutes FDA safety finding

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

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

MedPAC to vote on pharmaceutical disclosure recommendations

November 5th, 2008

Tomorrow, the Medicare Payment Advisory Commission will vote on final recommendations to Congress for a public reporting system of physicians’ financial relations with drug and device manufacturers.

A draft version of the recommendations, laid out in a June 2008 report, outline a plan that would require pharmaceutical and medical device makers, as well as their subsidiaries, to disclose all payments totaling more than $100 annually to physicians and other prescribers, as well as those made to academic medical centers, professional medical associations, patient advocacy groups, and medical education communication companies (MECCS). The payments would be published on a public website maintained by the Dept. of Health and Human Services.

Many of the MedPAC draft recommendations are a stronger and more comprehensive than provisions in the Physician Payments Sunshine Act, a transparency bill proposed last year by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI).

The 17-member Medicare Payment Advisory Commission was created in 1997 to advise the U.S. Congress on issues affecting Medicare, including health care delivery, quality and access. Since Medicare does not have its own policy arm, the commission’s work is not only highly respected but has often served as a policy roadmap for recent Congresses around Medicare. We hope that these recommendations are approved Thursday, and that the 111th follows suit by passing the Sunshine Act.

RxP Weekly Reader: Jack-O-lection Edition

October 30th, 2008

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. 

RxP Weekly Reader: World Series edition

October 24th, 2008

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.

Heartburn

October 22nd, 2008

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.

RxP Weekly Reader

October 17th, 2008

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.

Reading between the headlines

October 14th, 2008

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 reporte 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.