CME, Zyprexa, leadership changes, and pharma on YouTube

September 12, 2008 – 2:13 pm

Thanks again to all those who dropped me an e-mail to express concern about my husband. I passed on the good wishes to Thom. I updated my previous post a bit, and am posting anew this week. There’s a renewed rumble of protest against pharma-sponsored CME and clinical research, spurred on by commentaries in last week’s JAMA and a proposal by ACCME that would prohibit writers paid for producing promotional material to also write CME; Lilly is facing new legal tribulations over Zyprexa as another state sues and a judge orders that more documents be unsealed; and a former U.S. executive for GlaxoSmithKline has become CEO of Sanofi-Aventis. Another researcher in the psychology community is singled out by Sen. Charles Grassley for improper reporting of pharmaceutical company payments, and there is more speculation about who may be buying ImClone as Bristol-Myers Squibb sends another letter to Carl Icahn in response to ImClone’s statement that the company has a mystery suitor. In addition, I take a look at blogger commentary on what pharma is doing with YouTube.

Trying to push out pharma influence

The commentary by Dr. Arnold Relman, Dr. Marcia Angell, and Dr. David J. Rothman and Dr. Susan Chimonas, not surprisingly, went strongly against the pharmaceutical industry’s participation in CME and the sponsorship of clinical trials.

Not surprisingly, Thomas Sullivan at Policy and Medicine was not happy about the commentaries. “Well, it is hard to imagine but this week Catherine DeAngelis, M.D., editor of JAMA and general industry basher went for a trifecta of commentaries on industry relationships with physicians,” Mr. Sullivan says. “With no surprises, all the commentaries say basically the same thing: That the academics know better than everyone else and that if we only gave these academics all the money, with no conditions, the world of medicine would be a much better place. … These series of commentaries are more about utopia than the real world. The commentaries are all written by the cauldron of anti industry activist under the guise of JAMA.” He describes the writers as “the anti-industry intelligentsia.”

Katharine Mangan at the Chronicle of Higher Education News Blog writes about the study done by Dr. Rothman and Dr. Chimonas about the impact of conflict-of-interest policies on academic medical centers. “Academic medical centers are finding it easier than expected to pull the plug on marketing practices that seek to sway doctors’ prescribing practices … Fears that faculty members would flee and industry-research financing would dry up if free lunches and gifts were banned have not been realized, the study found,” Ms. Mangan writes. (Meanwhile, the New York Times reports that Stanford University is another academic center severely restricting industry financing of CME at its school.)

Matthew Brown at Scientific Blogging sums up Dr. Relman’s points. “This may seem like just another commentary opining why industry support is a negative thing and why doctors must be especially vigilant in recognizing it as such, but two things make this commentary special: first, as a leader in the medical profession, Dr. Relman has a pretty loud voice, and second, Dr. Relman offers some ideas to actually mend the situation (though even Dr. Relman agrees that it won’t be an easy or quick fix),” Mr. Brown says.

Dr. Relman’s suggestions are: cut the expense of CME by not holding the events at resorts and not having the programs be administered by a profit-making third party; and have the full-time salaried clinical staff at schools and teaching hospitals teach the CME programs. “This would put CME on level terms with the training a doctor receives in medical school and during the residency program,” Mr. Brown says.

John Mack at the Pharma Marketing Blog asks once again, “Is it time to end pharma-sponsored CME?” He’s doing another survey of his readers on the topic.

Dr. Catherine DeAngelis of JAMA’s views on industry influence were circulated an AP story (hat tip to Jack Friday at PharmaGossip). “The influence that the pharmaceutical companies, the for-profits, are having on every aspect of medicine … is so blatant now you’d have to be deaf, blind and dumb not to see it,” she says. “We have just allowed them to take over, and it’s our fault, the whole medical community.”

Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma, sums up Dr. Angell’s sentiments about industry-funded clinical research. “Dr. Angell concludes that we can no longer allow what most national academic-medicine organizations and leaders persist in assuming to be the bottom line – that the drug industry will go on funding the clinical trials by which its own products are tested (and that the academic medical center can continue to rake in the resulting research grants plus whatever extras it can scarf up),” Dr. Brody writes.

Dr. Roy M. Poses at Healthcare Renewal also looks at the CME issue, analyzing the statements made by Dr. Anthony N. DeMaria, editor in chief of the Journal of the American College of Cardiology. Dr. DeMaria believes that industry-supported CME can do some good so long as there was full disclosure to physicians that would allow them to be properly skeptical of that support. “I disagree with Dr. DeMaria,” Dr. Poses says. “I do not think the current approach, based on full disclosure as an adequate way to manage the conflicts caused by industry funded CME, and to manage conflicts of individual continuing medical educators, is adequate.”

He points out that Dr. DeMaria did not disclose his own financial ties to the industry. “In my humble opinion, as I have said before, those who advocate particular health policy positions have the same obligation to disclose relevant conflicts of interest as do those who advocate particular approaches to clinical problems,” Dr. Poses says. “Policy positions ought to be skeptically evaluated taking into account whether those expressing them stand to gain personally from what they advocate. Failure to adequately disclose conflicts of interest ought to inspire even more skepticism.”

Meanwhile, the ACCME has proposed a policy that would keep physicians on speakers’ bureaus from teaching CME. Dr. Daniel Carlat at the Carlat Psychiatry Blog looks at the proposal, saying it “might actually do something significant in preventing bias in industry-sponsored CME … With this new policy, ACCME is saying to doctors: ‘If you want to be on speakers bureaus and advisory boards of drug companies, that’s fine. But you can’t double dip. You can’t then also get paid by the CME companies that are taking grants from those same companies.’”

Of course, the medical education companies and their supporters are not happy about the proposal. Dr. Barbara Martin at Pathophilia disagrees with Dr. Carlat, in saying that the ACCME proposal could be an infringement of First Amendment rights.

Mr. Sullivan, who is head of a medical education company (Rockpointe), calls attention to the response from the Council of Medical Specialty Societies. According to the group, “Persons paid to create or present promotional materials on behalf of commercial interests (who therefore disclose a coriflict ofinterest) need
not be excluded from accredited continuing medical education on the same subject if and only if their conflict of interest can be resolved.”

If you want to know more about the industry’s stance on CME, head down to Washington, D.C., Sept. 22, for the Center for Medicine in the Public Interest’s half-day conference. Peter Pitts, who blogs for CMPI at DrugWonks, posts the details here.

Update: John Kamp, the executive director of the Coalition for Healthcare Education, shared with me the coalition’s comments on the ACCME proposal. You can download the comments here.

More legal wranglings for Lilly

Federal Judge Jack B. Weinstein last Friday ordered that confidential documents about Zyprexa filed back in 2004 be unsealed. The documents had originally been filed by Lilly in relation to a lawsuit brought by patients against the company, and have been sealed since 2004, but the judge had issued the order as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions that want Lilly to repay them billions of dollars they spent on the drug.

Philip Dawdy at Furious Seasons reports the news. Mr. Dawdy is not sure that the documents being unsealed go beyond the Zyprexa documents he has had on his Website since lawyer Jim Gottstein obtained them and distributed them to various mental health advocates (Mr. Dawdy doesn’t say exactly how he himself got the documents). “Weinstein’s decision certainly shoots the hell out of Lilly’s earlier claims that the documents were cherry-picked by David Egilman, a plaintiff’s expert witness, from among millions of pages of documents in order to provide a distorted picture of Zyprexa’s safety and the company’s behavior,” Mr. Dawdy says.

After this was announced came the news from Ed Silverman at Pharmalot that Dr. David Egilman, the expert witness who had given the documents to Mr. Gottstein, who had then given them to Alex Berenson at the New York Times, settled with Lilly. Mr. Silverman got a statement from Dr. Egilman: “”I call on Lilly to release the documents,’ Egilman tells Pharmalot. ‘I’ve never heard of a company hiding documents that prove its drug is safer than others. All that is needed for the forces of evil to succeed is for enough good people to remain silent.’”

Mr. Silverman points out that Lilly may not want to do so while the company is being investigated by several states for improper marketing of Zyprexa. He reports that Idaho is the most recent state to sue Lilly, alleging that the drug was improperly marketed. Mr. Silverman provides more background on the state lawsuits here. Back in March, Lilly had settled with Alaska for $15 million.

Avery Johnson at the Wall Street Journal Health Blog points out although the settlement is over, the arguments drag on between Dr. Egilman and Lilly.

Mr. Johnson reports, “Alexander Reinert, a lawyer representing David Egilman, the expert who settled with Lilly, tells the Health Blog that the company mischaracterized his client’s signed statement. Egilman never admitted doing anything illegal and didn’t cherry-pick documents to send the Times. ‘Lilly has an interpretation we don’t believe is accurate,’ Reinert says. While Egilman admitted to violating a protective order, ‘that’s not saying he did something illegal,’ Reinert says.

“Au contraire, Marni Lemons, a Lilly spokeswoman fires back. ‘We strongly believe violating the terms of the agreement to be illegal,’ she says. And Lilly maintains Egilman released documents ’selectively.’”

William G. Childs at the TortsProf Blog writes about the settlement and posts the order here. In reponse to Mr. Reinert’s argument that Dr. Egilman did not do anything illegal, he says, “Violation of a federal case management order is not necessarily criminal, and in that (narrow) sense, I suppose it’s not the admission to ‘anything illegal,’ but he [Dr. Egilman] explicitly acknowledges violating a court order.

A new leader for Sanofi-Aventis

Ed Silverman at Pharmalot and Jacob Goldstein at the Wall Street Journal Health Blog both picked up at the same time the appointment of former GlaxoSmithKline U.S. pharmaceuticals head Chris Viehbacher as CEO of Sanofi-Aventis. But the best headline was from Jack Friday at PharmaGossip.

Chris Morrison at the InVivo Blog humorously suggests that Mr. Viehbacher’s appointment is perhaps the result of the Large Hadron Collider opening up a pharma parallel universe. He points out that the announcement was made about the time the first particles started zipping through. “To be fair, since the French company’s takeover of Aventis in 2004 Sanofi has lost a modicum of its Francocentrism,” Mr. Morrison says. “But the idea that an outsider, much less a non-Frenchman (and yes, we’re aware of his french cred, but still), would become CEO of the French giant seemed a bit far fetched . At least until they turned on the LHC.”

Jim Edwards is now blogging over at Bnet, and he had some interesting things to say about the appointment. He speculates that Mr. Viehbacher could de-Frenchify Sanofi-Aventis, something that is needed. “The company gets more than half of its revenues on its top drugs from the U.S. (as you can see on page 39 of Sanofi’s half-year report) and yet it sometimes behaves as if the American market were an afterthought,” Mr. Edwards points out. “The announcement of Viehbacher as the new CEO was written in Franglais (’Septembre … continue to provide his competences’?), and the company holds its investor calls at a time that is inconvenient for U.S. analysts.”

What could Mr. Viehbacher bring to Sanofi-Aventis? Mr. Edwards lists several things, linking to posts from Pharmalot and other articles. He says Mr. Viehbacher can play hardball, implying this through the hiring of Daniel Troy, “the Darth Vader of right-wing drug lawyers,” as GlaxoSmithKline’s general counsel earlier this year; he points out that it was Mr. Viehbacher “who wrote that letter to the governor of Massachussets threatening to pull GSK’s business from the state if the law there was changed to require transparency in drug marketing;” that is was Mr. Viehbacher who turned all of GlaxoSmithKline employees “into an army of pro-pharma dinner table lobbyists;” and that “no challenge is too hopeless” for him.

However, “Sanofites expecting a culture clash may be surprised,” Mr. Edwards says. “Viehbacher isn’t actually an American. In fact, he’s German-Canadian, speaks French, German and English, and only spent the last couple of years in the U.S. As such, he could be the perfect Sarkozy-style candidate to translate the U.S. ethic to a workforce that likes to take a vacation for the whole of August.”

Another target for Grassley

This time, Sen. Charles Grassley spoke out against Dr. Karen Wagner, a researcher at the University of Texas. Ed Silverman at Pharmalot has the details here. “Barry Burgdorf, the university’s vice chancellor for legal affairs tells us there doesn’t appear to be a major problem with the 15-branch university’s disclosure system,” Mr. Silverman says.

According to Mr. Silverman, Mr. Burgdorf says, “’Any disclosure system must rely on disclosure of the people you’re for disclosure…It doesn’t mean you don’t have good system in place…We have 18,000 faculty…If we have one doctor who fails to disclose something, that would say nothing about our ability to manage disclosure or conflicts…In my opinion, we have a very robust policy in place.’ He adds there is no action planned to review university policies.”

Scott Hensley at the Wall Street Journal Health Blog writes about Mr. Grassley calling out Dr. Wagner here.

Mr. Silverman followed up with another post, saying Mr. Grassley is targeting another University of Texas researcher, Dr. John Rush.

At her blog, Alison Bass, the author of Side Effects (the book that she claims got Mr. Grassley digging into the relationships between psychiatrists and pharma), asks whether the American Psychiatric Association can heal itself. She says the APA’s leadership doesn’t seem to to get it, judging by the response of the society’s leadership to the Senate Finance Committee’s queries. “This past Monday, Nada Stotland, current president of the APA, wrote a long memo to the association’s members explaining that the requested information was delivered to Sen. Grassley’s office on Sept. 2, along with a letter explaining the revenue information,” Ms. Bass says. “In her Sept. 8 memo, Stotland said the letter could be ‘accessed at APA’s website by logging into the Members Corner and clicking on Grassley response.’ In other words, only paying members can access the letter, not to the general public. The APA’s communications office has yet to respond to my request for a copy of the letter. Transparency this is not.” (Hat tip to Healthcare Renewal.)

The upshot of all this? The less transparent doctors are about their industry ties, the more infuriated the politicians and the journalists are going to get. I don’t think anyone is going to come out a real winner in this battle.

Who’s buying ImClone?

I love the facetious “Dear Carl” letter Scott Hensley composed at the Wall Street Journal Health Blog: “Dear Carl, What’s the problem? We agreed with you that ImClone is worth way more than other people thought. But $70 a share? C’mon! You dissed our $60-a-share cash offer without even talking with us. Your mystery buyer hasn’t even done due diligence, but we’re ready to go right now. Can we sit down and get this deal done? Sincerely, Jim PS: We’re not going to give an inch on our licensing deals for Erbitux and that snazzy medicine IMC-11F8. Bye bye!”

In the real letter, Mr. Hensley says, Mr. Cornelius is clear about the intent of Bristol-Myers Squibb to buy the rest of ImClone, but, “What isn’t clear is if Bristol will budge, even a little, on price. Cornelius restates the company’s standing offer but doesn’t do much to defend the $60 price, other than pointing out that the other guy hasn’t done due diligence yet. Sounds like there’s still room to move on the final value.”

Additionally, Mr. Hensley says, “Cornelius does include a threat of a kind. He puts Icahn and ImClone’s secret suitor on notice that Bristol won’t restructure the licensing deals for Erbitux and related drugs in development to loosen its hold on large share of the sales of the medicines.”

Ed Silverman at Pharmalot is amused. “The posturing and sniping that occurs during a hostile bid is so interesting, is it not?” he says. Apparently, Mr. Icahn responded to Mr. Cornelius’ letter. “I received today’s letter from Bristol and don’t understand your point,” Mr. Icahn says. “Obviously, should you wish to make another offer which you believe we would not find inadequate, you are free to do so. Upon receipt of that offer, we will respond appropriately.” Ouch.

Pharma on YouTube, some better than others

It’s inevitable that pharmaceutical companies adopt YouTube or other video channels as part of their education and marketing strategies, but few are involved. Some have done it better than others. Mark Senak at Eye on FDA has been writing a lot on this topic; as a communications professional, he has a lot of advice for pharma companies.

This week, he particularly likes the videos Johnson & Johnson has posted about ADHD, and he praises the company’s efforts. “As frequently mentioned, Johnson & Johnson’s YouTube presence seems more defined and certainly more active than either Abbott or GSK,” he says. “They now have a total of 37 vids … Why more pharmas are not here is baffling.”

Last week, Mr. Senak reminded us why Johnson & Johnson is doing a better job on the Web than Abbott or GlaxoSmithKline in using the Web. He talked about Johnson & Johnson’s launch on Facebook of Acuminder, an application on Facebook that reminds contact lens wearers to help them with compliance. Mr. Senak says, “by engaging the digital community so completely, J&J is poised to communicate more effectively and efficiently with consumers during any possible crisis as they move into a more interactive level of communication than they could with a plain old Website. Plus, the move engenders the trust of consumers and brings the brand closer to them.”

John Mack at the Pharma Marketing Blog looks at the efforts of PhRMA on YouTube through “The Adventures of PhRMA Intern,” his semi-regular comic strip.

“Yes, PhRMA is now on YouTube!” Mr. Mack reports. “Actually, it has launched an integrated media campaign called ‘Sharing Miracles,’ which includes a Website (set up to resemble a blog, although it does not accept comments from readers), a Sunday-morning cable TV show, and a YouTube channel - all featuring celebrity spokespeople like Montel Williams (also PhRMA’s Partnership for Prescription Assistance program spokesperson) and Greg Louganis (Olympic diving champion of long ago). These and other ‘low-budget’ celebrities are augmented by two lesser, even lower-budget, celebrities: PhRMA president & CEO, Billy Tauzin - who, representing the ‘thousands of hard-working men and women who develop new medicines to treat chronic diseases,’ provides on-screen introductions and PhRMA Vice President and PR spokesperson, Ken Johnson – who provide the voiceovers!”

And he seems even less impressed with the interactivity. “I submitted the comment, ‘A good series of videos. At last PhRMA engages in Web 2.0 activities!’” Mr. Mack says. “But I don’t see it published - yet. This may be another case where the pharmaceutical industry dips into Web 2.0, but doesn’t really engage in two-way conversation with the public.”

The Prescription Access Litigation Blog takes a look at FDA’s efforts on YouTube, but says the agency’s efforts fall a little flat. “The FDA might be better off not simply reciting label text in these videos, but rather summarizing the warnings/label changes/what-have-you in a more consumer-friendly fashion,” the blog says. “If the purpose behind posting these videos on YouTube is to reach consumers, then the the FDA is failing miserably on that front, as the language used in impenetrable and inaccessible. It’s safe to assume that consumers watching these videos have no idea after they’ve watched them whether it was good news, bad news or no news about the drug in question.”

Around and about …

Peter Pitts at DrugWonks talks here and here about FDA’s first report listing drugs with safety signals under the Adverse Effect Reporting System. In the first post, he says, “One way to help modulate the unintended consequences (aka, ‘general hysteria’) these things tend to generate is to make sure drug companies have some advance warning of these postings so they can be prepared to communicate their perspectives to patients, physicians, and payers,” Mr. Pitts says. Finding out from FDA that the agency only notified companies whose drugs appeared on the report less than 24 hours before the report was posted, he asks, “Why not sooner?”

Mr. Silverman writes about the AERS list here. The drugs listed include Cymbalta, Tykerb, Heparin, Revlimid, Tysabri, OxyContin, Dilantin and Seroquel. “How pharma and its investors react to this will be interesting,” he says. “For months, execs have complained the FDA’s focus on safety, which they maintain has resulted in more delays in approvals and outright rejections. By highlighting drugs already on the market, but not previously identified as problematic, is likely to cause still more consternation. Not every drug on the first list, for instance, has previously been the subject of a public health advisory or some other FDA communication.”

Philip Dawdy at Furious Seasons comments on the list, particularly on Cymbalta and Seroquel’s possible adverse effects. “Urinary retention sounds like a perfectly awful side effect of an anti-depressant,” he says. “But then so do overdoses of Seroquel.”

John Mack at the Pharma Marketing Blog takes a look at the recent study about the distribution of samples to patients. Apparently, physicians were much more likely to prescribe generics to patients when brand-name samples were not available. “This reminded me of a passage from Matthew 13:12 - ‘For whosoever hath, to him shall be given, and he shall have more abundance: but whosoever hath not, from him shall be taken away even that he hath,’” Mr. Mack says. “This ‘parable of the sower’ is appropriate given the role of free samples to ’sow’ the seeds for new scripts.”

Dr. Daniel Carlat at the Carlat Psychiatry Blog also took a look at the study. “The data are clear,” he concludes. “Free samples are simply another marketing tool for drug companies. I guess it’s time for me to empty out my sample closet!”

I found this post by Dr. Roy Poses at Healthcare Renewal, about the transportation options of pharma company CEOs, very interesting. He had picked up the story, via Ed Silverman at Pharmalot, of how Bristol-Myers Squibb is selling its Gulfstream jets and Sikorsky helicopters (Mr. Silverman in turn had picked up the story from my old alma mater, the Times of Trenton). Dr. Poses argues that by shuttling around their top execs in luxury, companies such as Bristol-Myers Squibb, Merck, and Pfizer are buffering them from real life. “Remember that what used to be called ‘ethical pharmaceuticals’ are meant to relieve symptoms, mitigate disability, and even sometimes cure the diseases of individual patients,” Dr. Poses says. “Understanding how well they do so requires some understanding of the lives of the ordinary people who take them. Yet the leaders of pharmaceutical companies have now been increasingly protected from experiencing the vicissitudes of life that their patients or clients, or employees for that matter, experience. … Hence, I suggest that to improve the leadership of health care organizations, we must make sure that they have a better understanding of the real life in which their products and services are used.”

Dr. Poses also commented on the StandUp2Cancer telethon, picking up on Gary Schwitzer’s post at the Schwitzer Health News Blog. Dr. Poses notes that the listing of the membership of the group’s 19-member scientific advisory committee includes four people who work full time for pharmaceutical or biotech companies, and says all together, 13 of the 19 members, including the board chair and vice-chair, had multiple and significant financial ties to pharmaceutical and device companies. “A major new effort to raise money to do research on the extremely important topic of cancer, supposedly devoted to transparency, should at least make clear what financial ties the people in charge of the effort have to companies that have commercial interests in selling cancer tests and treatments, and stand to benefit from particular research directions,” he says. “This is even more important when appeals for funding are widely broadcast to an audience which may not be very sophisticated about biomedical and clinical research, and not in an easy position to determine who may be benefited from research that goes in particular directions.”

Scott Hensley at the Wall Street Journal Health Blog shares the rumors that Pfizer is thinking about bidding on Bayer, picking up a story from the Dow Jones newswires.

But don’t believe the rumors, says Dr. Derek Lowe at In the Pipeline. “That sounds ridiculous to me, and if Pfizer actually does such a thing, then its management is even more starved for ideas than its nastiest critics could believe,” he says. He argues that Bayer is a bad fit for Pfizer. Additonally, he says, “I’d argue that Pfizer is in the shape it’s in because they’ve pursued the big, big, acquisition strategy. Their own labs have been unproductive, and they unfortunately seem to spray down the research organizations they purchase with whatever’s in the air supply at the home base. OK, that’s probably unfair – but no one can deny that as a whole, Pfizer’s internal drug discovery efforts have been remarkably frustrating for many years now.”

Dr. Lowe also looks at the complicated causes of cancer. Apparently researchers are finding that many cancer lines have wide varieties of mutations. “The first impulse might be to think ‘Great! Plenty of drug targets to go around!’” he says. “But hold on. For one thing, even though these mutations are surely not all equal, the fact that there are so many makes you wonder about whether attacking any one of them alone can make much of a difference. And different patients can have varying suites of those mutations, so it’s difficult to imagine that going after just one or two of those targets will be enough to treat a majority of cases. This work follows up on earlier studies in other tumor lines, all of which seem to point in the same direction: patients who are currently classed as having the same type of cancer really don’t.” Dr. Lowe also takes the opportunity to pick apart a Wired article about developing SiRNA therapies for cancer. I have to agree with him that the Wired article was pretty shallow.

The anonymous blogger at Clinica Psychology and Psychiatry: A Closer Look examines a recent study of atypical antipsychotics use among Medicare patients in Oregon, and doesn’t like the results. “Here’s the deal,” this bloggers says. “The authors suspect that a lot of these low-dose prescriptions are being written to manage agitation and as sleep aids. The authors note that there are likely less expensive/more effective medications for such conditions. Not to sound too cavalier, but one could also recommend behavioral treatment to help with sleep as well. Nah, that’s crazy talk – not enough money to be made in that.”

Bob Ehrlich at DTC-In-Perspective is puzzled by the study that apparently concludes DTC is not worth it. “I decided to comment on this questionable study because much of the trade and business media picked it up and ran it as a big story,” he says. “Some senior drug company managers may see ‘Harvard’ and DTC ‘not effective’ and question their DTC groups as to why they are still doing DTC. The answer, Mr. Executive is that there are many good U.S. studies that show it works well, including other Harvard studies done in the good old U.S.A. Somehow, I think these Harvard professors who used Canada as their laboratory are naive and misguided. This study is low in value in my opinion. S. has studies that put ROI on average at about 2 to 1. They use rigorous research They have produced nothing here that adds to the body of good ROI research. … Beware, my DTC colleagues, of research that is flashy but faulty. By all means read this flawed study and add it to your assessment of DTC ROI. I am sure the study authors can explain it better than I can.”

When the debate about evidence-based medicine comes up during the election, DrugWonks may want to use this oldie but goodie from the British Medical Journal. The study abstract, titled, “Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials,” concludes, “As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.”