FDA Warns Researcher For Promoting A Drug
28 CommentsBy Ed Silverman // January 27th, 2010 // 8:44 am
Clinical trial investigators better be careful about discussing a drug with the media now that the FDA has chastised a researcher for touting an anti-wrinkling compound. The agency’s Division of Drug Marketing, Advertising, and Communications sent a warning letter to Leslie Baumann for violating regs over comments she made about Ipsen Biopharm’s Dysport to two magazines and NBC’s Today show.
Baumann conducted Phase III trials of the med, which was also known as Reloxin, for treating frown lines between the eyebrows. And she excitedly told Allure in an April 2007 article that the drug “will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market - the Botox people (Allergan) raised their price another 8 percent this year!”
In its Jan. 11 letter, the FDA said its regs on pre-approval promotion apply to investigators as well as sponsors. Baumann, a former professor of dermatology at the University of Miami, became an investigator in the Dysport trial in July 2006 and made the comments to the media while she was involved in the research, although Arnie Friede, a former associate chief counsel for the FDA, tells The Pink Sheet the agency erred. He says that if Baumann was sincere in saying she was acting on her own and not on behalf of the drugmaker, the FDA shouldn’t have issued the warning.
What do you think?
Should the FDA Have Issued a Warning to the Investigator?
- Yes (64%, 171 Votes)
- No (36%, 96 Votes)
Total Voters: 266
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Condor
While not the worst sort of misconduct we’ve seen — from putatively “independent” investigators, the idea that someone could conduct truly objective research on a drug, whilst actively promoting it, and on national TV, to boot — seems. . . well, beyond the pale.
Great stuff, Ed!
Namaste
patrons99
Yes, Condor. This one is definitely exceptional, beyond the pale, and one of the strongest indictments that can be leveled against DTCA. All DTCA should be banned, not just that in which a physician pharma-shill is involved, and not just that in which Phase III study data is referenced.
To Ed: I can’t properly vote on this one, because you really need a 3rd choice: No, a warning, plus a strong deterrent (e.g. a fine) should have been issued. Bottom line: new legislation is needed which bans all DTCA. No exceptions.
Justice in MI
Well, short of banning DTC, I guess I’m less certain on this one. I think context is everything–there is a difference between hype and genuine discussion of ongoing work (hard as it may sometimes be to find it!). That said, “excitedly told Allure” does not sound like sober, medical reflection…
In any event, if FDA is “upset,” imagine how they feel at Allergan….
pharmavet
The comment to Allure, which had the appropriate qualifiers was nothing worse than the pre-approval hype I hear at every Phase III presentation I hear at scientific meetings. Since she has no control over pricing, that particular comment was pure speculation.
Lisa Van Syckel
DTC will never be banned, It is protected under the Constitution’s 1st ammendment, says Pharma.
pharmavet
Lisa is right. The Washington Legal Foundation successfully argued this in Supreme Court a number of years ago. The next-to-last paragraph in the link below cites the decision.
http://www.heartland.org/custom/semod_policybot/pdf/23316.pdf
Lisa Van Syckel
Pharmavet,… You mean The good ole boys from “K” Street.. lol
Condor
Hold on a sec, here, partners –
(1) pharmavet: “. . .the pre-approval hype I hear at every Phase III presentation I hear at scientific meetings. . .” — she was SUPPOSED to be INVESTIGATING the drug, NOT promoting it. Perhpas more significantly, NBC’s “Today Show” doesn’t usually televise scientific meetings, or the poster sessions — this was an unapproved ADVERTISEMENT for a not-yet-approved drug. Q.E.D.
FDA plainly has the right to require impartiality in clinical trials. Next. . . .
(2) pharmavet (channeling Lisa): “first amendment. . .” — only half right.
[Paul Harvey's] the “rest of the story” is that clearly the FCC, FTC and FDA possess the power to regulate “time, place and manner” of commercial speech, in all industries — like this, but especially in pharma (an inherently dangerous good).
Note that TV no longer carries cigarette ads; note also that the court’s ruling in Western States is a very-limited precedent — is simply prevents outright-banning of commercial speech.
Consumer difficulty in evaluating prescription drug health claims suggests that the supposed free market benefits are less significant in the context of FDA prescription drug promotion restrictions, than elsewhere. See, David C. Vladeck, Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements, J. PUB. POL’Y & MKT., June 30, 2000 at 132 (“Indeed, no one realistically expects consumers to wade through volumes of preliminary and often conflicting and inconclusive scientific literature involving clinical trials, laboratory animal experiments, and epidemiological studies to assess whether a particular health claim is well founded. That task often confounds experts. Even the most well-informed, health-conscious consumer could easily fall prey to preliminary scientific findings disseminated as part of a sales pitch. . . .”).
The FDA plainly has the constitutional right to effectively regulate DTC in pharma (an inherently dangerous good) — and could all but regulate it out of existence.
And so, I’d be careful about throwing your weight around here, pharma — the Congress may yet act, to end the worst of the abuses.
And it would very likely be upheld, in the Supreme Court. The Executive Branch “police power” would trump the right to provide “misleading” information about an inherently dangerous good.
Namaste
pharmavet
FDA requires, and educational psychologists have confirmed that drug ads must be worded in such a way that anyone with a Grade 12 education should be able to understand them. If we want to dumb them down further, that’s ok with me. But to say that consumers have difficulty in evaluating prescription drug health claims assumes that most people can’t read and understand at a 12th grade level. I think we can agree that doctors can handle 12th grade material, hence the disclaimer at the end of the DTC that says “see your doctor”.
Lisa Van Syckel
Condor, I have walked the halls of Congress, and I can assure you, that, Pharma DTC ads are alive and well, and will remain that way. Even Rep Frank Pallone stepped back on his opposition of DTC ads, and one would consider that being huge because he is the Chairman, of the Energy and Commerce’s, Subcommitte on Health.
pharmavet
Being from NJ (”the nation’s medicine chest”), it’s fair to say that no matter their political stripe, NJ politicians are loaded with conflicts of interest with respect to pharma.
RockDoc
If this physician was speaking on behalf of herself based on her direct knowledge of the investigational drug from her participation as a researcher in clinical trials, she should have every right to express her opinion. Isn’t this what we (the medical community and public) want–qualified academic and clinical researchers to share their expertise with us about medicines and treatments? I agree with Arnie Friede here. I believe the FDA has overjealously overstepped its legal and regulatory authority. I hope Dr. Baumann successfully appeals this warning, requests and receives a public apology from the FDA.
M. Black
Yes, but did it need to hit THREE major media sources including national TV before anyone said anything? Is the company THAT flirtacious with the regs and / or are regulators THAT seemingly asleep on the job?
Me
To me the important point in the article is that she talked to the media while she was still particpating as an investigator in the study. I have a problem with that. if the study was already completed and the data presented than it is a different story.
Justice in MI
Lots of interesting points here.
Re: DTC, there was serious consideration in Congress of a ban on DTC during the first three or so years a drug was out, and especially if there were required phase IV trials. One proposal was trading that for extending exclusivity. As I recall, Bill Frist supported this at one point, and it was part of one version of the FDAAA.
Of course, it didn’t make the final cut…..
As far as the WLF case, regulating is not the same thing as banning–and, of course, we already have regulation of various kinds that can be amended.
Condor
Hello Lisa — I must have been less than clear.
I simply wrote that pharma runs the risk of additional legislation, here — consider Stupak and Dingell’s letter, that echos House Chairman Waxman’s remarks (and Senator Grassley’s — here.).
So — as I say — the integrity of clinical research is likely a paramount value over huckster-ish promotion of unapproved drugs.
As to pharmavet — with all due respect, the issue is not whether the ADVERTISMENT is “understandable” by a 12th grader, but whether the “independent” PI — on a study should of a drug should effectively be appearing in one — BEFORE the drug is FDA approved.
As to RockDoc — “time, place and manner(s)” — that is the issue.
Namaste
Condor
Sorry — the italics code was unclosed
That should fix it.
Namaste
Condor
Finally — JiM’s reminds me:
PhRMA members Merck and Pfizer have agreed (among others) — in consent decrees, with the DoJ — NOT to conduct DTC in the first two years of a drug’s first approval.
Namaste
Justice in MI
I missed that, Condor–interesting. Do you (or others) know if this has become general practice? And was this was in agreement with the DOJ as part of particular cases (as opposed to now being PhRMA policy more generally)?
online pharmacy
I found your site on Google and read a few of your other entires. Nice Stuff.I’m looking forward to reading more from you.
Condor
Hey JiM —
In general, as a bargaining chip in DoJ settlements, this is becoming “part of the process” — Merck also “inherited” its DTC restricitons from its-oh-so-lucky merger partner, Schering-Plough, via the 2007 extension (through 2012) of an existing Corporate Integrity Agreement, originally struck with the US Attorneys office in Boston (by Schering-Plough), if memory serves.
So, I would bet (but have done no research on the point) that Lilly, Amgen and J&J, are also among those whose DoJ agreements include such a two-year DTC ban.
I think one of Sen. Grassley’s propsed bills (from 2008) would effectively codify the two year ban — for all pharma players. I hope this is useful information.
Namaste
Pharmacy Schools
What does a ‘warning’ mean? Are any fines involved or is it just a slap on the wrist?
JaT
I missed something. Is the 2 year DTC ban so that there is a reasonable opportunity to review post marketing data?
Condor
Hey JaT — I think the policy argument for a two year ban on DTC, after first FDA approval — is that demand for the new drug should be driven by actual physicians’ informed uptake, NOT marketing departments, to potential-patients-created hype (from cute Bumble-Bee TV ads, or strong, virile but graying men, rowing in tights on placid lakes!). . .
In the consent cases with DoJ, there is also the whiff that some of accused company’s DTC lacked balance, or didn’t fully comply with FDA regulations — so they sit in a two year penalty box, on new drugs.
For what it’s worth — but it is not uniform, across big pharma — by any stretch, at least not yet. [See next comment for PhRMA Guidelines -- and signing companies.]
Namaste
Condor
JiM and JaT — I forgot to set out the current PhRMA guidelines on DTC, for NEW drugs:
“. . . .6. In order to foster responsible communication between patients and health care
professionals, companies should spend an appropriate amount of time to educate
health professionals about a new medicine or a new therapeutic indication and to
alert them to the upcoming advertising campaign before commencing the first DTC
advertising campaign. In determining what constitutes an appropriate time,
companies should take into account the relative importance of informing patients
of the availability of a new medicine, the complexity of the risk-benefit profile of
that new medicine and health care professionals’ knowledge of the condition being
treated. Companies are encouraged to consider individually setting specific periods
of time, with or without exceptions, to educate health care professionals before
launching a branded DTC television or print advertising campaign. Companies
should continue to educate health care professionals as additional valid information
about a new medicine is obtained from all reliable sources. . . .
Q: How long must a company wait under Principle 6 before advertising a new
medicine after the medicine is approved by FDA?
A: Principle 6 demonstrates the companies’ commitment to devote sufficient
resources and time to health care professional education before launching a
direct to consumer advertising campaign. Principle 6 ensures that health care
professionals will have a reasonable opportunity to learn about new medications
before their patients ask questions about them so they will have accurate,
up-to-date information to use in responding to patients’ inquiries and guiding
patients to the most appropriate treatment option. Establishing a single
uniform waiting period for all companies and all medicines could have the
unintended consequence of denying patients important information about
new medicines, even after health care professionals have been well educated.
In setting the appropriate periods of time, companies may consider adjusting
the periods to take into account such factors as the level of health care
professional awareness of the new medicine or indication.. . .”
These companies have signed this amorphous code:
Abbott
Amgen Inc.
Amylin Pharmaceuticals, Inc.
Astellas US LLC
AstraZeneca LP
Bayer HealthCare Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals, Inc.
Bristol-Myers Squibb Company
Celgene Corporation
Daiichi Sankyo, Inc.
Eisai Inc.
EMD Serono
Endo Pharmaceuticals, Inc.
Genzyme Corporation
GlaxoSmithKlineHoffman-La Roche Inc.
Johnson & Johnson (Pharmaceutical Companies)
Eli Lilly and Company
Merck & Co., Inc.
Millennium Pharmaceuticals, Inc.
Novartis Pharmaceuticals Corporation
Novo Nordisk, Inc.
Pfizer Inc
sanofi-aventis U.S.
Schering-Plough Corporation
Solvay Pharmaceuticals, Inc.
Takeda Pharmaceuticals North America, Inc.
Wyeth
Namaste
Justice in MI
Thanks, Condor, very useful.
JaT
Ditto
Thanks so much.
elmore
Here’s the thing. It takes a publicist-and maybe an agent–and usually a lot of work to get yourself booked on those venues. It didn’t just “happen”–and it wasn’t a coincidence that the appearances coincided with the “great news.” If this didn’t have the full–or at least tacit– approval of Ipsen Biopharm, I’d be really surprised. And that most assuredly deserves an FDA response.