The Wall Street Journal reported yesterday that the FDA approved Ketek, an antibiotic used for the treatment of respiratory infections, despite initially rejecting the study -- called study 3014 -- Aventis (now Sanofi-Aventis AG, based in Paris) submitted for the initial review. Instead, the FDA relied on adverse reaction data from European (French?) sources. See "Fraud, Errors Taint Key Study Of Widely Used Sanofi Drug. Despite Some Faked Results, FDA Approves Antibiotic; One Doctor's Cocaine Use"; WSJ, Monday, May 1, 2006; subscription required).
Now, the usual US Congressional suspects -- including Grassley and Waxman -- are asking questions about the agency's handling of Ketek ("Lawmakers Ask FDA About Sanofi-Aventis Drug"; WSJ, Tuesday, May 2, 2006; subscription required).
It should be noted that at least a few deaths due to Ketek have been reported in the literature. As reported in a Health Canada warning to consumers: "An article in the Annals of Internal Medicine recently reported three cases of liver failure associated with Ketek. All three patients had jaundice (yellowing of the skin) and abnormal liver function. One patient recovered, one required a transplant, and one died." (See Antibiotic Ketek and possible association with liver failure.)
All this comes to light just days after the Government Accounting Office (GAO) released a report suggesting the FDA cannot adequately monitor drug safety after launch and protect US citizens from harm (see "Spinning Bad News about FDA & Drug Safety").
It's ironic that the FDA and PhRMA -- the pharmaceutical industry's lobbying group -- continually harp on the dangers of importing cheaper drugs from foreign sources (see "Terror Politics vs Drug Importation") while the FDA seemingly relies on foreign data to approve drugs.
Why this special treatment for Ketek? Could it have something to do with the Anti-bioterrorism initiative?
Under that initiative, the US is stockpiling anti-infectives to protect US citizens in the event of a biological terrorist attack, which most likely would involve infecting the respiratory tract.
Could it be that the FDA fast tracked Ketek approval and ignored trial 3014, relying instead on data from non-US sources, in order to get a new anti-biotic into the strategic stockpile? If so, it sounds as fishy as handing over port security to a foreign corporation. In the case of Ketek, the FDA handed over drug safety to a foreign country (it may be France and not an Arab country, but in the eyes of the current Washington administration, this difference is slight).
I find it interesting that the book, "The Karasik Conspiracy," which PhRMA once tried to commission to scare Americans about the threat of terrorism to our drug supply (see "PhRMA's Terrorist Plot"), is about a plot to taint a drug to treat bacterial infections! "Ketek", "Karasik": get it?
BTW, when the "The Karasik Conspiracy" story blew up, PhRMA withdrew its support and the authors and publisher went ahead anyway, but changed the story to ream the drug industry a new one. In the published version of the book, a big US pharmaceutical company (PharmCorp, a fictitious name) is a major villain and unwittingly supplies the cash used by the terrorists. The company's goal is to scare US citizens about buying drugs online: "What America needs," says a PharmCorp VP, "is a good honest-to-god attack by terrorists using these damn Internet sites."
In real life it turns out you don't need a terrorist group to attack Americans with dangerous drugs. You just need a federal regulatory agency to approve a drug without enough credible drug safety data.
The results are in! Lunesta wins both the DTC National Gold Award as well as Prescription Access Litigation (PAL) Project's "While You were Sleeping" Bitter Pill Award! (For more on these awards, see "DTC National Advertising Awards Winners" and "The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone who's ever had a Bad Night's Sleep").
Guess which one Lunesta marketing director Jay Popli and McCann-Erickson (the Lunesta ad agency) general manager Andrew Schirmer will hang on their walls?
I wasn't at the DTC National Award Dinner -- me getting a press pass for that event is about as easy as a camel passing through the eye of a needle -- but I was invited to PAL's online Bitter Pill awards press conference.
These two organizations square off against each other viz-a-viz competing drug ad awards every year.
PAL claims to represent consumers in class action lawsuits against pharmaceutical companies and targets deceptive marketing. It is against any DTC advertising -- including 60-second TV ads -- that do not include the full product labeling (see "FDA DTC Hearings Day 2").
DTC Prespectives Magazine, which hosts the DTC National Awards, is an industry publication whose very existence obviously completely depends on DTC advertising.
These two organizations could not be further apart on the DTC advocacy spectrum. Both agree, however, that Lunesta deserves an award -- isn't that nice?
According to PAL, Lunesta had more than $321 million in sales in 2005 and Sepracor spent more than $215 million advertising it that year, making it #2 in direct to consumer advertising for all prescription drugs (PAL cites credible sources for these data).
I guess you could call that a positive return on investment: for every dollar spent on advertising, Lunesta made $1.49. It's a bit less, however, than the $1.68, estimated for DTC in general (see "eDetailing ROI Better than DTC?"). Keep in mind that it's only the first year the product is on the market and the competition for market share is fierce. "Its sales in 2006," notes PAL, "are expected to increase significantly as the aggressive marketing begins to really pay off."
PAL levels several criticisms of the Lunesta ad campaign including the allegation that Sepracor is violating the PhRMA DTC Guiding Principles by running reminder ads. I have also pointed this out recently (see "Sepracor Sneaks In Lunesta Reminder Ad"). Either PAL is confirming my observation or else they are just picking up what I posted without attribution to me. I didn't bother to ask them what evidence they had to back up their claim.
What Chutzpah!
Given that some Lunesta ads are in violation of at least one of PhRMA's DTC guidelines, I find it strange that attendees of the DTC National conference would have the chutzpah to give Lunesta marketers a Gold Award at a conference in which "Critical Issue #1" was "What is the future of DTC marketing? Are you ready for the new rules -- from FDA -- from Congress? The PhRMA guiding principles?" Not only that, but representatives from the FDA, PhRMA, and Public Citizen -- Ralph Nader was an invited speaker/panel member -- were also in attendance!
Tell me, Ralph, did you find any irony in this?
Nicholas Genes, a physician who publishes Blogborygmi, a blog he characterizes as a "digest of developments in the life of an emergency medicine resident" posted an April Fool's joke on his blog, which depicted an all-too believable scenario of GSK influence over physician bloggers:
"Over the past few weeks I've been negotiating with a team at GlaxoSmithKline. They want to 'get into this blog business,' and we're looking for ways expand the readership of mdical [sic] blogs. I saw an opportunity." [See "Grand Rounds, brought to you by GlaxoSmithKline."]
I must admit I fell for it!
I believed the premise that GSK was interested in blogging because a GSK executive responsible for grassroots campaigns expressed an interest in blogs. However, I didn't envision that the best way for GSK or any pharma company to get involved with blogs was by promoting physician bloggers and influencing what they say. I suggested instead that GSK start its own corporate blog to improve the company's public image (see, for example, "Sales Reps Make Poor Spokespeople" and "GSK Strikes Back with a Grassroots Campaign").
Still, pharma companies are being pushed to get into blogging not for PR purposes but to achieve marketing goals (see "Buzz 'n Blogs -- Stealth Marketing"). Dr. Genes' farce is a strategy that could easily be adopted by a pharmaceutical company.
Genes farce depicted GSK as a sponsor of "Grand Rounds," a weekly compendium of the "best in medical blogging" hosted by different physicians on their blogs. According to Genes' farcical description of how this might work is as follows:
"[Grand Rounds] has exemplified two principles: 1) there's no better way to learn about healthcare than from those in the field and 2) self-promotion is a powerful motivator.
"Glaxo recognizes this, and they want to capitalize. It's the high quality of written submissions, the creative hosting efforts, and brazen opportunism that have make Grand Rounds great -- and led us to this unique new collaboration.
"So, starting this week [April 1, 2006] , the GlaxoSmithKline homepage will run a link to Grand Rounds every Tuesday morning! Also, Glaxo drug reps will start handing out cards with the URL of the Grand Rounds archive to doctors and students they identify as "computer-oriented" or "loners."
"Now, in return for this torrent of traffic, Glaxo has asked for something in return. They would like each host to run a link to GSK.com and, as appropriate, to individual product sites. The hosts can choose to whether to place this link in the body of the Grand Rounds post, or high up in their blog's sidebar. Hosts can also choose the color of the text.
"This ties in closely with something else: Glaxo will be encouraging more "theme" editions. Now, some of the best Grand Rounds have featured themes. These new themes will revolve around some of the drugs Glaxo makes.
"For instance, the upcoming April Fourth edition will be hosted by a urologist, and so will naturally feature submissions on erectile dysfunction. Specifically, posts about Levitra will be prominently displayed up at the top of Grand Rounds. "
I re-iterate that this is a fantasy -- as of now. I haven't seen any links on GSK's home page and I haven't seen Levitra ads in the urology Grand Rounds posting. But I have seen some blog "theme" articles published by Grand Rounds participants.
On April 21, for example, the (non-farcical) post "An interesting DTC approach" was made to Health Business Blog (a Grand Rounds participant) by David Williams who happens to be a "co-founder of MedPharma Partners LLC, strategy consultant to pharma, biotech, device, and technology enabled healthcare services industries."
The approach that Williams found "interesting" was a GSK marketing program for the new Fruit Chill flavor of its OTC Nicorette gum.
The "interesting approach" is based on the use of coupons and a chance to win prizes as a ploy to get consumers to buy Nicorette. While Nicorette is not an Rx product, the use of coupons in Rx marketing has drawn some attention lately by the FDA (see, for example, "FDA, Coupons, and Sleep Aid DTC Ads"). FDA intended to look at whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. A few days later, however, the FDA mysteriously "yanked" its notice in the Federal Register (see "FDA Backs Down on Coupon Study").
Genes ends his farce thusly:
"While I suspect this may ruffle some feathers, I want to stress that bloggers can write whatever they want about Levitra -- Grand Rounds is still very much an open forum (though representatives from Glaxo have asked to evaluate each submission before its inclusion in Grand Rounds; the hosts will comply). If you're worried about participating in some kind of viral marketing campaign, remember: Glaxo makes antivirals."
I should have been tipped off by the humorous bit at the end. However, Genes does provide a link to the Relenza product Web site. Relenza is GSK's product for the treatment of influenza. I didn't think that was a joke. It is thoroughly conceivable that pharma marketers could negotiate product placement ads on physician blogs. I notice Viagra ads placed in plenty of movies and HBO programs.
The main lesson I learned from all this is -- don't believe everything you read! I should have noted the date of Dr. Genes' post and put two and two together. But I was primed to believe the story. For that, I apologize to GSK, the Grand Rounds physician bloggers, and to the readers of this blog.
Peter Pitts, former spinmeister -- er... I mean Associate Commissioner for External Relations -- for the FDA and currently spinning for the pharmaceutical industry at Manning, Selvage & Lee, is also a "pundit" at DrugWonks, which cranks out tons of pro-pharma BS under the guise of "debate."
A recent post by Pitts entitled "General GAO's Chicken" is a good example of the Pitts style. Aside from dissing my favorite Chinese takeout dish, this post is critical of the just released Government Accountability Office (GAO) report that found that "the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings." [see the report "Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process"; read the Washington Post story: "FDA Is Criticized Over Drugs' Safety Problems".]
Pitts simply dismisses the entire report by suggesting it's old news and that the real issue is money ("Senator [Grassley, whose Senate committee ordered the GAO report after the Vioxx debacle], for the umteenth time — SHOW FDA THE MONEY!").
Actually money is not the real issue, as anyone who takes the time to read the recommendations of the GAO report would quickly see. [Pitts, of course, does not bother to provide any links to primary or even secondary sources so readers can check his facts or make up their own minds. Typical of a spinmeister who needs to control access to information, not share it. Some blogger!]
The GAO recommendations are as follows (and I quote, see page 2 of the report):
- To improve the decision-making process for postmarket drug safety, GAO suggests that the Congress consider expanding FDA'’s authority to require drug sponsors to conduct postmarket studies when needed.
- GAO also recommends that FDA systematically track postmarket drug safety issues,
- revise and implement its draft policy on major postmarket safety decisions,
- improve the dispute resolution process, and
- clarify ODS's [Office of Drug Safety] role in scientific advisory committees.
None of these recommendations seems to require a bigger FDA budget, although I concede that recommendation #1 may require pharmaceutical companies to spend more dough, which is probably Peter's real gripe.
Speaking of postmarketing studies by the drug industry, it is a well-known fact that the industry is renegging on its pledge to do the necessary research on drug safety. The FDA recently reported on the status of postmarketing study commitments made by the industry (see the March 3, 2006 Federal Register entry). The data are plotted in the following chart (which I find much more enlightening than looking at numbers in a table):
- Pending: The study has not been initiated, but does not meet the criterion for delayed;
- Ongoing: The study is proceeding according to or ahead of the original schedule;
- Delayed: The study is behind the original schedule;
- Terminated: The study was ended before completion, but a final study report has not been submitted to FDA; or
- Submitted: The study has been completed or terminated, and a final study report has been submitted to FDA.
Clearly, if 65% of these studies haven't even started and only 14% have been completed and submitted, the FDA does need more authority to enforce these commitments by the industry.
The FDA plans to interrupt about 1,800 "self-identified, moderately overweight" shoppers at malls to survey them on the content and format of the brief summary in direct-to-consumer (DTC) print ads, according to a notice published today in the Federal Register ["Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs"; DOCID:fr25ap06-80]
This is what a "brief summary" statement looks like in a typical print ad:
A mall is probably an ideal place to find moderately overweight consumers. But you gotta wonder what incentives FDA plans to offer people to spend 20 minutes reading this stuff? Perhaps a coupon for a free Big Mac!
Current FDA regulations require every risk in an advertised drug's approved labeling to be included in the brief summary, which my friend Harry Sweeney rightly pints out is "neither brief, nor a summary" (see "Communicating Risk: Let the Dialog Begin" in the April 2006 Issue of Pharma Marketing News).
One thing the FDA intends to study is its "less is more" idea: ie, is a "short list" of side effects better than a "long list"?
The number of side effects will be varied to create "short" and "long" levels as follows:
Short: "Side effects include a, b, and c. This is not a complete
list. Talk to your doctor for more information."
Long: "Side effects include a, b, c, d, e, f, g, and h. Talk to
your doctor for more information."
The Coalition for Healthcare Communication (CHC), which recently submitted a petition to the FDA seeking to simply the communication of risk information in broadcast, print, and Internet DTC ads (see "DTC without the Risk"), should be interested in the proposed FDA survey of consumers. In its petition, the CHC suggested that a short list is best.
The CHC has been doing its own survey about drug safety and DTC. Unfortunately, the results of their survey do not support the "learned intermediary" premise of their petition to the FDA. Here are some results of that survey:
1. Drug prescribers are keenly aware of the safety issues surrounding every drug they prescribe. 68% of respondents disagreed with this statement, 18% agreed, and 20% were unsure.
The CHC believes that patients should rely on their physicians as "learned intermediaries" and not on DTC advertising for communicating drug risk details. If this survey is any indication of how "learned" physicians are, then we are in big trouble.
2. Most patients think drugs are safe if prescribed by their doctors. 89% agreed and 9% disagreed.
3. Most patients read, understand and pay strict attention to the warnings that are given by their doctors and/or that are contained in product inserts and pharmacy literature. 91% disagreed and 7% agreed.
This result suggests that patients need to be exposed to warnings about drug side effects in multiple ways, not just through their physicians.
4. Most doctors are careful to be sure that patients understand the possible side effects of drugs being prescribed. 84% disagreed, 7% agreed.
It seems that despite these indications that physicians are not prepared to take up the slack, the FDA intends to have less risk information in DTC print ads and force consumers to rely more on physicians to communicate the details. The FDA survey will no doubt support that effort.
