"The Crowd is My Only Drug," Says GSK Olympics Anti-Doping DTC Ad Campaign

GlaxoSmithKline (GSK) will raise awareness of its role in anti-doping measures at the London 2012 Olympic Games as part of its first consumer-facing corporate campaign in the UK (see here).

Advertisements will appear across a range of media, including television, and outdoor advertising space, commencing July 23. One TV ad is currently available on Youtube:



Obviously, when the athlete star of this video is quoted as saying "The Crowd is My Only Drug," he means illegal drugs that some athletes may use to boost performance, not the drugs sold be GSK for legitimate use. But I wonder if social media "crowds" -- as in "Wisdom of the Crowd" -- can replace some Rx drugs for some people? I'm thinking about GSK drugs such as diet pill Alli and diabetes drug Avandia, both of which have been problems for GSK (see here and here).

Type 2 Diabetes in Obese Children Proves Difficult to Treat with Drugs Alone

Metformin, "the only pill approved in the U.S. for treatment of children with type 2 diabetes is proving surprisingly ineffective, according to a new study, heightening worries about the fast-growing and largely preventable disease," reports the Wall Street Journal (see here).

The study also included GSK's Avnadia, which is not approved for use in children and has been linked to an increase of heart attacks, curtailing its use in treatment.

699 children between 10 and 17 years old, essentially all of whom were obese and who had been diagnosed with type 2 diabetes for an average of eight months were randomly assigned to one of three treatments: metformin, the mainstay diabetes medicine; metformin plus a lifestyle-intervention program; or metformin plus Avandia.

52% of those on metformin alone had failed, compared with 47% on metformin plus lifestyle change and 39% on the two-drug regimen. Statistically, only the two-drug treatment was considered superior to metformin.

The results prompted other experts to renew calls for societal efforts to combat diabetes and obesity among young people. Here is a chart showing the prevalence of obesity among young people in the U.S.:

Coincidentally (or maybe not), the National Institutes of Health (NIH) sent out a press release today announcing "The Weight of the Nation" documentary series and public awareness campaign focused on obesity in the U.S. HBO, in association with the Institute of Medicine, NIH and the Centers for Disease Control and Prevention, and in partnership with the Michael & Susan Dell Foundation and Kaiser Permanente Foundation, developed four documentaries focused on obesity. The project also includes a three-part HBO Family series for kids, 12 short features, a social media campaign, and a nationwide community-based campaign to mobilize action to move the country to a healthier weight. See the press release here.

Avandia and Janet Woodcock, the Next FDA Commissioner

By now you all know about FDA's decision to put restrictions on how physicians prescribe Avandia in the US (see "FDA will significantly restrict the use of the diabetes drug Avandia"). European regulators, however, chose to completely ban the sale of Avandia.

Why the difference in approach between two regulatory agencies whose decisions were announced simultaneously in what has been described as "an unusual degree of coordination" (see WSJ article "FDA Restrictions on Avandia Will Lead to 'Minimal' Sales")?

The WSJ tells us the answer: "By keeping the drug on the market with restrictions, FDA Commissioner Margaret Hamburg gave a nod to a powerful internal faction led by drug chief Janet Woodcock, who maintained for years that the evidence against Avandia wasn't conclusive," noted the Wall Street Journal. "Dr. Woodcock noted the divisions Thursday, saying FDA scientists couldn't agree on how to weigh the evidence of Avandia's risk, resulting in 'different conclusions.'"

IMHO, it looks like Janet Woodcock is keeping on the good side of the drug industry, which is now donating large sums of money to the GOP in the hopes of defeating Obama in the 2012 presidential elections. If that happens, it is unlikely that Margaret Hamburg will remain on as FDA Commissioner and the one person remaining who has the backing of the drug industry is Janet Woodcock.

I learned about pharma's support of Woodcock during and after the 2008 elections, when I hosted a survey that tried to determine who among the likely candidates at the time would be nominated by Obama as the next FDA Commissioner (see "Meet the Person Likely to be the Next FDA Commissioner").

[It's interesting to note that several of the candidates for FDA Commissioner in 2008 have been involved in the controversy over Avandia and were mentioned in the Wall Street Journal article; namely, Janet Woodcock, Dr. Steven Nissen, former FDA Commissioner David Kessler, and current FDA Deputy Commissioner Joshua Sharfstein.]

While Hamburg was hardly mentioned as a contender for commissioner in 2008, Janet Woodcock was and she received 11% of the votes from US respondents overall in my survey. However, Woodcock received 56% of the vote of respondents who said they were employed by pharmaceutical companies (see chart below, click for enlarged view).

David Kessler -- not known as a friend of the drug industry -- also received a majority of pharma respondents' votes, which is something I am at a loss to explain.

Of course, this survey of over 450 people should not be considered "scientific." Similarly, according to Woodcock, the meta data results upon which Avandia's cardiovascular risk was pegged are also not scientifically "robust or consistent." "We still feel there's considerable uncertainty about the magnitude and existence" of the risk," said Woodcock.

It's clear that if Janet Woodcock were FDA Commissioner, the fate of Avandia would have been very different. But there's still hope! The fact that Avandia remains on the market means that the reports of its demise may be a bit premature. First, GSK, which markets Avandia, can still supply the FDA with data from its RECORD study that proves the cardiovascular risk of Avandia is not substantial. Second, FDA's actions can be reversed if there is a new regime at FDA after the 2012 elections. The person most likely to head such a new regime is Janet Woodcock.

Actos Launches DTC Attack on Avandia

Ha! Takeda's sneak attack: Launches Actos DTC campaign today, a day that will live in infamy! 

Read the story here.

GSK Kills the FDA Beast! Avandia Lives Another Day. Stay Tuned for DTC.

It seems that the 14 million pages of documents that GSK submitted to the FDA in defense of Avandia has had the intended effect: overwhelming FDA's advisory panel with "science," questionable as it may be.

I'm reminded of the scene in the original King Kong movie that fascinated me as a kid: the scene in which King Kong rips open the jaws of the T Rex and kills it. That's exactly what GSK has done to the FDA -- ripped open its regulatory jaws and rendered it powerless to take Avandia off the market even though it is known that the drug is responsible for the deaths of 400 times more people per year than is Toyota's cars (see "If Drugs Were Like Automobiles").

I have no doubt that the FDA will follow the recommendations of the advisory committee, the majority (17) of whose members voted to keep Avandia on the market albeit with stronger warnings or tighter restrictions on prescribing. Although 10 members voted to take the drug off the market, I don't see that view being taken seriously by the FDA. After all, Avandia's patent will expire within a year and it has received such bad press lately that it is hard to imagine physicians prescribing it. FDA's strategy may be to slap restrictions on Avandia and hope it dies a death of a thousand cuts. That way, the agency can appear to be responsible and science-driven rather than being gung ho anti-industry.

All this leads me to consider how GSK will address the problem of a likely drop off in prescribing by physicians. This is already happening. GSK hopes to solve that problem with a clinical trial that demonstrates that Avandia is as safe (or just as unsafe) as its competitors. It is reported, however, that GSK is having problems recruiting patients for this new study.

Just as BP is hedging its bets on stopping the Gulf oil leak by placing a new cap on the well rather than relying on the success of the relief well option, GSK will roll out a direct-to-consumer (DTC) ad campaign to hedge its bet on the comparison study.

A DTC campiagn can be launched almost immediately and may already be ready to roll. Such a campaign may resemble the Celebrex campaign that Pfizer launched after competitor drug Vioxx was removed from the market and put Celebrex's safety in doubt (see "Celebrex Ad: Let's Dive Deeper").

Keep in mind that DTC campaigns are aimed NOT just at consumers, but also at physicians who are even more likely to watch the evening news on TV than you or I. GSK may also simultaneously launch an equivalent direct-to-physician ad campaign.

The new Avandia advertising campaign will draw upon positive data that GSK cherry picks from its 14 million pages of documents just as the Senate Committee cherry picked negative data.

It was destined that the great Ape would die and so will Avandia. It won't be the FDA gunships that kill Avandia, however. It will be the "beauty" of the marketplace!

Police Lieutenant: Well, Denham, the airplanes got him.

Carl Denham: Oh no, it wasn't the airplanes. It was beauty killed the beast.

GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Repsonsibility to Patients?

The New York Times reports (see here) that as far back as March 29, 2001, a SmithKline (precursor to GSK) executive held back clinical trial data that suggested Avandia was "no better than Actos, but ... also provided clear signs that it was riskier to the heart." In an e-mail that the NYT recently received, this executive said "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." In another email message, this executive said "These [data] put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day."

"Hiding the results of negative clinical trials was once widespread in the drug industry," says the Times. That was supposed to change when Congress mandated such disclosures. "But the postings are often little more than cryptic references, so the issue is far from resolved," says the Times.

As I write this, GSK is presenting its case before an FDA advisory committee. You can follow this meeting on Twitter -- but don't look at GSKUS, GSK's official Twitter account. That account, so far, is silent about this unfolding story.

Here is GSK's Advisory Committee Briefing Document (pdf). It's 166 pages long and full of meta and other data purporting to prove the conclusion that "observational, and large controlled clinical studies continue to support the overall positive benefit risk profile of RSG as an important medicine for type 2 diabetes mellitus (T2DM) patients. Better durability of glycemic control with RSG compared to both SU and MET has been demonstrated in two long-term studies. This durability benefit has the potential, in real life conditions, to reduce microvascular complications of type 2 diabetes and to avoid the need for additional therapy, including insulin. Treatment with RSG does not demonstrate an increased risk in macrovascular complications compared to MET and SU. Therefore, the overall benefit risk profile for RSG remains positive."

Whatever the new data show, it is clear that GSK in the past conspired to hold back negative data from the public. And not only negative data about Avandia. "GlaxoSmithKline was found in 2004 to have hidden data that showed that its antidepressant, Paxil, led children and teenagers to have more suicidal thoughts and behaviors," noted the Times article. GSK settled a lawsuit by agreeing to publicly post data from all of its trials.

Given this kind of attitude, it's no wonder the public has a low opinion of drug companies. I myself started writing this blog when Merck was found to be hiding negative data about Vioxx, a drug that was eventually withdrawn from the market -- a fate that I believe awaits Avandia.

UPDATE: @GSKUS posted this: GSK responds to July 12 Senate Finance Committee letter to FDA #FDA http://tinyurl.com/25t3fvd

The first sentence of GSK's response: "The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation."

14 million pages! Holy cow! I guess GSK learned from GM about how to swamp your opponents with tones of paper! I'm referring to the case that Nader brought against GM in "Unsafe at Any Speed." Remember the Gene Hackman movie "Class Action" that portrayed the story behind the case? When asked to supply relevant data, the auto company in the film sent a truckload of boxes of documents to bury the lawyers.