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.

Social Media Is Quicksand. Better Wear Your "Swimmies!"

My Twitter pal @PhilBaumann made a comparison between social media and quicksand in his blog. "What I’m saying is this," said Phil, "you can learn to swim in quick sand. But you’ll drown if you think you’re walking on solid ground. Sometimes assuming the worst can help you understand and see what’s best." See "What If Social Media Was Called Quick Sand" to get the point Phil was trying to make, which is be aware of what's below the surface.

Regardless of the point that Phil was trying to make, his statement immediately conjured up an image in my mind, which having nothing better to do, I created in Photoshop and posted here on the left.

In reply to Phil's comment, I tweeted  "You can't swim in quicksand, but you CAN dip your toe in. Exactly what pharma is doing in SM now."

What's MY point? You can dip your toe in social media and that's fine. You won't go under. But if you want to fully immerse yourself and start swimming in it, you better have "swimmies" such as guidelines from the FDA and some social media standard operating procedures and policies.

One Pharma Company's Social Media Policy: Threaten Physicians Who Complain About Your Drug Online

According to an article in today's Wall Street Journal (see here), URL Pharma's general counsel sent letters to several physicians who criticized the company's new treatment for gout in an online message board for rheumatologists sponsored by the American College of Rheumatology. The drug in question is Colcrys, which is equivalent to generic colchicine, a drug that cost pennies and has been around for so long that its use "predated the Food and Drug Administration and therefore didn't require the agency's vetting."

When Colcrys came on the market, a number of physicians voiced their displeasure online. Some doctors had advocated use of colchicine. "In response, URL Pharma's general counsel sent letters to several of the critics asking them to 'clarify the record' and saying there were 'potential risks and liability' associated with using unapproved versions."

"'These are shake-down letters to silence' critics, said John Goldman, an Atlanta rheumatologist. In his postings, he had criticized URL Pharma for conducting limited research and for its pricing of Colcrys. URL Pharma says it reached out to physicians to educate them about its clinical trials and help them prescribe the drug appropriately, not to quash criticism."

"We were trying to alert this small group of misinformed physicians to the fact that they were being led into medical malpractice liability," the company said in a statement.

URL's action may not be indicative of how the pharma industry as a whole "engages" with physicians who use social media, but it raises an important issue regarding pharma's participation in closed social networks such as the rheumatology discussion board in question. Obviously, URL physician employees or physicians hired by URL or an agency of URL were "lurking" on the board monitoring discussions. This is probably a common practice of many pharma companies. Should these agents identify themselves to the community?

In other cases, pharma companies have been transparent about their monitoring of physician communities. Pfizer, for example, has a deal with Sermo that allows their physicians to join the Sermo physician community. These physicians are clearly identified with a special logo, I believe. They obviously can "lurk" and not be seen unless they post a message, but Sermo and Pfizer were quite open about it to the Sermo community (see "Pfizer has a Gold Mine in Sermo!").





BTW, URL Pharma should have read this post I made over a year ago: "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!"

Also see How Should Pharma Engage in Patient/Physician Social Networks? Survey Results.

Sex, Lies, and the Media: Did Businessweek Distort the Relation Between ED Drugs and STDs?

The headline in a recent story reported in Bloomberg Businessweek tells it all: "Men on Viagra, Cialis Show Triple Rate of Sex Diseases in Study." This was duly summarized in the Blogosphere on PharmaGossip:

"Men on Viagra, Cialis Show Triple Rate of Sex Diseases in Study - BusinessWeek

"Men taking drugs for sexual potency showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications, a Harvard University study found.

"The results, from an analysis of the health insurance claims of men aged 40 and older, may have more to do with the nature of the men using the impotence drugs than with the medicines leading them to have riskier sex, the research report said. The study, looking at men taking Pfizer’s Inc. Viagra and Eli Lilly & Co.’s Cialis, was published today in the Annals of Internal Medicine."

Reading just the headlines and summaries such as the one above, you might be lead to believe that ED drugs CAUSE unsafe sex, which leads to more sexually-transmitted diseases (STDs). Right? WRONG!

You have to read down to the 11th paragraph of the 16 paragraph story to learn that the study does NOT prove that taking ED drugs leads to more unsafe sex. Quite the contrary: users of these drugs actually showed a DECREASE in STDs AFTER taking the drugs compared to BEFORE taking the drugs!

That paragraph states the study results: "The risk of getting HIV in the year before taking the pills was 3.32 times higher in drug-takers and 3.19 times greater in the year after, compared with those not taking the pills." [Find the article here.]

In other words, the groups of men who were prescribed ED drugs were in a high risk group BEFORE being prescribed ED drugs. In the abstract, the study authors were careful to point out "Significant changes in STD rates from the year before to the year after the first ED drug prescription was filled were not documented." [Find the abstract here.]

Pharma often complains that the media are "anti-pharma" and often emphasize the negative aspects of clinical trials, advertising, etc. (see, for example, "What's the Cause of the Drug Industry's Bad Reputation?"). The BusinessWeek article is just one case where I have to agree, although overall I sense that the industry gets a lot more positive traction from the media than negative (see, for example, "Academics Exaggerate, Journalists Regurgitate. What About Bloggers?").

What do YOU think?

Does the Media focus too much on bad news about the pharma industry?
	Yes, definitely
	Absolutely not
	Maybe, sometimes
	More often than not
	It's pretty much balanced

What's Top of List in Your Social Media Implementation Plan?

Sanofi-Aventis recently experienced a FaceBook fiasco and learned from the experience (listen to this podcast: "What Has Sanofi-Aventis Learned from Its Facebook Experience?"). In fact, it probably learned more from that experience than it learned from reaching out to people like me who were asked to provide some insights.

IMHO, every company should have a social media implementation plan in place. It may not prevent crises like the one S-A was faced with, but it will help your company deal with them.

To determine the relative importance of elements of a social media plan, I started a survey that asks respondents to indicate how important the following action items are in implementing a social media plan:

• Unblock corporate access to social media so employees can monitor and use applications such as Facebook while at work
• Have a sustained vision/goal
• Become a dialogue company - learn how to listen and respond, not just push messages out
• Get everyone - including marketing, regulatory people, corporate communications, C-level execs - on board
• Develop guideposts, internal and external standard operating procedures
• Train people who will be interacting directly with consumers
• Develop a moderation strategy
• Marshall necessary resources - use the best tools available
• Create a social media Tsar position to oversee all the company's SM projects to assure compliance with guidelines

Respondents can answer

• Should be TOP of list
• Very important, near top of list
• Somewhat important
• Good idea
• Ambivalent (not sure how important)
• Near bottom of list
• At very bottom of list

These items were suggested to me at an interactive session I moderated at a recent industry conference. The results to date from this survey are presented in the following chart:

Please take the survey and tell me what you think: