Monday, August 22, 2005

Jury as Focus Group

While Merck is pre-occupied planning its appeal of last week's judgment against the company in the first Vioxx liability case, it is hoped that Merck's CEO and other pharmaceutical executives correctly interpret and learn from the jury's messages.

As reported in the Wall Street Journal ("
Jury Finds Merck Liable in Vioxx Death"; 8/20/2005), Mark Lanier, attorney for Carol Ernst, the plaintiff, "told reporters, referring to the jury: 'These people are good, solid people. They know right and they know wrong. It sends the message that the drug companies must tell us the good the bad and the ugly.' "

The industry should consider this jury as an
independent focus group. Focus groups are often used by the industry to do market research. The difference is, this group was presented both sides of the case and had access to a lot of information, including the good, the bad, and the ugly.

Message #1: Merck did NOT put patients first
Matthew Pallardy, a 24-year-old juror from Alvin, Texas, said his vote was a message to Merck: "You did wrong. You dropped the ball. We rely on Merck. We're hoping that they would protect us and not keep stuff from us."
In a new TV ad campaign costing $20 million, Merck proclaims a new slogan: "Merck. Where patients come first." As I said in a June post to this blog ("Patients Come First?"): "Not so long ago, when Merck was trying its best to hide evidence that Vioxx could cause serious heart problems, it seemed that patients came last at Merck." The jury in the Texas case agreed and said that Merck hid important information not only from the public, but also from physicians.

Message #2: Warnings were delayed to protect sales

A Reuters story ("
Texas Jury awards $253 mln in Vioxx trial"; 8/19/2005) reported:
"Juror Derick Chizer, 43, said the jury, which deliberated almost two days, knew their award would probably be cut, but felt Merck needed a jolt to change its ways.

"That ($229 million award) was a message to them," he said.
The $229 million in punitive damages awarded to the plaintiff -- as opposed to the additional $24 million in actual damages -- is, according to Lanier and at least one juror, the exact amount of money "Merck made and saved by putting off their product label changes."

Message #3: Warnings were hidden in the labeling

In an MSN News interview of jurors immediately after the decision, the jury foreperson said the jury was "alarmed" that the
revised, post-VIGOR Vioxx labeling had a "small warning [which] wasn't something that would catch your attention or catch the doctor's attention." This information appeared in a small paragraph on page 7 of the labeling copy.

Another juror remarked that the information was not, as claimed in court, "naked to the gross eye. You had to dig for it."

Not only did Merck hide important side effect information in the labeling to physicians, it is also accused of training its sales reps to "dodge" direct questions about cardiovascular side effects from physicians:
According to company documents, representatives known as ''detailers" were told by superiors to sidestep questions about heart risks. If a doctor expressed concern, they were told to produce a pamphlet written by the Merck marketing department that said Vioxx was eight times safer for hearts than similar painkillers. The pamphlet did not include details from the Merck study that showed a fivefold increase in heart attack and stroke risk with Vioxx compared with naproxen, another painkiller. ("Merck told sellers to avoid talk of Vioxx heart risks"; Boston Globe, 5/6/2005)
"Kill all the Lawyers"?
Characters plotting a revolution in Shakespeare's play Henry VI vowed to get rid of all the lawyers as the first benefit of their new regime. Less reliance on lawyers may be good for the drug industry as well.

The package insert figured prominently in the first Vioxx trail. I have criticized the typical package insert language in a previous post to this blog (see "
Future of Drug Print Ads") and noted that lawyers, not clinicians or specialists in medical communications, are primarily responsible for the wording of drug labels (see "Labeling / TV DTC Revisited").

We now have the spectacle of lawyers getting pharmaceutical companies into trouble, but unable to get them out of it! Either way, they get paid!
The pharmaceutical industry is in the midst of a revolution thrust upon it by the failure to "put patients first." The industry has come up with new DTC guidelines that promise to lead the way in this revolution. But the course of the revolution is in danger of being hobbled at every turn by an over-reliance on advice from lawyers rather than on advice from the industry's customers: the public (patients) and physicians.

Message to Pfizer

Pfizer is the pharmaceutical company we now all expect to lead the way as America's pre-eminent and most trusted pharmaceutical company. Pfizer also has a Cox-2 inhibitor product, Celebrex, which is very similar to Vioxx. So it's natural to think of Pfizer as the company that can best learn from Merck's mistakes. It may be too late for Merck, but not for Pfizer.

Pfizer and many other pharmaceutical companies recently have pledged to educate physicians about new drugs before initiating DTC advertising campaigns (see "
Pfizer DTC Pledge: ED is Litmus Test"). This commitment should extend throughout the product lifecycle. In addition, pharma's communications with physicians need to be transparent about risks as well as benefits. No more dodging questions and no more hiding side effects in legalese mouse-sized print on labeling!

Pfizer also pledged to improve risk communications:
Pfizer will fund research to find ways to further improve risk communication in DTC TV advertising. We will conduct this research with input from the FDA and third parties and will adjust Pfizer's communications based on the results. (See "Pfizer Announces Improvements to Consumer Advertising for Prescription Medicines.")
Forget going to the FDA! Pfizer and the entire drug industry would benefit more by assembling into focus groups the hundreds of jurors that will be generated from current and future Vioxx trials. These people will have a lot to say.

Are you listening?

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