I assume that anyone reading this blog today must be looking for something else besides election news or leaked exit poll numbers. How about some drug industry stuff? That I have, but it isn't good. Monday's Wall Street Journal brought a disturbing story about some leaked e-mails and internal memos from Merck and its troubles with Vioxx.
This piece, by Anna Wilde Matthews and Barbara Martinez, led to Merck's stock taking a terrible beating in today's trading, and it's pretty damned easy to see why. If these items are correct, and I've no reason to think that they aren't, Merck is in even bigger trouble than I thought. And believe me, that's really saying something.
It appears that prominent people inside the company not only thought early on that Vioxx had cardiovascular liabilities, but then did everything they could to divert attention and keep the drug on the market for as long as possible. Says the Journal story:
A Merck internal marketing document reviewed by The Wall Street Journal, addressed to "all field personnel with responsibility for Vioxx," provided an "obstacle handling guide." If a doctor said he was worried that Vioxx might raise the risk of a heart attack, he was to be told that the drug "would not be expected to demonstrate reductions" in heart attacks or other cardiovascular problems and that it was "not a substitute for aspirin." This wasn't a direct answer.
One training document is titled "Dodge Ball Vioxx" and consists of 16 pages. Each of the first 12 pages lists one "obstacle," apparently representing statements that might be made by a doctor. Among them are, "I am concerned about the cardiovascular effects of Vioxx" and "The competition has been in my office telling me that the incidence of heart attacks is greater with Vioxx than Celebrex." The final four pages each contain a single word in capital letters: "DODGE!"
There's more, including incidents of Merck coming down hard on academic researchers who presented negative appraisals of the drug. They seem to have gone way over the line - at least, what should be the line - in trying to protect their blockbuster drug. It's ugly and it's disappointing, because I always had a high opinion of the company. This is just the kind of thing that gives my industry a sleazy reputation, and it infuriates me to see how much of it can be deserved.
Naturally, Merck says that the statements in the article are taken out of context. Perhaps some of them are, but it would have to be a pretty unusual context for this stuff not be be what it looks like. And what it looks like is blood in the water for the lawyers, who will now go even more beserk than usual. Who could blame them? Who knows what other things might turn up in discovery proceedings, if goodies like this are already available?
No, I already thought that Merck was in major trouble, but this is going to be one for the record books. Merck is going to be out many, many billions of dollars, far more than they ever made from Vioxx itself. I don't see how the company gets out of this without terrible damage, with most of it done to the cheers of an angry crowd. It's sad, because in many ways Merck has been a great company that's done a lot of good in the world. But not always, and not this time.
Merck has a lot of very bright, very competent, very hard-working researchers. But trouble that's coming is going to lay waste to the good and the bad, the innocent and the guilty. Who will be spared?
1. threegoofs on November 2, 2004 10:25 AM writes...
I read that WSJ piece and the 'dodgeball' thing was certainly taken out of context. Having attended more than my share of sales training sessions, I can see that this sales training piece was clearly not meant to tell Merckians to dodge questions as much as stay on the message that Vioxx should be giving.
Drug promotion in the field is hampered by many legal considerations, and when you have a 30 second session with an MD and are not legally allowed to discuss data like the VIGOR trial, the reps must learn to stay 'on message' and not get diverted, lest they say something illegal or divert their precious seconds talking about adverse events that are not proven, clear or even understood. The documents from the researchers may have also been taken out of context, or there might have been someone with a contrary opinion to others in the company, who, in retrospect, turned out to be right.
Permalink to CommentBut it does look bad when its published in the WSJ.
2. mark on November 3, 2004 9:18 AM writes...
I too have always had the highest regard for the ethics and business practices of Merck. If true, the current revelations force a revision to that view, which is very sad. Beyond that emotional disappointment, what do we know? It's a lot worse than just the embarrassment of dodgeball marketing tactics. First and most obviously, it appears that patients had avoidable heart attacks and strokes because of conscious executive decisions at Merck. Second, the Merck execs obfuscated and otherwise attempted to downplay risks they knew of, thus depriving physicians of the full information needed to evaluate therapeutic benefit. I find it particularly troubling that trials were designed to avoid including patients with cardio issues, to make it LESS LIKELY that such problems would show up in the body of clinical evidence on the safety and efficacy of the drug. Where was FDA in this? It is shameful thing to focus the precious talents of the Merck development organization on designing trials meant to avoid the exploration of known (or at least suspected) problems. How does this fit with the company's mission to improve health? Third, these were highly educated, highly paid executives, entrusted by "the system" and, for the physicians amongst them, bound by the Hippocratic Oath to behave ethically, in a way that does no harm to patients. It makes the behavior that much more hard to stomach.
Again, if the allegations are true, it will cost Merck many billions to settle up just with the patients it has harmed. The damage to the public trust will be even greater, though perhaps more difficult to quantify. The somewhat rickety system we have for clinical trials, which depends heavily on a trusting public believing that trials are for valid purposes (with correct, truth seeking designs), is now damaged. It will be harder to get patients to volunteer, it will be harder to interest physicians to serve as investigators. Regulators will show more skepticism when the industry needs more trust and cooperation. Trials will take longer, cost recovery will be slower, costs of capital will rise, and fewer new drugs will come to market. Even Merck doesn't have enough money to pay for these damages. A very sad situation all around.
Permalink to Comment3. threegoofs on November 3, 2004 10:52 AM writes...
This risk of MI is much more complicated than at first glance. What is overlooked is that any clinical trials involving the drug were going to skew the results to more heart attacks. You could not enroll patients taking aspirin (inherently higher risk groups), and the control group would probably be taking an old style nonsteroidal that would be potentially cardioprotective. So if you did enroll higher risk people, you would be actively biasing your study to show Vioxx had higher MI risk. So there was a real question for years that the VIGOR study, and other observational trials, were falsely showing increased CV risk when none really existed. In addition, most of the patients at risk for CV events were probably going to take aspirin anyway, which nullified anything Vioxx was (or wasnt) doing. The follow up trial showed that this was a real event, though, and Merck pulled it from the market. Seems like things worked as well as could be expected to me.
Permalink to Comment4. fourgoofs on November 4, 2004 5:49 AM writes...
Don't know if it's because of the type of profession or what but marketing, sales and executive positions seem to attract a lot of very bad aggressive apples. Also the worst of the lot seem to be attracted to power and tend to rise up the corporate ladder more so than those who have a conscience.
It's a very competitive world out there and some people with not much in the way of conscience will cheat the system. I'm not surprised that they marked their materials with the word "dodge" in fact I'd be surprised if a company didn't do so.
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