August 2006 Monthly Archive

August 30, 2006

$51M Vioxx Verdict Overturned

Judge Fallon decides that the jury's $50M award is a bit much for a heart attack in which the guy is still alive and well.  He leaves in place $1M punitive damage award.  (The $50M was compensatory damage.)

I also refer you to the PointofLaw blog, in which is observed the inconsistency of the jury's verdict: no,  they aren't strictly liable for failing to warn about and causing the MI; and yes, they were negligent in failing to warn and causing the MI.   How can you be negligent if you weren't liable?

 

Liable=responsible

negligent= "careless in not fulfilling responsibility" (from law.com).  There was a duty toward the person AND you didn't do what a reasonable person would have done AND what you did actually caused the damage



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August 17, 2006

Vioxx

Merck's previous win in the Vioxx suit gets thrown out because the judge was concerned about the new criticism of the NEJM study.

What happened is an idiot's guide to forensic computing.  Greg Curfman, executive editor of NEJM, was going to give a deposition in the trial of Frederick Humeston, an Idaho postal worker (or he was just curious about the data after Vioxx was pulled-- depends on which story you read) and so pulled the manuscript.  Back in 2000 you'd submit a paper copy and a disk; NEJM says they worked off paper, so the first time they looked at the disk was Oct 5, 2004 (days after Vioxx was withdrawn.)

 

Here's the fishy part: on the disk was a table called "CV events," which was blank. 

Time stamps in the software indicated that the table was deleted two days before the manuscript was submitted to The New England Journal on May 18, 2000. "When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says 'Merck,'" Curfman says.

What's so terribly misleading about this and NEJM's "Expression of Concern" is this statement:

We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000.

This isn't true.  First, the missing MIs were never in the table to begin with.  Second, the table was deleted, but the data itself was still in the paper. 

 

Now it is obvious the study attempts to minmize the thromboembolic risks.  What do you expect from an academic study? Let me assure you-- if you think drug reps are biased, go find yourself a professor.   So I acknowledge the criticism that the study is misleading.  But.
 

But it's the social policy angle that gets me, the moralistic high ground of journal editors who are far worse than study authors.  The gateway to hell is peer reviewed. 

The article says Curfman was deposed by plaintiff's lawyers.  Was Curfman paid by them?  It doesn't mean he's biased, but if you have to disclose Pharma sponsorship, don't you think you should disclose lawyer sponsorship?  (and I am looking to find out if he was indeed paid.)

As I have absolutely no interest whatsoever in the actual outcome of these trials-- my interest is really about how doctors butcher science and promote themselves to senators-- but, we should take a look at what this revelatory missing data says.

What they found was that with the inclusion of the missing data, the rate of heart attacks would have been 5 times greater than naproxen, not 4 times.  0.5% vs. 0.1%.

Just to put this in perspective, of course, you should know that the missing data was three more heart attacks, raising the number of patients with MI from 17 to 20 (out of 4000+ patients), vs. 4 in tha naproxen group.

BTW, "five times" and "four times" may sound like big differences, but they do not even approach statistical significance in this study. 

BTW, strokes were the same in both groups.  Not that anyone cares, of course.



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August 10, 2006

Plan B Emergency Contraception: Doctors Out of Their League, Again

"In a long overdue concession to science, the Food and Drug Administration could finally, grudgingly, be ready to allow an emergency contraceptive to be sold without a doctor's prescription." (USA Today Opinion 8/2/06)

"Concession to science?"  Wow!

I have admittedly almost zero interest in the way Plan B has become a proxy war for anti/pro abortion armies.  But when  doctors become social policy analysts I take note.  

Why are "scientists" saying that this drug should be sold without prescription?  Why should oral contraceptives require prescription, but this should not?  Or, to reverse it, if this doesn't need a prescription, then what does?  How do we decide what needs a script and what doesn't?  Expediency?  Political advantage?

The argument that this is an important option in the event of a pregnancy scare is premised on the notion that Plan B will be rarely used.  This is false. It overlooks a very key point: every unprotected sexual intercourse is a pregnancy scare.  And people usually have a lot of sex.

Look at it this way:

Before Plan B: you're a woman, you have sex.  You're worried-- not really worried, it's not the "right time of the month," he pulled out, etc, etc, but it's in the back of your mind.  But there's nothing you can do, too late now, so you just wait it out.

After Plan B: you're a woman, you have sex, etc, etc, but now exists a safe, non-prescription way to ensure you don't get pregnant. Why wouldn't you take it, just in case?  Even if the chances you are pregnant are really small-- Why not?  What does it hurt?  It's safe, the FDA said so, and even put it over the counter.  A little nasuea to guarantee you don't get pregnant?

See?  It's a no-brainer.

But what about the next night?  And the next?  What if you have sex-- 10 times a month?  It's not frequent enough to embark on the oral contraceptive-- after all, you don't have that much sex, you can't afford to go to the doctor, you don't have the time, etc-- but you know, Plan B is available in seconds...  Why not?

I know men who take Viagra "just in case."  (And that requires a prescription.)  You think this will be different?

Look, Plan B might actually be safe, even if taken every day.  But isn't every-day-Plan B chemically identical to an oral contraceptive-- which requires a prescription?  And if it isn't safe taken daily, why wouldn't a prescription be required?  I should point out that Plan B actually has three times more hormone in it than an oral contraceptive.  Hmm.  Is taking three birth control pills a day safe?  Anyone?

Again, this isn't about whether Plan B is moral or a social necessity-- something on which doctors are no better equipped than lumberjacks to pass judgment.  This is about whether Plan B should need a prescription, based on the drug's safety.

This isn't about women's rights or abortion or anything else.  It's about "scientists" picking and choosing what they want to believe; about becoming intoxicated with the power to drive social policy, and manipulating the infrastructure of the discipline to generate a smokescreen of science to support them.

Remember: these are the same people who discovered (read: decided) Vioxx causes heart attacks and Zoloft drives people insane-- years after their release-- but Plan B is so safe it doesn't need a prescription.

If I were a class action lawyer, I'd start clearing my desk...

 


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Levonorgestrel: WHO recommends 1.5mg as a single dose; "Plan B" is .75mg in two doses (12hrs apart.)


Assume the average OCP has 0.25mg of levonorgestrol. (a levonorgestrol-only OCP, called Microval, has only .03mg).

 

Addendum 11/24/06:  Turns out that  Plan B emergency contraception does not reduce pregnancy rates.  Big surprise.  But the one difference was that those with easy access took it more often.  (News article here.) My post about this here.



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