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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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April 7, 2008

Pre-emption For Real?

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Posted by Derek

There's talk again about an idea that's been kicking around for some years: are drug companies shielded from liability after the FDA has approved their drugs for sale?

Obviously, the current answer is "Not at all": consider the lawsuits over Vioxx. But the decision by the Supreme Court in February in Riegel v. Medtronic has the idea being taken seriously again. That ruling seems to shield medical device companies from lawsuits over safety or efficacy after the FDA has signed off on those issues - as long as the device is the same, and used in the approved manner. And no, for the politically motivated among the readership, this wasn't some barely-realized 5:4 scheme from Justice Scalia; the decision went 8 to 1.

There's a roughly similar case before the court now, Wyeth v. Levine. At issue is the labeling and usage of Wyeth's histamine antagonist Phenergan (promethazine), with the suit being brought by a patient who was injured after the drug was used in a method warned against on the label. This one hinges on a federal/state dispute, though, as the petition for certiorari (PDF) makes clear:

"Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration pursuant to the FDA's comprehensive safety and efficacy authority. . .preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe to use".

This seems, if it goes Wyeth's way, as if it would keep various state jurisdictions from coming in with different liability claims, but the situation seems less stark to me if a state's standards were the same as the federal government's. Would this really pre-empt liability suits entirely? I'll let actual lawyers set me straight on that if I'm looking at it incorrectly.

There's another case that was granted cert. last fall, Warner-Lambert v. Kent, which could also have a bearing on the whole issue. This hinges on the approval (and later withdrawal) of the PPAR drug Rezulin (troglitazone), and whether Michigan state law on pre-emption of lawsuits is in conflict with the federal law. Again, I would have thought this one would probably be decided as a state-versus-federal issue, without extending to any sweeping thoughts on pre-emption in general. But that Medtronic decision makes a person wonder if the Court is in the mood for just that.

So, there's the background. Arguing will now commence on whether pre-emption is a good idea or not. I've thought for some time that all approved medications should be labeled as "investigational new drugs", and that everyone taking them agrees that they are participating in a post-approval clinical study of their safety and efficacy. (I suppose that's my own form of pre-emption). But there's room to argue if the FDA is ready to take on the full responsibility of drug approval, without the option of later redress in the courts if something goes wrong. (Counterargument: that's what they're supposed to be doing now. . .) And all of these schemes have to make room for new information turning up, or for outright fraud (which is most definitely in the eye of the beholder). Personally, I'm glad not to be a judge.

Comments (15) + TrackBacks (0) | Category: Drug Development | Press Coverage | Toxicology


1. Bunsen Honeydew on April 7, 2008 11:45 AM writes...

I think that public expectation of lack of side effects is stupidly high. At once we are expected to be gods who can create compounds to heal people and Satan because we deliver the desired efficacy with undesirable side effects. It's pathetic. We are not gods. Like everyone else, we scientists do our jobs as best we can. I will concede that many management types in pharma are unscrupulous s.o.b.s who only see as far as the short term financial gain of the company and themselves. One problem is that these folks are killing the industry.

Back to the public. They vilify scientists for not giving them a perfect solution. Ok, we didn't give you perfect, 100% quality of life. Well, guess what, Joe Schmoe, if it weren't for us, your quality of life would be far less. We're giving you the best we have and it's not easy or cheap to do that so suck it up or don't patronize our industry and live with the effects of your own genetics and lifestyle.

Should companies be protected from lawsuits regarding approved products? For the most part, yes, absolutely! I don't think Merck did anything wrong with Vioxx. Within 48 hours of receiving the data, Merck voluntarily pulled Vioxx off the market. That's all that could reasonably be done and that should make Merck immune from lawsuits.

I also happen to believe that Vioxx should still be on the market. Allow people to make an informed choice. Here's a scenario for you. A person has chronic, debilitating pain that has reduced their quality of life. Let's quantify that quality of life at 25% of normal. Tell them that they can take Vioxx and it may give them 80% of normal quality of life but there is a 50% of a heart attack within 5 years. Given the choice of 80% quality of life for 5 years versus 25% for say, 20 years, almost everyone would take their chances and take the drug. This is what a free and democratic society is about- informed choice! You are told the risks, you make and choice and you live with it.

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2. d_orbital on April 7, 2008 1:07 PM writes...

Here, Here!!

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3. d_orbital on April 7, 2008 1:08 PM writes...

or better yet Hear, Hear (I'm an idiot) :)

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4. pissed on April 7, 2008 1:41 PM writes...

mfg sure have no problem charging lots of money and making billions off of crap that they have no clue about though huh!!!!
..geee why doesn't everyone just repackage rat poison and can it the wonderdrug...

people are entrusting their lives to drugs to cure them not kill them

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5. molecular_architect on April 7, 2008 1:57 PM writes...

I've argued for years that two basic changes in the law would help mitigate some of the current problems in the idustry and help cut prescription costs. 1) Patent protection should begin with FDA approval, and 2) FDA approval should protect drug companies from all but actual damages, i.e. no putative damagea awards, no class action suits, etc.

One big exception though, which is highlighted in the NY Times article about J&J's birth control patch. If a company is aware of negative data and hides or misrepresents that data to obtain FDA approval, all protection should be lost. In such a case, the company should be investigated to determine the highest ranking executive(s) with knowledge of the data. He/she/they should then face civil and criminal charges along with the company itself. If convicted, he/she/they should be personnally financially liable and GO TO JAIL. Likewise if negative data which surfaces for an approved drug is misrepresented.

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6. Clark Kent on April 7, 2008 1:58 PM writes...

I agree with your last paragraph about how Vioxx should be re-introduced to the market with the appropriate warnings. However, Merck should not be blameless in the Vioxx fiasco. Merck pursued a marketing campaign targeting people who should not have been given more expensive, less studied drugs, when current therapies worked. The ads should be: take naproxen for pennies a day and have 80% chance of 80% quality of life but a chance of GI issues, if you are among the 20% where naproxen doesn't work, take Vioxx for dollars a day and accept its risks.

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7. thump on April 7, 2008 5:26 PM writes...

rat poison, huh? Ever hear of Warfarin? It is still used pretty often.

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8. Jose on April 7, 2008 6:52 PM writes...

"people are entrusting their lives to drugs to cure them not kill them"

Do you drive, or ever fly? You (presumably) happily accept the risk of these!

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9. sroy on April 7, 2008 7:49 PM writes...

Well I agree that

1] The FDA should take the hit if they approve unsafe drugs. I mean it is THEIR job to ensure that the approved drugs are safe.

2] It is true that people expect drugs with no adverse effects. That is very hard to achieve (if at all possible)- especially when it comes to rare but nasty side effects.

However educating consumers about the risk/ benefit analysis is the job of pharma marketing.
For reasons that elude me (sarcasm), those marketing guys seem to be more interested in pushing drugs for RLS and GERD, than educating people that heart problems in a few people due to an anti-cancer kinase inhibitor are not a big deal (given the alternative).

3] A significant part of the the problem mentioned in 2] results from living in a system where the education is dumbed down and the culture is excessively feminised/ risk averse.

Do you think we would have the chemical industry, pharma industry, nuclear power, artificial satellites, airplanes or pretty much anything which is necessary for modern life if we had always been so risk averse?

4] For the love of god- do not try to put vioxx in the category of a good but unfairly maligned drug. Any drug that kills more people from all causes than another older drug which has the same therapeutic effect and is much cheaper is not a good drug.

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10. vioxx victim on April 7, 2008 9:47 PM writes...

I agree we need the scientists to continue to come up with drugs to help and cure us. But we also need the companies to tell the public when their trials turn deadly. If Merck would have taken the right path and been up front with the trial information it would have saved lives. This deceit should not be tolerated by the American public and by our Doctors.

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11. TW Andrews on April 10, 2008 11:28 AM writes...

people are entrusting their lives to drugs to cure them not kill them

That's mostly because they don't know very much about how drugs work, or have a realistic idea of what can be expected from them.

Some of this can be pinned on poor science education, some on the (implicit) claims of drug manufacturer in their marketing material, and some portion of it on the fact that people who are in the position to need drugs really, really want to believe that they're getting a cure.

The fact is that most drugs on the market today are actually pretty barbaric in their treatment of the systems they interact with. Sure, many of them end up muting the manufacture of a particular protein, or catalyzing this-that-or-the-other reaction, which in turn addresses the problem the drug was created for, but along the way a lot of other systems are impacted. When we're lucky, Med Chem people like Derek and his friends the pharmacologists are able to find ways (either by modifying the drug or adjusting the dosage) to minimize these impacts--but rare (mythical?) is the drug that is so selective it only does what it needs to and absolutely nothing else along the way.

Someday, a long time from now, we'll have a very good understanding of how the human body works, and we'll regard the current state of pharmaceutical medicine in the same way we currently think of bloodletting.

But for now, it's what we've got.

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12. James Powell on April 12, 2008 12:41 AM writes...

This is a very hard call- I am for the regulating athority taking the responsiblity for the safety of the drug. When the regulator (be it FDA or any other) sees the data for a new drug, they have "experts" look it over, and evaluate it. Derick has repeatedly gone over a lot of what is evaluated for- basically, it is the risk:benefit calculation. Vioxx is a interesting case, as it would seem to me that it was pushed into too many people too fast. It was sold to people as being rather less side effect prone as other choices. That is something which takes time to find. I'm also with people who say that the date of patent should be from date of approval- that way, if it takes 10 years or 20 years to prove a drug is better than what is already there, then it does not mean the company is left with a very short time to recoop the development costs of the drug. (if the net is that companies loose money, no one will spend $ on discovering new drugs...). I think that patent reform needs to address that particular issue.

So- where does that leave us? 1. FDA should take responsibility (or gov legislate 0 responsibility for approved drugs),
2. Patent laws need adjusting to allow for 1. and a reasonable profit margin

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13. TNC on April 12, 2008 1:26 AM writes...

rare (mythical?) is the drug that is so selective it only does what it needs to and absolutely nothing else along the way

I'd like to hear examples of exactly this; in the med chem world, this does appear to be the strived-for ideal.

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14. NeoCon on April 14, 2008 10:04 AM writes...

I agree. All corporations should be exempt from any government oversight and exempt from any proscecution.

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15. NeoLib on February 27, 2010 2:56 AM writes...

Only if you wish to serve as low slave to Viacom, NeoCon

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