Topic somehow came up in the death penalty thread and another poster encouraged me to start this thread. I worked at a major law firm that represented some of the largest pharma companies in the world on cases where they were accused of withholding clinical trial data that disclosed that their drugs had fatal side effects.

I can't ethically disclose specific details of those cases, but I'd be happy to answer any general questions. To be really honest, I don't even remember the specifics (since it is incredibly complicated, which actually is what enables them to manipulate data...most people won't know).

And I'm not claiming to be any expert by creating this "ask me" thread. Certainly others are much more knowledge than I, so let's use this thread to encourage general discussion. But I will answer questions that I can.

I'm going to sleep soon, though.

Do you ever feel ethical qualms with your job? Much like a lawyer defending Big Tobacco; yeah you're making bank and yeah you're doing what is constitutionally mandated and can't be blamed, but don't you ever just feel a little bit of sadness?

Not an attack on you; I want to go into law but I worry about that sometimes.

WAS my job. But yes I did. I remember working and thinking that I can't believe I'm doing this. My firm was paid $12 million in fees to write a "neutral report" about one pharma company after a 6-month investigation. Who is going to write a neutral report when the company itself is paying you $12 million? Write one report that is unfavorable and see how many more companies are gonna hire your law firm when every other law firm in the world would kill for that job. The worst part was that it is labeled a "neutral report," so the company afterwards can be like, "look at this NUETRUAL report that shows that we're the most ethical people in the world" (ok, exaggeration). Yeah, the opposing counsel can cross-examine to show how it might not really be neutral, but the label is there and the housewives and constructions workers on the jury see that before they understand the complexities of manipulating complicated clinical trial data.

Sorry, just reread where it was 'worked'.

How much work on the neutral report did you actually do? I'd imagine most of it would be seriously delegated and micromanaged.

and srsly lol and at the same time to all of it.

I did a lot of the grunt work. I'm 29, and was only there for a short while. I was the lowest level associate on the team. Good thing is that you get inundated (sp?) with facts and details so that you know the cases upside down and backwards, bad thing is that you're stuck in that minutia and it can be a real grind.

Last question which is off topic I guess:

Still a lawyer?

nope. poker player.

well, I have a couple cases that I work on, but nothing pharma related.

Ever read "Thank You for Smoking"?

Thanks for offering to discuss, fds. I recently was trying to be a pharma sales rep, but decided to head in another direction.

Must have been tough to sleep at night doing this...were you compensated well? How much?

What do you think the role of the FDA is in all of this? Could they have done more, are they part of the problem etc etc?

ugh, to much politics going on with the banks and Pharm companies.

No. Didn't see the movie either. But I've heard good things.

The pharma reps and general marketing practices is a huge issue, too. We had to review all the training materials that were used to train the sales reps to see if the companies were training the reps to market the drugs for off-label uses - meaning any use not approved by the FDA. A doctor can prescribe a drug for any use he deems medically appropriate, even if the FDA has not approved the drug for that use. But the drug companies cannot market their drug for off-label uses. Needless to say, they do. They also take doctors on extravagant trips for "educational seminars" about their drugs, which basically means the doctor gets a 4-day vacation in the bahamas to go to a 1-hour "educational seminar" (read: sales pitch) about their drug, all expenses paid.

I'm sort of rambling, but the point was you considering being a pharma rep, and I certainly couldn't do it. It is also incredibly competitive. That's another thing -- there is no incentive for the reps to not push their drugs for every use possible, regardless of the risks, because they get paid in commition (or at least a large percentage of their income is based on their sales). So yeah, it's like getting paid to sell cars, except with a product that could kill people.

I was paid very well, especially for my age. With my bonus, I made about 200K per year. And I was the lowest paid because I was entry level.

This requires a long answer, which I might provide later. But yes, the FDA is certainly responsible as well. "Could they have done more?" Yes. That said, sometimes the FDA is working with maniupulated data that the pharma companies submit, so the FDA makes it's decision without all available information -- and, believe me, the withheld information is always unfavorable for the drug.

You have to remember that the financial incentive is just ridiculously strong. these drugs can make these companies billions and billions of dollars. It gets to the point where it is economically sound for them to get the drugs approved and market them any way they can - even if they know of significant risks and are not disclosing them - because the profits will easily outweigh any fines paid to the FDA, NYAG, DOJ and all the payouts and expenses of civil litigation. For instance, it is public knowledge that Merck set aside $700 million to defend against all the Vioxx cases, and they will likely need to pay more. While that number sounds quite large, it is insignificant compared to the billions of dollars generated by Vioxx.

Also, drugs that can treat a condition but not cure it are always the drugs that are most likely to be manipulated because they generate the most profits. Think about it -- if a drug can cure a condition, then people no longer need to buy the drug. But if it only treats a condition, then people will have to buy endless supplies of those drugs.

Again, kinda rambling. Sorry.

Huh? What drug cures anything?

While defending all these depositions, did you ever get sick of seeing the same old "doctor" who was really a professional "expert" every single trial?

I think the sewers, and those being sewed are normally both equally to blame.

what was your firm's role? if you were representing the companies, why were you preparing a neutral report?

Certain drugs alleviate a condition ("take this for 2 weeks and you'll be fine") whereas other drugs can only tame down a condition and need to be taken indefinitely. For example, NSAIDs could not cure arthritis, but only tame the pain, and you had to take them until you died; once you stop, the pain returns (same the with antidepressants, etc.).

In the cases that I worked, the experts truly were the world's greatest minds on the subjects, not just some hack who has decided that he could make more money doing expert reports. Those guys certainly exist, though.

The question of who is equally to blame - the plaintiff or defendant - is very case specific. A broad generalization is unfair imo.

We played multiple roles depending on the case:

I defended criminal investigations by the DOJ and NYAG.

I defended a securities fraud case brought by the company's shareholders. Here, what happens (at least allegedly) is that since the company did not disclose this negative information to the public, the stock price of the company was artificially inflated. Once the news is disclosed (by whatever method), the stock price drops to a level that it should have been trading at the entire time. The stockholders that got ****ed then file a class action lawsuit against the company.

I also worked as an independent investigator. The way this works is that the shareholders are suing derivately, not directly against the company. In order to do that, they have to make a demand on the board of directors to investigate if their claim has merit. Since the board of directors is biased, they hire an outside independent board of directors, who are "intended" to be neutral. They then hire a law firm to do the investigation. The company is paying the bill, though, so this is never really neutral.

If you're going to post in this thread just to take potshots at OP, you'll be infracted and banned.

You give good reasons why these reports aren't neutral, how biased are they though? I would expect some code of ethics in law firms to try to be as neutral as possible, not only because it is the right thing to do, but because if people find out they were not independent observers, then they could not be trusted again. I mean, if I know someone is not trust worthy as a third party, then why should I trust his opinion? It seems that being known as someone reliable and objective would also be good for a firm.

I'm exaggerating to an extent. These reports are incredibly detailed and, for the most part, pretty accurate when it comes to reporting the actual facts. The problem is that usually the facts are undisputable, but the "when did the executives become aware of this" or "who ordered this" or "what scientific reasoning did you use to exclude patient X (who suffered an adverse effect) from the trial data" or "what scientific reasoning did you use to disregard this entire clinical trial (which obv showed very unfavorable results for the drug)" are all very subjective questions. Obviously, it is not written incredibly one-sided like a legal brief, but the ultimate conclusions are almost always favorable to the company. Some small bull**** will be reported negatively to try and act like its "neutral" but the ultimate conclusion usually is not. I worked on one, I saw the data, and I could not believe what our final report concluded. And I've read others.

Huh?

Lots of drugs cure things.

Antibiotics for one. They're overused, and misused, but they cure infections.
I live a short drive from Virginia City - there are several neat old cemeteries up there. One of them has a whole run of kids from the same family who all died of scarlet fever. We don't see that any more.

Epinephrine cures anaphylaxis. Prilosec cures reflux.

A fair number of meds are only palliative, but there are a fair number of cures.

MM MD