Drugs have side effects. Does anybody feel better about the television commercials touting "may" "increased risk" "rare" - they told you...

Face it, most people are too innumerate to understand the risks vs the benefits, and are too conditioned to accept authority (doctors) to question the treatment they get.

Meanwhile, we have the commercials from all the lawyers. "Have you or a loved one suffered or died from taking X?"

Since the FDA is looking out for us, why is this happening?

What about the other side of the problem? Namely the people who might have been helped by a drug that is still waiting for approval - or wasn't approved because of side effects? If you had a disease that was goiing to kill you in a year and a drug offered a 60 percent chance of saving your life, but a 40 percent chance of killing you, would you take it? Too bad, the government won't let you - it's too dangerous.

I say publish the data as a condition of approval. Make the officers of the company liable for undisclosed side effects that were known.

I'm an adult. I make my own decisions and I own the consequences.

Take a deep breath and say this "every freaking drug out there has side effects". Every one. I was taking meds for hypertension that were not leading to a perfect BP. Doc changed them to new ones. I fell over and cracked my head while using the restroom. Went to see doc and he seemed unconcerned. That very same day, I was rushed to the hospital in an ambulance with lights and siren blazing. Seems like my BP was like non existent. My kidneys had shut down and I almost died. On topof that I picked up an infection while in hospital and almost lost a leg. All of that from a simple prescription change. Not all drugs have the same affect on every patient. Bad things can happen with the safest drugs. I personally want the pharmeceutical companies to keep making drugs. They have improved the quality of life for millions of people, including the blog lady here.

I mean, how in the world did we survive the first thousand years without an agency telling us what was poisonous or not? They would be the first in a long line of my cutbacks. Nothing is safe for everyone, so therefore does that mean FDA should approve nothing? And then, we expect them not to take a portion of the billions of dollars in profits as a bribe to approve what they do approve...I mean wave thousands of dollars in perks in my face and I'll probably agree with whatever you want. I'm ethical to a point, but I, like every other person, have a price.

The saddest part about this entire diatribe that no one fails to bring up. Schizophrenics, in most situations, don't have a choice in deciding what medicine to take. And Diabetes is not considered important of a side effect when comparing these medications either.

I was on Abilify for hallucinations at one point. The medicine made it impossible to exercise, as all my muscles would cramp and spasm...and I walked over three miles everyday going back and forth to work. I couldn't ride a motorcycle for longer than fifteen minutes or I would have problems walking. I also had to give up caffeine of any kind. When, I approached the doctor about these awful side effects, he told me to simply stop doing those things. I told him I'd rather see people that weren't there than give up the activities that made my life enjoyable. As he raised my prescription, despite my objections, I found a new doctor. Had I been institutionalized, I would have had no choice.

"Should those side-effects be a secret to those taking them?"

They weren't a secret to anyone who went to enough effort to inform themselves. Go to Google Scholar, type in "Zyprexa obesity" or "Zyprexa diabetes", and look only for papers published between 1995 & 2000, long before the NYT expose. You'll find plenty. The information was out there. If people didn't have internet access back then, they could have found it in public libraries.

It stands to reason that a medicine powerful enough to tackle schizophrenia is powerful enough to do people harm. I'm not letting Eli Lilly of the hook. I'm just saying that when a doctor prescribes you or your children a powerful medicine, you have a responsibility to inform yourself. Government agencies don't absolve you of this responsibility.

Without full disclosure of all the raw data, science simply isn't.

One key advantage of releasing all raw data is that another scientist may look at that data and something may click with work he or she is doing.

(One problem with having drug companies fully disclose everything are those lawyers who will run ads trying to find anyone with one of the side effects, even it had nothing to do with a particular drug. One problem is that during drug trials ALL effects are recorded, even if there was no causative effect from the drug.

Suit happy lawyers don't care about that; they just want their fees. I can't count the number of class action notifications I've received where I get jack shit and the lawyers walk away with tens of millions.)

what joe said. My mother and father both passed away from what was diagnosed as emphysema. My father worked in the shipyard for 30 years, much of it around asbestos. When I see those scumbag lawyers advertising on tv for anybody with any remote link to asbestos, it makes me sick. Does anyone honestly think that asbestos would have been used if companies new the potential health impacts. Being held liable after the fact is an amazing concept to me. Drug companies know their drugs have potnetial side effects. Taking daily meds, I always watch for the symptoms of the published side effects, and do indeed research the same. I take responsibility for my actions, and like I said, I did not hold my doctor liable for trying to help me and missing a bit. I would still argue that the risks (big picture) are miniscule compared to the reward.

This is one, of many reasons, I won't take any drugs. It's very challenging to get full disclosure of the real risks (like the odds ratio rather than just a blanket rare side effects include...)and the majority of times the benefits are way over-inflated. People shouldn't trust their doctors to know best, many of them are remarkably ignorant of chemistry and also just believe what the drug companies tell them. I'm not particularly interested in the gov't telling me how I should do anything or what I can and can't do, but I certainly don't trust the doctor or the drug company to know what's best.

This is one, of many reasons, I won't take any drugs. It's very challenging to get full disclosure of the real risks (like the odds ratio rather than just a blanket rare side effects include...)and the majority of times the benefits are way over-inflated. People shouldn't trust their doctors to know best, many of them are remarkably ignorant of chemistry and also just believe what the drug companies tell them. I'm not particularly interested in the gov't telling me how I should do anything or what I can and can't do, but I certainly don't trust the doctor or the drug company to know what's best.

Is Egilman soliciting donations?

Has anyone looked at the "side effects" of aspirin? Scary! Doesn't keep me from taking it, though. Indeed, I am grateful it was successfully "grandfathered" a century or so back, I doubt the FDA could approve it under today's regs - almost certainly not for more than one purpose.

Too, not all "side" effects are necessarily bad. I take Coumedin by prescription: you may know it better as Warfarin. It was developed, and is still sold, as rat poison - but its effects were noted, there was speculation those effects could actually have benefit in less-than-fatal dosages...

BTW, there was a great pair of reviews in the NYROB lately on the mood-enhancing drugs being prescribed. Scary stuff--the drugs may be making things worse.

And few laypeople will ever gravely cite "medical studies" after reading these reviews.

Medical studies can be primped, like anything else.

All kinds of things can go wrong, but considering the harm we do to our bodies with sedentary lifestyles, horrible diet, and bad habits in general, I'm thinking...big whoop.

Bottom line is that drugs have go through lots of hoops to get approved. If they make it to the general public, odds are tremendously low that anything negative will happen, and that if anything does, odds are very good that it won't be worse than what it is treating.

If you want a magic bullet, cast spells and let the placebo effect do its thing, in the real world, medicine can backfire. Its arguably worse that the 1 in every 1,000,000 whom has a horrible reaction, can expect to get a big cash settlement...for his lawyers...when the other 900,000 just get better.

Its tragic when some horrible side effect happens to someone, but if a drug is widely effective, how can we really be angry at the company on the rare occasions that it doesn't work? There are billions of people on the planet, chances are some people will have rare reactions to things millions have no reaction to at all.

That said though, if a company deliberately withholds information about any dangers...I say hold the CEO criminally responsible, and both the CEO AND the Company financially responsible. With ALL profits from that product seized as assets to the crime.

If deadly side effects are withheld from the public, and publishing them in some obsure journal that noone ever hears about, or an article which never saw the light of day doesnt count. Then everyone involved in the withholding of such information should be charged with depraved indifference murder, or whatever the coresponding charge is in the district someone died.

I gaurntee should a few CEO and reaserch scientsts wind up spending the rest of their lives behind bars, getting charged in a new juridiction everytime they are paroled or served their time in a differetn jurisdiction this shit would stop.

All side effects and their probable percentages need to be spelled out on a pamphlete with the medication.

At that point anyone who chooses to use it cant sue as they can claim they ddnt know the risk.

Resist your Hollywood-script tendency to make Egilman into a hero. He was an expert witness-- meaning that he was hired by the plaintiffs' attorneys to support the plaintiffs' claims in a lawsuit. This is a regular line of work for Egilman and he earns millions at it.

The plaintiffs' attorneys may have hired other experts who came to different conclusions about the effects of Zyprexa and Lilly's disclosure of risk to doctors, but we'll never know.

Why? Because plaintiffs' attorneys are only required to disclose the names and research of expert witnesses that they plan to use at trial. If an expert witness doesn't produce the result the plaintiffs' attorneys want, the plaintiffs' attorney can claim attorney-client privilege to hide the uncooperative expert witness' name and
research from the defendants.

In contrast, Eli Lilly conducts research in order to get FDA approval. Unlike plaintiffs' attorneys, Lilly can't hide contrary results by claiming attorney-client privilege, because Lilly's research wasn't conducted in the course of litigation.

So the plaintiffs and Egilman comb through all of Lilly's research and cherry-pick those data points that support plaintiffs' case, and they hide the data from their own research that doesn't support their claim.

Doesn't make for a sound scientific approach, does it? That's because litigation isn't about science, it's about advocacy for the interests of the parties, with the judge and/or the jury deciding who presents the most convincing evidence and expert witnesses. If you get only one side's data, like the data that Egilman assembled, you get a deceptively one-sided picture.

Egilman isn't without his own interests. If Lilly's confidential information is made public, it becomes easier for other plaintiffs to "piggyback" on the prior lawsuits. The new plaintiffs don't need to do their own, expensive research; they can hire Egilman to testify for them as a ready-made expert. So Egilman's release of confidential information greatly increases the value of Egilman as an expert witness.

How valuable is Egilman's expert witness gig? I'll let the man's own words explain it:

[A judge's ruling excluding Egilbert's expert testimony as unreliable] eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me).

Yeah, this is all about science and the good of the public.

Now what about the $100K he had to pay for releasing confidential information? Here's the 2nd Circuit Court of Appeals opinion upholding the trial judge's irate opinion that nailed Egilman for his dishonesty and general plaintiff's-bar-sleaziness. In short this is what "hero" Egilman did:

1. Signed a protective order forbidding him to distribute Lilly documents he received as part of his role as an expert witness.

2. Once he received the documents he promised to keep confidential, he conspired with Berenson at the NYT and an Alaskan attorney to release the documents in violation of the protective order. At Berenson and Egilman's prompting, the Alaskan attorney issued a sham subpoena for the Lilly documents in a legal proceeding that had nothing to do with Zyprexa.

Hero? No. Self-righteous, dishonest zealot? Yes.

What would you think if you were one of the people who developed diabetes or other diseases while taking Zyprexa?

Psychoactive medications often have an impact in terms of weight gain or loss. This is not because the medications act directly to raise blood sugar or cause diabetes; instead, they effect the appetite of the person taking the meds. Weight gain is not inevitable-- the patient needs to work with their doctor to modify their diet and avoid it, just as they would if they had weight gain without taking the psychoactive medication.

And any thoughtful user should be skeptical of information in document dumps by unethical "heroes".

"Does anyone honestly think that asbestos would have been used if companies new the potential health impacts."

In short, yes, they would.

Every manufacturing process has its hazards. Communicating these, whether it's to the worker or to the general public, depends on a ridiculously long set of circumstances that is assessed correctly most of the time - but not always.

For instance, the use of asbestos as an insulator becomes a hazard depending on how it is supplied by the vendor, then how the product is handled by the yard.

So, if the engineers specify one form, but a different one appears at the loading dock, the hazard can be greater. If the yard has a big problem with high temperatures (think Pascagoula, MS), it might be tough to keep workers in the respirators and suits.

Older structures containing asbestos are supposed to be identified so that any work done, which will send asbestos fibers airborne, will have workers in suits again - but what if the old structure is just abandoned in place, and nobody pays for the labeling? The next crew has to be careful - and if they aren't paid to handle asbestos, the project will get stopped. Then, somebody will do what they can to restart the project.

This isn't an endorsement of shortcuts. It's just an explanation of how they are taken.

Risk = Probability x Consequences. Anybody who isn't personally involved tends to undervalue those terms, and they are likely to view the certainty of losing a project more important than any hazard.

Because, after all, a hazard is not an automatic death sentence for anyone.