Dewey, Chetham, and Howe at it again

This is Dave Young's Forum.
Can you really bridge the gap between reality and training? Between traditional karate and real world encounters? Absolutely, we will address in this forum why this transition is necessary and critical for survival, and provide suggestions on how to do this correctly. So come in and feel welcomed, but leave your egos at the door!
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

Medicine is always a cost/benefit proposition. It's important we not pollute the information gathering process with punitive actions.
It is more important from the start that we not pollute the information gathering process with misinformation.

Gene
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

The problem we have here is that it took millions and millions of doses of Cox II inhibitors to begin to see this barely measureable increase in risk.
The risk increase was 3.9. Not barely measurable, by any means.

Gene
User avatar
Bill Glasheen
Posts: 17299
Joined: Thu Mar 11, 1999 6:01 am
Location: Richmond, VA --- Louisville, KY

Post by Bill Glasheen »

Not true... I compute odds ratios all the time.

It takes years of doing something to cause a cardiovascular event. And then you have data variability. It takes millions of doses over many years to find something with that distal a clinical outcome to come out as a statistically significant odds ratio (so different from 1.0 that it isn't due to random chance.) We see higher-than-normal risk scores all the time that turn out over time to be due just to statistical noise. Sometimes you'll flip a coin 10 times and have it come out as 10 times heads.

And those kinds of risks are computed only after removing variability from myriad other sources. Lots of things cause heart attacks, like the kinds of things that make people want to take analgesics in the first place.

FYI

You're view of how information should be shared shows a total disconnect with doing business, Gene. I've told you repeatedly that things often are held to the chest BECAUSE of our litigeous society. You continue not to accept that.

And there are other issues with open research practices. This is a brave new world where NIH and NSF and the FDA do not do the research. They are putting that all on the companies to fund independent entities to do all that. It's not all the rosey, gotta have it this way world you'd like to see. There are plenty of business realities to deal with, not the least of which is corporate espionage. Ask Bill Gates (software) and Hollywood (DVDs) how much money they lose to China piracy these days.

And once again on the "misinformation" business... That's lawyer language (a.k.a. misinformation), Gene, used to sell their slimey lawsuits to people who don't understand the science.

Walk a mile in their shoes...

- Bill
Valkenar
Posts: 1316
Joined: Mon Aug 21, 2000 6:01 am
Location: Somerville, ma.

Post by Valkenar »

Bill Glasheen wrote: Ask Bill Gates (software) and Hollywood (DVDs) how much money they lose to China piracy these days.
Okay, this is kind of off-topic I guess, but this is not a valid point. They aren't losing money to Chinese piracy, they just aren't making as much as they legally should. It is not reasonable to describe it as a cost, any more than it would be reasonable to describe Mac users as costing them money.

PostPosted: 25 Aug 2005 14:24 Post subject:
Not true... I compute odds ratios all the time.

It takes years of doing something to cause a cardiovascular event. And then you have data variability. It takes millions of doses over many years to find something with that distal a clinical outcome to come out as a statistically significant odds ratio (so different from 1.0 that it isn't due to random chance.) We see higher-than-normal risk scores all the time that turn out over time to be due just to statistical noise. Sometimes you'll flip a coin 10 times and have it come out as 10 times heads.

And those kinds of risks are computed only after removing variability from myriad other sources. Lots of things cause heart attacks, like the kinds of things that make people want to take analgesics in the first place.
I've told you repeatedly that things often are held to the chest BECAUSE of our litigeous society. You continue not to accept that.
You telling him something doesn't mean you can accept it. I can agree that some things are kept secret due to litigation, but there's no way companies would suddenly become noble and forthcoming about the problems if lawsuits ceased to be possible. What's your explanation for how that would work? What possible reason would a company have to tell the truth when there's no financial repercussion to lying?
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

Histoy shows time and time again that drug companies have always sought to hide data, minimize findings and weasel out of research on drug safety. Examples are well known. They habitually are dragged kicking and screaming to do what's right.

Removing the threat of litigation would just reward them for being obstructionist all this time. They will get what they wanted.

What you want to do, Bill, is reward bad behavior.

Yes, Bill. I have read your repeated posting of how things are often held to the chest because of our litigious society. And perhaps you are true.

Holding information close to the vest is a valid business decision. But withholding information that Merck had a duty to disclose was a sh!tty business decision and was illegal. Even our friend, Dr. Ian, agrees.

And please, Bill, go right on saying how much I use "lawyer speak" when writing here. I consider it a badge of honor and that I understand the issues better than you.
There are plenty of business realities to deal with
Ahh, now we get to why this frosts Bill so much: He thinks companies should lie, trick and prevaricate if its in consonance with business realities!

Gotta run. I've got LSAT class in an hour!

Gene
User avatar
Rising Star
Posts: 280
Joined: Wed Aug 24, 2005 12:31 pm
Location: Townsend, MA
Contact:

Post by Rising Star »

Gene, come back don't do it. Did the LSAT thing, kicked butt, got into law school, graduated early with honors, passed the bar the first time.

Now all I want to do with the law is be the legal consultant to the Junior Tourney Series and the Rules Committee. I much prefer the ongoing and exciting challenge of opening and growing my own dojo. Most lawyers make little or nothing anyways these days, trust me I know!
It's what we do!
IJ
Posts: 2757
Joined: Wed Nov 27, 2002 1:16 am
Location: Boston
Contact:

Post by IJ »

"Another random question: It's all well and good to take the view that in a perfect world people wouldn't seek to lay blame and everyone would just work together to fix mistakes. But without lawsuits and punitive damage, what is there to incentivize companies to do what's right? Isn't there a clear history of corporations doing a cost-benefit analyis of fixing safety concerns vs. paying off people hurt by flawed products? If the price of paying off hurt people goes down, wouldn't that just make it more profitable for companies to ignore, downplay or conceal problems?"

Not random at all! The question is, what system besides punitive lawsuits would induce companies to act the right way? My view is there will always be a balance... people must have a profit incentive to develop good stuff. But there must also be incentives to develop good, not terribly rewarding stuff. Some examples:

Vaccines (see Waxman quote above) are not big investments but they are crucial. To keep them coming the government tried (the lawyers are trying to ruin the process for all of us) to take well-intentioned companies that make them out of range of punitive lawsuits. You see, a perfectly made vaccine may occasionally injure someone, often a child--or more often, that child will have a condition RARELY associated with vaccines but that will almost always generate a punitive lawsuit and usually a verdict despite the iffy link. The resulting damages outweight the meager profits and a smart company will stop making vaccines until they are protected, as we have tried to do, from greedy attacks.

I already mentioned eflornithine, the "resurrection drug" that the USA stopped producing because of financial concerns. Hairy upper lips have since brought that wonder drug back into production :roll: . Can government subsidize such products, or incentivize their production, or can companies use the loss as good PR? YES.

Lemme flip your question around: must we always FORCE merck to not do the wrong thing--or is there a way to remove the incentive to misbehave, or to reward good behavior? YES. Government should be able to hold a future merck UNTOUCHABLE if its future Vioxx is 1) developed and studied ethically and approved by the FDA 2) studied appropriately post market and 3) promptly and responsibly portrayed to consumers and doctors by the maker. Patients should be asked to, while reaping the tremendous benefits of modern pharmaceuticals, simply ACCEPT that adverse outcomes are a part of life and may or may not occur with their treatment. If they want every benefit of medicine YET want to retain the right to crybaby and sue for untold millions when they have a side effect that took time to discover, they can move to planet FANTASYWORLD. Thus, in my system, if Merck had simply reported possible concerns as soon as possible and not FOUGHT with doctors trying to learn the truth about Vioxx, and had taken ethical steps such as having an independent body of physicians advise them of appropriate warning labels and informing patients of untoward effects some of which might not yet be known, they should be held IMMUNE to lawsuits.

Merck should, on its own, also recognize the PR and financial consequences of being less than forthcoming to make a buck. I sooo wish they had.

Is there some other way to encourage a future Merck to be completely transparent about a drug fault when they make 1/4 of their profits off it? Tough. It's be nice if their compensation was guaranteed if they did the right thing, but that's impossibly expensive. Maybe they could be at least reimbursed for development expenses? Perhaps this step could be taken for at least medically necessary drugs. We really need a gut motility drug, for example. An AIDS vaccine. Etc.

I remember at one point a major automotive maker faced two simultaneous lawsuits--the first from a family whose kid had been paralysed by an airbag that deployed at government mandated speed (!!) and the second from the family of a girl who drove off a road asleep and died perhaps because she CHOSE to buy a car not equipped with an airbag (!!). Whatever the outcome, that automaker, doing basically the right thing in following standards and allowing choice, got spanked by opportunist lawyers on both sides. This is the nonsense we must prevent.

Beware, all ye who dislike doctor babble, for Gene took me up on my aldactone example:

Re: aldactone and CHF, this drug, which carries a risk of causing high potassium which can be harmful or fatal, was shown to substantially reduce death in advanced heart failure. Yet, after this finding occured, evidence accumulated that CHF deaths weren't down, and high potassium was more common. Basically, the strict inclusion criteria for this trial and the varying characteristics of patients and kidney function and baseline potassium are complicated. An MD might NOT order aldactone for a patient who qualified for it by the trial criteria, and if that patient died, s/he could be sued, BUT the doc might have been right that the benefits outweighed the risks in that individual because that person, while meeting the criteria for the trial, may have been so unlike most of the patients studied that the results could not have been generalized to the patient. OR a doctor might try to broaden use of the drug to slightly less sick CHF patients to help more people and get dinged when one of those gets a high potassium.

Basically, even if there are guideliness, even if there are studies, there are tremendously complicated statistical questions that need to be answered and that national experts disagree about as far as subgroups, patient characteristics and individual risk, and so on. I've prepared a lecture on this topic and the summary is 4 pages 10 point single spaced. It takes my medical residents an hour to review the basics and much longer to process it and make up their own minds and then they differ. Frankly, a dozen high school educated people faced with a grieving widow and arguing experts is not able to take this GRAY issue and squash it into the BLACK box of 100% guilt and million dollar per patient liability or the WHITE box of pure innocence. To settle such issues in the court is stupid.

No one can say if vioxx caused this or that heart attack or whether the patient would have taken the drug after hearing the risk or whether they might have died anyway or earlier without the drug because of a GI bleed from the ibuprofen they took instead or a lack of exercise due to pain. Merck made a broad error and has broad liability, but damages for specific lost wages are plain nuts.
--Ian
IJ
Posts: 2757
Joined: Wed Nov 27, 2002 1:16 am
Location: Boston
Contact:

Post by IJ »

Gene, Bill had a good question before: what would an ethical person do if they made many millions of dollars as a trial lawyer, and then found out that they were wrong, and had driven up malpractice costs, destroyed a company, and so on?

Is this just the price of progress, a side effect of punishing those really bad doctors who WERE wrong? Like sending innocent people to jail or the death chamber, except on a lower standard of evidence? What restitution is due the injured party in that case? Do you keep the millions? WWJD?
--Ian
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

what would an ethical person do if they made many millions of dollars as a trial lawyer, and then found out that they were wrong
You're going to have to define "wrong".

Interesting question. The Constitution has that answer - or at least it's a good place to start. Reference previous post on the 7th Amendment.

Gene
Last edited by Gene DeMambro on Fri Aug 26, 2005 3:12 am, edited 1 time in total.
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

Not true...
"Rofecoxib has now been taken off the market by Merck, following the premature cessation, by the data and safety monitoring board, of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, which was designed to determine the drug's effect of benign sporadic colonic adenomas. This action was taken because of a significant increase by a factor of 3.9 in the incidence of serious thomboembolic adverse events in the group receiving 25 mg of rofecoxib per day as compared with the placebo group."

Fitzgerald GA, Coxib and Cardiovascular Disease. NEJM 351;17: 1709-11

I apologize. I need to brush up on proper citations.
BUT the doc might have been right that the benefits outweighed the risks
That's the patient's job, Ian. But we can talk informed consent leter, if you wish.

Gene
Gene DeMambro
Posts: 1684
Joined: Sat Dec 12, 1998 6:01 am
Location: Weymouth, MA US of A

Post by Gene DeMambro »

Rising Star:

Just started Doctoral school, so jurisprudence will have to wait a year or two. But no harm in preparing now!

Gene
Valkenar
Posts: 1316
Joined: Mon Aug 21, 2000 6:01 am
Location: Somerville, ma.

Post by Valkenar »

IJ wrote: Not random at all! The question is, what system besides punitive lawsuits would induce companies to act the right way?
I should've clearly defined "right way" but that's okay. I meant more in terms of dissuading them from malicious behavior, rather than persuading them to behave altruisticly.
Can government subsidize such products, or incentivize their production, or can companies use the loss as good PR? YES.
I agree with your statement about the vaccine incentives and think that is a fine mechanism. I wuold never suggest suing a company for failing to produce a product that it would be nice of them to make.
Government should be able to hold a future merck UNTOUCHABLE if its future Vioxx is
So is it your belief that as it stands a person is able to succesfully bring suit for experiencing side effects which they were clearly informed of prior to taking the medication? As I understand it, these suits are *only* succesful when there is some kind of negligence or maleficence.

That being the case, how does your system differ from what already exists? You say if they "promptly and responsibly portrayed to consumers and doctors by the maker" they won't be sued. But what if they don't? Then they would be subject to legal action, no? Isn't that the situation we presently have? As far as I can tell, the only difference is that it would not be possible to bring suit at all until it is proven that the company has done some wrong. But how can that wrong be proven except in court? Would revelation in the press be enough? If not, what stops a company from simply keeping its mouth shut about side-effects, knowing that nobody can possibly sue them and find out that they were hiding it?
Patients should be asked to, while reaping the tremendous benefits of modern pharmaceuticals, simply ACCEPT that adverse outcomes are a part of life and may or may not occur with their treatment.
I think people do that every day. Do you believe that anything like a majority of negative side-effects result in lawsuits?
Merck should, on its own, also recognize the PR and financial consequences of being less than forthcoming to make a buck. I sooo wish they had.
Not to be too cynical, but as far as I can tell PR is not as significant as people make it out to be. People have short memories, and generally think with their wallets. That, and as far as I can tell almost nobody cares what another company does if they don't perceive that they personally were wronged.
Maybe they could be at least reimbursed for development expenses?
Are there not government grants for medical research? I would certainly expect that if companies were being paid to develop medicines, that those medicines would become public domain quite quickly since ultimately we're the ones taking the risk on the research. I have no problem with government-funded vaccine research though, I think it's a great idea.
Whatever the outcome, that automaker, doing basically the right thing in following standards and allowing choice, got spanked by opportunist lawyers on both sides. This is the nonsense we must prevent.
I would like to know how those cases turned out, but I'll leave that aside. The question is, how do you make a situation where it's possible to get compensation and punish companies who do wrong while still preventing this "nonsense"? How would you determine, before the legal process, whether a given complaint has merit or not? What is your process for assessing the legitimacy of a complaint? There are a lot of cases that get thrown out because they have insufficient grounds, are you just saying that there should be more of this?
Beware, all ye who dislike doctor babble, for Gene took me up on my
Actually I love doctor babble.
To settle such issues in the court is stupid.
...
Merck made a broad error and has broad liability, but damages for specific lost wages are plain nuts.
I agree that whenthere are multiple factors it isn't reasonable to pin all the blame on a single one. I would argue Vioxx's liability in dual case should be equal to the proven increase in risk that their product creates, based on their concealment of this fact..

They have broad liability, but who is going to do the penalizing, if not individuals? The government?
User avatar
Bill Glasheen
Posts: 17299
Joined: Thu Mar 11, 1999 6:01 am
Location: Richmond, VA --- Louisville, KY

Post by Bill Glasheen »

Gene wrote: And please, Bill, go right on saying how much I use "lawyer speak" when writing here. I consider it a badge of honor and that I understand the issues better than you.
Why do you find it necessary to tell me this after you've been unable to show it?

Funny guy! :?
Rising Star wrote: Most lawyers make little or nothing anyways these days, trust me I know!
True statement. My brother retired, read the law, and then hung his own shingle up to do general practice. He doesn't really make much in the way of money, but understands the personal fulfillment of ethical business practices. "Tort reform" doesn't apply here. The majority of attorneys understand the fulfillment of providing useful services.

You find the criminals in every profession - including medicine. Software I help design and maintain measures physician efficiency. When it comes to looking for the bad guys, it isn't hard finding them. Those are the ones who are several standard deviation units away from the mean in behavior. A closer look reveals that what they do has little to do with providing a service; they are in it to take everything from the system for themselves that they can. Don't let the white coat fool you. One physician who used to work for me used to go out in the field and have "talks" with these characters. She was an amazing woman - an MD with an MBA who did work in the free clinic once a week. After coming back from her first visit, she told me she felt like she needed to take a bath.

A law degree is a license for this kind of person to steal and claim they do it legally.
Justin wrote:
Bill Glasheen wrote: Ask Bill Gates (software) and Hollywood (DVDs) how much money they lose to China piracy these days.

Okay, this is kind of off-topic I guess, but this is not a valid point. They aren't losing money to Chinese piracy, they just aren't making as much as they legally should. It is not reasonable to describe it as a cost, any more than it would be reasonable to describe Mac users as costing them money.
We've had these discussions before, Justin, on the topic of online music piracy (a.k.a. stealing). I remember I couldn't convince you that this practice wasn't ethical. It still amazes (and concerns) me.

There's a BIG difference between lost revenue to a legitimate competitor in a free market (Apple) and lost revenue from stealing (such as the "five finger discount" in retail, music piracy, video piracy, corporate espionage, breaking in and entering, bank robbery, etc., etc.).

Some time when you get a chance, check out what it costs to produce the average blockbuster film that you probably enjoy like the next guy. There are a LOT of people who put a LOT of creative efforts into those causes. But yet it's OK for folks in China to get a digital copy and start selling it?

Justin do you know one of the biggest reasons why the price of a gallon of gasoline is going up today? (Hint - it has nothing to do with the Iraq war.) If the China economy is booming so well, don't you think they ought to pay full price for those American services they enjoy?

Whenever someone in the system takes what is not their's, everyone is hurt.

The fact that we need to have these discussions confirms my suspicions that there's some ethically bankrupt thinking going on here. And I love it when the ambulance chasers want to wrap themselves in the "ethics" and "the little guy" flag.

Amazing...

And speaking of stealing...

Gene, I hope you don't mind me telling you that I don't really read your posts with that much detail. Evelyn Wood would be pround... Let's see, what was your language.. You consistently show yourselves to be an apologist for lawyers who deserve to be in jail for their immoral behavior.

I found this little piece amusing...
Bill wrote:
Gene wrote:The biggest winners are the lawyers - every single time.

Good for them. They took on a huge case.
Wow... All this activity, and everyone is hurt but the lawyers who make a fortune. And you can't see the harm in that. It's law school, and dollar signs, and rationalizations for a status quo that is causing harm.

We had a similar case in our local news here, Gene.
Arrests in Henrico home invasion

From NBC12 News
Thursday, August 25, 2005


Four people were arrested Wednesday after what police describe as a bold, daylight home invasion in eastern Henrico County. Police say there were people in the home in the 12-hundred block of Herman Street near New Market Road, when four men stormed into the home about 3:30 yesterday afternoon.

Police were alerted and an aerial unit was able to pick up on a suspicious vehicle, leading to a brief chase and arrests.

There were no injuries.
So how about those 4 fellows, eh? Good for them. They took on a huge case. Think of the risks they took, after all. I know of at least 3 homes in the county were these Robin Hoods would have encountered an "interesting" response.

You know the difference between these four and the ambulance chasers you so predictably defend, Gene? A law degree.

- Bill
User avatar
Bill Glasheen
Posts: 17299
Joined: Thu Mar 11, 1999 6:01 am
Location: Richmond, VA --- Louisville, KY

Post by Bill Glasheen »

Gene wrote: "Rofecoxib has now been taken off the market by Merck, following the premature cessation, by the data and safety monitoring board, of the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, which was designed to determine the drug's effect of benign sporadic colonic adenomas. This action was taken because of a significant increase by a factor of 3.9 in the incidence of serious thomboembolic adverse events in the group receiving 25 mg of rofecoxib per day as compared with the placebo group."

Fitzgerald GA, Coxib and Cardiovascular Disease. NEJM 351;17: 1709-11
Hey Gene, what does this have to do with arrhythmias? Wasn't that what the defendent died from?

Just wondering...

BTW, this is on an NIH website
In late September, 2004, Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.
Wow, a voluntary withdrawal. Imagine that - a big, bad, money-hungry drug company doing the right thing.

What's the world coming to?
Gene wrote:
Bill wrote: Meanwhile, who is sueing Bayer because they have stomach bleeding from taking aspirin, or died from a hemmoragic stroke from the same? Or lost their kidney from taking a lifetime of aspirin? Nobody.
Warnings about aspirin are printed prominently on every bottle. Not so with Vioxx. Merck fought like hell to get cardiac warnings out of the product info.
No need to go through all the "by the hour" arguments from you, Gene, when just one or two faux pas like these make it so easy.

You could be forgiven here because of your youth, but you really should know better. Aspirin has been on the market for generations with no warning labels. Many have died from using aspirin, and they didn't know any better. And many have enjoyed its therapeutic benefits.

And you have no factual basis for claiming that Bayer didn't fight "like hell" to put warning labels on their aspirin bottles (or that Vioxx did...). Furthermore, you don't get anywhere near the product information inserts with aspirin like you do for modern drugs - including Vioxx.

Got any knives in your kitchen, Gene? If you cut yourself, are you going to sue the manufacturer because they didn't warn you? If so, maybe we should limit you to plastic utensils, like the precedent set in airplanes today. We wouldn't want you to hurt yourself, after all...

- Bill
Valkenar
Posts: 1316
Joined: Mon Aug 21, 2000 6:01 am
Location: Somerville, ma.

Post by Valkenar »

Bill Glasheen wrote: We've had these discussions before, Justin, on the topic of online music piracy (a.k.a. stealing).
The correct term is copyright infringement.
I remember I couldn't convince you that this practice wasn't ethical. It still amazes (and concerns) me.
Well you obviously didn't read my position very closely if this is your understanding of it. However you are right that your argument was not persuasive. But that's a different subject, and I'd rather not totally derail this thread.
But yet it's OK for folks in China to get a digital copy and start selling it?
I said no such thing. I said that it's not a cost, and it isn't. They are not "losing money to China." That simply is not true. This is why it's dishonest to call copyright infringement theft. Do I really have to explain the why?

The above paragraph does not say that it's ethical to infringe copyright.
Gene, I hope you don't mind me telling you that I don't really read your posts with that much detail.
Or in other words "I don't know what your point is but I'm going to tell you it's wrong anyway." Seriously Bill, if you're going to take the position that you don't need to bother reading other people's messages, what right do you have to get upset when you think they haven't read yours? Moreover, why should anyone bother talking to you if you're going to ignore what they have to say?
Post Reply

Return to “Realist Training”