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
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Post by Gene DeMambro »

What Panther said. I'm lucky as my house is only a mile or so away from a Verizon CO, so I get max speed 'cause there aren't any distance limitations.

Even though connections usually come at less than optimum speeds, if you aren't getting close to the speed you're patying for, then time to turn the heat up with the provider.

Gene
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RACastanet
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Post by RACastanet »

Thanks for the inputs. A Verizon tech showed up unannounced at 3pm and fortunately I was here. He traced the signal at various points from the main distribution network right up to the modem. Boy would it be neat to have the little digital line reader he had.

Problem seems to have been a combination of my two line phone and a splitter I was using. I had it connected the right way but the splitter was eating up signal and the two line phone was creating dial tone crosstalk.

So, he eliminated the splitter by running two lines and I said goodbye to one phone and hello high speed DSL. I'm now getting a higher speed than advertised!

We shall see how it holds up as the day wears on as the trouble usually occured in the evening.

Rich
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RACastanet
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Post by RACastanet »

One more thing to note...

The tech removed the original phone surge arresters that were installed when the house was originally built in 1987. They had deteriorated over time and were sucking down the speed.

Rich
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Gene DeMambro
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Post by Gene DeMambro »

Not bad of Verizon's part.

As a former QC guy, Rich, how did Verizon do with you vis a vis fixing your problem and getting the customer back on track?

Gene
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Post by RACastanet »

Good question Gene.

I am pleased that someone showed up and had the equipment to quickly find the problem areas. That has prevented me from just cancelling tomorrow. However, it is still intermittant this evening. There is something going on somewhere in the system that is dragging my line down.

The tech gave me his card and cell # so I'll ask him to come back. I'll give it another week but if not 99% reliable I'll go back to dial-up before the 30 trial ends. Dial-up is slow but always works here.

Rich
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IJ
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Post by IJ »

http://content.nejm.org/cgi/content/full/353/10/969

Free full text article from NEJM. People ought to be mad that their drug administration is this stupid. I've always wondered why they will approve a broad spectrum antibiotic like spectracef to treat a minor infection simply handled by penicillin, such as strep throat... when there is, far as I can tell, never a reason for such a use. But some of the things they do are even dumber. Anyone remember natrecor, too?
--Ian
Gene DeMambro
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Post by Gene DeMambro »

Good article. Lots of good stuff.

Gene
IJ
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Post by IJ »

http://news.yahoo.com/s/ap/20050916/ap_ ... lfunctions

See also excerts from NEJM below:

Let's see what comes of this one. Surely there's a lot of money to be made of off Guidant as well. Unlike the Merck case, I haven't heard a lot about the company motives and exact steps in the medical press, and the only lay media I take in is 1-2 minutes of NPR driving or the daily show. Nobody expects these devices to be perfect... and I think another factor is that AICDs (automated implanted cardioverter defibrillators) are

1) designed for sick people whose hearts might stop without warning, so deaths aren't a shock (pun intended)
2) "causing deaths" here only in the sense that they may fail to prevent them. Vioxx (rarely) caused heart attacks; Guidant's devices (rarely) failed to try to reverse a sudden death--and there's no guarantee a perfectly functioning device would have saved that life. Or that the person wouldn't have died 1-3 months later.

While I wouldn't be shocked if a lawsuit came out of this one too, and from the info I have Guidant needs to explain why it didn't warn people about known defects, there's very important math here:

In most of the patients that died, it will not be possible to prove the device failure was "more likely than not" responsible for the death.

So here's my gripe with the tort system. Individuals are not harmed by these errors; populations are. It can't be said if the exact person in question was harmed; honestly, all that can be said is that the average harm is, oh, a few percent, or whatever the math spits out. Everyone involved should receive that fraction of, say, lost wages. But this is not how it will play out, and of course, I don't believe tort is the best way to solve these problems either.

Steinbrok R. The controversy over guidant's implantable defibrillators. NEJM 2005 353:221-4.

Oukrop, then a 21-year-old college student, collapsed and died in a remote area of southeastern Utah during a spring-break bicycling trip with his girlfriend... When the manufacturer analyzed his ICD, it determined that the device had short-circuited internally while trying to deliver high-voltage therapy and had been permanently disabled (see diagram)...

In June, Maron recalled: "We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, `What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, `Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, `I think this is the biggest mistake you will ever make.' They said they didn't agree."

It was subsequently disclosed that Guidant, the second-largest manufacturer of implantable defibrillators, had identified the electrical flaws in the Prizm 2 DR in February 2002 and had made manufacturing changes, on April 16 and November 13 of that year, in an effort to prevent this rare but unpredictable and catastrophic type of failure...

Guidant, however, continued to sell devices that had been manufactured before that change was made and issued no public statements about the problem or the corrections. The company's first announcement came on May 23, 2005 — more than three years after Guidant had become aware of the problem and hours before the New York Times published an article about Oukrop's death...

On July 1, the FDA classified as class I recalls Guidant's recent notifications with regard to Prizm 2 DRs that were manufactured on or before April 16, 2002, and two other models of implantable defibrillators, the Contak Renewal Model H135 and the Contak Renewal 2 Model H155, that were manufactured on or before August 26, 2004. A class I recall indicates the highest level of risk, because "there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death."5 Of 42,000 affected devices of the three recalled types worldwide, 20,600 (including about 13,900 Prizm 2 DRs) are still implanted in patients....

In June 2003, Endovascular Technologies, a subsidiary of Guidant, pleaded guilty to 10 felony counts and agreed to pay $92.4 million in civil and criminal penalties related to its Ancure Endograft system, a stent–graft device inserted by means of a catheter for the treatment of abdominal aortic aneurysms. The company admitted that it had lied to the government and hidden thousands of serious health problems, including 12 deaths. The company stopped selling the system in March 2001, made changes, and reintroduced it to the market in August 2001....

Since the merger agreement was announced, Guidant executives have sold millions of dollars of company stock, according to filings with the Securities and Exchange Commission. For example, on May 17, 2005, Lorell, the chief medical and technology officer, sold 23,300 shares for $1.71 million. On May 23, 2005, the day before the problems with the Prizm 2 DR were the subject of a front-page article in the New York Times, she sold 22,667 more shares for $1.68 million. When asked to explain the transactions, Lorell did not respond. "

((I worked with Dr. Lorell at Beth Israel and knew only that she was the director of the cardiomyopathy clinic. No idea she was a multimillionaire! There are Martha Stewart overtones tho.))
--Ian
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Panther
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Post by Panther »

In June, Maron recalled: "We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, `What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, `Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, `I think this is the biggest mistake you will ever make.' They said they didn't agree."
Why can't those people who made the decision to withhold the information from patients be charged beyond civil fines and wrongful death suits? Why can't they each be charged with multiple counts of negligent homicide? Doctors have malpractice insurance and the vast majority of them dedicate their lives and livelihoods to helping people who are ill and saving lives. It is inevitable that a Doctor will lose a patient. (Just as it is inevitable that we will all die at some point, barring cryogenic freezing and some future miracle :mrgreen: ) But these people KNEW there were defects in their product, worked to correct those defects not once but twice on their assembly line, yet STILL chose not to inform anyone about the defects in the early versions. We aren't talking something that is painful and needs to be fixed but which isn't fatal to the patient, this is something that they KNOW can be fatal to the patient and they have cases that PROVE it. So, perhaps both the Doctors and the Lawyers can let us know why they're immune to criminal negligent homicide charges?
IJ
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Post by IJ »

Better question for a lawyer to answer. I saw a case of a mentally retarded woman who was impulsive and for whom a state pyschiatrist recommended medication and very close observation; the state declined to do either and she later killed a lover. She was sentanced to death. Her lawyer fell asleep during the trial and omitted that the state knew of the risk and did nothing and that the clients capacity to control impulses and make good decisions was limited. My question: why doesn't this incompetent sonafabich have to get tortured with malpractice threats like the physicians his colleagues sue? Or, as Panther asks, why wasn't this negigent homicide?

Short answer per me: in our culture, we don't sue lawyers, lawyers don't sue lawyers, it isn't thought of. It's not on people's radar. When they see lawyer error they think, "retrial opportunity!" When they see doctor error they often think, "cash punishment!" Could it be done? I don't see why not.

As for negligent homicide charges for doctors....

I'd oppose this in all but extreme cases because it would be bad for the system and because of the system itself.

First, charging doctors would ruin careers and deter people from entering the field and accelerate their departure. Maybe this wouldn't be a major loss in a big institution where doctors for some reason will work for peanuts just to have the institution's name on their coat. But expense would be extreme in some cases. What if the small town doctor forgets something (more likely because he or she has to be all doctors for them) and someone dies... who profits if the doctor is charged, jailed, and the town is now doctorless and unable to recruit a new doctor?

The second is that most things that constitute errors have system roots. I just saw "the constant gardner," and believe me, it doesn't matter what doctor you put in the kenyan village clinic, the care will be poor. To a lesser extent this happens in the US too. A doctor is supposed to do a dozen things for a dozen people or more every day in the hospital. He or she may might forget to order low dose heparin to prevent blood clots, quite easily... in fact the rates of this being utilized appropriately are about half in most institutions. If half is being mis-ordered... then any doctor is guilty of an omission and with bad luck or enough time, they'll have a death as a result and could be charged.

The approach to that problem is to fix the system not attack the individuals. Just as with lawsuits, usually.

On another scale think about referral centers. People get transfered all the time to academic medical centers. Sometimes its for obvious level of care (no ventilator at home, patient needs ventilator, send patient to town) but more often its for expertise. So are we saying that every person at a nonreferral center is getting negligent care?
--Ian
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Bill Glasheen
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Post by Bill Glasheen »

Ian wrote: most things that constitute errors have system roots
Bingo! Very often it's a process setting individuals up for failure, and the unscrupulous following behind and picking out cases from which to cash in.

That's the whole premise for six sigma.

As for who is a target and who isn't, well that follows Sutton's law. These suits follow the money. Where there is no money, there will be no civil litigation.

I've always felt being open and forthright is good policy. But candor needs to be taken in context. I wouldn't want my frank remarks be fodder for someone else's lawsuit later on. Discourse and debate are all part of truthseeking, and I don't see the merit of cherrypicking comments and memos out of the context of a broader discussion. That just causes the "hold it to the vest" behavior being commented on here. And that serves nobody (worth being served).

- Bill
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Post by Panther »

IJ wrote:Short answer per me: in our culture, we don't sue lawyers, lawyers don't sue lawyers, it isn't thought of. It's not on people's radar.


Could it be done? I don't see why not.
(my emphasis added...)

First let me state that I did not mean that doctors should be charged when errors happen or just because someone dies. I thought I was very clear on that. What I was suggesting was that those people (more than likely not researchers, scientists or doctors) who made the decision knowingly to keep vital information hidden from the public, could perhaps face stiffer penalties since they knew the product in question had problems which had been fatal!

Now a comment about the post I've quoted above...

I have been involved and have also been informed about a number of cases where an attorney was guilty of gross negligence or malpractice or egregious violations of the code of ethical conduct. It is not because it isn't on people's radar or minds that attorneys are immune to malpractice, negligence or unethical behavior lawsuits, it is because it is basically impossible to find an attorney who will take such a case against another member of the club! And in addition to that, the chances of either the Bar OR a Judge finding for the wronged victim, ummmmm, "client" is slim to none! I know of cases where there are literally file bins FULL of evidence of ethical violations... I know of cases where there are literally file bins FULL of evidence of malpractice, negligence, or malfeasance... And it is more than disheartening to see and hear good attorneys who can sympathize and who understand and who agree with the thought of cleaning house on the unethical, incompetent, or negligent attorneys, BUT who state very clearly that they can't afford to go near the case with a 4000' pole! It's simple, their days as an attorney would be numbered and with a low number at that... because they would have gone against a "colleague". They'd be ostricized by other attorneys and could kiss any fair shake from any Judge good-bye forever. That's despicable, but that's the way the (in)justice system has evolved. It truly is ashame, because there are good decent attorneys out there, but the chances of punishing any of the bad ones is basically nil.

As someone said recently, the problem with lawyer jokes is that lawyers don't think they're funny and everyone elses just thinks they're the truth!

:cry:
IJ
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Post by IJ »

No worries Panther, I didn't mean to suggest you'd suggested that many physicians would face nbegligent homicide charges. Recently, staff of a nursing home was charged with negligent homicide for abandoning their patients to face a hurricane alone, and of course the debilitated and needy patients drowned, etc. That's a case of a clear duty, and a failure to meet that duty, and a clear harm. Naturally no one is perfect and some storms are unbeatable, but yeah, you ought to at least have a plan in place for severe flooding when you're under water.

It isn't much of a stretch to say that when there is a clearly established and well known therapy a patient needs, and MD forgets to prescribe it (substitute similar error) then if the patient dies, we're in the same situation. But this is also what we commonly term plain ole malpractice. Perhaps its because docs have tons of duties to tons of people and its a lot harder to run that sort of life without failing to follow thru on such a duty than when you are, say, a computer salesperson. I dunno. But, it can be complicated.

Doctor deliberately fails to wash hands to cause an infection; patient dies: reckless endangerment? negligent homicide?

Doctor mistakenly fails to wash hands; patient gets a surgical infection and dies: malpractice; but what about this isn't negligent homicide?

Doctor mistakenly fails to wash hands because is rushing to do a procedure with only seconds to spare, which saves the patient's life; later gets infection and dies: heroic, but still might get sued.

Doctor washes hands very carefully and patient STILL has a surgical site infection and dies: No fault, yet, might still get sued
--Ian
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Bill Glasheen
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Post by Bill Glasheen »

I couldn't help but post this today. What do I think when I read this article?

1) It flies in the face of the preachings of the ambulance chasers who seek to characterize these companies as something they are not.

2) The ambulance chasers smell more money.

But I'm a cynic (with a little bit of inside information... ;))

And you know what? The kids of these trial attorneys will be some of the first in line to get the vaccine. And the health care system they attack will give them what they want - without question - as they should. What's wrong with that picture?

- Bill
Cervical Cancer Vaccine
Is Successful in Study


Merck Treatment Prevented
Nearly 100% of Growths;
Plans for FDA Application


By MARILYN CHASE
Staff Reporter of THE WALL STREET JOURNAL


October 7, 2005; Page B4


An experimental vaccine to prevent cervical cancer showed success in pivotal studies, preventing nearly 100% of growths that can lead to the deadly disease.

The vaccine by Merck & Co. is aimed at four types of the human papillomavirus, or HPV, a sexually transmitted virus that infects many Americans and in certain forms can cause cervical cancer. The disease will cause 3,700 deaths in the U.S. this year and 290,000 world-wide, government experts predict.

The vaccine performed well in early testing, so the results weren't a surprise, though a senior government scientist called them "quite impressive."

Merck, of Whitehouse Station, N.J., said it plans to apply to the Food and Drug Administration later this year for approval to sell the vaccine, called Gardasil. The positive results on what some analysts said could be a blockbuster are welcome news for beleaguered Merck...
chewy
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Post by chewy »

Now we just need to see if it saves more lives in the short term than it takes in the long term :wink: .

We can be cinics too Bill. One study does not a miricle drug make. Don't get me wrong, this is great news and hopefully further studies and long term real world use will prove it to be a reliable life saving drug. This is one of those cancers that left a lot of people scratching their heads for a while. I sincerely hope we can find some similar treatments for other tough cancers (pancreatic comes to mind... particularly deadly).


cheers,

chewy
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