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PostPosted: Mon Aug 07, 2006 9:01 pm 
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Here's a wonderful brief summary of how and why market forces push companies that create and distribute pharmaceuticals to do what they do.

At the cross hairs are "unmet medical needs" and "need for market growth and penetration."

This is also the area that has grown most quickly with DTC adversiting

[url=http://www.frost.com/prod/servlet/report-brochure.pag?id=A747-01-00-00-00}
U.S. Insomnia Therapies Markets[/url]

If the pharmas were in detroit, they'd make cars, same as hollywood. What is different is that instead of making money off transportation or entertainment they're making money off diseses.

I'm alive today because of pharma drugs. I need them to stay alive. That doesn't keep the industry from holding a doubled edged sword IMHO.

So is the argument on the table that all medically-based litigation is a bad idea? Cause it sure is starting to sound that way.

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PostPosted: Mon Aug 07, 2006 9:50 pm 
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Thanks, Dana; the insomnia "epidemic" is a great example of the creation of illness. Profits are driving this decision for sure. There is NOT much data on how the treatment of insomnia helps.... you feel better the next day, or function better... it's mostly just patient satisfaction which means when people get the notion that its a disease if you worry a little bit at night, don't fall asleep in 10 minutes, or, as healthy people often note as they age, simply sleep less but suffer no ill consequences, that they'll believe they have a disease and then a cure when they take a pill. And certainly we don't want them to hear that sleep hygiene is just as important or more so... or that medications are not a cure for stress or caffeine use or anything else that might be keeping them up.

"A large number of patients, however, do not consider insomnia to be a serious condition. Very often, they use OTC products containing antihistamines or they seek treatment for another ailment that they deem to be the original cause."

Why would a maker of a supposedly effective sleep aid, that really only helps you get to sleep 14 minutes faster, and may make you more tired tomorrow, want the patient to learn they don't have a problem, that the problem can be solved for pennies with an OTC drug, OR represent "another ailment?" Afterall, insomnia due to med side effects, depression, heart failure, sleep apnea, etc may all respond to sleep aids.

The FDA may be allowing these drugs to be promoted long term on the basis of little evidence, but that doesn't make it the sole bearer of responsibility.

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PostPosted: Mon Aug 07, 2006 11:26 pm 
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Dana wrote:

So is the argument on the table that all medically-based litigation is a bad idea? Cause it sure is starting to sound that way.

I never say never.

Right now I'm addressing this one case (as I have the lawsuits against OBs for delivering cerebral palsy babies, or silicone breast implants causing connective tissue disorders) as a classic case of a runaway tort system with no recourse by the defendants.

There ARE many who could put up a good argument for the case that such suits do not improve the quality of health care. But that's beyond the scope of this thread.

This one case seems to bother Ian because he thinks Merck could have done their research and reporting better. That's a fine standard, so long as you apply it to the makers of all the other NSAIDs and COX-2 inhibitors out there. Better yet, apply it to all the many drugs that were approved and then quickly pulled off the market in the last few years. But it hasn't.

And again with Vioxx, no one case meets the burden of proof (causality). Ian may want to punish Merck because he doesn't like their research methods, but that can't legally or ethically be done by any one of these 14,200 lawsuits.

Ian and I are going to have to agree to disagree on many aspects of the Merck study.
Ian wrote:

Actually, No. Merck suppressed some data, such that what was published wasn't accurate. Read the NEJM's expression of concern. Just because there are flaws with the drug approval process which must be fixed, it does not mean that merck must be or is blameless. Merck suppressed data about bad outcomes! That violates the golden rule; you can't do that in court; according to JC, you're not supposed to do it ever. It's wrong. It's also disturbing it was done for money. I would not have done it. Merck erred.

Perhaps if you had published more, you would understand the discussion I'm making about releasing "all information" or "negative findings" or " contradictory results." It's a muddled mess. There are few studies where all data are released, whether it be industry or academia.

Again, hindsight of the peanut gallery offers wonderful "vision" of the state of affairs. A classic example is the study of malaria. In early work, one researcher put in his personal notes that there were an awful lot of mosquitoes around, but that didn't make it into early publications. Sometimes the data are right there trying to bite you in the arse, but you can't see something in plain sight.

It's particularly problematic when the approval process that the FDA created opens the door for these types of issues. Just look at what I posted from NEJM a few posts before. They agree with me.
Quote:
The rofecoxib story also reflects poorly on the process that leads to drug
approval.
The rational basis for addressing the cardiovascular effects of
these drugs has been clear for the past five years, yet even the most
fundamental questions have not been addressed directly. Much information
could have been derived from careful mechanistic studies in small numbers
of patients and volunteers. However, drug companies are driven by the
current requirements for drug approval
to design studies such as TARGET.

This country isn't the only one with "issues" for the release and use of drugs. In Europe, the only standard is that it's safe. Being "effective" is not necessary for approval. Finis origine pendet.
Ian wrote:

Profits are driving this decision for sure. There is NOT much data on how the treatment of insomnia helps.... you feel better the next day, or function better... it's mostly just patient satisfaction

If you were czar of the health care system, Ian, you might run into trouble pretty quickly.

What is quality? Does quality mean better outcomes? Does it mean better value? Does it mean better patient satisfaction? A study I did about a decade back shows many examples where the three dimensions can be completely independent of each other. And when it comes to the way the U.S. does business, "the voice of the customer" is considered golden. A classic example is chronic back pain and access to specialists. If you "gate keep" access to specialists, you get better outcomes at a quarter of the costs, but patients are REALLY pissed. Allow them open access to specialists and they get worse outcomes at a higher cost, but they are MUCH more satisfied. So, which is right? Good luck explaining that to the chronic pain patient.

As a physician medical director once told me, "Sometimes you need to put tail fins on the car."

- Bill


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PostPosted: Tue Aug 08, 2006 12:20 am 
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So Bill, why did the NEJM raise all that fuss about the study author's failure to release data? Do they just need to "publish more" to understand the finer points here, or what?

If MD's had been made aware of the problem earlier, they could have elected to switch their patients to traditional NSAIDs with proton pump inhibitors, a solution which is very similar in terms of gastrointestinal protection (and unfortunately, because the PPIs are costly, it also costs about the same). Some patients who died would have lived longer if this had been the case.

As for satisfaction with insomnia outcomes, my point is not that patient satisfaction is an irrelevant outcome. My point is that "insomnia" is becoming more of a problem because drug companies are coaching us to feel ill and to insist on pharmacologic therapy. My point is that ideal care of the patient would involve an individualized assessment and a plan, which might involve changing other meds, treating other conditions, teaching the patient about proper sleep hygiene (eliminating caffeine and alcohol especially before bed, proper exercise, regular schedules, no naps, getting up if you don't feel tired and coming back only when you do, using the bed only for sleep and sex, not reading and tv, etc, etc), reassuring them that limited sleep is ok unless the patient is fatigued as well, and possibly using a drug (as short term, intermittent, and with the understanding that it may just improve the sense of sleep than any meaningful outcome) IF needed.

Now, that evaluation is not in the drug company's interests. Their financial incentive is to get as many people using the drugs as possible for as long as possible. (The proton pump inhibitor people do this, trying to make lifelong customers where there need not be any, in a point that was well made by no other than Bill Glasheen on another forum). The proper assessment of insomnia is damn near impossible when someone comes in with their own diagnosis insistent that they walk out with some Lunesta or Rozerem or Placebon for $60 a month (which, to use Bill's logic again, is a tax on all of us just like lawsuits against Merck, just mediated through higher insurance costs).

What is best for the patient is not the same as what is best for the drug company, and the FDA is imperfect, as Bill has demonstrated, at doing this; while that problem is repaired or a new solution engineered, drug companies should factor in what's best for patients for both ethical AND financial reasons. As an analyst explains in an article I mentioned above, (Oberholzer; Merck's REcall of Rofecoxib) Wall Street's impression of Merck was far harsher than a financial analysis of Vioxx stats alone allows. Investors punished Merck for a lapse of good judgement and ethics. That's the world Merck lives in. Merck would do well to remember the consequences next time--which is not saying I support a million suits against them, but that's the world they live in.

Note: Realized I forgot to reply to Rich. Appreciate the confidence; insurance costs me nothing because I work at a hospital that covers it. Well, I'm sure I would get paid more if there was no malpractice crisis, but no direct costs.

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 Post subject: Yawn... more replies
PostPosted: Tue Aug 08, 2006 12:45 am 
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"And here is where I believe I have a right to "lecture" you, Ian...." "It is your responsibility to understand this big picture, Dr. Ian."

Actually, Bill, I'm aware of my responsibilities and was before. I haven't said anything that suggests otherwise. I reviewed what I said about heart attacks being more of a medical problem than a mechanical problem, and its correct. Only one of us is trained to diagnose and treat cardiovascular disease in humans; only one of us has done so; only one of us trains other physicians to do so.

I said: "Vioxx killed a percentage of patients, including some with, you guessed it, preexisting coronary artery disease."

You replied, saying I contradicted myself: "There's your mechanical problem. And you can't get the platelets to stick without it. Heart attacks start with the mechanic problems."

I had previously been crystal clear: "heart attacks are more of a medical or molecular problem than a mechanical problem." Emphasis on the MORE. I didn't say there wasn't cholesterol junk. We all know that. I am saying that in the years I have been in practice alongside cardiologists, thinking has evolved from viewing this like a series of clogged pipes to a situation where issues of thrombgenicity and inflammation are the current major targets. Only with patients having acute heart attacks or in need of bypass surgery is a mechanical solution primary; otherwise the treatment is medical, targeting inflammation and platelet function. When people die of heart attack, they don't die of cholesterol junk; arteries that narrow slowly and even occlude allow for the growth of collateral vessels. When people die, the cause is platelet activation and clot formation usually on a less clogged artery, say 30% more often than 80%. And it is not an excuse that cholesterol junk is present when you market a drug for arthritis primarily, one that will be given to millions of older americans with known and unknown coronary artery disease. It's like saying blood thinners don't kill people, preexisting ulcers that bled once the blood thinner was given do. Well, when marketing a blood thinner, you have to be upfront about the risk of bleeding from conditions affected by, if indepdent from, your drug.

"Ask ANY researcher in academia or industry what does or does not get released in the literaturer. Negative findings aren't sexy."

Fundamental misunderstanding. First, I am stating a personal belief that a drug company has a duty to warn patients of potential hazards. That is an ethical debate, not one about the sexiness of publications. Second, Merck may not have to submit "Vioxx has no effect on Dandelion Flowering Rates" especially because no one would publish it. BUT they do have a responsibility to report to the editors of their journals, publication pending, if there have been any changes. For example, since you keep bringing me into this: I'm shopping around a case report on a novel antibiotic's first use in endocarditis. One journal didn't want it; every time I resubmit it, I review the literature to make sure my claims remain true. If I were to have it accepted then someone published such a case before mine came out, and I knew, I'd report it to my journal to change the language. That's basic intellectual honesty. If I knew more cardiovascular deaths occured after acceptance and well before publication, I'd at least discuss it with the editors to make sure they could decide what to do with the data.

As for my original statement that drug companies seek to make money first and do the right thing for the world second, I still am confused about what your counterclaim is. They... do... put... money... first. That's what all my examples show. They're in business for profit. Otherwise, they'd be nonprofit. Profit motivates companies to do unethical things, such as use cartoons as spokespeople or research child smoking habits, to get more longterm customers hooked. Merck has a more, but not purely, noble mission. This is all I am saying.

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PostPosted: Tue Aug 08, 2006 10:03 pm 
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Ian wrote:

As for satisfaction with insomnia outcomes, my point is not that patient satisfaction is an irrelevant outcome. My point is that "insomnia" is becoming more of a problem because drug companies are coaching us to feel ill and to insist on pharmacologic therapy. My point is that ideal care of the patient would involve an individualized assessment and a plan, which might involve changing other meds, treating other conditions, teaching the patient about proper sleep hygiene (eliminating caffeine and alcohol especially before bed, proper exercise, regular schedules, no naps, getting up if you don't feel tired and coming back only when you do, using the bed only for sleep and sex, not reading and tv, etc, etc), reassuring them that limited sleep is ok unless the patient is fatigued as well, and possibly using a drug (as short term, intermittent, and with the understanding that it may just improve the sense of sleep than any meaningful outcome) IF needed.

You're preaching to the choir, Ian. Please look at my response to Mary's post. When direct-to-consumer advertising was allowed, the health care paradigm changed dramatically. I see the result of that in data every day. The subsequent rising consumerism in health care is a difficult train to derail.
Ian wrote:

If MD's had been made aware of the problem earlier...

  • They could have avoided all the deaths potentially linked to naproxen.
  • They could have avoided all the deaths potentially lined to Celebrex.
  • They could have avoided all the deaths linked to calcium channel blockers.
  • They could have avoided all the pain and suffering caused by ABMT - which turned out not to improve outcomes in spite of the claims at a cost of $100K per case by oncologists.
  • Etc.
You keep making this out to be a clear cut case that it isn't, Ian. You must know more about the inside workings of Merck than I do. (Which I doubt.)
Ian wrote:

they could have elected to switch their patients to traditional NSAIDs with proton pump inhibitors, a solution which is very similar in terms of gastrointestinal protection

Man, that's rough! I'd rather be in pain! 8O

NSAID's cause the harm they do by interfering with the building of the lining of the gastrointestinal tract. PPIs won't stop that; they just stop you from digesting the weakened GI tract - or your food - as well.

PPIs scare me. They are not without their own class of side effects that took years to figure out (like the COX II inhibitors). I'm glad I don't have to take them.
Ian wrote:

What is best for the patient is not the same as what is best for the drug company, and the FDA is imperfect, as Bill has demonstrated, at doing this; while that problem is repaired or a new solution engineered, drug companies should factor in what's best for patients for both ethical AND financial reasons.

****

I am stating a personal belief that a drug company has a duty to warn patients of potential hazards.

Ian, do you work for profit, or are you a nonprofit entity? Do you have ethics?

It appears to me that you are promoting a theme that a for-profit entity (like a drug company or a physician) is incapable of acting in an ethical fashion.

Good ethics is good business. God knows I've had major doses of ethics training in 2 different Fortune 500 companies I've worked for. I can get fired for unethical behavior which I know from first-hand experience that SOME physicians exhibit on a routine basis (because they can). Now and then you see a real whopper going on in industry, and generally the bad guys get it in the end. It's unfortunate in a company as large as Enron that bad behavior can affect people on a grand scale before bad guys go to jail.

People who get PhDs don't do it for the money. I know - I gave up a lot of money (time value) getting my own. Many spend 5 to 10 years of postgraduate education before they get their first post-doc job paying less than what an undergaduate gets in an average job. The research scientists at a place like Merck do what they do because they love science and love saving lives. The business side of Merck you like to poke at involves MBA types who help the scientists focus on doing what they do best - saving lives through better pharmacology. Without the flow of revenue, everyone loses.
Ian wrote:

As an analyst explains in an article I mentioned above, (Oberholzer; Merck's REcall of Rofecoxib) Wall Street's impression of Merck was far harsher than a financial analysis of Vioxx stats alone allows. Investors punished Merck for a lapse of good judgement and ethics.

No... Investors don't like putting their money where trial attorneys can steal it. There's no emotion involved; there's only self preservation. When the investors put their money elsewhere, the price of a share of the company goes down.
Ian wrote:

Merck would do well to remember the consequences next time--which is not saying I support a million suits against them, but that's the world they live in.

The people at Merck for the most part are good people. And I don't think they're going to behave differently at the end of the day. The company (and others like it) will however donate to concerns that are in their best interest.

Check out where the money flows at election time. Who do the trial attorneys donate to? Where does Wall Street donate?

"Punishment" - particularly when it's random, pointless, and selfish - rarely gets the desired effect. More often than not, what happens is those on the receiving end learn how to avoid the abuse rather than experience any great epiphany. A more enlightened approach would be to fix the process so health care is improved for all, and everyone (from the Merck pharmacologist to the physician to the patient to the little guy saving for retirement) makes an honest, healthy living.
Ian wrote:

Only one of us is trained to diagnose and treat cardiovascular disease in humans; only one of us has done so; only one of us trains other physicians to do so.

Question... How come you never came to visit me in Cobb Hall when we were doing experiments in coronary physiology 3 days a week? I could have introduced you to quite a few good cardiologists and cardiothoracic surgeons at the time. I also could have introduced you to quite a few Cardiology Fellows whom I trained to do bench research, and who now are publishing members of the research community.

Just wondering... ;)

(FWIW, we biomedical engineers are used to the Rodney Dangerfield phenomenon. Ask Robert Jarvik why it took decades for him to get recognition, while the surgeon who installed one of his artificial hearts made front page news.

No biggie. 8) )
Ian wrote:

I reviewed what I said about heart attacks being more of a medical problem than a mechanical problem, and its correct.


****
I had previously been crystal clear: "heart attacks are more of a medical or molecular problem than a mechanical problem." Emphasis on the MORE. I didn't say there wasn't cholesterol junk. We all know that. I am saying that in the years I have been in practice alongside cardiologists, thinking has evolved from viewing this like a series of clogged pipes to a situation where issues of thrombgenicity and inflammation are the current major targets.

This is going to get into an argument over semantics.

How you attack a problem and what the problem is can be 2 entirely different issues. The truth is that the cascade of events that lead to an MI are as complicated as how a blood clot is formed. At the end of the day, you get narrowed vessels that are at risk of being clogged via thrombosis or other "clogging" event. It is what it is.
"Ian wrote:

When people die, the cause is platelet activation and clot formation usually on a less clogged artery, say 30% more often than 80%.

A 30% narrowing of a coronary artery is a big deal, Ian. Flow is proportional to the 6th power of the radius.

Furthermore, such changes in the geometry of a tube will cause laminar blood flow to change to localized turbulent flow. These changes in fluid MECHANICS have been shown to induce clot formation.

FWIW... ;)
Ian wrote:

arteries that narrow slowly and even occlude allow for the growth of collateral vessels.

If collateral circulation increases to myocarcial tissue perfused by slowly-occluding vessels stopped heart attacks, then nobody would have had them before NSAIDs and COX 2 inhibitors came about. But that wasn't the case, was it?

Many of these stenoses are at or near the root of the LCX, the LAD, and the RCA. That's approximately 1/3 each of the total left ventricular coronary perfusion (in the human). No heart can survive that loss of myocardial function - even with maximal collateral growth.

But it is fun studying the growth of collateral circulation. You'll find quite a bit on the subject in the literature (some with my name on it ;)).
Ian wrote:

And it is not an excuse that cholesterol junk is present when you market a drug for arthritis primarily, one that will be given to millions of older americans with known and unknown coronary artery disease.

So what you seem to be implying, Ian, is that Vioxx had side effects which Merck had FULL KNOWLEDGE of and didn't report, and no other pain reliever had side effects which the physician community didn't know about.

Remember the BFD that came about when the news came out - thanks to the research on Merck's drug? MDs started switching patients to other COX 2 drugs and NSAIDs, but then they were found to have many of the same side effects. Oops! :oops:

It's a good thing Merck got the drug out on the market. Imagine how many more deaths there would have been from Celebrex, Bextra, and Naproxen useage!

Yes I am dripping with sarcasm here. But the point is valid. If it wasn't for Merck jumping on the COX 2 inhibitor bandwagon, we'd have know about all of this a lot of lives later.

Once again, NOBODY knew the full story, and ALL MEDICATIONS HAVE SIDE EFFECTS. And not all of them can be known, or are completely understood even when first viewed in the data.
Ian wrote:

As for my original statement that drug companies seek to make money first and do the right thing for the world second, I still am confused about what your counterclaim is. They... do... put... money... first.

No they don't. They first provide a service or a product that the consumer wants. THEN the money comes. Big difference. Furthermore, a company as large as Merck and with the reputation of Merck wants to be in business tomorrow. That can't happen if you don't meet the needs of the customer, and show yourself to be concerned about your customer. You can't fake that kind of concern for long.

- Bill


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PostPosted: Wed Aug 09, 2006 12:48 am 
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"You're preaching to the choir, Ian."

Just responding to your comments. As was the case with that thread about the girl who was tossed from religious school for being lesbian, sometimes I say something that seems to upset you and when I reply to your concern, I'm preaching to the choir, or something. It feels like a moving target at times.

"You keep making this out to be a clear cut case that it isn't, Ian."

Big companies oftentimes manage to keep wrongdoing or sketchydoing obfuscated by piles of legal mumbojumbo. Sometimes summaries are in order. What I'm doing is summarizing a complex case thusly: they weren't as forthcoming as they could have been. It's complicated. But Jesus Christ would have reported the findings to the editorial staff at the NEJM. That's all I'm saying.

I'm sorry to hear that you are frightened of PPI's. I don't believe they should be used indiscriminately, as they are, and I believe gastric acid is there for a reason. They are linked in retrospective analyses to higher rates of c diff and pneumonia--things that are less common and less deadly than MI. So it's odd how you're making a fuss of their side effects--you've never reacted to a mention of coxibs by saying "man, that's rough, I'd rather be in pain." And despite your theoretical concern that they don't actually change the nsaid impact on the gastric lining, the fact remains that the nsaid/ppi combo is as good for avoiding ulcers, which was the whole point of the coxibs in the first place--and they're not as miraculous at avoiding ulcers as we thought anyway. It'll be your choice to be in pain, to take an nsaid/ppi combo, or to take a coxib, but most of my patients care whether or not they have a bleeding ulcer, not why.

"Ian, do you work for profit, or are you a nonprofit entity? Do you have ethics?"

Ah, I do work for profit. And I do have ethics. And the way I link them is by refusing to have any stake in the care I give to the patients, other than accepting "pay for performance." I will not therefore have a conflict of interest, but may have a synergy of interests--better care, better pay. Merck had a conflict of interest. This is key.

"It appears to me that you are promoting a theme that a for-profit entity (like a drug company or a physician) is incapable of acting in an ethical fashion."

Hyperbole. I'm proposing that conflicts of interest can lead to decisions that are good for your wallet and bad for ethics. I find fault with tobacco companies because they have a conflict of interest--doing the right thing for their customers VS making money selling them lethal products. MD's shouldn't own stakes in companies who make things they sell to patients, for example, they shouldn't co-own imaging centers they refer to, because they tend to order more MRIs because they get paid for each. MD's have a conflict of interest when they were infusing natrecor for literature-unsupported heart failure treatments, because they were making mad cash per patient doing so. And they should answer for those questionable ethics. I'm salaried.

"Good ethics is good business."

I agree. Do you agree that Merck, as evidence by the lawsuits, as evidenced by the wall street reaction, as described in the article I cited, suggests they may have ultimately made the wrong business decision? When lives are or are potentially at risk, avoiding even the appearance of taking risks with patients is paramount. You state that the investors were merely afraid of losing to trial lawyers, but the analyst explained that wasn't the case: "the decline in Merck's market value on September 30 was much larger than estimates of the financial and legal cost of withdrawing rofecoxib."

"How come you never came to visit me in Cobb Hall when we were doing experiments in coronary physiology 3 days a week?"

I believe you left UVa before I arrived. No invitation was left unaccepted.

"A 30% narrowing of a coronary artery is a big deal, Ian. Flow is proportional to the 6th power of the radius."

It is a big deal, clinically, because it indicates the patient is at risk for acute MI, but not because of the limitation in flow. Cardiologists do not stent these lesions. Surgeons do not bypass them. Clinically, the decline in the flow is unimportant. This is a difference between bench and bedside.

"If collateral circulation increases to myocarcial tissue perfused by slowly-occluding vessels stopped heart attacks, then nobody would have had them before NSAIDs and COX 2 inhibitors."

Not true. They would have had acute MI from plaque rupture and thrombosis, just like they do, but more often, on coxibs.

"So what you seem to be implying, Ian, is that Vioxx had side effects which Merck had FULL KNOWLEDGE of and didn't report."

Nope. Never said full knowledge. I'm not Oliver Stone. Knowledge that suggested a risk. Knowledge they might have told their mom, but didn't get into the paper.

"ALL MEDICATIONS HAVE SIDE EFFECTS."

Yeppers. Hence the importance of advising patients of this, and vigilance for the post marketing experience and full publication of any possible warning signs. Salmeterol MAY increase asthma deaths--from what I've heard, the company didn't suppress the issue, which is now known to clinicians, discussed with patients, and the subject of no big lawsuit. Guidant knew about malfunctioning leads on its defibrillators and didn't tell patients ASAP--guess what that means?

This is getting to be a rehash on diverging topics, so I'll let you reply however, and try to keep replies to new issues, such as what we ought to do next, etc.

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 Post subject: Could Lipitor be next?
PostPosted: Wed Aug 09, 2006 2:36 am 
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From Business week:

Quote:
Statins Could Cause Legal Headaches
Pfizer insists that Lipitor's safety record "is very well established"


For the article:

http://www.businessweek.com/magazine/co ... 997052.htm

It would be a shame if this useful family of drugs is attacked.

Rich

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PostPosted: Wed Aug 09, 2006 4:05 am 
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Ian wrote:

Do you agree that Merck, as evidence by the lawsuits, as evidenced by the wall street reaction, as described in the article I cited, suggests they may have ultimately made the wrong business decision? When lives are or are potentially at risk, avoiding even the appearance of taking risks with patients is paramount. You state that the investors were merely afraid of losing to trial lawyers, but the analyst explained that wasn't the case: "the decline in Merck's market value on September 30 was much larger than estimates of the financial and legal cost of withdrawing rofecoxib."

There's some very good research done concerning perception of risk vs. actual risk. There are many cases where the two don't match up, and it has nothing to do with "punishing" an entity. It is what it is.

People get spooked on Wall Street all the time - particularly day traders, novice investors, margin traders (borrowing some of the money you invest, and being subject to margin calls), and those with an aversion to risk. I always take the long approach, and people who do so generally make much more money.

Ian wrote:

Bill wrote:

A 30% narrowing of a coronary artery is a big deal, Ian. Flow is proportional to the 6th power of the radius.


It is a big deal, clinically, because it indicates the patient is at risk for acute MI, but not because of the limitation in flow. Cardiologists do not stent these lesions. Surgeons do not bypass them. Clinically, the decline in the flow is unimportant. This is a difference between bench and bedside.

Hemodynamically it IS significant. You get turbulent blood flow, and TBF leads to clot formation. (This is one reason why artificial hearts throw off stroke-causing clots). YOU said a 30% stenosis was a problem with Vioxx. Are you changing your mind?

In any one individual, clotting rate (platelet aggregation) can vary quite a bit based upon a range of physiologic stimuli. What won't happen at "rest" may happen under stress, etc. Medications are one of many issues.
Ian wrote:

Ah, I do work for profit. And I do have ethics. And the way I link them is by refusing to have any stake in the care I give to the patients, other than accepting "pay for performance." I will not therefore have a conflict of interest, but may have a synergy of interests--better care, better pay. Merck had a conflict of interest. This is key.

Ah, but physicians DO often have a conflict of interest when it comes to the treatment of their patients. You can deny it if you want, but there's a wealth of literature out there which shows otherwise.

  • Fee-for-service plans encourage utilization. More medicine isn't necessarily better medicine. Excessive care is one of the 4 key quality issues in medicine.
  • Capitated arrangements create an incentive for less care. Underutilization is another of the 4 key quality issues in medicine.
  • Various pay-for-performance plans may create perverse incentives - as you acknowledged.

Meanwhile, Merck doesn't have a conflict of interest when the medications they sell reduce morbidity, mortality, and suffering. I'd call that a fairly well-aligned incentive.

Why do physicians so commonly view themselves as the good guys, and everyone else not so? Strange...

- Bill


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PostPosted: Sat Aug 12, 2006 10:21 pm 
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"YOU said a 30% stenosis was a problem with Vioxx. Are you changing your mind?"

I've been crystal clear and accurate on this. Hemodynamically it is NOT clinically significant. Medically it is because these are lesions that rupture, clot, cause acute MI.

"In any one individual, clotting rate (platelet aggregation) can vary quite a bit based upon a range of physiologic stimuli. What won't happen at "rest" may happen under stress, etc. Medications are one of many issues."

Yes, shoveling snow, anger, coexisting infection, etc affect risk--doesn't in the slightest give the drugs a pass.

"Ah, but physicians DO often have a conflict of interest when it comes to the treatment of their patients. You can deny it if you want, but there's a wealth of literature out there which shows otherwise."

I said *I* deliberately avoid conflicts of interest. Other "Physicians" may not. If that leads to consequences, or even the possibility of them, they should be responsible just like a lawyer, analyst, judge, wall street trader or anyone else.

A literature review on NSAIDS and cardiovascular risk is in the works. It's been 10-13 hours a day for the last 13 days...

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--Ian


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PostPosted: Mon Aug 14, 2006 8:15 pm 
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Ian wrote:

Bill wrote:

Ah, but physicians DO often have a conflict of interest when it comes to the treatment of their patients. You can deny it if you want, but there's a wealth of literature out there which shows otherwise.


I said *I* deliberately avoid conflicts of interest. Other "Physicians" may not. If that leads to consequences, or even the possibility of them, they should be responsible just like a lawyer, analyst, judge, wall street trader or anyone else.

It appears you don't understand what I'm communicating, Ian. The "conflict of interest" that you claim the drug companies have (sell more drugs = make more money) is the EXACT same "conflict of interest" that exists in a fee-for-service health plan (more procedures = more money). That's just one of many examples. You are casting a shadow on the "bad drug compaines" for being subject to the same system that you and all physicians are subject to unless you are part of a staff physician model (e.g. Kaiser Permanente). For a better understanding of this, you might go back and look at the many publications that were spun off of the RAND Health Insurance Experiment. It's also worth reading the Institute of Medicine report on quality, which speaks of the "chasm" which exists today between what physicians do vs. evidence-based care.

And no, sending lawyers out after these physicians doesn't result in better patient care. Quite the contrary, there's evidence that it makes it worse. (It could be described as a "balloon effect.")

For a more recent article that refers back to the HIE, see Consumer-directed health plans and the RAND Health Insurance Experiment in Health Affairs. That will give you a good review on how all the various economic forces affect both patient behavior (initiation of an episode of care) and physician behavior (cost of an episode of care).

Here's a recent article which highlights the problem (emphasis my own)

- Bill

Quote:
Jt Comm J Qual Patient Saf. 2005 Apr;31(4):211-9.

The QUEST for quality: what are medical groups doing about it?

Solberg LI, O'Connor PJ, Christianson JB, Whitebird RR, Rush WA, Amundson GM.

Care Improvement Research, HealthPartners Medical Group, Minneapolis, USA. Leif.I.Solberg@HealthPartners.com

BACKGROUND: It is important to know whether medical groups have quality improvement (QI) priorities, approaches, activities, and congruence that will allow them to achieve major improvements in quality of care.

METHODS: Simultaneous surveys were sent to medical and administrative leaders of 18 medical groups, 84 of their constituent clinics, and their primary care physicians providing the majority of the primary care in the Minneapolis/St. Paul metropolitan area.

RESULTS: Of the 18 medical groups, 17 have an overall physician leader for QI and 11 have the same at each of their constituent clinics. Nearly 100% of clinic leaders report their group leaders see QI as important and expect clinics to improve care, while 69%-84% of their physicians report the clinic leaders are committed to QI for diabetes and heart disease. Diabetes and coronary heart disease are the priorities for improvement by 14 and 12 medical groups respectively. Only seven groups report adequate QI resources and only three report that incentives are aligned with quality. Intermediate groups generally appear to be just as active and supportive of QI as large ones.

DISCUSSION: These medical groups and their constituent clinics and physicians appear ready to work on the issues raised by the Institute of Medicine (IOM). However, they believe that limited resources and financial incentives that are not aligned with quality constrain their ability to help America cross the quality chasm.


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PostPosted: Tue Aug 15, 2006 2:11 am 
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No sir, the misunderstanding is yours. You state,

"The "conflict of interest" that you claim the drug companies have (sell more drugs = make more money) is the EXACT same "conflict of interest" that exists in a fee-for-service health plan (more procedures = more money)."

I, once again, am salaried. I do not get reimbursed more if i see more patients, or do more procedures. I did not say that this applies to all physicians, in fact, I said that we should try to avoid any fee for service arrangement that might be a conflict of interest. I should point out that I expect a doctor who works twice as many hours to see twice as many patients and get paid twice as much. that is not a conflict of interest, and i also don't see how someone who doesn't control their patient flow is subject to this kind of conflict of interest.

And it's not "exactly" the same when a physician is paid to see a patient who makes an appointment as when a drug company promotes a drug and/or isn't as forthcoming about side effects as it could be. It's complicated but I trust you see some differences.

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--Ian


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PostPosted: Tue Aug 15, 2006 2:48 pm 
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Ian wrote:

I, once again, am salaried. I do not get reimbursed more if i see more patients, or do more procedures.

So are most of the people who work for Merck, Ian. The exception would be people in sales, etc.

Does the place you work for get more money if more patients are seen? What would happen to this place of business if for instance the patient load was cut in half? If you are a hospitalist (work for a facility) does the hospital get reimbursed on a per diem (per day), case rate (by DRG) or other means?
Ian wrote:

And it's not "exactly" the same when a physician is paid to see a patient who makes an appointment as when a drug company promotes a drug

I agree it isn't the same, Ian, because you're comparing apples and oranges. Your underlying logic is faulty.

Do the scientists who invent the drugs within Merck advertise? Do the statisticians who set up the clinical trials advertise? Does the cleaning crew advertise?

Do hospitals not advertise? Do physicians and physician groups not advertise? If you say no, then please come visit me for a day and turn on the television. Also, check out the Yellow Pages.

Here is the hospital where number 1 son was born.

Henrico Doctors Hospital

Is that website not a big bloody advertisement? This Columbia HCA hospital so aggressive here that the insurance companies privately call them Henrico Dollars Hospital. Oh and by the way, UVa Hospital System - a nonprofit, academic institution - advertises big time on all the football games (TV and radio). We see/hear it here in Richmond.

Here is the place where I take number 1 son to get his eyes checked for his ambliopia.

Virginia Eye Institute

Pretty nifty music on that website, no? So this isn't advertisement?

You used to work here, right?

Beth Israel Hospital

So this is different? If so, how?
Ian wrote:

or isn't as forthcoming about side effects as it could be

Merck was the first company to remove its COX II inhibitor. Meanwhile, Pfizer is STILL selling Celebrex, albeit with big-time warnings. But they didn't get that information out any faster, did they? If it wasn't for the research done due to the emergence of Merck's drugs, would there have been more adverse events due to the use of celecoxib or even other NSAIDS like naproxen?

20/20 hindsight by the peanut gallery isn't what I would call enlightening. Walk a mile in their shoes.

It's also worth noting that yes, there was internal dialogue about all this in Merck as the discoveries were being made and before the warnings came out to the public. Do you know what this means to me? It means Merck is a healthy, functioning company where people in the know (e.g. scientists) get to voice their concerns and reign in the MBAs and marketing types. But you know what the ambulance chasers are doing? They're trying to use this dialogue AGAINST Merck, showing that the company didn't immediately turn on a dime when the scientists first started voicing their concerns. And do you know what this does to "business as usual" in a large company such as Merck? Think about it. And trust me, I know. I work for a large health care company, and I know how this after-the-fact activity puts a chill on internal communication. It isn't right, and the consumer loses in the end.

It's kind of like a dictatorship vs. a democracy. In the former, everything is fine and there are no problems. Yea, right... In the latter, we get to see all the gore that goes along with the battle of ideas. It's very messy. And generally it works - so long as we don't put a damper on free speech.

Off of soap box, and back to checking data. 8)

- Bill


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PostPosted: Tue Aug 15, 2006 7:02 pm 
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The difference at Merck is that the people (perhaps salaried) who make the final decisions about releasing data and pulling drugs at Merck are expected to make $$$--as a far and away first task, which is the opposite of my situation--which is to take care of patients assigned to me, first and foremost. Sure there are consequences if I am far out of line with patient satisfaction or make financially absurd decisions on a regular basis--no system could function without some kind of brakes--but its orders of magnitude different. We are explicitly told to serve our patients interests without thinking of anything else....

This is why the doctors at Beth Israel, since you brought them up, treated a woman who had an antibody to a clotting factor and kept bleeding. They treated her with what she needed, extremely costly chemo agents and a recombinant factor that costs $10,000 a dose. Every 4-6 hours for weeks. The hospital lost 1.5 million on one person. We were told to transfuse an elderly dying man as needed without regard to whether the blood bank might run short, to avoid any--you guessed it--conflict of interest. The doctors view that as a necessity; companies, like insurance companies, freak out, and try to get out of paying such tabs. They dropped one of my patients because he'd been admitted once and had a second diagnosis--diabetes, which he was doing his best to control. But the doctors don't drop him. They never send him out early. Someone came in to UCSD not long ago who'd bounced around other hospitals in mexico with a foot infection and heart disease--we gave the uninsured guy definitive care for both issues. Killer, illegal immigrant, jerk, whatever. They get the care they need.

This is the difference between healthcare professionals and companies. You don't see 1,000 doctors getting together and screwing over a whole population for cash and giggles the way Enron did; that's mob thinking, exploitive rationalization about what's best for the company and themselves. For a popular example, consider the "formula" that the car industry analyst applied in Fight Club. Figure out whether it costs more to pay the victims of an exploding car or to recall the car, and make the decision thusly. Now, eveyone knows that movie was satire. But they also know that satire is best when it hits close to home. And they know that individual healthcare professionals facing real sick people make completely different kinds of decisions than do companies.

How ab out a hypothetical... gatifloxacin and moxifloxacin were considered interchangeable drugs until recently, when we learned gati causes diabetes in some people who take it. If a panel of physicians sits down to make recommendations about which is best to use, do you seriously think that they'll reach the same conclusions as, say, the (salaried as they may be) advisory boards or advertising divisions of the competing companies that make those drugs?

Doctors don't sell cigarettes. Companies do. There are exceptions, shades of gray, and degrees of similarity. But everyone reading this forum knows what I mean and they know to trust the advice of healthcare professionals more than corporate lawyers about what's best for them--unless they're discussing how to make money making America obese, to highlight an issue from your forum, or something a lot like that.

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--Ian


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PostPosted: Tue Aug 15, 2006 7:50 pm 
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Ian wrote:

The difference at Merck is that the people (perhaps salaried) who make the final decisions about releasing data and pulling drugs at Merck are expected to make $$$--as a far and away first task, which is the opposite of my situation--which is to take care of patients assigned to me, first and foremost.

Apples and oranges again. How are you different from the chemists and the scientists at Merck? And how are the MBAs and marketing types who run your institution different from those at Merck?

I still want to know how your medical center gets reimbursed. Check it out. (FWIW, it probably varies by insurance company contract.) Also, "free" care isn't free. Taxpayers often make up the difference when nonprofits run in the red. U.Va. passes the bill on to the state all the time. And yes, there is push-back.

You are very blind to hospital administrators, Ian. (Un)fortunately I've had more than my fill of them. I was responsible for releasing case-mix-adjusted efficiency data for hospitals (by body system) to the public. You should have heard those business types in institutions such as yours scream. God forbid we publish the truth. Then you have an honest hospital such as out in Lynchburg that wants to know why they didn't get a bigger piece of the pie. How could they have been so ignorant? Sigh...

And yes, pharmaceutical companies do charity work all the time. What about all the HIV drugs going at cost or cheaper to Africa? It's being done because it's the right thing to do. Sound familiar?

You're conveniently wearing blinders, Ian. Meanwhile, the health care sector has the worst inflation in the economy, and quality that would put a company like GE out of business if they made jet engines like that. If you're wondering why I know so much about it, I'm finishing up white papers on software products that measure efficiency, risk, and compliance to evidence-based care. I'm also finishing up benchmark data with these products, which shows just how bad things really are. This has been a "protected domain" of the medical profession. No longer...

I'm not bashing, Ian. I'm just asking you to take the blinders off and look around.

- Bill


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