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.
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.
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.)
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!
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.
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.
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.
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.
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.
(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.
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.
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.
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
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!
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.
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.