Moderator: Dave Young
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.
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.
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.
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
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.
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
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.
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.
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.
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 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.
When people die, the cause is platelet activation and clot formation usually on a less clogged artery, say 30% more often than 80%.
arteries that narrow slowly and even occlude allow for the growth of collateral vessels.
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.
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.
Statins Could Cause Legal Headaches
Pfizer insists that Lipitor's safety record "is very well established"
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."
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.
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.
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.
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.
I, once again, am salaried. I do not get reimbursed more if i see more patients, or do more procedures.
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
or isn't as forthcoming about side effects as it could be
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.
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