BTox said:
This is from the FDA's Center for Drug Evaluation and Research. Scroll down a bit to the section titled: ADRs - Prevalence and Incidence.
fda cder adverse reactions
thanks so very muchly!
BTox said:
This is from the FDA's Center for Drug Evaluation and Research. Scroll down a bit to the section titled: ADRs - Prevalence and Incidence.
fda cder adverse reactions
Rouser2 said:[]Originally posted by BTox [/i]
>>So yes, the risk is 100,000 die every year, the benefit is tens of millions of lives are saved every year. Not a bad tradeoff.
A completely unproven, and unproveable pronouncement. But here you prevously stated that prescription drugs were safe, effective, all double-blind tested and really cool.
-- Rouser
Another fictional and ludicrous statement by Rouser. All OTC and prescription drugs in the U.S. have, unlike herbal treatments, multiple well-controlled, double-blind clinical trials documenting efficacy and safety.
Rouser2 said:A completely unproven, and unproveable pronouncement. But here you prevously stated that prescription drugs were safe, effective, all double-blind tested and really cool.
-- Rouser
SteveGrenard said:So my question is why are we jumping up and down everytime somebody dies after taking an off the shelf herbal but not after they take an OTC aspirin? Is it okay for ephedra to kill if its made by a big name pharmaceutical company but not if its in some small packager's diet product?
BTox said:
Not at all, it's a medical fact. You don't seem to be able to understand the concept of risk vs benefit. There is no such thing as a therapeutic drug with no adverse reactions. In order for a drug to gain approval from FDA, it must be demonstrated that the benefits (i.e. lives improved, lives saved) significantly outweigh the risks (i.e. severe adverse reactions, including deaths). A very simple concept, really.
You aren't listening, are you? Admit it.Rouser2 said:
Funny how over 100,000 adverse reaction deaths a year don't count for much with the FDA. That, of course, is the visable, seen, proveable consequence of FDA "approved" drugs. The alleged benefits of playing Russian Roulette with these drugs for the alleged diseases they treat and allegedly cure -- that is truly unseen, and is entirely speculative.
-- Rouser
Rouser2 said:
Funny how over 100,000 adverse reaction deaths a year don't count for much with the FDA. That, of course, is the visable, seen, proveable consequence of FDA "approved" drugs. The alleged benefits of playing Russian Roulette with these drugs for the alleged diseases they treat and allegedly cure -- that is truly unseen, and is entirely speculative.
-- Rouser
Rouser2 said:Originally posted by SteveGrenard [/i]
>>. What's it worth for a thousand to die when the availability of a drug saves a million or more.
Yeah, well I'd just like to know just what drug that would be.
Rouser
BTox said:
Vaccines, antibiotics, statins, just to name three classes.
BTox said:
This is from the FDA's Center for Drug Evaluation and Research. Scroll down a bit to the section titled: ADRs - Prevalence and Incidence.
fda cder adverse reactions
Fremont-Smith K. JAMA, November 25, 1998-Vol 280, No. 20,
1741-4:
"The authors' conclusion that fatal ADRs in the United States number
approximately 106,000 annually is erroneous as applied to the present.
This number of deaths was calculated by multiplying the total number
of hospitalizations in 1994 by an incidence rate of fatal ADRs of
0.32%, based on data from all studies published since 1965. Thus,
three quarters of these data are 20 to 30 years old. The studies
published in the last 10 years report a total of only 5 ADR deaths
among 11376 hospitalized patients studied, ie, an overall incidence
of 0.04%. Using the authors' estimation of the correct total number
of hospitalizations, deaths in the United States attributable to ADRs
is approximately 13,000. According to the data cited by Lazarou et
al, ADRs are not a leading cause of death today."
Same issue Kravitz GR:
"Fully 14 of the 18 studies [cited in the Lazarou paper] were
performed prior to 1981, and I question the appropriateness of
including these 14 studies in the meta-analysis... Reanalysis of data
including only studies published since 1982 reveals that the reported
mortality is only 3 cases per 5,854 admissions (ie, a mortality rate
of 0.0005 per admission), which is only one third that of the
estimate by Lazarou et al. All the reported mortality comes from a
single study by Bates et al done on medicine wards at 2 Boston,
Mass., tertiary care teaching hospitals. Extrapolating this rate to
non-teaching hospitals, community hospitals, pediatric hospitals,
chronic care hospitals, and psychiatric hospitals and then
multiplying the rate by the number of admissions each year greatly
overestimates true mortality. For example, the 335-bed community
hospital at w practice had 23,984 medical-surgical admissions in
1997. On the estimated mortality (0.0019 per admission) by
Lazarou et al, we should have seen 46 deaths due to ADRs. Even using
my adjusted figure from studies published since 1982 (0.0005 per
admission), the expected mortality would result in 15 deaths. The
number of deaths we reported is actually less than one tenth of the
estimates of Lazarou et al... The results of the meta-analysis by
Lazarou et al deserve a reality check. Lumping together voluminous
mounds of archaic data with more recent data from a sample of
hospitalized patients and then extrapolating to entire US patient
population can lead to egregious errors... The problem of serious
ADRs should not be compounded with erroneous estimates of their
mortality. The study by Larazou et al grossly overestimates the
magnitude of this problem."
kookbreaker said:There's some strong reaction to that "100,000" figure..even if it is only 40,000-96,000 (does that range look kinda strange to you?
The original figure seems to be another one of the "joys of metanalysis".
thaiboxerken said:
It doesn't take much to be a woo-woo, just a suspension of logic, reality and intelligence.
Rouser2 said:
Quite true. In many, many cases I do not. Death, however, is a fairly clear-cut outcome.