Officially Recommended Doses
Of FDA Approved Medicines Often Too High;
Can Have Fatal Consequences Context for Medical Marijuana Debate
(Marijuananews note: There is no mention of
marijuana in this story, but there are several points here that are very important in the
context of the medical marijuana debate. First, insisting on FDA approval to protect
the public is unwise. FDA approved drugs, used properly, kill over 100,000
people every year. Of course, marijuana has no lethal dose.
Second, prohibitionists claim that testing under FDA auspices is necessary to know the
proper dose, but FDA testing methods do not really determine the correct dose.
Third, one of the prohibitionist mantras against medical marijuana is "No medicine
is smoked." While smoking has its problems, which can be largely overcome through
vaporization, it has the very great advantage of letting the patient control the dosage
much more effectively than is possible by oral administration.
See
Counterblaste to DEA: Fallacious
Pharmacology.
"The contention that smoking cannot possibly be an acceptable route for the
administration
of a therapeutic substance is morality dressed up as science." by Peter Webster
Finally, this is just one more demonstration of the problems with
the medical marijuana and much else in the public discourse. Medical marijuana is often
held to impossible standards, while things approved by the official medical establishment
are held to standards that are blatantly inadequate.)
See
The Harsh Reality Of
Clinical Trials
Shows Another Case of The Double Standard For Medical Marijuana.
The Context For "Research." -- 2 Articles
October 12, 1999
From The New York Times
letters@nytimes.com
http://www.nytimes.com/
http://www10.nytimes.com/comment/
By Denise Grady
TOO MUCH OF A GOOD THING? DOCTOR CHALLENGES DRUG MANUAL
When doctors need information about what dose of medicine to prescribe, they usually
consult a fat navy blue book called the Physicians' Desk Reference -- P.D.R. for short --
which is an extensive compilation of data about drugs from their
manufacturers.
But the doses recommended in the P.D.R. may be too high for many people and may cause
adverse reactions, ranging from dizziness and nausea all the way to death,
according to an article published last month in the journal Postgraduate Medicine.
For many drugs -- including Viagra, Prozac and some medicines used to treat high blood
pressure, allergies, insomnia and high cholesterol -- smaller doses
would work just as well as the standard ones, with far less risk of bad reactions,
said the author of the article, Dr. Jay S. Cohen, an associate professor of psychiatry at
the University of California at San Diego.
"Side effects drive a lot of people out of treatment that
they need," Dr. Cohen said, noting that people with chronic conditions like high
blood pressure, headaches and depression often give up trying to treat their illnesses
when they find that the cure is worse than the disease. But if doctors were to
individualize dosages for each patient, more people might take their medicine.
Dr. Cohen said he became aware of the problem because he encountered many patients who
suffered from side effects even though they had taken what were supposedly the correct
doses of medicine. When Dr. Cohen consulted medical journals and textbooks, he discovered
studies showing that many patients were helped by smaller than usual amounts of
medication. And many of his own patients did better with reduced doses.
He said his findings helped explain a study published
last year by other researchers, who reported that drug reactions in hospitals were among
the nation's leading causes of death, killing more than 100,000 Americans a year. The
deaths that the team studied were not due to medication errors by doctors or patients;
they occurred in people taking doses thought to be correct.
See
Adverse
Pharmaceutical Reactions Major Cause of Death; Marijuana Does Not Kill But Must Be
Approved By FDA?
and
Painkillers
Put Millions At Risk Of Ulcers; Hospitalize 76,000 & Kill 7,600 Annually; One That
Doesnt Kill Is Illegal
and
Aspirin And
Related Drugs Are 15th Leading Cause Of Death In DEAland
Context For Medical Marijuana
and links
But Dr. Cohen thinks many of the patients died because they were taking too much medicine:
the "correct" doses were too strong for them. People vary greatly in their
sensitivity to drugs, he said, and one person's remedy may be
another's overdose. Although weight, age and sex help determine how a dose of
medicine will affect someone, it is also possible for two people who are identical in
those traits to react quite differently to the same dose of the same drug. Dosing
guidelines from drug companies may be right for most people, but too high for "large
subsets of patients," Dr. Cohen said.
Dosing guidelines generally tend to be too high because they are based on studies
conducted in limited numbers of patients by drug companies when they are seeking approval
for new products, Dr. Cohen said. For those studies to run efficiently, doses need to be
high enough to show as quickly as possible that the drug works. But later, after the drug
is approved, far more people take it, sometimes along with other drugs, and individual
differences begin to show up. That information does not always make it into the P.D.R.,
Dr. Cohen said.
(Marijuananews note: Remember that one of the excuses that the
prohibitionists use to justify arresting sick people for using medical marijuana is that
modern medicine is built around single molecule medicine, not compounds like those in
cannabis. Of course, then the doctors prescribe a wide variety of such molecules without
knowing how they will interact. Unlike those in whole cannabis -- which act
synergistically -- the combination of prescriptions can be counterproductive and even
deadly.)
Dr. Peter Honig, deputy director of the office of postmarketing risk assessment at the
Food and Drug Administration, said, "We learn a lot about a drug after it's been
approved. I think we would agree with that. I think he makes some good points.
Individualized dosing is the way to go. But it's not well taught in medical school."
Dr. David Bates, an associate professor of medicine at the Harvard Medical School,
called Dr. Cohen's idea an interesting hypothesis.
"In the elderly, it's clear that you want to start with lower doses," said
Dr. Bates, who has written about adverse reactions for medical journals. "In them in
particular it's quite clear that you get in trouble if you use a 'one size fits all'
dosing, which doctors have tended to do. It may well be for younger people, too, that
there's considerable variability in the way drugs are broken down."
Doctors are taught to "start low, go slow," Dr. Bates said, when prescribing
medicines for people over 60 or 65, but that the advice may apply to younger patients as
well.
Dr. Raymond Woosley, chairman of the department of pharmacology at Georgetown
University in Washington, called Dr. Cohen's article "an outstanding paper, and a
very important message."
Dr. Woosley named several drugs with recommended doses that he considered too high,
including Viagra and the over-the-counter allergy medicine Chlortrimeton. In addition, he
said, the AIDS drug AZT was first marketed at doses that turned out
to be far too high and that had to be reduced.
Dr. Cohen said doctors might identify some people at risk for reactions by asking
patients whether they had ever had an adverse reaction to a drug and whether they
considered themselves unusually sensitive to medications or prone to side effects.
Having a strong reaction to a little bit of alcohol or
caffeine may also be a clue that a patient will be very sensitive to medicines, he
said.
Drugs that have caused trouble in the past should be avoided, he said, and
people who seem very sensitive to medicines can be started on low doses, which can be
gradually increased if necessary. Some pills, but not capsules, can
be cut to fine-tune doses.
But Dr. Woosley said that in his experience a bad reaction to one medicine could not be
used to predict how a patient would fare with others.
Dr. Cohen cautioned that patients should not begin tinkering with doses of prescription
drugs on their own. He said they needed to work with doctors to adjust the doses safely.
With some drugs, doses cannot be changed: for example, antibiotics, antivirals and other
medications used to treat infections must be taken full strength, according to the
directions on the label. And in emergencies, he said, it is always safest to stick with
the recommended doses.
A spokesman for Medical Economics Inc., publisher of the P.D.R.,
said that the information in the book was supplied by drug manufacturers and approved by
the Food and Drug Administration.
Dr. Carl Peck, a former director of the Center for Drug Evaluation and Research at the
Federal drug agency, said, "One dose fits all is a marketing myth, but it's the holy
grail that every drug company tries to achieve."
While at the drug agency, Dr. Peck conducted a study that showed that some drugs did
come to market from 1980 to 1993 with dosing advice that had to be lowered. But, he said,
that is less likely to occur today because during the last decade drug manufacturers have
begun to study ranges of doses in the trials done before drugs are approved.
Some newer drugs, like cholesterol lowering agents and a nose spray for allergies, come
with labeling that gives a recommended dose range and advises doctors to try to find the
lowest effective dose. Dr. Peck is now director of the center for drug development science
at the Georgetown University Medical Center.
"The whole issue of getting the dose right has become an
important focus for the F.D.A.," Dr. Peck said, "and I think the F.D.A.
and the drug companies are making a good-faith effort to do better these days."
(Marijuananews note: Isnt that nice. Now consider this in
the context of the debate about medical marijuana, for which the patient can control the
dosage, and for which there is no lethal dose.)
Copyright: 1999 The New York Times Company
See
Prescriptions For
Anti-Depressants Increase 17 Percent In One Year,
But What Works Better and Faster?
The Context For Medical Marijuana. An Article and A Letter
and
More For The
"They Are Legal, So They Must Be Safe" Files
Context For Medical Marijuana And "Drug Education" Debates
and
Two Articles Together
Tell Us More Than Perhaps We Want to Know.
Context For The Medical Marijuana Debate
and
Philadelphia
Inquirer Finally Reports On Class Action Suit
And Al Gore Calls For More Accurate Information On Drugs Sort of
The Context for Medical Marijuana
and
Medication Given For
Glaucoma Can Cause Symptoms Of Senility In Some Patients
But They Cannot Be Given Marijuana Because It Causes Symptoms of Happiness
Context For Medical Marijuana Debate
and
Lethal
Dose Of Cynicism From Makers Of Tylenol Poll On Aspirin Dangers
Context Of Medical Marijuana Debate
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