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Published 2008-05-15 16:20:00
 


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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 Doesn’t 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: Isn’t 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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