Posted by June in Toronto (June Floyd,June in Toronto), May 02,2002,06:14   Archive
As advised by Ann Brett on the Dystonia Foundation:

"This was in our newspaper this morning and I thought it most interesting and needed to be shared!

New Drugs Called Riskier Than Old Study Says Harmful Side Effects Spurred Warnings, Withdrawals By Marc Kaufman Washington Post Staff Writer Wednesday, May 1, 2002; Page A01

Newly approved drugs are riskier than older ones and doctors should avoid prescribing them when equally effective and long-used medications are available, according to a study reported in today's Journal of the American Medical Association."

If you want to read the `actual' article, it's up on the Journals of AMA
website - use the link below:

Vol. 287 No. 17, May 1, 2002

Timing of New Black Box Warnings and Withdrawals for Prescription

June in Toronto (beb/meige)

Related link: http://jama.ama-assn.org/issues/v287n17/rfull/joc11497.htm

--modified by June in Toronto at Thu, May 02, 2002, 06:17:12

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Re: DRUGS/June

Re : DRUGS --- June in Toronto
Posted by Kathy in Atlanta (kathy,Kathy in Atlanta), May 02,2002,06:21 Top of Thread Archive
I'm sure it's interesting June, but how do you use this site? They are asking for a lot of info and a password to access anything. Would you use the BEBRF as the institutional subscriber or what?

--modified by Kathy in Atlanta at Thu, May 02, 2002, 06:22:07

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Re : Re: DRUGS/June --- Kathy in Atlanta
Posted by June in Toronto (June Floyd,June in Toronto), May 02,2002,06:32 Top of Thread Archive
OOPS - don't know, Kathy -I just copied it from a dystonia info. letter and didn't actually check the link. This is part of what was quoted (maybe it will suffice):

"Newly approved drugs are riskier than older ones and doctors should avoid prescribing them when equally effective and long-used medications are available, according to a study reported in today's Journal of the American Medical Association.

In a provocative review of a quarter-century of unexpected and harmful side effects from the most innovative new prescription drugs, the authors found that more than 10 percent had been taken off the market or required new warnings against dangerous "adverse reactions."

"Based on our results and those of others, clinicians should avoid using
new drugs when older, similarly [effective drugs] are available," the authors conclude. "Patients who must use new drugs should be informed of the drug's limited experience and safety record."

The findings add to the increasingly contentious debate over whether the Food and Drug Administration is doing enough to protect consumers from the risks posed by new drugs.

Among the medications taken off the market recently were the nighttime
heartburn drug Propulsid (removed because of fatal heart rhythm
abnormalities), the diabetes drug Rezulin (removed after causing liver
failure) and the irritable-bowel-syndrome treatment Lotronex (removed for causing fatal constipation and colitis). All three were taken off the market in 2000.

While the FDA's job is to ensure that drugs coming on the market are safe and effective, officials there acknowledge that a small number of harmful side effects undetected during pre-market trials are inevitably discovered only after a drug has been approved and used by millions of patients.
Because the FDA approved many more drugs during the 1990s than in previous decades, more unexpected harmful side effects are appearing.

"Our data found that only half of all serious adverse reactions are
detected seven years after a drug enters the market," said the study's lead author, Karen E. Lasser. "Millions of patients are exposed to
potentially unsafe drugs each year."

In an accompanying commentary in the journal, a top official with the FDA's Center for Drug Evaluation and Research Policy, Robert J. Temple, argues that the study's assessment of the agency's track record on safety issues is misleading. He says many of the warnings added after the drugs entered the market reflected subsequent scientific findings or the discovery that medications known to be toxic turned out to be more
toxic than expected.

"This is a useful study," Temple said in an interview. "But when I looked more carefully, many of the problems described are not good reasons to avoid using a new drug. . . . Patients needn't be nervous about using new drugs prescribed by their doctors."

Temple said recent changes in how drugs are developed should help limit the number of problematic side effects. He also said regulators are now
focused, in particular, on potential liver damage from new drugs -- the cause of some of the most significant drug withdrawals.

The drug industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) yesterday called the JAMA study "misinformed and misleading."

"We note that Dr. Lasser et al. state that the benefit/risk ratio of new
medicines sometimes shifts as new information is acquired after marketing, but they fail to state that it often shifts to the benefit side," PhRMA said in a statement. "For example, cholesterol-lowering drugs have been found after marketing to have significant additional benefits."

But Sidney Wolfe of Public Citizen's Health Research Group, a coauthor of the JAMA report, said that despite FDA assurances significant safety problems remain. "Rather than getting better, we believe the situation is just as bad, or worse," he said.

The authors of the study, most from Cambridge Hospital and Harvard Medical School, used FDA announcements and the Physicians' Desk Reference -- an annual compendium of drugs on the market -- to study how many medications were withdrawn and how many required new safety notices to doctors, called "black box" warnings. Between 1975 and 1999, they report, 548 new chemical entities were approved by the FDA as prescription drugs, and 56 were either withdrawn or given new black box

Because many of the 548 drugs were approved recently, the researchers used a probability analysis to estimate how many would require FDA action. Based on experience, they conclude that about 20 percent of the drugs would acquire a new black box warning over a 25-year period or would be taken off the market.

A decade ago, the FDA came under intense pressure from the drug industry
and some legislators to speed its drug-approval process. Congress approved a program in 1992 that allowed the FDA to raise additional funds through a user fee program supported by the drug industry. Reauthorization of that program is being debated in Congress, where it has broad bipartisan support. However, some lawmakers and others argue that the user fees give the drug industry undue influence over the FDA, and have contributed to the kind of safety concerns raised in the JAMA article.

But the pressures to speed approvals continue, as illustrated by a poll conducted by the Competitive Enterprise Institute that was released yesterday. The institute, a free-market advocacy group, found in its poll that more than 60 percent of cancer specialists believe the FDA is still moving too slowly."

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Re: DRUGS/OOPS!!!!!/June

Re : Re: DRUGS/OOPS!!!!! --- June in Toronto
Posted by kathy in Atlanta (kathy,kathy in Atlanta), May 02,2002,09:32 Top of Thread Archive
Thanks, June for this info! Also I'm glad none of us no longer has to worry about our obits mentioning fatal constipation as the cause.

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Re : DRUGS --- June in Toronto
Posted by Alan Phair , May 02,2002,19:47 Top of Thread Archive
June, I saw the same thing on TV the other day although the article didn't surprise me. Common sense says that drugs that are on the market longer are going to most likely have a less chance of dangerous side effects simply because they have been through more live patient testing over the years. That still would not stop me from taking something new if if it were touted to significantly improve my condition. I guess I am one of those that says someone has to pave the way so others can benefit and I am not afraid of doing so. Unfortunately, not everything is caught prior to a drug being released. At some point, the overall benefit to the general public has to be weighed against minimal risk. I would hope that a cancer drug will evolve some day that can save millions of lives even if it poses a risk to a few others. Why wait to give it ten or twenty more years of testing.

Anyway, thanks for pointing out the article. It did have some good points to it....Alan

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