Healthy Skepticism Library item: 2696
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Vedantam S.
U.S. Alters Test Policy On Psychiatric Drugs; FDA Won't Require 6-Month Studies
Washington Post 2005 Oct 26
http://www.washingtonpost.com/wp-dyn/content/article/2005/10/25/AR2005102501576.html
Keywords:
FDA
Notes:
Ralph Faggotter’s Comments:
1/. “ The panel’s vote came after it heard a barrage of complaints from industry executives, academic researchers and patient advocates. “
All 3 of the groups noted above- industry executives, patient advocates and academic researches can really be considered as one group under the one heading – ‘sponsored by the pharmaceutical industry’
rather than 3 separate entities which tends to look more impressive on paper.
2/. One of the arguments used here for not having 6 month trial is that- “ Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that do not, Michelson and others said. “
This is an incredible statement! Mr Michelson demonstrates a stunning lack of confidence in his own products here.
Translated- “ Our drugs are so hopeless that it is a waste of time testing them for 6 months as they wont be doing any good by this time.”
3/. Has the FDA learned nothing about the dangers of bowing to industry pressure for short-term political comfort at the expense of long-term public health?
The is a queue of impending law-suits already stretching from here to eternity over Vioxx and other bungles caused by the FDA fast-tracking drugs and not properly cross-checking data presented by drug companies.
Angela Bischoff’s Comments:
The key sentence in the article is this:
“Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that
do not, Michelson and others said.” Mchelson works for Eli Lilly. He’s actually saying that the majority of users don’t do well over the long term. Why then in their propaganda do they encourage doctors to keep patients on the drug, to reduce drop-out rates?
Janet Currie’s Comments:
“ Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that do not, Michelson and others said. “
Dr Michelson’s statement can also be translated to mean that-
1) if we test psychiatric drugs long
enough the side effects will be so intolerable that people will
drop out of the trial – the rate of drop off for SRRIs within the
first few months is 50% and for antipsychotics by 18 months the drop-off
is 75% and 2) people will become addicted and
we will somehow have to account for that. 3)other side effects
like enormous weight gain among people taking anti-psychotics
(which lead to other health problems) might have to be “faced”
Janet Currie
Director
Focus Consultants
Phone: 250-479-2962
Fax: 250-479-2961
focus99@shaw.ca
Full text:
U.S. Alters Test Policy On Psychiatric Drugs
FDA Won’t Require 6-Month Studies
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, October 26, 2005; Page A03
The government will back down from a plan to require long-term studies of new psychiatric drugs before allowing them on the market, regulators said yesterday.
The reversal of the recently adopted policy came after a panel of experts unanimously recommended against requiring such studies as a condition of approval. While such studies are needed, the experts said, delaying decisions on new medications would hurt patients.
The panel’s vote came after it heard a barrage of complaints from industry executives, academic researchers and patient advocates. All the critics predicted that the policy would lead to delays in bringing new drugs to market while providing little new information that may not apply to most patients. They also warned that the policy would cause drug companies to scale back on developing new drugs because of the potential increase in expense and risk.
The new plan, which the Food and Drug Administration had begun to implement over the past six months, called for companies to conduct studies for as long as half a year before seeking approval of new drugs. Like many other medications, psychiatric drugs are typically approved on the basis of positive results from two short-term studies, each of which may last only eight weeks.
Because physicians routinely prescribe psychiatric drugs for much longer periods, the FDA had started demanding longer-term data, as do regulators in the European Union, said Thomas P. Laughren, director of FDA’s Division of Psychiatry Products. After the emphatic rejection by the panel yesterday, Laughren said regulators will “back off.”
Criticism of the plan was voiced in all 15 presentations made at the panel meeting yesterday, prompting the chairman of the advisory panel, University of Florida psychiatrist Wayne Goodman, to implore his fellow scientists to mount an argument in favor of the requirement, if only to play “devil’s advocate.” But all the panelists agreed with the academic researchers, patient advocates and industry executives from Merck and Co., Wyeth Pharmaceuticals, Eli Lilly & Co. and other companies in stressing that the new federal requirement would have adverse consequences.
In the real world, as many as half of all psychiatric patients switch medications after three months of treatment, and as many as 70 percent switch after six months, said David Michelson, executive director for neuroscience medical research at Eli Lilly, which makes Prozac and other psychiatric drugs.
Asking companies to conduct trials that show that medications work for six months or longer will lead to trials that focus on the small subset of patients who do well for such long periods, rather than on the majority that do not, Michelson and others said. As a result, added Gary Sachs, a Harvard University researcher who testified at the meeting, such data will be of little help to clinicians in the real world who usually have to deal with less predictable cases.
“I believe the public interest is not served by this requirement, and it could cause a lot more harm and confusion than benefit,” Sachs told the panel. “It would be telling someone with a heart attack that we have a drug that we know works, but we can’t give it because we don’t yet know whether it would prevent further heart attacks.”
Sachs and other experts said “effectiveness studies” that can guide clinicians about which drug to try first, and when patients should stop taking a medication, are very valuable — but their complex design and requirements mean they are best conducted at public expense by research institutions such as the National Institute of Mental Health.
While that institute does fund such studies, Sachs said, “their commitment to do that is substantially less than we would wish.”
