- The New York Times this morning is publishing one of
the most troubling articles ever on antidepressants. Troubling enough for
drug companies to at least give them a few sleepless nights.
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- "British health authorities have promised to "urgently"
examine the implications of their findings for adults."
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- And Dr. Jeffrey Lieberman who sat on the FDA panel in
1991 to determine the safety of Prozac stated, "Now there is evidence,
at least in children, and I wouldn't rule out that it's in adults, too."
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- One of the biggest bombshells in the article is that
in light of the new information recently released out of the UK on Paxil
7 out of the 10 FDA 1991 panel members would change their vote of safety
and likely would issue the warning of possible suicide.
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- And now "The F.D.A. is considering whether to impose
new restrictions on the use of the antidepressants."
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- I testified before that FDA panel and was certainly shocked
to learn in this article that the panel chairman was wearing a bullet proof
vest and that they were mobbed! It is news to me that anyone was mobbed
that day. I certainly saw none of it and I sat up front and then stood
visiting with Dr. Martin Teicher for some time right at the front of the
room after his "presentation" that he really did not get a chance
to give.
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- What I did see was the FDA press room laughing uncontrollably
and jeering at the panel from behind mirrored windows saying that they
must be out of their minds to think that anyone would believe the line
of "bull" they were being fed by this panel to calm their fears
about this drug.
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- And I witnessed all the drug company representatives
- a huge panel of dark suits sitting right up front next to the panel breathing
down their necks and laughing a jeering at those who were testifying to
the horrors their families had experienced.
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- I sat with LeAnne Westover, Del Shannon's widow, and
together we heard nasty remarks from those from the drug company about
how John Travolta would likely be coming in next. It was clear to me that
this was all a big joke to them. The most horrifying reports one could
imagine were being made by family members and they were laughing at them.
I could not believe my eyes or ears!
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- Everyone prescribed one of these drugs should have to
watch the video of that FDA testimony. I have one in my office and show
it as often as I can.
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- I spoke in my book about how even though Dr. Martin Teicher
was invited to present information about the problems with these drugs
he was cut off immediately and not allowed to speak. It was such an obvious
sham.
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- Although much of the information of what went on behind
closed doors in keeping these drugs on the market is in the "Aftermath"
document on our website at www.drugawareness.org, there is great satisfaction
in seeing this information on the front of the New York Times website!
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- I found information in this article shocking because
it is being admitted openly by doctors. For Dr. Emslie to state that he
has to sign contracts pledging secrecy about what they learn in these clinical
trials! The obvious reason for that secrecy is to hide the negative findings
as long as possible so as to make as much money as possible before the
word gets out to the all too trusting patients. He goes on to raise concerns
about other studies that have not been reported showing additional problems
with other of the SSRIs. This should be of utmost concern to anyone who
has a child on ANY of these SSRI antidepressants!
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- "Dr. Graham Emslie, a professor of psychiatry at
the University of Texas Southwestern Medical Center who was a researcher
in four of GlaxoSmithKline's studies of Paxil, said he suspected that the
other studies went unpublished at least in part because the results were
unfavorable."
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- "Some of these studies were finished a couple of
years ago," Dr. Emslie said. "But negative trials tend not to
get published."
-
- "According to Dr. Emslie, other companies have withheld
negative studies of S.S.R.I.'s. "I know of at least a half-dozen other
studies of antidepressant treatments in children and adolescents that have
been completed but as yet have not been published," he said. "More
than enough time has passed for these to be published at least in abstract
form." He refused to identify the companies or the drugs involved
because he, like other researchers involved in similar research, has signed
contracts promising secrecy."
-
- PLEASE get this to your local papers and get them to
run similar articles. I am available for interviews and we have LOTS of
parents of children who have died or committed violent crimes as a result
of using these drugs who are willing to be interviewed as well.
-
- Dr. Ann Blake Tracy, Executive Director, International
Coalition For Drug Awareness & author of Prozac: Panacea or Pandora?
- Our Serotonin Nightmare & tape on safe withdrawal "Help! I Can't
Get Off My Antidepressant!"
-
- Order Number: 800-280-0730 Website: www.drugawareness.org
-
-
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- http://www.nytimes.com/2003/08/07/health/07DEPR.html?hp
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-
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- Bloomberg News
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- Unpublished studies about Paxil show that it carries
a substantial risk of prompting teenagers and children to consider suicide.
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- Debate Resumes on the Safety of Depression's Wonder Drugs
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- By GARDINER HARRIS
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- arnings by drug regulators about the safety of Paxil,
one of the world's most prescribed antidepressants, are reopening seemingly
settled questions about a whole class of drugs that also includes Prozac
and Zoloft.
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- Doctors are just beginning to react to the finding -
reported first by British drug authorities in June and then endorsed the
next week by the Food and Drug Administration - that unpublished studies
about Paxil show that it carries a substantial risk of prompting teenagers
and children to consider suicide.
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- Because the studies also found that Paxil was no more
effective than a placebo in treating young people's depression, the regulators
recommended that doctors write no new Paxil prescriptions for patients
under 18. Experts say that the suicide risk is highest in the first few
weeks young patients are on the drug.
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- The concern that Paxil and drugs like it could cause
suicide had been weighed, and rejected, by regulators a dozen years ago,
amid early concerns about the group of antidepressants known as selective
serotonin reuptake inhibitors, or S.S.R.I.'s. In the meantime, millions
of people have taken the drugs, and many experts say that they have prevented
far more suicides by teenagers and children than any reading of the new
findings suggests they could have caused.
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- Almost no one suggests that Prozac, Zoloft, Paxil and
their cousins are not safe for the vast majority of adults, although studies
have shown them to be only modestly effective.
-
- Still, the warnings have the early critics saying they
feel vindicated. Plaintiffs' lawyers who have uncovered evidence that they
say shows drug makers withheld evidence of the S.S.R.I.'s suicide risk
from regulators say the warnings give fresh urgency to their claims.
-
- And the findings have unsettled some of the very experts
who absolved S.S.R.I.'s of a link to suicide a dozen years ago. Of the
10 American specialists who, as members of an ad hoc F.D.A. panel, formally
cleared the drugs of a link to suicide in 1991, seven now say that the
new information would prompt them to reconsider that decision, if they
were asked.
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- "In 1991, we said there wasn't sufficient evidence
to support a link between these drugs and suicide," said Dr. Jeffrey
A. Lieberman, a professor of psychiatry and pharmacology at the University
of North Carolina and a member of the panel. "Now there is evidence,
at least in children, and I wouldn't rule out that it's in adults, too."
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- British health authorities have promised to "urgently"
examine the implications of their findings for adults. The F.D.A. is considering
whether to impose new restrictions on the use of the antidepressants. The
agency's warning emphasized that younger patients "should not discontinue
use of Paxil without first consulting their physicians," adding, "it
is important that Paxil not be abruptly discontinued."
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- While the regulators' warnings address only Paxil, many
of the experts on the 1991 panel said all S.S.R.I.'s act similarly in the
body, so concerns about one could apply to all.
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- The drugs' manufacturers, which sell billions of dollars
of S.S.R.I.'s every year, have treaded carefully in responding to the warnings.
Without criticizing the regulators, they maintain that there is no proof
that their drugs have a link to suicidal thinking in young patients - and
they point out that the F.D.A. in the past found no merit in such claims.
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- "We're trying right now to look at this issue with
the F.D.A. and come up with an understanding together of what the data
mean," said Dr. Philip Perera, a medical director of GlaxoSmithKline,
the British company that makes Paxil. Pfizer, the maker of Zoloft, said
that its drug was different from Paxil and had passed all F.D.A. safety
evaluations, including one as recently as June 12. Eli Lilly & Company
said that Prozac does not cause suicides.
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- So far, there is little evidence that the warnings have
affected doctors' prescribing practices. Teenagers and children account
for about 5 percent of S.S.R.I. prescriptions, and companies that track
the industry have detected no falloff in sales.
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- "I can hardly imagine working without these drugs,"
said Dr. William Schreiber, a Louisville, Ky., internist. "These are
good drugs, and I think they're safe drugs."
-
- But the warnings are beginning to seep into doctors'
awareness. Connecticut officials, for example, last month dropped Paxil
from their list of approved medications for foster children. And even doctors
who do not believe there is a link between S.S.R.I.'s and an increased
risk of suicide are emphasizing that patients need to be closely monitored
in their first weeks on the drugs.
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- "See them every day, if you need to," Dr. Perera
of GlaxoSmithKline said.
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- The drugs are widely prescribed by general practitioners,
who do not have the same training in depression and treatment as psychiatrists.
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- With S.S.R.I.'s now the most prescribed drugs for depression,
it is easy to forget how high passions ran when the F.D.A. convened an
expert panel in 1991 to weigh claims that Prozac and other S.S.R.I.'s may
cause some patients to become suicidal. The panel's hearing in Bethesda,
Md., was mobbed; its chairman wore a bulletproof vest.
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- Dozens of people told stories like the one related by
Melinda Harris. Blaming Prozac, she described how her father came into
the kitchen one morning, picked up a 12-inch butcher knife and stabbed
himself repeatedly in the stomach.
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- Just as emotionally, advocates for the mentally ill pleaded
with the panel to reassure patients that they could take Prozac with confidence.
Representatives of Eli Lilly cited studies finding no connection between
suicide and the drug, which had been on the market for almost four years.
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- Despite the sharp conflict, the panel voted unanimously
in Prozac's favor, and the controversy died down. To this day, the panel's
findings are cited to rebut claims that the drugs can be harmful.
-
- But some of the early critics say the warnings demonstrate
their prescience. "I feel vindicated," said Joseph Glenmullen,
author of "Prozac Backlash," a fierce critique of antidepressants.
"These companies have vehemently denied this side effect for over
a decade, and now their own data indicate there's a significant risk."
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- The British regulators said that their analysis of the
nine studies of Paxil found 3.2 times the likelihood of suicidal thoughts
or suicide attempts among teens and children given the drug as among patients
given a placebo. They also said that Paxil has not proved effective against
depression in children and teenagers.
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- Some experts suspect that in the first few weeks of therapy,
drugs like Paxil can shove a small number of patients toward a mental precipice,
perhaps because they can cause a severe form of restlessness known as akathisia.
Patients who make it through the first weeks of drug therapy uneventfully
do fine on the medication on the long term, these experts say.
-
- Teenagers and children seem particularly vulnerable,
said Dr. Mark A. Riddle, director of the division of child and adolescent
psychiatry at the Johns Hopkins Children's Center.
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- "Kids tend to get quite activated, especially on
adult doses of S.S.R.I.'s," said Dr. Riddle, who in 1991 conducted
one of the first studies of the drugs in younger patients. "We had
a lot of cases of kids who became so disinhibited they did reckless things,"
he said, describing those early findings.
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- In recent years, most debate among doctors and researchers
about the S.S.R.I.'s has focused on whether they are effective, rather
than whether they are safe.
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- Dr. David Shaffer, a researcher at Columbia University,
noted that teenage suicides have fallen significantly in every country
where Prozac and its cousins are in widespread use.
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- "This amazing, undreamt of and unhoped for reduction
in suicide rates is probably the result of more liberal treatment of young
people with S.S.R.I.'s, and it's suggestive that these drugs may be responsible
for saving a lot of lives," Dr. Shaffer said. "The introduction
of S.S.R.I.'s has been a revolution."
-
- Yet most studies - including those recently reviewed
by British and American health regulators - have found that S.S.R.I.'s
are no more effective in fighting teenage depression than sugar pills.
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- Even in adults, S.S.R.I.'s have been found to offer only
modest benefits. In about half of all adult tests, the drugs prove no more
effective than placebos. On average, they reduce symptoms of depression
by about 41 percent on a widely used scale, versus a 31 percent reduction
among those taking placebos, according to a survey in 2000 of studies used
by the F.D.A. in approving the drugs.
-
- Researchers, moreover, have not been able to analyze
much of the data on the drugs, because they have not been made public.
-
- GlaxoSmithKline, for instance, has acknowledged that
just one of its nine studies of Paxil in children and adolescents has been
published - a study that made only passing mention of suicide and concluded
that the drug was effective against depression. According to the F.D.A.,
the combined results of all nine trials show that the drug is not effective
against depression in patients under 18. Of the S.S.R.I.'s, only Prozac
is approved by the F.D.A. to treat depression in children and teenagers,
although doctors also widely prescribe the others.
-
- Dr. Graham Emslie, a professor of psychiatry at the University
of Texas Southwestern Medical Center who was a researcher in four of GlaxoSmithKline's
studies of Paxil, said he suspected that the other studies went unpublished
at least in part because the results were unfavorable.
-
- "Some of these studies were finished a couple of
years ago," Dr. Emslie said. "But negative trials tend not to
get published."
-
- Dr. Perera, the GlaxoSmithKline official, said that publishing
studies "takes time." He declined to say if the company would
seek to publish the eight Paxil studies that have not appeared in journals.
-
- According to Dr. Emslie, other companies have withheld
negative studies of S.S.R.I.'s. "I know of at least a half-dozen other
studies of antidepressant treatments in children and adolescents that have
been completed but as yet have not been published," he said. "More
than enough time has passed for these to be published at least in abstract
form." He refused to identify the companies or the drugs involved
because he, like other researchers involved in similar research, has signed
contracts promising secrecy.
-
- With negative results not disclosed, researchers and
physicians often believe that drugs are more effective and safer than they
actually are, according to Dr. Marcia Angell, a former editor of The New
England Journal of Medicine. "It changes the way medicine is practiced,"
Dr. Angell said.
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- Back in 1991, in their presentation to the blue-ribbon
committee reviewing Prozac, Lilly scientists made much of the fact that
studies analyzing Zoloft and Paxil failed to show any link between those
drugs and an increase in suicides.
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- "There is simply no scientific evidence whatsoever,
no placebo-controlled double-blind study, that has established a cause-and-effect
relationship between antidepressant pharmacotherapy of any class and suicidal
acts or ideation," said Dr. Charles B. Nemeroff, a professor of psychiatry
at Emory University who worked as a consultant and spoke on behalf of Lilly.
-
- In an interview, Dr. Nemeroff said he believed that his
statement was accurate then and remains so, since he has not seen any published
study to contradict it.
-
- The British and American regulators have reached a different
conclusion. And experts hired by lawyers suing the manufacturers over claims
that the drugs led to suicides question whether the F.D.A. received a full
picture of the available research in 1991.
-
- For instance, F.D.A. procedures required Lilly to inform
the agency of any concerns about Prozac raised by other national health
authorities. But court records show that Lilly never told the F.D.A. or
the expert panel that German regulators initially refused to approve Prozac's
sale in 1985 because of concerns over a link with suicide.
-
- In their analysis of Lilly's data, the German authorities
said that Prozac seemed to have caused a substantial increase in suicide
among users, according to court records. Ultimately, the Germans approved
Prozac with a warning that physicians should consider using sedatives for
patients at risk of suicide.
-
- No such warning is included in Prozac's label in the
United States, although the risk of suicidal thinking is listed among the
drug's side effects.
-
- Gary Tollefson, a Lilly executive who spoke before the
1991 panel, was asked in a deposition why he did not tell the experts about
the German concerns.
-
- "That was not a question I was asked," he said,
according to court records, "so I did not answer that question."
-
- Documents brought to light in other cases suggest that
Lilly struggled for years to reconcile suicidal events among patients taking
Prozac in its trials. One memo shows that a top Lilly executive asked the
company's own researchers to record suicide attempts as "overdose"
and thoughts of suicide as "depression."
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- In another memo, a Lilly employee objected to those instructions,
making reference to the German health authority, known by its initials
as the B.G.A. "I do not think I could explain to the B.G.A., a judge,
to a reporter or even to my family why we would do this especially on the
sensitive issue of suicide and suicidal ideation," he wrote.
-
- In a recent statement, Lilly said: "There is no
credible scientific evidence that establishes a causal connection between
Prozac and violent or suicidal behavior. To the contrary, scientific evidence
shows that Prozac and other antidepressant medications appear to reduce
these behaviors."
-
- Lilly representatives told the 1991 panel that the company
had put together a series of proposed studies to examine the suicide issue
and said one of the studies had already been started. According to plaintiffs'
lawyers, Lilly never completed the study; Lilly declined to comment.
-
- Were the F.D.A. to reconstitute the 1991 panel, its members
would again be presented with a confusing mix of data on the issue - despite
the passage of 16 years since Prozac's introduction and the use by tens
of millions of people of it and other S.S.R.I.'s.
-
- Under the circumstances, one member of the panel, Dr.
Keh-Ming Lin, a professor of psychiatry at the University of California
at Los Angeles, said the new information unearthed by regulators might
lead him to change his vote absolving S.S.R.I.'s of suicide risk.
-
- "If you have data that's worrisome, you tend to
be conservative," Dr. Lin said, "even when the question isn't
resolved."
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- _____
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- Dr. Tracy is the author of Prozac: Panacea or Pandora?
- Our Serotonin Nightmare Order 800-280-0730 Office 801-282-5282 Cell 801-209-1800
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