NY Times: SSRI's Urgently Examined For Safety

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Its long... Sorry, but it seemed well worth it...

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Misty L. Trepke

http://www..com

 

NY Times: SSRI's Urgently Examined for Safety in Adults

 

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.

 

" British health authorities have promised to " urgently " examine the

implications of their findings for adults. "

 

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. "

 

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.

 

And now " The F.D.A. is considering whether to impose new

restrictions on the use of the antidepressants. "

 

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.

 

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.

 

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.

 

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!

 

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.

 

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.

 

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 http://www.drugawareness.org, there is great

satisfaction in seeing this information on the front of the New York

Times website!

 

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!

 

" 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. "

 

" 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: 801-282-5282

Website: www.drugawareness.org

 

 

 

http://www.nytimes.com/2003/08/07/health/07DEPR.html?hp

 

 

 

Bloomberg News

 

Unpublished studies about Paxil show that it carries a substantial

risk of prompting teenagers and children to consider suicide.

 

Debate Resumes on the Safety of Depression's Wonder Drugs

 

By GARDINER HARRIS

 

Warnings 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.

 

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.

 

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.

 

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.

 

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.

 

" 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. "

 

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. "

 

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.

 

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.

 

" 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.

 

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.

 

" 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.

 

" See them every day, if you need to, " Dr. Perera of GlaxoSmithKline

said.

 

The drugs are widely prescribed by general practitioners, who do not

have the same training in depression and treatment as psychiatrists.

 

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.

 

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.

 

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.

 

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. "

 

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.

 

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.

 

" 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.

 

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.

 

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.

 

" 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.

 

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.

 

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.

 

" 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. "

 

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. "