Fwd: [drugawareness] NY Times: SSRI's Urgently Examined for Safety in Adults

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drugawareness

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Thu, 7 Aug 2003 02:32:59 EDT

[drugawareness] 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

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

 

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.

 

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. "