PAXIL KILLS (DITTO PROZAC, ZOLOFT)

By an amazing coincidence, just as their patents are running out, the
"blockbuster" antidepressants introduced by Eli Lilly, Pfizer, and other
pharmaceutical corporations in the late 1980s and early 1990s are being exposed
as dangerous -potentially fatal, in fact. The New York Times ran a front-page
story Aug. 7 stating "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week by the Food and Drug Administration -that unpublished studies about Paxil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."

British government regulators analyzed data from nine studies and concluded
that Paxil more than tripled the incidence of suicide attempts -not just
fantasies-in children and teenagers! Moreover, Paxil is only slightly more
effective than sugar pills at relieving depression. Since Prozac, Zoloft,
Celexa and other "selective serotonin reuptake inhibitors" affect the same
neurotransmitters, they presumably have similar safety and efficacy profiles.

The drug companies have responded to the British report with a predictable
array of tactics-deny, obfuscate, claim benefit instead of harm, stall in the
name of science, then negotiate the mildest possible slap on the wrist.
"'We're trying right now to look at this issue with the FDA 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 FDA safety evaluations... Eli Lilly & Company said that Prozac
does not cause suicides."

That Prozac causes suicide has been known to Lilly since the mid-1980s, when
German regulators reported the connection. Then, almost immediately after its
release in the U.S., we began hearing about bizarre Prozac-induced suicides and
homicides. In response to the swell of ominous anecdotal evidence, the FDA
convened a panel of experts -most of them on drug-company payrolls-who promptly
gave Prozac their seal of approval.

Is the Times story implicitly critical of the FDA is designated experts for
exposing millions of people to dangerous drugs without so much as a small-print
warning on the labels? No, science writer Gardiner Harris invites their
self-justifications, which he quotes without challenge. Here's Jeffrey A.
Lieberman, a professor of psychiatry and pharmacology: "In 1991 we said there
wasn't sufficient evidence to support a link between these drugs and suicide.
Now there is evidence, at least in children, and I wouldn't rule out that it's
in adults, too."

But there WAS evidence in 1991 -Peter Breggin, MD, presented it to the FDA with
ample documentation- and Lieberman and his colleagues chose to ignore it. What
enables Scientists (with a capital S and corporate or government affiliation)
to ignore obvious reality is the sanctity of ithe literature" -the
ever-expanding set of peer-reviewed journals, a modern-day Talmud, complete
with prestigious expositors and quasi-religious authority.

The "peer review" process involves an editor at a journal (supported by
drug-company ads) submitting an article to researchers of his acquaintance (who
are employed directly or indirectly by drug companies) for approval prior to
publication. As if that made the results irrefragably true!

"Unpublished" as used in the lead of the Times story, means "has not appeared
in 'the literature.'" A small, flawed study conducted by a PhD in the pay of
Eli Lilly and printed in the pages of a journal supported by ads from Eli Lilly
is "published," and therefore presumed to be valid. A fact-filled book by an
iconoclastic doctor like Peter Breggin or John Lee is "unpublished" and
therefore dismissed as "mere anecdotal evidence." That's Science for you in the
corporate state. The drug companies pay for studies of their products and then
don't publish the ones that show dangers and ineffectiveness.

The Times story quotes Charles B. Nemeroff, a Lilly-funded professor of
psychiatry at Emory University: "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.i 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 Times puts the total number of SSRI prescriptions issued in the U.S. at
just under 120 million, with about six million going to kids and teenagers. If
a typical 'script is good for two months and is renewed twice, that means two
million American kids are on Prozac and its analogues. We know that at least
two of them, Eric Harris, of Columbine, Colorado and Kip Kunkel of Springield,
Oregon, plotted massacres under the influence of their legally prescribed
SSRIs. But donit let eem have any marijuana!

According to Harris of the Times, "Some of the early critics say the warnings
demonstrate their prescience. 'I feel vindicated,' said Joseph Glenmullen,
author of 'Prozac Backlash...' Your correspondent does not feel vindicated, he
feels powerless and desperate and depressed beyond what any drug can relieve.
Is there a sadder phrase in the language than "I told you so?"

Second Item

Sneak Preview of the Mikuriya Hearing

The Medical Board of California's case against Tod Mikuriya, MD will be argued
by the Attorney General at a hearing set to begin Sept. 3. It is expected take
about a week. The Board will call an expert witness to testify that the level
of care Mikuriya provided to16 patients was substandard. Some of those patients
- -or most, or all, if the defense can get it together-will testify that Mikuriya
listened attentively and empathetically when he took their medical histories;
discussed a "treatment plan;" warned against smoking (as opposed to
vaporization); was available for follow-up consultation, if needed; and that
their cannabis use has continued to be beneficial, with no significant adverse
effects. Even if the witnesses get cut off on the stand, the media will get the
story and Mikuriya will win big in the court of public opinion -if his patients
stand by him. The ultimate disposition could be influenced, too: punishing a
doctor on the basis of 16-out-of-16 success stories would make the Board and
the AG look vindictive and insane.

One of the patients involved is a 60-year-old vet named Robert Hemstalk.In
October '98, I accompanied Mikuriya as he drove to Sonora to testify on
Hemstalk's behalf. Hemstalk's original crime was cultivation of three plants
- -"for self-medication," explained Mikuriya, "although he hadn't gotten approval
in advance."

After his bust, Hemstalk accepted diversion, which meant he was subject to
urine testing. "In most of the 215 cases people plea bargain their rights
away," Mikuriya lamented as we drove east that morning. "They're facing time,
they're scared, and they take probation with the usual conditions -meaning you
give up every civil right."

Hemstalk stayed clean for eight months, but he wanted to use marijuana for pain
relief and as an alternative to alcohol. His substance abuse counselor, Travis
S. Busey, Jr. of Sonora, told him that a doctor's recommendation would entitle
him to do so. Hemstalk drove to Oakland on March 26, 1998, and Mikuriya
diagnosed him as suffering from chronic pain and alcoholic encephalopathy. Soon
thereafter Hemstalk was drug tested and violated, as they say, and found
himself facing prison time.

"It's just blatant non-compliance with the law," said Mikuriya, who seems
forever surprised that not everybody took their civics lessons as literally as
he did. "You have the government blocking safe, affordable access when the law
says it has to ensure safe, affordable access. They're acting directly contrary
to the wording of the law and the will of the people!"

Mikuriya resented having to cancel his appointments and make the three-hour
drive to the Sierra foothills. He'd offered to explain his approval of
Hemstalk's cannabis use in a written declaration, but Tuolomne County Superior
Court Judge Eric DuTemple had refused to accept it into evidence. DuTemple, a
pale Republican in his mid-40s with hair an unnatural rust color, also rebuffed
an attempt by Hemstalk's public defender to have Mikuriya designated an expert
witness, which would have meant remuneration of $400 an hour, the going rate
for medical expert testimony.

The courthouse in Sonora is a solid, old three-story building made out of
yellow brick, with high ceilings and big windows. The massive oak door leading
to Judge DuTemple's courtroom had been retrofitted to accommodate a stark, ugly
metal detector -three steel girders in an inverted U. Hemstalk was already
there -a sunburnt, wiry man with a handsome head of gray hair and what looked
like a knife scar on his cheek. His voice was a rasp.

The public defender's first case didn't show and Mikuriya took the stand on
behalf of Hemstalk. His cross-examination by a young deputy DA named Clancy
- -scripted by Attorney General Lungren's right-hand man, John Gordnier-can be
read as a mini-preview of the ordeal the AG has planned for Mikuriya next
month.

Mikuriya testified that he'd interviewed Hemstalk on March 26. He'd made a
recommendation under section 11362.5 of the state Health & Safety Code.
Written? Yes. The document was produced and entered into evidence. The
diagnosis? Post-traumatic arthritis, alcoholic encephalopathy ["wet brain" to
the layman]. Clancy wanted details. Mikuriya described Hemstalk's cerebellar
atrophy, vocal chord paralysis, obvious ataxia when he walks...

Did you perform a physical examination? No.

Was your opinion based on what he said? And examination of his records, and a
review of the medical literature.

How has Hemstalk fared using marijuana? He seems slightly improved.

What percent of your practice is devoted to time spent at the so-called
cannabis clubs? About ten percent.

The rest? Going to hospitals. I'm called in by attending physicians to see
patients and evaluate psychotropic medications.

On a typical day at Oakland, how many patients do you see? Three or four...

What percentage do you recommend marijuana for? About 85 percent.

Do you get paid for the work you do at these so-called clubs? $150 cash, per
patient, is my standard arrangement.

Judge DuTemple put in a few questions of his own:

What do you charge for a follow-up call? Probably 120.

With which hospitals are you associated? Four in the East Bay: Eden in Castro
Valley, Vencor and St. Luke's sub-acute in San Leandro, Vintage Estates in
Hayward.

What do you do at these hospitals? Consult with attending physicians on
patients' medication levels.

The prosecutor summed up: Hemstalk had paid $150 for a recommendation to use
marijuana. He and Mikuriya did not have a "legitimate doctor-patient
relationship as contemplated by 11362.5." Mikuriya's recommendation was based
on "a very superficial examination."

Public Defender Gerald Kahl argued that Hemstalk had tested clean for eight
months and assumed that by getting a doctor's recommendation to use marijuana,
he was in compliance with the law. Kahl added that Mikuriya's recommendation
reminded him of "the way in which my own doctor has said, 'We'll try this and
see if it works...'"

Judge DuTemple said he would rule in a week.

Leaving Sonora we passed a crew from the Sierra Conservation Center picking up
trash along the roadside -seven young men in green jumpsuits supervised by a
deputy. "There they are, the fruit of the criminal justice system," said
Mikuriya. He thought his testimony had gone okay. "That young DA was really
giving it the old college try. Asking questions about how much I charged and
how much time I spent in the interview- I'm sure that's part of the script
suggested by Gordnier. I think I would stack up favorably with almost any
physician in the amount of time I spend taking the history and the depth of
information I elicit. It was gratuitous prosecutorial effort. Asking if I
conducted a physical examination! Does a psychiatrist typically conduct a
physical examination? I should remind the defense attorneys to ask me, 'What
percentage of psychiatrists do physical examinations on office visits?' Most of
them would probably go out of business if they had to. It takes time and it
takes staff.

"The judge was just the prosecutor-surrogate... The record will make him look
pretty bad if he sends Hemstalk to prison. Assertions by the prosecutor that I
really didn't do a good-faith examination and adequate medical work-up are
going to not hold up. The defense attorney appropriately rebutted them and we
got in enough material about the evaluation."

A week later Mikuriya called Hemstalk and got the good news: the judge was not
going to send him to prison. "And so ends another wrong-metabolite-syndrome
case," said Mikuriya. But it wasn't the end, the state won't let it rest. Next
month in an Oakland courtroom the "standard of care" provided to Robert
Hemstalk by Tod Mikuriya will again be the subject of judicial review.

You read it here first.