|
CHILDREN
BOSTON GLOBE - Antidepressants appear to double the risk of
suicidal thoughts and actions in children who take them, US regulators
said in a study outlining the methodology used for a 2004 report
that led to warnings on drugs including Eli Lilly & Co.'s
Prozac and GlaxoSmithKline's Paxil. The Food and Drug Administration
first presented the findings, detailed yesterday in the Archives
of General Psychiatry, to an advisory panel in September 2004.
The agency followed with a requirement that makers of antidepressants
warn patients and doctors. The warning led to a 20 percent drop
in antidepressant prescriptions for children between March 2004
and June 2005, according to Psychiatric News, the newspaper of
the American Psychiatric Association.
JANUARY 2006
PRESSURE MOUNTS ON DOCTORS TO BREAK
TIES TO DRUG FIRMS
CECI CONNOLLY, WASHINGTON POST
- Declaring that the pervasive influence of drug industry money
is distorting doctors' treatment decisions and scientific findings,
a prestigious panel of medical experts called on their colleagues
yesterday to adopt far-reaching new conflict-of-interest policies.
In an article in the Journal of the American Medical Association,
the group said that voluntary efforts to limit corporate inducements
have failed, resulting in the over-prescribing of some medications
and the withholding of negative discoveries about others. Highly
publicized cases involving the anti-inflammatory drug Vioxx,
antidepressants for children and spinal implants made by Medtronic
-- all occurring while voluntary guidelines were in place --
highlight the need for stricter measures, they said.
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/24/AR2006012401483.html
http://www.iht.com/articles/2006/01/25/news/doctors.php
HALF OF AMERICANS ON PRESCRIPTION DRUGS
REUTERS - About half of all U.S.
women and 40 percent of U.S. men are currently using or have
recently used a prescription drug, according to government statistics
published on Thursday. This "snapshot" of information
was based on a survey that found that 54 percent of white non-Hispanic
women and 43 percent of white non-Hispanic men had used a prescription
drug in the past month, the National Center for Health Statistics
said in a statement. . . Nearly 44 percent of black women and
35 percent of black men reported using prescription drugs and
nearly 38 percent of Mexican-American women and nearly 26 percent
of Mexican-American men, the survey found.
DECEMBER 2005
DOCTORS TAKE $22 BILLION IN FREE GIFTS
FROM CORPORATE DRUG PUSHERS
G. JEFFREY MACDONALD, CHRISTIAN
SCIENCE MONITOR - Chen Kenyon and Dustin Petersen don't look
like rebels. They look scrubbed and eager to learn from any doctor
in a long white coat. But in the pockets of their shorter garments
lurk symbols of a movement aiming to topple one of medicine's
most entrenched traditions. Their pens read "Pharm Free,"
which means they don't take personal gifts of any size from the
pharmaceutical industry. And that is touching off a quiet ethics
war reverberating through the halls of academia and hospitals
across the country. Messrs. Kenyon and Petersen are among a growing
band of stethoscope-wearing students who believe the medical
profession needs more detachment from big pharmaceutical firms.
Consequently, they're turning
down everything from free catered meals to notepads, provoking
debates among fellow students and quizzical looks from doctors.
. . Behind the modest rebellion is the belief that taking gifts
from drug companies creates a conflict of interest for doctors.
The argument: To accept handouts is to feel indebted, and doctors
indebted to drug firms may not be prescribing medicines based
solely on what's best for their patients. The 60,000-member American
Medical Student Association urges students and doctors alike
to just say "no" to all personal gifts from drugmakers.
Doctors on the whole seem far
less worried about the practice. The American Medical Association
condones gift-taking from pharmaceutical representatives as long
as no single gift is worth much more than $100. And drug companies
seem to be finding plenty of takers: spending on marketing to
physicians jumped from $12.1 billion in 1999 to $22 billion in
2003 ($16 billion of which was in free samples), according to
data from Pharmaceutical Research and Manufacturers of America.
http://www.csmonitor.com/2005/1228/p20s01-lire.html?s=hns
38 SENATORS WITH DRUG STOCKS VOTE TO
GIVE THEM A BOOST
FOUNDATION FOR TAXPAYER &
CONSUMER RIGHTS - 38 U.S. Senators with up to $13.4 million in
pharmaceutical holdings increased the value of their stock portfolios
when they approved an amendment to the defense appropriations
bill that immunizes drug makers from accountability to the public
when they sell dangerous drugs and other products. . . FTCR released
an analysis of Senate personal financial disclosures last week,
revealing that 42 senators -- 27 Republicans and 15 Democrats
-- held pharmaceutical stock worth between $8.1 and $16 million
in 2004. Senators earned an additional $2.5 to $7.2 million in
capital gains and dividends, and two senators' spouses also earned
salaries from pharmaceuticals. . .
The provision grants immunity
to drug companies for any vaccine or product, classified by the
Bush Administration as necessary to respond to a public health
threat, when patients are harmed by dangerous drugs. Its broad
language will protect any product considered a "countermeasure,"
not just vaccines or drugs needed to respond to health emergencies.
Sen. Bill Frist added the provision to the defense conference
report, approved by the House of Representatives on Sunday, after
conferees had signed what they were told was the final product.
Nine members of the Senate conference committee hold pharmaceutical
stock.
DETAILS
http://www.consumerwatchdog.org/resources/SenPharma.pdf
MEDICAL JOURNAL ARTICLES BEING USED
FOR DRUG AGITPROP
PR SPIN - [Wall Street Journal
reports that] "Many of the articles that appear in scientific
journals under the byline of prominent academics are actually
written by ghostwriters in the pay of drug companies." Used
by doctors "to guide their care of patients," these
"seemingly objective articles ... are often part of a marketing
campaign." The New England Journal of Medicine recently
revealed that a 2000 article on Vioxx "omitted information
about heart attacks among patients taking the drug. . . The deletions
were made by someone working from a Merck computer." A 1999
"publications strategy" prepared for Pfizer by a WPP
Group agency listed 81 proposed articles, promoting Zoloft for
everything from "panic disorder to pedophilia." One
physiologist hired by Elsevier's Excerpta Medica says she was
asked to "slant" a 2002 paper in favor of a Johnson
& Johnson drug. Many journals ask for disclosure, but say
their ability to weed out ghostwriters is limited. "I don't
give lie-detector tests," said the Journal of the American
Medical Association's chief editor.
http://www.prwatch.org/spin/
PR SPIN - The only licensed U.S.
anthrax vaccine maker, Bio Port, turned government contracts
into "a gold mine," with help from the "right
lobbyists and public relations professionals," writes Bob
Evans. In 2002, following questions about vaccine safety and
its financial practices, Bio Port nearly quadrupled spending
on lobbyists (from $30,000 to $110,000) and hired Ruder Finn
and Fleishman-Hillard, "high-powered public relations firms
staffed by many former government officials." The company
began "sponsoring 'public education seminars' and studies."
In September 2002, a report released by "bioterrorism experts"
encouraged the government "to purchase millions of doses
of Bio Port's product." Evans says the report was actually
"written by either BioPort or its public relations agent."
Bio Port also pays $40,000 a year to upkeep a website that "says
it's sponsored by the Partnership for Anthrax Vaccination Education"
and touts Bio Port's product. This year, BioPort won "a
$122.7 million contract" with the Department of Health and
Human Services, with more funding under negotiation.
http://www.kansascity.com/mld/kansascity/news/nation/13368277.htm
NOVEMBER 2005
MEET THE CHEERLEADER WHO HELPS YOUR
DOCTOR PRESCRIBE YOUR DRUGS
STEPHANIE SAUL, NY TIMES - At game time, Onya cheers on the Washington
Redskins. But she saves some of her energy for her job in pharmaceutical
sales. Drug companies have found that former cheerleaders like
Penny Otwell are good at persuading doctors. Ms. Napier, 26,
was a star cheerleader on the national-champion University of
Kentucky squad, which has been a springboard for many careers
in pharmaceutical sales. She now plies doctors' offices selling
the antacid Prevacid for TAP Pharmaceutical Products. Ms. Napier
says the skills she honed performing for thousands of fans helped
land her job. "I would think, essentially, that cheerleaders
make good sales people," she said.
Anyone who has seen the parade
of sales representatives through a doctor's waiting room has
probably noticed that they are frequently female and invariably
good looking. Less recognized is the fact that a good many are
recruited from the cheerleading ranks. . . Some industry critics
view wholesomely sexy drug representatives as a variation on
the seductive inducements like dinners, golf outings and speaking
fees that pharmaceutical companies have dangled to sway doctors
to their brands.
But now that federal crackdowns
and the industry's self-policing have curtailed those gifts,
simple one-on-one human rapport, with all its potentially uncomfortable
consequences, has become more important. And in a crowded field
of 90,000 drug representatives, where individual clients wield
vast prescription-writing influence over patients' medication,
who better than cheerleaders to sway the hearts of the nation's
doctors, still mostly men.
BRITS TAKE AN AVERAGE OF 373 PAINKILLERS
A YEAR
INDEPENDENT, UK - One in 20 adults
takes at least six painkillers every time they are feeling ill,
according to a new survey. The British Medical Association said
patients were "misusing" pills and urged doctors and
pharmacists to be on the look-out for patients who take too many.
Pharmacologists warned that people would become addicted if they
took such levels of paracetamol, ibuprofen or aspirin. Britons
are taking an average of 373 painkillers every year, the study
revealed. The figure alarmed doctors, who said it was "staggering".
A study published in the British
Medical Journal earlier this year suggested that men and women
over 50 should consider taking an aspirin a day to reduce the
risk of heart attacks and strokes. A daily dose of aspirin is
already routinely prescribed to patients who have suffered heart
attacks. But doctors said such advice alone does not account
for the large average number of painkillers consumed. Many people
under the age of 50 take such drugs far less often
http://news.independent.co.uk/uk/health_medical/article328164.ece
JULY 2005. . .
CHARGE: NIH SCIENTISTS WERE CLOSE TO DRUG FIRMS
BLOOMBERG - Almost four dozen
scientists at the National Institutes of Health violated rules
governing outside contracts with the pharmaceutical industry
and nine may be investigated for criminal violations, U.S. lawmakers
said. Forty-four scientists failed to report income from drug
makers or take personal leave for outside work or seek approval
before starting such work, an internal NIH review found. The
probe cleared 37 scientists, said Representatives Joe Barton,
a Texas Republican who is chairman of the House Energy and Commerce
Committee, and John Dingell, a Michigan Democrat.
The NIH review suggested the agency's ethics issues are widespread,
the lawmakers said in a statement. A Congressional inquiry last
year uncovered potential conflicts of interest among senior NIH
scientists, as many supplemented their incomes with thousands
of dollars from consulting contracts with companies including
Pfizer Inc., the world's largest drugmaker.
DRUG INDUSTRY SPENDING HUGE BUCKS TO
BUY POLITICIANS
PR WATCH - The Center for Public
Integrity has released the results of its year-long investigation
into lobbying by the pharmaceutical industry, which found that
the industry has spent more than $800 million since 1998 on lobbyists
and political campaigns. In the past year alone, the industry
hired nearly 1,300 lobbyists, including hundred of former public
officials. "It is astonishing to learn that no other interest
has spent more money to sway public policy in this time period,"
said CPI executive director Roberta Baskin. In addition to lobbying
for industry-favorable policies domestically, the drug industry's
trade lobby has enlisted the Office of the U.S. Trade Representative
to pressure pressure foreign governments into removing price
controls on pharmaceuticals and restricting sales of lower-priced
generic drugs.
MAY 2005. . .
FDA FINALLY ADMITTING DANGERS IN CALMING
DRUGS
LIZ SZABO USA TODAY - The Food
and Drug Administration plans to add new warnings about psychiatric
side effects to the label of Concerta and other drugs for attention
deficits and hyperactivity, according to documents posted on
the FDA website and confirmed by the agency.
At a meeting today of the FDA's
Pediatric Advisory Committee, officials will discuss safety concerns
about Concerta, a form of methylphenidate, the active ingredient
in Ritalin and similar medications.
A briefing document about the
meeting says the review was prompted by reports of hallucinations,
suicidal thoughts, psychotic behavior and aggression among methylphenidate
users. Officials note that Concerta's label already lists possible
psychiatric side effects but suggests the problems aren't serious
or that the drug might only aggravate existing problems. . .
Attention-deficit hyperactivity
disorder affects about 7.5% of school-age children, Concerta's
maker says. The drug, approved in 2000, is intended to improve
concentration and impulse control. Patients filled 7.8 million
prescriptions last year, the FDA report says.
EX-EDITOR: MED JOURNALS TO
CLOSE TO DRUG FIRMS
http://news.bbc.co.uk/go/rss/-/2/hi/health/4552509.stm
BBC - Medical journals are an
extension of the marketing arms of drug firms, says an ex-British
Medical Journal editor. Dr Richard Smith, who edited the BMJ
for 13 years, criticised the journals' reliance on drug company
advertising. Writing in Public Library of Science Medicine, he
also said journals were undermined by relying on clinical trials
funded by the drugs industry. The BMJ said a debate was needed,
but drug industry representatives rejected the criticisms.
Dr Smith, who is now chief executive
of healthcare firm United Health Europe, said the most conspicuous
example of the dependence was reliance on advertising, but he
added it was "the least corrupting form of dependence"
since it was there for all to see. Dr Smith said the publication
of industry-funded trials was a much bigger problem.
He said: "For a drug company
a favourable trial is worth thousands of pages of advertising,
which is why a company will sometimes spend upwards of a million
dollars on reprints of the trial for worldwide distribution."
And Dr Smith argued, unlike ads, these trials were seen as the
highest form of evidence. "Fortunately from the point of
view of the companies which fund these trials - but unfortunately
for the credibility of the journals who publish them - they rarely
produce results that are unfavourable to the companies' products."
. . . BMJ editor Dr Fiona Godlee said she agreed with much of
what Mr Smith said
NPR SHILLS FOR CORPORATE DRUG
PUSHERS
http://newstandardnews.net/alivewires/business/content/? show_item=1791#more
BRIAN DOMINICK, NEW STANDARD
- Today on All Things Considered I caught one of he worst reports
I have ever heard or read in the mainstream media. . . ATC host
Melissa Block introduced the piece:
"It's been a tough year
for the pharmaceutical industry."
What the hell is she talking
about? If this was a "tough year," easy years must
be phenomenal. True, a number of pharma co's saw their profits
shrink in the first quarter of 2005. For instance, Pfizer reported
a meager $301 million in profits. And just yesterday, Bristol-Meyers
moved $110 million of profits into a reserve fund, leaving it
a pathetic $533 million in net "earnings." Meanwhile,
others are just plain blowing minds. And let's not forget this
gargantuan new tax break for drug companies. . .
"There have been complaints
about the high cost of medicine, as well as safety questions
about popular drugs to treat depression and pain. Both have eroded
the industry's reputation. In response, the industry's high-powered
Washington trade group, known as PhRMA, has hired a high-profile
new leader. NPR's Julie Rovner reports. . . "
"Billy Tauzin says his top
mission as president and CEO of the Pharmaceutical Research and
Manufacturers of America is to recapture the trust of the American
public. . . [Tauzin] said he agreed to take the job at PhRMA
because of his recent bout with intestinal cancer.
"But while Tauzin says regaining
public trust is at the top of his agenda, he also made it clear
that the industry isn't backing down on its opposition to some
highly popular issues now before Congress. The biggest is whether
or not to allow lower cost drugs to be imported from Canada and
other countries. Tauzin says its simply too dangerous.
"Anybody who makes it the
law of the land that counterfeiters and cheats and people working
in dirty labs in Indonesia can ship drugs into this country that
might not even be the drugs you need -- anybody who votes for
that, and people start dying as a result, or terrorists get ahold
of that situation and start importing products into this country
to harm us on purpose -- is gonna live with that on their conscience."
Rovner's narrative continues:
"The group also remains
unalterably opposed to efforts to negotiate prices for the new
drug benefit that starts next year -- part of the law Tauzin
helped write."
We hear from Tauzin again. .
.
"It's price control. That's
how it starts, that's how it ends. If you accept it in little
chunks and bigger and bigger chunks, like wholesale blocks, you're
walking right into the direction that Europe and some of the
other places have gone. And if you really want rationing of medicine...
good place to start."
Rovner:
"Tauzin says what the industry
wants to do most is help those who can't afford their medicines
[to] get them, both by improving insurance coverage for drugs
and more immediately by spending what he described as tens of
millions of dollars on an effort to link uninsured Americans
with drug company-sponsored assistance programs."
APRIL 2005
ELDERLY PATIENTS HURT MOST
BY DRUGS
http://tinyurl.com/59a7x
CBC, CANADA - A CBC News investigation
reveals that Canadian seniors account for 44 per cent of adverse
drug reactions causing death that are reported to Health Canada,
even though they make up just 13 per cent of the population.
CBC's analysis of Canada's adverse drug reaction database, obtained
from Health Canada under Access to Information laws, suggests
up to 16,500 elderly patients have died due to suspected drug
reactions in the last five years. . .
Older people are more vulnerable
to drug reactions partly because they use more drugs than the
general population. Seniors are also more vulnerable because
they metabolize and excrete drugs more slowly.
But when drugs are being developed,
they're rarely tested in seniors, so their effects can be a surprise,
says Dr. Robyn Tamblyn, an epidemiologist and researcher at McGill
University.
"When a drug is approved
to come into the market, you're almost in an experimental situation
when you're trying it out on people for which it was never tested,"
said Tamblyn. Tamblyn says that in a given year, nearly one in
10 seniors who take drugs will have a reaction serious enough
to put them in hospital.
In most cases she says it's a
result of inappropriate prescribing: the wrong drug, the wrong
dose, the wrong combination of drugs, or even unreadable handwriting
on prescriptions that leads to mistakes. . .
CBC found that in 2004, 1.5 million
Canadian seniors ­ more than one-third ­ were given drugs
that are either ineffective in the elderly or put seniors at
an unnecessarily high risk when safer alternatives are available.
DRUG MAKERS HAVE HUGE INFLUENCE
IN WASHINGTON
http://www.ahrp.org/infomail/05/04/26a.php
ALLIANCE FOR HUMAN RESEARCH PROTECTIONS
- USA Today provides a glimpse into the way the pharmaceutical
industry controls health care policy by buying influence at the
highest level of government, and underwriting professional and
lay healthcare organizations whose spokespersons parrot industry's
agenda. Of the 1,274 people registered to lobby in Washington
for drugmakers in 2003, according to the Center for Public Integrity,
476 are former federal officials - including 40 former members
of Congress.
- $158 million: Spending in 2004
to lobby the federal government.
- $17 million Campaign contributions
in 2004 to federal candidates (67% to Republicans).
- $7.3 million Support for the
2004 political party conventions (64% to Republicans).
"They are one of the strongest,
most well-connected and most effective lobbies in Washington,"
says Amy Allina of the National Women's Health Network. "Going
up against them is more often than not a losing battle."
|
SELLING SICKNESS
IN A FLYER for their forthcoming
book, Selling
Sickness, Ray Moynihan and Alan Cassels quote the head of
Merck thirty years ago saying something we have always suspected
of the pharmaceutical corporados but never thought we'd find
in print: "Wishing his company was more like the chewing
gum maker Wrigley's, the chief executive of Merck said it had
long been his dream to make drugs for healthy people, and 'sell
to everyone.' " |
WHAT STATINS CAN DO TO THE
ELDERLY
http://www.geriatrictimes.com/g040618.html
BEATRICE A. GOLOMB, M.D., GERIATRIC
TIMES - Statins. . . are among the best-selling prescription
drugs in the world and are widely viewed as very safe and effective.
Their benefits to coronary artery disease have been copiously
documented and are incontrovertible. In addition, statins have
been shown to benefit survival in a large study of middle-aged
men with, or at high risk for, heart disease. Nonetheless, all
drugs have potential adverse reactions despite their potential
benefits. . .
Evidence suggests the balance
of benefits to risks may be less favorable in the elderly: Cholesterol
becomes a less potent predictor of cardiovascular problems, and
adverse reactions from drugs, including statins, may become more
prominent. . . No trend toward survival benefit is seen in elderly
patients at high risk for cardiovascular disease . . .
Muscle problems are the most
common reported adverse effects of statins. . . Perhaps the most
feared adverse effect of statins is rhabdomyolysis--a condition
in which there is severe breakdown of muscle tissue that may
be toxic to the kidneys and result in kidney failure or death.
. .
Cognitive problems also occur
with statins and may also have more impact in elderly patients.
. .
A large variety of other adverse
effects have been reported with statins, including (but not limited
to) gastrointestinal and neurological effects, psychiatric problems,
immune effects (e.g., lupus-like syndrome), erectile dysfunction
and gynecomastia (breast enlargement in men), rash and skin problems,
and sleep problems.
Of particular note for the elderly
population, the PROSPER trial found a significant 25% increase
in incident cancer in participants over age 70 randomized to
statin therapy versus placebo.
ACTORS EXPOSE EFFECT OF DRUG
ADVERTISING ON DOCTORS
SHANKAR VEDANTAM AND MARC KAUFMAN WASHINGTON
POST - Actors pretending
to be patients with symptoms of stress and fatigue were five
times as likely to walk out of doctors' offices with a prescription
when they mentioned seeing an ad for the heavily promoted antidepressant
Paxil, according an unusual study being published today. . .
Most who did not report symptoms of depression were not given
medications, but when they asked for Paxil, 55 percent were given
prescriptions, and 50 percent received diagnoses of depression.
The study adds fuel to the growing
controversy over the estimated $4 billion a year the drug industry
spends on such advertising. Many public health advocates have
long complained about ads showing happy people whose lives were
changed by a drug, and now voices in Congress, the Food and Drug
Administration and even the pharmaceutical industry are asking
whether things have gone too far. Nearly every industrialized
country bans such advertising, and physicians said the new study
raises new questions.
FEBRUARY 2005
MINNESOTA KILLINGS RAISE MORE
QUESTIONS
ABOUT ANTI-DEPRESSANTS AND VIOLENCE
PROGRESSIVE REVIEW - Following
Columbine, the media ignored the possible connection between
the killings and prescribed mood-altering drugs. Thanks perhaps
to increased skepticism about the pharmaceutical industry and
the FDA, there has been somewhat more interest following the
Minnesota killings. As well it should be given that no matter
how effective such drugs have been for millions of Americans,
the possibility that they have also contributed to mass murders
should at least be as prominent a public issue as the Schiavo
case. The moral questions in a drug that works fine for most
but has disastrous effects on others needs to be widely discussed.
And there are other questions such as: are non-psychiatric medical
doctors qualified to prescribe these drugs to patients when they
may not have adequate training to notice changes in violent tendencies?
And why does the media (such as the NYT in the story below) and
the government make such a clear distinction between suicide
and violence? Isn't suicide, as one expert noted, just self-directed
violence? As Dr Peter Breggin has said, "Experts in the
field agree that suicide and violence emanate from the same basic
impulses. A drug that causes suicide will also cause violence,
and vice versa."
MONICA DAVEY AND GARDINER HARRIS,
NY TIMES - In their sleepless search for answers, the family
of Jeff Weise, the teenager who killed nine people and then himself,
says it is left wondering about the drugs he was prescribed for
his waves of depression. On Friday, as Tammy Lussier prepared
to bury Mr. Weise, who was her nephew, and her father, who was
among those he killed, she found herself looking back over the
last year, she said, when Mr. Weise began taking the antidepressant
Prozac after a suicide attempt that Ms. Lussier described as
a "cry for help."
"They kept upping the dose
for him," she said, "and by the end, he was taking
three of the 20 milligram pills a day. I can't help but think
it was too much, that it must have set him off.". . .
The effects of antidepressants
on young people remain a topic of fierce debate among scientists
and doctors. Last year, a federal panel of drug experts said
antidepressants could cause children and teenagers to become
suicidal. The Food and Drug Administration has since required
the makers of antidepressants to warn of that danger on their
labels for the medications.
Although some studies link the
drugs to an increased suicide risk, the research does not suggest
such a connection to violence like Mr. Weise's rampage through
Red Lake High School. . .
"What I can say is that
his physician, I'm sure, made the appropriate recommendations
based on whatever the dosages were," said Morry Smulevitz,
a spokesman for Eli Lilly, which makes Prozac. The dosage range,
Mr. Smulevitz said, runs from 20 milligrams to 80 milligrams
a day, so Mr. Weise's 60 milligram dose fell in that bracket.
Mr. Weise, though just 16, was taller than 6 feet and weighed
250 pounds.
Ms. Lussier, who lived with Mr.
Weise in her mother's house on the Red Lake Indian reservation
in far northern Minnesota, said she could not understand what
else, aside from drugs, had changed to explain his sudden violence.
http://www.nytimes.com/2005/03/26/national/26shoot.html?
ABC NEWS - The teenager who went
on a shooting rampage at his high school was put on the antidepressant
Prozac after a suicide scare last summer, a longtime friend says.
Jeff Weise, 16, also had watched a movie about a school shooting
with friends earlier this month skipping ahead to some of the
most violent scenes, according to Sky Grant, a friend of Weise's
since sixth grade. . .
Grant and his mother, Gayle Downwind,
said Weise was taken to a psychiatric ward in Thief River Falls
last summer after Weise frightened another friend with suicidal
computer messages. Grant said he didn't know how long Weise stayed
at the hospital. Grant, who was taking Zoloft, said he and Weise
talked in detail about antidepressants.
He said Weise told him he was
taking 40 milligrams a day of Prozac: 20 in the morning, 20 at
night. "He was a lot more quiet. I wouldn't say any better,"
Grant said.
http://abcnews.go.com/US/wireStory?id=615224
DR PETER R. BREGGIN, Sep 14,
2004 - The FDA is finally admitting that the newer antidepressants,
especially the SSRIs and Effexor, cause suicide in children.
I first drew these conclusions about the SSRIs and began publishing
them in 1994 in Talking Back to Prozac. In addition, I reviewed
and analyzed the entire literature shortly before the February
hearings. Ten years is a long time to wait for official recognition
of such important risks. . .
The FDA overlooked other related
hazards that swell the numbers of children afflicted with serious
and life-threatening adverse drug reactions. Antidepressant-induced
mania is very common. The FDA-approved label for Luvox, for example,
cites a rate of 4% for mania and manic-like symptoms. A controlled
clinical trial disclosed a 6% rate of mania for children taking
Prozac in a controlled clinical trial. Antidepressant-induced
manic behavior can disrupt a child's life and result in injury
to others. It commonly results in a false diagnosis of bipolar
disorder leading to stigmatization and many years or a lifetime
of unnecessary, harmful treatment with drugs.
While mentioning violence as
a potential subject for investigation, the FDA did not analyze
data related to antidepressant-induced violence. Experts in the
field agree that suicide and violence emanate from the same basic
impulses. A drug that causes suicide will also cause violence,
and vice versa. . .
The FDA conducted an epidemiological
study comparing rates of violent behavior for Prozac and another
antidepressant, trazodone. The reports were drawn from the FDA's
spontaneous reporting system that includes all events reported
to the drug company and the FDA. The FDA found greatly increased
reporting rates for violence on Prozac even when taking into
account the higher number of prescriptions for Prozac. Also,
the increased rate of violence reports began even before there
was publicity and controversy surrounding the problem. When I
attempted to obtain this data from the FDA, the agency told me
it had been lost. However, I was able to obtain the data in the
form of charts from the drug company through discovery. I testified
about this in 1994 and published it in my books, but again the
FDA and the drug company have not responded. . .
Finally, the FDA has insisted
on requiring confirmation from controlled clinical trials before
admitting that antidepressants can cause suicide. This has been
a massive subterfuge. In the past, when the FDA has increased
the severity of warnings for psychiatric drugs or withdrawn them
from the market, the agency has almost always relied upon increased
numbers of clinical reports in combination with a general medical
analysis of the potential problem. On this basis, the capacity
of Prozac to cause violence and suicide has been known since
the 1980s, and was clearly documented in my books as early as
1994.
The FDA has colluded with the
drug companies in hiding the dangers of the antidepressant medication.
The risk of suicide in children is but the tip of the iceberg
that includes high rates of antidepressant-induced suicide, violence,
over-stimulation, and mania.
http://www.ahrp.org/risks/SSRI0904/Breggin.php
CATHY REDFERN, SANTA CRUZ SENTINEL, APR
24, 2004 - Jurors on
Thursday found a Southern California man innocent of attempted
murder and assault after a prominent neuropsychiatrist testified
that he struck his friend in the head four times with a pronged
brass knuckles-type weapon because of an adverse reaction to
Zoloft, a popular antidepressant. Andrew Meyers, 28, had been
taking the drug for two weeks when he struck his longtime friend
in the head with a "ninja key ring" on June 20, 2002.
The two had had a disagreement about a bike Meyers had sold the
man five years ago, said Kristin Carter, the public defender
who successfully tried the case. "Everyone was shocked he
did this; Meyers was shocked," she said.
The Food and Drug Administration
last month warned makers of 10 antidepressants, including Zoloft,
to add warnings about a possible heightened risk of suicide in
some patients, saying the drugs may cause agitation, anxiety
and hostility in rare cases.
SARA HOFFMAN, JURAND, MAR 1 2003
- Vicky Jo "Brynn" Hartman of California was given
a sample pack of Zoloft by her child's doctor. She was not diagnosed
with--or even evaluated for--clinical depression, anxiety attacks,
or any other psychological disorder. She merely mentioned she
needed a "pick-me-up" to help with stress. Soon after
starting the medication, she shot her husband, comedian Phil
Hartman, and then herself. . .
Once considered wonder drugs,
these antidepressants have reportedly helped millions of people
with depression and anxiety disorders. Yet the drugs have had
disastrous consequences for others. The manufacturers insist
the drugs have only mild side effects and are non-habit-forming.
Plaintiff attorneys across the country disagree, and they are
working to debunk the drug makers' claims and obtain compensation
for people allegedly harmed by the drugs. . .
By 1997, Prozac was the fifth-most-prescribed
drug in the United States; Zoloft was 11th; and Paxil, 17th.
In 1990, one of the first public
reports of Prozac's propensity to induce suicide appeared in
an American Journal of Psychiatry article by two Harvard psychiatrists
and a registered nurse. One of the authors, Dr. Jonathan Cole,
testified in a 2000 wrongful death case, "The SSRI drugs,
as a class, clearly have the potential to cause, and in reasonable
medical probability or certainty do cause, akathisia in some
patients ... [which could] trigger or contribute to violent or
suicidal behavior."
Akathisia is a neurological phenomenon
characterized by intense internal restlessness, agitation, aggression,
and suicide attempts. Some patients describe it as wanting to
"jump out of their skin." They have reported it as
a side effect of Prozac, Zoloft, and Paxil. The makers have defended
the drugs for over a decade by saying that most patients taking
SSRIs suffer from clinical depression--and that depressed people
can be suicidal. . .
In 1986 clinical trials, researchers
found suicide rates of 12.5 patients per 1,000 taking Prozac,
compared with 3.8 patients taking a non-SSRI antidepressant and
2.5 patients taking a placebo.
A 1995 study of suicides among
British patients whose general practitioners prescribed antidepressants
compared the rates of suicide for 10 drugs: Far more people killed
themselves while on Prozac than on the others. The study found
an annual rate of 187 suicides per 100,000 depressed patients
taking Prozac, compared with 30 suicides per 100,000 depressed
patients in general.
http://www.baumhedlundlaw.com/SSRIs/Lawsuits%20over%20antidepressants.htm
JEFF SWIATEK, KNIGHT RIDDER,
JUN 7, 2001 - The manufacturer of the nation's second-best-selling
antidepressant must pay $6.5 million to the relatives of a Wyoming
man who killed himself and three others after taking the drug
Paxil, a jury in Cheyenne, Wyo., said Wednesday.
Jurors in the U.S. District Court wrongful-death civil suit returned
the verdict against GlaxoSmithKline after an 11-day trial. The
five-woman, three-man jury deliberated about five hours over
two days. The decision is the first time a jury has held any
of the leading antidepressant makers liable in a wrongful-death
case.
Paxil is a chemical cousin to
Prozac, a product of Indianapolis-based Eli Lilly and Co. that
revolutionized the treatment of depression. Such antidepressants
have raised controversy for their alleged ability to induce violent
behavior in some users.
Relatives of Donald Schell, 60,
claimed that the Gillette, Wyo., man took two Paxil tablets before
shooting his wife, their daughter, his granddaughter and himself
to death on Feb. 13, 1998. The plaintiffs' lead attorney, Andy
Vickery, had asked the jury to award a total of $25 million in
damages.
Vickery is a Houston lawyer who
specializes in handling lawsuits against antidepressant makers.
In 1999, he lost a similar case against Indianapolis-based Lilly
over a murder committed by a Hawaii man who had taken Prozac.
Lilly faces about 10 other wrongful-death lawsuits involving
the drug.
http://www.baumhedlundlaw.com/SSRIs/Paxil-Schell.htm
AUSTRALIAN, May 25, 2001 - A
Supreme Court Justice in an Australian courtroom ruled that Zoloft
was the cause for David John Hawkins strangling his wife of nearly
50 years. . . Justice O'Keefe stated in his ruling: "It
can be seen that the medical evidence strongly supports a conclusion
that but for the effect of the 250mg of Zoloft he had taken,
it is wholly unlikely that the prisoner would have committed
the crime to which he had pleaded guilty."
http://www.baumhedlundlaw.com/media/zoloft/Australian%20Zoloft%20Ruling.htm
SYDNEY MORNING HERALD, 2001 -
Hawkins first took Zoloft in 1996 after the death of his youngest
daughter from breast cancer. He suffered an adverse effect after
taking one tablet. His depression returned in 1999 and Hawkins
saw a different doctor, who prescribed him Zoloft again.
The doctor told him not to take
the medication until breakfast on Sunday, August 1. But he woke
at 2 am and took five tablets. At 7.30 am, as his wife prepared
to light the fire, Hawkins strangled her.
"I was looking at my wife
but I wasn't seeing her face," he told a doctor. Hawkins
then attempted to kill himself. A spokesman for Pfizer, which
makes Zoloft, defended the drug, saying there was no evidence
to suggest it had any side effects of aggression or aggravation.
Dr Bill Ketelbey said: "It is pure speculation that aggression
is a side effect. . .
Sertraline is the essential ingredient
in Zoloft. . . It can cause sleeplessness, agitation, confusion,
hallucination and psychosis. . . * The Australian Department
of Health and Aged Care says sertraline has been officially recorded
as the sole drug implicated in 20 cases of aggression, 319 cases
of agitation, 43 cases of hallucination, 34 cases of manic reaction,
63 cases of confusion, 18 cases of psychosis, eight cases of
delirium and five cases of delusion.
http://www.baumhedlundlaw.com/media/zoloft/SMH-Drug_Turned_Loving_Man_Killer.htm
CNN, APR 29, 1999 - Reports surfaced
Wednesday that one of the gunmen in the Littleton, Colorado,
school shooting, Eric Harris, was rejected by Marine Corps recruiters
days before the Columbine High School massacre because he was
under a doctor's care and had been prescribed an anti-depressant
medication. Harris' prescription was for Luvox, an anti-depressant
medication commonly used to treat patients with obsessive-compulsive
disorder.
It is one of a class of drugs
called selective serotonin reuptake inhibitors. Other SSRIs are
Prozac, Paxil and Zoloft. Prozac is the most commonly prescribed
anti-depressant in the United States. Serotonin is a chemical
released in the brain that can affect mood and behavior. SSRIs
work by enhancing the brain's ability to use serotonin. . .
It is not known if Harris actually
took the medication, and investigators said Wednesday early toxicology
tests performed by the medical examiner's office showed no evidence
of drugs or alcohol in the body of either gunman, Harris or Dylan
Klebold.
http://www.cnn.com/HEALTH/9904/29/luvox.explainer/
REPORT: PAINKILLERS DAMAGE INTESTINE
REUTERS - More than 70 percent
of patients who took painkillers such as ibuprofen for more than
three months suffered damage to their small intestines, U.S.
researchers reported on Monday. The study is yet another blow
to patients trying to find ways to treat arthritis pain, after
reports that the most advanced drugs, called COX-2 inhibitors,
can raise the risk of heart death.
Dr. David Y. Graham of the Baylor
College of Medicine in Houston and colleagues studied 21 patients
taking a range of drugs called non-steroidal anti-inflammatory
drugs, or NSAIDS. They compared them to 20 patients taking either
acetaminophen, an unrelated painkiller, or nothing. "Small-bowel
injury was seen in 71 percent of NSAID users compared with 10
percent of controls," they wrote in Monday's issue of the
journal Clinical Gastroenterology and Hepatology. . .
"Anybody who takes aspirin
or (other) NSAIDS for a year has a 1 to 4 percent risk of serious
gastrointestinal complications," Graham said in a telephone
interview. "If the drugs didn't have such benefits, we'd
have taken them off the market some time ago." Acetaminophen,
sold generically and also under the brand name Tylenol, does
not work for many patients, Graham said.
NEW CHOLESTEROL GUIDELINES
A GIFT TO DRUG FIRMS
http://www.forbes.com/healthcare/2004/07/12/cx_mh_0712mrk.html
MATTHEW HERPER, FORBES - New
guidelines issued by the United States government could increase
the number of people who take cholesterol-lowering medicines;
already the top-selling medication in the world with $26 billion
in annual sales. . . Under previously existing guidelines, 36
million people should be taking cholesterol-lowering pills such
as Lipitor, Zocor, or Pravachol to prevent heart attacks. In
reality, only about 11 million do. Changes issued today by the
National Cholesterol Education Program, advocate lowering cholesterol
in even more patients. Moreover, patients at the highest risk
should receive even more aggressive treatment--meaning higher,
more expensive doses of these drugs. Now, that figure will increase
by millions of people, as the new guidelines suggest treating
diabetics and people who at one time would have been considered
healthy.
PHARMACIDE GROWING IN U.S.
http://www.realcities.com/mld/krwashington/10443482.htm
TONY PUGH AND SETH BORENSTEIN,
KNICHT-RIDDER - Thousands of Americans are getting sick and many
are dying each year from prescription drugs that were pushed
onto the U.S. market ahead of the rest of the world.
A Knight Ridder analysis shows that as the number of new drugs
given first to Americans has increased, the reports of drug-induced
ailments have soared. Yet, even as the deaths and damage have
increased, the Food and Drug Administration has never instituted
an aggressive system to track the safety of drugs once they're
on the market. . .
Nearly 60 percent of all the
genuinely new drugs sold in the world in 2003 - those with active
ingredients never before marketed - were first dispensed in America.
That's up from about 3 percent 20 years ago when most drugs were
first introduced abroad, where the approval process in many countries
is much more stringent than in the United States. "We're
the guinea pigs in the sense of extensive population exposure,"
said Dr. Marcus Reidenberg, a professor of pharmacology, medicine
and public health at Cornell University Medical School in New
York City. . .
Knight Ridder found that in 1992,
just before Congress directed the FDA to speed up drug approvals,
there was an average of one adverse drug reaction for every 16,300
prescriptions filled. In 2003, adverse reactions hit one in 9,000.
While the FDA has no official
estimate on the number of people killed by these drugs, the agency
says 106,000 people a year die from all types of drug reactions.
One new drug, the painkiller Vioxx, which was pulled from the
market this fall, may have caused 55,000 deaths, a top FDA scientist
said recently.
DRUGGING OF AMERICA BY PHARMACEUTICALS
SOARING
HEALTH BENEFITS DON'T CORRELATE
WHILE SPENDING for drugs has
gone 9% in the time period discussed mortality rates for the
big diseases has declined only 1-3%. Even if all that decline
is due to drugs - which of course it isn't - it would appear
that Americans would have to spend about a $1.5 dollars a year
just to reduce mortality from cancer and heart disease by ten
percent. Note also how we are drugging boys for hyperactivity
far more than girls
AND NOW THE REALLY DIRTY secret
nobody talks about: while 84% of Americans over 65 are on highly
expensive drugs the life expectancy of such people has increased
only 3.6 years for men and 4.4 years for women since 1950.
AP - The annual report on Americans'
health found that just over 44 percent of all Americans take
at least one prescription drug, and 16.5 percent take at least
three. Those rates were up from 39 percent and 12 percent between
1988 and 1994, the Centers for Disease Control and Prevention
reported.
The report, "Health, United
States 2004," presents the latest data collected by CBC,
the National Center for Health Statistics and dozens of other
Federal health agencies, academic and professional health associations,
and international health organizations.
Deaths from heart disease, cancer
and stroke - the nation's three leading killers - are all down
1 percent to 3 percent, the analysis said. The study also found
that spending on health climbed 9.3 percent in 2002 to $1.6 trillion.
Prescription drugs, which make up about one-tenth of the total
medical bill, were the fastest growing expenditure. The price
of drugs rose 5 percent, but wider use of medicines pushed total
expenditures up 15.3 percent in 2002. Drug expenditures have
risen at least 15 percent every year since 1998. . .
Usage peaked at 84 percent for
people aged 65 and over, with the top rate at 89 percent for
black women over 65. Even for people under age 18, however, nearly
one-fourth - 24.1 percent - were taking at least one prescription
medication. The rate rose to 34.7 percent between age 18 and
44; for those ages 45 to 64, it was 62.1 percent.
ROBERT PEAR, NY TIMES - Adults'
use of antidepressants almost tripled from 1988 to 2000. Use
was higher among women than among men. In 1999-2000, 10 percent
of women 18 and older reported taking antidepressants in the
previous month, compared with 4 percent of men. Use of cholesterol-lowering
statin drugs among people 45 and older more than tripled from
1995 to 2002, the report said.
The report also confirms a sharp
increase in the use of stimulants by children ages 5 to 17. Such
drugs, like Ritalin, are often used to treat the impulsive, aggressive
traits known as attention deficit hyperactivity disorder, the
most commonly diagnosed psychiatric disorder in children. Boys
are much more likely than girls to receive such drugs when they
visit doctors' offices and clinics. In 2000-2002, the government
counted an average of 13.5 such visits for every 100 boys ages
5 to 17, up from an average of 8.5 visits in 1997-1999. The comparable
figures for girls were 5.3 and 3.3.
The report also shows a sharp
increase in heart surgery among elderly patients in the last
decade. Ms. Bernstein said this reflected an increase in procedures
to clear clogged arteries and to insert the wire mesh tubes known
as stents, which prop open the arteries.
In 2002, the infant mortality
rate was 7 deaths for every 1,000 live births, up from 6.8 in
2001. Much of the increase was attributed to deaths in the first
month of life, especially the first week.
Large racial and ethnic disparities
persist. The infant mortality rate for 2002 was 5.8 deaths for
every 1,000 births among whites, compared with 13.8 for blacks,
5.6 for Hispanics and 4.8 for Asian Americans.
Mortality from heart disease,
the leading cause of death, declined almost 3 percent in 2002,
continuing a long-term trend. Mortality from cancer, the second
leading cause of death, decreased more than 1 percent in 2002,
continuing a decline that began in 1990.
http://www.nytimes.com/2004/12/03/politics/03drug.html?oref=login
Deaths caused by terrorists on
U.S soil since 1999: c. 3,000
Deaths caused by the drug Vioxx
on U.S. soil since 1999: 25,000-55,000
Budget of Homeland Security Department:
$30 billion
Budget of Food & Drug Administration:
$1.8 billion
Punishment for terrorist killing
people on U.S. soil: Execution
Punishment for drug companies
killing people on U.S. soil: Not much, it seems
DRUG COMPANIES OUT OF CONTROL
TONY PUGH, KNIGHT RIDDER - The
recently withdrawn painkiller Vioxx may have caused as many as
139,000 heart attacks, strokes and deaths, a government drug-safety
scientist told lawmakers. He said the Food and Drug Administration
and the public are "virtually defenseless" against
a similar future catastrophe with another drug.
David Graham, the associate director
for science and medicine at the FDA's Office of Drug Safety,
made the charges in a scathing assessment of the FDA's reviews
of drugs already approved and marketed.
Graham told the Senate Finance
Committee that his agency's earlier projection that Vioxx may
have caused roughly 28,000 heart attacks or sudden cardiac deaths
was "an extremely conservative estimate." Graham said
Thursday that the number of deaths alone may have been as many
as 55,000.
Graham blamed the Vioxx deaths
on the FDA's decision in 1999 to approve Merck & Co.' s sale
of the drug, despite data that suggested the arthritis medication
was linked to increased risks of heart attack and stroke. Unless
the FDA establishes an independent division to monitor the safety
of drugs once they're on the market, Graham said, more Vioxx-like
disasters are likely.
"We are faced with what
may be the single greatest drug-safety catastrophe in the history
of this country or the history of the world... a catastrophe
that I strongly believe could have (and) should have been avoided,"
Graham testified.
Additionally, Graham said the
FDA was derelict in approving the sale of five other drugs that
he felt pose serious safety risks. According to Graham, those
drugs are Crestor, a cholesterol-lowering drug by AstraZeneca
PLC; Meridia, a weight-loss drug produced by Abbott Laboratories;
Accutane, an acne-fighting drug by Roche Holdings; Bextra, an
arthritis pain-relieving drug by Pfizer; and Serevent, an asthma
treatment by GlaxoSmithKline.
PR
WATCH - After challenging
Food and Drug Administration policies that he claims leave the
public "virtually defenseless" against questionable
drugs, FDA drug safety official Dr. David Graham contacted the
Government Accountability Project, a non-profit organization
that protects whistleblowers. Shortly afterwards, anonymous callers
to GAP charged Dr. Graham with "scientific misconduct"
and being a "bully." After further research, GAP concluded
that "the callers were trying to smear [Graham]." In
addition, GAP's legal director said he's "certain [the anonymous
callers] were supervisors at the FDA because of the details of
the arguments they made and the phone numbers from which they
called."
NY TIMES EDITORIAL - Not many
years ago, the F.D.A. was routinely criticized by the drug industry
and conservative commentators for being too nitpicking in demanding
proof of efficacy and safety before allowing new drugs on the
market. A result, that line of argument went, was that valuable
new drugs were first introduced abroad and long delayed here,
depriving American consumers of their benefits. Now the balance
has shifted. Approval times for new medicines have been cut sharply,
and new drugs often go into use first in this country. Whereas
disastrous consequences once showed up first in Europe (witness
thalidomide babies), now they are more likely to show up here
first.
That makes post-marketing surveillance
of drugs increasingly important, but the F.D.A.'s authority in
this area is shockingly weak. The system relies on doctors to
make voluntary reports to drug companies about any adverse side
effects they spot. Only a small fraction of the bad outcomes
are actually reported. Even more problematic, the prime responsibility
for collecting and evaluating data from post-marketing studies
rests with the manufacturers. It defies belief that any company
whose fortunes are riding on a blockbuster drug will be hard-nosed
when assessing unexpected consequences.
The typical pattern - shown in
cases like Vioxx and Baycol, both ultimately withdrawn from the
market - is that manufacturers cling to any rationalization that
might explain away hints of danger in their products until the
evidence becomes too strong to ignore. The F.D.A., alas, has
no power to order a manufacturer to test for possible dangers
after a drug is being sold. Indeed, the agency is so impotent
that manufacturers mostly fail to complete even the post-marketing
trials they have pledged to conduct as a condition for their
drug's approval
DECEMBER 2004
BRITISH OFFICIALS ADVISE LESS
USE OF ANTI-DEPRESSANTS
http://www.washingtonpost.com/wp-dyn/articles/A41332-2004Dec6.html
SHANKAR VEDANTAM WASHINGTON POST
- British health officials advised doctors yesterday not to prescribe
antidepressants for about 70 percent of the patients who show
up complaining of depression without first trying exercise, self-help,
talk therapy or just waiting a couple of weeks to see if they
got better. In issuing new treatment guidelines for doctors,
the British regulators and a standards-setting panel said patients
with mild depression who are able to go to work and function
normally, even if they complain of symptoms such as a lack of
interest in things, low energy, dark mood, difficulty sleeping
or difficulty concentrating, should avoid widely used antidepressants
at first because of the possibility of side effects and withdrawal
symptoms. . .
Numerous studies have shown that
antidepressants are among the fastest-growing sectors of the
U.S. pharmaceutical industry. A government report last week said
the latest figures indicated that one in 10 American women is
taking an antidepressant.
SEPTEMBER 2004
DOCTOR WHO CAUSED INQUIRY INTO ANTI-DEPRESSANTS
SAYS HOMICIDE RISK IS BEING IGNORED
[We have noticed that a number
of young mass murderers in the news were on anti-depressants.
It would make sense to demand an accounting of the drugs that
young mass murderers were using at the time of their crime.]
SARAH BOSELEY, GUARDIAN - Evidence
that antidepressant drugs like Seroxat and Prozac could make
people homicidal is being ignored by the body responsible for
regulating medicines in the UK, a leading expert said yesterday.
The charge came from David Healy, an expert on psychiatric drugs
from north Wales whose warnings that the drugs could cause suicide
prompted a major inquiry. That investigation, by an expert working
group of the Medicines and Healthcare Products Regulatory Authority,
led to the entire class of drugs except Prozac being banned last
year from use in children. . .
Dr Healy, director of the north
Wales department of psychological medicine, says he has seen
data from the clinical trials that show even some healthy volunteers
- people with no illness at all volunteering to take part in
the earliest safety trials of the drugs - became unaccountably
aggressive. Their reaction is coded as "hostile" which
can include homicidal behavior and serious aggression.
"I think there is very clear
evidence for all of the SSRI group of drugs that in addition
to making people suicidal, they can make people homicidal or
seriously aggressive and the data have been sitting in the MHRA's
files on this issue," he said.
The signal from the healthy volunteer
trials is supported by data from trials in children on Seroxat
for obsessive compulsive disorder, depression and social phobia.
Children taking part amounted to 738 on Seroxat and 647 on placebo.
Of those, there were 27 hostile events on Seroxat and only four
on placebo. Taking the children with OCD alone, those on the
drug were 17 times more likely to become aggressive than those
on placebo. . .
GlaxoSmithKline last night denied
that its drug caused adults to become hostile, although it acknowledged
there had been a problem in the children's trials.
NEW DATA CONFIRMS RISKS IN ANTI-DEPRESSANTS
FOR CHILDREN
SHANKAR VEDANTAM WASHINGTON POST
- Six months after the Food and Drug Administration withheld
an internal finding that antidepressant medications were associated
with an increased risk of suicide among children, a second staff
analysis has arrived at the same conclusion. The agency has not
publicly disclosed either report, despite growing pressure from
critics and Congress.
STUDY: PROZAC INCREASES CHANCE OF SUICIDE
IN YOUNG BY 50%
USA TODAY - Prozac, the only
antidepressant certified as safe for children, may make kids
more suicidal, according to evidence out Monday. A large, new
study added to previous research on Prozac shows that kids taking
the drug have about a 50% higher risk of suicidal thoughts and
suicide attempts than those getting placebos, says Robert Temple,
director of the Office of Drug Evaluation at the Food and Drug
Administration. . .
Other major antidepressants prescribed
for kids already have been found to raise the risk of suicidal
behavior. Prozac had been an exception. "What's interesting
and persuasive is that these studies now all lean the same way,"
Temple says.
USE OF ANTI-DEPRESSANTS FOR CHILDREN
SOARING
BLOOMBERG - Children throughout
the world are increasingly prescribed antidepressants and other
drugs designed to calm or stimulate their brains, according to
two studies published in Archives of Disease in Childhood. .
. In Germany the increase was 13 percent, the lowest recorded,
while the U.K. had the highest with 68 percent, the researchers
said.
"We believe the use of psychotropic
medications in children is a global public health issue, which
should be studied in partnership with pharmaceutical companies,
governments and researchers," said Ian Wong of the Centre
for Paediatric Pharmacy Research at the University of London.
EARLIER
STUDY WARNS AGAINST ANTI-DEPRESSANTS
FOR CHILDREN
GARDINER HARRIS, NY TIMES - Pediatricians
and family physicians should not prescribe antidepressants for
depressed children and adolescents because the drugs barely work
and their side effects are often significant, Australian researchers
have concluded. The researchers analyzed data from five published
trials of three antidepressants, Prozac, Zoloft and Paxil, in
depressed patients under age 18. They found that the drugs offered
only a "very modest" benefit over placebos. At the
same time, the drugs carry significant risks, the researchers
said in their report, published in today's issue of the British
medical journal BMJ.
PRESCHOOLERS BIG USERS OF ANTI-DEPRESSANTS
JOYCE HOWARD PRICE, WASHINGTON
TIMES - Preschoolers are leading the growth in use of antidepressants
by U.S. children, even though many questions persist about the
safety and effectiveness of using these drugs on minors. A study
published in the journal Psychiatric Services found that children
5 years old and younger are the fastest-growing segment of the
non-adult population using antidepressants today.
ANTIDEPRESSANTS FOUND INEFFECTIVE ON
TEENAGERS
ROD MICKLEBURGH, GLOBE &
MAIL, CANADA - Widely used antidepressant drugs prescribed to
tens of thousands of Canadian teens and children are barely more
effective than placebos in treating adolescent depression, according
to a leading Canadian expert in the field. The assertion by psychiatrist
Jane Garland follows a recent cascade of critical information
questioning the risk and effectiveness of prescribing antidepressant
medication for troubled young patients.
"The disappointing reality
is that antidepressant medications have minimal to no effectiveness
in childhood depression beyond a placebo effect," Dr. Garland
said in a commentary in Tuesday's Canadian Medical Association
Journal.
Dr. Garland, head of the Mood
and Anxiety Disorders Clinic at Children's Hospital here, said
the lack of evidence showing significant benefits from adolescent
use of the drugs is stunning, given the huge increase in such
prescriptions over the past few years.
Seven drugs known as SSRIs (selective
serotonin reuptake inhibitors) are under fire, one of them is
well-known Prozac. Although no national figures for adolescent
use are available, in British Columbia, an estimated 6,200 children
and teens were prescribed SSRIs in 2002, more than double the
number four years earlier. All told, nearly 14 million SSRI prescriptions
were written for Canadians of all ages in 2002 and cost $869-million.
Drug manufacturers have come
under increasing attack for withholding trial results indicating
slight increases in suicidal behavior, adverse side effects and
only minimal effectiveness of SSRIs in children and teenagers.
Several drug tests that came
to light last year prompted British authorities in effect to
ban prescription of all SSRIs except Prozac to patients under
18.
RITALIN MAY DAMAGE BRAIN RESEARCH SUGGESTS
PRAVIN CHAR, ASSOCIATED MEDIA,
UK - Children given Ritalin to control hyperactivity could be
permanently brain damaged, it was claimed yesterday. Research
suggests the controversial 'chemical cosh' drug raises the risk
of depression and anxiety in adulthood. Ritalin alters the brain's
chemical composition so that it has a lasting effect on mental
health, US scientists believe. Because these changes take place
while a child's brain is growing, they could cause irreversible
damage. . . . British GPs dispensed a record 254,000 Ritalin
prescriptions last year, up from 208,500 in 2001. One in 20 children
is said to have ADHD, which makes them boisterous and unfocused.
In one test, giving Ritalin to
young, healthy rats increased the presence of certain chemicals
linked to depression in adults. A second study found higher levels
of stress hormones and anxiety-like behaviors.
THE PSYCHOTROPIC DRUG DEBATE
A weblogger takes
on Dr. Bruce Levine whose criticisms of psychotropic drugs we
cited yesterday. But on one point they agree, when Dr. Levine
says:
"Our society
is perhaps the most economically successful culture in the history
of the world, materially. But in our one-dimensional quest for
productivity, consumption and efficiency, we have forgotten about
a whole bunch of things that people need to stay human -- like
community, autonomy, diversity. All of those things have shrunk.
Taken together, this may help to explain why so many kids are
being diagnosed with attention deficit disorder and all these
other various childhood disorders. The largest increases we have
seen in new illnesses are the ones that affect children...We
have created that. And that is what we, as a culture, don't want
to admit: We've created fewer and fewer places for different
kinds of personalities to feel good about themselves and to make
a living.
BRITISH GOVERNMENT BANS MAJOR ANTI-DEPRESSANTS
FOR CHILDREN AS SUICIDE RISK
All major antidepressant drugs
other than Prozac, known as SSRIs, are set to be banned for children
under 18 by the Government today, amid concerns that the drugs
cause young patients to commit suicide. . . Doctors will be told
not to prescribe Lustral, Cipramil, Cipralex and Faverin to under-18s.
Fifty thousand children are estimated to be on antidepressants
in Britain.
The MHRA was said to have told
doctors last night they should not prescribe any selective serotonin
reuptake inhibitors, other than Prozac. It will also warn that
Prozac will help only one child out of 10. However, the agency
will say that patients already on medication should not stop
it suddenly, to avoid withdrawal symptoms.
GROUPS BLAST NEW CHOLESTEROL GUIDELINES
LINDA A. JOHNSON, ASSOCIATED
PRESS - Most of the heart disease experts who urged more people
to take cholesterol-lowering drugs this week have made money
from the companies selling those medicines. Consumer groups on
Friday blasted the new cholesterol guidelines as being tainted
by the influence of major pharmaceuticals that make blockbusters
such as Lipitor and Pravachol. Last year, drug makers earned
$26 billion worldwide on cholesterol-lowering medicines, the
top-selling class of drugs.
The new guidelines issued Monday
by the American Heart Association and the federal government
were aimed at preventing heart attacks. They were written by
nine of the country's top cholesterol experts. At least six have
received consulting or speaking fees, research money or other
support from makers of the most widely used anti-cholesterol
drugs. . .
"It's outrageous they didn't
provide disclosure of the conflicts of interest," said Merrill
Goozner, with the Center for Science in the Public Interest.
"It doesn't mean that their research is wrong," Goozner
added, but doctors and the public need to know "that the
people who are giving you this advice have their research funded
by a party who has a self interest in the outcome of that research."
. . .
Dr. Sidney Wolfe, co-founder
of Public Citizen's Health Research Group, said disclosure, even
in a publication, is not adequate. "These people should
be disqualified from being the principal authors of publications
that have the imprimatur of the government on it," he said.
He noted that side effects such as possible liver and muscle
damage can make the drugs more dangerous than beneficial to people
who have only a moderate risk of heart attack.
MEDIA MALPRACTICE
A DRAMATIC CHANGE in recommended
levels of cholesterol was reported by both the NY Times and the
Washington Post with hardly a hint of the possible economic factors
behind the decision. This is an increasingly important issue
for if pharmaceutical companies are successful in defining health
downward, millions of new customers for its drugs are created.
What follows is the sum total
of the two papers' references to possible problems with the drugs
followed by a sample of concerns that have been raised elsewhere.
Note that the NY Times makes only passing mention that the decision
had no effect on the drug companies' stock prices and the Washington
Post, at the very end of its article, admits that "most
heart disease researchers receive at least some funding from
drug companies."
No conclusion is suggested other
than that the NY Times and Washington Post do their readers a
huge disservice by not presenting this issue in its true complexity.
NY TIMES -
No one doubts that the new recommendations will be expensive.
But, Dr. Cleeman said, statins, which cost about $100 a month,
are cost effective in those who should be taking them, because
heart disease costs "hundreds of billions of dollars."
Statins, which can reduce the risk of heart disease by 30 percent
to 40 percent, he said, "compare very favorably to other
standard treatments, like treatments for hypertension."
The stock of Pfizer and Merck,
two manufacturers of statin drugs, showed little change yesterday.
Heart disease researchers say
they are taken aback by the speed at which the old rules of cholesterol
lowering are being rewritten in response to growing evidence
that lower is better.
"It is really quite extraordinary,"
said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic.
He said, "When I was in medical school, I was taught that
any cholesterol level under 300 was normal.". . . "Now
here we are a few decades later saying that patients at high
risk should take their L.D.L. levels to 70 or less," Dr.
Nissen said. He and others, like Dr. Valentin Fuster, director
of the Cardiovascular Institute at the Mount Sinai School of
Medicine in New York, predict that the optimal levels for L.D.L.
cholesterol will go lower still.
WASHINGTON POST - The panel endorsed
a combination of diet, exercise and cholesterol-lowering drugs
to cut LDL levels. The most commonly used drugs, statins, are
considered very safe but in rare cases can cause serious muscle
and liver problems. . . Most heart disease researchers receive
at least some funding from drug companies but maintain that their
work is not influenced by such connections.
[And this from the same issue
of the NY Times]
NY TIMES -
Four medical and scientific journals recently published studies
that failed to disclose the authors' financial conflicts of interest,
according to a report by the Center for Science in the Public
Interest. Many journals have tightened disclosure policies in
recent years as ties between pharmaceutical companies and researchers
have come under increasing scrutiny, and the journals cited in
the report have conflict-of-interest disclosure policies.
The study, which was released
yesterday, looked at four journals from last December to February.
It examined the 163 articles that had no disclosure statements
for the major authors. In 13 of the articles, or roughly 8 percent,
at least one of the authors did not reveal ties to companies
that stood to profit from the research or other information that
could have influenced the findings, the researchers found.
In most of the 13 cases, the
researchers determined that the authors violated disclosure policies
by neglecting to provide the journals with appropriate information.
[One publication got it right.
. . the business journal, Forbes]
MATTHEW HERPER, FORBES - New guidelines issued by the United
States government could increase the number of people who take
cholesterol-lowering medicines; already the top-selling medication
in the world with $26 billion in annual sales. Under previously
existing guidelines, 36 million people should be taking cholesterol-lowering
pills such as Lipitor, Zocor, or Pravachol to prevent heart attacks.
In reality, only about 11 million do. . . Now, that figure will
increase by millions of people, as the new guidelines suggest
treating diabetics and people who at one time would have been
considered healthy. Those at high risk, or who have had recent
heart attacks, should be treated even more aggressively. . .
Christopher P. Cannon, a cardiologist
at Brigham & Woman's hospital, says 50 million people should
take the drugs. Another cardiologist, Steven E. Nissen of the
Cleveland Clinic, said that number looked reasonable, although
James I. Cleeman, a researcher at the National Heart Blood and
Lung Institute and a co-author of the report said it was "a
little high." The cost of treating that many people with
even the lowest dose of Pfizer's Lipitor could approach $40 billion.
[And now some earlier stories]
ASSOCIATED PRESS - A 39-year-old woman has died of a muscle-destroying
condition linked to the controversial new anti-cholesterol drug
Crestor, a consumer advocate said Thursday, citing 16 cases of
serious side effects in urging a ban of the drug. Crestor is
in the popular family of cholesterol-lowering drugs called statins.
It won Food and Drug Administration
approval in August, after a delay because of safety concerns:
Seven cases of the potentially fatal, muscle-destroying condition
called rhabdomyolysis occurred during studies involving patients
on an 80-milligram dose. For that rare condition to pop up in
clinical trials was unusual - and particularly worrisome since
another statin, Baycol, had been pulled off the market in 2001,
linked to dozens of rhabdomyolysis-caused deaths worldwide. In
studies, Crestor also was linked to some cases of kidney abnormalities
not seen with other statins.
Still, FDA ultimately decided
to approve Crestor, saying it appeared to be slightly more potent
than other statins and thus may be important for some patients.
To lower the risk of side effects, FDA recommended starting doses
of 5 mg. to 10 mg, and said patients should never exceed 40 mg.
But records from the FDA and health agencies in Canada and Britain
show life-threatening side effects occur even at those lower
doses, said Dr. Sidney Wolfe of the consumer advocacy group Public
Citizen, in a petition filed with FDA Thursday seeking a ban.
Among the records:
- Seven patients with rhabdomyolysis,
including the 39-year-old American who died after using a 20-mg
dose, and a second death from an unspecified country.
- Four patients with acute kidney
failure, including a 79-year-old U.S. man who died.
- Five additional patients with
less severe kidney damage.
Also, among six patients, Crestor
interacted dangerously with the blood-thinner Coumadin, commonly
used by heart-disease patients. One had a hemorrhage, Wolfe said.
PUBLIC CITIZEN, AUGUST 2001 - Doctors and the public must be warned
to immediately discontinue use of statin drugs at the onset of
muscle pain, muscle tenderness, muscle weakness or tiredness.
Renal damage due to myoglobinuria (a pigment resulting from massive
breakdown of muscle) as a result of rhabdomyolysis is potentially
fatal. Prompt cessation of the use of statins at the first sign
of muscle pain, muscle tenderness, muscle weakness or tiredness
and prompt evaluation by a physician including a blood test for
creatine phosphokinase ( a measure of muscle destruction) may
avoid the progression to more extensive muscle damage, rhabdomyolysis,
and death. . . Increased use of statins without additional warnings
of potentially dangerous adverse effects is likely to lead to
an increase in the number of statin-induced rhabdomyolysis cases
and resulting hospitalizations and deaths.
PREVENTION - In a small study, researchers found that there
may be a link between statins and severe muscle damage--of a
sneaky sort that eludes the standard blood test (creatine kinase)
for muscle breakdown. Researchers in large cholesterol clinics
think that up to 1 in 10 people who take statins may have a mild
form of this muscle toxicity. They may just feel tired, or have
trouble getting out of a low chair. Meanwhile, a huge Danish
study found that long-term statin users had a 4 to 14 times higher
risk of peripheral neuropathy, nerve damage that can cause weakness,
pain, and trouble walking.
NOTE: If some 100 million people
take statins - a conservative estimate - a side effect is found
in just two percent - as suggested by the drug makers own warnings
- this would amount to two million persons being affected. And
this is just for one side effect.
HEALTH JOURNAL, FEB 2001 - The
Wall Street Journal reports that doctors and patients have noted
several side effects of the most widely prescribed drugs in the
U.S. - statins (some brand names are Lipitor, Zocor, and Provachol).
Common complaints of patients taking statins include memory loss,
personality changes, irritability, and aching muscle pain. .
. The article quotes Dr. Peter Lansjoen, a Tyler, Texas cardiologist
as follows: " You take these fragile elderly people, lower
their cholesterol in half and deplete them of this essential
nutrient and it makes sense they're going to have trouble. I
think we're going to see some real trouble if we're not careful."
CBS, MAY 24, 2004 - When Jim Matthews needed to slash his cholesterol
and heart attack risk, he joined the millions taking the world's
top-selling drug, Lipitor. After five weeks, he was struck by
cognitive chaos and confusion. All of a sudden, he found himself
asking: "Did I go get the mail or did I just think I was
going to go get the mail? Did I give my dog her thyroid pill,
or did I just think I gave the dog the thyroid pill?" He
couldn't function for hours.
When he came back to his senses,
he suspected Lipitor was to blame, but only found one glowing
report after another on Lipitor and similar drugs - all called
statins. In fact, some doctors are so high on statins, they seem
to think most everyone should take them, that there's no down
side. Lipitor's maker even says it may help Alzheimer's patients.
But researcher Dr. Beatrice Golomb
warns the studies generating the bulk of the positive press were
funded by the companies that make the drugs, like Pfizer, which
earns $9 billion a year from Lipitor.
"I made the decision that I really didn't want to take money
from the drug industry," says Golomb.
Funded by the government and
not the drug makers, Golomb is taking an independent look at
studies already done on statins, pinpointing severe muscle problems,
which Pfizer has disclosed, and cognitive dysfunction -- not
mentioned in patient leaflets. "We have people who have
lost thinking ability so rapidly that within the course of a
couple of months they went from being head of major divisions
of companies to not being able to balance a checkbook and being
fired from their company," says Golomb, an assistant professor
or medicine at the University of California in San Diego.
Golomb says statins do help the
heart, but may also hamper the brain's performance and trigger
other serious problems. She's leading an independent clinical
trial to find out what harm statins may be doing. The results
should be out in a few months. |