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NOVEMBER 2008
MAJOR MEDIA HYPE ANOTHER
PHARMA FUNDED STUDY OF STATINS
Progressive Review - The
Washington Post, running a front page study supporting the use
of statins by healthy people, took 24 paragraphs to reveal that
the study was funded by Asta Zeneca, which makes Crestor. The
Post cited a researchers claim that "the company had no
influence over the analysis" even thouhgh "he and his
hospital receive royalties from the high-sensitivity CRP, or
HSCRP, test, adding that "other researchers said that was
no reason to doubt the findings."
If the Post had covered
auto safety this way it would have happily accepted a report
funded by GM that seat belts weren't really necessary. And, of
course, there was no mention of reports of muscle deterioration
and memory loss from use of statins or of natural alternatives
include red yeast rice. Maybe the editors just forgot. The New
York Times story was just as bad.
Here's one important thing
to remember about all medical research. Since 1850, the life
expectancy of a white male has increased 37 years and 41 years
for a white female, but over half that increase is the result
of higher survival rates of those under 30. By the time you reach
70, all the money and effort we have spent on medicine has improved
life expectancy by four years. Four white males over 60, life
expectancy has gone up five years. Yet a major part of pharma
marketing is directed to this audience.
JULY 2008
EUROPEAN DOCTORS TO INCLUDE WARNINGS
WITH STATINS; STUDIES KEPT SECRET
DAILY EXPRESS, UK - Alarming
new health warnings are to be issued over cholesterol-lowering
wonder drugs taken daily by more than four million patients.
In some cases, users of
statins have suffered a rare form of lung disease. More commonly,
patients prescribed statins have suffered depression, sleep disturbance,
memory loss and sexual problems.
An investigation by the
Daily Express has found that one in 20 patients who complained
that statins gave them side-effects highlighted those four conditions.
. .
A safety review by the
European medicines watchdog has concluded there is enough evidence
to alert both doctors and patients. From the autumn, drug firms
will have to add the warnings to information sent to doctors
as well as leaflets included in the box of pills. . .
New data on these side-effects
collected by drugs firms was recently handed to a European working
party and has resulted in the demand for patients to be informed.
The European Medicines Agency and the UK's Medicines and Healthcare
Regulatory Authority have now contacted drugs firms telling them
of the change.
However, an attempt by
the Daily Express to access the studies seen by the European
regulators has been refused on the grounds that it is commercially
sensitive to the drug firms.
This secrecy means GPs
will be left without vital information on whether one brand of
statin causes fewer side-effects than another.
Until now, only a few
brands of statin warned patients that they might cause problems.
But some drugs firms do not even reveal these warnings to GPs.
LEAD AUTHOR OF STATIN FOR KIDS
REPORT HAS WORKED FOR MERCK
PSYCHIATRIC ASSOCIATION GETS 30%
OF INCOME FROM DRUG INDUSTRY
NY Times. After a series
of stinging investigations of individual doctors' arrangements
with drug makers, Senator Charles E. Grassley, Republican of
Iowa, is demanding that the American Psychiatric Association,
the field's premier professional organization, give an accounting
of its financing. . .
"I have come to understand
that money from the pharmaceutical industry can shape the practices
of nonprofit organizations that purport to be independent in
their viewpoints and actions," Mr. Grassley said Thursday
in a letter to the association.
In 2006, the latest year
for which numbers are available, the drug industry accounted
for about 30 percent of the association's $62.5 million in financing.
About half of that money went to drug advertisements in psychiatric
journals and exhibits at the annual meeting, and the other half
to sponsor fellowships, conferences and industry symposiums at
the annual meeting.
This weekend in Chicago,
the psychiatry association's board will meet behind closed doors,
in part to discuss how to respond to the increasingly intense
scrutiny and questions about conflicts of interest.
JUNE 2008
FLORIDA FINDS PRESCRIPTION DRUGS
THREE TIMES AS DEADLY AS ILLEGAL ONES
THE BIPOLAR CAREER OF JOSEPH BIEDERMAN
ALTERNET The New York Times reported
the following about Joseph Biederman: "A world-renowned
Harvard child psychiatrist whose work has helped fuel an explosion
in the use of powerful anti-psychotic medicines in children earned
at least $1.6 million in consulting fees from drug makers from
2000 to 2007 but for years did not report much of this income
to university officials, according to information given congressional
investigators."
Due in part to Biederman's influence,
the number of American children and adolescents treated for bipolar
disorder increased 40-fold from 1994 to 2003, and as Bloomberg
News reported (September 2007), "The expanded use of bipolar
as a pediatric diagnosis has made children the fastest-growing
part of the $11.5 billion U.S. market for anti-psychotic drugs."
Pediatrician and author Lawrence
Diller notes about Biederman, "He single-handedly put pediatric
bipolar disorder on the map." Biederman has been in a position
to convince many doctors to diagnose bipolar disorder in children
and to medicate them with anti-psychotic drugs. In addition to
being a professor at Harvard, Biederman is also chief of research
in pediatric psychopharmacology at the Massachusetts General
Hospital, which publishes more than 30 papers yearly on psychiatric
disorders. And Biederman himself has authored and co-authored
approximately 500 articles, 70 book chapters, and more than 450
scientific abstracts, as well as being on the editorial board
of many professional journals. . .
In addition to his popularization
of bipolar disorder for children, Biederman is one of the most
significant forces behind the commonplace diagnosis of attention
deficit hyperactivity disorder. Congressional investigators also
found that Biederman conducted studies of Eli Lilly's attention
deficit hyperactivity disorder drug Strattera that were funded
by NIH at the same time he was receiving money from Lilly that
exceeded the maximum amount permitted.
MAY 2008
THE
SORRY RECORD OF ANTI-DEPRESSANTS
SSRI STORIES is a collection of 2200 news
stories with full media articles, mainly criminal in nature,
that have appeared or that were part of FDA testimony in either
1991, 2004 or 2006, in which antidepressants are mentioned. Antidepressants
have been recognized as potential inducers of mania and psychosis
since their introduction in the 1950s. Since the introduction
of Prozac in December, 1987, there has been a massive increase
in the number of people taking antidepressants. Preda and Bowers
reported that over 200,000 people a year enter a hospital with
antidepressant-associated mania and/or psychosis.
APRIL 2008
HALF MILLION KIDS HURT ANNUALLY
BY DRUG PROBLEMS IN HOSPITALS
MARCH 2008
ARE WE REALLY THIS ILL? BEHIND
THE MEDICATION OF AMERICA
CHOLESTEROL DRUG FOUND TO BE A BUST
AP Full results of a failed trial on Vytorin,
a medicine taken by millions of Americans to lower cholesterol,
left doctors stunned that the drug did not improve heart disease
even though it worked as intended to lower three key risk factors.
Use of Vytorin and a related drug, Zetia, seemed sure to continue
to fall after the findings reported today and fresh questions
about why drugmakers took nearly two years after the study ended
to give results. "A lot of us thought that there would be
some glimmer of benefit," said Dr. Roger Blumenthal, a Johns
Hopkins University cardiologist and spokesman for the American
Heart Association. . .
The study tested whether Vytorin was better
than Zocor alone at limiting plaque buildup in the arteries of
720 people with super high cholesterol because of a gene disorder.
The results show the drug had "no result- zilch. In no subgroup,
in no segment, was there any added benefit" in terms of
reducing plaque, said Dr. John Kastelein, the Dutch scientist
who led the study.
ARE WE REALLY THIS ILL?
CHRISTOPHER LANE, NY SUN America has reached
a point where almost half its population is described as being
in some way mentally ill, and nearly a quarter of its citizens
- 67.5 million - have taken antidepressants. These statistics
have sparked a widespread, sometimes rancorous debate about whether
people are taking far more medication than is needed for problems
that may not even be mental disorders. Studies indicate that
40% of all patients fall short of the diagnoses that doctors
and psychiatrists give them, yet 200 million prescriptions are
written annually in America to treat depression and anxiety.
Those who defend such widespread use of prescription drugs insist
that a significant part of the population is under-treated and,
by inference, under-medicated. Those opposed to such rampant
use of drugs note that diagnostic rates for bipolar disorder,
in particular, have skyrocketed by 4,000% and that overmedication
is impossible without over-diagnosis.
To help settle this long-standing dispute,
I studied why the number of recognized psychiatric disorders
has ballooned so dramatically in recent decades. In 1980, the
Diagnostic and Statistical Manual of Mental Disorders added 112
new mental disorders to its third edition, DSM-III. Fifty-eight
more disorders appeared in the revised third edition in 1987
and fourth edition in 1994.
With over a million copies in print, the
manual is known as the bible of American psychiatry; certainly
it is an invoked chapter and verse in schools, prisons, courts,
and by mental-health professionals around the world. The addition
of even one new diagnostic code has serious practical consequences.
What, then, was the rationale for adding so many in 1980?
After several requests to the American
Psychiatric Association, I was granted complete access to the
hundreds of unpublished memos, letters, and even votes from the
period between 1973 and 1979, when the DSM-III task force debated
each new and existing disorder. Some of the work was meticulous
and commendable. But the overall approval process was more capricious
than scientific.
DSM-III grew out of meetings that many
participants described as chaotic. One observer later remarked
that the small amount of research drawn upon was "really
a hodgepodge - scattered, inconsistent, and ambiguous."
The interest and expertise of the task force was limited to one
branch of psychiatry: neuropsychiatry. That group met for four
years before it occurred to members that such one-sidedness might
result in bias.
Incredibly, the lists of symptoms for some
disorders were knocked out in minutes. The field studies used
to justify their inclusion sometimes involved a single patient
evaluated by the person advocating the new disease. Experts pressed
for the inclusion of illnesses as questionable as "chronic
undifferentiated unhappiness disorder" and "chronic
complaint disorder," whose traits included moaning about
taxes, the weather, and even sports results.
Social phobia, later dubbed "social
anxiety disorder," was one of seven new anxiety disorders
created in 1980. At first it struck me as a serious condition.
By the 1990s experts were calling it "the disorder of the
decade," insisting that as many as one in five Americans
suffers from it. Yet the complete story turned out to be rather
more complicated. For starters, the specialist who in the 1960s
originally recognized social anxiety - London-based Isaac Marks,
a renowned expert on fear and panic - strongly resisted its inclusion
in DSM-III as a separate disease category. The list of common
behaviors associated with the disorder gave him pause: fear of
eating alone in restaurants, avoidance of public toilets, and
concern about trembling hands. By the time a revised task force
added dislike of public speaking in 1987, the disorder seemed
sufficiently elastic to include virtually everyone on the planet.
. .
Over-medication would affect fewer Americans
if we could rein in such clear examples of over-diagnosis. We
would have to set the thresholds for psychiatric diagnosis a
lot higher, resurrecting the distinction between chronic illness
and mild suffering. But there is fierce resistance to this by
those who say they are fighting grave mental disorders, for which
medication is the only viable treatment. Failure to reform psychiatry
will be disastrous for public health. Consider that apathy, excessive
shopping, and overuse of the Internet are all serious contenders
for inclusion in the next edition of the DSM, due to appear in
2012. If the history of psychiatry is any guide, a new class
of medication will soon be touted to treat them. Sanity must
prevail: if everyone is mentally ill, then no one is.
Mr. Lane, a professor of English at
Northwestern University, is the author of "Shyness: How
Normal Behavior Became a Sickness."
DRUG PUSHER REVEALS PHARMA PHRAUD
MARCUS
BARAM, ABC Shahram Ahari, who spent
two years selling Prozac and Zypraxa for Eli Lily, told a Senate
Aging Committee chaired by Sen. Herb Kohl, D-Wisc., that his
job involved "rewarding physicians with gifts and attention
for their allegiance to your product and company despite what
may be ethically appropriate." Ahari claims that drug companies
like hiring former cheerleaders and ex-models, as well as former
athletes and members of the military, many of whom have no background
in science.
"On my first day of sales class, among
21 trainees and two instructors, I was the only one with any
level of college-level science education," Ahari told ABCNews.com.
During their five-week training class,
Ahari claims that instructors teach sales tactics, including
how to exceed spending limits for important clients, being generous
with free samples to leverage sales, using friendships and personal
gifts to foster a "quid pro quo" relationship, and
how to exploit sexual tension.
"The nature of this business is gift-giving,"
says Ahari. He claims that he's heard stories about sales reps
helping to pay the cost of a doctor's swimming pool and another
doctor who was routinely taken to a nightclub where a hostess
was paid to keep him company.
Drug reps develop a positive view of their
drug and a negative view of the competitors, according to Ahari.
"You drink the Kool-Aid. We were taught to minimize the
side effects and how to use conversational ploys to minimize
it or to change the topic.". . .
Included in his prepared remarks, Ahari
cites a quote from a senior marketing executive at Parke-Davis:
"I want you out there every day selling Neurotonin. Neurotonin
is more profitable than Accupril, so we need to focus on Neurotonin.
Pain management, now that's money.. I don't want to see a single
patient coming off Neurotonin before they've been up to at least
4,800 milligrams a day. I don't want to hear that safety crap,
either."
A spokesman for Parke-Davis did not immediately
respond to ABC News' request for comment.
FEBRUARY 2008
HOW AMERICA GOT SOLD ON STATINS
ALTERNET - No doubt you've heard about
the recent Business Week cover story, "Do Cholesterol Drugs
Do Any Good?", which blew the lid off the theory that "statins"
-- drugs like Lipitor, Crestor, Mevacor, Zocor and Pravachol
-- can cut the odds that you will die of a heart attack by slowing
the production of cholesterol in your body and increasing the
liver's ability to remove LDL, or "bad cholesterol,"
from your blood.
It's true that these drugs can help some
people -- but not nearly as many as we have been told. Moreover,
and this is the kicker, we don't have any clear evidence that
they work by lowering cholesterol.
Although medical research suggests that
statins can definitely benefit one group -- men under 70 who
already have had a heart attack -- researchers are no longer
convinced that the drugs stave off a second attack by lowering
the patient's cholesterol. The drugs do lower cholesterol, but
that is not what helps the patient.
In other words, researchers are questioning
the bedrock assumption that high levels of "bad cholesterol"
cause heart disease. "Higher LDL levels do help set the
stage for heart disease by contributing to the buildup of plaque
in arteries. But something else has to happen before people get
heart disease," Dr. Ronald M. Krauss, director of atherosclerosis
research at the Oakland Research Institute, told Business Week.
"When you look at patients with heart disease, their cholesterol
levels are not that [much] higher than those without heart disease,"
he added. "Compare countries, for example. Spaniards have
LDL levels similar to Americans', but less than half the rate
of heart disease. The Swiss have even higher cholesterol levels,
but their rates of heart disease are also lower. Australian aborigines
have low cholesterol but high rates of heart disease.".
. .
But hold onto your hats, I still haven't
gotten to what is most shocking about the cholesterol story.
What raises my blood pressure is the knowledge that Business
Week's scoop isn't really "new" news.". . . The
truth is that medical researchers have been questioning for many
years the theory that widespread use of statins to lower cholesterol
will save lives.
You can find the research questioning the
benefits of statins in medical journals like Lancet (2001) and
BMJ (2006), as well as in reports from medical conferences ("Tales
From the Other Drug Wars," 1999).
Occasionally, doubts popped up in the mainstream
press and then disappeared.
Five years ago, veteran healthcare blogger Matthew Holt pointed
to a BMJ article suggesting that statins might be no better than
aspirin. That same year, Holt raised pointed questions regarding
the risk of taking statins, including possible memory loss."
Nevertheless, the very next year, the National
Cholesterol Education Program at the U.S. National Heart, Lung
and Blood Institute issued new recommendations that drastically
lowered the threshold for statin therapy. . . The bottom line:
NCEP was urging millions of Americans to go on statins.
http://www.alternet.org/healthwellness/77916/
STUDY: ANTI-DEPRESSANTS DON'T WORK
INDEPENDENT, UK - They are among the biggest-selling
drugs of all time, the "happiness pills" that supposedly
lift the moods of those who suffer . . . But one of the largest
studies of modern antidepressant drugs has found that they have
no clinically significant effect. . .
The finding will send shock waves through
the medical profession and patients and raises serious questions
about the regulation of the multinational pharmaceutical industry,
which was accused of withholding data on the drugs.
It also came as Alan Johnson, the Health
Secretary, announced that 3,600 therapists are to be trained
during the next three years to provide nationwide access through
the GP service to "talking treatments" for depression,
instead of drugs, in a L170m scheme. . .
In the study, researchers conducted a meta-analysis
of all 47 clinical trials, published and unpublished, submitted
to the Food and Drug Administration in the US, made in support
of licensing applications for six of the best known antidepressant
drugs, including Prozac, Seroxat - which is made by GlaxoSmithKline
- and Efexor made by Wyeth. The results showed the drugs were
effective only in a very small group of the most extremely depressed.
Professor Irving Kirsch of the University
of Hull, who led the study published in the online journal Public
Library of Science Medicine, said . . . "Given these results,
there seems to be little reason to prescribe antidepressant medication
to any but the most severely depressed patients, unless alternative
treatments have failed to provide a benefit. This study raises
serious issues that need to be addressed surrounding drug licensing
and how drug trial data is reported.". . .
Alternative treatments for depression,
such as counseling or physical exercise , should be tried first,
Professor Kirsch said. . .
On the new training for therapists, Mr
Johnson said the program signaled a decisive shift away from
drugs in favor of non-drug treatments for depression. "We
are not taking the decision away from clinicians," he said.
"For many, medication is successful.
But talking therapies can have dramatic effects. We have put
a lot of emphasis on medication in the past and it is about time
we redressed the balance and put more emphasis on talking treatments."
NIU KILLER ON MIX OF PRESCRIBED DRUGS;
SAID PROZAC MADE HIM FEEL LIKE A 'ZOMBIE'
CHICAGO SUN TIMES - The gunman who killed
five students at Northern Illinois University last week was not
only taking anti-depressants, he also was taking an anti-anxiety
medication and a sleep aid, his girlfriend said. Jessica Baty
said her boyfriend, Steven Kazmierczak, was taking Xanax, Ambien
and Prozac, CNN reported.
Steven Kazmierczak, the gunman who killed
five students at Northern Illinois University last week, was
taking anti-depressants, anti-anxiety medication, and a sleep
aid, his girlfriend said. Kazmierczak, 27, had been seeing a
Champaign psychiatrist since June, but he had stopped taking
Prozac three weeks before the shootings because it made him feel
like a "zombie,'' Baty said.
She told CNN that since he stopped taking
the anti-depressant, he was a "little more irritable'' and
a "little quicker to get annoyed," but not erratic,
as police have said. Mental health experts say taking that trio
of drugs at the same time is not uncommon or dangerous.
http://www.suntimes.com/news/metro/805731,CST-NWS-invest21.article
LILLY MAY PAY $1 BILLION FINE
FOR MISLEADING DRUG PROMOTION
JANUARY 2008
WOULD TOM PAINE AND EMMA GOLDMAN BEEN
DIAGNOSED AS ODD AND GIVEN RITALIN?
BRUCE LEVINE, ALTERNET - For a generation
now, disruptive young Americans who rebel against authority figures
have been increasingly diagnosed with mental illnesses and medicated
with psychiatric (psychotropic) drugs.
Disruptive young people who are medicated
with Ritalin, Adderall and other amphetamines routinely report
that these drugs make them "care less" about their
boredom, resentments and other negative emotions, thus making
them more compliant and manageable. And so-called atypical antipsychotics
such as Risperdal and Zyprexa -- powerful tranquilizing drugs
-- are increasingly prescribed to disruptive young Americans,
even though in most cases they are not displaying any psychotic
symptoms. . .
In 1980, the American Psychiatric Association
created oppositional defiant disorder, defining it as "a
pattern of negativistic, hostile and defiant behavior."
The official symptoms of ODD include "often actively defies
or refuses to comply with adult requests or rules" and "often
argues with adults." While ODD-diagnosed young people are
obnoxious with adults they don't respect, these kids can be a
delight with adults they do respect; yet many of them are medicated
with psychotropic drugs.
An even more common reaction to oppressive
authorities than overt defiance is some type of passive defiance.
John Holt, the late school critic, described
passive-aggressive strategies employed by prisoners in concentration
camps and slaves on plantations, as well as some children in
classrooms. Holt pointed out that subjects may attempt to appease
their rulers while still satisfying some part of their own desire
for dignity "by putting on a mask, by acting much more stupid
and incompetent than they really are, by denying their rulers
the full use of their intelligence and ability, by declaring
their minds and spirits free of their enslaved bodies."
Holt observed that by "going stupid"
in a classroom, children frustrate authorities through withdrawing
the most intelligent and creative parts of their minds from the
scene, thus achieving some sense of potency.
Going stupid -- or passive aggression --
is one of many non-disease explanations for attention deficit
hyperactivity disorder. Studies show that virtually all ADHD-diagnosed
children will pay attention to activities that they enjoy or
that they have chosen. In other words, when ADHD-labeled kids
are having a good time and in control, the "disease"
goes away. . .
It would certainly be a dream of Big Pharma
and those who favor an authoritarian society if every would-be
Tom Paine -- or Crazy Horse, Tecumseh, Emma Goldman or Malcolm
X -- were diagnosed as a youngster with mental illness and quieted
with a lifelong regimen of chill pills. The question is: Has
this dream become reality?
http://www.alternet.org/healthwellness/75081/?page=entire
BEHIND THE STATIN HYPE
NEGATIVE REPORTS ON ANTI-DEPRESSANTS
KEPT FROM THE PUBLIC
BBC - The effectiveness of a dozen popular
antidepressants has been exaggerated by selective publication
of favorable results, according to a review of unpublished data
submitted to the Food and Drug Administration.
Since the overwhelming amount of published
data on the drugs show they are effective, doctors unaware of
the unpublished data are making inappropriate prescribing decisions
that aren't in the best interest of their patients, according
to researchers led by Erick Turner, a psychiatrist at Oregon
Health & Science University. Sales of antidepressants total
about $21 billion a year, according to IMS Health.
Wyeth and Pfizer declined to comment on
the study results. Both companies said they had committed to
disclose all study results, although not necessarily in medical
journals. GlaxoSmithKline PLC, maker of Wellbutrin and Paxil,
said it has posted the results of more than 3,000 trials involving
82 medications on its Web site, and also has filed information
on 1,060 continuing trials at a federal government Web site.
Schering-Plough Corp., whose Organon Corp.
unit markets Remeron, and Eli Lilly & Co., which makes Prozac,
said their study results were indeed published -- not individually,
but as part of larger medical articles that combined data from
more than one study at a time. The New England Journal study
counted a clinical trial as published only if it was the sole
subject of an article. . .
Pharmaceutical companies are under no obligation
to publish the studies they sponsor and submit to the FDA, nor
are the researchers they hire to do the work. The researchers
publishing in the New England Journal were able to identify unpublished
studies by obtaining and comparing documents filed by the companies
with the FDA against databases of medical publications. . .
A total of 74 studies involving a dozen
antidepressants and 12,564 patients were registered with the
FDA from 1987 through 2004. The FDA considered 38 of the studies
to be positive. All but one of those studies was published, the
researchers said.
The other 36 were found to have negative
or questionable results by the FDA. Most of those studies --
22 out of 36 -- weren't published, the researchers found. Of
the 14 that were published, the researchers said at least 11
of those studies mischaracterized the results and presented a
negative study as positive.
http://news.bbc.co.uk/go/rss/-/2/hi/americas/7192731.stm
ANTI-CHOLESTEROL DRUG FLUNKS TEST
BIG PHARMA SPENDS MORE ON PROPAGANDA THAN ON RESEARCH
SCIENCE DAILY - A new study by two York
University researchers estimates the U.S. pharmaceutical industry
spends almost twice as much on promotion as it does on research
and development, contrary to the industry's claim. The researchers'
estimate is based on the systematic collection of data directly
from the industry and doctors during 2004, which shows the U.S.
pharmaceutical industry spent 24.4% of the sales dollar on promotion,
versus 13.4% for research and development, as a percentage of
US domestic sales . . .
FREE DRUG SAMPLES DON'T REACH
POOR PATIENTS
USA TODAY - Few patients
complain about leaving the doctor's office with free drug samples.
. . A study, however, gives ammunition to critics who want to
do away with samples: Most of the free medications, the report
says, actually go to wealthier patients who have insurance. .
. Patients with the highest incomes were the most likely to get
free samples, according to a survey of nearly 33,000 Americans
in the February issue of the American Journal of Public Health.
Only 28% of those who got samples were poor, whether insured
or not, with incomes less than twice the federal poverty level
- $18,400 for a family of four in 2003, when the survey was taken.
DECEMBER 2007
PHARMAS WITHOLD NEGATIVE DATA
ON DRUG
JUNE 2007
FDA OFFICIALS MET 112 TIMES WITH PHARMA
LOBBYISTS BUT ONLY FIVE TIMES WITH CONSUMER ADVOCATES
RITA RUBIN, USA TODAY - While revising
their drug-review policy last year, Food and Drug Administration
officials met 112 times with industry representatives but only
five times with consumer and patient groups, according to data
from the House Appropriations Committee.The FDA provided the
data in response to questions submitted in March by Rep. Maurice
Hinchey, D-N.Y. . . "The FDA has essentially become the
government affairs office of the pharmaceutical industry,"
Hinchey said in a statement, which called the relationship between
the agency and industry "far too cozy and inappropriate."
Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor
of an FDA reform bill that would prohibit the agency from collecting
fees from the companies it regulates. Instead, the money would
be deposited into the general fund of the U.S. Treasury. According
to the Appropriations Committee, two officials of the Biotechnology
Industry Organization and two officials of the Pharmaceutical
Research and Manufacturers Association attended at least half
of the 112 meetings.
http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm?csp=34
NEW OVER THE COUNTER DIET PILL IS VARIATION
OF DRUG DOCTORS FOUND DIDN'T WORK WELL
JULIAN KESNER, NY DAILY NEWS - The first-ever FDA-approved over-the-counter diet
pill hits shelves with much fanfare - but consumers can expect
the same old poop. Overweight New Yorkers lured by a citywide,
multimillion-dollar advertising blitz, might just find themselves
$50 poorer, lacking in vitamins ... and suffering a bout of diarrhea.
That is when reality will set in, and they'll realize that Alli
(pronounced AL-lie) is far from a magic cure for obesity - like
every other diet pill - and they'll want their $50 back.
To be fair, Alli's maker, Glaxo Smith Kline,
isn't making any promises it can't keep. Phrases and words like
"hard work," "not a quick fix," "commitment"
and "dedication" are in big, bold letters in Alli's
hard-nosed user pamphlets.
The Alli literature also repeatedly includes
this mantra: "Alli requires eating reduced-calorie, low-fat
meals and physical activity."
Funny - isn't that what you're already
supposed to do to lose weight?
What Alli does is prevent absorption of
up to 25% of dietary fat in the gut. It's really just a lower
dose of the drug orlistat (sold by prescription as Xenical, made
by Roche), which was FDA-approved in 1999.
The problem is that more and more doctors
are deciding orlistat isn't worth prescribing. IMS Health, a
health-care information company, says Xenical sales were $93
million last year - down 31% in the last five years.
Yes, that $50 bottle is just a new name
and look for a drug that has already been rejected by countless
doctors and patients. Going OTC is an attempt to boost profits
for a lackluster drug. . .
Dr. Larry Gellman, bariatric surgery co-director
for the North Shore-LIJ Health System, has seen "hundreds"
of patients walk into his office after having little to no success
using Xenical/orlistat. . .
PFIZER FACES CRIMINAL CHARGES OVER NO-CONSENT
TESTS ON NIGERIAN CHILDREN
WASHINGTON POST - Officials in Nigeria
have brought criminal charges against pharmaceutical giant Pfizer
for the company's alleged role in the deaths of children who
received an unapproved drug during a meningitis epidemic. Authorities
in Kano, the country's largest state, filed eight charges this
month related to the 1996 clinical trial, including counts of
criminal conspiracy and voluntarily causing grievous harm. They
also filed a civil lawsuit seeking more than $2 billion in damages
and restitution from Pfizer, the world's largest drug company.
The move represents a rare -- perhaps unprecedented
-- instance in which the developing world's anger at multinational
drug companies has boiled over into criminal charges. It also
represents the latest in a string of public-relations blows stemming
from the decade-old clinical trial, in which Pfizer says it acted
ethically.
The government alleges that Pfizer researchers
selected 200 children and infants from crowds at a makeshift
epidemic camp in Kano and gave about half of the group an untested
antibiotic called Trovan. Researchers gave the other children
what the lawsuit describes as a dangerously low dose of a comparison
drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's
actions resulted in the deaths of an unspecified number of children
and left others deaf, paralyzed, blind or brain-damaged.
The lawsuit says that the researchers did
not obtain consent from the children's families and that the
researchers knew Trovan to be an experimental drug with life-threatening
side effects that was "unfit for human use." Parents
were banned from the ward where the drug trial occurred, the
suit says, and the company left no medical records in Nigeria.
http://www.washingtonpost.com/wp-dyn/content/article/2007/05/29/AR2007052902
107.html
MAY 2007
PHARMA PAYOLA TO PSYCHIATRISTS BOOSTS
SALES
NY TIMES - The intersection of money and
medicine, and its effect on the well-being of patients, has become
one of the most contentious issues in health care. Nowhere is
that more true than in psychiatry, where increasing payments
to doctors have coincided with the growing use in children of
a relatively new class of drugs known as atypical anti-psychotics.
These best-selling drugs, including Risperdal,
Seroquel, Zyprexa, Abilify and Geodon, are now being prescribed
to more than half a million children in the United States to
help parents deal with behavior problems despite profound risks
and almost no approved uses for minors.
A New York Times analysis of records in
Minnesota, the only state that requires public reports of all
drug company marketing payments to doctors, provides rare documentation
of how financial relationships between doctors and drug makers
correspond to the growing use of atypicals in children.
From 2000 to 2005, drug maker payments
to Minnesota psychiatrists rose more than sixfold, to $1.6 million.
During those same years, prescriptions of anti-psychotics for
children in Minnesota's Medicaid program rose more than ninefold.
Those who took the most money from makers
of atypicals tended to prescribe the drugs to children the most
often, the data suggest. On average, Minnesota psychiatrists
who received at least $5,000 from atypical makers from 2000 to
2005 appear to have written three times as many atypical prescriptions
for children as psychiatrists who received less or no money.
http://www.nytimes.com/2007/05/10/health/10psyche.html
LEADING DOCTOR WARNED OF DANGERS OF
AVANDIA SEVEN YEARS AGO; FDA KNEW OF PROBLEMS
STEPHANIE SAUL AND GARDINER HARRIS, NEW YORK TIMES
- A leading diabetes doctor sent
the Food and Drug Administration a letter seven years ago that
warned of the heart risks of the drug Avandia. And in the next
year, the FDA reprimanded the drug's maker for playing down safety
concerns, according to documents from 2000 and 2001. The documents,
found in a reporter's search of the FDA's database, indicate
that the agency had been warned of safety concerns with the Type
2 diabetes treatment Avandia, and that the drug's maker, GlaxoSmithKline,
was seeking to minimize Avandia's risks, before some of the same
cardiovascular concerns were brought to public attention on Monday
in an article and an editorial in The New England Journal of
Medicine. The FDA has acknowledged that the company alerted the
agency to concerns about a cardiovascular risk as early as 2005,
based on the company's analysis.
APRIL 2007
HOW THE DRUG INDUSTRY CORRUPTS MEDICINE
WITH SALES TECHNIQUES
In the journal, Plos
Medicine, a former drug rep and a physician who researches
drug marketing reveal the tactics used by drug reps to manipulate
physicians into selling drugs. "Drug reps increase drug
sales by influencing physicians, and they do so with finely titrated
doses of friendship," say the authors, Adriane Fugh-Berman
(Georgetown University Medical Center) and Shahram Ahari, a former
drug rep for Eli Lilly who now works for the School of Pharmacy
at University of California San Francisco. The specific strategy
used by a drug rep to manipulate a physician, say the authors,
depends very much on the personality of the doctor. A friendly,
outgoing physician is the easiest to influence, because the rep
can use the "friendship" to request favors, in the
form of prescriptions. If a physician refuses to meet with a
rep, "their staff is dined and flattered in hopes that they
will act as emissaries for a rep's message."
Physicians who end up prescribing the rep's
drugs are amply rewarded with gifts, such as golf bags or silk
ties. In the paper, Mr Ahari shares his experience as a company
insider. For example, when faced by a physician who preferred
to use a competitor drug rather than Mr Ahari's drug, "the
first thing I want to understand," he says, "is why
they're using another drug instead of mine. If it's a question
of attention, I commit myself to lavishing them with it until
they're bought."
Drug companies purchase data on physician's
prescribing habits in order to identify those prescribers who
might be open to influence by drug reps, say the authors. Many
doctors don't even realize that data on their prescribing habits
can be bought by drug companies. Another technique that drug
reps use is to give doctors "free" drug samples, which
the doctors can give to patients as a gift. Studies consistently
show that samples influence prescribing choices, say Fugh-Berman
and Ahari.
"Reps provide samples only of the
most promoted, usually most expensive, drugs, and patients given
a sample for part of a course of treatment almost always receive
a prescription of the same drug." A sales force of 100,000
drug reps (one drug rep per 2.5 targeted physicians) is providing
"rationed doses of samples, gifts, services, and flattery"
to those physicians who are likely to prescribe the rep's drug.
"Every word, every courtesy, every
gift, every piece of information provided is carefully crafted"
say the authors, "not to assist doctors or patients, but
to increase market share for targeted drugs."
THE SCRIPT FOR DIFFERENT TYPES OF DOCTORS
Friendly and outgoing: I frame everything
as a gesture of friendship. I give them free samples not because
it's my job, but because I like them so much. I provide office
lunches because visiting them is such a pleasant relief from
all the other docs. My drugs rarely get mentioned by me during
our dinners. Just being friends with most of my docs seemed to
have some natural basic effect on their prescribing habits. When
the time is ripe, I lean on my "friendship" to leverage
more patients to my drugs...say, because it'll help me meet quota
or it will impress my manager, or it's crucial for my career.
Outgoing, friendly physicians are every rep's favorite because
cultivating friendship is a mutual aim. While this may be genuine
behavior on the doctor's side, it is usually calculated on the
part of the rep.
Aloof and skeptical: I visit the office
with journal articles that specifically counter the doctor's
perceptions of the shortcoming of my drug. Armed with the articles
and having hopefully scheduled a 20 minute appointment (so the
doc can't escape), I play dumb and have the doc explain to me
the significance of my article. The only thing that remains is
for me to be just aggressive enough to ask the doc to try my
drug in situations that wouldn't have been considered before,
based on the physician's own explanation. Humility is a common
approach to physicians who pride themselves on practicing evidence-based
medicine. These docs are tough to persuade but not impossible.
Typically, attempts at geniality are only marginally effective.
Mercenary: The best mercenary docs are
typically found further down the prescribing power scale. There
are plenty of 6's, 7's, and 8's [lower prescribing doctors] who
are eagerly mercenary but simply don't have the attention they
desire fawned on them. I pick a handful out and make them feel
special enough with an eye towards the projected demand on my
limited resources in mind. Basically, the common motif to docs
whom you want to "buy out" is to closely associate
your resource expenditure with an expectation - e.g., "So,
doc, you'll choose Drug X for the next 5 patients who are depressed
and with low energy? Oh, and don't forget dinner at Nobu next
month. I'd love to meet your wife." This is the closest
drug-repping comes to a commercial exchange.
Delivering such closely associated messages
crudely would be deemed insulting for most docs so a rep really
has to feel comfortable about their mercenary nature and have
a natural tone when making such suggestions. Drug reps usually
feel more camaraderie with competing reps than they do with their
clients. Thus, when a doctor fails to fulfill their end of the
prescriptions-for-dinners bargain, news gets around and other
reps are less likely to invest resources in them.
High-prescribers: I rely on making a strong
personal connection to those docs, something to make me stand
out from the crowd. Friendship sells. The highest prescribers
(9's and 10's) are every reps' sugar mommies and daddies. It's
the equivalent of spitting in the ocean to try to buy these docs
out because, chances are, every other rep is falling head over
heels to do so. The highest prescribers receive better presents.
Some reps said their 10's might receive unrestricted "educational"
grants so loosely restricted that they were the equivalent of
a cash gift, although I did not personally provide any grants.
Prefers a competing drug: The first thing
I want to understand is why they're using another drug as opposed
to mine. If it's a question of attention, then I commit myself
to lavishing them with it until they're bought. If they are convinced
that the competitor drug works better in some patient populations,
I frame my drug to either capture another market niche or, if
I feel my drug would fare well in a comparison, I hammer its
superiority over the competing drug. If, during the course of
conversations, the doctors say something that may contradict
their limited usage of our products, then the reps will badger
them to justify that contradiction. This quickly transforms the
rep from a welcomed reprieve to a nuisance, which can be useful
in limited circumstances. We force the doctors to constantly
explain their prescribing rationale, which is tiresome.
Our intent is to engage in discourse but
also to wear down the doc until he or she simply agrees to try
the product for specific instances (we almost always argue for
a specific patient profile for our drugs). For reps this is a
core function of our job. We're trained to do this in as benign
a way as possible. No doc likes to be told their judgment is
wrong so the latter method typically requires some discretion.
Acquiescent docs: Most docs think that
if they simply agree with what the rep says, they'll outsmart
the rep by avoiding any conflict or commitment, getting the samples
and gifts they want, and finishing the encounter quickly. Nothing
could be further from the truth. The old adage is true, especially
in pharmaceutical sales: there is no such thing as a free lunch.
[NOTE: The Review rents space from Dr.
Fugh-Berman but does not suggest what drugs she should prescribe]
MERCK HUSTLING GARDASIL GUYS,
TOO
PHARMALOT - A recent three-day event
at the University of Chicago campus was held to promote awareness
of HPV and the new vaccine everyone has been talking about. And
it was co-sponsored by Peer Health Educators, a student program,
and three companies: Sony, Avon and Merck.
One day, there were free makeovers.
Another brought live music. And there was a day devoted just
to discussing men's health. "We felt that it's very rare
that there's a men's health event on campus. We wanted to bring
men's health into a seemingly women-specific issue," Colleen
Christensen, a second-year Peer Health Educator, tells the Chicago
Maroon, the school newspaper.
Not only were free coffee and t-shirts
given away, so were little bags of peanuts labeled with instructions
on how to give 'self-testicular exams.' Peanuts? Why not beer
bottles? Anyway, here's the message young men: One day, you won't
have to worry that your short and curlies are sporting warts
or growing harmful cells if the Merck vaccine is approved for
fellas like you.
A similar event is being held at
Ohio State University as part of a pilot program, and Merck plans
to sponsor the same thing at 20 other universities this fall.
By the time Merck convinces the FDA to approve Gardasil For Guys,
a whole generation of educated young men will be primed for a
shot. And they'll no longer have to associate peanuts with tricky
maneuvers.
http://pharmalot.com/2007/04/mercks_hpv_campaign_targets_co.php
SOME INSURANCE COMPANIES NOT
PAYING FOR GARDASIL
KAISER - Some health insurance companies
are not covering Merck's human papillomavirus vaccine Gardasil
and others only cover part of the vaccine's cost, the Detroit
News reports. According to the News, many physician offices are
requiring patients to pay for Gardasil up front or sign a waiver
stating they will pay for the vaccine if their insurance company
does not. . . According to some Detroit-area physicians, the
full cost of the vaccine, which is given in three injections
during a six-month period, is about $450. Two of the largest
insurance providers in southeast Michigan, Health Alliance Plan
and Blue Cross Blue Shield of Michigan, provide coverage for
the vaccine. BCBS only pays for the HPV vaccine when the plan
has immunization coverage, which is included in most employer
groups, an unnamed company spokesperson said. According to the
News, some health insurance plans stop immunization coverage
at age seven or 17. In addition, some insurance companies that
cover Gardasil have annual limits on preventive care that might
be lower than the cost of the vaccine. "The insurance issue
is a nightmare," April Sarvis, a Bloomfield Hills, Mich.-based
ob-gyn, said, adding that some physicians are not offering Gardasil
because insurance plans are not paying the full cost
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=43913
PHARMAS ON THE PROWL ELSEWHERE
RITA RUBIN, USA TODAY - Pfizer,
faced with the potential loss of billions of dollars as patients
with high cholesterol switch from Lipitor to generic Zocor, has
been helping doctors wage a letter-writing campaign to slow the
tide. Lipitor's U.S. patent doesn't expire until March 2010,
but health plans are encouraging patients and doctors to switch
to the cheaper generic Zocor, or simvastatin.
Generic simvastatin became available
in the USA last June. By December, doctors had written 2.5 million
prescriptions for it, Consumers Union says. Lipitor still accounted
for 43% of all statin prescriptions in the latter half of 2006,
the group found.
Pfizer sent doctors a CD containing
two letters, one to health plans, one to pharmacists. The letters
argue that switching from Lipitor to a generic statin "for
cost reasons alone will undermine the clinical judgment that
went into the decision to prescribe Lipitor for this patient."
"They're using doctors as a
human shield to protect them from losing business," said
Sidney Wolfe, director of the Public Citizen Health Research
Group. "I would say it's unethical."
http://www.usatoday.com/news/health/2007-04-02-pfizer-lipitor_N.htm?csp=34
MERCK TAKES ITS GARDASIL CAMPAIGN
TO EUROPE
SARAH BOSELEY, GUARDIAN, UK - A
campaign fronted by doctors and celebrities to persuade European
governments, including the UK, to vaccinate all young girls against
cervical cancer is being entirely funded by the drug company
that markets the vaccine.
Sanofi Pasteur MSD, which markets
Gardasil in Europe on behalf of the drug giant Merck, spent millions
on what was billed as the "first global summit against cervical
cancer", held in Paris on Thursday with doctors and patient
organizations from across Europe.
The revelation comes as public health
experts express disquiet about the promotion of a vaccine that
is only effective in young girls - possibly at the expense of
screening programs that are essential to protect adults. They
also worry that the long-term effects of the vaccine are not
known. The vaccine protects against the most common strains of
the sexually-transmitted human papilloma virus (HPV) which causes
cervical cancer.
Diane Harper, a professor at Dartmouth
medical school in New Hampshire, who led two vaccine trials,
said the vaccine would not protect against all strains of the
virus, and that nobody knows whether vaccinated 10-year-old girls
would still be protected in 10 years' time, when they are sexually
active and at risk. Mass vaccination programmes, she said, would
be "a great big public health experiment".
The Paris summit was believed to
be the brainchild of Professor David Khayat, a Paris-based specialist
in cancer treatment - not vaccines - who has in the past declared
consultancy and lecture fees from Merck. The organisers were
named as the Club Europeen de la Sante, an institution that promotes
public health, but its president, Dominique Dupont, told the
Guardian she agreed to participate only on condition that Sanofi
Pasteur paid.
Celebrities, doctors and journalists
were shipped in from across Europe and the United States by PR
agencies working for Sanofi. The summit, which resembled a political
rally, called for country-wide vaccination programs.
http://society.guardian.co.uk/health/story/0,,2042916,00.html
STUDY FINDS MASSIVE PAYOFFS TO DOCTORS
FROM PHARMAS
GARDINER HARRIS AND JANET ROBERTS, NY TIMES
- Minnesota, [is] the first of a handful of states to pass a
law requiring drug makers to disclose payments to doctors. The
Minnesota records are a window on the widespread financial ties
between pharmaceutical companies and the doctors who prescribe
and recommend their products. . . The Minnesota records begin
in 1997. From then through 2005, drug makers paid more than 5,500
doctors, nurses and other health care workers in the state at
least $57 million. Another $40 million went to clinics, research
centers and other organizations. More than 20 percent of the
state's licensed physicians received money. The median payment
per consultant was $1,000; more than 100 people received more
than $100,000.
Doctors receive money typically in return
for delivering lectures about drugs to other doctors. Some of
the doctors receiving the most money sit on committees that prepare
guidelines instructing doctors nationwide about when to use medicines.
. . In dozens of interviews, most doctors said that these payments
had no effect on their care of patients. . .
Doctors in Minnesota said they generally
did not tell their patients about these arrangements. Indeed,
few patients are aware of the financial connections between those
prescribing drugs and the companies making them.
A New York Times/CBS News poll last month
found that 85 percent of respondents thought it "not acceptable"
for doctors to be paid by drug companies to comment on prescription
drugs. Eighty-five percent also said such payments would influence
the decisions that doctors made about patient care.
http://www.nytimes.com/2007/03/21/us/21drug.html?pagewanted=print
PHARMA FOX FINDS ANOTHER WAY INTO THE
HEN HOUSE
STEPHANIE SAUL, NY TIMES - Many states,
looking to rein in the cost of expensive antipsychotic drugs
like Zyprexa, have turned to an unusual ally for help - the very
company that sells the drug. At more than $300 for a monthly
prescription, Zyprexa, which is used to treat schizophrenia and
bipolar disorder, is the single biggest drug cost for state Medicaid
budgets.
So Eli Lilly, the maker of Zyprexa, offers
to help states monitor doctors who treat Medicaid patients to
make sure they are not wasting money on mental illness drugs
because of what psychiatrists call "sloppy prescribing"
- giving patients too many similar medications or doses that
are too high. Twenty states use Lilly's free service.
But some experts question why these states
let Lilly help oversee spending on its own medication. "I'm
skeptical of a drug company program that says, 'We'll hold down
use of our drug,' " said Stephen W. Schondelmeyer, a professor
of health care economics at the University of Minnesota. He described
such programs as thinly disguised marketing.
Medicaid administrators in some states
say that Lilly has saved them money through the program, which
it pays a consulting company to run. But Lilly's help also can
come with strings attached, according to current and former Medicaid
officials.
http://www.nytimes.com/2007/03/23/business/23lilly.html?hp
MEDICAID LAW CHANGE JUMPS PRICE OF CONTRACEPTIVES
FOR COLLEGE STUDENTS
AP - Millions of college students are suddenly
facing sharply higher prices for birth control, prompting concerns
among health officials that some will shift to less preferred
contraceptives or stop using them altogether. Prices for oral
contraceptives, or birth control pills, are doubling and tripling
at student health centers, the result of a complex change in
the Medicaid rebate law that essentially ends an incentive for
drug companies to provide deep discounts to colleges. . . The
change is the result of a chain reaction started by a 2005 deficit-reduction
bill that focused on Medicaid, the main federal health insurance
program for the poor. College health officials say they had little
idea the bill would affect them. Before the change, pharmaceutical
companies typically sold drugs at deep discounts to a range of
health care providers, including colleges. With contraceptives,
one motivation was attracting customers who would stay with their
products for years. Another reason the discounts made business
sense was that they didn't count against the drug makers in a
formula calculating rebates they owed states to participate in
Medicaid. But in its 2005 bill -- which went into effect in January
-- Congress changed that. Now the discounts to colleges mean
drug manufacturers have to pay more to participate in Medicaid.
The result: Fewer companies are willing to offer discounts.
http://www.cnn.com/2007/EDUCATION/03/23/colleges.contraceptives.ap/index.html
FEBRUARY 2007
MERCK BACKS OFF OF VACCINE HUSTLE
RITA RUBIN, USA TODAY - Merck, maker of
the first vaccine against cervical cancer, has decided to stop
lobbying for state laws to mandate the shot as a condition of
school entry, a company executive said Tuesday. Texas Gov. Rick
Perry signed an executive order Feb. 2 requiring girls, beginning
in September 2008, to be immunized before entering sixth grade,
and at least 17 other states and the District of Columbia are
considering laws to mandate the vaccine, according to the National
Conference of State Legislatures.
But some vaccine proponents have raised
concerns that mandating the vaccine could lead to a backlash
against it. For example, the American Academy of Family Physicians
on Feb. 7 issued a policy statement that said it was "premature"
to consider requiring immunization for school entry. "Long-term
safety with widespread use, stability of supply and economic
issues" must be clarified first, the statement said. . .
Joseph Bocchini, chairman of the American
Academy of Pediatrics' Committee on Infectious Diseases, praised
Merck's decision. "At this point, we really don't know whether
we even need to consider a mandate," Bocchini said. "We
need to get some data over time."
http://www.usatoday.com/news/health/2007-02-20-merck-hpv-vaccine_x.htm?csp=34
GREGORY LOPES AND CHRISTOPHER M. DOLAN,
WASHINGTON TIMES - Lawmakers looking to force preteen girls to
take Gardasil, a new vaccine against a virus that causes cervical
cancer, are targeting the wrong age group, cancer data shows.
Middle-school girls inoculated with the breakthrough vaccine
will be no older than 18 when they pass Gardasil's five-year
window of proven effectiveness -- more than a decade before the
typical cancer patient contracts the sexually transmitted human
papillomavirus (HPV).
Infectious disease specialists and cancer
pathologists say the incubation period for HPV becoming cancer
is 10 to 15 years -- meaning the average cervical cancer patient,
who is 47, contracted the virus in her 30s and would not be protected
by Gardasil taken as a teen. "It is a delicate balancing
act," said Debbie Saslow, director of breast and cervical
cancer control at the American Cancer Society. "If the vaccine
is given at too young an age, it may wear off. Yet if it is given
too late, it won't work.". . .
Merck, which did not respond to repeated
requests for its HPV incubation statistics, unexpectedly suspended
its lobbying campaign yesterday.
http://www.washingtontimes.com/functions/print.php?StoryID=20070221-123326-7587r
[Your faithful journal was on Merck's case
back in January when a couple of DC council members fell for
the vaccine hustle. So far, the council members have neither
apologized nor withdrawn their legislation]
PROGRESSIVE REVIEW CITY DESK, JAN 11 -
Council members Catania And Cheh have introduced a bill that
would require young girls to take a new vaccine that is claimed
to prevent the sexually transmitted disease HPV, often found
in cases of cervical cancer. The issue here is not whether the
vaccine would work for many; the issue is the wisdom of requiring
by law the use of a pharmaceutical that has only just come on
the market and for which, for example, even the maker doesn't
know its effect on women who take it around the time of conception.
The true effects of a drug are often not realized until it's
been on the market for some time. And the pharmaceutical industry
has a dismal record - from indifference to outright fraud - on
policing itself. Mind you, we're talking about a drug that will
need to be taken in three $120 a shot doses. Consider that to
this day that most people have little idea of the danger of memory
loss with statins and that it took years of young people taking
anti-depressants before research showed a connection with suicides.
The wise move here is to provide but not require until we know
much more. As the Washington Post reported, "Although the
American Academy of Pediatrics recommends the vaccine for all
girls ages 11 and 12, an adviser to the academy said he thought
it was premature to recommend making it mandatory. 'I think it's
too early,' said Joseph A. Bocchini, who chairs the academy's
committee on infectious diseases. 'This is a new vaccine. It
would be wise to wait until we have additional information about
the safety of the vaccine.'"
PROGRESSIVE REVIEW CITY DESK - We noted
the other day the foolishness of DC requiring young girls to
take a vaccine to prevent cervical cancer before there was an
adequate history on the drug. The vaccine in question is made
by Merck and now we read in the Online Journal: "Let no
one say the studies in JAMA are funded by hidden drug company
money. The funding is right out in the open. 'Effects of Continuing
or Stopping Alendronate After 5 Years of Treatment,' in the December
27, 2006, issue of JAMA was funded by Merck that manufactures
alendronate, a bisphosphonate, under the patent name Fosamax.
Not only was the study 'supported by contracts with Merck and
Co.,' according to JAMA, it 'was designed jointly by the non-Merck
investigators and Merck employees' and written 'with editorial
input from Merck throughout the process.' Want further transparency?
'The final version of the manuscript was approved by all coauthors,
including Merck authors,' says JAMA.
HOW PHARMA PHRAUD IS COVERED UP BY SECRET
SETTLEMENTS
RICHARD ZITRIN, LA TIMES -
Eli Lilly & Co. recently settled 18,000 lawsuits brought
by people claiming they were injured by the side effects of its
biggest-selling drug, Zyprexa, which is used to treat schizophrenia
and bipolar disorder. But the $500 million in settlements says
less about the dangers of the drug than the dangers of secrecy.
About 18 months earlier, Lilly had settled 8,000 other Zyprexa
cases for $700 million.
But those settlements required the plaintiffs
to return all sensitive documents obtained through the legal
discovery process to Lilly - a requirement that kept the strongest
smoking-gun evidence out of public view. The plaintiffs also
had to agree "not to communicate, publish or cause to be
published, in any public or business forum or context, any statement,
whether written or oral, concerning the specific events, facts
or circumstances giving rise to [their] claims."
Lilly had strong motivation to settle.
The documents contained evidence that Zyprexa caused large, often
enormous, weight gain in many patients, significantly increasing
the risk of dangerously high blood-sugar levels and diabetes.
They also showed that Lilly knew about the problems in 1999,
largely through its own research. Other documents outlined a
marketing scheme to encourage physicians to prescribe Zyprexa
for elderly patients with early signs of dementia. This strategy
not only had no clinical evidence to support it, it promoted
an "off-label" use not approved by the Food and Drug
Administration, a violation of federal law. . .
When secrecy is the price of a legal settlement,
wrongdoers hide their mistakes as if they never happened and
continue with business as usual. That's what happened in the
Lilly case. The thousands of plaintiffs and dozens of lawyers
involved in the 2005 settlements kept their part of the bargain,
while Lilly continued to sell Zyprexa in huge quantities - a
reported $4.2 billion in sales in 2005 - without warning either
patients or doctors about the drug's dangers. . .
Courts have the power to grant protective
orders only to limit the disclosure of highly personal information
and legitimate trade secrets. But when all the lawyers in a case
agree, judges often grant protection even if the trade secrets
in question show how the product does not work, not how it does.
. .
In the Zyprexa cases, the documents eventually
were exposed when Alaska attorney James B. Gottstein, working
on an entirely unrelated case, subpoenaed the records of one
of the plaintiffs' expert witnesses. Gottstein not only used
the documents in his lawsuit but, to his great credit, disclosed
them to the New York Times and several healthcare groups. Gottstein
was almost immediately ordered to return all the documents he
had, but the train had left the station: The New York Times published
articles about the dangers of Zyprexa, and excerpts from the
documents began appearing on the Internet. Within two weeks,
with much of the Zyprexa evidence now out in the open, Lilly
settled the additional 18,000 cases. Negotiated secrecy, Lilly's
primary goal, had become moot.
PHARMA PHRAUD MAY HAVE INCLUDED BRIBES
TO SADDAM
GUARDIAN, UK - The Serious Fraud Office
has launched an investigation into allegations that a number
of major UK-based firms paid bribes to Saddam Hussein's regime
in Iraq. The firms being targeted include the drug giants Glaxo
Smith Kline, Astra Zeneca and Eli Lilly. The international oil
traders and UK bridge-builders Mabey and Johnson are also to
be investigated. They are on a long list of international companies
accused in a UN report of paying kickbacks under the discredited
oil-for-food sanctions regime, which enabled Saddam to illicitly
amass an estimated $1.8bn. Ministers have agreed to fund the
investigation with £22m over three years.
The investigation - the first official
inquiry into the oil-for-food scandal - was urged on the British
government by Paul Volcker, a former chairman of the US Federal
Reserve, who compiled a UN report, delivered two years ago, into
abuses of the program. . .
Mr Volcker said the kickbacks were disguised
by various subterfuges. Contracts were inflated, usually by 10%
to cover so-called "after-sales services" fees. More
than 2,200 companies were listed, using evidence drawn from ban
PHARM FREE MOVEMENT CHALLENGES THE ABRAMOFFS OF
DRUG INDUSTRY
LA TIMES - Casey KirkHart was in many ways
a typical medical student. . . Unlike many of his peers, however,
he routinely passed up the lunch that accompanied a weekly lecture,
even though the food was everything a student could want: tasty,
convenient and, thanks to the pharmaceutical company that catered
it, free. After getting "weird looks" from peers and
instructors alike, KirkHart, then at the New York College of
Osteopathic Medicine, put together a Power Point presentation
to explain why. Using charts and graphs, he cited studies showing
that about 90% of the drug industry's $21-billion marketing budget
went to physicians and that all those mugs, meals, drug samples
and speakers' fees influenced doctors' prescription decisions.
. .
The "pharm-free" movement he
championed is spreading around the country in the wake of an
article in the Journal of the American Medical Assn. challenging
academic medical centers to ban drug industry freebies. . . In
2002, the industry group and the American Medical Assn. responded
to rising criticism by issuing voluntary ethics guidelines. Such
lavish gifts as fishing trips, expensive football tickets and
greens fees at swanky golf resorts were out. Gifts had to be
relatively small - pens, pads, stethoscopes - and related to
patient care. Drug reps, all 90,000 of them, were urged to deliver
educational programs over modestly priced lunches or dinners.
TEXAS TO REQUIRE POORLY TESTED VACCINE
[The tests on this vaccine have been mainly
on older girls and women, have been short term and were sponsored
by Merck]
RALPH BLUMENTHAL, NY TIMES
- Texas on Friday became the first state to require all 11- and
12-year-old girls entering the sixth grade to be vaccinated against
a sexually transmitted virus that causes cervical cancer.
GREGORY LOPES, WASHINGTON TIMES - The National Vaccine Information Center yesterday
warned state officials to investigate the safety of a breakthrough
cancer vaccine as Texas became the first state to make the vaccine
mandatory for school-age girls. Negative side effects of Gardasil,
a new Merck vaccine to prevent the sexually transmitted virus
that causes cervical cancer, are being reported in the District
of Columbia and 20 states, including Virginia. The reactions
range from loss of consciousness to seizures. "Young girls
are experiencing severe headaches, dizziness, temporary loss
of vision and some girls have lost consciousness during what
appear to be seizures," said Vicky Debold, health policy
analyst for the National Vaccine Information Center. . .
Merck began marketing Gardasil last year
after the Food and Drug Administration approved it for females
ages 9 to 26. The vaccine is the first of its kind to build immunity
against two strains of HPV, which lead to 70 percent of cervical
cancer cases in the United States. . .
Its side effects were reported to the Vaccine
Adverse Event Reporting System, a federal reporting system for
consumers to notify federal regulators of bad reactions to medications.
The adverse events began being reported in July 2006, when an
advisory panel to the Centers for Disease Control and Prevention
recommended girls ages 11 and 12 receive the series of shots.
The types of side effects reported are
not cause for alarm, according to the American Cancer Society.
"We have not been informed of an instance that would call
into question the overall safety of the vaccine," said Debbie
Saslow, director of breast and cervical cancer control at the
American Cancer Society, adding that about 70 similar events
had been known in October 2006. . .
Clayton Young, an obstetrician/gynecologist
in Texas, objects to Merck's claim that Gardasil will prevent
cervical cancer. "There is no proof Gardasil will stop cervical
cancer," he said. "They haven't been studying it long
enough to make that claim.". . .
Gardasil is delivered in three separate
injections that cost $120 to $150 per injection. Blue Cross Blue
Shield, an omnipresent health insurer in the Mid-Atlantic region,
covers the vaccine for girls in the federally recommended age
groups. Merck revenue from Gardasil reached $155 million for
the fourth quarter of 2006 and $255 million for the entire year.
PHARMA PHREE MEDICAL EDUCATION
SANDRA G. BOODMAN, WASHINGTON POST - Armed with a $400,000 grant, [Adrienne] Fugh-Berman
and several Georgetown colleagues launched Pharmed
Out, a free, Internet-based alternative for doctors seeking
[continuing medical education courses]devoid of industry funding.
The site lists more than 200 online classes available to doctors
at no cost, many of them sponsored by federal agencies such as
the Food and Drug Administration and the National Institutes
of Health. It also includes links to studies exploring the role
of drug company funding in medical education and research, as
well as a You Tube interview with a former drug salesman who
candidly discusses the ways he deflected doctors' concerns about
a widely prescribed psychiatric drug that has been linked to
massive weight gain and diabetes. . .
There is no dispute that CMEs are big business.
According to the Accreditation Council for Continuing Medical
Education, which oversees the courses, more than $1.7 billion
was spent on CME programs in 2005, more than double the $842
million reported in 1998. About $1 billion comes from drug companies,
Fugh-Berman noted in an article posted last year in Virtual Mentor,
an online ethics journal published by the American Medical Association.
DRUG FIRM BEHIND EFFORT TO
REQUIRE CERVICAL CANCER VACCINE
AP - Merck &
Co. is helping bankroll efforts to pass state laws requiring
girls as young as 11 or 12 to receive the drug maker's new vaccine
against the sexually transmitted cervical-cancer virus. Some
conservatives and parents'-rights groups say such a requirement
would encourage premarital sex and interfere with the way they
raise their children, and they say Merck's push for such laws
is underhanded. But the company said its lobbying efforts have
been above-board.
With at least 18 states debating whether
to require Merck's Gardasil vaccine for schoolgirls, Merck has
funneled money through Women in Government, an advocacy group
made up of female state legislators around the country.
A top official from Merck's vaccine division
sits on Women in Government's business council, and many of the
bills around the country have been introduced by members of Women
in Government. . .
A government advisory panel has recommended
that all girls get the shots at 11 and 12, before they are likely
to be sexually active. But no state has yet to add Gardasil to
the list of vaccinations youngsters must have under law to be
enrolled in school.
JANUARY 2007
UNDISCLOSED SIDE EFFECTS OF THE DAY
HOUSTON BUSINESS JOURNAL - Bayer
Corp. will pay $8 million to 30 states, including $200,000 to
Texas, as part of a settlement requiring the company to fully
disclose when drugs pose risks for patients with specific health
conditions. According to the settlement, Bayer failed to adequately
warn physicians, pharmacies and patients of clinical studies
revealing serious consequences of taking Baycol, a cholesterol-lowering
drug. The company pulled the drug from the market in August 2001
due to its muscle-weakening side effects. The terms also extend
to the disclosure of clinical studies involving other Bayer drugs
with possibly harmful side effects.
http://houston.bizjournals.com/houston/stories/2007/01/22/daily29.html
COALITION AGAINST BAYER DANGERS
http://www.CBGnetwork.org
STUDY QUESTIONS USE OF STATINS FOR THOSE
WITHOUT HEART DISEASE
JOHN ABRAMSON, MD, HARVARD MEDICAL
SCHOOL, AND JAMES WRIGHT, MD, BRITISH COLUMBIA, LANCET - The
last major revision of the US guidelines, in 2001, increased
the number of Americans for whom statins are recommended from
13 million to 36 million, most of whom do not yet have but are
estimated to be at moderately elevated risk of developing coronary
heart disease. In support of statin therapy for the primary prevention
of this disease in women and people aged over 65 years, the guidelines
cite seven and nine randomized trials, respectively. Yet not
one of the studies provides such evidence.
For adults aged between 30 and
80 years old who already have occlusive vascular disease, statins
confer a total and cardiovascular mortality benefit and are not
controversial. The controversy involves this question: which
people without evident occlusive vascular disease should be offered
statins? With about three quarters of those taking statins in
this category, the answer has huge economic and health implications.
. .
We have pooled the data from
all eight randomized trials that compared statins with placebo
in primary prevention populations at increased risk. Unfortunately,
our analysis is imperfect because these trials are not solely
primary prevention: 8.5% of patients had occlusive vascular disease
at baseline. We used two outcomes to estimate overall benefi
t (benefit minus harm): total mortality and total serious adverse
events (SAEs). Total mortality was not reduced by statins (relative
risk 0.95, 95% CI 0.89-1.01). . .
The frequency of cardiovascular events, a less encompassing outcome,
was reduced by statins. However, the absolute risk reduction
of 1.5% is small and means that 67 people have to be treated
for 5 years to prevent one such event. Further analysis revealed
that the benefit might be limited to high-risk men aged 30-69
years. Statins did not reduce total coronary heart disease events
in 10,990 women in these primary prevention trials. Similarly,
in 3,239 men and women older than 69 years, statins did not reduce
total cardiovascular events.
Our analysis suggests that lipid-lowering
statins should not be prescribed for true primary prevention
in women of any age or for men older than 69 years. High-risk
men aged 30-69 years should be advised that about 50 patients
need to be treated for 5 years to prevent one event. In our experience,
many men presented with this evidence do not choose to take a
statin, especially when informed of the potential benefits of
lifestyle modification on cardiovascular risk and overall health.
ALEX BERENSON, NY TIMES - Stepping up government investigations
into Eli Lilly's marketing of its best-selling drug Zyprexa,
state prosecutors in Illinois and Vermont have demanded that
the company turn over information about the way it promoted the
medication. . . The orders are the civil equivalents of criminal
subpoenas, according to Deborah Hagan, the chief of the Illinois
consumer protection division.
Illinois and Vermont are now
part of a coordinated five-state civil investigation into the
way Lilly promoted Zyprexa, a treatment for schizophrenia and
bipolar disorder. The states are investigating whether Lilly
tried to hide Zyprexa's risk of causing weight gain and other
risks associated with diabetes and whether the company promoted
Zyprexa for use in patients who do not have schizophrenia or
bipolar disorder. Federal laws prohibit such so-called "off
label" marketing, although doctors may prescribe any drug
for any disease that they believe the drug will help.
JOHN RUSSELL, INDIANAPOLIS STAR - Drug companies, including Indianapolis-based
Eli Lilly and Co., spend lavishly to advertise drugs for insomnia,
migraine headaches, dry eye, brow furrow, fungus, high cholesterol,
irritable bowels, arthritis and dozens of other maladies. But
the huge advertising tide, worth about $4 billion a year, might
be turning as a chorus of critics accuse the drug companies of
using the ads to bring consumer pressure on doctors to prescribe
unnecessary and costly drugs. The industry trade association,
Pharmaceutical Research and Manufacturers of America, defends
the practice, saying it helps inform consumers and starts "important
doctor-patient conversations about conditions that might otherwise
go undiagnosed or untreated."
But congressional Democrats who
have criticized the growing ad campaigns are now in power. Although
no bill has been introduced to curb drug advertising, many observers
expect it to happen. . .
Drug company spending on direct-to-consumer
advertising has increased twice as fast as spending on promotions
to physicians or on research and development from 1997 to 2005.
ONE THIRD OF BRITISH MENTAL HEALTH PATIENTS
FOUND TO BE GIVEN TOO MANY DRUGS
BBC - Up to one in three mental
health patients are being over-prescribed drugs, says the Healthcare
Commission. A report found mental health patients were more likely
to have problems with medicines than those in other trusts. .
. In research undertaken by the Prescribing Observatory for Mental
Health, 36% of people were found to have been prescribed more
than the maximum recommended dose of anti-psychotic medicines.
http://news.bbc.co.uk/1/hi/health/6256185.stm
Mental health drugs overused
HOUSE DEMOCRATS SELL OUT TO DRUG FIRMS
WASHINGTON POST - Before taking
control of the House last week, Democratic leaders briefly considered
proposing a new government-run prescription drug program as a
way to reduce seniors' drug costs, according to Democratic aides
and lawmakers involved in the deliberations. But House Speaker
Nancy Pelosi (D-Calif.) and her allies chose a far less ambitious
plan - to require the government to negotiate for lower Medicare
drug prices . . . They stepped back largely out of concern that
the pharmaceutical industry would stall a complex change, denying
them a quick victory on a top consumer-oriented priority, aides
say. . . Despite years of lopsidedly favoring GOP lawmakers with
campaign cash and other benefits, the drug lobby continues to
wield tremendous power in the Democratic-controlled Congress.
. . To strengthen their position, drug firms and their trade
groups have been transforming their Washington operations by
hiring top Democratic lobbyists to gain access to new committee
chairmen, bolstering Democratic political donations and spending
millions on public relations campaigns to overcome an image,
indicated in recent surveys, that the industry puts profits ahead
of patients.
Even longtime industry nemeses
like Rep. Fortney "Pete" Stark (D-Calif.), chairman
of a House health panel, are impressed. "They're pretty
potent," he said this week. "They're not bush-leaguers
when it comes to spending money and lobbying."
http://www.washingtonpost.com/wp-dyn/content/article/2007/01/11/AR2007011102081.html
NEW WEB SITE TO HELP DOCTORS THROUGH
PHARMA PHOG
Pharmed Out, is a site designed
to help physicians identify objective information and counter
misleading pharmaceutical promotion practices, has been launched
by Georgetown researchers. It also provides links to continuing
medical education courses that are not funded by pharmaceutical
companies.
"Most CME courses are funded
by pharmaceutical companies, and are designed to transmit marketing
messages," said Adrienne Fugh-Berman, director of the project
and Associate Professor in the Department of Physiology and Biophysics.
"We've identified more than 100 free, web-based CME courses,
so no physician in the United States has to depend on pharmaceutical
companies for education."
Pharmed Out's website, PharmedOut.org,
also offers news, original videos, and links to articles, slideshows,
and other materials on drug promotion, industry-sponsored research,
evidence-based medicine, and many other topics.
Its video interview of an ex-drug
rep describing how he sold Zyprexa (olanzapine), has already
received media attention. An articles, "Doctors must not
be lapdogs to drug firms", describes how pharmaceutical
sales representatives walked out or threatened to withdraw educational
funding from a hospital in New Mexico after Fugh-Berman spoke
about how drug companies manipulate physicians. "Pharma
isn't supposed to have control over the CME courses they fund,"
says Fugh-Berman. "But they do. It's an unspoken agreement;
conference organizers understand that speakers must not say anything
critical of pharmaceutical companies."
Plans for the project include
live CME courses for physicians and physicians-in-training courses,
and a series of articles and film clips designed to increase
awareness about pharmaceutical marketing techniques.
Pharmed Out is funded through
the Attorney General Consumer and Prescriber Education grant
program, created as part of a 2004 settlement between Warner-Lambert,
a division of Pfizer, Inc., and the Attorneys General of 50 States
and the District of Columbia, to settle allegations that Warner-Lambert
conducted an unlawful marketing campaign for the drug Neurontin
(gabapentin) that violated state consumer protection laws.
http://pharmedout.org
HUMANA USES BAIT AND SWITCH ON ELDERLY
WITH SUDDEN HUGE RISE IN DRUG PLAN PRISE
JEFFREY KRASNER, BOSTON GLOBE - The more than two million senior citizens
nationwide who signed up last year for Humana Inc.'s least expensive
Medicare prescription drug plan face average premium increases
of 60 percent -- and in seven states, increases of 466 percent
-- starting tomorrow. . .
Medicare added the prescription
drug benefit in 2006, and in most states dozens of drug plans
with varying coverage are available through insurance companies.
Healthcare advocates say Humana kept its prices low in 2006 to
gain market share. The strategy may prove lucrative, they say,
because many seniors spent considerable time researching and
selecting their drug insurance and were unlikely to switch plans
for 2007, despite increased premiums.
The roughly 3.5 million members
in Humana's three prescription drug plans nationwide were notified
by mail of the price changes by Oct. 31. Enrollment for 2007
Medicare drug benefit, called Part D, ends today.
"You have to state the obvious,"
said David Shove, a stock analyst with Prudential Equity Group
in New York. "You sell something cheaply and get a lot of
customers, and then you raise the price to improve the profitability."
Shove said the start-up of the Medicare prescription drug benefit
"was a once-in-a-lifetime opportunity" for Humana to
attract new customers.
Steve Findlay, a healthcare analyst
with Consumers Union, the publisher of Consumer Reports, called
Humana's price increases a "bait and switch" tactic.
"That's not an acceptable inflationary increase in prices,"
he said. "That's sucker them in and you just start raising
the prices."
But a Humana spokesman, Chris
Curran , blamed most of the price hike on a subsidy formula used
by the Centers for Medicare and Medicaid Services, or CMS, which
oversees the drug benefit. Insurance companies seeking to sell
insurance under Medicare Part D submit bids to CMS and the agency
uses the bids to calculate the subsidy each company will receive
to help offset the cost of providing coverage. Insurers take
the subsidies into account when setting premium rates.
Paul Spitalnik , a CMS actuary,
disputed Humana's contention that the subsidy formula was the
deciding factor in setting prices. "If a plan wanted to
have a lower-priced competitive product, they needed to have
a lower bid than they did for 2006 plans," Spitalnik said.
DRUG FIRM PUSHED DOCTORS TO
PRESCRIBE DRUS FOR UNAPPROVED ILLNESSES
ALEX BERENSON, NY TIMES - Eli Lilly encouraged primary care
physicians to use Zyprexa, a powerful drug for schizophrenia
and bipolar disorder, in patients who did not have either condition,
according to internal Lilly marketing materials. The marketing
documents, given to The New York Times by a lawyer representing
mentally ill patients, detail a multiyear promotional campaign
that Lilly began in Orlando, Fla., in late 2000. In the campaign,
called Viva Zyprexa, Lilly told its sales representatives to
suggest that doctors prescribe Zyprexa to older patients with
symptoms of dementia. . .
Zyprexa is not approved to treat
dementia or dementia-related psychosis, and in fact carries a
prominent warning from the F.D.A. that it increases the risk
of death in older patients with dementia-related psychosis. Federal
laws bar drug makers from promoting prescription drugs for conditions
for which they have not been approved - a practice known as off-label
prescription - although doctors can prescribe drugs to any patient
they wish.
Yet in 1999 and 2000 Lilly considered
ways to convince primary care doctors that they should use Zyprexa
on their patients. In one document, an unnamed Lilly marketing
executive wrote that these doctors "do treat dementia"
but "do not treat bipolar; schizophrenia is handled by psychiatrists."
As a result, "dementia should be first message," of
a campaign to primary doctors, according to the document, which
appears to be part of a larger marketing presentation but is
not marked more specifically.
WIDELY USED ANTI-DEPRESSANTS
DOUBLE SUICIDE RISK IN YOUNG ADULTS
[We continue to wonder what part
these drugs played in various school murders. The media and the
medical profession seem to be avoiding this issue, even though
a number of the slayers were on such medications]
SHANKAR VEDANTAM, WASHINGTON POST - Widely used antidepressants double
the risk of suicidal behavior in young adults, from around three
cases per thousand to seven cases per thousand, according to
a huge federal analysis of hundreds of clinical trials. It marks
the first time regulators have acknowledged that the drugs can
trigger suicidal behavior among patients older than 18. . .
The new finding created a dilemma
for the regulators. Even as it vindicated some of what critics
of drugs such as Prozac, Paxil and Zoloft have said for years,
the earlier official warnings about the drugs appear to have
led to a drop in their use -- and there are troubling signs that
this can lead to an increase in suicides.
After concerns were raised in
the Netherlands about the suicide risk, there was a 22 percent
drop from 2003 to 2005 in antidepressant prescriptions for patients
under 18 and a 50 percent increase in suicides, said Robert Gibbons,
a professor of psychiatry at the University of Illinois in Chicago.
The number of suicides went from 34 to 51. . .
Critics of the drugs said they
were deeply distrustful of both the medical profession and FDA
itself because of conflicts of interest with the pharmaceutical
industry. Allen Jones, of the consumer advocacy group Alliance
for Human Research Protection, said, "the love affair between
the pharmaceutical industry and our government institutions has
to end.". . .
Two experts critical of the drugs,
British psychiatrist David Healy and Joseph Glenmullen, a psychiatrist
who lectures at Harvard University, said the FDA analysis played
down the magnitude of the suicide risk. Information uncovered
in lawsuits, they said, suggested that several suicides in industry
trials were never disclosed.
"Industry controls the data,
and industry with the aid of FDA have miscoded the data so all
the articles in all the journals that purport to represent clinical
trial data are misleading," Healy said in an interview.
His own analysis, published in the British Medical Journal in
2005, found a two-fold increase in risk among all adults taking
the drugs. "The idea you would have a risk in one age group
but not another is just wrong," Healy said.
GOVERNMENT SCIENTIST SENTENCED
IN PHARMA PHRAUD
BALTIMORE SUN - A senior government scientist originally from
Baltimore pleaded guilty yesterday to accepting hundreds of thousands
of dollars in undisclosed fees from the same drug manufacturer
whose public-private research collaboration he oversaw. As part
of his agreement with federal prosecutors, Pearson "Trey"
Sunderland III, chief of the geriatric psychiatry branch of the
National Institute of Mental Health, which is part of the National
Institutes of Health, is expected to receive a sentence of two
years' supervised probation and must forfeit $300,000 in illegal
proceeds and reimbursements.
His ethical misdeeds came to
light after a series of newspaper stories led to a congressional
investigation into the federal government's premier collection
of research centers based in Bethesda.
With proper disclosure and approval,
NIH scientists are allowed to receive outside income. But the
discovery of dozens of private financial arrangements between
drug companies and publicly employed scientists has embarrassed
the agency in recent years and led to yesterday's plea. "This
case is not a technical mistake," Maryland U.S. Attorney
Rod J. Rosenstein said at a news conference after Sunderland's
plea. "This case is not an honest mistake."
NOVEMBER 2006
YOUNG PUT ON DANGEROUS PSYCHIATRIC DRUG
COMBINATIONS
GARDINER HARRIS, NY TIMES - There
is little doubt that some psychiatric medicines, taken by themselves,
work well in children. For example, dozens of studies have shown
that stimulants improve attentiveness. A handful of other psychiatric
drugs have proven effective against childhood obsessive compulsive
disorder, among other problems.
But a growing number of children
and teenagers in the United States are taking not just a single
drug for discrete psychiatric difficulties but combinations of
powerful and even life-threatening medications to treat a dizzying
array of problems.
Last year in the United States,
about 1.6 million children and teenagers - 280,000 of them under
age 10 - were given at least two psychiatric drugs in combination,
according to an analysis performed by Medco Health Solutions
at the request of The New York Times. More than 500,000 were
prescribed at least three psychiatric drugs. More than 160,000
got at least four medications together, the analysis found.
Many psychiatrists and parents
believe that such drug combinations, often referred to as drug
cocktails, help. But there is virtually no scientific evidence
to justify this multiplication of pills, researchers say. A few
studies have shown that a combination of two drugs can be helpful
in adult patients, but the evidence in children is scant. And
there is no evidence at all - "zero," "zip,"
"nil," experts said - that combining three or more
drugs is appropriate or even effective in children or adults.
"There are not any good
scientific data to support the widespread use of these medicines
in children, particularly in young children where the scientific
data are even more scarce," said Dr. Thomas R. Insel, director
of the National Institute of Mental Health.
http://www.nytimes.com/2006/11/23/health/23kids.html?
ei=5088&en=f1766195258101f2&ex=1321938000&adxnnl=1&partner=rssnyt&emc=rs
s&adxnnlx=1164308891-hgXeQnLYej2n8KSdvsz2/A&pagewanted=print
WHAT HAPPENED WHEN A DOCTOR SPOKE OUT
ON THE INFLUENCE OF THE DRUG INDUSTRY ON MEDICAL EDUCATION
ADRIANE FUGH-BERMAN, BRITISH
MEDICAL JOURNAL - Last month I gave a talk at Presbyterian Hospital
in Albuquerque, New Mexico, about the influence of the drug industry
on continuing medical education. As usual, pharmaceutical companies
contributed funds to the conference, and there was a small exhibition
area with the usual monopoly of drug firms.
Immediately after my talk, one
pharmaceutical company representative announced to a conference
organizer that her company would no longer support the annual
conference. Another packed up his exhibit and walked out. Other
drug representatives were observed muttering angrily into their
cell phones, which may, or may not, have been related to the
near total exhibitor boycott the next day. Only one exhibitor
showed up, prompting a physician friend of mine to remark, "Maybe
he missed your talk.". . .
The organizers arranged a debate
with a sales representative on whether pharmaceutical companies
should fund continuing medical education for physicians. The
drug representative who agreed to the debate later backed out
on the advice of "legal." Despite having been offered
equal time, this is the same person who announced that her company
would not support future conferences. . .
The audience of physicians, nurses,
and allied health professionals seemed immensely interested-and
acutely aware of the rarity of an occasion in which the relationship
between medicine and the drug industry was questioned. Several
physicians noted on their comment forms that the organizers were
brave to address the subject. Some delegates even offered to
pay higher registration fees in the future to offset the drug
firms' defection. . .
Corporate support of continuing
medical education courses, meals, and treats are not merely our
just rewards for being hardworking, dedicated doctors. The illusion
that the relationship between medicine and the drug industry
is collegial, professional, and personal is carefully maintained
by the drug industry, which actually views all transactions with
physicians in finely calculated financial terms. Drug representatives
are paid to be nice to us, as long as we cooperate, sustaining
our market share of targeted drugs and limiting our continuing
medical education lectures to messages that increase drug sales.
This is an unspoken agreement, but no less clear for being covert.
The drug industry is happy to
play the generous and genial uncle until physicians want to discuss
subjects that are off limits, such as the benefits of diet or
exercise, or the relationship between medicine and pharmaceutical
companies. Any subject with the potential to reduce drug sales
is anathema. Fair enough. He who pays the piper calls the tune.
If we remain dependent on pharmaceutical companies for sponsoring
continuing medical education, then these courses will remain
under the control of the drug industry. This control is not contractual,
but it is enforced through psychological manipulation.
If corporate sponsorship of medical
meetings is deemed indispensable, why limit sponsorship to pharmaceutical
companies? Surely the manufacturers of cars, luggage, and travel
services would pony up for the opportunity to sell their goods
to physicians. Conference organizers could solicit sponsorship
from firms that market practice management software, office furniture,
or other business related goods. As a last resort, we physicians
could actually pay for our continuing education, as do lawyers,
accountants, business people, and aerobics teachers, to mention
a few. Medicine must shed both its docility and the corporate
leash. Let us not be a lapdog to the pharmaceutical industry.
Rather than sitting contentedly in our master's lap, let us turn
around and bite something tender. Freedom calls. The drug industry
is happy to play the genial uncle until physicians want to discuss
subjects that are off limits
http://www.bmj.com/cgi/content/full/333/7576/1027?ijkey=g0spTSn4hbnro4G&keytype=ref
OCTOBER 2006
PHARMA PHRAUD: |