America's drug addiction
You take sixteen drugs, and what do you get?
Another day older
and the nation deeper in debt.
Adapted from a well-known song of the 1950s.
For the current relevance, see this.
Another blog at Blogspot is relevant:
Clinical Psychology and Psychiatry: A Closer Look.
I do not have the expertise to evaluate this blog for accuracy, veracity, etc.,
but it does seem to reference and discuss reputable sources.
The remainder of this post is
a collection of articles on this subject I have found of interest,
divided into these categories:
Conflicts of Interest
Miscellaneous Articles
Conflicts of Interest
2008-06-08-NYT-Biederman
Researchers Fail to Reveal Full Drug PayBy GARDINER HARRIS and BENEDICT CAREY
New York Times, 2008-06-08
[An excerpt; emphasis is added.]
[1]
A world-renowned Harvard child psychiatrist
whose work has helped fuel
an explosion in the use of powerful antipsychotic medicines in children
earned at least $1.6 million in consulting fees from drug makers
from 2000 to 2007 [ over $200K/year ! ]
but for years did not report much of this income to university officials,
according to information given Congressional investigators.
[2]
By failing to report income,
the psychiatrist, Dr. Joseph Biederman,
and a colleague in the psychiatry department at Harvard Medical School,
Dr. Timothy E. Wilens,
may have violated federal and university research rules
designed to police potential conflicts of interest,
according to Senator Charles E. Grassley, Republican of Iowa.
Some of their research is financed by government grants.
[3]
Like Dr. Biederman,
Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007,
[again, over $200K/year ]
and another Harvard colleague, Dr. Thomas Spencer,
reported earning at least $1 million
after being pressed by Mr. Grassley’s investigators.
But even these amended disclosures
may understate the researchers’ outside income
because some entries contradict payment information from drug makers,
Mr. Grassley found.
[4]
In one example,
Dr. Biederman reported no income from Johnson & Johnson for 2001
in a disclosure report filed with the university.
When asked to check again, he said he received $3,500.
But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001,
Mr. Grassley found.
[5]
The Harvard group’s consulting arrangements with drug makers
were already controversial because of
the researchers’ advocacy of unapproved uses of psychiatric medicines
in children.
[6]
In an e-mailed statement, Dr. Biederman said,
“My interests are solely in the advancement of medical treatment
through rigorous and objective study,”
and he said he took conflict-of-interest policies “very seriously.”
Drs. Wilens and Spencer said in e-mailed statements that
they thought they had complied with conflict-of-interest rules.
...
Dr. Biederman is one of the most influential researchers in child psychiatry
and is widely admired
for focusing the field’s attention on its most troubled young patients.
Although many of his studies are small and often financed by drug makers,
his work helped to fuel a controversial
40-fold increase from 1994 to 2003
in the diagnosis of pediatric bipolar disorder,
which is characterized by severe mood swings,
and a rapid rise in the use of antipsychotic medicines in children.
The Grassley investigation did not address research quality.
[This, I think, seems questionable.
How can the nation's children have become
so much more in need of psychiatric help
than in the past?
Can some of this change
be due to a feminism-caused decline in the quality of parenting,
as well as more sensitive tests?
Note also the incredible increase in the rate of diagnosis of autism.
How can both bipolar disorder and autism be so radically increasing?
The situation cries out for some serious answers as to causes,
not just the usual cry of the Democrats for more funds
to treat yet another developing “crisis”
(the solution of which, somehow, always seems to involve
more money for women and Jews).]
Doctors have known for years that antipsychotic drugs,
sometimes called major tranquilizers,
can quickly subdue children.
But youngsters appear to be especially susceptible
to the weight gain and metabolic problems caused by the drugs,
and it is far from clear
that the medications improve children’s lives over time, experts say.
In the last 25 years,
drug and device makers have displaced the federal government
as the primary source of research financing,
and industry support is vital to many university research programs.
But as corporate research executives recruit the brightest scientists,
their brethren in marketing departments have discovered that
some of these same scientists can be terrific pitchmen.
...
In the past decade,
Dr. Biederman and his colleagues have promoted
the aggressive diagnosis and drug treatment of childhood bipolar disorder,
a mood problem once thought confined to adults.
They have maintained that
the disorder was underdiagnosed in children
and could be treated with antipsychotic drugs,
medications invented to treat schizophrenia.
Other researchers have made similar assertions.
As a result,
pediatric bipolar diagnoses and antipsychotic drug use in children have soared.
Some 500,000 children and teenagers
were given at least one prescription for an antipsychotic in 2007,
including 20,500 under 6 years of age,
according to Medco Health Solutions, a pharmacy benefit manager.
Few psychiatrists today doubt that bipolar disorder
can strike in the early teenage years,
or that many of the children being given the diagnosis are deeply distressed.
“I consider Dr. Biederman
a true visionary in recognizing this illness in children,”
said Susan Resko, director of the Child and Adolescent Bipolar Foundation,
“and he’s not only saved many lives but restored hope
to thousands of families across the country.”
Longtime critics of the group see its influence differently.
“They have given the Harvard imprimatur to
this commercial experimentation on children,”
said Vera Sharav,
president and founder of the Alliance for Human Research Protection,
a patient advocacy group.
Many researchers strongly disagree over what bipolar looks like in youngsters,
and some now
fear the definition has been expanded unnecessarily,
due in part to the Harvard group.
The group published the results of a string of drug trials from 2001 to 2006,
but the studies were so small and loosely designed
that they were largely inconclusive, experts say.
In some studies testing antipsychotic drugs,
the group defined improvement as a decline of 30 percent or more
on a scale called the Young Mania Rating Scale —
well below the 50 percent change that most researchers now use as the standard.
Controlling for bias is especially important in such work,
given that the scale is subjective, and
raters often depend on reports from parents and children,
several top psychiatrists said.
More broadly, they said,
revelations of undisclosed payments from drug makers to leading researchers
are especially damaging for psychiatry.
“The price we pay for these kinds of revelations is credibility,
and we just can’t afford to lose any more of that in this field,”
said Dr. E. Fuller Torrey,
executive director of the Stanley Medical Research Institute,
which finances psychiatric studies.
“In the area of child psychiatry in particular,
we know much less than we should,
and we desperately need
research that is not influenced by industry money.”
2008-10-04-NYT-Nemeroff
Top Psychiatrist Didn’t Report Drug Makers’ PayBy GARDINER HARRIS
New York Times, 2008-10-04
[Its beginning; paragraph numbers and emphasis are added.]
[1]
One of the nation’s most influential psychiatrists
- earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007 [i.e., >$350K/year],
- failed to report at least $1.2 million of that income to his university
[>$150K/year],
and - violated federal research rules,
[2]
The psychiatrist, Dr. Charles B. Nemeroff of Emory University,
is the most prominent figure to date
in a series of disclosures that is shaking the world of academic medicine
and seems likely to force broad changes in
the relationships between doctors and drug makers.
[3]
In one telling example,
Dr. Nemeroff signed a letter dated July 15, 2004,
promising Emory administrators
that he would earn less than $10,000 a year from GlaxoSmithKline
to comply with federal rules.
But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo.,
earning $3,000 of what would become $170,000 in income that year
from that company —
17 times the figure he had agreed on.
[4]
The Congressional inquiry,
led by Senator Charles E. Grassley, Republican of Iowa,
is systematically asking some of the nation’s leading researchers
to provide their conflict-of-interest disclosures,
and Mr. Grassley is
comparing those documents
with records of actual payments from drug companies.
The records often conflict, sometimes starkly.
[5]
“After questioning about 20 doctors and research institutions,
it looks like problems with transparency are everywhere,”
Mr. Grassley said.
“The current system for tracking financial relationships isn’t working.”
[6]
The findings suggest that
universities are all but incapable
of policing their faculty’s conflicts of interest.
its relationships with drug and device makers.
...
2008-10-09-Warner-Nemeroff-greed
Diagnosis: Greedby Judith Warner
New York Times, 2008-10-09
[Judith Warner adds her two cents to the Nemeroff conflict-of-interest affair.]
2008-11-22-NYT-Goodwin
Radio Host Has Drug Company TiesBy GARDINER HARRIS
New York Times, 2008-11-22
[Its beginning; emphasis is added.]
[1]
An influential psychiatrist
who served as the host of public radio’s popular “The Infinite Mind” program
earned at least $1.3 million between 2000 and 2007 [ over $160K/year ]
giving marketing lectures for drug makers,
income not mentioned on the program.
[2]
The psychiatrist and radio host, Dr. Frederick K. Goodwin,
is the latest in a series of doctors and researchers
whose ties to drug makers have been uncovered by
Senator Charles E. Grassley, a Republican from Iowa.
Dr. Goodwin, a former director of the National Institute of Mental Health,
is the first media figure investigated.
[3]
Dr. Goodwin’s radio programs have often touched on
subjects important to the commercial interests
of the companies for which he consults.
In a program broadcast on Sept. 20, 2005,
Dr. Goodwin warned that
children with bipolar disorder who are left untreated
could suffer brain damage, a controversial view.
“But as we’ll be hearing today,” Dr. Goodwin reassured his audience,
“modern treatments — mood stabilizers in particular —
have been proven both safe and effective in bipolar children.”
[4]
That very day, GlaxoSmithKline paid Dr. Goodwin $2,500
to give a promotional lecture for its mood stabilizer drug, Lamictal,
at the Ritz Carlton Golf Resort in Naples, Fla.
Indeed, Glaxo paid Dr. Goodwin more than $329,000 that year
for promoting Lamictal, records given Congressional investigators show.
[5]
In an interview, Dr. Goodwin said that
Bill Lichtenstein, the program’s producer,
knew of his consulting activities but that
neither he nor Mr. Lichtenstein thought that
“getting money from drug companies could be an issue.
In retrospect, that should have been disclosed.”
[6]
But Mr. Lichtenstein said that
he was unaware of Dr. Goodwin’s financial ties to drug makers
and that he called Dr. Goodwin earlier this year
“and asked him point-blank
if he was receiving funding from pharmaceutical companies,
directly or indirectly,
and the answer was, ‘No.’ ”
[7]
“The fact that he was out on the stump for pharmaceutical companies
was not something we were aware of.
It would have violated our agreements,” Mr. Lichtenstein said in an interview.
...
In October, Mr. Grassley revealed that
Dr. Charles B. Nemeroff of Emory University,
an influential psychiatric researcher,
earned more than $2.8 million in consulting arrangements with drugmakers
from 2000 to 2007 [ over $350K/year ! ],
failed to report at least $1.2 million of that income to his university
and violated federal research rules.
As a result,
the National Institutes of Health
suspended a $9.3 million research grant to Emory,
and Dr. Nemeroff gave up his chairmanship of Emory’s psychiatry department.
[An action hardly calculated to instill fear in professors.
Many view chairmanship as an administrative burden (which it is),
part of the service componsent of the research/teaching/service trinity,
which only takes them away from
more interesting and profitable opportunities.
To bill to the outside world the loss of a chairmanship as punishment
is just more academic BS.]
In June, the senator revealed that Dr. Joseph Biederman of Harvard,
whose work has fueled
an explosion in the use of powerful antipsychotic medicines in children,
had earned at least $1.6 million from drugmakers from 2000 to 2007,
and failed to report most of this income to Harvard.
Mr. Grassley’s investigation demonstrates
how deeply pharmaceutical commercial interests reach into academic medicine,
and it has shown that
universities are all but incapable of policing these arrangements.
[Just a suggestion:
when serious conflicts are proven, administer serious sanctions.]
As a result, almost every major medical school and medical society
is reassessing its relationships with makers of drugs and devices.
“We know the drug companies
are throwing huge amounts of money at medical researchers,
and there’s no clear-cut way to know how much and exactly where,”
Mr. Grassley said.
“Now it looks like the same thing is happening in journalism.”
...
In an extensive interview,
Dr. Goodwin blamed a changing ethical environment
for any misunderstandings between himself and Mr. Lichtenstein
about his consulting arrangements.
“More than 10 years ago when he and I got involved in this effort,
it didn’t occur to me that
my doing what every other expert in the field does
might be considered a conflict of interest,”
He defended the views he expressed in many of his radio programs
and said that, because he consults for so many drug makers at once,
he has no particular bias.
“These companies compete with each other and cancel each other out,” he said.
This view is dismissed by industry critics,
who say that
experts who consult widely for drug makers
tend to minimize the value of non-drug or older drug treatments.
2008-12-03-NYT-Abelson-Cleveland
Cleveland Clinic Discloses Doctors’ Industry TiesBy REED ABELSON
New York Times, 2008-12-03
Miscellaneous Articles
2008
2008-04-06-WP-Brownlee
Big Pharma's Golden EggsBy Shannon Brownlee
Washington Post Book World, 2008-04-06
Marketing, not research, is now the core of the drug industry.
[Review of:]
OUR DAILY MEDS:
How the Pharmaceutical Companies
Transformed Themselves into Slick Marketing Machines
and Hooked the Nation on Prescription Drugs
By Melody Petersen
Farrar Straus Giroux. 432 pp. $26
Once upon a time there was an industry called pharma
that was interested in doing well and doing good.
Run by doctors and chemists,
drug companies employed battalions of researchers
whose scientific efforts resulted by mid-century
in a flood of life-saving drugs....
As George Merck, president of the company founded by his father,
put it in 1950,
“We try never to forget that medicine is for the people.
It is not for the profits.
The profits follow. . . .”
And how. Today, of course,
drug companies are hugely profitable enterprises
and the darlings of both Wall Street and K Street,
having spent more on lobbying than any other industry between 1998 and 2004.
Their transformation from small chemical manufacturers
to marketing machines with sidelines in drug development
is owed in large measure to blockbuster drugs.
This is the term for any medication
that generates more than $1 billion in sales annually.
Such drugs as Nexium, Celebrex, Claritin and, of course, Viagra,
whose brand names are household words, became blockbusters
not because they save lives,
or even because they are necessarily more effective than other remedies,
but because their manufacturers employ
some of the cleverest marketing on the planet.
...
2008-05-06-WP-Boodman
Five Doctors, StumpedBy Sandra G. Boodman
Washington Post, 2008-05-06
[This is a story of a 77-year-old women who was
“taking more than half a dozen medicines”
in order to “control her
cholesterol, blood pressure, Type 2 diabetes, a thyroid condition and
a mood disorder.”
Then she started having more problems, tremors and falls.
A series of trips to various doctors, with more medicines prescribed,
failed to cure these problems.
They got so bad her husband had her taken to a hospital emergency room,
and her husband, retired obstetrician Bruce Munro]
still vividly remembers the ER doctor’s first words:
“He said, ‘She’s got a lithium level of 2.1,’ ” Munro recalled.
“I knew that was toxic.”
A normal level is between 0.5 and 1.2 millimoles per liter.
At high levels, lithium,
which is used to treat mood disorders including manic depression,
can cause tremor, convulsions, confusion, memory problems, coma and even death.
The drug has a narrow therapeutic range:
A bit too much can be toxic and too little can be ineffective,
which is one reason people taking it receive blood tests to check their levels.
...
The symptoms of Parkinson’s disease and persistent intestinal problems
were in fact indicators of lithium intoxication.
Her therapeutic dose had become toxic.
“Everyone knew she was taking lithium, but nobody thought to check it,”
Munro said.
“If they had, they would have figured out what was going on”
and saved about $100,000 he estimates the tests and hospitalization cost.
...
Bettie Munro is philosophical.
“Having five doctors --
a psychiatrist, internist, Bruce, a neurologist and a gastroenterologist --
well, I thought they knew what they were talking about.”
[While the Post is probably trying to make a point about doctor error,
it also is raising, to me, an issue about how many drugs the elderly need.
Should the general taxpayer (and society)
be coerced into paying for such a extensive drug regimen?
(To the extent that her medicines are paid for by Medicare, that is.)
I think not.
There is also the medical issue
about the cumulative effect of all those drugs on a person,
how they interact.
One doubts that clinical trials have been conducted
on all the combinations of drugs that are now being taken.]
2008-07-26-NYT-childhood-obesity
Weight Drives the Young to Adult Pills, Data SaysBy STEPHANIE SAUL
New York Times, 2008-07-26
2008-07-26-WP-AIDS-Africa
AIDS Funding Binds Longevity of Millions to U.S.Open-Ended Commitment of Money Is Implied
By David Brown
Washington Post, 2008-07-26
2008-08-14-WP-Watt-Teens
Teens Cite Ease of Access To DrugsBy Holly Watt
Washington Post, 2008-08-14
2008-09-02-NYT-Zetia-Vytorin
For Widely Used Drug, Question of Usefulness Is Still LingeringBy ALEX BERENSON
New York Times, 2008-09-02
[An excerpt; paragraph numbers and emphasis are added.]
[1]
When the Food and Drug Administration
approved a new type of cholesterol-lowering medicine in 2002,
it did so on the basis of
a handful of clinical trials covering a total of 3,900 patients.
None of the patients took the medicine for more than 12 weeks,
and the trials offered no evidence
that it had reduced heart attacks or cardiovascular disease,
the goal of any cholesterol drug.
[2]
The lack of evidence has not stopped doctors from heavily prescribing that drug, whether in a stand-alone form sold as Zetia
or as a combination medicine called Vytorin.
Aided by extensive consumer advertising,
sales of the medicines reached $5.2 billion last year,
making them among the best-selling drugs in the world.
More than three million people worldwide take either drug every day.
[3]
But there is still no proof
that the drugs help patients live longer or avoid heart attacks.
This year Vytorin has failed two clinical trials meant to show its benefits.
Worse,
scientists are debating whether there is a link between the drugs and cancer.
[4]
Researchers reported last month that
patients in three clinical trials
had a 40 percent higher chance of dying from cancer
if they took Vytorin instead of a sugar pill or another medicine,
although the leader of that study says the finding might be due to chance.
[5]
Now some prominent cardiologists say that
the evidence has swung so decisively against the drugs
that they should not be sold.
“The only place people should be taking it is in a clinical trial,”
Dr. Allen J. Taylor of the Walter Reed Army Medical Center said of Zetia.
(Vytorin is a single pill that combines Zetia with a statin,
an older form of cholesterol-lowering medicine
whose effectiveness and safety are not in question.)
...
Pharmaceutical companies argue against changing the current approval system.
Determining whether a drug reduces death or disease
can require a trial
that enrolls 10,000 or more patients and lasts four years or more.
Requiring longer and costlier trials
might discourage the development of new medicines,
said Ken Johnson, senior vice president
of the Pharmaceutical Research and Manufacturers of America.
He said the current system enabled patients
“to access life-saving and life-enhancing remedies more quickly.”
[And the drug companies to sell more drugs.]
2008-09-18-NYT-migraine-gangrene-amputation
Drug Label, Maimed Patient and Crucial Test for JusticesBy ADAM LIPTAK
New York Times, 2008-09-18
[An excerpt; emphasis is added.]
In the spring of 2000, suffering from a migraine,
Diana Levine visited a clinic
for a treatment she had received many times:
Demerol for the pain and Wyeth’s drug Phenergan for nausea.
“Nothing wrong with either drug,” Ms. Levine said.
“They’re both safe when given the right way.”
But if Phenergan is exposed to arterial blood,
it causes swift and irreversible gangrene.
For that reason, it is typically administered by intramuscular injection.
According to Ms. Levine’s lawyers,
using an intravenous drip is almost entirely safe as well.
This time, though, a physician’s assistant used a third method.
She injected the drug into what she thought was a vein,
a method known as “IV push.”
But the assistant apparently missed.
In the following weeks,
Ms. Levine’s hand and forearm turned purple and then black,
and they were amputated in two stages.
[The Times article is mainly about legal questions concerning
how much Ms. Levine should be given
as compensation for the gruesome results of her treatment.
But the situation brings up, to me, some other questions as well.
Migraine is surely an age-old condition,
while such extensive treatments as not one but two drugs for it surely are not.
We keep hearing, especially from Democrats, about health care “crises,”
in particular, the “crisis of rising health care costs.”
One wonders how much of rising health care costs
are being caused by situations such as this,
where women demand expensive treatment for such things as headaches.
Would taking aspirin and, perhaps, Tylenol really been so much inferior?
In making this suggestion,
let me stress that I have no specific expertise in either medicine or ethics;
rather,
I am just asking what I consider some common sense questions
given the enormous rise in America’s health care bill,
and general interest in how to reduce that,
and in why costs keep increasing.]
2008-10-16-Warner-migraine
Adverse Effectsby Judith Warner
New York Times, 2008-10-16
[To make a long story short:]
I tried out a new migraine preventive medication,
and lost a little bit of my mind.
[What is it about Jewish women rushing to their doctor for treatment for their migraine,
and having some sort of medical disaster strike?
Is this a trend?
(Two reported in the NYT within a month.)
Do Jewish women have more migraines than other people?
Are they just more hypochondriac?
Or unlucky?
Or do they just tend to have more access to the media than, well,
almost anyone else?
As for me, if I’ve ever had a migraine, I didn’t know about it.
But then I’m a WASP male.]
2008-11-19-NYT-antipsychotics
Use of Antipsychotics in Children Is CriticizedBy GARDINER HARRIS
New York Times, 2008-11-19
[Its beginning.]
WASHINGTON —
[1]
Powerful antipsychotic medicines
are being used far too cavalierly in children,
and federal drug regulators must do more
to warn doctors of their substantial risks,
a panel of federal drug experts said Tuesday.
[2]
More than 389,000 children and teenagers were treated last year with Risperdal,
one of five popular medicines known as atypical antipsychotics.
Of those patients, 240,000 were 12 or younger,
according to data presented to the committee.
In many cases, the drug was prescribed to treat attention deficit disorders.
[3]
But Risperdal is not approved for attention deficit problems, and
its risks — which include
substantial weight gain,
metabolic disorders and
muscular tics that can be permanent —
are too profound to justify its use in treating such disorders,
panel members said.
2008-12-03-NYT-Harris-Cost-Benefit
British Balance Benefit vs. Cost of Latest DrugsBy GARDINER HARRIS
New York Times, 2008-12-03
2008-12-13-NYT-Wyeth
Wyeth’s Use of Medical Ghostwriters QuestionedBy DUFF WILSON
New York Times, 2008-12-13
Wyeth, the pharmaceutical company,
paid ghostwriters to produce medical journal articles
favorable to its hormone replacement therapy Prempro...
At least one article was published
even after a federal study found the drug raised the risk of breast cancer.
2009
2009-01-15-NYT-Carey-Rabin-antipsychotics
Study Finds Drug Risks With Newer AntipsychoticsBy BENEDICT CAREY and RONI CARYN RABIN
New York Times, 2009-01-15
[Its beginning; emphasis is added.]
The popular drugs known as atypical antipsychotics,
prescribed for an array of conditions,
including schizophrenia, autism and dementia,
double patients’ risk of dying from sudden heart failure,
a study has found.
The finding is the latest in a succession of recent reports
contradicting the long-held assumption that the new drugs,
which include Risperdal, Zyprexa and Seroquel,
are safer than
the older and much less expensive medications that they replaced.
The risk of death from the drugs is not high,
on average about 3 percent in a person being treated at least 10 years,
according to the study,
published Thursday in The New England Journal of Medicine.
Nor was the risk different from that of the older antipsychotic drugs.
But it was significant enough that
an accompanying editorial urged doctors
to limit their prescribing of antipsychotic drugs,
especially to children and elderly patients,
who can be highly susceptible to the drugs’ side effects,
including rapid weight gain.
In recent years, the newer drugs,
which account for about 90 percent of the market,
have become increasingly controversial,
as prescription rates to children and elderly people have soared.
Doctors use the drugs
to settle outbursts related to a host of psychiatric disorders,
including attention deficit disorder and Alzheimer’s disease.
Most are not approved for such use.
After an analysis of study data,
the Food and Drug Administration required that
all antipsychotics’ labels contain a warning that
the drugs were associated with a heightened risk of heart failure
in elderly patients.
The new study, an analysis of more than 250,000 Medicaid records,
is the first to rigorously document that risk for the newer drugs
in adults over 30 without previous heart problems.
2009-01-28-WP-Pearlstein
Not What the Doctor OrderedBy Steven Pearlstein
Washinagton Post, 2009-01-28
[An excerpt; emphasis is added.]
[The pharmaceutical industry] is an industry that
deserves to be treated with deep suspicion by antitrust regulators
because of its congenital distaste for competition.
It is an industry that
spends lavishly on lawyers and lobbyists to protect and extend its patents
and throw up endless challenges to approvals of competitive drugs.
It is an industry in which
companies rarely compete on the basis of price,
both because
its patents give it near-monopoly pricing power
and because
the people who decide which drug to use (doctors)
are not the ones who pay the bills (insurers and consumers).
It is an industry in which
companies facing expiration of lucrative patents
routinely pay millions of dollars to potential rivals
to delay the introduction of lower-priced generic drugs
under the guise of “joint ventures”--
payments that the Federal Trade Commission
has described as kickbacks designed to lessen competition.
And it is an industry that, when all else fails,
would always rather buy a rival than compete against it.
2009-10-06-WP-Drug-Ads
Tune Out Those Drug Adsfrom Consumers Union of United States Inc.
Washington Post, 2009-10-06
When exactly did urinary incontinence become known as “overactive bladder”?
What about impotence, commonly referred to as “erectile dysfunction”?
By coining those terms,
today’s drug advertisers may be blurring the line between
what’s normal for your body and
what are serious conditions that require treatment.
Some experts say this change stems from
consumers having a better understanding of the causes and extent of diseases.
But others say the trend is disease mongering:
an attempt to widen the market,
increasing the number of new tests and treatments
by giving fancy new names to old medical problems.
...
2009-12-28-WP-Goldstein-doughnut-hole
The not-so-sweet side of closing 'doughnut hole'By Amy Goldstein
Washington Post, 2009-12-28
[An excerpt:]
Pat Liberti, a retired nurse in Salem, Mass.,
who has heart disease and diabetes and has had five small strokes,
takes 16 prescription drugs.
She is 59, six years younger than the typical age to join Medicare,
and is eligible because her health problems have classified her as disabled.
She’s entered the doughnut hole each year, this year in May.
At that point, her Blue Cross/Blue Shield plan
stopped paying 75 percent of her medicine’s price.
Since then, she has spent $2,206 on drugs.
“You know, I did everything right. I worked. I saved. I own my own home.
I have an IRA,”
Liberti said.
She had hoped to save
the long-term disability checks she gets from her former job
for her old age.
Instead, she spends them on medicine.
2010
2010-04-02-WSJ-2009-spending-on-prescription-drugs-tops-300G
Prescription-Drug Sales Rise 5.1%By JONATHAN D. ROCKOFF
Wall Street Journal, 2010-04-02
[I’d call that a rather astounding, and totally uncalled for,
expansion of spending on drugs.
From 1960 up until about 2006 that’s practically an exponential curve.]
[1]
Spending on prescription drugs topped $300 billion in the U.S. last year, rising 5.1% despite the economic downturn, according to IMS Health. But the rate of growth was at the low end of historical levels, reinforcing the difficulties brand-name drug makers face relying on the U.S. market to increase revenue.
[For comparison, the U.S. GDP was roughly $14,000 billion.
Thus roughly 2% of U.S. GDP went for drug purchases.]
[2]
The number of prescriptions dispensed in the U.S. also edged higher last year, increasing 2.1% to 3.9 billion, IMS Health reported Thursday. IMS Health collects data from drug makers, pharmacies and other sources and advises companies on health-care trends.
[3]
The results underscore the “resilience” of prescription-drug demand in the face of a down economy, said Murray Aitken, a senior vice president at IMS Health. In 2008, the spending rose just 1.8%, only the third time since 1957 the rate of growth was below 5%.
[4]
Investors have traditionally viewed pharmaceutical stocks as good options during down economies, although some companies, such as Merck & Co., said the recent recession was damping sales.
[5]
Still, the data pointed to concerns for branded drug makers. The number of prescriptions dispensed for generic drugs rose 5.9% last year, but those for branded drugs declined 7.6%. Of all prescriptions dispensed, 75% were for generics last year, up from 57% five years earlier.
[6]
Partly due to the rising use of those generics, prescription-drug spending managed to increase overall for the year to $300.3 billion, Mr. Aitken said. Drug makers and retailers also encouraged prescription-drug use by offering patients discounts on co-pays and other incentives. Slightly higher prices for certain brand-name treatments also contributed to higher revenue.
[7]
IMS Health said it couldn’t specify how much the prices for brand-name drugs increased.
[8]
Sales of brand-name drugs are expected to keep rising at relatively low rates in the mid-single digits, Mr. Aitken said. Making matters difficult for brand-name drug makers, several of their top-selling medicines, including Pfizer Inc.’s popular Lipitor, are scheduled to lose patent protection over the next few years.
[9]
One sign of the problems ahead for branded drug companies was in the results for cholesterol-fighting drugs. They continued to be the largest class of prescription medicines by prescription volume. But they dropped to third place from second in terms of overall sales, due to rising use of generic versions.
[10]
Antipsychotic medicines were the top-selling class of drugs in the U.S. last year, with sales of $14.6 billion. Proton-pump inhibitors were second with sales of $13.6 billion, IMS Health said.
2012
2012-08-19-NYT-Sunday-Review-Hruska-raising-the-ritalin-generation
Raising the Ritalin GenerationBy BRONWEN HRUSKA
New York Times Sunday Review, 2012-08-19
I REMEMBER the moment my son’s teacher told us,
“Just a little medication could really turn things around for Will.”
We stared at her as if she were speaking Greek.
“Are you talking about Ritalin?” my husband asked.
Will was in third grade, and his school wanted him to settle down
in order to focus on math worksheets and geography lessons and social studies.
The children were expected to line up quietly
and “transition” between classes
without goofing around.
This posed a challenge — hence the medication.
“We’ve seen it work wonders,” his teacher said.
“Will’s teachers are reprimanding him.
If his behavior improves, his teachers will start to praise him.
He’ll feel better about himself and about school as a whole.”
Will did not bounce off walls.
He wasn’t particularly antsy.
He didn’t exhibit any behaviors I’d associated with
attention deficit or hyperactivity.
He was an 8-year-old boy with normal 8-year-old boy energy —
at least that’s what I’d deduced from scrutinizing his friends.
“He doesn’t have attention deficit,” I said.
“We’re not going to medicate him.”
The teacher looked horrified.
“We would never suggest you do that,” she said,
despite doing just that in her previous breath.
“We aren’t even allowed by law to suggest that. Just get him evaluated.”
And so it began.
Like the teachers, we didn’t want Will to “fall through the cracks.”
But what I’ve found is that once you start looking for a problem,
someone’s going to find one,
and
attention deficit has become the go-to diagnosis,
increasing by an average of 5.5 percent a year between 2003 and 2007,
according to the Centers for Disease Control and Prevention.
As of 2010, according to the National Health Interview Survey,
8.4 percent, or 5.2 million children, between the ages of 3 and 17
had been given diagnoses of attention deficit hyperactivity disorder.
What I didn’t know at the time is that there’s no clinical test for it:
doctors make diagnoses based on subjective impressions
from a series of interviews and questionnaires.
Now, in retrospect, I understand why the statistics are so high.
We made an appointment with a psychiatrist on the Upper East Side of Manhattan.
After we filled out an extensive questionnaire,
she did the interviews and had Will’s teachers
fill out short behavior questionnaires, called Conners rating scales,
which assess things like “squirminess” on a scale of one to five.
In many cases, I discovered, diagnoses hinge on the teachers’ responses.
A few weeks later we heard back.
Will had been given a diagnosis of inattentive-type A.D.H.D.
It was explained to us this way:
Some children who are otherwise focused
(Will had been engaged during his interview),
have a hard time focusing in “distracting situations” —
in Will’s case, school.
The doctor prescribed methylphenidate, a generic form of Ritalin.
It was not to be taken at home, or on weekends, or vacations.
He didn’t need to be medicated for regular life.
It struck us as strange, wrong, to dose our son for school.
All the literature insisted that
Ritalin and drugs like it had been proved “safe.”
Later,
I learned that the formidable list of possible side effects included
difficulty sleeping, dizziness, vomiting, loss of appetite, diarrhea, headache, numbness, irregular heartbeat, difficulty breathing, fever, hives, seizures, agitation, motor or verbal tics and depression.
It can slow a child’s growth or weight gain.
Most disturbing, it can cause sudden death,
especially in children with heart defects or serious heart problems.
I consulted our longtime pediatrician,
who told me that
if Will had A.D.H.D.,
medication was the only way to give him real relief.
I also read through hundreds of online posts,
though I stopped after a diatribe about a nation
poisoning children’s developing brains.
Meanwhile, Will was sitting out of music class on a regular basis.
In addition to hating the recorder, he’d discovered
he could get a cute girl to laugh by making funny faces.
We decided to trust the doctors and the school.
If Will really had A.D.H.D., we should treat it.
Starting in fourth grade, he took his medicine every morning,
and he went to the school nurse after lunch for another pill.
The doctor raised the dosage until the teachers saw results.
One afternoon, Will told me that during reading period
he forgot to talk to his friends.
“Everything got really quiet,” he explained.
“It was like I was inside the book.”
It was what his teachers had wanted. What we’d wanted.
For the medication to focus him.
I should have been elated that the problem was so simple to fix.
But I wasn’t.
I couldn’t help wondering
why forgetting to talk to his friends was a good thing
and why we were drugging him to become a good student.
At home, he didn’t seem different, just hungry,
since he now ate almost nothing at school.
When I did some research, I learned that
methylphenidate is also prescribed as an appetite suppressant.
The next year, in fifth grade, the pills stopped working.
The doctor upped the dosage a few more times,
then switched medications twice, but nothing.
I thought back to Will’s fourth grade teacher, who had liked him.
Then I thought about his current teacher;
some of the other parents had complained that
she didn’t seem to know what to do with boys at all.
Maybe Will’s successful fourth grade year
had had less to do with the medication
than we’d all believed.
Sometime toward the middle of fifth grade,
he simply refused to take the pills.
He’d seen a television show about
a girl whose parents kicked her out of the house
for crushing and snorting her Adderall,
and that convinced him that his medication was too dangerous.
THAT was five years ago.
Will is about to start his sophomore year of high school.
He’s 6 feet 3 inches tall, he’s on the honor roll and he loves school.
For him, it was a matter of growing up, settling down and learning how to get organized.
Kids learn to speak, lose baby teeth and hit puberty at a variety of ages.
We might remind ourselves that
the ability to settle into being a focused student
is simply a developmental milestone;
there’s no magical age at which this happens.
Which brings me to the idea of “normal.”
The Merriam-Webster definition, which reads in part
“of, relating to, or characterized by
average intelligence or development,”
includes a newly dirty word in educational circles.
If normal means “average,” then schools want no part of it.
Exceptional and extraordinary, which are actually antonyms of normal,
are what many schools expect from a typical student. [????]
If “accelerated” has become the new normal,
there’s no choice but to
diagnose the kids developing at a normal rate with a disorder.
Instead of leveling the playing field
for kids who really do suffer from a deficit,
we’re ratcheting up the level of competition with performance-enhancing drugs.
We’re juicing our kids for school.
when faced with other challenges that high school, college and adult life
are sure to bring,
our children will use the coping skills we’ve taught them.
They’ll reach for a pill.
Bronwen Hruska is the author of the forthcoming novel “Accelerated.”
2013
2013-12-15-NYT-Schwarz-the-selling-of-attention-deficit-disorder
The Selling of Attention Deficit Disorderby Allan Schwarz
New York Times, 2013-12-15
The Number of Diagnoses Soared Amid a 20-Year Drug Marketing Campaign
After more than 50 years leading the fight to legitimize attention deficit hyperactivity disorder, Keith Conners could be celebrating.
Severely hyperactive and impulsive children, once shunned as bad seeds, are now recognized as having a real neurological problem. Doctors and parents have largely accepted drugs like Adderall and Concerta to temper the traits of classic A.D.H.D., helping youngsters succeed in school and beyond.
But Dr. Conners did not feel triumphant this fall as he addressed a group of fellow A.D.H.D. specialists in Washington. He noted that recent data from the Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder had soared to 3.5 million from 600,000 in 1990. He questioned the rising rates of diagnosis and called them “a national disaster of dangerous proportions.”
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”
The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.
Few dispute that classic A.D.H.D., historically estimated to affect 5 percent of children, is a legitimate disability that impedes success at school, work and personal life. Medication often assuages the severe impulsiveness and inability to concentrate, allowing a person’s underlying drive and intelligence to emerge.
But even some of the field’s longtime advocates say the zeal to find and treat every A.D.H.D. child has led to too many people with scant symptoms receiving the diagnosis and medication. The disorder is now the second most frequent long-term diagnosis made in children, narrowly trailing asthma, according to a New York Times analysis of C.D.C. data.
Behind that growth has been drug company marketing that has stretched the image of classic A.D.H.D. to include relatively normal behavior like carelessness and impatience, and has often overstated the pills’ benefits. Advertising on television and in popular magazines like People and Good Housekeeping has cast common childhood forgetfulness and poor grades as grounds for medication that, among other benefits, can result in “schoolwork that matches his intelligence” and ease family tension.
...
2014
2014-09-29-WP-overdose-deaths-spur-families-to-march-on-white-house-over-opioid-epidemic
Overdose deaths spur families to march on Mall over opioid epidemicBy Aaron C. Davis
Washington Post, 2014-09-29
...
[Some protestors] wanted more action on the front end,
beginning with the resignation of the head of the Food and Drug Administration.
Many speakers in the coalition that gathered Sunday
had signed a letter calling for the replacement of
FDA Commissioner Margaret A. Hamburg,
arguing that under her leadership
the agency has exacerbated the nationwide overdose epidemic involving opioids.
The agency overrode its advisory committee’s recommendation
to reject the controversial new opioid drug Zohydro,
a pure hydrocodone formulation.
Dozens of state attorneys general also objected to allowing the drug on the market,
and multiple governors have tried to effectively ban it.
“Come on, we don’t want these drugs in our community,”
said Jennifer Weiss, who lost her son to an overdose in 2011 and now runs a nonprofit group called Healing Addiction in Our Community.
“We are losing the equivalent of two jumbo jets full of people a week.”
Hamburg has acknowledged the problem of opioid abuse and says the FDA is “deeply committed” to fighting it.
But she also says opioid drugs are a key part of treating chronic pain for millions of Americans.
Over the past decade,
in part because of research generated by drug companies and pain specialists playing down the risks of opioids,
the prescription use of painkillers has skyrocketed,
and they have become a relatively common treatment for everything from back pain to arthritis.
Overdose deaths related to the powerful painkillers, according to the CDC,
have more than tripled in the past two decades.
2016
2016-10-15-WP-the-drug-industrys-answer-to-opioid-addiction-more-pills
The drug industry’s answer to opioid addiction: More pillsBy Ariana Eunjung Cha
Washington Post, 2016-10-15
...
[The} pharmaceutical industry is bombarding doctors and the public with information about
a serious, if previously unrecognized, condition common among the millions of Americans who take prescription painkillers.
They call it “opioid-induced constipation,” or “OIC.”
The story of OIC illuminates the opportunism of pharmaceutical innovators and the consequences of a heavily drug-dependent society.
Six in 10 American adults take prescription drugs,
creating a vast market for new meds to treat the side effects of the old ones.
Opioid prescriptions alone have skyrocketed from 112 million in 1992 to nearly 249 million in 2015, the latest year for which numbers are available,
and America’s dependence on the drugs has reached crisis levels.
Millions are addicted to or abusing prescription painkillers such as OxyContin, Vicodin and Percocet.
Statistics from the Centers for Disease Control and Prevention show that,
from 1999 to 2014,
more than 165,000 people died in the United States from prescription-opioid overdoses,
which have contributed to a startling increase in early mortality among whites, particularly women —
a devastating toll that has hit hardest in small towns and rural areas.
The pharmaceutical industry’s response has been more drugs.
The opioid market — now worth nearly $10 billion a year in sales in the United States —
has expanded to include a growing universe of medications aimed at treating secondary effects rather than controlling pain.
...
posted by KHarbaugh at 02:25
<< Home