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| DRUG
ISSUES |
| Informed
Consent and Drugs |
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Your physician
may suggest one or more medications to help you feel better. Using
these medications should be your decision, but first, you need answers
to some important questions. To get those answers, you might ask
your doctor or pharmacist, check a book about medications at the
library or search a reliable information source on the Internet.
Double check with your health care provider before making a final
decision. Ask questions about the benefits and risks of the drug
or drugs so that you can make a truly informed decision about your
treatment and whether what the doctor recommends will do you more
harm than good.
If your psychiatrist
or health care provider will not work with you on managing medicines
so that you may take the medicine that has the best effect for your
personal condition with the least harm or risk, then it would be
wise for you to find another health care professional who will listen
to your concerns, cooperate with you on finding treatments that
are not debilitating and hesitate to prescribe "drug cocktails"...combinations
of several drugs, some with severe unwanted effects, all of them
with potential to interact in ways that make functioning difficult
if not impossible. A physician who truly cares will be interested
and eager to hear your issues and put the utmost effort in helping
you reach your full potential with a minimum of chemical therapy.
Remember that your doctor is working for you...You are paying this
professional either via insurance for which premiums are deducted
from your disability checks or salary and also out of pocket. As
a client, you are entitled to services that do the most good with
the least risks or unwanted effects, and if you are seeing a provider
who refuses to respect your preferences and try alternatives to
what doesn't work for you, then you probably need to find another
doctor or provider who will be flexible and considerate of your
expressed needs and hopes in all aspects of therapy.
What are the
common name, product name, product category, and suggested dosage
level of this medicine? What does the physician expect the medication
to do? How long will it take to do that? How well has this medicine
worked for other people? What are the possible long- and short-term
side effects of taking this medicine? Is there any way to reduce
the risk of experiencing these side effects? What, if any, restrictions
(like driving or avoiding certain foods) need to be considered when
using this medicine? How are medicine levels in the blood checked?
What tests will be needed before taking this medicine and while
taking the medicine? How do I know if the dose should be changed
or the medicine stopped? How much does it cost? Are there any programs
that would help me cover some or all of the costs of the medications?
Is there a less expensive medication that I could use instead? Can
generics or non-brand name medications be substituted for any the
doctor suggests? Are there any medications or supplements that I
shouldn’t take at the same time as these? What about over-the-counter
medications? What are possible alternatives to a drug with unwanted
or potentially harmful effects?
If your symptoms
are so bad that you are having trouble understanding this information,
ask a family member or friend to learn about the medication and
to help you decide whether this is the right course of treatment
for you. In deciding whether to take a medication or have a certain
treatment, you might ask yourself whether the benefits of the medication
outweigh the risks. You might also decide that you will take it
for a trial period and then re-evaluate. Or you may request a trial
of an alternative therapy you feel may be helpful. Sometimes psychotropic
drugs themselves can adversely or negatively affect judgment and
ability to understand, so it is important to report all unwanted
effects, behavior changes or unusual experiences/perceptions to
your doctor because a change of medicine may be necessary if the
drug or drugs you agree to take distort your perceptions or alter
your behavior in ways that others notice or that make you uncomfortable
or afraid. Again, if the psychiatrist refuses to hear you about
side effects or ineffectiveness of the drug or drug combination
you choose, it is better to find a therapist who will cooperate
with you on finding the medication that benefits you most with the
least unwanted effects. If you must take more than one drug, make
sure you are informed of all the possible adverse effects and interactions.
If you decide to use one or more medicines, you must manage them
very carefully to get the best possible results and to avoid serious
problems. To do this: use the medicines exactly as the doctor and
pharmacist have suggested. report any side effects to your doctor,
and keep notes for yourself about what you experience, when you
experience it, and what the doctor’s response is. Tell your doctor
about any times that you have not been able to take your medicine
for any reason so the doctor can tell you what to do—do not double
the next dose unless the doctor tells you to. avoid the use of alcohol
or illegal drugs. (If you are addicted to them, ask your doctor
for help.) Pay close attention to lifestyle issues that cannot be
corrected by medications, such as stress, chaos, poor diet (including
excessive use of sugar, salt, caffeine, smoking), lack of exercise,
light and rest. If these are problems for you, you will need to
address these issues at some time in order to feel really well.
But take it one step at a time
Withdrawal from some psychotropic medications can result in a rebound
effect...recurrence of unwanted behaviors, feelings, moods, etc.
If this occurs and your physician will not listen to you, find another
doctor who will hear you and work with you on any medication issues
that cause you alarm or concern.
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| Possible
Adverse Reactions |
Adverse
Psychiatric Reactions Information
Iatrogenic
Psychiatric Disorders (Medication Induced Disease)
Most of the following
text is quoted from the Textbook
of Adverse Drug Reactions - Davies 1991 Oxford University Press (OUP)
Psychiatric disorders section by K.
Davison and F. Hassanyeh
"Adverse drug reactions
account for a substantial amount of psychiatric morbidity (illness)
which is increasing as new and ever more potent drugs are introduced.
A survey of adverse drug reactions in general practice revealed that
neuropsychiatric reactions accounted for 30 per cent of cases, second
only to gastrointestinal reactions (Martys 1979)
The Boston Collaborative Drug Surveillance Program (BCDSP 1971) recorded
adverse psychiatric reactions in 2.7 per cent of 9000 hospital patients
receiving non- psychiatric drugs.
The difficulties
attaching to establishing the validity of any alleged drug reaction
are greatly magnified for psychiatric reactions. The latter may be
delayed in onset, and some reactions may persist for weeks or months
after drug withdrawal. The chapter continues after elaborating on
the difficulties. "Many reports emanate from non-psychiatrists, who
tend to equate hallucinations and delusions with ' psychosis' or even
'schizoprenia' and apathy with ' depression' when the correct diagnosis
is 'delirium'.
Application of a recognized diagnostic system, such as the International
Classification of Diseases (ICD-9) (WHO 1977) or that of the American
Psychiatric Association (DSM-111-R) (APA 1987) would help to obviate
this difficulty. These problems emphasize importance of national systems
of reporting adverse drug reactions.
Predisposing factors to adverse psychiatric reactions
An important variable
in the production of adverse psychiatric reactions is personal predisposition.
The risk of increased in those with pre-existing impairment of brain
function, such as the elderly or brain-damaged, or with past or present
psychiatric illness, or a history of alcohol or drug abuse, but those
with unblemished psychiatric records are by no means immune. Although
a family history of affective disorder (depression or mania) predisposes
to the drug precipitation of the same conditions. (Whitlock and Evans
1978), the relationship is less clear - cut for paranoid or schizophreniform
psychoses (Davison 1976).
These disorders
can also appear in those without such predisposition. Other predisposing
factors include extreme youth (Prescott 1979), concurrent physical
disease (James 1975), and stressful environments, such as intensive
treatment units (Tomlin 1977; Davison 1989a) Types of Reaction The
vast majority of adverse psychiatric drug reactions are of Type A
in that they are dose-dependent or recognizably related to the known
pharmacological properties of the drug. Even when a reaction occurs
at therapeutic plasma drug levels there is often an interaction of
an identifiable drug effect with individual predisposition." END OF
QUOTE
The following is quoted from "Iatrogenic
Diseases"
by D'Arcy
and Griffin 1986 (OUP):
"If an unexpected
psychiatric disturbance arises suddenly in a person of good previous
personality, shortly after a drug of any sort has been taken, no matter
how harmless it usually is, it is clearly wise to suspect a drug-induced
reaction and, if possible, to discontinue or reduce the dose of the
suspected medication."
It is also good practice to avoid unnecessary polypharmacy (drug cocktails),
to attempt to treat one psychiatric condition with one drug if possible,
and to remember that the use of two drugs from the same group (antidepressant,
neuroleptic, minor tranqullizer, etc.) can rarely, if ever, be justified.
Delirium
A very wide range
of drugs have been associated with toxic confusional reactions (acute
brain syndrome) which are characterized by a fluctuating clouding
of consciousness, restlessness, emotional changes (usually fear and
perplexity, and paranoid delusions and/ or visual hallucinations in
severe cases.) Detailed descriptions of delirious states were given
in the classic paper by Wolfe and Curran (1935) who reviewed 106 cases
associated with 27 different precipitating noxious agents. The only
drugs involved in these cases were alcohol, barbiturates, bromide,
lead and copper. Wider range of drugs can be associated with such
reactions, either during administration or in withdrawal."
Some
Psychiatric Effects:
List modified from McConnell and Duffy, 1994
Antihypertensive drugs
Clonidine depression, mania, agitation
Propanolol depression, mania, delirium, psychosis
Nifedipine depression
Captopril mania, agitation
Antiarrhythmics
Procaninamide depression, mania, delirium, psychosis
Lignocaine depression, delirium, psychosis
Disopyramide delirium, psychosis Antimicrobial Agents Penicillins
depression, agitation, visual halucinations Tetracycline depression,
hallucinations Cephalosporins delirium, psychosis Antimalarials psychosis,
visual hallucinations Antiparkinson drugs Anticholinergics delirium,
psychosis, visual hallucinations, dementia Amantadine depression,
agitation, delirium, psychosis visual hallucinations Levodopa depression,
mania, anxiety, agitation, psychosis visual hallucinations, delirium,
cognitive impairment Antihistamines H1 Blockers (diphenhydramine)
delirium H2 Blockers (cimetidine) depression, mania, delirium, psychosis,
visual hallucinations Antineoplastic drugs Interferon depression,
agitation, delirium Vincristine depression C-asparaginase depression,
delirium, psychosis Endocrine Agents Corticosteroids depression, mania,
psychosis, delirium Oral contraceptives depression Thyroxine anxiety,
agitation, mania, psychosis, visual hallucinations Antiepileptic drugs
Barbiturates (phenobarbitone, primidone) hyperactivity (especially
in children), sedation, sexual dysfunction, aggression, learning deficits,
cognitive impairmant, depression, personality change Positive effects:
anxiolytic/hypnotic (hypnotic, or soporific drugs produce sleep by
depressing brain function and often cause hangover effects in the
morning) Benzodiazepines: (clonazepam, diazepam) aggression, confusion,
depression, disinhibition, irritability, cognitive impairment Positive
effects: anxiolytic/hypnotic; antimanic (clonazepam) Carbamazepine
depression, irritability, sexual dysfunction, mania Positive effects:
antidepressant, antimanic, treatment of aggression and bipolar disorder
Clobazam similar side effect profile to other benzodiazepines but
may have lower overall incidence of cognitive and behavioural side
effects anxiolytic/positive psychotropic effects Gabapentin sedation,
ataxia, (shaky movements) aggression and hyperactivity (children);
Few drug interactions, positive psychotropic effects, Hydantoins (phenytoin)
sedation, ataxia, dementia, affective disorder, confusion, cognitive
impairment, progressive encephalopathy (disease that affects functioning
of the brain) Positive effects? antiaggressive, anxiolytic effects
Lamotrigine may have added toxicity when used with carbamazepine:
ataxia, dizziness; positive psychotropic effects Succinimides (ethosuximide,
methsuximide) Psychosis ("alternating psychosis"- adolescents, young
adults) Drowsiness, insomnia, irritability, cognitive effects, personality
change, Positive effects: improvement in attention/concentration (likely
related to seizure improvement) Topirimate sedation, confusion, cognitive
dysfunction, asthenia (weakness loss of strength) Valproate progressive
encephalopathy, dementia, depression, extrapyramidal effects (muscle
spasms etc) Positive effects: antimanic, treatment of aggression and
bipolar disorder Vigabatrin depression and psychosis |
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Making
Drugs, Shaping the Rules
The New York Times
February 1, 2004
By Melody Petersen
The drug industry
has created vast markets for products like Viagra, Celebrex and Vioxx
by spending billions of dollars on consumer advertising.
But to sell medicines that treat schizophrenia, the companies focus
on a much smaller group of customers: state officials who oversee
treatment for many people with serious mental illness. Those patients
- in mental hospitals, at mental health clinics and on Medicaid -
make states among the largest buyers of antipsychotic drugs.
For Big Pharma, success in the halls of government has required a
different set of marketing tactics. Since the mid-1990's, a group
of drug companies, led by Johnson & Johnson, has campaigned to convince
state officials that a new generation of drugs - with names like Risperdal,
Zyprexa and Seroquel - is superior to older and much cheaper antipsychotics
like Haldol. The campaign has led a dozen states to adopt guidelines
for treating schizophrenia that make it hard for doctors to prescribe
anything but the new drugs.
That, in turn, has helped transform the new medicines into blockbusters.
Ten drug companies chipped in to help underwrite the initial effort
by Texas state officials to develop the guidelines. Then, to spread
the word, Johnson & Johnson, Pfizer and possibly other companies paid
for meetings around the country at which officials from various states
were urged to follow the lead of Texas, according to documents and
interviews that are part of a lawsuit and an investigation in Pennsylvania.
How did this play out?
In May 2001, as Pennsylvania was weighing whether to adopt the Texas
guidelines, Janssen Pharmaceutica, a Johnson & Johnson subsidiary
that sells Risperdal, paid $4,000 to fly two state mental health officials
to New Orleans, where they dined at an elegant Creole restaurant in
the French Quarter, visited the aquarium and met with company executives
and Texas officials, according to documents. Janssen also paid two
Pennsylvania officials $2,000 each for giving speeches at company-sponsored
educational seminars for doctors and nurses working in the state's
prisons.
The payments were discovered a little more than a year ago by Allen
L. Jones, an investigator in the inspector general's office in Pennsylvania,
who stumbled upon them when he was looking into why state officials
had set up a bank account to collect grants from pharmaceutical companies.
With the help of his congressman in Pennsylvania, Mr. Jones, who
is 49 and a former parole officer, brought the information to the
attention of federal health officials - after, he says, his superiors
removed him from the investigation, citing the political influence
of the drug industry. The Department of Health and Human Services
has asked the health care fraud unit of the Federal Bureau of Investigation
to determine whether any laws were broken, according to letters Mr.
Jones has received from federal officials.
Details of the drug companies' efforts, recorded in Mr. Jones's investigative
files and confirmed in part by drug companies and state officials,
offer a glimpse inside the drug industry's behind-the-scenes efforts
to promote the new-generation antipsychotics, called atypicals because
their action in the body is unlike that of earlier drugs. There is
no proof that drug-industry money changed any state official's opinion
about the drugs. And compared with the billions of dollars spent marketing
to doctors from their first days as medical students - or the billions
spent to underwrite and publish research - the dollar amounts are
small. But questions have multiplied about the many ways that the
drug industry tries to influence the medical information that determines
its products' success or failure. Last month, for example,
some senators sharply criticized the National Institutes of Health
for allowing its scientists to accept consulting fees and stock options
from drug and biotechnology companies. Officials of the agency
said that its top-level scientists were no longer accepting such compensation.
Sales of the new antipsychotics totaled $6.5 billion last year, according
to an estimate by Richard T. Evans, an analyst at Sanford C. Bernstein
& Company. About a third of those sales were to state Medicaid
programs, whose costs have ballooned with their adoption of the new
medications. Texas, for example, says it spends about $3,000 a
year, on average, for each patient on the new drugs, versus the $250
it spent on older medications. The escalating costs have prompted
a few states to try to limit access to the new antipsychotics - efforts
that drug makers have opposed vigorously. The Texas guidelines
advise doctors to choose Risperdal or one of four other new antipsychotics
- Zyprexa from Eli Lilly, Seroquel from AstraZeneca, Geodon from Pfizer
or Abilify from Bristol-Myers Squibb - unless they can explain
in writing why an older drug would be better. If a patient does poorly
on the first medication, doctors at state hospitals and mental health
clinics are advised to try another of the new drugs next. Texas officials
said such guidelines were simply a road map for doctors, who can explain
to the state on written forms why they are not prescribing a recommended
drug.
The drug companies deny doing anything untoward. They say it was
appropriate for them to help pay for the development of guidelines
aimed at giving patients the best care. The ones for schizophrenia,
they say, were written by medical experts and Texas officials without
industry interference.
"Janssen did not participate in nor influence the content or the development
of the guidelines,'' said Doug Arbesfeld, a spokesman for Janssen
Pharmaceutica. Officials in some states asked the company for financial
grants so that they could learn about the guidelines, he said. Dr.
Steven P. Shon, who as medical director of the Texas mental health
department led the work on the guidelines, said the effort was not
the drug companies' idea. Rather, he said, state officials decided
that guidelines were needed because of the wide variations in prescriptions
being written for patients.
Dr. Shon said that the condition of many patients had improved when
their care followed the guidelines. Even without them, he added, doctors
in Texas would have prescribed the new drugs. "Everyone wants to use
the new thing,'' he said.
When work on the Texas guidelines began in 1995, only two of the new-generation
drugs were approved for sale: Risperdal and Clozaril, a medicine
from Novartis that doctors were uncomfortable prescribing because
of its known potential to cause a life-threatening blood disorder.
At the time, Janssen had little research on which to base its claims
that Risperdal represented a medical advance. In fact, when federal
regulators approved the drug, they forbade the company from claiming
in marketing materials that it was better than the older drugs. Now,
doctors widely prefer the new medications, saying that the older drugs
cause a higher incidence of side effects like stiffness, trembling
and uncontrollable jerks that can stigmatize patients and prompt them
to stop taking the drugs. But some recent studies have complicated
the picture for doctors by showing that the new medicines have potentially
serious side effects, too, including the development of diabetes in
some patients. On Tuesday, four medical groups, including the American
Psychiatric Association, warned that the new drugs could increase
a patient's risk of obesity, diabetes and high cholesterol - which
can all lead to heart disease. Some leading experts on schizophrenia,
after reviewing the accumulated scientific evidence, have developed
a set of guidelines that clash with the Texas policy. These recommendations,
produced entirely with federal government financing, say that physicians
should not consistently choose the new drugs over the older medications.
"You choose the one that seems the best for the patient," said Dr.
Anthony F. Lehman, the chairman of the psychiatry department at the
University of Maryland School of Medicine. Dr. Lehman was the leader
of the panel, called the Patient Outcomes Research Team, that put
together the alternate guidelines under a grant from the National
Institute of Mental Health. The guidelines are expected to be published
this spring. As early as 1999, physicians were raising questions about
the drug industry's financing of the Texas guidelines.
In an article that year in The Journal of Practical Psychiatry
and Behavioral Health, Dr. Peter J. Weiden and Dr. Lisa Dixon
argued that corporate financing created a potential conflict of interest
that could hurt the project's credibility. Dr. Weiden, professor of
psychiatry at the State University of New York Downstate Medical Center
in Brooklyn, said in an interview last month that he believes the
new drugs have benefits over the older ones. But he continues
to worry, he said, that the industry controls too much of what doctors
learn in psychiatry. For example, Dr. Weiden said, industry-sponsored
educational events focus on medications, while subjects like how to
talk to patients to motivate them to get better fall through the cracks.
"The industry drives education right now," Dr. Weiden said.
"Across the board, there has been a shifting of education toward psychopharma,"
meaning drug treatment. Mr. Arbesfeld, the Janssen spokesman,
said that the company disagreed with the recommendations of Dr. Lehman's
panel. A growing body of evidence, Mr. Arbesfeld said, shows the benefits
of the new drugs. He pointed to a 2002 study that found that patients
treated with Risperdal had a lower risk of relapse than those treated
with Haldol. He also noted that the National Institute for Clinical
Excellence, part of the National Health Service of the British government,
recommends the new drugs as a first-choice treatment for schizophrenia.
Other companies say it is important that they help educate doctors
about the intricacies of their drugs.
"There is no one who knows more about our products than we do," said
Mariann Caprino, a spokeswoman for Pfizer. The company, like
many others, gives financial grants for educational events
but says that it is not involved in writing the instruction materials.
Industry financing of the Texas guidelines began in 1996, when Janssen
agreed to help pay for a survey of dozens of experts about the best
way to treat schizophrenia, according to the article by Dr. Weiden
and Dr. Dixon. Texas officials relied on the experts' conclusions
to help them write the guidelines, which were first applied to patients
in 1997. The initial ones called for doctors to use either Risperdal
or one of the earlier generation of antipsychotics.
Three years later, Janssen and five other companies helped underwrite
an update of the consensus; Texas, in turn, used it in updating the
guidelines. The 1999 version established a preference for the new
drugs. Dr. Shon said 11 drug companies had given Texas a total of
$285,000 for the project. The effort produced guidelines for treating
schizophrenia as well as for treating bipolar disorder and major depressive
disorder in adults, and attention deficit hyperactivity disorder and
major depression in children. In all, Texas has spent about
$6 million on the guidelines and on educating doctors about how to
use them, Dr. Shon said. In addition to the drug industry support,
the state has received help from the federal government, universities
and nonprofit foundations. The largest grant, $2.4 million, came from
the Robert Wood Johnson Foundation, a leading backer of health care
research, which was established by the estate of a longtime chief
executive of Johnson & Johnson.
David J. Morse, a vice president of the foundation, said that it made
the grant because one of its goals is to help find the best possible
medical treatments. The foundation has about 50 percent of its
financial assets invested in Johnson & Johnson stock, he said, and
has former company executives on its board. But it is "completely
independent" of Johnson & Johnson, Mr. Morse said.
In May 2002, a manager in Pennsylvania's public health department
reported to state investigators that mental health officials
had created a bank account to collect grants from drug companies.
Mr. Jones said the inspector general's office soon dispatched him
to look into the report. Pennsylvania's ethics law covering state
workers bars them from accepting honorariums and gifts if they are
made to influence officials' decisions; ethics officials say the ban
can also extend to accepting reimbursements for travel in some cases.
Violators can be punished by fines and criminal penalties. Mr.
Jones said he began to believe that drug companies were trying to
buy the loyalty of state officials. "The more research I did,
the more alarmed I became," he said in an interview. As he reconstructed
the flow of deposits into the account, he interviewed drug company
executives and state officials.
Pennsylvania mental health officials, he determined, were beginning
to express interest in the Texas guidelines by October 2000. Janssen
paid twice for Dr. Shon to fly to Pennsylvania, according to notes
from an interview Mr. Jones conducted with Janssen executives in September
2002. Janssen made the grant covering Dr. Shon's travel expenses "to
expand atypical usage," according to a company document that was given
to Mr. Jones. On April 17, 2002, Janssen paid for an educational seminar
on the guidelines for doctors and nurses working in Pennsylvania's
prisons. Each of the speakers - including Steven J. Fiorello, the
top pharmacist in Pennsylvania's mental health office, and Dr. Frederick
R. Maue, clinical services director of the state's Department of Corrections
- was paid $2,000, according to Mr. Jones's interviews and documents
he obtained. Comprehensive NeuroScience, a marketing company in White
Plains working for Janssen, provided Mr. Fiorello with slides to use
as a model for his talk, according to an e-mail message that Comprehensive
Neuroscience sent to Mr. Fiorello. In the message, Comprehensive
Neuroscience asked him to personalize the slides and then send them
back for Janssen's review.
Sandra Forquer, vice president for educational services at Comprehensive
Neuroscience, said in an interview that Mr. Fiorello had written his
own speech. She also said that Mr. Fiorello had requested that his
$2,000 payment be given to charity, but that her company sent it to
him directly by mistake. According to Mr. Jones's interview notes,
Mr. Fiorello described several instances in which drug companies gave
him honorariums but said he was unsure about which ones he had kept
and which ones he had given to charity.
Stephanie Suran, a spokeswoman for the Department of Public Welfare
in Pennsylvania, said Mr. Fiorello was not available for comment.
She said that she could not comment on Mr. Jones's findings because
of a continuing investigation. Mr. Jones's interview notes show that
Ms. Forquer also told him that Janssen, through Comprehensive Neuroscience,
paid Dr. Maue $2,000 for each of two other speeches, in Orlando, Fla.,
and Sacramento. A spokeswoman for Dr. Maue said that he had turned
over any honorariums he received to the state; state officials confirmed
that he had sent the money to the state's general fund. But Mr. Jones
learned that Janssen nurtured other ties to state officials.
It named Dr. Steven J. Karp, medical director of Pennsylvania's mental
health office, to the advisory board of a newsletter, Mental Health
Issues Today, that a marketing firm created for Janssen. Janssen paid
to fly Dr. Karp, as well as top officials from other states, to advisory
board meetings in Seattle, Washington, D.C., and Tampa, Fla. According
to Mr. Jones's interview notes, Dr. Karp said he eventually became
uncomfortable about attending the meetings because a Janssen executive
was always present. Ms. Suran, the spokeswoman for the Department
of Public Welfare, said that Dr. Karp was not available for comment.
The records that Mr. Jones compiled in his investigation are now
part of a lawsuit he filed against his supervisors in the Pennsylvania
inspector general's office after they removed him from the inquiry.
Mr. Jones said he did not know if the inspector general's office had
investigated the matter further. Mr. Jones contends in the lawsuit,
which has been transferred to the United States District Court in
Scranton, Pa., that his bosses violated his rights by trying to hide
the evidence he found. "I was told that drug companies write checks
to politicians on both sides of the aisle," said Mr. Jones, who still
works as an investigator in the inspector general's office.
W. Scott Foster, a spokesman for the inspector general's office, said
that the office did not comment on lawsuits or its investigations.
In court, lawyers for the state health officials have argued that
the officials did nothing wrong and did not violate the rights of
Mr. Jones. Pennsylvania officials believe that the schizophrenia guidelines,
adopted by the state in 2001, are saving money, Ms. Suran said. In
the past, many doctors prescribed more than one drug for schizophrenia
patients, the mental health office found. The guidelines, however,
rarely allow multiple prescriptions. Preliminary data also show that
the mental health of some patients has improved, Ms. Suran said.
Before he was pulled off the investigation, Mr. Jones said, he learned
that Janssen was not the only drug company that had made payments
to Pennsylvania officials involved in adopting the guidelines. According
to Mr. Jones's interview notes, Mr. Fiorello said that Pfizer had
paid twice for him to travel to its Manhattan headquarters from Harrisburg
for meetings of "an elite group of pharmacists," put him up at one
of the Millennium hotels in Manhattan and paid him an honorarium of
less than $1,300 for each meeting. According to the notes, Mr. Fiorello
also told Mr. Jones that Pfizer had paid for him to travel with a
Pfizer sales representative to Maryland to meet with a mental health
official from that state and discuss Pennsylvania's use of the guidelines.
Pfizer paid him an honorarium, he said, but he could not remember
how much.
Ms. Caprino, the Pfizer spokeswoman, said the company finances development
of treatment guidelines to ensure that patients get the best possible
medications. The company, she said, plays no role in writing the guidelines.
In addition, Ms. Caprino said, Pfizer often hires medical professionals
as consultants and pays them for their time. Pfizer cooperated with
Pennsylvania officials as they investigated the payments, she said,
and the officials later told the company that it had not acted inappropriately.
Some payments went to patient groups instead of directly to state
officials. In 2002, Janssen gave the Olympia, Wash., chapter of the
National Alliance for the Mentally Ill a grant of $15,000
to fly Dr. Shon and other Texans to speak to Washington state legislators
about the guidelines, according to Bill Pilkey, the chapter's former
treasurer. Each speaker, he said, was paid $1,500. Dr. Shon said that
he gave the $1,500 to the Texas mental health department. In all,
he said, he has traveled to more than a dozen states to talk about
the guidelines, with most of the trips paid for by grants from either
the Robert Wood Johnson Foundation or the federal government.
When he asked the drug industry to cover various expenses, Dr. Shon
said, it was because of a lack of state money.
"It was the only source of funding to complete or do all the things
we wanted to do," he said. Dr. Shon said he was working with three
more states -Alabama, Hawaii and Wyoming - to help them adopt the
guidelines. Referring to the effort to draw up state guidelines that
began in 1995, he said, "None of us ever imagined it would grow into
what it has become.'' |
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Making
Drugs, Shaping the Rules
The New York Times
February 1, 2004
By Melody Petersen
The drug industry
has created vast markets for products like Viagra, Celebrex and Vioxx
by spending billions of dollars on consumer advertising.
But to sell medicines that treat schizophrenia, the companies focus
on a much smaller group of customers: state officials who oversee
treatment for many people with serious mental illness. Those patients
- in mental hospitals, at mental health clinics and on Medicaid -
make states among the largest buyers of antipsychotic drugs.
For Big Pharma, success in the halls of government has required a
different set of marketing tactics. Since the mid-1990's, a group
of drug companies, led by Johnson & Johnson, has campaigned to convince
state officials that a new generation of drugs - with names like Risperdal,
Zyprexa and Seroquel - is superior to older and much cheaper antipsychotics
like Haldol. The campaign has led a dozen states to adopt guidelines
for treating schizophrenia that make it hard for doctors to prescribe
anything but the new drugs.
That, in turn, has helped transform the new medicines into blockbusters.
Ten drug companies chipped in to help underwrite the initial effort
by Texas state officials to develop the guidelines. Then, to spread
the word, Johnson & Johnson, Pfizer and possibly other companies paid
for meetings around the country at which officials from various states
were urged to follow the lead of Texas, according to documents and
interviews that are part of a lawsuit and an investigation in Pennsylvania.
How did this play out?
In May 2001, as Pennsylvania was weighing whether to adopt the Texas
guidelines, Janssen Pharmaceutica, a Johnson & Johnson subsidiary
that sells Risperdal, paid $4,000 to fly two state mental health officials
to New Orleans, where they dined at an elegant Creole restaurant in
the French Quarter, visited the aquarium and met with company executives
and Texas officials, according to documents. Janssen also paid two
Pennsylvania officials $2,000 each for giving speeches at company-sponsored
educational seminars for doctors and nurses working in the state's
prisons.
The payments were discovered a little more than a year ago by Allen
L. Jones, an investigator in the inspector general's office in Pennsylvania,
who stumbled upon them when he was looking into why state officials
had set up a bank account to collect grants from pharmaceutical companies.
With the help of his congressman in Pennsylvania, Mr. Jones, who
is 49 and a former parole officer, brought the information to the
attention of federal health officials - after, he says, his superiors
removed him from the investigation, citing the political influence
of the drug industry. The Department of Health and Human Services
has asked the health care fraud unit of the Federal Bureau of Investigation
to determine whether any laws were broken, according to letters Mr.
Jones has received from federal officials.
Details of the drug companies' efforts, recorded in Mr. Jones's investigative
files and confirmed in part by drug companies and state officials,
offer a glimpse inside the drug industry's behind-the-scenes efforts
to promote the new-generation antipsychotics, called atypicals because
their action in the body is unlike that of earlier drugs. There is
no proof that drug-industry money changed any state official's opinion
about the drugs. And compared with the billions of dollars spent marketing
to doctors from their first days as medical students - or the billions
spent to underwrite and publish research - the dollar amounts are
small. But questions have multiplied about the many ways that the
drug industry tries to influence the medical information that determines
its products' success or failure. Last month, for example,
some senators sharply criticized the National Institutes of Health
for allowing its scientists to accept consulting fees and stock options
from drug and biotechnology companies. Officials of the agency
said that its top-level scientists were no longer accepting such compensation.
Sales of the new antipsychotics totaled $6.5 billion last year, according
to an estimate by Richard T. Evans, an analyst at Sanford C. Bernstein
& Company. About a third of those sales were to state Medicaid
programs, whose costs have ballooned with their adoption of the new
medications. Texas, for example, says it spends about $3,000 a
year, on average, for each patient on the new drugs, versus the $250
it spent on older medications. The escalating costs have prompted
a few states to try to limit access to the new antipsychotics - efforts
that drug makers have opposed vigorously. The Texas guidelines
advise doctors to choose Risperdal or one of four other new antipsychotics
- Zyprexa from Eli Lilly, Seroquel from AstraZeneca, Geodon from Pfizer
or Abilify from Bristol-Myers Squibb - unless they can explain
in writing why an older drug would be better. If a patient does poorly
on the first medication, doctors at state hospitals and mental health
clinics are advised to try another of the new drugs next. Texas officials
said such guidelines were simply a road map for doctors, who can explain
to the state on written forms why they are not prescribing a recommended
drug.
The drug companies deny doing anything untoward. They say it was
appropriate for them to help pay for the development of guidelines
aimed at giving patients the best care. The ones for schizophrenia,
they say, were written by medical experts and Texas officials without
industry interference.
"Janssen did not participate in nor influence the content or the development
of the guidelines,'' said Doug Arbesfeld, a spokesman for Janssen
Pharmaceutica. Officials in some states asked the company for financial
grants so that they could learn about the guidelines, he said. Dr.
Steven P. Shon, who as medical director of the Texas mental health
department led the work on the guidelines, said the effort was not
the drug companies' idea. Rather, he said, state officials decided
that guidelines were needed because of the wide variations in prescriptions
being written for patients.
Dr. Shon said that the condition of many patients had improved when
their care followed the guidelines. Even without them, he added, doctors
in Texas would have prescribed the new drugs. "Everyone wants to use
the new thing,'' he said.
When work on the Texas guidelines began in 1995, only two of the new-generation
drugs were approved for sale: Risperdal and Clozaril, a medicine
from Novartis that doctors were uncomfortable prescribing because
of its known potential to cause a life-threatening blood disorder.
At the time, Janssen had little research on which to base its claims
that Risperdal represented a medical advance. In fact, when federal
regulators approved the drug, they forbade the company from claiming
in marketing materials that it was better than the older drugs. Now,
doctors widely prefer the new medications, saying that the older drugs
cause a higher incidence of side effects like stiffness, trembling
and uncontrollable jerks that can stigmatize patients and prompt them
to stop taking the drugs. But some recent studies have complicated
the picture for doctors by showing that the new medicines have potentially
serious side effects, too, including the development of diabetes in
some patients. On Tuesday, four medical groups, including the American
Psychiatric Association, warned that the new drugs could increase
a patient's risk of obesity, diabetes and high cholesterol - which
can all lead to heart disease. Some leading experts on schizophrenia,
after reviewing the accumulated scientific evidence, have developed
a set of guidelines that clash with the Texas policy. These recommendations,
produced entirely with federal government financing, say that physicians
should not consistently choose the new drugs over the older medications.
"You choose the one that seems the best for the patient," said Dr.
Anthony F. Lehman, the chairman of the psychiatry department at the
University of Maryland School of Medicine. Dr. Lehman was the leader
of the panel, called the Patient Outcomes Research Team, that put
together the alternate guidelines under a grant from the National
Institute of Mental Health. The guidelines are expected to be published
this spring. As early as 1999, physicians were raising questions about
the drug industry's financing of the Texas guidelines.
In an article that year in The Journal of Practical Psychiatry
and Behavioral Health, Dr. Peter J. Weiden and Dr. Lisa Dixon
argued that corporate financing created a potential conflict of interest
that could hurt the project's credibility. Dr. Weiden, professor of
psychiatry at the State University of New York Downstate Medical Center
in Brooklyn, said in an interview last month that he believes the
new drugs have benefits over the older ones. But he continues
to worry, he said, that the industry controls too much of what doctors
learn in psychiatry. For example, Dr. Weiden said, industry-sponsored
educational events focus on medications, while subjects like how to
talk to patients to motivate them to get better fall through the cracks.
"The industry drives education right now," Dr. Weiden said.
"Across the board, there has been a shifting of education toward psychopharma,"
meaning drug treatment. Mr. Arbesfeld, the Janssen spokesman,
said that the company disagreed with the recommendations of Dr. Lehman's
panel. A growing body of evidence, Mr. Arbesfeld said, shows the benefits
of the new drugs. He pointed to a 2002 study that found that patients
treated with Risperdal had a lower risk of relapse than those treated
with Haldol. He also noted that the National Institute for Clinical
Excellence, part of the National Health Service of the British government,
recommends the new drugs as a first-choice treatment for schizophrenia.
Other companies say it is important that they help educate doctors
about the intricacies of their drugs.
"There is no one who knows more about our products than we do," said
Mariann Caprino, a spokeswoman for Pfizer. The company, like
many others, gives financial grants for educational events
but says that it is not involved in writing the instruction materials.
Industry financing of the Texas guidelines began in 1996, when Janssen
agreed to help pay for a survey of dozens of experts about the best
way to treat schizophrenia, according to the article by Dr. Weiden
and Dr. Dixon. Texas officials relied on the experts' conclusions
to help them write the guidelines, which were first applied to patients
in 1997. The initial ones called for doctors to use either Risperdal
or one of the earlier generation of antipsychotics.
Three years later, Janssen and five other companies helped underwrite
an update of the consensus; Texas, in turn, used it in updating the
guidelines. The 1999 version established a preference for the new
drugs. Dr. Shon said 11 drug companies had given Texas a total of
$285,000 for the project. The effort produced guidelines for treating
schizophrenia as well as for treating bipolar disorder and major depressive
disorder in adults, and attention deficit hyperactivity disorder and
major depression in children. In all, Texas has spent about
$6 million on the guidelines and on educating doctors about how to
use them, Dr. Shon said. In addition to the drug industry support,
the state has received help from the federal government, universities
and nonprofit foundations. The largest grant, $2.4 million, came from
the Robert Wood Johnson Foundation, a leading backer of health care
research, which was established by the estate of a longtime chief
executive of Johnson & Johnson.
David J. Morse, a vice president of the foundation, said that it made
the grant because one of its goals is to help find the best possible
medical treatments. The foundation has about 50 percent of its
financial assets invested in Johnson & Johnson stock, he said, and
has former company executives on its board. But it is "completely
independent" of Johnson & Johnson, Mr. Morse said.
In May 2002, a manager in Pennsylvania's public health department
reported to state investigators that mental health officials
had created a bank account to collect grants from drug companies.
Mr. Jones said the inspector general's office soon dispatched him
to look into the report. Pennsylvania's ethics law covering state
workers bars them from accepting honorariums and gifts if they are
made to influence officials' decisions; ethics officials say the ban
can also extend to accepting reimbursements for travel in some cases.
Violators can be punished by fines and criminal penalties. Mr.
Jones said he began to believe that drug companies were trying to
buy the loyalty of state officials. "The more research I did,
the more alarmed I became," he said in an interview. As he reconstructed
the flow of deposits into the account, he interviewed drug company
executives and state officials.
Pennsylvania mental health officials, he determined, were beginning
to express interest in the Texas guidelines by October 2000. Janssen
paid twice for Dr. Shon to fly to Pennsylvania, according to notes
from an interview Mr. Jones conducted with Janssen executives in September
2002. Janssen made the grant covering Dr. Shon's travel expenses "to
expand atypical usage," according to a company document that was given
to Mr. Jones. On April 17, 2002, Janssen paid for an educational seminar
on the guidelines for doctors and nurses working in Pennsylvania's
prisons. Each of the speakers - including Steven J. Fiorello, the
top pharmacist in Pennsylvania's mental health office, and Dr. Frederick
R. Maue, clinical services director of the state's Department of Corrections
- was paid $2,000, according to Mr. Jones's interviews and documents
he obtained. Comprehensive Neuroscience, a marketing company in White
Plains working for Janssen, provided Mr. Fiorello with slides to use
as a model for his talk, according to an e-mail message that Comprehensive
Neuroscience sent to Mr. Fiorello. In the message, Comprehensive
Neuroscience asked him to personalize the slides and then send them
back for Janssen's review.
Sandra Forquer, vice president for educational services at Comprehensive
Neuroscience, said in an interview that Mr. Fiorello had written his
own speech. She also said that Mr. Fiorello had requested that his
$2,000 payment be given to charity, but that her company sent it to
him directly by mistake. According to Mr. Jones's interview notes,
Mr. Fiorello described several instances in which drug companies gave
him honorariums but said he was unsure about which ones he had kept
and which ones he had given to charity.
Stephanie Suran, a spokeswoman for the Department of Public Welfare
in Pennsylvania, said Mr. Fiorello was not available for comment.
She said that she could not comment on Mr. Jones's findings because
of a continuing investigation. Mr. Jones's interview notes show that
Ms. Forquer also told him that Janssen, through Comprehensive Neuroscience,
paid Dr. Maue $2,000 for each of two other speeches, in Orlando, Fla.,
and Sacramento. A spokeswoman for Dr. Maue said that he had turned
over any honorariums he received to the state; state officials confirmed
that he had sent the money to the state's general fund. But Mr. Jones
learned that Janssen nurtured other ties to state officials.
It named Dr. Steven J. Karp, medical director of Pennsylvania's mental
health office, to the advisory board of a newsletter, Mental Health
Issues Today, that a marketing firm created for Janssen. Janssen paid
to fly Dr. Karp, as well as top officials from other states, to advisory
board meetings in Seattle, Washington, DC, and Tampa, Fla. According
to Mr. Jones's interview notes, Dr. Karp said he eventually became
uncomfortable about attending the meetings because a Janssen executive
was always present. Ms. Suran, the spokeswoman for the Department
of Public Welfare, said that Dr. Karp was not available for comment.
The records that Mr. Jones compiled in his investigation are now
part of a lawsuit he filed against his supervisors in the Pennsylvania
inspector general's office after they removed him from the inquiry.
Mr. Jones said he did not know if the inspector general's office had
investigated the matter further. Mr. Jones contends in the lawsuit,
which has been transferred to the United States District Court in
Scranton, Pa., that his bosses violated his rights by trying to hide
the evidence he found. "I was told that drug companies write checks
to politicians on both sides of the aisle," said Mr. Jones, who still
works as an investigator in the inspector general's office.
W. Scott Foster, a spokesman for the inspector general's office, said
that the office did not comment on lawsuits or its investigations.
In court, lawyers for the state health officials have argued that
the officials did nothing wrong and did not violate the rights of
Mr. Jones. Pennsylvania officials believe that the schizophrenia guidelines,
adopted by the state in 2001, are saving money, Ms. Suran said. In
the past, many doctors prescribed more than one drug for schizophrenia
patients, the mental health office found. The guidelines, however,
rarely allow multiple prescriptions. Preliminary data also show that
the mental health of some patients has improved, Ms. Suran said.
Before he was pulled off the investigation, Mr. Jones said, he learned
that Janssen was not the only drug company that had made payments
to Pennsylvania officials involved in adopting the guidelines. According
to Mr. Jones's interview notes, Mr. Fiorello said that Pfizer had
paid twice for him to travel to its Manhattan headquarters from Harrisburg
for meetings of "an elite group of pharmacists," put him up at one
of the Millennium hotels in Manhattan and paid him an honorarium of
less than $1,300 for each meeting. According to the notes, Mr. Fiorello
also told Mr. Jones that Pfizer had paid for him to travel with a
Pfizer sales representative to Maryland to meet with a mental health
official from that state and discuss Pennsylvania's use of the guidelines.
Pfizer paid him an honorarium, he said, but he could not remember
how much.
Ms. Caprino, the Pfizer spokeswoman, said the company finances development
of treatment guidelines to ensure that patients get the best possible
medications. The company, she said, plays no role in writing the guidelines.
In addition, Ms. Caprino said, Pfizer often hires medical professionals
as consultants and pays them for their time. Pfizer cooperated with
Pennsylvania officials as they investigated the payments, she said,
and the officials later told the company that it had not acted inappropriately.
Some payments went to patient groups instead of directly to state
officials. In 2002, Janssen gave the Olympia, Wash., Chapter of the
National Alliance for the Mentally Ill a grant of $15,000
to fly Dr. Shon and other Texans to speak to Washington state legislators
about the guidelines, according to Bill Pilkey, the chapter's former
treasurer. Each speaker, he said, was paid $1,500. Dr. Shon said that
he gave the $1,500 to the Texas mental health department. In all,
he said, he has traveled to more than a dozen states to talk about
the guidelines, with most of the trips paid for by grants from either
the Robert Wood Johnson Foundation or the federal government.
When he asked the drug industry to cover various expenses, Dr. Shon
said, it was because of a lack of state money.
"It was the only source of funding to complete or do all the things
we wanted to do," he said. Dr. Shon said he was working with three
more states -Alabama, Hawaii and Wyoming - to help them adopt the
guidelines. Referring to the effort to draw up state guidelines that
began in 1995, he said, "None of us ever imagined it would grow into
what it has become.'' |
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The
Going Rate on Shrinks: Big Pharma and the Buying of Psychiatry
By E. Fuller
Torrey
From
The American Prospect Online
Issue Date: 7.15.02
It was last summer
in Berlin when I first encountered pharmaceutical funhouses. I was
one of 4,000 attendees at the 7th World Congress of Biological Psychiatry.
Until about a decade ago, pharmaceutical companies passed out pens
or notepads with their companies' logos at such events, and most speakers
presented data and opinions based upon their true scientific beliefs.
That all changed when Big Pharma took over. At the congress, I counted
15 major displays on the way to the lunch area, including an artificial
garden (Janssen-Cilag), a brook running over stones (Lundbeck), and
a 40-foot rotating tower (Novartis). Almost all offered free food
and drink, T-shirts, or other inducements designed to get psychiatrists
to pause so that an army of smiling sales representatives could give
their sales pitch. Eli Lilly's display included two large, walk-through
tunnels set up like funhouses.
One tunnel, labeled "Zyprexa," included a mirrored room with dozens
of telephones dangling from the ceiling. Was Lilly trying to convince
me that God was calling, telling me to prescribe Zyprexa? The sales
representative said no, the phones were meant to illustrate the communication
problems common in schizophrenia, which Lilly claims Zyprexa improves.
The other funhouse, labeled "Prozac," featured a 10-foot mouselike
creature sitting in front of a blank television screen. I asked whether
Lilly was recommending Prozac for mice. The representatives said no,
the creature was really a depressed man who needed Prozac.
My favorite display, by the Dutch firm Organon, advertised Remeron,
an antidepressant. It featured a small, multihued tent with purple
doors and the painted head of a genie. Inside, a red-robed young woman
with sprinkles in her hair was taking Polaroid pictures, one by one,
of psychiatrists who had waited patiently in line for 20 minutes or
more. This was no ordinary picture but rather a snapshot of one's
aura, taken, as the Organon brochure noted, "with advanced biofeedback
equipment." The equipment consisted of two small machines, on which
I placed my hands. The result was a picture of my head peering out
of a red, orange, and yellow cloud. According to the brochure, "the
aura colors give you information about your appearance, character,
talents, and future energy." After taking my picture, the red-robed
young woman escorted me to a yellow-robed young woman with even more
sprinkles in her hair. "Hi! My name is Amber," she said, and proceeded
to interpret the picture of my aura as indicating intelligence and
good judgment, although with some hints of skepticism.
I privately asked the Organon sales staff if they thought it wise
to associate their product with auras, magic, New Age thinking, and
anti-science. They said the decision had been made at "a higher level"
but pointed out that the waiting line was an ideal place for engaging
psychiatrists in brief, friendly chats about the virtues of Remeron.
This is, after all, big business. Antidepressant and antipsychotic
drugs are among America's top-selling pharmaceuticals. Last year Prozac
and Zyprexa accounted for almost half of Eli Lilly's total sales.
Sales of antipsychotic medications have quadrupled in the past four
years to more than $4billion. These drugs are a major reason why the
profitability of the 11 pharmaceutical companies in the Fortune 500
"was almost four times greater" than the median for all Fortune 500
companies during the 1990s, according to a report by the Public Citizen
Health Research Group. Not surprisingly, psychiatrists have become
a prime target of pharmaceutical companies' marketing, because prescription
drugs can't be sold directly to consumers. In the United States, pharmaceutical
companies spend an estimated $8,000 to $13,000 per physician per year
on marketing.
At professional gatherings, of course, one must offer the attending
psychiatrist more than an opportunity to view one's aura. The Berlin
Congress offered 136 symposia plus workshops and lectures. Of these,
23 were clearly labeled as being sponsored by pharmaceutical companies;
all focused on drugs to treat psychiatric disorders. Several other
industry-sponsored talks had no disclosure of the sponsorship. Each
brought in two to four psychiatric experts, whom the sponsoring pharmaceutical
company usually gave business-class air tickets, four-star hotel accommodations,
and an honorarium, typically $2,000 to $3,000. If the expert organized
the symposium, the payments went as high as $5,000, and higher still
if the expert presented data very favorable to that company's drug
(or at least presented unfavorable data in a very favorable light).
One American expert was paid $10,000 last year to fly to Europe to
give a single lecture. Symposia and workshops on subjects not directly
concerned with drug prescriptions had little, if any, industry support.
The speaker at one such symposium, which was lightly attended, said
he "felt like the legitimate act at a burlesque show, included only
to keep the cops out." Honoraria and future invitations are directly
dependent on how experts present their data. Emphasizing adverse effects
of a drug, for example, may well cost the expert a trip to future
congresses. Some of the psychiatric experts sponsored by a pharmaceutical
company are also on the company's speakers bureau; many own stock
and thus have a direct financial interest in the success of the company's
products. The ultimate targets for this pharmaceutical extravaganza,
of course, are the practicing psychiatrists who constitute the vast
majority of attendees. Although meeting officials won't provide precise
numbers, they acknowledge that pharmaceutical companies had sponsored
more than half of the attendees.
Sponsorship normally includes coach-class airfare, hotel accommodations,
and registration fees as well as special receptions and parties, some
literally with dancing girls. Pharmaceutical companies in many countries
can now use computerized pharmacy databases (which delete the names
of the patients) to track how many prescriptions any given physician
writes for any given drug. So Eli Lilly could sponsor Dr. Smith from
Detroit or Manchester, send him to Berlin, and then monitor his prescribing
pattern following the congress. If Dr. Smith's prescriptions for Zyprexa
and Prozac do not increase sufficiently, a company representative
can remind him how well he was treated in Berlin. And besides, isn't
he interested in going to Copenhagen next summer? There is clear evidence
that attending conferences such as the Berlin meeting does affect
the prescribing practices of physicians. In one U.S. study, 10 physicians
were invited by a pharmaceutical company to attend "all-expenses paid"
symposia at "popular Sunbelt vacation sites."
The company tracked the physicians' prescribing patterns for two drugs,
for 22 months before and 17 months after the symposia. Though the
physicians had predicted that their attendance would not affect their
prescribing practices, their prescriptions for one drug increased
87 percent and for the other, 272 percent. Other studies have shown
that attending drug-sponsored education courses affects drug-prescribing
practices, even though the physicians deny it. Indeed, if it were
otherwise, why would pharmaceutical companies sponsor such activities?
Does any of this really matter? It does, for two reasons. First, patient
care suffers when physicians are misled. Psychiatrists trying to evaluate
schizophrenia drugs are not told that the expert who minimizes the
side effects of Zyprexa receives a $10,000 retainer from Eli Lilly
and also owns substantial company stock. Or that the psychiatric expert
claiming that Remeron reverses depression more rapidly in suicidal
patients receives $75,000 per year from Organon to support his laboratory.
Second, the hoopla adds to the cost of drugs. Payments to aura interpreters
and dancing girls are simply passed on to patients. The pharmaceutical
company costs for the Berlin congress were at least $10 million. According
to a recent report, in 2000 the 11 pharmaceutical firms in the Fortune
500 "devoted nearly three times as much of their revenue to marketing
and administrative costs (30 percent of revenue) as to research and
development (12 percent of revenue)."
Plainly some changes are in order. Reform should start with medical
students. As one observer summarized it in The New England Journal
of Medicine: "Medical training should not include acquiring a sense
of entitlement to the largesse of drug companies." Pharmaceutical
companies should be banned from giving gifts to medical students and
residents; the free pizza from the drug representative may seem trivial,
but it sets a pattern that rationalizes accepting a free trip to Berlin
later on. Practicing psychiatrists should get their continuing education
from objective sources, not from drug "detail" (marketing) persons
and industry-sponsored talks. Vermont has just made a modest beginning
with a law requiring disclosure of all drug-company gifts to doctors
valued at more than $25.
The profession's ethical standards should prohibit experts who are
involved in drug trials or giving talks at symposia from owning stock
in pharmaceutical companies. Unfortunately, most of the profession's
organizations, such as the American Psychiatric Association, are themselves
so indebted to drug companies that they are unlikely to lead reform.
For speakers at symposia such as the Berlin meeting, the solution
is simple. Prominently displayed next to the speaker's lectern should
be a sign reading: "For this talk, Dr. Smith is being paid $3,500,
business-class airfare, and four-star hotel accommodations by Eli
Lilly and Company." |
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