Terrific Expose of Drug Companies and Doctors -- aStory of Corruption (and Collusion)]

[Guest guest]

It's g1 MedicalConspiraciesood to see this being exposed.

 

Betty

 

NY Review of Books

 

http://www.nybooks.com/articles/22237

 

Volume 56, Number 1 · January 15, 2009

 

 

Drug Companies & Doctors: A Story of Corruption

 

By Marcia Angell

 

 

BOOKS:

 

Side Effects: A Prosecutor, a Whistleblower, and

a Bestselling Antidepressant on Trial

 

by Alison Bass

 

Algonquin Books of Chapel Hill, 260 pp., $24.95

 

------------------------

 

Our Daily Meds: How the Pharmaceutical Companies

Transformed Themselves into Slick Marketing

Machines and Hooked the Nation on Prescription Drugs

 

by Melody Petersen

 

Sarah Crichton/Farrar, Straus and Giroux, 432 pp., $26.00

 

-------------------------

 

Shyness: How Normal Behavior Became a Sickness

 

by Christopher Lane

 

Yale University Press, 263 pp., $27.50; $18.00 (paper)

 

------------------------

 

Recently Senator Charles Grassley, ranking

Republican on the Senate Finance Committee, has

been looking into financial ties between the

pharmaceutical industry and the academic

physicians who largely determine the market value

of prescription drugs. He hasn't had to look very hard.

 

Take the case of Dr. Joseph L. Biederman,

professor of psychiatry at Harvard Medical School

and chief of pediatric psychopharmacology at

Harvard's Massachusetts General Hospital. Thanks

largely to him, children as young as two years

old are now being diagnosed with bipolar disorder

and treated with a cocktail of powerful drugs,

many of which were not approved by the Food and

Drug Administration (FDA) for that purpose and

none of which were approved for children below ten years of age.

 

Legally, physicians may use drugs that have

already been approved for a particular purpose

for any other purpose they choose, but such use

should be based on good published scientific

evidence. That seems not to be the case here.

Biederman's own studies of the drugs he advocates

to treat childhood bipolar disorder were, as The

New York Times summarized the opinions of its

expert sources, " so small and loosely designed

that they were largely inconclusive. " [1]

 

In June, Senator Grassley revealed that drug

companies, including those that make drugs he

advocates for childhood bipolar disorder, had

paid Biederman $1.6 million in consulting and

speaking fees between 2000 and 2007. Two of his

colleagues received similar amounts. After the

revelation, the president of the Massachusetts

General Hospital and the chairman of its

physician organization sent a letter to the

hospital's physicians expressing not shock over

the enormity of the conflicts of interest, but

sympathy for the beneficiaries: " We know this is

an incredibly painful time for these doctors and

their families, and our hearts go out to them. "

 

Or consider Dr. Alan F. Schatzberg, chair of

Stanford's psychiatry department and

president-elect of the American Psychiatric

Association. Senator Grassley found that

Schatzberg controlled more than $6 million worth

of stock in Corcept Therapeutics, a company he

cofounded that is testing mifepristone­the

abortion drug otherwise known as RU-486­as a

treatment for psychotic depression. At the same

time, Schatzberg was the principal investigator

on a National Institute of Mental Health grant

that included research on mifepristone for this

use and he was coauthor of three papers on the

subject. In a statement released in late June,

Stanford professed to see nothing amiss in this

arrangement, although a month later, the

university's counsel announced that it was

temporarily replacing Schatzberg as principal

investigator " to eliminate any misunderstanding. "

 

Perhaps the most egregious case exposed so far by

Senator Grassley is that of Dr. Charles B.

Nemeroff, chair of Emory University's department

of psychiatry and, along with Schatzberg,

coeditor of the influential Textbook of

Psychopharmacology.[2] Nemeroff was the principal

investigator on a five-year $3.95 million

National Institute of Mental Health grant­of

which $1.35 million went to Emory for overhead­to

study several drugs made by GlaxoSmithKline. To

comply with university and government

regulations, he was required to disclose to Emory

income from GlaxoSmithKline, and Emory was

required to report amounts over $10,000 per year

to the National Institutes of Health, along with

assurances that the conflict of interest would be managed or eliminated.

 

But according to Senator Grassley, who compared

Emory's records with those from the company,

Nemeroff failed to disclose approximately

$500,000 he received from GlaxoSmithKline for

giving dozens of talks promoting the company's

drugs. In June 2004, a year into the grant, Emory

conducted its own investigation of Nemeroff's

activities, and found multiple violations of its

policies. Nemeroff responded by assuring Emory in

a memorandum, " In view of the NIMH/Emory/GSK

grant, I shall limit my consulting to GSK to

under $10,000/year and I have informed GSK of

this policy. " Yet that same year, he received

$171,031 from the company, while he reported to

Emory just $9,999­a dollar shy of the $10,000

threshold for reporting to the National Institutes of Health.

 

Emory benefited from Nemeroff's grants and other

activities, and that raises the question of

whether its lax oversight was influenced by its

own conflicts of interest. As reported by

Gardiner Harris in The New York Times,[3]

Nemeroff himself had pointed out his value to

Emory in a 2000 letter to the dean of the medical

school, in which he justified his membership on a

dozen corporate advisory boards by saying:

 

" Surely you remember that Smith-Kline Beecham

Pharmaceuticals donated an endowed chair to the

department and there is some reasonable

likelihood that Janssen Pharmaceuticals will do

so as well. In addition, Wyeth-Ayerst

Pharmaceuticals has funded a Research Career

Development Award program in the department, and

I have asked both AstraZeneca Pharmaceuticals and

Bristol-Meyers [sic] Squibb to do the same. Part

of the rationale for their funding our faculty in

such a manner would be my service on these boards. "

 

Because these psychiatrists were singled out by

Senator Grassley, they received a great deal of

attention in the press, but similar conflicts of

interest pervade medicine. (The senator is now

turning his attention to cardiologists.) Indeed,

most doctors take money or gifts from drug

companies in one way or another. Many are paid

consultants, speakers at company-sponsored

meetings, ghost-authors of papers written by drug

companies or their agents,[4] and ostensible

" researchers " whose contribution often consists

merely of putting their patients on a drug and

transmitting some token information to the

company. Still more doctors are recipients of

free meals and other out-and-out gifts. In

addition, drug companies subsidize most meetings

of professional organizations and most of the

continuing medical education needed by doctors to

maintain their state licenses.

 

No one knows the total amount provided by drug

companies to physicians, but I estimate from the

annual reports of the top nine US drug companies

that it comes to tens of billions of dollars a

year. By such means, the pharmaceutical industry

has gained enormous control over how doctors

evaluate and use its own products. Its extensive

ties to physicians, particularly senior faculty

at prestigious medical schools, affect the

results of research, the way medicine is

practiced, and even the definition of what constitutes a disease.

 

Consider the clinical trials by which drugs are

tested in human subjects.[5] Before a new drug

can enter the market, its manufacturer must

sponsor clinical trials to show the Food and Drug

Administration that the drug is safe and

effective, usually as compared with a placebo or

dummy pill. The results of all the trials (there

may be many) are submitted to the FDA, and if one

or two trials are positive­that is, they show

effectiveness without serious risk­the drug is

usually approved, even if all the other trials

are negative. Drugs are approved only for a

specified use­for example, to treat lung

cancer­and it is illegal for companies to promote them for any other use.

 

But physicians may prescribe approved drugs " off

label " ­i.e., without regard to the specified

use­and perhaps as many as half of all

prescriptions are written for off-label purposes.

After drugs are on the market, companies continue

to sponsor clinical trials, sometimes to get FDA

approval for additional uses, sometimes to

demonstrate an advantage over competitors, and

often just as an excuse to get physicians to

prescribe such drugs for patients. (Such trials

are aptly called " seeding " studies.)

 

Since drug companies don't have direct access to

human subjects, they need to outsource their

clinical trials to medical schools, where

researchers use patients from teaching hospitals

and clinics, or to private research companies

(CROs), which organize office-based physicians to

enroll their patients. Although CROs are usually

faster, sponsors often prefer using medical

schools, in part because the research is taken

more seriously, but mainly because it gives them

access to highly influential faculty

physicians­referred to by the industry as

" thought-leaders " or " key opinion leaders "

(KOLs). These are the people who write textbooks

and medical journal papers, issue practice

guidelines (treatment recommendations), sit on

FDA and other governmental advisory panels, head

professional societies, and speak at the

innumerable meetings and dinners that take place

every year to teach clinicians about prescription

drugs. Having KOLs like Dr. Biederman on the

payroll is worth every penny spent.

 

A few decades ago, medical schools did not have

extensive financial dealings with industry, and

faculty investigators who carried out

industry-sponsored research generally did not

have other ties to their sponsors. But schools

now have their own manifold deals with industry

and are hardly in a moral position to object to

their faculty behaving in the same way. A recent

survey found that about two thirds of academic

medical centers hold equity interest in companies

that sponsor research within the same

institution.[6] A study of medical school

department chairs found that two thirds received

departmental income from drug companies and three

fifths received personal income.[7] In the 1980s

medical schools began to issue guidelines

governing faculty conflicts of interest but they

are highly variable, generally quite permissive, and loosely enforced.

 

Because drug companies insist as a condition of

providing funding that they be intimately

involved in all aspects of the research they

sponsor, they can easily introduce bias in order

to make their drugs look better and safer than

they are. Before the 1980s, they generally gave

faculty investigators total responsibility for

the conduct of the work, but now company

employees or their agents often design the

studies, perform the analysis, write the papers,

and decide whether and in what form to publish

the results. Sometimes the medical faculty who

serve as investigators are little more than hired

hands, supplying patients and collecting data

according to instructions from the company.

 

In view of this control and the conflicts of

interest that permeate the enterprise, it is not

surprising that industry-sponsored trials

published in medical journals consistently favor

sponsors' drugs­largely because negative results

are not published, positive results are

repeatedly published in slightly different forms,

and a positive spin is put on even negative

results. A review of seventy-four clinical trials

of antidepressants, for example, found that

thirty-seven of thirty-eight positive studies

were published.[8] But of the thirty-six negative

studies, thirty-three were either not published

or published in a form that conveyed a positive

outcome. It is not unusual for a published paper

to shift the focus from the drug's intended

effect to a secondary effect that seems more favorable.

 

The suppression of unfavorable research is the

subject of Alison Bass's engrossing book, Side

Effects: A Prosecutor, a Whistleblower, and a

Bestselling Antidepressant on Trial. This is the

story of how the British drug giant

GlaxoSmithKline buried evidence that its

top-selling antidepressant, Paxil, was

ineffective and possibly harmful to children and

adolescents. Bass, formerly a reporter for the

Boston Globe, describes the involvement of three

people­a skeptical academic psychiatrist, a

morally outraged assistant administrator in Brown

University's department of psychiatry (whose

chairman received in 1998 over $500,000 in

consulting fees from drug companies, including

GlaxoSmithKline), and an indefatigable New York

assistant attorney general. They took on

GlaxoSmithKline and part of the psychiatry

establishment and eventually prevailed against the odds.

 

The book follows the individual struggles of

these three people over many years, culminating

with GlaxoSmithKline finally agreeing in 2004 to

settle charges of consumer fraud for $2.5 million

(a tiny fraction of the more than $2.7 billion in

yearly Paxil sales about that time). It also

promised to release summaries of all clinical

trials completed after December 27, 2000. Of much

greater significance was the attention called to

the deliberate, systematic practice of

suppressing unfavorable research results, which

would never have been revealed without the legal

discovery process. Previously undisclosed, one of

GlaxoSmithKline's internal documents said, " It

would be commercially unacceptable to include a

statement that efficacy had not been

demonstrated, as this would undermine the profile of paroxetine [Paxil]. " [9]

 

Many drugs that are assumed to be effective are

probably little better than placebos, but there

is no way to know because negative results are

hidden. One clue was provided six years ago by

four researchers who, using the Freedom of

Information Act, obtained FDA reviews of every

placebo-controlled clinical trial submitted for

initial approval of the six most widely used

antidepressant drugs approved between 1987 and

1999­Prozac, Paxil, Zoloft, Celexa, Serzone, and

Effexor.[10] They found that on average, placebos

were 80 percent as effective as the drugs. The

difference between drug and placebo was so small

that it was unlikely to be of any clinical

significance. The results were much the same for

all six drugs: all were equally ineffective. But

because favorable results were published and

unfavorable results buried (in this case, within

the FDA), the public and the medical profession

believed these drugs were potent antidepressants.

 

Clinical trials are also biased through designs

for research that are chosen to yield favorable

results for sponsors. For example, the sponsor's

drug may be compared with another drug

administered at a dose so low that the sponsor's

drug looks more powerful. Or a drug that is

likely to be used by older people will be tested

in young people, so that side effects are less

likely to emerge. A common form of bias stems

from the standard practice of comparing a new

drug with a placebo, when the relevant question

is how it compares with an existing drug. In

short, it is often possible to make clinical

trials come out pretty much any way you want,

which is why it's so important that investigators

be truly disinterested in the outcome of their work.

 

Conflicts of interest affect more than research.

They also directly shape the way medicine is

practiced, through their influence on practice

guidelines issued by professional and

governmental bodies, and through their effects on

FDA decisions. A few examples: in a survey of two

hundred expert panels that issued practice

guidelines, one third of the panel members

acknowledged that they had some financial

interest in the drugs they considered.[11] In

2004, after the National Cholesterol Education

Program called for sharply lowering the desired

levels of " bad " cholesterol, it was revealed that

eight of nine members of the panel writing the

recommendations had financial ties to the makers

of cholesterol-lowering drugs.[12] Of the 170

contributors to the most recent edition of the

American Psychiatric Association's Diagnostic and

Statistical Manual of Mental Disorders (DSM),

ninety-five had financial ties to drug companies,

including all of the contributors to the sections

on mood disorders and schizophrenia.[13] Perhaps

most important, many members of the standing

committees of experts that advise the FDA on drug

approvals also have financial ties to the pharmaceutical industry.[14]

 

In recent years, drug companies have perfected a

new and highly effective method to expand their

markets. Instead of promoting drugs to treat

diseases, they have begun to promote diseases to

fit their drugs. The strategy is to convince as

many people as possible (along with their

doctors, of course) that they have medical

conditions that require long-term drug treatment.

Sometimes called " disease-mongering, " this is a

focus of two new books: Melody Petersen's Our

Daily Meds: How the Pharmaceutical Companies

Transformed Themselves into Slick Marketing

Machines and Hooked the Nation on Prescription

Drugs and Christopher Lane's Shyness: How Normal Behavior Became a Sickness.

 

To promote new or exaggerated conditions,

companies give them serious-sounding names along

with abbreviations. Thus, heartburn is now

" gastro-esophageal reflux disease " or GERD;

impotence is " erectile dysfunction " or ED;

premenstrual tension is " premenstrual dysphoric

disorder " or PMMD; and shyness is " social anxiety

disorder " (no abbreviation yet). Note that these

are ill-defined chronic conditions that affect

essentially normal people, so the market is huge

and easily expanded. For example, a senior

marketing executive advised sales representatives

on how to expand the use of Neurontin: " Neurontin

for pain, Neurontin for monotherapy, Neurontin

for bipolar, Neurontin for everything. " [15] It

seems that the strategy of the drug marketers­and

it has been remarkably successful­is to convince

Americans that there are only two kinds of

people: those with medical conditions that

require drug treatment and those who don't know

it yet. While the strategy originated in the

industry, it could not be implemented without the

complicity of the medical profession.

 

Melody Petersen, who was a reporter for The New

York Times, has written a broad, convincing

indictment of the pharmaceutical industry.[16]

She lays out in detail the many ways, both legal

and illegal, that drug companies can create

" blockbusters " (drugs with yearly sales of over a

billion dollars) and the essential role that KOLs

play. Her main example is Neurontin, which was

initially approved only for a very narrow use­to

treat epilepsy when other drugs failed to control

seizures. By paying academic experts to put their

names on articles extolling Neurontin for other

uses­bipolar disease, post-traumatic stress

disorder, insomnia, restless legs syndrome, hot

flashes, migraines, tension headaches, and

more­and by funding conferences at which these

uses were promoted, the manufacturer was able to

parlay the drug into a blockbuster, with sales of

$2.7 billion in 2003. The following year, in a

case covered extensively by Petersen for the

Times, Pfizer pleaded guilty to illegal marketing

and agreed to pay $430 million to resolve the

criminal and civil charges against it. A lot of

money, but for Pfizer, it was just the cost of

doing business, and well worth it because

Neurontin continued to be used like an

all-purpose tonic, generating billions of dollars in annual sales.

 

Christopher Lane's book has a narrower focus­the

rapid increase in the number of psychiatric

diagnoses in the American population and in the

use of psychoactive drugs (drugs that affect

mental states) to treat them. Since there are no

objective tests for mental illness and the

boundaries between normal and abnormal are often

uncertain, psychiatry is a particularly fertile

field for creating new diagnoses or broadening

old ones.[17] Diagnostic criteria are pretty much

the exclusive province of the current edition of

the Diagnostic and Statistical Manual of Mental

Disorders, which is the product of a panel of

psychiatrists, most of whom, as I mentioned

earlier, had financial ties to the pharmaceutical

industry. Lane, a research professor of

literature at Northwestern University, traces the

evolution of the DSM from its modest beginnings

in 1952 as a small, spiral-bound handbook (DSM-I)

to its current 943-page incarnation (the revised

version of DSM-IV) as the undisputed " bible " of

psychiatry­the standard reference for courts,

prisons, schools, insurance companies, emergency

rooms, doctors' offices, and medical facilities of all kinds.

 

Given its importance, you might think that the

DSM represents the authoritative distillation of

a large body of scientific evidence. But Lane,

using unpublished records from the archives of

the American Psychiatric Association and

interviews with the princi-pals, shows that it is

instead the product of a complex of academic

politics, personal ambition, ideology, and,

perhaps most important, the influence of the

pharmaceutical industry. What the DSM lacks is

evidence. Lane quotes one contributor to the DSM-III task force:

There was very little systematic research, and

much of the research that existed was really a

hodgepodge­scattered, inconsistent, and

ambiguous. I think the majority of us recognized

that the amount of good, solid science upon which

we were making our decisions was pretty modest.

 

Lane uses shyness as his case study of

disease-mongering in psychiatry. Shyness as a

psychiatric illness made its debut as " social

phobia " in DSM-III in 1980, but was said to be

rare. By 1994, when DSM-IV was published, it had

become " social anxiety disorder, " now said to be

extremely common. According to Lane,

GlaxoSmithKline, hoping to boost sales for its

antidepressant, Paxil, decided to promote social

anxiety disorder as " a severe medical condition. "

In 1999, the company received FDA approval to

market the drug for social anxiety disorder. It

launched an extensive media campaign to do it,

including posters in bus shelters across the

country showing forlorn individuals and the words

" Imagine being allergic to people..., " and sales

soared. Barry Brand, Paxil's product director,

was quoted as saying, " Every marketer's dream is

to find an unidentified or unknown market and

develop it. That's what we were able to do with social anxiety disorder. "

 

Some of the biggest blockbusters are psychoactive

drugs. The theory that psychiatric conditions

stem from a biochemical imbalance is used as a

justification for their widespread use, even

though the theory has yet to be proved. Children

are particularly vulnerable targets. What parents

dare say " No " when a physician says their

difficult child is sick and recommends drug

treatment? We are now in the midst of an apparent

epidemic of bipolar disease in children (which

seems to be replacing attention-deficit

hyperactivity disorder as the most publicized

condition in childhood), with a forty-fold

increase in the diagnosis between 1994 and

2003.[18] These children are often treated with

multiple drugs off-label, many of which, whatever

their other properties, are sedating, and nearly

all of which have potentially serious side effects.

 

The problems I've discussed are not limited to

psychiatry, although they reach their most florid

form there. Similar conflicts of interest and

biases exist in virtually every field of

medicine, particularly those that rely heavily on

drugs or devices. It is simply no longer possible

to believe much of the clinical research that is

published, or to rely on the judgment of trusted

physicians or authoritative medical guidelines. I

take no pleasure in this conclusion, which I

reached slowly and reluctantly over my two

decades as an editor of TheNew England Journal of Medicine.

 

One result of the pervasive bias is that

physicians learn to practice a very

drug-intensive style of medicine. Even when

changes in lifestyle would be more effective,

doctors and their patients often believe that for

every ailment and discontent there is a drug.

Physicians are also led to believe that the

newest, most expensive brand-name drugs are

superior to older drugs or generics, even though

there is seldom any evidence to that effect

because sponsors do not usually compare their

drugs with older drugs at equivalent doses. In

addition, physicians, swayed by prestigious

medical school faculty, learn to prescribe drugs

for off-label uses without good evidence of effectiveness.

 

It is easy to fault drug companies for this

situation, and they certainly deserve a great

deal of blame. Most of the big drug companies

have settled charges of fraud, off-label

marketing, and other offenses. TAP

Pharmaceuticals, for example, in 2001 pleaded

guilty and agreed to pay $875 million to settle

criminal and civil charges brought under the

federal False Claims Act over its fraudulent

marketing of Lupron, a drug used for treatment of

prostate cancer. In addition to GlaxoSmithKline,

Pfizer, and TAP, other companies that have

settled charges of fraud include Merck, Eli

Lilly, and Abbott. The costs, while enormous in

some cases, are still dwarfed by the profits

generated by these illegal activities, and are

therefore not much of a deterrent. Still,

apologists might argue that the pharmaceutical

industry is merely trying to do its primary

job­further the interests of its investors­and

sometimes it goes a little too far.

 

Physicians, medical schools, and professional

organizations have no such excuse, since their

only fiduciary responsibility is to patients. The

mission of medical schools and teaching

hospitals­and what justifies their tax-exempt

status­is to educate the next generation of

physicians, carry out scientifically important

research, and care for the sickest members of

society. It is not to enter into lucrative

commercial alliances with the pharmaceutical

industry. As reprehensible as many industry

practices are, I believe the behavior of much of

the medical profession is even more culpable.[19]

Drug companies are not charities; they expect

something in return for the money they spend, and

they evidently get it or they wouldn't keep paying.

 

So many reforms would be necessary to restore

integrity to clinical research and medical

practice that they cannot be summarized briefly.

Many would involve congressional legislation and

changes in the FDA, including its drug approval

process. But there is clearly also a need for the

medical profession to wean itself from industry

money almost entirely. Although industry–academic

collaboration can make important scientific

contributions, it is usually in carrying out

basic research, not clinical trials, and even

here, it is arguable whether it necessitates the

personal enrichment of investigators. Members of

medical school faculties who conduct clinical

trials should not accept any payments from drug

companies except research support, and that

support should have no strings attached,

including control by drug companies over the

design, interpretation, and publication of research results.

 

Medical schools and teaching hospitals should

rigorously enforce that rule, and should not

enter into deals with companies whose products

members of their faculty are studying. Finally,

there is seldom a legitimate reason for

physicians to accept gifts from drug companies,

even small ones, and they should pay for their

own meetings and continuing education.

 

After much unfavorable publicity, medical schools

and professional organizations are beginning to

talk about controlling conflicts of interest, but

so far the response has been tepid. They

consistently refer to " potential " conflicts of

interest, as though that were different from the

real thing, and about disclosing and " managing "

them, not about prohibiting them. In short, there

seems to be a desire to eliminate the smell of

corruption, while keeping the money. Breaking the

dependence of the medical profession on the

pharmaceutical industry will take more than

appointing committees and other gestures. It will

take a sharp break from an extremely lucrative

pattern of behavior. But if the medical

profession does not put an end to this corruption

voluntarily, it will lose the confidence of the

public, and the government (not just Senator

Grassley) will step in and impose regulation. No one in medicine wants that.

 

Notes

 

[1]Gardiner Harris and Benedict Carey,

" Researchers Fail to Reveal Full Drug Pay, " The New York Times, June 8,

2008.

 

[2]Most of the information in these paragraphs,

including Nemeroff's quote in the summer of 2004,

is drawn from a long letter written by Senator

Grassley to James W. Wagner, President of Emory University, on October

2, 2008.

 

[3]See Gardiner Harris, " Leading Psychiatrist

Didn't Report Drug Makers' Pay, " The New York Times, October 4, 2008.

 

[4]Senator Grassley is current investigating

Wyeth for paying a medical writing firm to

ghost-write articles favorable to its hormone-replacement drug Prempro.

 

[5]Some of this material is drawn from my article

" Industry-Sponsored Clinical Research: A Broken

System, " TheJournal of the American Medical Association, September 3, 2008.

 

[6]Justin E. Bekelman et al., " Scope and Impact

of Financial Conflicts of Interest in Biomedical

Research: A Systematic Review, " The Journal of

the American Medical Association, January 22, 2003.

 

[7]Eric G. Campbell et al., " Institutional

Academic–Industry Relationships, " The Journal of

the American Medical Association, October 17, 2007.

 

[8]Erick H. Turner et al., " Selective Publication

of Antidepressant Trials and Its Influence on

Apparent Efficacy, " The New England Journal of Medicine, January 17, 2008.

 

[9]See Wayne Kondro and Barb Sibbald, " Drug

Company Experts Advised Staff to Withhold Data

About SSRI Use in Children, " Canadian Medical

Association Journal, March 2, 2004.

 

[10]Irving Kirsch et al., " The Emperor's New

Drugs: An Analysis of Antidepressant Medication

Data Submitted to the US Food and Drug

Administration, " Prevention & Treatment, July 15, 2002.

 

[11]Rosie Taylor and Jim Giles, " Cash Interests

Taint Drug Advice, " Nature, October 20, 2005.

 

[12]David Tuller, " Seeking a Fuller Picture of

Statins, " The New York Times, July 20, 2004.

 

[13]Lisa Cosgrove et al., " Financial Ties Between

DSM-IV Panel Members and the Pharmaceutical

Industry, " Psychotherapy and Psychosomatics, Vol. 75, No. 3 (2006).

 

[14]On August 4, 2008, the FDA announced that

$50,000 is now the " maximum personal financial

interest an advisor may have in all companies

that may be affected by a particular meeting. "

Waivers may be granted for amounts less than that.

 

[15]See Petersen, Our Daily Meds, p. 224.

 

[16]Petersen's book is a part of a second wave of

books exposing the deceptive practices of the

pharmaceutical industry. The first included

Katharine Greider's The Big Fix: How the

Pharmaceutical Industry Rips Off American

Consumers (PublicAffairs, 2003), Merrill

Goozner's The $800 Million Pill: The Truth Behind

the Cost of New Drugs (University of California

Press, 2004), Jerome Avorn's Powerful Medicines:

The Benefits, Risks, and Costs of Prescription

Drugs (Knopf, 2004), John Abramson's Overdo$ed

America: The Broken Promise of American Medicine

(HarperCollins, 2004), and my own The Truth About

the Drug Companies: How They Deceive Us and What

to Do About It (Random House, 2004).

 

[17]See the review by Frederick Crews of Lane's

book and two others, The New York Review, December 6, 2007.

 

[18]See Gardiner Harris and Benedict Carey,

" Researchers Fail to Reveal Full Drug Pay, " The New York Times, June 8,

2008.

 

[19]This point is made powerfully in Jerome P.

Kassirer's disturbing book, On the Take: How

Medicine's Complicity With Big Business Can

Endanger Your Health (Oxford University Press, 2005).