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 mifepristone the

> abortion drug otherwise known as RU-486 as 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 grant of

> which $1.35 million went to Emory for overhead to

> 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 $9,999 a 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 positive that is, they show

> effectiveness without serious risk the drug is

> usually approved, even if all the other trials

> are negative. Drugs are approved only for a

> specified use for example, to treat lung

> cancer and 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

> use and 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

> physicians referred 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' drugs largely 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

> people a 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

> 1999 Prozac, 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 marketers and

> it has been remarkably successful is 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 use to

> treat epilepsy when other drugs failed to control

> seizures. By paying academic experts to put their

> names on articles extolling Neurontin for other

> uses bipolar disease, post-traumatic stress

> disorder, insomnia, restless legs syndrome, hot

> flashes, migraines, tension headaches, and

> more and 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 focus the

> 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

> psychiatry the 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

> hodgepodge scattered, 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

> job further the interests of its investors and

> 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

> hospitals and what justifies their tax-exempt

> status is 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).

>

>

>

> ---

>