Articles by This Author
Are Antidepressents a Scam? 5 Myths About how to Treat Depression
By Bruce E. Levine
Alternet - December 6, 2010
A warning: for people satisfied with their standard depression treatments, debunking myths about them may be troubling. However, for critically-thinking depression sufferers who have not been helped by antidepressants, psychotherapy, or other standard treatments, discovering truths about these treatments can provide ideas about what may actually work for them.
Critical thinkers have difficulty placing faith in any depression treatment because science tells them that these treatments often work no better than placebos or nothing at all, and if one lacks faith in a depression treatment, it is not likely to be effective. In fact, it is belief and faith—or what scientists call “expectations” and the “placebo effect”—that is mostly responsible for any depression treatment working. Critical-thinkers can find a way out of depression when their critical thinking about depression treatments is validated and respected, and they are challenged to think more critically about their critical thinking.
Myth 1: Antidepressants Are More Effective than Placebos
Many depressed people report that antidepressants have been effective for them, but do antidepressants work any better than a sugar pill? Researcher Irving Kirsch (professor of psychology at the University of Hull in the United Kingdom as well as professor emeritus at the University of Connecticut and author of The Emperor’s New Drugs) has been trying to answer that question for a significant part of his career.
In 2002, Kirsch and his team at the University of Connecticut examined 47 depression treatment studies that had been sponsored by drug companies on the antidepressants Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Many of these studies had not been published, but all had been submitted to the Food and Drug Administration (FDA), so Kirsch used the Freedom of Information Act to gain access to all the data. He discovered that in the majority of the trials, antidepressants failed to outperform sugar pill placebos.
“All antidepressants,” Kirsch reported in 2010, “including the well-known SSRIs [selective serotonin reuptake inhibitors], had no clinically significant benefit over a placebo.” While in aggregate, antidepressants slightly edge out placebos, the difference is so unremarkable that Kirsch and others describe it as “clinically negligible.”
Why are so many doctors unaware of the lack of superiority of antidepressants as compared to placebos? The answer became clear in 2008 when researcher and physician Erick Turner (currently at the Department of Psychiatry and Center for Ethics in Health Care, Oregon Health and Science University) discovered that antidepressant studies with favorable outcomes were far more likely to be published than those with unfavorable outcomes. Analyzing published and unpublished antidepressant studies registered with the FDA between 1987-2004, Turner found that 37 of 38 studies having positive results were published; however, Turner reported, “Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, [falsely] conveyed a positive outcome (11 studies).”
Read the entire article at Alternet.
The Huffington Post
Psychiatric Drugs and Poor Kids
Posted: May 20, 2010 02:35 PM
Children covered by Medicaid are far more likely to be prescribed antipsychotic drugs than children covered by private insurance, and Medicaid-covered kids have a higher likelihood of being prescribed antipsychotics even if they have no psychotic symptoms. This is reported in the May19, 2010 Journal of American Medical Association (JAMA) article, "Studies Shed Light on Risks and Trends in Pediatric Antipsychotic Prescribing."
Researchers at Rutgers University and Columbia University found that children and adolescents covered by Medicaid were four times as likely as those with private insurance to receive an antipsychotic in 2004. Among those aged six to 17 years who were covered by Medicaid, 4.2 percent were prescribed at least one antipsychotic drug. In contrast, among those in this same age group who had private insurance, less than 1 percent were prescribed an antipsychotic. Nearly half of these Medicaid-covered pediatric patients receiving antipsychotic drugs had nonpsychotic diagnoses of attention deficit hyperactivity disorder (ADHD) or some other disruptive behavior disorder. In contrast, of the privately insured pediatric patients receiving antipsychotics, about one fourth were diagnosed with ADHD or some other disruptive behavior disorder.
Read the whole article here.
Suicide Spike for U.S. Soldiers
Psychiatric or Political Solution?
By Bruce E. Levine
In February 2009, Americans heard about a dramatic rise in suicides among U.S. soldiers. While treatment for emotionally troubled soldiers increasingly consists of antidepressants such as Prozac, Paxil, and Zoloft, recent investigations show that these drugs are no more effective than placebos and can actually increase suicidality. In order to prevent even more suicides, both the research and basic common sense instruct us that we need less psychiatric drugs and more political courage.
Suicides in the U.S. Army rose for the fourth straight year in 2008. Army statistics, which include the Army Reserve and the National Guard, confirm 128 suicides (with 15 more deaths under investigation). Suicides for the Marines also have increased, with 41 in 2008, up from 33 in 2007 and 25 in 2006.
The number of soldiers who committed suicide during January 2009 actually surpassed the number of soldiers who were killed in combat in Iraq and Afghanistan during that same time period. In January 2009, there were 16 U.S. combat deaths and, the Army believes, 24 suicides (the Army has confirmed 7 suicides and it believes that investigators will confirm an additional 17 other deaths as suicides). January 2009 suicide totals were more than five times higher than January 2008 totals.
Why are so many U.S. soldiers killing themselves? According to Colonel Kathy Platoni, chief clinical psychologist for the Army Reserve and National Guard, one major reason is multiple deployments. Army psychiatrist Colonel Charles Hoge reports that by early 2008, nearly 30 percent of troops were on their third deployment. Another reason appears to be more psychiatric drug use.
Increasing Antidepressant Use
For many mental health professionals, especially governmental ones, a "good treatment outcome" consists of a troubled person adapting to a miserable, dehumanizing environment in a way that causes the least problems for authorities. Too few mental health professionals tell authorities that the best "treatment" sometimes means helping a troubled person to exit from a miserable environment. Whether it is a troubled soldier in a horrifying war zone or a disruptive child in a boring school, mental health professionals are far less likely to recommend a radical altering of an environment than they are to recommend a chemical altering of the person suffering in it.
An increasing number of U.S. combat troops are taking daily doses of antidepressants to "take the edge off" and calm nerves. According to the U.S. Army, based on an anonymous survey of troops taken in the fall of 2007, about 12 percent of combat troops in Iraq and 17 percent of those in Afghanistan were taking antidepressants or sleeping pills. Those percentages have likely increased, and Colonel Platoni noted that the excessive use of antidepressants for troubled soldiers may be another reason why so many of them are killing themselves.
How can a drug that is called an "antidepressant" result in more suicidal soldiers? According to the Food and Drug Administration (FDA) "black box" warnings on Prozac and other so-called antidepressants, "Antidepressants increase the risk compared to placebo of suicidal thinking and behavior in children, adolescents, and young adults."
Grace Jackson, former staff psychiatrist at Bethesda Naval Hospital and author of Rethinking Psychiatric Drugs, is an outspoken critic of psychiatric drugs. Jackson states, "New reports about record-breaking numbers of Army suicides are alarming but not surprising." Jackson notes that there are several studies on military personnel, veterans, and the general public that show the suicidal effects of antidepressants.
One study, Jackson points out, is a 2007 investigation reported in the American Journal of Psychiatry ("Relationship Between Antidepressants and Suicide Attempts: An Analysis of the Veterans Health Administration Data Sets"), which examined veterans who received treatment for depression in either 2003 or 2004. Study findings were that antidepressant treatment was associated with a higher rate of suicide attempts relative to those who were not treated with drugs.
Especially damning for antidepressants is a 2009 Journal of Affective Disorders study ("Psychopharmacological Treatment Before Suicide Attempts Among Patients Admitted to a Psychiatric Intensive Care Unit"). Investigators reported that patients who had attempted suicide were more likely to have received antidepressants (as well as benzodiazepines such as Xanax) than patients who did not attempt suicide, and this finding was not biased by differences between the groups in baseline severity of symptoms. Researchers concluded, "The results of this study suggest that the use of antidepressants in patients with mood disorders is not associated with a reduction of suicide attempt rate. Furthermore, from the present study, it is not possible to exclude that antidepressants or benzodiazepines may induce, worsen, or precipitate suicidal behaviors in some patients."
Read the whole article here.
The Huffington Post
The films Revolutionary Road and A Beautiful Mind both portray mathematicians turned mental patients who create havoc for their families. But the similarity ends there.
In director Ron Howard's A Beautiful Mind (2001), the facts of the real-life recovery of Nobel prize winner John Nash are fabricated to create a politically-correct version of mental illness -- and Howard's film was rewarded with four Oscars, including best picture and best director. In contrast, director Sam Mendes's recent Revolutionary Road stays true to the facts of Richard Yates's 1961 novel, including Yates's now politically-incorrect more psychological perspective of mental illness - and Mendes's film was not rewarded with any Oscars last February.
While the mental illness of John Nash (Russell Crowe) is the focus of Howard's A Beautiful Mind, mental illness is not at the center of either Mendes's film or Yates's novel, but the contribution of mental patient John Givings (Michael Shannon) is vital in both the film and the novel.
What then is the center of Yates's novel? In 1972 Yates told Ploughshares, "I thought I was writing a novel about abortion. . . a series of abortions, of all kinds -- an aborted play, several aborted careers, any number of aborted ambitions and aborted plans and aborted dreams -- all leading up to a real, physical abortion." Mendes's film certainly conveys that, and it is also true to Yate's character John Givings, who serves as the outspoken truth teller in both film and novel. When Michael Shannon was asked by the Los Angeles Times to describe the movie and his character John Givings's significance, he said:
He really is important to the story. It's a hard movie to describe to people when they ask you what it's about. But if you boil it down to its essence, it's about these two people - Frank [Leonardo DiCaprio] and April [Kate Winslet] -- trying to make a decision: Do we stay here and suffer silently or do we try to liberate ourselves and escape to a better life? The first time we see John they are celebrating their decision and kind of reveling in this newfound sense of freedom. John is there to kind of celebrate and validate their decision. Then John comes back, and this freedom has crumbled, and he's there to castigate and punish them for their loss of faith. I think that's the really beautiful thing about the character.
John Givings is pained, and he can be obnoxious, hurtful, disruptive, and tension producing - what mental health professionals label as "inappropriate." But there are reasons for his anger, reasons that Yates did not reduce to defective biochemistry, and this gets the novel-faithful Mendes an F in political correctness.
The current PC explanation of serious mental illness brought to us by Big Pharma -- follow the money trail -- is that it is caused by this or that neurotransmitter or brain structure and has nothing to do with oppressive families and dehumanizing environments. It is also now PC to mock the notion that mentally-ill diagnosed people may sometimes be like canaries in the mine, more sensitive and reactive to insidious toxins.
John Givings -- though psychiatrically hospitalized and a recipient of multiple electroshock treatments which have damaged his mathematical abilities -- is clearly not delusional about oppressive family relationships, not wrong about meaningless jobs, not incorrect about gutless frauds, and not mistaken about a dehumanizing society. He, like many people I have known diagnosed with mental illness, feels alienated and powerless. And he is no diplomat. Truth serves as his only source of potency, and he uses it as both a constructive tool to celebrate and validate courage and as a hurtful weapon to castigate and punish gutlessness.
I am not alone in recognizing John Givings in real people diagnosed with severe mental illness. So did Richard Yates. Ploughshares asked Yates, "When you first planned the book, did you have John Givings in there?" Yates responded:
No, I didn't. He occurred to me as a character about midway through the writing of the book. I felt I needed somebody in there to point up or spell out the story at crucial moments, and I did know a young man very much like that at the time, a long-term patient in a mental hospital who had an uncannily keen and very articulate insight into other people's weaknesses, so I worked a fictionalized version of him into the book.
Today, the PC handling of Mr. Untreated Paranoid Schizophrenic is to depict him as having only meaningless craziness to utter until he begins taking his medication regularly, at which time he can function in the world and bring smiles to his long-suffering family. In this regard, Mendes gets another F on his PC report card by accurately depicting Yate's John Givings, who may be a son of a bitch but one who does not voice meaningless craziness. John Givings has valuable observations about familial relationships and society, and the powerful Shannon is so compelling that you want him on the screen.
In contrast to Revolutionary Road, A Beautiful Mind is, ultimately, a feel-good movie about mental illness that steps on no powerful institution's toes, and perhaps that is part of why it won all those Oscars.
First, let me be clear that Howard's film did some good things, including his emphasis on the therapeutic value of supportive relationships and his hopeful message about the possibility of recovery. I know many people who have been diagnosed with schizophrenia, paranoid schizophrenia, and other severe mental illnesses who have gone on to have satisfying and meaningful lives -- with or without medication, with or without doctors, but always with respect and support.
The shame is that Howard, perhaps afraid of upsetting the mental health establishment, gave Russell Crowe's Nash a line which the real John Nash never said, a line which was untrue, a line which was unnecessary to move the story along, but a line which was completely necessary for the pharmaceutical industry and the institutions it financially supports -- including the American Psychiatric Association, the National Alliance for the Mentally Ill, and the drug-advertisement addicted media.
The line? In Howard's A Beautiful Mind, John Nash, when informed that he was being considered for the 1994 Nobel Prize, mentions, "I take the newer medications." However, as the documentary A Brilliant Madness (broadcast on PBS's "American Experience" in 2002) reported, "Nash had stopped taking medication in 1970."
Howard's "newer medications" line served, in effect, as a product placement not for a single company but for an entire drug-dependent mental health industry that would show its appreciation. Former Boston Globe science journalist Robert Whitaker, author of Mad in America, reported in 2002, "The National Alliance for the Mentally Ill has praised the film's director, Ron Howard, for showing the 'vital role of medication' in Nash's recovery." However, notes Whitaker, Sylvia Nasar in her biography of Nash (also called A Beautiful Mind), reports something quite different about Nash's recovery. Specifically, Nasar writes:
Nash's refusal take the antipsychotic drugs after 1970, and indeed during most of the periods when he wasn't in the hospital in the 1960s, may have been fortuitous. Taken regularly, such drugs, in a high percentage of cases, produce horrible, persistent, symptom like tardive dyskinesia. . . and a mental fog, all of which would have made his gentle reentry into the world of mathematics a near impossibility.
Nash's recovery without psychiatric drugs is no anomaly. A third of so-called "chronic schizophrenic" patients released from Vermont State Hospital in the late 1950s completely recovered, reported psychologist Courtenay Harding in 1987; and she found that patients in the "best-outcomes" group shared one common factor: all had stopped taking antipsychotic drugs. So Howard actually could have made a more honest feel-good movie about the real life John Nash, but it would have been one that upset powerful institutions who are dependent on drug money.
The World Health Organization, in two different studies (1979 and 1992), reported that the United States and other "developed" countries are inferior to "developing" countries such as India, Nigeria, and Colombia in helping people diagnosed as psychotic to recover, One likely reason for this inferiority in the "developed world" is its almost complete reliance on drugs, and another likely reason is our relative absence of genuine community and supportive groups.
It is convenient for many people -- and lucrative for drug companies and the institutions that they support - if all disruptive, crazy-sounding, tension-producing people can simply be handed off to doctors to be labeled and drugged. If we can neatly compartmentalize and medicalize the John Givings of the world, then families and society don't have to halt the assembly line and ask questions such as: "What is exactly happening in this person's life that has made him or her so angry or frightened? Why does he or she feel so alienated? Is society oppressive for many people, and is this person simply more unbridled in their reaction to that fact? Is there something suffocating about nuclear families in which temperamentally mismatched people are forced to have relationships? Should we be satisfied with a paycheck and a full belly -- or is that not enough?
I have met many angry, rude, tension-producing people labeled with severe mental illness. Some of them are completely dominated by their own victimization and seek only to inflict payback pain on those around them. Others though, when feeling safe, state truths which, if taken seriously, would create a more loving family, a more caring community, and a more stimulating world.
When April and Frank take John seriously, he relaxes, stops being hurtful, and shares with them, among other insights, that "maybe it does take a certain amount of guts to see the emptiness, but it takes a whole hell of a lot more to see the hopelessness. And I guess when you do see the hopelessness, that's where there's nothing to do but take off. If you can."
Richard Yates, Sam Mendes, and Michael Shannon remind us that people who are diagnosed with seriously mental illness can -- when feeling respected -- say profound things that are worth taking seriously. But in today's PC mental health professional world, that kind of reminder is mocked as a romanticization of a disease. Amidst the emptiness of such a world, where only disturbing symptoms and biochemistry are taken seriously, it is no accident that many hurting people become hopeless and conclude that there's nothing to do but take off - any way that they can.
By Bruce E. Levine, AlterNet. Posted March 3, 2009.
At this point, the pharmaceutical company Eli Lilly is basically a public menace.
Eli Lilly & Company's rap sheet as a public menace is so long that for Lilly watchers to overcome the "banality-of-Lilly-sleaziness" phenomenon, the drug company must break some type of record measuring egregiousness. Lilly obliged earlier this year, receiving the largest criminal fine ever imposed on a corporation.
If Americans are ever going to revoke the publicly granted charters of reckless, giant corporations -- well within our rights -- we might want to get the ball rolling with Lilly, whose recent actions appalled even the mainstream media. And with Lilly's chums, the Bush family, out of power, now might be the right time.
On January 15, 2009, Lilly pled guilty to charges that it had illegally marketed its blockbuster drug Zyprexa for unapproved uses to children and the elderly, two populations especially vulnerable to its dangerous side effect. Lilly plead guilty to a misdemeanor charge and agreed to pay $1.42 billion, which included $615 million to end the criminal investigation and approximately $800 million to settle the civil case.
One of the eight whistle-blowers in this case, former Lilly sales representative Robert Rudolph, says the settlement will not completely change Lilly's business practices, and he wants jail time for executives. "You have to remember, with Zyprexa," said Rudolph, "people lost their lives."
Rudolph is not exaggerating. Zyprexa, marketed as an "atypical" antipsychotic drug, has been promoted as having less dangerous adverse effects than "typical" antipsychotic drugs such as Thorazine and Haldol. However, on February 25, 2009, the Journal of the American Medical Association reported that the rate of sudden cardiac death in patients taking either typical or atypical antipsychotic drugs is double the death rate of a control group of patients not taking these drugs.
Zyprexa -- though not nearly as well known as Lilly's previous blockbuster Prozac -- is today one of the biggest-selling drugs in the world. Zyprexa has grossed more than $39 billion since its approval in 1996, with $4.8 billion of that in 2007 (and it was projected to equal or surpass that gross in 2008 when earnings are reported).
Lilly has had other Zyprexa scandals, but in this current one, Lilly executives matched Charles Dickens scoundrels. Zyprexa is approved by the Food and Drug and Administration (FDA) for schizophrenia and bipolar disorder, but Lilly illegally marketed it for sleep difficulties, aggression, and other unapproved uses. Lilly sales reps aggressively pushed Zyprexa as a wonderful drug to chill out disruptive children and the elderly who were not schizophrenic or bipolar. The lawsuit against Lilly stated, "In truth, this was Lilly's thinly veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients."
Doctors can prescribe drugs for unapproved uses (called "off-label prescribing"), but drug companies are not allowed to market drugs for unapproved uses. Many drug companies break this rule, but Lilly broke it with gusto. “The company made hundreds of millions of dollars by trying to convince health care providers that Zyprexa was safe for unapproved uses," said Laurie Magid, acting U.S. Attorney for the Eastern District of Pennsylvania where the case was prosecuted. Magid said that Lilly was responsible for "putting thousands and thousands of patients at risk."
One marketing effort consisted of the Lilly sales force urging geriatricians to use Zyprexa to sedate unruly nursing home and assisted-living facilities patients. Lilly sales reps distributed a study claiming that elderly patients taking Zyprexa required fewer skilled nursing staff hours than were necessary for patients taking competing medications. Magid stated that Lilly sales reps were "trained to use the slogan five at five, meaning five milligrams at 5 o'clock at night will keep these elderly patients quiet." Illegally marketing Zyprexa for elderly patients was especially troubling for prosecutors because Zyprexa increases the risks of heart failure and life-threatening infections such as pneumonia in older patients.
Read the whole article here.
Fundamentalist Consumerism and an Insane Society
By Bruce E. Levine
At a giant Ikea store in Saudi Arabia in 2004, three people were killed by a stampede of shoppers fighting for one of a limited number of $150 credit vouchers. Similarly, in November 2008, a worker at a New York Wal-Mart was trampled to death by shoppers intent on buying one of a limited number of 50-inch plasma HDTVs.
Jdiniytai Damour, a temporary maintenance worker was killed on "Black Friday." In the predawn darkness, approximately 2,000 shoppers waited impatiently outside Wal-Mart, chanting, "Push the doors in." According to Damour's fellow worker Jimmy Overby, "He was bum-rushed by 200 people. They took the doors off the hinges. He was trampled and killed in front of me." Witnesses reported that Damour, 34 years old, gasped for air as shoppers continued to surge over him. When police instructed shoppers to leave the store after Damour's death, many refused, some yelling, "I've been in line since yesterday morning."
The mainstream press covering Damour's death focused on the mob of crazed shoppers and, to a lesser extent, irresponsible Wal-Mart executives who failed to provide security. However, absent in the corporate press was anything about a consumer culture and an insane society in which marketers, advertisers, and media promote the worship of cheap stuff.
Along with journalists, my fellow mental health professionals have also covered up societal insanity. An exception is the democratic-socialist psychoanalyst Erich Fromm (1900-1980). Fromm, in The Sane Society (1955), wrote: "Yet many psychiatrists and psychologists refuse to entertain the idea that society as a whole may be lacking in sanity. They hold that the problem of mental health in a society is only that of the number of 'unadjusted' individuals, and not of a possible unadjustment of the culture itself."
While people can resist the cheap-stuff propaganda and not worship at Wal-Mart, Ikea, and other big-box cathedrals—and stay out of the path of a mob of fundamentalist consumers—it is difficult to protect oneself from the slow death caused by consumer culture. Human beings are every day and in numerous ways psychologically, socially, and spiritually assaulted by a culture which:
- creates increasing material expectations
- devalues human connectedness
- socializes people to be self-absorbed
- obliterates self-reliance
- alienates people from normal human emotional reactions
- sells false hope that creates more pain
Increasing material expectations. These expectations often go unmet and create pain, which fuels emotional difficulties and destructive behaviors. In a now classic 1998 study examining changes in the mental health of Mexican immigrants who came to the United States, public policy researcher William Vega found that assimilation to U.S. society meant three times the rate of depressive episodes for these immigrants. Vega also found major increases in substance abuse and other harmful behaviors. Many of these immigrants found themselves with the pain of increased material expectations that went dissatisfied and they also reported the pain of diminished social support.
Devaluing of human connectedness. A 2006 study in the American Sociological Review noted that the percentage of Americans who reported being without a single close friend to confide in rose in the last 20 years from 10 percent to almost 25 percent. Social isolation is highly associated with depression and other emotional problems. Increasing loneliness, however, is good news for a consumer economy that thrives on increasing numbers of "buying units"—more lonely people means selling more televisions, DVDs, psychiatric drugs, etc.
Read the whole article here.
Forget Pot Smokers: What's It Going to Take to Lock Up Drug Company Execs?
By Bruce E. Levine, AlterNet. Posted January 16, 2009.
"Laws are like cobwebs, which may catch small flies, but let wasps and hornets break through." - Jonathan Swift
After reading "The Neurontin Legacy -- Marketing through Misinformation and Manipulation" in the January 8, 2009 issue of the New England Journal of Medicine, one may conclude that (1) America's prisons would be put to better use incarcerating drug company executives instead of pot smokers, and (2) society may need a return of public scorn via the pillory for those doctors who are essentially drug-company shills.
Drug-company corruption of American medicine is of course not news. What is news is that such corruption has become so egregious, so transparent, and so embarrassing that the New England Journal of Medicine, perhaps the most influential American medical journal, is now stating that "drastic action is essential to preserve the integrity of medical science and practice and to justify public trust."
Neurontin was approved by the Food and Drug Administration (FDA) in 1993 in doses of up to 1800 mg per day as adjunctive therapy for partial complex seizures. How did U.S. annual sales of Neurontin increase from $98 million in 1995 to nearly $3 billion in 2004? The answer is "off-label" marketing, in which Neurontin manufacturer Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000) marketed Neurontin to doctors for uses not approved by the FDA (because doctors can legally prescribe drugs for uses not approved by the FDA).
While aggressive off-label marketing to doctors is standard among drug companies, it is routinely kept quiet. But thanks to a Parke-Davis whistle blower, we have first-hand evidence of off-label marketing -- and how the Neurontin financial bonanza was created.
In 1996, David Franklin, a young biologist, took a sales representative position for Parke-Davis. But shortly after beginning the job, Franklin grew concerned that he was participating in the illegal marketing of Neurontin. Franklin reports that a Parke-Davis executive informed him and his fellow sales reps:
"I want you out there every day selling Neurontin. . . .We all know Neurontin's not growing for adjunctive therapy, besides that's not where the money is. Pain management, now that's money. Monotherapy [for epilepsy], that's money. . . . We can't wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME [continuing medical education] programs, consultantships all work great but don't forget the one-on-one. That's where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 mg/day. I don't want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it's a great drug."
Franklin left Parke-Davis and filed suit (ultimately, United States of America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis Division of Warner-Lambert Company) alleging that off-label marketing of Neurontin constituted false claims designed to elicit payments from the federal government. In 2004, Warner-Lambert resolved criminal charges and civil liabilities by agreeing to plead guilty and pay $430 million -- less than 15 percent of the $3 billion the drug company had grossed on Neurontin in 2004.
Read the whole article here.
The U.S. Psycho-Pharmaceutical-Industrial Complex
As mental illness has become profitable, we are seeing more of it
By Bruce E. Levine
Z Magazine, November 2007
Read the original text here.
In Eugene Jarecki's documentary film Why We Fight, about the U.S. military-industrial complex, U.S. foreign policy critic Chalmers Johnson states: "I guarantee you when war becomes that profitable, you are going to see more of it." Similarly, as mental illness has become extremely profitable, we are seeing more of it.
On September 4, 2007, the New York Times reported, "The number of American children and adolescents treated for bipolar disorder increased 40-fold from 1994 to 2003. . . .Drug makers and company-sponsored psychiatrists have been encouraging doctors to look for the disorder" ("Bipolar Illness Soars as a Diagnosis for the Young").
Not too long ago, a child who was irritable, moody, and distractible and who at times sounded grandiose or acted without regard for consequences was considered a "handful." In the U.S. by the 1980s, that child was labeled with a "behavioral disorder" and today that child is being diagnosed as "bipolar" and "psychotic"--and prescribed expensive antipsychotic drugs. Bloomberg News, also on September 4, 2007, reported, "The expanded use of bipolar as a pediatric diagnosis has made children the fastest-growing part of the $11.5 billion U.S. market for antipsychotic drugs."
Psychopathologizing young people is not the only reason for the dramatic rise in sales of such antipsychotics as Eli Lilly's Zyprexa and Johnson & Johnson's's Risperdal (each, in recent years, grossing annually from $3 to $4 billion). Much of Big Pharma's antipsychotic boon is attributable to generous U.S. government agencies, especially Medicaid. The Medicaid gravy train has been fueled by Big Pharma corruption so over-the-top that it has been the subject of recent media exposures.
The Associated Press, on August 21, 2007, reported, "A groundbreaking Minnesota law is shining a rare light into the big money that drug companies spend on members of state advisory panels who help select which drugs are used in Medicaid programs for the poor and disabled." Those advisory panels--dominated by physicians--have great influence over the $28 billion spent by Medicaid on drugs, but only Minnesota, Vermont, and Maine require drug companies to report monies paid to physicians. The AP article focused on John E. Simon, a psychiatrist on the Minnesota advisory panel since 2004, who received $489,000 from Eli Lilly between 1998 and 2006. The top drugs paid for by Minnesota Medicaid, according to the AP article, have been antipsychotic drugs, especially Eli Lilly's Zyprexa.
Serotonin Deficiency and WMDs
With the advent of Eli Lilly's serotonin-enhancer Prozac at the end of 1987, the general public and doctors began receiving a multi-billion dollar marketing blitz proclaiming that depression is caused by a deficiency of serotonin, and that this deficiency could be corrected by Prozac (and, later, other serotonin-enhancer antidepressants such as Zoloft, Paxil, Celexa, Lexapro, and Luvox). Between 1987 and 1997, the percentage of Americans in outpatient treatment for depression more than tripled. Of those in treatment, the percentage prescribed medication almost doubled. In 1985 the total annual sales for all antidepressants in the U.S. was approximately $240 million, while today it is approximately $12 billion. In 2006, the American Journal of Psychiatry reported that the percentage of American adults with major depression in 1991 was 3.33 percent, but by 2001, the percentage had more than doubled to 7.06 percent.
The serotonin-deficiency theory of depression was so successfully marketed that it was news to many Americans when Newsweek's February 26, 2007 cover story, "Men and Depression," mentioned that scientists now reject the theory that depression is caused by low levels of neurotransmitters such as serotonin. Thomas Insel, director of the National Institute of Mental Health, told Newsweek that "a depressed brain is not necessarily underproducing something."
The demise of the serotonin-deficiency theory of depression should not be considered news in 2007 because in 1998 The American Medical Association Essential Guide to Depression was already stating: "The link between low levels of serotonin and depressive illness is unclear, as some depressed people have too much serotonin." That same year Elliot Valenstein, professor emeritus of psychology and neuroscience at the University of Michigan, in his book Blaming the Brain pointed out, "Furthermore, there is no convincing evidence that depressed people have a serotonin or norepinephrine deficiency." (Antidepressants that increase the neurotransmitter norepinephrine as well as serotonin include Effexor and Cymbalta). In 2002 the New York Times reported: "Researchers knew that antidepressants seemed to raise the brain's levels of messenger chemicals called neurotransmitters, so they theorized that depression must result from a deficiency of these chemicals. Yet a multitude of studies failed to prove this precept." Unfortunately, that fact was buried under more than fifty preceding paragraphs.
Similar to the Bush administration, which knew it is was far easier to sell a war when Americans believed they were threatened by weapons of mass destruction, antidepressant manufacturers know it is much easier to sell serotonin-enhancer drugs when people believe depression is caused by a deficiency of serotonin. The Bush Administration and the mental health establishment (including the National Institute of Mental Health) have retreated from their respective theories, but neither has spent a great deal of time or energy getting the word out. Since each officialdom's earlier claims were so loudly trumpeted and their later retractions so quietly whispered, many Americans continue to believe in mistaken rationales for policies and treatments that continue to affect millions of lives.
The reality is that when patients report Prozac, Paxil, or Zoloft as "working," it is not because these drugs are correcting any kind of chemical imbalance. These drugs can temporarily "take the edge off"--as is the case with many psychotropic drugs, legal or illegal. But for a significant number of people, these drugs produce extremely unpleasant side effects, while for many others, these drugs have little or no effect. So, overall, the difference in effectiveness between antidepressants and a sugar-pill placebo is "clinically negligible." This was the conclusion of University of Connecticut professor of psychology Irving Kirsch, who used the Freedom of Information Act to gain access to 47 antidepressant studies sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone that had been submitted to the U.S. Food and Drug Administration (but many of which had not been published). Kirsch discovered that in the majority of the trials, the antidepressant failed to outperform a sugar-pill placebo (Prevention & Treatment, "The Emperor's New Drugs," 2002).
Why now are we hearing more from the corporate media about the demise of the serotonin-deficiency theory of depression? Perhaps it is because the blockbuster serontin-enhancer drugs have either lost their patent protection or are soon to lose it and drug companies are preparing us for the next wave of patent-protected drugs and biochemical justifications for them. The Newsweek article on "Men and Depression" went on to state, "Instead of focusing on boosting neurotransmitters (the function of the antidepressants in the popular SSRI category such as Prozac and Zoloft), scientists are developing medications that block the production of excess stress chemicals."
Big Pharma, FDA, NIMH, and Congress
There are other parallels between the military-industrial complex and the psychopharmaceutical-industrial complex. Vital to the profits of both are supportive U.S. government regulatory, research, and purchasing agencies.
There is nothing more important for a drug manufacturer than FDA approval and so it is common sense that a pharmaceutical company will spend whatever it takes to ensure FDA approval.
In 2000 an article in USA Today, "FDA Advisors Tied to Industry," reported that in 55 percent of the FDA advisory meetings on drug approvals, half or more of the FDA advisers had financial connections to the interested drug company; and in 92 percent of these advisory meetings, at least one FDA adviser had a financial conflict of interest. Joseph Glenmullen, in Prozac Backlash (2000), notes that Paul Leber, director of the FDA's division of neuropharmacological drug products, left the FDA in the late 1990s to direct a consulting firm that specializes in advising pharmaceutical companies attempting to gain FDA approval for new psychiatric drugs.
The revolving door of employment is also used by Big Pharma to maintain influence over the National Institute of Mental Health. In Talking Back to Prozac (1994), Peter and Ginger Breggin report that in 1993 Steven Paul, scientific director of NIMH, resigned to become vice president of Eli Lilly (maker of Prozac and Zyprexa). In 2001 Roche Pharmaceutical (manufacturer of Valium, Klonopin, and other psychiatric drugs) proudly announced that Lewis Judd, a former NIMH director, had joined its scientific advisory board.
To the delight of Big Pharma, NIMH uses taxpayer monies to fund researchers who are financially connected to pharmaceutical companies. One important example is the "Sequential Treatment Alternatives to Relieve Depression (STAR*D)," a $35 million U.S. taxpayer-funded study that proclaimed the effectiveness of antidepressant treatment. The results of STAR*D were widely reported by the corporate media. Unfortunately, the NIMH press release about STAR*D excluded the fact that STAR*D researchers received consulting and speaker fees from the pharmaceutical companies that manufacture the antidepressants studied in STAR*D--and this fact went unreported by the corporate media. Also not in the press release and unreported is the fact that STAR*D researchers failed to include a placebo control and failed to incorporate relapse rates in the overall results. So in reality, STAR*D antidepressant results were no better than the customary placebo results or the results of no treatment at all--this also unreported by the corporate media.
The corruption by Big Pharma of the FDA and NIMH is not difficult when these agencies' overseer, the U.S. Congress, has also been corrupted by Big Pharma. Billy Tauzin, a former Republican congressperson from Louisiana, is one example. Tauzin, as chairman of the House Energy and Commerce Committee, helped shepherd passage of the Medicare prescription drug law --a bonanza for Big Pharma. Soon after this favor to Big Pharma, Tauzin became head of Pharmaceutical Research and Manufacturers of America (PhRMA), Big Pharma's trade organization. Tauzin's annual salary as head of PhRMA (as reported on April 1, 2007 by "60 Minutes") is $2 million.
Robert Whitaker, in his book Mad in America (2001), summarized the beginnings of Big Pharma's corruption of America's psychiatrists and their professional organization, the American Psychiatric Association (APA): By the early 1970s, all of psychiatry was in the process of being transformed by the influence of drug money. Pill-oriented shrinks could earn much more than those who relied primarily on psychotherapy (prescribing a pill takes a lot less time than talk therapy); drug-company sales representatives who came to their offices often plied them with little gifts (dinners, tickets to entertainment, and the like); and their trade organization, the APA, had become ever more fiscally dependent on drug companies. 30 percent of the APA's annual budget came from drug advertisements to its journals."
Whitaker also reported that the APA relied on drug company grants to fund its "educational" programs. Such grants have continued and in the first quarter of 2007, Eli Lilly reported providing grants of over $412,000 for two APA programs: "Improving Depression Treatments" and "Understanding the Complexity of Bipolar Mixed Episodes."
Drug companies have also been successful hijacking university psychiatry departments. In 2005 the Boston Globe reported that Harvard Medical School's psychiatry department at Massachusetts General Hospital received $6.5 million from four drug companies. Marcia Angell, physician and former editor-in-chief of the New England Journal of Medicine and author of The Truth About the Drug Companies (2004), reported that the head of the psychiatry department at Brown University Medical School made over $500,000 in one year consulting for drug companies that make antidepressants. Angell remarked, "When the New England Journal of Medicine, under my editorship, published a study by him and his colleagues of an antidepressant agent, there wasn't enough room to print all the authors' conflict-of-interest disclosures. The full list had to be put on the website."
Drug companies also provide major funding for so-called "mental health consumer organizations," the most well-known of which is the National Alliance for the Mentally Ill (NAMI). NAMI received $11.72 million from drug companies between 1996 and mid-1999, according to Mother Jones in 1999, which also reported that Eli Lilly was NAMI's leading drug company funder and that "in the case of Lilly, at least, 'funding' takes more than one form. Jerry Radke, a Lilly executive, is 'on loan' to NAMI, working out of the organization's headquarters."
Exposés of Big Pharma methods of influencing NAMI have not stopped the practice. In the first quarter of 2007, Eli Lilly's "Grant Office 2007" posted that Lilly provided NAMI with a grant of $450,000 for NAMI's "Campaign for the Mind of America 2007." For those troubled by the success of the psycho-pharmaceutical-industrial complex at manufacturing consent in the United States, the title "Campaign for the Mind of America 2007" is a chilling one.
Bruce E. Levine, Ph.D., is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007). www.brucelevine.net