(3/4) Dr John Rengen Virapen, Blows the Whistle on his Former ‘Big Pharma’ Employer

“If you’ve never picked up DSM-IV™, we strongly recommend that you do so. You’ll find yourself in it. You’ll find your friends and associates in it. You’ll find your family members in it. Indeed, you’ll find everyone in it. In other words, from the point of view of psychiatry, everyone has a “mental disorder.” For psychiatry, there is no such thing as mental health, only degrees of pathology!” ~ C.S.Hyatt – The Psychopath’s Bible

Dr. John Rengen Virapen is a former Eli Lilly & Co executive who after 35 years of loyal service decided to quit and speak out on the many crimes “Big Pharma” is responsible for and whose crimes mainly go by unnoticed to the public as it enjoys the unethical protection from its big allies, the mainstream media, the FDA and the government.

Part 1/4

Part 2/4

Part 4/4

Supplemental Material:

1. From Wikipedia:
   

   Eli Lilly is also one of many drug companies that give soft money to advocacy groups and political action committees (PACs) to help influence lawmakers and regulators. Historically Eli Lilly favors pro-business Republicans over Democrats with its political contributions (75% to 25% in the last nine US election cycles).[38] Source

   He [Tobias] and Lilly have been major donors to the Republican Party. He gave $4,000 to Bush from 1999 to 2001, and he and his wife donated a total of $37,000 to the GOP and its state elections committee during that period. Lilly, meanwhile, gave another $23,000 to Bush’s campaign in 2000 and spent $234,000 on direct mail to its stockholders on Bush’s behalf, according to the Center for Responsive Politics. Source

   Also see the Political Base website for an oversight of Eli Lilly’s contributions to various political parties.

2. From the New York Times article “Children’s Use of Prescription Drugs Is Surging, Study Shows”:
   

   Prescription drug use is growing faster among children than among the elderly and baby boomers, according to a new study that says spending on prescription medicines for pediatric patients has increased by 85 percent over the past five years.
   [...]
   The research, scheduled to be made public on Thursday, did not find that children take more medicine than adults. In fact, said Dr. Robert Epstein, Medco Health’s chief medical officer, children accounted for just 5 percent of prescription drug expenditures.

   But in examining prescription drug use among 500,000 children under age 19, Dr. Epstein did find that more young people are taking medicine today than five years ago and are taking drugs for longer periods.
   [...]
   Experts, including Dr. Epstein, attributed the rise in spending to several factors. First, certain conditions, including asthma and allergies, as well as hyperactivity, are being diagnosed more frequently and treated more aggressively than ever before. In addition, the overall cost of medicines is going up; Dr. Epstein said 30 percent of the rise in spending was attributable to an increase in drug prices. Source

   Also check out the page by the New York State – Department of Health:

   Q: How big a problem is prescription drug abuse?

   A: Most people take prescription medication responsibly under a doctor’s care. However, there has been a steady increase in the non-medical use of these medications, especially by teenagers. Prescription drug abuse knows no boundaries; it occurs in all social, economic, geographic, and ethnic groups.
   Q: At what age are teens abusing prescription medications?

   A: Kids as young as 12 are trying prescription drugs to get high. Prescription drugs are often more easily available to children than illicit drugs like marijuana because they can be stolen from the medicine cabinet at home, rather than having to be bought on the streets. An added danger of abusing prescription drugs is that teens consider them safer than street drugs because they are manufactured by a pharmaceutical company.
   Q: What are some of the most commonly abused prescription drugs?

   A: Although any prescription drug can be abused, the three types of drugs that are most commonly abused are:

   * Pain Killers, also known as narcotic or opiates. Examples include morphine, codeine, OxyContin (oxycodone), Vicodin (hydrocodone) and Demerol (meperidine). A large single dose can cause severe respiratory depression and death. Long-term abuse leads to physical dependence and, in some cases, addiction.
   * Depressants, which are prescribed to treat anxiety and sleep disorders. Examples are Nembutal (pentobarbital sodium), Valium (diazepam), and Xanax (alprazolam). They slow down normal brain function and can cause a drowsy, uncoordinated feeling. Large doses can depress breathing and cause a coma. Long-term abuse can lead to physical dependence and addiction.
   * Stimulants are often prescribed to treat attention-deficit hyperactivity disorder (ADHD). Examples include Ritalin (methylphenidate) and Dexedrine (dextroamphetamine). These drugs elevate blood pressure and heart rate. High doses can cause dangerously high body temperature and cardiac arrest brought on by an abnormal heartbeat. Source

3. Drugging Children
   

4. The Drugging of our Children (Gary Null) (SSRI drug dangers)(Columbine shooting)
   

5. Making a Killing: The Untold Story of Psychotropic Drugging

6. From Wikipedia:
   

   The Diagnostic and Statistical Manual of Mental Disorders (DSM) is published by the American Psychiatric Association and provides diagnostic criteria for mental disorders. It is used in the United States and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies and policy makers.

   The DSM has attracted controversy and criticism as well as praise. There have been five revisions since it was first published in 1952, gradually including more disorders, though some have been removed and are no longer considered to be mental disorders. It initially evolved out of systems for collecting census and psychiatric hospital statistics, and from a manual developed by the US Army. The last major revision was the fourth edition (”DSM-IV”), published in 1994, although a “text revision” was produced in 2000. The fifth edition (”DSM-V”) is currently in consultation, planning and preparation, due for publication in May 2012.^[1] An early draft will be released for comment in 2009. ^[2] The mental disorders section of the International Statistical Classification of Diseases and Related Health Problems (ICD) is another commonly-used guide, used more often in some parts of the world. The coding system used in the DSM-IV is designed to correspond with the codes used in the ICD, although not all codes may match at all times because the two publications are not revised synchronously.
   [...]

   Symptomatological bias

   By design, the DSM is primarily concerned with the symptoms of mental disorders, it does not attempt to analyze or explain the conditions it lists or even to discuss possible patterns or relationships between them. As such, it has been compared to a naturalist’s field guide to birds, with similar advantages and disadvantages.^[29] The lack of causative or explanatory material, however, is not specific to the DSM, but rather reflects a general lack of pathophysiological understanding of psychiactric disorders. As DSM-III chief architect Robert Spitzer and DSM-IV editor Michael First outlined in 2005, “little progress has been made toward understanding the pathophysiological processes and etiology of mental disorders. If anything, the research has shown the situation is even more complex than initially imagined, and we believe not enough is known to structure the classification of psychiatric disorders according to etiology.”^[30] The DSM’s apparent superficiality is therefore largely a result of necessity, since there is no agreement on a more explanatory classification system.

   Despite the lack of consensus, advocates for specific psychopathlogical paradigms have nonetheless faulted the current diagnostic scheme for not incorporating the innovations of their particular model; the most recent example being evolutionary psychologists‘ criticism that the DSM does not differentiate between genuine cognitive malfunctions and those induced by psychological adaptations, a key distinction within evolutionary psychology, but one widely challenged within general psychology.^[31][32][33] Source

(2/4) Dr John Rengen Virapen, Blows the Whistle on his Former ‘Big Pharma’ Employer

‘Considering the benefit and the risk, we think this preparation totally unsuitable for the treatment of depression.’ — May 25th 1984 communication to Lilly US from Lilly Bad Homburg by B v.Keitz containing a translation of an unofficially received medical comment on the Fluoxetine application to the German regulators. Let Them Eat Prozac

Dr. John Rengen Virapen is a former Eli Lilly & Co executive who after 35 years of loyal service decided to quit and speak out on the many crimes “Big Pharma” is responsible for and whose crimes mainly go by unnoticed to the public as it enjoys the unethical protection from its big allies, the mainstream media, the FDA and the government.

Part 1/4

Part 3/4

Part 4/4

Original mixed English-German source, here. More on Dr. Rengen Virapen here (only German).

http://www.mazaruni-publishing.eu/

Supplemental Material:

1. What is iatrogenic disease?
   

   

   What does the word “iatrogenic” mean?

   Iatros means physician in Greek, and -genic, meaning induced by, is derived from the International Scientific Vocabulary. Combined, of course, they become iatrogenic, meaning physician-induced. Iatrogenic disease is obviously, then, disease which is caused by a physician.

   Or perhaps it is not so obvious. The growing complexity of modern life (and medicine) has promoted the elasticity of language. In common usage, then, iatrogenic disease is now applied to any adverse effect associated with any medical practitioner or treatment. The practitioner need not be a physician, he might be a nurse or a radiology technician, or any one of the scores of differentiated healthcare workers encountered in hospitals, clinics, nursing homes, or offices, or for that matter in the ambulance on the way to one of those places. Source

2. Excerpts from Gary Null’s Death by Medicine, on the unnecessary medical interventions taking place in the US:
   

   As shown in the following table, the estimated total number of iatrogenic deaths—that is, deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures— in the US annually is 783,936. It is evident that the American medical system is itself the leading cause of death and injury in the US . By comparison, approximately 699,697 Americans died of heart in 2001, while 553,251 died of cancer.(5)

   

   Using Leape’s 1997 medical and drug error rate of 3 million(14) multiplied by the 14% fatality rate he used in 1994(16) produces an annual death rate of 420,000 for drug errors and medical errors combined. Using this number instead of Lazorou’s 106,000 drug errors and the Institute of Medicine ’s (IOM) estimated 98,000 annual medical errors would add another 216,000 deaths, for a total of 999,936 deaths annually.

   

   The enumerating of unnecessary medical events is very important in our analysis. Any invasive, unnecessary medical procedure must be considered as part of the larger iatrogenic picture. Unfortunately, cause and effect go unmonitored. The figures on unnecessary events represent people who are thrust into a dangerous health care system. Each of these 16.4 million lives is being affected in ways that could have fatal consequences. Simply entering a hospital could result in the following:

   • In 16.4 million people, a 2.1% chance (affecting 186,000) of a serious adverse drug reaction(1)
   • In 16.4 million people, a 5-6% chance (affecting 489,500) of acquiring a nosocomial infection(9)
   • In16.4 million people, a 4-36% chance (affecting 1.78 million) of having an iatrogenic injury (medical error and adverse drug reactions).(16)
   • In 16.4 million people, a 17% chance (affecting 1.3 million) of a procedure error.(40)

   These statistics represent a one-year time span. Working with the most conservative figures from our statistics, we project the following 10-year death rates.

   

   Our estimated 10-year total of 7.8 million iatrogenic deaths is more than all the casualties from all the wars fought by the US throughout its entire history.
   Our projected figures for unnecessary medical events occurring over a 10-year period also are dramatic.

   

   These figures show that an estimated 164 million people—more than half of the total US population—receive unneeded medical treatment over the course of a decade. Source

3. 
   In their study, Leape and his colleagues examined patient records at hospitals throughout the state of New York. Their 1991 report found that one of every 200 patients admitted to a hospital died as a result of a hospital error.

   That number of deaths is the equivalent of what would occur if a jumbo jet crashed every day; it is three times the 43,000 people killed each year in U.S. automobile accidents.

   “It’s by far the number one problem” in health care, said Leape, an adjunct professor of health policy at the Harvard School of Public Health.

   Researchers such as Leape say that not only are medical errors not reported to the public, but those reported to hospital authorities represent roughly 5 to 10 percent of the number of actual medical mistakes at a typical hospital.

   “The bottom line is we have a system that is terribly out of control,” said Robert Brook, a professor of medicine at the University of California at Los Angeles.

   “It’s really a joke to worry about the occasional plane that goes down when we have thousands of people who are killed in hospitals every year.” Brook’s recognition of the extent of hospital errors is shared by many of medicine’s leaders.

   Care — not treatment — is the answer. Drugs, surgery and hospitals become increasingly dangerous for chronic disease cases. Facilitating the God-given healing capacity by improving the diet, exercise, and lifestyle is the key.

   Effective interventions for the underlying emotional and spiritual wounding behind most chronic disease is critical for the reinvention of our medical paradigm. These numbers suggest that reinvention of our medical paradigm is called for. Source

4. What is FAB?
   

   We promote benefit statements called FAB statements throughout the sales process. What is a FAB statement and how is it organized?

   F for Feature – What is the feature

   A for Advantage – What does the feature do

   B for Benefit – The “What’s in it for me?” for the customer

   As you meet with your customers and find out about their priorities and specific requirements, the information they provide you will enable you to use FAB statements to positively influence the sale. What you are doing is making the buying process straightforward for the client. Rather than imposing on the client by making them translate the value in your product or service, you are spelling it out for them. This clarifies the process and puts you one step closer to a “yes”. The FAB takes what your product and ties it into PPI – Productivity, Profitability and Image. Source

   So, FAB is just a clever sales technique. Since it’s used by the Big Pharma peddlers too and since they apparently also neglect mentioning any detrimental side-effects to potential customers, it goes to show that indeed sales quota are more important than customer welfare.

5. From Wikipedia:
   

   Selective serotonin reuptake inhibitors or serotonin-specific reuptake inhibitor^[1] (SSRIs) are a class of compounds typically used as antidepressants in the treatment of depression, anxiety disorders, and some personality disorders. They are also typically effective and used in treating premature ejaculation problems as well as some cases of insomnia.

   SSRIs increase the extracellular level of the neurotransmitter serotonin by inhibiting its reuptake into the presynaptic cell, increasing the level of serotonin available to bind to the postsynaptic receptor. They have varying degrees of selectivity for the other monoamine transporters, with pure SSRIs having only weak affinity for the noradrenaline and dopamine transporter.

   The first class of psychotropic drugs to be rationally designed, SSRIs are the most widely prescribed antidepressants in many countries.^[2]
   [...]
   Medical indications
   
   The main indication for SSRIs is clinical depression. SSRIs are frequently prescribed for anxiety disorders like social anxiety, panic disorders, obsessive-compulsive disorder (OCD), eating disorders, chronic pain, and occasionally for Posttraumatic stress disorder (PTSD). Though not specifically indicated by the manufacturers, they are sometimes prescribed to treat irritable bowel syndrome (IBS), Lichen simplex chronicus, and premature ejaculation.

   All SSRIs are approved in the US for use with psychiatric disorders as outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM IV).

   The uses for which SSRIs are approved vary by country and is determined by the overseeing medical branch of government in charge of regulating drugs. In the United States, the Food and Drug Administration (FDA) makes these approvals after trials have been submitted by pharmaceutical companies. In Europe, drugs can be approved either by the European Medicines Agency for human consumption throughout the European Union or by the regulatory agencies of individual countries for use within those countries.^{[citation needed]}. In Canada the drug approval process is carried out by Health Canada. Source

6. A sample of those who have been on the Eli Lilly payroll includes:

   • Former President George Herbert Walker Bush (one-time member of the Eli Lilly board of directors)
   • Former CEO of Enron, Ken Lay (one-time member of the Eli Lilly board of directors)
   • George W. Bush’s former director of Management and Budget, Mitch Daniels (a former Eli Lilly vice president)
   • George W. Bush’s Homeland Security Advisory Council member, Sidney Taurel (current CEO of Eli Lilly)
   • The National Alliance for the Mentally Ill (a recipient of Eli Lilly funding)

   [...]
   In 2002, Eli Lilly flexed its muscles at the highest level of the U.S. government in an audacious Lillygate. The event was the signing of the Homeland Security Act, praised by President George W. Bush as a “heroic action” that demonstrated “the resolve of this great nation to defend our freedom, our security and our way of life.” Soon after the Act was signed, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute and on November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that—incredibly—will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.”

   Thimerosal is a preservative that contains mercury and is used by Eli Lilly and others in vaccines. In 1999 the American Academy of Pediatrics and the Public Health Service urged vaccine makers to stop using mercury-based preservatives. In 2001 the Institute of Medicine concluded that the link between autism and thimerosal was “biologically plausible.” By 2002, thim- erosal lawsuits against Eli Lilly were progressing through the courts. The punchline of this Lillygate is that, in June 2002, President George W. Bush had appointed Eli Lilly’s CEO, Sidney Taurel, to a seat on his Homeland Security Advisory Council. Ultimately, even some Republican senators became embarrassed by this Lillygate and, by early 2003, moderate Republicans and Democrats agreed to repeal this particular provision in the Homeland Security Act.
   [...]
   Looking back further to 1992, Alexander Cockburn, in both the Nation and the New Statesman, was one of the first to connect the dots between the Bush family and Eli Lilly. After George Herbert Walker Bush left his CIA director post in 1977 and before becoming vice president under Ronald Reagan in 1980, he was on Eli Lilly’s board of directors. As vice president, Bush failed to disclose his Lilly stock and lobbied hard on behalf of Big Pharma—especially Eli Lilly. For example, Bush sought special tax breaks from the IRS for Lilly and other pharmaceutical corporations that were manufacturing in Puerto Rico.

   Cockburn also reported on Mitch Daniels, then a vice president at Eli Lilly, who in 1991 co-chaired a fundraiser that collected $600,000 for the Bush-Quayle campaign. This is the same Mitch Daniels who in 2001 became George W. Bush’s Director of Management and Budget. In June 2003, soon after Daniels departed from that job, he ran for governor of Indiana (home to Eli Lilly headquarters). In a piece in the Washington Post called “Delusional on the Deficit,” Senator Ernest Hollings wrote, “When Daniels left two weeks ago to run for governor of Indiana, he told the Post that the government is ‘fiscally in fine shape.’ Good grief! During his 29-month tenure, he turned a so-called $5.6 trillion, 10-year budget surplus into a $4 trillion deficit—a mere $10 trillion downswing in just two years. If this is good fiscal policy, thank heavens Daniels is gone.” Source

7. See under section Eli Lilly and the Bush Family at Wikipedia.

8. Donald Rumsfeld & Aspartame Scandal
   

(1/4) Dr John Rengen Virapen, Blows the Whistle on his Former ‘Big Pharma’ Employer

“And it seems to me perfectly in the cards that there will be within the next generation or so a pharmacological method of making people love their servitude, and producing … a kind of painless concentration camp for entire societies, so that people will in fact have their liberties taken away from them but will rather enjoy it, because they will be distracted from any desire to rebel by propaganda, brainwashing, or brainwashing enhanced by pharmacological methods.” Aldous Huxley on psychological totalitarianism (1959)

Dr. John Rengen Virapen is a former Eli Lilly & Co executive who after 35 years of loyal service decided to quit and speak out on the many crimes “Big Pharma” is responsible for and whose crimes mainly go by unnoticed to the public as it enjoys the unethical protection from its big allies, the mainstream media, the FDA and the government.

Part 2/4

Part 3/4

Part 4/4

Original mixed English-German source, here. More on Dr. Rengen Virapen here (only German text).

Related John Rengen video:

Ex-Lilly Executive talks

Basic Background

Company profile

Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world’s largest corporations. Eli Lilly’s global headquarters is located in Indianapolis, Indiana, in the United States. The company was founded in 1876 by a pharmaceutical chemist, Eli Lilly, after whom the company was ultimately named.

[...]

A Fortune 500 corporation, Eli Lilly had revenues of $20 billion in 2008, making it the 148th largest company in the United States and the 10th largest corporation by global pharmaceutical sales. The company is publicly traded on the New York Stock Exchange and is a member of the S&P 500 stock index. Eli Lilly was one of the Nifty Fifty stocks that propelled the mid 20th century bull market.

Eli Lilly is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).^[1]

[...]

Pharmaceutical brands

Among the company’s major pharmaceutical breakthroughs are cephalosporin, erythromycin, insulin, and Prozac (fluoxetine), a selective serotonin reuptake inhibitor (SSRI) for the treatment of clinical depression.

Among other distinctions, Lilly is the world’s largest manufacturer and distributor of medications used in a broad range of psychiatric and mental health-related conditions, including clinical depression, generalized anxiety disorder, narcotic addiction, insomnia, bipolar disorder, schizophrenia, and others.

[...]

Prozac

Further information: Fluoxetine

Prozac was one of the first therapies in its class to treat clinical depression by blocking the uptake of serotonin within the human brain. It is prescribed to more than fifty-four million people worldwide.

Prozac has given rise to a number of comparably-functioning therapies for the treatment of clinical depression and other central nervous system disorders such as obsessive compulsive disorder, bulimia nervosa, and panic disorders.

The label on Prozac states: In clinical studies, antidepressant increased the risk of suicidal thinking and behaviour in children, adolescents and young adults with depression and other psychiatric disorders.

Prozac in popular culture

Because of its wide appeal as a popular anti-depressant, Prozac has had numerous references to it in popular culture, including many books, movies, and songs. The autobiographical book Prozac Nation was authored in 1994 by Elizabeth Wurtzel; it was turned into a movie of the same name, Prozac Nation, in 2001, starring Christina Ricci. A 1993 book, Listening to Prozac, was a generally critical look at Prozac and its side effects. Another book, Talking Back to Prozac, also focuses on Prozac side effects.

[...]

Thimerosal

Further information: Thiomersal

Eli Lilly has developed the controversial vaccine preservative Thiomersal (also called Merthiolate and Thimerosal). Thiomersal is effective by causing susceptible bacteria to autolyze. SOURCE

Drug Controversy

Oraflex

the American version of Benoxaprofen, was withdrawn from the market in 1982, just one month after gaining FDA approval. A British medical journal found five cases of death due to jaundice in patients taking the drug and the FDA accused Lilly of suppressing unfavorable research findings. In 1985, the U.S. Justice Department filed criminal charges against the company and Dr. William Ian H. Shedden. Lilly pleaded guilty to 25 criminal counts and paid a $25,000 fine.

Zyprexa

According to a New York Times article published on December 17, 2006,^[1] Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers. These documents and e-mail messages were soon made publicly available as a location hidden Tor service,^[2] and then made available on the public Internet. Eli Lilly sought and obtained a “Temporary Restraining Order” from a U.S. District Court on January 4, 2007 to stop the dissemination or downloading of Eli Lilly documents about Zyprexa, and this allowed them to get a few U.S.-based websites to remove them. The documents can now only be downloaded from public Internet sites outside the U.S.^[3] These health risks include an increased risk for diabetes through Zyprexa’s links to obesity and its tendency to raise blood sugar. Zyprexa is Lilly’s top-selling drug, with sales of $4.2 billion last year. Source

Eli Lilly Agrees to Pay Largest Corporate Criminal Fine in History

Late last week, Eli Lilly and Company agreed to plead guilty to charges that it promoted the drug Zyprexa for uses that had not been approved by the FDA. As part of the resolution, Eli Lilly was left with the largest corporate criminal fine in history for a individual corporation: $515 million. Additionally, Eli Lilly must pay up to $800 million in a civil settlement with the federal government and the states. SOURCE

Fox, Douglas Kennedy, Lilly pays $1.42 billion in Zyprexa suit

Zyprexa Drug Rep

Prozac

Eli Lilly agreed on January 4, 2007 to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa. Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.^[6]

The signs of violence and suicidality were there since Prozac was tested in premarketing trials. In May 1984, Germany’s regulatory agency (Bundesgesundheitsamt, BGA) rejected Prozac as “totally unsuitable for treating depression.” In July 1985, Eli Lilly’s own data analysis—from a pool of 1,427 patients—showed high incidence of adverse drug effects and evidence of drug-induced violence in some patients.^[11] In May 1985, FDA’s (then) chief safety investigator, Dr. Richard Kapit, wrote: “Unlike traditional tricyclic antidepressants fluoxetine’s profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation.” He warned: “It is fluoxetine’s particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression.”^[12]

Dr. Kapit’s safety review described the clinical trial data from 46 trials with a total of 1,427 patients. He noted under the section, “Catastrophic and Serious Events,” 52 cases of “egregiously abnormal laboratory reports which were the reason for early termination,” and “additional adverse event reports not reported by the company [which] were revealed on microfiche.” Dr. Kapit reported: “In most cases, these adverse events involved the onset of an unreported psychotic episode.” There were ten reports of psychotic episodes; two reports of completed suicides; 13 attempted suicides; four seizures—including a healthy volunteer; and four reports of movement disorders.

In 1985 Dr. Kapit recommended “labeling warning [for] the physician that such signs and symptoms of depression may be exacerbated by this drug”. No such warning was issued until 2004. SOURCE

Prozac and Depression

Darvon

Darvon, Distalgesic, Co-Proxamol – the worst drugs ever

Transcript of the presentation here.

Controversial Modus Operandus

Eli Lilly has been featured as one of the most unethical of all drug companies by the Wall Street Journal, edition of November 14, 1996.
[...]
For the pharmaceuticals industry, persuading able-bodied people to sample untried and potentially dangerous drugs is a tough sell. To woo their human subjects, most companies have to advertise heavily and shell out $125 or so a day, occasionally as much as $250; SmithKline Beecham PLC even pays referral bonuses. By contrast, Lilly advertises less frequently and, at $85 a day, pays what competitors believe is the lowest per diem in the business.

Alone among its peers, Lilly has become a potent magnet for homeless people. For more than two decades, Lilly’s testing clinic has drawn from the ranks of the homeless, often alcoholic men who drift in and out of Indianapolis’s church-run inner-city missions. Some mission directors privately express misgivings about this but say they are reluctant to speak up because they receive funding from a foundation built on Lilly stock, even though the foundation is independent of the company and its clinic.

Word of mouth about testing at Lilly — a company best known for the blockbuster drug Prozac — has gradually spread through soup kitchens, prisons and shelters from coast to coast. Today, so many homeless men come to Indianapolis seeking admittance to Lilly’s research clinic that Matias Vega, medical director of the local Homeless Initiative Program, credits the clinic with creating a “shadow economy.” One veteran nurse at the Lilly Clinic says that the majority of its subjects are homeless alcoholics.
[...]
Dr. Thompson says the practice of using homeless people was well under way when he arrived at Lilly in 1982. “We were constantly talking about whether we were exploiting the homeless,” he recalls. “But there were a lot of them who were willing to stay in the hospital for four weeks.”

He says an independent board that oversees the clinic approved the practice. Both the board and Lilly’s top executives felt that employing the homeless was a philanthropic act, Dr. Thompson explains, adding that he, too, took this position. “Providing them with a nice warm bed and good medical care and sending them out drug- and alcohol-free was a positive thing to do,” Dr. Thompson says.

Lilly has persisted in this approach despite drawing regulatory censure following a 1993 disaster with an experimental hepatitis drug called FIAU. (See article below.) But as for Lilly’s overall safety record, the FDA has no way of knowing, because oversight of Phase I testing is limited. Robert Temple, an official of the FDA’s Center for Drug Evaluation and Research, says: “We haven’t seen anything that makes Lilly look worse [than other drug companies], but we haven’t looked.”
[...]
FDA Once Chastised Lilly For Using Alcoholics in Study

In 1994, the Food and Drug Administration issued an unusual rebuke to Eli Lilly & Co. for using alcoholics in a drug study that triggered the company’s most public drug-testing disaster.

The experimental drug, known as FIAU, was intended to treat hepatitis B. In early 1993, two subjects who took FIAU in a trial at Lilly’s Indianapolis clinic experienced liver abnormalities, and one was hospitalized. The drug also was given to 15 people with hepatitis, who were enrolled in a Phase II trial at the National Institutes of Health. Five later developed toxic liver reactions and died.

In the aftermath, the FDA took Lilly to task for using two supposedly healthy test subjects who turned out to be alcoholics. In a previously undisclosed warning letter to Lilly Chairman Randall Tobias, the FDA told Lilly that “the use of volunteers with a history of daily alcohol intake … is not in keeping with good clinical investigational practice.” SOURCE

Supplemental Material:

1. Schizophrenia Drugs (Zyprexa, Risperdal, Seroquel) FDA …

2. The Dangers of Vaccines – Part 1 (Autism, Mercury, MMR, HPV, Thimerosal, Aluminium, Vaccinations)
   
   Part 2

3. Mercury and the brain do not mix:

   How Mercury Causes Brain Neuron Damage – Uni. of Calgary

4. Eli Lilly Zyprexa Litigation, including legal documents.

5. Prozac in the Drinking Water! – Nutrition by Natalie
   

6. Hippocratic Oath and Primum Non Nocere