The Company Attacking their Critics Fixed Lawsuits Fraudulent Research & Side Effects Conclusion


I
should probably say this first...When trying to withdraw from psychiatric drugs, patients can experience serious and even life-threatening emotional and physical reactions. It is dangerous not only to start taking psychiatric drugs, but it can also be dangerous to stop. Withdrawal from psychiatric drugs should be done gradually and under medical and clinical supervision. You should not take this article as medical advice, only your psychologist / doctor / psychiatrist can provide that. As I will state, there are many cases where drug treatments provide adequate treatment with no harm. I am NOT suggesting you refuse to take drug treatments.

Secondly, this article is about psychiatrists, not psychologists. There are significant differences. Different training, different degrees, different opinions. Psychiatrists can prescribe drugs, psychologists usually cannot. Psychiatrists thus focus on drugs in therapy much more than psychologists do. We won’t be talking about psychology, OK?

I also do NOT intend to say that all drug treatments of disorders such as depression are bad; clearly drugs have benefits in many cases of such disorders. I personally know of someone who had severe depression, which only improved with drug treatment. At the same time I also know someone whose depression was made worse by drugs, and who improved drastically once the drugs were stopped and other therapies used. I do not intend to imply that all psychiatrists over-diagnose disorders or prescribe drugs irresponsibly - just a lot of them, particularly in the US.

This is about the abuse of the health system by corporations. Our increasingly consumerist society is hell-bent on easy cures and quick fixes - but mental health is not that simple. You can’t expect a miracle pill to be a panacea for all people. But that’s what Eli Lilly & Co have been trying to do. Eli Lilly make drugs (Prozac, Ritalin, Zoloft) with which they hope to cure mental illnesses. Fair enough. But these drugs do not affect everyone identically. They cause harm to some people. Bad harm. That is a fact, but it is being ignored - while meanwhile, millions of people have been put on these drugs and take them everyday.


You should not take this as some big scare or conspiracy theory. Nor should you take this as some anti-drugs polemic, or something to make you cynical and paranoid. However, you are not living in the land of the Happy Elves. Bad stuff is happening, and many corporations don’t want you to know. By criticising corporations and the capitalist system I am not trying to take away your right to wear designer underpants and sip Coke. I just want to inform you, and hopefully encourage a few more people to live in reality.

The Company

Eli Lilly & Co claim on their website that they “create and deliver innovative medicines that enable people to live longer, healthier and more active lives. Lilly medicines treat depression, schizophrenia, diabetes, cancer, osteoporosis and many other diseases”. They “create value for patients, healthcare providers and payers, and reduce the cost of disease”. Eli Lilly are apparently “committed to providing answers that matter in medicine, life sciences and health care.”

Sounds like a wonderful cause, helping us all in our quest for “answers that matter.” They have packed their website with testimonials from people cured by their wonderful products. However, in 1994 there were about 160 lawsuits against the company, so their clients mustn’t all be happy. However, the company beams, “Prozac is the world’s most widely prescribed antidepressant; it has been used by more than 35 million people worldwide.” Apparently there are no problems.

Not financially, anyway. In fact, you can use their website to access shareholder reports and all kinds of investment information. Investors will be pleased to know there is a shitload of money to be made in the business of chemical mindfucking.

Safe?

Eli Lilly and Co say Prozac is safe. In 1993, 28,623 reports of adverse reactions to Prozac had been received by the US Food and Drug Administration (FDA). These included effects such as delirium, hallucinations, convulsions, violent hostility, aggression, psychosis, 1,885 suicide attempts and 1,734 deaths - 1,089 by suicide. However, this didn’t seem to be enough to provoke the FDA to act against the company.

This is hardly surprising, though. During the drug’s pre-release clinical trials, both Eli Lilly and officials of the FDA were aware of least 27 deaths linked to Prozac. One document shows that as of October 15, 1987, two months before Prozac was allowed on the market, there had already been 15 suicides linked to it - six by overdose, four by gunshot, three by hanging and two by drowning. A total of 12 other deaths are also described in the document provided by Lilly to the FDA. Previously, the FDA has recalled products for causing as little as two deaths. Instead of a recall, Prozac was given final FDA approval on December 29, 1987.

But that’s not all. A safety review of Prozac, dated March 23, 1986, by the FDA’s Richard Kapit, observed that “Fluoxetine [Prozac] may exacerbate certain depressive symptoms and signs.” (And here I was thinking it cures depression). Kapit, a medical doctor, noted, “Certain clinical risks of mild to moderate severity did appear to be associated with the use of Fluoxetine. These potential risks include intensification of the vegetative signs and symptoms of depression.” In addition to this, the safety review also discovered that Lilly had failed to report information about the onset of psychotic episodes in people during Prozac’s testing. Still, no action was taken against the drug company.


Kapit’s safety concluded with a warning: “It is suggested that labeling be developed which advises physicians about possible exacerbation of the vegetative manifestations of depressive illness.... If the drug is marketed, post-marketing studies should be required to assess more precisely the severity of these potential risks.” The drug company still hasn’t put warning labels of this sort on its product.

As early as 1986 - almost two years before Prozac’s approval for public consumption - there was clear evidence linking Prozac to worsened symptoms of depression and the onset of psychotic episodes. Not to mention the 1,089 suicides, or the many episodes of senseless violence, homicide and even multiple murder linked to the drug. The FDA had other opportunities to act in the public interest. In 1991, the FDA’s psychopharmacologic Drugs Advisory Committee held a hearing to review evidence showing links between Prozac (and related drugs) and psychotic, violent acts. For over three hours, more than two dozen Prozac victims or surviving family members recounted horror stories linking the drug to multiple murders, suicide, attempted suicide, self-mutilation, psychosis and other nightmarish effects. The Committee ignored this information and voted against relabelling Prozac to carry a proper warning of its dangers. One doctor asked to present slides correlating Prozac with violent, suicidal thoughts; the Committee refused to see them.

There is clear evidence that the drug is dangerous in some cases. So what’s with the FDA? Might have something to do with the fact that at least five out of ten members of the Committee at the time had business dealings with manufacturers of antidepressant drugs - including Lilly - totaling a minimum of US$1,108,587. One Committee member, David Dunner of the University of Washington, was in receipt of around US$100,000 in research grants related to the company. It is claimed that Dunner has received up around US$1.4 million from Lilly since 1982. Another member received an estimated US$4 million in grants related to Prozac research from the company. A few members had been paid to lecture on the benefits of the drug. When the FDA held a panel in 1991 to review concerns about Prozac and violence, eight of the 10 members were psychiatrists. Their livelihood, of course, depends a fair bit on the prescription of antidepressants such as Prozac. Every single member was either a psychiatrist or had research grants from the company pending. Not exactly an ideal in objectivism.

Attacking their Critics

Rather than take this barrage of data lying down, the company used its considerable wealth to attack and discredit its critics.
First Eli Lilly launched a massive campaign to popularise “depression” as a modern illness for which a miracle cure was available. In 1990 they acquired the services of Thomas D Bell, aide and adviser to then-US Vice President Dan Quayle. At the time Quayle was the chair of the White House Council on Competitiveness. This council worked closely with the Pharmaceutical Manufacturers Association. They pushed through measures allowing the FDA to speed up its approval process for new drugs. The FDA was also now allowed to contract non-government scientific experts to review pending drug applications. What this means is that the research on the drug’s safety could be conducted by the drug makers themselves (who I’m sure were very objective).

One of Prozac’s major critics is Peter R Breggin, MD. He has written many anti-Prozac books, such as Talking Back to Prozac. He claims the company “knew from early on, and suppressed, that Prozac has a dangerous stimulant effect similar to the amphetamines and cocaine, including the production of agitation, anxiety, nervousness, hyperactivity, insomnia, nightmares, and weight loss. Prozac can cause mania, paranoia and violence, as well as “crashing” with depression and suicide.” He also claims, “Prozac is so stimulating that many patients require simultaneous treatment with sedatives, such as Klonopin or Xanax. This exposes them to the additional risks of addiction, behavior abnormalities, and mental dysfunction from these sedative tranquilizers.” He says that, “in controlled studies for the FDA, Prozac’s beneficial effect was commonly no better than a sugar pill (or placebo).” He claims that in a clinical trial, 6% of the kids on Prozac turned psychotic.

The company publicly and falsely denounced Breggin as a scientologist (even though Breggin has in fact been a public critic of scientology since 1975). However, much of Breggin’s credibility was damaged, many people trusting their friendly drug corporation and assuming he was a member of some strange cult. The company even pressured media outlets; warning them not to interview Breggin. But Breggin has the last word, stating: “Were truth on Lilly’s side, the company would be dealing with my criticism in a much more forthright manner - through open discussion and debate.”

Fixed Lawsuits

Many happy customers (particularly in the US) have been so satisfied with these quality products that they sued the company. Many of these cases have been settled out of court. Settlements have been made secret - without the knowledge of the judge - and juries have then been bribed. A watered down or weak case has then been presented against the company in exchange for the settlement. Plaintiffs have often refused to bring in evidence damaging to the company. The result? It appears in the media that all these lawsuits were resolved in the company’s favour. In May 1996, a Kentucky Judge had severe doubts about the case of “Potter vs Eli Lilly & Co.” There were major questions over whether the case should proceed because “there was a serious lack of candor with the trial court and there may have been deception, bad faith conduct, abuse of judicial process or perhaps even fraud.”
The Kentucky Supreme Court severely criticised the drug company for manipulating the judicial system. The judge forced Eli Lilly & Company to admit that they had secretly settled the case and then rigged the trial.

Fraudulent Research and Side Effects

$$ In 1985, after tests of Prozac found the drug not to be significantly more effective than the placebo, an FDA statistician suggested to Lilly that the test results be evaluated differently - resulting in findings favourable to Prozac.

$$ More than 15,000 reports of adverse reactions to Prozac were dismissed as having “limited value.”

$$ Side effects reported by Prozac users: heart attack, impotence, hair loss, cataracts, kidney disorders, hepatitis, arthritis, breast cysts, breast pain, convulsions, coma, migraine headache, bronchitis, pneumonia, deafness, duodenal ulcer, stomach ulcer, gallstones, pelvic pain, inability to control bowel movements, painful sexual intercourse for women, urinary tract disorders, eye bleeding, spitting blood and vomiting blood.

$$ ‘Clinical Pharmacy’ contained an article discussing “a patient with no prior history of epilepsy who experienced a seizure shortly after initiation of fluoxetine [Prozac] therapy.” The research indicated a “possible relationship between the seizure episode and fluoxetine therapy.”

$$ Prozac and its analogues [such as paxil, zoloft, luvox, effexor, serzone, anafranil & the diet pills - fenfluramine, fen-phen & redux] are being prescribed for everything from headaches and flu to acne and home sickness, even severe PMS. Yet, according to FDA spokespersons, there have been more adverse reaction reports on Prozac than any other medical product.

$$ A five year study of 1000 patients by Ann Blake Tracy, Ph D found: “Patients taking psychiatric drugs such as prozac, paxil, zoloft, luvox, effexor, serzone, anafranil & the diet pills - fenfluramine, fen-phen & redux, are in a total anaesthetic sleep state while appearing awake and functioning. Increasing serotonin - exactly what these drugs are designed to do - induces both nightmares and sleepwalk. Patients report that they have lived out their worst nightmare, many have no recall or little recall of what they have done. Often someone must prove to them what they have done while they where under the influence of these drugs before they will believe it to be true. One patient stated that he could not detect during his two year use of Prozac what was real or what was a dream.”

$$ Ann Blake Tracy also claims: “As of October, 1993, a total of 28,623 complaints of adverse side effects had been filed with the FDA, including 1,885 suicide attempts and 1,349 deaths. The FDA’s general rule of thumb for estimating the true figures is that these reports represent only one to ten percent of the actual figures. This would indicate the staggering amount of 286,230 - 2,862,300 actual adverse reactions, 18,850 - 188,500 actual suicide attempts and 13,490 - 134,900 actual deaths attributed to Prozac by the end of 1993.”

Conclusion

As I noted before, Prozac or related drugs might work for you - and that’s fine. However, they are clearly not safe for everyone, but are being promoted and prescribed as if they are. Research is needed to limit the risks of side effects from these drugs (either physical symptoms or behavioural: eg, violence).

Many gain benefits from the drugs, but for a growing minority these drugs do not work. Their lives (or brains) are often destroyed. And for what? For money. That’s all. And why won’t governments stop this? Probably because it’s a lot cheaper to put someone on drugs than provide them with other forms of mental health care. It might also have something to do with cash incentives, massive corruption, and all the usual stuff. Obviously this is a good argument against privatising the health system.

Meanwhile, Prozac and similar drugs manufactured by Eli Lilly are prescribed worldwide everyday. This is probably worst in the US. An estimated 6 million American children between the ages of 6 and 18 are taking some kind of legal mind-altering drug. Is there really that much mental illness in the US? Imagine how many adults must be poppin’ the pills. Have a think about US school shootings:

March 24, 1998: Mitchell Johnson, 13, and Andrew Golden, 11, opened fire on their classmates. Johnson was on psychotropic drugs at the time; the details of which were kept private.
May 21, 1998: Klip Klinkel, 15 years old, murdered his parents and then opened fire on students at his school. He killed 2, wounded 22. He was on both Ritalin and Prozac.
April 16, 1999: A 15 year-old named Shawn Cooper fired 2 shotgun rounds at staff and students at his school. He was on Ritalin at the time.
April 20, 1999: Two 18 year olds, Eric Harris and Dylan Kleebold, killed 12 students and a teacher at their school, then killed themselves. Harris had been under the influence of Luvox (a new kind of antidepressant) prior to the shootings.
May 20, 1999: A 15 year old, TJ Solomon, opened fire on and wounded 6 classmates. He was taking Ritalin for depression at the time.

None of these kids suffered from abuse or illegal drug / alcohol problems. The only thing they all have in common is that they were prescribed drugs of this group.


Sources of information, chunks of text ripe for plagiarism, and propaganda

http://www.lilly.com/
http://www.breggin.com/
http://www.pnc.com.au/~cafmr

Too many journals to list, such as: Journal of Clinical Psychopharmacology, Journal of Clinical Psychiatry, Lancet, American Journal of Psychiatry, New Dawn, Neurology.