Suppressed Memo: Eli Lilly Hid Increase in Suicidal Thoughts and Aggression with Prozac for Years
It would seem that every time there is a mass shooting in this country, the shooter has either been taking psychotropic medications, usually in the form of antidepressants, or the shooter has recently quit taking antidepressants.
It is well known that these medications can cause suicidal thoughts, especially in young people up to around age 24. If a medicine can cause suicidal thoughts, it would only follow that it can possibly cause violent or homicidal thoughts as well.
A multitude of studies have linked antidepressants to everything from birth defects (including a very serious birth defect called persistent pulmonary hypertension of the newborn, causing the Food and Drug Administration to place a black box warning on them) to increased suicidal tendencies (causing the FDA to update the initial black box warning to include an additional suicidal tendencies warning).
Eli Lilly, the pharmaceutical giant that brought us Prozac, knew this from its own trials as far back as 1984, but the company kept it from the public and the FDA for years, long after the drug was approved in 1988. This information only came to light through a highly controversial litigation.
What do these documents, which the company reportedly worked to keep hidden, reveal about the potential dangers of Prozac (fluoxetine)?
The “confidential” report opens by stating that:
“Fluoxetine [Prozac] may produce both activation (nervousness, anxiety, agitation, insomnia) and sedation (somnolence, asthenia). Approximately 19% of patients might be expected to report activation during acute therapy with fluoxetine which was not present prior to therapy and which could be attributed to fluoxetine (in trials, 38% fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine).”
It is worth noting, however, that the control used in trials was apparently also a psychotropic drug, trazodone, a serotonin antagonist reuptake inhibitor (SARI) that carries “activation” risks of its own, including suicidal and violent behavior. Therefore, the true effects may have been downplayed through semantics and parameters set by the study.
At any rate, Lilly’s own internal report on clinical trials matches up incidence reports for fluoxetine against trazodone (an SARI), amitriptyline and desipramine (both tricyclic antidepressants), as well as maprotiline (a tetracyclic antidepressant). It shows a dramatically higher rate of suicide attempts, psychotic depression, hostility and intentional injury for fluoxetine-based Prozac than any of the other antidepressants used in the company’s own trials.
While suicide attempts represented 3.7% of total reports for fluoxetine in trials, it accounted for only 0.2% of the incidents in trazodone, 0.8% in amitryptyline, 0.3% in desipramine and 0.0% for maprotiline. While Lilly attempted to explain away six of the 12 suicide attempts which occurred during its trials of Prozac, but even if you buy their maneuvering, that’s still a 6:1 ratio of suicides potentially induced by Prozac verses controls.
Similarly, psychotic depression reports spiked in fluoxtine at 2.3% while they represented <1% in the other drugs; fluoxetine was two-and-a-half to four times more likely to cause hostility than other drugs tested, and at least eight times more likely to trigger episodes of intentional injury.
Those results show enough risk and red flags it should give any doctor pause before prescribing them to anyone. The 1984 memo even describes ways to explain these findings away to doctors, stating, “Several suggestions may be helpful in presenting this information to physicians” including emphasis on positives like lower discontinuation rates and encouraging physicians to understand “the meaningfulness of subtracting the placebo rate from the drug associated rate” to “point out these values are relatively low”. (Does history show that, just by the way? Obviously not.)
However, with these studies suppressed, Prozac became the “star drug” for depression and Eli Lilly’s blockbuster.
But at what cost, not only to patients, but to legal protections and a right-to-know for the general public, many of whom may be taking, or could be prescribed Prozac?
According to his report on the documents, Dr. Peter R. Breggin, M.D. was responsible for uncovering several concealed internal Lilly memos during the discovery process as a scientific expert in litigation in the early 1990s – and Lilly certainly did not want them to come to light.
Dr. Breggin explains the bizarre and utterly concerning case this way:
I am familiar with these documents because I initially found them in the early 1990s while searching through mountains of paper produced by the drug company in the discovery process. At the time I was the scientific expert for the combined Prozac suits and one of my tasks was to evaluate Eli Lilly’s discovery materials for all the initial cases…
[…]
Paul Smith, the attorney for the plaintiffs, secretly settled the case during the trial and then denied the fact to presiding Judge John W. Potter. The plaintiffs agreed to water down their presentation of the case to the jury in return for a large secret settlement. After Eli Lilly seemed to win the trial by a 9-3 vote, Judge Potter found out that the trial was a sham aimed at exonerating the drug company.
The Supreme Court of Kentucky declared that Eli Lilly may have committed “fraud” and that the drug company had “manipulated” the judicial system. The judge voided the jury verdict and changed it to “settled with prejudice” by Eli Lilly. Although the initial “victory” by Eli Lilly was widely covered in the press, the change in the verdict was largely ignored.
Consumer protection and medical malpractice hangs in the balance of a very determined legal and marketing team in the modern day world of Big Pharma corporate dominance.
The Indianapolis Star, based in the hometown of Eli Lilly, reported on the legal cunning of the Prozac makers in deflecting liability through “secret deals” and “hardball tactics”:
Critics charge Lilly became adept at lawsuit-quashing through aggressive and sometimes unethical legal tactics. They earned the rebuke of three courts, spurred at least three separate lawsuits and gave rise to charges of trial-fixing, conspiracy and document-hiding.
[…]
The deal was “arguably unprecedented in a Western court,” wrote Cornwell.
Zitrin views the deal as an attempt by Lilly to “create a situation where the trial was fixed.” The deal required Smith to withhold key negative evidence about Lilly from the jury in the end stage of the trial. [Editor’s Note: And also required no appeals or punitive damages.]
The evidence concerned Lilly’s 1985 guilty plea to 25 criminal counts for failing to tell the U.S. Food and Drug Administration about deaths and illnesses of patients taking a Lilly arthritis drug called Oraflex, plus related charges. [Editor’s Note: Analysts say Lilly barely obtained a victory]
[…]
“Lilly made the verdict the centerpiece of a national publicity campaign, touting the safety of Prozac,” said a 1997 ruling by the 7th U.S. Circuit Court of Appeals.
Wow. That is spin at work.
If the reports are true, then a liability in the way of secret deals, suppressed evidence and proof of harm was cleverly turned around into a promotional “victory” for Eli Lilly that dispelled the notions that the drug was harmful or unsafe.
Lilly knew from its own drug trials that nearly 1-in-5 patients would, statistically, undergo “activation”… and could be at risk for a significant increase in suicidal tendencies, as well as aggression and hostilities that were not otherwise expressed.
Reports show that 12 people attempted suicide during Lilly’s own trials, way more than with the other drugs tested, and even with half of these somehow explained away by other factors in the study, the warning would have been apparent if the information had been made available to the FDA and the public.
Read the PDF for yourself.
Instead, profits were put ahead of public health concerns, and many consequences – including shattered lives and even mass shooting incidents – have arguably been connected to this ethical failure to put patients and drug safety first.
Today, the US is a Prozac Nation, where more than one in ten people are taking antidepressants. A new study just came out which found that over 2/3rds of people taking drugs like Prozac aren’t even clinically depressed.
Guess it makes for a much more manageable public.
On an interesting side note, kind of makes you wonder why exactly George H. W. Bush became director of the CIA the year after its MK Ultra mind control scandal broke, only to join the board of directors of, you guessed it, Eli Lilly (also involved in MK Ultra) for two years while Prozac was being developed…
October 28, 2015 -
Posted by aletho |
Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | Eli Lilly, Prozac, United States
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