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by Rick Giombetti
Monday, Aug. 27, 2001 at 9:55 AM
email@example.com PO Box 2464 Seattle, WA. 98111
The author provides the reader with a Seattle mother's story of her son's 1990 suicide while on Prozac, a corrective to the media myth that Prozac produces few side effects at the passing of Eli Lilly & Co.'s patent on the drug at start of August, a brief history of Prozac and, finally, the author analyzes a recently published article by Dr. David Dunner of the Department of Psychiatry at the University of Washington.
Prozac: A Mother's Story
"There's no such thing as a safe and effective drug," said Coralie Reid of Seattle while reflecting on the 1990 suicide of her son Chris, who had been on Prozac for five weeks when he took his own life. "Alcoholics can't function without alcohol. Nobody thinks this is a good thing. Now why do so many people think it's a good thing that millions of people in this country can't live without their Prozac?"
Reid isn't counting herself among the media led applause for Prozac at the passing of Eli Lilly & Co.'s patent on its top selling antidepressant drug, which happened at the beginning of August (Lilly has been granted exclusive marketing rights over a repackaged version of Prozac called Sarafem for the next several years. Sarafem is prescribed for a variant of PMS known as "Premenstrual Dysphoric Disorder," or PMDD). Reid can be counted among the growing number of people who boo at Eli Lilly's contention that Prozac and its clones, like GlaxoSmithKline's Paxil or Pfizer's Zoloft, are essentially safe and effective drugs that produce few side effects.
Reid's 18-year-old son started taking Prozac after it was prescribed to him by a psychiatrist in February 1990. Chris made his appointment with a psychiatrist while seeking psychotherapy. He wasn't severely depressed, much less suicidal, and the last thing he thought he would need was a prescription for a psychiatric drug. What he got instead was a 20 minute consultation, a psychiatric diagnosis and a prescription for Prozac, the latest wonder drug for depression at the time. Chris's experience with the mental health system has become the rule over the past three decades, as the modern mental health system has steadily changed its focus on psychotherapy to a focus on psychiatric diagnosis and the prescribing of drugs like Prozac. The only other contact Chris would have with his psychiatrist would be for the purpose of refilling his Prozac prescription. It was after Chris began using Prozac that his family and friends began noticing his strange, out-of-character behavior.
"Before he died, he fell asleep with his feet on a radiator," said Reid. "He melted the soles of his shoes and he never woke up while it was happening. Chris had no consciousness about what he was doing when he was on Prozac. Anything he did seemed like it was all right to him." Everything about Chris changed after he began taking Prozac, says Reid. He became severely agitated when he took his daily 20 mg. dose of the drug in the morning. On a few occasions he would come down from his Prozac-induced agitation and fall asleep in the early afternoon. He became a heavy coffee drinker while on Prozac. He cried more than he ever had before while on Prozac. He backed a car into a window on the family home. He suffered a tremendous weight loss while taking Prozac. His mother noticed that Chris's arms were nothing but skin and bone as she walked down the aisle arm-in-arm with him at his sister's wedding. The most disturbing change happened when Chris became verbally and physically abusive towards his girlfriend, something that had never occurred before he began taking Prozac.
The next occasion for a family gathering after her daughter's wedding would not be a happy one for Coralie Reid. It would be for her son's funeral. Chris Reid died after he started an automobile in an enclosed garage on March 11, 1990. He never told anybody he was suicidal. He left no suicide note. He had never been suicidal or violent before taking Prozac. Chris's shocking behavior and his suicide left a mother wondering why it all happened. Coralie Reid could not get any answers from anybody about Prozac and its side effects during her son's short time on the drug. It would take years before she would begin to understand what had happened to her son while he was on Prozac.
Lilly's Prozac Patent Passes: Let The History Rewriting Begin
Barr Laboratories had just begun shipping it's generic version of Prozac, Fluoxetine Hydrochloride, to market in August of this year and the rewriting of the actual history of Lilly's side effect prone drug was already on. Barr won the right to ship its generic version of Prozac to market three years early and the event was met with a flurry of media attention reflecting on Prozac's effect on the history of psychiatry and mental health treatment. "It (Prozac) became a blockbuster (selling drug) because it lacks the harsh side effects of earlier depression medicines," wrote Theresa Agovino in an August 3 Associated Press article about Barr's first shipment of its generic Prozac. "Prozac's success was partly due to the drug's reduced side effects compared to earlier antidepressants," Shankar Vedantam wrote in an August 5 Washington Post article reflecting on Prozac's legacy. Examples of this kind of rewriting of the history of Prozac can be found at the local level across the nation as well. Writer Mary Feingold repeats the same line about the safety and effectiveness of Prozac and its clones while pondering why anti-depressant drug use is so high in such a great place to live like Madison, Wisconsin in the August issue of Madison Magazine.
The actual record of Prozac speaks to a much different reality than the assertions of efficacy and safety being made in most of the media. In fact, Prozac has logged more reports of Adverse Drug Reports (ADR's) with the Food and Drug Administration (FDA) than every other prescription drug combined. As of June 18, 1992, Prozac had been associated with 23,067 ADR's, including 1313 deaths. The total number of ADR's for all other drugs combined at the time was 15,274, including 861 deaths. As of October 1993, Prozac had logged 28,623 ADR's only into its sixth year on the market. At the same time Elavil, an older anti-depressant that had been on the market for 20 years, had received only 2,000 complaints of adverse reactions. Valium, the most popular psychiatric drug before Prozac, had only received 7,000 complaints at the time after 22 years on the market. After only several years on the market Prozac had creamed the field in producing ADR reports. This year the total number of ADR's for Prozac is now at about 44,000, including about 2,500 deaths (Prozac: Panacea or Pandora?, 2001 edition).
It's worth noting that ADR's are only made to the FDA on a voluntary basis. This makes these figures even more amazing given that Lilly has never stopped asserting that its top selling drug is basically safe since its approval for commercial use in December 1987. It also means that the public has anything but a complete picture of how many adverse side effects this drug has really produced in the tens of millions of people who have taken it, as all too often adverse reactions to the Prozac class of drugs are wrongly attributed to the worsening of a patient's psychiatric symptoms.
Contrary to all the assurances of expert defenders of Prozac and its clones that there is nothing to worry about these drugs is the September 1997 FDA recall of the popular diet drug Redux, or Phen-fen. Redux was pulled from the market because of its link to valvular heart disease in individuals using the drug. Perhaps the above quoted writers don't know this but Redux is designed to do the same thing Prozac does to the brains of its user. Namely, Redux revs up the presence of the neurotransmitter serotonin in the brain. Most disturbing of all is a study investigating the brain damage done to monkeys given Redux published in the August 27, 1997 Journal of the American Medical Association. The group of researchers lead by Dr. Una McCann at the National Institute of Mental Health argued that brain damage in Redux may only become "manifest with advancing age."
Redux is an extremely toxic combination of two drugs known as phentermine and fenfluramine, hence its shortened nickname "Phen-fen." Redux had been used for years as a treatment for obesity in Europe and its potential dangers had been identified by researchers long before it had won FDA approval as a diet drug in 1996. Peter Breggin of the Center for the Study of Psychiatry and Psychology in Bethesda, Maryland wrote in his his new book The Anti-Depressant Fact Book that "for several decades evidence had been accumulating that fenfluramines, including dexfenfluramine (Redux), destroy brain cells and chronically impair mental function. They are amongst the most neurotoxic drugs ever approved for use in the United States, but the medical and psychiatric profession showed shockingly little concern about permanently damaging the brains of their patients."
There are also plenty of breaking developments on this issue that are there for the taking but it's hard to find much interest in them in the Seattle Times or the Seattle P-I. The most important development on this front has to be the recent jury verdict in a civil trial against British pharmaceutical giant GlaxoSmithKline (GSK), manufacturer of the potent Prozac clone known commercially as Paxil (Its known as Seroxat in the United Kingdom) and the world's largest drug company. A jury in a federal district court in Cheyenne, Wyoming ordered GSK to pay the family of Donald Shell .4 million for his murderous rampage while on Paxil on February 13, 1998 in Gillette, Wyoming. Schell took two Paxil tablets before shooting his wife, his daughter and his 9-month-old grand-daughter to death. Schell then took his .22 calibre pistol to himself and committed suicide. Company documents revealed that GSK was aware that Paxil could cause healthy volunteers to become suicidal during clinical testing for the drug. The jury found Paxil to be 80 percent responsible for Schell's murderous actions towards his family and himself (abcnews.go.com, June 6, 2001). GSK argued that Schell would have committed suicide without taking Paxil and that its drug would have prevented the suicide if it had time to take effect. The company is appealing the verdict in federal court in Denver.
Furthermore, and most importantly, GSK admitted to the the Medicines Control Agency, the British version of the FDA, that patients who begin drugs like Prozac or Paxil may be at an increased risk of suicide in July of this year. GSK agreed with the MCA's request to issue a warning to doctors and patients about potential suicidality linked to Paxil. In fact, the MCA has been requesting the same suicide warning for all of the Prozac class of drugs, including Prozac, Zoloft, Luvox, et al., for over a year now("Suicide Fear Over Anti-Depressant," by Sarah Boseley, Guardian Unlimited, July 10, 2001). What is most interesting about the GSK cave-in to the demands of the MCA is that it was brought about by the verdict of a jury in a U.S. courtcase, yet the media in this country has shown little interest in covering this story.
None of these amazing developments have been reported in the Times or P-I. The Times did run an article about the marketing of Paxil by Shanker Vendatam of the Washington Post on July 17. Yet no article about the verdict in the Paxil trial or GSK's new warning about Paxil's potential link to suicide was ever published. Neither the Denver Post nor the Rocky Mountain News, the two closest large circulation dailies from where the Paxil trial took place, ever published any articles about the trial either. Searches of the websites of the New York Times, the Washington Post and the L.A. Times turns up only a couple of articles about these developments in the NY Times. The NY Times reported the jury verdict in the Paxil trial on June 8 and the judge's refusal of GSK's request for a retrial on August 11. Neither of these three major newspapers reported GSK's compliance with the MCA's request to include a suicide warning with its drug Paxil.
The plaintiff's expert witness in the Paxil trial in Wyoming was Dr. David Healy, one of the United Kingdom's foremost researchers in anti-depressant drugs and author of The Anti-depressant Era. Guardian health editor Sarah Boseley reported on May 7 that Healy calculates that at least 250,000 people worldwide have attempted suicide because of Prozac, and 25,000 of them have succeeded. Healy conducted the first study ever to demonstrate that Prozac can induce suicidal thoughts in healthy volunteers. Healy argues that between 1 in 20 and 1 in 10 people who take Prozac can develop akathisia, or extreme, restless agitation, and become suicidal (Primary Care Psychiatry 2000; 6:23-28). Prozac manufacturer Eli Lilly adamantly denies any link between Prozac and suicide.
Healy's high reputation within academia internationally has been a cause of worry for Lilly and the last thing the Indianapolis-based pharmaceutical giant would want is for the British psychiatrist to make his home on this side of the Atlantic. Even though Prozac's patent has run out, the drug still stand's to be a steady revenue stream even at the reduced generic price. Prozac sales were .6 billion for Lilly in 2000 so even at the 25-40 percent reduced price the drug could still generate over billion per year in sales for the foreseeable future. The only thing that could put an end to Prozac's money making potential for Lilly would be a suicide warning label easily accessible to doctors and patients here in the U.S., like the suicide warning British regulators have forced GSK to put on Paxil.
Boseley continues with her story about Healy in the May 7 Guardian by describing a prestigious Canadian university's abrupt rebuff of a job offering they had made to Healy. The University of Toronto began courting the respected Dr. Healy for a job at its Centre for Addiction and Mental Health (CAMH) in 1999. By January of 2000 Healy had accepted the job offer and the only obstacle to his moving to Toronto was the red tape involved with emigrating to Canada. Then Healy gave a talk at a two day conference at the CAMH later in the year on November 30. In his talk Healy didn't shy away from claiming that Prozac can cause suicide. Eight days after Healy gave the talk he was told by David Goldbloom, physician-in-chief at the CAMH, that they weren't going to be hiring him for his new job after all. Healy and his defenders believe that the reason why he wasn't hired was because of the behind-the-scenes pressure being applied by Lilly. Lilly is a major funder of the CAMH and Healy believes that was the decisive factor in what prevented him from getting the job he was offered. Lilly denies having anything to do with the decision.
Whether or not Lilly cost Healy his job in Toronto, there can be little doubt that the company will fight long and hard to prevent the term "suicide" from being exported from Britain to North American shores. Perhaps no drug company has gone to greater lengths than Lilly has to market and defend a drug, as in the case of Prozac. Lilly has weathered every media inspired controversy surrounding the drug and every lawsuit against the drug quite well. The drug's reputation as a therapeutic agent for depression has remained intact despite being the record holder for adverse side effects reported to the FDA and the mounting evidence linking it to violence and suicide in its users.
Perhaps no greater disservice has been done to public health during Prozac's 13 year reign as the top selling antidepressant drug than the lack of information for doctors, patients and family members about what this drug does and the side effects it produces. Observing the marketing of Prozac and public discourse about the drug, one is left with the impression that what is being talked about is not a drug, but rather a feel-good-in-the-morning bon-bon. Prozac is almost seen as candy, but it's not. This is a powerful drug that disrupts the body's entire biochemistry and it produces multiple side-effects. Yet it's not marketed as such by Lilly.
Perhaps no prescription drug in history has been marketed with so many claims of safety and therapeutical benefits and so little evidence to back it up. As we will observe in the next section, not even 300 people finished the clinical trials that won FDA approval for Prozac and the average trial lasted about 4-8 weeks. Although these drugs were originally tested and marketed as anti-depressants, in over a decade on the market the additional conditions Prozac and its clones are prescribed for include anxiety, obsessions, compulsions, eating disorders, headaches, back pain, impulsivity, drug and alcohol abuse, hair pulling, nail biting, upset stomach, irritability, sexual addictions, premature ejaculation, attention deficit disorder and premenstrual syndrome. A majority of these drugs are now prescribed by primary care physicians with little or no knowledge of their potential long term side effects or their potential for causing addiction. This is why Coralie Reid could find almost no information about what Prozac was doing to her son before he committed suicide. To understand how this happened it is necessary to know the story behind Prozac, its manufacturer Eli Lilly and the nonexistence of an effective regulatory apparatus that could have warned Reid and countless millions of others about the dangers of Prozac.
The Prozac Story: A Drug Company With A Dark Past Pulls Off A Marketing Bonanza With Prozac
As far as example of previous prescription drugs are concerned, Prozac and its clones are most similar to LSD. Most of the public associates this drug with the '60s drug counter-culture. There was acid guru and former-Harvard professor Timothy Leary, who longed for nothing more than a day when everybody would take this drug. There was also Ken Kesey's Merry Prankster's and their famous "acid tests" immortalized in Tom Wolfe's The Electric Kool-Aid Acid Test. What most people don't know is that LSD was patented by Prozac manufacturer Eli Lilly in 1956 and, of course, the company marketed is as a wonder drug, much like it would do with Prozac over 30 years later. The drug was created by Swiss pharmaceutical Sandoz in 1943. Lilly was awarded the U.S. patent for the drug mainly for supplying the CIA with it for its own "research" purposes. LSD didn't sell well and would go on to be most remembered for its illegal use within the counter-culture.
The other famous hallucinogenic drug of the '60s and '70s drug culture that is similar to Prozac was PCP, or "angel dust." The drug was developed and patented by Parke, Davis and Co. in 1957 as a pain killer and anesthetic. Although the actual experience with PCP proved to the contrary, the drug was marketed by Parke, Davis as having a large margin of safety. By 1967, Parke, Davis pulled the drug from the market. It wasn't until 1978 that the drug was classed as a schedule three drug (having no therapeutic use). The drug became notorious for producing violent manic reactions in users during its heyday as a street drug of abuse in the '70s. Police officers feared seizing it because intoxication could be induced by way of mere skin contact.
"There's nothing new about these drugs (Prozac and its clones)," says Dr. Ann Blake Tracy of the Coalition For Drug Awareness in West Jordan, Utah. "These kinds of drugs have been around for decades. The only difference with Prozac and its clones is that each new drug being marketed is stronger than the preceding drug." Utah is the depression capital of the United States. The state has the highest per capita usage of Prozac and other antidepressant drugs in the nation so Tracy considers herself well placed to document the side effects of Prozac and its clones ("Washington State No. 4 In Anti-depressant Use," Seattle Times, June 21, 2001). Tracy argues in her seminal book on research into Prozac, Prozac: Panacea or Pandora?, that every drug termed an "anti-depressant" by the pharmaceutical industry and psychiatry basically boosts levels of the important neurotransmitter serotonin, much like LSD and PCP.
The theory behind Prozac and other anti-depressant drugs is that low levels of serotonin is what causes depression in people. Serotonin is an important neurotransmitter found in the brain and throughout the body. This chemical fires synapses in the brain and regulates the movement of muscles in the intestinal tract and throughout the body. Lilly and other drug companies argue that revving up the amount of Serotonin in the brain has therapeutic benefits for people experiencing depression and other mental disorders. The pharmaceutical industry's main selling point with anti-depressant drugs is that they "selectively" rev up the amount of serotonin in the brain and nowhere else in the body. By selectively disrupting the metabolism, or "reuptake," of serotonin in the brain, Prozac and its clones are claimed by the pharmaceutical industry and psychiatry to only affect a particular neurotransmitter in a particular part of the body, and nowhere else in the body. Hence, the term "Selective Serotonin Reuptake Inhibitors," or SSRI's, is the name Prozac and its clones have been given by the pharmaceutical industry.
There are limitations to Prozac in theory and practice that the health care profession and the media don't seem to want to deal with. Serotonin is an important neurotransmitter but it's only one of more than 100 that have been discovered so far (Glenmullen, Prozac Backlash). Little is known about how serotonin and the rest of the body's neurotransmitters work. So isn't trying to rev up the amount of serotonin in a particular part of the body like putting your eggs in one basket? How would doing this affect the more than 100 other neurotransmitters throughout the body? Would the body compensate for the increase in serotonin by decreasing the amount of the other neurotransmitters, like dopamine, which regulates the movement of involuntary muscles? Can this claim of "selective" action on serotonin in the brain by the SSRI drugs really be taken seriously? About 90 percent of serotonin is found in the intestinal tract so wouldn't SSRI's increase the amount of the chemical in that part of the body as well?
"I can't believe the drug companies have gotten away with telling the public that low levels of serotonin are what causes depression," says Tracy. "We've known for decades that high levels of serotonin can cause depression and lead to violence in people and animals." Tracy cites the research of Felix Sulman in Israel in the '50s. Sulman found that increased serotonin levels could cause violence in rabbits, which rank among most docile of all creatures. If serotonin levels become high enough, they can lead to what is known as Serotonin Syndrome, which can cause organ failure and possible death. Further research has linked increased serotonin levels with an agitated sleeplessness that can lead to mania and suicide. This is why the CIA was interested in researching the affects of LSD on people. The agency wanted to see if individuals on the drug be put into a drug-induced insanity, and this turned out to be the case in many of the subjects tested on the drug. This is why Tracy argues that the claim that low levels of serotonin leads to depression is turning the research into serotonin upside down.
The period of the clinical trials leading up the FDA approval for Prozac was a dark time for Lilly. The company was reeling from the marketing debacle of its Oraflex drug, which was recalled by the FDA in August 1982 after only three months on the market. Oraflex was prescribed as an anti-imflammatory agent to treat aches and pains due to conditions like arthritis. The marketing campaign for Oraflex got off to a fast start, reminiscent of the company's campaign for Prozac several years later. Prescriptions for Oraflex quickly reached 55,000 per week. However, Oraflex would eventually be linked to the deaths of over one hundred patients in the U.S. and Britain. Lilly, including its chief medical officer, Dr. William Shedden, were cited by the federal government with 25 counts related to mislabeling side effects. Lilly pleaded guilty to the charges in 1985 and the multi-billion-dollar-per-year company was handed a ,000 fine. Dr. Shedden pleaded "no contest" to the charges, was not sentenced to any jail time and found a job at another pharmaceutical company after leaving Lilly.
Although the federal government only handed Lilly a wrist slap for a fine, the admission of guilt in federal court led to approximately 1,500 lawsuits being filed against Lilly, possibly costing the company billions of dollars. In one Oraflex case Lilly paid out million to the son of an 81-year-old woman who died while taking the drug. Lilly had to market a new wonder drug or possibly face the music in bankruptcy court. It was in this atmosphere that Dr. Leigh Thompson would succeed Dr. Shedden as the company's chief medical officer. It was Thompson who would go to the mat to defend Prozac and prevent the drug from suffering the same fate as Oraflex did. There was almost nothing Lilly wouldn't do to prevent Prozac from being associated with adverse reactions and death. It was in this atmosphere that the clinical trials were being conducted by Lilly paid scientists.
An interesting fact about the FDA, the regulatory agency that oversees the pharmaceutical industry, many people are probably not aware of is that the agency does not test drugs it approves for medicinal use. All of the clinical trials that lead to the approval of drugs for commercial use in the U.S. are funded and directed by the companies who market and manufacture the drugs. This should be kept in mind when drug company officials and their paid scientists calmly assure the public that rigorous, long term testing into the safety and efficacy of prescription medications are done before they are brought to market. This is absolutely untrue. Given that private drug companies rely on marketing drugs they have exclusive patents for, it shouldn't be surprising that these companies do anything but long term drug testing in the trials they fund or that they do everything they can to conduct trials which favor the new drug. The trials that lead to the FDA approval for Prozac were no different in this regard.
One of the methods Lilly used in the clinical trials for Prozac was what is known as the "placebo washout." The placebo washout is when researchers deliberately exclude subjects who respond well to a placebo, or sugar pill, from a clinical trial. All drugs being tested for FDA approval must be tested in studies that use the new drug, an older variant of the new drug and a placebo. These are what are known as double-blind studies, whereby the subjects and the doctors administering the drugs and placebo don't know what is being taking. Critics argue that the purpose of the placebo washout is to rig the trial in favor of the new drug by showing it can work better than a placebo. The point of the placebo washout out is to show a statistically significant difference in subject response in favor of the new drug over a placebo. This can only be achieved by lowering the number of subjects a researcher believes might respond well to a placebo before the trial happens. Yet more than one of the trials found Prozac to work only a little or no better than a placebo. Prozac did not do any better when compared to older anti-depressants as well. Breggin notes in The Anti-Depressant Fact Book that every anti-depressant approved by the FDA used the placebo washout in clinical trials (The author got into an argument with a pre-med student about the pros and cons of the placebo washout while writing this story. The pre-med student argued that the placebo washout actually creates a higher standard for the new drug because people who respond well to placebo would respond well to anything, including the new drug. One of the lead investigators for Lilly during the Prozac trials was Dr. David Dunner of the University of Washington. Perhaps Dunner would make a similar argument in defense of the placebo washout but he refused to be interviewed for this article.).
Lilly knew from the beginning that Prozac could cause adverse side effects in people taking the drug. Company documents revealed in the hundreds of lawsuits that have been filed against Prozac show that the company was aware of the possibility of the drug causing Parkinson's-like shaking and severe agitation in the first human subjects who took the drug in the late '70s. One case of severe agitation was so bad the subject had to be taken off the drug. The company began permitting the use of benzodiapine tranquilizers on patients to calm them down while taking the drug. One of the ways Lilly masked these adverse reactions of Prozac in the clinical trials during the '80s was by explicitly excluding any investigation into links between the drug and suicide. The company masked any suicidal reactions to the drug by labeling them with the term "depression."
Critics argue that the most egregious example of rigging during the Prozac trials was the use of tranquilizers by researchers in order to mask the new drug's stimulant profile. The use of other drugs in clinical trials is strictly forbidden for the obvious reason that it makes it impossible to conclude which drug is responsible for which adverse side effect. Yet Lilly did this throughout the Prozac trials and the FDA allowed the company to get away with it, demonstrating once again its inability to act as an impartial regulatory agency of the federal government. In Talking Back To Prozac, Peter Breggin demonstrated how Lilly hid Prozac's stimulant profile by using tranquilizers in combination with the drug on Prozac trial subjects and by creating an unreadable label for the drug.
The FDA would approve Prozac for commercial use as an "anti-depressant" medication in December 1987 despite its obvious stimulant profile, overriding the concerns of its chief medical officer in charge of evaluating Prozac, Richard Kapit. Kapit was concerned the drug could cause "a set of adverse effects which resemble those caused by amphetamine," and that "fluoxetine (Prozac) may negatively affect patients with depression." Lilly would begin marketing Prozac as a drug that was found to be safe and effective after rigorous, long-term testing on thousands of subjects. Breggin discovered when he became an expert witness in some of the hundreds of lawsuits filed against the company for its marketing of Prozac that only a total of 286 subjects ever finished the trials used for the drug's approval. The average length of the trials was only about 4-8 weeks. Lilly has never challenged Breggin in court on these numbers. Like with every other drug approved by the FDA, Prozac was brought to market with basically no long term testing on enough subjects to determine its long term side effects. This left an uninformed public as de facto guinea pigs for determining the long term side effects of Prozac. The drug would quickly become the all-time leader in logging reports of adverse reactions to the FDA.
The early marketing of Prozac went much like the marketing of Oraflex. Lilly touted its latest wonder drug as a break through in the science of treating depression. Prozac was the first drug to ever selectively increase the amount of serotonin in the brain, Lilly's early advertisements for Prozac stated. The actual experience of patients on Prozac has proven to be quite different from the claims made by Lilly in its marketing of the drug, as patients have consistently reported the drug having affects throughout the body. Prozac quickly became the top selling anti-depressant drug in the world.
The first five bell alarm Lilly had to contend with happened early in the Prozac era. On September 14, 1989 Joseph Wesbecker, an employee who had been on leave from his job at the Standard Gravure printing plant in Louisville, Kentucky for stress-related reasons, walked into his former place of employment armed with an AK-47. Wesbecker took an elevator to the third floor of the plant and in robot-like fashion began opening fire on his former colleagues. Eight people would be killed and twelve injured before Wesbecker took his own life. Wesbecker was on Prozac when he went on his murderous rampage. It was a murderous attack remarkably similar to the Littleton, Colorado high school shooting ten years later for its remorseless savagery (One of the killers in Littleton, Eric Harris, was taking the Prozac clone known as Luvox at the time. Breggin confirms this fact in The Anti-Depressant Fact Book. What psychiatric drug Harris's partner-in-crime Dylan Klebold was on at the time of the shooting has not been discovered.).
Although the sales of Prozac were sky rocketing early in its marketing, the number of adverse reactions to the drug being reported were sky rocketing as well. The drug's dangerous side effects began getting national media attention by the beginning of the '90s. Most distressing of all for Lilly was a seminal study about Prozac's potential links to suicidality by a team of researchers lead by Harvard's Martin Teicher. The results of the study were published in the February 1990 issue of the American Journal of Psychiatry. Teicher and his fellow researchers Jonathan Cole and Carol Glod found that Prozac could induce "intense, violent suicidal preoccupation." With the reports of adverse reactions to Prozac coming in from across the nation, the FDA decided to convene a "blue ribbon panel of experts" to investigate the safety of Prozac in 1991.
The day-long FDA hearing on Prozac's safety on September 20, 1991 was rigged from the start to favor Lilly and Prozac. These "blue ribbon" panels of experts are supposed to be comprised of individual experts with no conflicts of interest. However, the FDA allowed five of the nine panel members, including Dr. David Dunner of Department of Psychiatry at the University of Washington, to sit on the panel despite their links to the drug industry. Dunner had been a lead investigator into one of the four trials Lilly submitted to the FDA for approval of Prozac (for more on Dr. Dunner see the section below). Also, four of the panel's six consultants had links to the drug industry. The FDA waived its own standards regarding conflict of interest by granting these nine individuals "waivers" in order to participate in the hearing. The FDA used the specious reasoning that the panel being convened that day would not specifically discuss Prozac. This was ridiculous given that concerns about Prozac's safety were the reason for the hearing in the first place.
Fifty members of the public addressed the panel for up to five minutes each. Many of these people told dramatic stories of becoming suicidal while on Prozac. Others told the panel of stories of family members who had committed suicide while on Prozac. Among those attending the hearing was Coralie Reid of Seattle. She never did testify before the panel about her son's suicide or even present the panel with any written testimony. She met Ann Tracy for the first time at the hearing and would go on to assist her research for Prozac: Panacea or Pandora? Reid would help Tracy obtain the official records of Dr. Dunner's fundraising from drug companies for his department at the University of Washington. Tracy points out in her book that at the time of the Prozac hearing Dunner had received over .3 million in research grants from Lilly since 1982.
Meanwhile, the hearing continued after the public testimony phase. Four Lilly scientists were given a generous amount of time to present the company's case before the panel. Teicher was also asked to speak before the panel about his seminal study into Prozac and suicidality but was completely stifled when he attempted to present his findings. In a decision nobody could have predicted, the panel unanimously gave Prozac a clean bill of health in the area of safety. However, the panel was divided on the issue of whether or not to give Prozac a stricter label warning of its potentially violent side effects. The panel voted 6-3 against requiring a stricter label for Prozac. Dr. Dunner voted against including a stricter warning label for the drug.
Lilly would use the rigged outcome of the Prozac hearing to trumpet Prozac's safety to doctors and in the media. Lilly had weathered the first Prozac scare quite well. The drug was at least immune from being recalled the same way Oraflex had been nine years earlier. The only other public relations threat to Prozac the company now needed to fight off was the bad press and high costs that come with hundreds, potentially thousands, of lawsuits, like the 1,500 lawsuits over Oraflex that put the company on the verge of bankruptcy. In order to fight off the trial lawyers Lilly would engage in what might be the most egregious example of the rigging of a court trial in U.S. history. Twenty-seven survivors and family members of the deceased in Joseph Wesbecker's murderous rampage while on Prozac filed suit against Lilly. The case came to trial in the fall of 1994. While the nation's attention was riveted to the ongoing developments in the O.J. Simpson trial, Lilly would quietly score a courtroom victory that basically put an end to most of the more than 150 pending lawsuits against the company over Prozac at the time.
When the case came to trial Lilly had to desperately fight off attempts by the plaintiff's attorneys to introduce the Oraflex debacle as evidence before the jury. Lilly's lawyers furiously fought against the introduction of any mention of Oraflex in the trial in the private chambers of the judge in the case, John Potter. Judge Potter initially ruled in Lilly's favor on this matter but when Lilly officials testified about how wonderful the company was and how the company would never market a dangerous product to the public, he changed his mind.
The details of what exactly happened after Potter gave the plaintiff's attorneys the go ahead to introducing the Oraflex debacle as evidence in the trial are not completely known even to this day. What is known is that Lilly secretly entered into negotiations for settlement with the plaintiff's attorney's in the case while the trial continued. What Lilly did was promise to pay a higher amount of money in the settlement to the plaintiff's, if they went through with the trial and Lilly won in the trial verdict. The only way the plaintiff's lawyers could throw the case in Lilly's favor would be to not include any mention of the Oraflex debacle to the jury. After the plaintiff's attorney's told Judge Potter that they weren't going to introduce any of the Oraflex evidence they had fought so hard to include only a day after his ruling on the matter, he asked all parties in the case on more than one occasion if settlement had been reached. On each occasion the parties lied by denying having reached a settlement. The nerves of Lilly's officials would have to hold out for the verdict in the trial and they would eventually get their wish. The jury voted 9-3 in favor of Lilly, deciding that Prozac was not the primary cause of Joseph Wesbecker's murderous rampage. It was the narrowest margin allowable in a civil trial. One more vote against Lilly would have ended the trial in a hung jury.
Lilly quickly played up the verdict as a vindication for Prozac and the story of the Wesbecker verdict instantly became headline news. What didn't receive the same amount of media attention was Judge Potter's later ruling overturning the court room verdict and changing it to a settlement. Potter was upset with the appearance of his courtroom being used for Lilly's own PR purposes. He would have to take his case all the way the Kentucky Supreme Court in order to conduct a hearing into whether or not a settlement had been reached behind his back during the trial. Potter eventually overturned the trial verdict and the Kentucky Attorney General would later rule in his favor after conducting an investigation into the case. Nicholas Varchaver wrote about Lilly's rigging of the Wesbecker trial in a 1995 American Lawyer article titled, "Lilly's Phantom Verdict." British Journalist John Cromwell's reporting of the Wesbecker trial is summarized in his 1996 book Power to Harm: Mind, Medicine, and Murder on Trial.
The headline media coverage of the verdict in the Wesbecker trial and the almost complete lack of coverage of the overturning of the verdict helped Lilly decisively vindicate Prozac in the public eye. Most of the 150-plus pending lawsuits against Lilly over Prozac at the time were quickly dismissed or quietly settled out of court. There would be no tidal wave of thousands of Prozac lawsuits. Lilly would hold onto to its Prozac patent with the drug's reputation intact for another seven years.
The final major PR exercise Lilly conducted in defense of Prozac was when the company sponsored a closed symposium on what the company termed "SSRI Discontinuation Events," held December 17, 1996 in Phoenix, AZ. The results of the symposium were published as Supplement 7 in the 1997 Journal of Clinical Psychiatry. Instead of dealing head on with one of Prozac's adverse side effects, one of the reports put together by the group of Lilly sponsored scientists advocated using the euphemism "antidepressant discontinuation syndrome" rather than "withdrawal" because: "Unfortunately, the public often perceives wrongly that antidepressants - like alcohol and barbiturates - are addicting." The term "discontinuation" instead of withdrawal is used throughout the 40-page supplement making it a case study in industry double-speak. However, the supplement does contain a frank discussion by Jerrold Rosenbaum and John Zajecka starting on page 37 about how doctors should go about "discontinuation," or withdrawal, with patients experiencing adverse withdrawal reactions, including how to go about a gradual tapering off of SSRI's. The closed symposium and the published findings of the symposium basically amounted to an admission by Lilly that SSRI's can and do cause addiction in it users.
On the topic of withdrawal Dr. Tracy has always been an advocate of a slow, tapered withdrawal from all SSRI's. She would disagree with Rosenbaum and Zajecka's assertion that there is no need to go through with a tapered withdrawal from Prozac because it has the shortest half-life of all the SSRI's. She wouldn't agree with the rates of taper they suggest either, usually ranging from 25 to 50 percent reductions over a 5-7 day period. Every SSRI introduced since Prozac, first with Zoloft, then followed by Paxil, Luvox, Celexa and others, is stronger and more fast acting. Hence, the shorter half-lives of the stay of the newer SSRI's in the bodies of patients. However, this doesn't mean Prozac can't cause withdrawal reactions. SSRI withdrawal should always be done in small, incremental amounts, like five to ten percent reductions per week. Never start SSRI withdrawal by cutting daily dosages in half or begin taking a daily dosage every other day, says Tracy.
Now over a decade into the Prozac era it has become safe even for mainstream critics of SSRI's to speak out about the dangers of these drugs. In his 2000 book Prozac Backlash: Overcoming The Dangers Of Prozac, Zoloft, Paxil, and Other Antidepressants With Safe, Effective Alternatives, Harvard psychiatrist Joseph Glenmullen reaches basically the same conclusions about the dangers of SSRI's Breggin and Tracy had a decade before he published his book. The main value of Glenmullen's book is his extension review of recent peer-reviewed scholarly investigations into the adverse side effects caused by SSRI's that have been conducted throughout the '90s and his accounts of the adverse reactions patients have experienced while on SSRI's in his private practice. Glenmullen is an advocate for psychotherapy but he is not a complete opponent of psychiatric drugging like Breggin and Tracy are. Also, his position as a faculty member at Harvard makes it more difficult for Lilly to charge that criticism of SSRI's is part of a campaign against psychiatry inspired by the usual suspects.
Not only should patients taking SSRI's be made aware of the potential for increasing their risk for suicide while taking these drugs, writes Glenmullen, they should also be made aware of the permanent neurological damage these drugs can cause. The title for Glenmullen's book, Prozac Backlash, is the term he uses to describe how the body compensates for the increased level of serotonin when patients begin taking SSRI's. The body responds by decreasing its production of the neurotransmitter dopamine, which has been linked with loss of control of involuntary muscles, including up to full blown Parkinson's in some cases. This indirect effect on dopamine ends up creating side effects in SSRI's similar to those produced by a previous generation of psychiatric drugs.
Thorazine was the most popular of a previous generation of drugs known as "neuroleptics," or "anti-psychotics." Thorazine and the other tranquilizers suppress dopamine directly, whereas the SSRI's are believed to affect it indirectly. Approved for commercial use in treating schizophrenia in the mid-50's, Thorazine would go on to become the Prozac of its era, with 50 million U.S. patients having been prescribed the tranquilizer by 1965. Eventually, an estimated 250 million people worldwide would be exposed to the major tranquilizers. The appearance of Parkinson's like tics, or loss of control of involuntary muscles in the face and extremities, by patients on SSRI's is why these drugs are suspected of indirectly suppressing dopamine. Thorazine was never pulled from the market and only received a stricter warning label in 1985, after thirty years on the market and long after most of the patents on the major tranquilizers had expired. It was too late for the patients who had suffered permanent neurological damage from long term use of the these drugs.
Glenmullen also documents the links between SSRI's and sexual dysfunction. Not only have patients on SSRI's reported loss of sexual function, writes Glenmullen, some have reported penile and vaginal anesthesia, or complete loss of sensation in genital areas.
Dr. Dunner: The Pharmaceutical Industry's Man At UW
Carol Ostrom's front page article in the June 21 Seattle Times reported the findings of a study by Express Scripts, a large pharmacy-benefits manager for major corporations, investigating anti-depressant drug use nationwide. The study found Washington state ranks fourth nationally in per capita anti-depressant drug sales. The only expert source for the story was psychiatrist Dr. David Dunner, director of the University of Washington's Center for Anxiety and Depression. In the article Dunner says that doctors in Washington state are not recognizing depression nearly enough and, therefore, are allowing it to go undiagnosed and untreated. Dunner concludes that "the fact we're No. 4 in the nation is a good sign," but this high ranking is occurring "in a climate of terrible undertreatment and underrecognition." Meanwhile, the June 13 Wall Street Journal reported an 800% increase in anti-depressant drug sales since 1990, having reached .2 billion in 2000.
Just who is Washington state's high ranking in anti-depressant drug sales good for? The patients who keep getting prescribed these drugs with little or no warning of the dangerous side effects these drugs produce? Dr. Dunner's ability to keep winning drug industry financed grants for his department? Ostrom could have easily asked Dunner these questions and more because of his position as a professor at a publicly funded university. Virtually everything he does is available through public records requests at UW. Dr. Dunner refused to be interviewed for this article about the safety and efficacy of SSRI's and his links to the drug companies who help fund his department.
Dunner conducts clinical trials with psychiatric drugs for drug companies. He was one of the lead investigators into one of the trials that lead to Prozac's approval by the FDA in the 80's. Dunner found in the trial he lead that "there was essentially no difference in efficacy between fluoxetine (Prozac) and placebo."
A year before Dunner took part in the FDA hearing into Prozac safety in 1991 described above, he had given a presentation for doctors on depression at a workshop sponsored by Lilly. A report on his presentation in Psychiatric Times describes Dunner as citing Teicher's study on intense suicidal preoccupation in response to Prozac. The report, summarizing Dunner's remarks, states, "While there is no evidence from controlled studies to support these findings, close clinical monitoring is advisable." Breggin argues in Talking Back To Prozac that it would have been helpful if the FDA and/or Dunner had made any of his past remarks or his finding of failure for Prozac in the clinical trials known during the hearing.
"He (Dunner) is the main reason Washington state is number four on that list (of anti-depressant drug sales)," says Dr. Tracy. "He is the biggest drug pusher in Washington state." Tracy sees Dunner as little more than a shill for drug companies, who pushes their drugs on patients without informing them of their potentially dangerous side effects. Dunner's fundraising from Eli Lilly from 1982 up to 1991 mentioned above is documented by Tracy in her book. Not much has changed in this regard since then. Records obtained from the University of Washington show that Dunner has received 253 grants and contracts awards since 1992 totaling ,119,371. The majority of these grants and contracts awards have come from drug companies, including 16 awards from Bristol-Myers Squibb since 1995 totaling 5,640, 22 awards from Eli Lilly since 1992 totaling 3,278 and 20 awards from Forest Laboratories since 1998 totaling 2,624. Dunner's links to the drug industry is hardly a revelation about a medical academic. What is more revealing though is investigating how these relationships might affect what he is willing to say in public as opposed to what he says among his fellow academics.
Dunner would not be interviewed for this article and Carol Ostrom's Times article does not mention the side effects SSRI's produce. However, at about the same time Dunner was being interviewed by Ostrom he had just published an article with six other researchers in the June issue of the Journal of Clinical Psychiatry. Much of the record of the adverse side effects SSRI's can cause in patients has been recorded in boring, sleep-inducing academic journals like the JCP. Journalists, much less the public, never look at the contents of these kinds of publications when they interview big name researchers like Dunner. The title of Dunner's latest published article in the JCP is eye opening to say the least: "Efficacy and Safety of Mirtazapine in Major Depressive Disorder Patients After SSRI Treatment Failure: An Open-Label Trial." The real kicker here though is what Dunner and his fellow researchers write in the opening two sentences of the article: "Approximately 29% to 46% of depressed patients show only partial or no response to an initial course of treatment with antidepressants. Lack of efficacy and intolerance are frequent causes of treatment failure or discontinuation."
At the same time Dunner was telling Ostrom at the Times how good it is that Washington state ranks fourth nationally in anti-depressant sales and of the need to prescribe these drugs more often, he had published an article with six other researchers basically saying that Prozac and its clones don't work. Perhaps Dunner could argue that a majority of patients taking SSRI's still benefit from them based on the statistic cited in his article. However, when approximately one in four to one in two patients on these drugs can't stay on them due to lack of efficacy and intolerability, no reporter should be stating that these drugs produce few side effects. Given this statistic, nobody could argue that such drugs are the miracle cure-all drug manufacturers claim they are.
It should be noted here that this statement was not necessarily being made in the interest of science or in informing patients of the dangers of SSRI's. The study was funded by Organon and its purpose was to investigate the efficacy and safety of switching patients from an SSRI that isn't working for them to mirtazapine, or what is known commercially as the non-SSRI Remeron. Organon is the manufacturer of Remeron. Organon is a unit of the multinational concern Akzo Nobel. Dunner has been awarded four grants from Akzo Nobel-Organon since 1996 totaling ,442.
"It is not uncommon these days for drug companies to have control over the distribution of the information in the research they fund," said Keith Hoeller of the Northwest Center for the Study of Psychiatry and Psychology in Seattle, which is affiliated with Breggin's organization in Maryland. Hoeller edits the peer reviewed publication Review of Existential Psychology and Psychiatry. "Many contracts for research now come with clauses stipulating company control over research results. This gives the company the power to withhold information found in studies they don't want the public to see. This gives researchers an incentive to find results their funders are looking for."
Not surprisingly, Dr. Dunner and his six co-authors in the JCP article concluded that, yes, "Our results also indicate that switching to mirtazapine is a safe and effective approach for depressed patients who do not respond to or do not tolerate SSRI's." This is the kind of industry-backed boosterism journalists love to swallow in stories about these drugs because the companies know that journalists almost never read the studies they derive such claims from. The truth is that Remeron didn't prove to be a better treatment option than SSRI's in the study.
Of the 101 subjects who participated in the study, 43 dropped out prematurely, with 26 subjects reporting adverse reactions and 17 for other reasons (e.g. lost to follow up). Only 44 of the study subjects responded positively to Remeron treatment. Given the stated standard Remeron is being compared against, a 29 to 46 percent failure rate for SSRI's, a 43 percent drop out rate, with 26 percent reporting adverse reactions, is hardly a ringing endorsement for the drug.
The most alarming adverse reactions to Remeron by subjects in the study were from 16 who reported psychiatric symptoms. Three reported aggravated depression and two reported mania. These kinds of reactions might include violence and suicide but we can't know this because the study excludes those categories as possible adverse reactions. Also, one subject reported a coronary artery disorder, or a heart problem, as a reason for quitting the study. These kinds of adverse reactions should not be taken lightly in a study with only 101 subjects. If Remeron is eventually prescribed to 10 million patients and only 1 percent of them experience violent and/or manic reactions while on the drug, then up to 100,000 violent acts and/or suicide attempts could happen as a result. A similar scenario could unfold in the area of emergency room visits if the drug consistently causes heart problems in a minority of patients.
Remeron was approved for commercial use by the FDA in 1996 and it was touted by Organon as a new breakthrough in drug treatment for mental illness. Remeron is known as an "NaSSA," or "Noradrenergic and Specific Serotonin Antidepressant." In other words, the drug affects both noradrenergic and serotonergic neurotransmitter systems. The main selling point for Remeron is that it does not cause the same side effects experienced by patients using SSRI's, like insomnia, nervousness and sexual dysfunction. Given the experience of patients on SSRI's for the past 13 years and the fact that these claims are coming from the drug's manufacturer, the public should take these claims with a high degree of skepticism. The same theory of "selectively" inhibiting and/or increasing the presence of certain neurotransmitters is being used here. Even Dunner's study found 20 of 101 patients experienced nervousness and 11 of 101 patients experienced insomnia while on Remeron. These are very high numbers for a trial involving only 101 patients, which lasted only a maximum of eight weeks. Even if Remeron proves in clinical practice to be less likely to produce insomnia and nervousness in patients than SSRI's, such a high incidence of these adverse reactions in such a small body of patients over such a short period of time suggests that Remeron is hardly a long term solution to the adverse reactions experienced by many patients taking SSRI's.
And what about the potential for Remeron causing violence and suicide since the study entirely avoids this issue? Remeron is relatively new and it must compete with an alphabet soup of other psychiatric drugs so not nearly as much is known about its adverse reactions when compared with SSRI's. Breggin describes a man who assaulted and a murdered his wife while on Remeron in The Anti-Depressant Fact Book. Outside of this case, there isn't much information in the public domain about the adverse side effects experienced by patients on Remeron. One can only speculate what patients might experience if they are switched en masse from SSRI's to Remeron.
There wouldn't be any reason to be concerned about Dr. Dunner's JCP article but companies like Organon use these studies they fund to tout the efficacy and safety of their drugs. There is too little skepticism in the media and the public about claims made about the wonders of prescription drugs precisely because very little, if any, attention is paid to the fact that the vast majority of clinical research into prescription drugs is designed and funded by the drug companies themselves.
So why wouldn't Dr. Dunner be interviewed for this article about the adverse side effects to SSRI's in patients, while he was more than willing to co-author an article stating the fact that SSRI's produce plenty of side effects? Given the funding source of the study, a manufacturer of a drug being marketed as an alternative to SSRI's, doesn't this give Dr. Dunner the appearance of a scientist for hire? Breggin notes in Talking Back To Prozac that Dr. Dunner receives honoraria from Lilly for speaking engagements in addition to supervising pharmaceutical industry grants for his department. That was 1994 but there is no reason to believe Dr. Dunner isn't receiving honoraria from drug companies for making speeches at industry sponsored events in 2001.
What does Dr. Dunner tell his patients and subjects about the potential dangers of SSRI's, including extreme agitation, insomnia, sexual dysfunction and possible violence and suicide? If Dr. Dunner won't discuss these issues publicly, then the funding sources of his department must be considered a factor in this. Also, Dr. Dunner can't be unaware of Dr. Healy being turned down for a job at the University of Toronto and the belief it happened because Healy hasn't shied away from linking Prozac to suicide.
Conclusion And Prospects
Perhaps the most culturally detrimental aspect of Prozac's reputation as a therapeutic agent is its ability to raise the profile of dangerous street drugs and discredited prescription drugs. At the beginning of chapter 2 in The Anti-Depressant Fact Book, Breggin describes an article in the New York Times Magazine noting the similarities between the street stimulant Ecstasy and Prozac. The writer dismisses government research into the potential dangers of the Ecstasy because its effects on users are similar to that of Prozac. He reminds the reader that "Prozac style anti-depressants produce some morphological (structural) abnormalities in the serotonin nerve network of rats that resemble changes seen with Ecstasy taken in high levels. Yet few people advocate the banning of Prozac." Instead of reaching the conclusion that perhaps the public should be made more aware of the dangers of Prozac, the writer extolls the virtues of the Ecstasy.
In an ABC News article published on the Internet on March 22, 2001 reporter Robin Eisner writes about current research into medical hallucinogens, including LSD, that could eventually be prescribed to the mentally ill. Despite the long-term damage LSD did to users in the '60s counter-culture, like in the Haight-Ashbury scene in San Francisco, medical research into hallucinogens is now being taken seriously because of Prozac's high profile as a prescription drug.
It is now becoming increasingly difficult for Prozac's defenders to claim that it is essentially a safe, effective drug. There is nothing knew about this, writes Glenmullen in Prozac Backlash. Glenmullen discusses what he terms the 10-20-30 year life span pattern of prescription drugs. This is a process whereby drug companies and drug proponents unequivocally defend the safety and efficacy of prescription drugs in the first decade of their marketing. As time goes by and more research into a drug's dangers becomes available, regulators and professional organizations eventually have to take steps to curb over prescribing of popular prescription drugs. This cycle is usually completed after a certain class of drugs has been on the market for about 30 years.
This was the case with Thorazine. The FDA only required a stricter warning label for the drug in 1985, years after the damage the drug could do had been confirmed in research and after 30 years on the market. The manufacturer of the drug, Smith, Kline & French, never stopped extolling the medical value of the drug. In 1990, after more than three decades of harming patients with irreversible neurological damage, the company shamelessly advertised Thorazine's 35th year on the market with the slogan "Trust 35 Years Of Proven Experience."
The kind of scientifically dubious testing and marketing of these drugs will continue as long as the public allows the FDA to function as little more than a subsidiary of the drug industry. The agency, like so many others in Washington D.C., is filled with officials with past financial links to the drug industry. Many FDA officials use their jobs as a springboard for more lucrative jobs in the private sector after leaving the agency. Glenmullen describes the case of Paul Leber, the FDA's director of Neuropharmacological Drug Products, which was responsible for approving Prozac and led the investigation into Prozac safety in 1991. Leber was an adamant defender of Prozac and in the late '90s joined a consulting firm that specializes in advising drug companies looking to gain FDA approval for new psychiatric drugs.
The FDA will continue to be the lax regulatory agency it is for the foreseeable future. As long as this remains the case, drug companies will continue to market new drugs as scientific break throughs with few side effects. The fact that these kinds of advertising claims will be made in light of a complete lack of long term testing of new drugs will continue as well. As long as the drug companies hold the keys to the FDA, we can expect the public to be unknowing guinea pigs for much of the research that discovers the long term adverse effects of prescription drugs. None of this will change unless the public demands and financially supports a tough FDA that does long term testing on new drugs before they are approved. If that had been done in the case of SSRI's, most if not all them might never have been approved by the FDA. Even if they had been approved after long term testing, they would have come to market with such a strict warning label that most patients who have taken the drugs might not have risked the damaging side effects.
What of Dr. Dunner at UW? Well, he is what he is because the people of Washington state allow him to be that way. With the state's budget having been whittled to the bone over the past several years, Olympia can barely fund our public universities and community colleges anymore. This means that public institutions of higher learning in Washington state will have to rely on even more private funding to stay afloat financially in the near future. As long as Washington state residents refuse to pay the taxes necessary to fully support public universities, Dr. Dunner will continue to raise money from drug companies and conduct research funded by them. As long as journalists continue to ignore where Dr. Dunner receives his funding and the industry funded science he authors in scholarly journals, they will continue to quote him as an unbiased authority on psychiatric drugs. This will have to change in order for more accurate information about SSRI drugs to reach the public.
Finally, what of the documenting of the stories of patients who have experienced adverse reactions to SSRI's Dr. Tracy is conducting in Utah? Whose perspectives on the dangers of SSRI's would we find more reliable? Many of the stories Dr. Tracy has documented in Prozac: Panacea or Pandora? and will be documenting in three upcoming books will be based on anecdotes. This approach to documenting adverse side effects to SSRI's comes with some limitations no doubt. But what of the testing into the FDA approval for Prozac? Most of the 286 subjects who even finished the trials only took the drug for four to eight weeks. Even though the trials were funded by Eli Lilly and the rule book was thrown out by the company in order to gain approval for Prozac, the FDA accepted the company's claims that it had used sound science in the trials at the 1991 hearing into the drug's safety. Meanwhile, the same panel convened to look into Prozac safety callously dismissed the testimony of citizens who had suffered adverse reactions to the drug as mere "anecdotes."
The fact that one of the few ways patients on SSRI's in the '90s could find any information about the side effects of these drugs was and continues on discussion groups on the Internet, like at www.prozac-side-effects.com, should be scene as a major public policy embarrassment for our nation. Here in the wealthiest and most technically advance country in the world drug companies and doctors are not even required to report adverse reactions to drugs in patients. This should be seen as unacceptable but it does not mean that we should discount the experiences of adverse reactions from SSRI's reported by patients across the nation. Breggin notes in his introduction to Dr. Tracy's book that "I myself have learned far more about the dangerous effects of Prozac from Prozac survivors than from the drug company promotional materials."
So whose stories about Prozac safety should we find more believable? The stories of the Coralie Reid's of this world or the calm assurances that we have nothing to worry about coming from the men and women in the white coats, like Dr. Dunner at UW? I would suggest that the time is long overdue for the media to start exposing Dr. Dunner's links to the drug industry and start listening the what Coralie Reid has to say about Prozac.
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