How a New Policy Led to Seven Deadly Drugs

How a New Policy Led to Seven Deadly Drugs

http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm

By DAVID WILLMAN

WASHINGTON–For most of its history, the United States Food and Drug Administration approved new prescription medicines at a grudging pace, paying daily homage to the physician’s creed, “First, do no harm.”

Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as “partners, not adversaries.”

The FDA achieved its new goals, but now the human cost is becoming clear.

Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.

According to “adverse-event” reports filed with the FDA, the seven drugs were cited as suspects in 1,002 deaths. Because the deaths are reported by doctors, hospitals and others on a voluntary basis, the true number of fatalities could be far higher, according to epidemiologists.

An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role. But the reports are regarded by public health officials as the most reliable early warnings of danger.

The FDA’s performance was tracked through an examination of thousands of pages of government documents, other data obtained under the Freedom of Information Act and interviews with more than 60 present and former agency officials.

The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.

The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for its speed than its caution. In 1988, only 4% of new drugs introduced into the world market were approved first by the FDA. In 1998, the FDA’s first-in-the-world approvals spiked to 66%.

The drug companies’ batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80% of the industry’s applications for new products, compared with about 60% at the beginning of the decade.

And the companies have prospered: The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.

Once the world’s unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe.

“This track record is totally unacceptable,” said Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University. “The patients are the ones paying the price. They’re the ones developing all the side effects, fatal and non-fatal. Someone has to speak up for them.”

The FDA’s faster and more lenient approach helped supply pharmacy shelves with scores of new remedies. But it has also yielded these fatal missteps, according to the documents and interviews:

1. Only 10 months ago, FDA administrators dismissed one of its medical officer’s emphatic warnings and approved Lotronex, a drug for treating irritable bowel syndrome. Lotronex has been linked to five deaths, the removal of a patient’s colon and other bowel surgeries. It was pulled off the market on Nov. 28.

2. The diet pill Redux, approved in April 1996 despite an advisory committee’s vote against it, was withdrawn in September 1997 after heart-valve damage was detected in patients put on the drug. The FDA later received reports identifying Redux as a suspect in 123 deaths.

3. The antibiotic Raxar was approved in November 1997 in the face of evidence that it may have caused several fatal heart-rhythm disruptions in clinical studies. FDA officials chose to exclude any mention of the deaths from the drug’s label. The maker of the pill withdrew it in October 1999. Raxar was cited as a suspect in the deaths of 13 patients.

4. The blood pressure medication Posicor was approved in June 1997 despite findings by FDA specialists that it might fatally disrupt heart rhythm and interact with certain other drugs, posing potentially severe risk. Posicor was withdrawn one year later; reports cited it as a suspect in 100 deaths.

5. The painkiller Duract was approved in July 1997 after FDA medical officers warned repeatedly of the drug’s liver toxicity. Senior officials sided with the manufacturer in softening the label’s warning of the liver threat. The drug was withdrawn 11 months later. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure.

6. The diabetes drug Rezulin was approved in January 1997 over a medical officer’s detailed opposition and was withdrawn this March after the agency had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect in 391 deaths.

7. The nighttime heartburn drug Propulsid was approved in 1993 despite evidence that it caused heart-rhythm disorders. The officials who approved the drug failed to consult the agency’s own cardiac specialists about the signs of danger. The drug was taken out of pharmacies in July after scores of confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect in 302 deaths.

The FDA’s handling of Propulsid put children at risk.

The agency never warned doctors not to administer the drug to infants or other children even though eight youngsters given Propulsid in clinical studies had died. Pediatricians prescribed it widely for infants afflicted with gastric reflux, a common digestive disorder.

Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be “not approvable” for children.

“We never knew that,” said Jeffrey A. Englebrick, a heavy-equipment welder in Shawnee, Kan., whose 3-month-old son, Scott, died on Oct. 28, 1997, after taking Propulsid. “To me, that means they took my kid as a guinea pig to see if it would work.”

By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.

Questions also surround the recent approvals of other compounds that remain on the market, including a new flu drug called Relenza. In February of 1999, an FDA advisory committee concluded that Relenza had not been proved safe and effective. The agency nevertheless approved it. Following the deaths of seven patients, the FDA in January issued a “public health advisory” to doctors.

A ‘Lost Compass’
A total of 10 drugs have been pulled from the market in just the past three years for safety reasons, including three pills that were approved before the shift that took hold in 1993. Never before has the FDA overseen the withdrawals of so many drugs in such a short time. More than 22 million Americans–about 10% of the nation’s adult population–took those drugs.

With many of the drugs, the FDA used tiny-print warnings or recommendations in package labeling as a way to justify approvals or stave off withdrawals. In other instances, the agency has withheld safety information from labels that physicians say would call into question the use of the product.

Present and former FDA specialists said the regulatory decisions of senior officials have clashed with the agency’s central obligation, under law, to “protect the public health by ensuring . . . that drugs are safe and effective.”

“They’ve lost their compass and they forget who it is that they are ultimately serving,” said Dr. Lemuel A. Moye, a University of Texas School of Public Health physician who served from 1995 to 1999 on an FDA advisory committee. “Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry.”

The FDA’s shift is felt directly in the private practice of medicine, said Dr. William L. Isley, a Kansas City, Mo., diabetes specialist. He implored the agency to reassess Rezulin three years ago after a patient he treated suffered liver failure taking the pill.

“FDA used to serve a purpose,” Isley said. “A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what’s been swept under the rug.”

FDA officials said that they have tried conscientiously to weigh benefits versus risks in deciding whether to approve new drugs. They noted that many doctors and patients complain when a drug is withdrawn. “All drugs have risks; most of them have serious risks,” said Dr. Janet Woodcock, director of the FDA’s drug review center. She added that some of the withdrawn drugs were “very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one.” Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors “to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That’s why drugs are prescription drugs.”

In a May 12, 1999, article co-authored with FDA colleagues and published by the Journal of the American Medical Assn., Woodcock said, “The FDA and the community are willing to take greater safety risks due to the serious nature of the [illnesses] being treated.”

Compared to the volume of new drugs approved, they wrote, the number of recent withdrawals “is particularly reassuring.”

However, agency specialists point out that both approvals and withdrawals are controlled by Woodcock and her administrators. When they consider a withdrawal, they face the unpleasant prospect of repudiating their original decision to approve.

Woodcock, 52, received her medical degree at Northwestern University and is a board-certified internist. She alluded in a recent interview to the difficulty she feels in rejecting a proposed drug that might cost a company $150 million or more to develop. She also acknowledged the commercial pressures in a March 1997 article.

“Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting on the market,” Woodcock wrote in the Food and Drug Law Journal. “On the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid.”

But this summer–following the eighth and ninth drug withdrawals–Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve safety concerns.

“As medical practice has changed . . . it’s just much more difficult for [doctors] to manage” the expanded drug supply, Woodcock said in an interview. “They rely upon us much more to make sure the drugs are safe.”

Another FDA administrator, Dr. Florence Houn, voiced similar concern in remarks six months ago to industry officials: “I think the lessons learned from the drug withdrawals make us leery.”

Yet the imperative to move swiftly, cooperatively, remains.

“We are now making decisions more quickly and more predictably while maintaining the same high standards for product safety and efficacy,” FDA Commissioner Jane E. Henney said in a National Press Club speech on Dec. 12.

Motivated by AIDS
The impetus for change at the FDA emerged in 1988, when AIDS activists paralyzed operations for a day at the agency’s 18-story headquarters in Rockville, Md. They demanded immediate approval of experimental drugs that offered at least a ray of hope to those otherwise facing death.

The FDA often was taking more than two years to review new drug applications. The pharmaceutical industry saw a chance to loosen the regulatory brakes and expedite an array of new products to market. The companies and their Capitol Hill lobbyists pressed for advantage: If unshackled, they said, the companies could invent and develop more remedies faster.

The political pressure mounted, and the FDA began to bow. By 1991, agency officials told Congress they were making significant progress in speeding the approval process.

The emboldened companies pushed for more. They proposed that drugs intended for either life-threatening or “serious” disorders receive a quicker review.

“The pharmaceutical companies came back and lobbied the agency and the Hill for that word, ‘serious,’ ” recalled Jeffrey A. Nesbit, who in 1991 was chief of staff to FDA Commissioner David A. Kessler. “Their argument was, ‘Well, OK, there’s AIDS and cancer. But there are drugs [being developed] for Alzheimer’s. And that’s a serious illness.’ They started naming other diseases. They began to push that envelope.”

The wielding of this single, flexible adjective–“serious”–swung wide the regulatory door knocked ajar by the AIDS crisis.

New Order Takes Hold
In 1992, Kessler issued regulations giving the FDA discretion to “accelerate approval of certain new drugs” for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application.

The newly elected Clinton administration climbed aboard with its “reinventing government” project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce “by an average of one year the time required to bring important new drugs to the American public.” As Clinton put it in a speech on March 16, 1995, the objective was to “get rid of yesterday’s government.”

For the FDA’s medical reviewers–the physicians, pharmacologists, chemists and biostatisticians who scrutinize the safety and effectiveness of emerging drugs–a new order had taken hold.

The reviewers work out of public view in secure office buildings clustered along Maryland’s Route 355. At the jet-black headquarters building, the decor is institutional, the corridors and third-floor cafeteria without windows. The reviewers examine truckloads of scientific documents. They are well-educated; some are highly motivated to do their best for a nation of patients who unknowingly count on their expertise.

One of these reviewers was Michael Elashoff, a biostatistician who arrived at the FDA in 1995 after earning degrees from UC Berkeley and the Harvard School of Public Health.
“From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make,” said Elashoff, the son and grandson of statisticians.

Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval.

“The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza,” Elashoff wrote, adding that many patients would be exposed to risks “while deriving no benefit.”

An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza. After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug.

Lost Faith in the System
Elashoff and other FDA reviewers discern a powerful message.
“People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it’s worth,” he said. “Before I came to the FDA I guess I always assumed things were done properly. I’ve lost a lot of faith in taking a prescription medicine.”

Elashoff left the FDA four months ago.

“Either you play games or you’re going to be put off limits . . . a pariah,” said Dr. John L. Gueriguian, a 19-year FDA medical officer who opposed the approval of Rezulin, the ill-fated diabetes drug. “The people in charge don’t say, ‘Should we approve this drug?’ They say, ‘Hey, how can we get this drug approved?’ ”

Said Dr. Rudolph M. Widmark, who retired in 1997 after 11 years as a medical officer: “If you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you are holding up the drug to your bosses. . . . You cannot imagine how much pressure is put on the reviewers.”

The pressure is such that when a union representative negotiated a new employment contract for the reviewers last year, one of his top priorities was to defend what he called the “scientific integrity” of their work.

“People feel swamped. People are pressured to go along with what the agency wants,” said Dr. Robert S.K. Young, an FDA medical officer who in 1998 formed a union chapter to represent the reviewers. “You’re paying for these highly educated, trained people, and they’re not being allowed to do their job.”

Each new drug application is accompanied by voluminous medical data, enough at times to fill 1,000 or more phone books. The reviewers must master this material in less than six months or a year, while juggling other tasks.

“The devil is in the details, and detail is something we no longer have the time to go into,” said Gurston D. Turner, a veteran pharmacologist with the FDA’s scientific investigations division who retired this year. “If you know you must have your report done by a certain date, you get something done. That’s what they [top FDA officials] count, that’s all they count. And that is really, to me, a worrisome thing.”
The FDA did spur reviewers to move at record speed.

In 1994, the FDA’s goal was to finish 55% of its new drug reviews on time; the agency achieved 95%. In 1995, the goal was 70%; the FDA achieved 98%. In 1996, the goal was 80%; the FDA achieved 100%. In both 1997 and 1998, the goal was 90% and the FDA achieved 100%.

From 1993 to 1999 the agency approved 232 drugs regarded as “new molecular entities,” compared with 163 during the previous seven years, a 42% increase.

The time-limit goals quickly were treated as deadlines within the FDA–imposing relentless pressure on reviewers and their bosses to quickly conclude their work and approve the drugs.

“The goals were to be taken seriously. I don’t think anybody expected the agency to make them all,” said William B. Schultz, a deputy FDA commissioner from 1995 to 1999.

Schultz, who helped craft the 1992 user-fee act as a congressional staff lawyer, added: “You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous.”

Indeed, the FDA drug center’s 1999 annual report referred to the review goals as “the law’s deadlines.” And, Dr. Woodcock, the center director, elaborated in a subsequent agency newsletter:

“In exchange [for the user fees], FDA makes a commitment to meet certain goals for review times. [The agency] has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the number of new approved drugs has doubled, and the review times have been cut in half.”

The user fees have enabled the FDA to hire more medical reviewers. Last year, 236 medical officers examined new drugs compared with 162 officers on duty in 1992, the year before the user fees took effect.

Even so, Woodcock acknowledged in an FDA publication this fall that the workloads and tight performance goals “create a sweatshop environment that’s causing high staffing turnover.”

An FDA progress report in 1998, describing the work of agency chemists, said that “too many reviews are coming ‘down to the wire’ against the goal date. . . . This suggests a system in stress.”

Said Nesbit, the former aide to Commissioner Kessler: “The clock is always running, whereas before the clock was never running. And that changes people’s behavior.”

Dozens of officials interviewed by The Times made similar observations.

“The pressure to meet deadlines is enormous,” said Dr. Solomon Sobel, 65, director of the FDA’s metabolic and endocrine drugs division throughout the 1990s. And the pressure is not merely to complete the reviews, he said. “The basic message is to approve.”

Over the last seven years, “there has been a huge shift,” said Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide who now is a drug industry consultant. “FDA, historically, had an approach of, ‘Regulate, be tough, enforce the law [and] don’t let one thing go wrong,’ ” Holcombe said, adding that now, “the FDA sees itself much more in a cooperative role.”

How Deaths Were Calculated
Reports of adverse drug reactions to the Food and Drug Administration are considered by public health officials to be the most reliable early warnings of a product’s danger. The reports are filed to the FDA by health professionals, consumers and drug manufacturers. The Los Angeles Times inspected all reports filed in connection with seven drugs that were approved and withdrawn since 1993. By hand and by computer, The Times counted 1,002 deaths in which the filer identified the drug as the leading suspect. Since fall 1997, this top category has been termed “primary suspect.” The Times did not count any death in which the drug was identified as the “secondary suspect” or less. The methodology and results were reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an assistant professor at the University of Maryland’s department of pharmacy practice and sciences.

The perception of coziness with drug makers is perpetuated by potential conflicts of interest within the FDA’s 18 advisory committees, the influential panels that recommend which drugs deserve approval or should remain on the market. The FDA allows some appointees to double as consultants or researchers for the same companies whose products they are evaluating on the public’s behalf. Such was the case during committee appraisals of several of the recently withdrawn drugs, including Lotronex and Posicor, The Times found.

Few doubt the $100-billion pharmaceutical industry’s clout. Over the last decade, the drug companies have steered $44 million in contributions to the major political parties and to candidates for the White House and both houses of Congress.

The FDA reviewers said they and their bosses fear that unless the new drugs are approved, companies will erupt and Congress will retaliate by refusing to renew the user fees. This would cripple FDA operations–and jeopardize jobs.

The companies’ money now covers about 50% of the FDA’s costs for reviewing proposed drugs–and agency officials say that persuading Congress to renew the user fees into 2007 is now a top priority.

Yet even if the user fees remain, the FDA is prohibited from spending the revenue for anything other than reviewing new drugs. So while the budget for pre-approval reviews has soared, the agency has gotten no similar increase of resources to evaluate the safety of the drugs after they are prescribed.

“It’s shocking,” said Dr. Brian L. Strom, chairman of epidemiology at the University of Pennsylvania. “How can you say, ‘Release drugs to the market sooner,’ and not know if they’re killing people? . . . It really is a dramatic statement of public priorities.”

More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported each year. And those “adverse-event” reports by doctors and others are only filed voluntarily. Experts, including Strom, believe the reports represent as few as 1% to 10% of all such events. “There’s no incentive at all for a physician to report [an adverse drug reaction],” said Strom, who has documented the phenomenon. “The underreporting is vast.”

Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including preexisting disease or use of another medicine.

To be sure, a chain of events affects the safe use of a prescription drug: The companies’ conduct of clinical studies; the FDA’s regulatory actions; the doctor’s decision to prescribe; the pharmacist’s filling of a handwritten prescription; the patient’s ability to take the drug as directed. A lapse at any link could prove fatal.

And once a pill is approved by the FDA, the manufacturer often spends heavily on promotion to seize the largest possible market share. This can exacerbate the risk to public health, according to experts.

“Aggressive promotion increases exposure–and doesn’t give you the time to find the problem before patients get hurt,” said Dr. Raymond L. Woosley, pharmacology department chairman at Georgetown University and a former FDA advisory committee member.

When serious side effects emerge, the FDA officials have championed using package labeling as a way to, in their words, “manage” risks. Yet the agency typically has no way to know if the labeling precautions–dense, lengthy and in tiny print–are read or followed by doctors and their patients.

The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. But the research frequently is not performed–prompting the inspector general of the Department of Health and Human Services to say in 1996 that “FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence.”

Since that report was issued, the FDA has not withdrawn any drug due to a company’s failure to complete a post-approval safety study. Officials conceded this week that they still do not know how often the studies are performed.

One consequence is that greater risk is shifted to doctors and patients.

For example, Woodcock and her senior aides allowed Rezulin to remain on the U.S. market nearly 2 years after it was withdrawn in Britain in December 1997. The FDA recommended frequent laboratory testing of patients using the drug but had no scientific assurance that the tests would prevent Rezulin-induced liver failure.

“They kept increasing the number of liver-function tests you should have,” noted Dr. Alastair J.J. Wood, a former FDA advisory committee member who is a professor of medicine at Vanderbilt University. “That was clearly designed to protect the FDA, to protect the manufacturer, and to dump the responsibility on the patient and the physician. If the patient developed liver disease and he hadn’t had his [tests] done, somebody was to blame and it wasn’t the manufacturer and it wasn’t the FDA.”

Industry Assurances
Leading industry officials say Americans have nothing to fear from the wave of drug approvals.

“Do unsafe drugs enter and remain in the marketplace? Absolutely not,” said Dr. Bert A. Spilker, senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, in remarks last year to industry and FDA scientists.

But during interviews over the last two years, current and former FDA specialists cited repeated instances when drugs were approved with less than compelling evidence of safety or effectiveness. They also said that important information has been excluded from the labels on some medications.

Elashoff, for instance, was surprised at the labeling for a drug called Prograf, approved in 1997 to prevent rejection of transplanted kidneys. The drug first had been approved in 1994 for use among liver-transplant patients.

The new label notes that Prograf was proved effective in a study of 412 U.S. kidney transplant patients. But no mention is made of the company’s 448-patient European study, in which 7% of the patients who took Prograf died–double the 3.5% death rate among those who received a different anti-rejection drug, documents show.

Contributors to this Report
Design director: Joe Hutchinson
Photographer: Brian Walski
Photo editor: Steve Stroud
Graphics: Rebecca Perry
Graphics editor: Chris Erskine
Researchers: Janet Lundblad, Sunny Kaplan
Editors: Roger Smith, Nan Williams, Steve Devol, Bobbi Olson, Kathie Bozanich
Web site Editors: Sarah D. Wright, Clare Sup

An auditor from the FDA’s scientific investigations unit, Antoine El-Hage, examined the European study results and concluded the “data are reliable.” Elashoff agreed in his review.
Yet the only way for doctors or patients to find that data is to search the medical literature or seek the FDA’s review documents.

Excluding the European study from the Prograf label, Elashoff said, “was just a total whitewash. . . . I think any rational person would reconsider taking this drug if they knew what happened in Europe.”

A spokesman for the manufacturer of Prograf said the company had no objection to including the European study results in the labeling. William E. Fitzsimmons, a vice president of drug development for Fujisawa Healthcare Inc., said the decision to exclude the results was entirely the FDA’s.

“We submitted that data,” he said. “It came down to what the FDA was comfortable putting in the label. We certainly have no interest in trying to hide that information. We presented it at major meetings on transplantation. . . . We’re comfortable with that information being out in the public domain.”

But if the FDA had included the European results in the label, it would have impugned the agency’s basis for approving the new, expanded use for Prograf, according to Elashoff and others.

Asked why the agency excluded the information, Woodcock said the European results were “unreliable and could be potentially misleading to doctors and patients in the U.S. if these were included in the label.”

Copyright 2000 Los Angeles Times

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CELEXA: Youth in India Dies During Clinical Trial

Paragraph 10 reads: “Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram [Celexa] by the Sun Pharma Advanced Research Centre in Vadodara. ”

http://www.himalmag.com/Bodies-for-hire;-The-outsourcing-of-clinical-trials_nw3213.html

Bodies for hire; The outsourcing of clinical trials August 2009
By: Sandhya Srinivasan

Medical testing by Western countries is having a staggering impact on India, if only we were to care to pay attention. And the government’s own policies are encouraging this.

Karen Haydock
In November 2008, the Hindustan Times’ LiveMint broke the story of an infant in Bangalore having died after being administered a vaccine in a drugs trial. The Drugs Controller-General of India (DCGI), Dr Surinder Singh, halted the testing, reportedly the first time that the office of the DCGI had taken such action. The trial, for a new pneumonia vaccine, was being conducted by a Hyderabad-based contracted research organisation, GVK Biotech, for the US-based multinational Wyeth Pharmaceuticals. The infant had been recruited from St. John’s Medical College, a reputed private medical institution in Bangalore.

GVK’s spokesperson claimed that the vaccine had nothing to do with the death, as the child had received an approved and widely used vaccine – not the experimental product. However, the DCGI’s investigation revealed that the infant had a heart condition, and that the trial had been meant to be conducted only on healthy babies. According to C M Gulhati, editor of the Monthly Index of Medical Specialities, India and a Delhi-based expert on clinical-trial regulations, the investigation revealed a number of other irregularities as well: the informed-consent document had not been signed before the child was recruited; and the St John’s ethics committee had not been properly constituted, as it was not chaired by an external member to ensure independent functioning.

Yet the infant’s death was not an aberration. In December 2008, 25-year-old K Surender, of Hyderabad, died in a ‘bioequivalence’ trial of a blood-pressure drug, felodipine. Bioequivalence trials test generic versions of drugs to ensure that they are as effective as the original, and involve administering the drug and then monitoring the individual through blood tests and other investigations. These tests are conducted on healthy people who are paid for their participation. The Hyderabad trial also happened to be run by GVK Biotech, which subsequently issued a statement that Surender had simultaneously been part of many bioequivalence studies, with GVK as well as other contracted research organisations. This multiple trial participation could have accounted for his death, argued the company.

Such an explanation is unconvincing. If Surender had taken part in many trials, it would only have been for the money, which would amount to an inducement according to national and international ethical guidelines for research – an inducement that might have made him overlook the risks of the trials. And, in any case, why did the company let him take part in the felodipine trial when it was aware that he had taken part in many others? The answer to this question lies in the compulsions of the global pharmaceutical industry. The GVK trials are among the increasing number of international clinical trials that are taking place in India – and the concerns that they raise will come up increasingly frequently in the future. The reports of various government and private bodies put the potential of the clinical-trial industry into billions of dollars, though the method of calculating these numbers is not available. One market-research company, Frost and Sullivan, reportedly estimates a USD two billion turnover by 2010.

Marcin Bondarowicz
The growth of the outsourced clinical-trial industry in India followed changes in the law in January 2005 that encourage clinical research in India. The most important of these was an amendment to the Drugs and Cosmetics Rules, permitting clinical trials in India to be carried out at the same time that they are done in other countries, rather than waiting until the results of drug trials in other countries were made public. Previously, this ‘phase lag’ had ensured that India was of no interest to big pharmaceutical companies to test their drugs. At that time, Phase II trials were permitted in India only after the results of a Phase III trial abroad were declared. And Phase I trials of foreign drugs were simply not permitted. (Phase I or safety trials are done on healthy ‘volunteers’, Phase II trials look at the drug’s safety and effectiveness on patients, and Phase III trials also look at safety and effectiveness, but in large numbers of patients.) It should be noted, though, that an exception was made for drugs deemed of importance to India. While the Drugs and Cosmetics Rules do not specify, such drugs would probably include the HIV vaccine.

This changed in January 2005, and India is now prominently on the radar screen of the international pharmaceutical industry in terms of clinical trials, given its vast population of potential trial subjects. As of today, the bulk of clinical trials are still located in rich countries. To illustrate, as of 19 July 2009, the US government clinical-trial database lists a total of 76,018 trials, of which 44,758 have sites in North America and 17,878 have sites in Europe – accounting for the bulk of trials. In contrast, only 1021 clinical trials have sites in India, in addition to 122 in Pakistan, 61 in Bangladesh and 12 each in Nepal and Sri Lanka.

However, the number of trials in India is growing fast. Figures given by the DCGI’s office show that the number of newly approved trials every year went from 100 in 2005, when the new rules kicked in, to about 500 in 2008. What is of concern here is that many of the trials that come to countries such as India are likely to be those rejected as unethical in Western countries. As trials shift to countries such as India, there has been an international debate on ethical concerns of the outsourcing boom. This debate has been partly responsible for amendments in the World Medical Association’s Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects” in 1996, 2000 and in October 2008. Drug regulators in Europe and the US require that clinical trials submitted to them adhere to the Declaration.

Some of these changes have dealt with placebos or ‘sugar pills’. The October 2008 revision took a strong stance against the use of a placebo in a trial when a treatment exists. Clinical trials compare the effect of an experimental drug to an existing drug. If there is no drug for the condition, the experimental drug may be compared to a placebo. Using a placebo when a treatment exists deprives the trial participant of effective treatment. The ethical guidelines of the Indian Council of Medical Research and the World Medical Association’s Declaration of Helsinki both forbid the use of a placebo when an effective treatment exists, with certain specific exceptions. While both of these documents have been a bit ambiguous in the past, the 2008 revision of the Helsinki Declaration is clear: placebos can be used only when absolutely methodologically necessary, and when the risk to the participant is low. This revision was reportedly preceded by behind-the-scenes lobbying by the drug industry to permit greater use of placebo controls.

In the same month that the revised Declaration was announced, the US Food and Drug Administration (FDA) amended its own requirements for clinical trials. While placebos are rarely necessary, regulatory bodies such as the FDA require placebo-controlled trials to give marketing approval to new drugs. Yet as of October 2008, trials conducted for FDA approval no longer had to adhere to the Declaration of Helsinki – an internationally accepted document, but not binding unless incorporated into national regulations. The FDA would continue to require placebo controls, and no one was going to tell them otherwise.

Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram by the Sun Pharma Advanced Research Centre in Vadodara.

Certain types of trials are more likely to be conducted in India and other countries where regulatory and monitoring mechanisms are weak, or regulators are too willing to please drug companies. The use of placebos is a good example, as it is not difficult to conduct placebo trials in India. In 2005-06, Indian patients with schizophrenia were taken off their regular medication and given either a new, ‘extended-release’ formulation of an approved drug (quetiapine, marketed by AstraZeneca) or a placebo, to compare the time it took for people in each group to have a relapse attack of schizophrenia. The trial was conducted by a Contract Research Organisation (CRO) called Quintiles, in India as well as a number of countries in Eastern Europe. One patient (not in India) who was on the placebo committed suicide. Experts are unanimous in their view that a placebo was methodologically unnecessary in that trial, as the new formulation could have been compared to the existing ‘immediate-release’ drug. But the European regulators required a placebo-controlled trial, noted Irene Schipper and Francis Weyzig of the Dutch research organisation Centre for Research on Multinational Corporations, in a 2008 report. They also argued that placebo-controlled trials for severe conditions, which put the participants at greater risk, are more likely to be conducted in developing countries.

Trials in government hospitals in India can also be of special concern. In one trial, 290 people who had been hospitalised because they were having a severe attack of acute mania were given either a drug (risperidone, marketed by Johnson & Johnson) or a placebo. The idea, of course, was to examine how many people recovered with the drug, and how many with the placebo. This subjected seriously ill people to harm. The majority of patients in this India-only trial, also conducted by Quintiles, were recruited from government hospitals where, according to the principal investigator of the trial, the most seriously ill patients could be found. It is also where patients can be recruited easily, because trial participation ensures a hospital bed and free, quality treatment.

Another concern about trials in government hospitals is that they are conducted on poor people who may have no access to the drugs tested on them after the trial is over. In August 2008, the media reported that 49 children died in 42 clinical trials that were conducted over two and a half years in the Department of Paediatrics at the All India Institute of Medical Sciences (AIIMS) in Delhi. An investigation ordered by the National Human Rights Commission concluded that the trials were conducted properly: the children in the trials were seriously ill, and all the deaths occurred because of the serious illnesses, not the treatments. However, the committee’s report left many questions unanswered. What, for instance, was the purpose of these trials? Would they help other poor children in India?

One of these trials tested the blood-pressure drug valsartan, supplied by its manufacturer Novartis. Paediatric hypertension is indeed a serious condition, but companies conduct paediatric trials for various reasons, including to get information for the benefit of doctors who prescribe the drug to children. Another reason is because the US FDA extends a drug’s exclusive marketing rights when it is tested on children; this provision is meant to encourage research on children who are otherwise prescribed drugs based on the results of research on adults. However, companies also use this clause to maximise their profits. Another trial was linked to gene-activated human glucocerebrosidase, a treatment for Gaucher’s disease, a serious genetic condition in which a fatty substance (lipid) gets deposited in cells and specific organs. The drug for this trial was provided by the US-based Shire Human Genetic Therapies. Will the drug be made available in India once it is proved effective? Both the Helsinki Declaration and the ICMR’s guidelines emphasise that a community on which a drug is tested should have access to the drugs, if proven effective, once the trial is over. Unfortunately, this is rarely the case. Although all of the new drugs being tested in India will indeed be available in India, this will be at prices unaffordable to the very people who agree to have them tested on their bodies.

More generally, but of no less concern, AIIMS has stated that the trials did not “target” children from poor backgrounds. But there is no need to target poor people at AIIMS – they constitute the majority of patients at this government referral hospital. The simple fact is that the vast majority of people seeking care at the AIIMS centre would be there because they cannot afford treatment elsewhere.

Body market
The pharmaceutical industry depends on constantly getting new drugs into the market. New drugs include new uses for old drugs (a cancer drug that can also be used for infertility?) or ‘improved’ or ‘me-too’ versions of older drugs (all those antacids, blood-pressure and cholesterol-lowering drugs, anti-depressants or antibiotics). These drugs must be tested on human beings before they can go into the market. Permission has to be obtained, patients have to be recruited, trials carried out and the results filed – all at top speed, because time is money.

This is where the Contract Research Organisation – the CRO, such as GVK Biotech referred to earlier – steps in. The CRO undertakes all aspects of the process involved in getting regulatory clearance: getting the necessary permissions, tying up with doctors and hospitals to recruit patients on whom the drugs are to be tested, analysing the data that emerges from the trials, monitoring the trial to make sure that the information collected meets standards, putting together reports and even ghostwriting articles for publication in medical journals. Of course, the most important aspects of all this is the recruitment of patients. The best place to recruit patients for, say, a diabetes-drug trial, is a country with a large diabetic population. And diabetics who have not received treatment make better trial subjects, as the results of drugs tested on them will not be ‘contaminated’ with the results of drugs that they have already used.

Clinical trials in developing countries depend not only on physical infrastructure – hospitals and laboratories – and trained human power. They also depend on drug companies getting access to bodies on which they can test their drugs. So, CROs in India market Indian bodies. In a 2006 advertisement on their website (which has since been removed), a CRO named Igate advertised the ‘India advantage’ as “40 million asthmatics, about 34 million diabetics, 8-10 million people HIV positive, 8 million epileptic patients, 3 million cancer patients.”

CROs in India all claim to have ‘access’ to patients with various health problems for which drugs can be tested. For instance, a research group called Veeda claims to have “access to vast patient populations and has specific expertise in recruiting patients with cardiovascular disease, oncology, diabetes, renal disease”. The CRO Quintiles India once boasted that, for a paediatric-flu-vaccine trial, it recruited 201 one- to three-year-olds from three sites in India in just six days. What kind of network does Quintiles have, and what kind of influence does it have with the medical profession, that it can round up 200 children and convince their parents to let them get an experimental flu shot – all in just six days flat?

It seems that at least some of this is able to take place through wilful misinformation. Spectrum Clinical Research specialises in recruiting patients, collecting patients through networks of private clinics, hospitals, specialists and family physicians. It also runs ‘awareness campaigns’ – for instance, a “white ribbon initiative” on osteoporosis, co-organised with the women’s magazine Femina of the Times of India stable, collected data on 2000 patients with osteoporosis. Another campaign, this time to “defeat diabetes”, collected data on 1000 patients with diabetes. In these ways, people who think they are joining patient-support groups are actually being tracked so they can potentially be put on a trial.

Behind a veil
Other than the boasts of CROs, there is little information available on the hundreds of clinical trials being conducted in India. This is despite the evidence that many of these trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; that trial subjects could be put at risk; that subjects often have not given their informed consent to participate; that they might be provided care that is of lower quality than if they had been recruited for a trial in the West; that injuries during a trial might not be investigated thoroughly, and that those injured may not receive treatment of the highest standard, or even compensation; and that drugs that are tested are often too expensive for people who need them in India.

The only institution to have direct power over the conduct of a trial is the ethics committee (EC). Research institutions appoint their own institutional ethics committee to conduct an ethics review of all research proposals from within the institution. Independent or freelance ethics committees undertake ethics review for a fee, from anyone who applies – usually the CRO or drug company who coordinates the trial at a number of small nursing homes or private clinics, which don’t have their own ethics committee. The EC is a collection of specialists from various fields who review trial documents, including the trial design, the manner in which subjects are recruited, the patient information sheet and the informed-consent form, and approve or reject the application. These committees also have the authority to investigate a trial, and even to stop it if they feel that something is not right.

Ethicist Amar Jesani points out that ethics committees have a lot of power, as the DCGI requires that all trials be passed by such an appointed group. In fact, the DCGI only requires approval by an ethics committee, since it does not monitor the actual conduct of the trial – it does not check that informed consent is taken, that the investigators do their job correctly, that subjects are not harmed, and so on. Thus, says Jesani, it is the ethics committee, not the DCGI, that is the real regulator of clinical trials.

Yet the effectiveness of an ethics committee depends entirely on the setting in which it functions. Important factors, for instance, include the institution that funds the committee’s work or that determines its level of independence, the training of its members, and their competence in terms of doing a proper ethics review. Likewise ‘independent’ or freelance ethics committees are more accountable to the companies that pay for their services. Even the patient information sheet and informed-consent document are treated as confidential documents by the ethics committee – and, of course, the trial’s sponsor. These contain the information on the purpose of the trial, its risks and benefits, and an assurance that a patient’s treatment will not be jeopardised by refusal to participate, or withdrawal from a trial. There is nothing here of proprietary value – on the contrary, everything in these documents is of public interest, and they should be available to the public. Ethics committees are also often poorly educated in their responsibilities.

The reports of people dying in trials are likely to be merely the tip of the proverbial iceberg. And many more are likely to suffer an injury related to the trial drug, injuries that require treatment and that could result in temporary or permanent disability. Indian guidelines require that trial participants be compensated for injuries suffered during research. However, a study by Urmila Thatte and others in a 2009 issue of the UK-based Journal of Medical Ethics found that many trial investigators as well as ethics committee members are not even aware of this requirement. The guidelines of trial sponsors – such as drug companies – provide for medical treatment of any participant who suffers a trial-related injury, or reimbursement of their medical costs. However, Thatte and her colleagues found that none of the companies sponsoring trials, or ethics committees reviewing their trials, had a policy of compensation for trial-related disability or death. Yet for ethics committees to be a law unto themselves is hardly surprising, given the overall environment of lax regulation and monitoring.

Now, the FDA’s decision to do away with the Declaration of Helsinki will create a dilemma for the DCGI. If CROs in India are to follow the FDA requirements – such as using a placebo even when it is not absolutely necessary, and when it might put subjects at risk – they will be violating Indian regulations, which require that the Declaration of Helsinki be followed. The latest revision of the Declaration is quite clear that the placebo may be used in very few circumstances. At the moment, however, the DCGI’s record – permitting a number of unethical trials – suggests that his office places greater value on the potential financial returns of clinical trial outsourcing than on protecting the people who take part in drug trials in India.

Sandhya Srinivasan is a Bombay-based journalist specialising in public health and development issues. She is executive editor of the Indian Journal of Medical Ethics.

556 total views, 1 views today

PROZAC: Man Hallucinates for Two Weeks: U.S.A.

Paragraphs 2 and 3 read: “I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

http://www.clusterflock.org/2009/08/dear-clusterflock-have-you-ever-hallucinated.html

August 1, 2009

Dear Clusterflock: Have you ever hallucinated?

I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

1. I woke violently as a tiger jumped from sitting above the bedroom door, onto my pillow and then jumped up onto a shelf (which didn’t exist in reality) above the bed. I woke my wife, quite calmly pointed out said tiger, but was told to return to sleep as there wasn’t one. He only appeared once.

2. I woke to see a man standing in the doorway of the bedroom — that would have been about 4 feet from me. He didn’t scare me. I came around slowly to see him standing there. I don’t remember colour — I do remember him being an Abe Lincoln type ­ stovepipe hat, and a beard. He wasn’t moving. I woke my wife and asked her quite calmly if she could see the man stood in the corner ­ she could not. I lay there for a while looking at him, closing my eyes and opening them. He stayed for a while and then left.

He returned for quite a few nights. He was always in the same place, always in monochrome and he never spoke. Unfortunately, I never spoke to him.

3. I woke one night. I was lying on my back, and as I looked up at the ceiling it was alive with a sea of frogs ­ all moving as one. I again woke my wife ­ just for the reality check. They stayed until I closed my eyes, say 20 minutes, then disappeared.

383 total views, 1 views today

DEPRESSION MED: Violence: Man Beats Up Frail Neighbor: England

Fourth paragraph from the end reads: “Rod Hunt, in mitigation, said his client had been mixing alcohol with anti-depressant tablets, which had made him turn violent.”

Paragraphs four & five read: “In a letter to the court, Mr Hodgson described Summersgill as a decent man and said the brutal assault was out-of-character.”

“The pair were friends at the time, and Summersgill and his partner, Heather Barnett, acted as carers for their neighbour.”

Paragraphs seven & eight read: “Paul Newcombe, prosecuting, said that without warning, Summersgill turned to his housebound friend and said he would kill him.”

“He then grabbed him by the throat and squeezed tightly as he pushed him onto a bed in his front room.”

SSRI Stories Note: The Physicians Desk Reference states that antidepressants can cause a craving for alcohol and alcohol abuse. Also, the liver cannot metabolize the antidepressant and the alcohol simultaneously, thus leading to higher levels of both alcohol and the antidepressant in the human body.

http://www.thenorthernecho.co.uk/news/4515923.Man_jailed_for_threats_to_kill_frail_neighbour/

Man jailed for threats to kill frail neighbour
1:06pm Tuesday 28th July 2009

By Neil Hunter »

A DRUNK who throttled a wheelchair- bound neighbour after threatening to kill him was yesterday jailed for four years.

Paul Summersgill left the frail pensioner on the floor of his home and stole his mobile phone and spectacles before fleeing.

Teesside Crown Court heard that Bernard Hodgson, 65, blacked out during the attack, which left him covered in wounds and bruises.

In a letter to the court, Mr Hodgson described Summersgill as a decent man and said the brutal assault was out-of-character.

The pair were friends at the time, and Summersgill and his partner, Heather Barnett, acted as carers for their neighbour.

On the day of the attack, April 9, Summersgill had been at Mr Hodgson’s home watching television and drinking his beer.

Paul Newcombe, prosecuting, said that without warning, Summersgill turned to his housebound friend and said he would kill him.

He then grabbed him by the throat and squeezed tightly as he pushed him onto a bed in his front room.

On the brink of consciousness, Mr Hodgson then had his face pushed into a pillow.

Summersgill then loosened his grip and took the phone and glasses.

After a short time, Summersgill threw a chair at Mr Hodgson, knocking him to the floor.

Mr Newcombe said: “He then straddled him, using his knees on the victim’s shoulders to pin him to the floor. He again put his hands around the victim’s throat, strangling him and striking him repeatedly across the face.”

Rod Hunt, in mitigation, said his client had been mixing alcohol with anti-depressant tablets, which had made him turn violent.

Summersgill, 34, of The Bungalows, Grangetown, Middlesbrough, admitted wounding with intent to cause grievous bodily harm.

The court heard that last year he throttled his girlfriend, now pregnant, until she lost consciousness.

Judge Tony Briggs, who described Mr Hodgson’s supportive letter as “unusual and extremely generous”, said: “It was a nasty, vicious attack and custody is inevitable.”

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DEPRESSION MED: Talk Radio Show Host Fired for “Wacky” Personality Change…

Paragraph two reads: “The Hammer, sacked by ESPN Radio in May partly because of a couple of wacky nights he blamed on a change in depression medication, will sit in with Big Dick the next couple of afternoons 4-6 p.m. – today, Friday, Monday and Tuesday, to be exact – on Rational Radio KMNY 1360 AM’s and see where this thing goes.”

http://blogs.dallasobserver.com/sportatorium/2009/07/breaking_news_greg_williams_ta.php

BREAKING NEWS: Greg Williams, Take III
By Richie Whitt in Radio, TV and that Damned Media
Thursday, Jul. 2 2009 @ 7:00AM

Welcome back.

If you were surprised by Greg Williams’ cameo on with Richard Hunter yesterday afternoon, you haven’t been paying attention.

The Hammer, sacked by ESPN Radio in May partly because of a couple of wacky nights he blamed on a change in depression medication, will sit in with Big Dick the next couple of afternoons 4-6 p.m. – today, Friday, Monday and Tuesday, to be exact – on Rational Radio KMNY 1360 AM’s and see where this thing goes.

No defined role, and the gig is somewhere comfortably between a tryout and full-time. It’s the Wild Ass Circus, so who knows?

“It’s the talk radio equivalent of a jam session,” Hunter told me last night. “We wanted to do it before he went to ESPN, but he had a contractual conflict.”

I know this: Williams should be – and is – thankful to have a friend like Richard Hunter.

First, BDH invited him to be a groomsman in his wedding at this jumpin’ joint in Las Vegas. And now – you listening, Ticket boys? – when Williams needs a friend in the business Hunter is doing the opposite of turning his back on an old buddy.

I know, what a concept.

“There are two guys that I owe for my break in radio, and I will always have a place for either one of them to join me on air,” says Hunter. “Hammer’s one of them, and the other one is his former partner. I owe both those guys big time.”

No, I don’t think he’s referring to RJ Choppy.
Tags: Big Dick Hunter, Greg Williams, radio

436 total views, 1 views today

Strattera Deaths (German TV Request) False Reports from Eli Lilly

Wed Nov 12, 2008

We have received a request from a German TV crew who is doing a special on Lilly’s newer ADHD medication, Stratera. These investigative reporters from Germany are doing a 45 minute piece and looking for experiences of tragedy /suicide or severe adverse reactions in children treated for ADHD with this drug. I know we have had reports, but I do not keep close track anymore of which drug is involved after so many cases because all these drugs work basically the same way. An antidepressant is an antidepressant no matter what you callmit or what you prescribe it for or how you explain its supposed uniqueness. So if you or someone you know has been through a Strattera-induced nightmareand would be willing to help get some exposure of this in the press, please get in touch with me so that I can put you in touch the reporters.

O nce you read the following article on Strattera deaths you will see how very important it is to get information about this drug out to the public –

especially throughout the UK and Europe. What is going on here IS CRIMINAL!!
And here is just one example out of the article below that is full of data on how
the government agency in the UK who oversees these drugs is ignoring
critical information – even fatalities, and doing NOTHING but making excuses
for their own behavior:

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing “œpsychomotor hyperactivity. Lilly called
this an exacerbation of the “œunderlying ADHD”. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done not even from the manufacturer.

Do read the rest of the information because it is clearly eye opening!! This
newer ADHD drug, Strattera, which is really an SSRI antidepressant, is
getting away with murder right under everyone’s noses. So definitely if you
know someone who is willing to talk to this news crew about their experience with
this drug, please do let me know ASAP.

Thank you,

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_
medicines_agency_refuses_to_act.htm#_
(http://www.newmediaexplorer.org/sepp/2008/10/20/strattera_adverse_effects_uk_me\
dicines_agency_refuses_to_act.htm#
)

October 20, 2008
_Print this article_
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Strattera adverse effects: UK Medicines Agency refuses to act
By Sepp Hasslberger

Categories
_Pharma_ (http://www.newmediaexplorer.org/sepp/pharma.htm)

Janne Larsson, an investigator and reporter in Sweden, has obtained
information about adverse event reports on Eli Lilly’s ADHD drug Strattera,
using the Swedish freedom of information laws. The data, coming from both the FDA’s
adverse reaction database and from reports to the UK’s Medicines agency, shows
numerous adverse effects and scores of deaths by suicide.

Yet the agency, even after repeated prodding by Larsson to initiate action,
has refused to budge or even acknowledge that there is a problem. MHRA
apparently accepts the drug’s producer Eli Lilly’s data rather than its own and
the
FDA’s adverse event reports.

Image credit: _Monheit Law_
(http://www.monheit.com/strattera/contact_lawyer.asp)

Larsson says: An investigation of MHRA™s handling of the harmful effects of
the ADHD drug Strattera has proven the following:

MHRA has ignored data about instances of death among children in connection
with Strattera treatment. At least 41 children have died. The agency has not
investigated the reported cases and does not even have a compiled summary of
cases with fatal outcome. Further the agency has allowed the manufacturer Eli
Lilly to give false information about the number of fatal cases and has
taken no action against the company once the false information was revealed.

MHRA has for almost three years been in possession of data proving that
Strattera can cause agitation, mania and psychotic reactions with hallucinations
among children. Yet no warning has been issued to doctors and parents. The
agency has withheld these disastrous consequences despite clear evidence. Due
to bureaucratic procedures no warnings have been issued even if Eli Lilly reluc
tanly conceded to include these harmful reactions in its information to the
public almost a year ago.

MHRA has for almost three years been in possession of data showing that
Strattera in many cases actually can cause or worsen the œcondition it is
claimed to alleviate. More than 700 reports were submitted to the manufacturer,
Eli Lilly, about Strattera inducing œpsychomotor hyperactivity. Lilly called
this an exacerbation of the œunderlying ADHD. If we would apply this to
the area of real medicine and to diabetes we could say that the patient got a
diabetes medication with resulting heavy increase in blood sugar level. Such a
medication would probably be withdrawn very fast from the market. But the
MHRA has not yet, after three years, succeeded to get even a bad quality review
of these cases done“ not even from the manufacturer.
The background data for these conclusions can be found in the following text
and in the linked documents. When reading the data below please remember the
promise from the MHRA: we take any necessary action to protect the public
promptly if there is a problem._MHRA, About us_
(http://www.mhra.gov.uk/Aboutus/index.htm) [1]

Note that the linked documents (within letters described below) in most
cases could not be obtained in UK where the issuance of them would be deemed as
prejudicing œthe ability of the Assessory body to offer impartial advice and
where the MHRA wants to allow marketing authorisation holders the chance to
respond to regulatory action and make commercial decisions before data are
in the public domain. (MHRA, e-mail about FOIA-request, 29th September,
2006). However the documents could be obtained in Sweden, even if the MHRA has
tried to stop the issuance of them by implying that publication could threaten
the relations between Sweden and UK.
Deaths among children in connection with Strattera treatment

In May I submitted detailed data about cases of Strattera death to the MHRA.
1st October I finally got an answer from the Scientific Assessor of the
Vigilance and Risk Management of Medicines (VRMM). 7th October I got an answer
from Professor Kent Woods, CEO of the MHRA, referring to the letter sent by the
Scientific Assessor.

My data about Strattera deaths can be found _in the letter_
(http://jannel.se/Strattera.death2.pdf) Strattera: Eli Lilly gave false
information about
deaths from Strattera treatment “ a request for full investigation from 15th
May. [2]
The answer from the Scientific Assessor shows that MHRA is continuing to
ignore data about instances of death among children and adults in connection
with Strattera treatment. Despite limited resources and having to rely on data
released by reluctant medical agencies I had been able to produce a summary of
reported cases of Strattera death. Thats much more than the MHRA, with its
immense resources, had been able to do.

The agency was provided with specific data about instances of death forming
an excellent starting point for a full investigation. But instead of using
the data the MHRA used its energy to explain why it is impossible to
investigate these cases further, and in doing so presents some remarkable
comments.

The Scientific Assessor states _in the letter 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3]:

in order to calculate the total number of reports with a fatal outcome
it is not simply a case of adding up reports with a fatal outcome mentioned
in our assessment reports of the PSURs [Periodic Safety Update Reports] and
those available on the FDA website as these different sources may contain
duplicate information. [Emphasis added.]

I fully agree and it takes only a casual reading of my letter from 15th May
to find out that much care has been taken to exclude possible duplicates. It
is quite easy to see that the data presented about fatal cases in my letter
is NOT simply a case of adding up reports with a fatal outcome. The only
way to come to another conclusion would be not to look in the first place and
it is a condemnation of the effectiveness of the agency to state the following
in the letter:

We have looked at the data you have sent us to see if they can add insight
to the statutory sources of data we have received and do not think that they
are of benefit as we cannot verify their source or accuracy. (p. 3)
[Emphasis added.]

I must add to all the data provided in my letter 15th May that the our

of the information about fatal cases is FDA™s Medwatch system and the PSURs
(submitted directly to the MHRA). I must make it clear that is very easy for
a lay person to find out that almost all reports about fatal outcome from
Strattera treatment submitted to the FDA came from Eli Lilly!

Thus the our of the information about fatal cases was in most of the
cases the manufacturer itself“ Eli Lilly. And yet the MHRA has not been able
to verify the source or accuracy of the information. The MHRA Scientific
Assessor states in the letter:The sources of data that regulators use such
as company data, spontaneous adverse reaction reports and literature are set
out in European and national law.
My FOIA request earlier this year to get a compilation of fatal cases in
connection with Strattera treatment was answered 12th August:

Thats very good and now we know that the data I submitted to the MHRA about
all fatal cases from Strattera treatment “ in the absolute majority of cases
were known by and reported via the manufacturer Eli Lilly.
The MHRA holds no data other than that previously released to you [the
misleading data from Eli Lilly in November 2007, see my letter from 15th May
for
more data] which was the data provided by the company. If you have any
questions about FDA data or the data provided by the company, you should
contact those organisations.

In other words the MHRA didn’t have a compiled summary of cases with fatal
outcome in August and the agency has not to this point been able to compile
such a summary.

As the agency has not been capable of getting the data or not even been
capable of using the specific data submitted for its use in a full
investigation NO action is taken despite the many verified deaths among
children in connection with Strattera treatment. This disregard for the safety of children is a scandal which should lead to a full formal investigation by the
Department of Health.

Drug induced agitation, mania and psychosis with hallucinations

Ive been contacted by parents asking if Strattera can induce mania and
psychosis with hallucinations. Their children have had such symptoms. The
parents have not found any warnings about it and their childrens doctors don’t
think that the symptoms are caused by the drug. The parents were desperate.

However the MHRA has known for almost three years that Strattera can cause
agitation, mania and psychotic reactions with hallucinations among children,
but has refused to issue warnings about it.

The Scientific Assessor from the MHRA _in the letter of 1st October_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf) [3] now confirms my
earlier arguments that the agency had knowledge about these effects a long time ago:

following an initial request in the assessment report for the Periodic
Safety Update for the period (dates 27-05-2005 to 26-11-2005) we asked Eli
Lilly for more information to enable us to review this issue in more detail. (p. 2)

This means that in the period ending 26th November, 2005 at the time when
Strattera was approved only in UK and four other European countries, but not
in the 22 additional European countries where it is now approved Eli Lilly
and the MHRA had knowledge about these disastrous effects in children taking
Strattera. But neither the MHRA nor Eli Lilly told anything about it and
Strattera was approved in 20 additional European countries in April 2006.
Image credit: _Wikimedia Commons_
(http://commons.wikimedia.org/wiki/Image:Strattera_atomoxetin.jpg)

Professor Kent Woods, CEO of the MHRA seems to be very misinformed by his
staff when answering about Strattera in a recent _letter of 7th October, 2008_
(http://jannel.se/answer.kent.woods.pdf) . In the letter Professor Woods
states [4]:

The MHRA is committed to ensuring that all safety concerns are subject to
robust scientific assessment and the best possible regulatory action is taken
in a timely manner. We strive to maintain the highest standards of work and
review our practices to ensure these standards are maintained or improved
upon where necessary. (p. 1)

In their 3rd March, 2006 report Psychiatric Adverse Events Associated with
Drug Treatment of ADHD: Review of Postmarketing Safety Data [5], the FDA
stated that there was compelling evidence for a likely causal association
between [Strattera/amphetamine drugs] and treatment emergent onset of signs and/or
symptoms of psychosis or mania, notably hallucinations, in some patients.

(p. 17) 360 reports about the drug inducing these effects had been received
up to June 2005.

From this FDA report the MHRA had knowledge about the œcompelling evidence for Strattera causing these effects on or about 3rd March, 2006 but did nothing.

In August the same year (2006) the MHRA requested the same data set from Eli
Lilly that was submitted to the FDA and which formed the basis of the FDA
report for Strattera. The data was sent to the MHRA some days later. But the
agency then decided not to do anything with the information. Instead it was
decided that Eli Lilly the manufacturer should do an analysis of the data
and submit its conclusions to the agency.

Professor Kent Woods says in his letter: An important aspect to this [ robust scientific assessment, highest standards] is ensuring that data from all available sources have been consider This may be true in some other area but it is definitely not true for the
safety work around Strattera. A very good example of this is the complete
rejection of the robust scientific assessment of Strattera in the FDA report.
Answering the question why the agency did not use the compelling evidence for harm in the FDA report _an official at the MHRA declared in a letter_
(http://jannel.se/mhraanswer.pdf) [6]:

Changes to European product information are based on assessment by EU
regulators, agreement between member states and in line with legal requirements
about product information, not on conclusions of FDA assessors. (25th May,
2007) [Emphasis added.]

Responsible officials at the MHRA had instead decided to rely completely on
the analysis of the manufacturer of the drug Eli Lilly. (In an article in
the Daily Mail this summer, Andrew Herxheimer, editor of the Drug and
Therapeutics Bulletin, and emeritus fellow of the Cochrane Centre commented:
Asking a drug company to review its own product is crazy, but it goes on quite a lot.
) [7]

At the end of 2007/beginning 2008 Eli Lilly submitted its review of
Strattera induced agitation, mania and psychosis with hallucinations to the
MHRA. It was a complete whitewash.

In summary: FDA was very clear about the psychosis-inducing effects of
Strattera; the MHRA did not listen. Instead the MHRA turned to the
manufacturer. Eli Lilly tried to explain away all the bad results found in its review. For
the full history about MHRA’s failure in this area and for a comparison of
the FDA report with the Lilly report, please see the following letter: _The
ADHD drug Strattera“ actions needed now_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] from January 2008, and
the letter _The ADHD drug Strattera“
an analysis of reports of drug induced mania, psychosis and hallucinations_
(http://jannel.se/strattera.mhra.March.08.pdf) [9] from March 2008.

In the letter from March [9] Eli Lilly’s whitewash report for the period up
to November 2007 is presented. At the end of that report Lilly says [10]:

Nevertheless, Lilly will consider adding language regarding psychotic symptoms
including hallucinations to its product information sheet. (p. 1279)

Larsson – _Suicides & Psychiatric Drugs_
(http://www.newmediaexplorer.org/sepp/suicide.psychiatricdrugs.pdf)

And so we come to October 2008 and the letters from Professor Kent Woods and
from the Scientific Assessor for Strattera. We are reassured that the MHRA
is acting to ensure that Strattera is used as safely as possible that

all safety concerns are subject to robust scientific assessment and the best
possible regulatory action, that any new safety signals are evaluated in
an independent, scientifically robust manner (Woods); we are told that

discussions between European Member States and Eli Lilly are ongoing to agree
on the most appropriate information to be included in the product information
for patients and prescribers; we are told to be patient, to understand that
it takes time from the point where œupdates have been agreed for inclusion in
the product information to the point where these will appear in the packs
in the market place due to movement of stock in the supply chain, and that
the appearances are estimated to be within the next 6 months (Scientific
Assessor).

It is probably hard to find a more obvious violation of the promise¦ we
take any necessary action to protect the public promptly if there is a
problem than the case described above. The worried parents still have no answers if
Strattera can induce the symptoms they find in their children. And the MHRA
knew about it three years ago but withheld the data. This should be
included in the investigation of the agency by the Department of Health.

Strattera causing hyperactivity“ the condition it was supposed to alleviate In my earlier letter to the Department of Health (29th August) I took up the data about the 700 forgotten cases of hyperactivity. I referred to my _letter 2nd January to the MHRA_
(http://jannel.se/letter.mhra.strattera.jan08.pdf) [8] and gave data about the
fact that Eli Lilly had withheld sensitive information and classified harmful effects as an exacerbation of the underlying ADHD.

The logical solution would have been for the MHRA to request all data about
this security risk, followed by an independent review of the data. But this
was not done and as expected nothing is still done. MHRA asked Lilly for an
explanation about this signal stemming from Periodic Safety Update Report
5 (dates 27-05-2005 to 26-11-2005) but got no answer. Three years later the
Scientific Assessor from the MHRA writes in the letter from 1st October:

The information submitted by the MAH [Market Authorization Holder] has been
evaluated and the MAH will be requested to provide further detailed
information within the next 2 months to ensure the issue has been investigated
in a thorough and scientific manner. (p. 2) [3]

The MHRA got this safety signal almost three years ago and is still in
the process of getting some sensible answers from Eli Lilly.

————

I again request the Department of Health to take action. This does not
concern only the children in UK; it concerns the children in the whole of
Europe, indeed it concerns all the children of the world.

The failure of the agency will also mean that psychiatrists within The
Guideline Development Group in NICE can push through more treatment with
Strattera and other ADHD drugs. The MHRA is withholding the clear evidence for
harmful effects and the psychiatrists with close relations to the manufacturers
of the drugs can unimpeded recommend these medicines to unsuspecting
doctors and parents.

The answers given by Professor Kent Woods and the Scientific Assessor did
not in any way handle my concerns. On the contrary, they finally proved that a
full formal investigation of the matters raised above is needed.

Yours sincerely,

Janne Larsson

Reporter – investigating psychiatry
Sweden
_janne.olov.larsson@…_ (mailto:janne.olov.larsson@…)

[1] MHRA, About us, _http://www.mhra.gov.uk_ (http://www.mhra.gov.uk/)
[2] Larsson, Strattera: Eli Lilly gave false information about deaths from
Strattera treatment“ a request for full investigation, May 15, 2008,
_http://jannel.se/Strattera.death2.pdf_ (http://jannel.se/Strattera.death2.pdf)
[3] MHRA, Re: letter of 9th September 2008 to “Assessor responsible for
Strattera, October 1, 2008,
_http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf_
(http://jannel.se/Reply.from%20MHRA.Assessor.October.pdf)
[4] MHRA, Re: Open letter to Pr. Kent Woods (10th August 2008), October 7,
2008
_http://jannel.se/answer.kent.woods.pdf_
(http://jannel.se/answer.kent.woods.pdf)
[5] FDA, Psychiatric Adverse Events Associated with Drug Treatment of ADHD:
Review of Postmarketing Safety Data, released March 3, 2006.
_http://www.fda.gov/ohrms/dockets_
(http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4210b_11_01_AdverseEvents.\
pdf
)
[6] MHRA, answer FOI request, May 25, 2007,
_http://jannel.se/mhraanswer.pdf_ (http://jannel.se/mhraanswer.pdf)
[7] Daily Mail, Heart attacks and suicides… yet the dangers were all kept
so quiet. So how CAN you trust your medicine? July 7, 2008,
_http://www.dailymail.co.uk/_
(http://www.dailymail.co.uk/health/article-1033132/Side-effects-include-suicide-\
heart-attacks-So-prescribed-drugs.html
)
[8] Larsson, The ADHD drug Strattera – actions needed now, January 2, 2008,
_http://jannel.se/letter.mhra.strattera.jan08.pdf_
(http://jannel.se/letter.mhra.strattera.jan08.pdf)
[9] Larsson, The ADHD drug Strattera – an analysis of reports of drug
induced mania, psychosis and hallucinations, March 9, 2008,
_http://jannel.se/strattera.mhra.March.08.pdf_
(http://jannel.se/strattera.mhra.March.08.pdf)
[10] Eli Lilly, Cumulative review of Spontaneous Case Reports of Mania,
Psychotic Disorders, Hallucinations, and Agitation, Appendix 16 to Periodic
Safety Report 9 for Strattera, 2008,
_http://jannel.se/Lilly_psychosis_strattera.pdf_
(http://jannel.se/Lilly_psychosis_strattera.pdf)

See also:

_Doctors told to curb use of Ritalin in hyperactive children_
(http://www.timesonline.co.uk/tol/news/uk/science/article4813727.ece)
_Children’s suicide attempts raise concerns about ADHD medication_
(http://www.theglobeandmail.com/servlet/story/RTGAM.20080703.wadhd03/BNStory/spe\
cialScie

nceandHealth/home)
_The ADHD drug Strattera: Lilly to issue warnings about psychosis,
hallucinations, mania and agitation_ (http://jannel.se/strattera.psychosis.doc)
_Strattera side effects_ (http://www.bonkersinstitute.org/stratteraffex.html)

_Strattera – 10,988 adverse “psychiatric reactions” reported in less than
three years_ (http://www.24-7pressrelease.com/view_press_release.php?rID=16662)
_Attention Deficit Hyperactivity Disorder? No, they’re just naughty, say
experts_
(http://www.dailymail.co.uk/news/article-1031436/Attention-Deficit-Hyperactivity\
-Disorder-No-theyre-just-naughty-say-experts.html#
)

475 total views, 2 views today

Prozac and Alcohol

“I have experienced blackouts when drinking alcohol and engaging in embarrassing and even dangerous behaviors during the blackouts.”

I want to share my recent experience with Prozac. My e-mail address may be posted, but not my name.

I have taken Prozac for close to 15 years, and I would have to say it has provided relief from my depression. Several months ago, I was going through an ugly marital separation and other problems and felt very depressed again. My doctor doubled my Prozac dosage from 20 mg. to 40 mg.

I have always been a social/moderate drinker, consuming 1-2 glasses of wine with dinner most evenings. It never presented a problem on the 20 mg. of Prozac. However, since increasing my dosage, I have experienced blackouts when drinking alcohol and engaging in embarrassing and even dangerous behaviors during the blackouts. I am also craving alcohol in a way I never have before. I also feel that my short-term memory has been negatively impacted.

It has taken me several months to make the connection between my recent behavior and the altered Prozac dosage, but I am absolutely convinced the first is a result of the second.

karenshome@cox.net

 

384 total views, 1 views today

Suicidal Urges on Seroxat and Alcohol

“…if you mix alcohol and Seroxat you are playing a very dangerous game indeed.”

 

I found your site on Sunday morning after having taken approximately 60 20mg Seroxat tablets whilst under the influence of alcohol the night before. I must have known that it would not kill me, but I am writing to post my opinion that if you mix alcohol and Seroxat you are playing a very dangerous game indeed.

I cannot describe the relief when I found your site and realized that I have not been imagining things. Approximately 36 hours after taking the tablets I am still mildly nauseous, occasionally vomiting, and as yet unable to sleep properly, but these are all improving so I am going to sit tight, and then slowly wean myself of this disgusting drug. My tremor is so bad that I cannot leave my house because it would alarm people to look at me. I am a twitching trembling mess and feel so ashamed of myself. But because of this whole episode I found your website, and am glad to be given the opportunity not only to wake up and smell the coffee but also to share my story so far.

I was initially prescribed the drug around two years ago, stayed on it and was well for around nine months. I then stopped taking the drug with fairly disastrous effects and was put back on it in January of this year – this is where the problems have started. In thirty years I have never ever had any compulsion to harm myself until January. However about a month after going back on it whenever I drank alcohol I was overcome with the most incredible urge to kill myself, I cut my wrists several times. The drive to harm myself was very strong and when I had been drinking I would sit and plot how to kill myself, who would find me and so on.

I thought I was losing my mind, but again and again when I drank alcohol with Seroxat I became irrational, over-emotional, promiscuous, aggressive and rarely had any memory of what had gone on the night before. It is a measure of how wonderful my friends and family are that they are all still with me after these six long months. I was beaten up in a nightclub and another time rescued by the police whilst having a conversation in the street with a notorious pimp and crack dealer. I am aware with my 20-20 vision in hindsight that I should have stopped drinking whilst on this drug.

Saturday night was my graduation dinner, the culmination of five long years of studying. I had a fabulous evening with my friends. I have a loving and supportive family. I currently have no symptoms of depression. I have a fantastic job lined up and am so excited about my future. Why would I then come home and take an overdose? Please be careful with this drug, and never EVER mix it with alcohol. I consider myself so lucky to have found this out before I lost my life, please don’t risk yours as well.

Please feel free to email me, I would love to hear from you, EG

Elaine Gibney
sickfromseroxat@hotmail.com

 

6/24/2002

This is Survivor Story number 20.
Total number of stories in current database is 48

362 total views, no views today

Samples of Zoloft and Xanax turn Brother into Criminal

I am unforgiving of a medical profession who cares so little for the very human beings that they swore to help.”

 

After 9 long and horrible years you cannot know the relief that I am feeling after reading about all the experiences that I have read tonight.

My brother is currently serving a twenty-year sentence for a crime so completely and totally out of character for him that I am still astounded.

This was a young man who could be considered irresponsible and unmotivated at worst, at least until he started taking the prescription drugs Zoloft and Xanax.

After a period of depression that I knew then and know now to have been brought on my a sense of low self esteem my brother went to a doctor he had never been to before and explained how he was feeling. This doctor determined in less than thirty minutes of knowing my brother that what he had was “a chemical imbalance in his brain”. This man sent him home with an entire sample box of Zoloft and an entire box of Xanax. He promised my brother that he would be a brand new man in three months. He did not lie. Three months later my brother was someone that I did not know.

Buddy Joe never drank, ever. He just didn’t like it. Yet after taking the drugs for a while he began to crave alcohol. He started introducing himself to new people using the name Austin. When we questioned him he would say that he just liked the name better. He was never, and I want to stress the never part, violent. So what he was becoming was an agitated alcoholic named Austin.

He had been out all night drinking and I later learned through friends acting extremely wild. He came home and committed a crime that I still find too difficult to actually go into. He says he remembers that night like a strobe light blinking off and on in his head.

I have spent nine years knowing that the Zoloft was behind the events leading up to that night and I am so thankful to have read the different stories sent in by so many people with different and yet similar experiences.

My heart breaks for those who have lost those that they love to the horrors of these medications. But I am unforgiving of a medical profession who cares so little for the very human beings that they swore to help.

Thank you all for sharing your stories.

Sincerely,

Annette Royce
AlnRyc@aol.com

 

4/4/2002

This is Survivor Story number 31.
Total number of stories in current database is 48

437 total views, no views today

The Aftermath of Antidepressants

The Aftermath Of Prozac, Zoloft, Luvox, Fen-Phen, & Many Other Serotonergic Drugs

By Ann Blake-Tracy – Executive Director,
International Coalition For Drug Awareness

Ann Blake-Tracy has specialized for 10 years in adverse reactions to serotonergic medications. She is the executive director of the International Coalition for Drug Awareness (www.drugawareness.org) and author of the book PROZAC:PANACEA OR PANDORA?

WARNING: IT SHOULD BE NOTED THAT A GRADUAL TAPERING OFF OF MEDICATIONS IS SAFEST WITHDRAWAL METHOD TO AVOID SERIOUS WITHDRAWAL EFFECTS

Often there is the terrible withdrawal associated with the SSRIs. Unless patients are warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them in half or taking a pill every other day, they can go into terrible withdrawal which is generally delayed several months. This withdrawal includes bouts of overwhelming depression, terrible insomnia and fatigue, and can include life-threatening physical effects, psychosis, or violent outbursts.

Note: Keep in mind that these drugs are all serotonergic agents and clones or “copy cat” drugs of Prozac – the first SSRI antidepressant introduced to the market in America. Basically what applies to one, applies to the others. For instance we have more data out on Prozac because it has been around longer, but as the mode of action is the same for all of these meds the effects will be the same for the other drugs on this list as it is for Prozac. If we are discussing one drug, similar effects would be expected from any other company’s version of the drug. In fact it would be more honest to give them the titles of Prozac #1, Prozac #2,Prozac #3, etc. rather than the brand names they have been given, from the second clone, Zoloft, to the latest Prozac clone, Celexa.

My concern is that each new SSRI introduced seems to be a little stronger on serotonin reuptake and therefore potentially more dangerous. And the all too common practice of going from one SSRI to another blocks additional receptors and magnifies the harmful effects of these medications. It is crucial to learn that according to medical research the theory behind this group of drugs is invalid. Known as serotonin reuptake inhibitors. They are designed to block serotonin in the brain, thereby increasing brain levels of this neurotransmitter. Yet for three decades researchers have been intensely interested in serotonin because LSD and PCP produce their psychedelic effects by mimicking serotonin. Elevated serotonin is found in: psychosis or schizophrenia, mood disorders, organic brain disease, mental retardation, autism and Alzheimer’s. While low levels of the metabolism of serotonin (which also produces high serotonin), are found in those with: depression, anxiety, suicide, violence, arson, substance abuse, insomnia, violent nightmares, impulsive behavior, reckless driving, exhibitionism, hostility, argumentative behavior, etc. The drugs increase serotonin and decrease the metabolism of serotonin leading to any and all of the above results. This information is extremely crucial for patients and physicians to learn as soon as possible. We have a high rate of use of these drugs nationwide. Raising serotonin and lowering the metabolism of serotonin in such a large number of people can produce very serious, widespread and long term problems for all of society.

So why are we now in the 90’s being told that increased serotonin is good for us? Is it because it is good for the pocketbooks of the manufacturers? One manufacturer is running full page newspaper and magazine ads and half hour TV infomercials to bring in over $7 million daily, while on the other hand they are settling Prozac suicide cases for huge amounts of money in exchange for silence from victim’s families on the details of those settlements. The silence in the court cases insures that the drug will be allowed to finish out its patent time, thus bringing in the highest possible profits for the company. They know that with $7 million coming in daily, they can afford to settle a large number of lawsuits and still come out “smelling like a rose” financially.

Eli Lilly has been sued for Prozac related deaths in numerous state and federal courts with most of these cases being settled or dismissed – many were dismissed due to the unethical manipulation of the Wesbecker verdict
(see time line for details).

We have witnessed no decrease in suicide, but increases in murder/suicide, suicide, unwed pregnancies, domestic violence, manic-depression, MS, hypoglycemia, diabetes, bankruptcies, divorce, mothers (parents) killing children, road rage, school shootings, cancer, Chronic Fatigue Syndrome, and Fibromyalgia since these serotonergic drugs have become so popular and I relate it directly to the effects of these drugs.

The death toll has continued to climb drastically since I wrote PROZAC: PANACEA OR PANDORA? Some of the cases you may be familiar with are:

1. Mr. and Mrs. Phil Hartman (Zoloft), Prozac was found in the van of Mark Barton, the Atlanta day trader, who recently killed his family and others in a shooting spree before taking his own life;
2. Neal Furrow, in LA Jewish school shooting was reported to have been court ordered to be on Prozac along with several other medications;
3. The Salt Lake Family History Library shooting;
4. School shootings in Littleton, Colorado (Luvox), Atlanta, Georgia, Springfield, Oregon (Prozac), and Caldwell, Idaho;
5. Another boy in Pocatello, ID in 1998 who in seizure activity from Zoloft had a stand off at the school;
6. 15 year old Chris Shanahan (Paxil) in Rigby, ID who out of the blue killed a woman;
7. The shooting at the lottery in Connecticut last spring by Matthew Beck (Luvox) that left five dead in a murder/suicide;
8. The New York City Subway bombing by Edward Leary (Prozac);
9. Nick Mansies (Paxil) in New Jersey who was convicted of killing a little boy who was selling cookies door to door;
10. In Orange County, CA Dana Sue Gray (Paxil) who co-workers described as a very caring nurse killed several elderly people;
11. Officer Stephen Christian (Prozac) one of the finest officers on the Dallas Police force, who ran into a police substation shooting at fellow officers and was killed;
12. 13 year old Chris Fetters (Prozac) in Iowa who killed her favorite aunt;
13. David Rothman (Prozac) killed two co-workers and himself at the Dept. of Agriculture in Ingelwood, CA;
14. Williams Evans (Zoloft) shot one co-worker at the Ohio Bureau of Employment Services before shooting himself in Columbus, OH;
15. Winatchee, WA where 43 people were wrongfully imprisoned in a false accusation of sexual abuse “witch hunt” fury started by a child under the influence of Prozac and Paxil;
16. Christopher Vasquez (Zoloft) killed Michael Morrow in Central Park;
17. Megan Hogg (Prozac) duct taped the mouths and noses of her three little girls and took a handful of pills; Vera Espinoza (Prozac) in Randolph, VT shot her small son and daughter before shooting herself;
18. An elderly man (Prozac) in Layton, UT axed his wife and daughter to death;
19. Margaret Kastanis (Prozac) used a knife and hammer to kill her three children before stabbing herself to death;
20. An elderly man (Paxil) in Dallas, TX strangled his wife before shooting himself twice in the chest;
21. Larramie Huntzinger (Zoloft) blacked out and ran his car into three young girls killing two in Salt Lake City, UT;
22. Mary Hinkelman (Prozac), a nurse in Baroda, MI shot her two small daughters and her sister before shooting herself;
23. Lisa Fox (Prozac) shot her small son and her dog before shooting herself in Brighton, MI;
24. Debi Louselle (Zoloft) shot daughter and then herself in Salt Lake City, UT;
25. A father in Wyoming shot his wife, daughter and baby grand-daughter then himself after only days on Paxil;
26. A mother (Prozac) in Pleasant Grove, UT killed her 17 year old son with a sledge hammer while he slept before she attempted suicide by drinking Drano;
27. Larry Butz, a superintendent of schools in Ames, IA shot his wife, son and daughter before shooting himself – many cases pending in court are not mentioned.

This is only a handful of MANY, MANY more cases – there would not be room for anything else if I continued listing the cases.

A few additional famous victims: Princess Di (Prozac) and Dodi Fayed -via their driver Henri Paul (Prozac), Monica Lewinsky (Prozac, Zoloft, Effexor, Serzone and Phen-Fen), Chris Farley (Prozac), Pres. Clinton’s ex-partner Jim Mc Dougal (Prozac), Abby Hoffman (Prozac), Del Shannon (Prozac), Danielle Steele’s son (Prozac), INXS singer Michael Hutchence (Prozac), Sarah – Dutchess of York (Phen-Fen)

The latest figures show Prozac has about 44,000 adverse reports filed with the FDA. Out of those reports there are about 2,500 deaths with the large majority of them linked to suicide or violence.

The suicide statistics relating to women are shocking. According to the CDC there are about 30,000 suicides yearly in the United States. Out of those about 6,000 are women – a ratio of about 4.3 to 1, male to female. About twice as many women as men are treated for depression demonstrating that generally men are more than 8 times as lethal in their suicidal gestures as women. Women were known to use less lethal means until the SSRI antidepressants hit the market. But on Prozac and Paxil, women committed 40% of the suicides – many were strikingly violent and clearly leaving no
means for rescue. (Remember that because Prozac was the first of this group of drugs its track record gives us a vision of what is to come with other serotonergic antidepressants, especially when they are so powerful in the reuptake of serotonin.)

TIME LINE OF CRITICAL INFORMATION DISCOVERED SINCE THE BOOK:

*NOTE: Any documents beginning with PZ are Lilly documents on Prozac which have been ferreted out by attorneys and are now being used in lawsuits against the drug company. (Christian vs. Eli Lilly, by Vickery & Waldner, Houston, TX)

* Mid 1950’s: Dr. Felix Sulman began his research on those who suffer from high serotonin levels because of an inability to metabolize serotonin. He found that serotonin is a stress neuro-hormone leading even rabbits, the most docile of creatures, to be aggressive. He coined the term “serotonin irritation syndrome.” He found that those who were unable to break down serotonin would have the levels increase. They were in effect being poisoned by the serotonin produced by their own bodies, the irritation victims suffered from migraines, hot flashes, irritability, sleeplessness, pains around the heart, difficulty in breathing, a worsening of bronchial complaints, irrational tension and anxiety. . . horrifying nightmares. It also caused his volunteers to sleep badly – that is, always on the edge of consciousness so that they were not properly rested – and to wake after only a few hours of sleep.” (sleep apnea) He also found it caused pregnant women to abort.
* October, 1977: Slater, et.al., Inhibition of REM Sleep by Fluoxetine, a Specific Inhibitor of Serotonin Uptake, October 1977, at p. 385 – Prozac was found to affect sleep habits, specifically to suppress deep sleep, which the scientists call REM (rapid eye movement) sleep in cats. By the fourth day of drug treatment the cats receiving the larger doses, which had been friendly for years, began to growl and hiss. After cessation of the drug treatment, the cats returned to their usual friendly behavior in a week or two; those on the higher doses recovering more slowly. – – 1977: [PZ 1298 1999] “A total of six dogs from the high dose group were removed from treatment … due to severe occurrences of either aggressive behavior, ataxia, or anorexia.”]
* July 31, 1978: [PZ1061 1025-28, July 31, 1978] Human subjects began to be used by Lilly in controlled clinical trials. The first group of patients showed no improvement in their depression, but there were a “large number of reports of adverse reactions.” The first human to receive Prozac experienced “dystonia resembling an extrapyramidal reaction” – an uncontrollable, Parkinson-like shaking or trembling.
* July 23, 1979 [PZ 1297 969] The clinical studies in depression showed that “some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off drug. In future studies the use of benzodiazepines to control the agitation will be permitted.”
* August 3, 1979: The clinical trials excluded patients who had serious suicidal risk. [E.g. control #001519, IND Protocol No. 14, August 3, 1979; PZ1135 695, July 2, 1986 memorandum of Dr. Wernicke].
* December 17, 1984: [PZ 65 449, report of Lilly to FDA] Lilly reported to the FDA that benzodiazepines and other sedatives were given with Prozac throughout the clinical trials. This was to help offset the stimulant effect of the drug. In a memorandum of Lilly scientist Charles Beasley [PZ 541 2007-08] issues of “agitation vs. sedation” and concomitant sedative medications like benzodiazepines (to control the agitation) are discussed. Concerns are that agitation in a suicidal patient can induce suicide.
* March 3, 1986 Lilly controlled the flow of information to the FDA and decided that suicide data on Prozac should not be evaluated, “in the safety-update for the FDA the number of suicides and suicide attempts will not be especially evaluated.” [PZ 879 1966, March 3, 1986 telex]
* September 12, 1986: German BGA very concerned with the risk of suicide and ultimately approved Prozac on the condition that physicians be warned of the risk of suicide and told to consider using sedatives and closely monitor patients. [PZ 878 1383, report of Lilly consultant Pohlmeier; PZ 2467 299, September 12, 1986] Lilly actually warned physicians in Germany and other countries that this measure “can be necessary” to minimize the risk of suicide, [PZ 1341 402, December 6, 1989 German warning; PZ 2469 490]
* February 7, 1990: In response to the Harvard study, Teicher, et al., Lilly’s top scientist, Leigh Thompson, told his fellow executives that “Lilly can go down the tubes if we lose Prozac”. [PZ 1941 827, February 7, 1990]. In the ensuing months Dr. Thompson spoke frequently with his principal FDA regulator about the issue, once at 6:15 in the morning. [PZ 391 1959, July 18, 1990]. Lilly later described the man as “our defender”. [PZ1941 2256, September 12, 1990]
* May 29, 1990, Lilly added “suicidal ideation” in the section dealing with post-marketing reports. [PZ883 562, July 26, 1990 memorandum]
* September 14, 1990: Contrary to the advice of his staff, Dr. Thompson told the Eli Lilly Board of Directors that suicide and hostile acts were probably, caused by the patients’ underlying disorders rather than Prozac. [PZ542 2101, September 14, 1990; PZ4002 889, Board Minutes]. The staff was concerned because they knew that this issue was never studied during the clinical trials.
* September 11, 1990: Note from Dr. Bruce Stadel, Chief of the Epidemiology Branch, attaching an analysis done by Dr. David Graham, Section Chief within the Epidemiology Branch, of Lilly’s July 17, 1990 submission to the FDA on the Prozac/suicidality/violence issue. The following factors were (a) brought to the attention of those in the higher echelons of the FDA, but (b) ignored, discounted or “trashed” by them: #1 Lilly’s analysis improperly excluded 76 out of 97 suicides; as Dr. Stadel expressed it, “[i]t is inappropriate in a safety analysis to exclude such a large proportion of case”; #2 Lilly admitted that its clinical trials “were not designed for the prospective evaluation of suicidality” and that “[i]n these trials, patients with current suicidal ideation were excluded”; #3 Lilly admitted that the HAMD-3 rating scale it used to assess suicidality in clinical trials was inadequate; and that Lilly’s statements about violence only demonstrated “how great under-reporting is” and that “[t]he actual data showed a higher percentage of treatment-emergent suicidality among fluoxetine (2.9% than tricyclic (0.8%) patients . . . [which percentage] was similar to that reported by Teicher.”
* July 1, 1992: A study lead by Dr. Lorne Brandes of the Manatoba Institute of Cell Biology in Winnipeg, Canada was published in CANCER RESEARCH linking the two most popular anti-depressants, Elavil and Prozac to cancer.
* 1994: A study headed by Howard Markell published in The Journal of Pediatrics showed LSD flashbacks and LSD reactions induced by Prozac.
* June 9, 1994: The New York Review of Books article by Dr. Sherwin Nuland slams Peter Kramer for pushing Prozac in his book Listening to Prozac. He pointed out that all docs are taught in med school this little poem about serotonin: “This man was addicted to moanin’, confusion, edema, and groanin’, intestinal rushes, great tricolored blushes, and died from too much serotonin.” He listed constriction of lungs and intestines, diarrhea, wheezing, flushing, mental confusion, tightening of bronchioles, and lessening conscious control over behavior from increases in serotonin. “Moreover, . . . it is still too early to arrive at a reliable estimate of possible dangers that may appear in the long term,” and 15% dropped out of the clinical trials on Prozac because of adverse reactions. He also discussed the similarity of serotonin to the psychedelics like LSD and PCP.
* November, 1994: Krystal JH, Webb E, Cooney N, et al., “Specificity of Ethanol-like Effects Elicited in Serotonergic and Noradrenergic Mechanisms,” ARCHIVES OF GENERAL PSYCHIATRY, Vol. 51, Issue 11, pgs 898-911, 1994 demonstrated that an increase in brain levels of either of two neurotransmitters, serotonin or noradrenalin, produces:
#1 a craving for alcohol,
#2 anger,
#3 anxiety.
They found this to be especially true for those who have a history of alcoholism. An increase serotonin in turn increases noradrenalin. Numerous reports have been made by reformed alcoholics who are being “driven” to alcohol again after being prescribed a serotonergic drug. And many other patients who had no previous history of alcoholism have continued to report an “overwhelming compulsion” to drink while using these drugs.

A few personal accounts:

#1 A young woman, a recovering alcoholic, reported that during the eight month period she had been using Prozac she found it necessary to attend AA meetings every day in order to fight off the strong compulsions to begin drinking again.
#2 In the Southeastern United States a middle aged psychologist, also a recovering alcoholic, after being prescribed Prozac, found herself needing to attend AA meetings morning, noon, and night to keep from destroying the sobriety she had achieved.
#3 A young father, who was Mormon and had never before in his life used alcohol, found himself drinking Ever Clear and exhibiting bizarre as well as violent behavior, after being prescribed Prozac and Ritalin.
#4 A young mother who had never used alcohol before began drinking large amounts within weeks of being prescribed Prozac and quickly found herself committed to a mental institution due to the psychotic behavior that resulted. Added to her Prozac prescription were anti-psychotic meds and electric shock treatments. She then began to experience seizures and was started on anti-seizure meds.
#5 A concerned neighbor reported her friend was drinking straight Vodka on a regular basis after being prescribed Zoloft. #6 A daughter reported her father, sober for 15 years, began drinking again on Prozac.

* December, 1994: Not guilty verdict on Wesbecker wrongful death suit against Lilly’s Prozac.
* Treatment emergent suicidality with Prozac has been demonstrated to be two to three times higher than any other anti-depressant. (Jick, et al., Antidepressants and Suicide)
* May, 1995: Judge John Potter who presided over the Wesbecker case filed documents to demand that Lilly be forced to disclose the secret deal they made with the plaintiffs to withhold very damaging evidence in exchange for settlement. In his pleading to the court Potter stated, “Lilly sought to buy not just the verdict, but the court’s judgment as well.” Potter accused Lilly of “giving the verdict the widest possible publicity” accompanied by the claim that Lilly had “proven in a court of law that Prozac was safe.” Furious with Lilly’s attempt to turn his courtroom into an advertising agency for Prozac, he claims his motion reflects “the court’s duty to protect the integrity of the judicial system.” He believes, as do prominent legal ethicists, that a full and open disclosure of the terms of the settlement is a necessary public safety issue.
* July, 1997: Mayo Clinic found that the increased serotonin, which produces blood clotting, was causing a gummy glossy substance to build up on heart valves. Dr. Heidi Connolly with the Divisions of Cardiovascular Diseases and Internal Medicine, who headed the study stated, “We do know that fenfluramine and phentermine [Fen-Phen] alter the way the brain chemical serotonin is metabolized, and serotonin that circulates in the blood can cause valve injury.” Fenfluramine produces a rapid release of serotonin, inhibits serotonin reuptake, and may also have receptor agonist activity. The study’s revelations should send a loud and very clear warning throughout the medical community concerning all serotonergic medications.
* August 25, 1997: Letter to Ann Blake-Tracy, “I caught the last part of your presentation on Radio Station KEX, Portland, while flipping through the dial last night. I was flabbergasted to hear you speak of the horrible potential side effects from Prozac, which I have been taking for approximately four years, particularly since I have been diagnosed recently with cardiomyalgia, severe artery disease, congestive heart failure and also Fibromyalgia. (I was a very “well” person prior to taking the Prozac and am now exhausted all the time, with horrible aching joints and considerable pain and a massive heart problem.) The adverse cardiovascular effects from Prozac, the one drug in this class of drugs out long enough to have somewhat of track record, are listed in the drug information sheet put out by the manufacturer. The “frequent” effects listed are hemorrhage and hypertension. The “infrequent” effects include very serious adverse effects: congestive heart failure, myocardial infarct, tachycardia, angina pectoris, arrhythmia, hypotension, migraine syncope and vascular headache.
* September, 1997: Redux and Phen-Fen were pulled from the market.
* October 20, 1997: Dr. Candace Pert, Research Professor at Georgetown University Medical Center, past head of the brain chemistry department at the National Institute of Health, and author of the new book, MOLECULES OF EMOTION, sounded an alarm in TIME, October 20. She stated, “I am alarmed at the monster that Johns Hopkins neuroscientist Solomon Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago. Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.”
As we are being led to believe these drugs produce effects only in the brain, Dr. Pert accuses the medical profession of oversimplifying the action of these drugs and adds that “the public is being misinformed about the precision of these selective serotonin-uptake inhibitors.” It is critical that both physicians and patients be made aware of these adverse physical reactions. She points out that the medical profession not only oversimplifies the action of these drugs in the brain, but “ignores the body as if it exists merely to carry the head around!” And that, “these molecules of emotion regulate every aspect of our physiology.” The body plays a very significant role in how we feel and act the way we do. This fact can no longer be ignored. Serotonin and serotonin receptors exist throughout the body, as well as the brain, and every aspect of the body’s physiology is affected by these serotonergic medications. In fact approximately 90% of the body’s serotonin is produced in the intestinal tract. According to Dr. Michael Gershon of New York’s Columbia Presbyterian, this is the reason why Prozac produces so many gastrointestinal side effects.
* March, 1998: Two new studies published. One that shows Prozac so strongly inhibits one particular serotonin receptor that this produces both obesity and seizures and the other discusses the blockage of muscle and neuronal nicotinic acetylcholine receptors indicating interactions between the serotonergic and cholinergic systems in the central nervous system.
* April, 1998: Our next generation of guinea pigs – one month before a 15 year old on Prozac, Kip Kinkel, in Springfield OR killed his parents and two classmates the American Psychiatric Association and the American Academy of Pediatric Psychiatrists asked the FDA to consider the serotonergic antidepressants for use in children as young as two and drugs for anxiety, aggression and manic depression in babies only one month old! The use of Prozac among young children ages 6 – 12 has increased an alarming 400% from 1995 (51.000 new prescriptions) to 1996 (203,000 new prescriptions).
* June, 1999: CLINICAL PSYCHIATRY NEWS reported that Dr. Malcolm Bowers a psychiatrist at Yale has found that physicians are not paying enough attention to patient factors that could make initiation of SSRIs dangerous. He found that “SSRI-induced psychosis has accounted for 8% of all general hospital psychiatric admissions over a recent 14-month period.” And “What is surprising is that this particular group of side effects is really underplayed.” (The 8% figure represents over 150,000 SSRI induced psychotic breaks per year!!!!!!!)

WARNING: Children so often get coughs and colds, yet using a cough or cold medication with dextromethorphan could cause the serotonin syndrome, a very serious and potentially fatal adverse reaction and/or produce PCP reactions.

Serotonin syndrome remains an often misdiagnosed or unrecognized fatal reaction due to the medical profession being so uninformed about this drug-induced disorder.

Developing brains are far more vulnerable than adult brains and brain damage generally becomes more apparent after the brain is fully developed, rather than immediately. Increases in cortisol produce brain damage while medical research shows that one single 30mg dose of Prozac DOUBLES the level of cortisol. This drastic increase in cortisol causes a multitude of serious physical reactions including impairment of linear growth, as well as impairing the development and regeneration of the liver, kidneys, muscles, etc. In light of so many unspeakable tragedies, I have grown weary of all the silly philosophical discussions we have heard since Kramer’s LISTENING TO PROZAC came out. Patients are dying or having their health destroyed mentally as well as physically (when do we begin to discuss the very serious physical side effects associated with high levels of serotonin?). These patients and their families are frantically searching for answers while this research sits right under our noses and could easily be made available to them. The widespread use of Prozac and its clones is not a statement of either their safety or their effectiveness. It is a statement about the effectiveness of an infinite marketing budget and incredible advertising campaign! These drugs have very serious physical side effects, as well as dangerous psychiatric side effects.

To prevent further tragedy this medical research must be acknowledged and addressed in headline news without delay rather than remain buried in seldom read medical research documents as has been the case in the past with other mind- altering medications, once thought to be safe, which were subsequently prohibited by law, i.e. LSD, PCP, cocaine, etc.

PRAISE FOR PROZAC: PANACEA OR PANDORA?

“I started having bad reactions . . . Oct ’96 I found Prozac to be causing joint and muscle pain itself . . . signs of Cushing’s Syndrome. . . I was very pro-Prozac until last October and wouldn’t have listened to anything said against it until I got problems (thought it was saving my life, while all the time it was insidiously and interested but quite skeptical. However, since reading it and having suffered so many problems with Prozac, I have come to the conclusion that the book is brilliant, and a life-line as far as I am concerned. I tried to fault the research and reasoning, but could not and still can’t. I would like to extend my thanks to you for your heroic stance on this enormously important issue. I have tremendous respect and admiration for your hard work, determination and courage in pursuing this subject so vigorously, against so much powerful opposition for the benefit of people like me. Your integrity puts many, if not most doctors and psychiatrists to shame. It is reassuring to find that there are a few people who are prepared to fight for the truth for the benefit of mankind.” Oct. 1998 note from a British nurse

“PROZAC: PANACEA OR PANDORA? is an incredible compilation of medical data that will lay the groundwork to educate other professionals and the general public about the new SSRI antidepressants – Prozac, Zoloft, Paxil, Luvox, Effexor and Serzone.” (Jeff Wise, psychologist, Salt Lake County Drug and Alcohol Abuse )

“In 15 years of reading books on drugs I have never read a book with more information or so well documented as PROZAC: PANACEA OR PANDORA?” (Dr. Kevin Millet, Bountiful, UT)

“As I lecture to physicians nationwide on the medical use of psychoactive drugs PROZAC: PANACEA OR PANDORA? always accompanies me in my brief case.” (Dr. Bruce Woolley, neuropsychopharmacologist, Brigham Young University)

“I found PROZAC: PANACEA OR PANDORA? fascinating reading and the most complete analysis of the various factors pertaining to the Prozac controversy.” (Attorney Donald Sokol, Susanville, CA)

“PROZAC: PANACEA OR PANDORA? literally saved my life, and if I’d known about it a year earlier, could have saved me untold grief and agony as well. It is the only collated, comprehensive source I know of for this information , . . .. this book described everything that had happened to me in great detail, gave scientific reasons why it happened, backed it all up with solid research, included testimonials from hundreds of others in the same situation, it immaculately details, explains, and refers one to the latest research on a whole hornet’s nest of ‘atypical’ side-and/or after-effects from the use of these antidepressants. It also contains information on how to reduce the severity of problems encountered while starting on or going off these meds.” (Nick Jameson, Prozac patient)

“Magnificent! This text is a monument to Ann Tracy’s tenacity and love for her fellow human beings.” (Dr. Paul Kennedy, N.J.)

“PROZAC: PANACEA OR PANDORA? has not left one question about these drugs unanswered! Ann Tracy has covered them all.” (Margaret McCaffery, N.Y. who lost her daughter, a neurosurgeon, in a Prozac suicide)

“The work Ann Blake-Tracy is doing is very important and she is truly a heroine.” (Dr. Candace Pert, Washington, DC, one of the two developers of the serotonin binding process which made possible the development of the serotonergic drugs. Dr. Pert has boldly stated, speaking of these serotonergic medications, “I am alarmed at the monsters I created!”)

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

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