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corporate dominance | health

Drugging America to death

The pharmaceutical industry already kills well over 100,000 people every year from correctly prescribed drugs in hospitals alone. [9] This does not include deaths occurring outside the hospital or from incorrectly prescribed medications, or the millions of disabilities each year. To further put this in perspective, the death rate from illegal drugs is 20,000 per year; the initial death rate from the Union Carbide chemical disaster in Bhopal, India was 20,000; and 58,000 Americans died in the Vietnam War.
FDA kept in the dark by drug corporations
FDA kept in the dark by drug corporations
Contrary to what most people believe, drug companies, not the Food and Drug Administration (FDA) or independent researchers, finance and control virtually the entire process of testing and bringing new drugs to market. Because pharmaceutical companies finance the vast majority of all drug trials, they design and structure the studies, select and pay researchers, choose the patients, analyze the test results, closely oversee the writing and publication of the final studies and release the drugs through their massive sales network to the medical profession. No independent source confirms or oversees the research, analysis or final conclusions. [10]

The subjects of drug trials are generally young healthy men, even though the target market for the drug may be women, children or the elderly. Many of the paid subjects are "regulars" who supplement their income by hiding their participation in multiple drug trials when not enough time has passed for the previous drugs to fully leave their systems. The fraud begins at the onset of the drug trial, as drug companies will frequently drop large numbers of subjects who show what the industry classifies as a "sensitivity" or "bad reaction" to the drug. In other words, test subjects who experience exactly the kind of toxic reaction the trial is supposed to be tracking are dropped from the results simply because it occurs early in the trial.

Drugs are frequently tested on much smaller numbers of people and for shorter periods than is generally thought. Psychiatric drug trials typically last only four to six weeks, and no psychiatric drug has ever been shown (i.e., tested) to be safe for long-term use. In many drug trials, only one or two dozen subjects actually finish the trial. Doctors who regularly prescribe Prozac believed that the drug had been tested on more than 10,000 patients before they prescribed it to their patients, a figure they had read in Eli Lilly marketing material. In fact, Dr. Peter Breggin went to great lengths to count the actual number of patients who had completed the trials and found the total number to be 286, a far cry from the thousands that the public had been led to believe. [11]

While most people believe that a drug that gains FDA approval has gone through many successful drug trials that have proven it to be substantially more effective than the placebo, in fact the entire drug trial system works on a simple "pass/fail" basis. When the company submits the trial results to the FDA and the FDA finds the drug insufficient or even harmful and rejects it, the company can simply drop and manipulate portions of data from the very same trial, submitting different permutations of the numbers over and over again until the FDA finally accepts the drug. It takes only two successful trials, even with small numbers of patients, and includes trials that had been previously rejected by the FDA but later passed with reworked numbers, for the FDA to approve a drug. And the drug does not have to show a substantial benefit over the placebo, only that it is "marginally" better than the placebo. [12]

Drug companies also systematically obscure adverse drug reactions and even deaths that occur during the trials by simply deleting or mislabeling them in the data submitted to the FDA. Suicides that occurred during the testing of Prozac were systematically mislabeled as "no drug effect" or "depression," so that when the FDA examined the drug data, patient suicides could not be found and counted. [13] Suicide was one of the first major problems encountered when Prozac was released on the market, leading to multiple deaths and lawsuits. Most of the very symptoms fueling the current debate about the dangers of anti-depressant drugs were known and documented by the drug companies during the trials, but the drugs were released anyway.

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FOOTNOTES

9 Jason Lazarou, Bruce H. Pomeranz and Paul N. Corey, "Incidence of adverse drug reactions in hospitalized patients: A meta analysis of prospective studies," Journal of American Medical Association, April 15, 1998, 279(15): 120005. This study found more than 100,000 deaths per year and 2,000,000 severe side effects in U.S. hospitals alone. However, this study did not include deaths from pharmaceutical drugs that occur outside the hospital, or deaths from prescription errors by doctors or pharmacists. Additionally, because 9099 percent of all adverse drug reactions are never reported (see footnote 18), this figure should be adjusted substantially upwards.

10 Thomas Bodenheimer, "Uneasy alliance-clinical investigators and the pharmaceutical industry," New England Journal of Medicine, May 18, 2000, 342(20):153944.

11 Dr. Peter Breggin, The Anti-Depressant Fact Book: What Your Doctor Won't Tell You About Prozac, Zoloft, Paxil, Celexa, and Luvox (Cambridge, Mass.: Perseus Publishing, 2001), p. 148.

12 Dr. David Ginsberg, The Investigators Guide to Clinical Research, CenterWatch, Inc.; 3rd edition (January 2002); Dr. Jay Cohen, Overdose, Jeremy P. Tarcher/Putnam (2001); Stephen Fried, Bitter Pills, Bantam (April 1998).

13 Breggin, p. 6.

18 David Kessler, " Introducing MedWatch: A new approach to reporting medication and device adverse effect and product problems," Journal of American Medical Association, July 2, 1993, 269(21): 276568.


this article originally posted;
 http://www.isreview.org/issues/33/druggingtodeath.shtml

The Other Drug War: Big Pharma's 625 Washington Lobbyists;
 link to www.Citizen.org

Death by Medicine, by Gary Null PhD, Carolyn Dean MD ND, Martin Feldman MD, Debora Rasio MD, Dorothy Smith PhD;
 http://www.mercola.com/2003/nov/26/death_by_medicine.htm

the ACLU comments on the repressive Model State Emergency Health Powers Act;
 http://archive.aclu.org/issues/privacy/Model_health_feature.html

Great Post Lynne 01.Feb.2004 22:27

The Sane Left

Lynne, thanks for a great post with great citing and links. Too many progressives ignore this important issue of pharmaceutical/medical/psychiatric abuse. I'd like to see a movement that brings the Prozac makers and distributers to their knees.

Legal pharmaceuticals kill more people than heroin & crack combined 02.Feb.2004 00:59

GRINGO STARS

What blows me away is that properly-prescribed pharmaceuticals kill more people in hospitals alone - than ALL illegal drugs - by a factor of 5. This is a telling comment on the systematic heartlessness of the major drug companies. They will literally do anything to make a buck.

FDA Drug Report Linking Anti-Depressants to Child Suicide Barred 02.Feb.2004 08:25

Adrian

A scientist at the Food and Drug Administration has been barred from publicly presenting his finding that several leading antidepressants may increase the risk of suicidal behaviors among children, according to sources inside the FDA.

FDA medical officer Andrew Mosholder was to present his report Monday at an FDA advisory hearing in Washington that promises to be a contentious affair involving competing medical experts and parents whose children took their own lives while on the medications.

A senior FDA official said the study wouldn't be presented because it wasn't "finalized." But critics fear that the agency's action indicates it is not prepared to take stronger action against the drugs, despite warnings about their possible effects on children.

Mosholder had been asked by the agency to perform a safety analysis of antidepressants after reports emerged this summer of high rates of suicidal behavior among children enrolled in clinical trials for Paxil, Effexor and other antidepressants.

Mosholder, a child psychiatrist, reviewed data from 20 clinical trials involving more than 4,100 children and eight different antidepressants. His preliminary analysis, according to two FDA sources familiar with the report's contents, concluded that there was an increased risk of suicidal behavior among children being treated for depression with Paxil and several other antidepressants.

An initial agenda for Monday's hearing listed Mosholder and his findings, but his presentation was removed from a revised agenda, and Mosholder was told that he could not present his findings at the hearing, one FDA official, who wished to remain anonymous, told The Chronicle.

According to the official, in early January, Russell Katz, director of the division of neuropharmacological drug products, called Mosholder in for a meeting. "He told him that he was sorry, but he wasn't going to be able to present (his report) because he had reached a conclusion and therefore was biased," the official said.

Mosholder declined several requests to be interviewed and was not made available despite repeated requests to FDA's press office. Katz was unavailable to comment on the charges.

In a telephone interview Friday with The Chronicle, Anne Trontell, deputy director of the agency's Office of Drug Safety, who is Mosholder's direct supervisor, said the analysis would not be presented because it had not yet been approved within her office.

"The consult on that is not finalized. It's not a final document within the Office of Drug Safety," Trontell said.

However, Trontell said that at Monday's hearing, Mosholder would provide a rundown of reports of suicidal behavior received by the agency from doctors and other professionals.

While Mosholder's safety analysis report may eventually be completed and made public, some FDA insiders fear that withholding it from Monday's hearing indicates that the agency may be siding with the pharmaceutical industry in its long-running battle with critics of antidepressants.

"Why is the agency sitting on its hands and acting as if there isn't a risk when their own scientists have looked at the data and concluded that there is?" one FDA official remarked.

The use of antidepressants and other psychiatric medication among children has more than tripled in recent years and now approaches adult usage rates, according to a January 2003 study in the Archives of Pediatric and Adolescent Medicine. Study author Julie Zito, an associate professor of pharmacy and medicine at the University of Maryland, estimates that more than 1 million American children used antidepressants in 2000.

Advocates of the drugs argue that they are imperfect but necessary weapons against a rising tide of mental illness among children.

Last month, a task force of the American College of Neuropsychopharmacology released its own preliminary review of published studies on antidepressants and suicide and stated it found no statistically significant increase in suicide attempts among children taking the drugs.

"The most likely explanation for the episodes of attempted suicide while taking SSRIs (selective serotonin reuptake inhibitors) is the underlying depression, not the SSRIs," said Graham Emslie, a child psychiatrist and researcher at the University of Texas Southwestern Medical Center in Dallas.

But critics, including consumer advocates and mental health professionals contend, based on other studies, that the drugs are often ineffective and sometimes dangerous and that the FDA has failed to vigorously investigate the risks and protect children's safety.

"The FDA is shielding the industry," said Vera Sharav, president of the Alliance for Human Research Protection, a consumer advocacy group.

Mosholder's analysis appears to be similar to the conclusions reached by British regulators, who told doctors in December to stop prescribing Paxil, Zoloft, Effexor and three other antidepressants to children because of an apparent "increased rate of self-harm and suicidal thoughts."

British regulators took action against Paxil in early June after new data presented to U.S. and British authorities showed that children taking the drug were nearly three times as likely to consider or attempt suicide as children taking placebos.

Later that month, the FDA issued a similar warning, urging doctors not to prescribe Paxil to children and announced that it would conduct a detailed review of pediatric trials of Paxil. The review was subsequently broadened to include seven other antidepressants, including top sellers Prozac, Zoloft and Effexor.

In October, the agency wrote to physicians to "call to (their) attention" reports of suicide among children in antidepressant trials. The agency did not, however, urge doctors to stop prescribing the drugs.

Several current and former FDA staff members interviewed by The Chronicle said the dispute over Mosholder's report highlights a lack of assertiveness within the agency over safety issues. They spoke of a split between the Office of Drug Safety -- Mosholder's office -- and the FDA's drug-reviewing divisions.

As an example, they cite a hearing last March on a rheumatoid arthritis drug, Arava, which had generated numerous reports of adverse effects, including nine deaths, after being approved by the FDA.

Members of the Office of Drug Safety, who had prepared a 37-page safety report, were present at the hearing but were not allowed to speak. A representative of the FDA division that originally approved the drug, along with the pharmaceutical company that makes the drug, did most of the talking.

A documentary crew from the PBS series Frontline filmed the meeting and afterward, in the hallway, caught up with David Graham, a senior epidemiologist with the Office of Drug Safety. The producers had been denied previous requests to interview Graham, but the government scientist gave a brief interview without permission.

"We had a different perspective, and we really weren't given an opportunity to present our side of the story," Graham, on camera, told the producers. "And the people who did present, the reviewing division and the company, you know, they didn't see a problem. This was a very hostile process. And let's just leave it at that."

Paul Stolley, a professor and former chairman of the department of epidemiology at the University of Maryland, spent a sabbatical year as a senior consultant in the Office of Drug Safety in 2000 and 2001. While there, he recalls, he tussled with agency managers over the safety of Lotronex, a drug used to treat irritable bowel syndrome, a chronic but usually not serious disease.

Stolley said his investigation uncovered high rates of negative side effects, including a number of deaths, among patients using the drug and led the company to withdraw the drug from the market.

A few months later, over Stolley's objections, the agency allowed the drug back on the market with a "risk management" program aimed at educating patients and doctors about the drug's risks. Stolley said he was excluded from internal FDA meetings on the issue.

"I'm worried about the agency," he says. "I didn't expect people to think I was right just because I was very senior. What I did expect was a vigorous debate and instead of having a vigorous debate, they made a policy decision and then excluded me."




 http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/02/01/MNGB64MJSP1.DTL