Subject: FDA a "partner" of the pharmaceutical industry. 2 9 06
[Fred A. Baughman Jr., MD: Here is the present-day FDA, hardly a protector of the American public, and yet they masquerade as such. Today, after the first day of hearing on strokes and deaths due to all of the ADHD Schedule II controlled substances (amphetamines and amphetamine cogener, Ritalin) NBC came out with a mere "25 deaths" when there were 160 1990-1997 and an added 26, 1998-2000. Not a word was said of the fact that ADHD is not a disease; that children said to have it are entirely normal--until they begin the drug. A black-box such as was recommended by the panel is not what is needed, rather, like the deadly drugs below, these drugs need to be removed from market for all psychological/psychiatric entities (ADHD, Conduct Disorder, Oppoistional-defiant disorder)--permanently. The total number of deaths from methylphenidate, 1990-2000 inclusive was more likely 18,600 (100 x 186) than 186 as reported to the FDA. Fred Baughman, MD]
Wednesday, December 20, 2000 How a New Policy Led to Seven Deadly Drugs Medicine: Once a wary watchdog, the Food and Drug Administration set out to become a "partner" of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal. By DAVID WILLMAN, Times Staff Writer http://www.latimes.com/news/nation/reports/fda/ 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."
[Fred A. Baughman Jr., MD: as with barring thalidomide from market here in US late 50's/60]
Then in the early 1990s, the demand for AIDS drugs changed the political climate.
[Fred A. Baughman Jr., MD: it wasnt AIDs drugs as much as economic forces entering medicine since 65, increasingly dominant power of big pharma]
with the 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."
[Fred A. Baughman Jr., MD: and partners they have become, no longer intent on protection of public]
*** sidebar *** Dr. Janet Woodcock, director of the FDA's drug-review center, says the agency depends on doctors "to take into account the risks, to read the label. ... That's why drugs are prescription drugs."
[Fred A. Baughman Jr., MD: doctors should not be prescribing drugs they do not use regularly and know well. They should not be prescribing drugs they read about for the first time, having no experience with it]
BRIAN WALSKI / Los Angeles Times *** end sidebar *** 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.
[Fred A. Baughman Jr., MD: Nowhere in the current discussion of heart attacks and strokes due to ADHD drugs has there been the least discussion of the fact that ADHD--for which these deadly drugs are given, is not a disease but a contrivance/illusion of a disease.]
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.
[Fred A. Baughman Jr., MD: According to the FDA Medwatch program, it could be 100 times higher.]
An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role.
[Fred A. Baughman Jr., MD: again, ADHD is not an abnormality/disease. There is no justification for giving any drug--all foreign compounds--poisons]
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.
[Fred A. Baughman Jr., MD: ADHD has never been proved to be a disease. Dr. William Carey testified at the 1998 Consensus Conference that the behaviors of so-called ADHD were characteristic of all normal children]
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%. *** sidebar *** Video: Willman reacts to receiving the Pulitzer Prize for this report. Real | Quicktime *** end sidebar *** 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."
[Fred A. Baughman Jr., MD: the FDA is supposed to protect the public, they protect profit-takers.]
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: * 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. * 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. * 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. * 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. * 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. * 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. * 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. *** sidebar *** Michael Elashoff: The biostatistician was upbraided by senior FDA officials after he recommended against the approval of Relenza, a new flu drug. An agency advisory committee agreed with him, but the drug was approved by the FDA as safe and effective. BRIAN WALSKI / Los Angeles Times *** end sidebar *** 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=