Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts | | Another revealing example of how our system fails us can be seen with the marketing of a drug called rezulin. The pharmaceutical company who manufactured this drug wanted a new money-maker to capitalize on the growing Type 2 diabetes market. The FDA provided fast track approval for the drug in the summer of 1997. In December 1997, British regulatory officials withdrew rezulin from the market after 6 Rezulin-related deaths were reported.3
However, in the U.S., pharmaceutical representatives promoted the drug to doctors, and doctors prescribed it, without qualms, to their patients. | | Eastman was a paid "faculty" member of Warner Lambert's "Rezulin National Speakers Bureau," an MD group that encourages practicing physicians to use their drugs.
Rezulin was the drug eventually removed from the marketplace because a number of deaths from liver disease were linked to it. An MD, a St. Louis endocrinologist, said the drug firm deliberately omitted reports of liver toxicity and misrepresented serious adverse events experienced by patients in their studies.15 What kind of doctor would let these results slide without bringing the flaws to the attention of authorities. | | In December 1997, British regulatory officials withdrew rezulin from the market after 6 Rezulin-related deaths were reported.3
However, in the U.S., pharmaceutical representatives promoted the drug to doctors, and doctors prescribed it, without qualms, to their patients. It was the newest, it was the best, and it had FDA approval. Because our reporting system for adverse events is so poor and based on voluntary reports of clinical occurrences, the sudden rise in Type 2 diabetic deaths due to liver failure went unheralded. Between mid-1997 and its withdrawal from the U.S. |
Hyla Cass
See book keywords and concepts |  Another drug in this class, rezulin (troglitazone), was found to cause liver damage and liver failure, and was withdrawn. |
Mike Adams, the Health Ranger
See article keywords and concepts |  The astonishing story of rezulin, a diabetes drug, is a good example.
Repeatedly banned and confiscated herbs and nutritional supplements that compete with prescription drugs. Ephedra, for example, was banned by the FDA based on a political agenda, not good science.
Conducted armed raids on alternative medicine clinics, confiscating computers, threatening alternative health practitioners, and scaring away patients. |
Mike Adams, the Health Ranger
See article keywords and concepts |  Add aspartame to the FDA's Hall of Shame, right alongside Vioxx, rezulin and the ordered destruction of recipe books that dared to mention the stevia herb as an ingredient. It's just one more way in which the FDA continues to betray the American people and subject them to life-threatening ingredients that any honest Food and Drug Administration would have banned long ago. |
Earl L. Mindell, RPh, PhD with Virginia Hopkins, MA
See book keywords and concepts | | Following close on the heels of the fen-phen fiasco was the diabetes drug rezulin, which is implicated in an incredible 391 deaths due to liver damage. The number of others who have developed nonfatal cirrhosis because of rezulin has not been tallied, but our guess is that it's a significant number. Before rezulin was finally banned in 2000, the FDA finally got around to telling U.S. doctors to monitor patients' liver function while they were using the drug.
There's more. |
Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts | | The companies that brought you rezulin, Prozac, Vioxx, Celebrex, and hundreds of other poisons approved by the FDA are entrusted with the purity, molecular identity and quantitative guarantees of the product contained in each vial of insulin.
Paraphrasing Thomas Jefferson, "every good democracy must have a citizenry that is willing to stage a revolution periodically in order to rid itself of those looking to abridge the rights of a free society." Are you too sick to stand up for your rights? |
Mike Adams, the Health Ranger
See article keywords and concepts |  Mike: I am glad that you brought up rezulin, by the way. It’s a good example of the disparity between the FDA and pharmaceutical regulatory bodies in other countries. This was a drug that was pulled from the shelves very quickly in Europe, yet it was pulled quite slowly in the United States.
Dr. Strand: That’s really true. rezulin was never actually taken off the market. What happened was that two other drugs came out and the FDA kind of let the company just take their drug back because they had better options on the market. It was never theoretically ever withdrawn, and that's scary. |
Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts | | For example, with the above issue regarding rezulin, suppose only 10% of university funding for diabetes research did come from Warner Lambert. Ten percent seems an inconsequential amount; but consider that monies from the NIH — public, taxpayer monies — supporting the same research, was tainted by the influence corporations exert on government agencies. How unbiased will the research results actually be? Lines separating government and academia from corporate influence have become so smudged that virtually all research results become suspect. |
Hyla Cass, M.D.
See book keywords and concepts | | Another drug in this class, rezulin (troglitazone), was found to cause liver damage and liver failure, and was withdrawn. |
Andreas Moritz
See book keywords and concepts |  One of them, rezulin, was designed to stimulate the uptake of glucose from the bloodstream by the peripheral cells and inhibit the normal secretion of glucose by the liver. After the drug killed well over 100 diabetic patients and crippled many more, it was pulled off the market. Neither the oral hypoglycemic agents nor insulin injections have any effects on increasing the uptake of glucose by the cells of the body. This essentially means that the diabetic patient cannot expect to improve or become cured by any of these treatments. |
Melody Petersen
See book keywords and concepts |  Between 1975 and 2005 at least twenty prescription drugs, including big sellers like rezulin, for diabetes, and the diet pill Redux, were removed from the market. In 2002 a group of researchers studied the deaths and serious injuries caused by the newest medicines. They found that of the hundreds of drugs approved between 1975 and 1999, more than 10 percent were either taken off the market or given the government's most serious warning, one that is outlined in a boldfaced black box on the label and meant to send an alarm to doctors that the product can kill. | | The letter said the company was soon introducing a new medicine called rezulin to help people with diabetes, a problem Jerry just happened to be struggling with.
He remembers thinking, "Well, maybe this will help."
Jerry ran a forklift at the big meatpacking plant in his hometown of Ottumwa, Iowa. His wages were enough to support his wife, Sadie, and their four sons and still pay for things like an annual trout fishing trip to Colorado. A burly guy, he had also worked construction and built roads, bridges, or, in his words, "just about anything." But that year he had not felt well. | | Jerry said months after he left the hospital he heard a report that rezulin had been pulled from the market because of its propensity to ravage the liver. That's when he finally understood what had happened to him.
"I was sitting on the couch, watching the World News" he said. "I said, 'Hell, that's the pill I took.'"
Jerry still doesn't understand how the marketers at Parke-Davis obtained his name and address, which allowed them to send him that promotional letter back in 1996. He doesn't know how the drug executives knew he had diabetes. |
J. Douglas Bremner
See book keywords and concepts |  Another glitazone, called rezulin, has been taken off the market because of lethal side effects related to liver damage. There is always concern that whenever there is a major side effect with one drug in a class, other drugs of the same type will have the same side effect. Therefore there is concern that other glitazone drugs have the potential to cause fatal liver damage, although so far the glitazone drugs still on the market have not been associated with an increased risk.
Concerns about the glitazones include the possibility of an increased risk of heart disease and increased weight gain. |
Melody Petersen
See book keywords and concepts | | After nine months of taking rezulin, Jerry felt nothing like the smiling people he saw in the drug ads. He felt nauseated, as if he had the flu. When the malaise lingered and grew worse, he began to fear he had cancer. People told him his skin had a strange bright yellow tint.
On an early spring day in 1998 he was settling in to watch television when a disabling pain swept through him. "It was like someone hit me in the chest with a baseball bat," he said.
He thought he was having a heart attack. | | I was ticked off what it done to me," he said of rezulin. He remembers how he once listened to the drug ads on television, thinking that the list of side effects mentioned in each one was not worth worrying about. "Now I tell people it would be smart to stay away."
Medicines work and provide their benefits by interfering in some way with the chemical makeup of the body's cells. Scientists design drug molecules to have a certain desired biological effect, but every one has unplanned and unpredictable effects as well. | | Years after getting a new liver, Jerry and scores of other patients who were harmed by rezulin, as well as the families of those who died after taking it, received financial settlements from Pfizer. But the money won't bring back Jerry's old life. He says he tires easily and can no longer hunt pheasants and deer as he used to. It seems he is always at the doctor's office. He has arthritis, he said, and "holes in my spine" because of the prednisone, a steroid drug, he had to take for five years as part of his liver transplant. |
Too Profitable to CureBrent Hoadley, Ph.D.
See book keywords and concepts | | Cohen, in his book6, went on to explain that any responsible scientist could have seen that liver problems related to rezulin were just disasters waiting to happen.
Should we believe, as stated in Death by Medicine, that the number one cause of death is not disease but the health care system? Perhaps we should go one step further and look for criminal intent and criminal wrongdoing in the pharmaceuticals' pursuit of profit.
The criminal landscape includes a wide range of victims and potential victims. Doctors and the government now classify obesity as a disease. |
Donald L. Barlett and James B. Steele
See book keywords and concepts |  USA Today told readers that rezulin "may reduce or eliminate the need for insulin shots for nearly 1 million diabetics . . . The drug is taken orally and will help some Type II diabetics control blood sugar levels. Of the patients who can take rezulin, 15% might be able stop insulin shots, officials said."
When potential side effects were even mentioned, they were dismissed as inconsequential. The Copley News Service called them "quite mild. |
Mike Adams, the Health Ranger
See article keywords and concepts | | Strand: That’s really true. rezulin was never actually taken off the market. What happened was that two other drugs came out and the FDA kind of let the company just take their drug back because they had better options on the market. It was never theoretically ever withdrawn, and that's scary. When you start to research this and you read my book, Death By Prescription, you start to gain a respect for these drugs. It’s not only old people who are dying from these adverse drugs reactions, it's also young people. |
Mike Adams
See book keywords and concepts |  Rigged with officials who maintained financial ties to Warner-Lambert, the panel voted 11 to 1 in favor of keeping rezulin on the market. Meanwhile, Lumpkin engaged in diversionary tactics, secret meetings with Warner-Lambert executives, and other stonewalling tactics. When one FDA scientist, frustrated by the lack of action by Lumpkin, went to Congress with FDA emails and scientific findings, he was targeted in a complaint from Warner-Lambert and placed under an internal affairs investigation for leaking non-public information. |
Mike Adams, the Health Ranger
See article keywords and concepts | | You will see drugs like rezulin that came out as a diabetes drug, and the typical pattern is when a drug is starting to run into trouble, first of all, it is not the drug that causes the problem. It has to be that the patient develops liver disease or something like that. Then, more and more deaths are reported and, finally, the pharmaceutical company has to admit, "Yes, our drug can cause liver disease (for this example), but it only happens one in one hundred thousand times." I have heard that in my office so many different times with different drugs. |
Greg Critser
See book keywords and concepts |  But sales were already soaring: rezulin was a poster child for the new, post-Hatch-Waxman pharmaceuticals industry. The drug had benefited from every innovation — legal, medical, regulatory, financial, and marketing — that the era offered. Its review had been expedited via the new, industry-friendly regulations at the FDA — regulations designed to show Congress and pharma that the agency deserved to continue to receive the industry user fees upon which it increasingly relied. | | The Parke-Davis division anticipated the approval of two new drugs, one for high cholesterol called Lipitor, one for type 2 diabetes, called rezulin. Both drugs had huge market potential, and the executive who presided over their successful launch would flourish, both professionally and personally. Was he up to the challenge?
Wild was. But he also knew a lot about the internal politics of Warner-Lambert, how the conglomerate often sabotaged and beggared the drug division's ability to exploit new drugs. So he presented his recruiters with his survival plan for the company, and for himself. | | By 2003, some 8,700 people had sued Pfizer for damages over rezulin alone, with 32,000 possible plaintiffs waiting in the wings. Bayer faced at least 8,600 claimants over the recalled statin Baycol. Wyeth, already beleaguered, was looking at another 90,000 additional victims of Redux. In 2005 (at the time of this writing), Merck's Vioxx liability was so huge as to elude any reality-based estimate.
And if many Americans were still willing to give pharma the general benefit of the doubt, when it came to the issue of pricing, the PR battle was all but lost. | | Think Vioxx, Redux, Paxil, and rezulin.
For the most part, physicians believe that they are immune to these new forces, that their advanced education, advanced social status, and professional ethos serve as a sort of inoculation against bullshit and hype. (The late Dr. Louis Lasagna, a clinicaltrial pioneer, revered by both industry and industry critics, once noted that physicians always feel that they are in the "authoritative," or superior, position, until it comes to payment, "when suddenly they see the patient as an equal." | | COX-2 inhibitors (Celebrex, still on the post-Vioxx market) and statins (among them Lipitor and Zocor) are two of the biggest-selling classes of chronic disease drugs, and liver testing is recommended for both; they are nowhere near as toxic as rezulin, but they will need to be scrutinized ever more intensely if they are to remain controllable. Both are the subject of enormous scientific and marketing campaigns to expand the percentage of Americans who take them. Hence, the liver remains on the front line. |
Mike Adams
See book keywords and concepts | | Later, in response to an LA Times investigative article that highlighted 33 rezulin deaths, the FDA's new commissioner, Jane E. Henney, ordered a review of the safety
Silencing public health advocates: outspoken Vioxx critic loses job after testimony against Merck in federal trial
News Target Network, Alexis Black, March 29, 2006
There's something fishy going on at the Cleveland Clinic. In a surprising move in December 2005, the prestigious clinic removed Dr. |
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