Gerald E. Markle and Frances B. McCrea
See book keywords and concepts |  Bayer's baycol was removed from the market in 2001 after reports that 31 people taking it had died from a rhamdomyolysis, a rare disorder involving muscle-tissue breakdown that leads to kidney failure. According to a 2004 article in JAMA, Bayer learned as early as 1999 that serious adverse reactions were associated with their drug. "To our knowledge," claim the JAMA authors, "these findings were not disseminated or published. |
Greg Critser
See book keywords and concepts |  About one in one thousand patients will experience some form of the disease, which almost always remits when the statin in question is discontinued. baycol, unfortunately for those who took it, provoked a severe form. More recently, a new statin,
Crestor, has come under attack by the same researchers and public health advocates who blew the whistle on baycol for causing a similar reaction while providing no better results than existing, proven statins. |
Donald L. Barlett and James B. Steele
See book keywords and concepts |  This is the industry that, with the FDA's approval, sold baycol as a safe treatment for lowering cholesterol until it was determined that in some instances it caused rhab-domyolysis, a disease that destroys skeletal muscle and can be fatal. Some two dozen deaths were linked to baycol and the disease. Baycol's maker, Bayer Pharmaceuticals, took it off the market in 2001.
This is the industry that, with the FDA's approval, sold Rezulin as a treatment for diabetes until it was determined that it led to liver failure in scores of patients and was linked to hundreds of deaths overall. |
Hyla Cass
See book keywords and concepts |  The silver lining about the Vioxx debacle (not to mention the ones involving Prempro, baycol, and several other drugs) is that it raised public consciousness about the fact that prescription drugs can have risks. Any drug powerful enough to have substantial effects on a disease process will be powerful enough to cause harm.
Potential sources of conflict of interest that might allow dangerous drugs to hit the marketplace and be marketed to billions of consumers are getting more media attention. |
Jacky Law
See book keywords and concepts |  One is that most doctors can still vividly recall the withdrawal of Bayer's statin, baycol, in 2001 because of its potentially fatal muscle-wasting side effect. The second is that doctors are cautious by nature. baycol was a potent product, and Christopher Cannon, a heart researcher at Brigham and Women's Hospital in Boston, says his research shows doctors typically prescribe statins at doses lower than those used in trials.10
Besides, they know that everything in the body has some function. If lower really were better, it would follow that none was better still. Can this really be the case? |
Andreas Moritz
See book keywords and concepts |  The FDA approved the sale of the statin drug baycol to lower cholesterol. One severe adverse reaction, discovered later, was the potentially fatal condition known as rhabdomyolysis, in which destruction of muscle tissue occurs. Despite such a severe adverse reaction, the FDA continues to approve the use of other statin drugs that are also associated with this deadly side effect.
• The FDA has aggressively suppressed natural alternatives to drugs. Red yeast rice, for example, known to be a safe and effective alternative to cholesterol-lowering drugs, was banned by the FDA in 2001. |
Hyla Cass, M.D.
See book keywords and concepts | | While we hear daily of new drug miracles, more often, it's the latest debacle: baycol, a drug for lowering cholesterol, withdrawn because of deaths and transplants due to severe liver damage; Vioxx, for arthritis, withdrawn because of heart disease-related complications; and hormones such as Prempro, once seen as a boon to all post-menopausal womankind, now viewed as posing an unacceptable risk of breast cancer and heart attack.
How can this happen? As physicians, we take the Hippocratic oath to "first, do no harm. | | The silver lining about the Vioxx debacle (not to mention the ones involving Prempro, baycol, and several other drugs) is that it raised public consciousness about the fact that prescription drugs can have risks. Any drug powerful enough to have substantial effects on a disease process will be powerful enough to cause harm.
Potential sources of conflict of interest that might allow dangerous drugs to hit the marketplace and be marketed to billions of consumers are getting more media attention. |
Melody Petersen
See book keywords and concepts |  At the time of the meeting, according to its written minutes, baycol had only 5 percent of the market. Dr. Wolfgang Plischke, the president of Bayer's North American pharmaceutical division, attended the meeting and declared his optimism for higher sales. Dr. Plischke "reiterated the need to drive future sales," the minutes said, "and his belief that we can achieve blockbuster status."
When both corporate executives and government regulators agree that a prescription drug comes with a small but real risk of death, how many deaths does it take before there is one too many? | | America did not need another cholesterol-lowering drug when executives at Bayer introduced baycol in 1997. Other companies were already selling five of these drugs known as statins, including Lipitor, Zocor, and Pravachol. But that did not stop the plans of the executives at the German chemical giant. They needed a new bestseller and were excited by the fast-rising use of statins by Americans, who were reminded every day to watch the levels of cholesterol in their blood. Thanks to the marketers of the first statin pills, "Know your numbers" had become a mantra of the fifty-and-older set. | | Just over a year later, federal officials pressed Bayer to take baycol off the market. More than one hundred patients had died while taking the drug. The number of deaths had surged when patients began taking the 0.8 milligram dose.
With no limit on the amount of money faculty could receive from the industry, some professors were receiving annual fees from a single company that could buy a classy Mercedes or pay to send a child to Harvard. For example, I found the name of Dr. | | They added language to Baycol's written label explaining that such injuries had been reported. The label, which is also known as the prescribing instructions, is the official guide to a drug and is carefully monitored by the FDA. The language added by Bayer about the rhabdomyolysis cases served as a warning to physicians. It also served to protect Bayer from lawsuits brought by patients. The company could now point out that it was not hiding the danger. The problem was that studies had shown that many doctors ignored these labels. | | Some executives were "scared to uncover such data (bad data)," the person wrote, because the company was anticipating higher sales as it launched a new version of baycol containing a higher dose.
"If FDA asks for bad news, we have to give," the executive wrote, "but if we don't have it, then we can't give it to them."
The next month Patricia Stenger, a manager in Bayer's scientific affairs division, e-mailed Dr. Richard Goodstein, the vice president for scientific relations at Bayer. Ms. | | Within a hundred days of the first baycol prescription in the United States, the company received disturbing reports of seven patients who had taken it. The patients had developed a potentially fatal condition known as rhabdomyolysis or had tested positive for an enzyme that was a sign of the condition.
Rhabdomyolysis is the rapid breakdown of the body's muscles. As the muscle cells disintegrate, their contents flow into the bloodstream. Mild cases can cause severe pain and muscle weakness. In serious cases, the condition can cause paralysis and death as the kidneys shut down. |
Hyla Cass
See book keywords and concepts | | While we hear daily of new drug miracles, more often, it's the latest debacle: baycol, a drug for lowering cholesterol, withdrawn because of deaths and transplants due to severe liver damage; Vioxx, for arthritis, withdrawn because of heart disease-related complications; and hormones such as Prempro, once seen as a boon to all post-menopausal womankind, now viewed as posing an unacceptable risk of breast cancer and heart attack.
How can this happen? As physicians, we take the Hippocratic oath to "first, do no harm. |
Jacky Law
See book keywords and concepts | | It had taken the over-the-counter decongestant PPA off the US market, and it had contributed to the team effort that protected the public from the adverse effects of GlaxoSmithKline's Lotronex, Bayer's baycol, and Johnson & Johnson's Propulsid.
Another indication that public trust in medicines regulation may be misplaced came when Graham returned to work, having just testified against his employers. According to the British Medical Journal, he received a standing ovation. Graham had not minced his words. |
Greg Critser
See book keywords and concepts | | In 2000, the statin known as baycol, made by Bayer, was removed from the market for causing thirty-one deaths from rhabdomyolysis. All statins carry some risk of "rhabdo," a sudden and devastating weakness of the muscle tissue; as it turns out, the same statin action that inhibits coenzyme A also suppresses other vital cell-maintenance enzymes, particularly one that maintains muscle and heart tissue. So far, the rate of true rhabdo has remained very low. |
Ray Moynihan and Alan Cassels
See book keywords and concepts |  Reports of sometimes fatal muscle-wasting linked to Bayer's statin baycol, when taken in conjunction with a second drug, led to a voluntary withdrawal from the market several years ago, and the company and its insurers have had to put aside more than a billion dollars to fight or settle thousands of the resulting lawsuits.56 The company's view is that it marketed the statin responsibly, and it is fighting each suit on a case-by-case basis. Without admitting any wrongdoing Bayer has so far settled 3000 cases, and has another 8000 pending. |
Greg Critser
See book keywords and concepts | | 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. On that count, no one was buying the now nauseating line that high prices were simply a reflection of the high cost of developing new drugs. | | More recently, a new statin,
Crestor, has come under attack by the same researchers and public health advocates who blew the whistle on baycol for causing a similar reaction while providing no better results than existing, proven statins. AstraZeneca, the maker of Crestor, has chosen to fight such charges, investing millions in a public relations and ad campaign to establish Crestor as the next blockbuster statin. It is too soon to tell what will happen. |
Mike Adams, the Health Ranger
See article keywords and concepts |  So it’s a very poor system, and we are seeing drugs being pulled. baycol was another one pulled from the market because of multiple damages, kidney failure and death. It was taken off about two years ago. So you start to look at the process, and it’s really not a very good one.
Mike: The timing of all this is quite interesting, because, since the time your book was published, the marketing and propaganda about prescription drugs has skyrocketed.
Dr. Strand: It was even before that. |
Mike Adams, the Health Ranger
See article keywords and concepts |  Acomplia will likely be a very popular drug, and five or ten years down the road, after tens of millions of Americans have taken it, we may begin to find some problems with it, in the same way that we found serious health problems with Vioxx, baycol, NSAIDs and antidepressants. People may be harmed by Acomplia in ways that modern doctors and the makers of Acomplia cannot foresee. And when that happens, the very people who are taking the drug will then turn around and blame the drug companies for their problems!
Because once again, the takers of the drugs are taking on the role of the victim. |
Jack Challem
See book keywords and concepts |  Statin Drugs Reduce CoQIO Levels
Fatigue, liver disease, and heart failure are among the risks associated with "statin" drugs, the largest category of cholesterol-lowering drugs (which include Lipitor, Mevacor, Pravachol, Zocor, and the now banned baycol). According to studies by Dr. Peter Langsjoen and many other researchers, statin drugs also decrease the body's production of CoQIO.
These drugs work by reducing the activity of a key enzyme involved in the production of cholesterol. However, the same enzyme is needed for CoQIO synthesis. |
Donald L. Barlett and James B. Steele
See book keywords and concepts | | Some two dozen deaths were linked to baycol and the disease. Baycol's maker, Bayer Pharmaceuticals, took it off the market in 2001.
This is the industry that, with the FDA's approval, sold Rezulin as a treatment for diabetes until it was determined that it led to liver failure in scores of patients and was linked to hundreds of deaths overall. The drug's maker, Parke-Davis and Warner-Lambert, took it off the market in 2000. |
Ray Moynihan and Alan Cassels
See book keywords and concepts | | Already, one of the statins, Bayer's baycol, has been pulled from the market after being implicated in several cases of death.4 The newest statin, AstraZeneca's Crestor, has also faced calls for its withdrawal, because of very rare but debilitating side effects of muscle wasting and kidney failure.5
The dawn of the new age of cholesterol came in 1987, when Merck launched the first of the statins, Mevacor, amid much excitement in the medical marketplace. |
Jacky Law
See book keywords and concepts | | The second is that doctors are cautious by nature. baycol was a potent product, and Christopher Cannon, a heart researcher at Brigham and Women's Hospital in Boston, says his research shows doctors typically prescribe statins at doses lower than those used in trials.10
Besides, they know that everything in the body has some function. If lower really were better, it would follow that none was better still. Can this really be the case? |
Dr. Timothy Scott
See book keywords and concepts |  The FDA does a tremendous job on many levels, but baycol, Rezulin, Ephedra, Lotronex, Propulsid and a host of other approved but later recalled drugs make it clear that adverse events may not show up for months or even many years after FDA approval is received. In view of such experiences, it is hard to believe that the FDA approved all the SSRI antidepressants with no more than 8 weeks of clinical trial data. |
Kevin Trudeau
See book keywords and concepts |  The FDA approved the drug baycol for reducing cholesterol. Again, the FDA said the drug was both effective and safe. Within months the drug caused a minimum of thirty-two patients to develop fatal kidney failure, causing the drug to be taken off the market.
• The pain killer Oxycontin is still on the market, yet there are confirmed 120 deaths.
• The most popular drugs in the world, cholesterol-lowering drugs, can actually trigger a heart attack. This is confirmed by the drug manufacturer's own research! But this information is kept from doctors, the media, and patients. |
Earl L. Mindell, RPh, PhD with Virginia Hopkins, MA
See book keywords and concepts | | There's more. baycol (cerivastatin), a popular statin drug used for cholesterol control, was recalled in 2001 because it caused at least 31 cases of a deadly muscle-wasting disease. Lotronex (alosetron), a drug prescribed for the relief of diarrhea-predominant irritable bowel syndrome, was linked to several deaths and hospitalizations due to severe constipation. It was recalled in 2000, but the FDA then agreed to put it back on the market—a move that astonished those who recognize its dangers. |
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ABOUT THE CREATOR OF NATURALPEDIA: Mike Adams, the creator of this NaturalNews Naturalpedia, is the editor of NaturalNews.com, the internet's top natural health news site, creator of the Honest Food Guide (www.HonestFoodGuide.org), a free downloadable consumer food guide based on natural health principles, author of Grocery Warning, The 7 Laws of Nutrition, Natural Health Solutions, and many other books available at www.TruthPublishing.com, creator of the earth-friendly EcoLEDs company (www.EcoLEDs.com) that manufactures energy-efficient LED lighting products, founder of Arial Software (www.ArialSoftware.com), a permission e-mail technology company, creator of the CounterThink Cartoon series (www.NaturalNews.com/index-cartoons.html) and author of over 1,500 articles, interviews, special reports and reference guides available at www.NaturalNews.com. Adams' personal philosophy and health statistics are available at www.HealthRanger.org.
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