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"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." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"The past decade has seen a litany of products that have fallen from grace—Vioxx, Avandia, Rezulin, Seldane, baycol, CETP inhibitors, Pre-marin, and more. Which drugs that millions consume today will be the fallen heroes of tomorrow? I am certainly not against medications or their intelligent use. But they should be used carefully, with full awareness of all their effects whether that's "drug action" or "side effects." Most medication is prescribed for conditions that are better treated by diet, nutritional therapies, and lifestyle changes." - Mark Hyman MD, The UltraMind Solution: Fix Your Broken Brain by Healing Your Body First (Get the book.)

"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." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"Indeed, kidney failure was reportedly a major cause of death amongst the baycol victims. baycol is not unique in its ability to damage muscle—all the statins have been shown to produce muscle disorders in susceptible patients, and muscle pain is one of the most common reasons for patients being taken off statin drugs(69). Researchers recently reported that some patients may suffer muscle deterioration caused by statins while still maintaining normal levels of creatine kinase, the most commonly used indicator of muscle damage(70)." - Anthony Colpo, The Great Cholesterol Con: Why Everything You've been Told About Cholesterol, Diet and Heart Disease is Wrong (Get the book.)

"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." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"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." - Donald L. Barlett and James B. Steele, Critical Condition: How Health Care in America Became Big Business (Get the book.)

"Indeed, kidney failure was reportedly a major cause of death amongst the baycol victims. baycol is not unique in its ability to damage muscle—all the statins have been shown to produce muscle disorders in susceptible patients, and muscle pain is one of the most common reasons for patients being taken off statin drugs(69). Researchers recently reported that some patients may suffer muscle deterioration caused by statins while still maintaining normal levels of creatine kinase, the most commonly used indicator of muscle damage(70)." - Anthony Colpo, The Great Cholesterol Con: Why Everything You've been Told About Cholesterol, Diet and Heart Disease is Wrong (Get the book.)

"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?" - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"I just quote from Bayer's 2001 company report: 'Lipobay? baycol?was said to be one of the growth boosters of the pharmaceutical industry. Having been on the market since 1997, the anti-cholesterolemic has become a blockbuster in no time; at last the turnover forecast was € 2.5 billion a year. Worldwide, approximately 6 million people were on the Bayer product. The decision of August 8, 2001 to take the product from the market, therefore, had extensive consequences for the whole group. Vioxx had an unbelievable sales share of 20% in the total turnover of the Merck & Co. group." - Kenneth W Thomas, Ron Gilbert, Gerd Schaller, Side Effects: The Hidden Agenda of the Pharmaceutical Drug Cartel (Get the book.)

"One statin, baycol, was pulled from the market because of fifty or more cases of fatal muscle damage. Fewer such catastrophes have been reported for the other statins, but there are catastrophes reported with exposure to each along with a number of cases with milder and reversible muscle toxicity.3 There's the rub. I can't tell you the long-term risk of statins; they are a unique class of agents, and our long-term experience is limited. We can gain a modicum of re- 2. Of course, this depends on which outcome you choose to treat for." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.)

"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." - Gerald E. Markle and Frances B. McCrea, What If Medicine Disappeared? (Get the book.)

"In March 2000 Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo, a database analyst, reported to Bayer executives that baycol "substantially elevates" the risk of rhabdomyolysis compared with similar drugs. But the two analysts said the magnitude of the problem could not be determined from Bayer's data. They wrote that the company was working to gather data from other organizations that would provide a more accurate analysis of the drug's injury rate. Their report remained a corporate secret that was not shared with the public. About that same time, Dr." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"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?" - Jacky Law, Big Pharma: Exposing the Global Healthcare Agenda (Get the book.)

"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." - Andreas Moritz, Timeless Secrets of Health & Rejuvenation: Unleash The Natural Healing Power That Lies Dormant Within You (Get the book.)

"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?" - Jacky Law, Big Pharma: Exposing the Global Healthcare Agenda (Get the book.)

"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." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"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." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.) "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." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"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." - Donald L. Barlett and James B. Steele, Critical Condition: How Health Care in America Became Big Business (Get the book.)

"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." - Hyla Cass, M.D., Supplement Your Prescription: What Your Doctor Doesn't Know About Nutrition (Get the book.) "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." - Hyla Cass, M.D., Supplement Your Prescription: What Your Doctor Doesn't Know About Nutrition (Get the book.)

"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." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"One statin, baycol, was pulled from the market because of fifty or more cases of fatal myositis. Fewer such catastrophes have been reported for the other statins, but some have been reported with exposure to each of the statins along with a number of cases with milder and reversible Of course, this calculation depends on which outcome you choose to treat for." - Nortin M. Hadler, The Last Well Person: How to Stay Well Despite the Health-Care System (Get the book.)

"The withdrawal of baycol, a cholesterol-lowering drug, was typical in many ways and illustrates some of the problems. The Bayer Corporation marketed the drug in 1997 in a low-dose tablet. It was introduced even though there were already five similar drugs on the market. These made up a class of drugs called statins that are chemically similar and that all lower cholesterol by inhibiting the same enzyme. Though it did indeed lower cholesterol, baycol was less effective than other drugs at its initial low dose and caused more serious side effects at higher doses." - Richard A. Deyo M.D. M.P.H., Donald L. Patrick, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises (Get the book.)

"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." - Jacky Law, Big Pharma: Exposing the Global Healthcare Agenda (Get the book.)

"Luckily, baycol wasn't as effective for me, and I switched back to Lipitor before baycol was recalled because of serious side effects. In this case, direct-to-consumer advertising prompted a useless change that might have been risky. Another concern is that patients with minor symptoms may be persuaded that they have a serious disease and seek expensive but unnecessary treatment." - Richard A. Deyo M.D. M.P.H., Donald L. Patrick, Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises (Get the book.)

"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." - Hyla Cass, Supplement Your Prescription: What Your Doctor Doesn't Know About Nutrition (Get the book.)

"Think Vioxx, Seldane, Thimerosal, baycol, Fen Phen, Propulsid, Rezulin, and PPA (phenylpropanolamine). PPA, remarkably, is still available in over-the-counter diet and cold medications. Buyer beware. Pop Quiz Most of us aren't good with statistics, and both sides of any debate can make statistics mean what they want. But in our case, there is a specific mathematical equation that can be used to illustrate the dangers of drug interactions and their potential side effects." - David H. Rippe, Jared Rosen, The Flip: Turn Your World Around (Get the book.)

"This study was scheduled to enroll 3,605 heart attack patients who were to be randomized to either baycol or placebo for three months. The trial was supposed to have had a two-year follow-up, but when cerivastatin was pulled from the market in 2001, the trial was stopped, and the data acquired after 4.5 months was tallied. Among those who had already completed 4.5 months of cerivastatin use, there was little evidence of increased myopathy or rhabdomyolysis risk, with adverse events similar in the treatment and placebo groups." - Anthony Colpo, The Great Cholesterol Con: Why Everything You've been Told About Cholesterol, Diet and Heart Disease is Wrong (Get the book.)

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