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Bayer Caves In to State AGs on One A Day Cancer Claims
Bayer Prostate Cancer Drug Cuts Death Risk by 30%, Study Shows

Bayer Caves In to State AGs on One A Day Cancer Claims


Drug Company Must Pay $3.3 Million to States and Support Future Claims with Competent Scientific Evidence

Bayer will be barred from claiming that its One A Day multivitamins may cure, treat, or prevent any disease, including cancer, unless the company can back up such claims with competent and reliable scientific evidence. As part of a settlement agreement reached yesterday with Attorneys General from Oregon, California, and Illinois, Bayer must also make a $3.3 million payment to those states. A complaint, filed by Oregon Attorney General John Kroger, accused Bayer of “deceptively leveraging fear of prostate cancer” in order to market One A Day multivitamins for men.

Bayer claimed that “emerging research” suggested that the mineral selenium in One A Day might reduce the risk of prostate cancer. But according to the Center for Science in the Public Interest, “emerging research” did no such thing. In fact, a seven-year, $118-million study funded by the National Institutes of Health found that selenium does not prevent prostate cancer in healthy men. That massive trial, which involved 35,000 men, was abruptly halted when it became clear to researchers that selenium was not protecting the men from prostate cancer and may have been causing unexplained cases of diabetes. Yet Bayer continued to claim a protective benefit from selenium.

In October of 2009, CSPI sued Bayer in federal court in California over the selenium claims on One A Day, which a judge dismissed on technical grounds. CSPI was planning on filing suit on behalf of a California consumer in another court. But in the wake of the settlement agreement reached with the Attorneys General, CSPI is announcing that it will not move forward with the second suit.

“We are very glad that the Attorneys General have obtained a binding settlement prohibiting Bayer from exploiting men’s fear of prostate cancer in order to sell more vitamin pills,” said CSPI litigation director Steve Gardner. “And we’re also pleased that Bayer seems to have had a change of heart, since after CSPI publicly questioned the company’s unsupportable claims on One A Day, its response then was to threaten us with a libel lawsuit.” Bayer has since backed off that threat, Gardner said.

The agreement reached yesterday is the latest in a long list of settlement agreements, fines, guilty pleas, and other enforcement actions involving the German pharmaceutical giant. In 2001, Bayer paid $14 million to U.S. and state governments to settle allegations that the company’s actions helped health care providers submit inflated Medicaid claims for drugs. In 2003, Bayer pleaded guilty to a criminal charge and paid $257 million in fines and penalties after a whistleblower exposed a scheme by the company to overcharge for the antibiotic Cipro. In 2004, Bayer pleaded guilty to a criminal charge and paid a $66 million fine after a Justice Department investigation into Bayer’s role in a price-fixing conspiracy involving a chemical used to make rubber products. And in 2007, Bayer paid $8 million to resolve allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.

Prior marketing for One A Day has also posed legal problems for Bayer. In 2007, it paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice. The case centered on weight-loss claims that the FTC said violated an earlier order requiring that all health claims for One A Day be supported by competent and reliable scientific evidence. And in 2009, Bayer was required to run a $20-million corrective advertising campaign about its birth control pill Yaz and to submit its ads for FDA approval, as part of a legal settlement secured by a number of state attorneys general and the FDA.

Need for even more government oversight

The agreement reached yesterday is the latest in a long list of settlement agreements, fines, guilty pleas, and other enforcement actions involving the German pharmaceutical giant. In 2001, Bayer paid $14 million to U.S. and state governments to settle allegations that the company’s actions helped health care providers submit inflated Medicaid claims for drugs. In 2003, Bayer pleaded guilty to a criminal charge and paid $257 million in fines and penalties after a whistleblower exposed a scheme by the company to overcharge for the antibiotic Cipro. In 2004, Bayer pleaded guilty to a criminal charge and paid a $66 million fine after a Justice Department investigation into Bayer’s role in a price-fixing conspiracy involving a chemical used to make rubber products. And in 2007, Bayer paid $8 million to resolve allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.

Prior marketing for One A Day has also posed legal problems for Bayer. In 2007, it paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice. The case centered on weight-loss claims that the FTC said violated an earlier order requiring that all health claims for One A Day be supported by competent and reliable scientific evidence. And in 2009, Bayer was required to run a $20-million corrective advertising campaign about its birth control pill Yaz and to submit its ads for FDA approval, as part of a legal settlement secured by a number of state attorneys general and the FDA.

Bayer Prostate Cancer Drug Cuts Death Risk by 30%, Study Shows


An experimental drug developed by Bayer AG (BAYN) and Algeta ASA (ALGETA) prolonged the lives of men with prostate cancer that’s spread to their bones, a study found.

A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.

The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.

“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”

Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.

To contact the reporter on this story: Simeon Bennett in Geneva at eMail To contact the editor responsible for this story: Phil Serafino at eMail
Source: www.bloomberg.com/news/2011-09-23/bayer-prostate-cancer-drug-cuts-death-risk-by-30-study-shows.html 

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Bayer Caves In to State AGs on One A Day Cancer Claims


Drug Company Must Pay $3.3 Million to States and Support Future Claims with Competent Scientific Evidence

Bayer will be barred from claiming that its One A Day multivitamins may cure, treat, or prevent any disease, including cancer, unless the company can back up such claims with competent and reliable scientific evidence. As part of a settlement agreement reached yesterday with Attorneys General from Oregon, California, and Illinois, Bayer must also make a $3.3 million payment to those states. A complaint, filed by Oregon Attorney General John Kroger, accused Bayer of “deceptively leveraging fear of prostate cancer” in order to market One A Day multivitamins for men.

Bayer claimed that “emerging research” suggested that the mineral selenium in One A Day might reduce the risk of prostate cancer. But according to the Center for Science in the Public Interest, “emerging research” did no such thing. In fact, a seven-year, $118-million study funded by the National Institutes of Health found that selenium does not prevent prostate cancer in healthy men. That massive trial, which involved 35,000 men, was abruptly halted when it became clear to researchers that selenium was not protecting the men from prostate cancer and may have been causing unexplained cases of diabetes. Yet Bayer continued to claim a protective benefit from selenium.

In October of 2009, CSPI sued Bayer in federal court in California over the selenium claims on One A Day, which a judge dismissed on technical grounds. CSPI was planning on filing suit on behalf of a California consumer in another court. But in the wake of the settlement agreement reached with the Attorneys General, CSPI is announcing that it will not move forward with the second suit.

“We are very glad that the Attorneys General have obtained a binding settlement prohibiting Bayer from exploiting men’s fear of prostate cancer in order to sell more vitamin pills,” said CSPI litigation director Steve Gardner. “And we’re also pleased that Bayer seems to have had a change of heart, since after CSPI publicly questioned the company’s unsupportable claims on One A Day, its response then was to threaten us with a libel lawsuit.” Bayer has since backed off that threat, Gardner said.

The agreement reached yesterday is the latest in a long list of settlement agreements, fines, guilty pleas, and other enforcement actions involving the German pharmaceutical giant. In 2001, Bayer paid $14 million to U.S. and state governments to settle allegations that the company’s actions helped health care providers submit inflated Medicaid claims for drugs. In 2003, Bayer pleaded guilty to a criminal charge and paid $257 million in fines and penalties after a whistleblower exposed a scheme by the company to overcharge for the antibiotic Cipro. In 2004, Bayer pleaded guilty to a criminal charge and paid a $66 million fine after a Justice Department investigation into Bayer’s role in a price-fixing conspiracy involving a chemical used to make rubber products. And in 2007, Bayer paid $8 million to resolve allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.

Prior marketing for One A Day has also posed legal problems for Bayer. In 2007, it paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice. The case centered on weight-loss claims that the FTC said violated an earlier order requiring that all health claims for One A Day be supported by competent and reliable scientific evidence. And in 2009, Bayer was required to run a $20-million corrective advertising campaign about its birth control pill Yaz and to submit its ads for FDA approval, as part of a legal settlement secured by a number of state attorneys general and the FDA.

Article on the above:

Men, are you taking selenium to protect yourself from Prostate Cancer. THere's no proof that it works and there is much evidence that it

selenium was not protecting the men from prostate cancer and may have been causing unexplained cases of diabetes.

Need for even more government oversight

The agreement reached yesterday is the latest in a long list of settlement agreements, fines, guilty pleas, and other enforcement actions involving the German pharmaceutical giant. In 2001, Bayer paid $14 million to U.S. and state governments to settle allegations that the company’s actions helped health care providers submit inflated Medicaid claims for drugs. In 2003, Bayer pleaded guilty to a criminal charge and paid $257 million in fines and penalties after a whistleblower exposed a scheme by the company to overcharge for the antibiotic Cipro. In 2004, Bayer pleaded guilty to a criminal charge and paid a $66 million fine after a Justice Department investigation into Bayer’s role in a price-fixing conspiracy involving a chemical used to make rubber products. And in 2007, Bayer paid $8 million to resolve allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol.

Prior marketing for One A Day has also posed legal problems for Bayer. In 2007, it paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice. The case centered on weight-loss claims that the FTC said violated an earlier order requiring that all health claims for One A Day be supported by competent and reliable scientific evidence. And in 2009, Bayer was required to run a $20-million corrective advertising campaign about its birth control pill Yaz and to submit its ads for FDA approval, as part of a legal settlement secured by a number of state attorneys general and the FDA. bayer.html