Tag Archives: us food and drug administration

Let’s Not Waste Another 12 Years

The federal government regulates everything from breakfast cereal and hair dye to horse feed and breast implants. The list of items regulated by our government includes just about every consumable product in America from prescription drugs to vegetables.

But there’s one item strangely absent from the list, the one that causes more preventable deaths than any other product. A powerful and well-funded lobby has managed to keep tobacco off the list of federally regulated products for more than 40 years after the first surgeon general’s report linked smoking to cancer. Even today, a simple list of ingredients is not required for tobacco products.

Tobacco companies have taken advantage of this lack of oversight and have shamelessly marketed to underaged recruits through cartoon advertising, nicotine and ingredient manipulation, fruity flavors, free giveaways at rock concerts, and ads in publications with high teen readership.

In 1996, the Food and Drug Administration assumed the authority to regulate tobacco as a consumable product and published rules regarding this regulation. Some basic common-sense approaches were proposed in those rules, including ways to prohibit the sale and marketing of tobacco to children. However, the Supreme Court ruled that only Congress could give the FDA authority to regulate tobacco.

Twelve years later, we continue to wait for Congress to take action regarding this lone unregulated product. We submit to you that this is twelve years too long.

Government RegulatorsCurrently being considered by Congress, the Family Smoking Prevention and Control Act, S. 625 and H.R. 1108, would give the U.S. Food and Drug Administration the authority to regulate tobacco products the way drugs, devices, and foods are currently regulated. The American Cancer Society encourages all members of Congress to stand up and be counted on this issue. We cannot afford another 12 years of inaction.

Clanton is chief medical officer for the American Cancer Society, High Plains Division, which includes Oklahoma. He is former deputy director for the National Cancer Institute at the National Institutes of Health.

Source: Mark Clanton, M.D., The Oklahoman

Anti-Smoking Drug Chantix Tied to Serious Mental Illness

Melinda and Kenny Peterson wanted to kick their two-pack-a-day smoking habit.

In early January, the Green Bay couple started taking three-month prescriptions of Chantix, a new anti-smoking pill. About six weeks later, they weren’t smoking at all.

But what the Petersons didn’t know was that as they were weaning themselves off cigarettes, the U.S. Food and Drug Administration issued an alert.

Chantix Causes Neuropsychiatric Symptoms

Some patients taking the powerful drug had experienced serious neuropsychiatric symptoms. And Pfizer, the maker of Chantix, had recently added a warning about these symptoms in a more prominent position in the drug’s information packet, at the FDA’s urging.

The alert was issued in early February. But the Petersons didn’t know about it until the end of March, when a friend who was a pharmacist filled them in.  By then, it was too late. About a week earlier, Kenny Peterson had spiraled into a deep depression. He told his wife he wanted to kill himself. His family checked him into a hospital psychiatric ward four days before Easter. Chantix’s safety is now under fire, as similar stories of patients with suicidal thoughts, depression and aggressive behavior surface. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. The FDA also said it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” About 5 million people use the drug.

“I think the jury is still out on what’s going on here,” said Carlyle Chan, a professor in the psychiatric department at the Medical College of Wisconsin. “Be aware that there are some concerns about (Chantix). It needs to be watched closely.”

A Pfizer spokeswoman said the company was rolling out Chantix globally but halted advertising the drug to consumers in February. The FDA approved the drug in May 2006.

The company maintained that the serious neuropsychiatric symptoms are rare, but physicians and patients should be on the lookout for them. Pfizer said a causal relationship between the drug and these symptoms has not been determined.

“The real problem out there right now is smoking,” Senior Vice President and Chief Medical Officer Joe Feczko said at a health investor conference in March.

Chantix can help shrink the global population of 1.3 billion smokers, he said, thus addressing health problems such as cancer and cardiovascular disease. In 2007, Chantix brought in $883 million in revenue.

Chantix, known generically as varenicline, works by blocking nicotine receptors in the brain. When people smoke, nicotine attaches to receptors and the brain releases the chemical dopamine, which gives pleasure. Chantix activates the receptors and blocks nicotine from attaching to them.

Before You take Chantix Be WarnedThe drug now includes a mention of possible serious neuropsychiatric symptoms in a warning section of the printed information that accompanies each prescription and is folded inside the packaging. Previously, the information was in a less prominent place in a section of the drug’s literature in which “adverse events” were reported. But there is no requirement to put the warning on the actual package because the FDA hasn’t mandated it.

None of this is comforting to Melinda Peterson, who believes that Chantix cost her family too much.

In the psychiatric ward, Kenny Peterson was diagnosed with bipolar disorder. He’s out of the hospital now but can’t work, and his doctors said they wouldn’t know when he would be able to work.

“He is completely mentally ill right now,” Melinda Peterson said. “My belief is that the drug caused him to go into a manic episode. He has paranoia. He has delusions.”

Chan said it was unclear whether Chantix actually caused depression and suicidal thoughts or whether Chantix exacerbated the symptoms of people who already have some sort of depressive behavior.

The FDA reported that it has seen both types of situations – some in which patients had no history of depression, and cases in which depression previously was an issue.

Source: Ellen Gabler,  journalsentinel.com