Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Tuesday, September 13, 2011

Did Bachmann's drug lobbyist claims ring true?

During Monday's CNN/Tea Party debate, Rep. Michele Bachmann criticized Texas Gov. Rick Perry's short-lived 2007 executive order requiring girls to get a vaccination for human papillomavirus, claiming in part that his former chief of staff lobbied for the drug maker, and that the company made millions of dollars because of the order.

"I just wanted to add that we cannot forget that in the midst of this executive order there is a big drug company that made millions of dollars because of this mandate. We can't deny that ... What I'm saying is that it's wrong for a drug company, because the governor's former chief of staff was the chief lobbyist for this drug company," Bachmann said. "The drug company gave thousands of dollars in political donations to the governor, and this is just flat-out wrong. The question is, is it about life, or was it about millions of dollars and potentially billions for a drug company?"
Perry replied, "The company was Merck, and it was a $5,000 contribution that I had received from them. I raise about $30 million. And if you're saying that I can be bought for $5,000, I'm offended."
The exchange involves multiple claims. We'll examine each:
Statement No. 1:
Bachmann: "We cannot forget that in the midst of this executive order, there was a big drug company that made millions of dollars because of this mandate. We can't deny that."
The facts:
Perry in February 2007 signed an executive order directing the state Health and Human Services commissioner to mandate human papillomavirus vaccination for all girls before admission to the sixth grade. Perry at the time released a statement saying that the vaccine "provides us with an incredible opportunity to effectively target and prevent cervical cancer," which HPV can cause.
At the time, the only such vaccine that the Food and Drug Administration had approved was Gardasil, made by Merck & Co.
Texas' rules were to take effect in September 2008. However, the Texas Legislature passed a bill overturning Perry's order in April 2007. Perry declined to veto the bill, which went into effect in May 2007, killing his order.
The verdict:
False. The executive order didn't last long enough to produce a mandate. Therefore, there was no mandate that would have caused Merck to make millions of dollars.
Statement No. 2:
Bachmann: "The governor's former chief of staff was the chief lobbyist for this drug company."
The facts:
Michael Toomey, a former three-term state representative from Houston, served as Perry's chief of staff from December 2002 to September 2004.
Toomey was a lobbyist for a number of companies -- including Merck -- before and after he served in Perry's office, according to the Texas Ethics Commission. He was registered in Texas to lobby for Merck from at least 1998 to 2002, and from 2004 to the present, according to the commission.
The verdict:
True. Toomey was as a lobbyist for Merck. However, CNN could not find evidence to confirm or dispute that he was the company's "chief lobbyist."
Statement No. 3:
Perry's defense: "The company was Merck, and it was a $5,000 contribution that I had received from them."
The facts:
Merck's political action committee did give Perry $5,000 in 2006, when he was seeking a second full term. But it also gave him nearly $25,000 more over the course of his career, including a $10,000 donation in 2004; $5,000 in 2002; $1,000 in 2005; $1,000 in 2000; $2,500 in 2008; and another $5,000 in his most recent run, in 2010.
The verdict:
Misleading.

Sunday, May 15, 2011

Popularity of melatonin desserts unsettling for doctors

Remember melatonin? In the 1990s, this over-the-counter dietary supplement was all the rage among frequent fliers, promoted as the miracle cure for jet lag. Now it is back in vogue, this time as a prominent ingredient in at least a half-dozen baked goods that flagrantly mimic the soothing effects of hash brownies — and do so legally. At least for now.
With names like Lazy Cakes, Kush Cakes, and Lulla Pies, these products are sold online and at stores such as 7-Eleven, Walgreens, smoke shops, and even at the Harvard Coop, the university’s student bookstore, for roughly $3 to $4 each. (A bottle of 60 8-milligram melatonin tablets costs about $11.) At some places, the drug-laced desserts can be paid for with food stamps.
Although the Food and Drug Administration has not approved melatonin as a food additive or deemed it safe, the dessert makers are marketing their products as a harmless way to promote relaxation.
The snacks are increasingly being endorsed by fans on Facebook and Twitter as an antidote to stress and sleep deprivation. (Who needs yoga?) On the Facebook page for Lazy Cakes, one woman who said she has bipolar disorder wrote that the treat “helps a lot with my sleeping and panic attacks I can lay off my Xanax a little.’’
Gabby Bevel, 22, a writer from Norman, Okla., and an insomniac who took Ambien and Lunesta in high school, said in an interview that she slept 13 hours after eating one Lazy Cakes snack recently. “I don’t like the idea of needing something unnatural to help me with anything,’’ she said. “Really, I think part of the appeal is it does come in a brownie.’’
But these products contain roughly 8 milligrams of melatonin per brownie or cookie, so selling them is similar to a parent serving an unsuspecting child applesauce containing a crushed aspirin tablet to make it go down easier.
“It’s making it much more difficult for the consumer to recognize that they are taking a drug,’’ said Dr. Charles A. Czeisler, the chief of the division of sleep medicine at Brigham and Women’s Hospital.
Nick Collado, a 26-year-old insomniac and the founder of Lulla Pies, argued that the melatonin they contain, while synthetic, is more “natural’’ than the Ambien he used to take. “I realized there’s got to be more people like me who don’t want to take prescription drugs anymore, who want to take an alternative,’’ Collado said.
But Dr. David S. Seres, the director of medical nutrition at Columbia Medical Center, cautioned that consumers should consult their doctors before trying such products.
“The promoters of these are appealing to people who think it’s better to do things outside of the medical establishment,’’ he said, adding that “the desire to help people is an extremely strong motivator, but so is money.’’
Seres pointed to a section of the National Institutes of Health’s website that lists several drugs, including sedatives such as clonazepam and birth control pills, whose efficacy might be altered by melatonin.
“A hangover effect has been reported’’ with large doses, said Anna Rouse Dulaney, a toxicologist with the Carolinas Poison Center.
Lazy Cakes appear harmless, even amusing, with swirly purple packaging; Kush Cakes have a tie-dye-printed wrapper. But they are not to be underestimated.
Of melatonin, Seres warned, “If you take it while you’re driving a car, you will find yourself in a ditch.’’
Maybe. Dr. Alfred J. Lewy, a professor of psychiatry at Oregon Health and Science University who has studied melatonin, a neurohormone, estimated that only a third of the population is susceptible to its effects in a supplement.
Some medical professionals are concerned that the chocolate taste of the desserts might encourage indiscriminate gobbling.
“It’s a colossally bad idea to put melatonin in food,’’ Czeisler said. “It should not be permitted by the FDA.’’
Technically, it is not. Stephanie Yao, a spokeswoman at the FDA, wrote in an e-mail that any item that uses melatonin as an additive “may be subject to regulatory action.’’
That is why the makers of these new baked goods label them “not for food use.’’ They want them to be considered dietary supplements, which do not need the FDA’s premarket approval and are not required to be proved safe or effective.

Tuesday, March 22, 2011

Factbox: Restrictions on Japanese food imports

The United States became the first nation to block produce from Japan's radiation zone, saying on Wednesday it will halt milk, vegetable and fruit imports from areas near the tsunami-damaged nuclear plant because of contamination fears.
Here are steps other countries have taken to test or block Japanese food imports:
CHINA
Monitoring food imported from Japan for signs of radiation.
HONG KONG
Authorities in Hong Kong have been checking all fresh food imports from Japan for traces of radioactive iodine and cesium since March 12.
MALAYSIA
Testing all consignments from Japan. Health Ministry is monitoring the situation daily but has no plans to ban so far.
SOUTH KOREA
Testing for signs of radiation in fresh agricultural produce, dried agricultural and processed food from Japan.
Korea Food & Drug Administration (KFDA) said on Wednesday it would not ban Japanese food at this stage.
TAIWAN
Taiwan's Fisheries Agency has advised local boats not to fish in Japanese waters after radiation was detected in the sea around the Fukushima nuclear plant.
The agency will check all catches on fishing boats returning from Japanese waters and destroy any catches with radioactivity exceeding permitted limits.
UNITED STATES OF AMERICA
The United States will block imports of milk and fresh produce from areas of Japan near the crippled nuclear power plant.
All milk and milk products and fresh fruits and vegetables from four Japanese prefectures -- Fukushima, Ibaraki, Tochigi and Gunma -- will be stopped from entering the United States, the Food and Drug Administration said.