Diabetes News

As regular readers of this SUGAR SHOCK! Blog know, I attended and graduated from the amazing Institute for Integrative Nutrition (IIN) in New York City, which brings in a Who's Who of nutrition experts to teach students there.

Now, as an alumni of IIN, I periodically receive e-mails about subjects of interest. I am including verbatim the contents of one such e-mail because it is vitally important. It's about the Farm Bill currently up for consideration in Congress.

I believe that it's important to galvanize as many people as possible to tell our legislators that they need to change the Farm Bill so that we make significant changes in the availability of healthy foods and nutrition education for Americans.

Please join the Institute for Integrative Nutrition, the Center for Science in the Public Interest and me to send an important message to your representatives in Congress so that they will realize that their constituents believe nutrition and health should be a major priority in the Farm Bill and that the bill should help:

• Improve the nutritional quality of school foods
• Increase the availability of fruits and vegetables in schools
• Expand research at the U.S. Department of Agriculture
• Ensure that low-income pregnant women and small children have access to nutritious foods
• Strengthen nutrition education initiatives through the Food Stamp Nutrition Education Program

This is what the Institute for Integrative Nutrition sent me:

Make your voice heard in Congress!

This month the American Congress will vote on the “Farm Bill,” a major piece of legislation on food, agriculture and nutrition in the U.S. for the next five years.

This legislation is a chance to make significant improvements to the availability of healthy foods and nutrition education in America. In partnership with Michael Jacobson and the Center for Science in the Public Interest, Integrative Nutrition and our students and alumni are getting active.

Please take a moment now to send a message to your representative in Congress. Let them know that you think nutrition and health are a major priority.

When you're done, please forward this message to everyone you know. Your life depends on it!

Together we can rock this world! Thank you for your support.

Please click here to take action now.

Again, I urge you to please join the Institute for Integrative Nutrition, the Center for Science in the Public Interest and me so that we make our legislators realize that we need the Farm Bill to increase the availability of healthy foods and improve nutrition education for Americans.

You can listen to me at 8 am on "The Big Show" with Michael Patrick Shiels, a radio program that is aired on 12 stations statewide on The Michigan Talk Network.

We're going to talk about the recent Kellogg's story about how the company is avoiding litigation by making some changes to improve the nutritional value of their cereal. What a great topic!

Listeners of "The Big Show," write to me here and let me know that you tuned in today. The first three listeners who contact me here at my SUGAR SHOCK! Blog will receive a free teleseminar on Wed., July 17 with famous children's obesity expert David Ludwig, M.D., Ph.D., who will help you help your kids to slim down. You'll be in for a real treat!

Check out the CBS website to find a description about Sunday's cover story about sugar, on the CBS News Sunday Morning. The piece is now entitled, "Short and Sweet." Here's the item on the CBS website.

Set your TiVos now if you plan to be busy for Father's Day. Learn first where the CBS News Sunday Morning airs in your area.

FYI, you can learn more about this segment here and also here, when I first posted about my exciting day with the CBS News Sunday Morning crew.

(CBS)

Exciting news comes from the Center for Science in the Public Interest.

After a year and a half of negotiations, the CSPI came to an agreement with the Kellogg Company to adopt nutrition standards for the foods it advertises to young children. In announcing the agreement, CSPI hails this as "an historic commitment."

Kudos really go to CSPI for its hard work to reach this new agreement, which now means that CSPI, as well as the Campaign for Commercial-Free Childhood (CCFC) and two Massachusetts parents, will not proceed with a previously announced lawsuit against the company. (FYI, I mentioned this pending lawsuit in my book SUGAR SHOCK! So this is the latest info that you can't currently find in my book.)

According to the new agreement with Kellogg, CSPI states, "foods advertised on media—including TV, radio, print, and third-party Web sites—that have an audience of 50 percent or more children under age 12 will have to meet new nutrition standards."

In addition, thanks to CSPI's efforts, Kellogg also agreed not to:

• "Advertise to children any foods in schools and preschools that include kids under age 12;
• "Sponsor product placements for any products in any medium primarily directed at kids under 12;
• "Use licensed characters (Shrek, SpongeBob, etc.) in mass-media advertising directed primarily to kids under 12 (for example, on the labels of food packages unless those foods meet the nutrition standards);
• "Use branded toys in connection with foods that do not meet the nutrition standards."

Watch CSPI executive director Michael Jacobson, Ph.D. discuss the settlement.

Note from Connie: News, revelations and insights about the Avandia-could-lead-to-heart-attacks scare are pouring in at a fast and furious clip. So, given my demanding schedule this week, SUGAR SHOCK! Blog researcher/writer Jennifer Moore brings you this latest update about the drug that's supposed to help type 2 diabetics.

The FDA is looking worse by the day. Now comes news, as reported by Stephanie Saul and Gardiner Harris at The New York Times, Anna Wilde Matthews and Jeanne Whalen of the Wall Street Journal, and Reuters that John Buse, M.D., Ph.D., president-elect of the American Diabetes Association, wrote the FDA a letter in 2000, warning our watchdog governmental agency about the dangers Avandia may pose to people's hearts.

Dr. Buse, who is also chief of endocrinology at the University of North Carolina in Chapel Hill, wrote that there was “a worrisome trend in cardiovascular deaths and severe adverse events” amongst patients taking Avandia. Dr. Buse also slammed GlaxoSmithKline, the Big Pharma maker and seller of the popular drug, for what he called its "pervasive and systemic efforts" to downplay Avandia's risks and overstate its upside, according to the New York Times.

This comes after news, which Connie posted about earlier on this SUGAR SHOCK! Blog, that Dr. Steven Nissen, the physician who first warned us of the dangers of the now withdrawn painkiller Vioxx, led a team of researchers to sound the alarms about Avandia in the latest issue of The New England Journal of Medicine, which spurred the FDA to issue a safety alert of this very popular medication.

One wonders why the FDA didn't speak up much sooner since they had ample evidence that Avandia could be dangerous to people who are already vulnerable to heart disease because of their diabetes.

Even GlaxoSmithKline told the FDA that Avandia raised the risk of heart attacks in its patients by 30%, according to Brain Wingfield of Forbes.com. Glaxo SmithKline's findings, which was revealed to the FDA back in 2005 and again in 2006, are very similar to those of Dr. Nissen and his team, who said that a type 2 diabetic would have a 28.9% chance of having a heart attack within 7 years of taking Avandia, according to the New York Times.

What's more, Stephanie Saul and Gardiner Harris of the Times reports, the FDA reprimanded GlaxoSmithKline for downplaying concerns about the drug's safety in 2001, a year after Dr. Buse wrote his rather troubling letter.

Predictably, Glaxo SmithKline issued a statement vigorously disputing Dr. Buse's analysis, calling it "unbalanced and unsubstantiated." That's a patently absurd position to take, given that Glaxo SmithKline itself admitted that the drug substantially raised heart attack risk. The pharmaceutical company can't have it both ways here.

To be fair, the Wall Street Journal makes the startling observation that Dr. Buse was a consultant for two companies marketing diabetes drugs competing with Avandia at the time he sent his warning to the FDA. And Dr. Buse has said that the FDA should wait for more data before taking any further on Avandia (though, tellingly, he doesn't recommend the drug to his own patients, The Times says).

But since Glaxo SmithKline itself revealed the drug's potential problems, and a second prominent, credible doctor did too, my inclination is to think Dr. Buse's position has a lot of merit. Glaxo SmithKline, on the other hand, is talking out of both sides of its mouth and has a vested interest--to the tune of $3 billion-a-year in sales, says the New York Times--in peddling the notion that Avandia's risks are overstated.

So while I find Glaxo SmithKline's behavior irresponsible, I'll save the bulk of my ire for the FDA, whose job first and foremost is to protect the public. Apparently, though, according to a very informative piece by Marilynn Marchione of the AP, which The Washington Post ran, the FDA doesn't always discover the risks of drugs it allows to hit the market.

In the case of Avandia, Marchione writes, the FDA didn't require Glaxo to show that Avandia had a clear clinical benefit to diabetic patients, like fewer hospitalizations or fewer serious problems with blood sugar, but was instead approved because it showed short-term improvements in certain blood sugar measurements. She writes that Avandia's dangers weren't clear until Dr. Nissen's team gathered all the pertinent data on the 28,000 subjects Glaxo SmithKline itself used in 42 experiments involving the drug.

Excuse me? Isn't it the FDA's job to make sure to get all the critical information about a drug in place before deciding that it can be sold to a trusting public? Shouldn't someone at the FDA have done what Dr. Nissen's team did, if not before approving Avandia for sale, certainly soon thereafter? Isn't that what our tax dollars go to the FDA to do?

Now, because of its apparent lapse, the FDA will have to answer to us and Congress in hearings on June 6. Additionally, Senators Max Baucus of Montana and Charles Grassley of Iowa have written the FDA demanding that the agency tell us what they knew about Avandia and when they knew it, and why they reacted in a "leisurely" fashion to Glaxo SmithKline's revelations about Avandia's cardiovascular risks, Forbes.com says.

The Forbes.com article also notes that the senators wrote a letter to Glaxo SmithKline, claiming that they've heard that the pharmaceutical giant silenced at least one employee who wanted to speak out about Avandia's cardiovascular risks. (Horrendous, if true.)

I can only hope that Avandia didn't cause a heart attack in any of the 6 million Americans who have taken the drug. What an appalling job by the FDA.

From Jennifer Moore for the SUGAR SHOCK! Blog

Note again from Connie: Thanks, Jennifer, for updating us. Folks, while you're learning about this scary drug disaster, make sure to read my follow-up press release, which quotes Dr. Stephen Sinatra (contributing author for SUGAR SHOCK!) pointing out that if you have type 2 diabetes or are at risk for the disease, you may not even need drugs after all. Kicking sugar, exercising, etc. may be the best treatment.

Oh no! Another nightmarish consequence of taking drugs!

The safety of Avandiaâ„¢ -- often prescribed to type 2 diabetics -- has been called into question by an eye-opening, scathing scientific article in today's New England Journal of Medicine. which finds, from reviewing 42 clinical trials, that the popular drug may raise the risk of heart attacks by 43 % and cardiovascular death by a whopping 64%.

The lead author of the original article is the respected Steven Nissen, M.D., chairman of the Department of Cardiovascular Medicine at the renowned Cleveland Clinic, and immediate past president of the prestigious American College of Cardiology. (Read his bio here.)

Avandia -- also known as rosiglitazone -- is widely used to help type 2 diabetics lower their blood glucose levels, and it is a $3 billion-a-year business now at risk of being drastically curtailed.

"Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease," said Dr. Nissen in a press release from the Cleveland Clinic.

Every news outlet was full of different takes on these scary conclusions.

• Stephanie Saul of the New York Times weighed in with an enlightening piece, in which she noted that Dr. Nissen was "one of the first doctors to raise questions about the cardiovascular safety of Vioxx, the Merck painkiller that was withdrawn from the market in 2004. His concerns about Avandia were first publicly raised last December in a letter in the Lancet."
• Julie Steenhuysen of Reuters pointed out that a congressional committee has already scheduled a hearing on the drug's safety. "Both the drug company and the FDA have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn't take immediate action to protect patients," the reporter quotes Montana Democrat Sen. Max Baucus, who chairs the Senate Finance Committee.
• Meanwhile, Marilynn Marchione of AP noted that although FDA officials issued a safety alert Monday, they "planned no immediate changes to the current side effect warnings on the drug's packaging." She reports that Rep. Henry Waxman, D-Calif., chairman of the House Committee on Oversight and Government Reform, announced a hearing for June 6 on the FDA's role. She writes: And on the Senate floor, Charles Grassley, R-Iowa, "criticized the agency for not acting more swiftly. "Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out," he said.
• Then, Seve Sternberg of USA Today talked about how nine months ago risks had been raised about the drug in an article with the alarming, but appropriate headline, "Diabetes drug called potential death risk."
• Meanwhile, TIME magazine's Jyoti Thottam offered a compelling overview of the scare and raised some pressing questions in an article entitled, "Is Avandia the next Vioxx?" She points out that Dr. Nissen told TIME that he began looking into Avandia because he was concerned by data from two of the largest studies of diabetic patients taking the drug. "The cardiovascular events were all going the wrong direction," he told the reporter. She writes: "Though the results weren't statistically significant, they pushed him to look at other data sets, including studies by the FDA and from the clinical-trials registry on GlaxoSmithKline's website. Nissen had gathered his data by April 24, and six days later submitted the paper to the Journal's editors."

You now can check out the FDA and drug-maker's responses.

• Here's the safety alert that the FDA rushed to issue.
• And now you can read GlaxoSmithKline's response to the NEJM's article.

More tomorrow on this new Avandia scare.

Coming up: Why don't we hear more about research and success stories, which definitely show that reducing or cutting out high-glycemic carbs (sugar and processed grains) and exercising may be the most effective ways to manage type 2 diabetes?