Fighting Diabetes, Proactively!

To Ban or Not to Ban  — FDA All Set to Debate Avandia Safety Concerns

When Avandia was first marketed in the late 1990s, doctors considered it a miracle drug for diabetics. Sales per annum reached the billion-dollar target and peaked at $2.3 billion in 2006. Then, in 2007, came the crash — the FDA restricted its use citing a study that claimed that Avandia increased the possibility of cardiac arrest and fatality.

Sales plummeted by almost half in the next two years. The 2007 study was the first of the many blows Avandia has received lately, others being a report prepared by the Senate Finance Committee criticizing the role of the FDA and more recent research that reinforces the findings of the original 2007 study. The latter, published on 28 June, indicates that Avandia (generic name rosiglitazone) can increase the possibility of heart attack by a massive 39%.

Another study, also published 28 June, promises more gloom for GlaxoSmithKline, the manufacturers of Avandia. David Graham of FDA and his team went through the insurance history of more than 220,000 patients to reach their conclusion: Avandia and another drug, Actos, could lead to not just heart attacks, but also increase the chances of stroke by 18%. What makes this study more authentic is the number of patients studied. Earlier studies could be faulted on lines of bad sample sizes that did not cover the entire population. Both the studies could have a significant impact on FDA’s decision when it deliberates on whether to pull Avandia from the market.

GlazoSmithKline has been quick to refute the latest claims. A company spokesperson said that there were six other studies to establish the effectiveness and safety of Avandia. A statementissued by the company said that there were studies to show that Avandia does not increase the risk of heart attack, stroke, or death.

The new studies doubting the safety of Avandia have also increased the pressure on FDA to ban the diabetes drug completely. Dr. David Juurlink from the University of Toronto has questioned the prescriptive use of this drug, arguing that safer alternatives were available.

All is not lost for Avandia, however. A team from the Washington School of Medicine studied an earlier research (not aimed at analyzing the link between Avandia and heart attack) to find out the risk of heart attack in patients who were prescribed Avandia. Dr. Richard Bach, who led the team, said that their analysis did not show any link between Avandia and heart attack.

Critics of Dr. Bach’s analysis claim that the sampling of patients for the study is flawed and therefore the conclusions are not credible. The FDA, however, has promised to take this study, besides other data, into consideration before they pass a verdict on whether or not to ban Avandia. The FDA debate is set for July 13 and 14.

For all those who have been regular readers of diabetesmoz, you know I have not been posting about events for a while. I have been a little busy, but now I am back. And here is an event people of the greater cleveland area would like to attend and support. “Swim for Diabetes” will raise funds for the Diabetes Association of Greater Cleveland at Ehrnfelt Recreation Center pool, 18100 Royalton Road. The swim will be 9 a.m. to 1 p.m. April 5.

Verizon Wireless is the sponsor of the event.
Those who raise $60 or more will receive a commemorative T-shirt. Those who raise $100 and turn in pledges by May 18 will receive a ticket to the Cleveland Indians vs. Milwaukee Brewers game on June 17.
Source

And another walk to cure diabetes in Forida area.

If you are taking either of the diabetes drugs rosiglitazone and pioglitazone, take care when you climb stairs.

Two common diabetes drugs — rosiglitazone and pioglitazone — are linked to higher fracture rates in women, according to a meta-analysis in CMAJ by a team of researchers from the University of East Anglia in the United Kingdom and Wake Forest University in the United States.

[Source: 1, 2]

Researchers at the Cambridge Institute for Medical Research at the University of Cambridge in the U.K. seem to have found a genetic link between type 1 diabetes and celiac disease, suggesting that the two diseases may be triggered by similar environmental factors.

Researchers had previously seen genetic links between type 1 diabetes and celiac disease, which, together, affect about 1 percent of the population, Todd said.

But the new research shows there is “considerable overlap, and much more than we anticipated” he said. “Almost every celiac disease susceptibility gene had an effect in type 1 diabetes.”

[source]

The main cause of is Type 1 diabetes is the failure “Islets”, the insulin-producing cells in the pancreas.

Researchers have been trying to go to the basics and transplant healthy Islets into Diabetic patients. Looks like the transplants are rejected, but a team of Israeli scientists seem to have found a way to successfully transplant healthy islet.

The Israeli team then opted for a new approach, ignoring the rejection of the grafted cells and focusing instead on inflammation caused by the transplant itself. Lewis grafted healthy islets into diabetic mice and treated them with an anti-inflammatory drug called alpha-1-antitrypsin, or AAT. Within months, they discovered three encouraging results:

Source: sfgate