Under tough new airline security measures, patients must carry documentation to be allowed to take vital supplies onto flights.

A Sydney intensive care physician, Dr George Skowronski, warned diabetics to seek approval from their doctors so they would not risk their lives.

He said a 54-year-old Sydney man was recently forced to fly from Norway to Australia without medication because he did not have a letter from a GP.

“The man’s protests were to no avail and he boarded without his insulin,” Dr Skowronski wrote in the latest Medical Journal of Australia. During the 25-hour journey to Sydney, the man, an engineer, developed sweating, breathing and urinary problems. He also vomited.

“Despite making cabin staff aware of the underlying problem, he was offered no assistance apart from a steady supply of airsickness bags,” wrote Dr Skowronski, a St George Hospital doctor.

The passenger was “very ill” on arrival, and was taken by ambulance to hospital where he slowly recovered.

“Australian doctors and their diabetic patients should be reminded that airline security requirements are now very strict in most countries, and that life-threatening [diabetic reactions] can readily develop during the course of a flight between Australia and the northern hemisphere,” Dr Skowronski warned.

“Insulin-dependent patients must continue to take their insulin during these flights and should not board an aircraft without their supplies.”

In Australia, the Department of Transport and Regional Services stipulates that people with medical requirements may carry prohibited items such as hypodermic needles, but must also carry a doctor’s letter, a medical certificate, or a current National Diabetes Services Scheme card.

Supplies should be clearly labelled, carried in a clear plastic bag and declared to security staff before being screened.

The review of 18 previous studies, involving 8000 patients, also echoes earlier warnings that the drug can elevate the risk of bone fractures and heart problems. But GlaxoSmithKline, the maker of Avandia, says the analysis included too few long-term studies to produce reliable results.

Avandia, known generically as rosiglitazone, received approval in the US in 1999 as a pill to help diabetics control their blood sugar levels. The drug works partly by inhibiting certain receptors on the surface of cells throughout the body, making them more willing to take up the sugar glucose.

Fluid retention

Now, a team of researchers led by Bernd Richter at Heinrich Heine University in Dusseldorf, Germany, has found more bad news to report about Avandia.

The team reviewed 18 studies, which had an average follow-up time of about six months. They found the risk of dangerous fluid retention in the body – a condition known as oedema – doubled in those taking the Avandia, compared with patients on other diabetes medications. The diabetics taking Avandia had a 7% risk of oedema – five times higher than those taking placebos.

Oedema is characterised by swelling of the ankles and legs, but can lead to more than just discomfort. Richter explains that the extra fluid in the body can create more work for the heart, causing a shortness of breath and possibly heart failure.

His team’s analysis also showed that patients receiving Avandia gained 50% more weight, on average, than their counterparts on other diabetes medications (2.1 kilograms compared with 1.4 kg).

These new findings, added to the earlier results suggesting the increased risk of heart attack and bone fractures with Avandia, should be a matter of concern, says Richter.

Richter adds that it is unclear exactly why the drug would cause complications such as oedema: “Nobody knows exactly why this happens”

“We are surprised and disappointed by the results we have seen so far in this important Phase 2b clinical trial, especially after the promising preclinical and early clinical results from smaller 14-day and 28-day studies,” said Mark Erion, chief scientific officer.

The company still has many unanswered questions about the compound and plans to work closely with strategic collaborator Daiichi Sankyo Co. to get insights for the further development of the compound.

Metabasis Chief Executive Paul Laikind said this was a failed trial but not a failed drug-development program.

Researchers from Johns Hopkins University’s Evidence-based Practices Center reviewed 216 previously published studies in their effort to compare the effectiveness, risks, and costs of older and newer diabetes pills. The study, which was made public today, will appear in the Sept. 18 issue of the Annals of Internal Medicine.

All diabetes medications help to lower blood sugar, but they work in different ways. Metformin and drugs in the class known as sulfonylureas, such as Glipizide or Glyburide, are among the least-expensive oral diabetes medications because generic versions are now available.

The newer oral medications Avandia (by GlaxoSmithKline) and Actos (by Takeda Pharmaceuticals), both in the drug class thiazolidinedione (TDZ, are now among the most widely prescribed diabetes drugs.

Among the highlights of the report:

Seventy-five percent of people with diabetes show no symptoms, so the best way to find out if you have diabetes or are at risk to develop diabetes is to get tested.

“There is no cure for diabetes, but people can live well if it is diagnosed early,” said Dr. Sheri Johnson, state health officer. “Early diagnosis and treatment of Type 2 diabetes can prevent serious problems caused by high blood sugars.”

Diabetes is a serious but controllable disease that affects the way your body uses food, and if left untreated, it can slowly damage blood vessels and nerves with no warning. Type 2 diabetes occurs when the body does not make enough insulin, or it might not be able to use the insulin as it normally should. Medications and insulin shots may be needed for treatment.

Pre-diabetes is a condition in which blood glucose levels are higher than normal, but not yet high enough for a diagnosis of diabetes. Early detection is the best way to control and manage all types of diabetes.

People with any of the following symptoms should contact their health-care provider to be tested for diabetes: frequent urination, excessive thirst, extreme hunger, unusual weight loss, increased fatigue/irritability and blurry vision

To help people reduce their risk of getting diabetes, communities can help promote healthier environments by:

Telomeres prevent the ends of chromosomes from fraying and sticking to one another. They are also believed to regulate how many times an individual cell can divide, according to background information in a news release about the study.

People with pre-diabetes or obesity-linked type 2 diabetes, who are at increased risk for coronary heart disease, have much shorter telomeres than healthy people, the researchers noted. Telomeres also become shorter as a person progresses from pre-diabetes to full diabetes.

Diabetics are more susceptible to oxidization and inflammation, and this could contribute to telomere shortening. So, a test to detect the shortening of telomeres could indicate the onset of diabetes and ultimately be a predictor for coronary heart disease, the researchers said.

The work is expected to be presented Sunday at the annual meeting of the Society for Experimental Biology.

Resveratrol is a phenolic derivative found in certain plants, peanuts and in the skin of black grapes. It is found in significant quantities in red wine. The results obtained by this research demonstrate how resveratrol improves energy expenditure in mice and protects them against obesity and diabetes.
The study was headed by Johan Auwerx, Professor at the Institute of Genetics and Molecular and Cellular Biology (3). At the macroscopic level, researchers have noticed that a dietary supplement of resveratrol had a considerable effect on the muscles of mice. In the presence of resveratrol, muscle fibres display a high oxygen consumption and therefore high energy expenditure during exercise, where they exhibit a surprising level of endurance, as well as during periods of inactivity.

At the molecular level, the researchers have studied the signalling pathway taking part in this process, leading them to the mitochondrion (4). This organelle, found in large numbers within muscle cells is responsible for energy production. They observed that resveratrol activates a protein from the Sirtuin (5) family (SIRT1) which then leads to an increased activity of another protein involved in mitochondrial function. By acting on the mitochondria, resveratrol enhances energy expenditure and therefore the reduction in weight gain.

Furthermore, this study links sirtuins with energy expenditure and raises the possibility of using SIRT1 activators as a means of prevention or treatment of metabolic disorders. For this reason, the sirtuins reveal themselves as attractive pharmacological targets. From a therapeutic point of view they would be potentially beneficial in certain pathologies related to mitochondrial dysfunction, which is often the case for disorders associated with aging such as obesity and Type 2 diabetes.

U.S. District Judge Leonard Sand in New York said Novo’s at tempts to show irreparable harm for both its current market standing and for future sales of its own inhalable insulin were speculative.

Sand wrote that stopping “the release of a new and less invasive treatment for diabetes would quite obviously be contrary to the public interest, particularly in the interval between now and trial.”

Novo Nordisk, whose U.S. operations are based in Princeton, sued Pfizer earlier this year, saying Exubera infringes on its inventions and would do irreparable harm to its reputation and its sales.

At a recent hearing, Stephanie Wheeler, a lawyer for Novo Nordisk, told Sand that Exubera violates Novo Nordisk’s patents covering insulin delivery to the lungs. Novo Nordisk expects to produce its own inhalable insulin product by 2011.

She said Novo Nordisk, which shares nearly half of the market for Americans who require insulin in jections to control diabetes, could suffer irreparable damages because studies show as many as 89 percent of people who rely on injections would switch to an inhaled drug if they could.

After Sand ruled yesterday, Wheeler said she had no immediate comment. A message left with a company spokesman was not immediately returned.

Pfizer, the world’s largest maker of prescription medicine, began marketing the drug through some diabetes specialists in July and plans a wider launch of the product through more general practitioners early next year. Approximately 21 million Americans suffer from diabetes.

Vanessa Aristide, a Pfizer spokeswoman, said yesterday patients who take insulin injections can take Exubera.

“If they choose to change from injections to Exubera, it’s as effective,” Aristide said.

The test strips are being sold for use with various models of LifeScan Inc. One Touch brand blood glucose monitors, the Food and Drug Administration said.

“The counterfeit test strips potentially could give incorrect blood glucose values - either too high or too low - which might result in a patient taking either too much or too little insulin and lead to serious injury or death,” an FDA statement said.

No injuries have been reported to date, the agency said, adding that FDA officials were still investigating the matter.

The counterfeit test strips included those sold under the brand One Touch Basic Profile with lot numbers 272894A, 2619932 or 2606340. English, Greek and Portuguese writing was displayed on the outer carton.

Another fake batch was sold under the One Touch Ultra name with the lot number 2691191. English and French text appeared on the carton.

The fake test strips were sold in 50-count packages, the FDA said.

Consumers should stop using the fake test strips, replace them immediately and contact their physician, the agency said.