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Posts with tag FoodAndDrugAdministration
Posted Sep 4th 2007 10:44PM by Allie Beatty
Filed under: Type 1, Type 2, Childhood, Adult Onset, Drugs, Allie Beatty, Support, Personalities
A recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this?
The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc.
Your doctor is too busy to file the necessary paperwork to notify the FDA a drug is potentially harmful. What is a patient to do? Good question and here's an answer! If you experienced any adverse side effects from the use of a prescription drug, please let the FDA know. Click BEGIN and bring this monkey business to an end!
Posted Jul 30th 2007 6:17PM by Diane Rixon
Filed under: Type 2, Drugs, Research, Complications

Earlier today
I blogged about the Avandia advisory panel which met today. As of earlier today, the word was an FDA official, David Graham, had issued a written preview of the comments he intended to make. In it, Graham stated his view that GlaxoSmithKline's diabetes drug Avandia is dangerous and should therefore be removed from sale.
Now comes
breaking news from the Associated Press that the panel will recommend, against the wishes of many - Dr. Graham included, that Avandia stick around. According to the AP, government health advisers have argued that, hey, sure Avandia may cause increased risk of
heart attack, but let's just keep it out there. What?! As of writing, the AP was still waiting for a tally of how the panel voted on the issue, but word is a majority voted against recommending a ban.
The FDA's patient representative for the panel was quoted as saying studies indicating Avandia causes heart trouble "have very significant weaknesses and are inadequate for us to make that kind of decision." In short, the FDA seems to be saying Avandia causes heart damage, but the study-based proof is not strong enough for a ban. Talk about your contradictory messages! Baffled? Disgusted? Join the club.
Posted Jul 18th 2007 6:00PM by Bev Sklar
Filed under: Type 2, Adult Onset, Drugs, Research
The first in-depth comparison of type 2 oral medications arriving on the scene over the last decade was published earlier this week in the Annals of Internal Medicine. The review determined older, cheaper diabetes drugs are as safe and effective as new alternatives. Oh boy, Big Pharma's newer drug sales teams won't like this conclusion.
Metformin, also known as Glucophage, was cited as the safest and best option, as it works as well as other oral medications, but does not cause weight gain or hypoglycemia. Bad cholesterol is also lowered on metformin, and the drug only costs about $100 a year. Newer drugs cost as much as $262 a month, stated lead researcher Dr. Shari Bolen, and there was no benefit to the newer drugs unless tolerance to an older one was at issue. They also noted taking two oral meds can improve blood sugar, but the cost and risk of side effects are both higher.
The researchers reviewed more than 200 published studies and some unpublished information from the Food and Drug Administration. Avandia's manufacturer, GlaxoSmithKline, stated this analysis was completed prior to the completion of one Avandia study that showed Avandia improved blood sugar control compared to two rival meds.
But the dinosaur Metformin does have a roar -- it can cause a rare, dangerous side effect called lactic acidosis. Read more in Globe and Mail.
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Posted Jun 3rd 2007 12:52PM by Allie Beatty
Filed under: Type 2, Adult Onset, Drugs, Research
Congressional investigators have been looking into very serious claims that Avandia's maker silenced medical professionals who attempted to speak out about the potential for cardiovascular problems by using the drug.
Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients' risk of heart attacks, and he criticized the company's marketing, saying it employed "blatant selective manipulation of data" to overstate the drug's benefits and understate its risks.
More recent questions about Avandia's potential risks, as outlined in a New England Journal of Medicine article last week, have prompted the Congressional hearing. The author of that article, Dr. Steven E. Nissen, a heart specialist at the Cleveland Clinic, has also been called to testify. See the full story on the upcoming congressional hearing.
Posted Mar 27th 2006 8:50PM by Diane Rixon
Filed under: Type 1, Childhood, Drugs

The Food and
Drug Administration recently declared the development of an artificial pancreas to be on its "critical path
opportunities" list, and stated that such a device could "revolutionize diabetes care and management." A
small biotech startup company is among those racing to meet this goal, and has just secured the financial backing it
needs. The company, Ultradian Diagnostics, LLC, is based at New York State University's Albany campus. Ultradian is
working on a continuous blood-glucose monitoring device, which diabetics could use instead of repeated daily finger
stick (pictured) or blood draws. The continuous monitoring system is attached to the skin with a micro-needle.
Ultimately, Ultradian hopes to pair the device with an insulin pump - essentially creating an artificial pancreas. Read
more at msnbc.com.