January 3, 2015

The World of Diabetes Unreported Adverse Events

These types of articles scare the dickens out of me. Yes, there are a lot of unreported adverse events that happen with diabetes medications. Not only this, but many in the medical profession do this intentionally because there are no clear rules or even guidelines for reporting adverse events. Plus there are no penalties for misreporting or not reporting.

This prevents an accurate accounting of what many of our diabetes medications are doing to patients and especially which ones cause a disproportionate number of deaths. There are also under reported cases of hospitalization caused by diabetes medications. I thought this statement was especially appropriate, “Diabetes drugs have been linked to thousands of deaths and hospitalizations over the last decade, a MedPage Today/Milwaukee Journal Sentinel investigation found -- but there is little ability to measure the true risk of the drugs.:

Not all of this can be blamed on the Food and Drug Administration (FDA), but this statement is still true, “Theres gotta be something better than approving drugs based on a lab test and then losing track of them.” This is only part of the reason we can honestly say that we have a broken medical system. Each year the FDA approves new drugs, but only provides a partial listing of potentially dangerous side effects. Diabetes drugs seem to bear the brunt of this because the endpoints, such as reducing heart attacks, strokes, blindness, or amputations are not tested before the release.

The following is important enough to quote.
“A MedPage Today/Milwaukee Journal Sentinel analysis of the case reports from 2004 through March 2014 found about 3,300 deaths and 20,000 hospitalizations in which diabetes drugs were considered the primary suspect.
The three drugs with the most reported problems were:
  • Sitagliptin (Januvia), a once-daily pill that helps boost insulin production in the pancreas and lower the amount of sugar made in the liver, approved in 2006: 964 deaths and 4,425 hospitalizations.
  • Exenatide (Byetta), an injectable that enhances the body's ability to release insulin, approved in 2005: 880 deaths and 7,115 hospitalizations.
  • Liraglutide (Victoza), another injectable product, approved in 2010: 319 deaths and 2,827 hospitalizations.
The three drugs made up less than 7% of the 180 million diabetes prescriptions dispensed in 2013, according to data supplied by IMS Health, a drug market research firm. But they accounted for more than half of deaths and reported hospitalizations last year.

The FDA has called the database a "critical element" in ensuring the safety of drugs once they are on the market, but experts say the system misses the vast majority of cases.

That is due in large part to the system being voluntary for healthcare professionals. That means professionals fill out lengthy case reports without incentive or reimbursement -- or even any guarantee they will trigger an FDA response.” Unquote

I think that this is a topic that needs exposure and I would urge everyone to read the full article.

January 2, 2015

The ADA on Older Adults, 2015

It is somewhat surprising that the ADA has continued to promote guidelines for the elderly. At least they admit that there are few long-term studies in older adults demonstrating the benefits of intensive glycemic, blood pressure, and lipid control. Patients who can be expected to live long enough to reap the benefits of long-term intensive diabetes management, who have good cognitive and physical function, and who choose to do so via shared decision making may be treated using therapeutic interventions and goals similar to those for younger adults with diabetes. As with all diabetic patients, diabetes self-management education and ongoing diabetes self-management support are vital components of diabetes care for older adults and their caregivers.

I can accept this, but I admit I am having trouble with the recommended levels for A1c goals as they say for some that goals can be similar to those for younger adults with diabetes. Then the tables used say the opposite with the minimum upper level being an A1c of less than 7.5. To me this one-size-fits-all guidance does seem very discriminatory and nothing is mentioned about properly assessing and individualizing any treatment when it comes to the elderly.

I do understand their fear of hypoglycemia, but why are they not concerned about hyperglycemia. I could guess they want people to develop complications, but as doctors, why do they insist on doing harm to patients.

The above is not the full table and below in the explanation for the 8.5%.

A1C of 8.5% equates to an estimated average glucose of 200 mg/dl. Looser glycemic targets than this may expose patients to acute risks from glycosuria, dehydration, hyperglycemic hyperosmolar syndrome, and poor wound healing.

This gives me some insight into why the Diabetes Clinic that I was using always wanted me to raise my A1c to the 7.5 to 8.0% level. Not that I will do this and I am no longer intending to return. My last A1c was higher that I like, but it will be back down by the next A1c in April and my eating habits are changing and my blood glucose levels are reflecting this.