Just what we didn’t need

Just what we didn’t need

Today has not exactly been a red letter day for diabetes. First we learned that diabetes may be associated with 24 types of cancer. If that wasn’t bad enough news, another report should that patients using metformin, the most prescribed diabetes medication, can cause vitamin B-12 deficiency.  

According to a study conducted by the German Cancer Research Center (GCRC), apparently revealed that, those people who are affected with type 2 diabetes are probably, more prone to 24 types of cancer especially, liver cancer and pancreatic cancer. A press release issued by the GCRC; “In order to precisely identify the types of cancer in which diabetes plays a role, Kari Hemminki of DKFZ collaborated with colleagues in Sweden and the United States to carry out the largest study ever on cancer risks of people with type 2 diabetes. The study included 125,126 Swedish citizens who had been hospitalized due to problems associated with type 2 diabetes. The epidemiologists compared the cancer incidence in these patients with that of the general population in Sweden.

The scale of the study also made it possible, for the first time, to quantify correlations between diabetes and less common types of cancer. The researchers discovered that people with type 2 diabetes have an increased risk of developing 24 of the types of cancer studied. The most significant risk elevation was established for pancreatic and liver cell cancers. The rate of these cancers in people with type 2 diabetes is elevated by factor six and 4.25 respectively compared to the general population. The epidemiologists also found the risk of cancers of the kidneys, thyroid, esophagus, small intestine and nervous system to be more than twice as high.”

This news should be of particular interest to Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) and the FDA. As everyone knows Amylin and Lilly are awaiting the FDA’s decision for their once-weekly GLP-1 Bydureon. The main issue is not whether Bydureon is effective rather should the drug receive a black box warning for increased risk of thyroid cancer. This warning was issued when the FDA approved Novo’s once-daily GLP-1 Victoza®.

It’s also true that the FDA issued a warning back in October 2007 over Byetta usage and pancreatitis; this warning lead to Amylin changing the label for Byetta in January 2008. When this issue first became public Diabetic Investor noted that we did not see a causal relationship between Byetta usage and pancreatitis as the incidence rate was actually lower for Byetta users than the general diabetes population.

Diabetic Investor has also long believed that Bydureon does not deserve a black box warning and we further believe the FDA was overly cautious issuing a black box warning for Victoza. This study appears to prove Diabetic Investor was correct with both the pancreatitis issue and thyroid cancer issue. As the study states; “The most significant risk elevation was established for pancreatic and liver cell cancers. The rate of these cancers in people with type 2 diabetes is elevated by factor six and 4.25 respectively compared to the general population. The epidemiologists also found the risk of cancers of the kidneys, thyroid, esophagus, small intestine and nervous system to be more than twice as high.”  (Highlighting, bold and underlining added by Diabetic Investor)

Hopefully the FDA has read this study and will take the findings into account when they finally approve Bydureon, an approval that SHOULD NOT come with a black box warning. Even before this study became public there was no scientific evidence to support the contention that either Bydureon or Victoza actually caused thyroid cancer. The evidence was even stronger for Bydureon as Amylin has the additional benefit of data from over one million Byetta users. As we have noted on several occasions Bydureon is not really a new drug rather it’s line extension of the Byetta franchise.

Unfortunately all of this data may not be enough to stop the FDA. It has become clear that the agency is becoming more conservative, almost hell bent on looking for reasons not to approve new drugs or approving new drugs with warnings that are not supported by credible scientific data. Hopefully for the millions of patients who would benefit from using Bydureon the FDA will come to their senses and approve this paradigm changing drug without a warning it does not deserve.

As if this news about cancer and diabetes wasn’t bad enough according to a study published in the British Medical Journal entitled; “Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomized placebo controlled trial”, the authors concluded; “Long term treatment with metformin increases the risk of vitamin B-12 deficiency, which results in raised homocysteine concentrations. Vitamin B-12 deficiency is preventable; therefore, our findings suggest that regular measurement of vitamin B-12 concentrations during long term metformin treatment should be strongly considered.”

Metformin is the most widely prescribed diabetes medication and is considered the cornerstone for treating patients with type 2 diabetes. Although Diabetic Investor does not believe physicians would be foolish enough to take their patients off metformin because of this study we are concerned about the possible impact it could have on patients being compliant with their therapy regimen. Already type 2 patients have been bombarded with information on how Avandia, a once popular now condemned medication for treating type 2 diabetes, is linked with adverse cardiovascular events.

Patients have also been informed that Actos and Avandia is linked to an increased risk of bone fractures, this adverse event goes along with their other well documented adverse events edema and weight gain. As noted earlier patients have been informed about Byetta and pancreatitis and then there was the largely refuted report of a link between Lantus, the world’s number one selling insulin which is used by millions of type 2 patients, and cancer.

It’s getting to the point where no drug used to treat type 2 diabetes, the most common form of diabetes is considered safe to use.  Given the popularity of metformin it would not surprise Diabetic Investor at all if the main stream media picked up on this study considering it comes from a highly respected source.  Soon physicians will be facing questions from their type 2 patients on whether or not their medication, the very medication that is saving their lives, is safe to take. And as sure as night follows day look for some opportunistic nutritional supplement company to start promoting their B-12 supplement to metformin patients.

In today’s world when news is literally available 24 hours a day on a patient’s mobile phone it’s naïve to believe that patients are not impacted by these studies. Keep in mind this is a patient population that is not receiving the education they need about the drugs they take and why it’s essential to keep taking them. With nearly 80% of all diabetes patients being treated by a primary care physician who lacks the time and resources to properly educate these patients, it’s perfectly understandable why therapy compliance or should we say lack thereof, is perhaps the biggest problem facing diabetes today.

The fact is every medication used to treat diabetes, type 1 or type 2, carries some degree of risk. Some of these risks can be serious, such as an insulin-induced hypoglycemic event while others like the B-12 deficiency are less serious and easily remedied. However, studies have shown that diabetes is unlike other disease states where patients strictly follow their assigned therapy regimen. The majority of patients with diabetes are living their lives WITH diabetes and not FOR diabetes. These are patients who besides their diabetes medications are likely taking additional medications to control cholesterol and high blood pressure.

For reasons that Diabetic Investor cannot fathom, this reality is lost on physicians who constantly complain that their patients are not complaint with their therapy regimen. Perhaps it may dawn on them one day that if they actually took a few moments to explain not only how a drug works but also the possible side effects that patients would actually feel more confident about taking their medications. The reality is therapy compliance would increase dramatically if patients were given just a small amount of education. We no longer live in a world where patients do something just because their physician says so. We live in a world where information is readily available, where class action attorneys are quick to jump on any drug related issue and where any person can start a blog or web site.

The bottom line here is if this situation is ever going to change it will not come from transparent efforts but real patient education. The fact is even truer today that it was when Diabetic Investor began our rant about the poor quality of patient education. The real question is there anyone out there who’s listening.