DIABETES: Have we underestimated the harmful effects of new anti-diabetics?

   2020-02-20       58        Health
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DIABETES: Have we underestimated the harmful effects of new anti-diabetics?

GLP-1 receptor agonist safety the investigation into new diabetes drugs led by British Medical Journal (BMJ) already provokes many reactions from medical experts who blame authorities for not reacting quickly enough at the first warning signs and to laboratories not to communicate all of the results of their clinical trials.

These new diabetes drugs, known as GLP-1 receptor agonists, have become a "treatment of choice" for diabetes "and bring in billions of dollars for the pharmaceutical industry. They treat type 2 diabetes by regulating blood sugar and also reduce appetite so are currently being tested as a possible treatment for obesity.

BMJ and Channel 4, a private British channel, have teamed up to investigate the possible risks of taking GLP-1 receptor agonists, including the risk of cancer. They conclude that there is evidence suggesting possible risks from these drugs that have never been published. Independent studies that call into question the studies carried out by the manufacturing laboratories, including 3 publications this year. To reach these conclusions, the authors of the BMJ thus reviewed thousands of pages of regulatory documents and found unpublished data which suggest these undesirable effects, in particular in the pancreas. The BMJ team also reports that despite these studies suggesting security "flaws", the laboratories

The demand for transparency in the communication of study data and the opening of a real dialogue on the problems of drug safety is therefore on the agenda. Dr. Deborah Cohen, author of the BMJ investigation adds that if the unpublished evidence may seem inconclusive, when considered with the previous data, the question of the safety of this class of drug arises. Some patient associations have already requested the withdrawal of these drugs pending further studies. Dr. Fiona Godlee, editor-in-chief, writes in the BMJ on June 10: " All authorization is based on a benefit-risk ratio for a drug, but instead of engaging in a transparent debate, the laboratories have been reluctant to share their data. During this time, millions of patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs . ” She concludes: " The debate would be much simpler if all the information were put in the public domain so that scientists, doctors and patients can freely form their own opinion ". In another BMJ editorial, Edwin Gale, professor of diabetology, explains that current regulatory procedures are insufficient to meet the challenge of drugs that have more than one biological target. He calls it shotgun therapy. Similar scenarios will recur as long as the laboratories control access to the study data. He explains that investors were aware as early as 2006 of a risk of acute pancreatitis with the anti-diabetic drug, exenatide (Byetta, Bydureon), a glucagon-like peptide-1 analog, a year before the US Agency, the Food and Drug Administration (FDA) is raising an alarm signal. Since then, all GLP-1 analogs have generated a risk opinion for pancreatitis, suggesting a class effect. The regulators then asked the laboratories to provide more data, and the laboratories communicated studies showing that acute pancreatitis is more common in diabetics than expected and concluded that there is no or insufficient clear evidence of a increased risk of pancreatitis with GLP-1 treatments.

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