This seems to be a trend. Just yesterday the FDA released this statement about the new drug Teplizumab, the WHOLESALE price of which is $194,000 for one brief course: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of …
This seems to be a trend. Just yesterday the FDA released this statement about the new drug Teplizumab, the WHOLESALE price of which is $194,000 for one brief course: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Is it really the job of an FDA regulator to breathlessly promote new drugs? Especially those on which the evidence of benefit over harm is slim, and which barely squeaked by in an advisory-commission vote?
Much further down in the article we learn that it's not all roses with this drug either. "The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield."
This seems to be a trend. Just yesterday the FDA released this statement about the new drug Teplizumab, the WHOLESALE price of which is $194,000 for one brief course: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Is it really the job of an FDA regulator to breathlessly promote new drugs? Especially those on which the evidence of benefit over harm is slim, and which barely squeaked by in an advisory-commission vote?
Much further down in the article we learn that it's not all roses with this drug either. "The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield."