Amgen’s NPLATE Effective, but Not Without Risks
The Food and Drug Administration (FDA) panel will vote Wednesday on whether Amgen’s drug, NPLATE, provides enough benefit to counteract the side effects associated with its use. NPLATE is intended to treat Idiopathic Thrombocytopenic Purpura (ITP), an autoimmune disorder characterized by very low levels of platelets leading to uncontrolled bleeding.
NPLATE is designed for use in hard to treat chronic forms of ITP. Two clinical studies of patients with ITP who failed other forms of therapy, showed positive results after treatment with NPLATE. Unfortunately some evidence suggests that it may increase the risk of developing leukemia and other blood-related disorders. There is also concern about the potential risk of heart attack, stroke and blood clots.
Panel of medical experts will decide if the benefits of the drug, outweigh the risks. In 2003, NPLATE received an “orphan drug” designation aimed at medications used to treat less than 200,000 patients per year.
- Should a drug for a condition with limited therapeutic options, but carrying potentially serious adverse effects, be allowed for use in those in need?
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It should be for the patient and his/her physician to decide if the drug is to be used… the physician should give the patient all the information, benefits, risks, but the ultimate decision should be made by the patient.
The drug should be used as ‘drug of last resort and all complications reported until a larger data base is amassed
Pete is right. These decisions should be made by the patient and their doctor. The FDA should not even have the power to deny people the right to try a medicine, if the patient and their doctor think it is right for their condition.
The problem may arise when some people and their lawyers start suing doctors for using the drugs for “unapproved” purpose, thus potentially limiting the future possibility of treatment for those who suffer from diseases with a small number of treatment modalities. For that reason I don’t think that many physicians would be willing to risk their good name/career for an unapproved therapy.
Oh great, another pharmaceutical that may end up in someone’s water supply.
Charming.
My father was a pharmacist and I used to work in his drugstore. One day a man came in with a paper bag full of prescriptions- 14 of them. As my Dad lined them all up for refilling I asked him what could possibly be wrong so that the man would need to take 14 different medications.
“This is the drug for his original condition,” my Dad said pointing to the first bottle. “The next one is for the side effects of that one. The one after that is for the side effects of the second one, and etc.”
I rest my case.
Alice Stevens
http://www.agingparentsauthority.com