So the doctor tells you - you have diabetes. The diagnosis is a shock. It's a lifetime condition, the doctor says. And it's not just the illness, he says, it's what can arise from the illness, including vision loss and blindness, kidney failure, cardiovascular disease, stroke, nerve damage leading to peripheral neuropathy, and even limb amputation.
Never mind, though. At least the doctor says that diabetes is treatable. You've been given lots of good advice about diet and exercise. And then there is this drug, canaglifozin, taken orally for the rest of your life, which helps control blood sugar levels. So it all sounds just fine. The drug will help the kidneys get rid of glucose from the bloodstream. Conventional medicine has it all in control!
Canaglifozin, marketed as Invokana, Invokamet and Invokamet XR, is a new drug, approved by the USA's drug regulator, the FDA, in March 2013. So it's effective, it does what it says, and it's safe. This must be so, that's the only basis that drug regulators approve a drug.
So roll on 4 years, to May 2017. The FDA now concludes that canaglifozen increases the risk of leg and foot amputations. The evidence, it says, is based on new data from two large clinical trials.
Damn! The drug will now be withdrawn, perhaps even banned. After all, conventional medicine states that its primary principle is "First, do no harm". And the precautionary principle will surely mean that the drug will no longer be available for used.
But no, hold on! The drug isn't being banned. The FDA is recommending a 'Black Box' warning to the labelling. You can still continue taking it. So how will you be protected? Will you be safe?
"Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional."
Okay! But it seems strange that you take a drug because you have diabetes, and the drug gives you an increased risk of suffering one of the worst consequences of having diabetes. This is not what your doctor told you. So what has your doctors got to do, how will they protect you?
"Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur."
Okay! Well, you can always have a word with your doctor next time you see him.
Except that, in actual fact, you don't even know about the increased risk of amputation! The threat may have been published on the FDA website, by Reuters, and by health websites like Health Watch, but whoever reads them. Why should you? Everyone else tells us that pharmaceutical drugs and vaccines are safe. Why on earth should we question what everyone tells us? And anyway, if you look carefully at the FDA's instructions, no-one has been asked or instructed to contact you, and inform you about the risk.
And note. This story has not appeared in any of the newspapers, or the radio and television channels, that most people watch.
So you may be taking a drug that could be harmful to your health, but don't worry about it - you are entirely unaware of it!
Never mind, though. At least the doctor says that diabetes is treatable. You've been given lots of good advice about diet and exercise. And then there is this drug, canaglifozin, taken orally for the rest of your life, which helps control blood sugar levels. So it all sounds just fine. The drug will help the kidneys get rid of glucose from the bloodstream. Conventional medicine has it all in control!
Nothing to worry about, then (?)
Canaglifozin, marketed as Invokana, Invokamet and Invokamet XR, is a new drug, approved by the USA's drug regulator, the FDA, in March 2013. So it's effective, it does what it says, and it's safe. This must be so, that's the only basis that drug regulators approve a drug.
So roll on 4 years, to May 2017. The FDA now concludes that canaglifozen increases the risk of leg and foot amputations. The evidence, it says, is based on new data from two large clinical trials.
Damn! The drug will now be withdrawn, perhaps even banned. After all, conventional medicine states that its primary principle is "First, do no harm". And the precautionary principle will surely mean that the drug will no longer be available for used.
But no, hold on! The drug isn't being banned. The FDA is recommending a 'Black Box' warning to the labelling. You can still continue taking it. So how will you be protected? Will you be safe?
"Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional."
Okay! But it seems strange that you take a drug because you have diabetes, and the drug gives you an increased risk of suffering one of the worst consequences of having diabetes. This is not what your doctor told you. So what has your doctors got to do, how will they protect you?
"Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur."
Okay! Well, you can always have a word with your doctor next time you see him.
Except that, in actual fact, you don't even know about the increased risk of amputation! The threat may have been published on the FDA website, by Reuters, and by health websites like Health Watch, but whoever reads them. Why should you? Everyone else tells us that pharmaceutical drugs and vaccines are safe. Why on earth should we question what everyone tells us? And anyway, if you look carefully at the FDA's instructions, no-one has been asked or instructed to contact you, and inform you about the risk.
And note. This story has not appeared in any of the newspapers, or the radio and television channels, that most people watch.
So you may be taking a drug that could be harmful to your health, but don't worry about it - you are entirely unaware of it!
- Johnson and Johnson, the manufacturer, knows about it, and they still want to profit by selling the drug. Of course they do!
- The FDA know about it, and they are quite happy for J&J to continue selling it to me. Well, drug regulators are controlled by the drugs industry anyway, so of course they do!
And if you live outside the USA? What then?
Well, there is no indication that drug regulators in the rest of the world know about it, or else they have decided not to do anything about it anyway. So you will certainly not know about it. So, just as the FDA instructs, please don't stop taking your diabetes medication. It must be doing you good - at least, as far as you are aware!
See also these blogs on the subject of diabetes.