It's only February, so it may seem early to be talking about one of the Food and Drug Administration's (FDA's) worst decisions of 2014. Yes, the year just started, but the FDA has already made a decision that could potentially harm thousands of patients.
The agency just approved a new diabetes medication that doesn't noticeably improve health but may in fact be linked to cancer.
It's called Farxiga (Dapagliflozin) and it will be available--and probably widely advertised--very soon. The good news is that the drug lowers blood sugar, which is a major symptom of type 2 diabetes. However, lowering blood sugar is not necessarily a way to improve health. The new drug is meant to reduce medical problems such as heart disease or kidney damage. Unfortunately, there is no evidence that it actually improves health--in fact, quite the opposite.
The FDA reports that the most common side effects of Farxiga are genital fungal infections and urinary tract infections. Not fun, but those aren't its most serious side effects. If a patient has moderate or severe kidney damage (as many diabetics do), the drug is not beneficial and could cause further damage, possibly even renal failure.
But the more frightening news is that patients taking Farxiga in studies done for the FDA were more than five times more likely to contract bladder cancer than the patients who took an older diabetes drug. Based on the findings of the companies making and selling Farxiga, FDA scientists concluded that the drug might stimulate bladder cancer in patients already at risk. The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer.
Bladder cancer can be fatal, and is especially dangerous in people who have diabetes.
The companies' studies also found that patients taking the drug were more than twice as likely to get breast cancer as diabetics not taking the drug, but they say this could have happened by chance.
It's important to mention that only a small number of African Americans were studied. Because African Americans are more likely to have diabetes than Caucasians, these studies should have included greater numbers of them to find out if the drug is safe or effective for them.
With so many other diabetes drugs already on the market, why would anyone want to take this drug, and why would the FDA approve it? Here's the scorecard, based on information provided by FDA scientists and available on the FDA website:
1. Is the drug new? Yes.
2. Does it reduce the medical problems caused by type 2 diabetes, such as blindness, heart disease, kidney damage, or amputations? No.
3. Can it cause kidney damage or make it worse? Yes.
4. Does research show that patients taking it are more likely to get bladder cancer. Probably.
5. Does research show that patients taking it are more likely to develop breast cancer? Maybe.
6. Does research show it is more effective than most diabetes drugs on the market? No.
7. Will it cost more than most other diabetes drugs on the market? No information on cost yet, but new drugs usually do cost more.
The FDA is requiring that the label for the drug warn patients with bladder cancer that they shouldn't take Farxiga because it might make their cancer worse. Ya think? And, the agency is requiring the companies to study 17,000 diabetes patients for at least four years to determine whether and how often patients taking Farxiga are diagnosed with cancer, liver problems, or heart disease when the drug is taken for a longer period of time.
The FDA rejected this drug two years ago because of these cancer concerns and questions about how well the drug prevents the major risks of diabetes. But the FDA has been beaten up by many complaining congressmen since then, and by some patient groups, pushing it to approve more new drugs quickly rather than waiting for safety studies to be completed. Also, the pharmaceutical companies don't like to take no for an answer, they spend lots of money on lobbying, and they are very effective at pushing FDA to reconsider rejections. Because of that, the FDA selected an advisory committee to review the data in December, and those doctors and scientists also expressed concerns about risks and benefits. I was at the meeting and pointed out that there were too many serious unanswered questions.
Despite my concerns, the concerns of FDA scientists and other experts, and the concerns of the advisory committee members themselves, the committee recommended that if the companies continued to study the drug after it was approved, in order to figure out what the actual risks are, the company could sell it now.
It's too early to say whether this will be the worst decision the FDA makes in 2014. Maybe the diabetes patients who take it will be lucky and not be harmed by the drug. Or maybe only a few patients will develop cancer or kidney failure as a result of taking it. Or the FDA scientists who expressed their concerns could be wrong, and I could have made a mistake when I agreed with them. But regardless of what happens with this drug, it still would be a bad decision to allow the sale of a drug with such serious (potentially fatal) unanswered questions.
Given the epidemic of diabetes in this country, the risks are huge. For that reason, this drug worries me even more than some of FDA's similarly mind-boggling decisions of 2013, such as:
- A drug for hot flashes that has no meaningful benefits but can increase the risk of suicide among women who weren't depressed
- An antibiotic for pneumonia that seems to kill more patients than other antibiotics
I've always respected the scientists at the FDA for working so hard to try to keep all of us safe. I still do. But decisions are being made at the agency that seem to ignore scientists and science, and that is dangerous for all of us. Whether we have diabetes, hot flashes, pneumonia, cancer, or any other disease, we deserve better.