Diana Zuckerman, PhD, president of the National Research Center for Women & Families
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 cause 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 FDA approve it? Here’s the scorecard, based on information provided by FDA scientists and available on the FDA website:
- Is the drug new? Yes.
- Does it reduce the medical problems caused by type 2 diabetes, such as blindness, heart disease, kidney damage, or amputations? No.
- Can it cause kidney damage or make it worse? Yes.
- Does research show that patients taking it are more likely to get bladder cancer. Probably.
- Does research show that patients taking it are more likely to develop breast cancer? Maybe.
- Does research show it is more effective than most diabetes drugs on the market? No.
- 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.
Diana Zuckerman is the president of the National Research Center for Women & Families. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, she spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, as well as in newspapers across the country.
Thank you for doing the research & sharing it with us. Very grateful.
Seems the FDA has joined other government depts. who are giving in to the loud and monied demands of big Corporations whose only concern is the bottom line and how much more money they can take from suffering people. I wonder how long this can go on before the people in the voting booth kick out the congress people who vote the way the lobbyist want and demand that the other government depts. do the same. We should ban all elected officials from getting any money of any kind from lobbyists! Thank you for giving us this news!
When is the FDA going to require that drug companies include diversity in clinical trials? It’s important that enough people of different races and ages (particularly the groups affected by the disease that the drug is supposed to treat!) are included so that results can be analyzed by race, age, gender, etc. We need to know who these drugs really help and hurt. It’s time that drug makers follow the same research rules that government researchers follow!
We shouldn’t be looking to create more drugs. What we should be doing is cleaning up our food supply, our air supply and do away with pesticides and chemicals. Then we won’t have any need for more drugs because we will be healthy. Remember the old saying, “You are what you eat”.
This information is vital not only for those with diabetes but for all consumers who need to understand that FDA approval does not equal a safe drug. The “scorecard” list of 7 points taken from the FDA website is especially awful. Dr. Diana Zuckerman is right, we do deserve better!
Consumers need to be aware of these facts that Dr. Zuckerman shares. Just because the FDA approves a drug, and a doctor recommends it, doesn’t mean one should ingest the drug. Clearly, mindful consumers need to understand the pros, cons, and alternatives for all recommended treatments.
This information clearly demonstrates the need for more extensive research to be done on new drugs. Without a diversified sample they are unable to represent variances in the side effects of these drugs. Thank you Dr. Zuckerman for sharing this important information for those who may use Farxiga as well as for all consumers.
Thank you for presenting this important information. Relying on the FDA to protect the public becomes less of a sure thing once you find out the “behind the scenes” actions that are driving their decisions. The public will likely be told nothing of these findings, just a doctor with his hand out, saying, “Here take this pill. It’s new.”
Dr. Zuckerman makes many important points. There are far too many unanswered questions. For the most vulnerable among us, this drug may do more harm than good.
Thanks for this blog post! Why are we depending on safety tests with life-threatening consequences to be done *after* the drug is approved, especially with the horrendous track record of post-market studies actually being completed? Patients deserve to know that FDA approval does not always mean they can trust the drug to be safe and effective.
Thanks for this critical info! Hopefully anyone who knows anyone with diabetes will watch out for this. We all rely on the FDA to make decisions based on quality evidence!
Thank you for this valuable information. I’ll be sharing it everywhere!
Wow, it’s people like Dr. Diana Zuckerman who are responsible when patients who could’ve successfully altered their disease for the better or treated something serious go the holistic route and suffer, it’s really fear mongering. She is a Dr. of Psychology, not an MD and has no business commenting here bc she is clearly very uninformed. Lowering blood glucose in diabetics doesn’t offer health benefits!? On what planet is this woman living?? The SGLT2i’s have their issues, and should ALWAYS come after diet/excersize have been maxed out (a patient should never take medication without necessity, I agree with her there) but this article is seriously fear mongering.
I don’t agree that this article is fear mongering Dr Kone. It sounds like you’re attacking the author of this article because she isn’t an MD. What’s your motivation — personal bias against non-MD’s and the holistic approach to medicine? I’m happy you’re not my doctor.
Well put, Dr. Kone. Compare the comments in her article to the actual research which the FDA approved in the prescribing information on the Farxiga website. If you choose to believe her comments rather than the outcome data from the clinical studies, then I’m sorry to say you will not be accurately informed. My guess is that she is being paid for services by another competing drug company. Although the black and white prescribing information isn’t as slick as this website, the information within is far more helpful. Disappointing that someone with a PHD wrote this…
Why is it the worst medicine