A popular diabetic drug was recently banned in Europe. The drug was Actos…and research shows it increases your risk of bladder cancer by 40 percent.
Now a new study–taken directly from the FDA’s own data–links two other diabetic drugs to pancreatic cancer.
The two new drugs are Januvia and Byetta…and they’ve been promoted as safer than other diabetic drugs. But new research from UCLA suggests they may be just as risky.
“These drugs–widely promoted for diabetes– could have serious side effects,” says Dr. Michael Elashoff. He led the study and heads up research for UCLA.
Now some doctors are saying these drugs don’t just harm you…they don’t do much good either. That’s because they don’t treat the actual cause of diabetes.
“We now have three trials of drugs in the treatment of diabetes,” says Dr. Nortin Hadler. “Based on these three, we doctors cannot offer any assurance whatsoever that these drugs will decrease the likelihood of stroke, amputation, renal failure, or blindness.”
Dr. Hadler is a Harvard-trained doctor and lectures about medical ethics at the University of North Carolina.
But despite what these doctors say…and what the studies show…all three drugs remain on the US market. So does that mean you should still be taking them?
Stay with us as we find out about these drugs…look at what the finding show…and investigate if they should remain on sale.
Digging into Diabetic Drugs
All three drugs that are making headlines are prescribed to type 2 diabetics. And the first drug to be linked to risk was the oldest of the three…Actos.
Actos was first approved in 1999. It’s made by Takeda. It remains one of the world’s most popular diabetic drugs. It’s used to lower blood sugar levels. And doctors say it makes your cells more sensitive to insulin.
Byetta is produced by Amylin. It was first approved for sale in 2005. It’s an injectable drug that reduces your blood sugar levels.
Januvia is made by Merck. It was approved by the FDA in 2006 and it also controls blood sugar levels. It regulates the levels of insulin your body produces after eating.
Both Januvia and Byetta offer a new way of treating diabetes. And they’ve been promoted as being safer than older diabetic drugs.
But the new UCLA study shows this may not be true.
Part of the mystery is because these drugs are so new.
So…they’re “the ones we know least about,” says study co-author Dr. Peter Butler. He’s the director of the Larry L. Hillblom Islet Research Center at UCLA. “When new drugs come out, the long-term side effects are not well understood.”
So what do the latest findings say about these drugs?
What the Studies Show
The two UCLA doctors decided to study Januvia and Byetta after reading animal studies that suggested the drugs increased pancreatitis risk.
When they looked at the FDA database…they saw post-marketing reports linking these drugs to acute pancreatitis.
So they began looking at all the reports in the FDA database. Those reports covered 2004 through 2009. And they found lots of reports linking the drugs to pancreatitis.
But they also discovered something else. As they dug deeper they found that the drugs were also linked to cancer. Specifically… pancreatic and thyroid cancer.
They then compared these drugs with four other diabetes drugs. They found more than a six-fold increase in reported cases of pancreatitis. And a 2.9-fold increase in pancreatic cancer.
They knew these results were important. So they took them to the European Association for the Study of Diabetes (EASD). They also published them in a recent issue of Gastroenterology.
Because these drugs are so new…that’s all the research done on them so far. But it’s a different story for the third drug Actos.
Germany and France banned it earlier this year. That’s because a French study showed that people taking it had a 22 percent higher risk of bladder cancer.
The study was based on 155,000 people who took Actos from 2006 to 2009.
And that’s not the only findings against Actos.
A second study shows it increases your risk of bladder cancer by 40 percent.
You can read about those findings in the journal Diabetes Care.
“Short-term use was not associated with bladder cancer,” say the researchers. “But use for more than 2 years was (linked) with increased risk.”
But the FDA hasn’t acted on this study.
That’s despite its own review which confirms this risk.
The review is based on an ongoing 10-year post-marketing study from the drug maker itself. The FDA has just done an interim review of this study. And looked at five years of data from on 193,099 people taking the drug.
The FDA confirmed that people on the drug had a 40 percent increased risk of bladder cancer compared to people who never used it.
So what happens now? The drug maker says it will keep an eye on these safety issues and “is committed to supporting (the 10-year study) through its conclusion.”
It also says it’s working with the FDA to “make appropriate updates” to packaging.
And despite the drug being banned in France and Germany…the FDA will allow the study to run its course and the drug to remain on sale.
But plenty of US doctors say that this isn’t right.
“I’ll ask my patients on Actos to consider dropping it and give them an alternative,” says Dr. Albert Levy. He practices at Mount Sinai School of Medicine in New York City.
Dr. David Nathan agrees. He’s an M.D. at Massachusetts General Hospital.
But he also says he’s not worried that one “dangerous drug will replace another potentially harmful drug.”
That’s because there are “other choices to treat diabetes.”
And Dr. Lee Green agrees. He’s an M.D. at the University of Michigan.
Or at least he did before the most recent study on Januvia and Byetta.
“I wouldn’t switch someone from a drug that might turn out to be a problem [Actos] to one that we know is a problem.”
Instead, he said he’d switch patients to safer drugs…and named Byetta and Januvia as his backup choice.
But since he said that, the UCLA study shows these drugs may be just as risky.
Defending Diabetes Drugs
Despite these findings…some doctors defend these drugs.
Take Dr. Barry Goldstein for example.
“(I) have full confidence in Januvia, which is used by millions of patients around the world,” he says.
And he should know. He’s a diabetologist in Philadelphia, PA. But he’s also a paid consultant for Merck Research Laboratories.
And he’s not alone. Dr. Joel Zonszein is championing Actos. He’s an M.D. at Albert Einstein College of Medicine in New York City.
He says the European decision on Actos is “precipitous and premature.”
“During the last three decades, studies have shown that treating diabetes early and aggressively results in much better outcomes,” he says. “There is a need for medications such as Actos that can slow down the devastating results of the diabetes epidemic.”
But Dr. Zonszein doesn’t just work for the Albert Einstein College of Medicine. He’s on the speaker’s bureau for Amylin and Merck. And he’s also on the advisory board of the drug maker that makes Actos.
So while these doctors defend these drugs…plenty of others say we should be wary of them.
One such doctor is Ronald Goldberg. He’s a professor at the University of Miami Miller School of Medicine.
“The study…raises a flag and is clearly something we need to pay attention to,” he says.
But that may not be so easy. At least not according to Dr. Joachim Spranger.
He’s an M.D. and lead researcher for the diabetes department at Charité-Universitäts medizin in Berlin, Germany.
He says that drug makers are doing everything they can to protect their profits. And because they have so much power…they can do a lot to keep their drugs on the market.
“Drug regulatory agencies are unlikely to receive data on drug safety that are independent of industry ties,” he says. “Until surveillance tools devoid of industry influence have been established to provide more robust data, such dilemmas of uncertainty regarding adverse effects will remain unsolved.”
And Dr. Hadler makes this same point more simply. He says it all comes down to industry greed and influence.
“I don’t think America realizes how much input industry has on medical organizations,” he says. “Several of these entities are so heavily underwritten as to be almost wholly owned subsidiaries of the pharmaceutical industry. Professional meetings have more the tone and feel of the marketplace than they do of the academy.”
He says many of the experts doing drug studies have good reason to promote them. And if a study comes out that suggests these drugs are risky…these same experts are quick to defend them.
“Their efforts are rewarded by the pharmaceutical industry,” he says. “Almost all are heavily involved in drug trials where they are paid for studying the drugs. And almost all are vying for a place on the committees that set treatment guidelines.”
And it’s hard to argue that these drugs aren’t important to the drug makers.
After all…these drugs are huge business.
Diabetic Drugs are Big Business
Sales of Actos have soared since 2007…bringing in $4.3 billion in 2010. That’s thanks to doctors who wrote 2.3 million prescriptions for Actos between January and October 2010.
It’s the same story for the makers of Januvia. Financial websites report that they tripled their net income in the first quarter of this year thanks to rising sales of the drug. Its net income came in at $1.04 billion and revenues reached $11.58 billion.
One financial site reports that…
“The most eye-catching performance came from Januvia which generated $739 million…up 45 percent…”
And Merck Chief Executive Kenneth Frazier says he’s very happy with his new diabetes drugs.
He says Merck is “making progress in our robust pipeline and leveraging the benefits of our expanded pharmaceuticals.”
And finally…Amylin is doing good business too. It brought in $174.2 million for the first quarter of this year.
The fact that these drugs generate so much money isn’t the problem says Dr. Hadler. He says the real problem is that these drugs don’t do much good. That’s because they don’t tackle the cause of diabetes. They just treat the symptoms.
“This is driven by the belief that if we normalize blood sugar we will improve longevity and decrease the incidence of blindness, kidney failure and stroke,” he says. “(Medical) leaders are so convinced of their belief that they focus on treating blood sugar and (don’t) question whether they are treating the patient.”
And Dr. Green agrees. Since his last comment about Actos…he’s seen that one drug may be as risky as the next.
“I think the larger message is not about which drugs for diabetes, but about the ultimate foolishness of trying to fix the problem with drugs,” he says. “As long as we keep supersizing ourselves, eating too much and moving too little, we’ll have this problem.”
What You Need to Do
For now there’s plenty of divided opinion about these drugs. Some doctors defend them. Others warn you to steer clear.
As always we’ll follow developments as they happen and keep you updated.
But doctors Hadler and Green both say that lifestyle changes may be the safest and most effective way to combat diabetes.
And the man behind this most recent debate–Dr. Butler–agrees.
“Being overweight is an important risk for both pancreatic cancer and diabetes,” he says. “The first advice to overweight patients with diabetes is to lose weight. By doing that, you reduce the risk of both.”
And there are some effective ways to do. You can read about them in our recent article here.
There’s also an all-natural way to fight diabetes. It comes from the leaves of a South East Asian tree. You can read all about that remedy here.
And because this is such a big issue…our team of medical researchers are working with some of the best experts in the business to create an effective product to help you balance your blood sugar safely.
We’ll have more news about how you can get hold of this natural remedy soon.
Wishing you good health,
Editorial Director, NHD “Health Watch”