I hate to say I told you so. But every time I come down tough on drugs, it turns out they really deserve it.
Take for example, the diabetes drug Actos. A few weeks back, I slammed Actos, despite new research (covered in TIME and The New York Times) that it decreases your risk of developing diabetes.
Turns out, I should have come down harder on that darned drug.
In fact, this week researchers published a report that found an association between Actos and a certain form of cancer. Plus, this isn’t the first study to uncover a link between Actos and increased cancer risk.
I’ll give you all the grisly details in a moment. But first, let’s back up a few months…
Proof mainstream reporters eat whatever’s fed to them
A month ago, Actos sounded like a wonder drug. Everywhere you looked the mainstream press kept repeating the same statistic…men and women with pre- diabetes who took Actos lowered their risk of developing full-blown diabetes by 72 percent.
Sounds impressive, right? Actos may prevent diabetes!
But remember the key flaw I told you about (and the mainstream press conveniently omitted)?
The study was exceptionally small. In the end, we’re talking talking about a total difference of 35 people! Considering that 300 million pre-diabetics live in the U.S., how could any doctor give Actos to just one of them based on such slim evidence?
And here’s the icing on the cake…
Takeda Pharmaceuticals, the makers of Actos, actually conducted this shaky study. In my book, it was purely a PR scheme to boost sales. Actos’s patent expired in January of this year. But Takeda Pharmaceuticals struck a deal to delay entry of generic versions of the drug until August 2012. Was this their last-ditch effort to boost sales before the generics hit the market?
Was it their last-ditch effort to boost sales before something far worse hit the fan…?
Researchers link Actos to cancer
The FDA tries to keep tabs on all prescription and OTC drugs once they hit the market.
So when you take a drug, even a drug like Tylenol, and have a bad reaction, you’re supposed to report it to the FDA. Similarly, when you go to see your doctor and talk about your bad reaction to a drug, your doc should report it to the FDA.
The FDA keeps track of all these “adverse reactions” — no matter how small — in a massive database. This is called the FDA’s Adverse Event Reporting Program. The FDA compiles and publishes the data annually.
But in the case of Actos…
A group of Italian researchers analyzed all the adverse events reported to the FDA between 2004 and 2009 for 15 diabetes drugs on the market, including Actos and metformin.
When they analyzed the reporting odds ratio (ROR), they found a “definite risk” linking Actos and bladder cancer. The risk of bladder cancer and the other diabetes drugs was “much weaker.”
The researchers aren’t sure why Actos may increase your risk of developing bladder cancer. But they think it may have to do with certain receptor cells in your body. You see, Actos works by opening receptor cells so they will become more responsive to insulin. But this may also encourage them to turn cancerous.
Now here’s what troubles even more…
Actos may be linked to even more problems
The FDA’s Adverse Event Reporting System isn’t perfect. (I know. It’s shocking, right?)
You see, it’s completely voluntary. It stands to reason there could be more cases of bladder cancer that we don’t know about.
For example, say Joe Smith from Indiana began taking Actos in 2004 for diabetes. Then, out of the blue, he got bladder cancer in 2008. Maybe his doctor never thought to connect Actos to his bladder cancer. None of this business about bladder cancer had hit the press yet.
Now, let’s say Joe is one of the lucky ones and went on to survive bladder cancer. He’s no longer in treatment. Now we know about the cancer link. But his doctor never reported it to the FDA back in 2008 because back then, no one did.
Hopefully, this new study will start to spread some awareness. Just don’t count on the FDA to move quickly. They have known about the possible link between Actos and bladder cancer for at least a year.
In fact, last year the FDA began to take a closer look at Actos after receiving early results from a long-term study by Takeda Pharmaceuticals. That study showed patients with the longest exposure (or highest cumulative dose) to Actos had in increased risk of developing bladder cancer.
It will be interesting to see if TIME or The New York Times follows up on their Actos report, won’t it?
(I’m not holding my breath. Before sending this week’s article off to my editor, I ran a quick Google search. At that point, The NYT still hadn’t run anything about the new data linking Actos to bladder cancer. That’s a full three days after the research hit the newswire. I’m betting they just let it slip on by.)
Well, maybe TIME Magazine will run something in its next issue. After all, the mainstream press is our last unbiased bastion of truth. (Yeah right.)
Dr. Allan Spreen
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