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New diabetes drug might have fatal side effects, but that's okay with the FDA

Fast Track to Nowhere

Don’t use newly approved drugs.

In a surprise announcement, FDA officials recently advised consumers to avoid taking any new drugs approved by the agency.

An FDA spokesman explained to reporters that drug approvals are often “fast tracked” so pharmaceutical companies can get valuable new drugs to market as soon as possible. In exchange, the companies promise to conduct trials to ensure drug safety.

The spokesman said: “This system obviously creates a giant black hole of safety hazards. That’s why we’re always a little concerned that a newly approved drug might cause serious, irreversible, or fatal side effects.

“So to be on the safe side, we’re now encouraging consumers not to use those drugs. Just hold off a couple of years – possibly three or four years, maybe five. By then the drug companies might have more studies finished up with a better look at safety issues.”

One reporter wondered if the spokesman could elaborate and give an example.

The spokesman said, “Glad you asked.”

A parade of red flags

“Victoza,” said the FDA spokesperson.

“Last month the agency approved the use of Victoza, a drug that treats type 2 diabetes. The drug appears to help control blood sugar, but safety is a huge question mark.

“In animal studies, Victoza caused thyroid tumors, and some were cancerous. In human studies patients who took Victoza developed pancreatitis (inflammation of the pancreas) more often than patients who took other diabetes drugs.

“So you’ve got a couple of serious red flags there. In fact, half the experts on our review panel recommended we not approve the drug. But the maker of Victoza, Novo Nordisk, they really had their hearts set on FDA approval, so we said, ‘Oh, okay, whatever.’ But we hit them with some pretty stiff requirements.

“First, they have to conduct an additional study to test safety in patients at high risk of heart problems.

“Second, they have to establish a cancer registry to monitor the rate of a specific type of thyroid cancer over the next 15 years.

“Third, they have to conduct a five-year study to test risk of thyroid cancer and other cancers, as well as pancreatitis and allergic reactions.

“In other words, anyone who takes this drug within the next five years is out of his mind. But hey, that’s between you and your doctor.”

Another reporter asked this question: “Last October, a report from the Government Accountability Office indicated that the FDA hasn’t followed up on a large percentage of drugs that gained approval under the accelerated approval process. Some of those drugs have been on the market for more than 10 years without completing follow up studies required by the FDA. How do you respond to that?”

FDA spokesman: “Looks like our time is up! Thanks for coming by and we’ll see you next time!”

Back to earth

Of course, the FDA has NOT advised consumers to avoid taking newly approved drugs (even though that would be an excellent idea). And of course, the FDA spokesman quotes above are fictional.

But all the information about Victoza is accurate, as are the results of the October GAO investigation of inadequate FDA follow up in the accelerated approval program.

The FDA is fully aware of the potential dangers of Victoza. But instead of waiting for safety studies to be conducted, agency officials are only recommending that Victoza should not be used as a first-line treatment. Which is like saying: If you’ve tried all the other diabetes medications and they haven’t worked, then what the heck? Go ahead and try this potentially dangerous one.

You don’t mind being a drug company guinea pig, do you?

To Your Good Health,

Jenny Thompson

Sources:
“FDA Approves New Treatment for Type 2 Diabetes” FDA press release, 1/25/10, fda.gov
“FDA Oversight of Unproven Drugs is Lacking: Government Report” About Law Suits, 10/27/09, aboutlawsuits.com

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