The Drug Reports

Taken from Jenny Thompson’s HSI Research News Letter:

In 2010 I asked, “Could this be the rock-bottom worst drug ever?”

In 2012 the answer is: “Good chance it is.”

The drug is Multaq, a treatment for patients with abnormal heart rhythm — also known as atrial fibrillation. More than two million people in the U.S. have AF, and millions more are at increased risk due to high blood pressure.

A few days ago, Michele sent you a Code Red message to alert you about a new Multaq safety review from the FDA.

But as usual, the FDA only got it partly right, leaving the impression that this drug is still safe for hundreds of thousands of patients.

Wrong. Multaq is a potential monster.

So Many Issues, So Little Time

Multaq doubles the rate of cardiovascular death, stroke, and heart failure” in patients with permanent AF.

That’s a staggering statement. And it comes straight from the FDA. And you would think it would be enough to shut down a drug and wipe it from the market. But no. That’s what rational people would do — not the FDA.

This past July — eight months after I nominated Multaq to the Must-To-Avoid Hall of Fame — the FDA informed healthcare professionals that a clinical trial had been halted when Multaq was linked to a two-fold increase in the deadly conditions listed above.

But that was just the FDA letting doctors know they were reviewing the study.

Finally, last month, the FDA confirmed Multaq’s overwhelming dangers in patients with permanent AF. (Why it took them five months to review a study I reviewed in half an hour I’ll never know.)

But what about patients with non-permanent AF? Here’s how Reuters addressed that question: “The FDA said Multaq is still safe to treat patients with brief bouts of irregular heart rhythm.”

Still safe? Reuters! What are you smoking?

FDA officials would only say they “believe” Multaq is beneficial for non-permanent AF. That’s based on a single study mounted by Sanofi-Aventis, the maker of Multaq.

In that study, Multaq was no more dangerous than placebo in patients with non-permanent AF. And yet, the FDA recommends that anyone who takes Multaq should be given an ECG “at least once every 3 months,” and “Patients prescribed Multaq should receive appropriate antithrombotic therapy.”

So this “safe” drug requires constant monitoring AND the use of another drug to prevent potential cardiovascular risks. Does that sound anywhere NEAR safe to you?

Meanwhile, the Multaq website warns that the drug may cause “slowed heartbeat” and “life-threatening liver failure.” And in 2010, an Institute for Safe Medicine Practices investigation linked Multaq to potential impaired kidney function and fatal irregular heartbeats.

The ISMP concluded: “We have seldom seen a drug with so many issues in so many areas of its safety profile.”

Put another way: Multaq is a train wreck!

If you’re taking Multaq, call your doctor immediately and let him know you want to put as much distance as possible between you and this rock bottom drug.

Gardisil

Dear Reader,

Here is a headline that many doctors and Merck executives hope you never see…

“Fighting Cervical Cancer With Vinegar and Ingenuity”

That’s a New York Times headline for a article that examines an inexpensive and highly effective way to prevent cervical cancer. And nowhere in the article will you find the words “Gardasil” or “vaccine.”

It’s Merck’s worst nightmare.

The Only Way To Go

The procedure was originally developed here in Baltimore at Johns Hopkins Medical School about 15 years ago, and in 2010 it was endorsed by the World Health Organization.

And it couldn’t be simpler.

When vinegar is brushed on a woman’s cervix, precancerous spots turn white. The spots are immediately frozen with a metal probe cooled by carbon dioxide.

Inexpensive. Safe. Easy. Done.

And it works.

Five things you can’t say about the so-called cervical cancer vaccine.

The technique is currently being studied in Thailand among 6,000 women. In 11 years not a single woman who has been treated has gone on to develop full-blown cervical cancer.

This procedure is being tested in Thailand because it’s one of those emerging nations where state-of-the-art healthcare isn’t available in many areas. This test and treatment combination is ideal for low-tech clinics, or temporary field clinics.

In more advanced countries — like the US — where lab testing is easily accessible, a doctor takes a pap smear, sends it to a lab, and test results reveal cervical cancer status.

Soon, women all over the world — from Times Square to rural Thailand — will have access to one of these two highly effective methods of cervical cancer treatment.