If your doctor prescribes this blood thinner, get another opinion

Six years ago the FDA received an alarming… even chilling… letter about Effient, a new blood thinner the agency was set to approve.

The letter warned of uncontrollable bleeding, trial data that may have been rigged, and that Effient may unleash a tidal wave of cancer.

The letter came from Dr. Victor Serebruany. He’s one of the world’s leading experts on blood thinners – and he’s also Effient’s inventor.

It’s been six years since Dr. Serebruany was unable to protect us villagers from the monster he created. Six years since the FDA bowed to pressure from a $23 billion drug giant and put the drug on the market.

Now the numbers are coming in. They’re proving that Dr. Serebruany’s nightmare scenario is coming true – and that you shouldn’t allow Effient within 10 feet of your medicine cabinet.

Blood money

It’s pretty unusual for Congress to launch an inquiry into a drug that hasn’t had its first paying customer yet.

But if there was any drug that deserved the full Watergate treatment, it was Effient, a prescription blood thinner that’s often given after you’ve had an angioplasty.

In 2009, just two days before a key FDA advisory panel was set to meet on Effient, drugmaker Eli Lilly made a disturbing call to the FDA.

They demanded that Dr. Sanjay Kaul from Cedars-Sinai Medical Center in Los Angeles be kicked out of the meeting. Dr. Kaul, a world-famous cardiologist, had apparently been doing his job and raising concerns about Effient’s safety.

But Eli Lilly wasn’t just settling a score with Dr. Kaul – it was trying to keep a growing mutiny from spinning out of control.

Dr. Serebruany, a Johns Hopkins researcher who helped develop Effient for Eli Lilly, had broken ranks and was warning cardiologists and regulators everywhere that Effient was too dangerous to be approved. And his message was starting to resonate.

The problems started with the disastrous TRITON-TMI 38 study that was supposed to show that Effient worked at least as well as other blood thinners on the market – and that it was safe.

Instead, when Dr. Serebruany and other researchers crunched the numbers, they found that Effient increased the “risk of fatal hemorrhage fourfold” – and that was after Eli Lilly allegedly stacked the deck to give Effient an advantage over other drugs.

Even more disturbing, Dr. Serebruany and his colleagues noticed a disturbing rash of aggressive cancers among patients on Effient. Your body’s platelets work to naturally stop the spread of slower growing, less threatening tumors – and it seemed Effient was keeping those platelets from doing their job.

Dr. Serebruany wasn’t ready to call Effient a carcinogen – but he was certain it was a “cancer promoter.”

Neither the FDA nor Congress had the backbone to keep Effient off the market – and none of the warnings nor concerns could stop the Eli Lilly marketing machine from turning it into a half-a-billion-dollar-a-year drug.

But now a second mutiny is forming against the drug – and this time it’s being led by cardiologists who are learning firsthand that the benefits of Effient don’t outweigh the risks.

At a recent, major cardiology conference in San Diego, researchers said they couldn’t produce any evidence that Effient works any better than a slew of other blood thinners now being used.

There’s no “statistically significant” evidence that it’s saving lives – but it may be ending plenty.

A second look from the original Effient trials found that people taking the drug had a 60 percent higher rate of either new or worsened solid tumors – especially the kind that can spread quickly. And the longer you stay on the drug, the greater your chances of a life-threatening cancer.

That’s especially dangerous because, as Dr. Serebruany points out, many patients who have had an angioplasty stay on blood thinners like Effient forever.

If you’ve been prescribed Effient, talk to your doctor about suitable replacements.

And if you haven’t been prescribed the drug, there may be good news ahead. Cardiologists are learning more about the dangers of Effient, and it’s coming off patent in just a few years.

That means both doctors and Eli Lilly may soon be losing interest in forcing this drug down our throats.

Unfortunately, it’s six years too late.

Sources:

“Real-world prasugrel use relegated to ‘healthiest’ of ACS patients” Michael O’Riordan, May 8, 2015, Medscape, medscape.com