Recalled killer med Vioxx may be back in another form

The killer med that’s coming back to haunt us

The arthritis drug Vioxx was a horror show that is estimated to have directly caused 60,000 American deaths from heart attack or stroke. Some experts, however, say that figure is just the tip of this deadly iceberg – that the true number of deaths is closer to half a million.

Merck recalled the drug back in 2004, coincidentally just a few days after executives there learned of an FDA study that was about to appear in a big medical journal and blow the lid off any pretense that this painkiller was safe enough to take.

But after all of the payouts Merck made to the victims’ families – totaling close to $5 billion – and the publicity of the recall, at least we could rest assured that it had been assigned to the scrap heap of pharmaceuticals, never to see the light of day again.

Or was it?

Shockingly, Voixx may make a return engagement, as it’s been brought back to life by a small pharma startup looking to be the next billion-dollar drug company.

This means that knowing what to watch out for if you’re given an Rx for pain has never been more important.

Because once this drug gets its foot in the door again, anyone suffering from aches and pains – especially those associated with arthritis — could end up opening Pandora’s bottle.

Gone today, here tomorrow

It’s a case of “orphan” abuse if there ever was one!

I’m not referring to kids, but rather the FDA’s “orphan drug” designation that encourages pharma to develop meds to treat diseases that affect only a small number of Americans — fewer than 200,000.

It comes with plenty of perks, such as tax breaks and a free FDA review.

And it’s how Brad Sippy, CEO of Tremeau Pharmaceuticals, hopes to get Vioxx back on shelves.

Sippy’s plan is to repurpose this killer med as a treatment for the joint pain that afflicts hemophiliacs. Such patients have blood that doesn’t clot normally, so they can’t take typical pain meds that trigger bleeding.

Since there are just a little over 20,000 people in the U.S. who suffer from this bleeding disorder, any drug intended to treat a problem specifically for them easily falls into the entitlement status of “orphan.”

Once Vioxx is back on the market, however, any doctor can prescribe it to any patient for any purpose. And that prospect of off-label use already has some investors drooling.

In fact, the president of a large investment firm has called it a “brilliant” move.

And don’t think that Sippy, who just so happened work for Merck at the same time it was trying to clean up its deadly Vioxx mess, isn’t well aware of the potential undercover blockbuster he’s got on his hands.

But then, he seems to enjoy the potential gains of playing with extremely dangerous drugs. His company only lists two meds in its hopper, rofecoxib (the generic name for Vioxx), which currently goes under the code name of TMR-201, and another pain med called etoricoxib, or TRM-359.

Etoricoxib (also a Merck creation) was actually rejected by the FDA nine years ago because it was considered too risky! How often does the agency do that?

Sippy’s company also snapped up the Vioxx name as soon as it became available (and officially registered it at the U.S. Patent and Trademark Office for the treatment of “pain, inflammation, and arthritis”), but he told a reporter that he’s not sure what he’s going to call this “new” drug, as that name might be too scary. No kidding!

But you don’t need to put your life on the line to deal with chronic pain, be it from arthritis or anything else. There are plenty of effective alternatives to OTC or Rx drugs that won’t send your heart attack and stroke risks off the charts.

One is the old standby chondroitin, which has been found to be just as good for arthritis pain as the prescription med Celebrex, which (like Vioxx) is also a highly risky COX-2 inhibitor (and the only one that somehow managed to stay on the market).

Other beneficial remedies include acupuncture, chiropractic adjustments, and yoga, as well as topical creams containing arnica and capsaicin.

But seriously, whatever Sippy’s drug ends up being called, this old killer should never even end up on your radar — let alone in your medicine cabinet.

“Shocker! Is Vioxx coming back… as an orphan drug?” Milton Packer, May 2, 2018, Medpage Today, medpagetoday.com