FDA Panel Urges Studies on Pain Drugs Known to Have Severe Side Effects

Somehow I suspect this will not end well.

Particularly because the conditions listed as potential indications for prescription of these clearly dangerous drugs are so common — chronic low back pain, osteoarthritis, and diabetic peripheral neuropathy — this has all the hallmarks of a trainwreck in slow motion.

Few if any people would want to rule out the use of even dangerous painkillers for people with, say, intractable cancer pain. But to jump from that potentially appropriate use (as the pharmaceutical companies always do) to using them from low back pain or arthritis, is breathtakingly irresponsible.

An FDA advisory committee has voted 21-0 that the investigational anti-nerve growth factor (anti-NGF) drug class should continue to be developed for pain treatment, despite the drug class’s link to joint-related adverse events.

There are no anti-NGF drugs currently approved, but three companies are deep into their development programs, testing the safety and efficacy of the drug class to treat a variety of pain, including pain associated with osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer.

For Monday’s meeting of the Arthritis Advisory Committee, FDA researchers reviewed data from the three drug companies and concurred with earlier findings that anti-NGF drugs do appear to cause rapid joint destruction. In patients who already had osteoarthritis, the joint deterioration was more severe than if their disease had progressed naturally, and, in some cases, patients who did not have osteoarthritis developed rapidly progressing joint deterioration during the trial.

Lower doses and less frequent administration of anti-NGF agents as well as placebo were both associated with naturally progressing osteoarthritis, while higher doses of anti-NGF drugs and use of an NSAID was linked to rapidly-progressing osteoarthritis as well as osteonecrosis.

An FDA reviewer and an outside academic reviewer performed separate analyses on 355 cases where patients receiving anti-NGF drugs underwent joint replacement surgery. Of those cases, 21% were determined to be rapidly-progressing osteoarthritis, and 7% were determined to be osteonecrosis.

For those not familiar with the terms, osteonecrosis is death of bone tissue and osteoarthritis is joint degeneration.

The ironic fact that the nonsteroidal anti-inflammatory drugs (ibuprofen, Advil, Motrin, etc.) routinely used for arthritis yield short-term pain relief┬ábut also cause long-term joint deterioration due to thinning of cartilage, is little known to the public.┬áThe FDA panel’s report on these anti-nerve growth factor drugs indicates that these, too, are known in advance to involve similar (and perhaps far more severe) trade-offs.

Not exactly what the doctor should order.