Taking Big Risk for Pain Relief
October 21, 2012
The Wall Street Journal
Dr. Pinna says…
These “epidural injections” are basically a PLACEBO EFFECT.
A study done by a government group had these results:
Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections
Essentially 12 percent of the patients claimed they had relief
when steroids were used. The remainder had the same results,
with or without steroids.
Steroids reduce inflammation, but for a short period of time,
one to two weeks maximum.
Steroid injections increase the rate of infection, as we are
seeing with the meningitis outbreak.
The reason? “Inflammation” is your immune system combating
infective agents. Block inflammation and you are killing your
These “shots” are not pain shots.
The major effect is in the patient’s imagination, the famous “Placebo Effect.”
The doctors and clinics giving these “shots” are making huge
amounts of money.
Here is an abstract from Australia:
An audit was conducted to determine if epidural injections for back pain and sciatica were practised in accordance
with guidelines prescribed by the National Health and Medical Research Council (NHMRC). More than 80%
of injections were used for conditions for which they were not indicated, and which the NHMRC considers
experimental. Most commonly, epidural injections afforded no benefit to the patients, yet were often repeated. In no
instance was informed consent recorded as recommended by the NHMRC. The practice of epidural injections is
dissonant both with the evidence-based literature and with recommended guidelines, and squanders both financial
and professional resources.
ARTICLE FROM THE WALL STREET JOURNAL
James Chamberlain receives a local anesthetic before his steroid injection Thursday. Mr. Chamberlain is continuing with the injections to treat back pain despite the deadly meningitis outbreak linked to such shots.
James Chamberlain, who has been getting steroid injections for the past five years to treat his debilitating back pain, had recently begun a new round of them when he heard such shots have been tied to a deadly fungal-meningitis outbreak.
He decided to continue with the treatment anyway, getting his latest injection Thursday. “If I didn’t have the epidural shots, I’d be quite miserable and quite lame,” said Mr. Chamberlain, 59 years old, of Forest Hills, N.Y.
Clinics and surgical centers that offer such injections say they are fielding a flood of patient questions about safety in the wake of the meningitis outbreak, which federal officials say has killed 20 patients and sickened 254. But doctors say demand for the procedures, in which steroids are injected into the epidural space in the spine, remains strong—a testament to the desperation of people seeking pain relief.
Clinics are turning to alternatives to replace the steroid supplied by New England Compounding Center, the Massachusetts drug-mixing pharmacy that has recalled its products and stopped operating amid a government investigation. Some clinics say they are buying steroids from traditional drug makers, but others say they are also turning to rival compounders as other players in the market push to fill the void. Compounding pharmacies custom-mix medicines but aren’t regulated like traditional drug makers.
PainCare Centers, a chain of 11 clinics in New Hampshire, continues to treat 100 or more patients a week, said Chief Executive Michael O’Connell. “Ninety percent of them proceed with getting injections,” he said, while the rest are trying alternatives such as physical therapy.
The chain, which had used NECC products before the recall, is treating patients with steroids made by pharmaceutical companies including Pfizer Inc., PFE -1.06%as well as compounding pharmacies, he said.
Steroid injections have surged in popularity in recent years, in part because they can provide almost instant, monthslong relief from debilitating back and leg pain, even when other drugs and exercise have failed, said Lynn Webster, president-elect of the American Academy of Pain Medicine.
Doctors give about four million of the injections each year, Dr. Webster said, double the number a decade ago.
Compounding pharmacies became the most common source for methylprednisolone acetate, a steroid used widely for pain, after two large drug makers—Teva Pharmaceutical Industries Ltd. TEVA -2.22%and Novartis AG’s NOVN.VX -0.17%Sandoz unit—stopped production in recent years.
Pain clinics turned to compounders to fill the void in part because their version of the steroid is free of the preservatives used by pharmaceutical companies that can help guard against fungal growth, in addition to extending shelf life. The preservatives can cause serious side effects when injected near the spine.
Although steroid injections are effective if given correctly, studies of the procedure have shown mixed results, partly because some medical professionals lack the training to do the procedure safely, said Ray Baker, a Kirkland, Wash., pain physician and president of the International Spine Intervention Society.
Another issue is that the injections are popular even among patients who should have surgery instead, said Roger Chou, an associate professor of medicine at Oregon Health and Science University, who helped write clinical guidelines to treat lower-back pain for the American Pain Society. “There’s undoubtedly some overuse,” Dr. Chou said.
Some clinics are stepping back from the procedures. John Bolinger, vice president for medical affairs at Union Hospital in Terre Haute, Ind., said the hospital has stopped the shots and is hoping for guidance from federal health officials about the use of compounded injections. Ninety patients of the hospital’s Wabash Valley Surgery Center received injections made by NECC, he said. None got sick.
Janet Woodcock, director of the Food and Drug Administration’s drug division, said in an interview that doctors interested in buying medicines from compounding pharmacies should check if there is an FDA-approved drug available and whether the pharmacy is mixing medicines in response to legitimate prescriptions for specific patients.
“There is a legitimate role for compounding pharmacies, but the stakes are raised when [a drug is supposed to be] sterile, and the stakes are raised further when it’s preservative-free, and the stakes are raised even further when there’s production of large lots,” Dr. Woodcock said.
The International Spine Intervention Society this week sent its 3,000 members a letter advising caution when using products made by drug-mixing pharmacies until “gaps in regulatory oversight are rectified.” The letter urges doctors to ask compounding pharmacies for details about their quality control and whether they follow American Society of Health-System Pharmacists standards.
Some compounding pharmacies are seeking to calm safety concerns. Hartley Medical Center Pharmacy Inc., of Long Beach, Calif., hosted webinars last week about its environmental monitoring programs, staff assessment and end-product testing. In an Oct. 8 email to pain clinics and other medical professionals, Hartley Medical wrote in a bolded, underlined font, “Not all compounding pharmacies are the same!” The pharmacy said it follows standards set by the American Society of Health-System Pharmacists.
At the Hospital for Special Surgery in New York City, Seth Waldman, Mr. Chamberlain’s doctor, said many patients have called or emailed asking about who supplies its steroid injections. He tells them the hospital buys them from pharmaceutical companies including Bristol-Myers Squibb Co., BMY -1.40%not compounding pharmacies. “There’s not been too much of a drop-off, but people are understandably worried,” said Dr. Waldman, director of the hospital’s pain-management division.