Better Safer Pain Management?

[ADR seeker]

Dr. Edward Tobinick and Enbrel injection for discogenic pain

This is from another spine forum.

Dr. Edward Tobinick and Enbrel injection for discogenic pain

There is very suggestive, but as yet not fully confirmed evidence, that Enbrel injection can dramatically alleviate discogenic pain. The principal evidence comes from a randomized controlled trial done at Johns Hopkins and Walter Reed for sciatica. The trial was small but the results dramatic.

Of 24 patients in the trial, 6 received placebo and the other 18 received varying dosages of Enbrel injected via the disc epidural. Only 1 of the 6 receiving placebo showed improvement. Of the 18 receiving Enbrel injection, 13 reported more than 50% pain improvement lasting more than 6 months. Most of the 13 had virtually no pain at all after just two injections.

Enbrel is FDA approved for use in auto-immune conditions. In theory it works for discogenic pain by "down-regulating" "the inflammatory process (I'm not certain what this means).

Off label use of Enbrel injection for discogenic pain was pioneered by a Dr. Edward Tobinick in Los Angeles and is available from him currently. Dr. Tobinick charges some $4200 per injection, which you must pay up front.. But because Enbrel is FDA approved, and because California law mandates insurance coverage of off-label use of FDA approved drugs if such use is supported by two or more published medical journal articles, I got almost full insurance coverage from Anthem Blue Cross of California.

Dr. Tobinick tells me that Enbrel injection will not work if the disc is literally compressing a nerve or the spinal cord. It works if the discogenic pain is from inflammation alone: it is known that a herniated disc, even if it causes no compression, emits proinflammatory chemicals.

Dr. Tobinick does not inject Enbrel into the epidural space but into a venous system specific to the spine. This is a less invasive procedure than epidural injection. According to Dr. Tobinick, the spinal venous sysem was documented in medical journals as long as 70 years ago but forgotten till he rediiscovered it.

Dr. Tobinick acquired patent rights to his injection treatment. Those rights were acquired by a major pharmaceutical co. Cephalon for some tens of millions. Cephalon is testing treatment of sciatica with a new drug of the Enbrel family. Trials are in Phase 2 stage, are centered in Wellesley, MA.

I tried the Enbrel injection from Dr. Tobinick because the Hopkins trial convinced me it really works for some. But it did not work for me, probably because I have disc compression of nerve/spinal cord.

By the way, Dr. Tobinick confirms that cervical disc patients can present with head pain or low back and leg pain. Dr. Tobinick thinks pro-inflammatory chemicals travel via the spinal venous system and can thereby cause symptoms at locations remote from the herniated disc injury. His view offer support for the clinical observations of a Dr. Herman Kabat, author of Low Back and Leg Pain, whom I saw back in the 1970s, and about whom, more later. Kabat thought a significant percentage of patients with head pain or low back and leg pain suffered from herniated C6-7, but that the true source was never suspected by doctors applying the usual diagnostic criteria.

[mmglobal]

It's funny that I just mentioned Disc Cure on another thread before I saw this. Tobinick and his brother were running this clinic. They were misrepresenting themselves as affiliated with the UCLA School of Medicine because they had offices near UCLA.

I went to talk to them twice and managed to navigate my way past their policy of $500 cash on the barrel before you can even talk to a doctor. Because their business seemed to be only about money, and with unrealistic promises... I never sought treatment from them.

My suspicisons about the clinic were confirmed when I had the opportunity to spend some time with Dr. Michael Whitworth. He is a wonderful interventional pain management doctor and was a frequent poster on the spinal disorders forum over at braintalk. He was in Los Angeles to testify against Tobinick. (Dr. W's website: Home)

I have no idea how capable a doctor Tobinick is. In my opinion, based on my experience, he's a crook. Note that I'm not suggesting anything about this treatment. Only about my experience with a sham clinic that (I believe) was shut down by the authorities.

Mark

PS... Here is one of my fond memories...

I was able to host Braintalk's beloved Dr. W. for a backyard BBQ:

[Maria]

I made an appt. to see this doctor however all I was able to see was some short film made ridiculously simple about how embrel worked and a "nurse" came in to see if I understood everything and told me if I wanted to consult with the doctor I had to pay $500. I agree w/Mark re misrepresentation in terms of having an office "affiliated" with UCLA. It would have been accurate to say that the office was located on the grounds however I checked out the affiliation status and found there was no such affiliation.

Embrel is not a drug to be administered lightly either so recognizing that this was probably more of a money making scheme than an actual physician dedicated to the care and management of spinal problems I chose to save myself the $500. In fact his specialty has nothing to do with the spine as I recall which was another tip off in terms of treatment.

Also when seeking treatment outside of the WC system (if desired treatment is not authorized and is still pursued by patient) if something is done and creates more of a problem then there is a possibility that WC can legally fenagle their way out of continuing care which I didn't want the possibility of losing over something like this.

[mmglobal]

According to this article from 2002 in the LA times, Dr. Tobinick is a dermatologist. I believe the article incorrectly states that the injection is below the skin. I do believe that this was an intradiscal injection.

Tobinick | 'Miracle Cure' for Back Pain Has Lots of Appeal--and Skeptics - Los Angeles Times


'Miracle Cure' for Back Pain Has Lots of Appeal--and Skeptics
Treatment

A doctor says he has given DiskCure to hundreds of patients, but some experts criticize his secrecy and the lack of clinical studies.
May 13, 2002|BENEDICT CAREY and DAVID R. OLMOS | TIMES STAFF WRITERSAbout eight in 10 Americans suffer from back pain at some point in their lives, and many try everything from bed rest to spinal surgery for relief--with mixed results. Millions are still hurting, and desperate for answers that doctors often can't provide.

Of the many therapies that are touted in newspaper and radio advertisements, perhaps the most visible in Southern California is a treatment program known as DiskCure. Ads for DiskCure promise a "breakthrough" drug treatment at a clinic known as the Institute for Neurological Research. "Freedom from pain. At last. Without surgery," says the clinic's Web site.

The clinic, operated by Dr. Edward Tobinick, a dermatologist and internist, is housed at 100 UCLA Medical Plaza, in the heart of one of the world's premier teaching hospitals. The clinic's Web site also asserts that the treatment, using "a new class of biotechnology medications," has brought relief to patients with various forms of back, neck or leg pain associated with disk disease.In an interview, Tobinick said his patients usually are given a single injection, applied under the skin. "It's a miracle cure, a magic bullet," he said.

Some other pain specialists are skeptical, however. Decades of research have failed to yield a single, all-purpose answer for back pain, they say, and doctors often don't even agree on what's causing the pain.

Tobinick said his clinic, with locations at UCLA and in Newport Beach, has treated about 1,500 people and that about two out of every three patients have had "a significant improvement in their symptoms." The clinic charges about $2,200 for a one-time treatment and consultation. Some patients may require more than one treatment, he said.

Kathleen McGarry, of Santa Maria, said she was "flat on her back for nine months with back and leg pain" and had gone from doctor to doctor before visiting Tobinick's clinic in October. "Within two minutes of the treatment, the pain was gone," said the 55-year-old administrative assistant, one of several former patients whose names were provided by Tobinick. "That was six months ago, and I'm back to work; I'm fine."

Tobinick is reluctant to discuss the DiskCure drug regimen in detail. He would not name the medications he uses, saying only that they are anti-inflammatory agents that moderate the body's immune response. The drugs are approved by the Food and Drug Administration, he said, but not specifically for treatment of back pain.

It's not unusual for doctors to prescribe a drug to treat a condition other than that approved by the FDA. For example, physicians experimented with injections of botulism toxin, or Botox, to smooth wrinkles, for years before the FDA finally approved the drug for that purpose last month.

Typically, doctors making use of an FDA-approved drug in a novel way share their findings, by presenting data at professional conferences or publishing their research in medical journals: This is how other doctors learn about and evaluate new uses for medications. Tobinick acknowledges that, so far, he has done neither. No studies of the drugs' effectiveness in treating back pain in humans have yet been made public, he said.

But Tobinick pointed to experiments in laboratory animals that have shown that the anti-inflammatory drugs he is using can be effective in treating disk injury. The studies were done in pigs and in rodents, he said, while declining to cite any specific studies.

Dr. James N. Weinstein, an orthopedic surgeon at Dartmouth University's Medical School and editor of the medical journal Spine, said he was aware of two such studies. In one, published in the April 15, 2001, issue of Spine, Swedish researchers reported that the drugs etanercept (whose trade name is Enbrel) and infliximab (Remicade) limited nerve damage and inflammation after disk injury in a group of pigs. In the other, Japanese doctors found that a similar anti-inflammatory drug limited disk damage in rats.

But, Weinstein noted, "studies in animals in no way suggest that the drugs are efficacious for all back problems. You would have to do clinical trials in humans to determine that."

Tobinick said he is organizing a human trial. The experiment, he said, will include 20 people with back and leg pain: Ten will receive an injection of the principal drug used in the DiskCure treatment and 10 will get a placebo injection, of saline solution.

Says Tobinick: "We are going to publish a big article in the New England Journal of Medicine, we hope."

The Trial Process

Dr. Eric Matteson, a rheumatologist at the Mayo Clinic in Rochester, Minn., who is studying anti-inflammatory drugs, said doctors who develop novel uses of a drug typically conduct initial pilot studies. "What you do first is develop a hypothesis, then a protocol for testing the drug," he said. "If you haven't formally studied novel uses, then you don't know that the treatment really works."

[mmglobal]

It's amazing how scam artists never have just one scam. It's scam after scam after scam. There is always a next con.

What's sad is that there may be something to some of his treatment. Unfortunately, he turns them into a con, presumably because he is unwilling or unable to do the legwork to generate the necessary proof of the treatment's efficacy.

More on the amazing Dr. Tobinick from:

http://stranger-worlds.blogspot.com/...1_archive.html

False claims of doctor who 'can reverse'

A doctor who claimed to be able to reverse the effects of Alzheimer's with an arthritis drug was disciplined last year by US health chiefs for claiming the same drug could halt back pain.

Sensational footage of Dr Edward Tobinick injecting a dementia patient who subsequently appeared to recognise his wife for the first time in five years was shown in Britain earlier this month.

It gave new hope to the 700,000 UK dementia sufferers and their families.

But this newspaper has learned Dr Tobinick, 56, has previously made unfounded claims that the same drug, etanercept, could cure chronic back and neck pain.

He also has a financial interest in the success of the drug because he owns shares in its manufacturer, Amgen.

Last year Dr Tobinick was disciplined by the Medical Board of California (MBC) after he failed to provide scientific evidence that etanercept was a 'breakthrough' treatment for back pain.

He was found guilty of unprofessional conduct and placed on probation for a year. He was banned from practising for 60 days - but the order was suspended for the period of his probation.

Last year researchers conclusively proved that etanercept was not an effective treatment for back pain, although Dr Tobinick contests their methods.

In 2001, he was involved in another row when he threatened legal action against a website that challenged claims he made about his patented laser hair removal treatment.

Dr Tobinick claims he teaches at the prestigious University Of California Los Angeles (UCLA) and is a member of its clinical faculty.

But a UCLA spokesman said Dr Tobinick merely rented an office in a private building also used by the university's medical centre.

He added that his work was not supported by the university and that any teaching he did was on a voluntary, unpaid basis.

Dr Greg Cole, assistant director of the UCLA Alzheimer's Disease Centre, called Dr Tobinick's Alzheimer's work "suspicious" and said it did not meet clinical trial standards. He added that most doctors were "very sceptical" of his claims.

Etanercept is part of a group of medicines which work by "switching off" a chemical that causes inflammation in the body. It is routinely used to treat rheumatic problems and severe psoriasis.

Dr Tobinick says he has given weekly injections to 50 dementia patients, many of whom have shown continuing improvement in problems such as forgetfulness and confusion.

The drug is injected into the neck near the spinal column and the patient is tilted, supposedly to encourage the drug to seep into the brain.

An Amgen spokeswoman said: "We have carefully examined this study and believe there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer's disease."

Alzheimer's experts in the US have also described Dr Tobinick's findings as "implausible".

When approached by The Mail on Sunday, he said: "Pilot studies are the initial scientific evidence that support further investigation of a new treatment approach. Our results support the initialisation of further large-scale clinical studies.

"This is how all new treatment approaches begin. I feel the disciplinary action was unfair. There is not a single study that shows my treatment methods do not work.

"My breakthrough ideas have been attacked by the scientific community for almost a decade. This is what happens when you are the first in the world to invent a new treatment. It has happened to every medical pioneer throughout history.

"My ideas are legitimate and valid - all of this just points to the fact that my work is ahead of its time."

[Maria]

Mark,
I often heard this saying used in medicine "if it walks like a duck and quacks like a duck.. it's a quack" I believe that's how it goes tho you may remember the saying better than I ~ anyway Dr.T sure sounds like a quack w/his quotes even if there may be some actual relief in his unorthodox and off label use of drug/treatments. His idea of running trials certainly seems to be pretty a bit turned around.

[DavidLogan]

He who has a permanent problem with back pain can se its treatment on this.

[mmglobal]

David Logan's post above is pure spam. It is postec by a service paid to improve a business' internet visibility. I've deleted the link, but left the post.

Since the business linked in his original post may be interesting to spine patients, I'll post some information about them.

Atlas Wellness Centre is located in Bedfordshire, north of London. Their website talks about their services, improving your 'wellness' and how that may improve your back pain.

Their website is atlaswellnesscentre dot com.

Mark