Sometimes I like to surf around news sites in other parts of the globe to get a better feel for what’s going on in other countries, as well as how the foreign press is presenting what’s going on here in the U.S.
In my opinion, access to folks in all the far flung places of the world is the greatest thing about the Internet.
Anyway, I was buzzing around the website for England’s The Daily Telegraph the other day, reading all the news that’s “Fit for Brits,” when I came across an interesting story about some breakthrough medical research being done at UCLA on Alzheimer’s Dementia.
Here’s the story titled UCLA drug aids Alzheimer’s patient ‘in minutes’. Please give it a read, and then come back here. It’ll only take a minute or two.
Basically, the story talks about a research project at UCLA in which researchers have been giving injections of the drug Etanercept by inter-spinous injection into the peri-spinal area in the back of the neck. What this means is that they stuck the needle between the spinous processes, which are the the little bumps you can feel under the skin along your backbone. They would then push this needle in until they were just adjacent to the spinal cord, which is where they would inject the medication.
This medicine was then theoretically absorbed into the cerebrospinal venous system, which is basically a rich network of connected veins surrounding the brain and spinal cord.
After injection, the patient was placed in what is known as the Trendelenburg position, which is a position where the patient is lying flat on his or her back on a table, and the end of the table where the head is located is lowered slightly so that he or she is lying at an angle with the feet higher than the head.
This was theorized to use gravity to enhance the medication getting into the brain.
So, why did they want to get this medication into the brain of an Alzheimer’s patient?
Well, there is still an awful lot we just don’t know about Alzheimer’s disease. We don’t entirely know what occurs or why it occurs. That said, there is also an awful lot we do know, thanks to hard-working people like the ones doing this particular research project.
One thing that appears to play a big role in the development of the lesions that cause Alzheimer’s is inflammation. There is a protein chemical that the body produces known as Tumor Necrosis Factor-Alpha that plays a big role in activating and amplifying inflammation.
Etanercept is a medication that works to block the effects of Tumor Necrosis Factor-Alpha. It is normally given by subcutaneous (under the skin, in the fatty tissue layer between the skin and the underlying muscles) injection to patients with auto-immune inflammatory diseases such as rheumatoid arthritis and psoriasis.
According to the article in The Daily Telegraph, Dr. Edward Tobinick and his team at UCLA wanted to see if this medication might help people with Alzheimer’s.
Some easy googleing on the Internet will show that Dr. Tobinick is quite interested in the cerebrospinal venous system as a possible route of delivery for medications for various medical problems. In fact he holds several patents for his therapeutic use of this venous system. So, if this new treatment proves to be effective and becomes a mainstream treatment for Alzheimer’s, it looks like Dr. Tobinick stands to make some cash.
Don’t misinterpret me here. This, in and of itself, is not a criticism of Dr. Tobinick. Rather it is a ringing endorsement of the free market economy as a powerful incentive driving forward new medical research and medical advances. Personally, I sincerely hope that Dr. Tobinick finds a cure for Alzheimer’s disease and many other diseases, and I hope he gets filthy stinking rich doing it.
That said, there is definitely some potential criticism of Dr. Tobinick’s research, as well as the Daily Telegraph story, which I will discuss later in this post.
For now however, I’ll get back off my soapbox and get back to the story…
So, the idea was that since Alzheimer’s appears to be in large part driven by inflammation…and since inflammation is in large part driven by Tumor Necrosis Factor-Alpha…and since Etanercept works to block Tumor Necrosis Factor-Alpha…how bout if we try using etanercept in some Alzheimer’s patients and see what happens???
So, why in the world do we need to inject this stuff right next to the spine rather than just give a nice subcutaneous injection, like all those folks with psoriasis and such are able to do?
Well, Dr. Tobinick theorizes that etanercept, being a large molecule, is too large to pass through the blood-brain-barrier and actually enter the central nervous system (brain and spinal cord). So, he wanted to use his patented injection technique to see if this method would be able to deliver the medication to the brain of Alzheimer’s patients and have any effect.
He did a 6-month pilot study, which was published in 2006, in which he injected Alzheimer’s patients with etanercept using his injection technique and found some improvements in their cognitive function using several different tests designed to assess cognitive function.
The Daily Telegraph article linked to above, talks about a case report Dr. Tobinick published of a specific clinic patient, who underwent Dr. Tobinick’s treatment and according to the report experienced a very marked improvement in clinical cognitive function that occurred very rapidly after receiving the injection.
According to this case report, this patient was not part of any formal study, but was rather an independent patient being treated by Dr. Tobinick. In the article, he details how the original pilot study was an Institutional Review Board approved study that lasted 6 months, but that in the period following this study, he has continued to see improvement in patients receiving his treatment. He details how they repeatedly saw the phenomenon in patients of rapid clinical improvement within minutes of receiving the treatment.
So this case report, the one the Daily Telegraph article was talking about, discusses the details of one particular patient.
Wow, sounds great right? Sounds like this guy has maybe discovered a major treatment, if not outright cure, for Alzheimer’s Dementia. This is a disease which affects millions. It is frequently devastating to families, so when I first read this story, my first reaction was one of jubilation. Yours was too, I bet.
But let’s take a little closer look.
First, lets look at the Daily Telegraph story itself. The very title of the story is misleading and incorrect.
First, this is not a UCLA drug. Etanercept is the generic name for the medication Enbrel. UCLA does not own this medication.
Second, although Dr. Tobinick is apparently a voluntary part time assistant clinical professor in the Division of Dermatology of the UCLA medical school, and his private practice is located in a building addressed at 100 UCLA Medical Plaza, UCLA did not have anything to do with this published case report.
Then we get into the story itself. The opening sentence “An Alzheimer’s patient improved “within minutes” of being injected with a new drug in a scientific breakthrough against the disease, it has emerged”, is, similar to the title of the story, false and misleading.
This story gives the image of a UCLA investigator exploring the effect of some new UCLA developed drug and discovering a breakthrough cure. Etanercept is not a UCLA drug, and it is not a new drug. Etanercept has been on the market for about a decade under the brand name Enbrel. As mentioned already, UCLA did not play any part in this case report.
Dr. Tobinick is not some UCLA neurological researcher. He is a dermatologist and internist in private practice in a laser hair removal clinic. As mentioned, his clinic is located in the UCLA Medical Plaza, which also houses the Institute for Neurologic Research, which is the medical group that treats patients with Dr. Tobinick’s Etanercept treatment.
As mentioned, Dr. Tobinick holds several patents for this delivery method for Etanercept.
Dr. Tobinick also holds stock in the company Amgen, which is the company that owns Etanercept and markets it under the brand name Enbrel.
In the medical research world, this situation is known as a “conflict of interest.”
There isn’t necessarily anything wrong with a conflict of interest and it does not in any way necessarily indicate any sort of dishonesty or deception on any-one’s part. It is certainly not my intention to make any sort of accusation against Dr. Tobinick or anyone else.
As I mentioned above, I sincerely hope Dr. Tobinick’s research proves to be 100% accurate and that he gets very very rich due to it. I would love for anyone to bring some relief to the millions of patients and their families suffering from Alzheimer’s and I truly feel that anyone who does that deserves to get wealthy doing so.
That said, a conflict of interest demands full disclosure and demands closer scrutiny by outsiders.
Dr. Tobinick does give full disclosure of his patents and his stock ownership in the article. Kudos to him for this.
In the Daily Telegraph story however, the author and Daily Telegraph Medical Editor, Rebecca Smith, has not in my opinion exhibited such intellectual honesty, and has not given appropriate scrutiny to the article she writes about. She does not paint an accurate picture of Dr. Tobinick and his article at all.
She seems to be less interested in presenting an accurate unbiased story than in presenting a sensational headline grabbing story about a breakthrough cure for Alzheimer’s. She’s the Daily Telegraph Medical Editor????
So, anyway, enough bashing on Ms. Smith. I’m sure she’s a nice lady and means well and has a tough job to do and one I wouldn’t want.
So, what about the research and case report from Dr. Tobinick?
Has he found the cure for Alzheimer’s?
I don’t know.
Maybe, maybe not.
On the surface, the stuff he’s published seems rather fascinating and promising.
I hope that he’s truly on to something remarkable.
Unfortunately, what you and I hope…what Ms. Smith hopes…what Dr. Tobinick hopes…heck, what the man on the moon might hope…has no bearing whatsoever on reality.
Dr. Tobinick may very well be onto something here, but he also might not be. This stuff needs further investigation. In my opinion, at least some of that investigation needs to be done by someone not connected with Dr. Tobinick or Amgen.
Some specific questions Dr. Sam has:
1. What were the controls in the original pilot study? In other words, they gave this treatment to a group of patients diagnosed with Alzheimer’s and monitored their cognitive function, but did they also have a group of Alzheimer’s patients that they monitored who did not receive this treatment, or who received other treatments, or no treatments perhaps, so that they could have some sort of controlled benchmark to compare the results of this treatment against? Would the results they saw have been any different if the patients had received a placebo injection?
I didn’t see any sort of controls in the original study and I still don’t see any sort of controls when looking at the published case report.
2. Does Dr. Tobinick’s patented injection method actually offer any benefit to the patient? In other words, does it really make any difference if this stuff is injected next to the spine rather than injecting it elsewhere, such as subcutaneously on the the thigh for instance?
I didn’t see anywhere were it has been shown that this medicine actually penetrates the brain (which is where Alzheimer’s has it’s effects), whether injected by Dr. Tobinick’s method, or otherwise.
I saw one reference on the Internet of a study done in rats where etanercept was found in the cerebrospinal fluid after subcutaneous injection, but in that study there was none found in the actual brain tissue.
My suspicion is that in at least some patients, there may in fact be some delivery of etanercept to the central nervous system by subcutaneous injection. I hold this suspicion due to the fact that one of the rare potential side effects of etanercept, when used in patients with diseases such as psoriasis, is demyelination within the central nervous system. That’s just a personal suspicion however, and I have no actual data to back it up.
If Dr. Tobinick’s research is indeed eventually confirmed, and his para-spinal injection of etanercept is indeed found to benefit Alzheimer’s patients, then I think it will definitely be necessary to compare it to other modes of delivery such as subcutaneous or intrathecal (in the brain or spinal cord itself) or subdural (in the cerebrospinal fluid that surrounds the brain and spinal cord) injections to see if there is any difference.
Dr. Sam’s bottom line:
1. The Daily Telegraph is a newspaper. It is not a medical journal. Reading the article this blog post was inspired by makes that patently obvious. The news that’s “Fit for Brits” ain’t fit for medical reporting in my opinion.
2. Dr. Tobinick’s research and published article are very intriguing and seem to show some very promising results. That said, they are in my opinion far from conclusive and the topic needs further research and investigation.
3. Dr. Tobinick does appear to have some definite conflicts of interest here, which to his credit he does fully disclose in his articles. As mentioned, conflicts of interest in and of themselves don’t necessarily indicate or imply that results and conclusions should be ignored. They do however demand close scrutiny of these results and conclusions by outside investigators who do not share these conflicts of interest. Other than really really hoping to see a cure for Alzheimer’s some day, Dr. Sam is not aware of any conflict of interest he has in this issue.
Dr. Sam has done a little brief surfing of the Internet looking for further stuff related to the topic at hand and found an interesting write up in the Alzheimer’s Research Forum. Dr. Sam in no way endorses the content of that link. Nor do I in any way refute it. I simply present it to the readers for their own personal edification and leave it to them to draw their own conclusions.
To Dr. Tobinick, I say “Good luck! I applaud all your efforts and sincerely wish you the very best in your pursuit of treatments for human ailments! I hope you have great success!”
So readers, what are your feelings on all this?