This Is MS Multiple Sclerosis Community: Knowledge & Support

[Anecdote]

Will anyone currently trying antibiotics, whether minocycline being used as an immunomodulator, or the full-blown treatment, please post updates in the regimens section? whether good, bad or no change. It would appear at the moment that it is only Byron's girlfriend and myself trying the complete treatment, Wilson on minocycline and Karrie who decided it wasn't for her. I know there are more, but it would seem we are the only ones.

Please!!

Sarah

[Anecdote]

It only needs to be a few lines, not a complete life history!

Sarah

[treez]

Anecdote,

I've asked this same question more than once and only got the same three responses...........including yourself. I know there MUST be more.

Update on Neuro visit to come soon......only have a few minutes right now

Treez

[Anecdote]

Thankyou Robin the Raven! (See regimens section.)

Sarah

[Anecdote]

More, please!!

Sarah

[coach]

After reading David Wheldon's paper on Chlamydia pneumoniae, which I think is very credible research, I'm personally convinced that a try with the antibiotics is worth it. The problem in the U.S., or at least my experience so far, is finding either a PCP or neurologist that will take the time to read the research, and then have a trial run with the antibiotics. I think one could possibly find an open-minded PCP or neurologist somewhere in the U.S. that would give the minocycline or doxycycline a try but I think one would be hard-pressed to find one that would give the antibiotic combination a try. The PCP's are intimidated by this being outside ther realm of expertise and the neurologist like to sing the siren song of the ABCR drugs If one gets some relief from the nagging life-altering symptoms of incredible fatigue, mental fog, etc., why wouldn't a doctor seek to help a patient in this way? It may not be the cure, but it should could improve the state of affairs for one who suffers from the disease. All this to say that the difficulty one may encounter in obtaining the antibiotics to try against MS may explain the limited number of posts on one's experience with the antibiotic regimen. Just a thought.

As one of our members had posted previously, if anyone knows of any open- minded neuro or PCP, please post the information on this site. I feel that many of us woud be willing to travel for a consult. Another option I suppose is to try to get into the study at Vanderbilt. So does one just call up and say I want to be included in your study?

Odd duck, how did you get an appointment there? I read your post about your appointment as well as some of your other posts and find them very interesting. You go girl!

Perhaps a letter writing campaign to newspapers across the country might attract some attention to the problem MSers face when looking for alternatives to the ABCRs which, according to Phillip's post on the Ch. pn. thread about a private conversation he had with his gf's neuro and according to an earlier editorial by Finn, lack proof of efficacy. Their cost versus their effectiveness leaves a lot to be desired in my opinion. Also, perhaps some of the high-profile people that suffer with MS, i.e., Neil Cavuto and Montel Williams, would be interested in this information and this web-site. I do think this web-site offers information for the scientifically minded of which I am one having received a B.S. in chemistry in college. I grow a little weary of the medical community thinking that sometimes we are intellectually challenged.

Well I have vented my frustration with the neurologists pushing one toward the use of the ABCRs and the PCP's seeming unwillingness to "think outside the box". Maybe it is the fear of lawsuits. Any chance that insurance companies that pay for the high-priced ABCR's might be interested in a lower- cost alternative?

[Daunted]

Coach,

I emailed everyone at Vanderbilt and asked this exact question. There may be an opportunity to be in a study if you have clinically definite MS and are willing to perhaps be prescribed a placebo. Contact them, I think it is Dr. Moses doing that particular study.

If you don't want to be in a study and would just like a neurologist to prescribe you antibiotics, good luck- Vanderbilt will be of no help, even though interesting research has originated there in the past.

I just heard that Dr. Stratton, the microbiologist I think? who has been on some of the cPN papers, is working on patenting his anti-chlymadial drug combinations as well as the diagnostic technology as well...? It doesn't surprise me but it does dissapoint me that he's more interested in getting rich than helping people; I emailed him and he never wrote back.

[OddDuck]

Sorry, Coach, I somehow didn't even see this question to me that you posted!

I got my appointment with Vandy (Dr. Moses) from a referral from my PCP. That's the only way you can get in to see them. By referral from another doctor.

Vanderbilt DOES have a link on their website for anyone to volunteer for any of their clinical trials or studies. They are always asking for volunteers. As a matter of fact, when I was there a couple of weeks ago, I even picked up one of their pamphlets they publish that asks for volunteers.

And yes, on another thread on this Board somewhere, we talked about how even Dr. Sriram himself won't prescribe the antibiotics. Their research isn't panning out completely like they had hoped, is my understanding.

Remember, also, that the FDA has some regulations about off-label use of drugs. Mind you, a physician DOES have some leeway in prescribing drugs for off-label use, but what we are referring to in this situation is a physician prescribing an antibiotic as an MS "therapy", not for symptomatic relief. There is nothing out there yet that substantiates that the antibiotics in MS are good for anything BUT possible "therapy". That's the Catch 22. A physician would be hard pressed to prove that they had prescribed an antibiotic for "symptomatic relief" in MS. That's where it gets sticky.

Especially recently, in light of the Neurontin fiasco and promotion of off-label use of drugs. Again, physicians will prescribe drugs for off-label use for "symptomatic" relief if there has been some substantiating evidence that they can rely on, but NOT as therapy. I know it appears to be only a slight difference to a layperson or the patient, but in legal terms (and malpractice terms), it's a huge one.

You may find some doctors willing to take the chance, of course, but I think (especially in the U.S., due to the FDA, malpractice lawsuits, etc.) you will find more who will not.

Deb

[Daunted]

OddDuck, I don't want you to think I am just chasing you around the threads trying to argue with you...even though it may appear that way! But I wanted to respond to this and I think these issues are important.

I don't know if it is true that the antibiotic research "isn't panning out", I think it is more accurate to say that they are still doing trials, and there has been some difficulty with recruiting patients and so forth, especially in light of what is considered relatively effective therapy, that of the ABCR drugs.

I had contacted Vanderbilt a while back and they had said that if I was interested in being in an antibiotic trial, that was a possibility, and the protocol would likely include an LP to look for cPN. It was going to be funded by the NIH and was starting sometime next year. So I don't think it is a matter of "not panning out" but just that further research needs to be done.

If anyone on-line is confirmed clinically definite MS and interested in participating in a trial next year, especially if you live in the TN area, I would encourage you to contact Vanderbilt. They were very courteous. It was, though, a placebo-controlled trial.

As far as off-label prescribing, I think the information you are passing on is incorrect- the Neurontin fiasco was about the PROMOTION of Neurontin for off-label uses, which IS regulated by the FDA. But it had nothing to do with the legal right of doctors to prescribe it if they thought it was clinically warranted.

To my knowledge the FDA has no authority allowing them to tell medical doctors what they can and cannot prescribe; if you are a medical doctor, you can prescribe whatever you want. I can tell you that in a few speciality fields where I have worked, they have definitely thrown anything they wanted to at certain diseases, and not just for "symptomatic relief".

When I told my GP I had suspected MS he offered to prescribe me a statin when the diagnosis was confirmed, based on the studies he had read- obviously that's an off-label use that is not for purely symptomatic relief, but for treatment of the underlying disease.

Now HMOs DO regulate what doctors can prescribe in their own way. And many doctors are worried about liability and thus wouldn't prescribe antibiotics, fearing that they'd be dragged into court after an iatrogenic injury and they'd have to explain to the jury that they prescribed them after reading some material on the Internet. And indeed that would be a difficult case to make to a jury.

However, if there some peer-reviewed scientific journal articles out there- even a couple- I think you would see doctors who were willing to prescribe antibiotics. I was encouraged to hear that Dr. Wheldon is working on this very issue right now. With a succesful trial or two, especially NIH funded, I think all of us would have an easier time with our doctors and this (now) outside-of-the-box antibiotic treatment.

But for now, the situation is that the doctors are legally allowed to prescribe us antibiotics, but choose not to, largely because of liability issues, I suspect (and as you said, as well).

[Anecdote]

Daunted, very true, he is, and the co-author is Charles Stratton of Vanderbilt. I haven't forgotten to let you know when it comes available.

Deb, as far as the research 'not panning out,' what Daunted said is quite correct: first you have to get the people willing to take part in the trials and stick with them. This they have always found to be a problem. Unfortunately the trials have to have a placebo arm, which adds to the difficulty of finding suitable candidates. Don't blame Vanderbilt for that: it is a requirement for funding.

Daunted, as far as patents go, I suspect that Stratton's patent was drawn up to establish intellectual originality; it may have been required by the University. It is not uncommon in the US for research laboratories to require that new developments be patented as a condition of employment. It kind of seals 'intellectual ownership', and ensures references to the inventors and their institutions. I doubt that it would be practicable to patent combinations of antibiotics which have been in common use for over thirty years, which can be prescribed by any doctor. Patents have not, as far as I know, been exercised on other antibiotic combinations, for example in tuberculosis, or in AIDS, but the patents exist: do a google search.

Sarah

[Daunted]

I don't know Dr. Stratton personally and for all I know, he is a great humanitarian- he is certainly an important researcher. But he's also the co-owner of a pharmaceutical company (since 1996) and therefore obviously interested in profiting off of his work.

Now maybe this is a great thing, because maybe this will speed the research process and lead to better treatments, quickly- as profit-driven markets often do speed things up. But, since it has been almost 4 years since this all began, I suppose the opposite could also be true- might this not slow things down as opposed to just making the information public domain so that other researchers might utilize it?

I guess (especially) since I'm aware that academic medical professors/researchers are hardly poor, I worry about the latter. That being said I'm glad he's working with your husband I look forward to hearing about the paper- I know there's a lag between acceptance and publication, but I've also seen my share of in-press papers distributed once they are accepted.

I'm sure you've seen this quote before-

Jonas Salk, asked after he'd developed a polio vaccine in 1955 who owned it, answered: "There is no patent. Could you patent the sun?"

So, while Dr. Stratton may indeed be required to patent his inventions per University policy, he's certainly not required to start his own pharmaceutical company, and I'd be quite curious about whether this will facilitate or retard the introduction of detection tests and/or treatments for cPN.

Below I've copied a news blurb about his company: (from *2001*)

Merlin Receives Investment From Vanderbilt University Chancellor's Investment Fund

Boston, Massachusetts, April 18, 2001 - Vanderbilt's Chancellor's Investment Fund (Nashville) increased Vanderbilt's equity position in Merlin Technologies, Inc. (Boston), an early stage pharmaceutical company, through an investment package totaling more than one million dollars. G. Mick Stadler, Managing Director of the Vanderbilt Fund, joined Merlin's prestigious Board of Directors. Merlin's Directors include Walter Gilbert, PhD, Nobel laureate and former founding CEO of Biogen, Barry Eisenstein, former Lilly executive and current VP of Science and Technology at the Beth Israel Deaconess Medical Center, and Raymond Baddour, PhD, former chemical engineering chair at MIT and co-founder and former director of Amgen.

Merlin also received exclusive worldwide licensure of Vanderbilt intellectual property covering the diagnosis and treatment of certain bacterial stealth infections. Stealth infections, especially persistent infections by Chlamydia pneumoniae, have been linked to heart disease, multiple sclerosis and many other deadly ailments. Vanderbilt researchers Charles W. Stratton, MD and William Mitchell, MD, PhD, and Boston biotech entrepreneur, Gary Magnant, co-founded Merlin in 1996.

Merlin's CEO, Chalom Sayada, MD, PhD called the deal "a key milestone for the Company. The addition of Vanderbilt's intellectual property to our portfolio gives Merlin the most comprehensive pending patent coverage of its kind in the world. The detection and treatment of Chlamydia pneumoniae and the chronic diseases induced by this organism are broadly covered, and will enable strong strategic partnerships with large pharmaceutical companies."

Mick Stadler concurs: "We are pleased to back this exciting early stage company. In addition to a refreshing, profit driven business model, Merlin has assembled a world-class management team and board of directors. We expect Merlin to grow rapidly and prosper."

Merlin is an early stage pharmaceutical company based in Boston. The Company is focused on the detection and treatment of stealth infections, and the chronic diseases that they trigger. Merlin expects to enter clinical trials this year with its first antibiotic new chemical entity.

The Vanderbilt University Chancellor's Fund is based in Nashville. The Fund invests in early and seed stage opportunities in biotechnology, information systems and other building blocks of the new economy.

Merlin's corporate backgrounder is available upon request.

[Anecdote]

I've certainly seen the Salk quote before, but remember that this was 1955, way before either of us was born. The world has changed since then. Whether for the better or the worse, that must remain a personal opinion.

Whatever one might think of the reasons for Stratton and Mitchell co-founding Merlin Technologies, the fact remains that they have developed the best detection test for the notoriously elusive 'stealth pathogen' C Pn and this may be used by any laboratory in the world which chooses so to do.

Any treatment stratagem can easily be found on the internet: there is no big secret here.


The main thing that has slowed down any research is the reluctance of people to end up in the placebo arm of any double blind trial which shows such promising results before it has even started.

Sarah

[Daunted]

You are certainly correct that the world has changed, and I am imposing my own values- but I've met too many doctors who are hardly altruistic, so I'm a bit of a skeptic, I admit, at least as far as motives.

I wasn't aware that the test he developed was so valuable- is it recommended for those with MS? I had read that cPN was so difficult to detect that empirical treatment was recommended in lieu of being tested (and therefore withholding antibiotics if the treatment was negative).

To further the discussion a bit- yes, treatment strategems may be found on the Internet- as in your husbands paper, which is quite valuable, and eventually I am sure in peer-reviewed publications, which will be invaluable, if this approach does indeed have as much promise as you (we?) think.

But (and perhaps this is incorrect) I had read on the Internet that Vanderbilt was remaining very close-mouthed about what exact antibiotics they have used with their patients- and you have to wonder why...? Or have the various regiments been published in peer-reviewed journals and I just haven't come across them?

There was some website where the guy contacted patients and asked them what regiments they had been on- but it looked like self-report and rumor, mostly, and not like the physicians at Vanderbilt had been interested in disseminating the information- which again, if true, makes me concerned.

[OddDuck]

Ok...as far as the research not panning out, I said that was only to my understanding (purely based on what one doctor - not my neuro, though - indicated to me personally). But I agree, he might not know what he's talking about. He's only an Associate Professor at Vandy himself, and not directly involved in the research study personally. (I live in Nashville, and my neuro is at Vandy.) As you say, it IS only heresay. That's why I said "to my understanding". I wasn't stating it as a concrete fact. I will say, though, that being right here in Nashville, we do tend to hear different things.

As far as prescribing off label, I never said doctors couldn't. I was talking in a "legal" context. If they DO take a risk of prescribing something that they cannot at least show some substantive evidence for doing so, IF they get sued [notice I said "I know it appears to be only a slight difference to a layperson or the patient, but in legal terms (and malpractice terms), it's a huge one."], if they can't show something supportive as to why they gave something to someone for "therapy" without any kind of backup, they could literally go down completely. (My previous neuro discussed how he had personally seen two of his colleagues go down for less.)

I'm speaking as a 30 year paralegal from a litigant's side only. Right now, with malpractice lawsuits at an alltime high, most doctors are more hesitant than ever to take even calculated risks. Right now, their malpractice insurance is almost unaffordable for them. But as I said, you will find some who will.

And the FDA does have guidelines to physicians regarding off-label use of drugs. See http://www.fda.gov/oc/ohrt/irbs/offlabel.html. In effect, the FDA is saying they can do it, but if they get into any type of "situation" regarding it, the FDA won't back them in court. That's the bottom line.

I quote an excerpt:

"Off-Label" and Investigational Use
Of Marketed Drugs, Biologics, and Medical Devices

"Off-Label" Use of Marketed Drugs, Biologics and Medical Devices

Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight. ...."

I apologize if I wasn't clear enough with my previous post.

Take care!

Deb

EDIT: And when did I "blame" Vanderbilt for anything? My medical care is DONE at Vanderbilt. LOL

[Anecdote]

Sorry Deb, I didn't mean that to sound as it does. I should have divided the paragraph up better, but I am suffering from a horrible stinky cold at the moment, so blame it on that! I know you don't blame Vanderbilt for anything.


Quote from Daunted:

I wasn't aware that the test he developed was so valuable- is it recommended for those with MS? I had read that cPN was so difficult to detect that empirical treatment was recommended in lieu of being tested (and therefore withholding antibiotics if the treatment was negative).

The test developed at Vanderbilt and now used at many other centres is primarily for detecting C Pn in the CSF, so logically it must be primarily for MS use. Any centre using another method will find detecting C Pn very difficult. If you don't want a lumbar puncture, you can be tested for antibodies in the blood serum. With an acute infection this can be very high, but with a long term chronic infection it can register as very nearly undiagnostic. Especially if the chronic infection is hidden away in the brain. This is where empirical treatment comes in.

In the last Vanderbilt trial they used rifampicin an amoxycillin, primarily because they had no immunomodulatory properties, whereas the tetracyclines and roxithromycin do. Doing this, any improvements could not be attributed to immunomodulation.

Sarah