Thursday, 10 September 2015

ClinicSpeak: unproven MS therapies

Beware of Quack doctors and unlicensed treatments. #MSBlog #ClinicSpeak

"At the MS Roadshow one of the attendees asked about whether or not I would recommend faecal transplantation as a treatment for MS. Apparently there is a clinic in the Southern Hemisphere providing this treatment to MSers at considerable cost. The scientific rationale for faecal transplantation is that the bowel flora (bacteria mainly) in MSers are responsible for driving inflammation and triggering MS. If we semi-sterilise the gut (clean it out with antibiotics and lavage) we can then replace your bacteria with good bacteria from someone who does not have MS. The problem with this hypothesis is that it needs to be tested. The science behind the microbiome and its impact in MS is in its infancy. Therefore any doctor, or clinic, offering faecal transplants as a treatment for MS, and is charging you for it, is simply ripping you off. Adjectives like Charlatan and Quack come to mind. The only place for faecal transplantation in the treatment of MS is part of a well-designed, ethically-approved, clinical trial. If you did volunteer for such a trial you should not be going out of pocket. Some unscrupulous medical practitioners sell their wares under the disguise of research, and make you pay for being part of their research project."


"Interestingly, Mouse Doctor predicted several months ago that it would only be a matter of  time before faecal transplantation was being peddled as a treatment for MS. How right he was! When it comes to predicting trends and outcomes of clinical trials he is much better at it than me."

"The perspective paper below in this week's New England Journal of Medicine takes the unlicensed stem cell clinics in the US to task. It is worth reading this paper as the issues it raises around unlicensed stem cell therapies are identical to those in relation to faecal transplantation and other unlicensed therapies."

"One argument that MSers supporting these therapies have is 'I have this awful disease and even if this treatment hasn't been shown to work then I am prepared to take the chance. After all it is my body and not yours and it is my money not yours'. These arguments at an individual level seem logical and fine. However, at a population level they cause all sorts of problems. Firstly, a large number of these off-license treatments have risks, some of them very serious risks. It is one of our responsibilities (healthcare professionals) to protect you from harm, or at least try and mitigate harm. With an unlicensed therapy we can't balance the risks and we have no idea of the effectiveness of the treatment. The money spent on some of these treatments could be better spent on other things. One of my patients who was medically retired because of his MS, and reasonably well off, spent close to £80,000 on repeated treatments to unblock his jugular veins in a clinic in Hungary. He was told he needed his jugular veins treated every 3 months. He simply couldn't afford these treatments; he has now had to sell his house and has had to drastically change his lifestyle. He will be spending the remainder of his life in relative poverty."

"Please be careful about therapies that are not licensed and the motives of those selling them to you."


Taylor-Weiner & Zivin. Medicine's Wild West — Unlicensed Stem-Cell Clinics in the United States. N Engl J Med 2015; 373:985-987.

Excerpts:

..... Although stem-cell therapy may hold great potential, the field is less advanced than the public has been led to believe. Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers.....

..... The FDA has approved few treatments involving stem cells. The approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system....


...... Since insurers don't cover unapproved stem-cell treatments, patients pay out of pocket for procedures that cost anywhere from $5,000 to $50,000....

..... Apart from directly harming patients, the activities of unlicensed clinics could hinder advances in the stem-cell field, if a tragedy resulting from unapproved treatment makes the public and regulators suspicious of stem-cell technologies in general......

....... In recent years, the FDA has issued warning letters and audited some stem-cell clinics to enforce the rules for stem-cell treatments .......

...... Although it's difficult to determine the number of unlicensed stem-cell clinics in the United States, there are strong indications that the FDA's actions to date are insufficient to enforce its regulations. ......

....... New policies are clearly needed to prevent for-profit human experimentation and protect patients......

....... The FDA can address the proliferation of clinics selling unapproved treatments by first establishing clear guidelines defining what procedures physicians may not perform in the absence of regulatory oversight. Then the agency may need to change its procedures for identifying and penalizing clinics that are out of compliance......

...... The FDA might increase its enforcement capabilities by coordinating with state medical boards, which have authority to revoke the licenses of physicians performing these procedures. By sharing the results of its investigations, the FDA could make it easier for these boards to penalize doctors who are defrauding patients. The added risk of an audit by a medical board might even be enough to discourage many physicians from offering unapproved procedures in the first place......

...... The Federal Trade Commission (FTC) may also be able to help reduce the misinformation in stem-cell-clinic advertising. Although clinic websites say the therapies are not FDA-approved and not proven to be effective, they suggest the procedures are based in scientific research and that there's hope for curative outcomes..... 

....... In other health care areas, the FTC has worked in coordination with the FDA to combat such deceptive advertising — for example, filing complaints challenging claims made by the supplement industry...... In regulating dietary supplements, the FTC has extensive guidelines regarding the amount and quality of evidence that must be collected before a claim can be advertised. It may be able to write similar guidelines requiring stem-cell clinics to consider the totality of the evidence, rather than individual studies, before making claims about a treatment's chances of success......

11 comments:

  1. Is Vitamin D3 not licenced for MS? I´m taking 10.000ui without medical prescription I fell better. VitD is cheap and safe.
    Why wait more time for fluoxetine? Neuroprotectant cheap and safe.
    MSers should research a lot.
    MS doctors are too cautious and fearful with cheaps and safes medicines but very confortable with harmful immunosupresives licenced DMT with risk of development PML. It´s my opinion.

    ReplyDelete
    Replies
    1. So are you going to have a fecal transplant?

      Delete
    2. No, i don't like the smell.

      Delete
  2. I do a fecal transplant everyday. First I eat and then about six hours later I have my transplant.

    ReplyDelete
  3. I'm off to the barber......leaches and blood-letting are the next big therapies - just wait and see.

    ReplyDelete
    Replies
    1. Probably as effective as "Liberation" therapy.

      Delete
    2. Leeches and blood letting were considered viable therapies 200 years ago. In 200 years from now what will they think of Lemtrada?

      Delete
    3. Good in its day but hopefully in 200 years MS will be a thing of the distant past.

      Delete
    4. Leeches are still used in medicine today; they help revascularize reattached fingers and one of the anticoagulants we use comes from a leech.

      https://en.wikipedia.org/wiki/Hirudo_medicinalis

      Delete
  4. Until MS researchers come up with an effective drug to stop or slow down progression, people will continue to do this.It is purely of sheer desperation.
    You know how hard it is watching your body waste away when you are still in your 30's 40's. Losing the use of your legs, cognition, vision.
    Even the most rationale people will think about doing this, why not. There might be 1 in 100,000 chance it might work, but I at least I will try.
    We have known about the disease since the early 19 hundreds and there is still jack in the market for people with PMS. They don't have time to wait until an effective treatment is out

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.