Saturday, November 29, 2014

Will That Clinic Cure You (Or Your Kid)?

One thing that I am thankful for, is the relative lack of quacks and charlatans in the world of type-1 diabetes.  Sure, we have a few researchers who say "cured in 5 years", and a plague of reporters and bloggers always looking forward to amplify whatever fool thing they say.  But that is very different from the outright fraudsters who are attracted to some other diseases.  We get fewer of those.  This posting describes how to look at doctors and clinics which claim to cure/treat type-1 diabetes and decide for yourself if they are worth your money, time and energy. Although it is targeted specifically at far away clinics (especially stem cell clinics). Most of what I write here will apply very well to other treatments "too good to be true".

Far Away Clinic X Says They Can Cure Type-1 Diabetes! 
Have You Heard Of Them?

Every now and then I get a question about some clinic or doctor who claims to be able to cure type-1 diabetes.  When I get these emails, if I have time, I look into the clinic or doctor.  They are mostly the same, they take stem cells from a person's bone marrow, and then reinject them back into the person.  Although some of them inject other stuff.

The rest of this blog contains four different ways to evaluate a clinic or doctor who claims to cure type-1 diabetes:
  1. Five questions to ask.
  2. Common excuses for not having data.
  3. Danger signs.
  4. How much evidence of safety and effectiveness do they have, and how much do you need?
Five Questions To Ask

Actually, before asking any questions, search the web.  What do the patients say about the clinic? Especially, what do the people who were cured of type-1 diabetes say about the clinic?  Obviously, any clinic that can cure type-1 diabetes is going to have scores of happy customers posting to every internet forum you can imagine.  (Not just one or two, but swarms of them.)  So start by reading posting on the various type-1 forums.  How many of their customers have posted happy results on www.childrenwithdiabetes.com?  How about tudiabetes.org?

I don't know about you, but if my daughter was cured, you couldn't stop me from posting everywhere about it!  I would go out of my way to help by talking to reporters, potential patients, venture capitalists, anyone…..  Nothing would make me happier than to make the discoverer of a cure for type-1 diabetes rich.

Clearly, it is easy to post fake reviews and postings in the web, so happy customer testimonials need to be researched.  (Do they reply to email?  Did they post somewhere besides the clinics' own web page?  Did they post on type-1 forums prior to their cure?)  But if you find nothing, then they obviously haven't cured anyone, or very few people.  

After that, here are the five questions that I would ask of any person or any clinic who says they can cure type-1 diabetes:
  1. Where is your data?  I'll describe how to use this data in the next section.  But if you ask this question, and get excuses rather than data, then it's clear they have nothing.  Remember, everyone who does not have data, will certainly have excuses.   Whatever the excuses, ignore them, but do look at the data they provide.  
  2. Who have you cured?  This is pretty obvious, but in the cases I've seen, the person or clinic has claimed to be able to cure people for a long time, yet doesn't have a bunch of cured people available.  In one case, the guy claimed to have cured over 10,000 people in the last 20 years, yet not one of them had ever posted to a forum or spoken to a reporter.  In another case, a clinic claimed to have used their cure for 15 years, yet again: no forum posts, no interviews with the media, no discussions with potential new patients, no one available. 
  3. What insurance do you take? / What country's medical plans send their type-1 patients to you to be cured?  This might strike you as silly questions, since none of these guys are ever covered by insurance.  But think about it: your insurance company spends thousands of dollars every year treating your type-1 diabetes.  They are going to continue to spend that money for years, maybe decades.  If someone could cure type-1 diabetes, even for $20,000, your insurance company would be overjoyed to pay for it.  Indeed, they would likely force you to go get cured, so they could avoid paying out all the money they do now.  So this is a serious question. Taking it a step further, there are many European countries which have "single payer", or have some form of public health insurance.  In those countries, the minute someone is diagnosed with type-1, the  public health insurance knows they are going to have to pay over $100,000 over that person's life.  In those countries, they would save vast amounts of money by chartering a jet, and shipping all their type-1 patients to this clinic to be cured.  Even if the country were in Scandinavia, and the clinic in Mexico.  So why don't they?
  4. How many type-1 diabetics work for you?  They're all cured, right?  Many people with type-1 diabetes end up working in clinics for people with type-1 diabetes.  So an obvious question is, do you employ any type-1 diabetics, and have you cured them?  After all, type-1 diabetics would flock to employment at a clinic that really could cure type-1 diabetes, both to cure themselves and to cure others. 
  5. What did you do before?  In a certain sense, I don't care what someone did before they cured type-1 diabetes.  If their previous job was sitting under a bridge and eating goats, that's fine with me, as long as they have peer-reviewed data showing that they cured type-1 diabetes. However, in cases where they don't have data, or it is not peer reviewed, then I think it is worthwhile to look into what they have done before.  For example, what if a guy's previous job was "the founder of the 'Essene Order of Light', an offshoot of a New Age religion based upon modern interpretations of the Essenes, an ancient Jewish sect?" (This quote comes from the man's self bio.)  Does that make you nervous? Should it?  And don't laugh about this example, it is a real guy, Dr. Gabriel Cousens, who really claims to be able to cure type-1 diabetes.  
Common Excuses For Not Having Data

Remember, when you ask for data, and the clinic gives you excuses for not having data, my advice is not to consider if the excuses are good or not, because it just doesn't matter.  If they don't have the data, then they don't have the data.  Having an excuse is never a replacement for missing information. But with that in mind, the following excuses are common:

Privacy is a common excuse which you should ignore, for two separate reasons: first of all, you don't want to know people's names, you want to know how they did, so you are not asking for personally identifying information; second, if this clinic has cured people, those people should be overjoyed and excited about others being told about their successes.  Think about it: if a clinic cured your child, and the clinic asked if they could write up your experience as a case study, and even have you talk to future patients, you would say "yes" in a heartbeat, right?  You would want to tell others about this cure.

Another excuse, is that "no one will publish my results showing a cure".  If you get that, say, "No problem!  I'll take a look at your manuscript, I don't care if it is published or not!"  And see what happens.  Obviously, a peer reviewed article would be better, but if they don't have a manuscript, they never even tried to get it published.

A third excuse is "no one will pay for a study to show my treatment works!".  Tell them, that's fine, but you'd still like a summary of how many of their patients were cured, and for how long. No complex study, just the basic data.  And if they don't keep that, what does that say about their follow up with their existing customers?

Danger Signs

In general, I focus on peer-reviewed evidence of effectiveness and safety; the kind that comes from clinical studies.  However, when looking at treatments for my daughter, I don't ignore danger signs associated with fraud.

No matter how much or how little data a clinic has to support their cure, these signs can provide a separate warning that you are getting into trouble.  None of these prove that the clinic or doctor in question is a quack, but I've found that they are suggestive that the treatment is shaky:
  1. Do they use the same treatment to treat different diseases?  Many of these clinics (especially the stem cell clinics) treat all diseases the same.  In some cases the treatment is absolutely identical, treating lung cancer, the exact same way as heart attacks, as type-1 diabetes, as eye problems, etc.  In other cases, the treatment is identical, except that the injection is in a different place. Ask yourself: does that make sense?  Cancers are a large group of related diseases, and they are treated very differently.  So does it make sense for these guys not only to treat all cancers the same, but heart attacks and autoimmune diseases, as well?  For me, it does not.
  2. Any clinic run by, or associated with, any doctor who has lost his license somewhere else.  (If they can cure type-1 diabetes, there is no reason for them to associate with anyone even slightly "shady".) 
  3. Associating their treatment with other, different treatments that are in the news. 
  4. Associating their research with reputable organizations (often Universities), which are actually doing different research.  
For points 3 and 4: Some of the more sophisticated clinics have links on their web pages to studies that supposedly support their ability to cure people. When I have tracked down these studies, I often find that they share only a buzzword or two with whatever the clinic is doing.  So if their marketing literature uses the term "stem cells" then they will have a link to some academic research, which also uses the same term, but otherwise is completely different from what they are doing.

How much evidence of safety and effectiveness do they have, and how much do you need?

The critical question, that you need to answer before you think about a specific clinic or treatment, is how much evidence do you need?  Not just for that one clinic or that one treatment, but for all of them.  For example, the FDA generally requires four clinical trials before they will approve a new treatment.  But that's them, and you are free to choose a different level of evidence, if you want. Maybe you are OK with only two clinical trials?  Or three?  Maybe you want four clinical trials, and two years worth of real world experience, before you will use a new treatment.  These are all reasonable answers to the question.  There is no one universal answer.

Once you have your answer, and you've considered it calmly, and grown comfortable with it.  Then, you need to apply it to these clinics.  In my experience, they have almost no strong evidence that their treatments work.  So even if you have quite low standards (just two peer reviewed papers showing results, for example), they usually can not even make that low bar.  Even if your requirement is "they don't need any published papers at all, I just want to talk to five people who they have cured, one of who I find myself", my guess is that you will not be able to find them.

My experience has been that these clinics are very strong in providing reasons why they have never published papers, why they don't even have the (unpublished) data you want.  Very strong in describing why the FDA, the AMA, the ADA, and everyone else is against them.  But they are very weak in terms of data to support you giving them thousands (sometimes tens of thousands) of dollars. At the end of the day, these kinds of excuses don't even start to suggest that they are actually curing anything.

Finally, I would be very careful about clinics that claim to cure type-1 diabetes, but only provide evidence that they are "helping" type-1 diabetes.  Often these clinics will provide personal testimony from people who say things like "my son's type-1 got much better after the treatment" or "he stopped having lows (or highs or big spikes after meals) after the treatment".  If this is the kind of improvement they advertise, then personal testimonials are the absolute worst way to document it. This is the kind of results where you need to see average BG numbers, or A1c improvements or other hard data that things are getting better.  One of the good things about type-1 as a disease, is that a cure is obvious.  No one can scam a cure.  But "improvements" are easy to scam, so that is what is claimed, then data points are even more important.  (And in reality, if they claim the treatment results in better control, how can they possibly claim that if they don't have specific data showing it?)

In Conclusion

Quack doctors and clinics will always have a good story. They tell you what you most want to hear, and so can be the siren song of hope. Selling cures to people with incurable diseases is a lucrative market for them. So I hope that when you see such cures available, you will ask the questions I discuss here, and think about the data you get in response.


Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com 
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Tidepool news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

1 comment:

Valentin Andrei said...

Hi,

Very, very, very good article, congratulation! If you don't mind, I want to translate it in my language, to be available to many other type 1 people.

On the 18th of December will be two years since my son was diagnosed with type 1. Since then I continuously search for a miracle, but the only miracle discovered was your blog. I appreciate very much your work and as a parent I perfectly understand you.

Please believe me that I tried to make political lobby to open a research center in Romania, the country who actually discovered insulin 93 years ago. If no one tried to discover the cure, then what is the hope for a cure? But nothing, nobody is interested in this. And please believe me that there is no day without reading and discussing with people about this.

Anyway, regarding your post, you're are right, there are many people that are promising the cure, but they have a lot of customers, even if there will be no cure. I remember the first week and the first month. I was desperate, and I remember I heard about The Tree of Live, you know that movie, etc. I purchased the books and I was in touch with those doctors. The firs meeting was supposed to be a conf call with doctor G.C. (500USD/30'). Then, for 21 days we had to pay around 20kUSD in Israel or much more in Arizona. I was tent to agree this, but I'm an engineer:P.

So, there are many examples, another one is this girl (https://www.facebook.com/FullyRawKristina?fref=ts) who was cured by raw vegan. We are vegans, 60%raw vegan, and also my boy. I see many many improvements, even if he eats a lot of carbs, but this in not a cure, is just an improvement. Maybe when he will grow up, I don't know.

Seeing that I cannot do so much thing for my boy, I created a business since 3 months ago. The website will be ready on February. I you donate all my profit, even if it will be 100Eur or 1.000.000 Eur to the first study in Romania. I swear! :) This will be an example to the Government.

Thank you Joshua! Keep up the good work