Someone recently commented that because he didn’t derive benefits from the Pridgen protocol that it must be snake oil. That would make sense if everyone with fibromyalgia was the same – and could be expected to respond similarly to a treatment but a recent New York Times article “Can a Treatment Help Me? There’s a Statistic For That” indicates that that’s not true even for well-characterized illness.
Drug treatment even in well characterized disorders is something of a crap shoot. Sometimes it comes up aces, often it does not.
The fact is that treating illnesses – even well characterized, heavily studied illnesses – can still be something of a crap shoot. Lots of times drugs don’t work. In fact, many drugs in common use don’t work the majority of the time. Many don’t even work ten percent of the time. Some that don’t work at all are in common use.
Number Needed To Treat
Welcome to the Number Needed to Treat (NNT) statistic. The NNT refers to the number of patients needed to treat with a drug in order for one to have a significantly improved result.
Check out a website – theNNT.com that’s devoted to providing NNT data – you might be a bit shocked.
The NNT, for using antibiotics, for instance, to treat a sinus infection, is 15. Studies indicate that you need to give antibiotics to 15 people with sinusitis in order to have one person derive benefit from it. Unfortunately since 1 out of 8 people who take the drug are harmed by it the risk/benefits ratio for antibiotics for sinusitis appears to be negative. Despite the miserably low NNT number and risk of side effects, one out of every five prescriptions for antibiotics written in the U.S. is for, guess what – sinusitis.
Humans are simply too complex to expect drugs to effect everyone or even most people in the same way…
The fact that four out of five people with sinusitis given placebo’s improve presents the dilemma. In some disorders, many people improve whether or not you give them a drug. Very few people with sinusitis get help from antibiotics but because virtually everyone with sinusitis gets antibiotics and most people improve over time, it looks like it’s the drug that’s doing it. The studies indicate, though, that’s only true 6 percent of the time. Since studies are usually done on
Since studies are usually done on a select population the NNT’s given are probably lower than in real-life situations.
Despite the fact that doctors often give antibiotics to people with bronchitis the number of bronchitis patients they would need to treat in order for one person to recover more quickly from bronchitis is zero – no studies suggest that antibiotics significantly help people recover from bronchitis at all.
No less than 23 trials involving 2,000 patients indicate they don’t provide any significant benefit at all to people with sciatica (NNT=0) either. That hasn’t prevented millions of people from getting epidural shots for sciatica.
PSA tests for prostate cancer are still controversial, but this site suggests that that they’re useless (NNT=0) for preventing death from cancer and can cause significant harms due to unnecessary biopsies. (The test may or may not be helpful in high-risk patients). The list goes on and on…Antivirals look like they should help people with Bell’s Palsy, but it turns out that they don’t.
Using defibrillation, on the other hand, in a person who’s having a heart attack is very effective; it actually prevents death in one out of every 2.5 people.
Many drugs are not listed on the NNT site presumably because the study evidence wasn’t sufficient or because the review has not been done yet. None of the drugs or treatments listed referred to fibromyalgia or chronic fatigue syndrome either, but the trend was pretty clear. Even in well-defined disorders many drugs only help a relatively small percentage of patients.
Giving Drug Trials A Break
That’s why we should probably reconsider our ideas about what constitutes a successful drug trial. Should we really expect Ampligen to be effective in everyone? Should we be surprised if the Pridgen protocol doesn’t help someone? Should we hope for even fifty percent success rates with Rituximab? Given how varied the ME/CFS and FM populations are we obviously shouldn’t.
Would a twenty percent success rate be a cause for celebration? In these big disorders it probably would be.
A ten or twenty percent success rate with a drug is actually a pretty good thing. It’s why your own experience with a drug or treatment – whether good or bad – doesn’t really say all that much about how another person with ME/CFS or FM will react to it.
Probably what we should hope for is a packet of drugs, each of which help some people with ME/CFS and/or FM, and which can be fit into already existing treatment regimens. Sometimes drugs or treatments really do hit the spot and a person is effectively cured, but my guess is that that’s rare and will remain rare for some time. It’s far more likely that drugs or supplements or drug/supplement combinations (Synergy trial) will be found that are helpful – not curative in themselves – but which may provide critical components for improved health.
What Does Work?
Personalized medicine – medicine tailored to the individual, not the group – is the way out of the NNT dilemma and medicine is moving that way.
The advent of companies able to do gene sequencing for individuals such as 23andMe are laying the foundations for one aspect of personal medicine. As more genetic information becomes available the types and doses of drugs you take will be tailored to your genetic makeup and gene expression.
Personalized medicine is where many future breakthroughs in treatment lie
Perhaps the closest ME/CFS and FM patients can get to personalized medicine may simply be by seeing experts (perhaps several of them, unfortunately) who are able to use their expertise to treatments to the individual.
Importantly, this list does not say anything about drug or treatment protocols. Chronic illnesses are probably much more likely to respond to multidimensional treatment protocols designed to fit specific patients needs than to single treatments. My guess is that the kinds of protocols that encompass diet, activity management, stress reduction, supplements and drugs – that encompass everything possible, really- are probably going to be the way to go for a long time.
But, ain’t that what studies are for?
Dr. Pridgen’s study showed a huge efficacy in the majority of FMS patients.
But I spoke to a loot of people on the protocol and only one of them showed improvment.
I’m not even saying it doesn’t work, and that “speaking with people” can reflect real statistics.
But are there patients being helped by that at all?
I don’t see how you can do a study with those kind of efficacy numbers and not have people being helped. That’s why statistical studies are relied on more than anecdotal reports. It’s possible that you just happened hit on people the protocol didn’t help – that’s a statistical possibility.
Yes, I work with that possibility.
I’m in no way dismissing his work.
The only thing is: the results were really really good… I mean, totally gamechanging.
And his claims were even more amazing: 90% got a lot better and the majority who didn’t was a result of not following the protocol exactly like it should. (he says that the protocol is much more than just taking Famvir and Celebrex, for example fixing things like depression and the gut beforehand)
With that in mind:
Shouldn’t we be hearing more about it? Specially in specific places where a lot of this patients get togheter, like here… The Dr. said himself that CFS and FMS are the same illness, so the protocol is supposed to help both.
I can’t lie too that I caught myself thinking more than once if is there any possibility of a fraud (I don’t think so) or a unwell designed study?
There are two possibilities.
One is what you said, Cort, that Folk just happened to run into nonresponders.
The other is that the study is measuring something that is not relevant to patients. There are a lot of things that can go wrong in doing studies, and this hasn’t yet been replicated (I haven’t heard of it being published yet, either, but I could have missed something). We won’t really know about the efficacy until we see the data and the protocols, and the trial has been well-replicated.
That being said, the overall point of your blog that it will likely take many different treatments and looking for the one treatment to rule them all is likely far-fetched, is spot on. Thanks for writing about that!
As you said, this doesn’t even happen on a regular basis in well-known diseases which already have tests and biomarkers for diagnosis (unless the treatment is really generic also, but even then it will miss some people who won’t respond or won’t be able to tolerate it or both).
Janelle
I can’t find anything being published either and it is not being replicated in any other studies. Something is wrong here. Leaks of success and so on but no hard data in a controlled study.
I am sticking with Dr. Montoya who is using 2 drugs on some people but the names of the drugs are not being released as they do not have the results of the study yet. It is rumored they are antivirals. Plus he did the brain scans showing inflammation of the brain. I think Stanford is on the right track and Dr. Klimas has done very good work also.
The key is: PUBLISHED study results not reports of study results.
Looking forward to Montoya’s study 🙂 I think the Pridgen abstract coming from the conference will be accurate though – the same statistics will surely show up in the published study ????
Many moons ago I read that antibiotics cure in 14 days. But then most people get well in 14 days without antibiotics anyway.
As to CFS/FM, surely they are Syndromes with multiple symptoms and varying degrees of severity for each person. Not everyone has all the recognised symptoms of each health condition, so surely it’s only logical that no one treatment is going to cure all. I, personally, don’t believe there is ever going to be one single treatment for any medical condition. Ever.
Until orthodox and alternative practitioners are willing to go beyond their education and experience and be open and receptive to this idea, then complex medical conditions are going to continue to perplex the Majority.
Why do some people die of Cancer and others (with the same type of Cancer and treatment) recover completely?
The issue for me is that drug approval would signify a change in direction for how ME is viewed and treated. Having treatment options gives hope for many people and that’s coming from someone who doesn’t generally respond well to medication. If Rituximab or Ampligen ever get to the stage where they are approved and rolled out, then ME will be viewed as an immune-related illness, not a psychological disorder with physical symptoms put down to deconditioning.
For sure it would help. After seeing fibromyalgia get approved for three drugs and finding some practitioners still thinking it’s all in FM patients heads – I think it will take time no matter what happens with drugs.
That said, FDA approval of an immune oriented drug would, of course, be a huge step forward…Let’s hope it happens..
A major problem is the class of the aproved drugs.
They’re not “Anti-Fibromyalgia”. Two of them are anti depressants, wich makes us hear “See? FMS is so psychological it is treated with anti-depressants”.
I know I’ve heard that enough at least… And sadly not from uneducted people, from physicians….
The ‘antidepressants” are actually being used to reduce pain – not depression. Studies indicate that they help FM patients witihout depression reduce their pain.
Many drugs have unexpected uses when used in different groups and many drugs have been “repurposed” to unexpected uses. Using Rituximab to treat either cancer or autoimmune disorders is a good example.
Yes.. I know that. What I meant is that the simple fact they’re called “anti depressants” is enough to create that confusion therefore reinforcing what we’re trying to end.
Agreed – unfortunately they were called anti-depressants before their anti-pain properties were uncovered.
I’ve been seeing that 23andme advertised for years now and I’m always so tempted to do it but today I decided to “Google” it and read more about it and I found this article in Scientific American and it’s good to see another take on it. http://www.scientificamerican.com/article/23andme-is-terrifying-but-not-for-reasons-fda/ Even though that ruffles your feathers on it and makes it sound a lot less tempting, it’s a Catch 22 because doing those big efforts is what brings the big discoveries that can help untold numbers of people with many different problems, but the tradeoff is the invasiveness of the system of that discovery. I think generations from now will ask “what does privacy mean”?
Until the full truth comes to the forefront in this illness including related auto immune conditions no medicines will help unless they find a treatment for ‘internal ionisation rdaition injuries’ broken cromosones with translocations all the websites about this research study or that one will go
absoluteky nowhere plus the fact we are dealing with the biggest frauds in history it’s called Rockefeller’s medical Cabal system we can go on & on & on about ebv cmv hhv6 hsv1 sycope autonomic dysfunction POTS Lyme Mold all ‘labels’ thrown at patients from fraudulent Quack
Doctors including P.T.S.D. & on top of all this they have the Gall to say G.E.T./C.B.T. works another scam to fraudulent take millions out of taxpayers funds…There are 2 ways to deal with these issues & Gail Kanky’s team is now proving this actual cause which will come out of
Private funding & last filing Private Commercial liens in the millions in damages for the cover up against the N.I.H./C.D.C. & other frausd artists involved…This is the way forward ‘the only way forward’
Hi, interesting stuff posted. Agree that it takes multiple meds to tackle this issue. I don’t understand how one med can help me with my migraines and IBS.Soreness also would take something different. I.E. Gabapentin
Cort can you please add me to the blog.
Will do