The NIH study needs patients (from Brian Vastag)

The NIH is many people and many groups. I don't think we can lump them all together saying "they" want to or don't want to help. From my experience as a patient in this study, I felt that the people involved in the study that I met definitely wanted to move us forward and be as helpful as possible, but proper research requires certain steps and certain sequences to be followed, so it will not be as fast as most of us wish for.

 

This is only the first step. From my conversations while participating in the study as a patient, as long as they find useful data, they would try to study other sub-groups later on, such as more severe patients, etc.

 

Dr. Walitt was definitely there for both of my study visits (November 2018 and April 2019). I have great respect for him and felt truly cared for by Dr. Walitt and the staff.

 

I participated in this study and very much agree with Brian Vastag's opinions here. Thank you for participating and speaking out about this important study. We will make progress together!

 

Right. Sigh.

 

A healthy volunteer in the study made several very short clips during his stay.







... and many more.

You can find them on the Solve Twitter account: https://twitter.com/PlzSolveCFS

 

To facilitate sharing:

 

This should be reposted time and time again!

It is completely above me why they after what, one year, still have not enough patients for this study, that is the dream for every moderate patient in my view to figure out what is going on!

Please repost this everywhere, also OMF and ME Action should post this, as well as Healthrising!

@Cort @JenB

 

It has been posted repeatedly. Vastag is the husband of the co-founder of ME Action. I think that the difficulty of obtaining diagnoses may contribute to the difficulty in finding people who have been sick for less than 5 years. By the time that people are diagnosed, they are often outside of the time window.

I believe that they will get enough patients for the study, but it’s not easy.

 

Thank you, still, I am quite active online, you are not hearing enough from it if you ask me. (of course nobody does )

 

It may be difficult to find participants for a study that are fairly ill that could be crashed and worsened by a study like this, without paying them (on top of travel expenses, etc). Especially with the lack of trust the patient community may have for the NI . Yes we are all willing to sacrifice anything for great scientific advancements but many of us may be skeptical that our personal sacrifice would even be proportionate to the dent it would make in the scientific ignorance of this illnes . The cost benefit needs to make sense. When people participate in cancer clinical trials they often get both a) the sense that they are contributing to speedy, cutting edge research, and b) a possibility of recovery.

Since we dont have clinical trials of much value for this illness, the NIH should offer pay to participants , beyond the stipends for travel, etc.

This is an example of where adequate funding could speed up the process greatly

 

I do think that it is important to note that all of the patients that I know of who have participated in this effort have found it to be a positive experience. If I were in the range of the cohort being studied, I would not hesitate to participate. This is an unusual opportunity - NIH doesn’t do these kinds of internal studies for most diseases. I hope that it gives us information that we might not have without the unique investigatory methods that NIH can employ to dig into this disease.

 

An important update that I have confirmed with Angelique Gavin, the recruiting coordinator.

Foreign (non-US) patients with medical records in English, French, Spanish, German or Russian are eligible for participation in the NIH intramural study. The NIH has a record translation service that will translate documents in these languages provided by applicants.

Foreign patients will be compensated for their participation, but their travel fees will only be reimbursed for travel inside the US (from the first point of entry). For example, if you fly from London to New York (JFK) then from JFK to the national airport in Washington DC (DCA), you will be reimbursed for the JFK-DCA round-trip.
With this being said, I know of one Canadian patient who will have their Vancouver-Dulles round-trip reimbursed, as it's not much more expensive than a domestic US flight.

Below are screenshots from the mail exchange I had with Angelique.

About foreign participants. Note that we talked about the travel fees on the phone after this mail, which is when she told me about reimbursement for US domestic travel.



About the language of medical records



I have applied to the study. I had a phone interview with Angelique yesterday and I'm now waiting for a call from Dr Wallitt.

 

Great. To facilitate sharing:

 

Thank you so much for tweeting this Tom! I really hope it will reach eligible patients, especially in the UK and in Canada since patients there won't even need to wait for their medical records to be translated.

 

I have applied for the study twice (by email) but have heard nothing back. Can you please tell me how you applied / provide me with a link to a working email address? Many thanks.

 

The study isn’t designed to be open ended. The original study design was for a three year period. I wouldn’t expect the most severely ill to participate, but in my opinion they are probably not the best candidates for this cohort anyway. Being bedridden and trying numerous treatments cause physical changes that could distort the results.

There are, of course, no guarantees that significant findings will come from this study, but if they don’t, with every possible technique NIH has being used to look at these patients, that will at least be an indication that we may need to rethink what we believe about this disease and go in a completely different direction.

I probably mentioned this before, but when this study was first announced, Dr Nath spoke here in Atlanta at CDC. Although I don’t get around easily, I was determined to see him eye to eye. As you may have noticed, I’m a fairly skeptical person and I wanted to see whether he was a reliable scientist.

I talked with him and was very impressed by him. ME/CFS is not his specialty and he doesn’t want it to be. He was asked to do this study by Dr Collins. But he was excited to see what he could find out. Nothing that I have seen makes me think that he is anything other than a world class scientist doing a careful and thorough study.

 

Angelique's contact details are:

Angelique Gavin, angelique.gavin@nih.gov, (301) 496-4000 (this is the number she called me with).
Alternatively you can try: mecfsemail@nih.gov, and one of the following phone numbers: (301) 496-1788, (301) 402-0880.

I hope this helps, please let me know if you're able to reach her. Otherwise I'll let her know and ask her for her most up-to-date contact info.

 

Many thanks - I’ll certainly keep you posted