Tag Archives: technology

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MAGIC Mitochondria (and more)

Hello and welcome back to my podcast.

My name is Eric Valor and today I have a few different subjects to cover. I will cover the new ALS treatment recently approved by the FDA, the latest message from Hope Now For ALS, MAGIC in yeast cells, and trouble for stem cell therapies.

But first, I would like to make a personal announcement. Some of you may already know this, but I was recently accepted to the Academy of Neurology as a researcher. It’s not a huge deal but it’s nevertheless something I am proud to have on my CV.

ENV AAN Cert

Now, to business. My first item on the board is the first drug to be approved for ALS in 22 years.

In May of 2017, the FDA approved edaravone, also called Radicut or Radicava, for use in the United States. Edaravone was developed and originally approved for use in Japan in 2001 for protection from the effects of a type of stroke. Its MOA, or method of action, is as a scavenger of free radicals. These molecules have an unpaired electron in one of their atoms, making them extremely reactive with other molecules. The radicals at subject are called reactive oxygen species or ROS, produced as a byproduct of the mitochondria creating energy for the motor neurons. These molecules, when not properly controlled, cause significant damage to cellular structures. There have been many attempts to eliminate these ROSs as a treatment for ALS, but all previous attempts have failed.

There are some side effects resembling allergic reactions, from redness and itching up to anaphylaxis, which requires immediate emergency medical assistance or the person can perish). The incidence of serious adverse effects (SAEs) was low, with the most common, dysphagia or difficulty swallowing, occurring in 12% of patients. Milder adverse events occurred at the same rate as placebo.

Edaravone Adverse Events

The dosing regimen is 14 days of one infusion per day of 100 milliliters administered over one hour followed by 14 days with no infusions. Subsequent cycles are 10 days of infusions followed by 14 days without. Edaravone showed up to 33% slower progression in patients who were fewer than 2 years post-diagnosis, were still ambulatory, and could still feed, dress, and bathe themselves. Three out of four clinical trials of edaravone for ALS failed to meet clinical endpoints, but the fourth, when restricted to the PALS described previously, met its endpoints. What that means is that it seems effective only in people very early on in progression.

The second item on the agenda is the recent update which Hope NOW for ALS posted about its activity. On May 10, 2017, HNFA released a statement describing their May 1, 2017 meeting with key officials at FDA CDER. The statement also mentioned the approval of Radicava and how it is the first drug approved to treat ALS in 22 years. The main point of the HNFA statement was to indicate willingness by the FDA to consider updated clinical trial methods to make clinical trials more accurate and humane. It’s a hopeful message and indicates, along with the new approval of a treatment for ALS, that the FDA may be really changing how it sees and deals with life-threatening or fatal conditions.

ALZ Forum Logo

Third, the ALZ Forum has a nice article on mitochondria making MAGIC. In a study published in the March 1st edition of Nature, a team from Johns Hopkins University describe mitochondria in yeast cells untangling misfolded cellular proteins before tearing them apart for recycling the components. The process was termed “mitochondria as guardian in cytosol” or MAGIC. Aggregated or misfolded proteins which become tangled in each other are known to be torn apart in cellular machinery called proteasomes. Without mechanisms for breaking down these aggregated proteins they would clog the entire cell like the white of a boiled egg. You can see the same process happen as you fry your breakfast in the morning. That would be very bad for the cell and ultimately us.

In MAGIC, these same aggregated proteins are imported into the intermembrane area, a small space between the outer and inner membranes of the mitochondria. There the proteins are untangled from each other, then passed into the inner mitochondria where the individual proteins are chopped up. When heat shock proteins in the cytosol of the cell aren’t working properly this puts more stress on the mitochondria which are already very hard at work creating energy for the neuron. Think of it like hauling a heavy trailer up a mountain road in your car. Your engine strains under the load, getting hotter and pumping more smoke out of the tailpipe. The “smoke” from the mitochondria is the ROSs. The authors further reported that this process also happens in human cells. If those holds true then it would tie together two critical factors of neurodegenerative disease: protein aggregation and mitochondrial dysfunction. That’s would be an important finding as it would further elucidate the mystery of ALS, Alzheimer’s, and Parkinson’s.

In another story, again from the ALZ Forum, it appears that significant efficacy differences exist between clinical-grade stem cell lines and their research-grade counterparts. The differences may explain why some clinical trials fail. Two studies in the February 14 edition of Stem Cell Reports (study 1 and study 2) suggest that the outcomes could have been anticipated if the production lines were animal-tested the same way as in preclinical studies. The two subject studies looked at the unsuccessful trials by StemCells Inc. of spinal injury treatment using neural precursor cells. The company reported that the cells remyelination and motor recovery in mice with spinal injury.

But in two different trials with the same cells expanded using the Good Manufacturing Process (GMP) standard, required for production for use in humans, the cells failed to demonstrate efficacy. When the same lines were later tested in mice for the subject studies, they matured at about half the rate as the research-grade cells and largely remained as undifferentiated clumps. In one study about 4 percent of the grafted cells continued to divide and in some cases extended neurites into the surrounding tissue. Obviously injecting undifferentiated stem cells is a very bad idea and no two stem cell lines are identical. Together these studies provide strong evidence for preclinical testing of clinical-grade cells prior to use in humans.

Finally, another announcement: Beginning with this podcast (and retroactively back to the prior podcast) the video portion will be included at the bottom of the transcript. This will make viewing easier for my blog readers.

Thank you for reading and/or viewing. Leave a comment with your thoughts or any questions, and subscribe to get a notice in your email whenever a new episode is published. Until then, keep breathing easy!

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Cyborg With ALS (podcast)

New Blog Format!

Folks Logo

Audio Podcast Here (192kbps MP3 for download).

YouTube video version here.

Hello to my readers, and now listeners. Welcome to my new blog format where I will post the same text and web hyperlinks as always, but now there will be an audio podcast version on my Youtube channel in the new Podcast List. My electronic avatar, which I specifically created to look like me, will “read” the podcast and a link to it will precede the corresponding post. My channel also has various videos related to ALS and a few personal videos from my past. I will also have a lower-bitrate sound file available as a download link on each blog post. My hope is that this format will make my blog easier for people to enjoy. Everyone now can listen to my posts and then later check out the text version and follow the embedded links to learn more.

This post is to announce my latest interview with a new lifestyle magazine called “Folks”. It’s a publication by PillPack, a full-service pharmacy which separates medication into individual doses. This is pretty handy for people who regularly take medication and may have difficulty with prescription adherence, and institutions like nursing homes and hospitals. The publication was launched about 9 months ago and features people living with various medical conditions, refusing to be defined by that condition. I guess that would include me.

I had the good fortune to be contacted by Josh Andrew. He is one of the writers for Folks and he had heard my recent interview by Reply All, a podcast by Gimlet Media. Our interview was conducted over email. Unlike the podcast, I did not need to also send sound files. The link to the Folks article is in the text version of this blog post. Josh was kind enough to assist me with this podcast by answering a few questions about Folks and how they found me, and how the interview was done. The questions I asked were:

  1. Please describe what Folks Magazine is and what it’s all about.
  2. Please describe how you found me and why my story was interesting to Folks Magazine.
  3. What was the interview by email like?
  4. Have you ever done this before?

His answers are in the podcast.

Thanks for listening and/or viewing. Please leave a comment on this blog post and let me know what you think of the new format.

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Cyborg Is As Cyborg Does – Reply All Interview

World’s First Fully-Functional Cyborg

Reply All Cyborg

I am the world’s first fully-functional cyborg! Need proof? My part in this Reply All podcast starts at 16:35.

This interview took place over about 3 weeks including one live telephone call and approximately 40 questions over email to which I replied both with text and individual MP3 files of the audio of my computer speaking each answer. It was a rather interesting experience and one that would certainly come in handy for any future interviews. Sruthi Pinnamaneni and Rick Kwan did a great job of stitching all of the questions and answers together to make a single coherent interview.

My desire was to demonstrate that life goes on after diagnosis and that there is still PLENTY that someone can still do despite full paralysis and being dependent on a ventilator. Hopefully other more newly-diagnosed PALS listening to the podcast can take a little inspiration to keep living and contributing your individual wonderful gifts to the world. Together, our voices are amplified and we can create the change we want to happen in the world.

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Reply All – ALS Reversals

Reply All Podcast – The Reversal

ReplyAll-Podcast-Logo

As many of you may know, Dr. Richard Bedlack has been investigating a very rare phenomenon known as “ALS Reversal” where the normally inevitably fatal disease can stop progressing and even where the patient recovers slightly or nearly fully. Over the past few months Dr. Bedlack has been interviewed for a podcast called “Reply All” (I know the timing because I was also being interviewed for supporting material). The podcast is worth a listen, and you can get read the transcript at the Reply All website.

This is more good exposure for ALS awareness. Thanks to Dr. Bedlack and to Reply All for a great story.

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Quora Top Writer Of 2017!

WOW! – Quora Top Writer Of 2017!

Quora-Logo

I just received an email today notifying me that I have been named a Quora Top Writer Of 2017! My contributions are tightly focused in the topic of Amyotrophic Lateral Sclerosis (which I created on Quora) with some attention in the broader topic of Neurodegenerative Diseases, along with a few answers in the topics Science, Physicists, and Stephen Hawking (to give a long-term patient’s perspective on some questions asked about the Professor, including one asking how he fathered children where my answer has 1.4 million views and over 20,000 up-votes – the Quora equivalent of a Like). I have to thank my friend Laura Copeland for introducing me to and getting me involved at Quora. Laura and I met in 2011 when she interviewed me for a story in my local newspaper. She and I remained friends ever since.

Quora is probably the best place to go for answers to questions about anything from science to global social issues and politics to personal hobby interest (maybe I should start a Surfing topic..?). It’s a highly erudite place, especially for a social media site and has astonishingly remained so for many years. Quora is a place where trolls are not tolerated and from which is almost totally free.

I am quite flattered to receive this distinction and am happy that my contributions have been deemed useful for the many people who have read my answers and those who have engaged in enlightening discussions after. It’s been a wonderful experience so far, where I have been able to definitely expand global public awareness of ALS/MND is a positive and engaging way. I am thankful for the opportunity and for the response. I look forward to many more years of engagement and enlightenment.

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Reddit AMA Guest Appearance

Reddit Tag-Along

reddit-logo

On Friday, November 18, 2016, I participated in a Reddit AMA as a co-guest in support of my friend, Jef Akst. Earlier this year she published a book titled Personal Trials: How Terminally Ill ALS Patients Took Medical Treatment Into Their Own Hands (available on amazon.com in both Kindle and paperback) about the Oral Sodium Chlorite Project I created along with Rob Tison and Ben Harris, and our journey through the DIY drug experience. Reddit asked her to do an AMA about the book and she asked me to tag along for the session to give the ALS patient perspective and as one of the subjects of the book.

It was my first time ever doing this and it was exhilarating. For two hours, Jef and I were furiously typing away trying to keep up with the deluge of questions. In fact, I am still going back and answering late questions right now. At first I was a little nervous about facing a bunch of trolls and kooks, as the Internet appears full of these days. But the questions were all quality and reflected a desire to actually learn something about the subject.

I am grateful to Jef for writing the book, telling the story of patients driven to find their own solutions to untreatable diseases. And I am extremely grateful to Reddit for giving us this opportunity to share a taste of the experience with others who may have never previously heard of ALS before today. And thank you again, Jef, for inviting me to help her tell the story.

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Guest Blog: Me!

SRG Research News – First A Little Background

As most of you know, I started SciOpen Research Group as a way for me to be able to fire actual bullets in the battle against ALS (well, actually metaphorical, but you get the idea). Our first project failed to extend life in the classic ALS mouse model so we retained the money raised to conduct the planned second part of that experiment. We had another project already in the research pipeline waiting to take the next step in development. For two years SRG was working on creating a novel molecule which would treat the desired pathway without becoming toxic like the reference molecule does at therapeutic doses. Suddenly we had the opportunity to collaborate with researchers already investigating the same pathway, albeit in different conditions (watch the video announcement), with their own library of candidate molecules.

Our collaboration’s first phase is to create a novel transgenic mouse species which represents a 100% drug efficacy in order to be a proof of concept. The project should run through the last half of 2016. As you will see below, a study was recently published which shows that SRG is definitely onto something. Our target protein is significantly elevated in human patients, and that targeting it brings positive results. The study is great indirect support of our project’s goal.

And now, the guest blog featuring myself!

Good News For Our Latest Project!

A recent report published in Science magazine strongly suggests that SciOpen Research Group is onto something with its currently ongoing study of necroptosis in ALS. Necroptosis is a “cousin” of apoptosis. In contrast to apoptosis, which happens regularly in the body, necroptosis is a form of programmed cell death which happens under inflammatory conditions and in which the components of the dead cell spill into the extracellular space. The spilling of the cellular components trigger a response in which immune cells are recruited to the area. Necroptosis is known to be a driver of both genetic ALS and sporadic ALS.

The subject study is not a direct support, in that it was looking at how the optineurin protein contributes to ALS. However, the results showed significant increase of the MLKL protein in human patients and that elimination of the RIPK3 protein or inhibition of RIPK1 had modest but nevertheless positive effects on survival of the SOD1 mice (along with positive biological evidence). This suggests that SRG is on the right track with its MLKL study. We believe that acting on MLKL will have a stronger effect without disrupting other cellular functions which depend on RIPK3 and/or RIPK31 (MLKL is involved only in necroptosis).

This study is YOUR study. It would not be position without your support. SciOpen Research Group is the world’s first fully functional “guerilla biotech”. We function only with your support and study pathways other research organizations either miss or ignore. And we can do it for much less because we are purely volunteer and have no overhead. 100% of your donations go directly to research. To support us you can make a tax-deductible donation (USA residents only) by going to our Donations page, purchase some SRG Gear, and/or go shopping on Amazon Smile and name SciOpen Research Group as your charity of choice (we are a registered and approved nonprofit under IRS 501c3). We work on ALS for you, the ALS Community, because we are part of the ALS Community. Help us continue our novel research into eradicating ALS.

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Guest Blog: Me!

Good News For Our Latest Project!

A recent report published in Science magazine strongly suggests that SciOpen Research Group is onto something with its currently ongoing study of necroptosis in ALS. Necroptosis is a “cousin” of apoptosis. In contrast to apoptosis, which happens regularly in the body, necroptosis is a form of programmed cell death which happens under inflammatory conditions and in which the components of the dead cell spill into the extracellular space. The spilling of the cellular components trigger a response in which immune cells are recruited to the area. Necroptosis is known to be a driver of both genetic ALS and sporadic ALS.

The subject study is not a direct support, in that it was looking at how the optineurin protein contributes to ALS. However, the results showed significant increase of the MLKL protein in human patients and that elimination of the RIPK3 protein or inhibition of RIPK1 had modest but nevertheless positive effects on survival of the SOD1 mice (along with positive biological evidence). This suggests that SRG is on the right track with its MLKL study. We believe that acting on MLKL will have a stronger effect without disrupting other cellular functions which depend on RIPK3 and/or RIPK31 (MLKL is involved only in necroptosis).

This study is YOUR study. It would not be position without your support. SciOpen Research Group is the world’s first fully functional “guerilla biotech”. We function only with your support and study pathways other research organizations either miss or ignore. And we can do it for much less because we are purely volunteer and have no overhead. 100% of your donations go directly to research. To support us you can make a tax-deductible donation (USA residents only) by going to our Donations page, purchase some SRG Gear, and/or go shopping on Amazon Smile and name SciOpen Research Group as your charity of choice (we are a registered and approved nonprofit under IRS 501c3). We work on ALS for you, the ALS Community, because we are part of the ALS Community. Help us continue our novel research into eradicating ALS.

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ALS-New-Drug-New-Scam? – Redux

So it looks like the entity behind “ALS New Drug” is back, this time with a new website host. The site has been changed so that every page begins with erroneous whining about how ALSUntangled supposedly ended some kind of “charitable funding”. First, that person, persons, or organization has no status as a charity in any country. Second, ALSUntangled has taken no stance on the subject whatsoever because the entity refuses to cooperate whatsoever by revealing any information about itself or the product it promotes.

Let me explain the facts of the situation:

Back in July of 2015 the “als-new-drug.com” domain was purchased by a man in Great Britain named Michael Richards. Apparently around September 2015, the website was put up. A [non-exhaustive] search of the Internet and PubMed reveals no Michael Richards from Essex, Great Britain, involved in neurology or ALS.

In April, 2016, the site was brought to my attention by another PALS. I read through the site and read a lot of claims backed up by absolutely no objective information in the form of links to studies involving the drug in question, no objective or clear information about what the drug actually is or how it works, and no identification of the inventor(s) or the entity promoting the drug. A deep Internet and PubMed search for RCH4 or the “scientific” name given revealed absolutely no hits (very unusual and highly improbable for a real drug that has supposedly been in development for many years). In fact, absolutely no objective information exists about this drug except for the claims made on the website.

After failing to find any corroborating information, my Internet domain information lookup results, and my decades of professional experience identifying Internet scams, I made the initial assessment published on my blog in the post titled “ALS New Drug New Scam?”. Because this had been brought to my attention by another PALS who was considering taking this “treatment” and because other patients were apparently already using it, I felt it was urgent to publish a warning that something was not right about this. I have been publishing this blog for exactly this reason since 2009 and I am known for my understanding of the neuroscience and pharmacology of ALS. That’s one of the reasons I was invited to join the ALSUntangled Review Group.

After I published my initial assessment – based on all the available objective information – I contacted Dr. Bedlack to ask if he knew anything about the subject. He informed me that it was on the list of Open Reviews (I don’t keep the list updated in my memory). Because it’s quite a long list and Dr. Bedlack is busy running a major ALS clinic, he asked if I would be interested in taking the lead in gathering information for this project and writing an initial draft report (something I have previously done multiple times for ALSUntangled). Of course, I agreed to assist. There is no title of “Lead Investigator” for ALSUntangled but I used that in email and forum postings to communicate with others because it’s a more succinct and convenient identification of my association with ALSUntangled. I then sent a request for information to the entity promoting RCH4 at the AOL email address given as contact on the website and began asking for patient experience and information on various forums dedicated to ALS.

The questions I sent to the contact email was the standard set sent to every promoter of an alternative treatment option, plus a few of my own customized to this case which were relevant to the investigation. The questions are:

  1. What exactly is this drug and how did you discover it?
  2. How does it work?
  3. What is published on the mechanism?
  4. What pre-clinical ALS data are there?
  5. Are these pre-clinical ALS data published?
  6. How many patients with ALS have taken this?
  7. What are you measuring in patients with ALS that take this?
  8. What happened to those measurements?
  9. Over what period of time and how often are measurements made?
  10. Has anyone had any side effects from this drug?
  11. What percentage of people who take it have any side effects?
  12. What are the most common side effects?
  13. What are the most serious side effects and how often did these happen?
  14. How much do you charge patients for this drug?

Additionally:

  1. If not why not and how are you capitalized?
  2. Will you identify the members of your group so that their qualifications can be examined?

These are standard questions that ALSUntangled asks of EVERY promoter of an alternative treatment option. They are intended to gather relevant data so that a scientific evaluation of the substance can be made, and I included the financial question so patients would have some information about the possibility of long-term access. The promoter is always free to not answer any particular question. The entity behind RCH4 reacted instead with hostility – as if the questions were attacks on their very character. Moreover, apparently they have patients sign nondisclosure agreements before any distribution of the drug begins so that automatically increases the difficulty of discovering the truth of the subject. These two facts, along with the lack of any objective information made available on their site or to prospective clients inquiring about it, only reinforces my personal initial assessment that something is very wrong with this entire program.

The entity says that ALSUntangled and/or I made an allegation of some criminality on their part. In fact, ALSUntangled has made no statement of any kind about RCH4 and I merely opined based on all the [still paucity of] currently-available information and my many years of professional training and experience. The entity says I have no medical credentials. This is true, but neither does it. I do have years of dedicated learning and am recognized as an expert on the subject of ALS and treatment options for it. The entity says I have no experience with drug development. This is untrue, as I have experience both in aiding others’ programs and in developing my own via my research organization, SciOpen Research Group. I also have quite a bit of knowledge of the development process from my experience with and founding of WideTrial, my experience with and founding of Hope NOW for ALS (both organizations deal with improving clinical trials and involve dealing with regulatory authorities and pharmaceutical companies). I also have nearly a decade of experience in advocacy and awareness in the ALS space. My record is impeccable and very publicly transparent. I invite the entity promoting RCH4 to exhibit the same public transparency.

The entity says that my blog post warning patients away from whatever RCH4 is somehow cost them their “charitable funding”. I was never contacted by anyone representing themselves as being affiliated with the RCH4 entity. While I realize that I have a reputation in the ALS Community of being knowledgeable, I highly doubt any funding organization would base its decisions on my personal opinion alone. But if for some reason it did, there was obviously very little faith in the RCH4 entity to begin with.

To recap:

  • In July 2015, a domain called “als-new-drug.com” was created and shortly thereafter the website promoting RCH4 was put up on the same URL;
  • In April of 2016, I was informed about it and did a personal search on RCH4 and the entity behind it;
  • After failing to find any objective information verifying any of the claims on the website or the identity of the entity and/or supporting scientific staff (a situation that persists to this moment), I posted my findings on my personal blog;
  • I then communicated with Dr. Bedlack about RCH4 where he asked me to gather information for an ALSUntangled review, including sending the standard questions to the entity promoting RCH4 and asking PALS claiming to be taking RCH4 about their experiences, an activity I began immediately;
  • I very quickly learned that PALS were required to execute nondisclosure agreements with the prior to being provided RCH4;
  • I received a response from the entity via comment to my blog post full of overly-dramatic wounded pride and a pledge to not cooperate with the ALSUntangled investigation;
  • Patients currently using RCH4 were warned by the entity to not cooperate with the ALSUntangled investigation;
  • In an effort to smooth any hurt feelings, I recused myself from the investigation – to no avail;
  • Shortly thereafter, the website disappeared and the entity apparently began informing patients that continued supply was in jeopardy;
  • I received hateful comments from a few patients – including death threats – demanding that I take down my post (as if that would suddenly change anything?);
  • The website returned, blaming ALSUntangled and/or me for ruining a “charitable treatment program”.

I made my initial personal assessment based on my many years of professional experience and more recent scientific knowledge, and upon previous public lectures by Dr. Bedlack on how to spot treatment scams. I was not acting on behalf of ALSUntangled but entirely on my own. Afterward, I was asked to gather information for their own review – information which would have been reviewed and discussed before a report is published by the entire group which includes many well-known MDs and PhDs involved in ALS research and treatment. The amount of available objective information has not increased one bit since my initial assessment. I would love to be proven wrong but that would require objective and verifiable information. The RCH4 entity is not only not helping, they are actively resisting all efforts at learning any facts about RCH4. Facts are not just unsubstantiated claims on a website. Facts are independently verifiable objective information. All scientists and doctors, retired or not, understand that they have a duty to first provide scientific rationale and preclinical data about their drug along with a clear description of its chemical makeup before providing it to patients. That is a basic fact about drug development which apparently I know and the RCH4 entity does not.

If the RCH4 entity wants my personal assessment and warning to PALS taken down, they can very easily provide me and/or ALSUntangled with the answers to the questions sent, and allow patients to communicate about their experiences. Until then, my personal blog post will stay up as a warning to PALS to not inject into their bodies an anonymous substance sent by an anonymous source. As stated earlier, I would love to be proven wrong, and indeed welcome it. However, everything so far has proven me right.

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TransFatty Lives – a film review

Last Saturday evening I watched TransFatty Lives and was stunned by the unique method of simultaneously telling two stories. The first story is his slow but inevitable descent into total quadriplegia following a diagnosis of ALS and the second is writing a time capsule letter to his son to explain his absence and inability to participate deeply in his son’s life. The film was scattered with amazing images showing POB’s delightful deliberate eccentricity and with scenes both hilarious and disturbing. Some scenes were personally disturbing as I remembered my own experience with that phase of decline. Others were colorful and outrageous in a way only Patrick could make them.

TransFatty Lives is a perfect film for seeing the effects of a fatal diagnosis on a young hedonistic man. As he faces each step of decline he becomes a little more introspective and gains more awareness of the value of the little moments that give life its value. How POB takes the viewer along reveals his genius – you don’t know you have learned something until the next scene begins.

Even more than “The Theory of Everything” or “You’re Not You”, “Transfatty Lives” is the most important film involving ALS. The faithful and honest treatment of both the horror and triumph which is ALS, and the amazingly creative style of POB, makes this a must-see for all PALS and CALS and their families. It should also be widely promoted for all people worldwide. Even for those for whom ALS is just a disease named for some baseball player, this is a wonderful film about human trial, triumph, survival, and love.

This film is amazing to experience. It is much more than a simple documentary. I easily rate this 5 stars, two thumbs up, one poop, etc. Rent or buy this film immediately and have a viewing party.