Celltex lawyers up

The Celltex/Glenn McGee/AJoB/RNL Bio/ICMS fiasco has snowballed into a much bigger story than I ever expected it would back when I first blogged about it in January. This is largely thanks to the efforts of Carl Elliott and Leigh Turner, both of whom are faculty members of the Center for Bioethics at the University of Minnesota. Elliott published a detailed article of the situation in Slate, with explanations of why the relationship between Glenn McGee (who was listed as editor in chief of the American Journal of Bioethics for at least part of the time that he was serving as president of ethics and strategic initiatives at Celltex) raised legitimate conflict of interest concerns. I for one share in Elliott's views, but Slate retracted the story following allegations of factual error and defamatory content by David Eller, the millionaire who serves as Celltex CEO (to which Elliott sent a rebuttal), and later by a law firm hired by McGee (which I also blogged about here).

Threatening academics with litigation since 2012.

More recently, a different law firm, representing Celltex, has sent a letter to the office of the president of the University of Minnesota making similar complaints about a letter that Ellliott's colleague Turner had sent to the FDA raising concerns about Celltex's activities. This has been covered extensively elsewhere, so I encourage readers interested in the details to read Turner's letter to the FDA, the complaint from the Celltex attorney, and a number of accounts of the legal threats that have been published elsewhere (Pharmalot has the most extensive writeup; others can be found here, here, and here). For the record, I think that both Elliott and Turner should be commended and supported by their university and the community at large for their courageous critiques. 


Celltex's carping over Turner's use the word "administer" in particular seems to be a dodge around larger problems alluded to by Turner and exposed in the excellent investigative work of David Cyranoski at Nature, who found that Celltex not only supplies cells to at least one local physician for unapproved uses, but in fact pays him a $500 commission for each use. (To my knowledge, there have been no threats of legal action against Nature for this or other articles it has published about the Celltex affair, suggesting this apparently litigious company accepts them as factual and true). So, rather than resorting to legalistic suppressive fire, it seems to me the company should be open about what it does with the cells it banks and processes, what it tells patients they can be used for, how they are described and delivered to physicians, and how it perceives its regulatory position with respect to current U.S. laws governing, inter alia, the banking and provision for clinical use of human cells and tissues. 


And just as Celltex could do right by making a full disclosure of its practices, now that McGee has quit the company, the editor-in-chief role at AJoB, his position at the Center for Practical Bioethics, and his position on the board of directors at the ICMS, he could certainly use his inside knowledge to help clear the air and make a valuable contribution to understanding the factors at play in this contentious case by providing verifiable documentary evidence detailing:

• The official positions of RNL staff members and others he spoke with in developing his findings (i.e., whether he had unfettered access)
• The nature of questions he asked and data he examined  during the course of his investigation, and the nature of the responses on the part of RNL Bio representatives (i.e., whether he performed due diligence).
• Specifically, whether he questioned the company regarding the justification for performing thousands of clinical interventions (many of which were for nebulous "anti-aging treatments" that were not supported by scientific evidence and outside the context of regulated clinical trials , and if so, the nature of their responses. 
• Whether he had access to full English translations or bilingual versions of regulatory, procedural and informed consent documents, and other important primary data (many of which presumably were originally in Korean).
• Whether he consulted any outside, independent experts not linked to the RNL Bio case or ICMS in developing his recommendations.
• Whether he is aware of the reasons for RNL Bio's non-compliance with the various ICMS recommendations; specifically, whether RNL refused to pay the "the negotiated, onetime, per patient procedure fee of $50" required by ICMS for participation in its Complications Treatment Registry program. (Presumably this would have cost RNL Bio $400,000 or more to register the 8,000+ patients it is reported to have treated.)   
• Whether he or members of his family subsequently received direct or indirect income or other financial considerations as representatives of the Center for Practical Bioethics (an NPO with which McGee and his wife were both affiliated at the time of his investigation) to conduct comprehensive ethics training, and if so, at what amount(s), for subsequent consulting or other services. 

As with much of the ugly, unscrupulous business of stem cell marketing in the absence of regulation or evidence, the whole Celltex affair smells bad, and no amount of waving briefs and threats of injunctions in people's faces will make that go away. Hopefully the U Minn administration and the FDA will recognize the stench of corruption, and not give in to strong-arm legal defenses of otherwise indefensible practices. And we should all look forward to McGee living up to his promise to provide "timely, lengthy, pointed comments on the matter."

Grekos kills again

Image source: Mugshots dot com

A friend of the blog just forwarded me a link to a CNN report on the latest grim development in the Zannos Grekos case, in which the Florida state medical board has now imposed an emergency suspension of his license after yet another patient died in his care. The Naples News further reports that the county sheriff is launching a criminal investigation into his (mal)practice. This time, an elderly patient is reported to have died during an illegal, expensive and unscientific procedure for pulmonary hypertension that Grekos advertises as involving processed stem cells he has named "regenocytes."  The emergency action by the medical board follows their emergency restriction of his license last March, after a different elderly patient died within days after receiving a lethal injection of a purported stem cell concentrate at his hands. Before getting the stem cell itch, Grekos had previously killed another patient back in 1997*, through simple neglect. 

Don Margolis, griefer extraordinaire and Grekos' business mentor, is going to have to start shopping for a new member for his advisory board. 

"Regenocyte Adult Stem Cell Therapy is safe, highly effective and presents minimal risk!" 

The identity of the deceased patient is being kept confidential for now, but the Lee County sheriff stated that he had traveled to Bonita Springs, where Grekos' practice was located. I have no doubt that he was very sick already, and it is too soon to determine whether the cause of death was an embolism caused by whatever Grekos injected, or some other complication relating to the anesthesia, surgical stress, or plain old incompetence. 

But what is clear is that doctors who beguile the trusting with simplistic pseudoscience, who jeopardize and impoverish their patients in pursuit of easy cash, and who excuse their refusal to proceed cautiously and scientifically as a right protected in the practice of medicine, are no different from the quacksalvers of yore. These are not bold pioneers - we need to recognize them for the base and craven swindlers they are.  


*Note: a previous version of the post indicated that this death had taken place in 2001.
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UPDATE (March 19, 2012): The Naples News has reported that Zannos Grekos' latest attorney is asserting that the most recent patient death connected to Regenocyte was not from a stem cell injection, as the patient had only received a liopsuction (presumably to harvest what Grekos advertises as stem cells), and that the procedure was performed by a different physician at the clinic. It will be interesting to see what the Florida medical board and local law enforcement authorities make of these claims. The victim's sister, however, is clear about who is to blame, saying about Grekos, "This guy needs to be stopped."

March update - allergy testing

Sorry I haven't written .... well not really ... I haven't written because I'm just feeling good and there's nothing to add.

Oh, I got allergy testing done. Remember how I ate at Bonefish Grill and had a crusted trout, so thought that since it was Bang Bang shrimp night that I got sick from shrimp contamination? Uh, surprise surprise. It wasn't the shrimp ...... it was the pecan crust on the trout! I'm allergic to pecans, peanuts (I knew), and sunflower seeds, but not shellfish.

I got a blood test done to confirm and don't have those results yet.

Still taking:

1 drop Lugol's iodine
Blood Builder, 1 tablet
magnesium
5HTP at bedtime
Armour Thyroid
Vitamin D3

Sometimes take:

Vitamin C
other antioxidants (resveratrol, or something else)

Update: My blood test came back as mildly allergic to clams, oysters, squid, and scallops.

Slate retracts, Nature reports, McGee resigns

I was disturbed to learn yesterday that Slate has made an editorial retraction of the article "The Celltex Affair" by Carl Elliott, and issued an apology to Glenn McGee, a bioethicist who has been criticized by me and many others for his professional involvement with the troubled Texas stem cell company and RNL Bio licensee, CellTex, at a time when he was also editor-in-chief of the American Journal of Bioethics. The retraction was apparently prompted by allegations of factual error and defamation made initially by David Eller (Celltex CEO), to which Carl Elliot responded, and later by a law firm representing McGee. The excellent blog Retraction Watch has provided a nice summary of the recent developments, and Leigh Turner has posted a thoroughgoing chronicle of the events and issues that surround this case up to the day before Slate's sudden retraction. (Turner's article was published on Feb. 28, while the retraction is dated Feb. 29).


With the intensive scrutiny and crying foul over the past month, I don't know if I have a lot to add to the commentary. I do note that my blog is mentioned in the letters from Eller and DeShazo and Nesbitt, McGee's lawyers, with particular reference to a correction I made to one point in my original post on the ICMS Potemkin investigation of RNL Bio, which had stated the McGee had participated in and authored the report of an investigation of RNL's provision of cells for use in unproven treatments overseas. He emailed me stating that he was not the author of this particular report, but that he wrote a different report specifically on the company's ethical practices. I noted this both in the original post and in the more recent one on his joining CellTex, and apologized for the mistake. 


It is clearly vital to get all the facts straight, and I am happy to correct any factual errors discovered in my writing, but equally clearly many of the other disturbing facts of the case remain uncontested, and I have to wonder why Slate would decide to retract such an important story, particularly given Elliot's rebuttal, which I found to be reasonable and compelling. Perhaps Eller's decade-long libel suit against Forbes and journalist William Barrett was more compelling evidence still of the potential cost of engaging millionaires in the courts.


I should further comment on one point in Eller's accusation, which claims "Fact: Dr. McGee has no knowledge as to whether Dr. Ra served on boards" (referring to the participation of RNL Bio CEO Ra Jeong Chan on the Laboratory Advisory Board of the International Cellular Medicine Society in fall of the year when the patient deaths in Japan and China occurred. In fact, I did email Dr McGee on September 10, 2010 at his bioethics.org address prior to writing my first blog post, as I thought at the time that he might be unaware of some important aspects of the ICMS organization. 


McGee did not acknowledge or respond to this email, so I cannot say whether he actually read it, but even if he failed to familiarize himself as a director with the members of other boards, he had clear opportunity to do so just by opening his inbox. I therefore do not think this particular defense is valid, and more generally feel Elliot is owed an apology from the editor of Slate for making a retraction when a correction or clarification on several minor points would have sufficed. This is particularly true as the basis for defamation seems to rely largely on intent, and neither Eller nor the McGee lawyers seem to have done anything to show any alleged error was made intentionally on Elliott's part. 


Things get even more interesting now that Nature journalist David Cyranoski has published a nifty bit of investigative journalism on March 1, with an accompanying editorial, that lays out how CellTex delivers processed adipose cells to a local physician and pays him a commission to inject them into patients with diseases like multiple sclerosis. What's worse, the Texas Medical Board, a group of 17 political appointees less than half of whom have an MD, has drafted new regulations that appear to suggest that Texas views FDA oversight over the clinical use of investigational agents (such as stem cells) as optional. The feds may tend to disagree, as they showed last year in arresting Fredda Branyon, Vincent Dammai, Alberto Ramon, and Frank Morales for similar practices (although it was allogeneic cord blood in that case, rather than processed autologous adipose cells). 


McGee, who did not agree to be interviewed for the March 1 Nature article, abruptly announced his resignation, effective Feb. 28, from CellTex, just three months after joining the company. He also previously stepped down as editor in chief of the American Journal of Bioethics, and says via twitter he is preparing "lengthy, pointed comments on the whole matter." 


Given all the many villains and clowns in this big-money drama, we can only hope that McGee opts to redeem himself through full disclosure.

Raw Food: Ignored advice to go slow!!!

Prior to becoming ill, I ate a TON of raw food! I tried to shoot for 50% or more. I juiced often. Then, when I got sick, I couldn't digest raw food at all. :( I could only eat vegetables if they were overcooked, so soups became a favorite because who likes overcooked side dishes?

Recently, I FINALLY can eat as much raw food as I want, so as I usually do, I went overboard. I read Norman Walker's book on Weight Control .... I didn't buy it, it came with my Norwalk Juicer .... but it has good information in it about eating raw. He warns, GO SLOW, don't change over all at once. Did I listen? Of course not!!! I'm too healthy for it to have been more than a little issue!

WRONG!!!

A day in, as usual, I had a little headache. Nothing big. Hardly noticeable. Three days in, my hips started hurting so badly that the pain woke me up in the middle of the night. The pain in the morning was severe. I did okay, but not great that day. That night, the pain reminded me of when I broke my leg!! OUCH! Two and a half hours after I went to bed and couldn't sleep because I was crying over the pain, I finally got up and ate an Udi's gluten-free bagel with butter and raw almond butter on it. I took a Vicodin, and went back to bed. I played on my iPhone until the Vicodin kicked in then went to sleep.

The next morning, they hurt again, but not so bad. After my evening juice, YOWEE!!! I wasn't messing around with it a second night, so took two Advil and a Norco. I ate some organic blue corn chips and had some wild rice with my dinner salad.

Today I got up and ate my new normal raw breakfast (a glass of fresh apple juice and a couple celery stalks with raw almond butter). I had leftover salad with wild rice for lunch. Multiple raw snacks. I feel much better today, no pain.

I was worried about not having enough food, not about an intense healing reaction. I've been eating raw seed bars, raw soaked almonds, avocados, and nut butters to be sure I'm getting enough fat and calories with all the pilates I've been doing. But I hadn't taken into account that going to fast might cause a healing reaction. Wow. I learned my lesson.

Here's a good site that talks about going raw and what can happen if you go too fast -link

I don't plan on eating all raw all the time, but I am happy to get back to eating a significant amount of raw fruits and veggies full of enzymes. Interestingly, last time I started juicing, a friend who only sees me once a week was so surprised how much younger I looked after only a week of it that she went out and bought a juicer that day. This time, hubby was out of town for four days, and when he got home he said the same thing. Why do I ever stop juicing?!?! LOL

"You're eating a raw food dinner? You better not, it will make you feel like $#!T!!! Yup, my body is weird. There is really no way to know why the detox reaction is in the hips. It started soon after starting raw food, and ended soon after adding cooked back in, so it was clearly related.

Being able to eat this way again tells me that I'm significantly healed. I've been finished with treatment of infection for a couple years now, but as you know I've been working on total healing since then. I want to change my body so that it's not the same as the body that got so gravely ill. I think I'm close to the last layer .... though you never know how many there are .... but this step is significant.

My plans are to eat raw all the way until dinner .... except for today, of course.

Iodine

I've been reading a lot about iodine supplementation lately and it's fascinating. Apparently, most of the population is iodine deficient. There is less iodine in salt and over 50% of people don't use iodized salt. Junk food that is loaded with salt, is loaded with plain salt, not iodized. People in trying to be healthy, cut out salt, which, by the way, is a macronutrient and important to our health.

Recent studies show that perhaps a much higher than RDA amount of iodine is needed. This is big in cancer prevention, specifically breast and prostate cancers.

It's also big in fighting everything from fungus, candida, bacteria, parasites, heavy metals, etc. It's needed for health.

So, I did the test, that has debatable accuracy, but I did it anyway. I painted a patch of my skin with iodine. It dissappeared in less than an hour. I bought Lugol's, the iodine used for many years by doctors.

Do you know anything about bromine? Yes, the stuff used in hot tubs instead of chlorine, that's what I'm talking about. Well, do you know you eat A LOT of bromine? Bread makers used to use iodine in bread. At some point they decided to switch to bromine. it's also in brominated vegetable oil. You say you don't eat brominated vegetable oil? Well, it's in Mountain Dew, Gatorade, Fresca, and other soft drinks. Yuck.

What's the big deal about bromine? It's in the same family of elements as iodine. Your body will use it as iodine, but it can't do all the things for you that iodine does, it just takes up iodine's place in your body. Could this be why we have an epidemic of low thyroid (and even obesity?)? Could this be my answer in getting off thryoid meds once and for all?

I started supplementing a few weeks ago. In the beginning, I did salt loading (I'll provide links so you can read more about the details of this). The salt provides chloride for the kidneys so the bromide doesn't get stuck there. You guessed it. Chloride is also in the iodine family of elements. So is flouride. How can flouridation and chlorination of our water be a good idea?

Many people have bromide detoxification reactions. My husband did. He felt like he had a bad cold and fatigue for the first couple weeks. I had a worse reaction, with over half of the symptoms they say you can have. My hips ached soooo bad. I also had the "cold" and fatigue. Now my left kidney is aching, so I started back with the salt. I'm taking a couple days off the iodine to give my kidneys a rest. I've also bought supplements that are supposed to give kidney support.

Here are some links -

Bromide and salt loading

Bromide dominance

Iodine deficiency

Update and shameless advertising

Well, since I'm doing so well, I really have no HEALTH updates for you at this point. YAY!!! Nice to have nothing to say about my health, right? :)

But, I finished my first 100 hours of pilates training with my new certification program (I'm already "certified", just adding to it). It was 25 hours per week, as I told you in my last post. I took the test, both written and teaching a client, and passed!! Onto the next stage!! The next stage starts this weekend with 18 hours of training over 3 days .... over half that will be doing pilates, so I'll be exhausted by Monday when I have a 90 minute massage scheduled!

I also wanted to tell you that my daughter started blogging. It's a more fun read than this one because it's all about fun topics and has pictures. Please check it out and let me know what you think! Her Halloween post has pictures of me with the goofy husband and goofy kids.

http://luvvleighb.wordpress.com/

Update- new bloodwork

I hadn't been to a gyno since my previous one ridiculed me right out of his office. That *could* be the subject of this post, but if you have Lyme, you can imagine the story and you'd be right ... and it included saying anyone who specializes in Lyme is probably a scam ... and he was speechless when I said I had all the symptoms, a positive test, and was doing better with treatment.

Anyway, this time I went to a female gyno for the first time. It wasn't weird, LOL. She specializes in women my age (not having babies). She did a lot of blood tests and I was impressed. She actually tested for vitamin D! I asked her for a ferritin test since mine was only 24 last spring, and she did one for me. Five vials of blood.

Seems I'm NORMAL!!! Not a big accomplishment for most people, but you know what I've been through.

My ferritin is up to 66. She mentioned it was still on the low side, but that low was pretty normal for someone with periods like mine. No wonder I have more energy!!! That's a BIG jump!!! I am still taking double Blood Builder. I muscle test every day, and around my period I can test for two or three twice per day, but normal days, two only once per day.

My vitamin D is up to 64 from 35 last spring. She mentioned that I must supplement because no one is ever in range. I told her I did. She asked how much .... it's 4000-8000 IU daily.

Since I'm taking so much vitamin D and so much iron, both of which "they" say you can take too much of, I was glad to get the confirmation that my body is doing well on it. And I like this new doc. The only thing I don't like is the AIR FRESHENER!!! I could hardly breath in the waiting room. I found it odd a doctor who knows this much about health would have such toxic poison in the waiting room. I would think maybe essential oils .... but not this toxic stuff. I was wheezing at night when I lied down to go to sleep. I couldn't figure out why because that is not normal for me .... then I remembered ... had to be the air freshener. I haven't had that problem since.

I'm feeling great! I'm in a pilates training program that is 25 hours per week. I'm having to memorize tons of stuff and doing fine with it. My brain has come a long way. I'm also on average doing about two hours of pilates a day five days a week, and that's going well, too.

I am photoning monthly again for about the last four months or so. I like to use blood this time of year because so many bugs are going around. I had taken a few months off and did fine.

So, there's your update. Right now I'm taking very little:

Vitamin D
Vitamin C
Iron
Armour Thyroid (one grain)
5HTP at night
Turmeric (with all this pilates, LOL)

TWO YEARS!!!

August marked two years of being free of Lyme and coinfections!!!!

As I look back, I see how many health issues I had and how many I overcame. When I was bedridden a few years back, on an all liquid diet and in a lot of pain, I never dreamt I would be living normally in the future. I never dreamt I'd be off all medications except thyroid. I never dreamt I'd feel this good. I thought I would be on a maintenance program for the rest of my life.

Even though the Lyme and coinfections were gone two years ago, my body had a lot of other healing to do. I still had the mold toxicity because I wasn't strong enough to take the medications my doctor had prescribed. I still had muscular imbalances. My skeleton was twisted. I was toxic from the infections, mold, and treatment. My digestion was still bad.

For two years I have had chiropractic work and massages along with working out on the pilates reformer. This has rebalanced my musculature. Pilates was such a huge help for me, I got certified to teach it and now share my passion for it with others. I've been teaching for over a year and a half and am getting ready to start another rigorous certification program that will take 9 months.

I believe Pilates also helped me to reach toxins and infection that were stored deeply in muscle.

I've done many detoxification programs, and recently one for mold.

I have done things to heal my gut.

I realize that my blog sounds crazy at times with the muscle testing and working by intuition, but if you knew me when I was sick, knew me two years ago when I was infection-free, and knew me today, you'd know that though it might sound crazy, what I did worked.

Two health issues that still bother me are 1) that I still rely on thyroid supplementation, and 2) that I am deathly allergic to shellfish.

So recently I started eating grain-free. I am interested in the various so-called caveman diets, but going into teacher training again, I can't start such a strict diet at this point. I'll see how things go and maybe fully go into one of them after the first of the year. These diets are supposed to heal the gut, which helps allergies. I've also read how it can help with hormones and even iron, which I still have to supplement. I'm willing to give it a try. Maybe by this time next year my gut will be even healthier and my allergies will be lessened. The shellfish allergy will likely always be here, but maybe I can eat in a restaurant without worrying that one of the cooks *touched* a shrimp that day. I believe I should be able to get rid of food intolerances, like to peaches.

The grain-free diet has been interesting. I'm glad I didn't start out with the strict introductory phase. It's lower carb than I'm used to, so it's a challenge. I'll keep you posted on how it goes. At some point I'll have to get back into the fermented foods, but right now I'm taking it one step at a time.

I think I'll always sound a little bit crazy, but at this point, I'm working to keep getting healthier ..... I've already reached good health. And I'll always be doing some kind of detox program .... right now, I'm on my yearly Dr. Natura but added Toxinout this time. So far, so good.