Is Anyone Using Medifast?

I have a niece who just became a health coach for Medifast and she was curious if I knew of anyone who uses Medifast.  She has lost 50 lbs. on the program and she said a woman at her meeting who has CFS & FM has seen improvement since using the products.  This was what she sent to me via email:

Last night at the Take Shape for Life meeting one of the ladies shared that she has fibromyalgia and chronic fatigue syndrome. She works 5 hours a day and when she would come home she would sleep or be in bed very early. Since starting the program she stated she has so much more energy, even her husband commented about it. She says now she is up to 10 or 11 at night and feels great!

I told her that I did not know of anyone using Medifast but I would find out by posting about it on here.  If you would like to check out Medifast, you can view her site by clicking here.   I know nothing about the products but I am going to a tasting in June so I might have more information by then.  Please comment if you have tried it, if Medifast has helped or if you know of someone who has used it.

New Formulation For Oxycontin Approved By FDA

The FDA has approved a new forumlation for controlled-released Oxycontin, a powerful pain medication that is typically prescribed severe, chronic pain.   The goal of this new Oxycontin formula is to help discourage abuse and overuse of the drug.  This could be really good news for chronic pain sufferers who have doctors who are afraid to prescribe the drug because of the previous threat of misuse.  This new formula should put doctors at ease when prescribing Oxycontin and more patients who are legitimately suffering from pain should be able to get the drug.  

The new Oxycontin formulation will be created in a way that the medication cannot be crushed for snorting or liquified for shooting up.  If the new formula gets wet or someone tries to dissolve it, the drug will become gummy.  Because there is just a reformulation of the drug, the timetable for a potential generic version hasn’t changed.   More good news.

The Interstitial Cystitis Association was involved in the stakeholder teleconference FDA held on Wednesday, April 7 to announce approval of the new formulation. The ICA reports:

During that teleconference, FDA’s Bob Rappaport, MD, explained that the agency will require the company to do a postmarketing study to collect data on how much the new formulation reduces abuse and misuse of this opioid. In addition, he said, FDA is requiring a “Risk Evaluation and Management Strategy” (REMS). This REMS will be a straightforward one that applies to this drug only: a medication guide will be issued to patients, and prescribers will be required to be educated about the appropriate use of opioid analgesics in the treatment of pain.

FDA didn’t take this opportunity to issue a REMS for all opioids. That’s still open for comment from legitimate pain patients like you who need these medications. Please continue to tell FDA how important your access to these medicines is and that you don’t need more barriers to receiving them.

Experimental Stem Cell Transfusion Treatment for ME/CFS

The following article discusses an experimental and groundbreaking treatment by Dr. Paul Cheney that involves stem cells.  It addresses the potential benefits of stem cell transfusions for ME/CFS patients; the benefit of “re-booting” the gene expression changes that ME/CFS brings about before pursuing stem cell therapy; the need to address “corrupted gut ecology” before the therapy; and the importance of selecting a high-quality stem cell laboratory and clinic. It has been requested that readers distribute it to other groups, lists and organizations.  This is why Fighting Fatigue has included the entire article, so that nothing is misprinted or misrepresented from the article posted on ProHealth.   Please redistribute this on your website or blog.   Carol Silverling, the author of this article, is a board member of the CFS & FM Support Group of Dallas-Fort Worth. 

Paul Cheney, MD, PhD has accompanied two groups of CFS/ME patients to stem cells clinics in Costa Rica and Panama this year, and many more will be going to Panama this fall.

The stem cells come from the afterbirth (placenta and umbilical cord) of healthy new born infants and are thus considered adult stem cells, not fetal. Future patients will also be given their own stem cells derived from belly fat in addition to the afterbirth stem cells.

Though it’s early yet to know the full benefit of the stem cell transfusions or how long such benefits will last, initial results range from good to spectacular. This has prompted several CFS/ME patients to seek out stem cell therapy on their own.

Dr. Cheney has three concerns regarding CFS/ME patients undergoing stem cell therapy.

1. Re-Boot Gene Expression
with Cell Signaling Factors

Dr. Cheney believes that better and longer lasting results will be obtained from stem cell therapy if patients first shift or “re-boot” their gene expression to a more normal genetic expression. “Gene expression” may not make sense to some, so here’s a simple explanation. Individual genes are either “on” or “off.” If they are off, something may trigger them into turning on, such as diet, environmental exposures, pathogens, toxins, stress, etc. Once on, it’s a matter of degree, like a dimmer switch. They can be on just a little, on moderately, or on all the way.

In all chronic illnesses, the body attempts to compensate or adapt to the illness. Doing so shifts the gene expression. The gene expression of a person with CFS/ME is far from normal – it reflects the illness.

The overall gene expression is difficult to change. Even if you address the underlying cause(s) of an illness, it can take months or even years for the body to realize the illness is gone and allow the gene expression to gradually shift back to normal.

A great example of this is Dr. Cheney’s own heart transplant made necessary by a diagnosis of idiopathic cardiomyopathy. After two years of increasingly severe symptoms, the underlying problem of heart failure was corrected surgically in a matter of hours. However, even after an outstandingly successful transplant, a resulting cardiac output of someone in their 20′s, and time to recover from the surgery itself, Dr. Cheney’s functional capacity was still very much what it had been before the transplant. He asked his doctors why he still felt so incapacitated. One doctor told him, “Well, your body adapted to the reality of a failing heart in order to survive and now that your heart is fixed, it will take a year or two for your body to re-adapt back to the reality of your new heart.”

In other words, all chronic illness always has two problems to solve: the problem at the core of the illness and the adaptation the body makes to survive. The first can sometimes be fixed very quickly (hours to weeks) but the latter takes time. There is no “hours to weeks fix” to the second problem of adaptation because it becomes programmed into one’s gene expression, also known as phenotype.

Since his surgery and adaptive cure from heart failure, Dr. Cheney has found that certain low molecular weight peptides called Cell Signaling Factors (CSF’s) have the ability to more quickly shift gene expression towards normal as measured by echocardiography. CSF’s can often improve function within 90 days, though tests results show progress well before the patient actually experiences it. For instance, measurements of cardiac diastolic function typically improve months before patients report feeling better and doing more. There is also the problem of genotype corruption which can only be addressed by stem cells.

Over the last three or four years he has determined which CSFs are most beneficial to CFS/ME patients. He does not order them from a company, but has arranged for his own private production of heart, pancreas, liver and kidney from the respective organs of bison. The brain CSF, also privately produced, is of porcine (pig) origin. The CSF’s are in a cream-like form and are typically rubbed into the forearms three times per week to daily.

The use of bison as the primary source for the CSF’s stems from several factors. Bison are incredibly aerobic animals with vast aerobic energetic potential. They are significantly more organic than virtually any other meat source. Finally, they are only one of two known animals who never get cancer, the other being shark. They also live three to four times longer than beef cattle and they do not have “mad-cow” disease, though skin cream makes this a non-issue. Finally, bison CSF’s are 50-100% more potent than comparable porcine or bovine CSF’s, as measured on echo.

Dr. Cheney uses adrenal and thymus CSF’s for testing purposes only – never for treatment. CFS/ME patients respond very negatively to them, usually with a major drop in energy on echo. Adrenal and thymus CSF’s should never be taken by CFS/ME patients. Porcine Liver also has a very negative effect in CFS patients and should not be used either for therapy.

Dr. Cheney is the only source of CSF’s made from bison because at this time he feels that they need to be used only under the care of a medical professional familiar with their use. For this reason, he only sells them to his own patients. He plans to also sell them to a few other physicians who are currently learning about their use, how to incorporate appropriate pretreatments, and how to individualize the CSF protocol for their patients. Information about the physicians who have access to the CSF’s and know how to use them will soon be posted on the Cheney Clinic web site (cheneyclinic.com).

There is anecdotal evidence that the use of CSF’s can significantly improve the benefits of stem cells. An 80-year-old man with Parkinson’s Disease as well as Coronary Artery Heart Disease (history of two heart attacks) was part of the group that received four consecutive daily transfusions totaling 45 million stem cells the last week of May. (He does not have CFS/ME but is related to one of the CFS/ME patients.) He’d been using four of the CSF’s for 18 months. While still in Panama receiving the stem cells, the tremors began disappearing and he was able to hold a fork and eat peas for the first time in two years.

One week after his last transfusion, an echo revealed that an area of his left ventricle (a chamber of the heart) that prior to the stem cell transfusions was dead and not moving, was now alive and moving. At that time he also had much less hand tremor, was walking more upright with much less shuffle and swinging his legs much better when he walked. He threw away his cane. The allergic bags under his eyes disappeared. He looks, acts and talks as if he were 10 years younger. His face is pink now rather than pale and gray. He is more alert and doesn’t slur his words. He feels much better and has much less foot edema. He even went back to work part-time.

The doctors at the Stem Cell Institute, who are familiar with Parkinson’s cases, were astonished at the degree of benefit he experienced, and so quickly. They are very intrigued by the potential of CSF’s to increase the benefits of stem cells.

Three studies* of patients who received stem cell transplants in the 90′s revealed that despite initial success, about ten years later the stem cells had been corrupted and the patients’ disease returned. Though the stem cells worked as expected and lasted 10 years, they were eventually corrupted by the same disease process that damaged the very cells they were replacing.

Dr. Cheney believes that CSF’s are necessary both before and after the transfusions to increase both effectiveness and durability of the stem cells. According to Dr. Cheney, “Putting stem cells into a corrupted environment will eventually corrupt the stem cells and blunt their otherwise potentially impressive benefits.” To use another of Dr. Cheney’s analogies, if you correct the “software” problem first (shift phenotype with CSF’s) and then address the “hardware” issue (shift genotype with stem cells), you’ll get much better results. You don’t expose a new hard drive to corrupted software programs, or the system will crash again! This is why he recommends that his patients continue to use the CSF’s even after the stem cell transfusions. Doing so is designed to prevent the gene expression from shifting back to the configuration of the original illness and corrupting the stem cells.

2. Care Must Be Given to a Corrupted Gut
Ecology Before Receiving Stem Cells.

Recent publications, especially by Kenny De Meirleir out of Belgium, as well as others, suggest that corrupted gut ecology is playing a very large role in a subset of the sickest CFS/ME patients. This corruption must be addressed or it may thwart the effects of stem cells or degrade their benefits over time.

The gut ecology must be measured by appropriate tests (such as the GI [2] panel from Diagnos-Techs, diagnostechs.com) and an integrated effort made to reduce the effects of this corrupted gut ecology on CFS/ME physiology. Stem cells can help attack the root causes of this corruption but the gut corruption and its consequences need to be minimized ahead of the stem cell transfusions. The core approach to improving the gut ecology is a modified elimination diet, copious use of digestive enzymes, immune support using bovine derived antibodies and immune factors (colostrum) and the judicious and careful use of probiotics with special attention to support of commensal E.Coli (a beneficial form of E.Coli marketed as Mutaflor).

3. Go to a High Quality Stem Cell Clinic
Affiliated with a US Company.

Dr. Cheney’s third concern is the quality of the stem cell laboratory and clinic doing the stem cell transfusions. Dr. Cheney chose MediStem, Inc (medisteminc.com), only after careful research and consideration of quality control issues. Medistem Inc. is a US-based company that assists in the operation of two clinics in Central America (cellmedicine.com) because those locations allow them to offer the treatment at a quarter of the cost of the same treatment in a clinic in the United States.

Dr. Cheney met with Neil Riordan, PhD, the laboratory director and CEO of both clinics, and toured their facilities in Costa Rica and Panama before taking patients there. The clinic in Panama is located near, and its doctors associated with, the newest and best hospital in that country. The Punta Pacifica Hospital (hospitalpuntapacifica.com) is located in downtown Panama City and is professionally tied to the Johns-Hopkins University Medical Center. There is, however, no direct association of the stem cell clinic to Johns-Hopkins.

The clinic stem cell laboratory, which produces the afterbirth derived stem cells used in treatment, is located in The City of Knowledge in the former US Canal Zone. Before a company can be established in this prestigious high technology development site, a thorough vetting process and due diligence approval from the Panamanian government is required. The fact that the laboratory is located here signifies its high standards and excellent quality control.

Touring a stem cell clinic and meeting its clinical staff is not the way to judge the level of treatment one will receive. The key to evaluating the quality of stem cells used and the effectiveness of the treatment received is to be found in the laboratory and its quality control operations, as well as the expertise of the laboratory personnel. Bear in mind that the laboratory and the clinic may be located in separate buildings, perhaps even very separate areas of a city.

There are serious concerns about stem cell clinics operating in Mexico and elsewhere. There are many bad actors and poor actors. Some actually transfuse patients with saline and claim that it’s stem cells. Others have no quality control and do not test the viability of their stem cells, which means they may have little power to effect healing. Poor quality control could also lead to lack of sterile procedures and at worst patients could end up with no stem cells and an infection!

Dr. Cheney strongly recommends that clinics and their laboratories in Mexico and elsewhere be carefully scrutinized, especially their quality control procedures, personnel and capitalization. Good stem cell laboratories require millions of dollars to capitalize and cost over a hundred thousand dollars per month to run just for laboratory expenses. They require deep pockets and a decade or more of expertise in the area of quality stem cell production and propagation from afterbirth. Significant capitalization acts to ensure quality control to protect the investment of millions of dollars.

Adult stem cell therapy holds immense hope and possibilities for CFS/ME, but requires a significant investment. Prospective patients should consider such a major investment very carefully and make decisions that ensure the safest, most effective, and longest lasting treatment possible.

For more information about the Cheney Clinic and Dr. Cheney’s research, see cheneyclinic.com and cheneyresearch.com.
_____
* Kordower JH, et al. Mov Disord 2008 Dec 15; 23:2303; Nat Med 2008; 14:501 and 504 (two separate articles)

A pdf of this message may be downloaded at http://sacfs.asn.au/download/CFS+and+Stem+Cells+final.pdf

 

Will Acetaminophen Drugs Be Restricted by the FDA?

 

This week an advisory committee voted to ban prescription pain medications Vicodin and Percocet, and to lower the amounts of Acetaminophen in products that we can currently purchase over the counter (Tylenol, several cold medicines, aspirin and Nyquil).  The advisory committee wants restrictions placed on Acetaminophen-containing products to help prevent a possible severe side effect of the drug – liver toxicity and possible deaths due to overdoses.  While the FDA doesn’t have to follow the advisory committee’s suggestions, they typically do.

According  to the news released from WebMD:

Billions of doses of acetaminophen are used safely every year. But acetaminophen-related overdoses cause 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths annually, according to studies done between 1990 and 1998.

For chronic pain patients, Fibromyalgia patients, and ME/CFS patients who frequently suffer from pain, this news is causing some major concern because the advisory committee wants common prescription Acetaminophen containing drugs banned.  Some of these include Vicodin, Percocet, Darvocet, & Tylenol with codeine to name just a few that contain both Acetaminophen and hydrocodone.   The advisory committee voted 20 to 17 that prescription medications that combine acetaminophen with other medications should be eliminated.

The combination prescription products, which have rapidly increased in use in the last five years, are clearly the biggest cause of the acetaminophen overdose, said Marie Griffin, MD, professor of preventive medicine at Vanderbilt University. But she worried that people will simply turn to plain narcotics, if the combinations are eliminated. “We need a broader answer to chronic pain, because these drugs are being used extensively in the older population,” Griffin said during the meeting. “And I am not sure that practitioners feel like they have many other choices.”

Richard DeNisco, MD, MPH, medical officer at the National Institute of Drug Abuse and a panel member, said that so much acetaminophen is going out to people in hydrocodone/acetaminophen mixes that he is uncertain why there is not more liver damage.  Prohibiting these combined products “would rock the system,” he said, but the two products should be prescribed separately, if necessary.

I have taken certain medications, particularly those for Interstitial Cystitis, where I had to have a blood test to check my liver twice a year but all of the years I’ve been on the Acetaminophen containing pain pills none of the doctors have had my liver checked once.  In my opinion, I think instead of these drugs being banned, because many of us do need them, physicians should be held more responsible for making sure they are prescribing the medications properly and testing their patients’ liver functions.   While there are now a couple of drugs FDA approved for Fibromyalgia, it is much cheaper to get drugs like Vicodin and Percocet than it is to get Cymbalta or Lyrica. 

I also think that the FDA should put stronger warning labels on the drugs but it will be a major upset to ban them all completely.  What will chronic pain patients do without these?  Over the counter pain medications do not work and if they lower the amount of Acetaminophen in OCT drugs, pain patients will probably take several pills at once just to try and get a little relief.

The advisory committee is recommending to the FDA that the daily dosage for adults of acetaminophen should be no more than 650 mg.  Currently two tablets of OCT medications contains approximately 1,000 mg. of acetaminophen. 

What do you think is going to happen?  Do you think the acetaminophen/hydrocodone  drugs will be banned?  What will be used to replace them or will they just be prescribed separately?

Still No Decision By FDA On Ampligen for Treating ME/CFS

On May 29th, I posted about the FDA postponing their decision on approving Ampligen as the first FDA approved treatment for ME/CFS.   At that time, I posted that the FDA reported that they needed an additional week or two in order to make their decision.   Allegedly, the delay was due to staff scheduling changes.  We are still patiently (and some patients probably not so patiently waiting) approval of this drug to help ease ME/CFS symptoms.  Ampligen will not be a cure or a magic pill for ME/CFS but anything that helps ease the symptoms is better than what we currently have to choose from.

Ampligen has received a lot of press recently and I have posted about both the positive and the negative if you look back over my posts the past several weeks under ME/CFS & Fibromyalgia Around the Web.   I had also received a few comments (which I deleted) that were not so happy with me posting the negative press on Ampligen.  Why is it that people have issues with me posting all sides of ME/CFS and Fibromyalgia?  It’s like certain people who read this site only want to read one side or their own personal opinion on these health issues and I refuse to do that.  In order for balance, and for everyone to make an informed decision, I think it’s important to post everything that is available on the illnesses and possible treatments.

To read more posts I have devoted to Ampligen, please click the links below.

• FDA Approval Sought for Ampligen
• FDA Accepts Antiviral Drug Ampligen For Review To Treat ME/CFS
• Approval Delayed Again By FDA

I have read reviews of Ampligen from those who were involved in the clinical trials saying that they had negative results from it and I have also heard stories of thsoe who were finally able to function as a result of Ampligen.  One of the pro-Ampligen ME/CFS sufferers is Mary Schweitzer and you can read about her journey with Ampligen in her Ampligen Diaries.  Mary is also a ME/CFS advocate and you can read more of her work on Life with ME/CFS – Essays by Mary Schweitzer.

Ampligen Delayed Again By FDA

The FDA has delayed once again the approval of Ampligen as the first prescription treatment for ME/CFS.  The FDA’s decision was supposed to be due on May 25th.  The first approval date was set to be sometime in February and was then postponed for a May decision. 

Hemispherx, the manufacturer of Ampligen, says that the FDA needs another week or two because of staff scheduling changes.  Is this really the hold up or is it just the FDA still not taking ME/CFS seriously?  CFS has been put on the back burner by the FDA many times over the years and we (CFS patients) have felt neglected and have felt that the FDA does not consider our illness as debilitating or as serious as some other illnesses.

Not only has Ampligen been studied for treating ME/CFS but it has also been studied to treat AIDs, Hepatitis B & certain types of cancer.  Side effects of Ampligen include flu-like symptoms that Hemispherx says will typically subside after the patient has used the medication over time.  Ampligen is said to work by down regulating an immune pathway (RNase L), which allows the immune system to fight infection better.  According to a study by Dr. Richard Podell, Ampligen increased performance of ME/CFS patients on a treadmill by 22% after patients were treated for 40 weeks.

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers & Fever Reducers

For immediate release by FDA News

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today’s date.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

Source:  http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html

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