Treatments

Study Found Isentress (AIDS Drug) Blocks XMRV

A recent study by the University of Utah & Emory University has found that Isentress, Merck’s AIDS treatment drug, fights the XMRV virus. While researchers are still saying that it is way too early to suggest that Isentress as a ME/CFS treatment, there is promise for the future with this drug.

From what I read on Dr. Teitelbaum’s blog researchers stated that:

…Isentress found the XMRV virus “more powerfully than 44 other anti-HIV compounds tested against the pathogen in laboratory experiments. According to a statement from Emory, GlaxoSmithKline’s Retrovir and Gilead Sciences’s Viread also prevented XMRV from replicating.

The results will need to be seen in clinical trials before the drugs can be used in a clincial setting.

Isentress is the first in a new class of AIDS medicines that halt HIV by blocking an enzyme called integrase, which the virus uses to insert its genetic material into the nucleus of healthy immune cells.

Methylation Protocol Effective Treatment for ME/CFS & Fibromyalgia

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In my previous post, I announced the release of a great new book by Dr. Neil Nathan, On Hope and Healing: For Those Who Have Fallen Through the Medical Cracks. In this book, Dr. Nathan discusses an effective treatment that he has found for ME/CFS & Fibromyalgia patients called the Methylation Protocol. Dr. Nathan says:

I suspect that the words “methylation protocol” are, at first glance, intimidating. But if you will hang in with me for a few paragraphs, I would like to make this both understandable and useful.

First of all, what is most important is that we have recently shown that the use of tiny doses of very specific combinations of vitamin B-12 and folic acid, has resulted in significant improvement in patients with fibromyalgia and chronic fatigue. That’s the bottom line.

So, if you are suffering with chronic fatigue and/or fibromyalgia, you may be interested in learning more about our research, and what we learned.

Let’s start with the word “methylation” and de-mystify it. In chemistry, a methyl group is simply a carbon atom surrounded by 3 hydrogen atoms, with chemically looks like this:

H
C — H
H

This grouping acts as a unit and if we tack this unit, this methyl group, on to another molecule, that is what we mean by methylation.

According to Dr. Nathan, methylation is critical to many of the important chemical reactions that we have in our bodies. We need methylation to create energy, glutathione, repair DNA, and to make melatonin from serotonin. These are just a few of the necessary functions that our bodies need to “methylate”.

Through research, Dr. Nathan says that they have recently begun to understand is that many of us are genetically compromised with the ability to “methylate”. Then when we get sick, like with CFS, Fibro, or another illness, it just adds a whole new level of difficulty to our illness and our body cannot compensate for it. But the good news is that this can be fixed. Nathan says:

By taking a combination of what are essentially vitamins, we can bypass these genetic “blocks” to methylation, and restore the body’s normal chemistry.

This concept was pioneered by Dr. Amy Yasko, who was working primarily with autistic children. She found that by treating methylation blocks many autistic children recovered to a remarkable extent. She suspected that other illnesses, such as chronic fatigue, fibromyalgia, Parkinson’s disease and other neurodegenerative diseases had a similar problem. Dr. Rich van Konynenburg, a biochemist, picked up on her concept and applied it to chronic fatigue and fibromyalgia. In a series of papers, he demonstrated that virtually every known biochemical imbalance known to occur in fibromyalgia and chronic fatigue could be explained by this inability to methylate properly.

How did the protocol work out after Dr. Nathan tried it on his patients?

Hearing Rich’s lecture in 2007, and having a huge practice of fibromyalgia and chronic fatigue patients, I was excited to try out this hypothesis on some of my sickest patients. These patients had not fully responded to the treatment program pioneered by Dr. Teitelbaum, which I have utilized for over 15 years now. As soon as I got back to my office, I gave 50 patients this combination of B-12, folic acid and vitamins recommended by Dr. van Konynenburg which was based on recommendations from Dr. Yasko.

To my delight, 70% of my patients had improved within 3 months, and 20% reported that they were much better, occasionally to the point of feeling cured.

Dr. Nathan then received a private research grant and was able to conduct a more formal study that didn’t involve any of his previous study patients. The 30 new study participants took the glutathione and SAM supplements for six months and improvements were greatly noted. Initially, the study participants all were found to have abnormal results on their methylation tests. Hopefully with research and time, patients will soon be able to access basic health insurance marketplaces to obtain specific treatment. Here were how the results played out in the study:

The initial methylation testing showed that every single patient had abnormal results. The average starting value of glutathione in our patients was 3.2 mmol/L (normal being 3.9-5.5 mmol/L)), and the average starting value for SAM (the major methylator) was 218 mmol/L (normal being 221-256 mmol/L). 83% started with low glutathione levels.

Can we demonstrate that taking these supplements raises those numbers into the normal range?

Yes.

After 3 months, the average glutathione level was 3.8 mmol/L

After 6 months, the average glutathione level was 4.3 mmol/L

After 9 months, the average glutathione level was 4.7 mmol/L, which represents a 47% improvement, and ALL patients now had a normal level.

After 3 months, the average SAM level was 227 mmol/L

After 6 months, the average SAM level was 238 mmol/L

After 9 months, the average SAM level was 241 mmol/L, with only one patient not up into the normal range

The average improvement was rated by our patients as 48%. Note that 27% reported so much improvement that they now felt essentially well! Several, who had not worked in over 5 years, were able to resume full-time employment without difficulty. It took an average of 5-6 weeks before the supplements started to work, and we can clearly show that the longer patients stayed on this program, the better they got.

Not everyone got better, but the vast majority (86%) improved.

Out of Dr. Nathan’s original 30 patients, all 30 completed the first three months of the study and 29 patients completed the first six months. There were a total of 25 out of the 30 who completed the full 9-month program. Nathan says that it is rare to run a study for so long and to have this type of participation the whole way through. The patients who dropped out: 3 left the program because they felt so well they didn’t see any need to continue; 1 left to have hip replacement surgery; and there was only 1 patient who dropped out because she didn’t see any improvement after six months.

If this protocol proves to be amazing as this study makes it sound, maybe there is new hope for us all. Dr. Nathan warns that while there are no known side effects to this protocol, there may be a detoxification reaction from mild to severe. This is due to the body’s improved ability to methylate and make more glutathione. He recommends that you do not try this program without the supervision of your physician.

FDA Limits Acetaminophen/Opioid Combination Dosages

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The FDA announced yesterday, 1/13/11, that they were asking manufacturers of prescription acetaminophen and opioid combination medications to 325 mg. per capsule, tablet or dosage unit, whatever may apply. According to the FDA, they believe that by reducing the dosages of acetaminophen in these medications, it will reduce the risk of liver damage that may occur due to acetaminophen overdosing. Liver injury from acetaminophen overdosing can lead to liver failure, liver transplant and even death.

Also in the FDA Safety Announcement released yesterday, the FDA states that a BOXED WARNING that highlights the potential for severe liver injury & a WARNING that highlights the potential for allergic reactions will be added to all drug products that contain acetaminophen. These reactions may include: swelling of the mouth, face and throat, breathing difficulties, itching or rashes.

Part of the release statement says:

These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.

Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).

OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.

What do you think of this change? How will this affect the chronic pain society? Will people start taking more medication to try and get relief? Let me know your thoughts in the comments!

Please check out the links below for more information from the FDA on the acetaminophen information:

FDA Bans Darvocet & Darvon (Propoxyphene) from Market

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The FDA removed Darvocet & Darvon from the market on November 19th citing serious heart risk. The FDA also warns that anyone taking these medications should call their doctor immediately. Darvocet & Darvon contain the opioid propoxyphene, which is used to treat mild to moderate pain. Darvocet combines both propoxyphene and acetaminophen and is the generic version of the branded drug, Darvon. There are also other generic versions containing propoxyphene.

The FDA is stating that there is now data showing that the use of propoxyphene can be damaging to the heart by causing “significant changes to the electrical activity of the heart” that can seriously affect heart rhythms and even cause sudden death. The better news being that apparently “once patients stop taking propoxyphene, the risk will go away.”

To view the full press release and to watch the video from the FDA website, please visit the link below.

Please comment if you will be affected by this ban and are worried about what you will do now for pain relief for your Fibromyalgia and/or CFS.

FDA NEWS RELEASE: Xanodyne agrees to withdraw propoxyphene from the U.S. market

XMRV-Positive Patients Respond Well to Ampligen Treatment

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There was a 40-week trial using the drug Ampligen to treat XMRV-positive tested patients. Only severely debilitated patients were selected for this study. Below is an excerpt from ProHealth and the link to the rest of the article on the study:

Retrovirus antibody positive CFS patients show response to Ampligen®, an experimental therapeutic, relative to XMRV negative group.

Hemispherx Biopharma, Inc. [presented] new clinical data(1) on the possible inter-relationships of XMRV positivity/chronic fatigue syndrome/Ampligen® responsiveness at the 1st International Workshop on XMRV held at the National Institutes of Health in Bethesda, MD, on September 7 and 8, 2010.

CFS is a severe disorder consisting of profound fatigue and a variety of other debilitating symptoms that affects up to 4 million Americans. Recently, DNA was identified from a human gamma retrovirus (XMRV) in 67% of CFS subjects. Evidence also suggested that approximately 50% of the CFS subjects mounted a specific antibody response against XMRV.

Source: XMRV-Positive Patient Responses to Ampligen® � 40-Week Trial Reported Sep 8 at XMRV Workshop

FDA Returns Midodrine To Market for Orthostatic Intolerance

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Just two weeks ago, the FDA had announced that they would be taking the drug midodrine off the market but now they have backtracked and decided to continue marketing the drug for orthostatic intolerance. The FDA originally stated they were pulling the drug because the drug maker’s had never confirmed that the medication helped allieviate the symptoms of orthostatic intolerance, which include dizziness and fainting for some people.

Apparently, many of the 100,000 patients that use midodrine complained heavily to the FDA so they decided to leave the drug on the market. According to the New York Times article:

In a different situation, we might act differently,” said Dr. Joshua Sharfstein, principal deputy commissioner. “But in this case, it does not make sense to pull access to the drug while we get better data.”

Dr. Janet Woodcock, director of the agency’s drug center agreed. “Patients are out there thinking doom is about to fall, and they can’t go about their normal business,” she said.

The agency’s flip-flop demonstrates the difficult choices regulators face in policing the nation’s drug market. Cracking down on drug makers sometimes means stranding desperate patients. And now that Congress has given the Food and Drug Administration greater powers to insist on better information about life-saving medicines, such disputes may become more common.

Is Anyone Using Medifast?

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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

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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

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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?

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421021_medication

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?

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