Drug May Substitute For Exercise

They were discussing the drug that supposedly substitutes for exercise. 
The doctor they talked to said he can see where it would be of help to
people in wheelchairs who can't exercise.
http://www.mandjshow.com/videos/exercise-in-a-pill/

The nutritionist and trainer (i.e., no medical training) completely
ignored the part about people who "can't exercise" and insisted that
there's no solution but exercise.

The drug made mice lose weight, run 44% further and for 23% more time.

In short, the doctor thinks this is valid research (from the respected
Salk Institute) and the drug shows promise.  It makes more mitochondria
(which Cheney thinks is a problem in CFS) "which is the engine that
drives muscles".  The heart is getting stronger.  His conclusion: "The
science may actually bear out" when applied to humans.

I agree with the concerns of the trainer and nutritionist that
otherwise healthy people may use this drug as a substitute for diet and
exercise.  However, it will be a PRESCRIPTION drug, therefore, they
can't get it without the compliance of a doctor.  Their doctors simply
need to stand up to them in the same way that my doctors stood up to me
when I requested the expert-recommended sleeping pills and pain pills,
and tell them "No, I want to prescribe something else instead."

If I'd been able to get any drug just because I wanted it, I wouldn't
be in my 8th year of relapse: I would have been back to work within a
few months.

If the drug is misused, not limited to just those of us who physically
can NOT exercise, don't blame the patients; blame the doctors who wrote
the prescriptions.

Laziness vs. CFS

http://www.time.com/time/health/article/0,8599,1827106,00.html

Is there a laziness gene?

(excerpts)

Based on some intriguing preliminary studies in animals, J. Timothy Lightfoot, a kinesiologist, and his team at the University of North Carolina, Charlotte, suggest that genetics may indeed predispose some of us to sloth. Using mice specially bred and selected according to their activity levels, Lightfoot identified 20 different genomic locations that work in tandem to influence their activity levels

Lightfoot, who originally wanted to coach college basketball and is himself an avid athlete, began studying activity levels as a way to try to figure out why, given all we know about the overwhelming health benefits of physical activity, so many people still choose not to exercise.

Exercise-prone mice put in a good 5 to 8 miles per day (the equivalent of an average man running 40 to 50 miles a day) vs. 0.3 miles per day for inactive mice. While the exercise wheels of the activity-prone mice would turn all night, some of the sedentary mice devised ingenious ways to avoid activity.

"When we used to talk about activity, it was whether or not people decided to be active," says Lightfoot. "Now it's clear that there's an inherent drive as to whether one is active or not active."

Exactly how that drive plays out in the body is still a mystery. There are two theories, Lightfoot says: Genes may affect either the way muscles work — perhaps causing them to use energy more efficiently and preventing fatigue — or some higher-order biochemical circuit in the brain, such as levels of the neurotransmitters dopamine or serotonin.

* * *

We’ve all known people who are too lazy to get off the couch, and then there are CFS patients, many of whom were avid athletes (both casual and Olympian) before they got sick, and would love to return to their previous level of activity. As Lightfoot says, "an inherent drive" to be active.

Had you asked my hobbies in 1982, 5 years before the virus, I would have told you dancing, playing volleyball, playing softball and taking long walks/hiking in the nearby mountains. I walked 3-4 miles a day on weekdays and 10-20 on weekends. Stitching was something I did on lunch hours and buses, places I couldn’t dance or play volleyball, and reading was only when it was too dark or rainy to be outdoors.

Had you asked my hobbies in 1992, 5 years after the virus, they would have been sitting on the couch stitching, sitting on the couch reading, and sitting on the couch watching other people play baseball. My personality hadn’t changed, but my health had – there was a Volleyball Café between the bus stop and my apartment, which was taking sign-ups for evening leagues, but by the time I got to their driveway, I was so exhausted from working an 8-hour day that I didn’t have it in me to walk through the parking lot to get to the café to sign up ... much less to actually play. I thought about it every day for a couple of years, and every day it was the same thing: "I’m not sure I have enough energy left to walk the 2 more blocks home without resting, I certainly am not able to play volleyball for an hour."  That's the "inherent drive" to be active, despite the illness that left me unable to be as active as I once was.

Had you asked my hobbies in 2002, 15 years after the virus, I would have told you my hobbies were lying squarely in the middle of the bed, flat on my back, hoping that I would not pass out, and praying for the screaming tinnitus to stop before it drove me to suicide. I couldn’t sit up to stitch, I couldn’t concentrate enough to read, and I kept the TV tuned to the talking heads on CNN because music of any sort (even the almost imperceptible background music of a movie) was too often in a key that clashed with the ringing in my ears. I hadn’t stopped thinking "I’d love to take a walk and go exploring", but the simple fact was, if I got off the horizontal I very quickly got dizzy and frequently passed out.

This is the difference between CFS and depression: people with depression have no desire to be active; they’re perfectly happy to stay on the couch. People with CFS want to get up and go out and do the things they used to do, but their bodies don’t cooperate. There’s the constant frustration of that "inherent drive" to be active, and the reality that if you stand up from the couch, you’re going to come to on the floor.

People’s personalities don’t change. Avid athletes don’t one day decide to become couch potatoes, and overachievers don’t overnight turn into sloths. The hard-charging businessman who escapes the rat race often starts training for a different kind of race, having been the best in his field, he now wants to best a field of world-class marathoner. The top lawyer, having made his millions, sets out to be a top-selling novelist. But, barring some outside force, like post-viral paralytic muscle weakness, avid athletes don’t take to their beds like delicate Victorian ladies. It’s just not in their nature.

Yet, despite the large number of CFS patients who were avid athletes, and the observations of CFS experts like Dr. Bell that patients tried to go back to their athletic endeavors and relapsed, the myth still remains that CFS patients are merely lazy and all they need is a kick in the butt to get off the couch and back to work.

Hopefully this genetic research proving that some people are born lazy and some are born active will quash that myth once and for all, and those of us who were once athletic and are now disabled will not have to listen to the rantings of those who think we've simply become lazy.

Ampligen (one of two drugs effective against CFS)

FDA accepts antiviral drug AmpligenR for review as first-ever ME/CFS
(`chronic fatigue syndrome') therapeutic

ImmuneSupport.com

07-08-2008

July 8 – After 30 years in development and testing, the
experimental "antiviral/immune modulatory" drug AmpligenR has been
accepted by the FDA for review as potentially the first prescription
drug approved in the U.S. for treatment of ME/CFS – specifically for
certain patients with severe ME/CFS.

Delivered intravenously, typically twice weekly over a year or more,
AmpligenR (AMPLified GENetic activity) has been available in Belgium and Canada for ME/CFS and HIV treatment since 1996.

AmpligenR (polyI:polyC12U) - still allowed only in specific clinical
trial settings conducted under U.S. governmental authorization - is
termed "a nucleic acid drug," designed to "modulate" the body's
immune system. Its mechanism of action in ME/CFS "is not entirely
clear," but it is thought to act on two enzyme systems so as to help
the immune system destroy viral RNA and speed the death of virus-
affected cells. In particular it may "downregulate" an anti-viral
pathway which research suggests has become "upregulated" in certain
ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).

The drug's maker – Philadelphia-based Hemispherx Biopharma, submitted
a New Drug Application to the FDA in 2007, and had been asked to
answer a series of questions. The FDA's acceptance of the drug for
safety/efficacy review was based on receipt of the requested data.
The maker reportedly suggests it is also researching oral delivery of
the drug.

A "Who's-Who" of the world's leading ME/CFS specialists have
participated in AmpligenR trials over the years.
---

To: All
From: Mike

At the last support group meeting (July 6th) we briefly discussed the
two new drugs approved by the FDA for the treatment of Fibromyalgia
(Lyrica and Cymbalta). I mentioned my feeling that the approval of
those drugs for FM pain made a huge difference in the perception of
the public and the medical community that Fibromyalgia was a real and
serious condition.
There is no similar FDA approved drug for the treatment of ME/CFS.
The one drug closest to approval is Ampligen. The article that I
posted says that Ampligen was "accepted" for study of efficacy and
safety by the FDA.
The process of getting approval by the FDA for a new drug is long,
expensive, and painstaking. Ampligen has been studied and tested for
over 30 years. Partly that's because the drug company making Ampligen
is very small and has a "checkered" history. They've almost gone
bankrupt a few times and they've never had success getting any drug
approved previously, that I know of.
Having said that, Ampligen is now on the FINAL step to getting FDA
approval. They've done the clinical trials, they've submitted an NDA
(a NEW DRUG APPLICATION), they've done everything the FDA wanted them
to do, to this point.
Now the FDA has to look at the results of the clinical trials done by
the drug company and decide if Ampligen is superior to placebo,
effective in treating CFS, what potential side effects there are, and
then render a verdict. This could still take months, but after 30 years we have never been this close to a drug approved specifically for CFS.
Mike
---

Ampligen, if approved by the FDA, would be a very expensive drug. I
think someone (Karen?) at the support group meeting said it ran a
couple thousand dollars per dose. That would still be the going rate
if it got approved by the FDA, so it's doubtful that many insurance
companies are going to jump to cover the cost of the treatments.

It is true that once a drug gets FDA approval, more doctors will feel
comfortable prescribing it to patients. If the drug begins to show
positive results, and doctors increasingly prescribe it, the cost of
the treatments will often go down. (Simple supply and demand, the
drug company doesn't have to charge as much per dose if they can sell
more of the doses.)

I don't think the average CFS/ME patient would be able to obtain
Ampligen at first. But I do think if the drug were to receive FDA
approval, that would be a huge psychological boost to patients with
this illness. As we've learned, the path to respect is slow, and once a drug is approved specifically for CFS it's another step to respectability. After all, how can there be a drug for an illness, if there's no illness? It MUST be REAL. RIGHT?

Keeping my fingers crossed.
Mike
* * *

According to "Osler's Web" (page 538) in 1991 Dr. Peterson observed "There's not a chance the Food and Drug Administration is going to approve this drug.  How can they approve a drug for a disease the NIH says doesn't exist?"

Dr. Cheney predicted they would delay approval as long as possible.  "They don't have the guts to kill it, because the patients will kill them.  But they don't have the guts to approve it, because Straus will kill them."

Straus is gone now, so maybe now, after decades of delays and excuses, we can finally get the best available drug to treat CFS.

As Mike points out, it's currently dreadfully expensive.  However, a lot of CFS patients were in good-paying careers before they were struck down.  If the government were willing to pay for me to get it for the first year or so, until I have enough improvement to go back to my former career, I would then be earning enough to cover the cost myself until retirement age.   Unfortunately, our government being pennywise and pound-foolish, I suspect that they would rather do without the next 20 years of my paying taxes on that good income than to pay the upfront costs of treatment that might get me back to work.

Speed of Mental Operations in Fibromyalgia

Speed of Mental Operations in Fibromyalgia: A Selective Naming Speed Deficit.

J Clin Rheumatol. 2008 Jul 17. [Epub ahead of print]

Leavitt F, Katz RS.

From the Department of Behavioral Sciences; and Department of
Internal Medicine, Section of Rheumatology, Rush Medical College, Chicago, IL.

PMID: 18636019


OBJECTIVE: Abnormal processing of information in fibromyalgia may
hold clues to brain abnormalities in this illness. The purpose of
this study is to examine the speed of mental operations in people
with the fibromyalgia syndrome (FMS) under the pressure of time. The
central question addresses whether FMS is associated with processing
speed deficits across a spectrum of speeded tasks.

METHODS: Sixty-seven patients with fibromyalgia with a history of
memory complaints and 51 controls presenting with complaints of
memory loss completed 10 timed cognitive measures of processing
speed. Controls were patients with memory complaints who did not have FMS.

RESULTS: The majority of FMS patients (>70%) performed within 1
standard deviation of the norm on 7 or more of 10 speeded measures.
However, more than 49% of FMS patients tested as impaired (>1.67 SD
below normative mean) on 2 specific validated speed tasks (reading
words and naming colors). Compared with controls, the number of FMS
patients showing impairment was 2.0 times greater for reading speed,
and 1.6 times greater for color naming speed. A mean time delay of
203 milliseconds was recorded for reading words and 285 milliseconds
for naming colors in the FMS impaired sample. A 203 milliseconds
delay in reading words represents a 48% (203/417) time increase over
the normal time for reading the same stimulus word.

CONCLUSION: Abnormalities in naming speed are an unappreciated
feature of FMS. Selective deficits in naming speed in association
with otherwise well preserved global processing speed set patients
with FMS apart from controls with memory complaints. Clinicians would
be wise to specifically request adding a rapid naming test such as
the Stroop Test to the cognitive battery; to document cognitive
dysfunction in FMS patients who otherwise appear to test normally,
despite often intense complaints of memory and concentration
difficulties that can affect job performance and increase disability.

* * *

Dr. Sheila Bastien has also identified a neuropsychological "signature" for CFS, which is very different from the test results for depression.  If you're applying for Disability, your attorney may want to read the sections of "Osler's Web" relating to Dr. Bastien's testing to verify that your test results are what they should be.

Fibromyalgia on CNN.com

http://www.cnn.com/2008/HEALTH/conditions/07/14/hm.fibromyalgia/index.html

(excerpts)

Lieberman believed it is related to a disordered sleep pattern and poor exercise. "It appears to be more of a neuro-chemical process," he said. "In other words, there really is no inflammation in patients with fibromyalgia."

Getting a proper diagnosis can sometimes be just as frustrating as finding out what's behind the disease.

"Fibromyalgia is to some extent a diagnosis of exclusion," Lieberman said. "There are lot of things it can be confused with such as thyroid disorders, metabolic disorders and certain rheumatologic inflammatory conditions."

"Sometimes fibromyalgia is used as a wastebasket term if a patient has pain and they don't know what it is from," he said. "It is frequently misdiagnosed. In fact, it is overdiagnosed and it is underdiagnosed."

The doctor is quick to point out that even with proper medication and adequate exercise, fibromyalgia has no cure.

Although Lieberman said some of his patients report the symptoms tapering off in their mid-50s and -60s, others are faced with years of managing the condition.

* * *
One of the problems faced by fibro patients is that they have routinely been sent to rheumatologists, who know everything about inflammatory conditions like arthritis, and try to treat fibro the same way.  Except that fibro is non-inflammatory, so NSAIDs won't do anything except give you an ulcer.

CFS, like fibro, is both under-and over-diagnosed.  There are doctors who think every case of "fatigue" is CFS, and others who diagnose every case of CFS as depression.  It's critical to get your diagnosis confirmed by an expert, so that you're not taking the wrong pills that won't help you (and may make you worse).

Empowerment from Online Support Groups

Note: The full text of this article is available
for free at
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2483925  .
_______________________________________________________________________________



Self-reported differences in empowerment between lurkers and posters
in online patient support groups.

J Med Internet Res. 2008 Jun 30;10(2):e18.

van Uden-Kraan CF, Drossaert CH, Taal E, Seydel ER, van de Laar MA.

Institute for Behavioural Research, University of Twente, PO Box 217,
7500 AE Enschede, The Netherlands.
c.f.vanuden-kraan@utwente.nl

PMID: 18653442


BACKGROUND: Patients who visit online support groups benefit in
various ways. Results of our earlier study indicated that
participation in online support groups had a profound effect on the
participants' feelings of "being empowered." However, most studies of
online patient support groups have focused on the members of these
groups who actively contribute by sending postings (posters). Thus
far, little is known about the impact for "lurkers" (ie, those who do
not actively participate by sending postings).

OBJECTIVE: In the present study, we explored if lurkers in online
patient support groups profit to the same extent as posters do.

METHODS: We searched the Internet with the search engine Google to
identify all Dutch online support groups for patients with breast
cancer, fibromyalgia, and arthritis. Invitations to complete an
online survey were sent out by the owners of 19 groups. In the online
questionnaire, we asked questions about demographic and health
characteristics, use of and satisfaction with the online support
group, empowering processes, and empowering outcomes. The online
questionnaire was completed by 528 individuals, of which 109 (21%)
identified themselves as lurkers.

RESULTS: Lurkers (mean age 47 years) were slightly older than active
participants (mean age 43 years, P = .002), had a shorter disease
history (time since diagnosis 3.7 years vs 5.4 years, P = .001), and
reported lower mental well-being (SF 12 subscore 37.7 vs 40.5, P =
.004). No significant differences were found in other demographic
variables. Posters indicated visiting the online support groups
significantly more often for social reasons, such as curiosity about
how other members were doing, to enjoy themselves, as a part of their
daily routine (all P < .001), and because other members expected them
to be there (P = .003). Lurkers and posters did not differ in their
information-related reasons for visiting the online support group.
Lurkers were significantly less satisfied with the online support
group compared to posters (P < .001). With regard to empowering
processes such as "exchanging information" and "finding recognition,"
lurkers scored significantly lower than posters. However, lurkers did
not differ significantly from posters with regard to most empowering
outcomes, such as "being better informed," "feeling more confident in
the relationship with their physician," "improved acceptance of the
disease," "feeling more confident about the treatment," "enhanced
self-esteem," and "increased optimism and control." The exception was
"enhanced social well-being," which scored significantly lower for
lurkers compared to posters (P < .001).

CONCLUSION: Our study revealed that participation in an online
support group had the same profound effect on lurkers' self-reported
feelings of being empowered in several areas as it had on posters.
Apparently, reading in itself is sufficient to profit from
participation in an online patient support group.

Distrust of the Medical System (well-earned, I say!)

http://www.nytimes.com/2008/07/29/health/29well.html?th&emc=th  

July 29, 2008

Well

Doctor and Patient, Now at Odds

By TARA PARKER-POPE

A growing chorus of discontent suggests that the once-revered doctor-patient relationship is on the rocks.

The relationship is the cornerstone of the medical system —nobody can be helped if doctors and patients aren’t getting along. But increasingly, research and anecdotal reports suggest that many patients don’t trust doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of "what your doctor won’t tell you" books promising previously withheld information on everything from weight loss to heart disease.

The Internet is bristling with frustrated comments from patients. On The New York Times’s Well blog recently, a reader named Tom echoed the concerns of many about doctors. "I, as patient, say stop acting like you know everything," he wrote. "Admit it, and we patients may stop distrusting your quick off-the-line, glib diagnosis."

Doctors say they are not surprised. "It’s been striking to me since I went into practice how unhappy patients are and, frankly, how mistreated patients are," said Dr. Sandeep Jauhar, director of the heart failure program at Long Island Jewish Medical Center and an occasional contributor to Science Times.

He recounted a conversation he had last week with a patient who had been transferred to his hospital. "I said, ‘So why are you here?’ He said: ‘I have no idea. They just transferred me.’

"Nobody is talking to the patients," Dr. Jauhar went on. "Everyone is so rushed. I don’t think the doctors are bad people – they are just working in a broken system."

The reasons for all this frustration are complex. Doctors, facing declining reimbursements and higher costs, have only minutes to spend with each patient. News reports about medicalerrors and drug industry influence have increased patients’ distrust. And the rise of direct-to-consumer drug advertising and medical Web sites have taught patients to research their own medical issues and made them more skeptical and inquisitive.

"Doctors used to be the only source for information on medical problems and what to do, but now our knowledge is demystified," said Dr. Robert Lamberts, an internal medicine physician and medical blogger in Augusta, Ga. "When patients come in with preconceived ideas about what we should do, they do get perturbed at us for not listening. I do my best to explain why I do what I do, but some people are not satisfied until we do what they want."

Others say the problem also stems from a grueling training system that removes doctors from the world patients live in.

"By the time you’re done with your training, you feel, in many ways, that you are as far as you could possibly be from the very people you’ve set out to help," said Dr. Pauline Chen, most recently a liver transplant surgeon at the University of California, Los Angeles, and the author of "Final Exam: A Surgeon’s Reflections on Mortality" (Knopf, 2007). "We don’t even talk the same language anymore."

Dr. David H. Newman, an emergency room physician at St. Luke’s-Roosevelt Hospital Center in Manhattan, says there is a disconnect between the way doctors and patients view medicine. Doctors are trained to diagnose disease and treat it, he said, while "patients are interested in being tended to and being listened to and being well."

Dr. Newman, author of the new book "Hippocrates’ Shadow: Secrets from the House of Medicine" (Scribner), says studies of the placebo effect suggest that Hippocrates was right when he claimed that faith in physicians can help healing. "It adds misery and suffering to any condition to not have a source of care that you trust," Dr. Newman said.

But these doctors say the situation is not hopeless. Patients who don’t trust their doctor should look for a new one, but they may be able to improve existing relationships by being more open and communicative.

Go to a doctor’s visit with written questions so you don’t forget to ask what’s important to you. If a doctor starts to rush out of the room, stop him or her by saying, "Doctor, I still have some questions." Patients who are open with their doctors about their feelings and fears will often get the same level of openness in return.

"All of us, the patients and the doctors, ultimately want the same thing," Dr. Chen said. "But we see ourselves on opposite sides of a divide. There is this sense that we’re facing off with each other and we’re not working together. It’s a tragedy."

well@nytimes.com

* * *

Too many doctors have only themselves to blame.

As Dr. Jerome Groopman wrote in "How Doctors Think", they often leap to conclusions after hearing just a few symptoms, and then ignore any evidence that they are wrong.

In 1988, I received a diagnosis from a virologist. That diagnosis was later confirmed by another specialist. Yet, in 2000, a PCP who was bound and determined to see a depressed divorcee convinced himself that both experts were wrong and he was right.

Had this doctor been honest with me upfront, that he does not know the first thing about the condition I was previously diagnosed with, I would have gone to someone else, no harm, no foul. Instead, he strung me along for months with empty promises that I'd get the tests I wanted and the referral to the specialist "next time" -- his ego was more important to him than my health. Now, because of him, I cannot work full-time, but I am also precluded from getting Disability benefits.

His best defense was "nothing you said made sense" ... which is true: nothing that I said made sense in the context of post-divorce depression because I was not describing depression. I was describing a post-viral neurological condition. But he'd already made up his mind what he was supposed to hear, and discarded all the puzzle pieces he was given that would have produced the correct diagnosis.