One FDA approved drug for ME/CFS will change how the medical profession views this disorder forever
We are asking your help to continue to push for treatments for ME/CFS. Our ME/CFS Treatment team will continue to work for meetings between the FDA and pharmaceutical companies with the sole purpose of urging them to develop and approve drugs to treat ME/CFS. People with this disorder must not be forgotten!
While many felt Ampligen did not receive a fair review at the Advisory Committee Meeting in December 2012, the FDA has taken positive steps. The Stakeholder’s Meeting and the Voice of the Patient document opened the FDA’s eyes to the debilitating effects of ME/CFS, and the FDA responded by stating they consider ME/CFS to be a serious disorder on par with diseases like heart failure and kidney disease.
That was a good beginning, but it’s only the start. One drug across the finish line will change the course of this disease forever.
(1)It will for the first time make an approved treatment available for ME/CFS patients everywhere.
(2)It will make the disease “real” in the minds of doctors and the public because there is a drug for it.
(3) A successful drug will encourage pharmaceutical companies to develop other treatments for it.
Ampligen
The FDA can do much more to approve Ampligen. It showed how much more it can do when it gave 6000 healthy Princeton students access to the drug Bexsero, unapproved by the FDA, because they might develop meningitis in the future. If Princeton students can get access to a drug for a condition they don’t haveand may never get,we believe people with ME/CFS should have access to a drug for use today that has been used safely by hundreds of patients, and which the FDA’s own panel voted was safe enough.
With Bexsero the FDA showed that when it wants to deliver a drug to a group in need it can find a way.
We believe ME/CFS patients have a right to try Ampligen, just as the Princeton students had a right to choose Bexsero. (Learn more about the Bexsaro story hereand here.)
Please help keep the pressure on the FDA and please send the following letter to the list below. The outpouring of emails and letters from patients last spring was tremendously effective – let’s do it again!
Please send letters to the elected officials and to the FDA names below. Janet Woodcock, M.D., is Director, Center for Drug Evaluation and Research, FDA. Margaret Hamburg, M.D., is Commissioner of the FDA. Monika Volante is Legislative Director for Representative Jos. Pitts, (R-PA); he has been helpful to our cause in the past. Other names are health aides to other legislators who have some influence in health affairs legislation.
Sincerely,
Bob Miller, Patient Activist and Advocate
Pat Larosa, NJCFSA President
Billie Moore, NJCFSA Advocacy Chair
Cort Johnson, Founder of Phoenix Rising and Health Rising
With no other options available to people with ME/CFS can’t the FDA find a way to give people with ME/CFS access to a drug that the FDA’s own panel voted was safe.
Why were 6000 Princeton students given the option to try an FDA-unapproved drug for a disease that struck only seven students when more than a million people with Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are denied access to a drug that ME/CFS expert practitioners whole-heartedly endorse? Ours is a serious disease also! And people are dying from its effects.
Why were these 6000 Princeton students who do not have meningitis but who might get it given more options than people with ME/CFS who have been sick for decades? I am talking, of course, of the unapproved drug Bexsero that the FDA recently allowed to be made available to students at Princeton after seven other students came down with the meningitis.
While healthy students get Bexsero, very sick people with ME/CFS are being denied access to a drug, Ampligen, which has been used safely by hundreds of patients, sometimes for years. The FDA review panel for Ampligen concluded that Ampligen was safe enough to be used by people with ME/CFS. Despite the fact that ME/CFS patients, like the Bexsero patients, have no FDA approved drugs to treat this very serious and life robbing disease, the FDA has not found a way to give them access to a drug that’s been safely used for decades.
Unlike the well Princeton students, 61% of ME/CFS patients have reported they are bedbound or housebound on their worst days (and there are far more worst days than best days).
Thankfully the seven students at Princeton will recover. I, however, will not – not unless a treatment option is made available.
Why not give ME/CFS patients the choice, in consultation with their doctors, and with whatever restrictions/guidelines the FDA feels is necessary, to try a drug that has been used successfully by ME/CFS specialists?
Severely ill patients with no other options available to them should be allowed to decide, in consultation with their physician, whether to try Ampligen, under suitably managed conditions! The FDA can find a way to make this happen.
It did it with Bexsero and it can do it Ampligen. Stop keeping people with ME/CFS from treatments! Stop keeping them from having hope of a better life! Give a million people with this disease the same option you’re granting to 6000 healthy Princeton students.
I’ve waited long enough. I have been sick since _________. Day to day my life looks like ____________________. Why is my life not worth that of a Princeton student?
Sincerely,
____________________________________
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It probably has to do “side effects”. I don’t know about Bexsero but there are horror stories about Ampligen. Apparently “healthy” people didn’t react to Bexsero but sick people did have bad luck with Ampligen. Dr Jamie Deck Off Jones says stay away from Ampligen.
That said, I believe one should able to do a waver and take whatever.
I have heard of negative side effects from a few people with Ampligen but really quite few. The doctors who have provided it have reported few side effects. Dr. Lapp did a retrospective survey of his patients on Ampligen and found that it was quite beneficial and had few side effects. I’m not sure where Dr. Deckoff is getting her information from (?).
In any case even if it has side effects as many drugs do, there are certainly many stories of people doing very well on it.
I think the waiver idea is a good one; something to allow many people to give this drug a try, realizing that the FDA asserts more studies are necessary. That waiver could help Hemispherx gather the data it needs.
I so agree with how you put it Cort … one drug, just one, “across the finish line”… and we’ve got a revolution! And I so agree with the reasons why, and in the same order: first, it will provide treatment for patients in need (the only rational and humanistic reason); second, doctors will think: “if there is a drug, then there must be illness!” (not really rational…but hey, if that’s what it takes , so be it!); and then the third point: if one pharmaceutical company makes money, then others will want to jump in! (nothing humanistic here at all… but once again , if that’s what it takes, so be it!)
Just please approve ONE drug…And we’ll have a domino effect.
I agree – my guess is it will be a new indication for an existing drug. I still think Trimetazidine has not been given proper consideration but I believe something is going on under the radar with this one.
FYI – trimetazidone is a metabolic modulator which has been shown to increase oxygen uptake during exercise by 25%. I can state firmly from experience that it works very well for FM and fatigue.
What an interesting drug! Did you get it for angina or was it prescribed for FM/ME/CFS?
How much did it help you?
“Trimetazidine is a drug for angina pectoris sold under the brand name Vastarel MR. Trimetazidine is described as the first cytoprotective anti-ischemic agent developed and marketed by Les Laboratoires Servier (France). Trimetazidine is an anti-ischemic (anti-anginal) metabolic agent, which improves myocardial glucose utilization through inhibition of fatty acid metabolism, also known as fatty acid oxidation inhibitor.”
By preserving the energy metabolism in cells exposed to hypoxia or ischemia, trimetazidine prevents a decrease in intracellular adenosine triphosphate levels, thereby ensuring the proper functioning of ionic pumps and transmembranous sodium-potassium flow whilst maintaining cellular homeostasis. It also inhibits oxidation of fatty acid in blood vessels.[6]
“Trimetazidine inhibits beta-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation.[7] In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the beta-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia. By preserving energy metabolism in cells exposed to hypoxia or ischaemia, trimetazidine prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of ionic pumps and transmembrane sodium-potassium flow whilst maintaining cellular homeostasis.[6]”
It works very well – gets rid of the morning stiffness and I can exert ( walking, normal daily activities) with no PEM. Completely eliminates the tachycardia – I love this.
A patent was filed 5-6 years ago for Trimetazidine for FM/CFS-ME but I didn’t hear much about it until a clinical trial showed up some time last year.
Really glad I stumbled on to this because it has made a big difference for me (functionally speaking). But here it is a 30 year old cheap generic that no one can make a gazillion dollars off so who knows if there is any future for access – certainly will never be FDA approved. There is more to the Trimetazidine story but will save that for another day :).
My sense is this class of drugs, metabolic modulators, hold much promise and I am not sure anyone is even looking at them.
Not sure why anybody with ME/CFS would be seeking FDA approved drugs. Getting off of them is a better idea. FDA approval is something to be avoided now.
I think people with ME/CFS want more options and they want good drugs that their insurance will cover. They don’t want palliatives that mask symptoms and make them worse over time, but a good drug that actually gets at core problems would be a very good thing
I was puzzled by the notion of giving people “access to a drug in case they get sick in the future.” Looking at the details, what was provided was access to a vaccine to prevent a certain kind of meningitis, which can be fatal. I agree that the decision not to approve Ampligen was wrong and based on faulty logic. However, I have no issues with vaccinating college students against a deadly bacterial infection that is known to spread in dormitory environments. Kudos to those involved in making this decision.
What we’re basically asking is that FDA use the same kind of creative thinking that it did when it found a way to get an unapproved drug to college students at risk.
ME/CFS is almost in a world of its own with regard to drugs; it’s affects high numbers of people, yet gets little research funding. The drug developed ‘for it’ was produced by a small pharmaceutical company that doesn’t have the money to do extensive studies.
I believe the FDA needs to find a way to assist drug companies in producing products for ME/CFS. This might involve giving more patients access to the drug under restricted conditions in order to allow the company to recoup its costs and to gather enough data (?).
There’s got to be some way for the FDA to get drugs to a people with a disorder that doesn’t get the funding that most chronic illnesses do.
I was puzzled by the notion of giving people “access to a drug in case they get sick in the future.” Looking at the details, what was provided was access to a vaccine to prevent a certain kind of meningitis, which can be fatal. I agree that the decision not to approve Ampligen was wrong and based on faulty logic. However, I have no issues with vaccinating college students against a deadly bacterial infection (kills 1 in 10, severely maims 1 in 5) that is known to spread in dormitory environments. Kudos to those involved in making this decision. I do hope that those who can benefit from Ampligen will get access to it as well.
Ok. I sent the letter. Only one mailer daemon response, which is a good thing, lol. And many are , imho, missing the point of the email which is that we need at the veryyyy least ONE drug and the right to try it. No one is saying that Ampligen is an across the board miracle.
Dave Mason, I’m curious, do you suffer from CFS? If so, have you found a cure that the rest of us haven’t? Because I myself am willing to try just about anything at this point…FDA approved or not; if it is proven to help with this horrific illness, I want the opportunity to try it.
Importation of Novartis meningitis vaccine not likely to make U. liable
Princeton’s plan to make a meningitis vaccine — called Bexsero — available to students in the near future likely has few legal ramifications for the University, despite the fact that the U.S. Food and Drug Administration has not yet approved the drug for use in the United States.
Since March, eight cases of meningococcal disease linked to the University have been reported. Following the seventh case, the University decided in coordination with the Centers for Disease Control and Prevention and the FDA to import the Bexsero vaccine and offer it to students and certain community members.
In order to receive the vaccine, students will have to sign an informed consent form that will likely go to great lengths to eliminate any legal risk the University might face should something go wrong during the implementation of the vaccination program, Associate Director of the Program in Law and Public Affairs and former professor of Health Law and Policy Leslie Gerwin said. This legal consent form has not yet been released to the public.
University General Counsel Peter McDonough was out of the office when contacted by The Daily Princetonian. University Spokesperson Martin Mbugua declined to comment Monday, noting that the consent form has not yet been approved or issued and that questions about the legal aspects of the form would be best answered by a legal expert.
The consent form will first need to be approved by the CDC’s Institutional Review Board.
Although the University administration is encouraging students to get the vaccine, Gerwin said the University is unlikely to assume any sort of responsibility in the event of problems with the vaccine.
“The University is not liable … because you will sign an informed consent form. And that informed consent will probably be very long and detailed,” Gerwin said.
The one point of possible legal contention could come with regards to whether or not the University has given students enough data to actually be informed when consenting to receiving the vaccine. University administrators have given little information regarding the contexts of specific cases of meningitis that have broken out on campus, Gerwin said, adding that this withholding could potentially be raised as an issue in court.
Email alerts sent to the student body have included information regarding the diagnosed students’ gender, when they developed symptoms and began to receive treatment, and some basic information on the location of the institutions where they were receiving treatment.
“The only legal challenge you would have is whether you had sufficient information to be informed,” Gerwin said.
Gerwin noted, however, that the Health Insurance Portability and Accountability Act, which protects the privacy of patient medical records, grants the University much leeway when it comes to withholding details of the outbreak in order to protect the privacy of the affected students. The University, Gerwin said, has to walk a fine line in determining the marginal benefit of providing more information to students interested in possibly receiving the vaccine.
Although the FDA has not yet approved the vaccine for general use in the United States, Gerwin noted that as far as legal issues go, the company behind the vaccine, Novartis, has followed established FDA protocol in its attempt to make Bexsero available to the University.
Specifically, the FDA has worked with the CDC to approve Bexsero as a “treatment investigational new drug,” which, according to the FDA’s website, is a drug or vaccine “showing promise in clinical testing for serious or immediately life-threatening conditions.”
Gerwin also pointed to the European Union’s approval of the vaccine as promising evidence of the drug’s safety. She noted that even Britain’s Joint Committee on Vaccination and Immunisation, which recommended against adding Bexsero to its routine vaccination program this past July, did so not because the drug was unsafe in any way, but rather because it was not deemed cost-effective in the context of the country’s government-payer health system.
BEXSERO® Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well after having BEXSERO. Like all vaccines, BEXSERO can cause side effects, although not everybody gets them. When BEXSERO is given to you or your child, the most common side effects that you may get are: pain at the injection site, redness at the injection site, swelling of skin at the injection site, hardness of skin at the injection site, generally feeling unwell, headache, fever (38°C or higher) and feeling irritable.
Very common:
fever (38°C or higher), loss of appetite, tenderness or discomfort to touch at the injection site (including severe tenderness at injection site resulting in crying when injected limb was moved), redness of skin at the injection site, rash (uncommon after booster), hardness of skin at the injection site, swelling of skin at the injection site, sleepiness, feeling irritable, unusual crying, vomiting (uncommon after booster), diarrhoea.
Common:
fever (39.5°C or higher).
The incidence of fever may be decreased by the use of paracetamol. Before you or your child receives vaccination, ask your doctor about the risks of fever and how to treat it, including what to do if fever does not respond to initial treatment.
Uncommon:
high fever (40°C or higher), seizures (including febrile seizures), dry skin, itchy rash, raised rash, paleness (rare after booster)
Rare:
Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue.
Adolescents and Adults
Very common:
pain at the injection site (including severe pain at injection site resulting in inability to perform normal daily activity), redness of skin at the injection site, swelling of skin at the injection site, hardness of skin at the injection site, painful muscles and joints, nausea, generally feeling unwell, headache.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
No studies on the effects on the ability to drive and use machines have been performed.
However, some of the side effects mentioned under section Side Effects may temporarily affect the ability to drive or use machines.
Ask your doctor or pharmacist to answer any questions you may have.
I sent the letter yesterday. Hope it wasn’t too late to do some good.
I’m thankful that Bob, Pat, Billie, Cort, Lory and Nancy saw the opportunity to point out again how we don’t have a single drug for ME/CFS. Any occasion will do to let the powers that be know that we are not going away and that we need help NOW.
Thank you, all advocates, for taking every opportunity to Act Up on behalf of our neglected population. If we can’t take to the streets, at least we can write, write, write, write and make calls. BTW, I’ve looked and can’t find an email address for the President. I feel he should be copied on every one of these writing campaigns. Does anyone have an address for the White House?
Hey Cort, have you thought of launching a campaign on change.org for this? It could reach a larger audience and has a good shot at passing. Just a thought.
Its been clear to me for a very long time that the FDA if they WANTED too would have drugs made available to us to at least be able to choose and try.. its complete bullshit that they cant do that. Instead, those who have ME/CFS are “discriminated” against by being treated differently to other serious health issues (probably cause they like to lump both ME and CFS together so not everyone is very sick).
We are given a heap of lies and excuses by government from there isnt money for funding (while they can put 20 times more into other serious illnesses) etc etc.
I personally think as a group, governments should be sued for discrimination against ME/CFS.
It probably has to do “side effects”. I don’t know about Bexsero but there are horror stories about Ampligen. Apparently “healthy” people didn’t react to Bexsero but sick people did have bad luck with Ampligen. Dr Jamie Deck Off Jones says stay away from Ampligen.
That said, I believe one should able to do a waver and take whatever.
I have heard of negative side effects from a few people with Ampligen but really quite few. The doctors who have provided it have reported few side effects. Dr. Lapp did a retrospective survey of his patients on Ampligen and found that it was quite beneficial and had few side effects. I’m not sure where Dr. Deckoff is getting her information from (?).
In any case even if it has side effects as many drugs do, there are certainly many stories of people doing very well on it.
I think the waiver idea is a good one; something to allow many people to give this drug a try, realizing that the FDA asserts more studies are necessary. That waiver could help Hemispherx gather the data it needs.
I so agree with how you put it Cort … one drug, just one, “across the finish line”… and we’ve got a revolution! And I so agree with the reasons why, and in the same order: first, it will provide treatment for patients in need (the only rational and humanistic reason); second, doctors will think: “if there is a drug, then there must be illness!” (not really rational…but hey, if that’s what it takes , so be it!); and then the third point: if one pharmaceutical company makes money, then others will want to jump in! (nothing humanistic here at all… but once again , if that’s what it takes, so be it!)
Just please approve ONE drug…And we’ll have a domino effect.
Thanks Christian.
It would be particularly interesting if it was an immune drug! That would be really something IMHO 🙂
I agree – my guess is it will be a new indication for an existing drug. I still think Trimetazidine has not been given proper consideration but I believe something is going on under the radar with this one.
FYI – trimetazidone is a metabolic modulator which has been shown to increase oxygen uptake during exercise by 25%. I can state firmly from experience that it works very well for FM and fatigue.
What an interesting drug! Did you get it for angina or was it prescribed for FM/ME/CFS?
How much did it help you?
“Trimetazidine is a drug for angina pectoris sold under the brand name Vastarel MR. Trimetazidine is described as the first cytoprotective anti-ischemic agent developed and marketed by Les Laboratoires Servier (France). Trimetazidine is an anti-ischemic (anti-anginal) metabolic agent, which improves myocardial glucose utilization through inhibition of fatty acid metabolism, also known as fatty acid oxidation inhibitor.”
By preserving the energy metabolism in cells exposed to hypoxia or ischemia, trimetazidine prevents a decrease in intracellular adenosine triphosphate levels, thereby ensuring the proper functioning of ionic pumps and transmembranous sodium-potassium flow whilst maintaining cellular homeostasis. It also inhibits oxidation of fatty acid in blood vessels.[6]
“Trimetazidine inhibits beta-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation.[7] In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the beta-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia. By preserving energy metabolism in cells exposed to hypoxia or ischaemia, trimetazidine prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of ionic pumps and transmembrane sodium-potassium flow whilst maintaining cellular homeostasis.[6]”
It works very well – gets rid of the morning stiffness and I can exert ( walking, normal daily activities) with no PEM. Completely eliminates the tachycardia – I love this.
A patent was filed 5-6 years ago for Trimetazidine for FM/CFS-ME but I didn’t hear much about it until a clinical trial showed up some time last year.
Really glad I stumbled on to this because it has made a big difference for me (functionally speaking). But here it is a 30 year old cheap generic that no one can make a gazillion dollars off so who knows if there is any future for access – certainly will never be FDA approved. There is more to the Trimetazidine story but will save that for another day :).
My sense is this class of drugs, metabolic modulators, hold much promise and I am not sure anyone is even looking at them.
Cheers
Chris,
Fascinating. Ischemia has been implicated in numerous studies. I would like to hear thenrest of the story. Have you read my blog on this site:
http://www.cortjohnson.org/wp-admin/post.php?post=3845&action=edit
It is about a research study done on allodynia and ischemia.
Not sure why anybody with ME/CFS would be seeking FDA approved drugs. Getting off of them is a better idea. FDA approval is something to be avoided now.
I think people with ME/CFS want more options and they want good drugs that their insurance will cover. They don’t want palliatives that mask symptoms and make them worse over time, but a good drug that actually gets at core problems would be a very good thing
There are mistakes in that sample email by the way, FYI.
I was puzzled by the notion of giving people “access to a drug in case they get sick in the future.” Looking at the details, what was provided was access to a vaccine to prevent a certain kind of meningitis, which can be fatal. I agree that the decision not to approve Ampligen was wrong and based on faulty logic. However, I have no issues with vaccinating college students against a deadly bacterial infection that is known to spread in dormitory environments. Kudos to those involved in making this decision.
What we’re basically asking is that FDA use the same kind of creative thinking that it did when it found a way to get an unapproved drug to college students at risk.
ME/CFS is almost in a world of its own with regard to drugs; it’s affects high numbers of people, yet gets little research funding. The drug developed ‘for it’ was produced by a small pharmaceutical company that doesn’t have the money to do extensive studies.
I believe the FDA needs to find a way to assist drug companies in producing products for ME/CFS. This might involve giving more patients access to the drug under restricted conditions in order to allow the company to recoup its costs and to gather enough data (?).
There’s got to be some way for the FDA to get drugs to a people with a disorder that doesn’t get the funding that most chronic illnesses do.
I was puzzled by the notion of giving people “access to a drug in case they get sick in the future.” Looking at the details, what was provided was access to a vaccine to prevent a certain kind of meningitis, which can be fatal. I agree that the decision not to approve Ampligen was wrong and based on faulty logic. However, I have no issues with vaccinating college students against a deadly bacterial infection (kills 1 in 10, severely maims 1 in 5) that is known to spread in dormitory environments. Kudos to those involved in making this decision. I do hope that those who can benefit from Ampligen will get access to it as well.
Ok. I sent the letter. Only one mailer daemon response, which is a good thing, lol. And many are , imho, missing the point of the email which is that we need at the veryyyy least ONE drug and the right to try it. No one is saying that Ampligen is an across the board miracle.
Dave Mason, I’m curious, do you suffer from CFS? If so, have you found a cure that the rest of us haven’t? Because I myself am willing to try just about anything at this point…FDA approved or not; if it is proven to help with this horrific illness, I want the opportunity to try it.
http://www.cortjohnson.org/blog/2014/02/06/health-valuable-college-students-call-action-mecfs-treatment-team/#comment-215497
Importation of Novartis meningitis vaccine not likely to make U. liable
Princeton’s plan to make a meningitis vaccine — called Bexsero — available to students in the near future likely has few legal ramifications for the University, despite the fact that the U.S. Food and Drug Administration has not yet approved the drug for use in the United States.
Since March, eight cases of meningococcal disease linked to the University have been reported. Following the seventh case, the University decided in coordination with the Centers for Disease Control and Prevention and the FDA to import the Bexsero vaccine and offer it to students and certain community members.
In order to receive the vaccine, students will have to sign an informed consent form that will likely go to great lengths to eliminate any legal risk the University might face should something go wrong during the implementation of the vaccination program, Associate Director of the Program in Law and Public Affairs and former professor of Health Law and Policy Leslie Gerwin said. This legal consent form has not yet been released to the public.
University General Counsel Peter McDonough was out of the office when contacted by The Daily Princetonian. University Spokesperson Martin Mbugua declined to comment Monday, noting that the consent form has not yet been approved or issued and that questions about the legal aspects of the form would be best answered by a legal expert.
The consent form will first need to be approved by the CDC’s Institutional Review Board.
Although the University administration is encouraging students to get the vaccine, Gerwin said the University is unlikely to assume any sort of responsibility in the event of problems with the vaccine.
“The University is not liable … because you will sign an informed consent form. And that informed consent will probably be very long and detailed,” Gerwin said.
The one point of possible legal contention could come with regards to whether or not the University has given students enough data to actually be informed when consenting to receiving the vaccine. University administrators have given little information regarding the contexts of specific cases of meningitis that have broken out on campus, Gerwin said, adding that this withholding could potentially be raised as an issue in court.
Email alerts sent to the student body have included information regarding the diagnosed students’ gender, when they developed symptoms and began to receive treatment, and some basic information on the location of the institutions where they were receiving treatment.
“The only legal challenge you would have is whether you had sufficient information to be informed,” Gerwin said.
Gerwin noted, however, that the Health Insurance Portability and Accountability Act, which protects the privacy of patient medical records, grants the University much leeway when it comes to withholding details of the outbreak in order to protect the privacy of the affected students. The University, Gerwin said, has to walk a fine line in determining the marginal benefit of providing more information to students interested in possibly receiving the vaccine.
Although the FDA has not yet approved the vaccine for general use in the United States, Gerwin noted that as far as legal issues go, the company behind the vaccine, Novartis, has followed established FDA protocol in its attempt to make Bexsero available to the University.
Specifically, the FDA has worked with the CDC to approve Bexsero as a “treatment investigational new drug,” which, according to the FDA’s website, is a drug or vaccine “showing promise in clinical testing for serious or immediately life-threatening conditions.”
Gerwin also pointed to the European Union’s approval of the vaccine as promising evidence of the drug’s safety. She noted that even Britain’s Joint Committee on Vaccination and Immunisation, which recommended against adding Bexsero to its routine vaccination program this past July, did so not because the drug was unsafe in any way, but rather because it was not deemed cost-effective in the context of the country’s government-payer health system.
BEXSERO® Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well after having BEXSERO. Like all vaccines, BEXSERO can cause side effects, although not everybody gets them. When BEXSERO is given to you or your child, the most common side effects that you may get are: pain at the injection site, redness at the injection site, swelling of skin at the injection site, hardness of skin at the injection site, generally feeling unwell, headache, fever (38°C or higher) and feeling irritable.
Very common:
fever (38°C or higher), loss of appetite, tenderness or discomfort to touch at the injection site (including severe tenderness at injection site resulting in crying when injected limb was moved), redness of skin at the injection site, rash (uncommon after booster), hardness of skin at the injection site, swelling of skin at the injection site, sleepiness, feeling irritable, unusual crying, vomiting (uncommon after booster), diarrhoea.
Common:
fever (39.5°C or higher).
The incidence of fever may be decreased by the use of paracetamol. Before you or your child receives vaccination, ask your doctor about the risks of fever and how to treat it, including what to do if fever does not respond to initial treatment.
Uncommon:
high fever (40°C or higher), seizures (including febrile seizures), dry skin, itchy rash, raised rash, paleness (rare after booster)
Rare:
Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue.
Adolescents and Adults
Very common:
pain at the injection site (including severe pain at injection site resulting in inability to perform normal daily activity), redness of skin at the injection site, swelling of skin at the injection site, hardness of skin at the injection site, painful muscles and joints, nausea, generally feeling unwell, headache.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
No studies on the effects on the ability to drive and use machines have been performed.
However, some of the side effects mentioned under section Side Effects may temporarily affect the ability to drive or use machines.
Ask your doctor or pharmacist to answer any questions you may have.
Is there a deadline for sending a letter or is it a get it done sooner than later kind of thing?
Also, how expensive is Bexero, and how does that compare to Ampligen?
Thanks as always Cort for awesome information!
I sent the letter yesterday. Hope it wasn’t too late to do some good.
I’m thankful that Bob, Pat, Billie, Cort, Lory and Nancy saw the opportunity to point out again how we don’t have a single drug for ME/CFS. Any occasion will do to let the powers that be know that we are not going away and that we need help NOW.
Thank you, all advocates, for taking every opportunity to Act Up on behalf of our neglected population. If we can’t take to the streets, at least we can write, write, write, write and make calls. BTW, I’ve looked and can’t find an email address for the President. I feel he should be copied on every one of these writing campaigns. Does anyone have an address for the White House?
Many thanks.
Hey Cort, have you thought of launching a campaign on change.org for this? It could reach a larger audience and has a good shot at passing. Just a thought.
Good letter.
Its been clear to me for a very long time that the FDA if they WANTED too would have drugs made available to us to at least be able to choose and try.. its complete bullshit that they cant do that. Instead, those who have ME/CFS are “discriminated” against by being treated differently to other serious health issues (probably cause they like to lump both ME and CFS together so not everyone is very sick).
We are given a heap of lies and excuses by government from there isnt money for funding (while they can put 20 times more into other serious illnesses) etc etc.
I personally think as a group, governments should be sued for discrimination against ME/CFS.