Congressman Rogers statements about Health care plan

Thought provoking speech on the present Health Care plan under consideration...

H1N1 vaccine flu mist package insert - SHOULD READ before taking vaccine

Please read the following excerpts from the package insert for the H1N1 vaccine (delivery - flu-mist) and then, read the insert itself. I have referenced the sections the excerpts were taken from for your convenience. The insert is a PDF file on the FDA website.

Package insert for H1N1 vaccine:

Contraindications:


Do NOT give to Children less than 24 months old

5.1 Risks in Children <24 Months of Age

DO NOT give to people with asthma - has not been studied in individuals with severe asthma!

5.2 Asthma/Recurrent Wheezing
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should not be administered to any individuals with asthma or children < 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefit outweighs the potential risk.
Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.

DO NOT GIVE TO Immune challenged (was studied in 57 people who were HIV positive but they say not enough data to justify administering in this group)

5.4 Altered Immunocompetence
Administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, or FluMist live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

"May not protect all individuals receiving the vaccine"

5.7 Limitations of Vaccine Effectiveness
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal may not protect all individuals receiving the vaccine.

Later, they admitted the vaccine had not been evaluated for effectiveness (way down in the document!) Different story from what we have read on the news, right?

Clinical trials - adverse reactions:

6.1 Adverse Reactions in Clinical Trials

Increased hospitalizations in children receiving "flu mist"

Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active control recipients.

Adverse reactions in adults: (same section as above)

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).
In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).

Post marketing experience: adverse reactions i.e. these are side effects of the vaccine noticed after they started marketing the vaccine!

6.2 Postmarketing Experience

Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome).
Gastrointestinal disorders: Nausea, vomiting, diarrhea
Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema and urticaria)
Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy
Respiratory, thoracic and mediastinal disorders: Epistaxis
Skin and subcutaneous tissue disorders: Rash

This vaccine is NOT approved for people, over 50 years old:

8.5 Geriatric Use
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals .65 years of age. Subjects with underlying high-risk medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat.

8.6 Use in Individuals 50-64 Years of Age
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals 50-64 years of age. In Study AV009, effectiveness of FluMist was not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were similar in type and frequency to those reported in younger adults.

They don't really understand HOW it works: (and how well it works)

12.1 Mechanism of Action
Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a role in prevention and recovery from infection.

They don't know if this vaccine will cause infertility or cancer:

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility.

This vaccine has not been found effective in people over 50 years old. In a subgroup of adults, 18-49, the vaccine reduced illness with fever from 10 percent to 23 percent. This was a study in non high risk adults i.e. adults with no other medical conditions.

14.2 Study in Adults

Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50-64 years of age. Primary and secondary effectiveness endpoints from the age group 18-49 years of age are presented in Table 5.

While in a double blind study (57 in experimental group) of adults with HIV, the vaccine did not cause any worsening of their condition, they did not know whether or not it was effective in proventing the swine flu:

14.3 Study in Adults with Human Immunodeficiency Virus (HIV) Infection
Safety and shedding of vaccine virus following FluMist administration were evaluated in 57 HIV-infected [median CD4 cell count of 541 cells/mm3] and 54 HIV-negative adults 18-58 years of age in a randomized, double-blind, placebo controlled trial using the frozen formulation. No serious adverse events were reported during the one-month follow-up period. Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on Day 5 only and none of the HIV-negative FluMist recipients. No adverse effects on HIV viral load or CD4 counts were identified following FluMist. The effectiveness of FluMist in preventing influenza illness in HIV-infected individuals has not been evaluated.

Medical providers were told that they can receive the shot and immediately go back to their patients without worrying about transmitting the viruses to their patients. But that's NOT what the package insert says... on the contrary, they DO NOT KNOW whether or not these viruses can be transmitted:

14.5 Transmission Study
FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients. The relationship of viral replication in a vaccine recipient and transmission of vaccine viruses to other individuals has not been established.

Although the PDF distributed to medical providers (containing a bunch of myths about the safety and efficacy of this vaccine) never mentioned this, look what *I* found on the LAST PAGE of the package insert information... basically MEDICAL PROVIDERS SHOULD GIVE INFORMED CONSENT about this vaccine:

That is, the package insert says on the last page that your provider of the vaccine should let you know ALL OF THE ABOVE BEFORE you consent to take the vaccine!

17 PATIENT COUNSELING INFORMATION
Vaccine recipients or their parents/guardians should be informed by the health care provider of the potential benefits and risks of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, and should be advised that there are two influenza vaccine formulations for this influenza season, the monovalent vaccine against disease caused by pandemic (H1N1) 2009 virus and seasonal trivalent influenza vaccine.

Convenient URL to share to read this package insert which is on the FDA website:

http://tinyurl.com/H1N1-pkg-insert (copy into email or blog)

testing a new vaccine - H1N1 but not telling you about it

ABC has a video on their site showing several doctors who have the same concerns many people have about the swine flu vaccine - fast tracked, untested, too new - and are telling their patients to wait on this one. ABC news "medical expert" stated pretty much the same inaccuracies that our state health dept stated in the PDF below... "oh no, it's totally pure, been throughly tested" (in three months of testing?) And "it's the same as the regular flu vaccine" which is totally inaccurate - it's a totally NEW vaccine in concept, formulation and delivery.

Following are the inaccuracies the CDC in conjunction with the media and health depts are telling people all over the USA - this seems one step further than just not giving us informed consent that they are actually testing a new vaccine on US!

This is taken from a document released from our state health dept, a PDF to medical providers and contains pretty much the same inaccuracies I've heard from several places - here is the "informed consent information" people SHOULD be given about this new vaccine:

1. "You cannot get the flu from attenuated virus vaccines"

Inaccurate: you CAN get the illness from ANY LIVE virus vaccine.... do health care workers really not know this fact?

2. "Fact 6: The H1N1 vaccine has been properly and rigorously tested for safety and efficacy."

Inaccurate: This vaccine was "fast tracked" meaning it's not been well tested for EITHER safety OR efficacy. That's impossible with a fast tracked medication. Furthermore, its delivery as "flu mist" inhaled is controversial because concerns have been raised about the viruses attenuated or other (there are ALWAYS SOME WHICH DO NOT GET WEAKENED in live virus vaccine) crossing the blood / brain barrier and causing problems. Which is why "flu mist" has never been a real popular delivery... despite it being more "attractive" than an injection.

A friend of mine saw a CDC person interviewed on TV - he admitted that they were basically testing this on the public who will receive the vaccine. That's a no brainer with a very different vaccine which has been "fast tracked" to FDA approval.

3. "Fact 7: Multi-dose vials of H1N1 vaccine contain safe amounts of thimerosal, a vaccine preservative, which prevents contamination with bacteria and fungi."

Partially accurate. Thimerosal which is a type of mercury, is used as a preservative but there has been NO SAFE amount established and some studies have linked the receiving of a yearly flu shot with higher risk of neurological disease and Alzheimers. Mercury is highly toxic even in minute amounts.

4. "Fact 8: No causal connection has been found linking the use of thimerosal as a vaccine preservative and the incidence of autism, speech or language delay, or attention deficit hyperactivity disorder"

Not accurate - some studies have found a link between the MMR and autism which has SUDDENLY greatly increased in incidence, including a well done clinical study of several years duration in the UK which has been ignored by the American media. (You know like the 38 worldwide studies suggesting a link between abortion and breast cancer have been ignored by the AMC and the AMA?)

5. "Fact 9: Healthcare workers can safely receive the live attenuated (“weakened”) Influenza virus vaccine (Flumist) and go back to work immediately without risk of spreading the weakened virus to their patients UNLESS they work directly with bone marrow transplant patients."

May be inaccurate as flu can take 7-10 days to incubate and in that period, a person is said to be the most contagious.

6. "Fact 10: There is a much higher risk of getting Guillain-Barré Syndrome (GBS) from having influenza illness than from getting vaccinated for influenza."

The CDC has admitted in other places, that there IS a risk of Guillain Barre with the H1N1 vaccine, specifically, and that it is unknown what that risk is. In 1976, they had 4000 cases of GBS FROM the vaccine and, by the way, the "great pandemic" predicted, never hit.

Australia ordered a version of the H1N1 vaccine without Thimerosal, without squalene and with DEAD viruses.... (i.e. their National Health Service).

The H1N1 vaccine also contains an adjuvant called "squalene" which is supposed to enhance the immune system however this has been poorly tested if at all and some studies have suggested it as a factor in the "Gulf war syndrome" (the vaccines given the soldiers had this in it and vaccines have not contained it since).

OK, Here's my take on this. The vaccine for H1N1 is TOTALLY new in every way for a flu vaccine, even the delivery. They are beta testing it on the public and if they pull it off i.e. do not have disastrous side effects, then think of what they will have... a vaccine which (1) enhances the immune system, (2) delivers a better immunity than a dead virus vaccine (though so far NONE of them deliver more than a couple of years immunity) and (3) has an attractive delivery system.... no shot!

Doing the math... a BIG SELLER! If they do have disastrous side effects, then they will say "oh well" because you know what.. the American public has a very short memory and so not much damage will be done... No one will remember it a couple of years down the line. So not really much of a risk for the pharmaceutical but a big risk for the American public who is NOT getting "informed consent" not even the medical providers... and if they JUST can test it on medical providers that will be enough of a test base for them. thousands. (a large segment of the public is NOT getting the H1N1 vaccine).

There was an article in Scientific American detailing this process - the fact that the pharmaceuticals (and surgeons) have to do this sort of thing with beta testing new procedures and drugs on the public largely because experimentation on human beings is against the law. They took the example of giving O2 to premies on the theory that it would help them... this blinded thousands of kids. They stated that if they had done a double blind study - 600 receive O2 and 600 do not, they would have found out within a year that o2 can cause blindness and you would have had no more than 600 blind babies instead of the thousands blinded over the 10 years they were testing this. But then, even if human experimentation WERE legal, who would volunteer?

They have done this sort of "beta test" several times... it's not a new concept and if Americans READ more instead of getting most of their info from TV, they would know this process... "who does not study history, is doomed to repeat it"

John McCain plain talks on the "Today Show"

As we all know, the President made a passionate speech to a joint session of Congress yesterday which was televised to the American people, at times, yelling at them to stop bickering and pass the darned bill already. He then tried to de-bunk what he called the "myths" going around. "This bill will strengthen your insurance if you have insurance and offer insurance to you if you don't have insurance." "There are no death panels," he said, criticizing Sarah Palin's remark. Continuing, Obama said "of course there are some details to be ironed out..." a comment which got quite a laugh from the Congress persons in attendance, obviously surprising the president who apparently did NOT make that comment in jest.

And at one point, a Republican Congressman did the unbelievable. He interrupted the President, yelling "You're lying!"

He of course, apologized to the White House later, saying his conduct was inappropriate but this seemed to leave the media with the question of "was Obama lying?", a question never even asked about Bill Clinton who was known to spin a tale or two.

So this morning, the "Today Show" filmed a live interview with Vice President Biden and John McCain. First they talked to Biden and asked him "was the president lying?" Biden backed up the president but basically just reiterated what the president had said, as if he had, if not written the speech, then at least, was very familiar with it because he used basically the same words the president did.

Vice President Biden, when asked if the interrupting Congressman had represented some feelings among other Congress persons, emphatically said that he didn't believe it did, since John McCain and the rest distanced themselves from the remark. "I believe there is some real unity about this," said the VP, "and that we will have a bill before Thanksgiving."

But the shocker came when John McCain, specifically named by VP Biden, for being "in unity" with the President, was interviewed.

Matt Lauer asked McCain about several points in the President's speech - was he lying, Lauer wanted to know (this is interesting in itself because I have never remembered the media even THINKING that a president would be lying).

First about illegal immigrants... will they be covered in the present bill, asked Lauer. McCain answered, "Illegal immigrants are not covered," adding that it changes the number of uninsured in the USA from 47 million down to about 30 million.

Huh? You want to tell me that with all the bucks proposed to be spent, the govt getting into our health care etc, the bill will only insure 17 million more than are insured now?

But it gets better.

Matt Lauer asked if Palin's remark about "death panels" had any truth to it. John answered that the current bill does not establish death panels BUT added that a $500 billion dollar cut in Medicare spending is planned - he pointed out that in other countries when that large a cut in spending was done, rationing DID happen which could lead to the "death panels" so the concern of seniors was definitely appropriate.

Matt Lauer asked if the President was truthful about the three basics the bill established: ensure those who do not have insurance, provide stability to those who are insured i.e. guarantees that they can keep the insurance they already have and cuts costs.

McCain had aleady said that it does not provide health insurance for all - only 17 million of the 47 million uninsured. He now added that it did NOT cut costs -

"According to the Congressional budget office it's going to cost an additional TRILLION dollars - I have yet to see any REAL MEANINGFUL reductions in cost - in fact the Congressional Budget office said that there will be cost increases..."

He also pointed out that if your employer switches to the government option (which might be cheaper than their current insurance contracts), and you are getting insurance through your employer then you will NOT be able to keep your present insurance but will have to go on the government plan.

"The president keeps saying if you like your Health Insurance policy you can keep it - well if the govt option is adopted by an employer and you have employer provided insurance then you're not going to be able to keep it so that's false also. It's certainly not accurate."

It should be noted that 2 of my friends' employers have already said if they pass a government plan, they will switch.

So much for our choice in keeping our present insurance.

Will the Plan add to the deficit and will there be spending cuts, asked Matt Lauer.

McCain's answer was:

"We've now gone from a 7 trillion dollar deficit to a 9 trillion dollar deficit just in the last few weeks over a 10 year period. There is very little if anything in this package that calls for real spending reductions and a trillion dollars is basically what it's going to cost. And that's according to the Congressional budget office!"

John McCain added that pork barrel spending and earmarking continues despite the President's promise to curve this.

And is it true as VP Biden said, that there was cohesiveness on this bill or should we start from scratch, Lauer asked.

McCain said that it had NOT been, (as the President told the American people) a bipartisan effort at all and in fact, so far, NOT ONE Republican had been present at the negotiation sessions.

"Perhaps we should start over and really BE bipartisan. The president mentioned that it has gone through 4 of the 5 committees but it has done so, without a single Republican negotiator in the room! There has been NO bipartisanship in addressing the Health Care Issue! I've BEEN in bipartisan negotiations. I know what they are and it has been totally absent from the addressing of this issue. Maybe we ought to really sit down and negotiate which we haven't done. Facts are stubborn things."

McCain concluded that he hoped Congress WOULD have a bill soon because we needed reform and there were many areas of agreement, but that it should be a REAL bipartisan effort and it should NOT lay another trillion dollars to the deficit, the real brunt of which would be felt by the next generation.

Thanks to John McCain for having the courage to speak out on the "Today Show". He is an American hero who is admired on both sides of the fence and known to be a "Plain talker". But today, he became even more of a hero to me and perhaps many other Americans who want to hear the real story on this.

New York Times says seniors' concerns are real

I've been studying the pro's and con's of the proposed health care bill and it is confusing.

The most voiced fears are those of seniors who fear health care rationing, a restriction on expensive procedures to prolong life for a few years and limited access to specialists.

I have said since all the debating began that a financially sustainable single payer healthcare system MUST, in fact, include the above and even WITH including the above, did anyone add the price of covering "everyone"? No, I'm sure they didn't but no one has noticed that the income taxes in countries with single payer healthcare are THREE TIMES higher than they are in the USA.

And of course, the President has said several times that we would all have to sacrifice and that he did not agree with a knee replacement for his grandma etc.

And if we had any doubts of this, there is a well researched book by medical ethicist, Daniel Callahan called "FALSE HOPES" where after researching all the single payer, govt systems in the world, he states the same sobering facts (even though he states up front, he feels a single payer system is the way to go).

But many have listened blindly to the politicians telling us that these worries are a "myth". Those were the nice politicians. The nasty ones tell us that the concerns and questions (which were NOT answered in the so called "Town Halls") are a conspiracy by the Republicans and/or Conservatives and/or religionists or whatever.

But now, those of us who have had concerns have had a breakthrough. The New York Times printed a story which included a statement that these concerns of rationing, limited access to specialists and restricting of expensive procedures for the elderly are NOT unreasonable at all.

In fact the Medicare advisory committee, concerned that Medicare is going broke, this week, suggested .... rationing, limited access to specialists (GPs are just as good they say - which we know is a crock) and restriction of expensive procedures as a way to save Medicare!

And we all know that if the New York Times prints it, people will believe what we have been saying for a couple of months now. Because people believe the New York Times like it's the gospel.

Here is another statement in another story in the New York Times (Gospel again, right?). This comes from a story called "Tackling the Mystery of what it costs".

"Under health insurance reform, insurance plans will be required to give consumers much more information about what is covered and what is not. They will be expected to warn consumers that if they go out of network, they can be hit with some very high costs."

To someone not involved with one of the large insurance companies, this may not mean much but I, being thus involved myself, can attest to the fact that we HAD to go "out of network" because the IN network providers were not only "not too good" but absolutely horrendous - wrong diagnosis, unneeded surgeries, wrong treatment etc.

So I HAD to go out of network. And the idea of "high costs" is not a nice one to me.

And then, there are things like the place where you are supposed to get your blood work, looks kind of like you are going to catch something. That is, IF they can get the needle IN. Most always I've gone there, there is a new person just learning - on me. Hence, we finally are paying the doctor's assistant to do the draw!

The pundits tell us that the in network providers will have to be improved. Anyone holding their breath for this to happen?

Anyway, there are REAL concerns for seniors - you can believe it because the New York times printed it. :)

figures, statistics and lies

Today, I got an "alternate health" ad in the mail. It claimed that the number 36,000 deaths a year from flu was a false figure and in fact only about 750 people died a year from the flu and "that was from the CDC".

I didn't believe it. I had never questioned the 36,000 deaths a year from the flu and had quoted the figure myself because it came from the CDC.

But the ad got my curiosity going. Easy enough to look up. I looked up "FLU DEATHS" CDC" and got this page.

http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm

As you can see, it IS on the CDC website. Turns out that the truth (according to the CDC) is no one KNOWS how many die from the flu so the estimations were made from a percentage of those who die from respiratory disease deaths and other mathematical constructs.

The CDC writes:

Does CDC know the exact number of people who die from flu each year?

CDC does not know exactly how many people die from flu each year. There are several reasons for this: First, states are not required to report individual flu cases or deaths of people older than 18 years of age to CDC. Second, influenza is infrequently listed on death certificates of people who die from flu-related complications [12]. Third, many flu-related deaths occur one or two weeks after a person’s initial infection, either because the person may develop a secondary bacterial co-infection (such as a staph infection) [1,8,11] or because influenza can aggravate an existing chronic illness (such as congestive heart failure or chronic obstructive pulmonary disease) [3]. Also, most people who die from flu-related complications are not tested for flu, or they seek medical care later in their illness when influenza can no longer be detected from respiratory samples. Influenza tests are only likely to detect influenza if performed within a week after onset of illness. For these reasons, many flu-related deaths may not be recorded on death certificates. These are some of the reasons that CDC and other public health agencies in the United States and other countries use statistical models to estimate the annual number of flu-related deaths. ***

Oh - that's enlightening! No one KNOWS so they use a mathematical model to come up with the 36,000 deaths a year from the flu. Here is it, right from the horse's mouth! But when this figure is quoted, have you ever heard they say they really DO NOT KNOW how many a year die from the flu and that the deaths are usually from something else? hmmmm

This even shocked ME....Somehow I had never questioned the 36,000 deaths they were claiming...

So why DOES the CDC "ESTIMATE" the number of deaths from flu (and puff it up... hmmm)

Here is their answer to that one:

Why does CDC estimate deaths associated with flu?

CDC feels it is important to convey the full burden of flu to the public. Flu is a serious disease that causes illness and deaths nearly every year in the United States. CDC estimates of annual influenza-associated deaths in the United States are made using well-established scientific methods that have been reviewed by scientists outside of CDC [10]. CDC feels that these estimates are a timely representation of the current burden of flu on the United States.

But these numbers are used by the media etc to scare folks into getting the vaccine which is BIG MONEY for the manufacturers....

Enlightening. That's why it's good to read EVERYTHING. I didn't believe the alternate health ad but that claim was bold enough for me to question something I might have never questioned and which, I guess, should have been questioned in the first place.

So let's talk about the proposed Health Care program. Obama tells us that the concerns of the public are all because of the evil Republicans and all a bunch of lies.

For example, abortion won't be paid for in the Health care bill, he tells us. But the bill says different. ALL SURGERIES are paid for and abortion is a surgery. So some Democrats and Republicans tried to introduce amendments that made sure abortion was EXCEPTED out of surgeries. And the amendments failed.

If abortion is not paid for, why didn't the amendments pass? We all remember the youtube video how Obama promised Planned Parenthood that he would not deviate from his total abortion stance (from conception to birth).

Seniors are concerned that the Health Care bill might mean rationing of care for seniors. Obama answers us with "there is no rationing in the bill" and that seniors are not to worry but seniors were not born yesterday. Treating seniors is expensive and they suspect unless there is an amendment which GUARANTEES them treatment, they don't trust Obama's reassurance, especially when he admitted that it was right to not give his grandmother a joint replacement and has talked about how expensive it was to treat seniors when they might only have a few years of life left. Seniors know that the expensive health care program has to be paid for in some manner and that in other plans, care IS rationed to save bucks.

This is not the "evil Republicans" or "insurance companies". This is just people finally beginning to do what they should have done in the first place. Question - everything and trust - no one.

You know the old "In God we trust - all others pay cash" idea?

Multiple Sclerosis- Tysabri - miracle drug?

Biogen, the manufacturer of Tysabri, saw its stock fall this week when 3 people taking the medication for Multiple Sclerosis, recently, came down with a potentially deadly brain infection called "progressive multifocal leukoencephalopathy", or PML. This was a disappointment because Biogen had hoped to make its mint off Tysabri since its other drug, Avonex has a lot of competition from similar drugs like Rebif. Biogen apparently is already doing damage control with a video on Fox news promising great results for the medication.

But if we listen closely, even the video tells us some rather unsettling things:

• How it works: this medication prevents immune cells from crossing into the brain (probably why it can cause that severe brain disorder - how many OTHER brain disorders can it cause which may not have yet, been connected to tysabri?)


• The patient said it was nice she didn't have to do daily or every other day injections like with the other medications she had tried, but the picture of how Tysabri is administered was quickly flashed with no explanation. It is INFUSED which is done in the oncology ward - an outpatient procedure in the hospital which comes with some issues of its own.


• Tysabri gives many patients a 70 percent improvement in symptoms said the video - but remember the placebo effect with MS is 85 - 90 percent (i.e. 85-90 percent of MS patients get better even if given sugar pills!) so that means not only is Tysabri NOT effective but since it doesn't even match up to the placebo effect, it must be making some patients worse.

Because several in the Tysabri trials also got PML (2 of whom died which is really bad because Multiple Sclerosis does NOT kill its victims), the medication was shelved by the FDA in 2005 pending more research. However pressure from several including a couple of celebs who wanted to take the drug and probably Biogen, caused the FDA to conditionally approve it the following year with a warning label.

And unfortunately many people with MS who are desperate (and feel they would rather be dead than totally paralyzed) flock to DO SOMETHING, take SOME medication even though with NONE of the MS medications is anything like a "cure" promised. The available drugs are called "disease modifying" which in plain English means it MAY make your symptoms better (but no guarantees), something we are hearing more and more often from the medical profession which no longer promises to "first do no harm".

The truth about the slowly progressive MS (which is the only type the medications are supposed to help) is that if you live healthy, do not smoke or drink, do NOT take any drugs or have any surgery for it and get your head together, reduce stress and other healthy things, MS will likely not progress to the point of causing much disability until you are VERY elderly (if at all).

One study by the MS society found that 10 years after diagnosis, the majority of MS patients were still walking and medical treatment of which the side effects are worse than the disease, has traditionally been that which causes early disability as do bad health habits like smoking, party drugs etc. (Note: this study was long before the so called "disease modifying" drugs many MSers take now)

When Sylvia Lawry was alive, and president of the MS society (which she founded - her brother had MS) the society was not real well funded and did not advocate any medical treatment, repeatedly assuring members that the best treatment for MS was good nutrition, good health habits and "some walking, some sitting, some standing and some lying" (i.e. rest periods during the day).

And as many folks who got sick from medical treatments, people still flocked to each new one. There was for example, the Medrol treatment which initially lightened symptoms but in the long run made patients worse and caused tuberculosis in some,and surgery like stereo-tactic brain surgery which Annette Funnicello had - despite the fact that it was condemned as a too risky not effective treatment for MS tremors at the 1972 symposium for MS at UCLA. There were the less risky quack treatments also, like the guy who sold small trampolines and said if you jumped on them facing east every day, the earth's magnetic field would cure your MS.

But when Lawry died, the MS Society took a different turn, perhaps one which Lawry would NOT have agreed with and formed alliances with several pharmaceutical corporations which yielded them millions of research bucks, and bucks for glitzy monthly magazines but had the down side of causing patients to be "strongly encouraged" to buy the medications from the pharmaceutical companies, most of which had not even been tested on diagnosed patients (they were tested on people who were thought to be coming down with MS) and were not shown very effective. (why they call the drugs "disease modifying").

I once asked one of the researchers why no "double blind studies" had been done on the medications offered for MS and he said "well, because they do show improvement in patients, it would be considered unethical to deny the controls the help." Sounded lame to me. Especially as the "improvement" is judged by the number of white patches in the brain which show on the MRI which are thought to be MS related, but the doctor admitted that these can change by the hour and one patient having a lot of white patches in one MRI could have several of these move or disappear in the next MRI. He also admitted that the white patches seen on the brain could be NON MS related.

All seems a bit of a house of cards to encourage patients to put a chemical into their bodies which is known to challenge the immune system thus making them more susceptible to illness INCLUDING cancer.

As shakey as the research was on the so called "ABC" drugs (Avonex,Betaserone and Copaxon), Tysabri was a different case because even their less than great research found the deadly repercussion of PML. (Other side effects include flu like symptoms, infusion-site reactions, fatigue, headaches, joint pain and Increased Susceptibility to Infections.)

It might be prudent for MS patients to rewind back to the society's advice before their marriage with the pharmaceutical companies - live healthy, de-stress and don't overdo - still the best "treatment" for Multiple Sclerosis.

It seems that only miracle about Tysabri is how MS patients flock to take it!

NOTE: a certain number of people diagnosed with MS may be actually suffering neurological symptoms from other disorders including aspartame allergies and/or B12 shortages. Newly diagnosed patients should quit drinking diet soda and other things with aspartame/nutrasweet in them and also consider taking B12 supplements or even B12 shots.