Friday, September 18, 2020

What if it (only) takes a new worldview to free ourselves from the new normal?

Today I told another patient that in fact, there was no need to be so worried about the pandemic.  Used early, hydroxychloroquine worked very effectively as a treatment.

And again the first thing I heard was, "Isn't that the drug Trump talked about?"

Why does what Trump said seem more germane to people than the SARS-CoV-2 virus being treatable?

I now have a retort:  "Even a stopped watch is right twice a day!"

But that is not really the point.  What remains shocking is that people have been so conditioned to fear the virus, that it is not even within the realm of possibility that there is light at the end of the tunnel.  Nor, to take an even greater leap of consciousness, are some people able to consider that, maybe, there didn't have to be a tunnel.  We have all been holed up in an imaginary tunnel, immobilized by fear and then by emergency regulations issued by fiat.

For six months, many people have known that certain drugs were very effective against SARS-CoV-2, but somehow that information has not been allowed to trickle down.

If I ask someone to believe that there is a cheap, safe, available pill that you can get in a drugstore, which could immediately end the lockdowns, masks, and the rotten new normal, I am asking them to give up believing in the world as they know it, and enter the Twilight Zone. 

I am starting to think that is considerably harder for many people to entertain a new worldview, than it is to accept the very rotten new normal.  

Thursday, September 17, 2020

The irrational fear of a cheap, effective drug/ Dr X in The Quadrant



https://quadrant.org.au/opinion/qed/2020/09/the-irrational-fear-of-a-cheap-effective-drug/

 Words are very powerful. They can incite hatred and violence. They can provide reassurance and hope.  They can incite fear and dread. We have not heard many reassuring and hopeful ones this year, but maybe that is about to change. The truth is coming to light, and that is perhaps the most important issue at stake:  Truth. Public policy, affecting the lives of every person in society now and into the future, should be informed by truth.
Well here are some of those truths: COVID-19 is an extremely infectious virus that can make you very ill and might even kill you. It might also leave you with debility, pain, fatigue and seriously compromised health. It spreads rapidly in aged-care facilities with devastating outcomes.
Now here are some less palatable truths: Doctors who have successfully treated this virus have been dismissed as cranks who don’t follow “the science”. Worse, they have been denied access to the very drug that could save lives.
This last point needs to be stressed because the drug is hydroxycholoroquine – a cheap, effective, off-patent medication. Numerous papers from around the world — the number of positive appraisals grows almost by the day — are documenting its effectiveness against this virus. Used in conjunction with zinc and an antibiotic it has stopped the progress of the virus. Patients administered the drug early in the course of the infection exhibit less severe symptoms and regain their health more quickly.
Why the war against a medication any reasonable person might regard as a godsend?
On April 29, 2020, the Victorian government “restricted the sale or supply or use of the poison or controlled substance Hydroxychloroquine under section 55(2) of the Drugs, Poisons and Controlled Substances Act 1981 for a period of twelve weeks.”
There is no clinical evidence that hydroxychloroquine is effective prophylaxis against  coronavirus
Hydroxychloroquine is in short supply and should be prioritised for use in recognised           indications including autoimmune conditions and Q-fever endocarditis.
The Pharmaceutical Society of Australia (PSA) have advised pharmacists to refuse the dispensing of hydroxychloroquine unless it is for a recognised indication.
Let us look at the underlined assertions one by one.
No clinical evidence?
Not so, says Dr Harvey Risch, professor of epidemiology at Yale School of Public Health.
Hydroxychloroquine is in short supply.
Clive Palmer provided 30 million doses of Hydroxychloroquine to add to the Australian stockpile.
PSA has advised pharmacists to refuse the dispensing of hydroxychloroquine.
So, should pharmacists enjoy the right to vet and veto what a doctor prescribes in consultation with his or her patient? Not according to the Australian Medical Association:
“Doctors are the only health professionals trained to fully assess a person, initiate further investigations, make a diagnosis, and understand the full range of clinically appropriate treatments for a given condition, including when to prescribe and, importantly, when not to prescribe medicines,” [AMA President, Dr Tony] Dr Bartone said.
“The AMA urges all governments to ensure that patient care is not fragmented, misdirected, or delayed by prescribing models that do not align with the AMA’s Standards.”
On August 3, news.com.au carried an item, Record Imports of dodgy COVID cures, which I cite as but one example of the official misinformation being fed to, and regurgitated by, unquestioning journalists:
Hydroxychloroquine can cause cardiac toxicity, which can lead to sudden heart attacks, irreversible eye damage, and severe depletion of blood sugar, which can lead to coma.
The media misrepresented this drug – at no time has it been recommended that people self-medicate. The treatment protocol has always been that it be made available only under medical supervision, as with any prescription medication.
The Victorian government has effectively prevented people with Coronavirus from accessing potentially life saving treatment. It has done so, not to put too fine a point on its conduct, by telling flat-out lies.
The Premier has told Victorians “there is no vaccine for this wildly infectious virus” so we will just have to stay at home, inside, isolated and masked until the virus goes away or we get a vaccine. 
There you have it: No treatment allowed. No vaccine available. Catastrophic social and economic shutdown.
Why the full-court press against hydroxychloroquine?
Here is a further fact to ponder: It is cheap and the new anti-virals are not cheap.
Remdesivir, on-patent and surrounded by much favourable publicity when first cast as the silver bullet against COVID-19, lists at US$3120 per treatment (US$390 per vial). Alas for manufacturer Gilead’s corporate bottom line,  its bally-hooed COVID-19 ‘remedy’ has not proven effective.
So a vaccine is needed and fast. Manufacturers in the US, UK and some other countries enjoy complete legal protection against litigation for vaccine damage.
Any fast-tracked vaccine which is not adequately tested for safety and efficacy prior to administration, and for which the manufacturer has full legal immunity against any damages claims, should be regarded with great concern. It should not be mandatory for citizens to have this vaccine, as Prime Minister Scott Morrison said in an unguardedly candid moment before backing away from it.
When you follow the developments of 2020, it seems that our greatest fear should be of the governments and bureaucracies that lie to us, confine us to our homes, shut down our businesses and destroy our livelihoods, tear our families apart, turn our nursing homes into institutions of incarceration for the elderly, mandate mask-wearing and threaten us with a vaccine that would never pass any ethics approval process.
It is time to start hearing the truth.
Dr X is a Melbourne GP with 36 years in practice. He has chosen anonymity because this is Victoria, where residents must now live according to the whim and wish of Premier Daniel Andrews.

Thursday, September 10, 2020

Anthrax Letters: I dissect/destroy the FBI's theory of the case, in a presentation for Lawyers for 9/11 Truth

The presentation is here, and my section starts at minute 48.

Lawyers for 9/11 Truth has today sent a petition to Congress asking them to reopen the case

Saturday, September 5, 2020

Peter Breggin has supplied extensive legal documents on the challenge to Ohio's restrictive measures on Covid

Peter Breggin and his wife Ginger have amassed a library of materials on many aspects of Covid.  They were among the first to notice the questionable origin of the virus, and collected academic papers showing how aspects of the current Coronavirus had been created in labs around the world, often with funding from the US government, but also funded by the EU, Australia, China and others.

Last week he and a group of lawyers filed a huge brief in Ohio on the HCQ restrictions, and challenged a series of other emergency measures applied in Ohio. Below is this collection.

https://breggin.com/dr-breggins-covid-19-totalitarianism-legal-report/

Dr. Breggin’s COVID-19 Totalitarianism Legal Report

For Case to Stop Emergency Declaration In Ohio and Elsewhere
Please try the below links a second time if the first try does not work

and if you go to his home page, or his coronavirus resource page, you will fined many more documents of interest.

Thursday, September 3, 2020

Roughly 500,000 Americans, who were not previous users, got HCQ scripts in March and April--at the time 1 M cases were diagnosed

The CDC has just released information, in its MMWR Weekly Report, on the prescribing of hydroxychloroquine in March and April in the US.

Approximately 500,000 prescriptions dispensed by retail pharmacies were "new," or dispensed to persons who had not received a previous prescription of the medication in the prior 12 months. These are presumed to have been in response to Covid-19.

By April 30, there were 1,075,000 confirmed or probable Covid cases in the US.

CDC's report has not examined how many of those receiving HCQ also tested positive for Covid. 

Nonetheless, it appears that a considerable number of Americans and their physicians saw value in using the drug to prevent or treat Covid, especially compared to the number of total known cases.  Where are their voices now?  Did the medication help?  Hurt?  

The rest of the country is dying to know.


Hydroxychloroquine: the EVIDENCE you have nothing to worry about. Doctors must speak up!

For those who are worried about the “harms" caused by hydroxychloroquine—have you taken it?  Prescribed it for a family member with Covid?  Prescribed it for probably 200+ patients over 2 decades?  Studied the literature? Well, I have done all of these. 


Here are 3 recent studies discounting the drug’s cardiac toxicity:



https://www.sciencedirect.com/science/article/pii/S2052297520300998 
  
If you lack a solid grounding in this medication, which BTW was being tested for many dozens of different conditions including obesity, cancer, heart disease prevention, miscarriage prevention, and osteoarthritis BEFORE Covid hit, because it was so very safe, even in pregnancy (https://pubmed.ncbi.nlm.nih.gov/14613284/), and potentially effective for them (see https://clinicaltrials.gov/ct2/results?cond=&term=hydroxychloroquine&cntry=&state=&city=&dist=), then please inform yourself.  Clinical trials.gov today lists 500 trials ongoing or completed using HCQ. 

The true harms of HCQ appear to be no greater than for drugs like the OTC NSAIDS (ibuprofen, aleve).  The excessive harms that have been claimed were pulled out of thin air, just like the Lancet’s Mehra/Desai/Surgisphere paper, for the same purpose.  That purpose is propaganda.  It is the responsibility of medical doctors to seek to distinguish between propaganda and fact.

This is not an intellectual exercise.  We are talking about a pandemic that has crashed the world economy, caused famines, and governments show no signs that things are going to change any time soon. So if there is a magic bullet or perhaps many (see lab data on repurposed drugs for  coronaviruses) -- the bullets need to be used asap, and not withheld to make way for remdesivir (about 3000x more costly and also more dangerous (https://www.drugs.com/sfx/remdesivir-side-effects.html) and poorly tested vaccines that use novel platforms and, if used under Emergency Use Authorizations, will waive manufacturer and government liability.  

Pay attention to the pre-Covid literature vs the post-Covid literature on HCQ harms.  

In 2007 the Oxford journal Rheumatology 
https://pubmed.ncbi.nlm.nih.gov/17202178/ found: "Conclusion: PR interval, QTc interval and heart rate were not different from normal values. The rate of heart conduction disorders was similar to what is expected in the general population, and contrasted with prior results in CQ-treated patients. Our results add further evidence on the safety of HCQ compared with CQ.”  [BTW, excessive or prolonged doses can cause damage that will not occur in those treated for Covid, briefly, with standard doses.] 

From Expert Opinion on Drug Safety 2011: 
https://pubmed.ncbi.nlm.nih.gov/21417950/: "Expert opinion: HCQ has been shown by numerous studies over the past 15 years to be efficacious in the treatment of autoimmune diseases, including systemic lupus erythematosus, discoid lupus erythematosus and rheumatoid arthritis. HCQ does not appear to be associated with any increased risk of congenital defects, spontaneous abortions, fetal death, prematurity or decreased numbers of live births in patients with autoimmune diseases. Therefore, in the author's opinion, HCQ is safe for the treatment of autoimmune diseases during pregnancy.

But it is too dangerous for patients with Covid?  Who is fooling who?

When tested in OUTPATIENTS (so the side effects of the drug are not confused with the clinical damage caused by Covid or other meds being used) the drug is safe, according to the second cardiotoxicity link I provided above:

https://www.medrxiv.org/content/10.1101/2020.07.16.20155531v2  "Conclusion: Data from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19.

Yet today, in Queensland, a doctor who prescribes HCQ for a patient with Covid is subject to 6 months in prison or an A$13,000 fine.  https://www.health.qld.gov.au/system-governance/legislation/cho-public-health-directions-under-expanded-public-health-act-powers/prescribing-dispensing-or-supply-of-hydroxychloroquine-direction

What a precedent!  If doctors don't educate themselves and speak up about what is happening, who else can?

Extraordinary times call for extraordinary measures.  Doctors, this is your wheelhouse.  Speak now, or forever hold your peace.

Covid-19 deaths in Italy: 96% had pre-existing conditions, 99% were age 50 or older...Basically confirming the CDC stats that only 6% of deaths were from Covid alone

The CDC informed the world several days ago that 94% of Americans who died from Covid-19 had other medical conditions.  When many people said, 'Aha! That means the pandemic is mainly killing those who are already ill," the mass media and fact-checkers went to work to debunk them.

USA Today quickly claimed that people were saying the deaths weren't caused by Covid-19, and it was a conspiracy theory.

But what I was hearing was simply that Covid-19 was mainly striking down people who were not otherwise healthy.  While they might be dying from Covid, most were already weakened by something else.

Here is what CDC wrote:
For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death. The number of deaths with each condition or cause is shown for all deaths and by age groups. 
But it turns out Bloomberg wrote about the same stats from Italy back in May, and guess what?  96% of those who died had co-morbidities, also known as pre-existing conditions. Sixty per cent of those who died had 3 or more preexisting illnesses. And the average age at death was 80:
  • "Italy Says 96% of [Corona] Virus Fatalities Suffered From Other Illnesses.
  • Virus killing mostly older Italians with previous conditions
  • Only 1.1% of fatalities were under 50, with average age of 80"

Monday, August 31, 2020

How CDC and WHO Rewrote the history of the 2009 swine flu pandemic--reprinted from 2012

The article below I wrote 8 years ago, but it has relevance to today.  I describe some of the tricks that were pulled when a pandemic vaccine was rushed into use in 2009, and how the agencies that rushed it covered their tracks over the next several years--Meryl


Saturday, August 4, 2012

Rewriting the history of pandemic swine flu (to justify vaccine policies?)


Remember the 2009 Swine Flu Pandemic?  There were going to be a huge number of illnesses and deaths, but then it turned out the flu virus caused less severe disease than usual.  
  • We were in dire need of vaccines, so it was said.  Therefore a bizarre vaccine approval process was instituted.  
This process was crafted to mislead the public.  Vaccines were approved on the basis of prior testing of so-called "mock-up vaccines".  The mock up vaccines were actually old bird flu vaccines tested years earlier for a potential bird flu epidemic.  They contained the same adjuvants as swine flu vaccines, but the antigens were completely different.  According to WHO:
... some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.
Approval of the new vaccines rested on sleight of hand:  regulatory agencies made the claim that the two vaccines were substantially identical.  Therefore, data from tests of old bird flu vaccines provided the proof needed to demonstrate safety and effectiveness of new swine flu vaccines.  According to the Guardian:
The clinical trials on which approval was based involved more than 6,000 people for each vaccine, each of whom received a version which was basically the same as the one to be rolled out, but originally contained an avian flu (H5N1) strain – which had been expected to cause a pandemic – instead of H1N1.
And POOF! -- hundreds of millions of people received the new, untested vaccines.

Later came the bad news.  

The epidemic was actually mild, and most of those affected had few if any symptoms.

The vaccines had been given late, when most of the epidemic had passed, and many vaccinated people were already immune.  The vaccine probably had little impact on the pandemic.

The shot itself was dangerous.  Glaxo's version caused 13 times the expected number of cases of narcolepsy in children, and different versions increased the risk of Guillain-Barre syndrome.


The Council of Europe got into the act, investigating WHO and the provenance of the contracts to understand how billions of healthcare dollars were spent to buy and administer unnecessary vaccines.

WHO (the World Health Organization) didn't take the assault lying down.  It arranged for its own investigation, which unsurprisingly found no big mistakes.


Instead of acknowledging these findings and planning for better vaccine testing, the swine flu pandemic's history was rewritten. 

Although Bloomberg/Businessweek mentioned the study showing a doubling of the GBS rate, it concluded flu vaccine was safe in pregnancy:
Today’s research and a Canadian study looking at the vaccine’s effect on Guillain-Barre syndrome, a disorder in which the body attacks its nervous system, shows the shot is safe and should be used as a precaution to prevent infection, he said. 
More whitewashing of the data followed:  there were no problems with fertility in women vaccinated during any trimester of their pregnancy.  Here's a link to the Danish study published in JAMA.


Except CDC didn't find them; instead, it estimated them.  What was the authors' conclusion?  
Although no estimates of symptomatic case fatality ratios were available from Africa and southeast Asia, a disproportionate number of estimated pandemic deaths might have occurred in these regions. 
A different review published by CDC scientists in May 2012, honestly noted:
Human infection with H1N1 has generally resulted in low mortality, although certain subgroups... have significantly higher risk of severe disease.
Let's examine the claim of vaccine safety during pregnancy.    

In the US, the major birth defect rate is about 3%.  In the Danish study cited, the major birth defect rate in offspring of women vaccinated during their first trimester was 5.45%.  But in the Danish control group, the major birth defect rate was 4.54%.  

The authors were able to dismiss the high birth defect rate by selecting a control group with a higher than expected rate, and by using groups small enough that the 0.91% increased rate in the vaccinated cohort was not statistically significant.  

Anders Hviid, the last author on the study, was involved in an earlier study that was not sufficiently powered to detect a 2.7-fold increase in GBS following swine flu vaccinations.  He was then able to conclude that "The risk of occurrence of Guillain-BarrĂ© syndrome is not increased after pandemic influenza vaccine."

I imagine these are only the first volleys in CDC's attempt to rewrite the history of swine flu and its vaccine, and justify its vaccine policies despite evidence to the contrary.  Keep an eye out for what's next.

Might Hydroxychloroquine Actually Be Good for Your Heart?/ AAPS

Many are afraid to take hydroxychloroquine (HCQ) for COVID as they have been told it could kill them because of its effect on the heart. Are you worried about this? 
It is a fact that HCQ, azithromycin (Z-Pak™), and other drugs can prolong the QT interval on the electrocardiogram (ECG)—see image below. This could make patients vulnerable to fatal changes in the heart’s rhythm (such as torsades de pointes or TdP). People with a rare condition called “congenital prolonged QT syndrome” are especially at risk.
You do not have to have an expensive ECG to check for this. It takes about 5 minutes with inexpensive new technology that fits in your pocket and can be used in your home (see below).
Hundreds of millions of people have taken HCQ without ever worrying about this issue. Have we overlooked a serious problem for more than 50 years? A just-published article that reviews the medical literature concludes that, on the contrary, HCQ protects the heart. 
In one case series of 251 COVID-19 patients treated with HCQ and azithromycin, extreme QT prolongation occurred in 23 percent. The HCQ was stopped; no deaths occurred. No reports of cardiac deaths were found in the review. Rather, “HCQ/azithromycin were uniformly found to substantially reduce cardiac mortality and also to decrease thrombosis, arrhythmia and cholesterol in treated patients.” 
Warnings issued by FDA, CDC, the American Heart Association, and others have suppressed the use of potentially life-saving HCQ treatment. However, author Chadwick Prodromos, M.D., notes that warnings cite no specific study, and do not comment on whether actual deaths have occurred.He concludes that: “HCQ decreases cardiac events. HCQ should not be restricted in use for COVID 19 patients because of fear of cardiac mortality.” 
It is important to remember that COVID-19 itself can damage the heart, increasing the importance of early treatment. 
Cardiologist Peter McCullough, M.D., M.P.H., of the Baylor Heart and Vascular Institute in Dallas, recommends HCQ and other measures for early treatment in a recent article in the American Journal of Medicine.

Saturday, August 29, 2020

The perfect storm created by poorly tested pandemic vaccines: when they are not tested, manufacturers cannot be found liable for injuries

I wrote this article in August, eleven years ago. The take-home lesson is that everyone having anything to do with a pandemic vaccine or drug program has had their product liability waived... as long as they don't know there are product defects.  This incentivizes manufacturers to avoid testing products and fails to penalize them for selling shoddy or deadly pharmaceuticals.  Please note that the links are 11 years old, and that there have been revisions to the laws I cited then, but generally the laws continue to provide broad immunity to all involved.  Furthermore, a recent modification provides the same immunity to pharmacists and their staffs, who may now vaccinate children with any licensed vaccine or one authorized via an EUA.  Note also that an additional Act regarding medical countermeasures and emergencies, PAHPRA was passed in 2013, so is not addressed in this 2009 article.  The 21st Century Cures Act, passed in 2016 also has some relevant passages, including the fact that all vaccines recommended by CDC in pregnancy get a waiver of liability--Meryl

Friday, August 7, 2009

Using New Laws for Swine Flu, Designed for a Much Deadlier Disease, May Create a Perfect Storm

1. The US government is using laws designed for dealing with a very deadly pandemic, or bioterrorism, to bring about a mass vaccination program for swine flu, beginning with the Public Readiness and Emergency Preparedness Act 0f 2006.

http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html

2. This law removes liability from the manufacturer, medical practitioners who use the product, and from "government program planners" who decided on using the law. A suit can only be brought if the DHHS Secretary allows it, and if there is willful misconduct on the part of the manufacturer.

This law has been invoked for swine flu drugs (Tamiflu and Relenza),

http://edocket.access.gpo.gov/2009/pdf/E9-14412.pdf

for swine flu vaccines, and for novel vaccine adjuvants (which may be used in vaccines to stretch the supply and possibly convey broader immunity).

http://edocket.access.gpo.gov/2009/pdf/E9-14948.pdf

3. If testing of these products is very limited, then the manufacturers are unlikely to become aware of their flaws, and specifically their adverse effects. Then there can be no willful misconduct.

4. Due to the fear that swine flu will cause a large outbreak once students return to schools, where the virus might rapidly spread, the US government has stated that vaccine is likely to be available, and used, before clinical trials are completed.

WHO says vaccine will be ready in September. Novartis began testing in humans in July, and Sanofi-Aventis and Glaxo Smith Kline are starting now.

http://www.google.com/hostednews/ap/article/ALeqM5i-Qd-q3ALSGUV0tZqwFVoy1GlGfQD99TEJN81

The Europeans are also planning for use before testing is completed, despite warnings by experts about the potential dangers of untested vaccines.

http://www.google.com/hostednews/ap/article/ALeqM5iCajXBnuqbQEUf_cH4_dblpysz_gD99MCRJO1


5. The adjuvants likely to be used to strengthen vaccines and stretch the supply are named MF59 (Novartis) and ASO3 (Glaxo Smith Kline). Only 3 vaccines using this type of adjuvant (oil-in-water, a.k.a. squalene-containing) have been licensed in Europe, and none have been given a license in the US. Two vaccines using these adjuvants are only used in people above the age of 65 (Fluad-MF59), and those with serious kidney disease (Fendrix-ASO4). Both advanced age and kidney failure weaken the immune system, so more powerful vaccines are needed, but in this population autoimmunity is unlikely to result from powerful immune stimulation. Cervarix is the third European vaccine (using adjuvant ASO4 against HPV) and its safety is controversial.

6. The then-Acting DHHS Secretary issued an Emergency Declaration in response to the swine flu epidemic on April 26, 2009. This allows use of unapproved (unlicensed) medical treatments and tests, or use of approved treatments for unapproved uses.

According to the Congressional Research Service, on April 27, 2009, the Food and Drug Administration issued four Emergency Use Authorizations (enacted in Section 564 of the Federal Food, Drug, and Cosmetic Act, amended by the Project BioShield Act of 2004) in response to requests from the CDC to make available certain drugs (Tamiflu and Relenza), diagnostic tests and respiratory protection devices.

7. Vaccines containing MF59 and ASO3 have not had Emergency Use Authorizations issued for them--yet. However, the government has purchased $698 million dollars' worth of these adjuvants in recent weeks.

http://www.hhs.gov/news/press/2009pres/07/20090713b.html

https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx

US and WHO officials have indicated the likelihood of their use, which is the only way to achieve adequate amounts of vaccine for the US and world population in the fall.

8. These vaccines have never been demonstrated to be safe in children, pregnant women or young adults. They have not undergone comprehensive testing; for example, MF59 has not and will not be tested for carcinogenicity by the manufacturer.

http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm095708.pdf
See page 391 for comments to FDA on carcinogenicity testing by Dr. Novicki, a Novartis scientist.

9. The result of the new bioterrorism laws (passed with the expectation of use for much more dangerous epidemics than the current swine flu), which allow use of untested products AND give manufacturers an incentive to avoid comprehensive testing (to avoid being found guilty of willful misconduct) have combined with the political imperative to provide citizens with vaccines in a hurry, yielding a potential Perfect Storm.

In the 1976 swine flu vaccine program, 45 million people were vaccinated with an inadequately tested vaccine. The government gave the vaccine manufacturers immunity from liability, but created an alternative compensation program. Five thousand people sought benefits for vaccine injuries. Four hundred twenty seven developed the autoimmune, paralytic illness Guillain-Barre Syndrome. Over thirty of them died.

Experts have suggested that in the absence of prelicensure clinical trial data, it will be important to perform postmarketing surveillance to learn about the side effects from swine flu vaccines. According to Reuters, "the FDA's Dr. Hector Izurieta said the agency had set up an exceptionally extensive network for what is known as post-marketing surveillance."

Postmarketing surveillance may be sufficient to identify severe side effects when new drugs are marketed, as they only gradually come to be used by large numbers of patients. But for a vaccine that will be employed in a mass inoculation campaign, targeted at half or more of the US population, tens (or hundreds) of millions will be vaccinated in a few weeks, before sufficient time has elapsed to learn about the adverse effects.
Untested swine flu vaccines employing novel adjuvants, which are likely to cause more autoimmune illness than occurred in 1976, will almost certainly be used. The manufacturers have been given liability protection, as have the government program planners. Efficacy and safety are unknown. But no compensation mechanism has been created. And the public has not been informed.