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Experts Predict Spread of Mystery Illness (SARS)
Salon.com ^ | April 5, 2003 | Daniel Q. Haney

Posted on 04/05/2003 1:52:43 PM PST by EternalHope

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To: chicagolady
I am always amazed when I hear someone speak with such venom concerning the "filty rich drug companies". I am 62 & fortunatly have never had a life threatning illness. I have required very little in the way of medicines in my life, so the drug companies haven't gotten much money from me. But I am greatful that the drugs are there for those who need them & for me if I ever do. Why should the drug companies not make a profit? If it were not for this profit they would have no reason to exist or to develop new & better drugs. Profit is not a dirty word, except to my liberal friends.
21 posted on 04/05/2003 2:52:21 PM PST by Ditter
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To: gavriloprincip
SARs status:

http://www.freerepublic.com/focus/f-news/880332/posts
Sars symptoms are a lot like those of the flu -- very high fever, shortness of breath and a dry cough. The disease is spread by close contact and antibiotics do not seem to work. The incubation period for the virus is said to be two to seven days. Some 80 to 90 per cent of infected people recover on their own, but there has been a 4 per cent casualty rate so far. SARS is poised to trigger a worldwide health emergency following reports of airborne transmission that has brought disease into the United States and Canada.

http://www.freerepublic.com/focus/f-news/885991/posts
Although the cause of the outbreak has not been proven beyond doubt, investigators say most evidence points to a previously unknown version of the coronavirus, the bug that causes about a third of all colds. Some who study this family of viruses say that because it spreads through coughs and sneezes, they cannot imagine totally wiping it out now that it has infected so many people.

http://www.freerepublic.com/focus/f-news/882458/posts
Autopsies revealed the virus caused parts of the lungs to hemorrhage blood, as would be the case with a hemorrhagic fever virus such as Ebola.

http://www.freerepublic.com/focus/f-news/880329/posts
"The longest possible incubation period that we've seen is 14 days," (WHO) spokesman Dick Thompson said March 30th in an interview from Geneva.

http://www.freerepublic.com/focus/f-news/880380/posts
The pattern of infection at the moment suggests that only those sitting next to or perhaps directly in front or behind an infected passenger is at risk. If whatever causes this disease is airborne then it becomes more likely that it could be transmitted through an aeroplane?s ventilation system. Currently SARS has a mortality rate of 4%. That is not that high, But WHO officials point out that the true mortality rate may be higher. The current figure is low in part as a result of the immense clinical effort that has gone in to providing supportive care for those who have fallen victim to the disease. One Hong Kong hospital has 150 patients with the disease, 30 of whom are being treated in intensive care. Many of these are on ventilators. The WHO says several would have died already without mechanical ventilation.

http://www.freerepublic.com/focus/f-news/880264/posts
The Canadian province of Ontario has 100 possible cases of the illness -- the highest caseload outside Asia.

http://www.freerepublic.com/focus/f-news/880292/posts
Hong Kong - Director of Health, Dr Margaret Chan, has ordered Block E of Amoy Garden in Ngau Tau Kok, Kowloon Bay, to be isolated for a period of 10 days starting from 6 am this morning (March 31) to prevent the spread of Severe Acute Respiratory Syndrome (commonly known as atypical pneumonia), a Government spokesman said. The decision was taken because of the continued steep rise in the number of cases of infection in the building in the past few days.

http://www.freerepublic.com/focus/f-news/880264/posts?page=10#10
CDC (March 30, 2003) - Sars, which has affected some 1,600 people worldwide, appears to spread more easily than was first thought, according to the CDC.


Frequently Asked Questions About Severe Acute Respiratory Syndrome (SARS)
http://my.webmd.com/content/Article/62/71651.htm?wbc_purpose=Basic

Timeline of disease spread from Nov 2002
http://www.freerepublic.com/focus/f-news/882353/posts

(CDC) Number of Suspected Cases Under Investigation in the United States
http://www.cdc.gov/od/oc/media/sars.htm
(WHO) Number of Suspected Cases Under Investigaion throughout the World
http://www.who.int/csr/sarscountry/en/
(CDC) SARS Fact Site
http://www.cdc.gov/ncidod/sars/
SARS Online - Information and Discussion
http://www.sarsonline.com/
22 posted on 04/05/2003 2:53:02 PM PST by cebadams (much better than ezra)
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To: unspun
DR. MERCOLA WEBSITE..............................

A mysterious form of highly infectious and deadly pneumonia has been spreading rapidly across Asia and has been spotted in Canada, prompting the World Health Organization (WHO) to issue an unusual global alert.

The disease triggers flu-like symptoms such as high fever, coughing and shortness of breath, but it hasn't been responding to either antibiotics or antivirals.

Experts say that it could take weeks to determine the cause of the outbreak, which they speculate is an exotic virus that has mutated into a new, more potent form or--in the worst-case scenario--a new form of influenza.


However, medical experts said that the spread of the disease is not as aggressive as most forms of influenza.

23 posted on 04/05/2003 2:54:06 PM PST by chicagolady
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To: TennesseeProfessor
It is not the dying I fear so much as the hospital bill that is if by the time I get sick there is still hospital space left for the sick.
24 posted on 04/05/2003 2:58:32 PM PST by CathyRyan
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To: Ditter
I cannot believe that you have no info on a lot of the "NEW" drugs out. Anti depressants are handed out like candy.
The new Cholestrol drugs are being banned because of the folks who have died the companies are having tremendous lawsuits comeout against them. Do a web engine seach on side effects of what ever drug you choose.

I understand your point to a point... Yes we need drugs. but they are over prescribed! THAT is why antibiotics are becoming in effective. THAT is no secret!
25 posted on 04/05/2003 3:01:06 PM PST by chicagolady
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To: TennesseeProfessor
SARS has no vaccine, affects healthy people, and has something approaching 3% fatality.

We don't know the true fatality rate. The only way SARS gets reported is if the person gets sick enough to require medical attention. Of THAT subgroup, something like 3-5% will die. The big unknown, currently, is what percentage of those infected get it mild enough that they don't seek medical attention

26 posted on 04/05/2003 3:01:59 PM PST by SauronOfMordor (Heavily armed, easily bored, and off my medication)
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To: Ditter
Drug Companies Put the Squeeze on Older Americans

Seniors' Most Popular Drugs Increase in Cost
Four Times the Rate of Inflation


AUSTIN, TEXAS - The price of a popular drug used to fight Parkinson's disease rose 385 percent over the past five years and another one to combat angina went up 111 percent. The two drugs were among 50 used extensively by older Americans whose prices far outpaced the rate of inflation during this period, according to a report released today by the consumer watchdog group Families USA and Consumers Union.


From January 1998 to January 1999, the prices of the 50 most prescribed drugs for older Americans increased 6.6 percent, four times the rate of inflation (1.6 percent), the report said. Over the past five years, the prices of these popular drugs rose twice as fast as the rate of inflation.


Meanwhile, the pharmaceutical industry continues to net record profits and outpatient prescription drugs are still excluded from Medicare coverage.


"There is something seriously wrong with this picture," said Lisa McGiffert, a senior policy analyst with the Southwest Regional Office of Consumers Union. "Seniors whose lives depend on prescription drugs are at the mercy of huge drug corporations, which are making money hand over fist at their expense."


While older Americans fill over 18 prescriptions per year, and nearly half of all Medicare beneficiaries live on less than $15,000 per year, the elderly are the last major insured consumer group without access to prescription drugs as a standard benefit.


"It is unconscionable that the sickest and oldest Americans go without prescription drug coverage as part of their basic benefit package," said Ron Pollack, executive director of Families USA. "Each year their social security checks increase only at the rate of inflation, while the costs of the drugs they take rise at two, three or four times the rate of inflation."


27 posted on 04/05/2003 3:08:24 PM PST by chicagolady
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To: SauronOfMordor
What's interesting here is that in a typical flu the morality rate is usually determined by the number of very young or very old who die from the disease. The 4% rate attributed to SARS is not based on these age groups. So the rate may be understated in a large population.
28 posted on 04/05/2003 3:10:46 PM PST by cebadams (much better than ezra)
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Comment #29 Removed by Moderator

To: gcochran
I have never had a flu Vaccine and have not had the flu, Since they tout the vaccine, thank you, I did fine without it.
If you would like to read about the effects of Mercury that is in the Flu vaccine you can go to the 2nd most read health website...www.mercola.com
Then make your informed and educated choice my friend.
30 posted on 04/05/2003 3:15:25 PM PST by chicagolady
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To: cebadams
Hospitalized Hong Kong SARS cases
Time Cases Increase Dispositon of Cases Total dead as % of case totals on previous days
Day Date New Total Day Week Hospital % Recover % Dead % Day ago 2 Day 3 Day 4 Day 5 Day 6 Day Week 2 Week
Wed 03/19 150
Thu 03/20 23 173 15.3%
Fri 03/21 30 203 17.3%
Sat 03/22 19 222 9.4%
Sun 03/23 25 247 11.3%
Mon 03/24 13 260 5.3%
Tue 03/25 26 286 10.0%
Wed 03/26 30 316 10.5% 110.7%
Thu 03/27 51 367 16.1% 112.1%
Fri 03/28 58 425 15.8% 109.4%
Sat 03/29 45 470 10.6% 111.7% 10 2.1% 2.4% 2.7% 3.2% 3.5% 3.8% 4.0% 4.5%
Sun 03/30 60 530 12.8% 114.6% 13 2.5% 2.8% 3.1% 3.5% 4.1% 4.5% 5.0% 5.3%
Mon 03/31 80 610 15.1% 134.6% 15 2.5% 2.8% 3.2% 3.5% 4.1% 4.7% 5.2% 5.8%
Tue 04/1 75 685 12.3% 139.5% 16 2.3% 2.6% 3.0% 3.4% 3.8% 4.4% 5.1% 5.6%
Wed 04/2 23 708 3.4% 124.1% 603 85.2% 89 12.6% 16 2.3% 2.3% 2.6% 3.0% 3.4% 3.8% 4.4% 5.1% 10.7%
Thu 04/3 26 734 3.7% 100.0% 619 84.3% 98 13.4% 17 2.3% 2.4% 2.5% 2.8% 3.2% 3.6% 4.0% 4.6% 9.8%
Fri 04/4 27 761 3.7% 79.1% 645 84.8% 99 13.0% 17 2.2% 2.3% 2.4% 2.5% 2.8% 3.2% 3.6% 4.0% 8.4%
Sat 04/5 39 800 5.1% 70.2% 673 84.1% 107 13.4% 20 2.5% 2.6% 2.7% 2.8% 2.9% 3.3% 3.8% 4.3% 9.0%
Averages 38 10.4% 109.6% 84.6% 13.1% 2.3% 2.5% 2.8% 3.1% 3.5% 3.9% 4.4% 4.9% 9.5%

31 posted on 04/05/2003 3:29:41 PM PST by per loin
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To: per loin
Very interesting statistics. Once we stopped getting new cases from the sick apartment complex the number of new cases seemed to drop encouragingly.

However, the number of new cases each day is still quite high. If the current containment measures are working, we should see a significant drop in new cases by the middle of next week.

On the other hand, it is still too soon for new patients infected by the apartment complex patients to start showing up. Since the new restrictive measures were not in place during part of the time these people may have been contagious, we could see a spike in cases simply from that source. If we do, it would not necessarily mean that the quarantine attempt will fail.

It would be nice to have access to the raw data. For instance, how many of the people infected on or before March 15th have been released, died, are in intensive care, on ventilators, etc.?

Even without having access to the raw data, it is readily apparent that most people are spending a long time in the hospital. The total number of recovered+dead patients is less than the total number of cases on March 19th.
32 posted on 04/05/2003 5:22:03 PM PST by EternalHope (Chirac is funny, France is a joke.)
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To: chicagolady
So what is your answer?
33 posted on 04/05/2003 5:36:49 PM PST by Ditter
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To: CathyRyan
...if by the time I get sick there is still hospital space left for the sick.

Very good point, often overlooked. It appears a high proportion of people who get SARS need hospitalization, meaning the medical system could easily get overwhelmed.

Another often overlooked point is the effect on people with weak immune systems. Aids is obvious, but many other people have weakened immune systems as well. Cancer patients, for instance.

34 posted on 04/05/2003 5:38:39 PM PST by EternalHope (Chirac is funny, France is a joke.)
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To: Ditter
The American Medical Association and Drug Companies could create a new mission statement that puts peoples health and well being above profits.
It is Profit Driven NOT health driven. That is my answer!


OF COURSE no one is against profits and good ones at that.
They rape folks, the article I sent is just a little spec of dust in the sand example.
Is that the reason why Doctors are turning to Alternative medicine where possible?
Folks demand it because in many cases it works and they are not charged an arm and a leg.
Ok, I do not want to hear about the alternative "Grapes kill cancer" quackery. I talking about authentic alternative therapies.
35 posted on 04/05/2003 6:06:25 PM PST by chicagolady
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To: Radioactive
" Each person who gets it may spread the infection to several others before they even know they have it. While many are infected through face-to-face contact, evidence is mounting that the virus may also spread through the air or be picked up from contaminated surfaces."

It does look like forced population control by China.

We can still control it here until we get a vaccine but Bush needs to apply his executive order in the necessary ramifications and that will mean stopping travel from all hotzones immediately. If he waits the costs in lives and $$$ will grow exponentially.
36 posted on 04/05/2003 6:37:41 PM PST by Domestic Church (AMDG...HOPE)
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To: chicagolady

What Causes Heart Disease? Experts to Discuss Emerging Theories

Contact: Sally Fallon
Phone: 202 333-HEAL

Experts will discuss the cholesterol theory of heart disease and present new theories on the causes of America’s most common medical problem at the 4th Annual Conference of the Weston A. Price Foundation, May 3-5, 2003.

Cholesterol-lowering diets and drugs have not reduced the rate of heart disease in America. Over half of all heart attack victims have cholesterol levels at or below the level considered normal. These statistics point to flaws in the currently held theory that heart disease is caused by diets rich in animal foods and elevated cholesterol levels in the blood.

Speakers on Saturday, May 3 include Dr. Uffe Ravnskov, author of The Cholesterol Myths and over 50 published papers on cholesterol and heart disease, who will present evidence that high cholesterol levels actually protect us against disease; Dr. Paul Rosch, President of the American Institute of Stress, who will discuss the subtle yet serious dangers of cholesterol-lowering measures; Dr. Kilmer McCully, highly acclaimed researcher and proponent of the homocysteine theory of heart disease, who will discuss the role of vitamins A, B6, B12 and folate in preventing heart disease; and Dr. Mary Enig, lipid biochemist and author of Know Your Fats, who will review evidence showing that trans fat made from vegetable oils, rather than animal fat, is a major cause of heart disease and will discuss how the USDA dietary guidelines have contributed to an increase in coronary problems.

On Sunday May 6, Dr. Peter Langsjoen, a physician in private practice, will present evidence that modern cholesterol-lowering drugs have contributed to an increase in heart failure; Dr. Duane Graveline, former astronaut, will describe his experience of total amnesia while taking cholesterol-lowering medication; and Dr. Leslie Klevay will present evidence that copper deficiency contributes to arterial inflammation leading to heart disease. Other speakers will present a variety of holistic therapies for heart disease, drawing from European and Asian traditions.


37 posted on 04/09/2003 8:38:19 AM PDT by chicagolady
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To: Ditter
Fosamax Type Osteoporosis Drugs Noted to Cause Serious Eye Problems


E-mail to a friend

Drugs commonly prescribed to osteoporosis and cancer patients may cause serious inflammation in several regions of the eye in some patients. Researchers hope the finding will make physicians more likely to monitor patients for such eye problems as well as prompt drug companies to add warning labels to their products.


Two medications in a class of drugs called bisphosphonates, which are often used to increase bone density in patients with osteoporosis, were found to cause the serious side effects in the eyes of some patients. The drugs are also prescribed to cancer patients, as lung, breast or prostate cancer that has spread to the bones can also decrease bone density.


Researchers reviewed thousands of cases in which patients were prescribed bisphosphonates and tracked 314 patients who also reported eye problems. Although the side effects were rare and did not occur in most patients, some types of eye inflammation can lead to vision loss or blindness if left untreated.


Of the patients who reported side effects, close to 100 suffered from blurred vision. Other problems included pain and swelling.


Researchers noted that the side effects went away when patients stopped taking the medication.


New England Journal Medicine March 20, 2003;348(12):1187-8

38 posted on 04/09/2003 8:39:49 AM PDT by chicagolady
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To: Ditter
Mercury In Vaccines Contributing to Autism Epidemic

By age two, American children have received 237 micrograms of mercury through vaccines alone, which far exceeds current EPA "safe" levels of .1 mcg/kg. per day. That's one-tenth of a microgram, not one microgram.

This means that children are getting 2,370 times the amount of mercury that the EPA deems safe from the shots which are mandated by the government.

The figure of one autistic infant for every 150 is now widely documented

Autism and mercury poisoning damage the:

Brain/nerve cells
Eyes
Immune system
Gastrointestinal system
Muscle control
The speech center.
Although mercury toxicity has been studied for decades, and EPA safety levels have been set, during all that time, a child's greatest exposure to mercury - thimerosol in vaccines - was never even included in the toxicity studies.

Many investigators believe the mercury in the vaccines has contributed to this epidemic of autism. Read the full story of how the mercury, called thimerosol, has been damaging American children for many decades

39 posted on 04/09/2003 8:42:34 AM PDT by chicagolady
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To: Ditter
Mercury in Vaccines

Uproar over a little-known preservative, thimerosal, jostles U.S. hepatitis B vaccination policy In 1997, when Frank Pallone, a Democratic congressman from New Jersey, attached a simple amendment to an FDA reauthorization bill, he could not have predicted that it would cause such a commotion two years later. His amendment ran just 133 words. It gave FDA two years to "compile a list of drugs and foods that contain intentionally introduced mercury compounds and . [to] provide a quantitative and qualitative analysis of the mercury compounds in the list.."

The bill later evolved into the landmark FDA Modernization Act of 1997 (FDAMA) and was signed into law on November 21, 1997. Pallone's amendment undoubtedly sprang from his long interest in environmental causes. But he had unwittingly set into motion a chain of events that would, two years later, bring turmoil to the immunization policy world and fears of harm to the nation's hepatitis B control effort.

Facts about thimerosal and mercury

Thimerosal is a water-soluble, cream-colored crystalline powder. It is 49.6% mercury by weight. In the human body, thimerosal is metabolized to ethylmercury and thiosalicylate. The literature on thimerosal metabolism and excretion is limited and old. Case reports have demonstrated toxicity after massive overdoses. Toxicological information on the chief metabolite of thimerosal, ethylmercury, is extremely limited.

During the recent controversy over the safety of thimerosal in vaccines, toxicologists have assumed that the toxicity of ethylmercury is equivalent to the toxicity of methylmercury. The toxicity of methylmercury is complex and depends on the type, level, and duration of exposure. The primary environmental exposure is through consumption of predator fish. A 6-ounce can of tuna fish contains an average of 17 micrograms of mercury.

A pediatric dose of hepatitis B vaccine contains 12.5 micrograms. The major toxicity of mercury is manifested in the central nervous system. Forty years ago, when women at Minamata Bay, Japan, ate fish contaminated with methylmercury from pollutants, their children were exposed to high levels in utero and were born with severe developmental and neurological disorders. Methylmercury poisoning also occurred in Iraq following consumption of seed grain that had been treated with a fungicide containing methylmercury.

In both the Japanese and Iraqi episodes, exposures to methylmercury were very high. Two population-based studies are often cited as the basis for calculations on the neurotoxicity of mercury in utero. In the first, a study from the Seychelles, infants were exposed to mercury in utero when their mothers ate a high daily consumption of methylmercury-containing fish. The mothers had mean mercury levels in hair of 6.8 ppm. No developmental defects were detected. In the second, a study from the Faroe Islands, infants were born to mothers with mean hair levels of 4.3 ppm.

In contrast to the Seychelles mothers, these mothers were exposed to mercury through intermittent "bolus" consumption of pilot whale meat. Lower scores on memory, attention, and language tests were associated with methylmercury exposure in the children (see Mercury Study Report to Congress, EPA, 1997).

Thimerosal, old soldier under a cloud

At first glance, someone looking for a controversy would not choose thimerosal. It has been used as a vaccine preservative since the 1930s, and, until recently, it has generally been viewed as a safe, reliable, and somewhat drab defender against bacterial and fungal contamination. The compound garners only one short paragraph in the 1249-page Plotkin and Orenstein reference book, Vaccines 3rd Edition (1999). Thimerosal is sometimes added to vaccines during manufacturing as a guarantee against production-related contamination. Its greatest value, however, is in the field, where it acts as a fail-safe against imperfect aseptic handling. It is especially valuable for multidose vaccine vials, in which the re-entry of needles greatly increases the risk of bacterial introduction.

Thimerosal's only competitor, 2-phenoxyethanol, is less effective than thimerosal in suppressing potential contaminants like Pseudomonas aeruginosa, E. coli, and Staph. aureus, according to data presented by Dr. Stanley Plotkin at an August workshop on thimerosal safety held at the National Institutes of Health. The problem with thimerosal is that it contains 49.6% mercury by weight. At high exposure levels, mercury causes neurotoxicity in humans, especially in fetuses and small infants whose brains are still developing.

But because of thimerosal's long track record as a defender against vaccine contamination disasters, discarding it is not easy. CBER mercury analysis triggered fears Over a year went by before the FDAMA mercury study got any public attention at FDA. Finally, on December 14, 1998, just 11 months before the congressional deadline, the agency published a notice in the Federal Register requesting manufacturers to provide data on mercury content. The agency published a second, more specific request on April 29, 1999.

The work of analyzing the vaccine data fell to FDA's Center for Biologics Evaluation & Research (CBER). Officials at CBER were aware that thimerosal had surfaced as a safety issue in Europe. In June 1999, the "European FDA", called the Agency for the Evaluation of Medicinal Products (EMEA), completed an 18-month inquiry into the risks and benefits of using thimerosal in vaccines. EMEA concluded that "although there is no evidence of harm caused by the level of exposure from vaccines, it would be prudent to promote the general use of vaccines without thimerosal.."

One of CBER's first tasks was to simply add up the total amount of mercury given to children through vaccines in the US immunization schedule. Although it may seem surprising that CBER had not done this before, CBER's mission, to ensure the purity, potency, safety, and efficacy of individual products, would never have required such an analysis. CBER researchers soon confirmed that thimerosal was present in over 30 licensed vaccines in the US in concentrations of 0.003% to 0.01%. According to the agency's calculations, an infant six months old who got all vaccine doses on schedule would receive 75 micrograms of mercury from three doses of DTaP, 75 micrograms from three doses of Hib, and 37.5 micrograms from three doses of hepatitis B vaccine - a total of 187.5 micrograms of mercury.

But was this enough mercury to worry about? The analysts next tried to compare the calculated mercury intake with federal guidelines for safe mercury intake, but they immediately ran into difficulty. Thimerosal is metabolized in humans to ethylmercury, but all guidelines for safe mercury intake relate only to methylmercury. No guideline exists for the ethyl compound. Indeed, the literature on ethylmercury toxicity is so scant that toxicologists do not even know whether ethylmercury is more or less toxic than its methyl cousin. Left with no choice, CBER analysts assumed that the toxicity of the ethyl compound is equivalent to the methyl compound.

Armed with this assumption, they compared the mercury intake from vaccines in children six months old, 187.5 micrograms, to the suggested safe limits for methylmercury intake published by three federal agencies: EPA, FDA, and the Agency for Toxic Substances and Disease Registry (ATSDR). It was then that they made a remarkable discovery - the mercury intake through vaccination in the first six months of life exceeded the limit set by EPA.

Sharpening a double-edged sword

The CBER analysts were concerned. Millions of American children under six months old had apparently received, and were continuing to receive, an amount of mercury from vaccines that exceeded a federal guideline. The finding was potentially serious, but it was muddled by several factors. First, the three federal agencies that publish mercury intake guidelines, EPA, FDA, and ATSDR, disagree about the safe limit. EPA's limit is significantly lower than the FDA and ATSDR guidelines. The intake of mercury from vaccination exceeded only the EPA guideline.

Second, EPA's guideline (called the EPA reference dose, or RfD) is truly cautious. It is based on a single episode of methylmercury poisoning in Iraq in which 81 children were exposed to high levels of mercury in utero. EPA calculated the RFD by determining the dose that produced a 10% prevalence of adverse neurological effects in the affected children, such as late walking, late talking, and abnormal neurological scores. The agency then placed a 95% confidence interval around this dose and divided the lower bound of the interval by an "uncertainty factor" of 10 to arrive at the RFD CBER's finding was also clouded by important differences in the nature of exposure between the Iraqi children and children exposed through vaccination. The Iraqi children sustained long-term daily prenatal exposures, while vaccinated children have intermittent intramuscular doses later in life, as infants. No one, however, could tell CBER exactly how these exposure differences might affect the potential neurotoxicity of mercury.

AAP sounds an alarm

In mid-June, CBER's findings came to attention of Dr. Neal A. Halsey, Director of the Johns Hopkins Institute for Vaccine Safety. Halsey is a pediatrician and a highly respected vaccine expert. When he learned of the CBER findings, he was finishing up a four-year term as chairperson of the AAP Committee on Infectious Diseases, the committee that determines AAP vaccination policy and edits the renowned Red Book. Long before he heard about the thimerosal findings, Halsey had become worried about the progress of vaccination protest groups in the US

They had chalked up significant successes in discrediting childhood vaccination. Five months earlier, a network television program had seriously questioned the nation's hepatitis B vaccination policy see Hepatitis Control Report, Winter 1998-99 issue). In May, Congress had held a contentious hearing on the dangers of vaccination (see Hepatitis Control Report, Spring 1999 issue). News media and political groups had picked up the anti-vaccination chant.

Halsey feared that the tide was turning against childhood vaccination, with potentially dangerous consequences. Halsey confirmed CBER's calculations and did his own research on mercury, consulting with experts around the country. He became convinced that the findings were worthy of alarm, and he worried that if they became public prematurely, vaccination protesters would use them to stage yet another attack on the nation's immunization programs. Halsey met with officials at CBER on June 22nd and then called Dr. Walter Orenstein, director of CDC's National Immunization Program (NIP). Eight days later, NIP staff flew to Washington to meet with FDA, AAP, and vaccine manufacturers.

From the start, Halsey and his colleagues at AAP, including the new chairperson of the Infectious Diseases Committee, Dr. Jon Abramson, took a strong proactive stance. They argued that physicians should be told - soon - about the amount of mercury in vaccines and the conflict with a federal guideline. Hectic negotiations led to AAP-CDC compromise, but differences lived on CDC was surprised by the urgent and undoubting position taken by Halsey and his colleagues at AAP.

CDC officials argued that there was no need for precipitous action. They pointed out that no child was known to be harmed from thimerosal, and they were loath to undermine confidence in existing vaccines by labeling some vaccines "bad" (thimerosal-containing) and some "good" (thimerosal-free). But, in further discussions through the first few days of July, it became clear that Halsey and AAP would not retreat - they believed that immediate action was needed. Within AAP, the issue ascended quickly from Halsey's committee to the executive board.

AAP executives felt that their members needed more than just information about thimerosal - they also needed a way to reduce mercury exposure in their tiny patients. They feared that pediatricians who continued to administer thimerosal-containing vaccines could face a flurry of lawsuits, perhaps claiming that children had acquired learning disabilities from mercury exposure. The discussions quickly veered toward pushing vaccine doses back from the first six months of life to a later time, when infants' bodies were larger and better able to tolerate mercury. Delaying vaccinations against diphtheria-tetanus-pertussis or Hemophilus influenza type b was not practical or could expose children to serious infections.

It soon became evident that the delayed vaccine would have to be hepatitis B. Only two single-antigen pediatric hepatitis B vaccines exist on the US market, Engerix-B (SmithKline Beecham) and Recombivax HB (Merck). Both contain thimerosal and 12.5 micrograms of mercury per 0.5 ml dose. AAP pressed CDC to agree to a delay of the hepatitis B vaccination series, usually started at birth, for children born to hepatitis B surface antigen (HBsAg)-seronegative mothers. The Academy argued that the delay would only be temporary, because both Merck and SmithKline Beecham had promised that they could quickly shift manufacturing to thimerosal-free vaccine, perhaps in just a few months.

FDA had already promised to review applications for thimerosal-free hepatitis B vaccine rapidly - within 30 days. At the CDC Hepatitis Branch in Atlanta, Dr. Harold Margolis, Chief of the Branch, and staff epidemiologist Dr. Eric Mast saw trouble. They and other hepatitis B control advocates had worked hard since 1991 to make infant vaccination routine, and it had become a cornerstone of the CDC-ACIP strategy to eliminate hepatitis B transmission in the US The strategy was working - hepatitis B rates had fallen consistently since the policy was implemented.

Margolis and Mast worried that delaying the routine birth dose, even temporarily, would cause hepatitis B vaccination rates to slide. Furthermore, once the policy was changed, it could be difficult to switch back. States were already under pressure from vaccination protest groups to drop hepatitis B vaccination school entry requirements (see Hepatitis Control Report, Winter 1998-99 issue). Margolis and Mast began working furiously to build a case against delaying hepatitis B vaccination. The CDC hepatitis group felt that AAP had not sufficiently accounted for the burden of hepatitis B virus (HBV) infection during childhood.

Mast had estimates showing that, in the years before routine vaccination began, 45,000 HBV infections had occurred annually in children less than 10 years old. Of those, 33,000 were in children of HBsAg-seronegative mothers. CDC also had data from the 1998 National Immunization Survey suggesting that a delay in the birth dose would decrease hepatitis B vaccination completion rates by 15% - perhaps even more in infants born to high-risk mothers.

Negotiations continued with AAP nearly around the clock. Everyone was becoming exhausted. AAP insisted on a six-month delay of hepatitis B vaccination for infants of HBsAg-negative moms. CDC resisted. As the groups continued negotiations over days, worries increased that the story would leak to the press in an uncontrolled way, triggering a general vaccination scare. "Everyone worried that, with the vaccination protest groups looking over our shoulders, if they got the sense that some [toxicological] standard was broken, all hell would break loose," said a senior official who worked on the issue.

Speaking later, AAP's Abramson said, "AAP and CDC diverged on the hepatitis B issue. It was a matter of how safe do you want to be? . Our perspective was let the individual pediatrician make a judgment for each family. CDC was looking at it from a public health perspective." Finally, after a week of late night meetings involving the AAP executive board, Surgeon General Dr. David Satcher, CDC Director Dr. Jeffrey Koplan and other CDC officials, FDA, the manufacturers, and others, the exhausted group struck a compromise.

An AAP-USPHS joint statement was issued on July 7 at 4:15 PM (see www.aap.org/advocacy/releases/jointvacc.htm). The statement said in part: Clinicians and parents can take advantage of the flexibility within the existing schedule for infants born to HBsAg-negative women to postpone the first dose of hepatitis B vaccine from birth until two to six months of age when the infant is considerably larger. Pre-term infants born to HBsAg-negative mothers should similarly receive hepatitis B vaccine, but ideally not until they reach term gestational age and a weight of at least 2.5 kilograms. Because of the substantial risk of disease, there is no change in the recommendations for infants of HBsAg-positive mothers or of mothers whose status is unknown.

Also, in populations where HBsAg screening of pregnant women is not routinely performed, vaccination of all infants at birth should be maintained, as is currently recommended. A few days later, AAP issued an "Interim Report to Clinicians" sharpening its own position: At this time, the only thimerosal-free hepatitis B vaccine available (COMVAX) also contains Hib vaccine (PRP-OMP). The product is not approved for use before 6 weeks of age because of decreased response to the Hib component. For that reason, where available, this thimerosal-free vaccine may be given to infants born to HBsAg negative women beginning at the two months visit. If thimerosal-free vaccine is not available, hepatitis B virus vaccination should be initiated at 6 months of age.. CDC issued its own supplemental guidance on July 14 (see http://www.cdc.gov/nip/news/thimerosal-guidance.htm), saying: Many hospitals have instituted policies to vaccinate all children at birth regardless of HBsAg status as a means of ensuring that all the infants of HBsAg positive women and infants of women with an unknown HBsAg status are vaccinated at birth.

These hospitals should continue current policies until procedures are or can be put in place to guarantee the proper management of all births to prevent perinatal HBV transmission.. CDC also said "hepatitis B vaccination at birth should be continued for infants born to HBsAg-negative mothers belonging to populations at risk for early childhood HBV infections, including Asian Pacific Islanders, immigrant populations from countries in which HBV is of high or intermediate endemicity., and households with persons with chronic HBV infection." The AAP and CDC policies remain slightly at odds. AAP prefers that infants of HBsAg-seropositive moms be delayed until two months if COMVAX is available, or until six months if it is not. CDC prefers that hepatitis B vaccine be administered according to the current recommendations of the ACIP, which allow vaccination to begin at two months .

Reaction in the real world In the weeks after the AAP and CDC statements were issued, state health departments reacted in a variety of ways. At least one state, New Hampshire, recommended no change in the hepatitis B vaccination schedule. At the other extreme, New Mexico opted for a full one-year delay. Most states have adopted a 2- or a 2-6 month delay for infants of HBsAg-seronegative women, and many of those states recommend COMVAX at two months.

Some physicians have criticized the new recommendations. "I can't believe the Academy doesn't think it has stubbed its toe on this one," said one prominent Texas pediatrician who is a member of AAP. "It's too much too fast. I mean, it's crazy." Dr. Paul Offit, chief of infectious disease at the Children's Hospital of Philadelphia and a member of ACIP, told The Philadelphia Inquirer that the fear of trace mercury in vaccines was "a theoretical and unproven problem which has been elevated to a level of importance that doesn't make sense."

Others have taken the opposite view - some leaders within AAP believe that the Academy did not go far enough to protect infants against mercury. But pediatricians in both camps feel obligated to follow the new policies for fear of legal liability if they diverge. Informal surveys indicate that hospitals have changed their hepatitis B vaccination policies rapidly to comply with the new recommendations, often on orders from their legal departments.

The consequences have not always been good. Dr. Barbara Watson, chief of immunization at the Philadelphia City Health Department, told attendees at the August NIH thimerosal workshop that she personally knew of three infants of HBsAg-seropositive mothers who missed being vaccinated in hospital because of confusion caused by the policy change. At the August NIH workshop, Dr. Eric Mast showed a CDC analysis estimating that 246 infants of HBsAg-seronegative mothers and 200 infants of mothers with unknown HBsAg status would become infected nationwide as a result of the new policy, assuming it lasted six months and produced a 15% to 25% drop in the newborn vaccination rate.

The aftermath

The nation's most well-known vaccination protester is pleased with the change in hepatitis B vaccination policy. Barbara Loe Fisher, President of the National Vaccine Information Center in Vienna, Virginia, said in a press release that the new policy "will result in the deaths and injury of fewer babies.. Eliminating mercury from childhood vaccines is an important safety initiative and we hope that further evaluation of the cumulative toxic effects of other vaccine ingredients, such as aluminum used as an adjuvant, will also be undertaken .."

But a physician from WHO, Dr. John Clements, said at the NIH workshop that "the US has gone on its due process to identify a problem and correct it. But there is a knock-on effect which the world must bear as a consequence." Clements pointed out that only multidose, multipuncture vaccine vials can be used in developing countries because of cost and cold-chain considerations. Removing thimerosal from these vials is not an option for WHO, at least for the next several years, he said.

The foreseeable future

The long-term effect of the controversy on hepatitis B vaccination rates remains murky. Vaccine manufacturers have agreed to provide a plan to eliminate or reduce the mercury content of vaccines as soon as possible (see editor's postscript). AAP and CDC plan to monitor immunization practices, immunization coverage, and vaccine preventable disease levels. ACIP will take up the thimerosal issue at its October meeting. In an August interview, Dr. Halsey defended the thimerosal decision-making process used by AAP and CDC. It would not have been possible to deal with thimerosal in the usual public forums like ACIP, Halsey said, because the presence of vaccination protesters would have made rational discussion hopeless. Deliberations were handled in the only way possible, he said.

But Halsey acknowledged that many of his immunization colleagues are angry with him and miffed about the way the issue was handled. Halsey said he does not believe that delaying the first dose of hepatitis B vaccine in HBsAg-seronegative mothers will have a major impact. He does worry, however, about the effects, real and perceived, that mercury may have on vaccinated infants. He pointed out that, to truly assess infants' exposure to mercury, the intake from thimerosal must be added to the intake from all other sources, especially maternal fish consumption. For infants born to women with high mercury consumption, he said, "no one knows what dose of mercury, if any, from vaccines is safe.. We can say there is no evidence of harm, but the truth is no one has looked."

http://www.hepatitiscontrolreport.com/vol/v4n21.html

COMMENT:

It appears that there is a very limited role for hepatitis B vaccination, but only in the children of mothers who are currently infected with the virus. It makes little sense to expose millions of others to the risk and dangers of this vaccination which extend far beyond the dangers of the mercury issue discussed above and which will likely be resolved in the next few years.

40 posted on 04/09/2003 8:46:06 AM PDT by chicagolady
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