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NY Times supports Oprah on free speech
off-site: Direct from Amarillo: Cattlemen vs. Oprah Winfrey
Hong Kong authorities recall patients given madcow disease-tainted drugs
CJD Voice: real people, real statistics
Families of E. coli victims meet
Cow and pig to human transplant ban urged

Free Speech About Food

January 19, 1998 NY Times
The lawsuit brought by Texas cattle ranchers against Oprah Winfrey will provide the first legal test of any of the "food disparagement" laws now in place in 13 states. These harmful and probably unconstitutional statutes are intended to protect farmers and ranchers from malicious or reckless statements suggesting that a food product is not safe for consumption. But if upheld, these laws could chill needed public debate about food safety and food processing methods.

The ranchers are suing Ms. Winfrey for a show on mad cow disease that aired in April 1996. A guest on her talk show discussed the perils of feeding ground-up animal parts to cattle, a practice that is thought to have spread mad cow disease in Britain. After hearing his remarks, Ms. Winfrey told her audience they would stop her from eating another hamburger.

The plaintiff cattlemen charge that the show caused an immediate drop in beef prices that resulted in the loss of millions of dollars to the industry. The Texas food libel law allows recovery of damages if the person making the remarks knows that the statements are false. But the trouble is, food-safety debates rarely involve assertions that are plainly true or false. Much of the time, the issue is about risk assessment and policy judgments about what level of risk is acceptable. Although there have been no cases of mad cow infection of cattle in this country, the Food and Drug Administration banned the use of ground animal parts in feed last June to guard against transmission of the disease.

Laws like the Texas statute could easily be used to dampen speech about potentially unsafe production methods and possible pathogens that are not yet fully understood.

Ms. Winfrey has the resources to defend herself against these libel charges, but smaller nonprofit consumer groups could be silenced by the legal threats from the agriculture industry. Recent incidents of bacterial contamination in ground beef, fruit juice and lettuce that have caused illnesses and, in a few cases, death underscore the need for more talk about food safety, not less. Americans enjoy a food supply that is among the safest in the world. But these unwise food-disparagement laws would shield producers from legitimate inquiry.

Hong Kong authorities recall patients given madcow disease-tainted drugs

January  22, 1998  Agence France Presse
Copyright 1998 Agence France Presse HONG KONG - Hong Kong health authorities announced Thursday they were contacting 111 patients given blood products contaminated with Creutzfeldt-Jakob Disease (CJD), the human variant of mad cow disease. The Hong Kong Hospital Authority told a news conference that two medical kits were sent to six hospitals which used them in treating 111 patients with lung and heart conditions.

The kits contained a reagent in a fluid which was injected into the patients before a body scan. The reagent was contaminated with an agent or protein responsible for causing CJD, it said. The authority added it was contacting the affected patients for tests and to provide counselling but said the chance of any of them contracting the disease was extremely slim.

"The first and most important thing is that we would reassure them that the chance of contracting the disease through administration of the test reagent is extremely remote, " Ko Wing-man, deputy director of Hospital Authority operations, told reporters.
Neurologist Patrick Li said although some of the 111 patients may have since died, they would have done so from their original illnesses and not of CJD as the disease has a 10 to 15-year incubation period.
"For those patients exposed and have since died, if we count the time from when they were given the contaminated products, it is extremely unlikely that it was related to CJD, " Li said, adding that the tainted blood products were administered only in the past few months.
The authority said the contaminated kits were provided by a UK-based supplier from July to December last year. The British manufacturer discovered the contamination after a donor from whose blood the reagent was manufactured died of CJD. Ko refused to say whether the territory would ban blood products from Britain following the contamination, saying only that "we trust that relevant authorities in the UK are adopting prudent measures. "

Hospital authority official Katherine So said officials had made appointments for 66 of the 111 patients to meet their attending physicians and were still trying to reach the remaining patients. Ko said that although the hospital lists registered 111 patients, he could not rule out the possibility that more people had received the CJD-tainted reagent. "I am confident there will not be too many patients involved, " he added.

After British scientists established a link between CJD and mad cow disease or BSE (bovine spongiform encephalopathy), a worldwide embargo on British beef was imposed in March 1996. CJD is held responsible for 22 deaths in Britain, with infected beef the main suspected cause. But last month it emerged that hundreds of patients throughout Europe were treated with British blood products that could be contaminated with CJD.

They were treated with the "contaminated " Amerscam Pulmonate, an injectable agent used in lung scans in radiology departments. It was withdrawn on November 18 following a warning from the British manufacturer Nycomed Amersham. The plasma in Amerscam Pulmonate was taken from British donors including one man who turned out to be infected with CJD. The product was distributed in up to 52 countries, Nycomed Amersham said. The manufacturers said 10,000 units of the product had been sold to countries including Belgium, Britain, Colombia, Denmark, Finland, Germany, Ireland, Indonesia, Malaysia, the Philippines, Portugal, South Korea, Spain and Sweden. European Union experts have determined it is "unlikely " that CJD can be transmitted through blood, a Swedish official said in December.

British Firm Says HK Overreacting In 'Mad Cow' Scare

Dow Jones : Thu, Jan 22, 1998
HONG KONG (AP)--The British manufacturer of a medical fluid at the center of a health scare in Hong Kong said Friday there was no evidence that its product was contaminated with a human equivalent of mad cow disease.

Alan Huw Smith, a spokesman for Nycomed Amersham PLC (NYE), said Hong Kong health officials overreacted by advising patients who were given the fluid to see a doctor if they exhibit symptoms associated with the brain-wasting Creutzfeldt-Jakob Disease.

  'It's incredibly irresponsible to take it this far,' he said in an
interview. 'They've gone bananas by the sound of it.' 
Warnings delivered Thursday by Hong Kong's Hospital Authority that the fluid was suspected to be contaminated and was given to more than 100 patients made front page headlines in many Hong Kong newspapers Friday. 'Mad cow alert,' said the South China Morning Post. 'Mad cow fear,' said the Hong Kong Standard.

The fluid, Amerscan Pulmonate II, is injected into patients requiring a lung scan and enables doctors using special equipment to get a picture of the lungs, the company spokesman said. The fluid incorporates serum made from blood. The company recalled batches of the product last year after a blood donor in Britain who died was diagnosed in a post-mortem to have had CJD, the spokesman said. The recall 'was a purely precautionary measure,' he said. 'There is no evidence that it was contaminated.' But he also said the company could not state that the product was 'zero risk.'

CJD can only be diagnosed in a post-mortem and there is no test to determine whether a product is contaminated, he said. Hong Kong's Hospital Authority said chances were 'very remote and extremely low' of being infected from suspect batches of the product.

CJD is the human form of bovine spongiform encephalopathy, which afflicts cattle and is known as mad cow disease. CJD has killed at least 20 people in Britain since fears over mad cow disease came to the fore in March 1996.

HK to help patients seek damages in ``mad cow'' scare

Reuters North America Fri, Jan 23, 1998 By Dominic Lau
HONG KONG - Hong Kong health authorities said on Friday they would help more than 100 people help seek compensation for a medical blunder which may have infected them with the human form of "mad cow" disease.
"If they want to seek compensation, we will help them. But, of course, we need first to look at the laws," Hospital Authority chief Doctor Yeoh Eng-kiong told reporters.
Health officials also appealed to medical suppliers worldwide for help in the "mad cow" alert in which 111 patients may have been exposed to contaminated medical tests.
"We are seeking clarifications from all the suppliers and the relevant authorities in UK," Hospital Authority deputy director Doctor Ko Wing-man told Hong Kong radio. "We are not sure the supplies have been contaminated," he said. "But we have to be careful about that possibility. That's why we call for this precautionary measure."
Authorities have said a test for heart and lung ailments might have infected the 111 hospital patients with Creutzfeldt-Jakob Disease (CJD), the human variant of "mad cow" disease which plunged Britain's cattle industry into chaos two years ago. Seven of the patients have since died.

Although doctors stressed it was unclear whether CJD had caused the deaths, the incident could not have come at a worse time for the former British colony, which became a special part of China last July. The city of 6.5 million people is already reeling from Asia's financial crisis, an economic downturn, and a mysterious "bird flu" blamed for six deaths and which prompted a mass cull of poultry.

Ko said the Hospital Authority was trying to contact the patients for testing but assured them the chance of catching the disease was minimal. The authorities have contacted more than 90 patients so far. "I must emphasise here that the risk of contracting CJD through this channel is very remote. All we are doing is purely precautionary measure," he said.

Contamination of the chemicals in the tests, known as reagents, was suspected after one of the donors of a pool of albumin, a protein used to make the test reagents, died of CJD in Britain. Health authorities said they were unaware of the suspected contamination until last week when the manufacturer recalled the test reagents.

London-listed company Nycomed Amersham on Thursday denied talk that it had supplied a contaminated product for the tests.

"There is no evidence that this batch of our product was contaminated. We volunteered to recall this batch as a precautionary measure following a change in European regulations," said Alan Huw-Smith, spokesman at the Anglo-Norwegian healthcare and technology group
. Ko said it was still safe to import blood products from Britain despite the latest scare.
"We understand and trust that the British authorities have done all that is necessary to prevent the infection of blood products by this particular disease," he said. "I think they have got the necessary mechanism in place to ensure the safety of blood products."
Doctor Leong Che-hung, a Hong Kong doctor and legislator, said the chances of catching CJD were slim, otherwise Britain would make an announcement to recall the products immediately.
"If they have come to this conclusion, they must have a reason and the reason must be that the chance is so minimal they do not want to announce it to alarm the public," he said.
Ko said CJD was a very rare disease that occurred in less than one person per million each year and the incubation period for the disease could be as long as 20 years.

American Red Cross

Jonathan Trouern-Trend  20 Jan 98 opinion
"I believe the FDA did not think it was necessary to notify these recipients. As to the issue of future blood donations by these individuals, the current policy is a temporary deferral for potential donors who received blood products in the last year. This includes red cells, platelets, and plasma.

Clotting factor concentrates cause a permanent deferral, while there is no restriction on receiving Albumin. The problem is that if a lot of plasma is recalled, it effects not only albumin mande from that plasma, but clotting factors, Immunoglobulins and other products.

Because the FDA chose not to notify these individuals, it is impossible to determine if a potential blood donor received an implicated lot. Under current conditions, if they are otherwise healthy, being a recipient of albumin would not disqualify blood donation."

CJD Voice Statistics

Jan. 19, 1998 Liz Armstrong of CJD Voice
Below are statistics based on the information submitted by CJD Voice members as of 1/18/98.
Total CJD Voice Members:  101
Members involved with CJD victims: 90
     (Active members:76 + Critical Info Only: 14)
Of these 90 members, 8 CJD victims are being reported by multiple family
members/friends.  Because of the multiple reports, the statistics below the
figure of 90 members is adjusted to a figure of 80 to represent a true
summarization of CJD victim information.
Members subscribing for informational purposes:  11
----------------------------------------
The following statistical information does not include the 11 members enrolled
for information, as they are not directly involved with a CJD victim.
------------------------------------------
YEAR OF DEATH REPORTING:
(52 out of 80 submitted a date of death = 65%)
1978 = 1
1979 = 1
1981 = 1
1987 = 1
1988 = 1
1989 = 1
1991 = 1
1993 = 2
1994 = 1
1995 = 2
1996 = 8
1997 = 30
1998 = 2
--------------------------------------------
CJD VICTIM AGE REPORTING
(52 out of 80 reporting = 65%)

AGE / TOTAL REPORTED
26/1 (still living)
41/1
46/1
48/1
53/1
54/2
55/2 (1 still living)
56/2
57/3
58/3
59/1
60/2
61/2
62/3
63/1
64/5
65/3
66/1
67/2
69/4
71/2 (1 still living)
74/1
76/3
77/1
80/1
83/1
86/1
-----------------------------------------------
AUTOPSY REPORTING
(51 out of 80 reported autopsy information = 64%)

No autopsy done = 18 (35%)
Of the 18 with no autopsy, 9 (50%) were due to refusal

Not sure whether autopsy was done = 2 (.04%)

Autopsy performed = 31 (61%)
Of those 31, 7 (23%) had difficulties in obtaining the autopsy.
------------------------------------------------------
STATE INFORMATION REPORTING
68 out of 80 members reported the state information(85%).
STATE/#REPORTED
AL/3
AZ/1
CA/4
CT/1
GA/4
IL/1
IN/3
KY/1
MN/2
MD/1
MI/1
MN/2
MO/1
MT/1
NC/1
NE/1
NJ/2
NY/5
OH/5
OK/2
PA/3
TX/2
VA/1
WA/3
WV/1
Outside the US:
Australia: 1
Canada: 2
S. Africa: 1
Israel : 1
---------------------------------------------------
INITIAL DIAGNOSIS REPORTING
38 out of 80 reporting initial diagnosis. (48%)
Alzheimer's = 2
Benign essential tumor = 1
Conversion reaction disorder = 1
degenerative brain disorder = 1
dementia = 3
deppression = 2
focal seizures = 1
Guillain Barre = 1
Herpes Enchilitis = 1
Inner Ear infection = 1
Multiple Sclerosis = 1
Neurodegenerative disorder = 1
Parkinson's = 2
Prion Disease = 1
Seizures = 1
sensory neuropathy = 1
stress = 2
stroke = 8
-------------------------------------------------------
INITIAL SYMPTOMS REPORTED
26 out of 80 members reported the following symptoms as being the first to
appear. (33%)
Anxiety = 1
Cough & hoarseness = 1
dementia = 2
dizziness = 2
erratic behavior = 1
flu like symptoms = 1
forgetfulness = 1
gait/balance problems = 3
insomnia = 2
leg pain = 1
personality change = 2
ringing in ears = 1
tremors = 2
vision problems = 2
vocabulary loss = 1
--------------------------------------------------
SECONDARY INITIAL SYMPTOMS
25 out of 80 members reported the following symptoms as appearing after the
initial symptom. (31%)
balance loss/gait problems = 4
cough = 2
depression = 2
dizziness = 2
forgetfulness = 2
inability to write name = 2
myoclonus = 3
odor changes/escessive sweating = 1
paranoia = 1
personality/behavior changes = 1
tremors = 1
vision problems = 3
vocabulary loss = 1
--------------------------------------------------
SUBSEQUENT SYMPTOM REPORTING
20 out of 80 members reported the following symptoms as appearing 3rd.  (25%)
ashasya (difficulty speaking) = 1
balance/gait problems = 4
coma = 1
dizziness = 1
forgetfulness = 4
mobility loss = 2
paranoia = 1
personality changes = 2
unable to swallow = 1
vision problems = 4
--------------------------------------------------------------
LENGTH OF ILLNESS REPORTING
49 out of 80 members reported the following time frames from onset of
symptoms. (61%)
DAYS
22 = 1
55 = 1
77 = 1
MONTHS
2 = 1
2-3 = 3
3 = 8
3-4 = 1
5 = 1
5-6 = 1
6 = 1
6-7 = 2
7-8 = 1
9 = 1
10 = 1
11-12 = 12
WEEKS
3 = 1
6 = 1
8 = 1
9 = 1
YEARS
1-2 = 1
2-3 = 2
5-6 = 1
over 10 = 2

Families of E. coli victims meet

January 18, 1998 By HERBERT G. McCANN, Associated Press Writer
Families of E. coli victims meet CHICAGO -- The families of victims of food-borne illnesses called for increased food safety efforts, as they marked the fifth anniversary Sunday of the E. coli outbreak that killed four children. Gathered in a downtown church in Chicago, 300 people lit candles, prayed and sang songs.
"We are here to remember those who have lost their lives and those who have suffered from food-borne illness," said Nancy Donley, president of Safe Tables Our Priority. "We are here to demand from government and industry respect for the value of individual human life by taking every possible precaution in the production of food."
Donley's 6-year-old child died after eating a contaminated hamburger in 1993. The gathering was organized by S.T.O.P., which advocates policies designed to ensure the safety of the nation's food supply. The group was founded by people whose children died from contaminated food. "We resolve that the lives and health of our loved ones were not sacrificed in vain," said Roni Rudolph, whose 6-year-old daughter died in an outbreak of E. coli bacteria linked to contaminated hamburgers on the West Coast in 1993. Agriculture Secretary Dan Glickman said the group has been a catalyst for change in the way the government inspects meat and poultry. A new inspection system goes into effect for the 312 largest meat and poultry plants on Jan. 26. The system will be phased in for smaller plants over the next two years. It changes meat and poultry inspection from the old sight, smell and touch system to one based on prevention that requires detailed record-keeping by companies.

Glickman said that he wants the department to have the power to order the recall of contaminated meats and poultry. He also wants the power to levy fines against processors who violate food safety laws.

"Those proposals do require congressional approval," Glickman said. "I hope S.T.O.P. will help get passage."
The federal Centers for Disease Control and Prevention estimates that 9,000 people die every year from food poisoning in the United States. Donley said additional measures are needed, including putting warning labels on raw foods with a history of contamination, whistleblower protection for food workers and increased surveillance of food-borne illnesses.

Animal-Human Transplant Ban Urged

 20 Jan 98 The Associated Press By LAURAN NEERGAARD
BETHESDA, Md. (AP) - Concerned that transplanting animal organs into people might cause new epidemics, a group of prominent scientists urged the government Wednesday to ban the experiments until the risks are better explored.

Doctors hope that animal transplants one day could save thousands of lives by easing a huge worldwide shortage in donated organs. So the call for a moratorium, published Wednesday in the medical journal Nature Medicine, is highly controversial.

``This is a very unusual situation,'' said Harvard University xenotransplantation researcher Dr. Fritz Bach, who joined six other public health experts and bioethicists in urging a moratorium. ``It is a situation where what we the medical establishment ... want to do puts the public at risk'' of new diseases possibly as bad as AIDS.
The call came as the Food and Drug Administration began a two-day meeting to propose tightening control over animal transplants and explore just how big a risk it is.

New concern arose last fall when scientists discovered the genes of pigs harbor previously unknown viruses that can infect human cells in test-tube experiments.

Nobody knows if people could catch or be sickened by the viruses, but the FDA temporarily stopped pig studies pending virus testing and scientists are tracking recipients of the first porcine transplants worldwide.

Xenotransplantation ``is still highly experimental,'' warned Dr. Phil Noguchi, FDA's chief of cellular and gene therapies. ``While the promise is there, ... it must be proven to be safe and effective.''

Support for the ban was not universal, however.

``Keep the benefits in mind,'' urged Dr. Suzanne Ildstad of Allegheny University, who performed a controversial baboon bone marrow transplant on an AIDS patient last year. ``We should proceed cautiously ... but we should proceed.''
In addition, Dr. Alan Hull of the National Kidney Foundation said that while spreading disease from animals to humans ``should be a concern,'' if a moratorium is imposed, ``you'll probably never find out the answers.''

Frustrated by years of failed attempts to get pig or ape hearts, kidneys and livers to work inside people, scientists are reporting new progress in overcoming immune system rejection of these organs. Biotech companies have poured more than $100 million into research and hope to launch a new round of experimental organ transplants within a few years. Doctors already are trying smaller-scale transplants of live animal cells, such as fetal pig cells in the brains of Parkinson's sufferers.

The need is stark: 53,000 Americans are awaiting an organ transplant, but 10 of them die every day because there aren't enough donors. For diseases like Parkinson's, traditional cures have failed.

Animals can spread deadly diseases. For example, monkeys carry the Ebola virus and are blamed for starting AIDS, and pigs breed flu. Scientists hoped to avoid such problems by breeding sterile herds. Then came the pig virus discovery and new threats like ``mad cow disease.''

Britain last year banned xenotransplants until scientists better understand the risks. That's what Harvard's Bach wants here until a national advisory committee can consult the public about whether society accepts the potential risks. Dying patients want to try xenotransplants, but ``have they got the right, the moral right, to put the public at risk?'' he asked.

The FDA, which already must approve any xenotransplant experiments, already is preparing tighter regulations, including a national registry to track every American given an animal transplant to enable government to track down those exposed and those who received transplants from the same herd if a new disease appears.

The FDA plans to treat xenotransplants as strictly as gene therapy, with a national advisory board to discuss the risks of studies publicly instead of the secrecy that cloaks drug development.

Early patient testing shows the risk so far appears hypothetical, said Corinne Savill of Imutran, a British company genetically engineering pig hearts to evade the human immune system.

``Retroviruses are carried by all mammals and usually are benign,'' said Savill, whose parent company, Swiss giant Novartis, is spending $25 million a year studying xenotransplantation.

Scientists move closer to brave 'moo' world with cow cloning

19 Jan 98 The Associated Press
BOSTON -- On a ranch in Texas, a herd of cows is about to give birth to what may be the future of the pharmaceutical industry. Scientists said Tuesday they have developed a technique for cloning genetically customized calves that will be able to produce medicines for humans in their milk.

The first cloned calves -- George and Charlie -- were born last week, giving hope that cloned cows could become living pharmaceutical factories. "The applications for this in pharmaceutical production are enormous," said Dr. Steven Stice of Advanced Cell Technology Inc., one of the collaborators in the project. Although the first clones are males, the real payoff will come with females.

Stice and the other principal researcher, James Robl of the University of Massachusetts in Amherst, said they will next try to use their technique to have cows make human serum albumin. Albumin, a blood protein that regulates the transfer of fluids in the body, is critical to people suffering from liver disease, malnourishment, extreme burns, and other conditions.

Cows that could produce human serum albumin would be a huge boon to hospitals, which are forced to rely on donated blood for the 480 tons of albumin needed every year. It is estimated that a single cow could produce up to 176 pounds a year of albumin.

"It's a big deal," said Mark Westhusin, a researcher at Texas A&M University, who wasn't involved in the project. "This technology has the potential to be a lot more efficient than the technology that we have now."
Patients suffering from liver disease lose significant amounts of blood protein through their urine. In cases of malnutrition, the body takes protein from the blood if it is not available through food. And because the skin holds much of the body's moisture, burn patients can become severely dehydrated and lose protein that must be replenished.

Advanced Cell Technology, which was founded by Stice and Robl, already has a deal with Genzyme Transgenics Corp. of Framingham to produce albumin. But there are other applications, scientists say. Researchers said the calves mark the most viable step so far toward "pharming" -- developing pharmaceuticals using farm animals. Pharmaceutical products may someday be able to be taken simply by drinking enhanced milk. Thirteen pregnant cows are waiting to give birth to cloned calves at the ranch near College Station, Texas. Six will be identical to George and Charlie. The rest are females.

The calves aren't the first animal clones with altered genes. Cloned lambs Molly and Polly in Scotland have a human gene expected to make them produce a protein helpful in blood clotting called Factor IX. But even Dr. Ian Wilmut, the Scottish researcher who genetically engineered Molly, Polly and Dolly, acknowledged that drug-making cows could be more valuable because cows produce much more milk than sheep. Stice said marketing such products is still years away, because the process must be perfected and approved by the Food and Drug Administration.

Robl said the technique his team used to clone the calves was a variation on the nuclear transfer process Wilmut used last year to clone Dolly. But Stice said that, unlike the method used with sheep, cloning the calves did not require surgery and was more efficient.

The scientists started by adding a gene to cells extracted from a cow's fetus. Then they removed the nucleus from an egg and replaced it with the nucleus from the genetically altered cell. The egg was incubated for seven days in the lab, then placed in the uterus of a surrogate mother. The resulting offspring had only the genes of the original cell.

To clone one sheep, Wilmut first used more than 250 embryos. Stice said it takes an average of only 50 embryos to succeed in cloning a cow. The rest are lost in the lab or while they are being transported, or the pregnancies fail. The process in sheep also requires at least two operations. Other techniques also have been used to reap drugs for the treatment of cystic fibrosis and heart attacks from the milk of genetically engineered sheep or goats. These animals, however, were produced by injecting genes into a fertilized egg and then implanting the egg in a surrogate mother.

Only about 2 percent of such eggs grow into live animals and only a small percentage of the survivors actually contain the target genes.

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