Worried Well
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BSE Inquiry fired back up
Scientists probe link between diet and Alzheimer's
U.S. probes profiteering in gamma globulin
More on worried well (who may not be well)
E.U. To Allow U.K. Beef Exports at end of May
Nobel scientist free after teen-age sex sentence
USDA-Harvard study: 'cigarrette science' in the making?

 The Inquiry people are back from recess with a fascinating history of
British rendering  back to Roman times (well, 1865).
  The Inquiry will return to scientific
evidence at
 the beginning of Stage 4 on Monday 1st June.  

This continues to be a most impressive forum in terms of openness and competency. The timely talk today about bypass protein sheds light on theories going around the Internet that blame the whole BSE mess on a former Unilever subsidiary named BOCM, the advent of linear programming and secret ingredients, cut-throat competitiveness, and an early cannabalistic product called UDP - undegradable protein.

Below is a color picture of Judge Phillps, Ferguson-Smith and June Bridgeman (but not Walker) from page 532 of the 9 April 98 issue of Nature:

Scientists probe link between diet and Alzheimer's

 Reuters North America  Sun, Apr 26, 1998 
LONDON - Scientists will unveil research this week that suggests a simple change in diet could protect millions of people from Alzheimer's disease, British newspapers reported on Sunday. The reports said the international team believes a simple supplement of folic acid -- which is found in many green vegetables and can be taken as a vitamin tablet -- could shelter potential sufferers against the debilitating disease, the main cause of senile dementia.

"It is a very promising finding," the Sunday Telegraph quoted one of the research team, Professor Helga Refsum of Norway's Bergen University, as saying. "We need something to go for, and the idea of reducing the risk of Alzheimer's disease by diet is a promising hypothesis." Refsum stressed that the results had so far only revealed an association, not a direct cause and effect, and pointed out that many older people suffer from conditions that can be exacerbated by taking folic acid.

The research is to be unveiled at an international scientific conference in the Netherlands this week. The newspapers said the study of hundreds of British patients revealed a link between Alzheimer's and high levels of a chemical produced by the body that is known to be affected by diet. The discovery, made by an international team co-ordinated at Oxford University, opens the way to a simple blood test for identifying those most at risk.

It also raises the possibility of avoiding the disease altogether by cutting levels of a compound known as homocysteine. This could be brought about by increasing a patient's intake of folic acid. The disease affects 500,000 people in Britain and causes progressive memory loss. It is the fourth commonest cause of death in the Western world.

"If the interpretation being placed on these results is correct, it is potentially dynamite," the Sunday Times quoted one senior scientist as saying.

Alzheimer's: homocysteine and folic acid

AP US & World Mon, Apr 27, 1998
NIJMEGEN, Netherlands (AP) -- Researchers have identified a chemical imbalance in Alzheimer's patients and say it could hold a key to understanding and treating the brain-wasting disease.

Scientists at Britain's Oxford University and Norway's Bergen University found that Alzheimer's patients have higher blood levels of the amino acid homocysteine -- a condition that is usually treated by a dietary supplement of folic acid and vitamin B12. The researchers presented their findings today at an international conference at Nijmegen Catholic University in the Netherlands.

The 76 Alzheimer's patients in their study had elevated blood levels of homocysteine and lower blood levels of folic acid and vitamin B12, as compared to levels found in a control group of 108 people of the same age who did not have Alzheimer's. The biochemical changes in the blood could be a consequence, rather than a cause of the disease, the researchers cautioned.

The results are being considered for publication in a medical journal. No further details of the research were made public today.

David Smith of Oxford University, who headed the project, said the findings were significant because they "provide a testable hypothesis that it may be possible to prevent or delay the progression of Alzheimer's disease." "Every finding is important because it can make the puzzle complete," said Jos van der Poel of the Alzheimer Foundation in the Netherlands.

However, there was no direct evidence that taking B vitamins will lower the risk of Alzheimer's. Alzheimer's disease is an irreversible type of senile dementia marked by intellectual deterioration and personality changes. The disease has no cure and it affects around 20 million people worldwide.

Folic acid, B12 could delay Alzheimer's

Reuters World Report Monday, April 27

LONDON, April 28 (Reuters) - British and Norwegian scientists believe that taking a simple supplement of folic acid and vitamin B12 could help prevent or delay the onset of Alzheimer's disease, they said on Tuesday. But the researchers at the Universities of Oxford in England and Bergen in Norway called for further research and stressed that so far their study has revealed only an association, not a direct cause and effect between diet and the debilitating brain disease.

"These findings are important because they provide a testable hypothesis that it may be possible to prevent or delay the progression of Alzheimer's disease in a proportion of potential sufferers," Professor David Smith, chairman of the department of pharmacology at Oxford, said in a statement. "However, testing this hypothesis will require long and costly trials," he added.

Smith and his colleagues studied 76 Alzheimer's patients who took part in the Oxford Project to Investigate Memory and Ageing (OPTIMA). The results were presented to an international conference on homocysteine metabolism in Nijmegen, in the Netherlands on Tuesday.

The researchers found that patients with Alzheimer's had moderately elevated blood levels of the amino acid homocysteine and lower blood levels of folate and vitamin B12, which controls homocysteine, compared to 108 healthy people of a similar age.

A moderate rise of homocysteine in the blood is also a known risk for heart disease and stroke. The discovery opens the way for an accurate blood test to identify people most at risk of the disease which is the main cause of senile dementia.

"We need something to go for, and the idea of reducing the risk of Alzheimer's disease by diet is a promising hypothesis," Professor Helga Refsum, one of the Norwegian researchers, told the Sunday Telegraph newspaper.

Alzheimer's affects tens of millions of people and although there is no cure, drugs can reduce some of its effects. OPTIMA has been conducting research since 1988 into changes that occur in the brain as part of the ageing process. A report of their latest research is being considered for publication in a medical journal.

U.S. Probes Shortage of Plasma-Derived Drug

Reuters Online Service Sun, Apr 26, 1998
NEW YORK - The federal government is investigating the causes of a nationwide shortage of a drug derived from plasma that has forced tens of thousands of patients to take lower doses or none at all of the medicine they need, the New York Times reported in Sunday editions.

A panel of the Health and Human Services Department will convene Monday to investigate if the six companies that make the drug, intravenous immune globulin, are working to end the shortage or if they are trying to profit from it, the Times said.

The drug, which takes 200 days to create from plasma, treats patients with deficient immune systems who without the drug suffer chronic infections and illnesses. Several causes so far have emerged in the national shortage, the Times said.

After a blood donor reported to the Red Cross that he had CJD, the human version of mad cow disease, the agency recalled the entire batch of medicine which could have contained his plasma.

The concern that the blood could have passed on the disease was strictly theoretical, but fearing a repeat of the scenario in which hemophiliacs were infected with HIV. from their clotting medicine, the Food and Drug Administration went further and recommended that blood products >from those even with a mere risk of exposure to Creutzfeldt-Jakob disease be withheld.

By 1997 that meant that seven percent of the supply of intravenous immune globulin had been recalled or withdrawn, the Times said. In addition four of the companies that manufacture the drug increased exports, further cutting into domestic supply, the Times reported.

When a batch of another plasma product drug was found to be infected and health officials were slow to react to a doctor's complaint, a larger investigation began. That revealed that one plant that made the drug had never been inspected in its 50 years of operation the Times said. Inspectors found so many violations, they temporarily stopped production there, the Times said. The scrutiny spread to the other plants, which also were slowed down by new requirements, the Times said.

Another factor in the shortage, the Times said, was that doctors have discovered that it is helpful in other diseases, including Multiple Sclerosis, which has increased demand.

Growth hormone recipient stunned by news

 Mon, Apr 27, 1998  By Cathy Gordon, PA News.

A young man injected with human growth hormone as a child today told the High Court today he was "gobsmacked" to discover he risked contracting CJD. Justin Parkes, a chef from Essex, described his feelings after being given the news by a doctor: "I thought `How could this be happening to me?' "I felt as if my world had turned upside down. I just couldn't believe it - that I had been having these injections and they could be contaminated."

Mr Parkes, 27, is one of six people injected with growth hormone from corpses as children who are involved in a damages test case before Mr Justice Morland at London's Law Courts. They say they have suffered psychiatric injury as a result of being told they may be incubating CJD (Creutzfeld Jakob Disease), the human form of "mad cow" disease.

The plaintiffs -- Mr Parkes; Paul Andrews, from Putney, London; Neil Scanlon from Ebbw Vale, south Wales; David Lockhart from Newmarket, Suffolk; Philip Johnston from Stoke-on-Trent, Staffs and his sister Claire who lives near Cheadle, Staffs -- are representative cases for 35 people treated with growth hormone after July 1, 1977, who fear they will contract the incurable fatal illness.

Mr Parkes told the court today that after hearing the news in 1992 that he was at risk he suffered sleepless nights, began over-eating comfort food and his then girlfriend left him. He was now in a steady and committed relationship, but was concerned about marriage because of his fear of leaving behind a young widow if he did contract CJD. The court heard how Mr Parkes had already courageously coped with other serious medical problems throughout his life, including a brain tumour and pneumococcal meningitis.

Mr Justice Morland was told at the start of the case last week that in the cases of Paul Andrews, 32, Neil Scanlon, 36, David Lockhart, 27, and Philip Johnston, 25, it was accepted by the defendant, the Secretary of State for Health, that psychiatric illness had been caused by learning of the risk of developing CJD.

In those cases the dispute between the parties is as to the nature and severity of the illness and the extent of damages which may be recoverable. In the so-called "mild" cases of Mr Parkes and Claire Johnston, 29, the defendant considered that no psychiatric illness has been sustained.

Between 1959 and 1985 nearly two thousand children in the UK whose growth was stunted because of a deficiency in the secretion of growth hormone in their pituitaries were treated with hormone from the pituitary glands of cadavers. The programme was brought to an end in May 1985 after several children who had been treated in the US died of CJD.

In July 1996 Mr Justice Morland ruled that the Department of Health was negligent in not heeding the warning of Dr Alan Dickinson, who in 1977 told the Medical Research Council about the risk of contracting CJD from the hormone treatment.

Last year people who were given the hormone treatment and claim they have suffered a psychiatric illness brought on by fear of contracting the disease were given the go-ahead by the same judge to seek compensation.

US CJD age distribution

From the CDC, March 1998 and NCBA BSE page The graph simultaneously plots CJD incidence and rate per million people per year as a function of age bracket. This gets up to about 6 cases per million per year for ages 70-74. It covers 1979-1995 and seems to reflect about 3000 cases. It needs a blow-up for the under-30 cases which do exist but are too few to show at the chosen scale.

E.U. Likely To Allow U.K. Beef Exports At End May

 Mon, 27 Apr 1998   DJ   Jonathan Stearns 
BRUSSELS --The European Union Commission will likely permit exports of British beef at the end of May, a spokesman said Monday. A Commission plan to allow the export of beef from Northern Ireland certified to be free of "mad cow" disease is on track after an E.U. inspection in the region, spokesman Filippo di Robilant told Dow Jones Newswires.

"It looks satisfactory," di Robilant said of the result of a Commission inspection last week of meat controls in Northern Ireland. The Commission, the E.U. executive, will send E.U. countries an inspection report in about 10 days and give them another 10 days to respond, di Robilant said.

Unless unforeseen obstacles arise, the Commission will approve exports of Northern Irish beef certified to be free of mad cow disease at the end of May, di Robilant said. The move will cover only meat from animals killed in one particular slaughterhouse and meat processed in one particular meat cutting plant in Northern Ireland, di Robilant said. This is because of the 10 slaughterhouses and 35 meat plants in Northern Ireland, only two put themselves forward for inspection under the so-called U.K. certified herds beef export plan, di Robilant said.

Nonetheless, the exports will be the first British beef exports in more than two years. The Commission in March 1996 banned the export of British beef after the U.K. announced a possible link between mad cow disease - or bovine spongiform encephalopathy - in British beef and a fatal brain ailment in humans.

In mid-March, E.U. agriculture ministers approved the proposal for a U.K. certified herds beef export plan. The plan allows the export of Northern Irish beef from animals between six months old and 30 months old and from herds with no history of BSE for at least eight years. Northern Ireland is the only U.K. region covered by the Commission proposal because it's the only U.K. region with a comprehensive computerized cattle identification system.

Nobel scientist free after teen-age sex sentence

Reuters North America Mon, Apr 27, 1998
FREDERICK, Md. - A Nobel Prize winning research scientist walked out of jail Monday after serving an 18-month sentence for having sex with a teen-age boy he brought back from one of his research trips to Micronesia.

Daniel Carleton Gajdusek, 74, who won the 1976 Nobel Prize in medicine, left the detention center in Frederick County, Md., a spokesman for the center said. Gajdusek, a pediatrician and research virologist, won the Nobel prize for his study of the transmission of viruses related to neurological disorders.

Before his arrest he also had participated in recent research into the development of a test for Creutzfeldt-Jakob disease, the human form of mad cow disease. At the time of his trial early last year, Maryland state attorney Scott Rolle said Gajdusek brought scores of young men back from his researches in Micronesia. His entry in Who's Who in America list 38 adopted children, most with Micronesian names. "He didn't abuse all the boys, just a few," Rolle said.

Gajdusek defended his actions as being within Micronesian cultural norms for expressing affection but he did not attempt that defense in court. Gajdusek retired in February 1997 from the National Institutes of Health in Bethesda, Md.

Scientist released after serving one year for molesting boy

April 27, 1998 By DAVID DISHNEAU, Associated Press Writer

Nobel Prize-winning scientist Daniel Gajdusek was released Monday after serving a year in jail for sexually abusing a teenage boy he brought home from a research trip to Micronesia. The 74-year-old scientist pleaded guilty in February 1997 to two counts of child abuse. The charges are punishable by up to 30 years in prison, but under the plea agreement, Gajdusek was to serve no more than a year. Gajdusek, who received the 1976 Nobel prize in medicine, plans to go to France, possibly as early as Monday night, said his brother, Robert.

The abuse occurred between 1989 and 1991 and began when the boy was 14. He was one of more than 50 youngsters Gajdusek brought home from research trips over three decades. The victim also has a civil suit pending against Gajdusek. "It has been hard for him in terms of trying to understand society and how it works and its mores," Robert Gajdusek said. "He has said every society is different. Read the journals, all eight yards of them. That's where the man is."

Gajdusek's published journals of his research trips to the South Pacific contain many passages documenting the sexual customs of those cultures, especially sexual relations between young boys and adult men. He received the Nobel prize for his work on so-called "slow viruses" that lie dormant before attacking the body.

USDA-Harvard study: 'cigarrette science' in the making?

26 Apr 1998  webmaster opinion
The USDA had press releases on the new BSE risk study, a sketchy backgrounder on Harvard PH risk study, a minimal chronology of USDA efforts, and a brief description of what study is supposed to do.

Harvard Public Health and Center for Risk Analysis: A study of Alzheimer drug effectiveness was once conducted. No expertise in TSE.

I question how non-biologists could possibly get up to speed on the underlying science of this complex topic in such a short time frame. They will have to rely on outside advisors -- are they to be a committee of USDA beef cheerleaders or working research scientists?

Is there to be an open process and opportunities for input and comment? If there are to be USDA/industry proxies installed as insiders, will there be an equal number of public interest representatives for balance?

Frankly, can risks be evaluated quantitatively in a meaningful way given the vast uncertainties surrounding every aspect of transmission, titre, and incubation time -- I think the answer to this is clearly no. In my opinion, we could just be looking at a gilded pro forma public relations exercise to soothe consumer fears. In two years we might hear again from our old friend, the one in a billion risk, worked backwards to see what the component parts needed to have been, wrapped in the flag of academic credibility and served out to a gullible public.

In the recent past, there have supposedly been some unsavory outputs from the risk center, things like putting a (low of course) dollar value on human life to allow direct comparisons to profits to business, as a way of decision-making in drug and environmental controversies, ie policy should be the larger of [profits, #lives*$ value per life]. I willpost the text of these if more than a disagreeable Internet rumor.

It looks like 'cigarette science' in the making to me (it doesn't cause cancer after all). The problem with the $500,000 consulting contracts is that you never get another one if a risk is reported back.

Studies such as this are better funded through a neutral agency after competitive peer review of merits -- here is the USDA (a beef regulatory agency) letting its people list themselves as official boosters at the Cattlemen's BSE page. Their people will be on the scene clarifying subtleties of the rendering industry to the Harvard naifs. HPH would be wiser to stick to qualitative risk analysis and forget the quantitative, as SEAC concluded.

More interesting is how they will handle the many studies in the pipeline crucial to their endeavor. If they don't use them until final publication, their study will be obsolete on day one; if they base it on unpublished studies, no one else can assess their analysis for a while (and the basis studies may be found flawed on peer review). My vote would be to use studies on track to publication.

USDA plans study to evaluate 'mad cow disease' measure

April 24/98 Dow Jones
> >WASHINGTON--The U.S. Department of Agriculture was cited as saying today >that it has entered into a cooperative agreement with Harvard's School of >Public Health to begin an analysis and evaluation of USDA's current >measures to prevent bovine spongiform encephalopathy.

The USDA BSE risk assessment project , to be conducted by the Harvard University, Department of Public Health, is to be funded by APHIS and to some degree FSIS. Dr. Catherine Woteki (USDA Under Secretary for Food Safety) is playing a leadership role in the Department. The announcement covers funding of the 2-year study to conduct a comprehensive risk assessment of BSE occurring in the USA.

Earlier BSE risk assessments in USA have been conducted by APHIS, co-ordinated by CEAH in Ft. Collins. These risk assessments have focused on sheep scrapie and sheep demographics as measurable risk factors. Conclusions have been that the risk of BSE occurring in the US due to the theoretical risk of it occurring due to scrapie is low and getting lower.

However this new independent [How independent is the if USDA coordinates month-by-month? -- see below. webmaster] study will focus on all known BSE risk factors, assess ways BSE could potentially enter the USA and identify prevention strategies and additional measures that could be taken to protect human and animal health. The USDA Office of Risk Assessment and Benefit/Cost Analysis will co-ordinate the study as it progresses. USDA will receive monthly progress reports.

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