nvCJD blood goes out to 46 countries
Inquiry ordered after organ donor found to have CJD
White blood cells could carry human equivalent of mad cow disease
Britain's ban of beef on bone
Infectivity of blood, meat, peripheral nerves long known
Bovine dietary supplements: UK to US
'Swallowing Anything: The Hype Behind Alternative Remedies'
US drug companies don't want Europe's Mad Cow Move
Irish firm claims mad cow test breakthrough
Daily Mail 5.12.97 and Dr. Steven Dealler's siteProducts from blood donated by a British case of nvCJD has been sold in albumin to 46 countries and the information for a recall was sent out from the National Blood Authority. New Zealand is now trying to trace 120 patients treated with one of the products.
The ministry's chief medical officer, Dr. Colin Feek, insisted there was no reason for anyone who received blood from the dornor to be alarmed, saying the risk of developing CJD was "low to zero."
International withdrawal of blood products that have an increased risk of CJD On November 25, the Central Laboratory Blood Transfusion Service Swiss Red Cross, Bern, Switzerland withdrew from the market two lots of immune globulin intravenous (human) Sandoglobulin and one lot of Albumin (human). The Central Laboratory was notified that the source material used in the production of Sandoglobulin and Albumin lots contained product derived from a donor who might have received Human Pituitary Derived Growth Hormone in 1969, putting the donor at increased risk for Creutzfeldt-Jakob disease.
The immune globulin was distributed in the US by Novartis Pharmaceutical Corp. of East Hanover, NJ; the albumin was distributed by Baxter Healthcare Corp. (Source: Center for Biologics Evaluation and Research Internet site, 11/26/97). The recent report that blood products from humans incubating nvCJD were sent to 46 countries has been a shock but it seems that all of these are either going to be withdrawn or the recipients followed up.
Lancet Dec 6 97 C A Ludlam et al.Risk of nvCJD from blood products:
People with haemophilia are at especial risk of blood-borne infection, and now it seems that they might be at risk of new variant Creutzveldt-Jakob disease (nvCJD). Two batches of factor VIII concentrate have been withdrawn in the UK because of contamination with plasma from individuals who developed nvCJD.
Christopher Ludlam, for the UK Haemophilia Centre Directors' Organisation, calls for patients to receive only recombinant factor VIII or plasma concentrates from countries where there are no recorded cases of the disease. It is now up to the Government and the blood transfusion centres to implement these recommendations.
4 Dec 97
"Regarding the recent CJD/organ donor incident, it appears that CJD tests may be being routinely carried out after deaths. I don't know whether just random sampling or on a wider scale. This would explain the 6 month delay between the transplants and the CJD test, a routine sample would have been taken and frozen for later analysis. The Government needs this information to be able to predict the course of any future epidemic. Presumably positive tests would be tracked back to check for for blood and/or organ donation, to identify whether action (such as white cell depletion in the blood supply) is cost justified.The fact that white cell depletion is being implemented at a cost of £50m per annum implies that a significant level of CJD infection is being found. Also, it is now certain that MAFF has developed a test for CJD presence in materials, this would be needed for testing human samples and identifying beef bone as a CJD carrier."
BMJ No 7121 Volume 315 News Saturday 6 December 1997 Bryan ChristieAn inquiry has been ordered into the screening system for organ donors in Britain after a woman who donated eye tissue to three patients was found to have been infected with Creutzfeldt-Jakob disease (CJD).
The case has highlighted a weakness in the current system, which can result in tissue infected with CJD being used in transplants before a donor's infected status becomes apparent. However, both CJD specialists and the government say that any such circumstances are likely to be extremely rare and the overall risks of the fatal brain disease being transmitted in this way are low. Mrs Marion Hamilton, 53, from Stirlingshire, died in February of inoperable lung cancer but she also had neurological problems that led to a postmortem examination at Stirling Royal Infirmary. Brain tissue was sent to the National CJD Surveillance Unit in Edinburgh because doctors suspected that she may have had the classic form of CJD.
Despite these fears, which were confirmed last week when the final results were produced, no action was taken to prevent Mrs Hamilton's corneas and sclera being used in transplants. The three patients who received this tissue have now been informed.
The government's inquiry is expected to focus on the decision to allow Mrs Hamilton's eyes to be used for corneal transplants when there were concerns that she may have CJD. Scotland's health minister, Sam Galbraith, said: "We need to know whether indications about the donor's condition at the time of her death should have led to more questions about the use of her eyes for transplantation."
Sandra Galloway of the CJD Support Network, a group established to help families who have experienced CJD, raised wider fears that CJD infected organs are being transplanted without anyone knowing about it. "Everyone involved with CJD feared this would happen. It would be so easy for someone carrying a donor card to be incubating the disease without knowing it."
Checks are carried out on organs and other tissues donated for use in transplant procedures in Britain to ensure that they are not infected with viruses such as HIV and hepatitis. But Dr James Ironside of the National CJD Surveillance Unit said that in the absence of an effective screening test for CJD, it was difficult to see how a system could be created to eliminate completely the risk of infection. "We cannot screen for CJD the way we can for HIV, and as a result we cannot tell if someone is incubating the disease. However, if someone dies with clinical features of the disease, then obviously these patients should not be admitted into the organ donation programme."
Mr Galbraith has called on doctors who are assessing the suitability of patients as organ donors to be aware of the possible risk of transmitting infectious diseases. "In the light of this case, the government are exploring urgently what steps can be taken to reduce even further the risk of something like this happening," he said.
Fri, 5 Dec 1997 The Associated PressLONDON - Scottish health authorities are investigating how tissue from the eyes of a woman who had suffered from the human form of ``mad cow disease'' was transplanted into three other people.
``We are aware there is a potential infection risk from tissue retrieved from a patient in Scotland,'' a spokesman for the government Scottish Office said Saturday on customary condition of anonymity. ``We do not know the full facts, but we are making urgent inquiries into how this could have occurred,'' he said.The 53-year-old woman suffered from lung cancer, but after she died a post- mortem examination showed she also had Creutzfeldt Jakob Disease. The brain- destroying disease is the human form of bovine spongiform encephalopathy, which afflicts cattle and is known as ``mad cow disease.''
No further details were given on the grounds of patient confidentiality. But the tabloid Sunday Mail said the post-mortem findings were not passed on to officials handling organ donor arrangements, and parts of her eyes, including the corneas, were transplanted into two men and a woman in her eighties.
December 5, 1997 ReutersLONDON - Hemophiliacs could face an increased risk of infection with the human equivalent of mad cow disease through white blood cells, a doctor warned on Friday.
Dr. Christopher Ludlam, chairman of the UK Hemophilia Center Director's Organization, said there was a possibility that white blood cells in people infected with the new strain of Creutzfeldt-Jakob Disease (nvCJD), but without symptoms, could transmit the infection. In a letter to The Lancet, he said the abnormal prion brain protein that causes the disease was found in the tonsils and spleen of victims. White blood cells are produced in both organs.
Two batches of Factor VIII blood concentrate, an essential clotting agent, that were produced from plasma from people who later developed the disease have already been withdrawn in Britain.
"We should not underestimate the anxiety that nvCJD has created for those with hemophilia," Ludlam wrote.He said Britain is already considering a move to remove white blood cells from donated blood and plasma. But even if the new policy is approved, it would take time to implement and new cases of the disease could lead to further recalls of clotting factor concentrates.
"The recent withdrawal of concentrates and other blood products in the UK means that patients will require counseling, not only recipients of these batches, but also others at risk from products derived from the same source plasma," he added.Hemophilia is an inherited disease in which sufferers' blood does not clot because of a deficiency in Factor VIII. Women carry the disease. Half their sons will be affected and half their daughters will be carriers.
Medical experts know that blood carries the agent that causes mad cow disease and CJD but so far there is no evidence that anyone has been infected with the brain-wasting disease through transfusions, plasma or other blood products. Britain's mad cow crisis heightened on Wednesday after the government ordered a ban on beef on the bone after research showed that the agent that causes BSE could be transmitted through nerves near the spinal cord.
PA News Thu, Dec 4, 1997 By John von Radowitz, Medical Correspondent, PA NewsWhite blood cells in people showing no symptoms could transmit the agent that causes the strain of CJD linked to mad cow disease, it was suggested today. Dr Christopher Ludlam, chairman of the UK Haemophilia Centre Directors Organisation, said the agent had been discovered in the tonsils and spleens of patients with new variant CJD. Both are parts of the body where white blood cells are made.
The find "raises the possibility that circulating lymphocytes (white blood cells) in the blood of symptom-free individuals could transmit the agent responsible for nvCJD," said Dr Ludlam, writing in the British Medical Journal today. [Not at Dec 6 BMJ. Probably refers to offline letter in 6 Dec 97 Lancet: 'nvCJD and treatment of haemophilia Ý C A Ludlam and others -- webmaster]
There was already concern over products made from blood plasma to treat haemophiliacs, he said. Two batches of the blood product Factor VIII produced using plasma from individuals who went on to develop new variant CJD have been withdrawn in the UK.
Dr Ludlam said the Spongiform Encephalopathy Advisory Committee, which helps shape Government policy on BSE and CJD, had now recommended that consideration be given to removing white cells from donated blood and plasma. A risk assessment by the Department of Health and a feasibility study by the National Blood Authority were now underway.
But Dr Ludlam added: "If such a policy is accepted it will take a considerable time to implement, and meanwhile further cases of nvCJD in blood donors may lead to further recalls of clotting factor concentrates manufactured from plasma donated in the UK."
He said the Haemophilia Centre Directors' Organisation was urging that patients be treated with an artificial form of Factor VIII made without the use of human plasma. Dr Ludlam, from Edinburgh Royal Infirmary, added: "We should not underestimate the anxiety that nvCJD has created for those with haemophilia.
"The recent withdrawal of concentrates and other blood products in the UK means that patients will require counselling; not only recipients of these batches, but also others at risk from products derived from the same source plasma."
Fri, 5 Dec 1997 By Patricia Reaney (Reuters)LONDON - Consumers were up in arms and butchers and farmers vented their anger on Thursday but medical experts said Britain had no alternative but to ban beef on the bone. Although the risk of new infection of mad cow disease is slight, they agreed that the government could not take a chance of letting contaminated beef into the food chain.
``It was certainly the right move. It would have been better to make that move years ago like in 1993 during the peak of BSE (bovine spongiform encephalopathy),'' said Hans Kretzschmar, a neuropathologist at the University of Gottingen in Germany.The scientist who has done research into prions, the brain protein that mutates and causes the disease, said Britain had no alternative after experiments showed that the agent that causes BSE and its human equivalent Creutzfeldt-Jakob disease (CJD) could be transmitted through nerves near the spinal cord.
``Knowing that the infectious agent is in there, there was no other move,'' he added.Agricultural Minister Jack Cunningham wiped T-bone steaks and ribs off the British menu after expert advisers on the government's Spongiform Encephalopathy Advisory Committee (SEAC) warned that infected tissue in the dorsal root ganglia -- swellings on the nerves near the spine -- could be left in the bone. Dr Richard Lacey, a professor at the University of Leeds and a staunch critic of Britain's handling of the BSE crisis, applauded the action, but like Kretzschmar felt it should have been done years ago.
``It was too little too late,'' he said. ``It's ridiculous that beef, in general being consumed is safe, and the bones are dangerous.''More than a decade after BSE first broke out in British herds, nearly two years since the European Union banned all export of British beef and despite the slaughter of 1.4 million cattle over the age of 30 months, the BSE crisis continued with a new twist which left Britons confused about which parts of the animal are safe to eat. Given the latest scientific findings, Cunningham chose what he said was the only option.
``Beef can only be allowed for consumption when there are no bones,'' he told a hastily arranged news conference after the shock move.The new evidence that dorsal root ganglia (DRG), and bone marrow in cattle in a late stage of the disease, could be infected emerged after scientists fed experimental animals with a large dose of BSE by mouth.
Groups of the infected cattle were slaughtered and tissue was injected into mice. SEAC stressed that the cattle were given a heavy dose of BSE and the infected tissue was found only in cattle aged over 30 months -- older than any cattle that would be allowed into the food chain.
It emphasised that the bone marrow result was provisional and required further tests. There was no evidence that meat, muscle or blood contained the BSE infection. SEAC estimated that ``next year of the approximately 2.2 million cattle to be slaughtered for human food only three will be near enough to the end of the incubation period to raise the possibility of infectivity in their DRG.''
Although there is only a five percent chance of one new case of the new strain of CJD resulting in 1998, the government felt it was still too high.
Seeking to calm the furore caused by the latest twist in the mad cow saga, Cunningham said every requirement ``that is necessary to safeguard British beef has been taken.'' But he admitted the crisis would probably continue into the new century. The research that resulted in the beef on the bone move will be published in the journal Veterinary Record.
Fri, 5 Dec 1997 Dr.Roland HeynkesGroschup et al. found scrapie infectivity in peripheral nerves 18 months ago:
Detection of Scrapie Agent in the Peripheral Nervous System of a Diseased Sheep Neurobiology of Disease 1996 Jun; 3(3): 1915 Groschup,M.H.; Weiland,F.; Straub,O.C.; Pfaff,E
"In an attempt to determine whether scrapie infectivity can be found in the peripheral nervous system of a scrapie-diseased sheep, mice were inoculated intracerebrally or intraperitoneally with 10-fold dilutions of homogenates of Nervus (N.) axillaris, N. ulnaris, N. medianus, N. ischiadicus, N. tibialis, N. fibularis, and N. saphenus. Mice were observed for clinical signs of scrapie for 700 days and their brains were analyzed for accumulation of pathological prion protein by immunoblot. Substantial amounts of infectivity were found in all peripheral nerves tested except N. saphenus. Infectivity at titers of approximately 104.5 mouse infectious units (MIU)/g were detected in N. axillaris and N. ischiadicus, of approximately 103.0 MIU/g in N. ulnaris, N. me dianus, N. tibialis, and N. fibularis, and of 106 MIU/g in the cerebellum."And what about muscle without bone? Scrapie infectivity was detected in goat muscle in 1962:
Distribution of the scrapie agent in the tissues of experimentally inoculated goats Journal of Comparative Pathology and Therapeutics 1962; 72: 233-44 Pattison,I.H.; Millson,G.C.
Sat, 6 Dec 1997 From Mad Cow U.S.A.: Could the Nightmare Happen Here? Section 5, chapter 5 pg.150-151: 'We See Nothing' Sheldon Rampton & John Stauber Common Courage Press, Nov. 1997 See also: Mad Cow Disease: Industrial Farming Comes Home to Roost Covert Action Quarterly, Fall 1997, #62 (Cover Story) pgs 56-63 by Sheldon Rampton & John Stauber "A chilling overview of the problem, including the efforts being made to silence people warning about the disease." FDA Moves to Prevent BSE: Will its ban on feed substances be enough? Humane Society of the US News, Fall 1997, Vol. 42 #4, pgs 10,11 "Article notes loopholes in the measures being taken"In November 1992, BSE concerns prompted the FDA to issue a letter to manufacturers of dietary supplements:
"Some supplements contain brain, nervous tissue, or glandular materials from a variety of animal species," noted Fred Shank of FDA's Agency for Food Safety and Applied Nutrition. "We are concerned that some amount of these materials may have come from countries experiencing Bovines Spongiform Encephalopathy. ... The possibility of transmission of animal spongiform encephalopathy agents to humans from consumption of animals brains from a variety of species, such as squirrel, goat, sheep, and hogs, and from consumption of sheep's eyeballs has been examined in the past. Although proof of such dietary transmission is lacking, some suspicions remain. The rarity of the disease, coupled with what is believed to be a long onset time (media-13 years), make more precise epidemiological studies extremely difficult."
Moreover, Shank added,
"FDA has recently been involved in investigating a consumer complaint involving a confirmed case of CJD. It is standard procedure for FDA to follow up on all consumer complaints involving death or serious injury. In the course of this investigation, FDA learned that the woman had taken a bovine tissue-containing dietary supplement. Although at the present there is no basis to conclude that this supplement played any role in causing this disease, FDA and NIH have decided that it is prudent to further investigate this matter. Therefore, both agencies have begun to conduct cooperative studies to determine whether nutritional supplements containing brain, nervous tissue or glandular materials from bovine and ovine species might be linked to human spongiform encephalopathies."
In the absence of clear scientific knowledge, FDA requested that manufacturers of food supplements
"reformulate your products using neural or glandular tissues that your are assured are BSE or scrapie free. .. We full recognize that there is no proven link between BSE or scrapie, and human disease, but given the devastating consequences of human spongiform encephalopathies such as CJD, we believe that our request is a prudent step at this time." (1)
In subsequent letters, FDA officials extended similar advice to
manufacturers of drugs and medical devices, to producers of FDA-regulated
animal feed supplements, and even to cosmetics companies, noting that
"extracts of listed tissues...are used in cosmetics
. Additionally, FDA is
unaware of data demonstrating that the processing techniques used in the
manufacture of cosmetics will inactivate TSE agents. Further, little is
known about the human risk of transmission from topical application of
cosmetics containing TSE agents to intact, broke or abraded skin." (2)
Once again, however, this advice remained nothing more than wishful think, strictly voluntary in nature. No penalty for noncompliance was imposed, nor were measures taken to monitor compliance.
2.) Linda A. Suydam (FDA) to manufacturers and importers of dietary supplements and cosmetics (letter), Aug. 17, 1994
Sat, 6 Dec 1997 PR Watch, Vol.4, #3, Dec. 1997 by Sheldon Rampton and John StauberConsumers Union scientist Michael Hansen says he was "pretty horrified" after looking into a question he received recently from Australia. The question came from a man who was trying to obtain a commercial, nonprescription nutritional supplement called "Complete Thymic Formula" from the United States for his girlfriend. The Australian authorities wouldn't let him import it due to fears that it might transmit Creutzfeldt-Jakob Disease (CJD), the human equivalent of mad cow disease.
CJD and mad cow disease both belong to a bizarre group of fatal brain disorders known as "transmissible spongiform encephalopathies" (TSEs), which kill by filling the brains of their victims with microscopic spongelike holes. In England, mad cow disease has reached epidemic levels in the cattle population, and the British beef industry has been devastated by the discovery that human beings are now dying from the disease after eating contaminated meat.
"The authorities had mentioned that human chorionic gonadotrophin from human sources had been linked with an outbreak of CJD cases in Australia," Hansen said, "so he was asking if presence of raw thymus and pituitary from cows was a problem. I emailed him, told him not to use the stuff and asked for information on where in the U.S. he planned to buy it."The company that manufactures "Complete Thymic Formula" is called Preventative Therapeutics. Hansen, who has been closely studying mad cow disease, was appalled to learn that the a daily dose of their product includes 1.2 grams of bovine thymus, 260 mg. of raw spleen, 130 mg raw lymph nodes, 130 mg. raw bone marrow and 20 mg. raw pituitary. The company suggested that this dose could be "doubled" for extra protection.
"If they'd only add raw intestine, brain and eyes they'd have a virtually complete list of all the tissues that have been shown to be TSE positive in animal tests," Hansen says with considerable irony. "I couldn't believe the amount of these bovine organs/glands that would be consumed. After all, one half a gram of cow brain fed to a sheep once in its lifetime is enough for it to contract BSE. I was also appalled to see that they recommended giving this supplement to children."And Preventative Therapeutics is only one of the supplement makers in the U.S. engaged in similar risky practices. A brief trip to health food stores by PR Watch found products including "Raw Adrenal," which containes bovine pituitary, adrenal extract and adrenal cortex extract; "Raw Pituitary," which calls itself a "glandular concentrate with synergistic complex" derived from "bovine sources"; "Pituitary Caps" which mix raw pituitary gland with ginseng and gotu kola (a source of caffeine); and "Ultra Female," a "balanced multi-glandular dietary supplement" that boasts of raw bovine ingredients including ovary, mammary, uterus, adrenal gland, pituitary gland, pancreas, thymus and spleen "in a natural base" of raw brain, eye, stomach and kidney.
There is no scientific proof that you will derive any health advantage from consuming these particular animal glands, and they could well kill you if the cow they came from had a transmissible spongiform encephalopathy. Unfortunately, lobbying by the multi-billion-dollar supplement industry has effectively guaranteed that most people will never hear about the risks associated with its products, and it has become damn near impossible to get to the truth about their purported benefits.
The rapidly growing $4-billion-a-year supplement industry has cast itself in the role of an "alternative" to the conventional health-care and food industries. Its marketing relies heavily on rhetoric and imagery that evokes a back-to-nature, anti-commercial, rebellious spirit of do-it-yourself healing in defiance of corporate power and government bureaucracies. In reality, however, the supplement industry has more in common with its mainstream counterparts than either would care to admit.
L-tryptophan, for example, was a popular, over-the-counter "natural amino acid" recommended for weight control and relief of insomnia, depression and stress until 1989, when its use was linked to 38 deaths and 1,500 cases of a painful, debilitating blood-and-muscle disorder called eusinophilia-myaglia syndrome. Investigators traced the outbreak to the Showa Denko company, a $3-billion-a-year Japanese chemical manufacturer that apparently caused the disease by using a new, genetically-engineered bacteria to manufacture contaminated L-tryptophan.
The L-tryptophan outbreak prompted criticisms of the U.S. Food and Drug Administration, which had issued warnings about health risks from amino acid food supplements as early as 1972 but had failed to take enforcement action. In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA), which gave the FDA new authority to require accurate labeling information on processed foods as well as food supplements. Under NLEA, all health claims appearing on package labels would have to be supported by "significant scientific agreement." In addition, products would be required to provide uniform information regarding the product's content of vitamins, minerals, fat, calories, sodium and other nutrients.
Under the FDA's proposed rules for implementing its powers, supplements marketed simply as nutritional aids would be subject to the same rules as other food products, while substances marketed as disease cures or treatments would be held to the same "safety and efficacy" standard as drugs sold by the pharmaceutical industry.
Nothing in this labelling proposal would have prevented the manufacture or sale of food supplements, but many supplement marketers rely heavily on extravagant health claims with little scientific backing. Rather than submit to FDA standards, they fought back with a successful orchestrated campaign aimed at persuading consumers that the government was trying to take away their right to buy vitamins.
Rogers & Cowan, a subsidiary of the Shandwick PR megafirm, is known for its Hollywood connections. Its $10-million-a-year income makes it the largest PR firm in southern California. It boasts of its ability to link "the corporate and consumer world with the powerful marketing influence and flair of the entertainment industry." Its clients include Microsoft, Baskin-Robbins ice cream, Nabisco foods and the R.J. Reynolds tobacco company along with film studios and movie stars such as Ann Margret and Dustin Hoffman.
The National Health Alliance campaign against the FDA combined Hollywood razzle-dazzle with grassroots anger. One TV advertisement depicted mock FDA agents dressed in riot gear, who raided Mel Gibson's house and confiscated his vitamins. Gibson joined celebrities such as Whoopi Goldberg, Randy Travis, Sissy Spacek, Laura Dern, Mariel Hemingway and Victoria Principal in making public service announcements claiming that the FDA was trying to block consumer access to vitamins.
At the grassroots level, supplement makers turned to their marketing network. Many supplements are sold through multilevel direct sales operations, hierarchical pyramids in which salespeople at higher levels receive royalties on orders filled by salespeople they recruit. At the top of the pyramid, profits can be quite high, but lower-level salespeople typically settle for a discount on their own purchases, combined with a tiny income from sales to friends and relatives. At all levels of the pyramid, salespeople are encouraged to recruit customers through personal testimonials, which in turn are driven by the dream of rising in the hierarchy and achieving "a lifetime of financial freedom."
These consumers/sales representatives, combined with the country's network of 10,000 health food stores and their customers, provided an army of grassroots campaigners which the supplement manufacturers sought to mobilize through millions of dollars in targeted advertising and flyers calling on supporters to "act now to protect your right to use safe vitamins, minerals, herbs, and other dietary supplements of your choice." One brochure by the NHA urged consumers to "write to Congress today or kiss your supplements goodbye."
The goal of the campaign was to ensure passage of the 1994 Dietary Supplement Health and Education Act (DSLEA), sponsored by Utah Senator Orrin S. Hatch, whose home state is a haven for multilevel marketers and supplement companies. DSLEA forbade FDA from treating food supplements as drugs or food additives and allowed companies to continue making health claims without scientific backing.
Displays were set up at health food stores with copies of letters to be sent to members of Congress. Some stores offered discounts to participants. Others provided free phone lines to call lawmakers. During a nationwide "blackout day," stores refused to sell products that they claimed were threatened. NHA's director warned darkly of a "worldwide conspiracy" led by the "pharmaceutical-medical combine trying to make sure they are not being threatened worldwide by inexpensive, non-patented dietary supplements that will prevent the onset of chronic disease." In the space of 12 months, the campaign generated more than 100,000 letters to members of Congress, more than half of whom responded by signing on to cosponsor Hatch's legislation.
The bill was almost universally opposed, however, by long-time mainstream consumer and health organizations, including Consumers Union, Consumer Federation of America, Center for Science in the Public Interest, the American Association of Retired Persons, the American Heart Association, American Cancer Society, American Dietetic Association and American College of Physicians.
The supplement makers' campaign was a
"big lie," according to Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest. "The consumers who wrote Congress had a financial interest in the matter or were duped into believing the FDA was using the new labeling law to ban their favorite vitamins. . . . People should have the right to try any type of health care that they choose. But what we're talking about is whether the manufacturers have the right to hype supplements on the basis of unreliable scientific information or downright false claims."
According to Jo Reed of the American Association of Retired People, the Hatch bill has made it impossible for the government to take action against a product "unless it has killed enough people to establish a pattern. . . . Why should we have to wait until damage is done?"
Podesta Associates is a Washington powerhouse PR and lobby firm known for its extensive contacts with both Republicans and Democrats in Congress, and its connections with the Clinton White House are about as close as they get, with Anthony Podesta's brother, John, serving as staff secretary to President Clinton from 1993-95. It works closely with high-tech and telecommunications companies, with clients including the U.S. Department of Agriculture, the Electronic Frontier Foundation, the National Association of Broadcasters, the Newspaper Association of America, and the Unilever Corporation, which is having Podesta Associates lobby on behalf of a fake fat product that Unilever has developed to compete with Proctor & Gamble's Olestra.
Podesta is also currently working on behalf of the National Association of Manufacturers to weaken federal air-quality standards. Its clients in the pharmaceuticals industry include the Biotechnology Industry Organization, Genentech, Inc., the Health Industry Manufacturers Association, the National Food Processors Association and the Pharmaceutical Research and Manufacturers of America.
Another supplement makers' lobby group, the National Nutritional Foods Association, uses McGuiness & Holch, a longtime lobbyist for the R.J. Reynolds tobacco company headed by former Orrin Hatch chief of staff Kevin McGuiness. The Utah Natural Products Association uses Parry & Romani Associates, a Washington lobby shop whose connections offer a classic glimpse of Washington-style incestuous influence-peddling.
Parry & Romani clients include the American Tort Reform Association, which lobbies to limit lawsuits over defective medical devices and other products; the Lockheed weapons company; Westinghouse Electric; and the Motion Picture Association of America. Its clients in the pharmaceuticals industry include industry leaders Genentech, Glaxo, Hoffman LaRoche, Pfizer, Pharmacia & Upjohn, Pharmaceutical Research and Manufacturers of America, Schering-Plough, and the Monsanto corporation, for which it recently lobbied to extend patent rights for the company's arthritis drug.
Parry & Romani is headed by Thomas Parry, who, like Keven McGuiness, is a former aide to Orrin Hatch. "The two have a mutually beneficial relationship," reports Washingtonian magazine. "Hatch refers Utah companies to Parry, Parry raises money for Hatch, Parry lobbies Hatch, the clients often gain."
The company's other principal, Romano Romani, served on the staff of Arizona Congressman Dennis DeConcini until DeConcini's embarrassment in the Charles Keating savings-and-loan scandal prompted him to decline seeking reelection. Now their roles are reversed, with DeConcini working as a lobbyist on the payroll of Parry & Romani.
The company also conveniently employs Scott Hatch, Orrin's son, who lobbies on behalf of clients such as the National Medical Device Coalition, the Non-Prescription Drug Manufacturers Association, and Herbalife International, a multilevel sales company whose controversial products include diet aids laced with diuretics, laxatives and caffeine. Herbalife products have drawn dozens of citations for safety and regulatory violations in both the United States and Canada. In response to complaints that its products cause cramps, diarrhea, nausea and headaches, company distributors have reassured customers by saying, "That's great, that's the toxins leaving your system."
"Mr. Balanchine obviously had some kind of neurological disease, but a specific diagnosis could not be reached," recalls Robert D. Wickham, MD, senior attending urologist at St. Luke's Hospital in New York City, in the book, I Remember Balanchine by Francis Mason. "It was not until an autopsy was done that the disease could be identified," Wickham says. "Jakob-Creutzfeldt disease is rare and the diagnosis is ordinarily made only by microscopic postmortem examination of tissues."Regarding the cause of the disease, Wickham writes that
"Mr. Balanchine was very much concerned about staying as youthful as possible. That preoccupation is common in many men as they age. He once told me that in the past he had obtained 'rejuvenation' injections in Switzerland. It is quite possible that he got CJD by way of these injections. Such injections have been available in European health spas and clinics for many years. They oftentimes contain extracts of animal glands such as testicular tissue. . . . If we were certain of how and where Mr. Balanchine got this rare and fatal disease, it would help prevent others from being inoculated with it."
AP Online Fri, Dec 5, 1997 By LAURAN NEERGAARD AP Medical WriterWASHINGTON -- A pending European ban on animal byproducts in medicines because of fears of mad-cow disease endangers the supply of drugs overseas and in the United States, U.S. health officials say. Eighty percent of oral medicines contain animal byproducts that the European Union has ordered banned by Jan. 1. The EU fears the byproducts could spread the fatal cattle disease, so named because of cows' symptoms, to people.
If the EU does not amend the ban, the time needed to change drug ingredients
"is such that there would be shortages everywhere," said Sharon Smith Holston, deputy commissioner of the Food and Drug Administration. "The infinitesimal risk of transmission ... compared to the risks from not having your needed medications -- there's just no comparison," she said.An unusual coalition of FDA regulators and drug manufacturers is pressuring Europe to back off. The European Commission, the policy-making body of the 15- nation EU, issued a statement this week suggesting a compromise that could give many drug makers another year to comply.
U.S. companies immediately said even another year is too little time to find new recipes for vital medicines. At a private meeting in Washington Friday, U.S. officials reiterated their concerns to European Commission members. The Clinton administration has warned Europe the ban could cause a trade dispute, with $4 billion in U.S. pharmaceutical exports at stake.
But the FDA and the industry's Pharmaceutical Research and Manufacturers Association contend public health is a bigger worry. The association estimates the European ban could cause shortages in 85 percent of medicines sold on the continent. Because companies use the same ingredients in U.S. and European versions of drugs, FDA officials fear domestic shortages also as companies struggle to change how they make drugs. Agency officials are making repeated flights across the Atlantic to argue for exemptions.
Mad cow disease caused a panic last year after the British government announced that eating infected beef may cause a new version of a fatal human brain illness. It has been blamed for killing about 20 people, mostly in Britain. Mad cow disease has not appeared in the United States. But the EU contends that nowhere is completely safe, particularly because mad cow disease is from a family of "transmissible spongiform encephalopathies," or TSEs, that attack different animals. Indeed, U.S. sheep can get one such illness, called scrapie. So the EU in July decided to ban from medicines ingredients made with "risk materials" such as brains, spinal cords and other bones and tissues.
Yet almost every pill or capsule contains tallow, made from boiled cattle carcasses, and gelatin, made from animal bones. To use such ingredients, companies would have to find suppliers who made them from animals specially slaughtered to avoid the banned parts.
TSEs have never been found in tallow or gelatin, drug makers say. Still, the Pharmaceutical Research and Manufacturers Association did a worst-case estimate [unpublished, not clear if this was ever really done or is simply PR invention -- webmaster] and predicted a one in 100 billion chance of sickness. Finding new supplies of risk-free gelatin could take eight to 12 months, not counting the time needed to manufacture new pills and win FDA approval of the manufacturing change, Holston said.
Agence France-Presse December 6, 1997DUBLIN - An Irish firm has developed a new testing method which could reduce from two weeks to two hours the time it takes to determine if cattle carcasses are contaminated with BSE, the firm announced Saturday.
Michael O'Connor, a vet and technical director [and part-owner] of Enfer Scientific, said field trials of the new testing procedures were complete and they were now in a position to test 14,000 cattle a day for BSE (bovine spongiform encephalopathy), otherwise known as "madcow disease." He said the test, which would cost about $33 per carcass, takes two hours instead of the normal two weeks. It would add about 10 cents to the retail price of meat.
Samples from the slaughtered animals in all 29 meat factories in Ireland could be delivered to Enfer and tested within a maximum of 6 to 7 hours. The results would be faxed back, allowing infected animals to be removed before they went through the 15 hour chilling cycle in the plants and entered the food chain.
The new test would mean meat could be sold as guaranteed BSE-free, for the first time. [Wrong and irresponsible: Every test has its detection thresholds beyond which no statement can be made. Recycling carcasses with low titre as feed to other cows could restart the epidemic. The new test could, however, be very useful in catching asymptomatic animals.-- webmaster]
O'Connor told Irish RTE TV that the development could mean the end of the BSE problem. He said he had not announced the completion of the company's trials until now as he wanted to be sure they were completely successful.
"I didn't want any false promises. If the Agriculture Minister drops the flag on Monday morning, we could start by Thursday," he said. He said that if the testing system was implemented, Irish cattle would have "the highest status in the EU. They would be prime stock."He said they tested for the prion infective agent and a 10 digit bar code system had been developed to keep check on each carcass tested. "We will know what day it was killed, what factory is was in and what carcass number it was. End of story." Special safety procedures have been developed and instruments designed to extract samples from the animals central nervous tissue and the brain. Enfer is a seven year old high-tech company which specialises in a variety of animal testing.
It employs over 30 and has laboratories in Dublin and Cashel. A third laboratory was set up for the BSE test field trials. It is a private company set up by O'Connor, a vet, and Louis Ronan, a meat factory owner.
Enfer has tested over 300,000 cattle carcasses for the presence of "Angel Dust" - the illegal growth promoter Clembuterol - over the past three years and the new BSE test was an adaptation of the technology they had been using. When the test was first developed earlier this year, the Irish agriculture minister welcomed it as a "significant breakthrough."
December 8 1997 Times Michael HornsbyFARMERS protesting at cheap beef imports and falling incomes ran into stiffer police resistance yesterday and abandoned a planned blockade of Britain's busiest port.
Dover police arrested five farmers for obstructing the highway and impounded their vehicles. About 20 tractors and cattle trailers turned round a mile from the entrance to the Eastern Docks after the drivers were warned that they too would be arrested if they tried to proceed. One tractor and a cattle lorry got as far as the port entrance but found their way blocked by a police van.
Hugh Richards, a farmer from Biddenden, in Kent, who organised the Dover protest, said: "We had no choice but to call the blockade off and we will not be trying it again. The police used very heavy-handed tactics and said they would arrest us just for threatening an obstruction."
The police defended their tactics, saying that they were no different from those used in the past to deal with animal welfare activists trying to stop livestock lorries boarding cross-Channel ferries.
"We are not prepared to negotiate with people over the extent to which they can break the law", a police spokesman said. "We have told farmers that if they break the law, they will be arrested, charged and put before the courts."Police in Wales and Scotland have allowed farmers to inspect the cargoes of arriving lorries, and browbeat drivers carrying Irish beef into turning back. At Holyhead, on Anglesey, one driver agreed to turn round at the weekend after picketing farmers discovered that he had concealed Irish beef beneath a load of mushrooms.
North Wales police said that they were studying video film of the incident a week ago, in which farmers threw a cargo of Irish beef burgers into the sea. Officers said they would start legal proceedings against those responsible if there was enough evidence.
Support for the farmers came yesterday from John Redwood, the Shadow Trade and Industry Secretary. He said on GMTV's Sunday programme:
"The conservative Party does not condone any illegal action. But we quite sympathise with the strong stance the farmers are taking because they have been pushed beyond the limits by a Government which has failed to negotiate anything for them, a Government which has given away so much to the European government already without asking for anything in return."Sir David Naish, the president of the National Farmers' Union, last night appealed to his members not to alienate public opinion by blocking roads: "The dispute is between ourselves and the Government, and not with farmers abroad ", he said.
He will make further contact to
day with Jack Cunningham, the Agriculture Minister, but said: "I am interested in a meeting only if there is something to discuss. There is no point in going to listen to platitudes. I just hope the minister realises how enormously serious the situation is, and how desperately worried farmers are about their future."Irish farmers yesterday demanded that the British Government and police take tougher action against port protests. Hundreds of farmers from Scotland and northern England picketed Stranraer, the main ferry port in Scotland for traffic from Ireland, saying they planned to stay until this morning.
Welsh farmers' sense of grievance is even sharper because returns from lamb production, their biggest earner, have also dipped sharply, leaving them more exposed to the fall in beef prices triggered by the disclosure last year that "mad cow" disease had probably infected human beings.
There are 70,200 beef farms in Britain, mostly concentrated in Scotland, Wales and north-west and south-west England. Most are relatively small operators, 60 per cent having fewer than 20 cows. Only 14 per cent have herds with more than 50.
In 1995-96, the latest year for which there are figures, the Ministry of Agriculture estimated that the average net income of cattle and sheep farms in hill areas to be £18,200 in England, £18,400 in Wales and £12,800 in Scotland. Incomes on dairy farms were markedly higher, £36,200 in England, £35,300 in Wales and £33,700 in Scotland. In the year since these figures were compiled, all farm incomes are estimated to have fallen by up to 47 per cent.
"Our latest calculation is that 60 per cent of farms in upland regions of Wales, which is where 80 per cent of our farmers are found and where beef and sheep farming are the main options, now have an average net income of £10,000 or less", Alan Morris, a spokesman for the Farmers' Union of Wales, said.Jack Cunningham has made matters worse, farmers say, by reducing the rate of compensation paid to farmers for cattle over the age of 30 months, which have to be culled and destroyed to keep animals that might develop BSE out of the food chain. Compensation has gradually been reduced from about £400 to £500 an animal, depending on weight in May of last year, to a current maximum of £311, with no distinction between elderly dairy cows and much heavier and more valuable cows from beef herds.
Underlying farmers' problems is the strong pound, which has a bigger impact on agriculture than most other sectors of the economy, and which has eroded the sterling value of EU farm subsidies.