Elk CWD: Montana named as traceback state
Transcripts of June 2-3, 1999 FDA blood meeting
Officials warn of US blood shortage
Sheep cell injections 'of no benefit to children'
Germany stops testing of cows
Neurologic signs from tainted Coke in Belgium still unexplained
Cystic fibrosis: bad article on bad folding
Bovine growth hormone slipping
Artificial fingers made from cows
Hemochromatosis: suitable blood donors?
Tue, 28 Jun 1999 Missoulian Online, 28 Jun 1999 [edited by Chan Yow Cheong ProMED Regional Moderator for AsiaA second elk from a Philipsburg, Oklahoma, game farm recently diagnosed with chronic wasting disease (CWD) raises concerns about public health as well as risks to Montana's wild deer and elk, according to the Montana Wildlife Federation.
Two elk traced to the Kesler Game Farm [in Montana] have been diagnosed with CWD at an Oklahoma game farm. The most recent case of the deadly brain disease was diagnosed in May, 1999.
The disease is similar to "mad cow disease'' (Bovine Spongiform Encephalopathy, BSE) that has affected cattle in Great Britain. It has been found in wild deer and elk in Wyoming and Colorado. It is always fatal. It has been linked by some scientists to the fatal human brain ailment, Creutzfeldt-Jakob disease (CJD).
Montana Department of Livestock officials have said no CWD has been found in the state, either in the wild, or in game farm animals. But transfer documents make it appear very unlikely the infected Oklahoma elk contracted the disease after being shipped from the Kesler Game Farm, a Wildlife Federation spokesman said this week. [This raises the question of how it was possible that the Dept of Livestock could issue opinions on CWD without even looking in its own records. -- webmaster]
"We did some digging and found some interesting things we think need to be brought to the public's attention,'' said John Kober, a western Montana field representative of the Wildlife Federation.
Kober examined records of Kesler Game Farm elk from Montana Fish, Wildlife and Parks and Montana Department of Livestock. The 2 agencies share regulatory responsibility for game farms.
The records show that the most recent elk diagnosed with CWD in Oklahoma was born and raised on the Kesler Game Farm. It was shipped directly to a game farm in Oklahoma City owned by Don Kaspereit in April 1997.
CWD can only be diagnosed through a necropsy. The elk, which died after it was gored by another elk, had no clinical signs of the disease. David Kesler, who owns Kesler Game Farm, said in an earlier interview he has no idea where the elk he sold to the Oklahoma farm may have contracted CWD. He added no animals at his game farm have ever shown signs of the disease.
But according to Oklahoma state veterinarian Gene Eskew, Kesler supplied all of Kaspereit's elk. Kaspereit's game farm has been quarantined with the only cases of CWD yet found in the state. No additional animals have been added to the herd.
Of the 84 elk that were sold to Kaspereit by Kesler, the Wildlife Federation's research showed, only one animal, a bull elk from Utah, did not originate from Kesler's Montana herd. Fifty of those animals were shipped to Oklahoma directly from Montana; while 33 of the elk were shipped from Montana to Idaho, where they spent about 2 months before being shipped to Oklahoma. All of those animals, except the bull from Utah, came from the Kesler Game Farm. The Utah bull is still alive.
"To act responsibly, and protect wildlife,'' said Kober, the Livestock Department "should absolutely admit that this animal did come directly from Montana, and that the possibility exists this infection occurred in Montana is actually likely, more likely than anywhere else.''
Tom Linfield, a veterinarian for the Montana Department of Livestock, said "it's certainly a possibility'' the CWD was present in Kesler's Montana elk herd.
"The difficulty for us,'' Linfield said, "is to determine where the source of the problem is. If it's here, where did it come from? Kesler's game farm was under quarantine for 5 years for TB. There's been no introduction of elk there.'' The Montana Wildlife Federation believes more thorough testing for CWD should be done by the Livestock Department on Montana game farms, Kober said.
Linfield said CWD has not been found on the Kesler Game Farm, which has been under quarantine since June 1998, after the first elk from there was diagnosed with the disease in Oklahoma. He said the quarantine means no elk can be shipped from the game farm except for slaughter. Any elk from the Kesler Game Farm that dies or is killed for slaughter will be tested for the disease, Linfield said. Any animal that shows neurological signs of the disease also will be tested, he said.
Linfield said at least 3 elk have been tested for CWD at the Kesler Game Farm. None tested positive.But records show that since 1995, 29 elk have died of causes other than for slaughter or market on the Kesler Game Farm, including 7 since 1998, Kober said.
"That's an inordinate number of game farm animals dead,'' Kober said. "Something is going on.'' Recent studies indicate that there is a real possibility that CWD, or its related brain diseases, can be transmitted between species, according to the Federation.
Opinion (webmaster): While it is important not to get ahead of the facts (only two Montana elk have tested positive in Oklahoma), the long incubation period of this disease, its potential for transmission among adult animals and for contaminating properties as in Colorado and Wyoming, and experience in other species definitely raise a cautionary flag about future incidence and extent of distribution.
The Wildlife Federation in Montana faxed this web site an interesting stack of CWD-related documents obtained from their state public records search, including xeroxes of state veterinary inspection reports on the 29 dead elk on a Montana game farm. These forms also have a checkbox for interstate movements of elk to and from the primary affected facility. They also found a document at the Montana Dept of Livestock, Animal Health Division, dated 27 Oct 98, giving these movements, as summarized below:
Movements of elk from David O. Kesler II trace herd at 58 Black Pine Rd, Phillipsburg, Montana 59858, tel 406-859-3390 there, game farm license #209. This town, pop 925, is a 40 mile east on route 38 from the Rocky Mtn Lab facility in Hamilton, Mt.
-- closed to new animals since 1990. Under TB quarantine 01/24/91 to 05/08/95.
-- sold 6 elk on 06/13/95 to Elk Valley Game Ranch in Hardin, Montana.
-- sold 4 elk on 11/28/95 to Elk Valley Game Ranch in Hardin, Montana.
-- sold 6 elk on 01/08/96 to Elk Valley Game Ranch in Hardin, Montana.
-- sold 2 elk on 09/02/97 to Elk Valley Game Ranch in Hardin, Montana.
(This herd had been designated a trace herd by 27 Oct 98. No information is available at this time about adverse elk health at this facility or elk shipped from this facility. Gregory L .and Dale P. Stires of Chino, Calif .and formerly Stanley Hall owned and operated the Elk Valley Game Ranch in Gallatin County as partners since 1986. In June of 1986, Hall purchased thirty-eight head of elk from Martin Carelli. In 1992, tuberculosis was found in a wild mule deer doe shot outside the fence of the game farm which hae been under a TB quarantine. Thre game farm is located on I-90 25 miles east of Billings.
-- sold 1 elk on 04/07/96 to "L" Livestock in Missouri
-- sold 1 elk in 96/97 to Ranch "H" in Iowa
-- sold 28 elk on 05/22/96 to Don Kaspereit in Oklahoma City
-- sold 22 elk on 04/14/97 to Don Kaspereit in Oklahoma City
-- moved 33 elk on 11/26/96 from Montana to second Kesler game farm in Hamer, Idaho 83425, tel 208 662-5468, in Jefferson County on I-15 in in eastern Idaho, halfway between Idaho Falls and the US Sheep Experiment Station, near the Camas National Wildlife Refuge.
-- imported 1 bull elk in 1996 from Lagoon Zoo, Brigham City, Utah to Hamer, Idaho facility.
-- sold 34 elk on 01/01/97 including the Utah bull to Don Kaspereit in Oklahoma City. The other 33 originated at Kessler's Montana game farm and spent 2 months at his Idaho facility. The Utah bull is still alive.
-- Don Kaspereit, residing at 12308 Kingsbrook Road, Oklahoma City 73142-5113, tel 405-755-0422 no email, game farm is located nearlby reports first confirmed CWD elk, dead on 22 May 98, lab confirmed 26 May 98. The ear tags on the first elk diagnosed with CWD were lost/destroyed. Thus it is not known whether that particular animal was one of the 33 elk transshipped through Idaho or one of the 50 imported directly from Montana.
-- Don Kaspereit reports second confirmed CWD elk, dead on May 99, lab confirmed May 99. This elk, which died after it was gored by another elk, had no clinical signs of CWD. Possibly the goring was triggered by subtle abnormal behavior or the elk's evasive capabilities were diminished by incipient CWD. This elk had Montana tag #850M and USDA tag #81APH5806.
This tag number suggests that APHIS registers all game farm elk in the US. This data would be publicly available under the Freedom of Information Act. I do not know which branch of the agency handles the National Uniform Ear Tag System. The Montana Department of Livestock has state regulatory jurisdiction over game farms relating to the marking, inspection, transportation, importation and quarantine of animals; hold orders; interior facilities; health; and enforcement of the preceding functions. Elk must be identified with a DoL approved tag and tattooed with a whole herd mark assigned to each animal owner by DoL. Newborns must be tagged by January 1 following their year of birth, and imported animals must be marked within 30 days of import. The Department of Fish, Wildlife & Parks has primary jurisdiction over game farm licensing, reports and recordkeeping, exterior fencing, classification of exotic species, inspection of perimeter fencing, and enforcement.
This elk was born and raised on the Kesler's Montana facility according to Karen Zacheim of DFWP, tel 406-444-3301. It was shipped directly to Oklahoma City in the batch of 22 elk shipped on 04/14/97 . According to Oklahoma state veterinarian Gene Eskew, tel 405-521-2840, Kesler supplied all 84 of Kaspereit's elk. Kaspereit's game farm has been quarantined; these are the only cases of CWD yet found in the state. No additional animals have been added to the herd. Movements of elk prior to quarantine have not been disclosed.
Luella Schultz of Montana Department of Livestock, tel 406-444-9525, with rules at http://www.liv.state.mt.us/CWD.HTM said Kesler's facility has been under quarantine for CWD since June 1998. Elk can still be sent out from Kessler's facility for slaughter. Apparently only slaughter and animals that die with neurological disease will be tested, according to Tom Linfield, a veterinarian for the Montana Department of Livestock, 406/444-2043.
The wildlife federation has saying Kesler in an earlier interview he has no idea where the elk he sold to the Oklahoma farm may have contracted CWD. He added no animals at his game farm have ever shown signs of the disease. Nothing has been disclosed about elk movement prior to 1990. Were elk imported from CWD hotspots in Colorado or Wyoming or from another Montana herd or from wild elk and if so, when? In my opinion, CWD is very unlikely to have originated at Kessler's facility. If these elk came from NE Colorado in say, 1985, there could many other trace back and trace forward herds between 1985-1990.
Linfield said at least 3 elk have been tested for CWD at the Kesler Game Farm. None tested positive. It is bizarre that the DoL veterinary in charge would not know how many CWD tests had been conducted. One document faxed to me has a difficult-to-read handwritten notation signed by the deputy state vet dated 01/26/99 seeming to read "brain tissue submitted to Matoon Veterinary Supply Lab for CWD examination." This female elk had Montana tag #1448 and USDA tag #81 ANC 1728. It was found dead between straw bales and fence, date of death estimated as 13 Jan 99. The vet's signature is illegible, the license number is #1102 or 1162; it is not Mark Randford,#1053, the state vet who signed most of the inspections.
Another elk is reported with a negative CWD test on 10/19/98 by Randford, Montana tag #1445 and USDA tag #8IAAC4809 according to a handwritten note initialled by TC (unknown party). This elk had uterine prolapse and was killed by injection.
This raises the question of whether a private lab would have previous experience with positive TSE and have the reagents on hand to to conduct prion immunohistochemistry on the obex of the medulla oblongata. How many positive cases of CWD would Matoon lab personnel have encountered during their training? The lab report would not be a public document. It is not clear whether Linfield has seen the report or is simply relaying something heard from Kessler. Since 1995, 29 elk have died of causes other than for slaughter or market on the Kesler Game Farm, including 7 since 1998 according to records obtained by the Wildlife Federation.
John Kober of the Montana Wildlife Federation, tel 406-449-7604, wrote this website saying, "Montana had an attempt to shift all responsibility from our Dept. of Fish, Wildlife, and Parks to our Dept. of Livestock in our last legislative session. We narrowly defeated this attempt." In Idaho, game farm operators did succeed in transfer of regulation to a more sympathetic agrilcultural promotion agency. As events have turned out, operators would have been far better off asking for tougher regulations to monitor and contain this disease.
In the webmaster's opinion, CWD is probably completely out of control by now and beyond the reach of all but the most draconian regulation. Elk have been traded like baseball cards for over 15 years of CWD. A highly sensitive test in live animals is nowhere in sight. Horizontal transmission and long term contamination of facilities seems very likely. It is only a matter of time before released and escaped elk bring the disease into further wild elk populations, judging from the Colorado, Wyoming, and South Dakota experiences.
The elk industry and affected states have waffled back and forth on disclosure and monitoring. The precedent here is scrapie. USDA never took any meaningful steps to contain scrapie, programs soon crumpled or became voluntary. The industry just kept plowing ahead marketing sheep from affected flocks. To this day, we do not know how safe it is to eat a scrapie brain, only that the scrapie converts normal human prion just as efficiently as BSE in vitro. CWD is also rumored to have the conversion capability. CWD has been passaged to 5-6 species including goat and primate but otherwise little is known about its transmission properties.
The policy of the National Association Of Elk Breeders 01/08/99 position on controlling CWD is online. They have implemented an additional tagging system that will be required for any elk registered with NAEBA beginning January 1, 1999. The Elk Research Council in Arcadia Florida has provided a location and 52 animals infected with CWD for study by researchers to develp a diagnostic test, mode of transmission, susceptibility, and incubation time.
CDC is going around the country looking for reassurances that wild game consumption does not cause CJD in young hunters. I obtained a memo dated 15 Mar 99 from DRVD, NCID to the director of CDC concerning the 27 year old deer hunter in Oklahoma (a fertilizer truck driver -- bone meal) and the Utah case. This had been initiated by Kristy Bradley, Oklahoma public health veterinarian and J Michael Crutcher, Oklahoma state epidemiologist. Earlier in the week a public health official in Oregon contacted me to see if I would accept a telephone call from CDC investigators. CDC personnel involved include Peter Drotman, Rima Khabbaz, Lawrence Schonberrger, Ermias Belay, James Childs, and Jennilfer McQuiston.
Update 8 July 99: The Wildlife Federation in Montana faxed the webmaster official state histopathology records on the Kesler elk game farm.
1. Dept of Livestock -- Diagnostic Laboratory Division Bozeman, Montana. tel 406-994-4885. LL Stackhouse, DoL vet signed the report dated 29 Sep 98. This concerned a 15 month old female elk, Montanta ear tag #1357 case 9-121, said to have died from acute grain overload. The date of death is not given, the date of sample collection is apparently 23 Sep 98. The chain of control is not clear; samples apparently went from the owner to private vet Mark Ransford to DoL vet Thomas Linfield of Helena, Mont. to the state MVDL vet Stackhouse.
The carcass was in poor condition at the time of autopsy due to extensive necrosis, congestion, edema, and postmortem autolysis, yet: "No significant changes were seen in the brain tissues Laboratory diagnosis: lesions not compatible with CWD."
In other words, we do not have the slightest idea of the CWD status of this animal. (I am translating from the Montanese.) Clinical onset at 15 months has never been observed.
2. Dept of Livestock -- Diagnostic Laboratory Division Bozeman, Montana. tel 406-994-4885. AW Layton, MVDL vet tel 406-994-6344 signed the report dated 29 Oct 98. Adult female elk, age not given, dates of death not given, Montanta ear tag 1445, USDA tag #81ANC4809, case number 9-151. The animal is said to have died from an actinomyces infection following calving and uterine prolapse. "No significant leasesions were identified in brain. Tissue blocks and slides submitted to NVSL for immunoperoxidase CWD testing."
The sample, said to have been collected by private Phillipsburg vet Mark Ransford on 19 Oct 98, was sent to NVSL in Ames, Iowa and given accession 99-03105. Three H&E medullary slides were submitted. WD Taylor of NVSL writes for histopathology of elk 9-151, "No significant lesion is present. Various changes suggest edema." However, in immunohistochemical results section, formalin-fixed paraffin-embedded tissues "from an elk" were stained for protease-resistant after hydrolytic autoclaving.
Attached is a document dated 2 Dec 98 signed by AL Jenny at Ames saying, "No Prp-Sc was detected in these tissues." This document makes no reference to elk tag but is anchored to NVSL case 99-03105 and 99RA52
Thus no CWD could be detected in this elk by an experienced lab using modern methods. There was no chain of evidentiary control establishing that the sample examined was in fact from ear tag #1445.
3. Dept of Livestock -- Diagnostic Laboratory Division Bozeman, Montana. tel 406-994-4885. AW Layton,MVDL vet tel 406-994-6344 signed the report dated 28 Jan 99. A female adult elk, age not given, date of death 13 Jan 99, date of sampling apparently 26 Jan 99, Montana ear tag #1448, federal tag 81ANC1728, case 9-269, tatoo 8102 died caught between hay bales and fence where it could not turn around. The sample was submitted by DoL vet Thomas Linfield on behalf of Kesler to AW Layton at MVDL.
"Slices of brain stem will be sent to NVSL for CWD immunoperoxidase staining." The following page is dated 10 May 99 and signed by Layton. It refers to the above ear tags and states the "immunohistocheical results as received from NVSL are attached."
The attached document, dated 4 May 99 and signed by AJ Wilson of NVSL, Ames, accession 99-12370, states that IHC 99RA312 using hydrolytic autoclaving on formalin-fixed, paraffin-embedded tissues "from one elk" were negative for Prp-Sc. The report does not link the elk examined to any particular Montana or federal tag number or case number though it shows Kesler as owner.
Here was an elk negative for CWD by an experienced lab using modern methods, but which elk was it? Without internal reference to its tag numbers, it cannot be definitely related to any particular submitted sample. Again, chain of control is unsatisfactory.
In summary, 3 of 29 dead elk were reported negative. For 1 elk, that was simply an off-hand opinion of the Dept of Livestock. For 1 elk, testing was good but linkage was broken. For 1 elk, testing was good and linkage provided. For all 3 elk, sample collection and control is inadequately described.
Participants evidently did not understand the importance of obtaining the age of the elk involved, in getting non-decomposed tissue, and in determining provenance. The age and source of elk should not be a mystery, given the ear tags and 5 year quarantine of the game farm.
The elk found with its head missing on 12 Oct 98 on Kesler's farm by Ransford remains the subject of speculation. It may or may not have been tested. It might be possible to work backwards with Freedom of Information Act from NVSL.
Some participants are concerned about the proximal cause of death. It is completely irrelevent what the animal died _from_. The only issue is, did it die _with_ CWD. The same issue comes up with Creutzfeldt Jakob disease, they die from a stroke or whatever but are nonetheless infectious from their subclinical CJD. It is infectivity that must be controlled, not morbidity.
Fri, 9 Jul 1999 TSE listserveQuestion:
Jane Pritchard, DVM Animal Health Lab Branch Food Safety Division Alberta Agriculture Farm and Rural Development Canada
There are only 3 labs in the world that have any substantial experience with testing for CWD. You would be far better off critically evaluating draft manuscripts and personal communications yourself from reputable people directly involved rather than waiting years for minor print journals to carry the articles.
After all, who are the referees going to be? Either someone from the aforementioned 3 labs or someone with no substantial experience with testing for CWD or a publisher (like the Vet Record) who will not take papers demonstrating preclinical animals because of export ramifications.
The real subtext of your question is possibly a desire to justify only doing histological surveys and not IHC, despite the clearly demonstrated superiority of the latter method. You know perfectly well what is on Medline. It has shown beyond any reasonable doubt that IHC can confirm CWD in some histologically negative aclinical animals and conversely that histopathology never is able to detect CWD when IHC cannot.
It is all a question of whether you want a tough CWD detection program or whether you want to defend a weak CWD certification program.
We see this over and over again in countries all over the world, take a badly decomposed brain and use the worst possible method on it, just so you can say, yeah we tested it. But is the marketplace is not so dumb that it will accept mickey mouse testing procedures over the long haul?
In my opinion, you are not helping your elk growers by just going through the motions. In the final analysis they are better off rid of CWD. Elk growers are ambivalent over what they want in certification programs. The ones with imported animals from suspect regions want superficial certification; the ones who are clean do not. If you don't have it in Alberta, what is there to be afraid of in IHC?
I personally will find zero credibility to Alberta's claim of being CWD free until the day complete trace-back histories of every single game farm in the provence are made publicly available on the Internet. These are readily available public records that your agency could easily acquire and analyze in a few days. If you don't have suspect imports in Alberta, what is there to be afraid of?
More likely, some of them did perhaps import elk from CWD-affected regions or game farms in the US. In this scenario, every single dead elk needs IHC on trace-forward facilities, preferably done by an independent lab abroad. Anything less and in my opinion, Alberta is simply conducting a public relations exercise. Not in your interest if you are really are CWD-free.
27 Jun 1999 FDA websiteThis meeting is where they voted to exclude people who visited England for more than 6 months cumulatively from donating blood in the US.
At a second unpublicised meeting on 14 June 99, HHS seems to have voted to back the advisory panel. It seems blood policy is made by jumping through 3 hoops: TSE advisory committee, HHS blood safety committee, and then FDA implementation rules. How long it takes FDA to issue these rules, when it would go into effect, or whether they automatically accept the recommendations of the second committee are all unkown. One Texas donor wrote on 24 June to a newsgroup saying his family was already excluded by a blood center.
Posted 6-14-99 By Richard A. Marini [found on a nursing website ]"In unanimously approving the restrictions, the HHS Blood Safety Committee acted less than a week after a Food and Drug Administration advisory panel voted 12-9 in favor of the precautions. It's now up to the FDA to develop a policy for implementing these new guidelines."
Gaithersburg, Md. Anyone who has spent a total of more than six months in Britain during much of the past two decades will be prohibited from donating blood under regulations approved last week by the Department of Heath and Human Services (HHS). The new restrictions are intended to prevent the spread of a variant of Creutzfeldt-Jakob disease known as mad cow disease.
Mad cow disease is a fatal illness that kills cattle by destroying brain tissue. In the mid-1990s it was discovered that a new strain of the disease, called new-variant Creutzfeldt-Jakob disease, could strike humans who ate beef from infected cattle.
The infection can remain hidden for years, however, and to date there have been only 40 confirmed cases-39 in Britain and one in France. It's unknown whether the disease can be transmitted through blood, but as a safety precaution Americans who have spent six months or more in Britain between 1980 and 1996 will now be prohibited from donating blood.
In unanimously approving the restrictions, the HHS Blood Safety Committee acted less than a week after a Food and Drug Administration advisory panel voted 12-9 in favor of the precautions. It's now up to the FDA to develop a policy for implementing these new guidelines.
Blood experts expressed concern that the new rules would exacerbate already tight supplies of blood. "We feel the restrictions are premature," said Richard Davey, MD, chief medical officer for the American Red Cross. "The risk the disease is transmittable by blood is still theoretical, and we should wait until we have more information before taking such steps." The new policy will cut the U.S. supply of donated blood by 2.2 percent, according to Davey.
The June 2, 1999 transcript is available now for the rtf version of the 449 k84 page 2,228 paragraphs (open as RTF in any version of Word) or for as pdf (see also 3518t1b, 3518t1c, 3518t1d)
The June 3 continuation is also online as rtf or pdf (plus 3518t2b, 3518t2c).
These two long documents begin:
UNITED STATES OF AMERICA + + + + + DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE + + + + + MEETING + + + + + WEDNESDAY, JUNE 2, 1999 The meeting was held in the Ballroom, Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland 20879 at 8:30 a.m., PAUL W. BROWN, M.D., Chairman, presiding. MEMBERS PRESENT: PAUL W. BROWN, M.D., Chairman RANDOLPH WYKOFF, M.D., Associate Commissioner ERMIAS D. BELAY, M.D. DAVID C. BOLTON, Ph.D. DONALD S. BURKE, M.D. DEAN O. CLIVER, Ph.D. LINDA D. DETWILER, D.V.M. BRUCE W. EWENSTEIN, M.D., Ph.D. BARBARA W. HARRELL, M.P.A. DAVID G. HOEL, Ph.D. PETER G. LURIE, M.D. J. JEFFREY McCULLOUGH, M.D. PEDRO PICCARDO, M.D. STANLEY B. PRUSINER, M.D. RAYMOND P. ROOS, M.D. ELIZABETH S. WILLIAMS, D.V.M., Ph.D. WILLIAM FREAS, Ph.D., Executive Secretary TEMPORARY VOTING MEMBERS PRESENT: WILLIAM D. HUESTON, Ph.D. LAWRENCE B. SCHONBERGER, M.D. EDMUND C. TRAMONT, M.D. F. BLAINE HOLLINGER, M.D. SUSAN F. LEITMAN, M.D. KENRAD E. NELSON, M.D. GUESTS PRESENT: LOUIS KATZ, M.D. MERLIN SAYERS, M.D., Ph.D. RONALD O. GILCHER, M.D., FACP CONSULTANT PRESENT: ROBERT G. ROHWER, Ph.D. SPEAKERS PRESENT: STEPHEN D. NIGHTINGALE, M.D. ALAN E. WILLIAMS, Ph.D. CHRISTL A. DONNELLY, Sc.D. PENNY CHAN, Ph.D., MHSc. PHILIP COMER MARY ELIZABETH JACOBS, Ph.D. DOROTHY SCOTT, M.D. PUBLIC COMMENT: CAPTAIN BRUCE D. RUTHERFORD KAY R. GREGORY, MS MT (ASCP) SBB DAVE CAVENOUGH DR. MICHAEL P. BUSCH DR. RICHARD DAVEY MELISSA McMILLAN DR. MARIAN SULLIVAN ALSO PRESENT: JAY EPSTEIN, M.D. DR. ED TABOR JAMES REILLY INDEX AGENDA ITEM PAGE Opening 5 Paul Brown, M.D., Committee Chair Administrative Remarks 6 William Freas, Ph.D., Executive Secretary, SEAC, FDA Introductory Remarks 13 Randolph Wykoff, M.D. Associate Commissioner for Operations, FDA Deferral of Blood Donors Based Upon 16 Foodborne Exposure to BSE Agent: Donor Survey Results, Time Course Of The BSE Epidemic And Its Relationship To nvCJD, Risk Estimates, And Reserve Capacity Of The U.S. Blood Supply Mary Elizabeth Jacobs, Ph.D. Office of Blood Research and Review, CBER, FDA Result of Survey of U.S. Blood Donors Conducted 25 by the American Red Cross, American Association of Blood Banks, America's Blood Centers, and the National Heart, Lung, and Blood Institute Alan Williams, Ph.D. American Red Cross, Holland Laboratories Rockville, Maryland Open Committee Discussion 51 Demographics of BSE, Associated U.K. Regulatory 79 Decisions, and Time Course of nvCJD Christl Donnelly, Sc.D. Head, Statistics Unit Welcome Trust Centre for the Epidemiology of Infectious Diseases University of Oxford, U.K. Det Norsk Veritas Risk Assessment 99 Philip Comer Director of Client Services Det Norsk Veritas, U.K. INDEX (Continued) AGENDA ITEM (Continued) PAGE Reserve Capacity of the U.S. Blood Supply: 140 Summary of the April 2930, 1999 Meeting of the Advisory Committee on Blood Safety and Availability Stephen D. Nightingale, M.D., Executive Secretary Advisory Committee on Blood Safety and Availability Canadian National Blood Safety Council Open Forum 150 Penny Chan, Ph.D., MHSc. Scientific Secretariat National Blood Safety Council Canada Open Public Hearing 174 Committee Discussion and Vote 224 Operational Definition of Possible nvCJD Case for Quarantine of Blood and blood Products 335 Dorothy Scott, M.D. Division of Hematology Office of Blood Research and Review, FDA Committee Discussion 343 (8:30 a.m.) CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling road show. We are asked yet once more by the FDA to consider a question of theoretical risk in the absence of sufficient knowledge on which to base any firm conclusion. The issue before us today is that of excluding categories of American blood donors who have either visited or resided for longer periods of time in Great Britain. The issue is sufficiently delicate, as you see that we have been moved outside the Beltway. (Laughter.) =-=-=-=-=-=-=-=-= Thursday, June 3, 1999 + + + The meeting was held in the Ballroom, Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland, at 8:30 a.m., Paul W. Brown, M.D., Chairman, presiding. PRESENT: PAUL W. BROWN, M.D., Chairman WILLIAM FREAS, Ph.D., Executive Secretary ERMIAS, D. BELAY, M.D., Member DAVID C. BOLTON, Ph.D., Member DEAN O. CLIVER, Ph.D., Member LINDA D. DETWILER, M.V.M., Member BRUCE M. EWENSTEIN, M.D., Ph.D., Member BARBARA W. HARRELL, M.P.A., Member PRESENT (Continued): DAVID G. HOEL, Ph.D., Member PETER G. LURIE, M.D., Member J. JEFFREY McCULLOUGH, M.D., Member STANLEY B. PRUSINER, M.D., Member RAYMOND P. ROOS, M.D., Member ELIZABETH S. WILLIAMS, D.V.M., Ph.D., Member LAWRENCE B. SCHONBERGER, M.D., Temporary Voting Member ROBERT G. ROHWER, Ph.D., Consultant LISA FERGUSON, D.V.M., Speaker JEFFREY ALMOND, Ph.D., Speaker RICHARD RACE, D.V.M. (by teleconference), Speaker DIANE SUTTON D.V.M., Speaker CHARLES DURFOR, Ph.D., Speaker DAVID ASHER, M.D., Speaker JOHN HONSTEAD, D.V.M., Speaker KIKI B. HELLMAN, Ph.D., Speaker ALSO PRESENT: DR. JAMES HOURRIGAN C O N T E N T S PAGE Presentation of Charles Durfor, Ph.D. 7 Presentation of David Asher, M.D. 29 Presentation of Professor J. Almond, Ph.D. 48 Presentation of Richard Race, C.V.M. 86 Presentation by Diane Sutton, D.V.M. 95 Presentation of John Honstead, D.V.M. 124 Presentation by Lisa Ferguson, D.V.M. 137 Committee Charge and Presentation of Questions, Kiki B. Hellman, Ph.D. 160Committee Discussion and Votes 166
27 Jun 99 The Associated Press By LAURAN NEERGAARDWASHINGTON (AP) - Americans take for granted they'll get a blood transfusion whenever they need one, but soon that may not be the case: Blood donations are dropping so low that serious, nationwide shortages could hit as early as next year.
The government is so concerned that Surgeon General David Satcher has a committee hunting ways to get more people to donate blood more often, studying such incentives as giving donors time away from work or small rewards like T-shirts. And some blood banks have started creative programs to lure donors - one in Iowa even gives puppet shows and science demonstrations to school students, grooming them to donate as soon as they turn 17.
``We operate on a very thin margin of safety for the blood supply, and if that trend continues it would put us in a year-round shortage in a few years,'' said Dr. Arthur Caplan of the University of Pennsylvania, who heads a federal committee on blood issues.
The National Blood Data Resource Center is more pessimistic: Its studies predict that next year, Americans will donate just under 11.7 million units of blood - but that hospitals will need 11.9 million units.
Blood donations are decreasing about 1 percent a year. Demand for blood is increasing by 1 percent a year.
Wed, Jun 30, 1999 Melissa McMillan of America's Blood Centers, 202-393-5725, ext. 21; or pager, 888-278-6010/
Current Blood Shortage Information; Helpful Tips for Blood Donors WASHINGTON, June 30 /PRNewswire/ -- Of America's Blood Centers' 73 members, almost half have very low inventory levels of most blood components heading into the July 4th weekend. Many blood centers are experiencing severe shortages, meaning there is less than a day's supply of blood components available for transfusion. Blood centers like to keep about a three-day supply of blood on the shelves at all times. Although surgeries are not being canceled because of low blood levels, many hospital orders for blood are being partially filled to enable all hospitals to receive at least some blood. Supplies of O negative and O positive, which can be transfused to patients with any one of the four main blood types, A, B, AB, and O, are at critically low levels. How To Donate Call 1-888-256-6388 (BLOOD-88) for the nearest blood center location. The phone system reads the caller's area code and provides a list of the nearest blood donation centers. Please bring photo identification and social security information with you to your donation appointment. Pre-Blood Donation Tips - Get a good night's sleep. - Eat breakfast. - Drink plenty of fluids several hours before you donate blood. - Relax. Post-Blood Donation Tips - Drink juice or something with sugar to raise your blood sugar levels. - Eat a hearty meal. - Do not drink any alcoholic beverages for five hours. - Do not smoke for one hour. - If you have any questions, please call your local community blood center. Examples of Blood Use Coronary Artery Bypass 1-5 units Fractured Hip/Joint Replacement 2-5 units Cardiovascular Surgery 2-25 units Bleeding Ulcer 3-30 units Brain Surgery 4-10 units Auto Accident/Gunshot wound up to 50 units Liver Transplant up to 100 units Other Organ Transplants up to 10 units Bone Marrow Transplant up to 2 units/day Sickle Cell up to 4 units/month Aplastic Anemia up to 4 units/month Cancer up to 8 units/week
Fri, 25 Jun 1999 Telegraph By Richard SavillComment (webmaster): This is from a trial in Scotland; some very unorthodox clinic offering rejuvenative injections to desparate parents. The story recalls the injections Balanchine got at a more upscale Swiss clinic. A possible test of experimental passage of scrapie to humans; perhaps some of the sheep tissues are still available for strain-typing.
Injecting sheep cells into brain-damaged children as a form of treatment would be dangerous and unlikely to benefit them, a jury heard yesterday. Keith Brown, a paediatric neurologist, told Glasgow Sheriff Court, that 17 out of 25 children given cell injections for stunted growth 25 years ago had died from mad cow disease and the others were expected to die.
Harvey Good, 49, an American medical consultant, denies recklessly injecting 11 brain-damaged children. Dr Brown, from the Royal Hospital for Sick Children in Edinburgh, said cells injected in the children's buttocks by Good could not get through a "protective blood-brain barrier". Cellular therapy was banned in Britain. He said: "There is no way I can see these cells getting into the brain and doing anything for the condition of the children."
Tue, Jun 22, 1999 By Charis Owen, PA NewsA woman who agreed for her brain-damaged son to be injected with sheep cells would not have allowed the procedure to go ahead if she had been told there were risks involved, a court heard today. Joan Henderson said she had agreed for her son, Russell, to receive the treatment after he received serious head injuries in a road accident at the age of 15 which left him blind, incontinent and with speech and walking difficulties.
She told Glasgow Sheriff Court her son, who is now 21, was given three sheep cell injections at a centre for brain-damaged children in Glasgow, but said she had never been told about a potentially fatal reaction, known as anaphylactic shock, that could result. Mrs Henderson said: "If the word risk came up he would not have been receiving the injections." Asked if a potentially fatal shock had been mentioned she said: "No, and once again if that point had come up, he might never have received an injection."
She added: "I wanted as much information as I could before I would put my son forward for the injections. Obviously one of the questions would be if there was any harm and I would never have let the treatment be done if I thought there was going to be any harm to him." Mrs Henderson said questions about her son's medical history had been asked before the treatment began, but she did not recall him being given any medicine before the injection designed to stop an allergic reaction. She said her son was given no specific aftercare following each injection and added: "The only thing that was mentioned was that he might feel drowsy." She said her son, who was a model and keen footballer before he received his injuries, had improved as a result of the treatment he received at the centre, which also included physical therapy. "He is no longer incontinent, he now asks to go to the toilet. He will ask for a drink, for something to eat, and can recall the words of the music he listens to. "He remembers the adverts on TV and he can actually join in with a conversation. But my son is still blind," she said.
She agreed she could directly attribute some of her son's progress to the injections and added: "The first two injections helped him physically etc, I had no hesitation in getting a third injection." When asked if her son had received any side effects as a result of the injections Mrs Henderson replied: "Absolutely none."
Harvey Good, 49, admits injecting brain damaged children with sheep cells while working as a medical consultant to a Scottish charity but denies recklessly having disregard for their safety and injecting them without approval. He also denies injecting children with foetal cells from pigs and cows which have not been clinically tested, proved or licensed and which one expert claimed could have infected them with fatal livestock diseases such as BSE, E-coli and scrapie. Eleven children suffering from brain damage and three adult stroke victims attending a clinic in Glasgow were given 34 injections allegedly containing the freeze dried animal cells between 1992 and 1996. The court has already heard the children, aged between two and 17, were given the injections after their parents took them to the Society for the Advancement of Brain Injured Children at the David Elder Centre in Govan, Glasgow.
Good, of Linhead Drive, Priesthill, Glasgow, also denies failing to have emergency treatment ready in case the children suffered potentially fatal shocks from the injections. The court also heard from Joyce MacIntyre, who used to work as a director of the SABIC Centre in Govan. She said according to his CV, Good had qualified as a doctor in Mexico.
She added: "We were always told that he wasn't registered in this country." When asked if this had caused her any concern she replied "No", and explained: "The treatment that he offered was controversial and if he had been registered in this country he would not be allowed to practise it." Ms MacIntyre said the substances for the cellular treatment were imported from Germany, but the clinic did not ask the medical establishment in Britain if they could be used in the UK. "I know what they would have said and that would have been No. They would not have allowed us to use it," she said. Ms MacIntyre later told the court she had first heard of Good and become interested in cellular therapy after speaking to a family whose brain-damaged child had received a cellular injection from him when he was living in Derbyshire and had apparently improved remarkably as a result.
She said she had then attended a conference in Germany where she heard about cellular treatment being used for burns and administered in the form of cream as well as injections. After attending the conference, the decision was made to import cellular substances from Germany, but Ms MacIntyre said she did not apply to an established medical body in the UK for permission to use the animal cells because she knew they would not approve. She told the court she was confident about going ahead with the treatment because Germany was "forward looking in its methods", whereas the UK was "well behind".
She said she was under the impression that the cells imported were from sheep, not pigs or cows, and when told that an examination by a Government chemist had found evidence of pig and cow cells, she replied: "That would come as a surprise." Ms MacIntyre said with the exception of Good, who visited the centre three or four times a year, none of the staff at Sabic had medical qualifications.
However, she said she was aware of a potentially fatal condition called anaphylactic shock which can result from injections but said from the literature she had read and advice she had been given she had no reason to believe it could result from cellular treatment. When asked if any precautions were taken against anaphylactic shock at the centre, she said: "There was an antihistamine used for some children if they were new children and Dr Good sometimes carried a kit about with him with adrenal in it, though I never saw it."
Ms MacIntyre told the court she was convinced of the merits of cellular therapy and had received it herself for angina, the symptoms for which had since disappeared. She said her 60-year-old sister had also received sheep cell injections for treatment for breast cancer and had subsequently been given the all-clear. Speaking about the children who received cellular therapy at the centre, she said: "There were huge benefits in the children who were progressing but very, very slow. When we gave them the cellular therapy it just seemed to make it a lot quicker." Ms MacIntyre added that she had never seen any adverse side-effects to the injections. The trial was adjourned until tomorrow.
Mon, 28 Jun 1999 Roland Heynkes Web BSE-L"Today Baerbel Hoehn, the minister for agriculture in Nordrhein-Westfalen (one of the states of Germany) stated that 5,029 cattle have been tested negative with the Prionics BSE-test since 3 March 1999. Unfortunately she is not prepared to continue with sporadic tests, even not for cows that will be imported from France or the Republic Ireland."
"I had the opportunity to ask Dr. David, the BSE-expert of minister Hoehn, for actual measurements against the spreading of possible BSE-infectivity within German food chains."
"From him I learned that the in BSE cattle most infective tissues are not excluded from human or animals food in Germany, that British sheep, milk and tallow are still allowed to become imported to Germany, that German calves are still allowed to drink tallow, gelatin and even blood within their artificial food, and that in Germany meat-bone-meal from apparently healthy farm animals is still produced with less than 100 degree Celsius.
Only pets, wild animals and sick farm animals have to be processed at 133 degree Celsius to become animal meal. But both, animal meal and meat-bone-meal are still allowed to be in the food for pigs, poultry and fish."
"Germany is not so small so 140,000 dollars for these 5,000 tests are peanuts even for Nordrhein-Westfalen which is only a relatively small part of Germany. This are less than 28 dollars per animal or a few cent per steak. This is essentially nothing and of course much less than the decrease of the prize for cattle as a consequence of the erosion of trust. "
"I am sure we agree that the costs are not the reason for the test stop in NRW or the refusal to test in other countries. The real reason not to test for BSE is of cause the fear to find something."
Thu, Jul 1, 1999 Reuters World ReportA European court on Thursday said a ban on sales of antibiotics produced by Pfizer (PFE.N) and Alpharma (ALO.N) for use in animal feed would not be removed until health risks could be adequately assessed.
The European Court of First Instance, in an initial ruling, said the ban, imposed over fears that humans were building up resistance to the drugs through eating meat, would not significantly hurt the two companies. "The two undertakings have not shown that they will suffer serious and irreparable damage," the court said.
The president of the court said in a statement he had weighed up the potential harm to Pfizer and Alpharma against the "risk of increased antimicrobial resistance in human medicine." "The protection of public health must take precedence over economic considerations," he said, adding that increased risk to humans could not be ruled out.
European Union farm ministers agreed in December last year to ban the two antibiotics, virginiamycin and bacitracin zinc, as part of a block on the use of four drugs in animal feed. The other two banned drugs were produced by France's Rhone Poulenc
June 28, 1999 By LAURAN NEERGAARD Associated PressBlood donations are dropping so low that serious, nationwide shortages could hit as early as next year, meaning Americans may no longer be able to take for granted they'll get a blood transfusion whenever they need one. The government is so concerned that Surgeon General David Satcher has a committee hunting for ways to get more people to donate blood more often, studying such incentives as giving donors time away from work or small rewards like T-shirts.
And some blood banks have started creative programs to lure donors - one in Iowa even gives puppet shows and science demonstrations to school students, grooming them to donate as soon as they turn 17. Blood donations are decreasing about 1 percent a year. Demand for blood is increasing by 1 percent a year.
"We operate on a very thin margin of safety for the blood supply, and if that trend continues it would put us in a year-round shortage in a few years," said Arthur Caplan of the University of Pennsylvania, who heads a federal committee on blood issues.
The National Blood Data Resource Center is more pessimistic: Its studies predict that next year, Americans will donate just under 11.7 million units of blood, 200,000 units less than hospitals will need. Already, some cities routinely experience temporary blood shortages during holidays like the Fourth of July weekend and the summer, when regular blood donors go on vacation.
Adding to the pressure, the government soon will ban Americans from giving blood if they've spent more than six months in Britain since the mad-cow disease epidemic began in 1980. Mad-cow disease has been linked to a human brain destroyer, so experts want the precaution of a donor ban even though there's no proof any mad cow-type illness could spread through human blood. But a ban will cut the blood supply another 2.2 percent a year.
"When you need surgery, when you need cancer treatment, when a woman gives birth - we all assume the blood will be there," Caplan said. "You can't make that assumption anymore." His committee just recommended one change that could provide up to 300,000 more pints a year: Use blood from people with a genetic disease called hemochromatosis that causes them to build up too much iron [from a defect in the HFE protein -- webmaster] . Giving blood regularly alleviates iron buildup. That blood is healthy, but today it's thrown away and patients must pay for the treatment.
Why are donations dropping? Nobody really knows, although blood banks say younger generations have never shown the enthusiasm of post-World War II donors. About 60 percent of Americans are estimated to be eligible donors, but only 5 percent donate. Satcher says convenience and publicity influence the level of blood donations.
Even "when I give blood, it's in the context of the Red Cross coming around to where you work," he said. "There are people who would donate at least twice as much if they knew they were needed." The Central Florida Blood Bank proved that Satcher's right: It created an automated program that leaves messages - recorded by an Orlando TV personality - on previous donors' answering machines saying, "Please donate blood this week." Last Memorial Day, a typical shortage period, the RealCall program prompted a 16 percent donation response.
The Mississippi Valley Regional Blood Center in Davenport, Iowa, gives puppet shows in hopes of grooming school children to become donors later in life - and hook their parents, too. "Joey scraped his knee, so I raced right over," says Paula Platelet in a skit explaining how platelets help clot blood. Other skits feature Whitey White Cell and Penelope Plasma. When kids get older, blood bank workers visit science classes yearly to explain donations and transfusions, and test students' blood type. They can't yet measure the puppets' effects. But the first students to get yearly science-class visits turned 17 last year, and the annual high school blood drive showed a 23 percent increase in first-time donors.
Blood banks hope Satcher's advisers will consider such programs in looking for ways to replace the donors who will be lost under the pending British travelers' ban. In addition, Rep. Thomas Bliley, R-Va., just asked the General Accounting Office to study how serious the shortage is, questioning the impact of that ban and of hemochromatosis donations.
Comment (webmaster): Let us hope that this hemochromatosis is not an infectious protein or that introducing mutant DNA containing the faulty gene does not recombine and introduce the disease genetically or somatically in an otherwise healthy recipient.
It's only a matter of time the first confirmed case of nvCJD (and cwdCJD?) show up in a US blood donor -- if they haven't already. If that person only spent, say, 3 months total time in the UK, obviously the deferral time will have to be tightened, exacerbating alleged shortages.
Now some people would say that the US has no blood shortage at all, but rather excessive surgery and excessive overseas marketing of blood products. Doctors here think nothing of liposuction in someone who could simply eat fewer potato chips or of a heart bypass in an 85-year old with terminal cancer and Alzheimer (provided the money is there).
But for the CDC, a solution to the problem is easy: people with a congenital disease, hemochromatosis, could donate blood. [See also: "Blood from patients with hereditary hemochromatosis--a wasted resource." Transfusion 1999 Jun;39(6):549-50 ]
This raises the question: if it is so safe, why are hemochromatosis donors excluded now? Would we even be considering this if it weren't for nvCJD deferrals? According to Medline, the proposed policy change is not based on new scientific information. Gene therapy is closely regulated and not really off the ground: it is thought potentially dangerous to introduce a good copy of a gene into a human with a bad copy to correct a serious genetic disorder. How good an idea then is reverse gene therapy: deliberately injecting a bad copy of a gene into a healthy human who already has good copies? (Note mature red blood cells themselves have lost their nucleus but leucocytes have not.)
Ironically, therapy and maintainence for hemochromatosis currently consists of donating blood to get rid of the red blood cell iron. Right now, the blood is not used and the patient pays $90 per phlebotomy session.
The argument apparently is that many individuals with this disease have _already_ been donating blood prior to diagnosis: one in 10 whites in the United States is a carrier for hemochromatosis and an estimated 1 in 200 is clinically affected [Transfusion 1999 Jun;39(6):651-6 ]. This sounds familiar -- people with undiagnosed CJD have been donating for a long time, why do an expensive recall when the odd case gets a timely diagnosis.
In other words, even though they could have easily and cheaply screened for this disease in donated blood, they don't. Excluding hemochromatosis is far simpler than AIDS or hepatitis: just look at the HFE gene with SSCP-CE for the main two missense mutations, C282Y and H63D. See OMIM and SwissProt.
If ever there was a poorly understood disease, it would be hemochromatosis. Mapping the gene was a decade-long bungle -- recombination was wrongly taken as linear in chromosome 6. The protein was finally determined to be an integral membrane protein of 348 amino acids that binds to transferrin receptor, lowering its affinity for iron-loaded transferrin. Defects result in excessive iron uptake from the intestine.
The features of hemochromatosis include cirrhosis of the liver (leading to a preventable cancer: primary hepatocellular carcinoma), diabetes, hypermelanotic pigmentation of the skin, and heart failure. The most common and troublesome symptoms are extreme fatigue, arthralgia, and loss of libido. Probably 10 million heterozygotes and 500,000 homozygotes in the US unwittingly take iron supplements which of course makes their condition worse.
In fact, I wonder if this is a disease at all on a low meat pre-civilization diet. C282Y is not a null allele by any means [Blood 1999 Jul 1;94(1):9-11 ]. It is most odd that a deleterious allele would occur in 1 in 10 persons: perhaps it is a positive adaptive change to a natural low iron diet. It would make good sense to screen every adult in the US for this condition, even though this is tantamount to preventative medicine and would be costly for liver centers. Hemochromatosis is a perfect example of what Linus Pauling called for in the 1960's: nutritional supplements adapted to the individual.
Taking a quick look at the protein sequence and at Medline for fibrils, aggregates, amyloid, and inclusions, to see if the abnormal protein could serve as amyloid seed, no smoking gun surfaced yet it is hard to give a green light to these donations on this and other grounds.
The Lancet, Volume 354, Number 9176 31 July 1999Sir--Analyses for the C282Y and H63D mutations of the HFE gene in clinical and population samples allow the identification of healthy individuals who are at risk of hereditary haemochromatosis.
Repeated phlebotomies are the only effective way to remove increased iron stores, and are required to prevent reaccumulation of iron in individuals at risk of haemochromatosis, thus affording them a normal life expectancy. Prophylactic periodic venesections are recommended to carriers of mutations of the HFE gene, especially if they are homozygous. However, the units of blood thus obtained are thrown away, on the grounds that blood from individuals with genetic diseases is unsuitable for transfusion.
In the Canary Islands, which has one of the highest rates of organ donors in the world, a chronic shortage of blood donations results in the frequent postponement of scheduled surgery. The blood units obtained from prophylactic venesections done only twice a year in the estimated 1 per 1000 population homozygous for the C282Y mutation of the HFE gene could boost by more than 5% the number of blood units in our region.
June 29, 1999 Associated Press By RAF CASERTBORNEM, Belgium - Kristof Fleurackers returned to school Tuesday, three weeks after becoming one of the first victims in Belgium's Coca-Cola health scare. It is still unknown, however, what exactly made the 14-year-old ill on June 8, when he and 38 other students were hospitalized after drinking tainted Coca-Cola products.
"I hope I will make it to summer camp but even then, I won't be able to take part in all of the activities," Kristof, said ruefully. Despite gelled hair and a hip, baggy outfit, he looked dazed and pale.
Ann De Man, another 14-year-old, was also among those who fell ill June 8. She joined the last four stricken students returning to class Tuesday to bid friends and teachers farewell on the last day of school.
De Man was well on her way to winning a portable CD-player in a local Coca-Cola competition when she drank one of the tainted bottles that day.
The 39 stricken students of the St. Mary Presentation school in Bornem, a town wedged between Brussels and Antwerp, were rushed to the hospital with heart palpitations, extreme nausea and headaches - symptoms that came on within an hour of drinking Coca-Cola products the students said looked and tasted funny. Although many have recovered, doctors are stumped over what keeps youngsters like Kristof and Ann complaining about "heavy legs" and being "tired, so tired."
The Belgian government is expecting an epidemiological report Wednesday on the incidents in Bornem and three other schools where similar events happened in the past weeks. Authorities linked 249 cases of illness to the Coca-Cola scare. But the report is unlikely to offer conclusive answers, according to a government official, who spoke on condition of anonymity.
Coca-Cola, which has offered to pay medical costs, said the problems were caused by substandard carbon dioxide used to put bubbles into bottled drinks and a chemical on wooden pallets. The government, however, said chemical tests did not support the company's explanation.
Veronique Verdonck, an expert on gastroenteritis, treated the first victims at Bornem's St. Jozef Hospital. "The first ones that came in were so sick," she said, denying suggestions the students suffered psychosomatic reactions. She sent four patients to a neurologist. "Clear objective muscle weakness was shown in the patients," she said. Verdonck said further tests were being carried out on the plant extracts that are part of Coke's secret formula. Initial show that some extracts in the suspect bottles "were divergent."
"One of the oils in excessive quantities can lead to such reactions," she said.
The school does not plan to sue Coke, said Bornem school director Odilon Hermans, but has started legal steps to establish that the company, and not the school, is liable for the incident. Young Kristof, for one, says he holds no grudges, but nevertheless has switched his brand to be safe. "Basically, I'm sticking to Pepsi," he said.
June 29, 1999 Reuters News ServiceATLANTA - Coca-Cola Co. said Tuesday it had investigated a report that four Belgian pub goers were sickened by Coke drinks weeks before a health scare forced the company to launch a massive product recall. Coke sent a research team to the pub near Antwerp where the drinkers fell ill on May 12, and worked with both government technicians and a supplier of carbonated gases to Coke, but no links were found, Coca-Cola spokesman Rob Baskin said.
"We got samples of the product ... and found nothing wrong and invited government inspectors and carbon dioxide suppliers to look also. There wasn't found to be any problem," he said.
On June 8, more than 30 teenagers at a school in Belgium were taken to hospitals with stomach complaints and dizziness blamed on Coke drinks. In all, more than 200 people in France and Belgium blamed illnesses on Coke products. Contamination problems were later found at Coke's Antwerp, Belgium, and Dunkirk, France, bottling plants.
Belgium imposed a 10-day ban on Coke products and the company launched the biggest recall in its 113 years, involving millions of cans and bottles. Coca-Cola's most popular brands, such as Coke and Fanta, will be reintroduced in Belgian stores beginning on Wednesday, Baskin said.
Belgium last week allowed Coke to resume production at its two Belgian bottling plants after earlier lifting a sales ban on the company's niche beverages. France lifted its sales ban on Coke products produced at the Dunkirk plant on Thursday. A Coke plant in Marseilles, France, had been unaffected by the ban.
Tue, Jun 29, 1999 Reuters Financial ReportBRUSSELS, June 29 (Reuters) - A new case of mad cow disease has been found in Belgium, bringing the total found in the country to nine, RTBF television reported on Tuesday.
A farm near Chimay in southern Belgium was diagnosed with mad cow disease, or Bovine Spongiform Encephalopathy (BSE), after the farmer reported symptoms and had it slaughtered, RTBF said. It is the second case to be discovered in Belgium this year. A cow in Lontzen, also in southern Belgium, was diagnosed in April.
Roland Hanot, veterinarian for the Chimay farm, told RTBF laboratory tests had confirmed the diagnosis, and a comprehensive enquiry had been launched to identify the source of the infection. RTBF said all the other cows on the farm were being taken away to be destroyed.
Belgian agriculture is still reeling from the country's crisis over the discovery cancer-causing dioxin had entered the food chain via contaminated animal feed.
June 29, 1999 Reuters News ServiceComment (webmaster):
WASHINGTON - A messily folded protein may be to blame for many of the problems caused by cystic fibrosis, researchers said on Tuesday. They said their finding could lead to better ways to treat the disorder, the most common inherited fatal disease among people of European descent.
Cystic fibrosis is caused by a defect in a single gene, known as the cystic fibrosis transmembrane conductance regulator, or CFTR. It controls a protein that regulates the levels of salt in certain cells, notably those lining the lungs and intestinal tract. People who inherit two bad copies of the gene develop cystic fibrosis, marked by chronic lung infections and an inability to digest food properly. An estimated one in 2,500 white Americans and one in 17,000 blacks are born with CF [making 1 in 50 whites a carrier for this recessive disorder, an incidence so high that there must have been selective value at one time to one allele. -- webmaster]
Young-Hee Ko and colleagues at Johns Hopkins University in Baltimore examined the CFTR protein using nuclear magnetic resonance spectroscopy. [No, they did not. They only looked at a synthetic 26 residue fragment representing 1.8% of a 1480 residue protein -- webmaster]. Writing in the journal Biochemistry [article not available, Medline Biochemistry 1999 Jun 8;38(23):7453-61 ], they said 70 percent of the mutations that cause CF are marked by the deletion of a single amino acid along a chain of nearly 1,500 amino acids making up the CFTR protein. [Actually, over 120 distinct mutations in this protein are known. The mutation studied was F508x located in the first nucleotide-binding domain (NBF1)
The deletion is at a critical juncture of the protein, so that instead of folding into an orderly shape, part of the molecule comes undone. The way a protein folds is key to its function. Proteins often operate in a sort of lock-and-key system within the body, and the shape of the folded molecule, usually depicted as a kind of long and twisted ribbon, is vital.
For example, a misshapen protein is blamed for causing deadly bovine spongiform encephalopathy (BSE or mad cow disease) and its human cousin, Creutzfeldt-Jakob disease.
In the cells of CF patients, molecules stop and destroy the badly folded proteins. Thus, they never get to the cell's surface, where they usually have the job of shuttling chloride ions and other essentials into and out of the cell. "The deleted amino acid is like a passport," Ko said in a statement. "Without it, the protein can't travel to the cell membrane, where it is critical for killing bacteria, especially in the lungs." [This protein has no signal peptide and the mutation has nothing to do with targeting -- webmaster.]
The researchers think they have found a way to make the CFTR protein fold properly. They used "heavy water" -- water made using deuterium, a slightly more massive version of hydrogen -- to fix the mutant CFTR fragment. It helped the faulty protein fold properly, they reported. Although heavy water cannot be used to treat people -- it is toxic in large amounts -- researchers now know what to look for in screening potential new drugs for CF, Ko's team said.
Wed, 30 Jun 1999 CI Press Release on rbGH/rbST Consumers International's websiteA decision today could severely limit the use of the genetically engineered hormone BST around the world.
Governments attending the biennial Codex Alimentarius Commission meeting in Rome failed to agree on an international standard on BST (Bovine Somatotropin) which is used to increase cows' milk production. The Codex Alimentarius Commission is the main United Nations body that sets international food standards.
Failure to agree to what is known as a Maximum Residue Level (MRL) for BST means that governments will have much more leeway at the national level to decide whether to allow the use of BST in their countries. Already, the European Union has a moratorium on its use in the EU and Canadian regulators have rejected Monsanto's request for its approval. However it is widely used in the United States.
The discussion at Codex today was unexpectedly brief with the United States immediately proposing, in view of the lack of consensus, that no standard be adopted. This was supported by the European Union and then adopted by the meeting. A long debate had been expected between the EU and the US. The US proposal took the meeting by surprise, as in previous discussions on this issue they had argued strongly for Codex to adopt a standard .
Consumers International, the federation of 245 consumer organisations in 110 countries, welcomes this decision and sees it as a victory for the health and safety of consumers. "With this decision Codex has taken an important step in listening to the concerns of consumers. Consumers International applauds this result and the fact that national governments will be able to act to ensure that their citizens are not forced to consume products produced with the use of BST" said Julian Edwards, Director General of Consumers International
The hormone has been widely criticised for its detrimental effects on animal welfare and could pose possible health hazards to those who drink the milk. Consumers International believes the hormones have not been proven to be safe. The adoption of a standard would have asserted that the hormone was safe to use and countries refusing to import dairy products from countries where BST is used could be brought before the World Trade Organisation on the grounds they are creating a barrier to trade.
Tuesday June 29, 1999 Reuters HealthArtificial human-like fingers, including joints, can be grown in mice using cow cells and biodegradable polymers, report an international team of researchers.
Three types of cow cells -- cells that make bone, cartilage, and tendons -- placed on biodegradable polymer 'scaffolds' grow into tissue ``in the shape and dimensions of human phalanges (fingers),'' according to plastic surgeons who presented their findings Monday at the 12th Congress of the International Confederation for Plastic, Reconstructive and Aesthetic Surgery in San Francisco.
Dr. Noritaka Isogai and colleagues of Kinki University Hospital in Osaka, Japan, collaborated with researchers at Harvard Medical School in Boston, Massachusetts. The team report that the technique resulted in new composite tissues 20 weeks after the cow cell-seeded polymer matrices were implanted into a special breed of mice.
Analysis of the new tissues under a microscope showed the presence of mature articular cartilage, such as that found in joints, and bone in structures ``as intricate as human (fingers) and joints,'' the investigators note. They conclude that ``the formation of (fingers) and small joints is possible with selective placement of (cells)... into a biodegradable polymer scaffold.''
Thu, Jul 1, 1999 By Dominic Hayes, Parliamentary Staff, PA NewsPublic confidence in British beef is higher than it has ever been, Food Safety Minister Jeff Rooker said today. Consumption of home-produced beef had risen 10% since December 1997 as people returned to eating it following the campaign to stamp out BSE in cattle, he told the Commons at question time.
"There is a greater confidence of British consumers in British beef than there has ever been and I think that's absolutely justified," Mr Rooker declared. "It will be even more justified when we can persuade our European partners to also start to accept the flow of beef once again."
But he gave no indication as to when the Government thought that would happen.
The Minister urged consumers to demand supermarkets label all meat according to its country of origin. "As a consumer, I want it," Mr Rooker told MPs, adding people should not assume that meat without a country of origin label was automatically British. But he stressed Britain could not force retailers to put country-of-origin labels on meat as that would be illegal under EU law.