The current budget crisis in California has resulted in an emergency session of the California Legislature to address a stated $14 billion dollar deficit in the State. Health care cuts have been passed by the legislature that amount to roughly 4 billion dollars. The impact on hemophilia treatment and care is certainly high for those community members dependent on California’s Genetically Handicapped Persons Program, GHPP.  Under the Legislature’s cuts GHPP reimbursement for all factor concentrates will be subjected to a 10 percent across the board cut.

The current budget crisis in California has resulted in an emergency session of the California Legislature to address a stated $14 billion dollar deficit in the State. Health care cuts have been passed by the legislature that amount to roughly 4 billion dollars. The impact on hemophilia treatment and care is certainly high for those community members dependent on California’s Genetically Handicapped Persons Program, GHPP.  Under the Legislature’s cuts GHPP reimbursement for all factor concentrates will be subjected to a 10 percent across the board cut.

In a decision handed down February 21, the Supreme Court allowed FDA approval of medical devices to be sufficient grounds to block efforts to sue their manufacturers.   Thus if a medical device has an FDA stamp of approval and an individual is harmed by that device he/she will no longer be able to seek redress in the courts.  On hearing of this ruling, Rep. Henry Waxman (D-CA) said “The Supreme Court’s decision strips consumers of rights they’ve had for decades. This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

The Court is currently preparing to hear oral arguments in a similar case where the issue is FDA approved drugs. If the Court takes its own devices ruling as precedent, it may well also provide the same immunity for the manufacturers of drugs. If both medical devices and drugs rulings are made precedents, can blood, blood components and blood products not be far behind? One could easily term the current decision and the potential for a similar decision regarding drugs as nothing short of a get out of jail free card for the manufacturers of drugs and medical devices.

Contrary to widespread belief, FDA approval is far more about the efficacy of a given drug or medical device than it is about the safety. The most important vehicle for ensuring the safety of medical devices and drugs and biologics for that matter is post-market surveillance, or what is known as phase IV testing. The FDA’s longstanding lack of authority to require phase IV testing once a product is in the marketplace was somewhat reduced in the FDA reform legislation of last year, but by and large drug or biologic manufacturers are not required to perform the post-market testing. This is the climate within which the Supreme Court’s recent decision must be viewed: it is another attempt to prevent the public from seeking redress in the courts for injuries resulting from pharmaceuticals. We are gravely concerned that drugs will follow the decision on medical devices and that blood (biologics) will not be far behind.
 
 

> AGENCIES
Crises in the Regulation of Food and Drugs
The burgeoning crises of meat recalls, un-inspected Chinese ingredients in mainstream drug products, the discovery that mad cow risks may be common in US beef processing operations, and surveys showing plummeting public confidence in the government’s ability to assure safe food and safe medications are all high in the nation’s awareness right now.  These issues have led the Chair of the House Appropriations Committee on FDA-Agriculture – essentially the person who funds FDA -- to release the following statement (in connection with the 60 Minutes expose Sunday the 17^th on Bayer’s Trasylol): “The influence of the drug industry within the FDA has been allowed to proliferate for far too long.  It is time to restore the agency’s mission of ensuring the safety of the products it regulates.”

Last year’s re-authorization of the Prescription Drug User Fee Act, under which Big Pharma pays FDA $400 million a year to review proposed new drugs, perpetuates a huge conflict of interest for the agency, cementing the influence of Big Pharma over government for another four years.  Advocates for an objective regulatory function at FDA have only this time to raise consciousness and raise funds so that when this act expires again, it is replaced with direct Congressional funding for new drug review functions, thereby cutting at least one set of FDA’s dependency ties to industry.

Last year’s re-authorization of the Prescription Drug User Fee Act, under which Big Pharma FDA $400 million a year to review proposed new drugs, perpetuates a huge conflict of interest for the agency, cementing the influence of Big Pharma over government for another four years.  Advocates for an objective regulatory function at FDA have only this time to raise consciousness and raise funds so that when this act expires again, it is replaced with for new drug review functions, thereby cutting at least one set of FDA’s dependency ties to industry.

Border Blood Safety

The joint letter on blood safety, as we have cautioned before, did not end the need for vigilance.  FDA Weekly Enforcement Reports, as excerpted on our website in the same file as the letter, show this. Although there is no signup to receive new reports weekly, the link for the February 20 report is http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01044.html     Some relevant items from recent reports can be found in Attachment #1 at the end of this Update.  Although the quantities of units released in these recalls are small, be aware: a) it only takes one to infect; and b) when the report says ‘recall is complete’ that includes situations where the provider or client contacted has already infused the unit(s) in question.

The joint letter on blood safety, as we have cautioned before, did not end the need for vigilance.  FDA Weekly Enforcement Reports, as excerpted on our website in the same file as the letter, show this. Although there is no signup to receive new reports weekly, the link for the February 20 report is      Some relevant items from recent reports can be found in Attachment #1 at the end of this .  Although the quantities of units released in these recalls are small, be aware: a) it only takes one to infect; and b) when the report says ‘recall is complete’ that includes situations where the provider or client contacted

You may also notice from these reports at least one recall of blood products affecting Texas.  Scanning more reports online will provide you substantial evidence of both processing and distribution problems there. COTT continues its monitoring of these issues, and continues to call for FDA collaboration in development of a National Blood Policy that can take into account social and geopolitical issues in keeping the US blood supply safe.

Creutzfeldt-Jakob Disease (CJD) (Mad Cow)

CJD is the name for Mad Cow disease in humans; one variant (vCJD) seems to be what caused the human cases in the UK believed to be related to cattle.  In cattle the disease is known as Bovine Spongiform Encephalopathy (BSE).

CJD is the name for Mad Cow disease in humans; one variant (vCJD) seems to be what caused the human cases in the UK believed to be related to cattle.  In cattle the disease is known as Bovine Spongiform Encephalopathy (BSE).

It has been 18 months since the US Department of Agriculture massively reduced its surveillance of beef processors to detect evidence of BSE. The USDA rationale was, essentially, that since they had found almost no cases during a period of increased surveillance, there was no need to continue that level of surveillance.

Hard to refute -- unless “increased surveillance” means looking harder in the wrong places.  Many observers had problems with the earlier, higher level of surveillance, much less the token program now:  There were not enough USDA inspectors to cover anything like all beef processors.  The largest processors are essentially exempted from any inspections.  Inspectors stand out like sore thumbs at the plants; since their presence on the line must be announced in advance, abuses can easily take place at any other time.  If USDA’s agents find an animal with the symptoms of possible BSE, the animal is to be removed from the food chain and the brain sent to USDA’s testing center in Iowa.  The symptoms included stumbling, to the point of inability to stand. Such animals are called “downer” cattle. There are other reasons a cow might be a “downer,” of course, but the testing program was set up for BSE.  The testing center does not have much backlog, since few brains were being sent.  Few inspected, fewer detected, fewer still sent for testing; those few our only known true negatives. Conclusion? No problem!

The USDA’s focus on sick cattle has disturbed those who feel they may be missing a larger number of infected (and infectious) but as yet asymptomatic animals.  Even so, one estimate is that USDA now tests some 40,000 animals a year, ¼ of them downers, but this level of coverage catches less than one percent of the downers which are out there, according to a recent issue of the National Market Cow and Bull Audit. The US herd is around 100 million; one-third are slaughtered annually. Forty thousand tested, downers and others, amounts to just over 1/10 of 1% of these.

Some stockyards want to do their own testing.  They have proposed using much more thorough and rapid tests than the 7-day test used at the Department’s Iowa center.  USDA rejected these requests. USDA has even gone to court to bar a stockyard that wanted to test all its animals before shipping, as was done in Japan (and as has been requested of the US by Japan).  A strange example of private product regulation (testing) being more stringent than the government version, yet being banned.  COTT wrote the Secretary of Agriculture about the ban on better testing: “The Department’s repeated efforts to constrain private testing put it further and further out of line with worldwide policies on BSE surveillance.” The USDA response: “… we can assure you that USDA remains committed to ensuring effective, scientifically sound testing ..”  But, many senior staff at USDA were hired directly from the beef industry association.

Last fall an employee of a beef processing plant in California, also a member of the Humane Society of the US, secretly filmed how “downer” cattle were handled there.  They were tortured.  Stun guns and pressure hoses to the face were used. Forklift trucks were used to stab, roll, and lift animals to a standing position – just so they could be ok’d for slaughter moments later.  These extreme methods were deliberate, to maximize the number of “downer” cows that could be included in the food chain. Also, not insignificant from the plant’s point of view, this would minimize then number of those remaining so ill that a potential BSE diagnosis could not be avoided – not an insignificant goal for the company.

Of course, many downers never arrive at the processor, but are quietly (if illegally) disposed of by their owner.  Another way in which Mad Cow risk may be underreported.

The video images, released by the Humane Society January 30, made national network news shows in the days thereafter.  USDA immediately suspended the plant from providing beef to 100,000 schools; recipients were told to remove this beef from their menu planning – and they no doubt began worrying about the health effects of the suspect beef already consumed. Ten days later local authorities arrested the two employees shown in the film (and no one else) on animal cruelty charges.  Two years’ product from the plant, well over 100 million pounds of beef, were then ordered ‘recalled.’  A main supplier to the US School Lunch Program, the meat also went to day care centers, to programs for the elderly, and to low-income families everywhere.

USDA shut the plant down by ordering its inspectors out.  Given the massive and long-term nature of the abuses, it was a wonder that any were even there.

The agency’s actions were anchored in procedural violations at the plant. They merely alluded to any food safety risk, minimizing it with no basis for saying so. As to human health risk, that is not a USDA responsibility and was downplayed even further.  For most of the month of February the Department’s statements (many first offered by the USDA Spokesman Ken Peterson on five or more network talk shows) denied the likelihood that any of the downer cattle beef entered the food chain! “There’s no evidence that any of the animals, particularly downers in particular, did in fact enter the food supply,” said Ken Peterson.

USDA even noted a basis for concluding the risk was low was that no one has gotten sick yet.  BSE has a years-long incubation period. Rather than believing that USDA between January 30 when the video came out and February 17 when it announced the recall was seeking out possible persons sickened by these millions of pounds of suspect beef, it seems they were instead getting their stories straight.

One Internet commentary notes that possibly a reason USDA announcements of recalls occur some weeks after problems are found is to allow time for the contaminated meat to be eaten, thereby reducing the amount of product and thus the expense to industry of the recall itself. A few dollars for your friends, at the expense of unannounced release of potentially fatal pathogens through the nation’s school system. Not a fair trade. 

On February 21, the Washington Post Metro section reported that several DC-area school districts received this beef but that USDA in informing them assured them that there was little or no risk. It also said, by way of proof of this low risk, that no illnesses have been reported from consuming this beef.  Reassuring – but baseless. They’re saying, here’s a supply of beef known to have been made including animals at highest risk for Mad Cow disease but relax – there’s no risk.”  It’s true – all risk has been eliminated, but from the coverage, not from the beef.

Much of the beef went to conventional markets, as well as to the school and other government programs.  However, for example, restaurants are not being notified about the suspect beef (as schools are) because, in Peterson’s words, “ Plant records all point to a singular conclusion that the product coming out of the plant not only meets regulatory requirements but is safe and wholesome.”  Why would you rely on records to prove the safety of the products of a plant shown on video (so graphic parents are warned before it is run) to abuse animals so grievously? So as, like the Inspectors, not to see the problem? The ostrich defense?

There has been no acknowledgement by the Department a) of legal action against the plant owners and/or managers; b) of punitive actions against the on-site USDA inspectors, or c) against the Food Safety and Inspection Service of USDA for which the Inspectors worked, either at the Regional level to catch the overseers, or at the national level, where Alfred Almanza ((202) 205-0158), its Administrator, has not been named in the coverage of this unfolding horror story.

In its public statements, the USDA, far from stepping forward as a tough regulatory agency, instead issued statements like ‘Well, there was no evidence that these downer cows did enter the food chain.’  And, ‘the nation’s beef supply is safe.’

And there has been only the broadest allusion to the likelihood that if this was discovered at one plant, it may well be occurring at thousands of others, year in and year out – the beef, un-diverted, going directly to your dinner table.  One nonprofit group has proposed installing video cameras in all of them.

As an example of the breadth of the public outcry for change, see Attachment #2 at the end of this Update – an editorial from the Arizona Republic, Phoenix AZ, on the subject.   The Congressional hearings it mentions are starting. The Appropriations Subcommittee that funds USDA holds a hearing later this month on the exposé, the USDA failures that permitted it, and the recall and its ramifications.

It is true that no case of indigenous vCJD has been diagnosed in the US.  Or rather, that no such case has been publicized.  Since from its surveillance plans to its public statements, USDA seems willing to bend rules and carve press releases to support only an “everything’s fine” point of view, it would seem entirely possible that the reality – number of sick cows, number of sick people – is different from the statements.

COTT thus follows Mad Cow disease issues for one reason:  there may in fact be cases in cattle in the US, and they are being slaughtered, and the beef sold in stores, and eaten by a widely varying range of American families, some members of whom may contract and begin incubating the disease – and these persons may well then donate blood.  We acknowledge that this chain of events may seem to lack credibility at present.  But if actual cases were in fact being identified (as could be the case), and news of them more widely available, these calls for precautionary behavior might not seem so far-fetched.  Blood bankers would join the fray as well, which would help. While concerned with the safety of the product, they are not however consumers of the product like the hemophilia community.  Like those unwitting, hamburger-loving school children discussed above.

There are several resources on the Internet for learning more about this situation.  Madcowblog.com is a good starting place.  Then there are discussion groups for and by those in the US whose family members have contracted, sickened and died from CJD. (At the top of this article we identified vCJD as cow related.  There is also a non-cow-related form of the human disease, called classical CJD (cCJD or just CJD) that occurs naturally in about 12-15 person per 10 million in the population (or some 500 cases per year).  THEY have interesting stories to tell; by and large they think that a number of their cases are cattle related.  See www.cjdvoice.com .

The beef industry press also recently carried reports of national surveys that show that fewer than 50% of Americans surveyed now have confidence in the safety of their food. Small wonder.

> INDUSTRY
 

Wellpoint

COTT continues to monitor the implementation of Wellpoint’s 11-state dictum that its Blue Cross subscribers in the hemophilia community may only obtain factor from Blue Cross’ own pharmacy.  In response, state organizations have been busy. “Any Willing Provider” legislation has been introduced and hearings held with hemophilia community witnesses; news media have been contacted and stories are pending.  COTT also is directly contacting a number of federal and state offices, and remains in direct contact with Wellpoint itself.

There are only a limited number of persons in our community in any given state who are covered by Blue Cross, but for those who are, in states where it is owned by Wellpoint/Anthem, we have a request.  Call the standard 800# you have been given by BCBS, and ask any minor question about the new arrangements with nextRx (formerly PrecisionRx). Write down your topic, and write down their initial response.  Send that record in to COTT via email. We don’t need your name, just your state and the date of the call. COTT was told by Wellpoint that a new Specialty Pharmacy 800# phone bank would be in place by March 11, and that standard Blue Cross 800# Customer Service operators would be trained to refer all questions containing key words like “factor,” “plasma,” “recombinant,” or Helixate, Kogenate, Benefix, etc., to the new 800#.  We want to learn how this change will come about, from your experience not their promises.

> COALITIONS

COTT continues to work with both NHF and HFA on the MediGap issue, and on another which has come to the national level only in the past few months, although it has been of interest and occasional action for over a decade: raising lifetime caps on health insurance benefits.  There is a Senator eager to introduce legislation, and perhaps assist in securing an updated national study of the impact of higher caps on the general insured population. The last such study, done in 1995, found that removing caps completely would raise general premiums less than two percent, while saving the government nearly $500 million in Medicare and Medicaid costs of those forced out of privately covered care due to hitting their caps.

COTT continues to work with both NHF and HFA on the MediGap issue, and on another which has come to the national level only in the past few months, although it has been of interest and occasional action for over a decade: raising lifetime caps on health insurance benefits.  There is a Senator eager to introduce legislation, and perhaps assist in securing an updated national study of the impact of higher caps on the general insured population. The last such study, done in 1995, found that removing caps completely would raise general premiums less than two percent, while saving the government nearly $500 million in Medicare and Medicaid costs of those forced out of privately covered care due to hitting their caps.

> COTT Operations

On Sunday, March 2, COTT will hold its first COTT Town Meeting of 2008, in the Los Angeles area.  Flyers such as the one included as Attachment #3 at the end of this Update are being widely circulated; interest in the insurance situation is already very high as California was the first state in which Blue Cross members of the hemophilia community were told unilaterally to use Precision Rx only (now nextRx) for factor.  Other COTT Town Meetings are already in the planning stages for New England and the New York City area.

On Sunday, March 2, COTT will hold its first COTT Town Meeting of 2008, in the Los Angeles area.  Flyers such as the one included as Attachment #3 at the end of this are being widely circulated; interest in the insurance situation is already very high as California was the first state in which Blue Cross members of the hemophilia community were told unilaterally to use Precision Rx only (now nextRx) for factor.  Other COTT Town Meetings are already in the planning stages for New England and the New York City area.

BLOOD SAFETY SUMMARY

FDA Enforcement Reports demonstrate that vigilance is sometimes lacking in blood and blood product processing operations, all the more calling for closer, ongoing scrutiny by advocacy groups. A number of these reports indicate problems in facilities and / or distribution in Texas. Protections to keep the US Blood Supply safe from prions carrying Mad Cow disease are not found; the USDA surveillance of the US herd for this condition suffers from inadequate industry oversight and falls far short of needed scientific data collection.  Big Pharma not only funds the FDA drug review process, but is now held by the Supreme Court safe from lawsuit on medical devices and, we fear, soon on drugs as well. Biologics may be next.

FDA Enforcement Reports demonstrate that vigilance is sometimes lacking in blood and blood product processing operations, all the more calling for closer, ongoing scrutiny by advocacy groups. A number of these reports indicate problems in facilities and / or distribution in Texas. Protections to keep the US Blood Supply safe from prions carrying Mad Cow disease are not found; the USDA surveillance of the US herd for this condition suffers from inadequate industry oversight and falls far short of needed scientific data collection.  Big Pharma not only funds the FDA drug review process, but is now held by the Supreme Court safe from lawsuit on medical devices and, we fear, soon on drugs as well. Biologics may be next.

ERRATA:  None

COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network

Attachment #1: FDA Enforcement Reports -- Excerpts

Some relevant items from recent FDA Weekly Enforcement Reports:

Some relevant items from recent FDA Weekly Enforcement Reports:

January 23:
PRODUCT
a) Buffy Coat, Recall # B-0371-08;
b) Red Blood Cells, Recall # B-0372-08;
c) Platelets, Recall # B-0373-08;
d) Fresh Frozen Plasma, Recall # B-0374-08;
e) Recovered Plasma, Recall # B-0375-08
CODE
a) FV16707;
b) FV17274, FV16707, FV16173, FV15720, FV15174, FV14583, KJ85579;
c) FV17274, FV15720, FV15174, FV14583, KJ85579;
d) FV17274, FV15174, KJ85579;
e) FV16173, FV15720, FV14583
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis C, but were collected from a donor who previously tested positive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 19 units
DISTRIBUTION: PA and FL
January 30:

PRODUCT
a) Platelets, Recall # B-0532-08;
b) Fresh Frozen Plasma, Recall # B-0533-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0535-08
CODE
a), b), and c) Unit: 5808077
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile beginning August 2, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the human immunodeficiency virus (HIV), but were collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE: 3 units
DISTRIBUTION: TX, NJ
PRODUCT
Recovered Plasma, Recall # B-0567-08
CODE
Unit: T26608
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on April 4, 2007.
Manufacturer: Michigan Community Blood Center, Traverse City, MI. Firm initiated recall is complete.
REASON
Blood product, which tested negative for human immunodeficiency virus (HIV), but was collected from a donor who previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MI

February 6:

PRODUCT

a) Platelets, Recall # B-0412-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0413-08
CODE
a) and b) Unit: 027GH13188
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on April 27, 2007 and by letter dated April 30, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information concerning a previous positive test for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE: 2 units
DISTRIBUTION: PA, VA

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0411-08
CODE
Unit: LG55278
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI, by telephone and letter dated May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested positive for CMV, but was labeled as CMV-negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE: 1 unit
DISTRIBUTION: MA
February 16:
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0621-08
CODE
Unit: G16211
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by facsimile on April 28, 2006 or May 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information concerning a previous positive test for the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0749-08
CODE
Units: 19GH79288, 019GH79290, 019GH79292, 019GH79295, 019GH79296
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on July 20, 2006. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TN

PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0756-08
CODE
Unit: 1254536 (2 units)
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated February 24, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured according to specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0758-08;
b) Recovered Plasma, Recall # B-759-08
CODE
a) and b) Unit: 041LH52930
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and fax beginning May 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred due to history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and Switzerland
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0782-08
CODE
Units: 163861824, 163861824
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc/dba United Blood Services, Meridian, MS, by telephone and fax on October 26, 2005.
Manufacturer: Blood Systems, Inc/dba United Blood Services, Flowood, MS. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process, for which the donor was not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
PRODUCT
Recovered Plasma, Recall # B-0622-08
CODE
Unit: G16211
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by facsimile on April 28, 2006 or May 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information concerning a previous positive test for the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
 

 

 

Attachment #2: Editorial on Mad Cow Risk

The Arizona Republic

(CIRCULATION 1,483,000)

Editorial

February 25, 2008

Inspect the system

People bite into their hamburgers with some simple expectations.

(1) They believe the food is safe.
(2) They assume the animal that produced the meat was treated humanely.

The recall of 143 million pounds of beef earlier this month challenges those expectations.

(1) Federal food safety inspectors didn't find the problems; the Humane Society of the United States did.

(2) The animal-protection group's surreptitiously filmed video shows workers abusing non-ambulatory animals in an effort to get them onto their feet for slaughter. Cows too weak to stand were kicked, smacked in the eye with a paddle and shocked repeatedly. Some were taken to slaughter by forklift.

(3) Federal regulations ban most "downer" cows from the food supply because an animal that is too sick to walk is more likely to carry mad-cow disease or other contamination. Inspectors should have excluded these animals from the slaughter.

But, according to society investigators, inspections were done on a set schedule. That meant violations could take place when no one was watching. What's more, the federal law banning downer cattle has huge loopholes, says Wayne Pacelle, president of the society.

The record meat recall at the Westland/Hallmark Meat Co. of Chino, Calif., is still under investigation, but the company has suspended operations. Topps Meat Co. of New Jersey was also closed after 22 million pounds of its meat was recalled last September. Federal inspectors didn't uncover problems there, either. Dozens of people became ill from E. coli contamination before the illness was traced to Topps.

The result of contaminated meat entering the human food supply can be devastating. The Centers for Disease Control and Prevention estimates there are 325,000 hospitalizations and 5,000 deaths each year from food-borne illnesses. Some consequences might surprise you. For example, the CDC says the most common cause of acute kidney failure in children is infection with E. coli 0157:H7, which can result from contamination by microscopic amounts of cow feces.

This is where animal cruelty and the threat to human health intersect.

The idea of using pain to try to rouse an animal that is so weak it wallows in its own feces is not just ethically offensive. Downer cows, more likely to be infected with mad-cow disease, spread feces to other carcasses in the slaughtering process. According to the CDC, one hamburger can include the meat of hundreds of cows, so one downer cow can have a huge impact. (emphasis added)

People have a strong aversion to animal cruelty, even when the animals in question are destined for slaughter. Arizonans approved a ban on confining pregnant sows in small crates because they recognized these animals as sentient beings that deserve respect.

After last fall's Topps recall, Congress talked about the need to overhaul a food-safety system that lacks uniformity, coordination and authority. Now, Congress is again talking about reforms. Hearings are scheduled for later this month and next month.

The attention is welcome, but the approach should not be crisis-driven. It will take a sustained effort to structure a food-safety inspection system that is up to the challenges presented by modern factory farming and emerging food-borne health threats.

It is not unreasonable to demand the meat in your hamburger be safely and humanely produced.

Attachment #3: Flyer for
COTT Town Meeting in March in Los Angeles

The Committee of Ten Thousand

In concert with the

L.A. Hombres

Invite you to a

Los Angeles
Town Meeting
On
Hemophilia Advocacy
Sunday March 2, 2008
2:00 – 5:00 pm
At the
Manhattan Beach Marriott
            1400 Parkview Ave.
            Manhattan Beach, CA
            (maps attached)
            310-546-7511
Briefings on the following topics will be given, to include questions & comments from the community, identification of new issues, and planning for the year’s advocacy efforts.  A brief training on legislative advocacy will also be part of the program.  Kids Welcome!!

·         Proposed California Health Program Cuts

·       Wellpoint-Anthem changes and community response  
·       ‘Any-Willing-Provider’ and Standards of Care Legislation
·       Hepatitis C compensation update
·       Presidential Candidate positions  
·       Blood Safety Update
·       MediGap campaign      

 

Others to be added at the Meeting!! See you there!!