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Why don't bone marrow donations harm the donor in the long term?

Why don't bone marrow donations harm the donor in the long term?



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I have googled about this, and the most I can really find is that donating bone marrow/blood stem cells is not harmful in the long run, but I want to know why and how much is really known about this.

My question “stems” from my maybe cartoonish notion that you have all the stem cells you'll ever have at the beginning of your life and that their depletion relates strongly to aging.

In my googling, I have read studies that lifespans of older mice can be extended with bone marrow stem cell transplants from younger mice. Based on my cartoon, I guessed that perhaps older mice have some depletion of and/or damage to their own hematopoietic stem cells that reduces overall formed element production, and this is the state that a transplant helps to fix. With this frame of mind, I have a hard time imagining that even a young donor of blood stem cells is not harmed in the long run. Hasn't their pool of stem cells effectively been aged somewhat by the donation? Or is damage to the population of cells over time by environmental factors much more significant, more the “bottleneck” in cell health than the gradual deterioration caused by repeated division? Is it that donation effectively only forces something on the order of one extra division per cell? I also wonder whether that “bottleneck” could vary depending on the typical longevity of the animal under study.

Regarding my question about what is known-I suppose I'm asking what kinds of principles or studied effects are likely being referenced in laypersons' articles declaring that donors do not experience long term harm.

I'm sure that I am probably saying some nonsense things because biology is not my field. Any corrections and disentangled conflations would be appreciated!


What does a bone marrow biopsy involve?

A bone marrow biopsy is a medical test in which a doctor requests the collection and examination of a sample of bone marrow. This is done to check if the tissue is healthy and blood cell production is normal.

In the procedure, a healthcare provider inserts a small needle into a large bone, drawing a sample of the bone marrow into the needle. Then, a laboratory technician analyzes the sample for a range of diseases, including several cancers.

In this article, we explain the reasons for having a bone marrow biopsy, what it involves, as well as the risks.

Share on Pinterest A bone marrow biopsy can help identify the causes of issues with blood cell production.

Doctors order bone marrow biopsies when signs or symptoms indicate problems with blood cell production.

Bone marrow biopsies are also used in people with blood-related cancers to monitor their treatment, for example, the progress of chemotherapy.

A bone marrow biopsy can support the diagnosis or evaluation of many symptoms and medical conditions. Some of these diseases and conditions include:

    , or a shortage of red blood cells
  • abnormal bleeding or clotting
  • bone marrow and blood cancers, such as leukemia, lymphoma, or multiple myeloma
  • cancers that have spread to the bone marrow from elsewhere
  • unexplained fevers

Bone marrow is the soft tissue inside most large bones. It produces many of the body’s blood cells, including red blood cells, white blood cells, and platelets.

Myeloid and lymphoid cells, which are two main types of stem cells within the bone marrow, produce the various blood cells.

Myeloid cells create red blood cells, white blood cells, and platelets. Lymphoid cells produce a specific type of white blood cell that is responsible for immunity.

Different components make up blood and have vital roles in maintaining health. Bone marrow makes these components.

Red blood cells play a critical role by carrying oxygen throughout the body. White blood cells are essential for helping the body fight infection. Platelets help stop bleeding by causing blood to clot.

A bone marrow biopsy procedure takes place a doctor’s office, hospital, or clinic. A person is likely to be at the appointment for around 30 to 45 minutes in total, with the biopsy itself taking around 10 minutes.

Before the procedure

Before the bone marrow biopsy, a doctor or other healthcare provider will ask questions to ensure the safest care. People may wish to prepare a list of questions and their medical history to speed up the process.

Bone marrow biopsies carry a risk of bleeding. The medical professional will ask about medications or herbal treatments a person might be taking that could increase this risk, including common pain relievers, such as aspirin, ibuprofen, and naproxen. Anticoagulants or blood thinners may also lead to excessive bleeding.

The doctor or healthcare provider will advise on whether to continue taking medications or stop the course before the procedure.

Allergies are also an important concern when having a biopsy. The healthcare provider will ask about any allergies someone may have, especially to anesthetics and latex.

A doctor may use an anesthetic during the procedure to numb the pain. People receiving anesthesia may need a friend or family member to drive them home afterward.

During the procedure

A bone marrow biopsy typically involves two steps:

  • Aspiration: The healthcare provider removes fluid from the bone marrow.
  • Biopsy: The healthcare provider removes a tiny piece of bone and bone marrow tissue.

A bone marrow biopsy usually takes place on an outpatient basis. However, some people may have the procedure done while staying in a hospital.

The pelvic bone is the most common site for a marrow biopsy, but a doctor might use other bones.

The steps of a bone marrow biopsy are usually as follows:

  1. Before the biopsy, the person under examination changes into a gown. The healthcare provider will ask them to lie on their side or stomach. The position may vary according to the site of the biopsy. The medical professional then cleans the biopsy area with an antiseptic.
  2. The healthcare provider applies an anesthetic with a needle to numb the biopsy area. Some pain might occur when the needle penetrates the skin, and the anesthetic enters the area.
  3. Once the biopsy site is numb, the healthcare provider makes a small incision at the biopsy site. Bone marrow aspiration usually takes place first. The medical professional will use a syringe to take a liquid sample of the bone marrow cells.
  4. After the aspiration comes the bone marrow biopsy. A biopsy needle is larger than an aspiration needle. The healthcare provider guides the needle into the bone, rotates it, and removes a sample of bone and tissue.

Does a bone marrow biopsy hurt?

People will usually experience some pain both during and after the procedure. The level of pain varies between individuals.

Studies have identified ways to make bone marrow biopsies more comfortable. An experienced health provider can help reduce the pain. Pain control medications, such as lidocaine and intravenous sedation, can also ease discomfort during the procedure.

Anxiety and worry about the procedure often make the experience more painful. People who are anxious about a bone marrow biopsy should talk to their doctor.

What happens after a bone marrow biopsy?

The results may be ready a few days after the biopsy but might take longer. A pathologist or hematologist, or doctor specializing in blood, will analyze the samples.

The health provider will then explain the results and possibly arrange follow-up tests.

The biopsy area may be sore for several days. It is important to closely follow the treating doctor or healthcare provider’s instructions about which pain relievers are safe to use. Some pain relievers, including aspirin, can increase the risk of bleeding after a bone marrow biopsy.

The carer will give instructions about keeping the area dry and when the protective bandage may come off. The bandage usually stays on for 1 to 2 days.

Watch out for physical signs that might signal an infection or complication. People should talk to their doctor if they experience any of the following:


Symptoms of bone metastasis

It’s very important to tell your cancer care team about any new symptoms you have. Finding and treating bone metastases early can help prevent problems later.

Bone pain is often the first symptom of cancer that has spread to the bone. The pain may come and go at first. It tends to be worse at night and may get better with movement. Later on, it can become constant and may be worse during activity. The bone might be so weak that it will break. This can often be prevented if the bone metastasis is found early.

There are many ways to treat pain caused by bone metastases. The treatment will depend on the type of cancer as well as the number and location of bone metastases. Sometimes treatment being used to treat the main (primary) cancer will help shrink the metastases. Other times medicines made to stop the effects of the cancer on the bone may be given. In addition, some more local treatments, like radiation therapy or even surgery, can help relieve the pain.

Pain medicines are also very helpful. Many kinds of pain medicines are used to treat cancer pain. There are also a lot of ways the medicines can be taken, such as pills, patches, and pumps that let you put the medicine into your body when you need it.

Fractures (broken bones or breaks)

Breaks might happen with a fall or injury, but a weak bone can also break during normal activities. These breaks often cause sudden, severe pain. Fractures most often happen in the long bones of the arms and legs and the bones of the spine. Sudden pain in the middle of the back, for instance, may mean a bone in the spine has broken.

When possible, your doctor will try to prevent the fracture. Cancer in the bone may cause severe pain for a while before the bone breaks. If an x-ray shows an arm or leg bone is likely to break, surgery may be done to put a metal rod in the weak part of the bone.

If the bone has already broken, surgery is usually done to put a steel support over the broken part of the bone. If bones of the spine break, a bone cement might be injected into the damaged bones (vertebroplasty). This can help support the bone.

Radiation treatments may be given after surgery to try to prevent any more damage. The radiation won’t make the bone stronger, but it might stop further damage.

If you feel confused, dizzy, or weak, talk with your cancer care team about safety equipment you can use at home, such as shower chairs, walkers, or handrails.

Spinal cord compression

Cancer growing in the bones of the back can press on the spinal cord. One of the earliest symptoms of spinal cord compression is pain in the back or neck.

If a spinal cord compression isn’t treated right away, the person can become paralyzed. Most often this affects the legs (so that the person can’t walk) but if the tumor is pressing on the spinal cord in the neck, the arms and the legs can be affected.

Spinal cord compression can show up in different ways:

  • Back pain (sometimes with pain going down one or both legs)
  • Numbness of the legs or belly
  • Leg weakness or trouble moving your legs
  • Loss of control of urine or stool (incontinence) or problems passing urine

If you notice symptoms like these, call your doctor right away or go to the emergency room.

If the cancer is just starting to press on the spinal cord, treatment can help prevent paralysis and help relieve the pain. Radiation is often used as part of the treatment, sometimes with a type of medicine called a steroid or corticosteroid. The radiation often is started right away, within the first 12 to 24 hours.

If the spinal cord is already showing signs of damage (such as weakness in the legs), immediate surgery followed by radiation may be the best treatment. This may allow a patient to walk and function better than if they get radiation alone. People with very advanced cancer or other serious medical problems may not be able to have this kind of surgery.

High blood calcium levels

When cancer spreads to the bones, too much calcium from the bones can be released into the bloodstream. This is called hypercalcemia.

High blood calcium levels can cause problems such as

  • Constipation
  • Passing urine often
  • Feeling sluggish or sleepy
  • Feeling thirsty all the time and drinking lots of liquids
  • Muscle weakness
  • Muscle and joint aches
  • Confusion
  • Coma
  • Kidney failure.

Treatment includes giving large amounts of intravenous (IV) fluids to protect the affected kidneys and medicines such as bisphosphonate drugs to bring blood calcium levels down quickly. Once the calcium level is back to normal, treating the cancer can help keep the calcium level from getting too high again.


Peripheral T-cell lymphomas

Cutaneous T-cell lymphomas (mycosis fungoides, Sezary syndrome, and others)

Treatment of these skin lymphomas is discussed in Treating Lymphoma of the Skin.

Adult T-cell leukemia/lymphoma

This lymphoma is linked to infection with the HTLV-1 virus. There are 4 subtypes, and treatment depends on which subtype you have.

  • The smoldering and chronic subtypes grow slowly. Like other slow-growing lymphomas (such as follicular lymphoma and small lymphocytic lymphoma), these subtypes are often watched without treatment as long as they aren’t causing problems other than mildly swollen lymph nodes. If treatment is needed, one option is interferon and the anti-viral drug zidovudine to fight the HTLV-1 infection. If the lymphoma is affecting the skin, it may be treated with radiation. Another option is chemo, using the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other combinations.
  • The acute subtype also can be treated with either anti-viral drugs or chemo (typically the CHOP regimen). If it responds well to treatment, a stem cell transplant might be considered.
  • Anti-viral therapy is not helpful for the lymphoma subtype, so it is typically treated with chemotherapy. It can also involve the tissues around the brain and spinal cord, so chemo is given into the spinal fluid (intrathecal chemo) as well. Treatment after chemo may include a stem cell transplant.

Because there is no clear standard treatment for this disease, patients might want to consider enrolling in a clinical trial, if one is available.

Angioimmunoblastic T-cell lymphoma

This fast-growing lymphoma might be treated first with steroids (such as prednisone or dexamethasone) alone, especially in older patients who might have trouble tolerating chemo. This treatment can reduce fever and weight loss, but the effect is often temporary. If chemo is needed, combinations such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) may be used. Another option might be the chemo combination of cyclophosphamide, doxorubicin, and prednisone, along with the monoclonal antibody brentuximab vedotin (Adcetris). If the lymphoma is only in one area, radiation therapy may be an option.

Standard doses of chemo rarely produce long-term remissions, so a stem cell transplant is often suggested after initial chemotherapy if a person can tolerate it.

Extranodal natural killer/T-cell lymphoma, nasal type

This rare lymphoma is often confined to the nasal passages. Patients with stage I or II disease who aren't healthy enough for chemotherapy may be treated with radiation therapy alone. Most other patients are treated with chemoradiation (chemo and radiation given together) or chemo followed by radiation. Several different chemo combinations can be used.

If the lymphoma doesn’t go away completely, a stem cell transplant may be done if possible.

Enteropathy-associated T-cell lymphoma

This lymphoma generally develops in the small intestine or colon. Intensive chemo using several drugs is usually the main treatment. Often CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) is the chemo used. If the lymphoma is only in one area, radiation therapy may be used as well. But if these treatments work, a hole (perforation) can develop in the intestines (as the lymphoma cells die), so surgery might be done first to remove the part of the intestines containing the lymphoma. Surgery may also be needed before chemo or radiation if a person is diagnosed with this lymphoma because it caused a perforation or intestinal blockage (obstruction). A stem cell transplant may be an option if the lymphoma responds to chemo.

Anaplastic large cell lymphoma (ALCL)

This fast-growing lymphoma mainly affects lymph nodes and is treated with chemo regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone). Another option might be the chemo combination of cyclophosphamide, doxorubicin, and prednisone, along with the monoclonal antibody brentuximab vedotin (Adcetris). Doctors might recommend radiation therapy as well for some patients.

This lymphoma often responds well to treatment, and long-term survival is common, especially if the lymphoma cells have too much of the ALK protein. If the cells lack the ALK protein or if the lymphoma returns after initial treatment, a stem cell transplant may be an option. Another option for lymphomas that no longer respond to initial treatment is brentuximab vedotin (Adcetris).

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): For ALCL that develops in the capsule (normal protective scar tissue) that forms around a breast implant, experts typically recommend removing the implant and the capsule surrounding it. Additional treatment might include chemo, sometimes with radiation.

Peripheral T-cell lymphoma, unspecified

These lymphomas are generally treated the same way as diffuse large B-cell lymphoma (DLBCL). Chemo with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other drug combinations is used. For early-stage disease, radiation therapy may be added. Another option for some of these lymphomas might be the chemo combination of cyclophosphamide, doxorubicin, and prednisone, along with the monoclonal antibody brentuximab vedotin (Adcetris). A stem cell transplant may be recommended when possible.

If other treatments are no longer working, newer chemo drugs such as pralatrexate (Folotyn), targeted drugs such as bortezomib (Velcade), belinostat (Beleodaq), or romidepsin (Istodax), or immunotherapy drugs such as alemtuzumab (Campath) and denileukin diftitox (Ontak) may be tried.

The outlook for these lymphomas is usually not as good as in DLBCL, so taking part in a clinical trial of newer treatments is often a good option.

The treatment information given here is not official policy of the American Cancer Society and is not intended as medical advice to replace the expertise and judgment of your cancer care team. It is intended to help you and your family make informed decisions, together with your doctor. Your doctor may have reasons for suggesting a treatment plan different from these general treatment options. Don't hesitate to ask him or her questions about your treatment options.


Elite Hospitals Plunge Into Unproven Stem Cell Treatments

The online video seems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and “regenerative medicine” for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, “It’s completely healed.”

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

“I don’t have any pain that stops me from doing anything I want,” Hyland says.

The video’s cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine. But the marketing video wasn’t filmed by a little-known operator.

It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.

Swedish is one of a growing number of respected hospitals and health systems — including the Mayo Clinic, the Cleveland Clinic and the University of Miami — that have entered the lucrative business of stem cells and related therapies, including platelet injections. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic’s campus in Florida.

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‘Expensive Placebos’

While hospital-based stem cell treatments may be legal, there’s no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.

“FDA approval isn’t needed and physicians can claim they aren’t violating federal regulations,” Turner said. “But just because something is legal doesn’t make it ethical.”

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don’t have to wrangle with insurance companies, which view the procedures as experimental and largely don’t cover them.

“It’s an out-of-pocket, cash-on-the-barrel economy,” Turner said. Across the country, “clinicians at elite medical facilities are lining their pockets by providing expensive placebos.”

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It preys on people’s desperation.”

In a joint statement, Pourcho and Swedish defended the online video.

“The terminology was kept simple and with analogies that the lay person would understand,” according to the statement. “As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.”

But Knoepfler said the guests on the video make several “unbelievable” claims.

At one point, Dr. Pourcho says that platelets release growth factors that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and “so you don’t get, say, eyeball in your hand.”

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of “any possibility of growing eyeball or other random tissues in your hand.” Knoepfler, who wrote about the video in February on his blog, The Niche, said, “There’s no way that the adult brain could send that kind of stem cells anywhere in the body.”

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called “New Day Northwest.” Although much of the show is produced by the KING 5 news team, some segments — like Pourcho’s interview — are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn’t labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

“The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,” Rose said. “We value the public’s trust.”

Increasing Scrutiny

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson’s disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called “bad actors.”

With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

“There are clearly bad actors who are well over the line and who are creating significant risks for patients,” Gottlieb said.

Gottlieb, set to leave office April 5, said he’s also concerned about the financial exploitation of patients in pain.

“There’s economic harm here, where products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket,” Gottlieb said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there is a broad “spectrum” of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are “for just about anything.” Hospitals operate somewhere in the middle, Marks said.

“The good news is that they’re somewhat closer to the most rigorous academics,” he said.

The Mayo Clinic’s regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that’s not yet the standard of care, Shapiro said.

Rickert said it’s easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.

“We have patients in our offices demanding these treatments,” Shapiro said. “If they don’t get them from us, they will get them somewhere else.”

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital’s consultation service, in which doctors explain patients’ options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

“Most of the patients do not get a regenerative [stem cell] procedure,” Shapiro said. “They don’t get it because after we have a frank conversation, they decide, ‘Maybe it’s not for me.’”

Lots Of Hype, Little Proof

Although some hospitals boast of high success rates for their stem cell procedures, published research often paints a different story.

The Mayo Clinic website says that 40 to 70% of patients “find some level of pain relief.” Atlanta-based Emory Healthcare claims that 75 to 80% of patients “have had significant pain relief and improved function.” In the Swedish video, Pourcho claims “we can treat really any tendon or any joint” with PRP, or “platelet-rich plasma” injections.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasn’t been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

“People will say, ‘If you inject PRP, you will return to sports faster,’” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. “But that hasn’t been proven.”

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that’s nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn’t work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren’t reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is “unable to recommend for or against” PRP.

“PRP is sort of a ‘buyer beware’ situation,” said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. “It’s the poor man’s approach to biotechnology.”

Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70% of patients, Fu said.

A 2016 review in the Journal of Bone and Joint Surgery concluded that “the value and effective use of cell therapy in orthopaedics remain unclear.” The following year, a review in the British Journal of Sports Medicine concluded, “We do not recommend stem cell therapy” for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

“The insurance companies don’t pay for fat grafting or bone-marrow aspiration, and rightly so,” Shapiro said. “That’s because we don’t have enough evidence.”

Rickert, an orthopedist in Bedford, Ind., said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn’t be charged for these services until they’ve been tested and shown to work.

Orthopedists — surgeons who specialize in bones and muscles — have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

Misleading Marketing

Some argue that joint injections shouldn’t be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections “orthobiologics,”noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said. In fat tissue, only about 1 in 2,000 cells is a stem cell, according to a March paper in The Bone & Joint Journal. Stem cells are even rarer in bone marrow, where 1 in 10,000 to 20,000 cells is a stem cell.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There’s no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don’t know why some patients who receive platelet injections feel better, but others don’t.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, “it seemed like an answer to a prayer,” said Walsh, of Stuart, Fla. “You’re so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.”

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. “My only regret,” she said, “is that I wasted so much time and money.”


Research for Your Health

The NHLBI is part of the U.S. Department of Health and Human Services’ National Institutes of Health (NIH)—the Nation’s biomedical research agency that makes important scientific discovery to improve health and save lives. We are committed to advancing science and translating discoveries into clinical practice to promote the prevention and treatment of heart, lung, blood, and sleep disorders including different types of anemia. Learn about the current and future NHLBI efforts to improve health through research and scientific discovery.

Learn about the following ways the NHLBI continues to translate current research into improved health for people with aplastic anemia. Research on this topic is part of the NHLBI’s broader commitment to advancing blood disorders and blood safety scientific discovery.

  • Program Helps Protect Blood Transfusion Recipients. The NHLBI’s Recipient Epidemiology and Donor Evaluation Study (REDS) program began in 1989 to protect the Nation’s blood supply and improve the benefits and reduce the risks of transfusions. Now in its third phase, called REDS-III, the program supports research in the United States and around the world.
  • Providing Access to NHLBI Biologic Specimens and Data. The Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) centralizes and integrates biospecimens and clinical data that were once stored in separate repositories. Researchers can find and request available resources on BioLINCC’s secure website, which maximizes the value of these resources and advances heart, lung, blood, and sleep research.
  • Supporting Safe Manufacturing of Cell-based Therapies. The NHLBI’s Production Assistance for Cellular Therapies (PACT) program supports translational research on cellular and genetic therapies by increasing the capacity to manufacture cell products that follow current Good Manufacturing Practices (cGMP) regulations. The PACT program is designed to increase the supply and safety of genetically modified cells available for patients who have blood disorders such as aplastic anemia.
  • Network Accelerates Research on Blood and Bone Marrow Transplants. The NHLBI and the National Cancer Institute (NCI) launched the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in 2001 to promote large multi-institutional clinical trials that seek to understand the best possible treatment approaches in blood and marrow transplantation. In the United States, about 20,000 patients receive blood or marrow transplants annually.

Learn about some of the pioneering research contributions we have made over the years that have improved clinical care.

  • Improving treatments for people who have aplastic anemia. NHLBI researchers pioneered the use of antithymocyte globulin (ATG) and cyclosporine, greatly increasing the survival rates of patients who have aplastic anemia. This combination treatment is now the standard of care for older patients who have aplastic anemia and those who do not have a matching bone marrow donor.
  • New treatments for aplastic anemia. About one-third of people who have aplastic anemia do not respond to medicines that calm the immune system, called immunosuppressants . NHLBI studies led to the approval of eltrombopag, which stimulates the body to make more blood cells in people who do not respond to standard immunosuppressants. Studies show that eltrombopag also helps patients who respond well to immunosuppressants.
  • Understanding risk factors for aplastic anemia. NHLBI researchers have helped determine some causes of aplastic anemia, such as parvovirus B19 infection, and how mutations in genes that protect the ends of your DNA can increase the risk of getting the disease.

In support of our mission, we are committed to advancing research on anemia, in part through the following ways.

  • We perform research. Our Division of Intramural Research and its Hematology Branch include investigators who are actively engaged in research on anemia, including aplastic anemia. Research in the Hematopoiesis and Bone Marrow Failure Laboratory spans the basic sciences, clinical trials , and epidemiology, and focuses on blood cell production in healthy individuals and patients with bone marrow failure.
  • We fund research. The research we fund today will help improve our future health. The Division of Blood Diseases and Resources supports research on the causes, prevention, and treatment of blood diseases, including aplastic anemia. Search the NIH RePORTER to learn about research the NHLBI is funding on aplastic anemia.
  • We stimulate high-impact research. Our Trans-Omics for Precision Medicine (TOPMed) Program includes participants with aplastic anemia, which may help us understand how genes contribute to differences in disease severity and how patients respond to treatment. The NHLBI Strategic Vision highlights ways we may support research over the next decade.

Learn about exciting research areas the NHLBI is exploring for aplastic anemia.


Research for Your Health

The NHLBI is part of the U.S. Department of Health and Human Services’ National Institutes of Health (NIH)—the Nation’s biomedical research agency that makes important scientific discovery to improve health and save lives. We are committed to advancing science and translating discoveries into clinical practice to promote the prevention and treatment of heart, lung, blood, and sleep disorders including different types of anemia. Learn about the current and future NHLBI efforts to improve health through research and scientific discovery.

Learn about the following ways the NHLBI continues to translate current research into improved health for people with aplastic anemia. Research on this topic is part of the NHLBI’s broader commitment to advancing blood disorders and blood safety scientific discovery.

  • Program Helps Protect Blood Transfusion Recipients. The NHLBI’s Recipient Epidemiology and Donor Evaluation Study (REDS) program began in 1989 to protect the Nation’s blood supply and improve the benefits and reduce the risks of transfusions. Now in its third phase, called REDS-III, the program supports research in the United States and around the world.
  • Providing Access to NHLBI Biologic Specimens and Data. The Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) centralizes and integrates biospecimens and clinical data that were once stored in separate repositories. Researchers can find and request available resources on BioLINCC’s secure website, which maximizes the value of these resources and advances heart, lung, blood, and sleep research.
  • Supporting Safe Manufacturing of Cell-based Therapies. The NHLBI’s Production Assistance for Cellular Therapies (PACT) program supports translational research on cellular and genetic therapies by increasing the capacity to manufacture cell products that follow current Good Manufacturing Practices (cGMP) regulations. The PACT program is designed to increase the supply and safety of genetically modified cells available for patients who have blood disorders such as aplastic anemia.
  • Network Accelerates Research on Blood and Bone Marrow Transplants. The NHLBI and the National Cancer Institute (NCI) launched the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in 2001 to promote large multi-institutional clinical trials that seek to understand the best possible treatment approaches in blood and marrow transplantation. In the United States, about 20,000 patients receive blood or marrow transplants annually.

Learn about some of the pioneering research contributions we have made over the years that have improved clinical care.

  • Improving treatments for people who have aplastic anemia. NHLBI researchers pioneered the use of antithymocyte globulin (ATG) and cyclosporine, greatly increasing the survival rates of patients who have aplastic anemia. This combination treatment is now the standard of care for older patients who have aplastic anemia and those who do not have a matching bone marrow donor.
  • New treatments for aplastic anemia. About one-third of people who have aplastic anemia do not respond to medicines that calm the immune system, called immunosuppressants . NHLBI studies led to the approval of eltrombopag, which stimulates the body to make more blood cells in people who do not respond to standard immunosuppressants. Studies show that eltrombopag also helps patients who respond well to immunosuppressants.
  • Understanding risk factors for aplastic anemia. NHLBI researchers have helped determine some causes of aplastic anemia, such as parvovirus B19 infection, and how mutations in genes that protect the ends of your DNA can increase the risk of getting the disease.

In support of our mission, we are committed to advancing research on anemia, in part through the following ways.

  • We perform research. Our Division of Intramural Research and its Hematology Branch include investigators who are actively engaged in research on anemia, including aplastic anemia. Research in the Hematopoiesis and Bone Marrow Failure Laboratory spans the basic sciences, clinical trials , and epidemiology, and focuses on blood cell production in healthy individuals and patients with bone marrow failure.
  • We fund research. The research we fund today will help improve our future health. The Division of Blood Diseases and Resources supports research on the causes, prevention, and treatment of blood diseases, including aplastic anemia. Search the NIH RePORTER to learn about research the NHLBI is funding on aplastic anemia.
  • We stimulate high-impact research. Our Trans-Omics for Precision Medicine (TOPMed) Program includes participants with aplastic anemia, which may help us understand how genes contribute to differences in disease severity and how patients respond to treatment. The NHLBI Strategic Vision highlights ways we may support research over the next decade.

Learn about exciting research areas the NHLBI is exploring for aplastic anemia.


Does insurance cover stem cell therapy?

Does insurance cover stem cell therapy? Even at clinics? Generally, no. What about coverage from employers? Only extremely rarely.

It’s an important question because the average total stem cell injection price tag for an individual customer can easily end up being $10K-$20K or more. The expense adds up in part because the cost per injection (see poll data here) has to be multiplied by the number of injections (see data here) the customer gets over time. Some patients have received one or two dozen injections. Some clinic practitioners also self-treat as well with unproven stem cells.

If insurance won’t cover the expensive, unproven stem cell “treatments” at for-profit clinics, and I don’t blame them since in my view they are generally a big waste of money and are risky, then can the average person afford to pay so much themselves? Often they can’t.

Sadly many clinics are frequently now pushing patients to take out loans or go fundraise online to scrape together money.

Weirdly some clinics falsely claim that their offerings are covered by insurance when really they aren’t, a fact patients will quickly realize if they do a little research.


Background

Bone metastases are generally incurable and clinically problematic, yet are present in over 80% of patients with advanced breast cancer [1, 2], representing a debilitating stage of disease with very poor patient prognoses during palliation, and one of the leading causes of breast cancer mortality among women worldwide [3,4,5]. Osteolytic (lytic) bone metastases, in particular, present a considerable challenge to patients and clinicians due to rapid microarchitectural deterioration of affected skeletal sites through tumour-driven dysregulation of bone metabolic activity in favour of excess resorption [1, 6, 7]. Metastatic breast carcinomas commonly deposit in trabecular (cancellous) regions of bone [6, 8,9,10], such as the skull, ribs, spine, pelvis and proximal and distal segments of long bones, owing to their strong affinity to red bone marrow [2, 7, 9, 11]. Of direct relevance, the majority of these skeletal structures are characteristically load-bearing [12,13,14], thus any accelerated bone loss and heightened fragility following tumoural infiltration [8, 10, 15,16,17] has immediate consequences for patients with cancer if left untreated or unmanaged. Consequently, this destructive skeletal process leads to increased patient morbidity and mortality, with heightened fragility, increased risk of spinal compression, potential development of hypercalcaemia, increased bone pain and increased fracture risk [7, 17,18,19] whilst simultaneously creating a localised microenvironment conducive to tumoural growth and invasion within affected bone sites [20,21,22,23].

Chemotherapy, hormone therapy, radiotherapy and anti-resorptive medications are the primary therapeutic agents used in breast cancer palliation to delay disease progression, alleviate bone pain and associated symptoms, preserve skeletal integrity and extend survival [24,25,26,27,28,29,30,31,32]. Whilst effective, these treatments produce well-documented side effects to varying degrees, which can lead to dose limitation or cessation, subsequently restricting their full clinical utility. For example, patients with advanced breast cancer with bone metastases are provided with bone strengthening (anti-resorptive) medications such as bisphosphonates or denosumab to fortify bone through induced sclerosis leading to increments in bone density [33, 34]. While efficacious in the mid-term long-term use of these medications themselves eventually generate skeletal fragility in the absence of a discontinuation period [35,36,37], which is not a clinically viable option for patients with advanced cancer and osteolytic bone metastases.

Bone is highly adaptive and osteogenically sensitive to its mechanical environment, principally through muscular contraction of neighbouring muscle, but also from impact and gravitational forces acting upon the skeleton during human movement and from external loads [12, 38, 39]. Up-regulation of osteoblastic activity through exercise may therefore allow mechanically driven regulation of bone metabolism (i.e. osteocyte-mediated coupling of osteoblast and osteoclast activity) to counteract tumour-driven dysregulation which could have two key benefits: (1) to preserve bone strength through anabolic morphological (material and structural) adaptations and (2) to interfere with tumoural processes that blunt osteoblastic formation and promote osteoclastic resorption, thus potentially suppressing tumour growth in affected skeletal sites. Preclinical studies [8, 13, 40, 41] have explored this potential relationship in rodent orthotopic models, implanting human breast cancer cells into trabecular skeletal tissue in order to induce osteolysis in the load-bearing tibia. Impressively, when comparing loaded and non-loaded tumour-affected tibiae within host rodents, repeated bouts of externally controlled mechanical compression preserved skeletal integrity (0% versus 71% degradation for loaded and unloaded conditions), blunted tumour-mediated osteolysis, and significantly suppressed tumour growth by approximately 80% [8, 13] in the absence of muscular influence. In addition to osteocyte-driven osteogenic signalling, the inextricable anatomical, mechanical, metabolic and pleiotropic link between muscle and bone [12, 38, 42, 43] provides another avenue of therapeutic osteogenic and anti-tumour potential not yet explored [14, 44,45,46,47]. The voluntary activation of muscle surrounding skeletal lesions may deliver anabolic cytokines and myokines (secretome cross-talk) to lesion sites [14, 44, 45, 48] to countenance catabolic tumour-mediated processes [46, 47, 49, 50]. Accordingly, mechanical signals propagated by muscle contraction may concurrently stimulate osteocyte-mediated metabolic activity and myokine-cytokine secretome cross-talk to promote osteogenesis while modulating tumoural behaviour and biology in order to slow tumour growth [14, 45, 48,49,50,51].

Human clinical trials have yet to be implemented in this space, owing to a historical and misplaced belief that patients with advanced cancer and bone metastases should be excluded from exercise programmes and synonymous research due to increased risk of skeletal complications or other potential adverse events [52,53,54]. Formative work by Galvão and colleagues [51, 55,56,57,58] demonstrated the safety and feasibility of delivering supervised exercise to patients with advanced prostate cancer and bone metastases, avoiding exercises that placed direct or targeted stress on bones with identified lesions. Separate work by Rief and colleagues [59, 60] demonstrated the safety and feasibility of physiotherapy-instructed spinal isometric training in isolation for patients undergoing palliative radiation therapy for spinal bone metastases, though in a small cohort of heterogeneous patients with cancer and disparate lesion types. Taken together, these studies illustrate the potential for preclinical studies to be translated to human patients specifically models of advanced breast cancer with osteolytic bone metastatic disease. This is particularly important as animal studies do not always translate to the human condition, particularly in exercise-mediated bone adaptation studies, often due to poorly designed human trials for equivalency [12, 61,62,63].

Given that bone metastases remain one of the leading causes of breast-cancer-related deaths worldwide, additional and novel interventions to target osteolytic lesions in skeletal tissue are highly clinically relevant. Expanding on our prior work, the aim of this study is to (1) assess the safety and feasibility of a supervised and individually tailored resistance, aerobic and flexibility exercise programme that includes targeted spinal isometric training in patients with advanced breast cancer and osteolytic bone metastases (2) explore the preliminary efficacy of the exercise programme to slow tumour growth and tumour biomarker activity in target osteolytic spinal lesions and (3) examine the broader efficacy of the exercise programme to preserve muscle and bone mass, improve physical fitness, enhance physical function, reduce cancer-related fatigue and increase quality of life. It is the working hypothesis of this study that the exercise programme will be safe and feasible will show signs of tumoural suppression and/or favourable alterations in tumour biomarkers and will lead to positive physical and psychosocial outcomes for patients. If successful, the outcomes of this trial will be used to improve clinical knowledge pertaining to exercise prescriptions for patients with advanced cancer who have metastatic carcinomas and high disease burden, and will be used as a foundation for future phase II and phase III efficacy-focused human clinical trials to establish the anti-cancer effects of exercise. It is anticipated that this new information will aid in the establishment and/or renewal of clinical exercise guidelines for the management of cancer across the disease spectrum.


Why don't bone marrow donations harm the donor in the long term? - Biology

The sensitivity that can be achieved with capillary electrophoresis makes it possible to detect the abnormal protein in blood. A peptide from the carboxyl terminal region, amino acid positions 218-232, was labeled at the amino terminus with fluorescein during the synthesis of the peptide. Antibodies that have been produced to this peptide were affinity purified and used in a capillary electrophoresis immunoassay. The amount of fluorescein labeled peptide in the capillary was 50 amol.

Blood was obtained from normal sheep and elk, from sheep infected with scrapie and elk infected with chronic wasting disease. Buffy coats and plasma were prepared by a conventional method. After treatment with proteinase K, which destroys the normal protein but not the altered one, the blood fractions were extracted and tested in the capillary electrophoresis immunoassay for the abnormal prion protein.

The abnormal prion protein was detected in fractions from blood from infected animals but not from normal animals. This assay makes a pre-clinical assay possible for these diseases and could be adapted to test for the abnormal prion protein in process materials that are used for manufacture of pharmaceuticals and products for human consumption.

Comment (webmaster): A rapid, sensitive, and specific blood test for TSE in living animals (and reportedly humans) is a major advance in this field. The test uses off-the-shelf equipment available from Beckman Instruments and standard buffy coat from blood, making it suitable for automation. The paper itself is limited in scope and the method for re-solubilizing prion protein is kept proprietary Dr. Schmerr has given much broader details at various seminars. However, it is important to have published details in a peer-reviewed journal.

Note that the method will give false negatives (fail to detect infectious prions) in situations where the carboxy terminal residue is not part of the final amyloid due to proteolysis or early termination. The conditions used for protease K digestion, 1 hr at 37 degrees C, may also make some fragile strains of TSE undetectable by this method. However, other epitopes and antibodies and milder conditions could easily extend the assay system.

Now the question is, even though a blood test is available, will it ever be used? And when results are positive, will they ever be announced? Who will conduct the tests, an agency or industry with massive conflicts of interest? While the test is cheap, rapid, and sensitive, confirmation of contamination could be extremely unwelcome. For example, a sample of Doug McEwen's blood was taken prior to death but was not analyzed prior to the decision was made in Dec 98 to allow his prior donations to be distributed worldwide (121 products, 20 countries). Apparently the technology was available to do the test in December 1998 but testing was not ordered by health officials.

If McEwen's blood should test positive for CJD, will this ever be announced? Will millions of recipients be notified and given counseling and follow-up? Will large volumes of blood products be discarded in other cases if _any_ amount of protease K resistant prion is found or must an arbitrary threshold be exceeded? The latter requirement places the burden of proof upon the victim rather than the manufacturer.

These same questions come up for the livestock industry. Scrapie is very widely distributed in the United States though its incidence has never been reliably estimated. Despite government assurances, no one in their right mind would eat tissue from any animal with a confirmed transmissible spongiform encephalopathy. (Those same hollow assurances were given in the early days of BSE.) Yet what is happening today with sheep with preclinical but confirmable scrape -- are they being sold into the human food chain?

The game farm industry also faces a difficult future. Individual animals can be extremely expensive to cull and some herds and premises are apparently seriously contaminated. The South Dakota state veterinarian recently said that CWD seems "not a disease that you can test your way out of." This means that although the blood test allows identification [and incineration] of some preclinical animals, these may have already infected others or contaminated facilities by the time the blood test first can detect illness.

Will Colorado begin a blood screening program any time soon for hunters exposed to CWD?

While it seems that very large numbers of cows could be tested without finding a single case of (any strain) of BSE in US cattle, there is still a substantial concern with older downer dairy cattle (given the Stetsonville episode and USDA estimates) or over encountering the one in a million cow expected from the Gibbs Principle to have sporadic or familial BSE. Even if no connection existed between US strains of bovine TSE and human disease, the public might react negatively and irrationally with catastrophic economic consequences for the industry.

England is placed in a quandry by the availability of the test. Should they test blood from cows selected for export, potentially jeoparizing the whole program? Should they test cows at random to see if BSE has become an established endemic disease? Should they test blood donors or determine the extent of the nvCJD epidemic?

This is the central paradox of CJD -- despite its horrific consequences, no one wants to know its true extent. Without knowing the true extent, funding for research is too low. No government is going to use a test until its outcome is mooted by a therapy.

IDEXX Laboratories, Inc. and Caprion Pharmaceuticals, Inc. Announce Collaboration On Development of Proprietary Reagents for Diagnosis of Mad Cow Disease

IDEXX will receive exclusive global rights for veterinary applications in diagnostics and therapeutics, while Caprion retains all rights to human diagnostic and therapeutic applications. IDEXX has made an equity investment in Caprion, and will support research at Caprion's Montreal-based laboratories. IDEXX will also conduct development work in its laboratory in Westbrook, Maine, contributing expertise in diagnostic test development. IDEXX will market veterinary products resulting from the collaboration and pay Caprion royalties on product sales.

The goal of the collaboration is development of a rapid diagnostic for detecting Bovine Spongiform Encephalopathy (BSE), commonly known as Mad Cow Disease, in live cattle. Current detection methods require brain tissue samples from slaughtered animals. A live animal diagnostic would allow governments and producers to implement cost-effective surveillance programs to protect and validate disease-free status. .

"BSE and other TSEs are important health concerns," stated Dr. Erwin Workman, executive vice president and chief scientific officer of IDEXX. "The veterinary market currently has no proven diagnostic for BSE in live cattle. Caprion's reagents and skills in the prion field position us well to take on this important challenge in veterinary health care." .

IDEXX Laboratories, Inc. is a world leader in providing diagnostic, detection and information systems for veterinary, food and water testing applications. The Company also operates an international network of veterinary reference laboratories and is a leader in the veterinary software and informatics market. IDEXX entered the veterinary pharmaceuticals market with its acquisition of Blue Ridge Pharmaceuticals in October 1998. Headquartered in Westbrook, Maine, IDEXX employs more than 2,000 people and offers over 350 products to customers in more than 50 countries.

Caprion Pharmaceuticals Inc. is a privately held Montreal-based biopharmaceutical company exploiting "shape-shifting" proteins as targets for diagnostics and therapeutic intervention. Prion proteins are the best-known shape-shifters and are the focus of Caprion's earliest products. Caprion is using its expertise in protein conformational change as a key interventional target in the development of neurological and immunological therapies.

Comment (webmaster): These companies would surely be aware of the Schmerr method. Whether there is any further connection is not known.

Beef-on-bone risk is tiny - Medical Officer

Professor Donaldson recommends that the use of beef-on-the-bone in manufactured foods should still be outlawed , because of the possibility that bone marrow is infective, and to give consumers the choice of avoiding all beef-on-the-bone if they wished. His report, written at the end of July, said: "A decision to lift the bone-in-beef ban should in my assessment be informed by the fact that the additional risk to human health created would at this stage of the cattle epidemic be tiny and unquantifiable in nature."

In his report, Prof Donaldson said the six months since his last review of the situation had been "vital", due to the combined effect of two bans -- the August 1996 ban on using animal protein in cattle food (the "clean feed watershed") and the ban on eating cattle older than 30 months. He said when the beef-on-the-bone ban was imposed in December 1997, possibly infected cattle were still entering the human food chain. But "currently the oldest animals eligible for human consumption would have been born in February 1997, a full six months after the `clean feed watershed'". [This is a new expression. Many people had thought the feed ban took places in the 1980's. Not so. -- webmaster]

He said in the past six months the clean feed watershed and the 30-month rule combined to "largely cut off the threat to human food chain from cattle that had acquired BSE from infected feed". Tough security regulations at slaughterhouses were being enforced and, with new cattle passports and tagging "appear to prevent older cattle `slipping through the net' and entering the food chain illegally".

[Other news accounts have Prof Donaldson saying in this same report that cases of nvCJD could run into thousands, with the true scale of the problem not known for 15 years, the number of cases could range from a few hundred to many thousand. He reportedly said: "What is absolutely certain is that the present relatively low number of cases of vCJD should not lead anyone to conclude that the worst is over. There can be no room for complacency in maintaining precautionary measures necessary to eradicate BSE in cattle, to make sure that it does not recur and to reduce any risk of transmission to people. The human disease, vCJD, should continue to be monitored and studied very closely. The high level of past exposure to BSE infection through the human food chain coupled with the uncertainty about the range of the incubation period of vCJD means that the human epidemic could still be quite large in years to come."]

The other possibility of infection coming from cows who inherited BSE from their mothers was being tackled by cattle offspring culls, introduced in January this year. These involved many male calves being killed at a few weeks old, further reducing the number of potentially dangerous cows being eaten.

Publication of the report will intensify pressure from farmers and the Opposition to lift the ban and see T-bone steak and beef ribs back in the shops. Agriculture Minister Nick Brown said he would not act to lift the ban until chief medical officers in Scotland, Wales and Northern Ireland agreed with Prof Donaldson that it was safe to do so. The Tories have leapt on the row as clear evidence of the problems caused by devolution.

Shadow constitutional affairs spokesman Sir George Young said English farmers and consumers were being penalised because the Welsh and the Scots were "dragging their feet". In a letter to Prime Minister Tony Blair today, Sir George said: "It is, I think, now clear that the Government's ill-thought out devolution plans have given the Scots and Welsh a veto over how England runs its affairs. "This has meant that, rather than helping farmers, the Government now spends its time squabbling with ministers in Cardiff and Edinburgh. "I hope you will be able to end this muddle as soon as possible. English farmers and consumers deserve nothing less."

Mr Brown, however, insisted England would not go it alone as he wanted to proceed in an "orderly" fashion. He told BBC Radio: "I am allowing some time for discussion and decision-making in the devolved authorities so that we can try to arrive at a common approach." He added: "We could just lift the ban in England, but it makes more sense to proceed in an orderly way to lift the ban across the whole of the United Kingdom."

Scottish, Welsh and Northern Irish chief medical officers want to wait for a specialist report on lifting the beef-on-the-bone ban due out in November. The row comes as the Government's 150 million aid package for farmers announced on Monday appeared to be defusing anger in rural areas at falling farm incomes. Mr Brown said tonight he was planning to meet pig farmers to see whether additional aid could be found for them.

His concessions led the National Farmers' Union to consider calling off a planned protest at the Labour Party Conference next week. NFU president Ben Gill said members were "seriously re-considering" whether to go ahead with the demonstration in which more than 10,000 members had been expected to march past the conference hall in Bournemouth next Monday. "It is a recognition of the Government's efforts in attempting to deal with the short term problems facing farmers," he said. The package was aimed at helping hill farmers and tackling the costs of red tape.

Britain Ready To Lift Beef Ban

Chief medical officers in Scotland, Wales and Northern Ireland, however, think the ban should continue for now.

The government banned the sale of beef on the bone - including rib roasts and T-bone steaks - in December 1997 based on scientific advice that a slight chance existed bone marrow could transmit the lethal brain disease to humans. The Spongiform Encephalopathy Advisory Committee said at the time that there was a low risk of infection from beef on the bone. It estimated a 5 percent chance of a single case arising in one year.

A new strain of Creutzfeldt-Jakob disease has been linked to the British outbreak of bovine spongiform encephalopathy, or mad cow disease. The spongiform diseases eat holes in the brains of victims, and no cure has been discovered. Forty-three people have died of the new variant in Britain since 1995, including four this year, according to the Department of Health. Other forms of CJD not related to mad cow disease have claimed 22 victims this year. Last month, the European Union lifted a ban on British beef exports that had been imposed in 1996 because of fears of disease.

The new Welsh National Assembly has called for the ban to be lifted as soon as possible, but Alun Michael, the head of the Welsh regional government, says it should not be done until new scientific reports are received. The delay in lifting the ban is one of the first practical problems to arise from the government's decision to return some powers to new regional governments in Wales, Scotland and Northern Ireland.

England `won't act alone' in lifting beef ban

Mr Brown said: "What I want us to do is to proceed in an orderly way across the whole of the United Kingdom and I am allowing some time for discussion and decision making in the devolved authorities so that we can try and arrive at a common approach." Mr Brown told BBC Radio Four's Today Programme: "We could just lift the ban in England but it makes more sense to proceed in an orderly way to lift the ban across the whole of the United Kingdom."

A spokesman for the Scottish Executive denied there was a split between ministers in Scotland and England over lifting the ban. He said: "There is all this rubbish about Scotland holding things up. "Scottish ministers act on independent advice, English ministers can do the same. "That has always been the case - you always listen to your own chief medical officer, he knows the situation on the ground in his territory."

The Scottish, Welsh and Northern Irish medical officers wanted to await the report of an expert working group based in Oxford, he said. He said Scotland's chief medical officer Sir David Carter did not think anything had changed to warrant the lifting of the ban until then. "Our Chief Medical Officer wants to wait and see the report. He will consider the position once he sees it." He added: "There is no split between ministers. No decision has been taken. "Nick Brown is minded to lift the ban. Clearly it should be lifted in all four areas together, that is what we would prefer. The three medical officers want to wait for the report from Oxford."

Tory constitutional affairs spokesman Sir George Young said Wales and Scotland now had a "veto" over decisions that affected England. English farmers and consumers were being penalised because the Welsh and the Scots were "dragging their feet", he said. "I think what we now have is an inequitable and rather unstable position on devolution," he told BBC Radio Four's The World At One.

Ministers had "recoiled" at a predictable consequence of devolution because it created a "political embarrassment" and England was losing out as a result. "That is manifestly inequitable," he said. "What they should do is lift the ban now on the sale of beef on the bone in England because that is what the English politicians have accepted to be right, fair and safe - they won't do that because that would create an anomaly with Wales and Scotland. "

If you are going to have devolution, you have to accept there will be differences between the three parts of the United Kingdom," he added.

Germany may lift beef ban by Christmas

"Frau Fischer said the ban in Germany could be lifted by Christmas," an agriculture ministry spokesman said after the meeting. "Both ministers said it was then up to the industry to convince consumers to buy British beef. "It was a very constructive meeting and there was basic agreement on both sides that the ban should be lifted."

Although the European Union lifted the ban - imposed in the wake of the BSE crisis - in August, Germany has resisted implementing the decision, saying EU regulations are not tight enough. The German health minister is now due to meet EU health commissioner David Byrne before reporting back to the German parliament's lower house in October. Mr Brown has also invited representatives of the German government and regional `Laender' to visit the UK and tour beef production from farm to processing.

Sewage sludge confirmed in cattle feed

European Union Health Commissioner David Byrne will press a meeting of the 15 EU farm ministers next Monday to impose a stricter definition of what can enter the food chain. Member states now interpret the existing legislation differently, allowing for loopholes.

Late Monday, the Belgian government confirmed reports that toilet and animal waste sludge had been mixed into animal fodder for years. Belgian Farm Minister Jaak Gabriels insisted the practice was stopped in June. Commission spokeswoman Thea Emmerling said reports on similar abuses had come from France, Germany and the Netherlands.

Pressure for the EU to tighten controls on animal feed has intensified since the outbreak of Britain's "mad cow" crisis in 1996. Belgium's recent scare over cancer-causing dioxin in poultry, pigs and other foodstuffs was caused by the contamination of feed with motor oil.

Belgium's sewage sludge report comes at an especially bad time, since the nation is still reeling from the dioxin crisis that led to a wide range of Belgian food products being pulled from supermarkets around the world. The government has said the dioxin crisis is under control and it is working to improve the image of Belgian food. Gabriels also said the government would investigate why it took so long to curtail the illegal use of such sludge in fodder. "These practices that existed in the past will not exist in the future," he said.

Belgium knew food controls inadequate in 1998 paper

French-language daily Le Soir said it had obtained a copy of a 400-page report produced by management consultants Price Waterhouse Coopers detailing the shortcomings of Belgium's food inspection systems. Le Soir said the report had been held by the ministries for some three months before being presented to the cabinet of former Prime Minister Jean-Luc Dehaene in March this year, but no action was taken ahead of the elections in June.

A spokesman for Health Minister Magda Aelvoet confirmed the existence of a Price Waterhouse Coopers report, but told Reuters it was designed for internal government use and that he could not confirm its contents. The spokesman could not say when it was given to Dehaene's ministers. Dehaene's centre-left coalition was defeated in the elections, partly over its handling of the crisis in which cancer-causing dioxins were found in eggs, chicken and pig meat. The chemicals were eventually traced to animal feed made with a batch of recycled fats contaminated with motor oil.

Le Soir said the 1998 report noted weaknesses in the country's food control systems, which were the shared responsibility of four separate ministries. It criticised food standards authorities for being inconsistent and failing to use effectively the tools and sanctions at their disposal. It also highlighted the lack of transparency in the animal feed industry, noting that there was no clear picture of who was supplying fat to feed producers. Firms in the industry had not been made aware of their responsibilities, the report said.

The need to restore the confidence of foreign consumers in Belgian food is crucial given that Belgium exports almost half its food production. The damaging claim that Belgium knew of the threats to its food industry follows the revelation on Monday that a waste disposal firm used polluted sludge to make animal feed, including waste water from showers and toilets, as well as cleaning effluent from abbatoirs.

The practices, banned since 1987, were uncovered by a Flemish regional farms ministry report published on Monday. The European Commission is investigating reports that animal feed in some member states including France, Germany and the Netherlands had been tainted with sewage sludge, dangerous pesticides and heavy metals.

New European Food Safety Commissioner David Byrne is due to raise the problem at a meeting of EU farm ministers next week. In a separate move, the European Commission said member state veterinary experts would consider a proposal to exempt Belgium's beef production from stringent tests to prove them dioxin-free. Similar tests would continue for the country's pork and poultry production.

Dioxin seen costing Belgium $899 million

Budget Minister Johan Vande Lanotte said earlier this month that measures taken to resolve the problems caused by contamination of animal feed with the carcinogenic chemical dioxin had cost nearly 26 billion francs. But a government source told Reuters on Tuesday that the government had made provisional estimates for additional costs amounting to some nine billion francs.

These included six billion francs in lost income tax revenues, one billion francs in lost social security income, and two billion francs for chemical testing and fees paid to veterinarians and accountants. That would bring the total cost to around 35 billion francs, confirmed the source, who spoke on condition of anonymity, adding that these figures were still "very provisional."

These latest estimates are, however, still way below initial forecasts made at the time of the crisis in May. In June the government predicted the scare could cost the state up to 60 billion francs. The crisis prompted scores of countries to ban Belgian food imports, hit farms and food producers and contributed to the defeat of the previous centre-left government in June elections.

It has also threatened to derail Belgium's debt-cutting programme which forms part of its commitment to European Economic and Monetary Union (EMU), launched this year. Belgium has one of the highest debt-to-GDP (gross domestic product) ratios in the European Union. In late June, outgoing Budget Minister Herman Van Rompuy said early measures taken to resolve the dioxin crisis had already eroded four billion francs off an expected 2000 budget surplus of 10 billion francs.

Belgium Admits Waste in Animal Feed

``Often we didn't realize what kind of filth was mixed into fodder,'' said Gabriels late Monday. ``It is incredible how people used to be duped.'' The minister stressed that the practice had come to an end at the time the dioxin food crisis broke in late May, when inspection of Belgium's food chain was intensified.

The food inspection report was likely to worsen the reputation of Belgian gastronomic produce, following the worldwide scare this spring when the government announced high levels of the cancer-causing chemical dioxin had been discovered in eggs, meat and dairy products. The fear led to a wide range of Belgian food products being pulled from supermarkets around the world, causing the biggest food safety scandal in Europe since the 1996 British Mad Cow crisis. The government has said the dioxin crisis is under control and is working on improving the image of the Belgian food across the globe.

Gabriels said the government would investigate why it took so long to curtail the illegal use of such sludge in fodder. ``These practices that existed in the past will not exist in the future,'' he said. ``Measures have been taken.''

Belgium is not alone with such problems. Last month, European Union health officials have asked French authorities to clarify a German news report alleging French companies have been putting residue from septic tanks and other banned substances into animal feed. The French government later acknowledged the sludge was found ``in raw material to be used in the fabrication of meal'' at three slaughterhouses and a gelatin production plant at the end of 1998 and early this year, but action by the authorities had stopped its use.

Pressure for the EU to tighten controls on animal feed has intensified since the outbreak of Britain's ``mad cow'' crisis 1996 when the practice of feeding cattle the ground-up remains of diseased sheep.

Dioxin unlikely to harm Belgian health

A similar message was given by experts testifying before a Belgian parliamentary committee of inquiry into the dioxin scare which began public hearings on Wednesday. The discovery in May that dioxins and toxic polychlorinated biphenyls (PCBs) had entered the food chain from animal feed contaminated with motor oil sparked an international health scare.

Supermarket shelves were stripped of many home-produced staples and countries around the world imposed restrictions or bans on food imports from Belgium. The scientists, from the toxicology unit of Leuven University near Brussels and Belgium's Agriculture Ministry, wrote in a letter to Nature that tests had shown that chickens and eggs had been contaminated with up to 250 times the normal tolerance level for PCBs -- 200 nanograms per gram of fat. Pig meat was less affected, with up to 75 times the tolerance level, while beef was effectively free of contamination.

However, the scientists said these contamination levels were much less than those recorded in incidents in Yusho, Japan, in 1968 and Seveso, Italy, in 1976. In the first incident, contaminated rice oil poisoned 2,000 people. In the second, nearly 450 people suffered skin injuries after an explosion at a chemical plant in Seveso released a cloud of smoke containing dioxin.

"It would require the consumption of 30 to 40 meals of highly contaminated chicken or eggs to double the body's PCB and dioxin burden. Even in such an extreme case, the maximum body burden would still be at least a factor of one hundred less than the victims of the Yusho accident, and in the Seveso residents," the scientists said.

They estimated the total amount of contamination in the Belgian incident at about one gram of dioxin and 50 kilograms of PCBs.

Belgian Health Minister Magda Aelvoet said in an interview published on Thursday that she planned to bring animal feed and other agricultural supplies under a planned food agency to ensure there was no repeat of the episode. She told newspaper Le Soir the government would support sanctions against firms supplying sub-standard products.

EU ends dioxin tests for Belgian beef

And of the one percent, there were only two cases of a very high level -- and these could be attributed to contamination from sources other than the tainted animal feed which sparked Belgium's health scare earlier this year, officials said.

But the scientific tests, which detect PCBs (polychlorinated biphenyls) and indicate dioxin contamination, would continue on the country's poultry and pork products, they added.

Companies throw in the towel on Frankenstein foods

The Swiss company's decision to rethink its involvement in GM foods comes just one month after Britain's AstraZeneca warned that it too might sell its agrichemicals business. AstraZeneca is a high profile GM company which has already put genetically engineered products on British supermarket shelves. It has also been the target of high profile demonstrations by environmental campaigners.

At the same time Monsanto, the large US company has seen its share price fall from $62 (#163#38) to $40 in the past 12 months ($37 dollars today). Analysts increasingly believe the GM foods research has the potential to inflict serious damage on the lucrative global pharmaceuticals business and are keen to see the controversial division put at arms length. "The market would like to see the life sciences business separate from the agribusiness," one analyst said. "There is little synergy."

But they also believe that agribusinesses are unlikely to attract buyers in the current climate. The business has been hit by a slump in the price of commodities, decreasing subsidies for farmers and a drop in the number of acres under crop production worldwide. It is also suffering from the g rowing backlash against so-called "frankenfood".

Agribusiness chief Heinz Imhof also called called on European authorities to set up a body similar to the US food and drug administration to reassure consumers that genetically modified products are safe. He also suggested that clearer labelling laws would help quell the growing controversy around the products such as modified seeds, which some critics say may be unsafe or may damage the environment.

"We are convinced that GM crops in the future will bring tangible benefits to the consumer," Mr Imhof said. Earlier this year Novartis announced that 1,100 jobs were to be axed in its agricultural division after the drop in sales which make up 25% of the company's revenue. Half of the sales come from North and South America. Yesterday Mr Imhof said that the job losses would now exceed the previous estimate. GM foods have become a battleground for British supermarket companies, with each struggling to establish their GM-free credentials.

Iceland and Waitrose have recently reported Sainsbury to the Advertising Standards Authority over its claims to be the first major supermarket to have eradicated all GM products from its own-label products. Marks & Spencer has become the latest to join the skirmish with its own advertising campaign. Food giants like Unilever and Nestle have now also pledged to remove GM ingredients from their products. A spokeswoman for Novartis admitted that GM foods had failed to win widespread public acceptance but insisted the decision to review the future of the agribusiness division was not connected.

USDA urged to support GM crop segregation

Hoeffelman, former president of the Benelux division of U.S. agribusiness giant Cargill, said he recently told U.S. Ambassador to the Netherlands Cynthia Schneider that current U.S. policy on GM foods was not working. It was unclear what premiums would be demanded for large volumes of non-GM supplies but some people have mentioned 10-20 percent, he added in an interview.

Trying to convince European consumers that GM foods were safe would be very difficult, Hoeffelman told Schneider during an informal session about the GM issue about two weeks ago in Rotterdam. "Basically what I said was winning your way is almost impossible and puts trade and industry in a very difficult position," he said.

Officials in the United States, where GM crops are widely accepted, argue that research supports the safety of GM crops and any moves by Europeans to put the brakes on such foods amount to unfair trade practices. But Europeans' confidence in food safety has been severely undermined following the mad cow crisis in Britain and the dioxin affair in Belgium this year.

Earlier this month, agribusiness giant Archer Daniels Midland Co surprised the trade and farmers by warning grain suppliers to begin segregating GM modified corn, soybeans and other crops from conventional ones. This year GM crops are estimated to account for about 35 percent of U.S. corn and 55 percent of soybeans. Europe imported about 16 million tonnes of U.S. soybeans last year.

"You can't ram it down peoples' throats. If people don't want it, if they say we want it segregated, let the consumer make the choice, that's a very reasonable argument," Hoeffelman said. Favouring segregation of GM crops does not translate into opposition to GM crops, but is a practical reaction to the stalemate between the United States and Europe, he added.

The grain and shipping industries would struggle on their own to create viable systems to separate GM and non-GM crops and might not gain the confidence of consumers without official cooperation, Hoeffelman said. "So the best thing would be if the USDA, directed by Washington, would cooperate with this," he said. Any move to segregate non-GM crops throws up a host of problems, such as proving that crops had not been inadvertently cross-pollinated by GM crops. Coming up with quick and economic testing methods was another challenge in the move to satisfy consumers' demand for non-GM foods.

In the long run, the EU must create a single food safety agency along the lines of the U.S. Food and Drug Administration, Hoeffelman said. There must be a broad-based scientific review of all the evidence on GM crops, with testing coordinated between Washington and Brussels, he added.

EU food fears "irrational and collective" - Daley

"The problems that people feel about hormone-treated beef or GM organisms are not based on scientic results. Rather, it has to do with an irrational and collective fear," Daley was quoted as saying. Daley also turned the spotlight on European food, which he said had been beset by problems such as mad cow disease and dioxin in animal feed.

"We're perhaps not as preoccupied by this question as Europeans because it is in Europe that there have been difficulties -- with European food, not American food," he said. "American food is safe. We don't have any worries about that."

He said that with regard to the conflict over hormone-treated beef, U.S. producers were willing to accept a system that would label U.S. beef as "Born in the United States" but Europeans felt this was insufficient.

Europe has mainatined a decade-old ban on imports of hormone-treated beef from North America, and opposition to GM crops has escalated in recent months. Earlier this year the U.S. imposed tariffs on select EU products after the World Trade Organisation ruled the EU was illegally restricting imports of hormone-treated beef.

Anti-Biotech Activists Plan Lawsuits

Until now, biotech opponents have focused their efforts on persuading food manufacturers not to buy genetically modified crops and getting governments to require the labeling of altered foods. The antitrust actions will force governments to consider curbing the power of a shrinking number of giant agribusiness companies, Rifkin predicted Monday.

Eight major antitrust law firms have agreed so far to handle the lawsuits, he said. In addition to Rifkin, the plaintiffs will include individual farmers and the National Family Farm Coalition. Biotech companies are genetically manipulating plants to make fruits and vegetables more attractive, speed the growth of crops or make them resistant to insects, disease and weedkillers.

The companies control the spread of the technology by patenting the seeds and then leasing them to growers, rather than selling them, to prevent the farmers from reproducing the seeds. While the crops have grown quickly in popularity with American farmers, the technology has had trouble getting accepted by consumers in Asia and Europe. Defenders of the technology say it can increase yields while reducing the need for pesticides and eventually will lead to nutritionally enhanced crops.

``Biotechnology is being adopted at an unprecedented rate by American farmers because it's giving them more choices than ever before in how they grow their crops. It's producing benefits for them in terms of higher yields and less use of pesticides,'' said Carl Feldbaum, president of the Biotechnology Industry Organization.

But critics say the technology raises a number of environmental concerns in addition to giving giant agribusiness companies, such as St. Louis-based Monsanto Co. and Novartis AG of Switzerland, new power over farmers. ``In less than five, six years from now virtually no farmer in the world will own any seed again,'' Rifkin said.

A third of the nation's corn crop and about 55 percent of the soybeans U.S. farmers are growing this year have been genetically engineered. The soybean seeds are sold by Monsanto for use with its popular Roundup weedkiller.

Rifkin said the lawsuits would be filed before the next round of negotiations by the World Trade Organization starts in November. Biotechnology is expected to be a major issue of the global trade talks.

The U.S. lawsuit will seek billions of dollars in damages from all major seed companies including Monsanto Co, DuPont Co, Zeneca Group, Novartis, as well as agribusiness giants Archer Daniels Midland and privately owned Cargill Inc., Rifkin said.

But seed companies have already abandoned that approach in favour of another way to recoup their millions of dollars invested in GM seeds, according to Per Pinstrup-Andersen, director of the International Food Policy Research Institute.

Companies are developing GM seeds that can ``turn on'' a special characteristic -- the ability to repel pests or drought -- only if a farmer buys a special chemical to treat the seeds, Pinstrup-Andersen said.

``If the seed it not treated, it will revert back to its original characteristics. That means the farmer is no worse off, but can choose to pay to become better off,'' he said.

``We don't go after bigness just because it's there,'' said Michael Hausfeld, an antitrust lawyer representing the groups. ``It's only a problem when it has the inherent potential for abuse, like with these seed companies.''

The filing of the antitrust lawsuit will be timed to coincide with the World Trade Organisation gathering in Seattle in late November. Heads of government and agricultural ministers are scheduled to launch a new round of trade talks aimed at phasing out government crop subsidies, improving food safety standards and discussing the impact of biotechnology.

Sen. Paul Wellstone, a Minnesota Democrat, is drafting a bill to call for a one-year halt to all mergers among agribusinesses with net revenues of more than $50 million. Wellstone, speaking in an interview, said he was concerned about ``the potential for abuse'' amid rapid consolidation in the grain, livestock and seed sectors of agribusiness.

``This is an area of concern for many farmers, who don't want to be able to buy seeds from just one company, much like they don't want to market their livestock to a single company, and sell their grain to one company,'' said Richard Stuckey, vice president of Council for Agricultural Science and Technology.

Planned lawsuit to further debate on biotech crop

The planned antitrust lawsuit, to be filed in a federal court by December 1, would raise a fresh issue in the growing international debate over bio-engineered crops.

Consumer groups throughout Europe have demanded labels on U.S. food made with GM soybeans, corn and other crops.

U.S. growers, who eagerly embraced GM crops to improve yields and pest resistance, are beginning to worry about a consumer backlash to bio-engineered foods. And farmers in less-developed nations have complained that patents on GM seeds unfairly bar them from re-using seed the following season.

``We're moving from the GM food labelling issue to an even broader issue of GM seeds and concentration in world agriculture,'' Jeremy Rifkin, an environmental activist and head of the Washington-based Foundation on Economic Trends, said in a telephone interview from London.

Billboards linking beef to impotence won't go up in Idaho

The ads feature a curvaceous, bikini-clad vegetarian declaring, "I threw a party -- but the cattlemen couldn't come. Eating meat can cause impotence." Dangling a string of suggestive sausages from her hand, she encourages consumers to "call my hotline at 1-900-GET-ON-UP" for more information.

The ad campaign has been turned down in cattle states across the country. Advertisers have refused to lease space for the billboard, claiming it is too racy to run. "I think it's in very poor taste," said Leah M. Clark of the Idaho Beef Council. "I think the claim is ridiculous and is not based on fact. . The bottom line is PETA kind of has been out to ruin our good time, whether it's in the dining room or the bedroom. It's unfortunate they've had to stoop to this level."

The Idaho Beef Council has put together a press release in response to PETA's claim, calling beef "the natural Viagra." In contrast to the PETA claim that fat and cholesterol in meat clog up the arteries going to all organs, not just the heart, Clark said lean beef is interchangeable with chicken in lowering serum cholesterol. She also said beef is a source of key nutrients that are important to sexual function. Zinc, which is an important nutrient in beef, is necessary for sexual maturation and reproduction. Beef also contains an amino acid called L-arginine, which is an element that helps men get an erection. "I think what people need to realize is any food, whether it's a white meat, vegetarian or a red meat diet, can contain cholesterol," Clark said. "There are many vegetarian diets that are extremely high in fat. We have to look at an entire diet, not one food."

John J. Keizur, a urologist at Moscow, Idaho, said the PETA claim is "kind of true, but not fully true. "A diet that's rich in red meat puts you at a higher risk for cholesterol and heart disease. That in turn can be a problem causing erections," Keizur said. However, "being a vegetarian doesn't prevent you from getting erectile dysfunction and eating red meat doesn't guarantee you'll get erectile dysfunction. It gives you a slightly higher risk ." Keizur said a diet high in saturated fats and cholesterol can cause hardening of the arteries and that is a risk factor for heart attacks, strokes and erectile dysfunction.

PETA president Ingrid Newkirk urges people to "choose a veggie burger in the kitchen for a whopper in the bedroom. Most vegetarians are far slimmer than meat-eaters, so they're more active and attractive, in and out of the bedroom."

Clark disagrees. "It's disgusting and it's very suggestive. I would think that most people would be appalled that a national group would stoop to this type of very tasteless advertising."

"Mad cow" to attack American Medical Association

Until recently, cattle ranchers in the U.S. were allowed to feed the remains of animals to cows, who are herbivores by nature. The FDA still allows animal tissues, including those from sick cows, to be fed to pigs and chickens. Cow remains, under current laws, can even be fed to calves. Two studies reported that up to 13 percent of U.S. Alzheimer's patients, examined after death, had been misdiagnosed and actually died of CJD.

"Mad cow can lie dormant in your body for ten years," says PETA President Ingrid Newkirk. "The government and American consumers need to know the risk and how to avoid it."

Comment (webmaster): This protest was evidently in response to an odd piece published in JAMA some time back. The 'review article' was written in mid 1998, approved by the AMA house of delegates in Oct 1998 and timed to be released shortly after the FDA committee voted to defer donors who had been in England 6 months cumulatively.

The authors, none of whom work in CJD research, state that they did not consult the medical or scientific literature on CJD but instead looked at newsclipping services, government reports, and journal abstracts. (Members of the AMA would be adversely affected if fewer elective surgeries took place in the US or heroic measures were not undertaken in the elderly.)

Various blood fractions have been since been shown to be infectious and a blood assay is available for the first time. The FDA was not sway by public relations pressure and made the recommendation final.

"Mad cow" asks CDC to recognize threat to humans. Mascot warns Alzheimer's misdiagnoses may hide U.S. epidemic

Recent American research shows up to 13 percent of patients studied had been misdiagnosed with Alzheimer's disease, when in fact they died of CJD, an always fatal ailment that causes dementia as victims' brains gradually shrink and become full of holes. PETA is urging the CDC to heighten surveillance for CJD by making it a "reportable disease" to track possible or confirmed cases of CJD.

Bovine spongiform encephalopathy (BSE or "mad cow" disease) appeared in British cattle after infectious tissue from sheep was included in their feed. Although the United Kingdom finally enacted a ban on feeding the rendered remains of animals to ruminants (who are herbivores by nature), the United States has only partially curtailed this practice, leaving the door wide open for tragedy, PETA contends.

The most likely cause of a new strain of CJD, known as nvCJD, is the consumption of BSE-tainted meat, according to the World Health Organization and researchers on both sides of the Atlantic.

"If the CDC won't recognize the possibility of a problem by making CJD a reportable disease, it's lost its mind," says PETA President Ingrid Newkirk.

Comment (webmaster): While the Manuelidis study did show a 13% figure, the sample size was small. The best available study is that of Boller et al at the Pittsburgh VA Hospital that showed 7.5% of Alzheimer in the Pittsburgh region was actually CJD. Other diseases were also found to have been misdiagnosed.

Portugal says EU lifting bull ban not enough

Portugal exports some 500 of the highly prized bulls to Spain per year, officials said. The rest of the global ban remains in force until February 2000. "This decision, even though it is insufficient and late, represents a positive step that deserves to be noted," the Agriculture Ministry said in a statement posted on its Internet site .

"It is in line with the position of the government which always considered the embargo on the export of beef and live cattle an unjust, discriminatory and disproportionate measure." The ministry said that in view of the tough controls Portugal had imposed to halt the spread of mad cow disease, the EU should move as swiftly as possible to end the rest of the global ban.

"The agriculture ministry hopes that, faced with the strong measures taken by Portugal in the battle against BSE (mad cow disease), whose rigour has been recognised by the EU's own experts, the total lifting of the embargo against remaining live cattle and beef produced in Portugal will be decided as soon as possible," it said. The bulls exported to Spain for bullfights are bred mainly in the agricultural regions of the Alentejo south of Lisbon and the Ribatejo in central Portugal. They are allowed to roam in large areas of land while they are fattened before export.

In professional competitions a bullfighter faces fully-grown bulls often weighing more than 500 kilos (1,100 pounds). Earlier this month, Portugal's Under-Secretary for Agriculture and Food Quality, Luis Vieira, told Reuters the country had made great efforts to eradicate BSE (bovine spongiform encephalopathy) at slaughterhouse and factory level and at its borders with Spain. He was optimistic that the EU would lift a global ban on Portugal's beef exports by next year.

Last September Portugal's Socialist government issued a decree banning the use of meat and bone meal in animal feed in order to stamp out the spread of BSE. At the time, France and Britain were the only other countries in the EU that had formally banned the use of potentially harmful feed in the animal food chain. The practice of feeding cattle meat and bone meal is widely believed to have been responsible for spreading the BSE epidemic in Britain.

Portugal, which has so far reported 298 cases of mad cow disease, one of the highest incidences in the EU after Britain, is not a major beef exporter. Before the ban, Portugal exported between 1,000 and 3,000 tonnes per year on average, much of it to Spain, officials said. The country imports 40,000 to 50,000 tonnes of beef per year.

EU Considers Risk Assessment Studies For Beef Hormones

The E.U. is waiting for the outcome of the studies before deciding on its next move in an ongoing trade war with the U.S. and Canada. The E.U. has previously said the studies will be ready in early 2000, but now they're not expected until mid-2000, Emmerling said.

The World Trade Organization has ruled that the E.U.'s ban on hormone-treated beef imports is illegal and has allowed the U.S. and Canada to slap about $124 million a year in retaliation on E.U. goods for beef producers' loss of trade. The E.U. has publicly stated that the studies are expected to present additional evidence that hormone-treated beef poses a health risk. Emmerling said the studies will give a scientific assessment of the impact of the hormones on humans, as well as a risk management assessment - such as controls involving the use of hormones.

However, the E.U.'s ban on hormone-treated beef imports is unlikely to be supported by the scientific studies, according to an internal document obtained by Dow Jones Newswires. The document says the scientific studies commissioned by the E.U. "have not been conceived to respond to the gaps in knowledge which have been identified in the opinion of the Scientific Committee for Veterinary Measures."

The document confirms E.U. officials' comments made last week to Dow Jones Newswires. The officials said the studies aren't likely to support the E.U.'s 10-year-old ban on imports of hormone-treated beef. "Legally we don't have a leg to stand on," one official said. "There is no international support for the ban."

E.U. spokesman Gerry Kiely added that the studies aren't expected to clarify what an acceptable risk level would be for residues of hormone-treated beef. In order to have the sanctions lifted, the E.U. will have to convince the WTO that the ban conforms to WTO rules and is based on a "qualified and respected risk assessment," according to the E.U. document.

Regardless of the outcome of the studies, the E.U. is expected to maintain the ban because of the current atmosphere of European consumer health fears sparked by the U.K.'s bovine spongiform encephalopathy, or "mad cow" disease, scare and the recent dioxin-contaminated food scare in Belgium. That means the E.U.'s next move is to challenge the level of the U.S. and Canadian sanctions under WTO arbitration rules, according to Kiely.

EU says no hormone beef studies before mid-2000

"The studies are ongoing and we will probably have the results by the middle of 2000," Commission spokeswoman Thea Emmerling told journalists. She said there were 17 separate scientific investigations being carried out, most on specific substances. Most focused on risk assessment, but four involved risk management, or how to minimise any potential risks should hormone beef be alllowed.

The EU agreed to the evaluations after a World Trade Organisation ruling that its decade-old ban on hormone-treated beef was illegal in a case brought by the United States and Canada. Washington argued the WTO decision meant the embargo should be lifted immediately and won approval to slap 100 percent duties on EU exports of mustard, foie gras and hams, which took effect at the end of July. Canada has also imposed sanctions worth $7.5 million.

But the EU is sticking to its line that the WTO ruling merely obliged it to undertake a scientific assessment of the risks, and following a preliminary report released in May which pointed to possible health dangers from hormone beef, says its ban is totally justified.

It is also seeking to have the so-called "precautionary principle," whereby countries can unilaterally put up trade blocks if they can prove health concerns, enshrined in the new global trade agreement due to be launched later this year.

Most beef in the United States is produced from cattle reared with artificial growth promoters, a practice that has long been authorised by the U.S. Food and Drug Administration. The U.S. cattle industry claims it is losing hundreds of millions of dollars a year because of the EU ban.

The EU has called the sanctions an "economic own goal" and offered the United States compensation in the form of increased access for other goods. This was rejected by Washington, which pressed ahead with sanctions.

French farmers in particular have reacted angrily to the duties, which have hit also sales of roquefort cheese. Fast food chain McDonalds has borne the brunt of their fury, with manure and rotting fruit dumped outside its restaurants across France.

Blood Supply worries overblown?

"While there is cause for concern about shortages of certain blood types or in certain regions, the blood supply as a whole is not in crisis," says the GAO report, scheduled to be released Thursday at a House Commerce subcommittee hearing.

Only 8 million Americans donate blood -- just 5 percent of eligible donors, the GAO said. But the amount of blood donations has decreased over the last decade, at the same time transfusion demand has increased. The National Blood Data Resource Center has predicted that next year, Americans will donate just under 11.7 million units of blood, while hospitals will need 11.9 million units.

That prediction came before the Food and Drug Administration's recent ban on blood donations by anyone who has spent six months or more in Britain since 1980, when that country's "mad cow disease" crisis began. The FDA anticipates that ban will cut the blood supply by 2.2 percent.

But the GAO's investigation says the prediction of a crisis next year is overblown. "The blood supply has declined more slowly" than previous studies suggested, it concluded. Also, it said, blood banks "may be able to increase collections."

Experts can disagree on how soon the demand for blood will outstrip supply, but the nation needs to prepare now, responded Marian Sullivan, executive director of the National Blood Data Resource Center. "Certainly action needs to be sooner rather than later," she said. The GAO acknowledged that shortages, usually of Type O or Type B blood, already occur in certain regions, particularly around holidays.

Almost 9 percent of hospitals in a recent survey said they had canceled elective surgeries due to blood shortages at least once in 1997 -- the latest year data is available. Also, the "mad cow" donation ban promises to hit hardest in major cities, home to more affluent blood donors who can afford frequent travel, the GAO said.

"The GAO's findings give us many reasons to be concerned," said Rep. Thomas Bliley, R-Va., who requested the GAO probe as part of his House Commerce Committee's investigation of blood safety and availability. The most up-to-date count of donated blood is due in November, when Sullivan's center completes a survey of whether the supply improved or worsened this year. X-From_: [email protected] Thu Sep 23 23:37:28 1999 From: [email protected] Date: Fri, 24 Sep 1999 02:36:51 EDT Subject: To: [email protected] MIME-Version: 1.0

U.S. Unveils System For Hormone-Free Beef Shipments

Last month, the USDA's Food Safety and Inspection Service suspended exports of hormone-free beef to the EU because it was concerned that American meat companies were not delivering what they promised. The Europeans complained that some meat labeled as hormone-free actually contained hormone residues.

The spat erupted at a time when Washington was separately battling the EU to win the right to export beef from American cattle treated with growth hormones.

A new certification system means EU buyers will be assured that the meat is free of hormones, the USDA said. The third-party certification system will restore credibility to the non- hormone treated cattle program, said Catherine Woteki, USDA undersecretary for food safety. [It is unclear how this certification system would improve over the earlier leaky certification system. -- webmaster]

Under the new system, the USDA's Agricultural Marketing Service or an accredited third-party must audit and verify every step in the beef production chain to guarantee that the meat is free of hormones, the USDA said. Details of the certification procedures will be released at a Sept. 9 public meeting in Omaha, the USDA said.

The EU buys a relatively modest 25 million pounds annually of American beef and veal that is certified to be free of hormones. Overall U.S. beef exports total more than 2.2 billion pounds.

In July, the Clinton Administration slapped 100-percent tariffs on a variety of European gourmet foods to punish the EU for blocking U.S. shipments of hormone-treated beef. About 90% of American cattle are given artificial hormones to make them grow faster and produce less-fatty meat.

Movement disorders in kuru -- the film

Movement disorders in Kuru

The comprehensive assembly of film record of kuru, which was collected by one of the authors (DCG) was reviewed. This comprised two parts: The first were films from 1957-1964 and included 17,397 ft of 16-mm film featuring 204 patients (children and adults) the second is assembled from films made from 1967-1976 and includes 9,138 ft. of film featuring 47 adult patients. Two movement disorders specialists categorized all movement disorders s observed and a representative videotape was produced .

Tremor is the most frequently encountered movement disorders in kuru and is typically of the action/intention type, which appears early in the disease and is soon associated with other clinical signs of cerebellar dysfunction. Widespread clonus is characteristic of advanced disease and can be difficult to differentiate from tremor. Dystonia/athetosis and choreiform jerks also appear as the disease progresses. Dystonia can involve the torso, distal limbs, neck, or jaw.

Myoclonic jerks can be superimposed on the cerebellar or dystonic features usually with an enhanced startle response. Parkinsonian symptomatology, other than resting tremor is frequent among the filmed subjects especially in the second stage of the disease. The clinical manifestations of kuru involved a wide array of movement disorders during all three stages of the degenerative illness.

Mad cow disease fear for brain patients

Mr Ralph Collins, senior hospital manager, said that records were being searched to try to trace the batch of material which was used and to confirm that it was of bovine origin . He added: 'At this stage we do not know the size of the batch or whether it was used to treat other people. If we find it was used on other people we shall try to trace them, although it may not be easy as this all happened eight years ago.'

Records of transplants of human or bovine material formerly used after brain tumour operations were incomplete, making it difficult to assess the scale of the problem. The Westminster inquest heard last Tuesday that Mrs Nuttall made a good recovery after surgery to remove a brain tumour. But last year she began suffering from distorted vision, slurred speech and difficulties in standing. She died on May 18.

Mr Collins said that the hole resulting from the operation was repaired using a membrane from a medical supplies company pre-packaged in what surgeons thought was a sterilised state. It was now feared that the sample was infected with a virus which led to Creutzfeldt Jakob Disease, the human equivalent of Bovine Spongiform Encephalopathy, or mad cow disease.

Since 1986 hospitals have avoided the use of membrane from cows or bulls in brain operations and now use artificial material. Mr Collins said: 'The hospital was not at fault. We believed the material was sterilised by the manufacturers and safe to use. 'It has since emerged that the sterilisation was ineffective., Although efforts would be made to contact anyone else who might have been affected, he said it was likely that any symptoms which were going to develop would have done so by now. Comment (webmaster):
This gets us back to the question of why the German medical doctor was collecting sheep dura mater on behalf or the Lyodura company. This 1991 CJD death was from an operation carried out in 1983. While it was apparently never resolved whether this patient had mad cow disease, mad sheep disease, nvCJD, or ordinary CJD, the article does establish that both bovine and human dura mater were routinely used in brain surgery at that time and through 1986. (Did they go over to use sheep dura mater after that?) Trans-species use was evidently so routine that the hospital didn't bother to record the species or company the surgeon evidently did not know either.


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