Is America’s blood supply safe? Despite FDA regulations, there are alarming risks associated with blood transfusions. Simply put, today’s blood supply still is not guaranteed safe from a wide range of infectious diseases—many of them potentially fatal.

Autologous blood banking, or storing your own blood for future need, is the best way to guard against receiving tainted blood or experiencing adverse reactions to incompatible donated blood during a medical procedure.

New York physician Joseph Feldschuh, MD, learned this the hard way more than 40 years ago. His nightmare experience prompted him to devote his life’s work to improving the safety of the nation’s blood supply, and to open the nation’s first autologous blood bank.

In this article, we take a close look at Dr. Feldschuh’s decades-long experience with America’s blood-banking industry, the problems that continue to bedevil the nation’s blood supply, and how autologous blood banking and blood volume analysis can help you improve your odds of surviving a surgery or other major medical procedure.

Personal Tragedy Fuels a Life’s Mission

In 1964, Dr. Joseph Feldschuh received a phone call. His father was ill and in precarious health, having suffered an allergic reaction to an incompatible blood transfusion for a bleeding ulcer. Another transfusion was required, but Dr. Feldschuh was told that a similar allergic response could be avoided if a close relative donated blood for the transfusion. Dr. Feldschuh rolled up his sleeve and contributed his own blood. His father later recovered and avoided any further complications due to Dr. Feldschuh’s blood contribution.

Until this incident, Dr. Feldschuh was unaware that there are hundreds of blood subtypes beyond the basic groups and that compatibility is a critical issue in blood transfusions. To learn more, he embarked on what would become years of research into the chemistry of blood and the practice of blood banking.

Dr. Feldschuh went on to a varied career in medicine, working at various times as a private practitioner, academician, researcher, chief corporate medical scientist, and CEO of Daxor Corporation. His work led to a number of medical firsts, including developing the first method for measuring blood volume with a high degree of accuracy, creating the first emergency medical laboratory, and inventing the only FDA-approved automated instrument for measuring blood volume: Daxor’s BVA100 Blood Volume Analyzer.

Throughout his career, however, the specter of his father’s terrible illness—and eventual contraction of deadly hepatitis from a blood transfusion—led Dr. Feldschuh to question the safety of the nation’s blood supply. Like most Americans, he had trusted and believed that the blood supply was safe. However, what he learned as he studied the world of transfusions and blood banking led him to an opposite conclusion. He decided to do something about it, and was in a unique position to do so.

To help others avoid what he considered an unsafe blood supply, Dr. Feldschuh created the world’s first autologous blood bank in 1985, where people could store their own blood over the long term for use if the need should arise. Far from being well received, his concept ran afoul of government regulators, was vilified by the blood-banking industry, and brought Dr. Feldschuh a world of professional trouble.

Undeterred and determined to provide people with a choice in blood banking, Dr. Feldschuh has battled the opposition for years and today still operates Daxor’s Idant Laboratories autologous blood bank. It is both a personal mission and his life’s work, and he wants the public to be informed of all he has learned while investigating blood-banking practices over many years.

Uncovering Problems in America’s Blood Supply

In his 1990 book, Safe Blood: Purifying the Nation’s Blood Supply in the Age of AIDS, Dr. Feldschuh documented his father’s tragic 1988 death from transfusion-acquired hepatitis, how the blood industry can be made safer through increased screening for infectious diseases, and how individuals can ensure their personal safety by self-donating and storing their own blood. Since the book was published, a test for hepatitis C has been developed and is now used to test donated blood. Unfortunately, notes Dr. Feldschuh, not much else has changed in the last 16 years.

"I knew relatively little about blood banking and, like everyone else, assumed that everything that could be done to make blood safer was being done," he explains. "My first shocking revelation was that one out of ten people transfused was getting hepatitis. It wasn’t just my father who had a problem. Blood banks always said their blood was safe, but one in ten is a very high figure."

Dr. Feldschuh examined statistics from the federal Centers for Disease Control and Prevention (CDC) for infections acquired through transfusions, and found that some of them made little sense. Incidents of hepatitis from transfusions are required to be reported. However, when he studied statistics from the 1970s and 1980s, curiously only 4,000-5,000 cases had been reported.

"During that time frame, about 4 million people each year received transfusions," he states. "If one in ten people transfused got hepatitis, that would have been about 400,000 cases. Yet the CDC got only 4,000 reports—meaning that about 99% of cases were never reported."

In the early 1980s, AIDS and the HIV virus brought blood safety and blood-banking practices into the public spotlight. Dr. Feldschuh felt there were far greater threats still being unaddressed. He maintains that there was no public outcry about the number of people contracting hepatitis from blood transfusions only because physicians and the public never knew about it.

However, the publicity surrounding AIDS did result in creation of the ELISA screening test for the HIV virus. Idant Laboratories, which had operated a sperm bank since the early 1970s, helped test the new screening procedure in 1984. In fact, the extreme level of testing done at the Idant semen bank provided what Dr. Feldschuh believed was a model for the blood-banking industry to follow.

"AIDS was never as big a problem as hepatitis," he says. "When the test for AIDS was developed, the blood-banking industry and organizations told the public that the blood supply was safe, but this was at a time when one of ten people still got hepatitis from transfusions."

The semen-banking industry, he says, tests for a myriad of infectious diseases that the blood-banking industry does not. These include cytomegalovirus (CMV), which can cause blindness and infertility in women; Epstein-Barr virus (EBV), which is a member of the herpes virus family; Chagas disease, a parasite found in Central and South America that causes serious illness; multiple forms of hepatitis; malaria; salmonella septicemia; and other blood-borne pathogens. Dr. Feldschuh notes that after Pope John Paul II was shot, he contracted both hepatitis and CMV from his blood transfusions.

Since the sperm-banking industry seems to have no problem testing for a slew of viruses and diseases, or quarantining and retesting semen donors, why can’t the blood-banking industry operate similarly? Dr. Feldschuh says a large part of the problem is cost.

"The real problem today is costs, but it should be a matter of patient choice," he explains. "Patients often aren’t told that there’s additional information you can get for an extra charge."

The FDA is charged with ensuring the safety of the nation’s blood supply by regulating the more than 3,000 centers that collect and process 14 million units of whole blood donated by volunteers each year.1 These groups and organizations fall into two categories: for-profit and paying taxes, or non-profit and tax-exempt. Dr. Feldschuh notes that just because a group does not pay taxes does not mean that it is operating in an altruistic fashion or in the public’s best interest. Among the many recent examples he points to is a case involving the American Red Cross in New Jersey, which stood accused of not alerting regulators when 600 pints of contaminated blood were released into the state’s general blood supply.

"Groups that collect volunteer donor blood provide an invaluable service, and we couldn’t operate without them," says Dr. Feldschuh. "Some compete with each other. This differs from the sperm-banking industry, which operates with paid donors. But collecting free volunteer blood doesn’t mean the blood is free—these groups sell the blood to hospitals at a profit, or at least they sell the service of collecting, storing, processing, and distributing blood. So money is still involved."

FDA’s Lax Enforcement Endangers Public Health

The FDA has developed and enforces quality standards, inspects facilities, and monitors reports of errors, accidents, and adverse clinical events. But is the current system working? The blood industry is often left to monitor itself, and reporting of errors and problems is more of an FDA suggestion than a requirement. The agency can propose solutions to problems in the system but then not follow through, as it did in June 2004 when it quietly dropped from its regulatory agenda an item that would have mandated a tracking and notification system to alert recipients of contaminated blood products.2

Congress has investigated blood banking in the past, but despite uncovering many flaws in the current system, it has made only recommendations. In 1996, for example, fully 15 years after the emergence of HIV as a threat to the nation’s blood supply, the Committee on Government Reform and Oversight issued a report entitled Protecting the Nation’s Blood Supply from Infectious Agents: The Need for New Standards to Meet New Threats.3 Among many strong statements, the report declared, "Current FDA and CDC regulatory systems are not adequate to meet the aggressive nature of emerging threats to blood safety. Product recalls and notification regarding possible exposure to blood-borne pathogens are not well communicated to physicians, pharmacists, patients, or the public. Regulation of blood collection, testing, and the production of blood-derived therapeutics is not well coordinated or consistently managed to minimize known risks."

The report also stated, "The public is not well served if patients are permitted to believe there is no risk in blood transfusions or in the use of blood-derived therapies . . . greater efforts should be made to convey known risks to consumers who may wish to minimize even those risks through the use of alternative procedures or therapies."

Shockingly, the report drew little media attention. The FDA insisted that over the years, it had developed a compliance system with "five layers of overlapping safeguards."1 The first, donor screening, requires donors to answer "specific and very direct questions" about their health, disease history, and high-risk behavior. Intravenous drug abusers are routinely deferred. Recently, donors who have lived in European countries with reported or suspected cases of "mad cow" disease have also been deferred. While the FDA claims this first line of screening weeds out 90% of unsuitable donors, it is entirely reliant on the truthfulness of the potential donor. Donors can answer the questions falsely if they so choose, and who is to know better?

Blood banks are required to keep a current list of deferred donors and not collect blood from them. Blood that is collected must then be quarantined until it can be tested for infectious agents. Currently, donor blood is required to be screened for hepatitis, human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), and syphilis. Screening for West Nile virus was instituted in 2003.

The FDA takes the stance that maintaining a blood supply with zero risk of infectious disease transmission may not be possible, but claims that the blood supply is safer now than it ever has been. Dr. Feldschuh disagrees.

"There’s nothing that prevents further testing of blood," he says. "The sperm-banking industry does it routinely. It costs more, but once again, shouldn’t that be the patient’s choice?"

Advantages of Autologous Blood Banking

Dr. Feldschuh realized that if the blood-banking industry was not going to change its practices, perhaps he could make a difference in another way. His next move was dictated by the simple fact that the only blood that is truly safe is your own blood. As president of a corporation that had underwriting, he used some of those proceeds to start the Idant Laboratories autologous blood bank, offering people the opportunity to freeze their own blood and thus have access to the safest form of blood if they needed it.

A blood transfusion is the most intimate contact you can have with another human being, says Dr. Feldschuh. Medically speaking, it is equivalent to an organ transplant.

"There are obvious benefits to donating blood to yourself," he explains. "You can’t give yourself anything that you don’t already have. Additionally, there’s strong evidence that you heal more quickly when receiving your own blood."

There is no transfusion reaction with your own blood, he adds, whereas there is always at least a little transfusion reaction when receiving someone else’s blood because there is never a perfect match. You avoid the risk of developing antibodies to one of the numerous human blood subtypes and suffering an allergic reaction, as Dr. Feldschuh’s father did. Your own blood also carries your own antibodies, a significant advantage if you happen to be having cancer surgery.

"There’s a fair amount of evidence that in colon cancer, for example, having a transfusion brings significantly higher risk of recurrence of the cancer, because someone else’s blood lowers your immunity," Dr. Feldschuh says. "It’s why we sometimes purposely give a transfusion to organ transplant patients, to lower immunity and decrease the chance of rejecting the transplanted organ."

Automated Blood Volume Analysis Revolutionizes Blood Transfusions

In addition to his important work with autologous blood banking, Dr. Feldschuh has developed a unique machine to measure a patient’s actual blood volume before or during surgery. This machine, the BVA100 Blood Volume Analyzer, eliminates the guesswork and risk of over- or under-transfusing a patient. Blood volume measurement is important in surgery and any situation involving blood loss, when physicians must decide whether or not to give a blood transfusion. Other conditions where blood volume abnormalities occur include hypertension, septic shock, anemia in cancer patients and HIV-positive patients on chemotherapy, renal or kidney failure, chronic fatigue syndrome, and pre-operative screening for low blood volume. The Daxor Corporation’s BVA100 Blood Volume Analyzer semi-automates the process of measuring blood volumes, but more important, provides measurements with 98% accuracy within an hour, making it invaluable in emergency situations, says Dr. Feldschuh. The machine works using a technique called indicator dilution. Albumin I131, an extremely low-dose, slightly radioactive tracer, is injected into the patient’s intravenous line. Blood samples are taken and the analyzer determines the dilution of the tracer in the blood. By comparing this to the same amount of tracer in a known volume, the unknown volume—that is, the patient’s blood volume—can be calculated. "One of the biggest risks of blood transfusions is not getting one when you really need it, or getting one when you really don’t need it," says Dr. Feldschuh. "These decisions have been made based on tests known to be inaccurate, namely hematocrit, which measures the concentration of red blood cells but doesn’t indicate how much blood you have." In cases of blood loss, how much was lost is not always evident. Dr. Feldschuh cites the case of a 29-year-old male stabbing victim, who spent hours in the emergency room and died without having received what could have been a lifesaving blood transfusion. "He wasn’t transfused because they didn’t notice how much blood he had lost," Dr. Feldschuh says. "They were depending on his hematocrit test, which appeared normal." Understanding the importance of blood volume requires an understanding of the body’s defense mechanisms against blood loss. Clotting at the location of the bleeding comes first. Next, to ensure continued blood flow to critical areas such as the brain and heart, the body utilizes vasoconstrictive mechanisms to reduce blood flow to non-critical areas. Thus, a bleeding person often feels cold and clammy, and the skin turns pale due to reduced blood flow to the skin. "Blood flow to the extremities is also decreased," Dr. Feldschuh explains. "But what you can’t see is reduced flow to the intestines, liver, spleen, and other organs, and a sharp decrease to the kidneys. The danger lies in waiting too long or not doing a blood transfusion. If blood flow to the kidneys is reduced to a point at which the kidneys are filtering waste products out of only 2-3% of the blood instead of the normal 25%, permanent kidney damage begins." The peculiarity of these bodily defenses, says Dr. Feldschuh, is that they may contribute to blood pressure that appears to be semi-normal. Therefore, a doctor may not realize that a large quantity of blood has been lost. Standard hematocrit and hemoglobin measurements may also appear normal. "The body handles blood loss by diluting the remaining blood, by gradually pumping more water into the circulation," Dr. Feldschuh explains. "When the body has time to compensate, a drop in the concentration of red cells is evident. But if blood loss happens rapidly, the drop in red cell concentration might not be seen at all." In surgical situations, where there is always blood loss, doctors often rely on a physical exam, blood pressure reading, pulse, and hematocrit when monitoring blood volume. But the body’s defenses against blood loss can make these findings misleading if they have not become abnormal enough to alert the physician. "No one knows the degree to which patients suffer collapse of the circulation or shock due to blood loss," says Dr. Feldschuh. "But the BVA100 is a tool that allows physicians to check blood volume immediately after a complex procedure or surgery, instead of waiting for signs such as kidney shutdown or blood pressure collapse. Avoid getting to that stage and you’ll more likely have a patient who survives." Daxor recently trademarked its Blood Optimization Program and will soon implement it at Cabrini Medical Center of Manhattan. The program, says Dr. Feldschuh, exemplifies measuring blood volume to the patient’s benefit. Well before a planned elective surgery, patients’ blood volumes will be measured, then they will be treated with blood stimulants such as epoetin alpha to increase blood production. The patients then donate and freeze their own blood. "Raising the blood volume before surgery means it’s closer to normal after surgery," Dr. Feldschuh explains. "The patient isn’t extremely anemic, but has his own blood on hand if needed. Patients who come out of surgery with a reasonably normal blood volume will recover better. Avoiding transfusions may be a worthy goal, but it risks a tradeoff between inadequate transfusion and no transfusion. No one should be in that kind of situation given today’s technology." A growing number of hospitals and medical facilities are acquiring the Daxor’s BVA100. If you are planning elective surgery and are interested in a facility that is routinely using the BVA100, speak with your physician.

Attacked by the Blood-Banking Industry

With so many benefits to autologous blood storage, Dr. Feldschuh thought the concept would be well received. He could not have been more wrong. To his great surprise, the criticism was loud and strong, particularly from established blood banks. Idant Laboratories was attacked for being a for-profit entity, even though the company did not make any money from the venture. Blood groups termed the practice "speculative blood storage" and said it was selfish and elitist. They also claimed it would create shortages and thus deprive the public of blood.

"We answered all of those points," Dr. Feldschuh says. "Frankly, if someone can’t be a donor to anyone else, they’d be adding to the supply because by storing their own, they wouldn’t need someone else’s blood. Those who can donate can still donate to others. To me, it’s something that would appear to be common sense. People should have the right to store their own blood, and it’s not very expensive."

While Idant did not promote its blood-banking service due to opposition from the blood-banking industry, the company received a huge boost in 1987 when Steve Ross, then chairman of Warner Communications, stored his own blood in preparation for prostate surgery and made what his doctors called a surprising post-surgical recovery. He bled less, says Dr. Feldschuh, and recovered quickly. Ross talked publicly about what he did, and went so far as to offer autologous blood storage to employees as a benefit, with the company paying part of the costs. This touched off another round of criticism.

Even worse, public records show that government regulators were none too thrilled with the Idant autologous blood bank. Dr. Feldschuh refuses to discuss this difficult period, but published sources and insiders indicate that what followed was a series of inspections, claimed violations, and license suspensions that inactivated the company’s blood and semen banks for several years. At one point, a city health inspector was discovered on the blood bank’s premises after hours, trying to drill holes into the blood storage freezers to ruin the contents. Idant was reimbursed for the costs and the inspector was permitted to resign from his job. Did he act on his own, or was he doing what he was told? No one would ever know. But when the chaos died down years later and the lawsuits and problems were gone, Dr. Feldschuh and his board of directors vowed to continue operating Idant’s blood bank.

According to Dr. Feldschuh, "The barriers to people getting their own blood are still significant. The concept needs public demand. Shouldn’t people have the right, if they so choose, to get their own blood, to undertake the expense if it’s not paid for by insurance? There’s a clear logic to why people would want to at least consider having their own blood available to them."

Dr. Feldschuh believes that if enough people used autologous blood banking, it would eventually become self-supporting and be part of the overall blood system.

"Think of it as reserves," he says. "In an emergency, autologous blood stores could be freed up for general use and people could re-donate to themselves. It’s good all around. We will always need a donor system. But unless the current system focuses more on testing, people should have the choice to store their own blood. It’s their right."

1. Available at: http://www.fda.gov/opacom/factsheets/justthefacts/15blood.html. Accessed July 31, 2006.

2. Available at: http://www.ombwatch.org/article/articleview/2387/1/280. Accessed July 31, 2006.

3. H.R. Rep. No. 104-746 (1996).