Overlooked Contaminant Found in Donated Blood…

Although the American Red Cross recommends not donating blood for at least two weeks after getting a yellow fever vaccination, it turns out that 89 US active duty trainees gave blood just four days after being inoculated with yellow fever vaccine.

The vaccinees did not report this during routine, pre-donation screening that included questions about recent vaccinations. The blood was recalled when investigators learned of the vaccine policy breach, but the damage had already been done.

Five persons, all of whom the CDC said were not ideal candidates for yellow fever vaccine, got vaccinated anyway through tainted transfusions. Three of the five tested positive for serologic response to yellow fever vaccine virus, and the CDC concluded that various blood products, including irradiated platelets, appear capable of transmitting the yellow fever vaccine virus.

This raises a question frequently asked about live virus vaccines – if blood products contaminated with yellow fever vaccine can transmit vaccine strain virus infection, then couldn’t the vaccines themselves also do so when they are injected?

The answer is that viral transmission has already been documented to occur with live virus polio and varicella (chicken pox) vaccines. And the CDC acknowledges that the possibility exists with other live virus vaccines, including the MMR and flu.

It also has been documented with the use of multi-dose bottles of various vaccines, and through the reuse of ventilator tubes and catheter hoses – a fact that the CDC probably would rather you didn’t know. But it’s a life-and-death fact that is real enough for the CDC and the World Health Organization to issue guidelines on the use of multi-dose vaccine bottles and reusable catheters.

All of this leads to a different, but related, life-and-death issue, one that was brought to light only a month ago in Wellesley, Massachusetts, when staff members were injected with insulin, instead of H1N1, at a school swine flu vaccine clinic.

Nobody was seriously injured, or died, from the school vaccine clinic mistake, and thankfully no children were involved, but the question still remains: No matter how much the CDC and other health officials claim that vaccines are completely safe, how do you guarantee that human error won’t harm or kill you?

Look at the History

The Baxter incident is a human error that could have had worldwide repercussions with deaths of massive proportions. The contaminated product, a mix of H3N2 seasonal flu viruses and unlabeled, live, H5N1 viruses, was discovered when ferrets in the Czech Republic died after being inoculated with the vaccine.

Ferrets don’t die from H3N2 – but they do from live bird, or avian, flu virus, which is what H5N1 is. Alarmed, Czech authorities contacted Baxter and demanded an explanation. The big pharmaceutical took its time confirming what the Czechs already knew, but finally admitted that the experimental vaccine was “live.”

According to media reports, the accidental mixture could have had “dire consequences,” since a person exposed to a mixture of the two strains simultaneously could have served as an incubator for a hybrid virus that could have transmitted easily person-to-person.

Had this virus taken hold like that, it’s hard to imagine what kind of worldwide consequences it could have had.

Thank goodness that didn’t happen, but the whole incident underscores the fact that, even at the highest level of security, it’s possible for major, scientific manufacturers to end up almost causing massive deaths by releasing laboratory-produced killer viruses to the general public.

It’s shameful that this company got away with this “mistake” without so much as a reprimand. To this day Baxter has offered no public explanation as to how this accident could have happened.

It kind of reminds me of the way the H1N1 vaccines have been handled: officials claimed this vaccine was as safe as the one for seasonal flu, even though it was manufactured in a hurry – with the clinical studies following after-the-fact.

And now, if you look at the H1N1’s short history, you can see that huge numbers of people are reporting all kinds of adverse reactions to this fast-tracked vaccine, including miscarriages and still births. But what do you get from the vaccine companies and the CDC when you question these reports? Not answers that affirm the adverse events, that’s for sure.

As far as the yellow fever-contaminated blood, this wasn’t the first time that tainted blood has been pumped into unsuspecting people’s arms, or that life-endangering mistakes have been made by medical professionals.

Remember back in the 1980s and ‘90s, when the CDC admitted too late that HIV could be transmitted through blood products? It was too late because thousands of people, including blood-transfusion-dependent hemophiliacs, had not only already contracted HIV through tainted blood, but had gone on to develop full-blown AIDS.

And what about the report in the Journal of the American Medical Association – one of the world’s most respected medical journals – just 10 years ago, that documented that medical error was the third leading cause of death in America?

That report was supposed to call attention to a tragedy that was causing 225,000 deaths per year in hospitals, from such things as unnecessary surgery, medication errors, infections, and from non-error, negative effects of drugs. And that was the low-ball figure – the Institutes of Medicine reported higher numbers.

I reported on this then, noting that it should be a wake-up call for anyone involved in the health profession, especially since another analysis concluded that between 4 percent and 18 percent of consecutive patients experience negative effects in outpatient settings with:

• 116 million extra physician visits
• 77 million extra prescriptions
• 17 million emergency department visits
• 8 million hospitalizations
• 3 million long-term admissions
• 199,000 additional deaths
• $77 billion in extra costs

These are staggering numbers, even in today’s topsy turvey eoconomic crisis . The point is, many of these illnesses and deaths could have been prevented because they could all be attributed to some kind of human – and therefore, preventable – error.

The JAMA article did spur the CDC and other health officials to address these issues, and to institute a number of new policies and guidelines to help reduce them. But obviously, they still happen.

Classic Case of the Fox Guarding the Hen House?

One of the persons who received the yellow fever-vaccine-infected blood was an 82-year-old man.

He had end-stage prostate cancer, and he died. Since an autopsy was not performed on this patient, it is not known if the tainted blood helped catalyze his death, even though yellow fever vaccine has been associated with serious adverse events in persons who are immunocompromised, or over age 60.

Another of the affected individuals was a pre-term infant, who failed to show any serological evidence of the antigen, probably because its immune system was too immature to mount a response.

The other three reported no serious adverse events from the mistake. But the CDC still did additional testing, to rule out two other possible adverse events from a yellow fever vaccine – cross-reactive antibodies for West Nile virus and encephalitis.

The tests came back negative, after which the CDC decided in its final report to reiterate the following comments and rules regarding blood donations and vaccines:

Transfusion-related transmission of attenuated YF vaccine virus is preventable.

Health-care providers should inform persons receiving live vaccines about the temporary deferral for blood donation.

Providing additional checks and balances is especially important when blood product donors receive several vaccinations within a short period (e.g., in the case of active duty military personnel or travelers).

If feasible, occupational health personnel at military training facilities should collaborate with the organizers of blood drives targeting military trainees to coordinate a minimum 2-week interval separating receipt of live vaccines and collection of blood products.

All potential blood donors should be individually screened for a recent history of receipt of vaccines containing live virus during the month before donation, and temporary deferment should be based upon the expected post-vaccination period of viremia (when the live viruses are still circulating through a person’s bloodstream).

Most temporary deferments due to receipt of live vaccines are 2 weeks; however, recipients of measles, mumps, and rubella vaccines and varicella vaccines should be deferred for 4 weeks because of the theoretical risk for prolonged viremia.

I put the last comment in boldface type because here, in its own words, the CDC is admitting that it IS POSSIBLE to transmit other live vaccine viruses through blood products. I commend the CDC for adding this warning to their statement. The only problem is that the warning is good only if everyone it’s aimed at pays attention.

In the yellow fever instance, these rules were already in place. But the rules didn’t work when a whole series of breakdowns in communication occurred, from the military base that allowed trainees to be part of a blood drive, to the trainees who either lied about their vaccine status, or simply failed to reveal it.

The bottom line is, the CDC can crow all it wants about the guidelines and rules it has to make sure vaccines are safe, and administered only to the right persons. But in the end, who’s watching the hen house to make sure the rules are followed?

What Was that Shot I Just Got?

While we’re talking about making sure that only those who are indicated to receive certain vaccines, receive them, let’s take a look at that school in Massachusetts, where staff members got sick after their H1N1 vaccines. Or, rather, insulin shots.

That’s right. Several staffers at a Wellesley, Massachusetts school came down with hypoglecemia after they were mistakenly given insulin instead of the intended H1N1 vaccine they were supposed to get during the school’s flu clinic.

How the school nurse got insulin confused with the vaccine is still a mystery – none of the many media reports about the incident had interviews with her. But, regardless, this was another human error that could have been, and should have been, prevented.

Sadly, according to an ABC News report, this isn’t the first time something like this has happened, just in this area of Massachusetts alone. Just last fall people in a neighboring town got seasonal flu vaccine instead of H1N1. And, in 2007, a teacher in a different nearby town got – guess what! – an insulin shot instead of flu.

Reports like this make you wonder: Just how many times is this same scenario repeated in communities large and small, every year across the country?

In analyzing the situation, health officials told ABC that these incidents should serve as learning tools that will improve vaccine safety – people should use this information to ask questions about the shots they’re getting, so they can feel safe in going ahead and getting their vaccines, they said.

I agree.

You SHOULD ask questions about any foreign substance being put into your body, especially vaccines. To borrow from the National Vaccine Information Center, before you get any vaccine, these are eight questions you should ask before getting any vaccine (the questions are framed with children in mind, but they apply to anyone):

1. Is my child sick right now?
2. Has my child had a bad reaction to a vaccination before?
3. Does my child have a personal or family history of:
   • Vaccine reactions
   • Convulsions or neurological disorders
   • Severe allergies
   • Immune system disorders
4. Do I know if my child is at high risk of reacting
5. Do I know how to identify a vaccine reaction?
6. Do I know how to report a vaccine reaction?
7. Do I know the vaccine manufacturer’s name and lot number?
8. Do I know I have a choice?

To those eight, I would add another, VERY IMPORTANT question: Have I read the manufacturer’s package insert for this vaccine?

And that leads us back around to our original question at the beginning of this report – can live vaccines transmit live virus infection?

Read the Manufacturers’ Package Inserts

The CDC is fully aware that some live virus vaccines, such as the rotavirus vaccine, the chicken pox vaccine and live attenuated influenza vaccine (LAIV), have a potential to transmit the viruses to other persons. For example, this CDC bulletin from 2003 says this about LAIV:

Because LAIV contains live influenza viruses, a potential exists for transmission of these viruses from vaccines to other persons

And, as I mentioned already, the CDC and the WHO know full well that disease has been transmitted – albeit rarely – by way of multi-dose vaccine bottles. Citing 19 studies – that’s right, 19 – that show these bottles to be a potential source of infection, as well as transmitters of diseases like hepatitis, the CDC and the WHO in 2003 drew up guidelines regarding the use of multi-dose bottles.

Several of the recommendations have to do with sanitation procedures and proper training in the use of sterile equipment – again, human controls that can result in human error, if the rules are not followed exactly.

This information was easy to find with an Internet search engine. Unfortunately, not all diseases and their vaccines are that easy to research. That’s why it’s important to know that one of the best resources you can use for learning about a vaccine is the manufacturer’s package insert.

Some Sample Package Inserts

Once you know how to do it, getting vaccine information straight from the horses’ mouths – the manufacturers themselves – really is quite easy. You don’t even have to know a manufacturer’s name to find what you’re looking for.

For example, if you want to know about the measles vaccine, just put “measles package insert” in your search engine.

And up pops Merck’s MMR (measles, mumps, rubella) vaccine, Attenuvax. Click on the PDF link and here’s what this package insert says:

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases.

Although there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin.

So, again, there’s your answer: yes, it is possible for the live MMR vaccine to transmit disease. If you read further, you’ll also find that:

… lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.

So there you have it: Breast milk is another possible means of transmission of a live vaccine virus – and not just with rubella. Only a few days ago, the CDC issued a special warning against vaccinating breast-feeding women with yellow fever vaccine, after a report that a woman had passed the virus on to her baby through her breast milk. Dated Februray 11, 2010, the CDC bulletin said:

Breast-feeding women should not receive yellow fever vaccine except in situations where exposure to yellow fever viruses cannot be avoided or postponed. … The vaccine is highly effective. However, the findings in this report indicate that yellow fever vaccine virus can be transmitted to infants via breast-feeding.

The breastfed infant in this report required hospitalization for encephalitis (acute inflammation of the brain) after her mother received yellow fever vaccine.

Bulletins like this are prompts for adding to, or making changes to vaccine package inserts, so I’m sure it will be added soon to the yellow fever vaccine package insert.

Besides information like this, vaccine package inserts also will give you details of the drug’s clinical trials, including side effects and adverse events discovered at that time.

For example, Sanofi Pasteur’s package insert for its yellow fever vaccine plainly states that a known, serious adverse event associated with this vaccine is encephalitis.

But don’t stop with yellow fever. Go ahead. Download more package inserts and read them all. I promise, the adverse events and possible side effects that the manufacturers are required to publish in there will make you wonder what else your public health officials aren’t telling you.

First, Do No Harm

The bottom line is, when people can be killed by something so simple as an allergy to a peanut, why are we suggesting a one-size-fits-all policy for vaccines, especially when massive mistakes – call them screwups if you like – and inconsistencies from the labs and manufacturers like the Baxter incident are so prevalent.

It just isn’t logical that, in the environment, vaccines are considered hazardous materials that you can’t even flush down the drain, or pour into the ground, while at the same time being called perfectly safe. They would like you to think that the only way they don’t cause danger or harm is to inject them in your body – primarily in infants and children.

Just how does that make sense?

So, what can you do to protect yourself so that no harm will come to you, or your family should you decide to receive a vaccine, or if you have to undergo some sort of medical procedure?

Everyone knows that physicians take an oath that includes a promise: First do no harm. Most health care providers, whether they are physicians or nurses, would never intentionally inflict harm on their patients. But as you know, sometimes accidents and mistakes happen.

The best way to help ensure that those mistakes don’t happen to you is by being an informed, proactive patient. Ask questions before you get a vaccine or medical procedure. Make sure that what you’re getting is what you’re supposed to get, even if that means asking to see the bottle or package that your drug comes in, before it’s injected into you.

Also, be diligent about ascertaining that every person caring for you is following proper sterile procedures, such as hand washing before and after they examine you.

And, finally, if you do experience an adverse reaction to a medical procedure or vaccine, make sure you report it to your local and state medical boards. Vaccine reactions should be reported to the national Vaccine Adverse Events Reporting System. If your physician or attending health care provider is reluctant to do that for you, you can do it yourself, here.

Also, remember that preventative care, not treatment, is the best way to stay healthy. Drugs, surgery and hospitals are rarely the answer to chronic health problems. Facilitating the God-given healing capacity that all of us have – implementing an improved diet, exercising, and living a healthy lifestyle – is the key.

Effective interventions for the underlying emotional and spiritual wounding behind most chronic illness are also important clues to maximizing health and reducing disease.