Envita’s Natural Issues Blog

Part 3 Childhood Vaccinations: Questions Every Parent Should Ask

Every so often we like to invite guest authors to contribute articles on certain topics. We are very pleased to have Marc Weissman, D.C., as our guest author for the next few weeks. Dr. Weissman will be writing a five-part series on the highly controversial and critically important topic of childhood vaccinations. Dr. Weissman has been studying this issue for sometime. He has extensively examined literature on the subject and has presented his work in an educational seminar. Dr. Weissman was awarded the Doctor of Chiropractic degree, magna cum laude, from Life University in 1998. He holds a Bachelor of Science in Biology and Chemistry from the State University of New York, College at Oneonta. He is Board Certified to practice Chiropractic as well as physiologic therapeutics. He is also a certified member of the International Chiropractic Pediatric Association. Dr. Weissman has attended numerous seminars in the field of chiropractic technique and annually attends post-graduate courses to stay current on the latest diagnostic and treatment procedures. Additionally, he has taught seminars to Chiropractic students preparing for the National Board. His clinical emphasis is on increasing the overall quality of life for adults as well as children through gentle chiropractic adjustments. Dr. Weissman is the owner and president of Mercado Chiropractic in Scottsdale, Arizona. The information contained within Dr. Weissman’s blog can be purchased from Koren Publications. Please visit http://www.korenpublications.com/ for more information.

The next logical question regarding vaccines you should naturally ask is: Is the vaccine that I am taking or giving to my child really providing the protection I want? In other words, is it effective? This may seem like a redundant question. You may be surprised by some of the information I am going to present in this section.

What does the term “effective” mean? Well according to the CDC: “Effective” means antibodies are produced, not clinical effectiveness (i.e. no disease). What this means is that the vaccine has to produce an immune response only. This does not mean that you are protected against a disease since they are not looking at a clinical effectiveness. There is often no correlation between antibodies and resistance to disease. That means people with high antibody counts may get sick while people with low antibody counts may not get sick.

In fact, there are a number of research studies that have shown that there in not a good clinical effectiveness when it comes to vaccines. In these studies, we can see that even though a large percent of the population was vaccinated, there was still the presence of the disease:

“[Pertussis] infections are common in an immunized population…more prevalent than previously documented.” 98% were vaccinated in this population.

He Q, Vijanen MK, Arvilommi H et al. Whooping cough caused by Bordetella pertussi and Bordetella parapertussis in an immunized population. Journal of the American Medical Association. 1998;280:635-637.

Outbreaks have occurred in 100% vaccinated populations.

Morbidity and Mortality Weekly Report. US Govt. 12/29/89/38(S-9):1-18.

“80% cases of measles are contracted in vaccinated people.”

Morbidity and Mortality Weekly Report. US Govt. 6/6/86/35(22):366-70.

How can you have an outbreak of a disease in a population that is 100% vaccinated? That is absolutely mind-boggling. If we are told that the vaccine will prevent a disease and then the disease occurs anyway is that vaccine doing its job? And if you take a closer look at these studies you will see that they are printed in very reputable peer reviewed journals. This information is reliable, not second rate science.

“The increase in pertussis incidence was higher among vaccinated than among non-vaccinated persons of all ages.”

De Melker HE, Schellekens JFP, Neppelenbrock SE et al. Reemergence of pertussis in the highly vaccinated population of The Netherlands: Observations on surveillance data. Emerging Infectious Diseases. 2000; 6(4).

Do you want to increase the risk of pertussis? Well according to this article, vaccinate for it! With mandatory vaccination and 5 doses of DPT vaccine, pertussis occurs at a far higher rate now than before the introduction of the vaccine. “There is substantial underreporting of pertussis…including hospitalizations.” Sutter RW and Cochi SL. Pertussis hospitalizations and mortality in the United States, 1985-1988. JAMA. 1992;267(3):386-390. There’s more pertussis now than before vaccination started and increased deaths in infants. Some vaccine! Why do they still give it? Doctors refuse to admit mistakes.

The rate of pertussis was declining consistently until 1978 when the DPT vaccine was mandated for school entry in 41 states. The decline immediately slowed, then stopped and began to rise again, and it has been rising ever since. This is comparing epidemic peaks with other epidemic peaks and inter-epidemic troughs with other inter-epidemic troughs, which is the only kind of comparison that reasonably can be done.

Mass vaccination is promoted because of the concept of herd immunity. The AMA encourages and supports childhood vaccination requirements because of ‘herd immunity’. Herd immunity was developed by A.W. Hedrich in 1933 who said when 68% of children under 15 were immune to measles, epidemics did not occur. His research was based on natural, not artificial immunity.

But as you can see, how can herd immunity work if epidemics have occurred in 90 to 100% vaccinated populations?

“The number of infants dying from whooping cough is rising despite record high vaccination levels. All the deaths in 2000 occurred among infants under the age of 4 months.”

“Since the early 1980s, reported pertussis incidence has increased cyclically with peaks occurring every 3-4 years.”

Morbidity and Mortality Weekly Report. Feb 1, 2002;51:73-76. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5104a1.htm

And in spite of all the vaccinations, pertussis returns on a cyclical basis. You can’t fool Mother Nature. However there is some good news. When Sweden stopped pertussis vaccinations, the disease all but disappeared in infants, adolescents and adults and returned to young children, where it should be. That’s why they’re called childhood diseases, you get them in childhood, not in infancy and not in adulthood. What can you do if you were vaccinated as a young girl and now are pregnant? Breastfeed. Breast-feeding offers a wide variety of natural protections. According to the American Academy of Pediatrics, babies should be breastfed for a minimum of one year and a maximum of – when the baby decides. Average age of weaning in the world is about 4 ½ years. To further promote natural health all children should have healthcare that promotes natural immunity, should be fed natural, healthy, immune-system-promoting foods and – very importantly – feel loved and cared for.

Apart from lack of protection, the vaccines cause a lot of sickness and disease. This is from a survey in the UK conducted by a law firm engaged in a class-action suit representing thousands of families of children injured by the measles shot after a government promoted measles campaign. Keep in mind that these conditions have been associated with other childhood vaccinations too. Encephalitis, Guillain-Barre syndrome, convulsions, seizures, anaphylaxis, atypical measles, thrombocytopenia, optic neuritis, ocular palsies, retinitis, deafness, otitis media, ulcerative colitis, bowel disease, Crohn’s disease, headache, dizziness, rash, autism, hearing and vision problems, arthritis, arthralgia, behavior and learning problems, chronic fatigue, diabetes, multiple sclerosis and death.

Richard Barr, Alexander Harris, Mumps, Measles and Rubella (MMR) Vaccines and Measles Rubella (MR)

www.whale.to/vaccines/dawbarns.html Dawbars (UK) 1997

In addition to these horrible side effects, we are now encountering some diseases that were unknown before vaccine. “The measles vaccine is associated with SSPE, (subacute sclerosing panencephalitis) which causes hardening of the brain and is fatal.” – Robert Mendelsohn, MD

lSSPE was first recorded following measles vaccination in 1968 in children who had the vaccine but not natural measles.

Fact sheet distributed by Dawbars Law Firm, Bank House, King’s Straithe Square, King’s Lynn, Norfolk PE30 1RD, UK. 1997.

Hepatitis B vaccine may actually be more dangerous than the disease itself. “The risk of a serious vaccine reaction may be 100 times greater than the risk of hepatitis B….asthma and diabetes… autism and attention deficit/hyperactivity disorder have [increased greatly ] since the introduction of many new vaccines….”

Jane Orient, MD, Executive Director Association of American Association of Physicians and Surgeons.

The chicken pox shot was not produced for health reasons but for economic reasons – so that parents would not have to miss work taking care of a sick child. This is the first time such a reason for vaccination was promoted. It is extremely rare for a child to die from chicken pox. A review of some of the records of such deaths shows the children received suppressive medical care (anti-fever drugs, steroids etc.). The chicken pox vaccine may result in significantly increased risk of shingles, an extremely painful, often difficult to treat, sometimes fatal condition among adults.

In closing, we began this section asking if vaccines were effective. Based upon the data that I have found, which is not a belief, I would have to say the answer is pretty obvious. One may ask themselves, “If vaccines are not effective, then why have all of these diseases virtually disappeared?”. My answer is simple. One of the biggest diseases that almost wiped out mankind was the Black Plague. It killed nearly 75% of the world’s population and then it just vanished. There was no vaccine or modern medicine to help stop it. What stopped it was a change in how people lived. Sewage removal, waste management, clean water and people taking better care of themselves were the key to ending the plague. Not a shot, a pill or a potion. In my opinion, the concept of injecting toxins into the body is outdated.

Thank you for taking the time to educate yourself. If you have any questions, comments or have any input please feel free to visit my website at www.mercadochiropractic.com and send me an e-mail.

Marc Weissman, D.C.

Mercado Chiropractic

10135 E. Via Linda

Suite 115Scottsdale, AZ 85258

(480) 661-7000

mercadochiro@qwest.net

December 11th, 2008 | Category: Childhood Vaccinations | Leave a comment

Part 2 Childhood Vaccinations: Questions Every Parent Should Ask

In this next part of my 5 part series on vaccines I am going to probe a little deeper into this miasma of uncertainty surrounding vaccines. Once again this is a complicated issue surrounded by fear and is emotionally charged. I do not present this information as a hardcore anti-vaccine campaign. I present this information as a way for the public to be educated about a part of the vaccine controversy that we are not told about.

One of the most common questions that I receive from parents has to do with the “What if?”. They usually will present something like, “Dr. Weissman, what if we don’t vaccinate our baby and something bad happens?” When a parent asks me this what I truly think they mean is “Do the benefits of vaccine outweigh the risks?”

This is the most important question we can ask. The justification for vaccination, in spite of all the damage it is known to cause, is that the damage is miniscule: “one in a million.” Whenever vaccination criticism surfaces, the media will interview some health department official or MD who will repeat the mantra: ‘Sure vaccines have some slight chance of causing damage, but (repeat after me) the benefits far outweigh the risks.’ The only problem with that statement is that it has never been proven.

No one knows what the chances are that your child may be hurt or killed by a vaccine. Why?

In order to do a risk/benefit analysis, we need to know how many children are being hurt. We do not know that because doctors and health officials rarely report vaccine injuries.

Even though by law MDs must report vaccine injuries to the government’s vaccine adverse event reporting system (VAERS), only one in ten vaccine-injured children is ever reported according to the FDA. This government statistic may be conservative, the actual amount of underreporting may be far greater. Kessler D. JAMA, 1993; 269 (No.21): 2785. Only about 1% of serious events are reported to the FDA.

The following quote comes from a book called “DPT, A Shot in the Dark”, it explains perfectly how there is an under reporting in the system:

“Janet asked the coroner why he could not state point-blank that Richie’s death was due to a DPT shot reaction, when it was obvious…He said he couldn’t write down on the death certificate that Richie had died from a DPT reaction because ‘the state’s standing on immunizations would be in an uproar.”

At an Institute of Medicine conference in Washington, DC. a representative of Connaught labs said this:

“The company estimates about a 50-fold underreporting of adverse events in the passive reporting system.”

-Froeschle, J. Connaught Laboratories. Adverse events associated with childhood vaccines, evidence bearing on causality. Washington DC: Institute of Medicine presentations. 5/11/92; 328 Appendix B.

Japanese research indicates that adverse reactions to MMR vaccine are 78 times as frequent as the UK’s Chief Medical Officer of Health has admitted. If those figures are correct, then the vaccine is more dangerous than the illness.”

- Richard Barr, Alexander Harris, Mumps, Measles and Rubella (MMR) Vaccines and Measles Rubella (MR) Dawbars (UK) 1997

An analysis of the CDC’s own data demonstrates that the number of actual injuries from the rotavirus vaccine is 500 times the injuries reported to VAERS. One in 500!!! And even with all this underreporting the rotavirus vaccine was so dangerous it was pulled from the market. Children were hospitalized and even died. How many children were really hurt or killed? We may never know.The next piece of information that I have to share with you is an actual quote from a report filed to VAERS:

“Approx two weeks post measles vaccination, patient experienced acute demyelinating encephalomyelitis, deteriorated rapidly and died. The cause of death was encephalomyelitis. An autopsy was performed, but the brain was liquefied.”

- VaersIDReportText134548

In the early 1980s pharmaceutical companies were settling so many lawsuits (out of court – records sealed) from vaccine-injured children and their families that they threatened Congress that if they didn’t have protection from liability they were going to stop making vaccines. Congress then passed laws protecting the vaccine companies from liability and created the National Vaccine Injury Compensation Program. Extra fees were added to each vaccine to pay the damages for vaccine-injured children. Over a billion dollars has been paid, even though most parents do not know this system exists and most requests are rejected by Justice Department lawyers. Further, the government only compensates for a limited number of severe injuries and only if they’ve occurred a few hours after a shot. It is a very bad, broken system and its reform is being discussed in Congress and fought by the vaccine lobby.

One of the most powerful (and frightening) statements ever made regarding vaccination is this one by Dr. Coulter:

“The symptoms manifested with pathological intensity in a small group will of necessity appear in milder form in a much larger proportion of the population. For every ‘autistic’ who is shut away in an institution there will be a thousand alienated individuals functioning as normal taxpaying citizens.”

- Coulter, HL. Vaccination, Social Violence and Criminality: The Medical Assault on the American Brain. Washington, DC: Center for Empirical Medicine. 1990; 37.

It is impossible to biologically stress a population and have an all-or-nothing response, i.e. mild or no reaction or severe reaction and death. Rather, the damage (in this case vaccine damage) will take a bell curve approach, that is, some people will be mildly hurt, and some severely hurt or killed but the vast majority of those damaged will fall somewhere in the middle between those two extremes. They may be the ones with chronic illness, slight IQ loss that isn’t considered a problem, but they aren’t as intelligent, or able to connect. They may be emotionally distant, with just a mild form of damage. This may become the majority of Americans. Not quite right, but not bad enough to be hospitalized or institutionalized – our new definition of normal!

I started out this section asking if the benefit outweighs the risk. The scary fact is that we simply just don’t know! The system that we use to determine this is so ineffective and broken no one can say with the data that we have that the benefit outweighs the risk.

In my next posting, I will be discussing the effectiveness of vaccines. Thank you for taking the time to educate yourself. If you have any questions, comments or have any input, please feel free to visit my website at www.mercadochiropractic.com and send me an email.

Marc Weissman, D.C.

Mercado Chiropractic

10135 E. Via Linda

Suite 115Scottsdale, AZ 85258

(480) 661-7000

mercadochiro@qwest.net

December 3rd, 2008 | Category: Childhood Vaccinations | Leave a comment

Childhood Vaccinations: Questions All Parents Should Ask

One of the most common questions that I receive from parents, especially first time parents, is “Should I vaccinate my child?” This is not an easy choice to make. This decision should be based on facts rather than coercion or pressure. This is an issue surrounded by fear and clouded by groups on both sides that feel that they are acting in the best interest of our children. I am going to attempt to share some facts with you in this 5 part series that will empower you to answer some questions for yourself. I feel it is absolutely essential for every person on this planet to have all the information possible before making this healthcare decision. Just ask yourself if the last time you made a financial investment in something substantial like a car or home appliance you put all your faith in the salesman or you did some of your own homework. You see, most people will take their time when they spend their hard earned money, but they will take what their family doctor says on faith because they trust them. As an educated healthcare consumer, you have the responsibility and the right to have ALL the facts before you do anything with your health or the health of your child. After you have the facts, it is up to you to weigh the scales and apply your value system to take action. I therefore ask you to keep an open mind to the information I am going to present.

We want to do all we can to have healthy children who will live long, happy and fruitful lives. We certainly do not wish to do anything that would interfere with that process. Many parents are refusing to vaccinate their children. They do so for a number of reasons. Some of the most common are:

That they consider the vaccines more dangerous than the disease. In fact, there are hundreds of studies and many books documenting dozens of chronic immunological and neurological conditions children have gotten from shots. It may surprise you that most pediatricians and parents are completely unaware of this.
Another reason is that they prefer natural rather than artificial immunity. Natural immunity lasts a lifetime. Artificial immunity – vaccination – does not.
They have a vaccine-injured child (this is, sadly a growing number, far larger than most people realize.) Or some other health reason why their child should not be vaccinated.
And some have religious or philosophical objections to vaccination.

If you are reading this then you probably have some concerns already about vaccines, and you are not alone!

lUSA Today. Oct. 30, 2000: “Roughly one fourth of American parents have serious concerns over the safety of vaccinations their children receive.”

lWall Street Journal, Aug 1, 2003, p. 1. “There is growing opposition to the number of shots required.”

By the time a child is 6 months old they are to be injected with 45 vaccines; at 18 months 64 vaccines, and at 4-6 years at least 74 vaccines!! Do they really need this many vaccines? Most parents have no idea how many vaccines their children are getting.

You’d think after 74 vaccines by age 6 our children would be protected and it would be enough already. Oh no, now there’s a big push to immunize adolescents. In fact, one of the most dangerous things childhood vaccination does is alter the age of occurrence of these diseases. Instead of young children, we now see newborns, infants and adults getting these childhood diseases. At those ages these diseases can be much more dangerous and have a higher death rate. For example, death from chicken pox is 30 times higher in adults (compared to children). Death from pertussis (whooping cough) is much more common among infants than in children over the age of 2.

Laws are even being proposed to make adult immunizations mandatory. If your vaccination papers are not in order you may not be able to rent a car, a motel or hotel room, or fly in a plane.

It is not just parents that are rejecting vaccines for their children. Today there are more and more health professionals also questioning the need for this line of vaccinating:

“There is no convincing scientific evidence that mass inoculations can be credited with eliminating any childhood disease…I urge you to reject all inoculations for your child.” Mendelsohn R. How to raise a healthy child…in spite of your doctor. Chicago: Contemporary Books.

In addition:

The Association of American Physicians and Surgeons calls for an end to mandatory childhood vaccines. “Our children face the possibility of death or serious long-term adverse effects from mandated vaccines that aren’t necessary or that have very limited benefits.” Jane M. Orient, MD, AAPS Executive Director. Nov. 2, 2000. www.aapsonline.org

I think it is very important to ask some basic questions about vaccines. As I stated earlier, we need to have all the facts in order to make a decision. How do you get the facts? Just ask!

1) Are vaccinated children healthier than non-vaccinated children?

The answer is surprising. Although parents have their kids vaccinated so they’ll be “protected” from disease, what they really want is for their children to be healthy. In fact, a normal child should be able to deal with any childhood disease and benefit from the experience (more on that later). How can the government promote mandatory vaccines if there’s no proof that they are making our children healthy? In fact quite the opposite appears to be the case. It appears that it’s the vaccinated children who have allergies, asthma, autism, seizures, dyslexia, chronic illness, ADD, ADHD, skin conditions, nervousness and other nerve and immune system disorders – NOT the vaccination-free children. The research done regarding vaccination safety and efficacy is so very poor it doesn’t even qualify as science. For example: Let’s say you own a drug company and you want to see if your drug is safe. You take two groups of people, match them for age and other factors. Half get the drug and the other half – the control group – gets a placebo – a sugar pill. Now you compare the groups. You’d watch them for days, weeks, months and even years to see if there is any long-term damage. That’s a long-term study. A short-term study does not give you what you need. That is the logical, the scientific, way to do things. How many long-term controlled studies are there for vaccines? Zero!

Example of Vaccine Science:

2,588 Navajo infants were given Hib, DPT and OPV (the “vaccine” group).

2,602 Navajo infants were given DPT, OPV AND lactose (the “placebo” group).

Santosham M, Wolff M, Reid R, et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenza type b polysaccharide and Neissereia meningitidis outer-membrane protein complex. New England J of Med; 1991, 324(25):1767-1772.

Note: This study was ended early because of the large number of deaths and injuries in both groups.

Death and injury from a placebo?

I know it sounds crazy but they don’t compare vaccinated with non-vaccinated kids; they compare kids vaccinated with an approved vaccine and kids vaccinated with an experimental vaccine. If both groups of children have a similar amount of neurological disorders, seizures, shock and deaths then the experimental vaccine is approved, because after all, it’s no worse than what’s already been approved. This is just one example, out of many, of the sloppy, weird so-called science of vaccination research.

Another problem is – this research was done on Navajo babies. Would there be more or less damage in babies of English, Irish, Italian, Jewish, German, French, African, Polish, Russian or other ancestry? We don’t know. We do know, for example, that Italian and Jewish babies have more autism, believed to be caused by vaccination. And there’s one last problem – this is not independent research – the people doing this research work for the drug companies. Independent researchers should do this work.

Also, test children are healthy, unlike those often vaccinated in real life. Premature, low birth weight or ill babies are not permitted in the test group. If a test child has a bad reaction, they aren’t revaccinated and are removed from the study. However, in real life, what really happens? MDs vaccinate all children, sick and well, high and low birth weight, full term and premature, with predispositions for allergies, or neurological disease and other conditions.

In a study from Epidemiology 1997;8:678-680, it was found that out of immunized children: 23.1% had asthma, and 30% had other allergic illnesses. In contrast, in non-immunized children: 0% had asthma or other allergic illness.

Are we saying that immunization is the only cause of allergies/asthma? No. These conditions existed, albeit quite infrequently, before the vaccine era. It is possible for non-vaccinated children to get allergies/asthma, usually if one or both parents were vaccinated. Homeopaths refer to this as the miasm (taint) which is the influence of one’s ancestor’s health on the child’s present health. I know of at least one family in which the children were not vaccinated and had allergies from infancy. The father had allergies. Their homeopath told them that this was not unusual since there was a tendency (taint) inherited from the parent who had allergies (and was vaccinated). Hugh Fudenberg, MD, the internationally famous immunogeneticist, has discussed the tendency for allergies in the children of previously vaccinated parents.

Children vaccinated with DPPT (or MMR) had 14 times more asthma and 9.4 times more eczema than non-vaccinated children. This was discovered by McKeever TM, Lewis SA, Smith C. Does vaccination increase the risk of developing allergic disease? Winter Abstract supplement to Thorax, 2002; 57: Supplement III.

Another article presented in an overseas journal found the following:

Vaccinated…25.6% asthma
Non-vaccinated…2.3% asthma
Vaccinated…>50% atopic disorders (allergies, rashes, chronic runny nose)
Non-vaccinated…<10% atopic disorders

Yoneyama H, Suzuki M, Fujii K, Odajima Y, The effect of DPT and BCG vaccinations on atopic disorders. Arerugi 2000;49(7):585-592.

So we started off this section asking if vaccinated children are healthier than non-vaccinated. The answer is that we just don’t know! There has never been any study to confirm or deny this. In fact, according to the articles presented here, we may be exchanging one illness for another. According to Robert Mendlesohn, M.D.:

“Immunization against relatively harmless childhood diseases may be responsible for the dramatic increase in autoimmune diseases…such as cancer, leukemia, rheumatoid arthritis, multiple sclerosis, Lou Gehrig’s disease, lupus and Guillain-Barre syndrome.”

In my next posting, I will be discussing the benefit vs. risk argument. In other words: do the benefits of the vaccine outweigh the risks involved? If you have any questions, comments, or have any input, please feel free to visit my website at www.mercadochiropractic.com and send me an email.

Marc Weissman, D.C.

Mercado Chiropractic

10135 E. Via Linda

Suite 115

Scottsdale, AZ 85258

(480) 661-7000

mercadochiro@qwest.net

November 25th, 2008 | Tags: Childhood Vaccinations | Category: Childhood Vaccinations | Leave a comment

The Vitamin C War Wages On: Should Cancer Patients Steer Clear?

A couple of months ago, we wrote an article entitled “The Vitamin C Eureka Moment: 30 Years After-the-Fact.” In that article, we reported on a study led by Mark Levine and researchers from the National Institute of Health showing that intravenous high-dose vitamin C can reduce tumor growth by half. (1) The study was published in the Proceedings of the National Academy of Sciences, and it showed that mice with aggressive brain, ovarian, and pancreatic tumors that received the intravenous vitamin C treatment had a 41-53% tumor reduction, and their cancers stopped spreading. (1) Furthermore, the study showed that the vitamin C treatment did not harm healthy tissue, which meant there were few to no side effects, as compared to traditional chemo and radiation administration. (1)

Then, on October 1, 2008, researchers from the Memorial Sloan-Kettering Cancer Center, led by Mark L. Heaney, published another study involving mice and vitamin C. According to these researchers, vitamin C supplementation reduced the efficacy of a wide range of chemotherapeutic agents. (2) The researchers reported that leukemia and lymphoma cell lines pretreated with vitamin C caused a 30-70% decrease in the effectiveness of various cancer drugs: doxorubicin, cisplatin, vincristine, methotrexate, and imatinib. (2) In mice that had lymphoma, those that received vitamin C two hours before treatment with doxorubicin had substantially larger tumors after 32 days than mice given doxorubicin alone. (2) The authors concluded that “vitamin C supplementation may alter the effectiveness of commonly used chemotherapy agents and adversely influence treatment outcomes.”

After this latest addition to the vitamin C debate, the news reports were plastered with such headlines as “Vitamin C May Reduce Chemotherapy Effectiveness,” and “Chemotherapy and Vitamin C Supplements Don’t Mix,” and “Vitamin C may Blunt Effect of Chemotherapy.” The study successfully managed to muddy the waters. The story caused considerable alarm and confusion among cancer patients, who didn’t know where to begin in making heads or tails of these conflicting reports. Were the NIH findings wrong? Does vitamin C hurt rather than help cancer patients?

To answer that question, we have to move beyond the media reports and look at the actual studies. First, a major distinction has to be made. In Mark Levine’s NIH study showing the potential beneficial effects of vitamin C in the treatment of cancer, he used a reduced form of vitamin C called Ascorbic Acid (AA). In fact, there are at least 22 studies to-date showing that AA increases the effectiveness of chemotherapy, reverses drug-resistance in certain cancer cell lines, and increases drug accumulation. (3) In humans, AA in combination with chemotherapy has not shown adverse effects in randomized trials and in clinical reports. (4)-(9) Specifically, two human randomized trials comparing chemotherapy with and without AA did not show signs of interference. (4),(10) Importantly, Mark Heaney and the Sloan-Kettering researchers did not use the AA form of vitamin C; they used dehydroascorbic acid (DHA), or the oxidized form of vitamin C in combination with AA in the cell lines. And furthermore, in an editorial printed in The Gazette (a Montreal publication), McGill University cancer researcher L. John Hoffer, M.D., noted that in the Sloan-Kettering study, DHA was mixed with cells in a concentration that never exists in nature. (11) In the mice, the Sloan-Kettering researchers used only DHA.

The difference between AA and DHA is critical. (Warning: Science explanation ahead that might put some or all readers to sleep.) First, their molecular structures are different, and the research suggests that they may act in radically different and even opposing ways. Unlike DHA, AA is an electron donor, which affects cells’ signal transduction pathways. (3),(5) Placing DHA both inside and outside cells may disrupt AA’s ability to cause cancer cell death, which would otherwise occur through the release of certain signals from the cancer cells’ mitochondria. (3),(6) Thus, DHA may actually block the therapeutic potential of AA. Sure enough, in one of the 22 studies showing the beneficial effects of AA in cancer treatment, the addition of DHA actually decreased those beneficial effects. (11) AA, when administered intravenously at high doses, acts in a very similar manner to chemotherapeutic drugs. Not surprisingly, in the Sloan-Kettering study, the introduction of DHA both inside and outside the cell most likely had the same negative impact on the therapeutic effects of the chemotherapeutic drugs as it does on AA.

But the differences between the NIH study and the Sloan-Kettering study don’t stop there. Not only did the two studies examine critically different forms of vitamin C, the Sloan-Kettering study also used radically different dosages as well. The Sloan-Kettering dosages were 10-20 times lower than that used in the NIH study. While this variable might not seem that big of a deal, it becomes enormous when viewed in light of the fact that the NIH study and others have specifically found that the drug-like effects and tumor-killing potential of vitamin C are only observed at high doses. In the Sloan-Kettering study, only around 2,000 milligrams of vitamin C were used (250 mg administered on 8 different days), an amount that Heaney and colleagues stated would be similar to that found in people taking oral vitamin C supplementation. (Incredibly, in one interview, Dr. Heaney warned that doses as low as 100 milligrams could have detrimental effects, which is the same amount found in a few glasses of orange juice.) In contrast, in Dr. Levine’s NIH study, they used doses as high as 4 grams per kilogram of body weight. Researchers at the NIH hypothesized that at extremely high doses, vitamin C actually acts as a prooxidant. As a prooxidant, vitamin C can generate free radicals and the formation of hydrogen peroxide, which can kill tumor cells (but unlike chemotherapy, leaves healthy cells alone). In fact, in their laboratory experiments on 43 cancer and 5 normal cell lines, the NIH researchers found that high concentrations of ascorbate had anticancer effects in 75% of cancer cell lines tested, while sparing normal cells. But like the NIH study, the vitamin C in the Sloan-Kettering study was administered intravenously. This fact is important, because intravenous administration greatly increases bioavailability of the vitamin to the body, as opposed to oral administration. But the problem still comes down to one of dosing. The NIH researchers specifically noted that they used intravenous administration in their study so that they could deliver very high doses of vitamin C. It is only at these very high doses that vitamin C (AA form) has been shown to kill cancer cells. When taken orally, the body is only able to use and process a limited amount of vitamin C, and the same tumor-killing effects have not been observed. In the Sloan-Kettering study, they used doses of vitamin C that are similar to what would be found through oral supplementation. In other words, even though the vitamin C was delivered intravenously, it was delivered in an amount that is similar to what the body could process orally, which is an amount that is too low to show tumor-killing effects. At such low doses, it is no wonder that Dr. Heaney and the Sloan-Kettering researchers failed to find the same results as the NIH study, even though they administered vitamin C through injection.

So the differences between the Sloan-Kettering study and the NIH study come down to two critical factors: the use of two different forms of vitamin C (DHA versus AA), and the use of radically different dosages (2,000 mg versus 4 grams per kilogram of body weight). In other words, comparing the two studies is like comparing apples and oranges. But unfortunately, that point has been lost in the media hype, and cancer patients come away thinking that vitamin C is bad for them. In other words, we have a repeat of the Mayo Clinic controversy. It seems that the reputation and work of Linus Pauling, and now, NIH researchers such as Mark Levine, have been clouded because the subsequent conflicting research studies have not been properly distinguished, and the critical differences have not been explained.

But as a result of the Sloan-Kettering study, a question still remains to be answered for cancer patients: should they stop taking oral vitamin supplements, such as vitamin C, while undergoing chemotherapy and radiation treatments? Heaney and the Sloan-Kettering researchers hypothesized that the reason the effects of chemotherapy were blunted on the mice that received vitamin C was because the vitamin has a protective effect on the mitochondria of cells. In contrast, chemotherapy damages cell mitochondria (to initiate cell death), and so the researchers hypothesized that vitamin C enables the cancer cells to withstand and counteract the drugs’ effects. (2) So should cancer patients avoid supplementing their diets with vitamins, as the Sloan-Kettering researchers recommend?

Let’s answer that question with data. To-date, fifty-one cellular studies and 81 animal studies using nutrients including vitamins A, B6, B12, C, D, E, K, and beta-carotene, other retinoids, selenium, or cysteine as single agents or in combination given together with chemotherapy and/or radiation, have all shown the same results – no interference with chemo and radiation, increased protection of normal tissues, increased tumor killing, and in some studies, increased animal survival. (14) Fifty human studies, involving 8,521 patients have been conducted using single or multiple nutrients in combination with systemic treatment and/or radiation and have shown that nutrients do not interfere with treatment. (14) Further, 47 out of these 50 human studies have shown that nutrients decrease side effects, and the other 3 studies showed no difference. (14) Many of those human studies reported that nutrients produce higher response rates and higher survival rates when administered alongside chemotherapy and/or radiation. (14)

To go even further, let’s highlight a few studies that have been conducted in humans using lower doses of vitamin C, such as that used in the Sloan-Kettering study. In one particular study, 18 patients with small cell lung cancer were treated with various cancer drugs: cyclophosphamide, doxorubicin, HCL (adriamycin), vincristine, and/or radiation. (15),(16) All patients were also given the following daily supplements of vitamins and minerals: vitamin A, beta-carotene, vitamin E, thiamin, riboflavin, pyridoxide, vitamin B12, nicotinamide, vitamin D, calcium, and biotin. (16) Specifically, vitamin C was administered in doses of 2,000 – 5,000 milligrams. (16) The administration of these vitamins during chemo/radiation treatment prolonged survival, decreased side effects, increased response rates (when compared to historical controls in the literature of patients who received only chemotherapy and radiation without vitamins and minerals). (15),(16)

In another study, 32 patients with breast cancer that spread to auxiliary lymph nodes were given conventional surgical and therapeutic treatments, as well as daily supplements of vitamin C, vitamin E, beta-carotene, selenium, essential fatty acids, and coenzyme Q10. (15),(17) Vitamin C was administered in doses of 2,850 milligrams. (17) Patients who were given the daily supplements had decreased rates of recurrence, increased quality of life, survival rates, and partial remission rates, as compared to those patients who only received conventional treatment. (15),(17)

In another study involving 63 patients with oral squamous cell carcinoma, participants received chemoradiotherapy with cobalt 60, peplomycin, and 5-fluorouracil. (15),(18) They were also given daily doses of vitamin C, vitamin E, and glutathione. (18) Vitamin C was administered in doses as low as 500 milligrams. (18) Patients experienced an increased response rate and a greater reduction in side effects. (15),(18)

In short, for 30 years, research involving cell lines, animals, and most importantly, humans, has shown that nutrients such as vitamin C can help improve the quality and length of life of cancer patients, as well as improving response rates to chemotherapy and radiation. High-dose intravenous vitamin C (AA form) has been shown to be the most promising in terms of actual tumor-kill and enhancing the effectiveness of chemotherapy. Oral vitamin C supplementation has been shown, in the majority of the research studies, to play a beneficial, supportive role during chemotherapy treatment, especially when it comes to reducing side effects and recovery. Now, in 2008, one study using an oxidized form of vitamin C has shown to blunt the effects of chemotherapy in mice. When you weigh this one study against the years of data to the contrary, it seems downright irresponsible for media reporters and researchers to not properly distinguish and quantify the research before causing widespread alarm and confusion.

So headlines such as “Vitamin C and Chemotherapy don’t mix” don’t quite tell the whole story. When the head researcher of the Sloan-Kettering study advises cancer patients not to take vitamin and nutrient supplements during chemotherapy, that doesn’t comport with the majority of the research studies either. But it does feed into the fear and misinformation regarding anything “non-conventional,” and it does succeed in scaring people away from treatments that could potentially help them. Of course, there are those more cynical individuals who have their own theories as to how and why this misinformation develops and spreads. The Orthomolecular News Service reported that the Chairman of the Board of Bristol-Myers-Squibb, a company that manufactures chemotherapeutic drugs, also sits as an Honorary Chairman of the Memorial Sloan-Kettering Cancer Center. (19) As the Orthomolecular camp suggests, positive endorsements of vitamin C as a cancer fighter are not in the best interests of pharmaceutical companies. Whether these types of conflicts of interests have played into the latest vitamin C controversy is impossible to prove and remains unknown (and one hopes it is not the case). But who can blame the Orthomolecular camp for pointing out these facts? Sometimes, given incidences such as this one, it’s mighty hard not to develop “conspiracy-theory” suspicions in the natural medical field.

Internet Resources:

Reuters Article “Vitamin C may blunt effect of chemotherapy”

NIH Press Release on Vitamin C Study

References for this Post:

(1) Chen, Q, Espey, MG, Sun, AY, Pooput, C, Kirk, KL, Krishna, MC, Khosh, DB, Drisko, J, Levine, M. Pharmacologic doses of ascorbate act as a prooxidant and decrease growth of aggressive tumor xenografts in mice. Proc. Natl. Acad. Sci. 2008 Sept; 105: 11105-11109.

(2) Heaney, M.L, Gardner, J.R., Karasavvas, N., Golde, D.W., Scheinberg, D.A., Smith, E.A., O’Connor, O.A. Vitamin C Antagonizes the Cytotoxic Effects of Antineoplastic Drugs. Cancer Research 2008 Oct; 68: 8031-8038.

(3) Hal Gunn, M.D. and Walter Lemmo, N.D. “Vitamin C and Chemotherapy: DHA vs. AA- looking at the broader evidence” (Letter-to-the-editor). Vancouver Sun, October 21, 2008. (See citations 2-24).

(4) Weijl NI, et al. Supplementation with antioxidant micronutrients and chemotherapy-induced toxicity in cancer patients treated with cisplatin-based chemotherapy: a randomised, double-blind, placebo-controlled study. Eur J Cancer 2004;40:10:1713-23.

(5) Carcamo JM, et al. Vitamin C is a kinase inhibitor: dehydroascorbic acid inhibits IkappaBalpha kinase beta. Mol Cell Bio 2004; 24:15:6645-52.

(6) Seung-Woo Hong, et al. Ascorbate (vitamin C) induces cell death through the apoptosis-inducing factor in human breast cancer cells. Oncology Rep 2007; 18:811-15.

(7) Koh WS, et al. Differential effects and transport kinetics of ascorbate derivatives in leukemic cell lines. Anticancer Res 1998; 18:4A:2487-93.

(8) Nevestani TR, et al. Vitamin C status in Iranian children with acute lymphoblastic leukemia: evidence of increased utilization. J Pediatr Gastroenterol Nutr 2007; 45:1:141-4.

(9) Anthony HM, et al. Severe hypovitaminosis in lung-cancer patients: the utilization of vitamin C in surgical repair and lymphocyte-related host resistance. Br J Cancer 1982; 46:3:354-67.

(10) Pathak AK, et al. Chemotherapy alone vs. chemotherapy plus high dose multiple antioxidants in patients with advanced non small cell lung cancer. J Am Coll Nutr 2005; 24:1:16-21

(11) Hoffer, John L. “Jury still out on the effect of Vitamin C on chemotherapy.” The Gazette. Tuesday October 7, 2008.

(12) Cameron, E., Pauling, L. Supplemental Ascorbate in the Supportive Treatment of Cancer: Prolongation of Survival Times in Terminal Human Cancer. Proc. Natl. Acad. Sci. USA. 1976 Oct; 73(10): 3685-9.

(13) Cameron, E., Pauling, L. Supplemental Ascorbate in the Supportive Treatment of Cancer: Reevaluation of Prolongation of Survival Times in Terminal Human Cancer. Proc. Natl. Acad. Sci. USA. 1978 Sept; 75(9): 4538-42.

(14) Simone, C.B., et al. Antioxidants and Other Nutrients Do Not Interfere with Chemotherapy or Radiation Therapy and Can Increase Kill and Increase Survival, Part I. Alternative Therapies. 2007 Jan/Feb; 13(1): 22-28.

(15) Simone, C.B., et al. Antioxidants and Other Nutrients Do Not Interfere with Chemotherapy or Radiation Therapy and Can Increase Kill and Increase Survival, Part II. Alternative Therapies. 2007 Mar/Apr; 13(2): 40-47.

(16) Jaakkola, K, Lahteenmaki, P, Laaksa, J, Harju, E, Tykka, H, Mahlberg, K. Treatment with antioxidant and other nutrients in combination with chemotherapy and irradiation in patients with small cell lung cancer. Anticancer Res. 1992; 12(3): 599-606.

(17) Lockwood, K, Moesgaard, S, Hanioka, T, Folkers, K. Apparent partial remission of breast cancer in ‘high risk’ patients supplemented with nutritional antioxidants, essential fatty acids and coenzyme Q10. Mol. Aspects Med. 1994; 15 Suppl: 231-240.

(18) Osaki, T, Ueta, E, Yoneda, K, Hirota, J, Yamamoto, T. Prophylaxis of oral mucositis associated with chemoradiotherapy for oral carcinoma by Azelastine with other antioxidants. Head Neck. 1994; 16(4): 331-339.

(19) Orthomolecular Medicine News Service, “Chemotherapy doesn’t work, so blame vitamin C,” October 7, 2008.

November 10th, 2008 | Tags: Mark Heaney, sloan-kettering vitamin c study, vitamin c and chemotherapy | Category: Cancer | Leave a comment

Part V: Why Doesn’t Insurance Cover Natural Medicine?

In this five-part series, we have taken an extensive look into the barriers, both practical and political, that stand in the way of insurance coverage of CAM (complementary and alternative medicine). In this last entry in the series, we will examine the pros and cons of insurance coverage and discuss whether it is even in the best interests of patients and the profession.

At first glance, insurance coverage of CAM sounds like a positive thing. Without insurance coverage, patients’ access to CAM therapies and treatments is limited by their ability to pay. Many patients are unable to obtain these treatments because they are not covered under their health plan, and they do not have the means necessary to pay for out-of-pocket care. Insurance coverage would open up widespread access to this area of medicine. For the profession as a whole, insurance coverage also appears to be a good thing, at first blush. Insurance coverage would seem to signify acceptance by large players in the mainstream medical system and would go a long ways towards truly integrating the two systems. It would also greatly expand CAM practitioners’ patient base, as lack of insurance coverage has been identified as the main reason patients do not seek CAM treatments (according to a study cited by the White House Commission on Alternative and Complementary Medicine Policy).

But what about the negatives?

The White House Commission on Alternative and Complementary Medicine Policy has pointed out that because patients who seek CAM treatments are paying out of their own pocket, they tend to take a serious interest in their treatment and participate fully in their care. If these treatments were to be covered by insurance, patients would lose their motivation to take an interest in their care. But this reason is small consolation to patients who desperately want access to CAM treatments but are blocked by financial limitations. Presumably, they are already taking a serious interest in their health, which is why they have taken the time to examine other treatment options in the first place.

On the other hand, concern over quality of care does raise a serious issue as to whether insurance coverage is really a step in the right direction. In Part I of this series, we reported that about one-fifth of Americans believe the current health system could be improved, and almost everyone in the remaining four-fifths feels it should be revamped altogether. As a result of this dissatisfaction, four out of ten U.S. adults go outside the health system to use complementary, natural, or alternative therapies. Some 600 million visits to these practitioners are made each year (which surpasses that made to conventional medical practitioners). Largely, this dissatisfaction is the result of the problems and constraints imposed by the insurance industry. In our blog article entitled “The Incredible Shrinking Doctor’s Appointment,” we reported on how the average appointment with a traditional medical doctor is now only 11 minutes in length. Patients are often rushed through appointments. One of the reasons that patients’ access to and time with their doctors is so constrained is because traditional practitioners are under pressure from insurance companies to keep appointments short.

Not surprisingly, so many people are going outside of the mainstream medical system for care because they are looking for individualized attention and a better quality relationship with their physician. These features are the hallmark of a CAM-approach to care, and in particular, a natural medicine approach, which is focused on identifying the root cause of illness. This approach is different from traditional medicine’s approach, which is often focused only on treating the symptoms or manifestations of the root cause. Individual attention and personalized treatment plans are considered by natural medical practitioners to be vital elements in the healing process. The amount of time a doctor spends with a patient to determine the root cause of illness is one of the greatest benefits that natural medicine offers. Patients who are disenchanted with the traditional medical system are often seeking the empathy and moral engagement provided by CAM practitioners. By giving insurance companies access to (and control over) CAM, it may be a step towards destroying the very fabric of the profession by suffocating patient care and severely limiting treatment options. CAM could take on the same constrained doctor/patient interaction, impersonality, and dehumanized care that many fault the traditional medical system for.

As a related concern, physician freedom and autonomy is paramount to the practice of CAM. Because the CAM approach to patient care is highly individualized, practitioners, such as naturopathic physicians, will often draw on a variety of treatments, which will be different for each patient, depending on the root cause of illness, symptoms, lifestyle factors, and other variables affecting the patient’s particular ailment. As a result, the practice of CAM does not lend itself well to standardized care and the attendant Clinical Practice Guidelines (which largely dictate the standard of care) described in Part III of this series. The insurance system depends largely upon uniformity to function- care must be standardized, because the system would fall apart if payment decisions had to be made on a case-by-case basis for every patient. Of course, that is not to say that CAM is devoid of agreement as to how to treat patients, but there is still a lot of variety in treatment methods in this extremely diverse field. The concern is that insurance coverage would signal the end of CAM practitioners’ ability to use the treatments and therapies that they believe best serve their individual patients.

Indeed, members of the CAM community who oppose insurance coverage often point to the osteopathic profession as an example of why coverage is a bad idea. Many in the CAM world believe that since osteopathic medicine has largely become a part of mainstream medicine, it has stopped existing in any meaningful sense. The fear is that the same would happen to CAM- the essence of the medicine would be washed away and watered down.

Another concern regarding insurance coverage of CAM has to do with the gatekeepers. Some in the industry have suggested that the best way to integrate CAM into the insurance world would be to have conventional medical doctors as the gatekeepers for referrals. The argument goes that having conventional medical doctors as the gatekeepers would eliminate the concern over run-away care and would provide some sort of model for integration. But many conventional medical doctors are not proficient in or even educated about CAM treatments, and they would have to start by learning the area. How would a conventional medical doctor refer a patient for a particular CAM therapy, if the doctor does not know much about that therapy or how it might benefit their patients? Finding doctors who do not hold preconceptions and biases towards CAM treatments and who would actually be willing to refer patients would also be a challenge. The same concern exists for the insurance companies themselves. These companies could potentially be making claims payment decisions and designing healthcare plans for CAM treatments without understanding the purpose or proper use of such treatments.

Ultimately, as outlined in this five-part series, there are a lot of steps that need to be taken and barriers to be overcome before widespread insurance coverage of CAM becomes a possibility. In the mean time, the debate wages on. For some patients, the potential negative consequences of coverage of CAM described above do not outweigh the benefit of having their preferred form of treatment covered. For others, they are concerned over maintaining the essential qualities and freedoms of the profession, even if that means that they have to pay out of their own pockets for care.

What is our hope for the future of medicine? Here’s a proposed model for healthcare:

The current model is based on “disease care” more than it is health care. So for starters, we would like to see the traditional medical system adopt a CAM-approach to primary care by placing an emphasis on prevention of disease, and by treating the cause and not just the symptoms of disease. Doctors would be encouraged to learn about CAM and preventative medicine in traditional medical schools. More time would be spent on biochemistry and nutrition, so that doctors would be able to educate their patients about wellness and not just about disease. To encourage utilization of preventative medicine, those primary care doctors who incorporate it into their practice would be rewarded through insurance reimbursement.

How would this model impact the world of medicine? If patients are being educated by their doctors on how to live healthy lifestyles and prevent disease, it would dramatically decrease overall healthcare costs. Most of our healthcare dollars in this country are spent on the three “big killers” – cardiovascular disease, cancer, and diabetes. Poor lifestyle choices can play a major contributing role in these diseases. With an emphasis on prevention and wellness, the incidences of these diseases would be dramatically reduced. Additionally, because fewer Americans would need to be medicated for high blood pressure and other preventable conditions, we would see a decrease in death rates due to drug interactions and reactions. Fewer surgeries would be needed. The number of law suits would decrease. Patients would receive more time and attention from their doctors and would feel better about the care they are receiving. Patients would also have more healthcare options, such as alternatives to drug options and access to non-invasive, effective procedures.

For those who have life-threatening diseases requiring surgery, they would be able to utilize CAM both pre and post operatively, and it would be built into their treatment and insurance plans. For patients with chronic disease and other serious conditions, integration of CAM treatments would allow them to achieve a better quality of life, better outcomes, faster healing times, and longer life spans.

At the moment, this model seems impossible. But as described in Part II of this series, steps are already being taken in this direction, especially in the area of cardiovascular disease. It goes without saying that our model would revolutionize the world of healthcare by actually promoting health and preventing disease. Better healthcare can happen, and it’s time to think outside the box. The infusion of CAM is just what the healthcare system needs to balance its shortcomings.

November 3rd, 2008 | Category: Insurance Coverage | Leave a comment

Part IV: Why Doesn’t Insurance Cover Natural Medicine?

In Part IV of this series, we continue our discussion from Part III regarding political barriers to insurance coverage of CAM (complementary and alternative medicine).

Safety, Efficacy, and Cost-Effectiveness Data

In the first two parts of this series, we examined some of the practical barriers to insurance coverage of CAM (complementary and alternative medicine), identified by the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). Some of those barriers included a reported lack of adequate information on the overall safety and efficacy of CAM therapies, as well as a lack of information on their cost-effectiveness. This information is critically important because it forms the foundation upon which coverage decisions are made, including everything from defining benefits, to designing health care plans, to making claims payment decisions and maintaining the financial soundness of the industry. Conventional medical coverage is based upon such information, and so coverage of CAM will be denied until it meets the same standards. But what about the quality of the information upon which conventional medical coverage decisions are made? How much of that information is reliable and free from non-scientific influences?

According to an article in the Journal of the American Medical Association (JAMA), recent studies have found that when investigators and medical researchers have relationships with pharmaceutical or product manufacturers, they are less likely to criticize the safety or efficacy of these agents. (1) Furthermore, this same JAMA article cited a study that examined the relationship between the source of funding for clinical trials and their reported outcomes. (1) The authors of the study determined that there was a significant association between positive results in general internal medicine clinical trials and funding from a pharmaceutical manufacturer. (1) These findings are not insignificant. According to the LA Times, in two and a half decades, drug companies’ funding of biomedical research (which has mainly been conducted at universities) has risen from $1.5 billion to $55 billion. (2)

But the concern over financial conflicts of interest is not limited to safety and efficacy data. Over the past decade or so, widespread use of economic analysis of pharmaceuticals and medical devices has become a valuable tool for healthcare decision-makers to assess the costs and benefits of drug therapies. These economic studies are playing an increasingly important role in healthcare decision-making because of the rising costs in the industry. This economic data, otherwise known as pharmacoeconomic studies, are used by managed care organizations and insurance companies, among others, to develop their coverage and payment decisions. As a result, pharmaceutical companies are increasingly conducting such studies to provide evidence that their products are cost-effective. And these drug manufacturers face increasing competition to show that their product offers more value and quality in terms of price than their competitors. But various articles have been written regarding concern over the lack of principles governing such studies. Concern has been raised over the validity, methodological quality, as well as the potential for bias and misuse. (1), (3), (4), (5) Pharmacoeconomics has developed into a complex specialty of its own, and at least one article published in JAMA showed once again that pharmaceutical sponsorship of economic analysis is associated with reduced likelihood of reporting unfavorable results. (1) Compounding this problem is the fact that many of those who need to use this pharmacoeconomic data are still not equipped to critically evaluate their quality or interpret them properly. The FDA was even prompted to issue guidelines enumerating principles it would use to review pharmacoeconomic claims for promotional purposes, in the hopes of addressing the lack of regulatory standards and potential for biased results. (4)

Nowhere is this debate over safety, efficacy, and cost-effectiveness more salient than in the area of cancer treatment. In an article published in 1993 in the Journal of the National Cancer Institute, issues regarding the efficacy and cost-effectiveness of cancer treatments were examined. (6) According to the authors, “many cancer treatments are, unfortunately, ineffective. Cancer mortality rates have not changed substantially in the past decade, despite a ‘War on Cancer.’” (6) The authors pointed out that while oncologists have focused on the question of whether treatment causes a “response,” society is asking whether treatment “increases survival or quality of life enough to justify the dollars spent compared with alternative uses of the same money….” (6) Given that now, in 2008, cancer is still claiming a life every 50 seconds, the same question remains: how effective are our current treatment methods?

In a highly controversial article published in 2004, three oncologists assessed the impact of cancer drugs on survival rates in Australia and the United States. (7) The authors analyzed the results of all randomized, controlled clinical trials performed in Australia and the U.S. that reported a statistically significant increase in 5-year survival due to the use of chemotherapy in adult cancers. Data from 1990-2004 were examined. The authors found that the overall contribution of chemotherapy to the five-year survival rate in adults was about 2%. In other words, as stated by one of the authors, Graeme Morgan, during a radio interview, “if there was no chemotherapy…the survival rate of all patients with cancer would drop from 62% to 60%.” As summarized by the authors, “despite the early claims of chemotherapy as the panacea for curing all cancers, the impact of cytotoxic chemotherapy is limited to small subgroups of patients and mostly occurs in the less common malignancies.” (7)

The authors addressed the issue of why so many patients undergo chemotherapy treatment when the benefits are generally so small. According to the authors, the answer is a game of statistics. The medical profession often presents the benefit of chemotherapy to patients in terms of relative risk instead of giving a straight assessment of the impact of such intervention on the overall survival rate. Ralph W. Moss, Ph.D., explained this difference in his March 5, 2006 newsletter. (8) Dr. Moss explained that while relative risk is technically accurate, it has the effect of making the intervention look more beneficial than it truly is. For example, as explained by Dr. Moss, if receiving a treatment causes a patient’s risk to drop from 4% to 2%, this can be expressed to a patient as a decrease in relative risk of 50%, which sounds very impressive. But another and equally accurate way of explaining this reduction in risk is to say that the treatment offers only a 2% reduction in risk, which most likely would not impress most patients. The presentation of these statistics in relative versus absolute terms has even been shown to influence treatment recommendations of oncologists. (8) Ironically, one of the criticisms of the 2004 chemotherapy study was that it examined absolute instead of relative benefit of chemotherapy to patients. The truth of the matter remains that if a seriously ill cancer patient was presented with a chemotherapy regime that would cause only a 2% reduction in risk while causing numerous and devastating side effects, he or she might opt for another form of treatment.

This argument, of course, is not to say that cancer drugs should not be covered by insurance. Indeed, at Envita, we treat certain patients with chemotherapy (alongside our natural treatments), as it still has a place in helping with particular malignancies. But the limitations and harsh side effects of these drugs must be recognized- and they should not be heralded as the answer to cancer.

Nor are we saying that all clinical trials involving conventional drugs should be dismissed or questioned as tainted by conflicts of interest. But the point is that before CAM coverage is denied on the basis of a purported lack of quality data regarding efficacy and safety, the same standards have to be applied to conventional medical coverage. Presumably, medical coverage decisions should not be based on just any data – the quality and reliability of the data should also be examined. And as discussed in Part I of this series, a threshold of what constitutes an “effective” and “safe” treatment must be established. If the threshold is an absolute benefit of only 2%, one has to wonder why alternative treatments are not already covered by insurance.

Both the political barriers discussed in Part III of this series, as well as the problems associated with the pharmacoeconomic model discussed here present considerable challenges to CAM’s gaining entry into the conventional medical system and accompanying insurance industry. Not surprisingly, these political barriers are not easily overcome, even when the scientific data fails to support the safety and efficacy of Big Pharma’s treatments. Let’s look at the real world example of bio-identical hormones.

An Example of Political Barriers to Entry: The Bio-identical Hormone Debate

Over the past decade, concern began to arise over the risks associated with synthetic hormone replacement therapy (HRT), used for the treatment of menopausal complaints and associated conditions. These synthetic hormones contain hormones that do not match those found in the human body, including estrogens from horses’ urine. In 2002, the U.S. government-sponsored Women’s Health Initiative (WHI) published a study showing a relationship between HRT and an increased risk in breast and uterine cancers, heart attack, stroke, and dementia. (9) The study involved 16,608 healthy postmenopausal women with a uterus, ages 50-79 who were randomized to either a test or placebo group. The test group received a combination of synthetic hormones, and the placebo group received none. The National Institute of Health had to halt the first part of the WHI study, because the results showed: a 26% increase of invasive breast cancer for those women who received the synthetic hormones over the placebo; a 29% increased risk of myocardial infarction or death from coronary heart disease; a 41% increased risk of stroke; a 200% increased risk of blood clots. (9) The sales of synthetic hormone therapies dropped almost 50% immediately, as patients and physicians began utilizing bio-identical hormones instead. Bio-identical hormones, unlike synthetic ones, match the structure and function of hormones naturally produced in the body. While synthetic hormones are produced by drug companies, bio-identical hormones are compounded by individual pharmacists.

Wyeth, the pharmaceutical giant that owns the Premarin synthetic hormone, saw a 68% decline in sales, from over $2 billion in 2002 to $880 million in 2004. Wyeth filed a petition with the Food and Drug Administration (FDA) in 2005 to stop the practice of compounding bio-identical hormones by individual pharmacists. Instead, in May of 2006, the FDA notified Wyeth of quality lapses in its manufacturing plant in Puerto Rico. But then in January of 2008, the FDA announced that there was no evidence that bio-identical hormone therapies are safer than prescription hormones made by drug companies. Still, synthetic hormone replacement therapy is generally covered by insurance while bio-identical usually isn’t. The bio-identical hormone debate is just one example of the barriers facing any CAM treatment that would take away from the sales of the pharmaceutical giants, regardless of the purported requirement of safety and efficacy data.

But barriers to insurance coverage of CAM are not necessarily a bad thing. In the last part of this series, we will weigh the pros and cons of insurance coverage of CAM and examine whether it is even in the best interest of patients and the profession.

References:

(1) Friedberg, M., et al. Evaluation of Conflict of Interest in Economic Analyses of New Drug Used in Oncology. JAMA 1999; 282(15): 1453-1457.

(2) Healy, Melissa. “From funding to findings.” Los Angeles Times. August 6, 2007, in print edition F-3.

(3) Task Force on Principles for Economic Analysis of Health Care Technology. Economic Analysis of Health Care Technology: A Report on Principles. Annals of Internal Medicine. 1995; 123(1): 61-70.

(4) Neumann, P., Zinner, D.E., and Paltiel, D.A. The FDA and Regulation of Cost-Effectiveness Claims. Health Affairs. 1996; 15(3): 54-71.

(5) Ofman, J.J., et al. Examining the Value and Quality of Health Economic Analyses: Implications of Utilizing the QHES. Journal of Managed Care Pharmacy. 2003; 9(1): 53-61.

(6) Smith, T.J., Hillner, B.E., and Desch, C.E. Efficacy and Cost-Effectiveness of Cancer Treatment: Rational Allocation of Resources Based on Decision Analysis. Journal of the National Cancer Institute. 1993; 85(18): 1460-1474.

(7) Morgan, G., Ward, R., and Barton, M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin. Oncol. (R Coll Radiol). 2004 Dec; 16(8): 549-60.

(8) Moss, R.W. Aussie Oncologists Criticize Chemotherapy- Part One. Cancer Decisions Newsletter. March 5, 2006.

(9) Moskowitz, D. A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks. Altern. Med. Rev. 2006; 11(3): 208-223.

October 27th, 2008 | Category: Insurance Coverage | Leave a comment

Part III: Why Doesn’t Insurance Cover Natural Medicine?

In Part I and II in this series, we examined some of the practical barriers to insurance coverage of CAM (complementary and alternative medicine), including those identified by the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP). Some of those barriers included a reported lack of research regarding the safety and “medical effectiveness” of CAM treatments, the lack of adequate information on the use, costs, and overall cost-effectiveness of CAM, as well as the operational hurdle presented by uniform billing codes.

But while these practical barriers can be overcome, the political barriers to coverage are a different matter. Because the discussion of political barriers will be an extensive one, we have had to split it up into two parts. As a result, our discussion of insurance coverage of CAM will now comprise Part III and Part IV of this series.

In order to understand the political barriers to coverage, we first need to understand the politics of the medical system itself.

Regulating the Standard of Care: Clinical Practice Guidelines

As discussed in Part II, insurance coverage largely depends on a system of uniformity- from consensus on appropriate and effective treatment to billing coding. The advent of clinical guidelines has played a large role in standardizing medical care.

Until recently, doctors were relatively free to rely on their own experience or judgment when selecting the best treatment for their patients. For example, in the treatment of high blood pressure, a doctor could recommend lifestyle changes or prescribe drugs. The doctor could decide which drug to prescribe, set a target blood pressure, and decide how long to wait before changing the prescription if the target blood pressure was not reached. (1) But over the past decade, governmental bodies, medical associations, and even insurance companies have begun producing clinical practice guidelines to standardize treatment decisions. (1) But while these guidelines are helping to set the standard of care, the tradeoff is physician freedom. (2)

As clinical practice becomes more standardized, physicians have become more restricted. Those who step out of the standardized practice guidelines make themselves vulnerable to litigation and become targets of their state’s medical boards. One of the worst examples of the penalties associated with stepping outside these imposed practice boundaries was described in our recent article regarding the treatment of Lyme disease. The Lyme disease treatment guidelines were written by the 14-member panel of the Infectious Disease Society of America (IDSA). For the physicians who have stepped outside of these guidelines, most have been hauled before their state’s medical licensing boards and have had their licenses suspended. One doctor was even sued by an insurance company for $100 million for his treatment of Lyme disease patients.

So given that clinical guidelines are largely shaping the practice of medicine and concomitantly, insurance coverage and reimbursement, we need to take a closer look at them. In an article that appeared in 2002 in the Journal of the American Medical Association, a group of researchers and physicians set out to examine the relationship between the authors of clinical practice guidelines and the pharmaceutical industry. (3) As stated in the article, at the time it was written, no data existed in the literature regarding the potential financial conflicts of interest for authors of clinical practice guidelines (CPG’s). As stated in the article, these relationships “may be particularly relevant since CPG’s are designed to influence the practice of a large number of physicians.” The article examined 100 authors of 37 different CPG’s. Out of those authors, 87% had some form of interaction with the pharmaceutical industry. Fifty-eight percent had received financial support to perform research, and 38% had served as employees or consultants for pharmaceutical companies. Fifty-nine percent of the authors had relationships with companies whose drugs were considered in the guideline they authored, and of these authors, 96% had relationships that predated the guideline creation process. Interestingly, almost 20% of the authors believed that their colleagues’ relationships influenced the recommendations they put forward. (3)

Once again, the IDSA guidelines for the diagnosis and treatment of Lyme disease provide a concrete example of these conflicts of interest. The IDSA guidelines have been widely criticized as inadequate and disastrous for those infected with the disease. The Attorney General of Connecticut, Richard Blumenthal, was even prompted to conduct an anti-trust investigation of the IDSA, suspecting that the guidelines process was tainted by the panel members’ conflicts of interest. Out of the 14 member panel, 6 of the panelists or their universities hold patents associated with Lyme disease or its co-infections; 4 received funding from test kit manufacturers for Lyme disease or its co-infections; 4 were paid by the insurance companies to write Lyme policy guidelines or serve as consultants in legal cases; and 9 members or their universities received money from Lyme disease vaccine manufacturers.

And it is possible that as a result of these conflicts of interest between the authors of CPG’s and the pharmaceutical industry, the clinical guidelines are not necessarily based on high-quality evidence. In an article published by the Public Library of Science (PLoS) in 2002, CPG’s from the United States, Canada, and Europe were examined for 3 conditions – diabetes mellitus, dyslipidemia, and hypertension. (1) The authors of the study set out to evaluate the quality of the evidence (based on the types of studies used, their internal validity, clinical relevance, and applicability) underlying therapy recommendations in evidence-based clinical practice guidelines. The authors found that of the 369 cardiovascular risk management recommendations in nine prominent national evidence-based guidelines, less than one-third (only 28%) were directly supported by high-quality evidence. (1) Indeed, with regard to the IDSA guidelines for the diagnosis and treatment of Lyme disease, out of the 400 scientific articles cited by the panel as support for their guidelines, about half were written by the panel members themselves. Meanwhile, a large body of contradictory scientific literature was ignored.

A perfect example of how financial conflicts of interest and the quality of the evidence can affect the development of CPG’s is the radical revision of the guidelines regarding cholesterol-lowering statins.

Prior to 2001, cholesterol-lowering statin drugs were used to treat adults with occlusive vascular disease. But in 2001, the clinical guidelines for diagnosing and treating high cholesterol in adults were revised, and a substantial proportion of the healthy population was put on statin drugs for preventative measures. The number of Americans for whom statins were recommended was increased from 13 million to 36 million. The 23 million additional Americans who were to receive cholesterol-lowering medication did not yet have coronary heart disease, but were estimated to be at a moderately elevated risk of developing it. In 2004, the National Cholesterol Education Program again revised the guidelines, this time adding 8 million more Americans to the list of candidates for cholesterol-lowering drugs.

In 2007, John Abramson, MD, of Harvard Medical School, and James Wright, MD, of the University of British Colombia co-wrote a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?,” which appeared in The Lancet. (4) According to Abramson and Wright, in revising the guidelines, the guideline authors did not rely on the data that already existed from primary prevention trials. Instead, the guidelines cite seven and nine randomized trials in support of statin therapy for prevention of cardiovascular disease in women and people over 65 years of age. But not one study provides such evidence to support the use of statin drugs in this manner. According to Abramson and Wright, the absolute risk reduction in coronary heart disease was small- about 1.5%, and to reach this minimal reduction, 67 people would have to be treated for 5 years to prevent one coronary heart disease event. Further, their analysis suggested that this minimal benefit is limited to high-risk men aged 30-69. Statins did not reduce total coronary heart disease events in 10,990 women in the primary prevention trials. As a result, Abramson and Wright concluded that “lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High risk men aged 30-69 should be advised that about 50 patients need to be treated for 5 years to prevent one event.” In other words, millions of Americans could be taking statin drugs like Lipitor without any clinical proof that they’re beneficial to disease prevention or their overall health. Further, the authors noted that “in our experience, many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall health.” Unfortunately, most people are not presented with the evidence or informed of the potential benefits of lifestyle modifications because of the various controls on the practice of medicine discussed above.

According to the LA Times, most of the doctors and experts on the committees that wrote these revised guidelines had financial ties to the pharmaceutical companies that produce statin drugs. (5) These new guidelines turned Lipitor, among others, into the world’s bestselling prescription medications. Lipitor is manufactured by Pfizer, which made more than $10 billion in sales of the drug in 2004 alone.

The implications of the politicization of medical care are far-reaching and directly affect insurance coverage for CAM. If pharmaceutical companies are largely controlling the standardization of medical care, how on earth is CAM going to gain entry into the system? The extremely diverse field of CAM does not possess the political power or economic stature to challenge the pharmaceutical companies. The issue of CPG’s does not even begin to touch on the other influences of the pharmaceutical companies on the practice of medicine, including the $8,000-$13,000 per doctor that the industry spends each year peddling its products, buying gifts, and paying for travel and other favors in an effort to influence treatment decisions. (6) Nor does it touch on the hundreds of millions of dollars spent each year on lobbying by Pharma and insurance companies alike. (6) Indeed, these other influences have a direct and powerful effect on the practice of medicine and the direction of medical research in our country.

In Part IV of this series, we will continue examining the political barriers to insurance coverage of CAM. Finally, in Part V of this series, we will examine whether insurance coverage of CAM is even in the best interests of patients and the profession.

References:

(1) McAlister, F.A., et al. How Evidence-Based are the Recommendations in Evidence-Based Guidelines? PLoS Med 2007; 4(8): e250 doi: 10.1371/journal.pmed.0040250.

(2) James, P.A. Family physicians attitudes about and use of clinical practice guidelines. J. Fam. Pract. 1997; 45: 341-447.

(3) Choudhry, N.K., et al. Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry. JAMA 2002; 287: 612-617.

(4) Abramson, J., Wright, J. Are lipid-lowering guidelines evidence-based? The Lancet 2007; 369: 169.

(5) Healy, Melissa. “From funding to findings.” Los Angeles Times. August 6, 2007, in print edition F-3.

(6) Weisbrot, Mark. “Uncle Sam Needs to Break Drug Companies’ Stranglehold on Prices.” San Francisco Chronicle. February 13, 2000.

October 20th, 2008 | Category: Insurance Coverage | Leave a comment

Part II: Why Doesn’t Insurance Cover Natural Medicine?

In Part I of this series, we began to examine some of the practical barriers to insurance coverage of CAM (complementary and alternative medicine). Our first entry examined some of the issues identified by the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP), including a lack of research regarding the safety and “medical effectiveness” of CAM treatments.

Another barrier identified by the Commission is the lack of adequate information on the use, costs, and overall cost-effectiveness of CAM. As described by the Commission, there currently exists an “information vacuum” when it comes to issues such as cost estimates for CAM therapies and treatments, which makes it difficult for purchasers and providers to comfortably and practically respond to consumer demand. The lack of information regarding the usage of CAM also does not bode well when it comes to insurance and managed care companies’ fear of runaway care.

But are the fears of costs and runaway care really justified? Since 1996, Washington State has had a law on its books that requires that private health insurance covers all licensed/certified categories of health care providers on an equal basis. Known as the “every-category-of provider” law, the statute stipulates that health plans cannot exclude any category of health care professional licensed to provide care for a condition covered by the basic health plan. (1) So under the law, a carrier must allow a subscriber to choose between providers in different categories when both are licensed to treat the condition. For example, for back pain, a subscriber may choose between an internist and an acupuncturist. (Not surprisingly, the law has endured its fair share of legal battles with the insurance industry.)

Washington State therefore served as the perfect “laboratory” for examining financial risks involved in CAM coverage in a 2006 study published in the American Journal of Managed Care. (2) The objective of the study was to examine how insured people used CAM and what role it played in overall health expenditures. The study examined covered services provided by four licensed provider types: acupuncturists, chiropractors, massage therapists, and naturopathic physicians. It analyzed three different health care plans involving a total of 600,000 enrollees ages 18 to 64 years, who were continuously enrolled for 12 months in a single, private health insurance plan. The authors concluded that “Payers have resisted covering CAM providers in part because of a fear that coverage would result in large, steadily increasing and unpredictable expenditures for CAM services, not unlike the history of prescription drug coverage. Our study performed six years after the mandated inclusion of CAM benefits in Washington state suggests that this is not going to be the case.” According to the authors, while the number of people using CAM insurance benefits was “substantial,” the impact on insurance expenditures was “modest.” The authors concluded that their data “suggests that insurance coverage of licensed CAM providers does not lead to runaway utilization.”

What about cost-effectiveness of CAM treatments? At least some data already exists on the cost-effectiveness of CAM when used in the area of prevention. Mutual of Omaha conducted a study with 333 heart disease patients. 194 of those patients followed comprehensive lifestyle changes including a low-fat plant-based diet stress management, exercise, and group support. 139 patients were in the control group. Those who followed the lifestyle changes were able to avoid invasive coronary bypass procedures and coronary angioplasty for at least 3 years without increasing the risk of a heart attack, stroke, or death. Savings were estimated to be about $29,500 per patient. As a result of the study, Mutual of Omaha now covers the lifestyle modification program. Similarly, a Highmark Blue Cross Blue Shield lifestyle modification study found significant decreases in cholesterol, blood pressure, weight, and depression, with cost savings as much as 30-60 percent. Highmark estimates that it saved over $16,000 on each patient who would have required surgery or angioplasty. In another study, Highmark found that claims were reduced from around $546 per patient to $273 in the year after entering the lifestyle modification program. Studies in the area of chronic pain and arthritis have shown similar cost-effective results from CAM interventions. In one particular study, physician visits decreased by 43% for those arthritic patients using CAM, which saved $648 per rheumatoid arthritis patient and $189 per osteoarthritis patient. Still, insurance companies state that they need more information on CAM’s cost-effectiveness for specific conditions.

But even if such fears regarding costs and utilization are overcome, further practical barriers still remain. From an operational standpoint, government agencies, insurance companies and managed care organizations use uniform coding systems for filing of claims and data management purposes. These codes drive much of healthcare and have taken on even further importance given the requirements of the Health Insurance Portability and Accountability Act (HIPPA), which greatly impact claim filing. The act now contains provisions that impose large fines per code for incorrect submitting and processing of claims. Insurance companies are even fined under the act for paying fraudulent claims. This coding data has also helped create a large database of information that is used by insurers to design health care benefit plans, set premiums, conduct actuarial analyses, manage provider networks and the costs and use of health services. Policy makers and health researchers also use this database of information to conduct clinical and health services research upon which public policy programs are grounded. But these uniform coding systems have developed alongside conventional health care, and they have a limited capacity to capture CAM practices and products. As stated by the Commission, this limiting coding capability presents a barrier to “health services research on the safety, benefits, and cost-effectiveness of CAM interventions, as well as on the efficiency of models of integration and collaboration, where claims data are needed by researchers.” It goes without saying that without standardized coding for CAM treatments, implementation of coverage and compliance with HIPPA regulations is difficult at best.

But while these practical barriers to coverage loom large, they are not insurmountable. Theoretically, a concerted and unified effort by CAM practitioners, governmental agencies, and insurance providers to develop universal standards of care, pursue coordinated research, and fill in the “information vacuum,” should go a long way towards expanding insurance coverage to more and more CAM treatments and practitioners. Of course, whether that effort is actually undertaken remains to be seen.

In Part III of this series, we will examine the political barriers to coverage. While the practical barriers can potentially be overcome, the political barriers present a different set of challenges. Finally, in Part IV, we will examine whether insurance coverage is even in the best interests of patients and the profession.

References:

(1) Wash. Rev. Code § 48.43.045.

(2) Lafferty, W.E., et al. Insurance Coverage and Subsequent Utilization of Complementary and Alternative Medicine Providers. Am. J. Manag. Care. 2006; 12: 397-404.

October 13th, 2008 | Category: Insurance Coverage | Leave a comment

Part I: Why Doesn’t Insurance Cover Natural Medicine?

It’s a question patients ask us all the time: Why doesn’t insurance cover natural medicine? Because this is such an in-depth and critical issue, we will examine it in a four-part series. In Parts I and II of this series, we will examine the practical barriers to insurance coverage; in Part III, we will examine the political barriers; and in Part IV, we will examine the pros and cons of having insurance companies cover natural medical treatments, and whether it is in the best interest of patients.

The United States spends about $1.5 trillion on health care each year. About one-fifth of Americans believe the health system could be improved, and almost everyone in the remaining four-fifths feels it should be revamped altogether. As a result of this dissatisfication, four out of ten U.S. adults go outside the health system to use complementary, natural, or alternative therapies. Some 600 million visits to these practitioners are made each year (which surpasses that made to conventional medical practitioners), and patients pay an estimated $30 billion out of their own pockets for such non-traditional care per year.

Currently, there is some insurance coverage for alternative therapies such as chiropractic visits and acupuncture, but the prevalence of this type of coverage is no where near that of conventional treatments. Usually large employers (with more than 20,000 employees) are more likely to offer access to these non-traditional practitioners than medium or small employers. This coverage usually exists in 4 forms: (1) as a rider or supplement to the basic benefit package, which will often contain strict controls on its usage; (2) as a discount program where covered employees pay out of pocket but are eligible for discounts off fees or products (usually tied to an approved network of non-traditional practitioners); (3) as a defined, core benefit, which is managed by: limiting the type of non-traditional services covered (usually to chiropractic and acupuncture), requiring pre-authorization or referral by a primary care physician, or setting visit or dollar limits and higher co-payments than that for routine physician visits; and (4) as a benefit account, which typically has an annual dollar amount. But this coverage excludes a vast number of treatments, including almost all of natural medicine, in addition to the fact that those services that are covered are extremely limited and restricted.

If consumer demand for natural medicine and alternative therapies is so high, why the big hold up? Why isn’t natural medicine covered by insurance already?

The White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) was formed in March of 2000 to address, among other things, issues related to access and delivery of CAM (complementary and alternative medicine). The 20-member Commission was established by the President’s Executive Order No. 13147, and its primary task is “to provide, through the Secretary of Health and Human Services, legislative and administrative recommendations for ensuring that public policy maximizes the potential benefits of CAM therapies to consumers.”

The Commission held a series of ten meetings in and around Washington D.C. over a span of two years. At these meetings, clinicians, researchers, medical educators, regulatory officials, policymakers, practitioners, and others were asked to provide recommendations regarding Federal policies related to CAM. The Commission also solicited public testimony during a series of Town Hall meetings around the country. Overall, the Commission heard from approximately 1700 consumers, professional groups, societies, and health care organizations. They also visited several medical institutions and CAM clinics throughout the country. One of the public policy issues examined by the Commission was coverage and reimbursement of CAM.

The Commission identified several barriers to coverage inherent in the healthcare industry. First, insurance and managed care executives interviewed by the Commission indicated that CAM therapies are not covered because there is a lack of evidence supporting their “medical effectiveness.” The current climate of “runaway care,” rising healthcare costs, and the constant stream of new technologies and drugs has left decision-makers in the insurance equation cautious about expanding any healthcare benefits. They are “concerned that their limited dollars be spent on care that has been shown to be safe and effective.”

But to say that more research is needed on the safety and effectiveness of CAM is an over-simplification of the issue and does not even begin to address the underlying practical and theoretical problems involved. Admittedly, the body of research supporting the effectiveness of CAM is not as extensive as that supporting conventional therapies. But this fact is not surprising given the astronomical costs associated with such research, which are costs that are more easily shouldered by pharmaceutical companies (that have direct financial interests) than by the multitude of individual practitioners that make up the hugely diverse field of CAM. While the industry average might be $30 billion, the industry itself is made up of everyone from internet peddlers to legitimate practitioners. Meanwhile, single pharmaceutical companies, such as Pfizer, report revenues well-above CAM’s entire industry average.

The economic barrier aside, another related barrier to this lack of research is that no universal theoretical model currently exists as to how to integrate CAM with conventional therapies. While the Commission’s recommendation is that research be conducted to compare conventional and CAM approaches for the same condition, to test the effectiveness of individual and combined CAM treatments, and to test CAM treatments offered in conjunction with conventional therapies, there is no consensus or universal “standard of care” within the diverse CAM world as to treatment or integration. In other words, there is no readily available design for a CAM benefit model. Before the process could even begin, CAM practitioners would have to sit down and reach a consensus on which therapies should even be included as the subject of research for treatment of a particular condition, and how such therapies would be integrated with conventional treatments for that particular condition, which would be no easy task. And a consensus would also have to be reached regarding the research methodologies that would be used to evaluate the effectiveness of CAM treatments. While the classic evaluation of the effectiveness of treatment focuses on “response,” or alterations in physical condition, this marker can ignore the serious impairment that such treatments can have on patients’ quality of life or even length of life, such as with cancer treatment, for example. In contrast, CAM often places equal emphasis on the total effect that treatments have on patients, including patient comfort, functionality, energy, sleep quality, pain, and mood. Would the criteria used to assess the effectiveness of conventional medicine be expanded to include CAM’s criteria regarding quality and length of life? Or would CAM treatments, which often operate from a different clinical paradigm, be squeezed into a conventional model in determining which treatments should be included in coverage?

Another related issue would be how the safety of CAM treatments would be assessed for the purpose of including them in coverage. CAM therapies and conventional therapies are held to different standards, and any examination of the safety of CAM treatments would most likely be subject to much more scrutiny than conventional treatments. Currently, more than 100,000 Americans die each year from complications caused by prescription drugs being used as intended, and more than 2 million are hospitalized with such complications. But the American public has come to accept such occurrences. These statistics and the side effects associated with conventional treatments have never raised pervasive concern. In contrast, adverse events associated with CAM treatments get widespread alarmist attention. Indeed, the Commission stated that in order to cover CAM, information would first be needed on how such treatments affect worker productivity, morale, recruitment, retention, and stress. It is doubtful that conventional treatments were subject to such evaluations or that such preconditions were placed on their coverage. It remains to be seen how these differing standards would affect approval of insurance coverage of CAM.

According to the Commission, the research regarding safety and effectiveness is needed to form the criteria used by insurance companies and managed care organizations in deciding what is “medically necessary” when it comes to treatment and claims. Insurers and HMO’s rely greatly on medical necessity criteria to define the extent of a benefit, manage the use of it, and make claims payment decisions. As stated by the Commission, these criteria are also used to control use of and spending on health care services, determine cost estimates on which premiums are based, and “maintain the financial soundness of the insurance and managed care industries.” The actual process of determining what is medically necessary is based on studies and criteria developed by academic medical institutions, professional organizations, private companies, and even the insurers and managed care companies themselves. But as stated by the Commission, currently, “few criteria are available to guide practitioners in deciding the medical or, more generally, the clinical necessity of CAM interventions.” Until this gap in research regarding safety and efficacy, and therefore clinical necessity, is filled in, this practical barrier to coverage remains in place.

Additional barriers relate specifically to Medicare coverage of CAM. Under Medicare’s 55 benefit categories, services and products must be “reasonable and necessary” in order to be covered. The criteria for determining what is “reasonable and necessary” are very specific. Once again, without the research on CAM’s safety and efficiacy, it is difficult to work such treatments into the “reasonable and necessary” criteria. The Commission delineates further barriers to CAM’s inclusion in Medicare coverage, including anti-kickback rules, which restrict referrals between conventional and CAM practitioners making it difficult to provide for medicare coverage in integrated practice settings.

At Envita, we believe that regardless of insurance coverage, the issue of data and research to support the efficacy and safety of advanced natural medicine is critically important. We are attempting to create, through our treatment protocols, a standard for the industry. We are using treatments that are already based in the published peer-reviewed scientific literature so that the clinical evidence of their effectiveness can be expanded. In addition, we have created quality of life studies so that there are tangible data to also support the benefits of advanced natural medicine on the overall well-being of patients. As more practitioners and treatment facilities do the same, the body of support for CAM will begin to grow, which inevitably will be a step towards removing some of the practical barriers discussed above.

In this article, we have just begun to scratch the surface when it comes to the barriers involved in coverage of natural medicine and CAM. In Part II of this series, we will continue our examination of the remaining practical barriers to coverage, including the lack of adequate information on the use, costs, and overall cost-effectiveness of CAM, as well as the operational hurdle presented by uniform billing codes.

October 7th, 2008 | Tags: insurance and natural medicine | Category: Insurance Coverage | Leave a comment

Under Our Skin: The Untold Story of Lyme Disease

On Saturday, September 27, 2008, the Fullness of Life Foundation hosted the first Arizona screening of Under Our Skin, a documentary film about the untold story of Lyme disease.

Lyme disease is the most common insect-borne disease in America and is one of the fastest growing infectious diseases in the country. According to the Centers for Disease Control (CDC), while about 20,000 new cases of Lyme disease are reported each year, it is estimated that there are actually over 200,000 new cases per year. This number is greater than the number of cases of AIDS, West Nile Virus, and the Avian Flu combined. Cases are so grossly underreported due to a number of factors, including: inaccurate testing, the fear by treating physicians that they will be subject to medical board scrutiny, and physician ignorance regarding how the disease is transmitted and its clinical diagnosis. According to the CDC, the NIH, and the FDA, Lyme disease should not be ruled out based on tests alone. Instead, Lyme diagnoses should be based on clinical signs, symptoms, history, exposure risk, course of illness, and testing should play only a supportive role. Conditions such as Fibromyalgia, Chronic Fatigue Syndrome, multiple sclerosis, ALS, Parkinson’s, and Alzheimer’s, as well as some 350 different diseases, have symptoms similar to Lyme disease. Known as “the great imitator,” the total number of symptoms associated with Lyme disease can total around 100. Lyme disease can also carry with it many co-infections that will interfere with its clinical diagnosis. Prolonged and intense treatment is often needed to rid the body of the disease if it is not caught in its initial stages. Still, the medical establishment, with input from the insurance industry, has stated that the disease is easily detectable and treatable, and that chronic Lyme disease does not exist.

About 250 people attended the Arizona screening of this eye-opening film. After the showing, Envita’s Chief Medical Officer, Dr. David C. Korn, D.D.S., D.O., M.D.(H), an expert in the diagnosis and treatment of Lyme disease, and Dr. Stephen E. Fry, M.D., a Lyme researcher for over 14 years, were on-hand to answer questions from the audience.

Also in attendance was the film’s senior producer, Kris Newby, who introduced the premier. Kris is an award-winning screenwriter and science writer, with engineering degrees from Stanford and the University of Utah. She also has first-hand experience with Lyme disease. Both she and her husband were infected with it. But it took them 10 doctors and $60,000 to get diagnosed properly. Their tests came back positive twice, but they were told by doctors that the chances that they both had it were like winning the lottery. They were told that they instead were suffering from a couple’s psychosomatic illness. Kris found out that she and her husband were not the only ones who were told that their debilitating symptoms were “all in their heads.” Kris was appalled at the way Lyme patients were being treated and misdiagnosed. After her experiences and struggles with a medical system that refused to acknowledge her illness, she could not just go back to life as usual and pretend as if her experience was an unfortunate but isolated incident. She had to do something about it. Together with Andy Abrahams Wilson, the film’s producer, director, and cinematographer, Kris began a four-year, $700,000 project of making the documentary. Andy’s twin sister had also been diagnosed with Lyme disease and similarly battled physician ignorance and hostility in her quest for proper diagnosis and treatment.

We were blown away by the film. Kris and Andy traveled to every corner of the United States interviewing Lyme patients and physicians to tell their stories. The documentary follows seven patients and four physicians as they battle for their lives and livelihoods amidst a health care system that is unwilling and unable to cope with the silent epidemic of Lyme disease. Interspersed throughout the film are head shots and sound bites from countless other Lyme sufferers. The film’s greatest testimony to the dire need for proper diagnosis and treatment came from its featured patients. The difference in the patients who were able to find Lyme-literate physicians to treat them, and their amazing but arduous roads to recovery stood in stark contrast to those patients who were unable to find help. The film’s worst case scenario of untreated neurological Lyme was a young man named Jared Shea, who is now confined to a wheelchair and is unable to speak after no doctor would diagnose or treat him, instead ascribing his problems to an “unknown etiology.”

The film also takes a terrifying look at the politics of the disease, including the 14-member panel that wrote the 2006 Lyme disease treatment guidelines. This panel was made up of members of the Infectious Disease Society of America (IDSA), a national medical group whose purpose, according to its website, is to improve healthcare in areas related to infectious diseases. But these guidelines have been widely criticized as inadequate and disastrous for those infected with the disease. Patient advocates maintain that insurance companies use the guidelines to deny payment for long-term antibiotic use. According to a recent John-Hopkins study, the IDSA-endorsed two-tiered testing procedure misses 75% of positive Lyme cases. (1) The guidelines also recommend only two weeks of antibiotic treatment for Lyme disease, yet research has shown that antibiotic treatment for 14 to 21 days results in a 26-50% failure rate, as the stubborn disease-causing bacteria persists much longer in the body. (2), (3) The guidelines also negate the existence of chronic Lyme disease, with one panel member instead characterizing it as “more related to the aches and pains of daily living rather than to either Lyme disease or a tick-borne co-infection.” Out of the 400 scientific articles cited by the panel as support for their guidelines, about half were written by the panel members themselves. Meanwhile, a large body of contradictory scientific literature was ignored. The Attorney General of Connecticut, Richard Blumenthal, even conducted an anti-trust investigation of the IDSA, suspecting that the guidelines process was tainted by the panel members’ conflicts of interest. Out of the 14 member panel, 6 of the panelists or their universities hold patents associated with Lyme disease or its co-infections; 4 received funding from test kit manufacturers for Lyme disease or its co-infections; 4 were paid by the insurance companies to write Lyme policy guidelines or serve as consultants in legal cases; and 9 members or their universities received money from Lyme disease vaccine manufacturers. Allowing diagnostic and treatment guidelines to be written by panel members who are tied to manufacturers that have a stake in the outcome raises serious and obvious concerns.

Equally horrific was the film’s glimpse into the lives of a handful of Lyme-literate physicians. Most were hauled before their medical licensing boards in a stupendous display of political showmanship and corruption. Their hearings were nothing more than procedural formalities; the outcomes and the fate of their medical licenses had already been determined as soon as they became known as prominent Lyme physicians. One doctor, Dr. Joseph Jemsek, M.D., was rejected from serving on the Lyme disease guidelines writing panel, despite the fact that he was one of the leading Lyme-literate private-practice physicians in the southern United States. Instead, he was charged by the North Carolina Medical Board for improperly diagnosing several patients with Lyme disease and offering controversial intravenous antibiotic treatments. He was officially sanctioned by the Board, and as the result of having to defend himself against the various accusations against him, ended up bankrupt and had to move his practice to South Carolina. The film concluded its story on Dr. Jemsek by reporting that he was recently sued by Blue Cross Blue Shield of North Carolina for $100 million for his treatment of Lyme patients. The majority of the medical complaints against Lyme physicians such as Dr. Jemsek are not from patients, but from insurance companies trying to get rid of doctors that cost them too much money. The end result of these witch hunts is that patients are losing access to the only physicians who can save their lives.

The Arizona screening of Under Our Skin was just one of many that have taken place all across the United States. Even though Kris and Andy are still looking for a distributor for the film, it has already been shown in over 100 locations simply due to the grassroots efforts of Lyme patients who believe, as Andy does, that “Awareness literally will save lives.” These patients have taken it upon themselves to host their own screenings for their communities. One of the most recent screenings took place at the Russell Senate Building on Capitol Hill. Andy played excerpts of the film for a standing-room only crowd during an historic congressional lunch-hour briefing. Legislators were invited to a full screening of the film at the Avalon Theater in DC the following day. Andy then flew to the Camden International Documentary Film Festival, in Rockland, Maine, where the film sold out the 400-seat Strand Theater. Next, it was on to North Carolina. Andy and Kris share the task of traveling all over the country to attend these grassroots premier screenings.

This film is a must-see for Lyme patients and practitioners alike. If you are interested in hosting a screening for your community, visit the screenings section of the Under Our Skin website to find out more information.

In case you missed it the last time, here is the preview to Under Our Skin:

Resource Links:

Fullness of Life Foundation

Under Our Skin Website

Envita’s Lyme Disease Education and Information

References:

(1) Coulter, P, et al. Two-Year Evaluation of Borrelia burgdoferi Culture and Supplemental Test for Definitive Diagnosis of Lyme Disease. Clin. J. Clin. Microbiol. 2005; 41: 5080-5084.

(2) Wahlberg, P, Granlund, H, Nyman, D, Panelius, J, and Seppala, I. Treatment of late Lyme borreliosis. J. Infect. 1994; 29(3): 255-61.

(3) Oksi, J, Marjamaki, M, Nikoskelainen, J, and Viljanen, M. Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann. Med. 1999; 31(3): 225-32.

October 1st, 2008 | Tags: under our skin | Category: Lyme Disease | Comments (2)

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Under Our Skin: The Untold Story of Lyme Disease

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