Part 6-HIV & Breastfeeding

In 1997, I was troubled with the statements made by the CDC about hiv and breastfeeding--it was not recommended. Why would breastfeeding, an immune system booster, a natural vaccination against the pathogens in a woman's environment, be counterindicated because of hiv? The belief was/is that hiv is more infectious than helpful. [Yet we know that researchers have never found "infectious" hiv in breastmilk. And we know that the hiv tests used back in the early days of the hiv/aids scare are no longer considered accurate for infants. ] At that time, my only understanding of hiv and breastfeeding was that it was not recommended. I believed that the CDC was an organization devoid of conflict of interest. Government had no vested interest in products. Their scientists must have a degree of freedom to pursue their interests. Wrong.

In 1995, the CDC Foundation was formed through legislation. The CDC Foundation partners with corporations to support the programs of the CDC. Sounds good, eh? If ya don't have the money from Congress, just turn to the corporations. This is an interesting quote from their website, "The CDC Foundation is fully accountable for monitoring the progress and success of all our programs. This focus on accountability offers partners the assurance that their investments are carefully protected."

http://www.cdcfoundation.org/about/whatwedo.aspx

Their featured partner is Cargill-helping 47 elementary schools with their nutrition policies as well as physicial activity. We learn at this website the names of a variety of companies that give unrestricted support to the CDC Foundation (which gives the money to the CDC). Of interest, is that for the year 2006-2007 some of the companies were Bristol-Myers Squibb (Mead Johnson infant formula), Coca-Cola, Hoffman-LaRoche, Kaiser Permanente, Merck, Merck Foundation, Novartis Vaccines and Diagnositics, Pfizer and their Foundation, Roche, Sanofi Pasteur, Wyeth (infant formula maker) and yes OraSure Technologies. I am intrigued at how we can believe that the CDC is independent of commercial interests??? for a listing of all the companies see

http://www.cdcfoundation.org/partners/corporations/index.aspx

Foundations are the middlemen. The CDC can say that they are not influenced by industry because technically they aren't getting the money directly from industry. Their foundation does that job. And the public will believe that health policy is written in an unbiased atmosphere of good science. Dream on....in some ways the hiv/aids policy is like our belief in the weapons of mass destruction in Iraq. We want to believe that our public policy is based in truth. We buy into the fear promoted by the media. Because how could the NY Times or the Washington Post be wrong? We believe we have an independent media. It is next to impossible for us to believe that public policy could be so wrong. With lives at stake, how could decisions be made based on the corporate need for profits. Some people still believe there are weapons of mass destruction in Iraq. Many people still believe that hiv=aids=death because health care policy is never questioned. Blind acceptance and blind obediance. Funny how the media is now saying that the hiv "epidemic" is over. Was there ever a epidemic? And why do they need more money now, if the epidemic is over?

Copyright 2008 Valerie W. McClain

Part-5 HIV & Breastfeeding

The Package insert for the OraQuick antibody test states, "The OraQuick Advance Rapid HIV-1/2 Antibody Test is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically."

http://www.fda.gov/CBER/pmasumm/P01004716S.pdf

If one is healthy, is it logical to be tested for an infectious disease based on antibodies? The package insert states that a diagnosis is based on "clinical syndromes" not on their antibody test. And yet we take a healthy population...and most pregnant women are a healthy group of people and we test them for antibodies. Healthy people have antibodies--its how our immune system works. It doesn't mean we are ill, it means our bodies picked up the disease and successfully fought it off. Otherwise, we would be sick or dead. But by current medical dogma, if you test positive for hiv, you are sick and will eventually get AIDS. The testing companies know that antibody testing on healthy populations will create a high level of false positives--its the reason for this statement in their package insert. The test was not meant to be a diagnostic. And yet we are using this test on almost all pregnant women. The prenatal clinics (one of the few places where hiv testing is available) in Africa use the number of positives on hiv tests to predict hiv/aids cases in Africa. So they predict an epidemic based on antibody testing. How accurate can that be??? Pregnancy is not a disease...women are going to prenatal clinics not because they are sick but because they want care for a biologically normal condition. One of the reasons for a false positive hiv test is pregnancy. Is antibody testing of pregnant women logical? Seems like a receipe for disaster. Heck the company told us in the package insert that it shouldn't be used as a diagnostic. They have wormed their way out of their liability.

Copyright 2008 Valerie W. McClain

Part 4-HIV Faith & Breastfeeding

"The bleeding heart"

HIV faith involves believing that "exclusive" breastfeeding should be promoted in "low-resource" settings (countries like Africa). And more recently studies are showing that abrupt cessation of breastfeeding does not improve survival of those infants of hiv-positive mothers. (New England Journal of Medicine, July 10, 2008-"Effects of Early, Abrupt Weaning on HIV-free Survival of Children in Zambia.") But in resource-rich countries like the USA, breastfeeding by hiv-positive mothers is discouraged. The word discouraged does not actually describe what is said to hiv mothers in the USA. Thus world policy on hiv and breastfeeding is like a forked tongue. Dependent on where you live, you will either be encouraged or discouraged to breastfeed. From the standpoint of a poor, under-educated hiv-positive woman who lives in a resource poor country and is being told to breastfeed, the policy makes little sense. Infant formula is the unattainable food that will save her infant. But she is denied this commodity because of her poverty. For the educated, hiv-positive woman in a resource rich country, breastfeeding is the value. But she is denied it because of her wealth. The policy is based on faith in HIV testing and its reliability. Policy is based on studies that did not define breastfeeding, and on on hiv tests that are no longer used to determine hiv status of infants.

One aspect of this policy is the belief that all women in the USA benefit from our resource-rich nation, all have access to excellent medical care. If infant mortality rates tell a story about the health of a nation, the story here in the US, would be a tale of two cities. The cities of the white and the wealthy with ease of access to medical care. And the cities of the poor, mostly non-white with little medical care and few resources. In Washington, DC in 2005 the black infant mortality rate in Ward 8 is 21.7 deaths per 1000 live births. In counties in Florida in 2006, the white infant mortality rate ranges from 3.4 to 6.9 and the nonwhite infant mortality rate is anywhere from 6.4 to 55.5. Cuba has an infant mortality rate of 5.9 (currentCIA statistics). Zimbabwe has an infant mortality rate of 50.58, Haiti 48.8, Vietnam 19.5, India 55.0. With such a racial divided infant mortality rate in the USA, why is that we believe that only poor hiv-positive women in Africa should breastfeed? Not one infant in 2006 in my county died of hiv (there was no AIDS category) but many infants died of pneumonia, septicemia, diarrhea, gastrointestinal and respiratory illness, SIDS. We will spend milions/billions on testing for hiv/aids. And companies like OraSure will ring the opening bell of the NASDAQ year after year.

Copyright 2008 Valerie W. McClain

Part 3-HIV Faith

In 2001, Scott Evertz became the Director of the White House Office of National AIDS Policy. In a variety of news article he is often referred to as the "White House AIDS czar." He was a public policy advocate in Wisconsin and worked closely with Tommy Thompson (head of the Department of Health under Bush until January 2005). In his capacity as the Director of White House Office of National AIDS Policy, he again worked with Tommy Thompson. Scott Evertz was also the President of the Wisconsin Log Cabin Republicans. The Wisconsin Log Cabin Republicans supported Bush's run for the president in 2000. And several members were rewarded for their support of Bush, besides Evertz.

Thompson left as head of the Department of Health in 2005 and later (2006)was hired as President of Logistics Health Inc. This company got its start in health screening for various professional agencies such as the FBI, Smith-Kline-Beecham, Sony, Target, & United Airlines. Their big financial break came when they got a contract with the military for vaccinating against anthrax The company provides health screening/services for the military-Department of Defense--as well as health testing for CSX Transportation.

http://www.logisticshealth.com/aboutlhi/history.aspx

There is an interesting article in the La Crosse Tribune regarding an outcry over this company having an unfair advantage in bidding for a contract to provide immunizations and physical and dental exams for reservists and National Guard members. Formal protests were filed with the GAO regarding this contract--companies bidding less, did not get the contract. The companies who lost believed that Logistics had an unfair advantage because of Tommy Thompson's previous position with the Department of Health and William Winkenwerder Jr. who previously supervised military health programs at the Pentagon.

http://www.lacrossetribune.com/articles/2007/10/27/news/00lead.prt

Getting back to Scott Evertz, once White House AIDS czar, he now holds the position of Vice President for International Affairs at OraSure. One can see that OraSure has a powerhouse of people with past connections to high government positions. And certainly that helps sell a product--when the President of the United States actually knows the name of the product you are selling and mentions it not only in the US but in the world forum. At one website dated in January of 2003, we learn that the President "widened his multibillion-dollar AIDS agenda and said a Bethlehem company's (OraSure) quick HIV test will be key to fighting the disease in the United States." Also mentioned in this article is how "regulations were waived so that the test will soon be more readily available."

http://www.hivworkshop.com/feb03-1.htm

One might call this the revolving door of business and government. How do we as members of a democratic society know for sure that decisions in government are totally unbiased regarding contracts made with corporations. Particularly, difficult to discern is whether there was some influence made on these government officials who later received good positions in companies that profit from government contracts. One company, Logistics, already has its competitors upset because of what is perceived to be an advantage of "influence." OraSure is luckier than Logistics because it has no to little competition when it applies for government contracts.

Newsweek had an article dated October 16, 2007 about OraSure "Investing in AIDS Testing." Brant, the writer of the article, states that Michael's, CEO of OraSure, hired Scott Evertz,White House AIDS czar, "who met with health ministers in Africa last month about making OraQuick more widely available through government-run health clinics." and "The CDC has been buying OraQuick in bulk an distributing them to clinics and even mobile testing units."

Troubling is the recent revelation that a number of health departments in the US are no longer using these test kits because of the number of false positives. Would OraSure have gotten as far as it has, if not for some well-placed people in the government? Why were regulations waived so quickly and easily? Why do we have faith in this test?

Copyright 2008 Valerie W. McClain

HIV Faith & Breastfeeding-part II

HIV Testing. We believe that a test will determine our fate. But maybe its time to look at the history of one hiv testing company that's fate is tied to the test of the NASDAQ. Their health and wealth is determined by the fickle fate of the state of their stock. Good news: a contract with the US Government and their stock goes up 4 points. Bad news: a Health Department questions their test kits reliability and down goes their stock. It's a roller coaster ride partly dependent on reality but mostly dependent on the minds of the buyers. OraSure Technologies (NASDAQ: OSUR)maker of a rapid saliva-based test kit for hiv was the creation of a merger between two companies (Epitope-based in Oregon, and STC). Epitope (public company in 1986) developed an oral fluid collection kit called "OraSure." They received approval from the FDA to test this kit on humans. In 1998 the FDA accused Epitope of paperwork and quality control violations. After inspection of their facility in Beaverton, Oregon they were cited for not ensuring that their collection devices were not contaminated. According to the OraSure's Company profile, history: "Although the actual product lacked full FDA approval and the company had yet to make a penny, its stock was valued at $160 million on the American Stock Exchange."

http://www.referenceforbusiness.com/history2/73/OraSure-Technologies-Inc.html

STC did substance abuse testing. Epitope and STC collaborated and created a kit called "Intercept." In 2000, STC and Epitope merger and became OraSure Technologies. The FDA in 2002 gave approval for the OraQuick Rapid HIV-1 test. Abbott Laboratories and OraSure agreed to "co-exclusively" distribute the test. In 2003 the CDC announced that it would use their test kit in their new national HIV testing initiative. That announcement created a rise in OraSure Stock. Writer Christian Berg in an article dated april 19, 2003 states, "OraQuick, the nation's only rapid, easy-to-use HIV test, is receiving phenomenal boosts from federal officials. Since it received federal approval five months ago, it's been touted by the Food and Drug Adminsitration, President Bush, Health and Human Services Secretary Tommy Thompson and now the CDC."

http://www.hivworkshop.com/apr03-1-1.htm

At the end of the article we learn that OraSure stock is $6.30 a share on the Nasdaq. Phenomenal boost...how does a company get recommendations from not only the FDA but the President of the US? One has to recognize that there are some dynamic individuals who created this testing kit and marketed it. Dr. Richard George is one such individual. Although he no longer works for OraSure, he worked for the CDC for 34 years and at the CDC served "as the Chief of Developmental Technology Section in the AIDS Program where he provided laboratory support and coordination for the CDC's international HIV/AIDS projects." (Business Wire Jan 10, 2003). He was a consultant to the World Health Organization. When he quit OraSure to join Calypte, he was hired as VP of Government Affairs--working with governement agencies. Thus the experience at the CDC would seem to be a helpful skill to any company marketing a product to the government. Another dynamic individual who still works at OraSure is Ronnie B. Lancaster, senior VP of Federal Government relations. He previously had worked at the US Department of Health & Human Services as an Executive Assistant for planning and evaluation of programs. He also worked for Assurant and the Morehouse School of Medicine. Employment in the US Government is a valuable asset to industry. Doors that are normally closed, open. The Presidential Advisory Council on HIV/AIDS 29th meeting (2006) had Douglas Michaels, President and CEO of OraSure as a speaker on "Prevention." All the other speakers were either from the CDC or US Health Department, Florida Health Department, NY Health Department or hiv/aids organizations. But this is not unusal for OraSure. In May of 2003, an event at the headquarters of OraSure had such guests as the deputy secretary of the US Department of Health, an ambassdor (Jack Chow), US State Department director, White House Office of National Aids Policy director, CDC chief ooperating officer, a captain from the US Navy, a representative from the office of US Senator Arlen Specter . In observance of National HIV Test Day, OraSure Technologies (June 27, 2008) opened the NASDAQ stock market with the National Association of People with AIDS. They also opened the NASDAQ in December of 2005 for World AIDS Day. I suspect that they get to open the NASDAQ stock market alot. On the December 2005 they "had a special NASDAQ-sponsored panel discussion and press conference on global HIV/AIDS prevention and treatment, featuring US Surgeon General Vice Admiral Richard H. Carmona,MD." (Business Wire-December 1, 2005.

In a summary of federal contracts to OraSure Technologies 2000-2007, we find that approximately $9 million of the $13 million given to them by the government was not competed for. No competition. The CDC and the Substance Abuse and Mental Health Services Administration were the top agencies that had these contracts with OraSure (also does substance abuse test kits).

It is interesting that Florida State Health Department literature states the use of OraSure test kits. They never say they are offering a rapid hiv test but use the product name, OraSure/OraQuick Rapid Hiv test. Name recognition, great marketing. How many know the name brand of a pregnancy test kit? I use to help at a Birth Center, doing pregnancy testing. I never knew the company or name of the test kit back then. It wasn't important--maybe because there were many different test kits--so we always said free pregnancy tests. But the Health Departments specifies OraSure, regarding the hiv test kit.

Recently the midday trading of Orasure dipped--New York City health officials' are suspending the use of the oral testing with OraSure/OraQuick rapid HIV test. The health officials reported, "a somewhat elevated number of discordant test results from October 2007 through April 2008." I think that means they were getting alot of false positives. The company in this article maintained that there is always a small possibility of false positive results but maintains that the test is 99.8 percent accurate." AP June 17, 2008 "NYC suspends oral fluid sample use in HIV tests" And the stock of OraSure dips to the tune of the misfortunes of some people in NY testing hiv positive when they weren't.

Copyright 2008 Valerie W. McClain

HIV Faith and Breastfeeding--part I

photo by Jessie McClain

Belief based on arrogance, ignorance, greed, and the rightness of your side is a sad religion. It makes for bad science. And that is what we have regarding the belief that HIV=AIDS=Death. Bad science and a very sad faith. The hiv/aids faith has created an economic imperative in the medical community: test kits, drugs, infant formula, or the last resort pasteurized human milk. The believer gives her/his blood so that the medical church can declare health or not. Faith is in the test. The test knows. The test is infallible like the pope. And if you fail THE TEST, then you are ill and must go through the exorcism of drugs...drugs that can kill. If you survive the drugs, you are still not pure enough because you have failed the test. If pregnant and the test failed, then it becomes a triple whammy of exorcism: drugs, c-section, and infant formula for the baby. If the baby is positive, then the baby also must face the exorcism of drugs.

Are the tests infallible? Who stands to made enormous amounts of money when all people are required to be tested? How is legislation passed on making hiv testing mandatory? Why do we believe that a test will determine our health, and not how we actually feel? What is the reasoning behind taking healthy populations and using antibody testing to determine health or non-health? The healthy person feels fine until they take THE TEST. THE TEST shows they have hiv. Now they feel sick, both physically and emotionally. But are they sick? It's an antibody test. A positive antibody tests shows the following possibilities a) the body has encountered the organism and successfully fought off the disease, b) it is fought off a disease but not necessarily the disease being tested for, c) the test kit was contaminated prior to testing, d) the testing itself was contaminated, e) you might have the disease but further testing is necessary. Now if you are pregnant and getting an antibody test then you are encountering another problem: the pregnancy itself may cause the antibody test to turn positive--this is not only true for hiv/aids but for other antibody tests during pregnancy such as the alpha-fetal protein. Now if the test is given to an infant, one encounters even more problems. The blood that is circulating in a newborn is maternal blood. In principle, if the mother is hiv positive, then the blood of the newborn is hiv positive. Infant's gradually make their own blood but will have maternal antibodies for up to 18 months or even longer. Thus antibody testing on a newborn tells you one thing, the hiv status of the mother not the infant's hiv status. PCR testing is the standard for determining an infant's hiv status. It is considered reliable at one month--but a retest must be done some months later because it isn't that reliable.

THE TEST becomes critical. For a healthy pregnant woman in the USA who believes in the diagnosis and what the health care system can do; a positive test will mean drugs (that may outright kill or maim the unborn baby), it will mean a C-section with all the risks of surgery to both mother and baby), not breastfeeding (increasing risks to the mother of breast and ovarian cancers), using formula (increasing the infant's risks to diarrhea, pneumonia, SIDS, future cancers-breast in particular, respiratory and gastrointestinal illnesses). The infant will be presumed to be at risk, whether in fact that is true or not, thus increasing medical interventions increasing the risks of illness and death.

And it all boils down to faith in THE TEST.

Copyright 2008 Valerie W. McClain

"Going for the gold" World Breastfeeding Week

Another World Breastfeeding Week around the corner, August 1-7. 2008. The theme this year is "Mother Support: Going for the Gold."

Well, it is certainly a going for the gold kind of year. How many patents and applications on human milk components? Over 2000. And add to that an application for a human milk composition, a standardized human milk.

Going for the gold.....a rather ironical statement...........oh the silence of the lambs....you won't hear a peep from me.......secrets and patents............sshh.......what a topsy-turvy world, where down is up and up is down..........and who really is going for the gold???

Ownership, invention, and control

The magnolia blossom unfolds magically. It must be magic--I didn't see it happen even though I stared at it for at least an hour. Just suddenly, there it is, and the bees and wasps are landing and relanding to get their fill of pollen. If I had the remote control for nature, I would just sit and watch this miracle happening over and over and over again. But I don't need a remote, because its there in my backyard and I can watch it all spring and summer long. I own the tree or so I think I do. It's on my property. I pay taxes on the property but do I really own it? Sometimes Florida Power & Light (FPL) thinks its their tree and hacks its branches out of the wires. They v-notch her, a butchered job, and I can't bear to watch or look at her for a month. FPL seems to own her, if she touches their wires. She is just a job to them, just a thing in the way of progress, our need for electricity. To me, she is a glorious living creature. Tall and beautiful, with wonderful shade in this hot and humid climate. A great invention, when men want to have her. But in the way and a burden to those of us who must have our electricity.

How do you patent human milk? Like the magnolia blossoming in its own time, breastmilk flows in its own time, regulated by birth and/or nipple stimulation. There it is...a miracle food for our children. We can't see the milk being produced nor see the ounces in designer plastic bottles. So, we question the magic, the miracle of nature. We think it is our property, afterall it is produced in our bodies. Yet someone else sees the beauty and decides that its utility should be shaped and pruned by men of science. They suddenly own it and can hack it into components that give it utility for our progressive society. Human milk as invention. Men will shape her into their definition of nature and natural. For after all they own this earth and with ownership one must control one's property. Fence, prune, and destroy it at will because one can do what one likes when its your property. But who truly owns nature? Who invents it? Who controls it? Men of science say they do. And then the hurricane comes......who controls who?

Copyright 2008 Valerie W. McClain

Human Milk ...An Invention

Isn't it bizarre to think that some humans are inventing a standardized human milk? Are the inventors (employees of Prolacta Bioscience) claiming ownership of pasteurized human milk with certain specifications? If so, what does this mean for the non-profit milk banking system? Will they be allowed to use their donated pasteurized milks for free? Or will they owe Prolacta?

What has this world come to when a part of our society believes that one can "invent" a standardized human milk? Who determines what the standard is regarding human milk? A corporation? Human milk is species specific, as are all mammal milks. Human milk is also specific for the individual--the mother's mammary gland reacts to the mother's environment by creating antibodies that protect the infant. Thus the level of protection through breastfeeding from mother to infant is far greater than an infant receiving donor milk (which is pooled, heat-treated, and/or fortified).

So what do breastfeeding advocates and organizations feel about this? Silence is acceptance. Is this an ethical approach to the problem of infant feeding? Is this justice? Is this taking away the power of human milk from its owners and designing a product to suit the whims of a new industry? Will the cries of our infants for the breast, for human intimacy be stilled? Human milk is not invention. It is not a product we redesign to suit the needs of an industry.

Copyright 2008 Valerie W. McClain

Ethics: Ask the roof cat

My roof cat, Neeko--photo by Valerie W. McClain

Ask a roof cat about life and living and she smartly stays silent. She prowls her territory with great agility and wisely surveys her domain from the safety of the roof. Ask a roof cat about ethics at breakfast time, and she meows quite loudly. How dare you postpone breakfast for some discussion that is of no interest to her life? Feed her and ask her again and she promptly runs to the roof. "Oh roof cat, what do you think about the patenting of human milk?" Meow and a graceful leap to the roof. She turns and leans over the roof to stare at you, unconcerned by the tumultous world of humans and their thoughts on ethics. She stares at you. She knows something, if only she spoke my language. She meows again and bolts to the other side of the roof to watch her mockingbird. Yes, her bird friend, who keeps her on her toes and tries to peck her to keep her from getting to close to the nest.

Ask a roof cat about birth and feeding her babies. How did it go for you? Birthing all those babies? Oh my roof cat, I am afraid I could not offer you drugs for your birth or even speed it up or slow it down. I sat and watched and petted you during the worst moments. I don't think you realized I was even there but then again maybe you do remember. Your kittens came one after another, ugly little wet animals, tail first looking like you were birthing snakes. I kept my hands out of your space and watched as you a new mother nursed your babies. I wondered were the babies correctly positioned? Should I move them closer? Should I touch your precious little ones? No, I think not. I let you and your family alone. I was astounded at how you as a new mother knew what to do. You fed them around the clock and never seemed to be weary. And as they grew older, you left them more and more. And when weaning began, you showed your irritation with the antics of your babies and yet you were their protector.

So roof cat, what do you think of the human world, where mother's milk can be owned and sold? If you could break the species barrier and speak to us, would you discuss the wisdom of companies owning mammal milks and selling them to save us all from the task of raising our young? Oh, I think you wouldn't care because you could not comprehend the enormity of a world gone mad. Jump to the roof, hide from the humans....it is a world gone insane by desire for wealth without conscience. Do you know roof cat that they have cloned a cat? Oh yes roof cat I am sure they have cloned a cat. Oh roof cat, roof cat...what do you think of that?

Copyright 2008 Valerie W. McClain