Saturday, February 20, 2016

The Pot Patent


In 2014 a Georgia farmer's okra plants were mistaken for pot-cannabis, marijuana.  When you garden, it's pretty hard to imagine anyone mistaking okra for cannabis.  But I suppose when seen from a helicopter, its rather easy to suppose that okra is cannabis.  There were a lot of gumbo jokes circulating in the media regarding this particular raid.  The retired Georgia farmer was understandably angry over the raid.  On the other hand a Texas organic farm in 2013 was treated quite a bit more poorly than the Georgia farmer.  The people on the Texas organic farm had their blackberries, tomatillos, and okra confiscated (not ever returned according to media reports)  All the adults were handcuffed, interrogated and a mother and her two-week old baby were separated. One adult was arrested for a traffic ticket violation.

Botany is a difficult subject and plant identification is not everyone's forte. Obviously, our government is waging a war on drugs.  Both these raids used heavily armed police.  And both raids were embarrassingly a mistake.  Human nature being what it is, is not always right in the matters of "truth, justice and the American way."  The only thing you can be sure of when you look up in the sky is that Superman doesn't live there anymore, just drones and helicopters.

As you can see this isn't my usual blog post.  I promise you this is about patents, just not human milk component patents.  You see I was curious as to how many patents did the US Department of Health and Human Services own. Why? Because they owned a human lactoferrin patent that I blogged about awhile ago.

 I wondered how many other patents did the government own? And in my search I got side-tracked by finding this patent entitled, "Cannabinoids as antioxidants and neuroprotectants," (patent # 6630507) filed in 1999 and owned by who else?  The United States of America as represented by the Department of Health and Human Services. In their abstract they state, "The cannabinoids are found to have particular applications as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia."

Rather ironic that the US Department of Health owns a patent on pot or should we say the components of the cannabis plant for its medicinal qualities.  Yet, it is an illegal drug.  Although in a number of states the medicinal use of cannabis is legalCould this change of attitude be because of patenting?  Have they licensed this patent out?  

It reminds me of the human lactoferrin patent owned by the Department of Health for use in immunocompromised patients (specifically hiv/aids patients).  Human lactoferrin is a component of human milk and in the USA hiv positive mothers are told not (prohibited in reality) to breastfeed.  Yet the government patent states the benefits of human lactoferrin in the treatment of hiv/aids.  Its like having a parent say do as I say, not as I do and not as I do to make money.

Politically, this is a major issue.  Governments owning medical patents is a conflict of interest, particularly when the government makes health care policies that increase monetary benefit to the government.  Is government a business?  I am confused about the boundaries of a government when they own patents.  Are official pronouncements about our health through the CDC and the FDA (who are part of the Department of Health) about health and safety?  Or maybe this is just another Catch-22 that all bureaucracies create.

" “There was only one catch and that was Catch-22, which specified that a concern for one's safety in the face of dangers that were real and immediate was the process of a rational mind. Orr was crazy and could be grounded. All he had to do was ask; and as soon as he did, he would no longer be crazy and would have to fly more missions. Orr would be crazy to fly more missions and sane if he didn't, but if he was sane he had to fly them. If he flew them he was crazy and didn't have to; but if he didn't want to he was sane and had to. Yossarian was moved very deeply by the absolute simplicity of this clause of Catch-22 and let out a respectful whistle." by Joseph Heller, Catch-22

Copyright 2016 Valerie W. McClain 


Wednesday, February 17, 2016

Crying Wolf or tales of the Zika, Zika virus

With apologies to Aesop...

Once upon a time there was a powerful Ruler, who owned many food, drug, vaccine and chemical companies.  This Ruler proclaimed that there was a vicious, viral, infectious Epidemic in the land.  The Ruler called his Social Marketeers together and had them proclaim to all in his land and every other land that there was an Epidemic spread by touch.  There was great fear in the land and quickly the infected took their medicines and vaccines.  Laws were passed forbidding the infected to touch the uninfected.  Those that broke the law were jailed. Lo and behold the Epidemic never happened as predicted. But many died. Some said they died from their treatment and some said they died from the infectious disease that was not a disease.   Some people questioned the truthfulness of the Ruler, particularly as they watched as the Ruler's companies became richer and richer.

Not long afterwards, the Ruler again proclaimed that there was a vicious, viral, infectious Epidemic in the land.  And once again the Ruler called his Social Marketeers to let his people know that there was an Epidemic in the land.  And once again the infected took their medicine.  There was great fear in the land but no one questioned the Epidemic.  They took their meds and vaccines.  And lo and behold the Epidemic never materialized.  And the people became angry. The people wondered why they were being lied to and some even questioned the right of the Ruler to profit from a misfortune that didn't exist.

Then the real epidemic came to the land, all the land.  The Ruler called his Social Marketeers and had them proclaim that there was an infectious viral Epidemic in the land.  And the people laughed and refused the medicine and the vaccines.  And the disease spread throughout the land.

The moral of the story is:  The Ruler who lies too many times is no longer believed when he tells the truth.

Copyright 2016 Valerie W. McClain

Sunday, February 7, 2016

Infant Formula in the USA, When Water Supplies Are Not Safe

"In general, the metals [lead, mercury, cadmium and other metals] found in breast milk are usually at lower levels than are found in maternal blood.  Thus breast milk is not the primary pathway of exposure for infants, prenatal trans-placental exposure is a much greater concern....infants fed formula made with tap water are at the highest risk from metals contaminating the water supply."
Natural Resources Defense Council,

The situation in Flint, Michigan is making headlines around the nation.  Unbelievable, upsetting and really heartbreaking that children, adults and pregnant women have been exposed to lead in their water.  Government officials have known about this contamination and kept quiet about it for over a year.  Which to my mind borders on criminal behavior.  I listened to Erin Brockovich on RealTime with Bill Maher.  She stated what is happening in Flint Michigan is just the "tip of the iceberg."  She mentioned a number of other cities in various states in our nation that are struggling with contaminated water supplies.  I read Michael Moore's website in which he details the situation in Flint.

In 2014 in West Virginia thousands of gallons of a toxic chemical, MCHM, leaked into the Elk River contaminating water supplies to 300,000 residents in the area. 

A number of states have confirmed that drilling/fracking has contaminated water supplies and/or private wells. 

In another article they state, "Public water supplies in 42 US states are contaminated with 141 unregulated chemicals for which the US Environmental Protection Agency [EPA] has never established safety standards..." 

Recently in Greene County in Pennsylvania they found high levels of radiation (60 times EPA levels) in a stream that flows towards a water treatment plant near Pittsburgh. 

And for second time in two years the "brain-eating" amoeba has appeared in the water supplies of St. Bernard Parish in Louisiana. 

The CDC declares on their website that the US has the safest water supplies in the world. But then they state that outbreaks of illness related to contamination of drinking water are reported every year. 

Health care policies regarding infant feeding choices are predicated on the safety of our drinking water.  It is presumed that in the US, our water supplies are safe. Therefore the choice to use infant formula is without risk.  Yet from the varied articles over the last two years it appears that this safety may not be necessarily true in some communities in the US.  And in fact it seems like more and more communities are experiencing various problems with their drinking water.

In the USA, hiv positive mothers are discouraged from breastfeeding because the presumption is that it is far safer to use infant formula than breastfeed.  Yet it is interesting that my water bill has stated for many years that immune deficient people such as those with hiv should use caution drinking the water because of Cryptosporidium (a parasite that causes diarrhea and can be deadly for those who are immune deficient).  The problem is that this parasite is very resistant to chlorine-based disinfectants and so it will survive the chlorination process.  Cryptosporidium is a problem that is world-wide and every community in the US has this problem. (Boiling the water for 3 minutes is the recommendation).  Is the public well-informed about this possibility?  And while breastfeeding builds an immune system, infant formula cannot do that.  The problem gets even more complex because the longer one boils water, the more concentrated contaminates like lead become in the water.  So you may eliminate the risk of cryptosporidium but if you have old lead pipes you increase the amount of lead in your water.  There are water filters that get lead out but that costs money and the filters have to be replaced.  Of course you can buy bottled water but often that bottled water is nothing more than tap water.  So being poor often means that such problems become too costly to correct.

If we continue down this path with more and more communities struggling to have clean drinking water, should infant feeding in the USA continue to be thought of as a balanced choice? Or shouldn't we be concerned about the expense and risk involved in choosing infant formula when drinking water is contaminated?
Copyright 2016 Valerie W. McClain



Monday, February 1, 2016

Burned at the Stake, Part 3: HIV Controversies and Experimentation

"It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.  I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine." --Dr. Marcia Angell

President Ronald Reagan's Secretary of Health and Human Services, Margaret Heckler announcing the probable cause of AIDS and introduces Robert C. Gallo, NIH scientist to the press on April 23, 1984.  On that very same day, April 23, 1984, at the US Patent & Trademark Office the United States of America as represented by the Department of Health and Human Services (assignee/owner to these patents) filed for 2 patents.  One patent #4647773 entitled "Method of continuous production of retroviruses (HTLV-III) from patients with AIDS and pre-AIDS," with inventors Robert C. Gallo and Mikulas Popovic.  And the second patent #4520113 entitled, "Serological detection of antibodies to HTLV-III in sera of patients with AIDS and pre-AIDS conditions," with inventors Robert C. Gallo, Mikulas Popovic and Mangalasseril G. Sarngadharan.


These inventions were about the creation of test kits for the detection of antibodies in the blood of AIDS and pre-AIDS patients.  This announcement coupled with the filing of these patents is an example of the haste to solve a crisis health situation.  And more importantly a haste to make money through ownership of an invention and a monopolization of that invention.  Should we be surprised that the US Government owns patents and licenses these inventions out, thus making money.  I had always believed that a government was a separate entity from a business.  Governments make laws that define and control a society and businesses make money and/or profits.  Yet here is situation where a government is invested in their own research and researchers-Gallo, Popovic, Sarrngadharan.  Ethically, the situation is somewhat disturbing if one believes that the US is a democracy.  It is government policies/laws that have determined that people, particularly pregnant mothers must be tested for this disease.  And the more people tested, the more money the government makes.  Thus the government is no longer a disinterested party in determining law or health care policies because it has an investment.

Believe it or not this situation gets even more ethically disturbing.  Prior to Gallo's discovery, he borrowed some cultures from the lab of Luc Montagnier.  Those cultures somehow got mixed in with his research cultures.  Either accidentally or deliberately Gallo's lab had contaminated their own samples with the French samples.  Those samples were considered the proof of Gallo's discovery of the probably cause of AIDs.

The Pasteur Institute in France sued the US Department of Health over this "borrowing."  The Pasteur Institute had applied for a patent on their cultures for a test kit for AIDs at the US Patent & Trademark Office a year prior to the US Department of Health's application for a patent.  For some reason the US Department of Health's patent application went through the process faster than the Pasteur Institute's patent application.  The US Department of Health's patent application became a patent while the Pasteur Institute's patent application just languished on a patent examiner's table.  Not surprisingly the Pasteur Institute in 1985 sued the US Department of Health over this situation.
This dispute went on for 2 years when a compromise was agreed to in which their would be a 50/50 split of credit for discovery of the virus and monies from the testing kits.  A few years later after further investigation, credit for discovery was given to Luc Montagnier and Francoise Barre-Sinoussi rather than Gallo and Popovic.  The 50/50 split became the 60/40 split in favor of the Pasteur Institute.  The Federal Office of Research Integrity found that Robert Gallo committed scientific misconduct. 

Gallo left his government research position at the NIH to form his own company. Luc Montagnier and Francoise Barre-Sinoussi won the Nobel Prize for their discovery of hiv and Gallo was left out.  These series of events in the discovery of hiv should be considered a themeIf hiv history was a Hollywood movie this would be the ominous cloud that would shroud the continuing events of  hiv/aids research and discovery. The use of AZT and its toxic nature and the thousands that died due to its toxicity should be engraved into the stone-cold history books of medical disasters.  

There are more tales of misconduct regarding hiv/aids research and let us begin with the drug trial of Nevirapine (manufactured by Boehringer Ingelheim) called HIVNET 012.  This drug trial is listed in a paper regarding unethical drug trials.  The problems with this drug trial were: "failure to get consent for changes in the experiment and administering wrong doses, poor record keeping, under-reporting of fatal and life threatening reactions, 12 deaths not reported."'Medicijnen'/examples_of_unethical_trials_feb_2008.pdf

HIVNET 012 was the first clinical trial to show that a single dose of nevirapine to mother and child would prevent hiv transmission.  Brooks Jackson was the clinical investigator in charge of this drug trial in Uganda.  John Hopkins had an article published about him prior to concerns about the ethics of this drug trial.  The rather fitting title is "The Pathologist Who Struck Gold." 

The HIVNET 012 trial was published in the Lancet in 1999 with many researchers involved besides Jackson. Some of the researchers are well-known to those who follow the studies done on Mother to Child Transmission of hiv:  LA Guay who is now VP of research at Elizabeth Glaser Foundation (which gets funding from Boehringer Ingelheim as well as Bill and Melinda Gates Foundation), L Mofenson who led hiv pediatric research at the NIH and is now employed by the Elizabeth Glaser Foundation, MG Fowler who is a professor of pathology at John Hopkins 

The HIVNET 012 trial collected breast milk samples and sent them back (frozen) to John Hopkins because they at that time did not have a PCR lab to test the breast milk.  Funny how John Hopkins is one of the co-owners of 2 human milk fat globule patents (to treat hiv/aids patients for diarrhea and/or rotavirus) patent #5505955 and #5667797 filed in 1995 and 1996.  Yes, just a coincidence.

HIVNET 012 drug trial became entangled in a Whistleblowing case involving Dr. Jonathon Fishbein, employed by the NIH, who alleged that there were well-known safety problems with NIH AIDS research in USA and Africa.  He was fired for his whistle blowing activity (much later reinstated).

An article in The Body entitled, "Internal Review says "Division of AIDS" A Troubled Organization..." states that Fishbein told a panel at the Institute of Medicine that "the Uganda study [HIVNET 012] was so poorly conducted that it potentially put the lives of hundreds of participants and infants at risk."

 In 2003 a US pregnant mom named Joyce Ann Hatford (diagnosed as hiv positive, although had no known risk factors) was enrolled in a study that was an outgrowth of the Uganda drug trial (yes, HIVNET 012).  She died 72 hours after a c-section from liver failure.  NIH researchers believed it was the drug that killed her.  An email from one of the NIH researchers stated that not much we [researchers at NIH] can do about dumb docs.  NIH researchers believed that Joyce Hartford's impending liver failure could have been picked up through testing and supposedly prevented.  Liver failure is a known side effect of nevirapine.

In 2004 investigative reporter, Liam Scheff wrote about hiv positive foster children and orphans  in Incarnation Care Center, New York City being used in experimental hiv drug and vaccine trials.  It was called, "The House That Aids Built."  The story was picked up by the NY Times and later by the BBC.

Liam Scheff's article, The House That AIDS Built.

The BBC video on Incarnation Care Center and the experiments done to foster/orphan children. 

These experimental drug and vaccine trials on foster and orphaned children were sponsored by the NIH and various drug companies.  These trials provided many research papers which are often used as references in the NIH Recommendations for drugs prescribed for hiv positive infants and children.
In an article written in 2005 by the Alliance for Human Research and Protection regarding the situation at Incarnation Children's Center, they state, 

"The nature and level of risk involved in these Phase I and II experimental trials dictated that the agencies responsible for the care of these foster children – such as the New York City Administration for Children’s Services (ACS) – were required to provide the mandated federal protection of an independent advocate for each child. After a year of denial by ACS, an investigation by the Associated Press uncovered evidence revealing that 465 NYC foster children were subjects in these trials and less than one third (142) of those children were provided with an advocate. ACS failed to provide the minimum protections afforded by law."

No advocates for these foster children for two-thirds of the foster children in these experimental drug and vaccine trials.  Ethical? And again the history of hiv/aids research and recommendations seems to stand on the shifting sands of scientific behavior.  Misconduct, lies, cheating to hold patents and make money. Foster children used as guinea pigs (many adults used as guinea pigs as well) and we are suppose to believe that what these researchers proclaim as truth is truth? Is it just an ethical problem?  It appears to me to be one massive ethical problem with many people turning a blind eye to the obvious inconsistencies of current hiv/aids science.  Strangely recent news on the discovery that a certain mosquito bite will cause microcephaly in the fetus of pregnant women reminds me of the similar crazy predictions made in the early 1980's regarding hiv/aids.  The media writes its propaganda and people act as if media stories are truth.  It seems that scientists are looking for a virus that causes microcephaly.  Although science has shown that pesticides, herbicides-including glyphosate, radiation, lead, can cause microcephaly.  So instead of looking at the obvious known reasons for microcephaly, we all must do the fear-laden dance of microbes out to get us humans.  I found myself laughing when some newspaper stated that it is believed that this is sexually transmitted disease.  Get bit by a mosquito, get the Zika virus and never have sex again.  Kinda like hiv/aids.  Get hiv and become a pariah in society. The only acceptable answer to hiv/aids is taking toxic drugs.  

We will kill the Zika virus by spraying more toxic pesticides.  Win-win for the pesticide/herbicide manufacturers, don't let anyone really look at what damage is done to our genes, our reproductive cells. While everyone is looking at mosquitoes as the cause, our toxic environment continues to destroy the health and well-being of life on earth.  Immune deficiency has everything to do with our toxic environment, the ingestion of toxic drugs and food/infant formulas that destroy the gut.  It is the gut with its beneficial microbes that maintains our immune system, our health.  We seem hell-bent on destroying not only our internal environment, our immune system, but also our external environment.  I feel like I am living a Greek tragedy in which I already know the ending.
Copyright 2016 Valerie W. McClain