Alternatives & Traditional

Posts tagged ‘inflammation’

Natural Prevention of Migraines

Migraines start when the blood vessels around the brain constrict tightly.  These blood vessels then rebound vasodilate causing them to leak leading to inflammation.

There can be multiple triggers for migraines including dietary amines, allergies, hormones, bright lights, etc.  Therefore, anyone suffering from migraines should keep a migraine log to look for their trigger so the trigger can be addressed as well.  A migraine log consists of keeping a list of whatever was eaten, or drunk, what you were exposed to (fumes, pollen, etc.), if a woman is it near her menstrual cycle, bright lights, etc. prior to the migraine.  Keeping a migraine log though can help narrow down the possible causes.  For example do they come on after ingesting foods or beverages containing tyramines?  Are they triggered off by smells or bright lights?  Did you ingest anything you were allergic to within the previous couple of days?………….

The best supplements for migraines are magnesium, coleus forskohlii (aka forskohlii) and kudzu.  

Magnesium deficiencies are common and can lead to a host of problems, including frequent migraines.  An influx of calcium causes blood vessels to contract, leading to the initial constriction.  Magnesium is a calcium antagonist, and relaxes blood vessels to help prevent the initial vasoconstriction that precedes migraines.  For this reason the magnesium should be taken by itself, not with any calcium.  This includes with foods that may contain calcium.  

I recommend taking the magnesium on an empty stomach at least 30 minutes before meals. Recommended dose is 300mg twice daily, morning and afternoon, on an empty stomach.  

If you take a calcium/magnesium supplement this is best taken at night before bed.  

Not all magnesium supplements are the same.  Magnesium oxide is the most commonly sold magnesium supplement due to being the least expensive form of magnesium.  Magnesium oxide though is poorly absorbed, neutralizes the stomach acid leading to various health problems and is used as a laxative because it burns the intestinal wall.  The best forms of magnesium are magnesium malate or citrate.  Magnesium itself as well as the acids used to make these forms of magnesium supplements, malic acid and citric acid, not only enhance absorption, but they also contribute to increased adenosine triphosphate (ATP).  ATP is the fuel that helps cells function and function properly.

Forskohlii and kudzu are both vasodilators to help prevent the initial vasoconstriction. Recommended dose is 2 capsules of either herb 3 times daily before meals, and in addition at the first signs of an impending migraine.

Forskohlii not only helps prevent the initial vasoconstriction, but forskohlii is also anti-inflammatory.  Forskohlii’s anti-inflammatory effects comes from fosrskohlii’s ability to block both inflammatory prostaglandins and leukotrienes.

Kudzu is preferred if there are hormonal imbalances since it also aids in hormone balance.  

For hormonal induced migraines digestive bitters are the quickest way to help normalize the hormones.  When bitters come in to contact with the bitter receptors of the tongue they stimulate the receptors, which in turn stimulates the vagus nerve.  Vagus stimulation increases output of digestive secretions, which is how they got the name digestive bitters.  Bitters also improve liver function though where excess hormones are broken down in the body.   

Bitters are sold in health food stores under names such as  Chinese Bitters, Grape Bitters, Swedish Bitters, etc. 

Recommended use is ½ dropper full on the tongue three times daily before meals.  It is important to drink plenty of water throughout the day when using bitters to help with removal of toxins, including excess hormones, being processed by the liver.

Bitters are not recommended though in the cases of peptic ulcer since bitters increase stomach acidity and if the gallbladder has been removed since bitters increase bile release.

Rice bran or oat bran can also help with hormone balance since they are both good sources of B vitamins needed by the liver to break down excess hormones.  These fibers also feed the intestinal flora, which also produce B vitamins for the body and further break down hormone metabolites.

I prefer rice bran since it also contains gamma oryzanol that helps with hormone balance.

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Is “Oleander Soup” for Cancer a Scam? Part 2

According to Tony Isaacs oleander extract has been found to be effective against a wide range of cancers based on a study that actually found oleander extract to be ineffective.

Even links posted on Tony Isaacs own website show oleander in Petri dish cultures were only effective against some cancer cell lines.  It is also important to keep in mind that even if oleander extract works against some cancer cell lines in a Petri dish this does not mean the effects will be the same in the human body.  For example, the first study done on oleander extract in the human body came to the conclusion once again that oleander extract was ineffective when given to humans despite limited success in culture tests.  In the words of the study researchers “No objective anti-tumor response was seen.”:

http://www.ncbi.nlm.nih.gov/pubmed/16763787

Invest New Drugs. 2006 Sep;24(5):423-7.

Phase 1 trial of Anvirzel in patients with refractory solid tumors.

Abstract

Anvirzel is an aqueous extract of the plant Nerium oleander which has been utilized to treat patients with advanced malignancies. The current study reports a phase 1 trial to determine the maximum tolerated dose (MTD) and safety of Anvirzel in patients with advanced, refractory solid tumors. Patients were randomized to receive this agent by intramuscular injection at doses of 0.1, 0.2, 0.4 ml/m2/day with subsequent patients receiving 0.8 or 1.2 ml/m2/day sequentially. Eighteen patients were enrolled and completed at least one treatment cycle of three weeks. Most patients developed mild injection site pain (78%). Other toxicities included fatigue, nausea, and dyspnea. Traditional dose limiting toxicity was not seen, but the MTD was defined by injection volume as 0.8 ml/m2/day. No objective anti-tumor responses were seen. Anvirzel can be safely administered at doses up to 1.2 ml/m2/day, with the amount administered intramuscularly limited by volume. The recommended phase II dose level is 0.8 ml/m2/day.

The following is part of the resulting conversation between Tony Isaacs and myself after the presentation of this evidence.  Once again statements I did not make at the time are being presented in italicized print.

Tony Isaacs:  Those who would like to detract from oleander point out that no tumor responses were noted in the trail.  However, what they fail to point out is that the trial only lasted for 3 weeks for most participants and its only purpose was to determine toxicity.

James Sloane:  Note that Mr. Isaacs here has clearly stated the study was only to determine toxicity, not efficacy.  Yet, Mr. Isaacs has posted on numerous internet sites that the study had shown oleander extract was “apparently  effective against a wide variety of cancers”.  In reality though, not only did the study fail to show that oleander extract was effective against any cancers, as Mr. Isaacs pointed out himself the study was not even to determine efficacy.  Therefore, why is Mr. Isaacs making false claims about the study finding oleander extract supposedly being effective against a wide range of cancers? As we will see though this is not the only contradictory statement that Mr. Isaacs has made concerning oleander extract.

First of all I would expect to see some type of progress within 3 weeks.  Even chemotherapy shows activity within 3 weeks.  And being that many people do not turn to alternatives until their cancers are well advanced they may not have 3 weeks to begin with.  So how many months or years does it take to see some type of response to oleander extract?  And let’s see the studies that show any activity against cancers in the human body.  Oh that’s right, I asked before and all you presented were Petri dish studies that only showed some activity against some cancers.  Of course this means NOTHING as many things can be applied to cancer cells in a Petri dish and will kill cancer cells.  But in the body these substances have absolutely no effect.

In response to the presentation that the first study showed no benefit from oleander extract Mr. Isaacs tried to claim the reason was the study was too short to allow time for a response:

Tony Isaacs:  Oleander does not usually work overnight when it comes to cancer, but rather usually works slowly but surely where it first begins to slow tumor growth (normally within the first two months), then stabilizes tumor growth and then ultimately regresses tumors until they often are no longer present at all.

James Sloane:  A big problem with Mr. Isaacs claim in this case is that the study he said was too short to elicit a response was conducted by giving the participants the drug for 3 weeks (21 days).  In the second human study where Mr. Isaacs falsely claimed the drug appeared to be effective against a wide range of cancers the test participants were only given the drug for 21 days.  So how does Mr. Isaacs justify his claim the first trial failed due to the short duration yet claims the second study was a success when it was conducted for the same exact duration?

Sounds like it is too slow to me for advanced or aggressive cancers.  Let’s see, someone with liver cancer usually has 6 months or less to live once their cancer is discovered.  You are saying it takes about 2 months to even start slowing this rapidly growing cancer. Then sometime in the future it may “stabilize” the cancer if the person is not already dead.  And how much will that cancer have metastasized by the time the cancer is supposedly stabilized?

Sounds to me like a person would have to be a fool to try something like this, especially if they have a fast growing and aggressive cancer.  And especially when there is no proof it works in the human body. Chemotherapy, which is quackery, has more evidence to back it than oleander extract does!!!

Tony Isaacs:  Though that trial was also intended to primarily identify limiting toxic doses, it was a longer trial and also returned some remarkable results.  At the end of two months, 9 out of 20 enrolled patients had their cancer’s stabilized and three of them had already begun to see tumor regression.

James Sloane:  Mr. Isaacs just got done claiming that it takes 2 months to even start seeing results, which was his excuse for why the first trial found no effect.  Yet here Mr. Issacs is now claiming that at the end of two months 9 out of twenty enrolled patients had their cancer’s stabilized.  How can that be if it takes two months to even start seeing results?  And where is Mr. Isaacs coming up with these numbers?  There have been only two human studies on oleander extract for cancer.  In the first study shown previously in this blog post there were only eighteen patients total, and no significant tumor responses were noted.  In the second human study:

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=80984

There were 46 participants, but only 7 had stabilized cancers for 4 months or more.  Even in the original report of this study there were only 15 participants at the time and only 3 participants with cancers stabilized for 4 months or more.  Nowhere is there evidence of a study with 20 participants, nor 9 cases of cancer stabilization as Mr. Isaacs claims.

In fact, Mr. Isaacs was asked repeatedly to present evidence of the clinical trials he claimed that had been finished.  Mr. Isaacs refused to provide evidence to the studies and I quickly found out why.  The first study found no effect from the oleander extract.  The second study had not been completed as Mr. Isaacs had claimed at the time.  By the time the study was finally completed there were only 7 of 46 participants that had cancers stabilized for 4 months or more.  Since these are the only two human studies conducted again where did Mr. Isaacs come up with the 9 out of 20 participants with stabilized cancers numbers?

After various claims made by Mr. Isaacs were shown to have been fabricated his next tactic was to present supposed testimonials by Dr. Ozel:

Tony Isaacs:  In real life, the aforementioned Dr. Ozel has a multitude of case reports which vouch for the effectiveness of oleander.  Some of those are:

Mesothelioma – HD
http://www.drozel.org/eng/diagnosis_mesothelioma_HD.htm

Adenocarcinoma (epithelial type malignant mesothelioma?) – US
http://www.drozel.org/eng/diagnosis_adenocarcinoma_US.htm

Small cell anaplastic carcinoma in the lung -YG
http://www.drozel.org/eng/diagnosis_smallcell_YG.htm

Malignant lymphoma, lung cancer – MG
http://www.drozel.org/eng/diagnosis_malignant_MG.htm

Prostate cancer with bone metastases – KE
http://www.drozel.org/eng/diagnosis_pancreas_SO.htm

Pancreas cancer with bone metastases – SO
http://www.drozel.org/eng/diagnosis_pancreas_SO.htm

Pancreas cancer – MH
http://www.drozel.org/eng/diagnosis_pancreas_MH.htm

Peritoneal carcinosis – HA
http://www.drozel.org/eng/diagnosis_peritoneal_HA.htm

Inoperable stomach carcinoma with metastases -VO
http://www.drozel.org/eng/diagnosis_stomach_VO.htm

Brain tumor – AS
http://www.drozel.org/eng/diagnosis_brain_AS.htm

Brain tumor – SD
http://www.drozel.org/eng/diagnosis_brain_SD.htm

Breast cancer (Ductal carcinoma) – SE
http://www.drozel.org/eng/diagnosis_breast_SE.htm

Antrum cancer – YT
http://www.drozel.org/eng/diagnosis_antrum_YT.htm

Brain tumor – EO
http://drozel.org/eng/diagnosis_brain_EO.html

James Sloane:  Supposed stories of cures in which there is no way to verify the information being claimed.  Common tactic of quack sites.  Where have these findings been presented to determine authenticity?  And where were they reported to determine long term effectiveness if any?

In fact according to your own claim earlier these reports are suspect.  You claimed that it took several months to even start slowing a malignant tumor.  Yet in the first report they are claiming that about half the mass had disappeared in a month’s time.

In the third report he claims a large remission of the cancer in “12 days”.  Yet the only published study we can find found no effectiveness with oleander extract in three weeks.  Sounds to me like someone is making up their “facts”.

This is a great example though of why unsubstantiated testimonials are completely worthless!!!  Multilevel marketing companies use this tactic all the time making up testimonials that of course cannot be verified so that they can make their compounds appear effective when they are really garbage.  So where are those medical study publications where these “cures” can be verified?  That would at least be real evidence.

I also find it interesting that Mr. Isaacs claims that Dr. Ozel has “cured thousands of cancer patients”, yet Tony Isaacs keeps posting the same 14 unverifiable “testimonials”.  If there are really thousands of people cured using oleander why are there not more testimonials?  Why can’t we find their case histories in any medical journals.  I can find various case histories for numerous other alternative cancer therapies in the medical journals, but none for any of Dr. Ozel’s patients that supposedly exist. Without their histories how do we know they actually exist? How do we know that they did not use other therapies known to work along with the oleander? How do we know if their cancers came back or if they even survived past 5 years cancer free?……..  And more importantly, why aren’t these people, if they exist, touting the cure on the internet? I would think that if these people really existed and survived their cancers that they would be so thankful that they would at least be on YouTube touting how they were cured by Dr. Ozel’s protocol. Yet, there is absolutely no real evidence that any of these people really exist.  And again, let’s not forget that the self proclaimed oleander expert, Tony Isaacs, clearly stated that oleander takes at least two months to start seeing results but according to these questionable testimonials significant reductions or cures are being reported within a few weeks.  Are these “testimonials” fake?  In my opinion they certainly appear to be. 

As mentioned earlier the first in human test of the oleander extract Anvirzel (Anti viral Ozel) found the product to be ineffective for cancer.  This can be explained in large part due to Dr. Ozel’s own claims. 

According to the article Immunologically Active Polysaccharides from the Aqueous Extract of Nerium oleander by Dr. Ozel and other authors the active component in this water extracted oleander extract is a polysaccharide. 

Contrary to Tony Isaacs’ claim that the active ingredients include the cardiac glycosides, the article states “Since the cardiac glycosides for some reasons cannot be responsible for the anti-tumor activity of the aqueous extract”.  Although some cardiac glycosides from various plants have been shown to have some anti-tumor activity in cell culture studies, Isaacs assumes that the same applies to in human effects.  There are several flaws with this assumption though. 

First of all as I pointed out earlier what happens in a cell culture does not always work the same way within the body.  Various factors such as digestive secretions, metabolic enzymes, binding compounds, etc. within the human body can create totally different effects than occur within a Petri dish. 

In addition, with highly toxic compounds such as cardiac glycosides, concentrations of the test substance can be applied to cells in a Petri dish safely that would kill a human if administered directly to a human. 

And this self proclaimed oleander expert, Tony Isaacs, keeps overlooking the fact that the cardiac glycoside oleandrin that he keeps claiming is an active component is not water soluble.  How can oleandrin be an active component in Anvirzel or his so-called “oleander soup” when the oleandrin being lipid soluble would not be extracted in these water extracted products? 

Therefore, the only active component would be the polysaccharide as Dr. Ozel himself points out.  Polysaccharides alone cannot kill cancer cells though.  If that were the case then we could use any of hundreds of polysaccharide rich plants to cure cancer without having to process the plants to render them non-toxic like must be done with oleander.  The purpose of these polysaccharides is to activate white blood cells.  The problem though is that cancer cells are very adept to evading the immune system, and white blood cells cannot attack the cancer cells if the cancer cells cannot be detected.  Therefore, polysaccharides have a very limited effect against cancer.

What polysaccharides can do to help fight cancer is activate the immune system against cancer microbes such as cancer viruses that account for the majority of cancers.  According to Mr. Isaacs though the germ theory is bogus and therefore he does not believe that microbes cause any diseases.  If Mr. Isaacs were correct about this claim then he is just providing further proof that oleander is completely worthless for the treatment of cancer.

If someone really wants to address cancer, in my opinion they should address the various aspects of cancer that can be targeted as weak points of these cells.  For example, addressing  the cancer causing microbes.  In addition, increasing interferon and other cytokines, increasing peroxides, addressing the Cori cycle, blocking angiogenesis, blocking hyaluronidase to prevent metastases, etc.  Simply stimulating white blood cells with polysaccharides alone is going to do virtually nothing for cancer as the oleander extract studies have shown.

It should also be noted that Mr. Isaacs is claiming that oleander extract is helpful for autoimmune disorders.  The exact opposite is true though.  Sources rich in immune stimulating polysaccharides are contradicted for a very good reason.  In autoimmune conditions there is an over production of low affinity (nonspecific) antibodies being produced that tag healthy tissues for destruction by white blood cells.  When the white blood cells are stimulated by high concentrations of immune stimulating polysaccharides the activated white blood cells speed up the destruction of the “antibody tagged” tissues aggravating the autoimmune condition.

Tony Isaacs:  There are also many other case reports about the successful use of oleander, as researched and reported in the book I wrote.

James SloaneSee above.  And keep in mind that the book was written by the same person who also presented Petri dish studies as “proof of effectiveness” after being asked for human studies showing actual proof of effectiveness.  This is why we cannot believe everything we read.

Tony Isaacs:  Neither have I stated that cancer can be caused by cellular hypoxia, but rather that he believes that cellular hypoxia is a result of the process that leads to cancer which most often begins due to a prolonged inflammation.

James Sloane:  Problem with this hypothesis is that inflammation INCREASES oxygen levels to the tissues.  When we are injured inflammatory prostaglandins dilate blood vessels in the area to INCREASE oxygen and nutrients to the injured area to help promote healing.

Tony Isaacs:  or exposure to a carcinogen.

James Sloane:  Radiation is a carcinogen, but this is because the radiation breaks chromosomes.  The broken strands of genetic material reattach where they can leading to changes in the metabolism of the cells.  Again this has NOTHING to do with lower oxygen levels to cells.  Radiation can also lead to immune suppression due to its destructive effects on the bone marrow.

Tony Isaacs:  Likewise, the moderator believes that the pleomorphic process of cancer involves a viral stage.

James Sloane:  Not all cancer microbes involve pleomorphism.  For example the fungus Aspergillus niger that produces aflatoxins that can lead to liver cancer.  And again there are a number of cancer viruses. They are not morphing in to each other.

This claim is also contradictory to Tony Isaacs other claim that the germ theory is wrong.  In another post Isaacs claims that the germ theory is wrong, and thus he does not believe that microbes are responsible for any diseases.  Yet here are claims that he believes that cancer is microbial in origin as the term “pleomorphism” here refers to the changing of disease causing microbes in to their various forms including viruses.  I guess Isaacs just believes in whatever fits his needs at that time rather than proven facts.

 

As a final note here a poster askedI’ve read that it (oleander soup) is very good at raising white blood cell counts. Is this true?”  According to Tony Isaacs in a 2010 article he wrote Isaacs claims that oleander has been shown to boost white blood cell counts.

This is yet another false claim.  The polysaccharides from oleander stimulate white blood cell activity, but they do not increase white blood cell counts.  Low white blood cell counts are most often from bone marrow damage.  This can be from a number of things including nonsteroidal anti-inflammatory drugs (NSAIDs), chemotherapy drugs, radiation, certain cancers or infections, etc.  Oleander has not been shown to restore bone marrow and thus increase white blood cells as Isaacs claims.  Nor has it been shown to reduce overactive splenic activity, the other cause of low white blood cells.

The reason for presenting all this is to get people to realize that they need to be EXTREMELY careful when getting their health information online.  There are many people pretending to be experts on topics they know virtually nothing about and promoting strange and unproven concepts about disease.  Just because someone makes claims in a book or online this does not make these true.  People get conned all the time by people who know just enough to make themselves sound like authorities.   They count on people not being willing to research the claims they are making.  Don’t get conned.  Take a little extra time and research some credible, non sales or propaganda sites, to verify health claims before jumping in to some therapy or taking some supplement.

For related articles see:

https://medreview.wordpress.com/2012/10/15/is-oleander-soup-for-cancer-a-scam-part-1/

http://medproductreview.wordpress.com/2012/10/12/quackery-alert-oleander-cancer-treatment/

Why Statins and Low Cholesterol Cause Heart Attacks and Strokes

No studies have ever proven that high cholesterol causes heart disease since this simply is not true.  Inflammation, not high cholesterol leads to atherosclerosis.  Yet the pharmaceutical companies keep pushing the cholesterol myth to promote drug sales while ignoring the fact that they are endangering lives.

Statins are the most commonly prescribed form of medicine for the treatment of “high” cholesterol.  The drug companies have failed though to inform the public about the dangers of not only these drugs, but also of the dangers of low cholesterol, which among other things can cause heart attack and stroke.

I find it rather ironic that the drug companies are pushing statins claiming they help prevent heart disease when these drugs are well known to increase the risk of heart failure, heart attacks and strokes!  There are several reasons for this.

Other than liver damage, the best known side effect of statins is a condition known as rhabdomyolosis.  This is a condition in which muscle tissue deteriorates.  The deterioration occurs from declining levels of CoQ10 in the tissues, which is required for the proper function of cells and their energy production through the formation of adenosine triphosphate (ATP).  What people often do not stop and think about is that the heart is also a muscle and is prone to the same damaging effects from the use of statins.  If taking statins I highly recommend taking at least 200mg of CoQ10 daily to help reduce the risk of statin induced heart failure.

The increased risk of heart attack and stroke actually occur for a totally different reason.  If you read my blog articles on the dangers of nonsteroidal anti-inflammatory drugs (NSAIDs) you will see that the risk of heart attack and stroke are related.  Several NSAIDs, such as Vioxx and Celebrex have been either pulled off the market or have required stronger warning labels warning of the increased risk of heart attack and stroke from these drugs.  Even though the drug companies tried to make it sound like a new discovery, the risk had been known prior to the drugs ever reaching the market.  The problem stems from the way these drugs work.  NSAIDs interfere with inflammatory prostaglandins.  Inflammatory prostaglandins are hormones that dilate blood vessels.  For example during injuries these hormones open up blood vessels to increase oxygen and nutrient levels to the area to promote healing.  By inhibiting these hormones NSAIDs decrease blood flow to the organs including the heart and brain.  If the blood supply is sufficiently reduced to the heart and brain, heart attack or stroke can occur.

So what does all this have to do with statins and cholesterol levels?  Prostaglandins, as with other hormones, are formed from cholesterol.  Therefore, reduced cholesterol levels lead to decreased prostaglandin formation, which in turn decreases blood flow to the organs.  This explains why studies have consistently shown increased mortality with decreased cholesterol levels.

The Cholesterol Myth

One of the largest frauds perpetuated on the American public has been the false claim that high cholesterol causes heart disease.  Even though this has been known for decades to be false the myth keeps getting promoted by the drug companies to increase drug sales of drugs, such as statins.  The whole idea of high cholesterol causing heart disease started with a faulty, outdated rabbit study from the 1920s.  No solid evidence of high cholesterol causing heart disease in humans has ever been shown.  In fact, evidence is to the contrary.  Several studies have confirmed that as cholesterol levels go down that the mortality rate goes up primarily from increased heart attacks and strokes.  It has been known for a while that around 50% of people who die from heart vascular disease have normal to low cholesterol levels.

What I really find interesting is how doctors who should be reasonably intelligent don’t seem to be questioning how people can have low cholesterol and clogged arteries or high cholesterol and clean arteries.  In fact I just heard a commercial for Lipitor where Dr. Jarvic is claiming that high cholesterol can lead to heart attack and stroke.  I would love to ask him in person to explain this mechanism since there is absolutely no science whatsoever to back up his claim!

Cholesterol levels are actually totally irrelevant to the risk of atherosclerosis.  It is inflammation, not high cholesterol that leads to atherosclerosis.  Cholesterol is actually a healing agent for the body.  Where there is an injury in the body cholesterol will increase in that area to aid in the healing by acting as both a patchwork and as a precursor for other substances such as hormones that play a role in healing.  Various things can cause trauma and inflammation to the arteries and are well known for increasing the risk of heart disease.  These include high blood pressure, diabetes, smoking and even bypass operations.  Damage to the arterial lining leads to inflammation.  In response, cholesterol floods the area and lays down as a “patchwork” over the injured area.  The problem is that if the source of inflammation is not removed then the cholesterol will keep depositing in an attempt to heal the injured area narrowing the artery.

PolyHeme Part 2

In August of 2006 Northfield Laboratories tried to get accelerated approval for PolyHeme.  The request was declined by the FDA until further study results come in.  I guess they were in a rush since they signed a $6.7 million agreement on June 16th, 2006 to purchase a 106,000 square foot property that they intend to use to manufacture their product.  This is really putting the cart before the horse since they don’t have approval for their blood substitute, nor is there any guarantee of approval.

This brings up the question of how far will Northfield Laboratories go to get their blood substitute approved to avoid losing their investment and the money of their investors?  After all this has been a costly venture.  Not only have they spent $6.7 million for the building they intend to manufacture their product in but they are also paying the hospitals $10,000 for each patient they test the blood substitute on.  Tack on to that other research and development costs, manufacturing equipment costs and other expenses.

Pursuant to CFR 50.24 certain criteria must be met in order for testing to be performed on patients without their consent.  For example, section (2) (ii) states “Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects”.  So where are these previous animal or preclinical studies?  The only study was halted early after a significant increase in deaths in patients receiving PolyHeme.  Section (2) (iii) states “Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.”  Again, the only clinical study was halted early because of a disproportionate death rate between those receiving PolyHeme and those that did not.  This is hardly reasonable when standard therapy has been shown to be considerably safer and effective.

The regulation also requires that they try to gain consent prior to, or as soon as possible from a legal representative such as a relative.  From what I have seen I don’t think this is being done.  For instance, if a married couple is in an accident, and only one has sufficient trauma to require blood are they obtaining consent from the spouse?  It does not appear that they are.  Instead, saline or PolyHeme were not chosen for the patient until the patient was on the way to the hospital.  And according to news reports, the decision was based on sealed envelopes the paramedics opened in route to determine what treatment the patient would be given.  Such a practice would prohibit the paramedics from explaining the risks and benefits to the spouse to allow them to make an informed decision or give time to obtain consent even if the spouse was aware of the risks.  If no legal representative can be found then the company must provide proof of attempts to contact a legal representative.

Section (7) (ii) states “ Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits”.

The first problem with this is that Northfield Laboratories did not disclose the adverse effects of their product found in the 1998 study.  In fact, they threatened to sue the group that made the fact public claiming that the adverse effects that included death were part of their trade secret.  I also see a problem with this regulation by the fact that everyone will not be aware of the study since not everyone follows or has access to the media.  For example, the homeless would not likely know about the study and therefore there will be no disclosure as is required to certain groups.  Despite this people in these groups may be subjected to the study.  The law does allow life saving measures in people unable to give consent such as unconscious patients.  This is called implied consent.  For instance, if a person tries to overdose on drugs to commit suicide and they refuse treatment the paramedics cannot touch the patient.  Once the patient passes out they can claim implied consent and start treatment.  The basis is that the person if they were conscious and able to give consent would likely give consent to save their life.  Does this apply to unapproved and untested drugs like PolyHeme though?  I doubt if such an argument would hold up.  A person would probably give consent if they knew or had reason to believe that the drug or treatment had been thoroughly tested and was an approved treatment.  A reasonable person is not likely going to consent to an unproven and potentially dangerous unapproved drug or treatment.  Especially when safer and proven therapies exist.  Northfield Laboratories claims to have followed CFR 50.24 explicitly.  I disagree based on the facts that they never completed previous trials, their product has a higher death rate than controls and those receiving blood, they have not informed the public of their testing, or the possible dangers of the therapy and I don’t see any evidence that they are really trying to obtain consent as is required by law.

Patients were allowed to opt out of the test in case they suffered a severe trauma that would leave them unable to give consent.  To do so though they had to obtain a blue plastic bracelet from the company that they had to be wearing at the time paramedics arrived.  In order to get the bracelet the person would first have to be aware of the test.  Many people were not aware that the test was going on until testing had almost been completed.  And as previously pointed out, people that did not follow the media or who had no access to the media would have still been uninformed about the testing.  The same could apply to those who do not speak English.  Even if the story came on the TV news it does not mean they would understand what the test was about or how to opt out.

So what are the potential side effects of PolyHeme?  Previous hemoglobin products have all been shown to cause kidney damage, liver damage, high blood pressure and inflammation of the arteries.  There is also concern that allergic reactions may occur.  Northfield Laboratories claims that these adverse effects are not possible and their product is safe.  Other researchers disagree.  And Northfield Laboratories has not had the greatest track record of being honest to the public about the safety record of their product.  For instance when they tried to suppress the fact that 10 patients died within one week of receiving their product and no patients receiving real blood died.  Or the fact that their study was halted early due to problems.  Would more deaths have occurred if the study had continued its full duration?  Other adverse affects reported by the use of PolyHeme were significant increases in the rate of heart attacks, arrhythmias and pneumonia.

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