The word spontaneous implies “without any apparent cause,”
and regression is defined as a decrease in the size of the tumor or in the extent of cancer in the body according to the national cancer institute (NCI).
Spontaneous regression occurs in most types of cancer and was recorded in the medical literature as early as 1742. The standard definition
of spontaneous regression as “the partial or complete disappearance of a malignant tumor in the absence of treatment or in the presence of therapy considered inadequate to exert a significant influence on the disease” was composed by Dr. Tilden
Everson and Dr. Warren Cole in the 1960s, with the further requirement that the original
presence of cancer was proven by the microscopic examination of tissues.
of cancer is not a rare occurrence as thought to be; in an average month during 2002, medical journals published more than four articles on the subject.
Cancer is probably the deadliest of human ailments. Cancer fatalities account for 12% of all deaths worldwide each year.
Across the globe, 10 million people are diagnosed with cancer annually and almost 7 million die from cancer. The global cancer rates could increase to 15 million by 2020.
Spontaneous tumor regression is a phenomenon
that has been observed for hundreds if not thousands of years. Although the term spontaneous implies “without any apparent cause,” a review of reports demonstrates that regression generally coincides with acute infections. Savarrio et al claimed to report the first ever case of spontaneous regression of a neoplasm of
the oral cavity of the subset of non-Hodgkin's lymphomas known as Ki-1 anaplastic large cell lymphoma (ALCL). King et al. reported a case of complete spontaneous regression of metastatic cutaneous melanoma with parotid and neck lymph node metastases.
The phenomenon of spontaneous regression is also
known as St. Peregrine tumor. Peregrine Laziozi (1265–1345), a young priest, was afflicted with cancer of the tibia requiring amputation of the leg; the lesion grew to a point where it broke through the skin and became severely infected. Miraculously,
by the time his operation was due his physician was astonished to observe that there were no signs of the tumor. St. Peregrine's tumor never returned.[7,10] Although numerous cases of spontaneous tumor regression have been published over the last
several hundreds of years, such reports have become rare in the current medical literature;
virtually all of these reports note regression concomitant with infections including diphtheria, gonorrhea, hepatitis, influenza, malaria, measles, smallpox, syphilis, and tuberculosis as well as various other pyogenic and nonpyogenic infections. Observation
of this non-specific effect led to the emergence of active cancer immunotherapies by the 1700s.[1,11]
In 1891, a young bone surgeon at New York Memorial Hospital began his search for a new approach
to cancer treatment, after the loss of his very first patient to cancer. Serendipitously, he discovered the record of an immigrant patient who presented with an egg-size sarcoma on his left cheek. The sarcoma was operated on twice and still recurred as a 4.5-inch grape-like cluster below his left ear. The extensive wound after surgery could not be closed
and skin grafts were unsuccessful. Ironically, this failure to close the wound would play a key part in the patient's eventual cure. The tumor progressed and a final operation only partially removed the tumor; the wound became severely infected with erysipelas
by Streptococcus pyogenes and the patient developed a high fever. Little could be done to stop the infection, yet surprisingly, after each attack of fever the ulcer improved; the tumor shrank, and finally disappeared completely. On a subsequent
review, the patient, still bearing a large scar from his previous operations, had no trace of cancer and claimed excellent health since his discharge– 7 years previously.[10,12]
Coley suspected that somehow the infection was responsible for the miraculous cure. He later realized that the patient's activated immunity in response to the acute infection was the key factor in cancer regression.
He decided to put his theory to the test and infected his next 10 patients with erysipelas.[12,13] Problems with this approach soon became apparent; sometimes it was difficult to induce an
infection, other times there was a strong reaction and the disease regressed. However, occasionally, the infection was fatal. Due to its unpredictability, he developed a vaccine containing two killed bacteria, the Gram-positive Streptococcus pyogenes and
the Gram-negative Serratia marcescens. Experimental work at the time suggested that the latter bacteria increased the virulence of the former.
In this way, he could simulate an infection with inflammation, chills, and fever without worrying about the risks of an actual infection. This vaccine became known as “Coley's toxins.” Coley stressed that the technique of administration and the
ability of the vaccine to induce mild to moderate fever was of paramount importance in the regression of cancer.[15,1] He successfully used his vaccine, in treating a man bedridden with an inoperable sarcoma involving
the abdominal wall, pelvis, and bladder. The sarcoma regressed completely and the patient was followed up until his death from a heart attack 26 years later.
Coley worked in the Department of Bone Service at the hospital, later becoming its chief in 1915, and her fathers discovery was further pioneered by Helen Coley Nauts Coley's vaccine was widely and
successfully used by other contemporaries for sarcomas as well as carcinomas, lymphomas, melanomas, and myelomas.
Coley's immunotherapy regimen was so outstanding that even when applied to patients in their final stages of disease, some remarkable recoveries were obtained, with patients often outliving their cancer.[17,18] Coley was considered
to have treated more sarcoma patients than any other physician up to that time.
Martha Tracy who formulated many of Coley's vaccine observed that
the most effective formulation was the one that induced both local and systemic reactions.
Coley considered several points crucial to a patient's survival. First and foremost was to simulate a naturally occurring acute infection, and thus, inducing a fever was essential. Injections were optimally administered daily or every other day for the
first month or two. To avoid immune tolerance to the vaccine, the dosage was gradually increased over time depending on the patient response. The vaccine was injected directly into the primary tumor and metastases when accessible. Finally, a minimum 6-month
course of weekly injections was followed to prevent disease recurrence. Ensuring a prolonged follow-up was the most difficult part of the treatment.
In the past, coincidental infections had in fact inspired a wide variety of rudimentary cancer immunotherapies. Coley also discovered that many past physicians had used these infections to the advantage of their
patients. Cancer immunotherapy was practiced thousands of years ago. In the writings of the Ebers Papyrus (c 1550 BC), attributed to the great Egyptian physician Imhotep (c 2600 BC), the recommended treatment for tumors (swellings) was a poultice followed
by an incision which would result in infection of the tumor and therefore its regression. By the 1700 and 1800 AD, crude forms of cancer
immunotherapy became widely known and accepted.
Before Coley's discovery of his killed vaccines, using live bacteria to initiate an infection was a risky experiment between life and death. Coley emphasized that the induction of fever was the key aspect of his treatment, a strong febrile reaction was
the symptom most associated with tumor regression. A retrospective study of the patients with inoperable soft tissue sarcomas treated with Coley's vaccine found a superior 5-year survival in patients whose fevers averaged 38–40°C, compared with those
having little or no fever (38°C) during treatment (60% vs. 20%).
The greatest value
of Coley's Toxins is evident in the lives of patients who received the therapy. Rather than surviving additional years with cancer, many of these patients lived the rest of their lives without cancer.[23,24]
The last recorded use of Coley's Toxins anywhere in the world was in China in the 1980s as a primary therapy for cancer in an adult male who had terminal liver cancer involving large tumors in both lobes of the liver; he received 68 injections
of Coley's Toxins in 34 weeks. By the end of this course of treatment, all of the tumors had completely regressed.
To most members of the medical community, non-surgical approaches to the treatment of cancer were simply of little interest. While most readers ignored Coley's articles, a number of independently minded doctors began
to make use of the new cancer treatment. Before the turn of the 20th century, at least 42 physicians from Europe and North America had reported cases of cancer that had been successfully treated with Coley's Toxins.
Stimulated immunotherapies ran a natural death in the latter half of the 20th century due to a number of reasons. First, with the newer concept of asepsis, cancer surgery like any other operation became a sterile procedure with fewer postsurgical infections especially
after Lister's aseptic techniques in the late 1800s. Second, by the time of Coley's death in 1936, radiotherapy was an established treatment for cancer and chemotherapy was slowly gaining acceptance. Such therapies though highly immunosuppressive could more
easily be standardized than Coley's approach. Third, the administration of antibiotics further reduced the incidence of postsurgical infections and antipyretics came into routine use to eliminate fever and discomforting symptoms of an immune response, and
the lastly due to an unfavorable approach of the medical industrial regulatory complex of the 1960s.[10,26]
Cancer therapies have been standardized and have improved since Coley's day, but these
improvements in treatment have resulted for the most part in prolonging the disease rather than curing it. For example, when the American Cancer Society claims, “Today, far more than half of all cancers are curable,” it is referring to the fact that about 60% of patients diagnosed with cancer during the period 1989–96 survived for at least 5 years. According to the National Cancer Institute, the 5-year survival rate includes persons who survive for 5 years after diagnosis,
whether in remission, disease-free state, or under treatment. This concept is far away from the ideal of achieving a cure for a disease-free
state. To this day, earlier diagnosis is the single most important contributing factor in the observed increase in 5-year survival rates. Presently, the medical literature has dropped its duration of cancer survival rates from an older standard of 5 years to a mere 3 years
and hence is the increase in the percentage of survival rates.
Though modern therapies
have added some years to the life of the average cancer patient, they have not reduced the patient's chances of dying from the disease. In fact, a resident of the United States is more likely to die of cancer today (225.4 per 100,000) than in 1950s (195.4
The primary cancer therapies, namely, surgery, radiotherapy, and chemotherapy, widely accepted and practiced have their own pitfalls. The risks, deficiencies, cost, specialized skills, and medical ethics are often
associated with these procedures. Even surgery, the most acceptable of the three in treatment of most tumors, has resulted in an ethical dilemma. Every time an incision is made into cancerous tumor, with even the least invasive type of incision called the
needle biopsy, there is a risk of spreading the disease due to cancer cells entering the bloodstream or becoming implanted in the surrounding tissue. There are at least 10 published cases of tumors arising along the route taken by a biopsy needle. Surgical excision usually done with an intention to cure also removes the protective barrier or the wall, body builds itself to protect itself
from cancer metastasis. Surgery and the subsequent healing process greatly increases the risk of death by metastasis in certain cancer patients by disrupting tumor integrity, facilitating metastasis, directly seeding the tumor, inducing local angiogenesis,
immune suppression, and enhancement of tumor growth. Surgical stress also greatly enhances
metastasis by increasing the expression of proteinases in the target organ of metastasis, metastasis being the primary concern of fatality in cancer patients.
The effects of radiation are often temporary and have little impact on survival rates. One study of 3,000 breast cancer patients found that those receiving radiation in addition to surgery did no better than patients
who received surgery alone. The great disadvantage of radiation therapy is the same as
that with surgery; it is simply not effective in the control of widely spread cancer. Chemotherapy and radiotherapy to some extent are highly immunosuppressive and therefore infections in these patients do not lead to any immunostimulation. Addition of antibiotics
further deprives these patients of the benefits of an immune response and subsequent regression if any.
Chemotherapy for head and neck cancer may result in a temporary reduction in the tumor size but has not translated into increased survival, control of the primary tumor, or decreased incidence of metastasis. The FDA has approved more than 80 anticancer drugs, 40 of which are chemotherapeutic agents. These drugs interfere with cell division, an essential activity of the immune
system, thereby profoundly suppressing the magnitude and the effectiveness of immune responses.[35,36] Hence the ability of the body to protect itself against an existing cancer is weakened; they
are also neocarcinogenic which can lead to the development of new cancers that did not exist prior to the administration of chemotherapy.
To effectively control the spread of cancer after the destruction or removal of the primary tumor, a systemic therapy is needed that can be delivered to the entire body that can destroy cancer wherever
it might be lurking. This can be delivered by an active immune system of the patient by activating its immense potential.
Spontaneous regression is a well-authenticated and natural phenomenon. Its study may lead us to a better understanding of the natural history of neoplastic disease which so commonly progresses but
rarely regresses. The comparative rarity of spontaneous regressions today may result from
the immunosuppressive nature of conventional cancer therapies. The spontaneous healing of
cancer, after having been the subject of many controversies, is now accepted as an indisputable fact. The percentage of spontaneous regression as quoted by Boyers is 1 in 80,000 and 1 in 100,000 by Bashford; it may be subjected to criticism but proves a remarkable
fact that cancer is not an irreversible process.
Regression is more commonly associated with groups of tumors like the embryonal tumors in children, carcinoma of the female breast, chorionepithelioma, adenocarcinoma of the kidney, neuroblastoma, malignant melanoma, sarcomas, and carcinoma of the bladder
The impediment toward the spontaneous
healing of cancer is due to the failure of recognition of cancer cells as non-self and dangerous by our immune system and hence it's subsequent escape to establish the disease, as well as the nature of contemporary cancer therapies which trigger metastasis,
suppress immune responses as well as compound any existing immune deficiency. The other major drawback is that primary cancer therapies especially the systemic ones are unable to differentiate between normal and abnormal, and therein lies their potential to
harm. The disturbance of tumor such as biopsy and surgical procedures cause a greatly increased number of cancer cells to enter the
bloodstream, while most medical intervention (especially chemotherapy) suppresses the immune system. This combination is a recipe for disaster. It is the metastases that kill, while primary tumors in general, and those in the breast in particular, can be relatively
harmless. These findings have been con-firmed by recent research which shows that surgery, even if unrelated to the cancer, can trigger an explosive spread of metastases and lead to an untimely end.
So how can we help our system recognize tumor cells as “tumor cells” and aid in natural
and biologic defence against cancer.
Infectious agents are present in nature that can cause cancer but we should also remember the dual role they play in preventing cancer. Acute infectious agents are a natural
source of immunostimulants that challenge our immune system from time to time as well as pep it up to confront newer challenges evolution brings about like cancer.[40,41] [Figure 1] Cancer is a disease that springs
up from within; it is a disease of our genes and inherited or acquired deficiencies in genome maintenance systems contribute significantly to the onset of cancer. Though all of us develop cancer cells in our life time, not all of us develop cancer. The proportion of risk of cancer varies from person to person and the individuals’ exposure
to common febrile infections as shown by epidemiologic studies. What helps the majority safe guard against cancer? Do acute infections have a direct and spontaneous role in the prevention and regression of cancer?
As early as 1899, British cancer researcher D’Arcy Power observed, “Where malaria is common, cancer is
rare.” Between 1929 and 1991, at least 15 investigations including 8 case–control studies examined the link between infectious
disease and cancer and all but one have found that a history of infectious disease reduces the risk of cancer.[41,28]
Since spontaneous regression is often associated
with a previous history of acute infections and fever, it is likely that fever-causing pathogens have a beneficial role to play in activating and stimulating the immune defenses which battle the invading pathogens as well as gain a new-found recognition of
cancer cells and attack them vigorously. Fever whether natural (acute infections) or induced (Coley's Toxins) stimulate a multitude of cascading, interlinking, and complex pathways of the immune system simultaneously releasing numerous products in the right
quantity and qualities to combat the disease which may not be humanly possible to reproduce in vitro. This may explain why single cytokine therapy or immune products don’t give desirable results in cancer therapy, besides being expensive,
toxic, and at times fatal due to the unnatural challenge they pose to the human system.[40,10]
The evidence and observations of rapid tumor
regression following infection sometimes within hours suggest that the innate rather than the adaptive immune response is a primary mediator of tumor regression in such cases. Unfortunately, even during cancer immunotherapy, an acute febrile reaction is often regarded as an unwanted symptom rather than an integral and healing component of the immune
A review of previous reports suggests
that the occurrence of fever in childhood or adulthood may protect against the later onset of malignant disease and that spontaneous remissions are often preceded by feverish infections. Pyrogenic substances and a more recent use of whole body hyperthermia
to mimic the physiologic response to fever have successfully been administered in palliative and curative treatment protocols for metastatic cancer.
Acute infections and fever provoke an immediate and effective immune response that can fight infectious agents as well as cancer at the same time; similarly Coley's Toxins were a highly effective anticancer treatment
because they worked by stimulating a powerful immune response. By itself, a powerful immune response is sufficient to cure some cancers in some patients but cannot cure all cancers in all patients. A powerfully stimulated immune system is only part of the
answer because cancer cells are frequently able to hide from the immune system. The immune system cannot kill what it cannot see. The
failure of the immune system to recognize cancer cells in the system is the major setback we face in our fight against cancer and this is compounded by the duality of the immune system of defense and repair; in the reparative mode the immune system can promote
cancer growth in its attempt to repair what it perceives as a “sterile wound.”[Figure 2] This can be overcome by the generation of inflammatory products during an episode of fever, be it natural or simulated (Coley's Toxins), when the well-studied defensive role becomes active at the onset of an acute infection, where
cytotoxic cells seek out and destroy invading pathogens.[1,45]
The dual nature of defense and repair of the immune system and its effects
Uwe Hobohm has recently observed about Coley's Toxins that the following cascade
might explain their effectiveness: “Fever generates inflammatory factors with co-stimulatory activity, which activate resting dendritic cells (DC), leading to the activation of anergic T cells, maybe accomplished by a second process, where a possible
physical damage of cancer cells leads to a sudden supply of cancer antigens to DC.” In other words, fever is a state in which body's own antigen recognition mechanism turns on to such a high level of activity that it becomes capable of recognizing
cancer and microbial invaders. Specialized cells like the dendritic cells then communicate the identity of the pathogen to lymphocytes to establish active immunity against stealth diseases. Fever plays a beneficial role when body's immunity is challenged,
and helps in the natural destruction of cancer cells. Cellular damage occurs only at temperatures above 108°F, but much good is accomplished at lower temperatures.[16,46]
Acute inflammatory responses have also benefited
terminal cancer patients in the reduction of cancer pain as well as fast wound healing. As observed by Coley, the immunological stimulation by his toxins led to a marked relief of pain, so that patients could often discontinue using narcotics. There was an
extraordinary enhancement of wound healing and even bone regeneration when the toxins were injected into the tumors. Similar observations
on infectious amelioration of cancer pain and enhancement of wound healing have been reported by others.
The recent 6-year Norwegian follow-up study on breast cancer in women also accepts the fact of natural regression in one-fifth of the untreated cases that were followed up; the authors concluded that this may reflect the fact that these cancers
are rarely allowed to follow their natural course.
It is interesting to note that the current primary cancer management procedures neither harness the benefits of patients’ own immune system nor stimulate it to achieve tumor regression but actively suppress it; thus it does not run parallel
to body's own defensive mechanisms but opposes its natural role. An ideal cancer management would involve the stimulation of the immune system, its complex effective and reproducible in vivo mechanisms that fight cancer. Acute infections
are beneficial in the prevention and regression of tumors. In conclusion, childhood febrile infections can prevent cancer in adulthood. Asepsis, fever control, surgery, and immunosuppressive therapies are known to have an inverse relation to cancer regression,
while acute infection, fever, and cancer vaccines by the virtue of immunostimulation induce regression of cancer even in the most advanced stage of disease and prove that cancer is not an irreversible process without a cure.[1,43]
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from Journal of Natural Science, Biology, and Medicine are provided here courtesy of Wolters Kluwer -- Medknow Publications
This article was written
by Joe Jarvis and originally published at The Daily Bell
Did you know that doctors and
scientists can be corrupt or simply wrong?
People seem to give doctors and scientists the benefit of the doubt when it comes to their findings and opinions on things like global warming, genetically modified organisms,
pesticides, chemicals, and how unhealthy certain foods and habits are.
But like any other humans, scientists and doctors are, well, human. They can be misguided, confused, corrupt, and stubbornly opinionated.
According to Natural News, as many as 20,000 doctors once recommended
smoking cigarettes to aid digestion. In 1940’s Camel ran an ad campaign that claimed “More Doctors Smoke Camels.” They even handed out packs of Camels to doctors at a medical convention and then polled the doctors on their way out the door,
asking what their favorite cigarette brand was, or what kind they had in their pocket at that moment.
Unfortunately, money has corrupted industries like big pharma who pay doctors and scientists to take a position and prescribe
particular drugs and treatment. Many peer-reviewed studies have predetermined outcomes which basically find the facts to fit their narrative. It is more a marketing ploy to publish in scientific and medical journals than proof of the actual findings.
But even absent actual corruption, basic mistakes are being made in scientific conclusions.
is not causation. This is a basic foundational tenet of science. Two things may be very strongly correlated, but that does not prove that one causes the other.
According to Reason Magazine:
Kabat discusses how “the dose makes the poison,” in that saying something doubles your risk of a disease could actually be statistically irrelevant.
For example, you may have heard that eating bacon increases the risk of colorectal cancer. Technically, this is true. If you eat two slices of bacon every day of your life the risk of colorectal cancer increases from 5 to 6 percent.
That is not exactly the same risk as smoking cigarettes, which increases the risk of lung cancer by 20 to 50 times over.
And then, of course, you must consider the editorial bias. You’re Risking Your Life
Eating Bacon is more likely to get a click than Everyday Bacon Eating Increases Cancer Risk by 1%.
Here’s the thing, I like to be healthy, and I personally often follow the better safe than sorry principle. But it is a huge miscarriage of authority to push this view on others through fear. It is the idea of I
know better than these silly peasants that unfortunately seems to permeate the scientific and medical communities.
Are GMOs, pesticides, and chemicals like BPA really as bad as they say? I personally avoid them,
but I honestly haven’t done enough of my own research to know for sure.Salt and fat have gone back and forth as being considered healthy
Salt and fat have gone back and forth as being considered healthy then unhealthy,
then healthy again by experts.
People look to doctors and scientists for guidance and too often are brainwashed with those
individuals’ own biases and unsubstantiated opinions.
If an expert cannot or will not answer questions about their work, that is a red flag.
When people talk about consensus among experts instead of the actual facts, that is another red flag.
There have been too many times in recent
history when the experts, the scientists, and the doctors were willfully or mistakenly wrong.
Sometimes, yes, we must defer to experts, since it is simply impossible to research it all on your own. But that
doesn’t mean we should forgo the due diligence in critical thinking that goes along with it.
Fear sells. We are used to it in the media but don’t
usually expect it from doctors and scientists. But they are humans too, and just as likely to push their agenda instead of the truth.
Unsuspecting Americans to be Hit Hard by this U.S. Scheme to Confiscate Your Savings:Alan Greenspan, 20-year head of the US Fed, reveals Washington's
nasty trick to confiscate the savings of unsuspecting Americans. Here's
How Some Americans Are Preparing
The lawsuit alleges that while acting
as FDA commissioner, Margaret Hamburg engaged in a wide-ranging conspiracy to approve an extremely dangerous drug known to cause severe (and even deadly) side effects, in order to financially benefit her husband's hedge fund which held very large financial
positions in Johnson & Johnson, makers of the drug. "Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin," says the complaint.
"This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening,
and deadly effects of a highly dangerous pharmaceutical drug named Levaquin," reads the opening of the lawsuit. The conspiracy complaint also alleges that over 5,000 people died as a result of Hamburg's conspiracy
cover-up at the FDA:
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy
and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information
been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance
Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each
and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials
and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous
drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying
from the highly dangerous effects of Levaquin.
"Both Alkermes and Johnson & Johnson stock value increased significantly during Hamburg's tenure," reports The
Margaret Hamburg "bought" her way into the FDA with financial contributions to Hillary Clinton and Barack Obama, alleges the lawsuit
A fascinating finding in the lawsuit alleges that Margaret Hamburg bribed her way into the top position
at the FDA by making large financial contributions to Hillary Clinton and Barack Obama:
Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's
recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance
Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson
stock, the manufacturer of the deadly drug, Levaquin.
...Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political
contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
...Defendant Hamburg, on behalf of all of the Defendants as part
of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
From what we now know about the Clinton Foundation's deep financial ties to Big
Pharma and Wall Street hedge funds, none of this comes as any sort of surprise. In fact, while these allegations may have been easily dismissed as a "conspiracy theory" in 2008, so much more awakening has happened among the American public that they are now
likely to be understood as an "actual conspiracy" being carried out among the political and financial elite who routinely conspire against the people in order to enrich themselves.
Horrible side effects from the drug destroyed the lives of countless victims
From the lawsuit:
May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular,
neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint
pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea,
constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis,
depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues,
tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
Highlights of the complaint
You can read the complaint here, posted by the Daily Caller
News Foundation. I've extracted some of the highlights of the complaint for reference, shown below.
This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns
by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin.
Dr. Margaret A. Hamburg was nominated as a result of
huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton's recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other
Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband's clear-cut conflict of interest –
specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.
Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality
that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently
dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband's financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg's husband, Peter F. Brown, reaped and continues
to reap huge financial gain as a result of Renaissance Technologies, L.L.C.'s holdings of Johnson & Johnson stock.
To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed
officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg's
tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly
illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.
Because of the Defendants' racketeering scheme and conspiracy to suppress warnings
and other material information about the extent of the deadly effects of Levaquin, Plaintiffs were precluded from discovering the extent of their injuries until 2015, not coincidentally after Dr. Margaret A. Hamburg no longer held her position as FDA Commissioner
in 2015 and material information about the full extent of the dangers of Levaquin were disclosed thereafter.
Defendants, each and every one of them, profited handsomely from their racketeering conspiracy by their agreed-upon failure to disclose
the harmful effects of Levaquin to Plaintiffs and the public at large. This case is thus of seminal importance not only for Plaintiffs, but also for the consuming public at large. It is a tragic testament to how corrupt companies like Johnson & Johnson
and their officials bribe and illegally collude with government officials and line their pockets at the expense of persons such as Plaintiffs.
Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political
contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.
Defendant Hamburg, on behalf of all of the Defendants as part of
this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.
In and around May 26, 2009, Defendant Hamburg was forced to divest herself of several
hedge fund holdings, as was her husband, Defendant Brown. This was done in order for her to take the position as the top food and drug regulator without any real or apparent conflicts of interest. However, the conflict of interest herein was never resolved.
Neither Defendant Hamburg nor Defendant Brown, nor any other Renaissance Technologies executive had fully disclosed to Congress and other authorities that Defendant Brown, Defendant Hamburg's husband at all material times, still held shares in – and
benefits financially from – all of the stocks of Renaissance, via Renaissance Technologies profit-sharing, as explained in detail by Defendant Simons, regardless of whether Defendant Brown divested himself of a particular hedge fund, in furtherance of
the racketeering enterprise and conspiracy.
While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an
estimated $90 million in 2012, due in whole or in part to Defendants' racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.
As part of Defendant Hamburg's pattern and practice of
acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns
stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval. In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro's approval.
Defendant Hamburg, as part of her pattern and practice of illegally acting outside the scope of her authority as Commissioner of the FDA, fraudulently used the U.S. mails and wires to commit overt acts in furtherance of the racketeering enterprise and conspiracy
by willfully and intentionally and illegally preventing the FDA from issuing warnings about the devastating and life-threatening effects of Levaquin.
On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally
exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with
the other Defendants to fraudulently withhold it.
From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation
of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory
system; digestive system; genitourinary system; and connective tissue.
Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle
wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing,
slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss,
glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks,
difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.
and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin.
Specifically, the purpose of Defendants' racketeering enterprise included,
but was not limited to, reaping large financial gain by willfully and intentionally suppressing material information, through the fraudulent use of the U.S. mails and wires, about the devastating, life threatening, and deadly effects of Levaquin. These Defendants
form this association in fact for the common and continuing purpose described herein and constitute an enterprise within the meaning of 18 U.S.C. SS 1961(4) engaged in the conduct of their affairs through a continuing pattern of racketeering activity. As described
in the foregoing paragraphs of this Amended Complaint, Defendants, each and every one of them, maintained an ongoing relationship during the course of their ongoing criminal enterprise.
PREDICATE ACTS Bribery in Violation of 18 U.S.C. SS 201, Predicate
Act No. 1 From May 2009 to March 2015, Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen committed acts constituting indictable offenses under 18 U.S.C. SS 201(b)(1)(A)-(C) in that they directly or indirectly, corruptly gave, and
offered and promised things of valuable, such as money, to Defendant Hamburg, who for the purposes of this predicate act was a public official as FDA Commissioner, with the intent to influence Defendant Hamburg to suppress material information about the devastating,
life-threatening, and deadly effects of Levaquin. This is evidenced by Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen's pattern and practice of using gratuities and bribery to secure favorable treatment for its products, as described
in paragraph 40 of this Amended Complaint. 109.
Predicate Act No. 19 From May 2009 to March 2015, Defendants Renaissance Technologies, Brown, Mercer, and Simons, in furtherance of the racketeering enterprise and conspiracy, transferred ill-gotten
and illegal financial gains from Defendant Renaissance Technologies' holdings of Defendant Johnson & Johnson stock to Defendants in order to continue to carry out Defendants unlawful conspiracy to conceal material information about the devastating and
life-threatening effects of Levaquin.
As set forth previously, in every quarter except one, from May 2009 to March 2015, while Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's employer, Defendant Renaissance Technologies,
held significant amounts of Defendant Johnson & Johnson stock, including as much as half a billion dollars in Defendant Johnson & Johnson stock.