Tag Archives: AstraZeneca

Big pharma takes aim at deadly counterfeits

 

By Katie McQue [Source]

GATEWAY TO AFRICA | In Africa the cost of all medications, including generic drugs, exceeds the means of most and many people are faced with a grim choice: purchase counterfeit medications, ingredients unknown, or go without treatment.

With 30% of the total available pharmaceuticals in Uganda believed to be counterfeit, the country, like many others, is struggling to keep control of a business that is both deadly and lucrative.

“A lot of deaths occur. But nobody reports these and nobody is going to investigate,” said Suraj Ali, a partner at the Ugandan legal firm Muwema & Mugerwa.

The situation in Uganda is typical in much of sub-Saharan Africa, and the reasons are economic. In regions of high prevalence of poverty the cost of all medications, including generic drugs, exceeds the means of most. Few people have medical insurance, and they are faced with a grim choice: purchase counterfeit medications – ingredients unknown – or simply go without treatment.

The big pharmaceutical firms are worried. “When you visit a market in Tanzania, you see that they are being sold everywhere,” Ed Wheatley, AstraZeneca’s investigations director for the region, said at June’s Visiongain Pharmaceutical Anti-Counterfeiting conference, in which representatives from major drug makers gathered to deliberate the problem.

This big problem is also a big business – it is widely estimated that counterfeit drugs have an annual turnover of US$75 billion worldwide, with a profit margin of about 70%. This means that the global share of counterfeit medications is 10% of the pharmaceutical market. Around the world 200,000 people die annually due to counterfeits.

Most of the fakes hail from factories in China, India and Pakistan, and counterfeiters are more concerned with matching the packaging than the ingredients of the original. Criminals steal hospital vials with branded labels, print their own hologrammed boxes – even buy tablet-making presses on eBay.

The World Health Organisation estimates that 32.1% of these drugs do not contain any active ingredients; 20.2% have incorrect quantities of active ingredients; 21.4% include wrong ingredients and 8.5% have high levels of impurities or contaminates.

The loss of sales and reputation is significant, as users of the fake drugs may still associate their illness with the genuine article. In some countries, drug makers can also be liable for harm caused by fakes.

In Germany, for example, a company can be called to account if it can be proven that it did not utilise all the possibilities provided by state-of-the-art technology to prevent counterfeiting. In most US states, any part of the manufacturing and sales chain can be liable for damages to the consumer arising from faults in a product’s construction, manufacturing or labelling.

Given this risk it is understandable why pharmaceutical companies are keen to intervene in the African counterfeit market. Some assist local governments with on-the-ground intelligence, leading to raids and prosecutions. This assistance is necessary in countries where awareness is low, resources devoted to the problem are scarce and corruption is high.

“There is a lot of corruption,” Ali said. “A lot of the magistrates are underpaid and they get bribed.

“We have a national drug authority that is supposed to prevent counterfeiting, but it is underfunded,” he added. “There are very few inspectors; they don’t have the equipment to check drugs properly… Things find their way into the country – the borders are very porous.”

 


Big Pharma: Sneezing Viruses From the FluMist Nasal Vaccine-Controlling the Military With Drugs

 

Experimental Vaccines

SOURCE

The United Kingdom is set to be the first country to offer the seasonal flu vaccination to all children enrolled in the public education system. The nasal flu vaccine being offered to over 9 million children is sold under the brand name Fluenz in Europe and FluMist in the United States, and is made by AstraZeneca’s MedImmune unit and has been available for the past decade in the United States.This is the largest contract the company has received outside of the U.S., taking its first steps into the global dissemination of inhalable poisons.

The FluMist vaccine contains a live virus and is squirted up the nose where the virus can live and breed for up to 28 days while it damages your immune system. Could the sneeze be the new WMD Weaponized Mucus Device a way to infect and spread diseases through the populations? Having been cooked up in a label run by the new world order’s pharmaceutical psychopaths you can only assume there is a hidden agenda and, as always, it includes reducing the global population. Read the rest on my website link HERE

Blog: http://experimentalvaccines.blogspot.com/
A warning to all psychiatric drug users

Thursday, August 23, 2012 by: Jonathan Landsman

drug(NaturalNews) Antidepressants are the most prescribed (often overprescribed) medication in the United States. But, contrary to popular belief – taking Zoloft, Prozac and Lexapro (to name a few) can be very dangerous to your health. These selective serotonin reuptake inhibitors (SSRI’s) can cause physical pain, involuntary movement, sexual dysfunction and life-threatening drug interactions. Clearly, most people have NOT been told the entire story. (keep reading)

Generally speaking, the consumption of psychiatric drugs will interfere with normal human emotions and mental activities – making a person less able to successfully handle personal problems or life challenges. If you know someone addicted to these harmful medications – ask them to join us on the next NaturalNews Talk Hour.

Visit: http://www.naturalhealth365.com and enter your email for FREE show details + a FREE 7-day juice cleanse!

The problem – you’ve never been told – about psychiatric drugs

Make no mistake – antidepressants and anti-anxiety drugs severely alter brain chemistry. Did you know that taking psychiatric drugs can lead to drug-induced mental disabilities? Just check out some of the many health problems associated with psychiatric medications:

Antidepressants cause emotional “numbness” – often providing an artificial relief from emotional suffering.

Antipsychotic drugs disturb frontal lobe activity – causing a chemical lobotomy – making emotionally distressed people more submissive and less able to feel.

Mood stabilizers slow down overall brain function – dampening emotions and vitality.

Benzodiazepines suppress overall brain function with temporary relief of tension or anxiety – at the cost of reduced mental function.

Stimulants blunt spontaneity and enforce obsessive behaviors in children, making them less energetic, less social, less creative and more obedient.

A warning to all psychiatric drug users

Thursday, August 23, 2012 by: Jonathan Landsman

drug(NaturalNews) Antidepressants are the most prescribed (often overprescribed) medication in the United States. But, contrary to popular belief – taking Zoloft, Prozac and Lexapro (to name a few) can be very dangerous to your health. These selective serotonin reuptake inhibitors (SSRI’s) can cause physical pain, involuntary movement, sexual dysfunction and life-threatening drug interactions. Clearly, most people have NOT been told the entire story. (keep reading)

Generally speaking, the consumption of psychiatric drugs will interfere with normal human emotions and mental activities – making a person less able to successfully handle personal problems or life challenges. If you know someone addicted to these harmful medications – ask them to join us on the next NaturalNews Talk Hour.

Visit: http://www.naturalhealth365.com and enter your email for FREE show details + a FREE 7-day juice cleanse!

The problem – you’ve never been told – about psychiatric drugs

Make no mistake – antidepressants and anti-anxiety drugs severely alter brain chemistry. Did you know that taking psychiatric drugs can lead to drug-induced mental disabilities? Just check out some of the many health problems associated with psychiatric medications:

Antidepressants cause emotional “numbness” – often providing an artificial relief from emotional suffering.

Antipsychotic drugs disturb frontal lobe activity – causing a chemical lobotomy – making emotionally distressed people more submissive and less able to feel.

Mood stabilizers slow down overall brain function – dampening emotions and vitality.

Benzodiazepines suppress overall brain function with temporary relief of tension or anxiety – at the cost of reduced mental function.

Stimulants blunt spontaneity and enforce obsessive behaviors in children, making them less energetic, less social, less creative and more obedient.

“Rapid Progress”: Controlling the Military With Drugs

Big Pharma uses drug patent settlements as payoffs to generic rivals to delay competitive drugs

Thursday, August 23, 2012 by: J. D. Heyes

drug(NaturalNews) Once again, Big Pharma seems to be putting profits over patients, this time in a scheme to prevent cheaper generic drug alternatives from hitting the market sooner. Only this time, the Leviathan is on the side of we, the people.

In a friend-of-the-court (amicus) brief, the Federal Trade Commission said makers of name-brand medications that settle challenges to patents by agreeing not to introduce their own generic alternatives are actually using those promises to delay generic competition, Reuters has reported.

In the amicus brief the FTC – a regulatory agency – said such patent settlements, in which drug manufacturers promise not to introduce their own authorized generic drug versions are really just a way of paying a generic rival to keep their products off the market longer.

Conspiracy to delay generic entry into the market

The FTC’s assertions came as a federal court in New Jersey – one that oversees a number of suits against Big Pharma – considers a private antitrust challenge to one such agreement between Pfizer, Inc.’s Wyeth unit and Teva Pharmaceutical Industries Ltd., the world’s biggest manufacturer of drugs.

“Empirical evidence confirms what the pharmaceutical industry has long understood: that a no-(authorized generic) commitment provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry,” the FTC said in the proposed brief.

A court should “carefully consider the economic realities of no-AG commitments and their impact on consumers,” the agency added.

The regulatory agency filed its brief in support of antitrust litigation filed by chain drugstores CVS Caremark Corp., and Rite Aid Corp., both of which accused Pfizer and Teva of a conspiracy to prevent generic versions of a popular antidepressant, Effexor XR, off store shelves.

In a statement, Pfizers Wyeth subsidiary refuted such allegations, saying its settlement agreement with Teva was correct and proper, and would allow a generic of Effexor XR onto the market a full seven years before its original patent expired.

The company went on to say that the FTC did not voice concerns about the settlement when officials with the agency originally reviewed it.

A spokeswoman from Teva told Reuters the company believes the suit has no merit and as such has filed a motion for dismissal.

But the two drugstore chains aren’t the only retailers who believe something fishy is going on. Walgreen Co., Kroger Co., Safeway Inc., Supervalu Inc. and HEB Grocery Co., had similar misgivings about the settlement in a suit those companies filed in the same court in December.

The presiding judge in the Effexor case sought amicus briefs to assess how the case might be affected by a recent 3rd Circuit Court of Appeals ruling that said payments by a branded drugmanufacturer to a potential rival generic drug maker can be “evidence of an unreasonable restraint of trade” if they prevented generic medications – which, of course, are generally much cheaper – out of the hands of patients.
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Antibiotics May Lead to Lifelong Obesity

Lisa Garber
NaturalSociety
August 23, 2012

pillantibiotics 235×147 Antibiotics May Lead to Lifelong ObesityAntibiotics have been associated with weight gain before, but new research indicates it may have the same effect on infants, too. Given that childhood obesity is linked to obesity later in life, prescribing antibiotics for children presents more problems for a nation already in the throes of an epidemic.

“We typically consider obesity an epidemic grounded in unhealthy diet and [lack of] exercise, yet increasingly studies suggest it’s more complicated,” says Dr. Leonardo Trasande from the New York School of Medicine.

Read more
Early Antibiotic Use Linked to Childhood Obesity
Thu, 08/23/2012 – 11:59am
NYU School of Medicine
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Researchers at NYU School of Medicine have made a novel discovery that could have widespread clinical implications, potentially affecting everything from nutrient metabolism to obesity in children.

Since the 1950’s, low dose antibiotics have been widely used as growth promoters in the agricultural industry. For decades, livestock growers have employed subtherapeutic antibiotic therapy (STAT), not to fight infection or disease, but to increase weight gain in cattle, swine, sheep, chickens, turkeys and other farm animals.

First author Ilseung Cho and colleagues set out to reveal how antibiotics were acting on the body to create this effect, hypothesizing that low doses of the drugs may alter the composition and function of the bacteria in the gut. The resulting study, appearing online ahead of print in Nature, confirmed their theory about the gut microbiome, the term used to refer to the community of bacteria that lives in the stomach, and raises new questions about how manipulating it can impact metabolism and disease in the body.

The researchers administered STAT to normal mice and observed that the mice receiving antibiotics developed increased fat mass and percent body fat. After about six weeks, the mice that received antibiotics had gained about 10 to 15 percent more fat mass than the mice that did not receive antibiotics. The researchers also note that bone density was significantly increased in STAT mice early in development and that particular hormones related to metabolism were affected by antibiotic exposure.

“By using antibiotics, we found we can actually manipulate the population of bacteria and alter how they metabolize certain nutrients,” says Cho, assistant professor of medicine and associate program director for the Division of Gastroenterology at the School of Medicine. “Ultimately, we were able to affect body composition and development in young mice by changing their gut microbiome through this exposure.”

Cho adds that the scientific community is only now beginning to understand just how complex the microbiome is and how it affects health and disease. With a better understanding about the interactions between the microbiome and hosts and how these interactions can be manipulated, he and his colleagues believe the finding has the potential to affect a wide array of conditions ranging from childhood obesity to metabolic syndrome in adults.

Discovered in the early 20th century, antibiotics came into widespread use after World War II with substantial public health benefits. Use of these antibacterial agents has increased dramatically in the years since, now approximating one antibiotic course per year in the average child in the U.S. However, there is increasing concern that antibiotic exposure may have long-term consequences, prompting a surge in recent research focused on the effects of antibiotics on development.

“This work shows the importance of the early life microbiome in conditions like obesity,” says lead investigator Martin Blaser, a professor of medicine at NYU Langone Medical Center. “The rise of obesity around the world is coincident with widespread antibiotic use, and our studies provide an experimental linkage. It is possible that early exposure to antibiotics primes children for obesity later in life.”

Blaser advises that more research is needed to confirm this theory, but that manipulation of the gut microbiome may have implications for other conditions affected by the functions of bacteria in the gut. “We’re still learning how far the impact of the microbiome reaches and the costs of perturbing it,” he says.

The study was funded, in part, by the National Institute of Diabetes and Digestive Kidney Diseases.
Painkillers Could ‘Increase Risk 16-fold’ of Male Reproductive Disorder

Elizabeth Renter
NaturalSociety
August 20, 2012

pillmedicationbottles 235×147 Painkillers Could Increase Risk 16 fold of Male Reproductive DisorderPreviously, the male reproductive disorder of crytochidism, or undescended testicles, was blamed on environmental pollution and endocrine disruptors like phthalates. Now, scientists say it could have more to do with the use of painkillers by a pregnant mother.
Male Reproductive Disorder Linked to Painkiller Use by Pregnant Moms

Undescended testicles occur when the male reproductive organs are actually inside of the body rather than descended. Often the condition is handled with surgery and can affect male fertility in adulthood.
The Guardian reports scientists in France, Finland, and Denmark have determined that taking more than one “mild painkiller” at a time during pregnancy could increase the risk of undescended testicles in a male infant by 7 times. Mild painkillers include ibuprofen, aspirin, and paracetamol.

According to researchers, the risk was greatest when the painkillers were taken in the second trimester where the use of any painkiller more than doubled the risk. Ibuprofen and aspirin quadrupled the risk, and taking more than one type of painkiller in the second trimester “increased the risk 16-fold.”

The issue was previously only linked to endocrine disrupters in the environment. Now, experts are saying that “a single paracetamol tablet [500 mg] contains more endocrine disruptor potency than the combined exposure to the 10 most prevalent of the currently known environmental endocrine disruptors during the whole pregnancy.”

Many women use these mild painkillers during pregnancy, unaware of the risks. They reason that the drugs are used by nearly everyone for nearly any ache or twinge of pain, so how on earth could they be harmful? But, evidence from the scientists work reveals something interesting: that pregnant women were reluctant to admit to using the painkillers, perhaps revealing that they were aware there was at least some risk involved, or that they undervalued the effects of the medicine.

Telephone interviews found that women significantly under-reported their use of painkillers in written questionnaires. Among 298 Danish mothers, 30.9% said they used painkillers when they filled in a questionnaire, but 57.2% reported using them when asked in a telephone interview. They explained that they had not considered the tablets to be “medication”.

Of course this isn’t the only issue with OTC painkillers. Taking just a little ‘too much’ Tylenol over the course of days or weeks can be even more deadly than massive overdose. Taking even slightly higher doses than recommended can cause liver damage that is potentially fatal. In fact, Tylenol overdose is the leading cause of acute liver failure in the U.S., creating 26,000 hospitalizations and around 500 deaths each year.

The solution? As always—look for natural pain management alternatives before turning to a pill.

Additional Sources:

Guardian.co.uk
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Trading chickenpox for shingles

Saturday, August 25, 2012 by: Craig Stellpflug
shingles(NaturalNews) It’s another case of the cure is worse than the disease. The shingles vaccine temporarily “protects” about half of those vaccinated (CDC, 2011). No one knows how long the “benefits” of the vaccine will last, and each Zostavax shingle vaccination contains a litany of additives including MSG and aborted fetal cells and DNA, among things. Shingles cases result in three times as many deaths and five times the number of hospitalizations as chicken pox (Goldman, 2006).Both chickenpox and shingles are caused by the herpes zoster virus. Shingles mainly affects people who have received a chickenpox vaccine (which contains a live attenuated form of the virus), do NOT have contact with children who are breaking out with chicken pox, and whose immune system weakens with age and constant Big Pharma drugs and bad diets.

The first sign of Shingles is usually a pain, tingling, or itchy feeling on the skin. This sensation lasts about three days and then a painful rash typically appears at the same location and almost always on a single side of the body. The rash begins as fluid-filled blisters similar to chickenpox, in a band or a cluster following a nerve.
Why do we get shingles?

The common assumption in the medical community is that occurrence of shingles increases as the individuals’ immune systems are declining. The latest research, however, shows the real reason is because of vaccinated populations are not expressing chickenpox, coupled to the fact that older people receive fewer natural boosts to natural shingles immunity as their contacts with young children goes down (NVIC, 2012).

The medical community’s answer? More vaccines… Medical folly has caused the shingles by giving a chicken pox vaccine, so now they want to give yet another toxic vaccine in the hopes that in doing so a patient can maybe avoid a shingles outbreak. In the International Journal of Toxicology is piece by Gary S. Goldman, Ph.D., revealing high rates of shingles since the government’s 1995 push for the chicken pox vaccine. Goldman shows that shingles is naturally suppressed in the adult by occasional contact with actual chicken pox. (Goldman, 2006)

Adults receive natural immunity boosts against shingles by coming into contact with children infected with chicken pox.
Natural solutions:

• Find a chickenpox party and get re-exposed! This will boost natural immunity and help prevent shingles outbreaks.

• Support your body’s natural immune function by taking probiotics.

• Support normal thyroid function. The immune system depends upon optimal thyroid function to battle disease.

• Take methylcobalamin B-12 as a daily supplement. In a body undergoing oxidative stress from shingles methyl B12 production is impaired and needs extra support. Intramuscular methylcobalamin injections are a wonderful source of shingles relief.

• Vitamin C is a potent virus fighter and is highly effective at stopping a shingles outbreak. Intravenous vitamin C is much more effective than oral vitamin C to treat an outbreak of shingles.

• Take Apple Cider Vinegar (ACV). Start with 1 tablespoon in 4 ounces of water imbibed 3 times a day. Using a cotton ball, dab some ACV directly to lesions (it will burn at first) several times a day.

• Manuka honey is more effective at treating secondary shingle bacterial infections than popular antibiotics.

Don’t be a patsy for Big Pharma. There are natural solutions to almost any health dilemma if you invest the time to make informed decisions and choose to invest your hard earned money in your health rather than lining the pockets of Big Pharma and its cronies.

Sources for this article include:

CDC. (2011). Shingles Vaccination: What You Need to Know. Retrieved from Center for Disease Control: http://www.cdc.gov/vaccines/vpd-vac/shingles/vacc-need-know.htm
Goldman, Gary S. (2006). The Case against Universal Varicella Vaccination. International Journal of Toxicology, 25(5):313-317.
Merck. (2011). ZOSTAVAXR Zoster Vaccine Live. Retrieved from http://www.merck.com
NVIC. (2012). Herpes Zoster (Shingles) & Shingles Vaccine. Retrieved from National Vaccine Information Center: http://www.nvic.org/vaccines-and-diseases/Shingles.aspx
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A Parent’s Guide: What to do if your child dies after vaccination
Guidelines to Autopsy Medical Tests: Parents Immediately Should Require an Autopsy That Includes Certain Tests

image source

Catherine J. Frompovich
Activist Post

Introduction

Over the years various medical doctors, attorneys, and parents have contacted the authors of this Guide seeking information about medical tests that could indicate a causal relationship between vaccines and their ingredients and the severe reactions in previously healthy infants, toddlers, or teenagers, many of whom succumbed after either: 1) receiving vaccination(s), or 2) experiencing protracted adverse events due to vaccines.

Since these requests are coming more frequently, apparently there is a need for such information. This Guide was vetted for accuracy, including omission of relevant information needed in the attempt to determine whether a child died as a result of neurotoxins and/or hazardous chemicals in vaccines. Some are listed in Vaccine Excipient & Media Summary / Excipients Included in US Licensed Vaccines: E-1 thru E-5; Vaccine-Production Media: E-6 & E-7 at the Centers for Disease Control and Prevention’ website here: (Source)

Another source of vaccine chemical ingredients is each vaccine’s package insert, which can be accessed at U.S. FDA Vaccines, Blood & Biologics website here: (Source)

With the current practice of injecting several multi-valent vaccines (often as many as 9 separate vaccines) into an infant or toddler during the same office visit, some recipients’ central nervous systems (CNS) apparently become overloaded and/or the brain suffers dramatic injury from multiple neurotoxins and other toxic chemicals crossing the blood-brain barrier (BBB); others experience severe allergic reactions to one or more of the vaccine components. Encephalopathy or anaphylaxis can occur with fatal results.

Conventional ‘wisdom’ claims vaccines are not harmful. However, it is becoming increasingly apparent this is not the case for all recipients. The information and tests discussed in this Guide can potentially help document vaccine damage, if parents and their attorneys secure pathologists who will perform those tests.

Parents’ Information

Parents should realize their gut instincts most often are correct, especially about their child whom they have been taking care of since birth. No one knows a child better than his/her mother. Ideally, parents will have documented any new health conditions their child experienced after receiving vaccinations, e.g., screaming fits, seizures, fevers, etc. That documentation will be most helpful later on.

There is nothing a parent can experience that is more traumatic than the death of a child. But, when a death tragically occurs shortly after vaccination, time is of the essence. Usually, the coroner is appointed by government authorities. Parents need to know they have every right to request the pathologist perform post-mortem blood and tissue assays/analyses, and to preserve the samples and data they reveal. Parents may need an attorney’s legal help and/or intervention to get the proper tests performed. Nevertheless, parents have every legal right to request an autopsy be performed, including certain tests looking for toxins, similar to what is done in drug overdose deaths. Parents also have the right to request storage of samples for future tests that are developed as new scientific discoveries are made.

Grieving parents must remember this is a time to rely on loving family and friends to help provide support in their quest to ascertain the child’s cause of death, which can be determined in most cases via proper post-mortem examination.

Parents must remember physicians and emergency room personnel are typically not trained to recognize adverse reactions from vaccines. Therefore, it is common practice for child abuse/neglect, or Shaken Baby Syndrome (SBS) legal charges to be filed against parents of children who die from vaccine damage to the brain, especially if there are no visible trauma marks on the child’s body. That’s when certain blood tests can be most helpful disproving such allegations. This Guide tells which tests should be performed as soon as possible after death to disprove SBS.

Attorney Information

Attorneys are not prepared, in most cases, to deal with vaccine damage cases. Tort law does not apply to vaccine damages. The National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury Compensation Program under which claims must be filed. However, the more medical documentation, e.g., post-mortem test results, attorneys can present with their client’s claim, the more likely the case you file will get attention from the Special Masters of the United States Court of Federal Claims. Various post-mortem tests can disprove SBS, SIDS, etc., which this Guide discusses later. Attorneys should report the death by filing a VAERS report to the HHS at http://vaers.hhs.gov/helpinstructions

Coroner / Pathologist Information

As every pathologist knows, it is important to ascertain cause of death. Chemicals, either legal drugs/medications (prescription drugs and their amounts in the body) or street drugs commonly are assayed. Since there are numerous neurotoxins, heavy metals (Hg, Al in 4 formulations), even recombinant DNA (rDNA), and industrial use chemicals in the formulation of vaccines, it should be incumbent upon the pathologist to perform extensive panels/assays of both post-mortem blood and key organ tissue samples, e.g., brain, liver, spleen, heart, and small intestine.

PLOS (“public library of science”) online published the Ken Tsumiyama, Yumi Miyazaki, Shunichi Shiozawa paper “Self-Organized Criticality Theory of Autoimmunity” [1] wherein their

Conclusions [indicate]

Systemic autoimmunity appears to be the inevitable consequence of over-stimulating the host’s immune ‘system’ by repeated immunization with antigen, to the levels that surpass system’s self-organized criticality.

The Tsumiyama, et al. paper contains information pathologists may find helpful.

[1] http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0008382

Qiagen’s Sample & Assay Technology is available at http://www.qiagen.com with ordering information, Fax numbers, and technical support phone numbers for the following countries: Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, The Netherlands, Norway, South Korea, Sweden, Switzerland, UK, USA.

Qiagen offers Gentra® Puregene® Handbook Second Ed. 2007–For purification of archive-quality DNA from: human whole blood, bone marrow, buffy coat, buccal cells, body fluids, cultured cells, tissue, mouse tail, yeast, bacteria

Infant/Toddler Vaccines Autopsy Tests

Test for CRP (C-reactive protein: if inflammation is high, that would indicate vaccines were to blame as a small infant or toddler could not generate such results) This would indicate severe brain inflammation.
Test for liver enzymes
Test for heavy metals, especially Hg and Al in blood and brain tissue
Test for formaldehyde and Formalin–in particular–which would come from vaccines. Even though the body manufactures a little formaldehyde, large amounts would implicate formaldehyde, or Formalin, especially in vaccines.
If brain tissue is taken, check for Hg and Al, which would indicate those metals crossed the blood brain barrier and may have been the precipitating factor in the child’s demise, as they are potent neurotoxins and can cause encephalopathy.

Run a cytokine panel:

Interleukin-1 beta (IL-1β) – IL-1beta is one of the key mediators of the inflammatory response to physical stress.
Interleukin-6 (IL-6)
Interleukin-8 (IL-8)
Tumor necrosis factor alpha (TNF-α) TNF-α is a growth factor for immune cells and osteoclasts, the cells that break down bone.
Fibrinogen
Vitamin C assay
Titer levels on all the vaccines. If they are sky high, that could make a case for molecular mimicry causing death.

Brain Tissue Samples Preserved as Paraffin Blocks

Brainstem: Pons, Medulla, Midbrain
Hippocampus
Cerebellum

HPV Gardasil® Vaccines for Teenage Girls and Boys

Each of the 3 injections contains 225 ug of aluminium hydroxyphosphate sulfate, plus sodium borate (a pesticide), andpolysorbate 80, an emulsifier linked with anaphylaxis, convulsions, collapse. Post-mortem blood and tissue findings should prevail in court if these substances were in the system at the time of death, since vaccines are one of the primary sources.

Additional Information

Parents should construct a retrospective timeline of the child’s last week before vaccination, e.g., did child have a fever, cold, asthma, allergy incident, influenza, or other health anomaly, plus a timeline of events occurring after vaccination.
Were those events reported to the MD/pediatrician who administered the vaccine and what was the advice given?
Before administering the vaccinations to the child, did the MD inquire as to the child’s general health at the time of the vaccination?
Parents need to obtain a complete copy of their child’s medical records as soon as possible and keep it for their records.
Parents need to make sure a report is filed with the Vaccine Adverse Event Reporting System.
When a vaccine is administered to your child, make sure the doctor/nurse records the vaccine lot number and expiration date on your child’s medical records.

Note: Children should not be given vaccinations if there is any immune response manifesting, e.g., seasonal allergies, food allergies, common cold, flu symptoms, etc.

Shaken Baby Syndrome

Were parents questioned about or charged with Shaken Baby Syndrome? If so, a Bone Density Test can prove/disprove SBS. See this very well documented paper regarding that.

Matthew B. Seeley, JD, paper “Unexplained Fractures in Infants and Child Abuse: The Case for Requiring Bone-Density Testing Before Convicting Caretakers,” published in the Brigham Young University Law Review Dec. 20, 2011.

Part 1:
http://www.vaccinationcouncil.org/2012/02/05/bone-density-test-can-disprove-shaken-baby-syndrome-by-catherine-frompovich/

Part 2:
http://www.vaccinationcouncil.org/2012/02/09/bone-density-shaken-baby-syndrome-part-2-by-catherine-j-frompovich/

This Guide will be updated periodically as pathologists and MDs report back to us what they feel is necessary to ascertain cause of death revolving around vaccine issues.

Norma Erickson is the President of SaneVax Inc., promoting Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information.

Catherine J. Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies.

Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.

Catherine’s latest book, A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, is available on Amazon.com.

Two of Catherine’s more recent books on Amazon.com are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick (2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008).

 


Big Pharma's global guinea pigs

 

(Reuters) – The Polish port city of Gdansk is famous for its shipyards. Hungary’s fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world.

In fact, Poland and Hungary together accounted for 21 percent of all subjects studied in the pivotal 18,000-patient trial — more than double the United States and Canada combined.

A few years ago that would have been unthinkable. Major drug companies, with an eye on the commercial promise of the world’s largest and most profitable market, would have run half their tests on a major cardiovascular medicine like this in U.S. hospitals under the supervision of U.S. doctors.

Today, the clinical trials business has gone global as drugmakers seek cheaper venues for studies and cast their net further afield for big pools of “treatment-naive” patients who are not already taking other drugs that could make them unsuitable subjects for testing new ones. And it is not only the practicalities of running big clinical trials as efficiently and cheaply as possible that is driving the change. The drug industry is also paying a lot more attention these days to the promise of emerging markets, whose healthcare authorities, just like those in the United States and Western Europe, are keen to see cutting-edge science conducted in their backyards.

“The motivation to involve lots of patients is very high in Eastern European countries and also in Asia,” says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. “There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid.”

The increasing reliance on clinical trials in Eastern Europe, Asia and Latin America raises serious questions. Is the quality of the data as reliable as that from a top U.S. medical center? Is it safe to extrapolate common clinical effects from studying patients with different lifestyles and genetic profiles? And are ethical standards in testing new drugs properly upheld in poorer countries? After all, there is an unhappy history of exploitation of the disadvantaged in trials, as highlighted by a shocking U.S. study in the 1940s which saw prisoners and the mentally ill deliberately infected with syphilis in Guatemala.

Given the sea change, it’s perhaps no surprise that the rush to globalize clinical studies is starting to cause some headaches.

SOMEWHERE ELSE

In the United States, the widespread “off-shoring” of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites — and as more experimental medicines move through the pipeline the numbers are set to increase further.

In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polish patients involved in such trials rose fivefold over the period, while Hungary was up 3-1/2 times.

“Today, wherever you stand in the world, the larger part of the data from clinical trials comes from somewhere else, so you have to have confidence in the framework in which those trials were done,” says Fergus Sweeney, head of compliance and inspections at the London-based EMA, Europe’s equivalent of the FDA.

Sweeney — an Irish pharmacologist who has been working on inspections at the agency since 1999 and who chooses his words carefully — spends an increasing amount of time grappling with the problem of foreign trials. But he admits the number of research sites actually inspected by EMA or FDA officials remains “tiny.”

Drug companies are also finding that conducting clinical trials in dozens of countries at once is a tricky business and results can be unpredictable. Just ask AstraZeneca.

Its drug Brilinta — a rival to Sanofi-Aventis SA and Bristol-Myers Squibb Co’s $9 billion-a-year seller Plavix, the world’s second biggest-selling prescription medicine — is potentially huge.

Yet while Brilinta has already been approved in more than 30 countries, including those in the European Union, it has been delayed in the United States — the one market that will ultimately make or break it commercially. The reason? While the big trial known as PLATO found Brilinta was clearly superior to Plavix at preventing cardiovascular deaths globally, people in North America actually seemed to do worse on the new drug.

Why is unclear. One theory is that U.S. heart patients get given more aspirin alongside other medicines and this may somehow interfere with Brilinta’s effectiveness. But it might just be play of chance, since the North American sub-group – which accounted for only 9.7 percent of patients — was too small to draw any statistically sound conclusions.

Whatever the explanation, the discrepancy has left the new drug hanging in the balance. Some industry analysts think the FDA may demand further evidence before approving it in the United States, despite an advisory panel vote in its favor last year. These days the FDA has little appetite for sticking its neck out and officials will think long and hard before approving a drug that might not work for Americans. The watchdog has been slammed in recent years for failing to prevent a string of drug safety scandals, including heart problems linked to Merck & Co Inc’s now withdrawn painkiller Vioxx and GlaxoSmithKline Plc’s diabetes pill Avandia, as well as deaths from contaminated Chinese supplies of blood thinner heparin.

The U.S. agency is due to give its verdict on Brilinta by July 20 — but the ripples from this study have already spread widely. According to an analysis of the situation by Dr. Magnus Ohman and Dr. Matthew Roe of Duke University Medical Center, the PLATO results “should serve as a warning to all stakeholders in global cardiovascular research that balanced enrollment around the world in pivotal trials should be the goal for any future drug development program.”

AstraZeneca says it is confident in the conduct and results of the trial. Yet the study is now a red-hot topic for pharmaceutical investors and it has also got a lot of doctors talking.

THROWING IN THE TOWEL

April’s annual meeting of the American College of Cardiology (ACC) in New Orleans was the usual frenetic mix of world-class science, networking and lobbying by the $850 billion-a-year pharmaceutical industry, seeking to promote its wares to key opinion leaders. The commercial razzmatazz of the convention centre’s giant trade stands, advertising big brand drugs and medical devices, painted a bright picture for medical science.

Under the surface, however, a growing number of doctors are worried about the tectonic changes in drug research. They resent the export of clinical trial work, which they blame not only on industry’s endless pursuit of lower costs but also on the increasing red tape surrounding trial procedures at home.

“Many of my colleagues have just thrown in the towel and say ‘I’m not going to do clinical research anymore’,” says Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at University of California-San Francisco, one of the top medical schools in the United States.

“It’s pervasive. They’ve just quit clinical trial work. It’s just too difficult and the expenses are so high you end up being in the red when you do a study.”

That’s in stark contrast to the experience of doctors in Hungary, many on a monthly salary of around 500 euros ($740), for whom working on a clinical study can double their pay. For medics in places like India — now also a major hotspot of clinical research — the salary boost can be even greater.

But Crawford says he does not want data from these places. He wants to see how a new medicine performs in his own country.

“I don’t have any way of assessing the quality of research in an Eastern European country. It may be wonderful, but I don’t have any way of assessing that. I know if a study is conducted in the United States and Canada, it’s done according to certain standards,” he says.

Dr. David Holmes, president of the ACC and professor of medicine at the Mayo Clinic in Minnesota, is more circumspect but also believes the Brilinta case raises important issues: “We can’t abrogate the responsibility of conducting clinical trials in the U.S. on people that live in the United States.”

The EMA’s Sweeney says there is no evidence that clinical trials conducted in developing economies are any worse than those done in the West. However, lack of evidence is not the same as positive proof and his team needs more resources to guarantee everything is squeaky clean on the front-line. Between 2005 and 2009, the European watchdog dealt with data linked to pivotal studies from 44,034 clinical trial sites, but it carried out only 44 good clinical practice inspections outside Europe and North America. The U.S. FDA, meanwhile, inspected 0.7 percent of foreign clinical trial sites in 2008, against 1.9 percent of domestic sites.

CHINA RISING

For now, the world’s emerging economies still play second fiddle to the United States when it comes to testing drugs. Clinicaltrials.org, a website run by the U.S. National Institutes of Health, currently lists more than 106,000 trials around the world, of which just over 50 percent are in the United States. But the balance is shifting, particularly when it comes to the big late-stage trials that really matter in deciding whether a drug is approved for sale. U.S. centers account for only 43 percent of the nearly 19,000 trials in final Phase III testing.

As in so many other areas of life, the rising star is China, which already has a total of more than 2,700 clinical trials and is experiencing exponential growth.

Less than two hours by high-speed train from Shanghai, Dr. Zhang Chenyu’s modern laboratory at Nanjing University’s School of Biological Science shows how Chinese medical research has vaulted up the global league table. After nine years working as a research assistant professor at Harvard Medical School, Zhang returned to China in 2004, where he is dean of the Nanjing school, and these days he finds the world’s top drugmakers beating a path to his door.

Zhang is a bit special because he and colleagues have discovered how certain molecules, or biomarkers, in blood can signal the presence of cancer as early as 33 months before conventional clinical diagnosis. As a result, his team is testing hundreds of U.S. blood samples in a lung cancer project with Johnson & Johnson, which is interested in developing a new diagnostic test using the biomarker. But Zhang is also convinced the wider Chinese research community has arrived firmly on the global clinical research scene, thanks to its relatively low cost base, its expertise, its modern facilities and — crucially — the huge potential market for Western medicine in the country.

China has already leapfrogged the likes of Germany and France to become the world’s third largest market for pharmaceuticals, and by 2015 it is set to overtake Japan as the second-biggest, behind only the United States, according to pharmaceutical market information company IMS Health.

“Drug companies will surely vie for such a market,” says Zhang. “Now, more Chinese can afford to buy Western-made drugs. So instead of performing a trial in China only after completing trials in Europe or the U.S., why not conduct them all at the same time?”

Independent expert Dr. Rory Collins, a professor of medicine at the University of Oxford and co-director of its Clinical Trial Service Unit, is a big fan of the power that Chinese clinical research can bring to medicine and is deeply impressed by how far the country has come in two decades.

“I remember 20 years ago giving lectures on randomized trials in China and the idea that you would randomly allocate people to get treatment, or not, was viewed as completely alien. The response was: ‘We know which treatment works, we just ask the professor.’ Today, China is a very organized place and all the structures are there,” he says.

Indeed, the results of Chinese drug research are already bearing fruit — and not just for patients in China.

Six years ago, Collins’s Oxford team led a huge 46,000-patient study in China — the biggest ever seen in the country — to test the blood thinner Plavix and a beta-blocker in the emergency treatment of heart attacks. They found that adding Plavix to aspirin produced further benefit, while the beta-blocker metoprolol did not. That important discovery has since gone on to influence medical practice around the world.

“That study would never have been done if we couldn’t have run this very streamlined trial in China at very low cost,” says Collins, who is currently working on another pivotal heart drug study for Merck that contains no U.S. patients. “My preference would be not to do any trial in North America because it is so inefficient and so costly.”

Western Europe may be a bit better but Collins and many other researchers are highly critical of the bureaucratic obstacles there as well, following the introduction of the European Union’s 2004 clinical trials directive, which has led to a mountain of extra paperwork for each trial.

The aim of the EU directive is to harmonize standards and protect subjects.

AVOIDING EXPLOITATION

Everyone agrees that patients should not be exploited during the testing of drugs but trying to square the circle on ethics leads to fierce debate. Enrolling in a clinical trial can be a big health boost for many patients in poorer countries, who receive better-than-normal healthcare while being studied. But is it right to test an expensive new drug in a country where local people may never be able to afford it? And do patients always understand the risks associated with testing an unlicensed drug?

Caring for patients properly means drug companies “not just parachuting in, doing a study and leaving without recognition that these patients have really made a contribution, taken some risks and deserve to be respected and provided with certain broader aspects of care”, FDA Commissioner Margaret Hamburg told the Reuters Health Summit in November.

Annelies den Boer of the Dutch non-profit Wemos Foundation, which has been following the globalization of clinical trials since 2006, worries a lot about just that sort of exploitation — and worse.

She is concerned that the current benchmark guidelines on good clinical practice from the International Conference on Harmonisation (ICH) — agreed by U.S., European and Japanese regulators and accepted by the drugs industry — are unbalanced in emphasizing efficiency over ethics. And she fears that the out-sourcing of a growing volume of clinical work by pharmaceutical companies to specialist firms known as contract research organizations, or CROs, makes proper oversight increasingly difficult.

“People in many developing countries are often poor or illiterate, which makes them vulnerable,” she says. “It’s very difficult to check if companies do indeed abide by ICH because governments in countries where these trials take place do not exercise a lot of control. There’s an entire chain — vulnerable patients, doctors with conflicts of interests, CROs that are geared to doing trials extremely fast — which is detrimental to ethical guidelines.”

Given the numbers involved, it’s no surprise that some subjects come out of the process disillusioned, as highlighted in testimonials gathered recently by den Boer’s team.

Take Barbara, a 30-year-old Polish woman, who was initially thrilled when her eight-year-old son Marek was chosen to test a new drug for attention deficit hyperactivity disorder (ADHD). She received 200 zlotys ($75) and, after about five weeks, the drug really seemed to work. Unfortunately, a short time later, the trial ended and the drug was withdrawn leaving Barbara both angry and deeply concerned about her son’s future treatment.

“I can’t believe I signed my son up for this trial without really understanding what I was agreeing to. I was blind. I realize now that people taking part in clinical trials should have the right to ask questions and be spoken to like human beings, not just guinea pigs,” Barbara says.

Other subjects in Poland, Russia, China and India tell similar stories of the easy money that can be made from trials. But common complaints center on the lack of follow-up support and the impenetrability of jargon-filled contracts that can run to 50 or 60 pages.

Lifen, a 23-year-old graduate student living in Beijing, has taken part in five clinical trials to help pay for her studies. “The money is good, although recently I’ve noticed the payment rates have been going down. I think this is because there are more and more volunteers coming forward,” she says.

Cases alleging serious side effects are rare, but not unknown. Pfizer Inc’s 200-patient trial of the antibiotic Trovan during a 1996 meningitis outbreak in Kano, Nigeria, triggered a decade-long legal battle, after 11 children died and the company was accused of not obtaining adequate prior consent. It inspired John le Carre’s novel “The Constant Gardener.” Pfizer has always argued that meningitis and not its antibiotic led to the deaths. Still, two years ago the drugmaker reached a $75 million settlement with Kano state government to compensate victims, and in February this year it settled all remaining lawsuits on undisclosed terms.

Other controversial cases in recent years have involved the testing of AIDS drugs in Africa, breast cancer and anti-psychosis drugs in India, and vaccines in Latin America.

History suggests we need to remain vigilant — and it is not only commercial operations that can be culpable. Last October, U.S. President Barack Obama personally apologized for an experiment conducted in the 1940s in which U.S. government researchers deliberately infected Guatemalan prison inmates, women and mental patients with syphilis.

ETHNIC DIFFERENCES

Today, the drugs industry insists, things are very different and its conscience is clear over the way modern clinical trials are conducted. The same strict standards apply to foreign trials as to those conducted domestically.

“We have exactly the same protocol and exactly the same standards for our trials around the world,” says Roche Holding AG Chief Executive Severin Schwan, who is impressed by the modern hospitals he visits these days in places such as Brazil and China. “Some years ago quality might have been a real concern. Today the situation is different. This is a reason why more trials are being conducted in emerging markets.”

The Swiss company, the world’s largest maker of cancer drugs, is also doing more trials in these places because the healthcare authorities there want to see data collected from their own populations.

“I see this as an opportunity. A broader range of patients can take part in our trials and the patient population of our trials becomes ethnically more diverse … If we do not include a certain portion of patients in our global trials, some countries might delay the approval of certain drugs,” Schwan says.

That ethnic issue is important. As drug treatments become more targeted, scientists are unraveling how small genetic variations may make one medicine suitable for a particular group of people. AstraZeneca’s lung cancer drug Iressa, for example, failed to help Western patients overall in tests but proved much more effective in Asians — a discovery that has shed valuable new light on ways of tackling the disease worldwide.

“We are starting to understand ethnic differences through the responses seen in global trials. If each of us were an island unto himself, there would be no way we could make this comparison,” says Dr. David Kerr, president of the European Society for Medical Oncology. “By cherishing our genetic diversity we can identify biomarkers like the one for Iressa. That is really exciting.”

For drug companies looking to globalize their vast portfolio of clinical trials it all boils down to two over-riding factors — time and money. And in this business, where the clock is always ticking down to the next drug patent expiry, time also means money because shaving six months off drug development timelines can spell hundreds of millions of dollars of extra sales.

So it is perhaps surprising that many in the industry are still struggling to work out just how much cheaper it really is to do clinical research in faraway places.

Back in 2008, former GlaxoSmithKline Plc Chief Executive Jean-Pierre Garnier gave a startling estimate of savings in an article for the Harvard Business Review, when he said a midsize company with 60,000 patients in clinical trials could save $600 million a year by switching 50 percent of its trials to low-cost places such as India and Latin America. A top-rate academic medical center in India would charge just $1,500 to $2,000 per patient case report, while a second-rate U.S. center would bill $20,000, he said.

In practice, things are a bit different, according to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development in Boston. He believes off-shoring clinical research is not quite the bargain many drugmakers had thought. Getz reckons the per patient cost of running a trial in India and China is probably about half what it would be in Western Europe or the United States — a big margin, of course, but considerably less than Garnier had suggested. And then there is the considerable extra cost of managing multiple studies across myriad sites.

“The economics are not nearly as attractive as once thought,” Getz says. “Clearly, companies want to test their drugs in markets where they hope to commercialize a new treatment, so that is a driver for deciding where to conduct clinical studies. But given the increased operating costs and the inefficiencies, which can sometimes result in delays in some parts of the world, I think companies will begin to rethink just how many countries they wish to use.”

FAIR PAY OR BRIBE

Reputational issues, too, may weigh on gung-ho Western drugmakers — not only because of the rising public profile of the issue but also as a result of some new legal questions. In the United States, the Justice Department has mounted an investigation under the Foreign Corrupt Practices Act to see if drugmakers are offering overseas bribes, and clinical trials are firmly in the spotlight. That’s because doctors in many countries are government employees and therefore any payments to them deemed above fair market value might be viewed as bribes. Britain, too, is introducing a strict new Bribery Act in July that also covers such overseas payments.

“Companies have to be aware that there is a legal power here and there is the possibility of prosecution,” says Lincoln Tsang, a partner at the London offices of law firm Arnold & Porter LLP. “It adds a level of uncertainty and companies will have to do more due diligence to ensure that any new clinical trial site will really add value to the existing network.”

In the offices of the European Medicines Agency in London and the FDA in Washington, plans are afoot to ramp up inspections of foreign clinical trial sites to check protocols are being followed and there is no risk of dodgy data that could skew approval decisions in the West and jeopardize patient safety. Getz expects both agencies to audit many more sites this year and next to address these concerns.

Yet the action will only scratch the surface and the small teams on tap at the EMA and FDA will be able to check only a fraction of the tens of thousands of trials conducted outside their own territories.

Back in Hungary, Dr. Horvath is very confident about the way clinical trials have been conducted over the years at his hospital and has the raw data going back decades to prove it. “Obviously you need to follow good clinical practice and stick by all the ethical criteria,” he says.

 


Corporate Crimes:Du Pont,Agent Orange & Monsanto

“We will never compromise our core values – safety and environmental excellence, integrity, high ethical standards and treating people fairly and with respect. They are our foundation. We must continually strive to find ways to enhance them.”[1]

However critics of the company see them in a somewhat different light:
“The business of Du Pont has been dangerous from the start”
Philip Mattera, World Class Business, 1992[2]

“The company has consistently treated the long-term interests of humanity as largely irrelevant” Curtis Moore, Former Counsel to the US Senate Committee on Environment and Public Works,[3]

There is hardly a single chemical toxin in which DuPont has not played a major role in developing. “The company pioneered the production of sulphur dioxide, leaded petrol, CFC’s and recently deep well injection of hazardous waste. The company then used dubious science, political manipulation and cover up to avoid restrictions on their use.” [4] During its 200 years of existence, DuPont has committed a staggering amount of corporate crimes (far too many to mention here). The following section contains just a selection of these.
Arms manufacturing

DuPont began life as a gunpowder company and has made an incredible amount of money from arms manufacturing over the course of its existence (see History). The company has made major contributions to the development of plastic and other forms of explosives, gun and rocket propellants, chemical warfare and the atomic bomb.[5] The 1996 International Defence Directory cites DuPont as providing synthetic plastics, rubber and textiles to the defence industry.[6] According to the Ethical Matters magazine website, DuPont was one of the companies that manufactured the defoliant Agent Orange that devastated human health and the environment in Vietnam. The company also ran chemical warfare plants for the US government.[7]
Control of the food chain

Attempting to monopolise food production
Now the largest seed company in the world, DuPont is exerting increasingly more control over the human food chain. The company supplies seeds, agricultural inputs and also owns food-processing technologies. Recently Dupont and Monsanto decided to live in sync by sharing their proprietary agricultural biotechnologies with one another. The decision was met with alarm by the ETC Group, which believes that the quasi-merger will result in less choice for farmers, at the same or higher prices. Hope Shand, Research Director at the ETC, expressed concern that the companies “are being allowed to create global technology cartels that run below the radar screens of anti-trust regulators.”[8]

In 2000, the Foundation on Economic Trends and the National Family Farm Coalition filed a lawsuit against DuPont and other GM seed producers, on behalf of both U.S. and international farmers who purchased genetically modified (GM) corn and/or soybeans, as well as farmers engaged in farming non-GM crops in the 1999-2000 growing season. They allege that the company was involved in a global cartel engaged in biotech product price-fixing. According to the plaintiffs’ complaint, a 1996 internal Monsanto document known as the “Maize Protection Business Plan” describes how Monsanto, DuPont, Dow Chemical, Novartis and AstraZeneca amongst others, formed a global cartel to monopolise and restrain trade in the GM seed market, effectively precluding additional competitors from entering the marketplace. [9]

Biopiracy and patenting
DuPont owns over 20,000 worldwide patents and over 14,000 worldwide patent applications. In 2001, it was granted almost 500 U.S. patents and over 1,800 international patents.[10] The company has been branded by Greenpeace as the “World-wide leader in biopiracy of plant genetic resources”. ‘Biopiracy’ is the term used to describe the patenting of genes, by private companies, that were originally selected for by indigenous people, using traditional breeding methods. Many developing countries regard this as the theft of their genetic resources, and biopiracy has become an extremely contentious issue in recent years. Greenpeace has accused DuPont of using ‘tricky patents’ (i.e. passing off items as their ‘inventions’ when they quite clearly aren’t) in an attempt to gain control over the most important food crops. They observe that DuPont has “a natural interest both in owning and exploiting plant genetic material, mostly derived from developing countries, and in replacing farmers’ own local varieties with few patented crops – and their often associated inputs.”[11]

A number of cases of DuPont abusing patent law have come to light recently. These include a patent application accepted by the European Patent Office in August 2000 (Patent EP 744888). This covers all maize plants containing over 50% oil, including those produced by traditional breeding methods. The patent also covers any use of these maize varieties, including cultivation, harvesting, and processing, whether for food, animal fodder or industrial use. By obtaining this patent DuPont has managed to pass off any such varieties of maize as its invention. This is despite the fact that such varieties already exist in Latin America, having been obtained through traditional breeding techniques. According to the Mexico based International Maize and Wheat Improvement Centre (CIMMYT), “this patent may considerably impede the development of maize varieties in Latin America.” Dr Sukestoshi Taba from CIMMYT states that the patent could “seriously discourage further research on maize oil content if it is not challenged.”[12]

According to Greenpeace, the maize patent application is just one example of a systematic strategy that DuPont is using to gain control of the most important food crops. Other ‘tricky patents’ that DuPont has filed based on fake ‘inventions’ include:
Describing special plant ingredients (e.g. protein or oil) and claiming all genetic resources with these characteristics.
Changing certain details in hybrid breeding processes and claiming all resulting seeds and plants.
Using cell culture techniques to reproduce plant genetic material and claiming all genetic resources with given characteristics.
Isolating genes in genome databanks and claiming gene sequences as their inventions.
Transferring foreign genes into existing varieties, then claiming all plants and seeds with the inserted genes.[13]

Dupont has also faced heavy criticism for it patenting of the oncomouse – a mouse genetically engineered to carry a cancer-causing gene.[14]

 

Genetically modified (GM) crops
DuPont is shifting a substantial portion of its research and production capacity into what is feared to be a dangerous new form of pollution – the release of genetically engineered organisms into the environment. According to A SEED, the company is currently playing a double tune: at the market level it is attempting to capture crop markets lost by GM crop companies due to lack of consumer confidence, whilst simultaneously moving heavily into GM seeds.[15]

One of the main arguments of GM-proponents is that GM crops are no different to crossbred varieties, which we have had for thousands of years. However, there are some distinct processes, now known as genetic engineering, which, unlike the creation of hybrids and other crossbred varieties, cannot be carried out by farmers. For example, farmers can not exchange genes between different species. On its website DuPont attempts to confuse the issue by suggesting that Pioneer Hi-Bred has been supplying farmers with genetically engineered maize since the 1970s. (http://heritage.dupont.com/touchpoints/tp_1999/overview.shtml) This appears like a deliberate attempt to convince the public that genetic engineering is the same as crossbreeding and therefore to be accepted, and it is a confusion we could do without.

DuPont has been criticised for its use of terminator technology. Terminator has been widely condemned as an immoral technology that threatens global food security, especially for the 1.4 billion people who depend on farm-saved seed. According to Julie Delahanty of the ETC Group, companies such as DuPont are trying to gain market acceptance for seed sterility as a biosafety tool. This will give them “carte blanche to use it as a monopoly tool for maximising seed industry profits” she argues.[16]

In 1999 Deutsche Bank analysts pointed out that for DuPont “there is more to biotechnology than just ag-biotechnology used for crops to feed humans and/or animals.” The analysts also predicted that “GMO cotton and other fiber crops, which will not enter the food chain, will not draw the attention or focus that corn and soybeans have.” DuPont aims to get 25 percent of its raw materials from biomaterials by 2010, a large portion through the next generation of GMO crops. [17]

Functional Foods
DuPont has been criticised for its marketing of highly processed food products as ‘healthy’.
“Functional foods are about marketing, not health” asserts Professor Marion Nestle, professor of nutrition and food studies at New York University “My concern is that functional foods will distract people from eating healthy diets and encourage companies to market absurd products as health foods because they contain one or another single nutrient.”[18]
Working conditions

Union Busting
Historically, DuPont was strongly anti-union. In the 1930s, the company crushed any attempts at worker unionisation. Later, DuPont created a series of company-dominated employee-associations.[19] However, the company now claims to have improved its record dramatically.[20]

Health and Safety
DuPont has a miserable environmental health and safety record and, in the past, has frequently run afoul of occupational safety and health laws.[21] In 1987, the New Jersey Supreme Court found that DuPont had deliberately concealed medical records identifying that several workers were suffering illnesses related to asbestos exposure. The same year, DuPont’s then subsidiary Consolidation Coal was cited for ‘reckless disregard’ in reporting worker injuries. Consolidation Coal was also among a group of coal companies fined for falsifying air samples provided to federal inspectors testing for conditions that could cause black lung disease.[22]

In 1999 the US Occupational Safety and Health Administration (OSHA) fined DuPont $70,000 for Health and Safety record keeping violations at its Seaford DE plant in the US. The company was also ordered to implement a series of Health and Safety improvements. Health and Safety records at the site were investigated in response to a complaint filed by an employee, whose cumulative trauma injury was not acknowledged by the company as work-related. It was found that the company failed to record 117 occupational injury and illness cases during 1997 and 1998 that should have been recorded and that certain cases of injury and illness were recorded incorrectly. [23]

Using prison labour
According to Transnational Obsevatory, DuPont is one of the companies in the US that use prison labour.[24]

Ripping off pensioners
DuPont has been recently been criticised for redesigning its U.S. health-care plan. This has dramatically increased the premiums for the company’s approximately 61,000 retirees and surviving spouses aged 65 and older.[25]

Genetic Screening
In the early 1980s, DuPont was reported to have tested thousands of US workers to determine if any of their genes made them vulnerable to certain chemicals in the workplace.[26] The company also apparently gave blood tests to all black job applicants to determine which were carriers of sickle-cell anaemia.[27]

Moving production to the developing world

DuPont has been criticised in the Multinational Monitor magazine for moving parts of its production to developing countries such as India, where labour is cheaper and environmental laws less strict.[28] The company has also been heavily criticised in the magazine for ignoring the rights of indigenous people in the areas in which it operates.[29] According to the company’s 2001 SEC filing, it has major plants in Puerto Rico, Mexico, Brazil, China and Argentina.[30]

Supporting oppressive regimes
According to the company’s website dated January 9th 2002, DuPont owns subsidiaries in Bosnia, China, Columbia, Croatia, Egypt, Indonesia, the Philippines, Russia, Saudi Arabia, Turkey and Yugoslavia. These countries are all classified by Ethical Consumer magazine as oppressive regimes. Their classification is based on a ranking system devised by the Observer newspaper, and is based on a range of indicators such as ‘use of torture, political prisoners, denial of religious freedoms and extra-judicial killings.’[31]

DuPont’s expansion into Turkey has been partially financed by the IFC (the International Finance Corporation – a branch of the World Bank). The IFC provided a loan $22.5million for the Dusa 2 Nylon expansion project, the primary sponsors of which are DuPont and the Sabanci group of Turkey.[32]

DuPont’s nylon plant in Goa
DuPont was voted one of the Worst Companies of 1995 by Multinational Monitor because of its activities in Goa, India. In 1985 DuPont formed a partnership with the Indian company Thapar to build a $217 million factory to make nylon 6,6 (a tyre ingredient) in the uplands of Goa. This venture set out on the wrong foot as far as community relations were concerned. The investors managed to get the State Economic Development Corporation to take over the factory site from a co-operative and then lease it to Thapar-DuPont Ltd. (TDL) in exchange for a State stake in the enterprise.[33]

Since industrial chemical concerns had been heightened in India since Union Carbide’s Bhopal disaster, TDL took out a full page advertisement in a local newspaper, proclaiming: “We will not handle, use, sell, transport, or dispose of a product unless we can do it in an environmentally sound manner.” What the advertisement neglected to say was that DuPont’s contract with TDL exempted it from liability for environmental claims or a Bhopal-style industrial accident.[34]

Activists from the environmental group the Goa Foundation managed to intercept an electronic message from DuPont to Goan project manager Sam Singh. The message acknowledged that the company had not taken appropriate measures to ensure four critical types of pollution control for the plant: groundwater protection, waste water treatment, solid waste recycling and air pollution control. Indian activists also acquired information concerning the hazardous chemicals that TDL was planning to use at the Goa facility and decided that they did not want the company as a neighbour. They first stormed the construction site in October 1994. Despite police repression, the protests continued into January 1995, when protesters refused to allow a bus load of US DuPont officials onto the factory site. Police responded by opening fire, killing 25 year-old Nilesh Naik. Naik’s funeral was held at the factory site. Before his funeral pyre was lit, somebody blew up the factory’s electricity generator.[35]

Finally getting the message, TDL began negotiating to reopen the factory elsewhere. In June 1995, it signed a memorandum of understanding with the state of Tamil Nadu to relocate the factory near Madras. S.N. Krishnan, the plant director, told the Indian paper Frontline that in the new plant 95% of the effluents would be recycled for use by the plant (compared to 70% at the Goan plant). Opposition in Tamil Nadu focussed on environmental concerns as well as the incentives that the State offered the company. These included: 150 acres of land, electricity at one-third of the usual industrial rate, a commitment of one million gallons of water a day and other subsidies and tax concessions.[36] In 1999 DuPont decided to cease Nylon production in India altogether, citing financial concerns as the reason for the decision.[37]

Endangering the public’s health

Numerous DuPont products and the pollution caused by their production have been implicated in a range of different health problems, including cancer and birth defects (see also Pollution).
DuPont has faced criticism for endangering the health of both its employees and the public (see also Working Conditions).

According to the Working Group on the Community’s Right to Know, a 1998 analysis of ten DuPont chemical plants shows that up to seven million people in surrounding communities are at risk from potential worst-case chemical accidents. The analysis of the plants’ hazards addressed three chemicals commonly associated with chemical accidents -chlorine, ammonia, and hydrofluoric acid.[38]
Irresponsible waste disposal
DuPont has an appalling record of irresponsible waste disposal although it is impossible to quantify how many people’s lives have been adversely affected by the company’s dash for profits at any cost.

In 1990 it was revealed that a former DuPont landfill site, in Newport, New Castle County, Delaware had contaminated the groundwater both on and off the site, with heavy metals, including barium, cadmium, and zinc, as well as trichloroethylene and tetrachloroethylene. According to the US Environmental Protection Agency (EPA) the pollution potentially threatened the water supply of 131,000 people.[39]

DuPont is one of the companies that operates in what has become known as “Chemical Valley” in Sarnia, Ontario. Chemicals discharged into the St. Clair River from this site include mercury, chlorinated organics, volatile hydrocarbons, PCBs and lead. The high levels of birth defects and cancer among indigenous residents on Walpoe Island have been attributed to pollution from the site.[40]

In 1998 DuPont was ordered by the US Environmental Protection Agency (EPA) to carry out a $65 million clean up of its Necco Park landfill site near Niagara Falls. This was necessary due to concerns regarding hazardous liquid seepage from the site.[41]

Pesticide production
Some of the chemicals used in pesticides produced and marketed by DuPont have been linked to brain damage and disruption of the hormone system. [42] The company has also faced a string of lawsuits in recent years, brought by parents whose children were born without eyes. These defects are alleged to have occurred due to the children’s mothers being exposed to the fungicide Benlate whilst pregnant (See Benlate).[43]

In 1994 DuPont agreed to phase out its toxic herbicide Cyanazine by 1999, when the US EPA discovered that it and other related herbicides were contaminating drinking water in parts of the US.[44] DuPont’s Sulfonylurea (SU) Herbicides, which it bills as environmentally sound and cost-effective, have also been found to be toxic according to studies by the US EPA and the National Coalition against the Misuse of Pesticides. These chemicals may also contaminate surface and ground waters, due to their high solubility in water and low soil absorption.[45]

DuPont has been criticised for exporting pesticides to developing countries, such as DDT, aldrin, clordane, and clorobenzolate, that have been banned in the US. However, even pesticides that are considered scientifically ‘safe’ can be dangerous in these areas. Due high illiteracy levels, farmers may ignore, or not understand, warning labels or instructions for proper use. Pesticides applied in too large doses, or to the wrong crops result in lethal consequences.[46] DuPont was recently fined $1.89 million by the US EPA for shipping pesticides on 380 occasions, without adequate labelling specifying that protective eyewear should be used when handling the product.[47]

Lead paint
The company is one of several facing dozens of lawsuits seeking recovery of lead paint damage and cleanup costs. State, county and local governments in New Jersey and Rhode Island in the US argue that lead paint manufacturers should have known and warned of health dangers.[48]

Formaldehyde
DuPont is a major producer of formaldehyde. This chemical is a known carcinogen and is also implicated in other health problems such as respiratory illness. Despite this, DuPont has vigorously fought efforts to get the chemical banned, using spurious science and disinformation. It is one of the companies that provided funding for the Formaldehyde Institute, a corporate front group set up to defend the chemical (see Influencing Research and Education).[49]

Dioxins
DuPont and other chemical companies have been accused of trying to suppress evidence regarding the severe toxicity of dioxins, hardly surprising given the quantities of these carcinogens they churn out every year. [50] Recently, residents in Mississippi, in the US, threatened a $3 billion lawsuit against DuPont, claiming damage from dioxin pollution. The pollution was left in wastes similar to those found piled near DuPont’s Edge Moor titanium dioxide plant in Delaware in 2001, for which the US EPA is forcing DuPont to pay approximately $12.4 million in remediation costs.[51]

Pollution
(see also Endangering the public’s health)

DuPont has an appalling pollution record and is responsible for the production of a wide range of polluting chemicals. In 1999 DuPont was listed by the US Public Interest Research Groups as one of the ‘Dirty Five’ – the five biggest polluters in the US – that together spent $6,523,677 over the period 1991-1998 in lobbying Congress, the House of Representatives and Superfund-related committees in order to prevent stricter legislation (see Influence).

In 1996 DuPont’s proposal to dispose of 85 tons of toxic pollutants a year into the Guadalupe River in Texas prompted a local shrimper, Dianne Wilson, to go on hunger strike for 31 days. The proposal related to a DuPont facility, which already disposed of 20 million gallons of wastewater a day, mainly through seven underground injection wells. Ms Wilson argued that “DuPont’s decision to begin toxic discharge into the Guadalupe River threatens an already sick bay. There is no need for this. Zero discharge is possible right now. All I am asking is that DuPont do a feasibility study to find out what it would take to achieve zero wastewater discharge from its Victoria plant.” DuPont however refused to accede to Wilson’s demands. This is despite the fact that independent research has demonstrated that virtually any petrochemical plant can go to zero water discharge with an additional capital investment of about 2 percent. [52]

In March 1991, the area around DuPont’s Quimica Fluor plant in Matamoros, Mexico, was judged so toxic that the Mexican President ordered 30,000 people to give up their homes in order to create a two mile buffer zone around the site. The company paid $2.16 million to nearby farmers whose crops were damaged by toxic releases.[53]

Oil exploration
Although DuPont has now sold its oil subsidiary Conoco, in the past this company was responsible for its fair share of environmental devastation and had an appalling Health and Safety record.[54] Since DuPont today still remains heavily dependent on the oil industry to provide it with the raw materials of its business, the company must shoulder its share of the blame for the atrocities committed by its suppliers.

Global warming and carbon trading
Through its production of energy intensive petrochemical-based synthetic fibres, DuPont is a major contributor to global warming.[55] The company produces large quantities of the greenhouse gases CO2, N2O (which has 310 times the warming effect of CO2), HFCs and PFCs[56]. DuPont is also reported to have provided funding for the Global Climate Coalition, a global fossil-fuel lobby set up by Burson-Marsteller in 1989 in an attempt to discredit scientific evidence for global warming.[57]

More recently, DuPont has been making a small fortune at the taxpayers expense through the new UK emissions trading scheme. This year the company looks set to walk away with £26.7 million of taxpayers’ money by bidding in emissions targets that have already been met as a result of regulatory requirements. According to the ENDS Report, the company looks set to meet its emissions target without lifting a finger and stands to make millions more by selling emissions credits of “dubious integrity”.[58]

3 case studies:

The following three examples show just how far DuPont is prepared to go to keep its toxic products on the market, regardless of their detrimental effects on human health and the environment.

· Tetraethyl lead
In the 1920s DuPont and General Motors developed tetraethyl lead, also known as ethyl, to help car engines run more smoothly (see History and Strategy). The product has been labelled by the World Health Organisation as “the mistake of the 20th Century”.[59] The lead ingredient of leaded petrol, TEL is said to account for 80-90% of all environmental lead contamination and is known to retard the mental development of children, cause hypertension in adults and impair coordination.[60] According to Curtis Moore, former counsel to US Senate Committee on Environment and Public Works, leaded gasoline “has irrevocably damaged the intelligence of two generations of American children and is responsible for 50,000 deaths a year by heart attack and stroke”.[61]

The chemical was discovered to be dangerous to human health quite early on. In 1924, reports broke out that 80 percent of workers involved in the production of TEL at DuPont and Standard Oil plants had been killed or severely poisoned. When TEL was pulled off the market, DuPont ran a series of advertisements in Life magazine, and managed to reverse the decision after a hearing in which it called TEL an “apparent Gift of God”. To entrench its market position, DuPont introduced a new car engine that ran only on leaded petrol. The product was finally banned half a century later, after scientists conclusively proved its detrimental affects. In December 1988, the US Department of Justice sought to collect $9.2 million from DP for illegally blending excessively high levels of lead into gasoline between 1983-1985.[62]

Once banned in the US in the 1980s, DuPont exported TEL to other countries where it was not banned. With Pemex, the Mexican Oil Company, it exported TEL to Latin America. DuPont finally sold its 40% shares in the production plant in Coatzalcoalcos, Mexico in 1992. According to the Council on Economic Priorities 1993 report on DuPont, the company has “aggressively promoted the use of leaded gasoline”.[63]

· Ozone depletants (CFCs, HCFCs)
“The parallel’s between DuPont’s handling of CFCs and Ethyl are striking. Both were invented by the same team in the same lab at roughly the same time…the DuPont company adopted similar strategies to maintain sales of these environmentally hazardous products. In both cases, DuPont answered critics’ concerns about health and environmental hazards with bold faced denials.”
Curtis Moore, Multinational Monitor, 3/1990[64]

CFCs were developed and patented by DuPont in the 1930s. In 1993, the company supplied 25% of the global CFC market and almost 50% of the US market. When ozone depletion was identified in 1974, DuPont was prominent in downplaying the scientific findings and in “orchestrating a political campaign to forestall regulation.”[65] At the same time the company was investing in researching alternatives. To strengthen the commercial sector drive for a non-regulatory approach, DuPont used its network to establish the Alliance for Responsible CFC Policy.[66] However, as the threat of federal legislation died down with the Reagan Administration, DuPont put a stop to its $3-4 million research programme for alternatives.[67]

In 1988, when pressure against the use of CFCs again began to mount, DuPont pledged to cease CFC production by 2000. As part of its solution strategy, the company put forward two of its products – Hydrochloroflourocarbons (HCFCs) and Hydroflourocarbons (HFCs) as substitutes for CFCs. At the time, neither of these chemicals were regulated by the Montreal Protocol or the US Environmental Protection Agency. HCFCs, however, have proven to be ozone depleters and greenhouse gases, while HFCs are potent greenhouse gases. As HCFCs and HFCs began to be criticised for their environmental effects, DuPont once again launched a multi-pronged strategy to ensure weak regulation and a distant phase-out.[68]

According to a 1996 Third World Network (TWN) report, DuPont will continue to manufacture CFCs in the US and other industrialised countries for export to the less-industrialised world until 2010. The company will also continue the use of HCFCs in industrialised countries until 2030, with no termination date set for less industrialised countries. The company is still also involved in the production of HFCs. [69] According to Jack Doyle from TWN “DuPont is probably most culpable for stringing out the CFC era for its own business reasons and for delaying a shift to safe alternatives.”[70]

· Benlate
On April 19th 2001 DuPont announced that by the end of the year it would stop selling the fungicide Benlate, after 33 years on the market. The company cited the high legal cost of defending the product as the reason for its decision. Litigation and settlement charges relating to the compound have cost the company approximately $1 billion over the last ten years. DuPont has set aside additional money to cover future losses and litigation expenses, bringing the total financial cost to $1.3 billion dollars.[71]

DuPont’s problems with the fungicide began in 1992 when it recalled its Benlate 50DF fungicide, in response to complaints from more than 2,100 US growers that the chemical had ruined their crops and land. The fungicide is believed to have been contaminated with a herbicide. By November of that year the company had paid more than $510 million in damages. The company then abruptly stopped payments however, claiming that its own tests showed that Benlate could not have caused the damage. As a result, more than 400 lawsuits were filed against the company in 21 states. Since then the company has been reprimanded five times by US for abusive litigation tactics and misconduct, including concealing evidence that supported the growers’ claims. DuPont was accused of shredding documents, destroying dead and dying plants, mislabelling documents and producing illegible records in an effort to withhold the results.[72]

In one of the cases US District Court Judge J. Robert Elliot fined DuPont $115 million. In his decision Elliot wrote that “Put in layperson’s terms DuPont cheated…and it cheated deliberately and with purpose.”[73] In August 2001, a Florida jury found the company liable under Florida’s racketeering statute (this allows plaintiffs to recover treble damages where they can prove a continuing pattern of fraud) and for product defect involving alleged crop damage. Plaintiffs are seeking to have judgement entered for about $88.5 million. As of 2001, DuPont plans to appeal.[74]

Twenty-eight cases are also pending against DuPont in the State Court in Broward County, Florida. These cases were brought by Ecuadorian shrimp farmers, who allege that Benlate run-off from banana plantations poisoned their shrimp farms. The company lost two cases to the shrimp farmers in the autumn of 2000 and in early 2001, and was ordered to pay $10.2 million and $12.3 million respectively. The company has appealed both cases. DuPont contends that the injuries alleged are attributable to a virus, Taura Syndrome Virus, and in no way involved Benlate. The untried cases are on hold awaiting resolution by the appellate court of the case tried in 2000.[75]

There are also concerns about the impact of Benlate on human health. The company has faced a string of lawsuits in recent years, brought by parents whose children were born without eyes. These defects are alleged to have occurred due to the children’s mothers being exposed to the fungicide Benlate whilst pregnant.[76] Reports in the UK from the Pesticides Trust indicate that the fungicide can cause eye birth defects at high dose exposure.[77]

The whole Benlate affair is a constant headache to DuPont, with approximately 110 cases pending and no end in site. Nevertheless the company still purports that “Benlate did not cause the damages alleged in these cases” and “denies the allegations of fraud and misconduct.”[78]Source


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