Exposed: CDC deliberately manipulated, covered up scientific data showing link between vaccines containing mercury and autism

(NaturalNews) Deniers of the link between mercury-laden vaccines and autism are going to have a hard time denying the latest findings by the Coalition for Mercury-Free Drugs (CoMeD). The nonprofit group has obtained critical documents via a Freedom of Information Act (FOIA) request that exposes the US Center for Disease Control and Prevention’s (CDC) role in deliberately lying about and manipulating a key Danish study that showed a clear link between vaccines containing mercury and autism. In 2003, the journal Pediatrics published a study conducted in Denmark that observed a significant decline in autism rates following the country’s elimination of Thimerosal, a mercury-based component, from vaccines. But thanks to the CDC’s corrupting influence, the published version of the study in Pediatrics actually claimed the opposite, and alleged that removal of Thimerosal brought about an increase in autism rates. According to the documents, CDC officials removed large amounts of data from the study that showed a decline in autism rates following the removal of Thimerosal. The agency then twisted the remaining data to imply an increase in autism rates following the removal of Thimerosal, and suggested that there was no link between Thimerosal and autism. Upon submission of the CDC’s tainted version of the study to Pediatrics , the study’s authors contacted CDC officials to let them know that the agency had incorrectly interpreted the data. They tried to tell the CDC that its figures and conclusions were wrong, and that corrections needed to be made. The CDC allegedly responded by saying that it would take a look at the incorrect data, but proceeded to submit the corrupted version of the study to Pediatrics anyway. After encouraging the editors of Pediatrics to perform an expedited review of the corrupted study, the CDC ended up convincing the journal to publish the fraudulent study, which it did in 2003. Now that this critical information has been officially released for the world to see, CoMeD is pressing the CDC to conduct a full criminal investigation into the matter, and make a formal declaration about whether or not scientific fraud was involved. CoMeD is also calling for a full, immediate retraction of the corrupted study from Pediatrics . “This should not be tolerated by those who are entrusted with our children’s health and well-being,” says Lisa Sykes, President of CoMeD. To learn more, visit: http://mercury-freedrugs.org/ Sources for this article include: http://www.anh-usa.org/cdc-mercury-in-vaccines/

Common painkiller drugs lead to male infertility

(NaturalNews) Phthalates, bisphenol-A (BPA), and other environmental toxins are now widely known to disrupt proper hormone function in humans, but a new study has revealed that common painkillers like aspirin and ibuprofen are far worse. According to scientists from Denmark, Finland, and France, pregnant women who take painkiller drugs have a significantly higher risk of bearing baby boys with reproductive problems than pregnant women who do not. Published in the journal Human Reproduction , the study draws urgent attention to the serious dangers associated with painkiller drugs. Pregnant women who take any painkiller drugs during their second trimester double their risk of having a baby boy with cryptorchidism, a condition in which the boy’s testicles do not properly descend due to inadequate testosterone production. And taking more than one painkiller drug during the second trimester raises that risk by a whopping 1,600 percent. “A single paracetamol tablet [500mg] 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,” explained Dr. Henrik Leffers, senior scientist at Rigshospitalet in Copenhagen and author of the study. “In fact, a single tablet will, for most women, be at least a doubling of the exposure to the known endocrine disruptors during the pregnancy and that dose comes on a single day, not spread out over nine months as with the environmental endocrine disruptors. Thus, for women using mild analgesics during the pregnancy, the mild analgesics will be by far the largest exposure to endocrine disruptors.” Taking painkiller drugs is largely considered to have no significant risks associated with it, so millions of people pop them every time they have an ache or pain. And use of such painkillers is quite common among pregnant women as well, with more than 57 percent of Danish mothers admitting in a telephone survey they used them. The modern world seems to be a minefield of assault against the male reproductive system. Even laptop computers are a threat, heating up male genitalia to temperatures so high that reproductive function becomes impaired (http://www.naturalnews.com/030326_laptop_computers_infertility.html). So it is important to be cautious and aware of the things you eat and exposure yourself to. Sources for this story include: http://www.guardian.co.uk/society/2010/nov/08/paracetamol-pregnancy-link-reproductive-disorder

Vitamin D deficiency could be a cause of autism

(NaturalNews) A new Danish study published in the journal Pediatrics has identified a link between neonatal jaundice and autism. Babies born with jaundice have a significantly increased risk of developing both general psychological problems and autism, and researchers believe a vitamin D deficiency is to blame. Formed from data on over 733,000 Danish children born between 1994 and 2004, the study revealed that jaundiced newborns are 87 percent more likely to develop a psychological disorder than newborns without jaundice. Jaundiced babies are also 56 percent more likely to develop autism than their otherwise healthy counterparts. Part of the reason why experts believe vitamin D deficiency might relate to autism is the fact that babies born between October and March were about twice as likely to develop autism than children born during other parts of the year. The months between October and March are during the wintertime in Denmark, when sunlight exposure is at a minimum. And besides producing vitamin D in the body, sunlight exposure also breaks down bilirubin, a substance implicated in causing jaundice. Bilirubin is a natural metabolite that the liver normally processes and eliminates, but newborns are incapable of breaking it down, which leads to jaundice. And excess amount of bilirubin are known to cause serious brain injury when left untreated, lending credence to the hypothesis that the chemical may be somehow involved in causing autism. According to Dr. John Cannell, vitamin D expert and director of the Vitamin D Council, prenatal vitamin D deficiency is strongly linked to autism. Vitamin D not only naturally eliminates bilirubin, but it cures neonatal jaundice as well. Dr. Cannell suggests that women take 5,000 IU of vitamin D a day during pregnancy. He also suggests that babies born with jaundice be exposed to natural sunlight as an effective treatment, and in order to avoid brain injuries. You can read more about Dr. Cannell’s research on vitamin D and autism by visiting the following page: http://www.vitamindcouncil.org/health/autism/ To learn more about autism, check out the NaturalNews.com autism page: http://www.naturalnews.com/autism.html Sources for this story include: http://www.foodconsumer.org/newsite/Non-food/Disease/neonatal_jaundice_linked_to_autism_1210100720.html

Widespread male infertility sweeping the globe

(NaturalNews) Nearly 20 years ago, Danish scientists first broke the news to the world that men from Western countries seem to be slowly becoming infertile. Recent research seems to back this up as well, with average sperm counts having dropped to half of what they were 50 years ago. According to reports, nearly 20 percent of men between the ages of 18 and 25 have sperm counts that are abnormally low. To put this in perspective, consider the fact that in the 1940s, men had an average of about 100 million sperm cells per millimeter of semen (m/ml). Today, the average is around 60m/ml. Those among the 20 percent with abnormal levels have less than 20m/ml. So what is the cause behind decreasing sperm counts? Realistically, there is probably more than just one cause. Environmental toxins, synthetic food and water additives, and estrogenic substances in food are all likely culprits. “It’s most likely a reflection of the fact that many environmental and lifestyle changes over the past 50 years are inherently detrimental to sperm production,” explained Professor Richard Sharpe, a fertility research expert at the Medical Research Council, in a U.K. report. But what scientists believe may be the biggest cause of poor semen quality in men has more to do with what their mothers were exposed to during pregnancy, than what the men themselves are exposed to throughout their lifetimes. A case in point is the disastrous chemical accident that occurred in 1976 in Seveso, Italy. The incident caused the highest known human exposure to toxic chemical dioxins. It was later revealed that pregnant women who were exposed to the chemical during that time bore male children who ended up having poor sperm counts. Other studies also seem to lend credence to the idea that lifelong sperm counts are determined during the early stages of male fetal development. Interference with the Sertoli cells, which are responsible for proper sperm development during fetal development, can lead to lifelong sperm production problems in males. “Maternal-lifestyle factors in pregnancy can have quite substantial effects on sperm counts in sons in adulthood, and the most logical mechanism by which this could occur is via reducing the number of Sertoli cells,” explained Professor Sharpe. In other words, prenatal exposure to toxic chemicals is a serious threat to male health, which ultimately threatens the existence of mankind. Sources for this story include: http://www.independent.co.uk/news/science/out-for-the-count-why-levels-of-sperm-in-men-are-falling-1954149.html http://en.wikipedia.org/wiki/Seveso_disaster

Big Pharma blackmails Greece; halts medicine supply over cash demands

(NaturalNews) In the midst of runaway economic problem in Greece, the pharmaceutical industry has decided to blackmail the nation and halt shipments of medicines to Greece until it agrees to pay full price for the drugs. In order to cut costs during its severe debt crisis, Greece had announced it would pay drug companies 25 percent less for their products, but this loss of profit was enough to convince several pharmaceutical companies supplying key drugs to the country to initiate their own medical blockade where they simply refuse to deliver any more medicines. In doing this, Big Pharma shows its true character. When the profits are flowing and the companies are raking in full-price profits, they’re you’re best friend. But when budgets get tight and everybody is asked to take a cut, Big Pharma betrays your country and its citizens, withholding medicines in a thinly-veiled blackmail attempt to force you to cough up more cash. The Big Pharma betrayal Such is the danger of any nation depending on the pharmaceutical industry. If nations based their health care systems on natural products such as healing foods, herbs, and nutritional supplements, they couldn’t be held hostage by patent-holding drug companies that will obviously use their medicines as economic weapons to try to extort yet more profits out of a nation. Pharmaceutical companies are determined to get their profits, you see, no matter what the cost. If a few thousand people have to die during a pharmaceutical blockade, that’s a small price to pay for them ensuring years of billion-dollar profits as a result. That drug companies would engage in this behavior exposes the real scam of drug-based medicine. Drug companies approach nations with the false promise that their patented chemicals will make people well. And yet they don’t. In reality, pharmaceuticals only cause more disease requiring more pharmaceuticals. There is no such thing as a “pharmaceutical cure” for any disease. If anything, using pharmaceuticals only creates more dependence on pharmaceuticals. This cycle of drug-symptom-drug continues until Big Pharma has most of your nation hooked on dangerous, high-profit chemicals. And if you try to negotiate a lower price, they’ll yank your chain and cut off their supply, leaving your entire population without medical options. All during this, by the way, they will also attack dietary supplements and healing foods, claiming those are all quack products while only their own patented chemicals have any medical merit. It’s all so blatantly obvious, isn’t it? These companies don’t care about your health; they only care about profits and market share. They are only your friend for as long as you keep writing those inflated checks that buy their drugs at ridiculous mark-ups such as 65,000 percent of the cost of ingredients. Danish drug companies blackmail Greece So far, two Danish pharmaceutical companies have announced their blackmail efforts targeting Greece: Leo Pharma and Novo Nordisk. Leo Pharma is withholding distribution of its anti blood-clotting drug, sending Greece’s pharmacies and hospitals into a panic. (Gee, don’t these people know omega-3 oils will accomplish the same thing?) A few days ago, Novo Nordisk halted supplies of its insulin product, leaving Greece’s diabetics with few options (and there are a LOT of diabetics running around that country, remember My Big Fat Greek Wedding?). The BBC is now reporting: “Greek government officials believe the Danish companies are blackmailing Athens because they monopolise the market with certain key drugs. Stefanos Combinos, the director general of the economy ministry, told the BBC that Greece was one of the three most expensive countries in Europe for medicines. He said pharmaceutical companies had enjoyed great profits out of Greece over the decades and had an obligation to accept price reductions.” Too bad, Greece! This is what you get when you deal with the devil. You would have been better off favoring natural remedies over pharmaceuticals, and had you done that, you wouldn’t be in this mess! I wonder how many people will die from lack of insulin drugs or anti blood clotting medicines because of this Big Pharma blackmail attempt? I also wonder how long it will take for Greek patients to simply turn to natural, alternative remedies that can accomplish the same thing as these drugs but without all the toxic side effects? Any nation that lives by pharmaceuticals will die by them. The drug industry is not your friend. It is in business to make money, period. And it will do anything and everything it can to make as much money as possible regardless of whose lives it will risk in the process . Your life means nothing to these drug companies compared to the value of their bottom-line monopoly profits. If you don’t believe me, just ask the Greek government. Sources for this story include: http://news.bbc.co.uk/2/hi/world/europe/10193799.stm

New study: Breast cancer deaths lower in areas without mammograms

(NaturalNews) A 2005 study concluded that a push in Denmark to screen large numbers of women for breast cancer with mammography had reduced breast cancer deaths in Copenhagen by a whopping 25 percent. Sounds like proof that regular mammograms are truly life-savers, right? Wrong. Scientists from the Nordic Cochrane Center in Copenhagen and the Folkehelseinstituttet in Oslo have re-examined this pro-mammogram study along with additional data and come up with an entirely different conclusion. First, they found that the scientific validity of the 2005 study doesn’t hold up because the research was deeply flawed. Even more important: the new report shows there’s no evidence mammography itself was the reason behind any reduction in breast cancer deaths. In fact, deaths from breast cancer were lower in areas where women didn’t undergo those screening tests. The Danish research team looked at annual changes in breast cancer deaths in two Danish regions where breast cancer screening programs were offered to the public and compared this to data collected in non-screened regions throughout the rest of the country. To get a broad picture of the trend toward more or less breast cancer mortality, they analyzed breast malignancy rates in the decade before the screening was started and also looked at the ten years after screening was introduced. The results showed that breast cancer deaths declined by 1% in women between the ages of 55 and 74 in the areas where regular mammography was frequently used. However, breast cancer rates went down more — 2% per year — in women of the same age living in non-screened areas. And this trend was the same in younger women, too. For those between the ages of 35 and 54, breast cancer mortality went down by 5% per year in the screened areas but it went down more, 6% per year, in the non-screened areas during the same time frame. The researchers noted that there’s no evidence that the drops in cancer deaths in the women screened for breast cancer had anything to do directly with mammograms, either. “We were unable to find an effect of the Danish screening program on breast cancer mortality,” the researchers concluded in their study, which was just published in the British Medical Journal (BMJ) . “The reductions in breast cancer mortality we observed in screening regions were similar or less than those in non-screened areas and in younger age groups, and are more likely explained by changes in risk factors and improved treatment than by screening mammography.” The BMJ study also noted that for women in the oldest age group (75-84 years), there was virtually no breast cancer mortality difference between those who were in areas where breast screening was pushed on the public and in non-screened areas. As NaturalNews has previously reported, in the U.S. even elderly women who are not expected to live long because they suffer from severe dementia are often regularly subjected to the expense, discomfort and added x-ray exposure of mammography (http://www.naturalnews.com/028095_mammograms_Alzheimers.html). Two members of the same Danish research team that published the BMJ study also published an additional paper in the March edition of the Polish medical journal Polskie Archiwum Medycyny Wewnetrznej (Pol Arch Med Wewn) . It directly addressed the balance between the supposed benefits and known harms of cancer screening programs. “By attending screening with mammography some women will avoid dying from breast cancer or receive less aggressive treatment. But many more women will be over-diagnosed, receive needless treatment, have a false-positive result, or live more years as a patient with breast cancer,” they concluded. Moreover, as readers of NaturalNews are aware, studies over the past few years have actually implicated mammograms in causing some breast cancers to develop in the first place. For example, a study published in the Archives of of Internal Medicine in 2008 found that the start of screening mammography programs throughout Europe has been associated with an increased incidence of breast cancer (http://www.naturalnews.com/024901.html). For more information : http://www.ncbi.nlm.nih.gov/pubmed/20332715 http://www.ncbi.nlm.nih.gov/pubmed/20332505 http://www.naturalnews.com/028407_mammograms_radiation.html

Reproduction industry risks: infertility treatments increase risk of stillbirths

(NaturalNews) The multi-billion dollar medical reproductive technology industry has resulted in the births of millions of kids. They were conceived through non-natural procedures including in vitro fertilization (IVF), also known as the process that produces “test tube” babies, and intracytoplasmic sperm injection (ICSI), which involves injecting a single sperm into an egg in the laboratory. But more and more problems are being linked to these high tech baby-making techniques. For example, as NaturalNews previously reported, evidence is mounting that children conceived using some assisted reproductive technologies have an increased incidence of metabolic problems, such as high blood pressure, abnormally elevated fasting glucose levels and excess body fat (http://www.naturalnews.com/026863_IVF_sperm_glucose.html). Now new research raises even more troubling concerns about the safety of IVF and ICSI. A study just published in Human Reproduction , Europe’s leading reproductive medicine journal, found that women who became pregnant with a single fetus after treatment with these techniques had a four-fold increased risk of their babies being born dead when compared to women who conceived naturally or after fertility treatments that did not involve IVF or ICSI. Dr Kirsten Wisborg, a consultant in the neonatal and intensive care unit at Aarhus University Hospital in Denmark, and colleagues investigated data from pregnant women taking part in the Aarhus Birth Cohort. These moms-to-be were all slated to deliver babies between August 1989 and October 2006. Out of 20,166 first-time pregnancies where only one baby was carried, there were 86 stillbirths — placing the overall risk of stillbirths at 4.3 per thousand pregnancies. But when the researchers broke down the statistics to see how many babies were born dead to women who had experienced infertility problems, the risk for stillbirths was clearly far higher for women who conceived after IVF/ICSI treatments when compared to those who conceived naturally. Specifically, for women who conceived after IVF/ICSI, the risk soared to 16.2 per thousand. For women who conceived after non-IVF fertility treatments, the stillbirth rate was 2.3 per thousand. In fertile and sub-fertile women (those who conceived naturally but only after a year of trying), the risk was 3.7 per thousand and 5.4 per thousand, respectively. “After adjusting for maternal age, body mass index, education, smoking habits and alcohol and coffee intake during pregnancy we found a significant, four-fold increased risk of stillbirth in women who conceived after IVF/ICSI compared with fertile women ,” Dr Wisborg explained in a statement to the media. “The risk of stillbirth in sub-fertile women and women who conceived after non-IVF fertility treatment was not statistically significantly different from the risk in fertile women.” “Until now, there has been speculation that the increased risk of adverse outcomes, such as stillbirths, in assisted reproduction might be due to factors related to the underlying infertility of the couples. However, we found the risk was similar between sub-fertile couples, women who had conceived after non-IVF fertility treatment and fertile couples. This may indicate that the increased risk of stillbirth is not explained by infertility and may be due to other, as yet unexplained factors, such as the technology involved in IVF/ICSI or some physiological difference in the couples that require IVF/ICSI,” she continued. “Hopefully, the results from our study emphasize the need for continuous follow-up of the outcome of fertility treatments, so that the information given to infertile couples seeking treatment can be differentiated to their individual circumstances.” Another recent study, also headed by Dr. Wisborg and published in the February 24th issue of Fertility and Sterility , reached an additional worrisome conclusion. The research team found a statistically significant increased risk of preterm deliveries in women who conceived after IVF/ICSI treatments, compared to women who conceived naturally. Although the Danish scientists’ studies did not discuss the possibility in depth, it seems logical that couples suffering from infertility problems that are so serious they turn to extremely expensive high tech baby-making technologies could have some type of systemic problems affecting their fertility. And these health factors might be either undiscovered, unknown — or ignored — by the medical establishment. A case in point: NaturalNews has reported on research showing that 93% of infertile women are deficit in vitamin D (http://www.naturalnews.com/News_000465_vitamin_D_infertility_womens_health.html). In addition, chemicals in the environment, including flame retardants called polybrominated diphenyl ethers (PBDEs) that are commonly found in household consumer products, have been linked to infertility. For more information: http://www.ncbi.nlm.nih.gov/pubmed/20188361 http://www.ncbi.nlm.nih.gov/pubmed/20179321

Antidepressants During Pregnancy Cause Premature Birth

(NaturalNews) Women who take strategic serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy are twice as likely to give birth prematurely as women who do not take the drugs, according to a study published in the Archives of Pediatric and Adolescent Medicine and funded by the Danish Medical Research Council. Many of the most popular depressants are SSRIs, such as Prozac. Researchers compared rates of premature birth between different women receiving prenatal care at the same hospital in Aarhus, Denmark. They compared women who were depressed and taking SSRIs with those who were depressed and not on any drugs, as well as those who did not suffer from depression. Women who took SSRIs while pregnant were two times as likely to give premature birth as those who did not take the drugs. On average, they gave birth four to five days earlier (relative to their due dates) than women who did not take the drugs. The researchers also found that the risk of an infant needing intensive care immediately after birth was significantly increased by SSRI use during pregnancy. While only 7 percent of babies born to non-depressed mothers needed intensive care, along with only 9 percent of those born to depressed mothers who were not taking drugs, 16 percent of babies born to women who had used SSRIs while pregnant required treatment in an intensive care unit. Babies born to SSRI-using mothers also appeared less healthy than other babies, the researchers said, based on measures including skin color, activity level after birth, pulse, breathing and response to external stimuli. Previous studies have confirmed that SSRIs can cross the placental barrier into the fetal bloodstream, and that infants born to women who used the drugs during pregnancy can suffer from withdrawal symptoms. Health professionals recommend that women who are taking SSRIs and are pregnant or thinking of becoming pregnant speak with a doctor about their options, rather than stopping treatment abruptly. Side effects of antidepressant withdrawal can be severe. Sources for this story include: www.guardian.co.uk.

Surge in infertility tourism leads to Viking babies

(NaturalNews) In vitro fertilization (IVF) has become a popular method by which women who are having trouble getting pregnant are able to use donor sperm to achieve pregnancy. In the UK, however, there is a shortage of donor sperm that is causing British women to have to travel to countries like Denmark in order to find some. A 2005 British law change outlawed the donating of sperm anonymously. UK law also has a long-standing rule that prohibits men who donate from receiving any sort of monetary compensation. Because of these rules, and the fact that many men fear having to provide their identities with the donation because the children may eventually try to find and meet them, few British men are donating sperm these days. As a result, the waiting list to receive IVF in the UK is several years. In 2007, Denmark changed its laws and now permits anonymous donors, which has led to a surge in foreign women coming there to receive IVF treatment. Danish donors are also compensated between $60 and $200 for their donations which has helped to facilitate a large number of casual donors. The Danish sperm bank, Cryos, is the largest sperm bank in the world and is a popular destination for “infertility tourists” seeking to have children. Denmark is one of the few nations that allows anonymous donations as well as monetary compensation for them. For this reason, Danish clinics are flourishing with increased business. DanFert in Copenhagen more than doubled its IVF customers since 2007. Vita Nova in Copenhagen has seen a 40 percent increase in women seeking IVF from Britain alone. Danish clinics also cater to single women who are trying to have children, a controversial scenario rejected by many other nations who aim to serve couples trying to conceive. Such liberal laws have attracted all sorts of women from around the globe who wish to bear children but are otherwise unable. Because of the popularity of the program, Danish banks have begun opening up franchised fertility clinics in other countries that permit it, including in the US and India. In these countries, men who are looking to make some extra cash often donate to the clinic, a practice that has all but ceased in Britain due to the laws. Many women are hoping that UK laws will once again allow for anonymous sperm donors. They believe it will help to increase supply and end the shortage that has prevented many women from receiving IVF there. Sources for this story include: http://news.bbc.co.uk/2/hi/health/8298465.stm

Paxil Birth Defect Litigation – First Trial A Bust for Glaxo

(NaturalNews) GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania. Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service. First Trial A Bust for Glaxo The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages. After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said. On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.” Glaxo’s lead attorney in the Kilker trial was King and Spalding partner, Chilton Varner. Over 600 Trials To Go A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches. “Although one might worry that this would cause a jury to blame the prescribing doctor,” says Vickery, “in this case, we can show that GSK encouraged this use, by sending out over 1500 “medical information” letters touting the benefits of Paxil for migraine headaches, and by leaving “approved WLF reprint” articles with the prescribing doctors.” Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow. In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised: “Despite this categorization,” says Vickery, “in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects.” “Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia,” he notes. Case of the Dead Rats During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were “going to see documents in this case that have never seen the light of day before.” “You will see internal GlaxoSmith documents that the FDA hasn’t seen, that the United States Congress hasn’t seen, and that no jury has ever laid their eyes on before,” he said. “They have been under seal for over three years.” Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs. Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980. Healy explained that a teratogen is an agent that will cause birth defects and “it could be a drug or maybe a virus or maybe an illness.” In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth. The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil. The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead. In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4. Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four. Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects. After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, “GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning.” “I would like you to note three things about the discussion in the product information about the animal studies,” she said. “First, there were no birth defects in the study,” she told he jury. “That is, there were no malformations or difficulties, structural difficulties, with the animals.” “Second,” she said, “the rat pups who died shortly after birth were dosed at something like ten times the normal dose.” “And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation,” Varner told the jury. “You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem,” she said, “it was during the lactation period that these pups died.” While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner’s claims in stating: “Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation.” He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. “Yes, they were,” Healy said. “They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after.” He also told the jury that there were three major malformations in the Paxil exposed group, and “there may well have been more.” “The figures from the studies do give grounds for concern that there were, in fact more,” he said, “far more.” The fact that the more Paxil they got the more they died, “indicates that the drug has played a part … in whatever the cause of death is,” Healy told the jury. “It’s clearly the drug that has caused the death,” he said. “What we aren’t clear from here is just what actually happened. Why they died.” In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies. In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner’s claim that the rats received 10 times the normal dose. “At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy,” Baldwin wrote. “That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed,” Healy told the jury. “That Paxil is a drug that if it comes on the market, may cause birth defects,” he said. “So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated.” Which “would mean in this case,” Healy said, “do not use the drug in women of childbearing years unless, for instance, they’re using some form of birth control.” Another portion of Baldwin’s memo stated: “On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels.” “This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects,” Healy told the jury. “We need to do more work to actually before it’s out, does the drug come with this risk or not.” “He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not,” Healy said. “The implication being that if they haven’t done it, we should.” In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. “I know they did further studies, but I don’t think they did anything to address the issues that were raised by 295, 296, 297,” he said. “Or if they did, they kept it well hidden it would seem.” Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, “Active Psychiatric Scandinavia,” and stated: “There appeared to be no selective effect on the embryo or any signs of teratogenicity.” Baldwin “appears to be saying here that there is no evidence that the drug causes birth defects,” Healy told the jury. “That appears to me to be incompatible with the data that we reviewed earlier.” Baldwin’s paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989. Incriminating Data Destroyed During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: “It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993.” Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. “From my work on the serotonin system back in the early ’80s, almost 30 years ago,” he said, “I still have the raw data.” “The idea that I would destroy the data is almost inconceivable,” Healy stated. People may be concerned about a particular study and want to go back and look at the books, he said. “It’s a bit like auditing a major company like Enron.” But it’s “even more important actually in science,” Healy told the jury. “People with a different point of view need to be able to say, look, show me the data.” They may “even suspect that I didn’t do the study,” he said, “so a defense for me is to be able to say here are the notebooks, here are the clinical records.” So you have to “be prepared to have all sorts of challenges,” he told the jury. “But for that to happen, the notebooks, the clinical records, the lab notebooks must be there.” Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. “I believe there were efforts to try and find the microfilms, but they have not been found,” he said. Healy explained that when studies are done, there are a set of procedures called “good laboratory practice,” or GLP. “And it is hoped these days when a company brings a drug to the market,” he said, “that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice.” “And part of the requirements here of good laboratory practice is that the raw data is maintained,” he told the jury. Later in Healy’s testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under “maintenance of records,” stated “this material will be stored,” and the “material will not be discarded or released from these laboratories without the sponsor’s prior consent.” Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus. During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil. A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony. Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C. When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company “do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born,” she said. “Cross-fostering is … taking rats from treated mothers and putting them with a control rat that didn’t receive the drug,” she explained to the jury. “So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born.” The FDA asked Glaxo to submit a protocol for the study, “for our concurrence,” before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study. She testified that such a study “would have helped to address where the negative effects were coming from.” While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam’s mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester. The label stated: “in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester.” Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label “implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester,” she testified. The label is saying “there is no evidence of teratogenic effects,” she said, “that means that it’s safe for the first trimester. ” “If a physician were to read this, they would be more likely to prescribe it early in pregnancy,” she told the jury. Evelyn Pringle epringle05@yahoo.com (The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at www.justiceseekers.com )