NEW YORK – Male factory workers in China who got very high doses of a chemical that’s been widely used in hard plastic bottles had high rates of sexual problems, researchers reported Wednesday.
Heavy exposure to BPA, or bisphenol A, on the job was linked to impotence and lower sexual desire and satisfaction, according to the study, which adds to concerns about BPA’s effects on most consumers.
The men in the study experienced BPA levels about 50 times higher than those faced by typical American men, said researcher Dr. De-Kun Li. “We don’t know” whether more typical doses have similar effects, he said.
People shouldn’t be alarmed by the finding, said Li, a reproductive and perinatal epidemiologist at Kaiser Permanente’s research division in Oakland, Calif. But he said it would be prudent to limit exposure to BPA while scientists look for any effects from lower doses.
The U.S. government recently announced new funding for research into BPA’s effects.
Li is lead author of the latest study, published online Wednesday by the journal Human Reproduction. The work was financed by the National Institute of Occupational Safety and Health.
BPA is used in a wide variety of consumer products, including some hard plastic bottles and metal food or beverage cans. Several makers of baby bottles recently said they had stopped using the chemical. Some 90 percent of the U.S. population carries detectable levels in the urine.
Scientists are concerned that BPA exposure might harm the reproductive and nervous systems, and possibly promote prostate and breast cancers. Last year, a preliminary study linked BPA to possible risks for heart disease and diabetes.
The Food and Drug Administration concluded last year that trace amounts of BPA that leach out of bottles and food containers are not dangerous. But the FDA is now reviewing that stance after criticism from its scientific advisers.
For the new research, Li and colleagues studied 164 factory workers in China who were exposed to high levels of BPA on the job. They were compared to 386 other men in the same town who either worked at other factories or were married to factory workers.
The scientists measured BPA exposure through air sampling, and interviewed the workers about their sexual functioning.
Compared to the other workers, men with high BPA exposure were about four times as likely to report trouble achieving erections, about seven times as likely to say they had difficulty ejaculating, and about four times as likely to report low sex drive or low satisfaction with their sex lives.
The effects are dramatic and “pretty clearly related to the exposure,” said Linda Birnbaum, director of the National Institute of Environmental Health Sciences, who was not involved in the research.
The finding fits in with animal studies and should be followed up by research in the general population, she said. Her institute said last month it will spend more money on BPA-related research, bringing the total to $30 million over two years.
Steven Hentges, a BPA expert and official with the American Chemistry Council, an industry group, said the work is “probably not very relevant for consumers.”
For one thing, the reported 50-fold difference in exposure seems to be an underestimate because of how it was calculated, he said. In addition, he said, the workers inhaled BPA or got it on their skin. Consumers get it through diet instead, which lets the body detoxify it, Hentges said.
Li said the workers probably were exposed not only through inhalation and skin contamination but also by swallowing BPA powder that contaminated their food. He said he didn’t know which route was most prominent in the Chinese factories.
Girls will be girls and boys will be girls: everyday ‘gender-bending’ chemicals are feminising increasing numbers of babies Photo: Getty Creative
“Diet, injections, and injunctions will combine, from a very early age, to produce the sort of character and the sort of beliefs that the authorities consider desirable, and any serious criticism of the powers that be will become psychologically impossible.”
- Bertrand Russell, “The Impact of Science on Society”, 1953
Gender-bending chemicals are largely exempt from new EU regulations, warns Geoffrey Lean.
Here’s something rather rotten from the State of Denmark. Its government yesterday unveiled official research showing that two-year-old children are at risk from a bewildering array of gender-bending chemicals in such everyday items as waterproof clothes, rubber boots, bed linen, food, nappies, sunscreen lotion and moisturising cream.
The 326-page report, published by the environment protection agency, is the latest piece in an increasingly alarming jigsaw. A picture is emerging of ubiquitous chemical contamination driving down sperm counts and feminising male children all over the developed world. And anti-pollution measures and regulations are falling far short of getting to grips with it.
Sperm counts are falling so fast that young men are less fertile than their fathers and produce only a third as much, proportionately, as hamsters. And gender-bending chemicals are increasingly being blamed for the mystery of the “lost boys”: babies who should normally be male who have been born as girls instead.
The Danish government set out to find out how much contamination from gender-bending chemicals a two-year-old child was exposed to every day. It concluded that a child could be “at critical risk” from just a few exposures to high levels of the substances, such as from rubber clogs, and imperilled by the amount it absorbed from sources ranging from food to sunscreens.
The Disappearing Male
The results build on earlier studies showing that British children have higher levels of gender-bending chemicals in their blood than their parents or grandparents. Indeed WWF (formerly the World Wildlife Fund), which commissioned the older research, warned that the chemicals were so widespread that “there is very little, if anything, individuals can do to prevent contamination of themselves and their families.” Prominent among them are dioxins, PVC, flame retardants, phthalates (extensively used to soften plastics) and the now largely banned PCBs, one and a half million tons of which were used in countless products from paints to electrical equipment.
Young boys, like those in the Danish study, could end up producing less sperm and developing feminised behaviour. Research at Rotterdam’s Erasmus University found that boys whose mothers were exposed to PCBs and dioxins were more likely to play with dolls and tea sets and dress up in female clothes.
And it is in the womb that babies are most vulnerable; a study of umbilical cords from British mothers found that every one contained hazardous chemicals. Scientists at the University of Rochester in New York discovered that boys born to women exposed to phthalates had smaller penises and other feminisation of the genitals.
The contamination may also offer a clue to a mysterious shift in the sex of babies. Normally 106 boys are born for every 100 girls: it is thought to be nature’s way of making up for the fact that men were more likely to be killed hunting or in conflict. But the proportion of females is rising, so much so that some 250,000 babies who statistically should have been boys have ended up as girls in Japan and the United States alone. In Britain, the discrepancy amounts to thousands of babies a year.
A Canadian Indian community living on ancestral lands at the eastern tip of Lake Huron, hemmed in by one of the biggest agglomerations of chemical factories on earth, gives birth to twice as many girls as boys. It’s the same around Seveso in Italy, contaminated with dioxins from a notorious accident in the 1970s, and among Russian pesticide workers. And there’s more evidence from places as far apart as Israel and Taiwan, Brazil and the Arctic.
Yet gender-benders are largely exempt from new EU regulations controlling hazardous chemicals. Britain, then under Tony Blair’s premiership, was largely responsible for this – restricting their inclusion in the first draft of the legislation, and then causing even what was included to be watered down.Confidential documents show that it did so after pressure from George W Bush’s administration, which protested that US exports “could be impacted”.
Now the Danish government is planning to lobby to have the rules toughened up. It is particularly concerned by other studies which show that gender-bending chemicals acting together have far worse effects than the expected sum of their individual impacts. It wants this to be reflected in the regulations, citing its discovery of the many sources to which the two-year-olds are exposed – modern slings and arrows, as it were, of outrageous fortune.
A groundbreaking, $30 million study into cell phones has found a link between long term use and brain tumors.
The World Health Organization is about to reveal that its decade-long investigation has found the devices can lead to cancer — and the internationally-respected body will soon issue a public health message with its findings, London’s Daily Telegraph reported today.
The conclusion goes against years of assurances by cell phone companies and scientists that cell phone use is safe.
But last month, Sen. Arlen Specter, D- Pa., organized Senate hearings to examine health implications of talking on-the-go.
The WHO’s Interphone investigation’s results showed, “a significantly increased risk” of some brain tumors “related to use of mobile phones for a period of ten years or more,” the Telegraph reported.
The study’s head, Dr. Elisabeth Cardis, said, “In the absence of definitive results and in the light of a number of studies which, though limited, suggest a possible effect of radiofrequency radiation, precautions are important.”
US, November 2, 2009, (Pal Telegraph) – Los Angeles–President Obama’s declared H1N1 emergency cannot be reconciled by either vaccine shortages or flu cases; only by medical “market-building,” vaccination intoxications, and mass murder for population reduction says common sense and mounting evidence. Over the weekend, initial reports from Reuters News Service and Fox News stated that the President’s declaration was intended to prepare the country in case of “a rapid increase in illness that may overburden health care resources.” The media quoted an unidentified administration official saying, “It’s important to note that this is a proactive measure — not a response to a new development.” This action was “similar to disaster declarations issued before hurricanes hit coastal areas,” Reuters reported.
Why would the Obama administration anticipate an H1N1 “hurricane” to hit when Purdue researchers concluded last week the epidemic was expected to peak this week? In fact, too soon for vaccines to be helpful.
Thus, most people getting vaccinated now risk side effects for NOTHING–no benefit what-so-ever!
Furthermore, CBS News determined last week the CDC’s reported H1N1 cases had been overblown up to 97 percent. Only about 1,000 people have died of H1N1 since April’s Mexican outbreak. That is merely 1/18th, or less than 6%, of expected deaths from a normal seasonal flu during the same time period.
It is highly suspicious that David A. Paterson, New York State’s Governor, suddenly suspended “mandatory” H1N1 shots for health professionals citing vaccine shortages, not litigation exposures, as cause for the policy change.
Neglecting notice that more than 60 percent of nurses in New York State refused to take the H1N1 vaccines according to polls, and unions had filed lawsuits against New York and Washington State to gain injunctions against mandated injections, Paterson’s yellow press blamed “limited vaccine supplies” as reason to inject pregnant women and children exclusively. Only two weeks earlier, New York State officials posted their first priority, “as established by the CDC,” to vaccinate health care workers and emergency medical services personnel.
Oddly, all this talk about sudden vaccine shortages being the cause of a federal emergency grossly contradicts what many health officials were saying merely three weeks ago. United Press International (UPI) reported, for instance, Dr. Judy Monroe, Indiana’s state health commissioner, said that an ample supply of the vaccine would be available for everyone by mid-October. Now, suddenly, there is an alleged shortage that compels mixed messages and general confusion.
Revelations of the Swine Flu and Forced Vaccinations
“Shortage Marketing” Disease and Death
“This is called “shortage marketing,” Dr. Leonard Horowitz explains. “It is an increasing trend in the industrial world to get consumers to purchase products that are unappealing, over-inventoried, or scarce.”
For weeks preceding Obama’s declaration of national emergency polls showed the vast majority of Americans, including health care workers, rejecting the seasonal and H1N1 flu vaccines. So with stockpiles high, despite allegations of manufacturing delays, the government’s promotions and policy changes simply reflect “shortage marketing.”
But this is a “superficial concern” according to Dr. Horowitz, who references neurobehavioral and neurocognitive disorders demonstrated in vaccine recipients who were normal before getting vaccinated. He credits the brilliant work of Andrew Moulden, MD, PhD, photographically detailing tremendous physical damage occurring following vaccinations. These previously unknown and unseen subtle changes in nerve function and physical appearance is now demonstrated in pictures by Dr. Moulden that are irrefutable in courts and the scientific world.
Dr. Horowitz, a Harvard-trained expert in behavioral science, media persuasion and public health education, has spent 20 years documenting drug industrialists’ and health officials’ criminal actions.
“The only way to reconcile President Obama’s declaration of emergency, given the increasing risks of vaccine injuries, post-peak diminishing risks of H1N1, and the anticipated public health nightmare caused by live viruses “shedding” from those vaccinated to unvaccinated persons, is to follow the flow of money,” Dr. Horowitz says. “In the process of shedding vaccination H1N1, the highly unstable shed virus is expected to pick up more lethal genes from other circulating viruses, including possibly H5N1 that kills nearly 60 percent of those infected.”
Dr. Horowitz notes that authorities have been mum on the triple recombinant H1N1 produced in labs for use in the “active” vaccine. Experts know this is highly unstable, because it is a man-made laboratory creation that did not evolve naturally over the millennia. This unstable mutant more readily recombines with other circulating viruses when it is shed for up to 3 weeks, thus exposing non-vaccinated people who are infected with other viruses.
This is the best explanation for Obama’s anticipated “hurricane,” explains Dr. Horowitz, who criticizes the mainstream media for completely neglecting this greatest risk while falsely reporting vaccine “shortages.” Something else is obviously happening behind the scenes that only seasoned investigators can discern, he says.
He diagnoses the alleged vaccine shortage as a profitable ploy used by those “who have outrageously obvious connections to the Population Council, the preeminent organization directing global depopulation, as encouraged by Obama’s science czar, John Holdren.
Dr. Holdren is the co-author of the 1977 book, Ecoscience, which calls for massive global depopulation using sterilizing vaccinations.
Dr. Horowitz points to the fact that Nonoxynol-9, a spermicidal drug causing spontaneous abortions in pregnant women, and birth defects in infants, is one of the many new “adjuvants” banned in the United States, but used by the American-based Baxter Company in their H1N1 flu vaccines stockpiled by European nations.
H1N1 Flu A Pharmaceutical Hoax
“Just get yer damn vaccine!”
Outrageous Conflicting Interests
Dr. Horowitz also suggests discerning conflicting interests between vaccine makers and the news sources that break the federal government’s announcements, in this case Reuters and FOX news.
Reuters is directed by Thomas H. Glocer, a Merck & Co. director making money from H1N1 vaccine sales through Merck’s subsidiary, CSL, Inc. Merck also sells Pneumovax, a vaccine suggested for use at the time influenza vaccines are given, yet contraindicated in people with active influenza infections.*
A “live” H1N1 vaccine infects those vaccinated with “active” viruses. Thus, Merck’s suggested Pneumovax usage is contraindicated according to their own package insert!
If that’s not bad enough, CSL, Inc. did its H1N1 vaccine safety testing on pregnant women, infants, and children at facilities financed by Rupert Murdoch and his family–the Royal Victoria Women’s Hospital directed by Elisabeth Murdoch, and the Murdoch Children’s Research Institute overseen by Rupert’s daughter-in-law Susan Murdoch. So much for FOX News’s impartiality.
The Wall Street Journal that announced “New York Ends Flu Shot Mandate for Health Care Workers” on October 23rd, is disqualified by way of its links to Merck also. . . . WSJ CEO Councilman, David Brennan, directs the AstraZeneca’s Flumist manufacturer, Medimmune, Inc. AstraZeneca drafted Brennan from Merck & Company, and appointed him CEO in 2006.
This pattern of gross conflicting interests, and coordinated multi-media genocidal counterintelligence, expands with reading Thomas Glocer’s article wherein Reuters plugs “an experimental new drug called peramivir, made by Biocryst Pharmaceuticals Inc.”**
Peramivir is produced by Jon P. Stonehouse’s BioCryst Pharmaceuticals, Inc. President and Chief Executive Officer, Stonehouse recently served as Senior Vice President of Corporate Development at (surprise, surprise) Merck. At Merck, Stonehouse was responsible for “leading strategic developments . . . [that] significantly changed the company,” according to BioCryst’s website.
The Partnership for New York City and Council for Depopulation
It is obvious that our H1N1 “intelligence” is being gathered and broadcast from the highest levels of the medical-media’s mafia. As previously reported in Dr. Horowitz’s “AFFIDAVIT,” submitted to the FBI earlier this month, and filed last week in a lawsuit against federal officials in Washington State, David Rockefeller, Rupert Murdoch, Thomas Glocer, and other media moguls are partnered in the world’s most powerful drug ring and biotechnology consortium. Its members include the government of New York State as well as the US Federal Government. Proof of these facts are available for inspection online at The Partnership for New York City (PFNYC). The site provides its members list and related pharmaceutical industry activities.
The Founder of PFNYC, David Rockefeller, wields tremendous influence over many of the foundations and institutions that direct the US Federal Government’s policies and practices. American “health care reform” is currently directed, on behalf of the Democratic party, by Sen. Jay Rockefeller.
The Rockefeller Brothers Fund granted millions of dollars to the Population Council of the City of New York during its formative years. Rockefeller family members founded this Population Council, according to The Rockefeller Archive Center. The organization currently advances globally as the world’s premier depopulation advocacy group. The US Federal Government and private institutions fund the Population Council at this time.
Doctor Oz Advises Kids To Get H1N1 Shot But Not His Own
Summary and Conclusion
“Biopreparedness” for the 2009 H1N1 Swine Flu is all about mind manipulation and vaccination for population reduction.
In the past week, the swine flu situation went from near ending to causing a “National Emergency.” People, aware of the dangers of H1N1 vaccinations, opted out and gained precedent-setting federal court prohibitions on mandatory vaccinations. CBS declared the numbers of H1N1 cases fraudulently overstated by the CDC, and additional lawsuits were filed exposing State and Federal officials for genocidal malfeasance.
Rather than admitting disgrace, government spin doctors integrated vaccine “shortage marketing” as a distraction for public consumption. New York State Health Commissioner, Richard F. Daines, who said only a week ago that health workers must be vaccinated for the seasonal flu and the H1N1 virus, or risk discipline, said that scarce vaccines would be given exclusively to pregnant women and children.
Ironically, US Health and Human Services Secretary, Kathleen Sebelius, pledged 10 percent of vaccines would be donated to other countries.
All of this preceded Barack Obama’s declaration of “National Emergency,” thus, exercising Executive power to implement The Model State Emergency Health Powers Act affecting most of the 50 States.
Obviously, none of this makes much sense unless you examine the fundamental and overriding intoxication and depopulation agendas, and what the media moguls know that few commoners learn: the H1N1 vaccines contain “live” viruses that are highly unstable. As laboratory “reverse engineered” genetically spliced germs, they are expected to recombine with more deadly viruses, possibly H5N1, by January, 2010. These new strains, circulating the globe, are projected to kill nearly 3 billion people. This Lex Lutheresque evil is obviously orchestrated by David Rockefeller’s family and friends that control vaccine manufacturing, “health care reform,” mass media persuasion, and global depopulation industries.
Like it or not, you are advised to prepare for the worst.
Researchers looked at the effect of soda drinks on more than 3,000 women taking part in the Nurses’ Health Study, a major lifestyle and health investigation in the US.
They compared drinks that were sweetened with sugar and artificially sweetened.
The results showed that two or more artificially sweetened drinks a day doubled the risk of a faster-than-average decline in kidney function.
No-such association was found with sugar-sweetened drinks.
The link persisted after taking account of other risk factors including age, high blood pressure, diabetes, smoking, and heart disease.
More work was needed to uncover the mechanism behind the trend, said the scientists from Brigham and Women’s Hospital in Boston, Massachusetts.
The findings were presented at the American Society of Nephrology’s annual meeting in San Diego, California.
A separate study by the team involving the same group of women also found a link between sodium intake and kidney damage.
Dr Julie Lin, who co-led the research, said: “There are currently limited data on the role of diet in kidney disease.”
The waves have been found to “unzip double-stranded DNA, creating bubbles in the double strand that could significantly interfere with processes such as gene expression and DNA replication.”
The latest airport security trend is the backscatter x-ray machine, touted as a powerful way to virtually frisk a traveler for contraband without the embarassment of a strip search.
Though touted as completely safe because the level of radiation is so low, travelers have been nervous about the devices — and not just because it shows off a nice outline of their privates to the people manning the machines — but because they remain scared of the health problems they might propose.
Looks like a little healthy paranoia might have been a good thing. While the conventional wisdom has held that so-called “terahertz radiation,” upon which backscatter x-ray machines are based, is harmless because it doesn’t carry enough energy to do cellular or genetic damage, new research suggests that may be completely wrong.
Specifically, researchers have found that terahertz radiation may interfere directly with DNA. Although the force generated is small, the waves have been found to “unzip double-stranded DNA, creating bubbles in the double strand that could significantly interfere with processes such as gene expression and DNA replication.”
I’m not a doctor, but that just doesn’t sound good.
The question now is whether this is or isn’t safe. Terahertz waves occur naturally in the environment, and we’re hit with them all the time. But should we bombard ourselves with them willingly every time we pass through an airport? No one knows how much terahertz radiation is OK for the body to absorb: Just like sunlight, a little may be fine, while a lot may be deadly. Where does the line get drawn?
Who knows? I, for one, am given a little pause by the news, and hope research continues on before these machines become commonplace.
Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.
Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.
“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.
Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.
She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”
There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.
Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.
Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”
Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”
However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”
Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.
This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old “is a great big public health experiment.”
At the time, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”
“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”
When asked why she was speaking out, she said: “I want to be able to sleep with myself when I go to bed at night.”
Since the drug’s introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.
Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.
The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: “The rate of serious adverse events is greater than the incidence rate of cervical cancer.”
Ms. Robinson said she respects Dr. Harper’s candor. “I think she’s a scientist, a researcher, and she’s genuine enough a scientist to be open about the risks. I respect that in her.”
However, she failed to make the case for Gardasil. “For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”
Antipsychotic drugs widely used in children caused youths to gain as much as 19 pounds on average after just 11 weeks on the medications, according to a new study published in the Journal of the American Medical Association.
The findings about the drugs, known as atypical antipsychotics, bolster concerns about giving the medicines to patients under 18 years of age. The study’s authors urged child psychiatrists to exercise caution before deciding to prescribe, and to closely monitor patients taking the drugs.
The powerful drugs are used to treat schizophrenia and bipolar disorder. They have faced growing scrutiny, not only because of concerns about weight gain that could lead to diabetes, but also because of the aggressive marketing tactics by their makers that have helped make them the highest-selling class of drugs in the U.S.
The study results come as the Food and Drug Administration considers approving younger patients’ use of a few of the drugs. Atypical antipsychotics have limited approval for youths, but doctors are free to prescribe them as they see fit and often give them to children and adolescents, say analysts and psychiatrists.
Psychiatrists turned to the new drugs after they began going on sale in the 1990s because they didn’t cause involuntary facial tics and other problems, as an earlier generation of medicines did. Last year, the drugs collectively generated $14.6 billion in sales in the U.S., according to IMS Health. But a growing number of studies suggest they have their own side effects.
“The weight gain is much larger than we thought,” said Christoph Correll, the study’s lead author, who is a psychiatrist and a scientist at the Feinstein Institute for Medical Research in Manhasset, N.Y. “It’s massive, and it’s the medication” that caused it, he said.
The JAMA study, conducted in 272 youths ages 4 to 19 years, is the largest and most definitive to date to establish a link between the drugs and weight gain, the authors said. Unlike earlier studies, it looked only at patients who hadn’t previously taken the medicines.
The drugs examined were four top-selling atypical antipsychotics: Abilify, sold by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.; Risperdal from Johnson & Johnson; Seroquel from AstraZeneca PLC; and Zyprexa from Eli Lilly & Co.
Zyprexa caused the most weight gain, the study found. Over 11 weeks of use, children on Zyprexa gained the most weight on average, nearly 19 pounds, or a 15% increase. The drug was also found to significantly raise levels of blood sugar, cholesterol, insulin and triglycerides, which can lead to diabetes and heart problems.
Patients taking the other three drugs gained from 10 to 13 pounds on average, according to the study. The impact on users’ blood sugar and other metabolic levels varied, depending on the drug.
The drugs’ makers say that the potential for increased weight gain is well known and that they have already updated labels to reflect possible side effects. Atypical antipsychotics are a valuable treatment option for severe mental illnesses, the companies add, and physicians and parents should weigh the risks from taking the medicines against the benefits.
Should the FDA approve Zyprexa’s use in adolescents, physicians should consider prescribing another drug first, a Lilly spokesman added.
In January, Lilly agreed to pay $1.42 billion to settle a federal probe into alleged improper marketing of Zyprexa. And other pharmaceutical companies have come under fire for allegedly promoting off-label uses of atypical antipsychotics and playing down the side effects.
The connection between the drugs and weight gain is poorly understood. As concerns about the side effects have mounted, prescriptions for children have slowed. Dr. Correll encouraged child psychiatrists to be even more careful about giving the drugs to youths and, when they do, to encourage a healthy diet and to check weight and metabolic levels every three months.
“The onset of the weight gain was so pronounced and so significant there’s probably an argument for doing those measurements every few weeks,” said Christopher Varley, a child psychiatrist at Seattle Children’s Hospital, who wrote an editorial accompanying the study.
The FDA will soon decide whether to approve younger patients’ use of Seroquel, Zyprexa and Geodon, another atypical antipsychotic. (Geodon wasn’t part of the study because it’s not often used in new patients and too few users enrolled in the trial, Dr. Corell said.) Each drug is currently FDA-approved for use by adults.
Critics are calling it a two-tier health system — one for the politically well-connected, another for the hoi polloi. As Germany launched its mass vaccination program against the H1N1 flu virus on Monday, the government found itself fending off accusations of favoritism by offering one vaccine believed to have fewer side effects to civil servants, politicians and soldiers, and another potentially riskier vaccine to everyone else. The government had hoped that Germans would rush to health clinics to receive vaccinations against the rapidly spreading disease, but the rising anger over the different doses may now cause many people to shy away.
Amid growing fears over a possible global flu pandemic, the German government prepared for its mass vaccination campaign earlier this year by ordering 50 million doses of the Pandemrix vaccine, which would be enough for a double dose for 25 million people, around a third of the population. The vaccine, manufactured by GlaxoSmithKline, contains an immune-enhancing chemical compound, known as an adjuvant, whose side effects are not yet entirely known. Then, after a report was leaked to the German media last week, the Interior Ministry confirmed that it had ordered a different vaccine, Celvapan, for government officials and the military. Celvapan, which is made by the U.S. pharmaceutical giant Baxter, does not contain an adjuvant and is believed to have fewer side effects than Pandemrix. (See how not to get the H1N1 flu.)
Anger at the news was widespread in Germany. “If mass vaccination is considered to be necessary, then everyone should be treated the same way,” says Birgitt Bender, the health spokeswoman for the Green Party. Ulrike Mascher, head of the VdK social welfare association, said giving government officials a different vaccine from the rest of the population sent the “wrong signal” and gave many people “the impression that they are second-class patients.” A story on the front page of the mass-circulation Bild newspaper accused the government of giving “second-class medicine” to regular Germans.
Doctors and medical experts are divided over the safety of Pandemrix. While some say it’s the best vaccine available, others have serious misgivings about it. “The Pandemrix vaccine can’t be recommended for pregnant women or young children because it has an increased risk of side effects. Pandemrix has an adjuvant which hasn’t been tested sufficiently up until now,” Alexander Kekulé, a virologist at the University of Halle, tells TIME. “Celvapan is a whole virus vaccine, which has fewer side effects than Pandemrix, but it leads more often to fever or local swelling when compared with the normal seasonal flu vaccine,” he adds. Although Kekulé called the government’s handling of the vaccination program a “scandal,” he said government officials and soldiers are not necessarily getting a better deal with Celvapan. “Neither Celvapan nor Pandemrix are ideal,” he says. (See what you need to know about the H1N1 vaccine.)
The Interior Ministry hit back at suggestions of preferential treatment, saying that it had ordered around 200,000 doses of the Celvapan vaccine from Baxter before the differences between the two vaccines were documented, and the government was bound by the terms of its contract. The government also points out that both Pandemrix and Celvapan have been approved by the European Union, and that other countries such as Britain and Sweden are using the Pandemrix vaccine. In an attempt to put a lid on the simmering controversy, Chancellor Angela Merkel’s spokesman, Ulrich Wilhelm, said that the German leader would consult with her doctor in the next few days and if she decided to receive a jab, it would be Pandemrix. (See pictures of thermal scanners hunting for swine flu.)
At least 26,000 people have been infected with swine flu in Germany, resulting in three deaths. Although the majority of patients have experienced only mild flu-like symptoms, a steady increase in the number of cases of H1N1 in recent months has raised alarm across the nation. In its latest report, the Robert Koch Institute, the federal agency for infectious diseases, said that new cases in Germany have jumped to around 1,600 each week, double the 700-800 weekly cases reported in early autumn. With the onset of winter, when seasonal flu infections typically peak, many experts are concerned that H1N1 infections will spike dramatically. Klaus Osterrieder, a virologist at the Free University of Berlin, now fears that with the worries over the possible risks associated with Pandemrix, many people will avoid getting a vaccine altogether. According to a survey conducted on Oct. 23 by the Emnid Institute, only 13% of Germans said they wanted to receive a swine flu vaccine this winter. (Read “Child-Care Centers and Parents Brace for Flu Season.”)
“The public debate is bad because it raises questions about the whole vaccination program,” Osterrieder says. If the government doesn’t find some way to remedy the current public relations disaster and clear up the confusion over the different swine flu vaccines, it could be faced with an even greater emergency if the country’s hospital wards start overflowing with flu patients in the coming months.
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