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News and commentary on the autism epidemic and my beautiful boy who is living with autism.
Novartis Q4 profit down as vaccine demand drops
Jan 27, 2011 5:32 AM ET
By The Associated Press
GENEVA (AP) — Swiss drug maker Novartis AG saw fourth quarter net profit slip 2 percent on the year to $2.32 billion amid one-off charges and a sharp drop in demand for its pandemic flu vaccine, the company said Thursday.
Profit in the October-December period was hurt by one-time charges of $789 million, including restructuring costs in the U.S. and Germany — only partially offset by a one-time gain of $392 million, the pharmaceutical company said.
Revenue in the fourth quarter grew from $12.92 billion to $14.19 billion. However, the vaccine division suffered a 74 percent decline in sales to $361 million following the end of the pandemic flu in 2010, after sales for the flu vaccine totaled $1 billion a year earlier.
The maker of hypertension drug Diovan and anticancer treatment Glivec — known as Gleevec in the United States — said its 2010 full year sales were up by 14 percent to $50.62 billion, including $2.4 billion revenue from the full consolidation of eye care specialist Alcon, Inc.
Full year 2010 net profit was up to $8.45 billion from $9.96 billion a year earlier, the company, based in Basel, said.
"Novartis achieved excellent results in 2010 as all divisions contributed to above-market growth," Chief Executive Joseph Jimenez said.
The company's results were helped by 13 key product approvals and the breakthrough of the multiple sclerosis medication, Gilenya, which has also been launched in the U.S., he said.
Analysts at Zuercher Kantonalbank said while Novartis' revenue is fully in line with market expectations, its net profit remained slightly below expectations.
In its outlook, Novartis said it expects sales to grow at constant currency rates by a "double-digit mark," and productivity gains to help improve margins while absorbing price cuts, generic competition and the loss of the pandemic flu vaccine sales.
The company's shares were trading lower on Switzerland's stock exchange Thursday morning, falling by 1.74 percent to 53.50 Swiss Francs ($56.71).
Child Flu Vaccine Seizures?
Posted by Sharyl Attkisson
More confusing news for parents trying to do the best, safest things for their children when it comes to vaccination.
According to a Vaccine Safety "update" issued by the FDA on Jan. 20, there's been an increase in reports of febrile seizures among infants and children following this year's flu vaccine. Febrile seizures are seizures associated with fever.
According to the FDA:
"FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age."
Bloomberg Businessweek:
Nearly Half of Americans Still Suspect Vaccine-Autism Link
18% don't trust measles-mumps-rubella shot, and 30% are undecided, Harris Interactive/HealthDay poll finds
By Amanda Gardner
Just a slim majority of Americans -- 52 percent -- think vaccines don't cause autism, a new Harris Interactive/HealthDay poll found.
Conversely, 18 percent are convinced that vaccines, like the measles-mumps-rubella (MMR) vaccine, can cause the disorder, and another 30 percent aren't sure.
The poll was conducted last week, following news reports that said the lead researcher of a controversial 1998 study linking autism to the MMR vaccine had used fraudulent research to come to his conclusion.
The poll also found that parents who have lingering doubts about the vaccine were less likely to say that their children were fully vaccinated (86 percent), compared to 98 percent of parents who believe in the safety of vaccines.
Still, the percentage of fully vaccinated children remains high, at 92 percent, the poll found.
"This sounds like a cup half-empty/cup half-full story," said Humphrey Taylor, chairman of The Harris Poll. He noted that while the number of people who believe in a connection between vaccines and autism is "only 18 percent," that nonetheless translates to "millions and millions and millions of people, and it's clear that in some cases that has led them to not vaccinate their children."
Vaccine safety has been a major concern for many parents since the publication of the 1998 study, led by now disgraced British doctor Andrew Wakefield, which concluded that the MMR vaccine caused autism. The journal that originally published the study, The Lancet, has since retracted the paper and Wakefield was recently barred from practicing medicine in Britain.
In recent weeks, another leading British medical journal, BMJ, has published a series of articles purporting to expose deliberate fraud by Wakefield in his handling of the research that served as the basis for the 1998 study.
In the new Harris Interactive/HealthDay poll, 69 percent of respondents said they had heard about the theory that some vaccinations can cause autism.
But only half (47 percent) knew that the original Lancet study by Wakefield and other researchers had been retracted, and that some of that research is now alleged to be fraudulent.
"Forty-seven percent is a huge number and this is a relatively new thing [allegations of fraud], so it's remarkable that they have heard of it. But that still means that half the population has not," Taylor said.
Still, the retraction and allegations of fraud do seem to have influenced public perception. Among those who had been following the news about Wakefield, only 35 percent believed the vaccine-autism theory, compared to 65 percent who had not kept up to date on the latest developments.
"There seems to be reasonable support for vaccination and I think this will increase with the revelation that a lot of this stuff was based on fraud or bad science," said Dr. Kenneth Bromberg, chairman of pediatrics and director of the Vaccine Research Center at the Brooklyn Hospital Center in New York City.
Overall, 69 percent of adults polled agreed that schools should require vaccinations -- including, interestingly, 52 percent of those who believe that autism might be connected to vaccinations.
Sixteen percent of all adults surveyed said they knew of at least one family whose children had not received all recommended vaccines due to concerns about autism. One-quarter of those who believed the vaccine-autism theory said they knew at least one family that had not fully vaccinated their children.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, which supports more research into the safety of vaccinations, said autism is just one concern linked to vaccines.
"Parents have legitimate questions about vaccine risks and want better vaccine science to define those risks for their own child," she said. "This concern long predated the debate about vaccines and autism. The National Childhood Vaccine Injury Act of 1986 was passed by Congress, in part, to address those concerns but has not done the job.
"The Harris poll points out the urgent need for a renewed effort to conduct new vaccine safety studies that are methodologically sound and free from real or perceived conflicts of interest," Fisher added, "or a significant portion of the public will continue to question the conclusions."
According to the U.S. Centers for Disease Control and Prevention, an estimated one in 110 children in the United States has an autism spectrum disorder, part of a group of developmental disabilities that can cause significant social, communication and behavioral challenges.
The Harris Interactive/HealthDay poll was conducted online within the United States from Jan. 11-13, and included 2,026 adults over the age of 18. Figures for age, sex, race/ethnicity, education, region and household income were weighted where necessary to bring them into line with their actual proportions in the population.
More information
Read more about the poll methodology and findings at Harris Interactive.
Novartis Q4 profit down as vaccine demand drops
Jan 27, 2011 5:32 AM ET
By The Associated Press
GENEVA (AP) — Swiss drug maker Novartis AG saw fourth quarter net profit slip 2 percent on the year to $2.32 billion amid one-off charges and a sharp drop in demand for its pandemic flu vaccine, the company said Thursday.
Profit in the October-December period was hurt by one-time charges of $789 million, including restructuring costs in the U.S. and Germany — only partially offset by a one-time gain of $392 million, the pharmaceutical company said.
Revenue in the fourth quarter grew from $12.92 billion to $14.19 billion. However, the vaccine division suffered a 74 percent decline in sales to $361 million following the end of the pandemic flu in 2010, after sales for the flu vaccine totaled $1 billion a year earlier.
The maker of hypertension drug Diovan and anticancer treatment Glivec — known as Gleevec in the United States — said its 2010 full year sales were up by 14 percent to $50.62 billion, including $2.4 billion revenue from the full consolidation of eye care specialist Alcon, Inc.
Full year 2010 net profit was up to $8.45 billion from $9.96 billion a year earlier, the company, based in Basel, said.
"Novartis achieved excellent results in 2010 as all divisions contributed to above-market growth," Chief Executive Joseph Jimenez said.
The company's results were helped by 13 key product approvals and the breakthrough of the multiple sclerosis medication, Gilenya, which has also been launched in the U.S., he said.
Analysts at Zuercher Kantonalbank said while Novartis' revenue is fully in line with market expectations, its net profit remained slightly below expectations.
In its outlook, Novartis said it expects sales to grow at constant currency rates by a "double-digit mark," and productivity gains to help improve margins while absorbing price cuts, generic competition and the loss of the pandemic flu vaccine sales.
The company's shares were trading lower on Switzerland's stock exchange Thursday morning, falling by 1.74 percent to 53.50 Swiss Francs ($56.71).
The Search for Safer Vaccines
The tragic death of little Elias Tembenis is yet another vaccine injury case you probably won't hear much about. Yet some medical experts believe it could teach us something about how to make vaccination safer.
It could also add to the limited body of knowledge as to why the vast majority of kids are vaccinated safely, but a minority become seriously ill, brain-damaged or even die. Still, government officials have said they have no plans to study cases like Elias': cases that victims are winning against the government in the little-known federal vaccine court.
According to court and medical records, Elias was born on Aug. 23, 2000 and appeared healthy until Dec. 26 when he received his second dose of DTaP vaccine. His parents noticed some swelling around the injection site. According to court records:
"Early in the morning on December 27, 2000, Elias's parents found him seizing in his crib and took him to the emergency room ("ER")...Within one day, he developed a fever, which led to a complex febrile seizure. Subsequently, Elias developed epilepsy. This fact pattern is commonly seen in the Vaccine Program."
According to court records, after the DTaP reaction, the once-healthy baby ended up with debilitating medical problems, including features of autism, ear infections and developmental delay. His parents first filed their case as one of the "omnibus" group of autism cases to be heard in federal vaccine court....
"I think you’ve hit the nail on the head - Misogyny.
Six months ago I was in a doc’s office with 4 to 5 moms and about 12 kids. The room went quiet for a moment and each mom gently tested the air. A moment later a mom said, “It’s mine, Jeffrey come here, time to get changed.”
It was incredible. In the space of 5 seconds each mom knew if their child had pooped or not from 10 feet away.
These are the moms who cannot tell if their child regressed after a vaccine?
It seems something vital has been lost in the last hundred years in our race to certainty, with hubris and misogyny playing a far bigger role than is honestly acknowledged."
"To parents out there, I would say please trust your instincts. In particular, maternal instinct has been a steady hand on the tiller of evolution for many thousands of years and we wouldn't be here without it. Parents have tended to relinquish that instinct in favor of a medical community. We assume doctors know a lot when in fact they know very little. Please mothers, trust your instincts. No one knows your child like you do and no one can take that away from you, so trust that. That is my most important message. - Andrew Wakefield
"The festering nastiness, the creepy repetitiveness, the weasly, deceitful, obsessiveness, all signal pathology to me," "And they wonder why their children have brain problems." - Brian Deer, on parents of children with autism.
Drugmakers, Doctors Rake in Billions Battling H1N1 Flu
Swine Flu Is Bad for Victims, But Good for Businesses That Cater to Expanding Market
By DALIA FAHMY
Oct. 14, 2009
ABC News/Money
Americans are still debating whether to roll up their sleeves for a swine flu shot, but companies have already figured it out: vaccines are good for business.
h1n1.
Drug companies have sold $1.5 billion worth of swine flu shots, in addition to the $1 billion for seasonal flu they booked earlier this year. These inoculations are part of a much wider and rapidly growing $20 billion global vaccine market.
"The vaccine market is booming," says Bruce Carlson, spokesperson at market research firm Kalorama, which publishes an annual survey of the vaccine industry. "It's an enormous growth area for pharmaceuticals at a time when other areas are not doing so well," he says, noting that the pipeline for more traditional blockbuster drugs such as Lipitor and Nexium has thinned.
As always with pandemic flus, taxpayers are footing the $1.5 billion check for the 250 million swine flu vaccines that the government has ordered so far and will be distributing free to doctors, pharmacies and schools. In addition, Congress has set aside more than $10 billion this year to research flu viruses, monitor H1N1's progress and educate the public about prevention.
Drugmakers pocket most of the revenues from flu sales, with Sanofi-Pasteur, Glaxo Smith Kline and Novartis cornering most of the market.
But some say it's not just drugmakers who stand to benefit. Doctors collect copayments for special office visits to inject shots, and there have been assertions that these doctors actually profit handsomely from these vaccinations.
It is a notion that Dr. Lori Heim, president of the American Academy of Family Practitioners, says is simply not true.
"According to most of the physicians I have talked to, the administration of these vaccines is done for the community's benefit as opposed to anything that helps profit," she says. Heim adds that even though doctors will not have to shell out for the H1N1 vaccine, they will bear the usual costs associated with storage and administering the shots.
"There is an administration fee, for the costs that you can't get reimbursed through Medicare or Medicaid," she says. "This is usually less than, or right at the break-even point."
Still, pharmacies also charge co-payments or full price of about $25 to those without insurance and often make more money if patients end up shopping for other goods.
"Flu shots present a good opportunity to bring new customers into our stores," says Cassie Richardson, spokesperson for SUPERVALU, one of the country's largest supermarket chains. Drawing customers to the back of a store, where pharmacies are often located, offers retailers a chance to pitch products that might otherwise go unnoticed.
Even companies outside of the medical industry are benefiting: the UPS division that delivers vaccines in specially designed containers, for example, has seen a bump in business.
New Entrants in Flu Shot Business
The intensifying competition has irked some doctors.
"Retailers and other non-medical professionals have siphoned off the passive income that once helped to cover medical overhead," says Dr. Caroline Abruzese, an internist in Atlanta. "The larger retail chains can invest up front in large volumes of vaccine at low prices, and market to customers already in their stores."
The promise of profits has attracted new players into the business. Some of the world's largest drugmakers, who in the past avoided the vaccine market because of its limited scope -- its not easy to convince healthy adults to get a shot for measles -- are now jumping into the fray.
Last month alone saw three large vaccine deals. Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm that makes and develops flu vaccines. Merck, which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL.
Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry.
Large and small drugmakers are drawn to the business largely because of scientific advances that promise to radically expand the range of health problems that vaccines can address. In addition to preventing childhood diseases such as measles and polio, vaccines can now also ward off cervical cancer, and researchers are working on vaccines for HIV and tuberculosis.
Scientists believe they can create therapeutic vaccines than treat diseases such as Alzheimers and diabetes after they have set in. (At least one company is betting on a vaccine that helps cigarette smokers quit.)
"These innovations broaden the market potential for vaccine makers and partly explained the renewed interest by drugmakers," says Anthony Cox, a professor at Indiana University's Kelley School of Business who specializes in the marketing of medical products.
But Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents the country's leading pharmaceutical research and biotechnology companies, says that drugmakers are also compelled by the government to join efforts to ensure that there is enough vaccine to go around.
"Because of national security implications, the government felt that they needed to encourage and ask [vaccine manufacturers] to move much quicker," he says. Grayson adds that vaccine manufacturers also face significant costs; aside from the expense of fitting a new vaccine into a tight production schedule, drugmakers GlaxoSmithKline and Sanofi Pasteur were forced to acquire new vaccine production facilities in recent years to keep up with demand.
Alternatives to Vaccines Are Few
While this promise of new treatments for painful diseases brings hope to many, vaccines continue to attract critics. The National Vaccine Information Center, a non-profit advocacy group, is at the forefront of a movement demanding that vaccines be tested more thoroughly before hitting the market. Although there has been little evidence to support their claim, detractors -- including the comedian Jim Carrey -- believe that vaccines are at least partly to blame for the sharp rise in autism in recent decades.
The swine flu vaccine has also attracted its share of critics. Frank Lipman, a New York-based doctor who specializes in a mix of Western and alternative medicine, points out that the swine flu is rarely fatal and that it's too early to tell if it's safe because it hasn't been widely tested.
Others argue that Americans have little choice. The cost of a widespread pandemic, similar to Spanish Flu outbreak in 1918, which killed 675,000 Americans (and 50 million worldwide), would be devastating. The Trust for America's Health, a Washington-based non-profit organization, estimates that a severe pandemic could push down GDP by more than 5 percent and cost Americans $683 billion.
"We're not seeing a pandemic that's this severe," says Jeff Levi, director of Trust for Americas Health. "We've dodged a lot of bullets."
"Subject: Wanting your opinion
Ginger, How do you respond to a radio personality who makes this post:
"When your car is repaired for an oil leak, and the next day the transmission fails, you blame the mechanic. But that deduction fails to consider that the car is old, and of course things will start to go bad. When a child is vaccinated, and later displays signs of autism, you can't say that all vaccines are dangerous. I am pissed that a lie had us focusing so much energy in the wrong direction."
I posted your link there. If you feel like making a comment, the gentleman's name is Chip Franklin. He's conservative ... but thinks anyone who questions the med industry or vaccine safety is nuts.
Thanks for all your links and information you bring to my attention. You are very appreciated !"
Here is how I would answer that.
When your car is repaired for an oil leak, and the next day the transmission fails, you go check to see what exactly is wrong with the transmission. When you find that you can't account for the damage naturally, and it looks man made, then you start checking with other clients of that mechanic. When you find that tens of thousands of his customers came in for oil and left with similar damage, both crippling to the car and vastly expensive if not impossible to fix, and you find out that the mechanic has been charged BILLIONS of dollars in fines internationally for outright fraud and attacking their critics, then you call the authorities and demand that they investigate him. You recommend that they might start by checking to see how often this mechanical failure happens as compared to those who have not brought their car in.
When the authorities REFUSE to investigate, and then you find out that those authorities used to work for the mechanic shop, and than many will work for it again when their job in government is over, then you call the media to investigate.
But when the media won't investigate, but merely takes any claim coming out of that mechanic shop or friends in government at face value, and you find out that the mechanic shop is a HUGE advertiser/client of theirs, and that those few in media who do investigate get punished and learn not to do it any more... THEN you decide the system is just so corrupt that you will never get answers, that the fancy house the mechanic has is likely paid for via taking advantage of the trust of customers and that the transmission problems are probably his fault as your own small investigations are telling you, and you and the other screwed customers make a car club, and learn how to fix each others cars.
And you stop listening to media for info on what is going on, and do your own research.
Don't know Chip, but I would encourage Chip to start by asking himself one question.
How does a "journalist" get copies of confidential childrens medical records?
Because apparently no one has called his attention to the fact that this entire "fraud" case is based on Brian Deer's claim that he has found information in the kids records, which he has has admitted to keeping in his apartment for months, and that no one can confirm most of these accusations because, again, he claims that they came from stolen children's medical records.
From there he can ask why the police are not at Deer's door arresting him. Then on to why the BMJ has published what cannot be confirmed. Then he might question why the "journalist" who first "broke" the story that there were problems with the study in 2004, then became the complainant in the case against him (since no actual patients could be found that would bring a case against Wakefield), then jumped back to becoming a "journalist" and reporting on the case as if he had nothing to do with it, then jumped back into the case, actually harassing parents of the children in question as the demonstrated on Wakefield's behalf at the hearing, then again jumped back to being an oh so objective journalist (by the way writing these stories for a British newspaper run by James Murdoch, board member of GlaxoSmithKline who makes the MMR) and reported on the case again, then again becoming involved in the case with a flurry of personal lawsuits between himself and Dr. Wakefield, then, after the case is settled, comes out with NEW information, that a six year trial in the GMC could not turn up, and prints it as a "journalist".
Then he can ask himself why the BMJ is not chastising him for stealing childrens medical records but actually publishing this? And ask them why they have removed calls from their web site from physicians and parents enraged that he stole childrens medical records and is claiming to publish the information (which again... can't be confirmed by outside sources because it supposedly comes from private medical records of minor children). And he can ask why, instead they actually published this instead of calling for a legal investigation on how Deer got the records he claims to have.
Then he should ask his own community why they are not investigating Brian Deer and why they are not horrified that the guy who brought the charges against Wakefield is posing as a "journalist" and stealing childrens medical records, instead carrying this garbage as if it is the gospel truth.
Then he can look into just who else was involved in the Deer investigation and check out the Pharma research group that "assisted" Deer in his "investigation".
And from there he can research actual vaccine/autism research and see that throwing out this study and saying that the vaccine/autism theory should be thrown out is like carving a pot hole in I-95 and saying the highway from Maine to Florida should be shut down. It is a 13 year old study, what it taught us about autism and vaccines has been at least replicated and at most adopted as standard practice from the medical profession at the behest of the CDC no less.
I have been writing about vaccine autism causation for five years, I never even read the Wakefield paper until last year, in more than a thousand posts I think I have done a few about Wakefield, but not many, and I have never even included this study. I think that the list of studies I point to is in the mid forties at this point. Encourage Chip to check it for himself: No Evidence of Any Link
Vaccine autism causation did not start with Wakefield, it started half a century earlier when Leo Kanner wrote the first paper about this new syndrome that he discovered that would be called "autism" when he noted that one of the first 11 cases ever defined was a regression following a smallpox vaccine. CBS found that our government had been paying autism cases from the Vaccine Injury Compensation Program as early as 1991, long before Wakefield ever laid eyes on a patient with autism. This whole thing is a pharma marketing campaign and Chip is unfortunately becoming a willing sucker.
Oh... and my child regressed into autism after his vaccines AND HE NEVER GOT THE MMR.
Saying that this study shuts down vaccine autism causation is like saying that the one study on the dangers of drunk driving is flawed so everyone can go ahead and crank up the party bus!
Please send him this.