Autism One Radio Schedule Dec 12 - 16 Influenza Vaccine & Bird Flu Dec 13
A Worldwide, Web-Based Radio Station for the Care, Treatment, and Recovery
of Children with Autism
http://www.autismone.org/radio
Monday, December 12th:
11:00 am - 11:30 ET Laura Cellini: Parent Activist
Tuesday, December 13th:
10:30 am - 11:30 ET Teri Small: Autism: Help, Hope, and Healing Guest:
Susan Owens, a member of the Defeat Autism Now! Think-Tank will discuss how
the sulfur system works, as well as the low oxalate diet.
Special: Part 1 of 2
12:00 pm - 1:00 ET Betsy Hicks: Path to Wellness Topic: Influenza
vaccine and Bird Flu issues. Guests: Dr. David Ayoub, Christina Blakey,
Anne Dachel, and Dr. Kenneth Stoller.
1:30 pm - 2:00 ET Chantal Sicile-Kira: The Real World of Autism with
Chantal Topic: "Growing up to be a successful adult with autism" Guest:
Judith H. Cohen, PhD, author of Succeeding with Autism: Hear my Voice.
Judith, a Professor of Education and attorney, tells the story of one of her
students, Michael, in the teacher education program she coordinated at
Adelphi University. Michael has autism, and Judith describes how he got to
the point of taking part in the teacher ed program, the strategies that
helped him, and where he is now. On Dec 20, Michael will be Chantal's
guest.
Wednesday, December 14th:
9:55 am - 10:25 ET Peta Cohen, MS, RD: Nutritional Approaches to
Treating Autism
11:30 am - 12:00 ET Seth D. Pearl, DC, CCN, CNS: The Health and
Wellness Hour with Dr. Seth Pearl Guest: Rebbecca Laber, OTR/L from Optimal
Kids. Topic: Eclectic approaches in occupational therapy for children with
special needs.
Thursday, December 15th:
1:00 pm - 1:45 ET Mary Coyle, D.I. Hom: Discussions on Bioenergetic
Therapies - A New Revolution in Healing. Topic: Discussions on the
Importance of Bioenergetic Protocol. Guest Anne Robertson and Mary discuss
many different bioenergetic therapies and the order to prioritize those,
especially prior to bio-chemical interventions.
Friday, December 16th:
1:00 pm - 1:30 ET Lisa Ackerman: Coffee Talk with Lisa Ackerman
2:00 pm - 2:30 ET Amy Lansky: There's Hope with Homeopathy
8:00 pm - 8:30 ET Valerie Herskowitz, MA CCC-SLP: Embracing the
Journey. Guest: Karen Simmons, founder of Autism TodayC. Karen is the author
of four books, including Little Rainman: Autism Through the Eyes of a Child
and Surrounded by Miracles, and is a co-author of an upcoming Chicken Soup
for Special Needs Community book. www.AutismToday.com.
December 10, 2005
Parents Want to Know About Every Pediatrician Error
(Hat tip: Schafer)
Parents Want to Know About Every Pediatrician Error
Same survey found they would be less likely to sue if told first.
By Amanda Gardner
ABC News
MONDAY, Dec. 5 (HealthDay News) — American parents want to know about medical errors involving their children, no matter how harmless or severe the mistake, new research suggests.
Parents also claim to be less likely to sue if they are told openly and honestly about an error, according to a study appearing in the December issue of Pediatrics.
"This is a very important study. Things aren't necessarily as well-studied in children as in adults, and our natural tendency is to assume that everything from adults applies to children, and that's not always true," said Dr. Marlene R. Miller, director of Quality and Safety Initiatives and an associate professor of pediatrics at Johns Hopkins Children's Center. "Among adults, we want more disclosure with more severe things. But parents of a small, vulnerable child want to know everything, regardless of the severity. That's a very key difference."
Medical errors have been a focus of attention lately, with a recent Institute of Medicine report estimating they are responsible for 100,000 deaths a year in the United States. According to the authors of this study, 42 percent of Americans say they have been affected by a medical error either personally or through a friend or relative.
Most of the information, however, applies to adults. Studies have shown that adults' desire to be informed of a medical error increases with the error's severity. It's been unclear whether parents felt the same way about errors affecting their children.
In this latest study, 499 parents of children presenting at a hospital emergency room answered a questionnaire outlining several different error scenarios. Participants were asked to rate the severity of the mistake, express preferences for disclosure and reporting, and to state how they expected to respond with or without that disclosure.
Virtually all (99 percent) of the parents wanted to be told of a mistake, while 39 percent wanted the error reported to a disciplinary body and 36 percent said they were less likely to pursue legal action if the error was disclosed by the doctor.
The finding that people were less likely to see legal recourse if the error was disclosed echoes previous studies in adults. "It's not so much the error that people get upset about —it's the anger at not being told," Miller said. "People can understand that medicine isn't black and white, that it's an art."
The desire to be told of a mistake did not differ by race/ethnicity, gender, age or insurance. However, the desire for an error to be reported to a disciplinary body increased with the severity of the error.
The challenge is how to integrate this information into the medical system. "We rarely teach how to disclose," Miller said. "Any time you advocate a big change in behavior or practice, you probably need some training, what is appropriate, how do we do it, when do we do it. It's not as simple as it sounds."
A second study in the same issue of the journal found that using a preprinted, structured order form for medications significantly reduced medication errors among children in the emergency department.
The study authors had previously found that 10 percent of children who went to a pediatric emergency department experienced medication errors.
On different days, physicians were asked to use either regular, blank order sheets for prescriptions or the preprinted, formatted sheets. Drug errors were identified in 17 percent of the regular forms, and only 10 percent of the preprinted forms.
"This is a breath of air that, if you're an institution that can't afford computerized order entry, there are some very simple pen-and-paper solutions. If you have the right culture around the pen and paper, it's easy to do," Miller said.
A third study in the journal found that expensive computerized systems are not always the panacea they are held up to be, Miller pointed out. In fact, it found an increase in mortality after a computer order entry system was installed. Among 1,942 children admitted to a hospital for specialized care during the study period, the mortality rate went from 2.8 percent before the computer system was installed to 6.57 percent after the system was up and running.
The preprinted order forms, however, only addressed the prescribing phase of giving a medication, not the dispensing phase or administration phase. "The bulk of errors actually occur at administration, but it's a nice breath of air because some pen-and-paper, simple things that cost a couple of cents can work," Miller said.
Visit the National Patient Safety Foundation for more on medical mistakes.
Parents Want to Know About Every Pediatrician Error
Same survey found they would be less likely to sue if told first.
By Amanda Gardner
ABC News
MONDAY, Dec. 5 (HealthDay News) — American parents want to know about medical errors involving their children, no matter how harmless or severe the mistake, new research suggests.
Parents also claim to be less likely to sue if they are told openly and honestly about an error, according to a study appearing in the December issue of Pediatrics.
"This is a very important study. Things aren't necessarily as well-studied in children as in adults, and our natural tendency is to assume that everything from adults applies to children, and that's not always true," said Dr. Marlene R. Miller, director of Quality and Safety Initiatives and an associate professor of pediatrics at Johns Hopkins Children's Center. "Among adults, we want more disclosure with more severe things. But parents of a small, vulnerable child want to know everything, regardless of the severity. That's a very key difference."
Medical errors have been a focus of attention lately, with a recent Institute of Medicine report estimating they are responsible for 100,000 deaths a year in the United States. According to the authors of this study, 42 percent of Americans say they have been affected by a medical error either personally or through a friend or relative.
Most of the information, however, applies to adults. Studies have shown that adults' desire to be informed of a medical error increases with the error's severity. It's been unclear whether parents felt the same way about errors affecting their children.
In this latest study, 499 parents of children presenting at a hospital emergency room answered a questionnaire outlining several different error scenarios. Participants were asked to rate the severity of the mistake, express preferences for disclosure and reporting, and to state how they expected to respond with or without that disclosure.
Virtually all (99 percent) of the parents wanted to be told of a mistake, while 39 percent wanted the error reported to a disciplinary body and 36 percent said they were less likely to pursue legal action if the error was disclosed by the doctor.
The finding that people were less likely to see legal recourse if the error was disclosed echoes previous studies in adults. "It's not so much the error that people get upset about —it's the anger at not being told," Miller said. "People can understand that medicine isn't black and white, that it's an art."
The desire to be told of a mistake did not differ by race/ethnicity, gender, age or insurance. However, the desire for an error to be reported to a disciplinary body increased with the severity of the error.
The challenge is how to integrate this information into the medical system. "We rarely teach how to disclose," Miller said. "Any time you advocate a big change in behavior or practice, you probably need some training, what is appropriate, how do we do it, when do we do it. It's not as simple as it sounds."
A second study in the same issue of the journal found that using a preprinted, structured order form for medications significantly reduced medication errors among children in the emergency department.
The study authors had previously found that 10 percent of children who went to a pediatric emergency department experienced medication errors.
On different days, physicians were asked to use either regular, blank order sheets for prescriptions or the preprinted, formatted sheets. Drug errors were identified in 17 percent of the regular forms, and only 10 percent of the preprinted forms.
"This is a breath of air that, if you're an institution that can't afford computerized order entry, there are some very simple pen-and-paper solutions. If you have the right culture around the pen and paper, it's easy to do," Miller said.
A third study in the journal found that expensive computerized systems are not always the panacea they are held up to be, Miller pointed out. In fact, it found an increase in mortality after a computer order entry system was installed. Among 1,942 children admitted to a hospital for specialized care during the study period, the mortality rate went from 2.8 percent before the computer system was installed to 6.57 percent after the system was up and running.
The preprinted order forms, however, only addressed the prescribing phase of giving a medication, not the dispensing phase or administration phase. "The bulk of errors actually occur at administration, but it's a nice breath of air because some pen-and-paper, simple things that cost a couple of cents can work," Miller said.
Visit the National Patient Safety Foundation for more on medical mistakes.
Louis Conte is Really Angry With Dr. Sanghavi
He sent this to me:
UPDATE: Mark Blaxil and Teresa Conrick are angry with Dr. Sanghavi too:
A Modest Proposal: Plutonium in Vaccines Now! Mercury is for wimps!
It occurred to me tonight that I should say something about Dr. Darshak Sanghavi's“Secret Truth” story (or propaganda piece) as I mixed the juice supplement cocktail that I prepare for my two autistic sons every day. I usually do not have time for creative writing as trying to recover two of my triplet sons from autism is kind of a full time job.
I have been a little worried that some members of the “mainstream” medical establishment were perhaps insensitive to our concerns about mercury in vaccines having played a role in the autism epidemic. I was a little worried that perhaps I was misunderstanding these people. I was a little worried that maybe I was short changing their genuine human concern for their patients. I was worried that perhaps, just maybe, I was casting them as monsters when they really were not.
Well, I can stop worrying now.
Dr. Sanghavi’s piece in the Boston Globe was one of the most offensive pieces of writing that I have ever seen in my adult life. This doctor visited a Utah family trying to recover their two children from autism and described them as much humanity as one might describe livestock. These parents related how their children had descended into autism after vaccination. Dr. Sanghavi noted that these parents were just falling prey to the erroneous causal connection” between vaccination and regressive autism. Sanghavi expressed that he found their efforts at treatment sort of useless and made no connection between the treatments and the improvements the children seemed to make. However, he stated his that he liked them and that he though they were “well intentioned.”
Dr. Sanghavi seemed to indicate that these parents were desperate fools and that their doctors (you know those people) were “quacks.”
Nice guy.
However, I did not fully understand this doctor’s real purpose until later in the propaganda. It seems he has possession of “secret knowledge” that the rest of us “herd animals” – Dr. Sanghavi means that expression quite literally – do not have. The “secret knowledge” is this: Our children were poisoned with mercury vaccines for decades because the principles of the public health establishment required it. The personal rights and health of our children meant nothing. The “secret” is that individual liberty means nothing. Personal freedom, it seems to Dr. Sanghavi , is “a dangerous thing.” The reason that childhood vaccines are required by public health officials is because of the concept of “herd immunity.” According to Dr. Sanghavi, we are simply a “herd.” If a few members of the herd get sick from vaccines, well that is just good public health policy.
That is Dr. Sanghavi ’s “secret truth.” Charming fellow.
With the gentle spirit of Dr. Sanghavi in mind, I now call on the ghost of Jonathan Swift and make the following Modest Proposal regarding vaccinating American children.
Take out all the mercury and aluminum now. The new vaccine preservative dujuor shall be plutonium.
Mercury is for wimps anyway.
Why go with the second most deadly substance on earth, when you can inject human infants and toddlers with the most deadly substance on earth? I will “bet the house” that plutonium kills bacteria way better than that old mercury based thimerisol ever could. Why make them autistic when you can make them glow?
I bet that a little radioactivity will kick the pants off measles or hepatitis.
What is that you say? We haven’t done any safety trials with plutonium? We didn’t do it with mercury either and Eli Lilly and those other companies got away with it. Besides, we will just tell people that “there is no direct link.” We will just tell people who report that their kids got sick after vaccines that it was all “just an erroneous causal connection.” We will just tell parents with suddenly radioactive kids that the symptoms just look like radiation sickness but are really some obscure genetic disorder that is suddenly on the rise. Or, we could say that there is no epidemic and that there were radioactive people laying around for centuries and no one ever thought to notice them. Then we will tell these parents that we do not know why their kids are sick. We will not spend one dime on researching medical interventions. We could just try blaming their mothers (everyone blames their mothers for their problems anyway) or their parenting styles. We could spread fear about decontamination treatments so that these kids could stay sick and so that their parents could stay hopeless because we would not want the cause of the disorder to ever be revealed. We could say there is no “evidence of harm.”
We could ridicule those who ask questions we do not like. We could label their research “junk science” and we could label them as “anti-vaccine nuts.” We could try wrecking the careers and reputations of those heroic enough to voice objection.
We could just poison an entire generation. We could just saddle society with a burden that will last decades and that will cost billions. Our political allies will cover our tracks with special protection legislation because we have paid them to do so.
Then, we will just walk away and hide safely behind our “secret truth.”
Do you think doing that would make us monsters?
UPDATE: Mark Blaxil and Teresa Conrick are angry with Dr. Sanghavi too:
Dear Dr. Sanghavi,
I just read your article, "The Secret Truth" in today's Boston Globe magazine. It is one of the most brazen pieces of propaganda yet written on the autism crisis. You were at least respectful of the Hansens. In all other respects, your essay was little more than propaganda for the National Immunization Program and more suited for a totalitarian dictatorship than America. I hope many people read it and think critically about the implications of your argument. More than ever, American citizens need to stand for an open society and against the coercive powers of the state. Your words should trouble us all.
You accuse parents of committing "classic errors." In turn, we would submit that many of our leading institutions are committing historic errors of medical negligence. You confuse the promotion and preservation of highly experimental (indeed radically interventionist) immunization strategies with the larger responsibility for the public health. In that confusion, you along with many of your colleagues are posing the wrong question. You want us all to be reassured about the safety of vaccines. As responsible parents and educated consumers of the policies and science that concern our families, we welcome safe health products and policies. But our interest is not to maximize our compliance or our consumption. Rather, our concern is the health of our children. And we find ourselves astonished that none of you are interested in asking the question that matters most.
Why are so many children sick?
The epidemic of autism and other neurological disorders is a crisis in our state and our country. The theory that these reported increases are somehow an artifact of a broader diagnostic concept and increased awareness is a spectacular yet testable hypothesis. You profess an admiration for Karl Popper; so am I (and as a Popper admirer, I question how much you really know about his philosophy). In any event, you might be interested to know that the "no epidemic" hypothesis has been tested and falsified at every turn. If you doubt this, I would be happy to educate you on the facts and the science of the issue.
I suggest to you that unless you begin with this question, you have little right to opine on any of the environmental hypotheses related to autism. You certainly cannot expect a rational person to support giving mercury, a known and potent neurotoxin, to infants in any form.
You resort to a number of transparent rhetorical devices. You demonize those who question the established order as dangerous and "anti-vaccine." That is incorrect. Autism parents generally support safe vaccination strategies. You resort to hysterical claims that immunization programs have almost been "derailed" in America. That is also incorrect. Vaccine compliance has never been higher. You claim a scientific consensus. That is an Orwellian assertion. The only consensus is among those who are uniformed or somehow interested by virtue of their scientific and/or medical specialty. A wide group of concerned scientists have deep concerns over the autism epidemic and its many potential environmental causes, but most of them have been cowed into silence by the brand of institutional intimidation of which your article is a prime example.
You say, "personal freedom is a dangerous thing." I submit to you that the unchecked power of government is a far greater danger. Our Founding Fathers knew it. Our entire Constitution and civic culture is based on principles of limited government power. Yet today, these principles are under attack as never before: we go to war based on lies; we consume medical products based on tainted research; we have seen the integration of science and commerce on an unprecedented scale and then we bemoan the loss of confidence in scientific institutions that results. In the meantime, we stand by as we raise the sickest generation of children in our lifetime while our public health leadership refuses to face the reality of their suffering and lost potential. It is a bad time to be a parent in America.
Sincerely,
Mark F. Blaxill
Vice President, SafeMinds
Cambridge MA
Your coverage of vaccines and autism on 12/04/05, "The Secret Truth", was very disappointing. While it is important to discuss vaccines, especially with the increasing media coverage on a possible pandemic, this was a one-sided infomercial.
What I found interesting was the focus on autism research, and the attempt to paint the picture of anti-vaccine parents. What really seemed apparent, was a doctor trying desperately to ignore facts, research and data, especially on thimerosal. Instead the article gave the impression that Dr. Sanghavi was pro-unsafe vaccines, which is actually frightening.
What was also odd, was that Dr. Sanghavi had a very good article in your paper on May 25,2004 ("Lead may be even more dangerous than we thought"). He detailed his thoughts on exposure, discussed the politics and medical controversies, and emphasized how public pressure was instrumental in halting exposure of lead from the paint and gasoline industries. It was clear he thought lead to be a potent neurotoxin.
Public pressure is now vocalizing the need for safe vaccines. Like the families who were outraged about toxic lead, todays families are letting it be known that they expect what is injected into their children is safe. Thimerosal is 50% mercury, and investigating its role in autism does not make anyone anti-vaccine. If it were in a gallon of paint rather than a shot, Dr. Sanghavi would be condemning it. But because it is in the sacred, herd immunity vaccines, he is singing its praises.
Sincerely,
Teresa Conrick
Chicago
December 9, 2005
Used Gaming Systems Wanted
From Autism Cares:
‘Tis the season….To help a child with autism affected by the hurricanes!
Has your child asked for the newest Xbox, PSP, Gameboy or other video gaming system for Christmas? What will you do with the old one? We have a solution for you that will keep your closets uncluttered, and you can help a child in need!
After the presents have all been unwrapped, assembled, installed and the kids are playing, please pack up their old video game systems and any old games and send them to us! We will send them to children with autism who lost theirs in the hurricanes.
To participate, please email us at games4autismcares@adelphia.net and we’ll send you shipping instructions.
Have a Happy Holiday and remember us when the old system gets unplugged!
Sincerely,
Holly Bortfeld
AutismCares Care Package Coordinator
800-960-1844
http://www.autismcares.org
AutismCares is a coalition of National Autism Organizations who have come together to help families dealing with autism who are victims of the Gulf Region Hurricanes.
Please forward to everyone!
‘Tis the season….To help a child with autism affected by the hurricanes!
Has your child asked for the newest Xbox, PSP, Gameboy or other video gaming system for Christmas? What will you do with the old one? We have a solution for you that will keep your closets uncluttered, and you can help a child in need!
After the presents have all been unwrapped, assembled, installed and the kids are playing, please pack up their old video game systems and any old games and send them to us! We will send them to children with autism who lost theirs in the hurricanes.
To participate, please email us at games4autismcares@adelphia.net and we’ll send you shipping instructions.
Have a Happy Holiday and remember us when the old system gets unplugged!
Sincerely,
Holly Bortfeld
AutismCares Care Package Coordinator
800-960-1844
http://www.autismcares.org
AutismCares is a coalition of National Autism Organizations who have come together to help families dealing with autism who are victims of the Gulf Region Hurricanes.
Please forward to everyone!
Patients Are Playing Doctor on the Web
Patients Are Playing Doctor on the Web. It is a Whole New Game for Pharma.
Nov 22, 2005
By: Alana Klein
PharmExec Direct
Consult your doctor? Make that: Consult your fellow patients. On a growing number of Weblogs—interactive Web sites better known as blogs—patients are advising one another about which medications to take and which to avoid. These self-styled experts may not have medical degrees, but they do wield growing influence among pharma’s end customers, not least because they talk frankly about the experience of using medications.
“Anecdotal evidence is underappreciated by the medical community, but patients really value it,” says Jerod Poore, who calls himself the “Chief Spazz” of CrazyMeds.org, a quirky blog dedicated to patients with neurological disorders. Poore, who says he is bipolar, epileptic, and autistic, created the site when he became frustrated with the information otherwise available.
“Product information sheets are incomprehensible,” he says. “Drug [company] Web sites are full of propaganda, and online support groups do little more than give you a gentle hug and tell you everything is going to be okay.”
CrazyMeds draws 5,000 to 6,000 visitors a day. It chronicles the pros and cons of drugs from a user perspective and, in Poore’s words, shares with fellow patients the “interesting stuff your doctor probably won’t tell you” about hundreds of drugs.
While patients use blogs for many purposes— to connect with other patients and trade information about treatments—most use the site to get information on a particular medication. Consequently, the drug guides get the most hits. In November, the top five most widely discussed medications were Topamax (topiramate), Lamictal (lamotrigine), Cymbalta (duloxetine), Seroquel (quetiapine) and Wellbutrin (bupropion). Holly Russell, a spokesperson from GlaxoSmithKline, says that her company has yet to form an opinion on blogs because they are still so new. Other companies manufacturing these medications declined to comment on how blogs impact their marketing strategies.
Some industry observers suggest that pharma should monitor blogs like CrazyMeds, since they reveal how consumers perceive their brands. “We are just beginning to understand how to tap into these blogs since they are a new phenomenon,” says Cathy Clift, chief planning officer for Rapp Collins Worldwide, a direct marketing agency.
“By understanding the psychological aspects of a disease, pharma can work towards making a better product,” says Debrianna Obara, vice president and director of media for Avenue A Razorfish, an interactive marketing firm.
But Poore’s intention is to help patients, not pharma. “I see CrazyMeds as another form of DTC,” he says. “The difference is that I try to provide patients with the good, the bad, and the funny of meds. Then, I let them make their own decisions.”
Nov 22, 2005
By: Alana Klein
PharmExec Direct
Consult your doctor? Make that: Consult your fellow patients. On a growing number of Weblogs—interactive Web sites better known as blogs—patients are advising one another about which medications to take and which to avoid. These self-styled experts may not have medical degrees, but they do wield growing influence among pharma’s end customers, not least because they talk frankly about the experience of using medications.
“Anecdotal evidence is underappreciated by the medical community, but patients really value it,” says Jerod Poore, who calls himself the “Chief Spazz” of CrazyMeds.org, a quirky blog dedicated to patients with neurological disorders. Poore, who says he is bipolar, epileptic, and autistic, created the site when he became frustrated with the information otherwise available.
“Product information sheets are incomprehensible,” he says. “Drug [company] Web sites are full of propaganda, and online support groups do little more than give you a gentle hug and tell you everything is going to be okay.”
CrazyMeds draws 5,000 to 6,000 visitors a day. It chronicles the pros and cons of drugs from a user perspective and, in Poore’s words, shares with fellow patients the “interesting stuff your doctor probably won’t tell you” about hundreds of drugs.
While patients use blogs for many purposes— to connect with other patients and trade information about treatments—most use the site to get information on a particular medication. Consequently, the drug guides get the most hits. In November, the top five most widely discussed medications were Topamax (topiramate), Lamictal (lamotrigine), Cymbalta (duloxetine), Seroquel (quetiapine) and Wellbutrin (bupropion). Holly Russell, a spokesperson from GlaxoSmithKline, says that her company has yet to form an opinion on blogs because they are still so new. Other companies manufacturing these medications declined to comment on how blogs impact their marketing strategies.
Some industry observers suggest that pharma should monitor blogs like CrazyMeds, since they reveal how consumers perceive their brands. “We are just beginning to understand how to tap into these blogs since they are a new phenomenon,” says Cathy Clift, chief planning officer for Rapp Collins Worldwide, a direct marketing agency.
“By understanding the psychological aspects of a disease, pharma can work towards making a better product,” says Debrianna Obara, vice president and director of media for Avenue A Razorfish, an interactive marketing firm.
But Poore’s intention is to help patients, not pharma. “I see CrazyMeds as another form of DTC,” he says. “The difference is that I try to provide patients with the good, the bad, and the funny of meds. Then, I let them make their own decisions.”
NIH: Aspartame Gives Rats Cancer
http://ehp.niehs.nih.gov/docs/2005/8711/abstract.pdf
Environmental Health Perspectives
First Experimental Demonstration of theMultipotential Carcinogenic Effects of AspartameAdministered in the Feed to Sprague-Dawley Rats
Morando Soffritti, Fiorella Belpoggi, Davide Degli Esposti,Luca Lambertini, Eva Tibaldi, and Anna Riganodoi:10.1289/ehp.8711 (available at http://dx.doi.org/)
Online 17 November 2005
Running title: Aspartame carcinogenicity
Article descriptor: Carcinogenesis
Key words: aspartame, artificial sweetener, carcinogenicity, rats, lymphomas, renal pelvis carcinomas, malignant schwannomas
Acknowledgements: A special thanks to the US National Toxicology Program (NTP) for convening a group of pathologists at NIEHS in order to provide a second opinion for a set of lesions of malignancies and their precursors related to the APM treatment, and for the help in statistical analysis. A special thanks also to all the staff who were involved in the project. This research was entirely supported by European Ramazzini Foundation of Oncology and Environmental Sciences, Bologna, Italy. Authors do not havecompeting financial interests in relation to the submitted article.
ABSTRACT
The Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation has conducted a long-term bioassay on aspartame (APM), a widely used artificial sweetener. APM was administered with feed to 8 week-old Sprague-Dawley rats (100-150/sex/group), at concentrations of 100,000; 50,000; 10,000; 2,000; 400; 80 or 0 ppm.
The treatment lasted until natural death, at which time all deceased animals underwent complete necropsy. Histopathological evaluation of all pathological lesions and of all organs and tissues collected was routinely performed on each animal of all experimental groups.
The results of the study show for the first time that APM, in our experimental conditions, causes:
1) an increased incidence of malignant tumor-bearing animals with a positive significant trend in males (p0.05) and in females (p0.01), in particular those females treated at 50,000 ppm (p0.01);
2) an increase in lymphomas and leukemias with a positive significant trend in both males (p0.05) and females (p0.01), in particular in females treated at doses of 100,000 (p0.01), 50,000 (p0.01), 10,000 (p0.05), 2,000 (p0.05), 400 (p0.01) ppm;
3) a statistically significant increased incidence, with a positive significant trend (p0.01) of transitional cell carcinomas of the renal pelvis and ureter and their precursors (dysplasias) in females treated at 100,000 (p0.01), 50,000 (p0.01), 10,000(p0.01), 2,000 (p0.05) and 400 ppm (p0.05); and
4) an increased incidence of malignant schwannomas of peripheral nerves with a positive trend (p 0.05) in males.
The results of this mega-experiment indicate that APM is a multipotential carcinogenic agent, even at a daily dose of 20 mg/kg b.w., much less than the current acceptable daily intake (ADI). On the basis of these results, a re-evaluation of the present guidelines on the use and consumption of APM is urgent and cannot be delayed.
Environmental Health Perspectives
First Experimental Demonstration of theMultipotential Carcinogenic Effects of AspartameAdministered in the Feed to Sprague-Dawley Rats
Morando Soffritti, Fiorella Belpoggi, Davide Degli Esposti,Luca Lambertini, Eva Tibaldi, and Anna Riganodoi:10.1289/ehp.8711 (available at http://dx.doi.org/)
Online 17 November 2005
Running title: Aspartame carcinogenicity
Article descriptor: Carcinogenesis
Key words: aspartame, artificial sweetener, carcinogenicity, rats, lymphomas, renal pelvis carcinomas, malignant schwannomas
Acknowledgements: A special thanks to the US National Toxicology Program (NTP) for convening a group of pathologists at NIEHS in order to provide a second opinion for a set of lesions of malignancies and their precursors related to the APM treatment, and for the help in statistical analysis. A special thanks also to all the staff who were involved in the project. This research was entirely supported by European Ramazzini Foundation of Oncology and Environmental Sciences, Bologna, Italy. Authors do not havecompeting financial interests in relation to the submitted article.
ABSTRACT
The Cesare Maltoni Cancer Research Center of the European Ramazzini Foundation has conducted a long-term bioassay on aspartame (APM), a widely used artificial sweetener. APM was administered with feed to 8 week-old Sprague-Dawley rats (100-150/sex/group), at concentrations of 100,000; 50,000; 10,000; 2,000; 400; 80 or 0 ppm.
The treatment lasted until natural death, at which time all deceased animals underwent complete necropsy. Histopathological evaluation of all pathological lesions and of all organs and tissues collected was routinely performed on each animal of all experimental groups.
The results of the study show for the first time that APM, in our experimental conditions, causes:
1) an increased incidence of malignant tumor-bearing animals with a positive significant trend in males (p0.05) and in females (p0.01), in particular those females treated at 50,000 ppm (p0.01);
2) an increase in lymphomas and leukemias with a positive significant trend in both males (p0.05) and females (p0.01), in particular in females treated at doses of 100,000 (p0.01), 50,000 (p0.01), 10,000 (p0.05), 2,000 (p0.05), 400 (p0.01) ppm;
3) a statistically significant increased incidence, with a positive significant trend (p0.01) of transitional cell carcinomas of the renal pelvis and ureter and their precursors (dysplasias) in females treated at 100,000 (p0.01), 50,000 (p0.01), 10,000(p0.01), 2,000 (p0.05) and 400 ppm (p0.05); and
4) an increased incidence of malignant schwannomas of peripheral nerves with a positive trend (p 0.05) in males.
The results of this mega-experiment indicate that APM is a multipotential carcinogenic agent, even at a daily dose of 20 mg/kg b.w., much less than the current acceptable daily intake (ADI). On the basis of these results, a re-evaluation of the present guidelines on the use and consumption of APM is urgent and cannot be delayed.
New Online Interview: Dr. Thomas Burbacher
From FAIR:
FAIR Autism Media has just posted one of our most recent interviews, featuring Dr.
Thomas Burbacher of the University of Washington.
In this interview, Dr. Burbacher discusses his study that examined the differences in
distribution between methylmercury and ethylmercury (from thimerosal) exposures in the brains of infant primates.
The interview is at http://www.autismmedia.org/media2.html
Enjoy,
Erik Nanstiel
Administrative Director,
Foundation for Autism Information & Research, Inc.
a 501(c)(3) organization
http://www.autismmedia.org/
3rd Annual Long Island Autism Fair & Conference
Event: 3rd Annual Long Island Autism Fair & Conference
Date: Saturday & Sunday, April 1st & 2nd, 2006
Place: Sports Plus, Lake Grove, NY (near Stony Brook)
Time: 8:30am-6:30pm
Website: http://www.autismfair.com
"Effective Teaching: Where Science Meets Common Sense"
"Handwriting Without Tears"
"Work Smart; Understanding Social Security Disabilitiy Benefits & Utilization of Work Incentives"
"Enzyme Replacement Nutrition"
"The Verbal Behavior approach to teaching children with autism"
"Multifactorial Causes of Autism - A Biomedical Perspective"
"Sensory Integration"
"Common Treatment Mistakes"
"Food Allergies & Testing"
"Common Gastrointestinal Problems in Children with ASD"
"How to start the GF/CF Diet"
"Introduction to Autism for First Responders"
Also performing both days is musician Mark Leland from Louisiana singing "Missing Pieces". http://www.markleland.net
We will have room for about 70 Vendor Tables throughout the building. All vendors must fill out the application on our website and be approved. More information can be found here: http://www.autismfair.com/vendors.php
Ticket information: http://www.autismfair.com/ticketorder.php Our online store will be up and running next week. Right now it's set up with all the prices and details. We'll be able to take credit card orders in a few days.
Various Sponsorships are also available and can be found at http://www.autismfair.com/sponsorinfo.php
The deadline for program advertisements is Feb 20th, 2006. We offer many different size ads to fit any budget. http://www.autismfair.com/program.php
Our General Information Tables are free to anyone who services the autism community. We will make 3-4 tables available for brochures, catalogs, flyers, business cards, etc. These tables are accessible to all participants and are a great way to share information. Please email Liz at cfiordalisi@netzero.com if you are interested in sending materials.
Look for our upcoming ads in TAP magazine http://www.theautismperspective.org/
and Mothering Magazine http://www.mothering.com
Sincerely,
The LIAF&C Planning Committee
PO Box 662 Stony Brook, NY 11790
http://www.autismfair.com
Christine Zichittella-Heeren
LIAF&C Coordinator
christine@autismfair.com
631-245-0293
"bringing the autism community together"
Date: Saturday & Sunday, April 1st & 2nd, 2006
Place: Sports Plus, Lake Grove, NY (near Stony Brook)
Time: 8:30am-6:30pm
Website: http://www.autismfair.com
"Effective Teaching: Where Science Meets Common Sense"
"Handwriting Without Tears"
"Work Smart; Understanding Social Security Disabilitiy Benefits & Utilization of Work Incentives"
"Enzyme Replacement Nutrition"
"The Verbal Behavior approach to teaching children with autism"
"Multifactorial Causes of Autism - A Biomedical Perspective"
"Sensory Integration"
"Common Treatment Mistakes"
"Food Allergies & Testing"
"Common Gastrointestinal Problems in Children with ASD"
"How to start the GF/CF Diet"
"Introduction to Autism for First Responders"
Also performing both days is musician Mark Leland from Louisiana singing "Missing Pieces". http://www.markleland.net
We will have room for about 70 Vendor Tables throughout the building. All vendors must fill out the application on our website and be approved. More information can be found here: http://www.autismfair.com/vendors.php
Ticket information: http://www.autismfair.com/ticketorder.php Our online store will be up and running next week. Right now it's set up with all the prices and details. We'll be able to take credit card orders in a few days.
Various Sponsorships are also available and can be found at http://www.autismfair.com/sponsorinfo.php
The deadline for program advertisements is Feb 20th, 2006. We offer many different size ads to fit any budget. http://www.autismfair.com/program.php
Our General Information Tables are free to anyone who services the autism community. We will make 3-4 tables available for brochures, catalogs, flyers, business cards, etc. These tables are accessible to all participants and are a great way to share information. Please email Liz at cfiordalisi@netzero.com if you are interested in sending materials.
Look for our upcoming ads in TAP magazine http://www.theautismperspective.org/
and Mothering Magazine http://www.mothering.com
Sincerely,
The LIAF&C Planning Committee
PO Box 662 Stony Brook, NY 11790
http://www.autismfair.com
Christine Zichittella-Heeren
LIAF&C Coordinator
christine@autismfair.com
631-245-0293
"bringing the autism community together"
Are U.S. Health Experts Inflating Flu Statistics?
Are U.S. Health Experts Inflating Flu Statistics?
By Ed Edelson
HealthDay Reporter
FRIDAY, Dec. 9 (HealthDay News) -- A Harvard grad student is charging that the U.S. government is hyping the threat of the annual (non-avian) strains of influenza. Specifically, Peter Doishi says, the estimate of 36,000 flu-related deaths a year by the Centers for Disease Control and Prevention is unsupported by the available data.
And, he suspects, the numbers may be inflated to help drug companies sell more flu vaccine.
It's a familiar charge -- a quick scan of the Internet turns up several Web sites claiming much the same thing -- and like many others who make the claim, Doshi is not a medical expert. He's a student in Harvard's department of East Asian studies.
But he presents his charges with one notable difference: They appear in the form of an article published in this week's issue of the prestigious British Medical Journal.
In his one-page article, Doshi lauded the BMJ's "system of open discussion and open debate through their on-line bulletin board ... a very democratic form of scientific discourse."
His criticism centers on a 2003 paper in the Journal of the American Medical Association in which CDC experts increased their estimate of flu-related deaths from 20,000 a year to 36,000 a year. The reasons the agency used to justify that rise are dubious at best, Doshi said.
For one thing, the National Center for Health Statistics lists only a few hundred deaths a year as directly caused by influenza, Doshi said. And the major explanation for the increased estimate -- the aging of the American population that puts more people in the highly vulnerable over-65 group -- doesn't hold water, he maintained.
"The 65-plus population grew just 12 percent between 1990 and 2000," Doshi wrote. How can the CDC justify an estimate of 36,000 U.S. deaths a year now when there were just 34,000 deaths recorded in the 1968-1969 "Hong Kong flu" epidemic? he asked.
But William W. Thompson, the CDC epidemiologist who was the lead author of the 2003 paper, said Doshi is missing the big picture.
The increase in older Americans has been substantial over the longer run -- up by 48 percent between 1976 and 1999, he said. The number of Americans in the most-vulnerable 85-and-older age group has doubled during that time, Thompson said.
That increase in the older population explains why more Americans die in an ordinary flu year nowadays than in the Hong Kong pandemic, he said. Most of them don't die directly of the flu, Thompson stressed. Instead, the immediate cause of death is often listed as pneumonia.
"Influenza is rarely reported on the death certificate, even though influenza is responsible for many deaths," Thompson said. "Pneumonia and influenza are grouped together because many pneumonias result from influenza. Influenza is listed as a secondary cause of death."
That is not how Doshi sees it. Instead, his article talks of a "public relations approach" linked to drug company profits. "CDC is already working in the manufacturers' interest by conducting campaigns to increase vaccinations," he wrote.
"I don't understand that argument," Thompson said. "We have used this method for the past 40 years, and we continue to use these estimates. We don't need drug manufacturers' approval or anything like it."
Thompson said the CDC's annual advice remains the same: "I think that people who are at high risk for flu- associated complications should get vaccinated."
Of the British Medical Journal, he said, "It surprises me that they would publish something like that without giving us a chance to reply."
Will there be a reply?
"We're considering it," Thompson said.
More information
Guidelines for the prevention and treatment of colds and the flu are available at the American Lung Association (www.lungusa.org ).
SOURCES: Peter Doshi, graduate student, Harvard University, Boston; William W. Thompson, Ph.D., epidemiologist, U.S. Centers for Disease Control and Prevention, Atlanta; Dec. 10, 2005, British Medical Journal
http://bmj.bmjjournals.com/cgi/content/full/331/7529/1412
Are US flu death figures more PR than science?
US data on influenza deaths are a mess. The Centers for Disease Control and Prevention (CDC) acknowledges a difference between flu death and flu associated death yet uses the terms interchangeably. Additionally, there are significant statistical incompatibilities between official estimates and national vital statistics data. Compounding these problems is a marketing of fear—a CDC communications strategy in which medical experts "predict dire outcomes" during flu seasons.
The CDC website states what has become commonly accepted and widely reported in the lay and scientific press: annually "about 36 000 [Americans] die from flu" (www.cdc.gov/flu/about/disease.htm) and "influenza/pneumonia" is the seventh leading cause of death in the United States (www.cdc.gov/nchs/fastats/lcod.htm). But why are flu and pneumonia bundled together? Is the relationship so strong or unique to warrant characterising them as a single cause of death?
David Rosenthal, director of Harvard University Health Services, said, "People don't necessarily die, per se, of the [flu] virus—the viraemia. What they die of is a secondary pneumonia. So many of these pneumonias are not viral pneumonias but secondary [pneumonias]." But Dr Rosenthal agreed that the flu/pneumonia relationship was not unique. For instance, a recent study (JAMA 2004;292: 1955-60[Abstract/Free Full Text]) found that stomach acid suppressing drugs are associated with a higher risk of community acquired pneumonia, but such drugs and pneumonia are not compiled as a single statistic.
CDC states that the historic 1968-9 "Hong Kong flu" pandemic killed 34 000 Americans. At the same time, CDC claims 36 000 Americans annually die from flu. What is going on?
Meanwhile, according to the CDC's National Center for Health Statistics (NCHS), "influenza and pneumonia" took 62 034 lives in 2001—61 777 of which were attributed to pneumonia and 257 to flu, and in only 18 cases was flu virus positively identified. Between 1979 and 2002, NCHS data show an average 1348 flu deaths per year (range 257 to 3006).
The NCHS data would be compatible with CDC mortality estimates if about half of the deaths classed by the NCHS as pneumonia were actually flu initiated secondary pneumonias. But the NCHS criteria indicate otherwise: "Cause-of-death statistics are based solely on the underlying cause of death... defined by WHO as `the disease or injury which initiated the train of events leading directly to death.'"
In a written statement, CDC media relations responded to the diverse statistics: "Typically, influenza causes death when the infection leads to severe medical complications." And as most such cases "are never tested for virus infection...CDC considers these [NCHS] figures to be a very substantial undercounting of the true number of deaths from influenza. Therefore, the CDC uses indirect modelling methods to estimate the number of deaths associated with influenza."
CDC's model calculated an average annual 36 155 deaths from influenza associated underlying respiratory and circulatory causes (JAMA 2003;289: 179-86[Abstract/Free Full Text]). Less than a quarter of these (8097) were described as flu or flu associated underlying pneumonia deaths. Thus the much publicised figure of 36 000 is not an estimate of yearly flu deaths, as widely reported in both the lay and scientific press, but an estimate—generated by a model—of flu-associated death.
William Thompson of the CDC's National Immunization Program (NIP), and lead author of the CDC's 2003 JAMA article, explained that "influenza-associated mortality" is "a statistical association between deaths and viral data available." He said that an association does not imply an underlying cause of death: "Based on modelling, we think it's associated. I don't know that we would say that it's the underlying cause of death."
Yet this stance is incompatible with the CDC assertion that the flu kills 36 000 people a year—a misrepresentation that is yet to be publicly corrected.
Before 2003 CDC said that 20 000 influenza-associated deaths occurred each year. The new figure of 36 000 reported in the January 2003 JAMA paper is an estimate of influenza-associated mortality over the 1990s. Keiji Fukuda, a flu researcher and a co-author of the paper, has been quoted as offering two possible causes for this 80% increase: "One is that the number of people older than 65 is growing larger...The second possible reason is the type of virus that predominated in the 1990s [was more virulent]."
However, the 65-plus population grew just 12% between 1990 and 2000. And if flu virus was truly more virulent over the 1990s, one would expect more deaths. But flu deaths recorded by the NCHS were on average 30% lower in the 1990s than the 1980s.
If passed, the Flu Protection Act of 2005 will revamp US flu vaccine policy. The legislation will require CDC to pay makers for vaccines unsold "through routine market mechanisms." The bill will also require CDC to conduct a "public awareness campaign" emphasising "the safety and benefit of recommended vaccines for the public good."
Yet this bill obscures the fact that CDC is already working in manufacturers' interest by conducting campaigns to increase flu vaccination. At the 2004 "National Influenza Vaccine Summit," co-sponsored by CDC and the American Medical Association, Glen Nowak, associate director for communications at the NIP, spoke on using the media to boost demand for the vaccine. One step of a "Seven-Step `Recipe' for Generating Interest in, and Demand for, Flu (or any other) Vaccination" occurs when "medical experts and public health authorities publicly...state concern and alarm (and predict dire outcomes)—and urge influenza vaccination" (www.ama-assn.org/ama1/pub/upload/mm/36/2004_flu_nowak.pdf). Another step entails "continued reports...that influenza is causing severe illness and/or affecting lots of people, helping foster the perception that many people are susceptible to a bad case of influenza."
Preceding the summit, demand had been low early into the 2003 flu season. "At that point, the manufacturers were telling us that they weren't receiving a lot of orders for vaccine for use in November or even December," recalled Dr Nowak on National Public Radio. "It really did look like we needed to do something to encourage people to get a flu shot."
If flu is in fact not a major cause of death, this public relations approach is surely exaggerated. Moreover, by arbitrarily linking flu with pneumonia, current data are statistically biased. Until corrected and until unbiased statistics are developed, the chances for sound discussion and public health policy are limited.
Peter Doshi, graduate student Harvard University pdoshi@fas.harvard.edu
Pregnant Women Warned By FDA to Avoid Paxil
Pregnant Women Warned By FDA to Avoid Paxil
By Marc Kaufman and Shankar Vedantam
Washington Post Staff Writers
Friday, December 9, 2005; A03
The Food and Drug Administration warned pregnant women and their doctors away from the antidepressant Paxil yesterday because of an increased risk of heart defects in newborns.
With the warning, the agency for the first time placed a popular antidepressant -- one in the same drug class as Prozac and Zoloft -- into its second-highest category for risk of birth defects. The agency did not say Paxil could never be used by pregnant women, but it did say the FDA "is advising patients that this drug should usually not be taken during pregnancy."
The advisory is based on early results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. The studies found that Paxil had a risk of birth defects that other common antidepressants did not.
"If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," said Robert Temple, the FDA's director of medical policy. "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change."
In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil.
Although researchers have been concerned for some time about the effect of selective serotonin reuptake inhibitors (SSRIs) on fetuses, yesterday's announcement by the FDA and Paxil manufacturer GlaxoSmithKline is the strongest indication so far that there may be significant risks. Since a large number of pregnant women suffer some form of depression -- some estimates are as high as 20 percent -- decisions about whether to start or continue on antidepressants are increasingly common and difficult.
Adding to the complexity of the decision, an earlier study published in the Journal of the American Medical Association found that the babies of mothers taking antidepressants were three times more likely to suffer from irritability, tremors and seizures in the weeks after birth. With so many concerns, support groups for pregnant women on antidepressants are now widespread.
Yesterday's advisory was based largely on a new analysis of data from Sweden's birth registry, which collects information on pregnant women and their offspring. An initial analysis of that large database found no correlation between birth defects and use of SSRIs, but a follow-up study found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all.
Most birth defects associated with antidepressants involve holes and malformations in the chambers of the heart. The defects often heal on their own, and more severe cases can be surgically repaired. Glaxo spokeswoman Gaile Renegar said the company is studying how and why its drug might be causing these defects, adding that it remains unclear whether there is a cause-and-effect relationship.
Kimberly Yonkers, a psychiatrist at the Yale School of Medicine who studies the treatment of mood disorders among pregnant women, cautioned that the database studies the FDA had used had limitations: Unlike controlled studies, Paxil may have been prescribed far more than other drugs, skewing the results. Also, she said, databases sometimes concealed unrelated medical problems that could alter outcomes.
"Depression is still undertreated," she said. "Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened."
Paxil is one of the world's most popular antidepressants, taken by tens of millions of patients since the drug was approved in 1993. It is also sold now in generic form as paroxetine. Renegar said yesterday that about 25 percent of Paxil users are women of childbearing age, between 18 and 45.
American regulatory officials have generally been slower to issue warnings about antidepressants than their counterparts in other countries, especially in Britain and Canada.
Officials here have repeatedly argued that the risks of antidepressants need to be balanced against their benefits. Many of the drugs, including Paxil, have been shown to be effective against depression, anxiety and other psychiatric disorders, especially among adults. No hard studies prove antidepressants lower the risk of suicide, but many experts believe that to be the case, and trace a lowered suicide rate in the United States to the increased use of antidepressants such as Paxil.
In its warning yesterday, the FDA acknowledged this trade-off. "In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus," FDA officials said. However, they added, in general, Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."
By Marc Kaufman and Shankar Vedantam
Washington Post Staff Writers
Friday, December 9, 2005; A03
The Food and Drug Administration warned pregnant women and their doctors away from the antidepressant Paxil yesterday because of an increased risk of heart defects in newborns.
With the warning, the agency for the first time placed a popular antidepressant -- one in the same drug class as Prozac and Zoloft -- into its second-highest category for risk of birth defects. The agency did not say Paxil could never be used by pregnant women, but it did say the FDA "is advising patients that this drug should usually not be taken during pregnancy."
The advisory is based on early results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1 1/2 to two times more likely to give birth to a child with a heart defect than women who took other antidepressants or pregnant women overall. The studies found that Paxil had a risk of birth defects that other common antidepressants did not.
"If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," said Robert Temple, the FDA's director of medical policy. "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change."
In the studies cited by the FDA, the risk of heart defects is about 1 percent overall and rose to 1.5 to 2 percent in infants born to women taking Paxil.
Although researchers have been concerned for some time about the effect of selective serotonin reuptake inhibitors (SSRIs) on fetuses, yesterday's announcement by the FDA and Paxil manufacturer GlaxoSmithKline is the strongest indication so far that there may be significant risks. Since a large number of pregnant women suffer some form of depression -- some estimates are as high as 20 percent -- decisions about whether to start or continue on antidepressants are increasingly common and difficult.
Adding to the complexity of the decision, an earlier study published in the Journal of the American Medical Association found that the babies of mothers taking antidepressants were three times more likely to suffer from irritability, tremors and seizures in the weeks after birth. With so many concerns, support groups for pregnant women on antidepressants are now widespread.
Yesterday's advisory was based largely on a new analysis of data from Sweden's birth registry, which collects information on pregnant women and their offspring. An initial analysis of that large database found no correlation between birth defects and use of SSRIs, but a follow-up study found that birth defects were twice as common among Paxil users as among women taking other antidepressants or none at all.
Most birth defects associated with antidepressants involve holes and malformations in the chambers of the heart. The defects often heal on their own, and more severe cases can be surgically repaired. Glaxo spokeswoman Gaile Renegar said the company is studying how and why its drug might be causing these defects, adding that it remains unclear whether there is a cause-and-effect relationship.
Kimberly Yonkers, a psychiatrist at the Yale School of Medicine who studies the treatment of mood disorders among pregnant women, cautioned that the database studies the FDA had used had limitations: Unlike controlled studies, Paxil may have been prescribed far more than other drugs, skewing the results. Also, she said, databases sometimes concealed unrelated medical problems that could alter outcomes.
"Depression is still undertreated," she said. "Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened."
Paxil is one of the world's most popular antidepressants, taken by tens of millions of patients since the drug was approved in 1993. It is also sold now in generic form as paroxetine. Renegar said yesterday that about 25 percent of Paxil users are women of childbearing age, between 18 and 45.
American regulatory officials have generally been slower to issue warnings about antidepressants than their counterparts in other countries, especially in Britain and Canada.
Officials here have repeatedly argued that the risks of antidepressants need to be balanced against their benefits. Many of the drugs, including Paxil, have been shown to be effective against depression, anxiety and other psychiatric disorders, especially among adults. No hard studies prove antidepressants lower the risk of suicide, but many experts believe that to be the case, and trace a lowered suicide rate in the United States to the increased use of antidepressants such as Paxil.
In its warning yesterday, the FDA acknowledged this trade-off. "In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus," FDA officials said. However, they added, in general, Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."
Genes Could Determine Diets
Genes could determine diets
December 9, 2005 - 1:24AM
Doctors will one day be able to tailor disease prevention diets for patients based on their genes, an Australian-based scientist believes.
Michael Fenech, of CSIRO Human Nutrition in Adelaide, will outline his vision of worldwide Genome Health Clinics at a conference in Singapore.
He believes the first one may be only a couple of years, rather than decades, away.
Dr Fenech, a geneticist and nutritionist, said studies had found links between increased DNA damage and adverse health outcomes such as infertility, cancer and neuro-degenerative disease.
But he said DNA damage, which increased as a person aged and reduced the body's ability to fight off diseases, could be minimised by supplementing people with nutrients such as folate and B12.
"How well a person responds depends on their genetic background and other nutrients in their diet," Dr Fenech said in an interview.
"For example, if you have too much riboflavin in a lower folate background, you're actually increasing DNA damage."
Dr Fenech said people with certain genetic defects may actually need higher - or lower - levels of some nutrients than others to offer a protective effect.
For example, he said studies had shown women with a defect in the Manganese superoxide dismutase gene benefitted from an increase in fruit and vegetable intake.
Genome Health Clinics may eventually even give advice on safe levels of alcohol, based on a person's genetic blueprint.
"We know that alcohol is damaging if you cannot detoxify it in the body," Dr Fenech said.
"Alcohol is a risk factor for many conditions, including breast cancer.
"If you knew what genotype you were, in terms of detoxification of alcohol, then of course you would be advised as to the amount of alcohol you should and shouldn't drink."
Visits to Genome Health Clinics may prove vital for women with faults in their BRCA1 and BRCA2 genes, DNA repair genes which are known to be linked with breast cancer.
"If you have those genes, it becomes increasingly important that you do not harm your DNA," Dr Fenech said.
"You could harm your DNA by drinking too much alcohol or by not having enough folate, for example.
"Put those two together, you can see that your odds are getting quite risky.
"It's known that if you're low in folate and high in alcohol your risk for breast cancer goes up, so this all fits. It's very, very plausible."
Ultimately, Dr Fenech wants to build a genome health nutrigenomics database based on the available information on genes and nutrition, which would allow doctors to take a simple blood test from a patient and design a diet to suit the individual.
He will detail his plans to the International Life Sciences Institute's conference on nutrigenomics.
December 9, 2005 - 1:24AM
Doctors will one day be able to tailor disease prevention diets for patients based on their genes, an Australian-based scientist believes.
Michael Fenech, of CSIRO Human Nutrition in Adelaide, will outline his vision of worldwide Genome Health Clinics at a conference in Singapore.
He believes the first one may be only a couple of years, rather than decades, away.
Dr Fenech, a geneticist and nutritionist, said studies had found links between increased DNA damage and adverse health outcomes such as infertility, cancer and neuro-degenerative disease.
But he said DNA damage, which increased as a person aged and reduced the body's ability to fight off diseases, could be minimised by supplementing people with nutrients such as folate and B12.
"How well a person responds depends on their genetic background and other nutrients in their diet," Dr Fenech said in an interview.
"For example, if you have too much riboflavin in a lower folate background, you're actually increasing DNA damage."
Dr Fenech said people with certain genetic defects may actually need higher - or lower - levels of some nutrients than others to offer a protective effect.
For example, he said studies had shown women with a defect in the Manganese superoxide dismutase gene benefitted from an increase in fruit and vegetable intake.
Genome Health Clinics may eventually even give advice on safe levels of alcohol, based on a person's genetic blueprint.
"We know that alcohol is damaging if you cannot detoxify it in the body," Dr Fenech said.
"Alcohol is a risk factor for many conditions, including breast cancer.
"If you knew what genotype you were, in terms of detoxification of alcohol, then of course you would be advised as to the amount of alcohol you should and shouldn't drink."
Visits to Genome Health Clinics may prove vital for women with faults in their BRCA1 and BRCA2 genes, DNA repair genes which are known to be linked with breast cancer.
"If you have those genes, it becomes increasingly important that you do not harm your DNA," Dr Fenech said.
"You could harm your DNA by drinking too much alcohol or by not having enough folate, for example.
"Put those two together, you can see that your odds are getting quite risky.
"It's known that if you're low in folate and high in alcohol your risk for breast cancer goes up, so this all fits. It's very, very plausible."
Ultimately, Dr Fenech wants to build a genome health nutrigenomics database based on the available information on genes and nutrition, which would allow doctors to take a simple blood test from a patient and design a diet to suit the individual.
He will detail his plans to the International Life Sciences Institute's conference on nutrigenomics.
Gimme an Rx! Cheerleaders Pep Up Drug Sales
Gimme an Rx! Cheerleaders Pep Up Drug Sales
Allison V. Smith for The New York Times
As an ambitious college student, Cassie Napier had all the right moves - flips, tumbles, an ever-flashing America's sweetheart smile - to prepare for her job after graduation. She became a drug saleswoman.
Penny Otwell, a former cheerleader and Survivor cast member, is a drug sales representative. Survivor: Penny Ramsey Otwell
Profile of Onya, Washington Redskins Cheerleader. At game time, Onya cheers on the Washington Redskins. But she saves some of her energy for her job in pharmaceutical sales. Drug companies have found that former cheerleaders like Penny Otwell are good at persuading doctors.
Ms. Napier, 26, was a star cheerleader on the national-champion University of Kentucky squad, which has been a springboard for many careers in pharmaceutical sales. She now plies doctors' offices selling the antacid Prevacid for TAP Pharmaceutical Products.
Ms. Napier says the skills she honed performing for thousands of fans helped land her job. "I would think, essentially, that cheerleaders make good sales people," she said.
Anyone who has seen the parade of sales representatives through a doctor's waiting room has probably noticed that they are frequently female and invariably good looking. Less recognized is the fact that a good many are recruited from the cheerleading ranks.
Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force. Some keep their pompoms active, like Onya, a sculptured former college cheerleader. On Sundays she works the sidelines for the Washington Redskins. But weekdays find her urging gynecologists to prescribe a treatment for vaginal yeast infection.
Some industry critics view wholesomely sexy drug representatives as a variation on the seductive inducements like dinners, golf outings and speaking fees that pharmaceutical companies have dangled to sway doctors to their brands.
But now that federal crackdowns and the industry's self-policing have curtailed those gifts, simple one-on-one human rapport, with all its potentially uncomfortable consequences, has become more important. And in a crowded field of 90,000 drug representatives, where individual clients wield vast prescription-writing influence over patients' medication, who better than cheerleaders to sway the hearts of the nation's doctors, still mostly men.
"There's a saying that you'll never meet an ugly drug rep," said Dr. Thomas Carli of the University of Michigan. He led efforts to limit access to the representatives who once trolled hospital hallways. But Dr. Carli, who notes that even male drug representatives are athletic and handsome, predicts that the drug industry, whose image has suffered from safety problems and aggressive marketing tactics, will soon come to realize that "the days of this sexual marketing are really quite limited."
But many cheerleaders, and their proponents, say they bring attributes besides good looks to the job - so much so that their success has led to a recruiting pipeline that fuels the country's pharmaceutical sales force. T. Lynn Williamson, Ms. Napier's cheering adviser at Kentucky, says he regularly gets calls from recruiters looking for talent, mainly from pharmaceutical companies. "They watch to see who's graduating," he said.
"They don't ask what the major is," Mr. Williamson said. Proven cheerleading skills suffice. "Exaggerated motions, exaggerated smiles, exaggerated enthusiasm - they learn those things, and they can get people to do what they want."
Approximately two dozen Kentucky cheerleaders, mostly women but a few men, have become drug reps in recent years.
While there are no statistics on how many drug representatives are former or current cheerleaders, demand for them led to the formation of an employment firm, Spirited Sales Leaders, in Memphis. It maintains a database of thousands of potential candidates.
"The cheerleaders now are the top people in universities; these are really capable and high-profile people," said Gregory C. Webb, who is also a principal in a company that runs cheerleading camps and employs former cheerleaders. He started Spirited Sales Leaders about 18 months ago because so many cheerleaders were going into drug sales. He said he knew several hundred former cheerleaders who had become drug representatives.
"There's a lot of sizzle in it," said Mr. Webb. "I've had people who are going right out, maybe they've been out of school for a year, and get a car and make up to $50,000, $60,000 with bonuses, if they do well." Compensation sometimes goes well into six figures.
The ranks include women like Cristin Duren, a former University of Alabama cheerleader. Ms. Duren, 24, recently took a leave from First Horizon Pharmaceuticals to fulfill her duties as the reigning Miss Florida U.S.A. and prepare for next year's Miss U.S.A. pageant.
Allison V. Smith for The New York Times
As an ambitious college student, Cassie Napier had all the right moves - flips, tumbles, an ever-flashing America's sweetheart smile - to prepare for her job after graduation. She became a drug saleswoman.
Penny Otwell, a former cheerleader and Survivor cast member, is a drug sales representative. Survivor: Penny Ramsey Otwell
Profile of Onya, Washington Redskins Cheerleader. At game time, Onya cheers on the Washington Redskins. But she saves some of her energy for her job in pharmaceutical sales. Drug companies have found that former cheerleaders like Penny Otwell are good at persuading doctors.
Ms. Napier, 26, was a star cheerleader on the national-champion University of Kentucky squad, which has been a springboard for many careers in pharmaceutical sales. She now plies doctors' offices selling the antacid Prevacid for TAP Pharmaceutical Products.
Ms. Napier says the skills she honed performing for thousands of fans helped land her job. "I would think, essentially, that cheerleaders make good sales people," she said.
Anyone who has seen the parade of sales representatives through a doctor's waiting room has probably noticed that they are frequently female and invariably good looking. Less recognized is the fact that a good many are recruited from the cheerleading ranks.
Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force. Some keep their pompoms active, like Onya, a sculptured former college cheerleader. On Sundays she works the sidelines for the Washington Redskins. But weekdays find her urging gynecologists to prescribe a treatment for vaginal yeast infection.
Some industry critics view wholesomely sexy drug representatives as a variation on the seductive inducements like dinners, golf outings and speaking fees that pharmaceutical companies have dangled to sway doctors to their brands.
But now that federal crackdowns and the industry's self-policing have curtailed those gifts, simple one-on-one human rapport, with all its potentially uncomfortable consequences, has become more important. And in a crowded field of 90,000 drug representatives, where individual clients wield vast prescription-writing influence over patients' medication, who better than cheerleaders to sway the hearts of the nation's doctors, still mostly men.
"There's a saying that you'll never meet an ugly drug rep," said Dr. Thomas Carli of the University of Michigan. He led efforts to limit access to the representatives who once trolled hospital hallways. But Dr. Carli, who notes that even male drug representatives are athletic and handsome, predicts that the drug industry, whose image has suffered from safety problems and aggressive marketing tactics, will soon come to realize that "the days of this sexual marketing are really quite limited."
But many cheerleaders, and their proponents, say they bring attributes besides good looks to the job - so much so that their success has led to a recruiting pipeline that fuels the country's pharmaceutical sales force. T. Lynn Williamson, Ms. Napier's cheering adviser at Kentucky, says he regularly gets calls from recruiters looking for talent, mainly from pharmaceutical companies. "They watch to see who's graduating," he said.
"They don't ask what the major is," Mr. Williamson said. Proven cheerleading skills suffice. "Exaggerated motions, exaggerated smiles, exaggerated enthusiasm - they learn those things, and they can get people to do what they want."
Approximately two dozen Kentucky cheerleaders, mostly women but a few men, have become drug reps in recent years.
While there are no statistics on how many drug representatives are former or current cheerleaders, demand for them led to the formation of an employment firm, Spirited Sales Leaders, in Memphis. It maintains a database of thousands of potential candidates.
"The cheerleaders now are the top people in universities; these are really capable and high-profile people," said Gregory C. Webb, who is also a principal in a company that runs cheerleading camps and employs former cheerleaders. He started Spirited Sales Leaders about 18 months ago because so many cheerleaders were going into drug sales. He said he knew several hundred former cheerleaders who had become drug representatives.
"There's a lot of sizzle in it," said Mr. Webb. "I've had people who are going right out, maybe they've been out of school for a year, and get a car and make up to $50,000, $60,000 with bonuses, if they do well." Compensation sometimes goes well into six figures.
The ranks include women like Cristin Duren, a former University of Alabama cheerleader. Ms. Duren, 24, recently took a leave from First Horizon Pharmaceuticals to fulfill her duties as the reigning Miss Florida U.S.A. and prepare for next year's Miss U.S.A. pageant.
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