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.”
December 9, 2005
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.
Frist Fans Public Fears of Avian Flu
Frist Fans Public Fears of Avian Flu to Ram Through Sweeping Liability Shield for the Drug Industry
Bill Would Leave Injured Consumers to Fend for Themselves While Industry Gets a Free Ride
WASHINGTON, Dec. 9, 2005 – A proposal to immunize the drug industry from legal accountability for death, disability or sickness caused by the use of pandemic flu vaccines and pharmaceuticals would be a gift to industry, but bad medicine for consumers, Public Citizen said today. The organization’s comments came after Senate Majority Leader Bill Frist (R-Tenn.) renewed his call for passage of legislation, which is being tacked on to a must-pass defense spending bill and has never been debated or voted on in either the House or Senate.
Frist’s plan is especially troubling because it provides no means for victims who are seriously injured to seek compensation, unlike other federal vaccine programs. Moreover, the industry does not need additional liability protection for the flourishing market for “pandemic vaccines” and antivirals, and the Department of Health and Human Services (HHS) already has authority to exempt drugmakers from liability under the kind of “hazardous” circumstances that would be present during a disease pandemic.
“Under the guise of an impending public health ‘emergency,’ Sen. Frist is inflicting collateral damage on unsuspecting health care workers and consumers,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “It is amazing how far he has strayed from the principles of first preventing harm to patients and is instead pandering to special industry interests.”
The backroom maneuver is such bad news because:
* Frist wants to shield companies from legal responsibility when their negligence, recklessness, deceptive claims – or even intentional failure to warn users about potential dangers – sicken or kill the people who take their pandemic vaccines and pharmaceuticals. Although emergency vaccines and medicines may be rushed to first responders and the public on short deadlines, with reduced scrutiny and less stringent testing, drug companies can rest assured that they will not have to worry about any harmful consequences. Some 4,000 people fell ill after taking the swine flu vaccine in 1976; 500 contracted a paralyzing nerve disorder and more than 30 people died. Some military personnel and first responders who took the smallpox vaccine in 2003 suffered heart attacks, increased risk of heart inflammation and neurological disorders. None of these people would have had any recourse under this bill. Moreover, conferring legal immunity on the drug industry could thwart the public health goals that a pandemic disease program is designed to achieve: ensuring that a critical mass of people are vaccinated or accept prophylactic treatments to stop the outbreak. The 2003 smallpox campaign failed in part because both first responders and ordinary citizens balked once they knew that lawsuits against the manufacturer were barred and they would have no way to get compensation if injured.
* Frist’s scheme gives innocent victims no means of obtaining compensation. Ordinarily, when the government grants liability exemptions to companies, it provides some form of relief for consumers who are injured. For example, the 1976 Swine Flu Act allowed those who had bad reactions to the vaccine to sue the government under an expanded version of the Federal Tort Claims Act. In 2003, the government set up a compensation plan for people injured by the smallpox vaccine after people refused to get vaccinated without it. And since 1986, a National Vaccine Injury Compensation Program has been available for children suffering bad reactions to childhood vaccines. In contrast, Frist’s plan would set up a system whereby injured people could seek compensation only if they could first clear hurdles so high as to effectively bar any chance of recovering damages.
* Frist’s claim that drug companies need the incentive of a liability shield because the vaccine business is not lucrative enough is bogus. The same companies that would benefit under Frist’s plan already are investing heavily in vaccine and antiviral production, lured by the prospect of huge profits driven by global need and the certainty of large government purchases. Established vaccine manufacturer Chiron has been working on an H5N1 vaccine since 1997. Novartis, which already owned 42 percent of Chiron, bought the rest of the company this past fall, offering the company 23 percent above its closing share price at the time of the deal. Roche estimates that sales of its antiviral Tamiflu will reach $1 billion in 2005 – about four times the 2004 level. Biotech firms like Novavax and Vical are competing to develop improved vaccine production techniques –and seeing their stock values soar to new heights.
* Frist is deceiving the public by not revealing that government indemnification of drug companies already is available under existing law and has been incorporated into recent contracts. Under an executive order, HHS can indemnify contractors that may not have sufficient insurance to cover their legal liability for damages. The contract that Sanofi-Aventis signed in September with HHS for $100 million worth of avian flu vaccine contains such an indemnification clause, according to Hill staffers familiar with the deal. Chiron’s contract for $62.5 million worth of avian flu, signed in October, also has the indemnification provision. In fact, the HHS Pandemic Influenza Plan released in November lists in its appendix of legal authorities “Executive Order 10789, as amended by Executive Order 13232” giving the agency the right to indemnify its contractors under the Federal Acquisition Regulations, 48 C.F.R. 50.403, for risks not covered by private insurers. Accordingly, Frist’s claim that immunity from liability is needed so that companies will agree to produce vaccines is unfounded.
“Giving blanket immunity to the drug industry without providing any means for victims or their families to get compensation for serious injury or death is unconscionable,” said Jillian Aldebron, civil justice counsel for Public Citizen’s Congress Watch division. “It looks like Christmas will come early for the drug industry, but consumers will only get a lump of coal.”
Bill Would Leave Injured Consumers to Fend for Themselves While Industry Gets a Free Ride
WASHINGTON, Dec. 9, 2005 – A proposal to immunize the drug industry from legal accountability for death, disability or sickness caused by the use of pandemic flu vaccines and pharmaceuticals would be a gift to industry, but bad medicine for consumers, Public Citizen said today. The organization’s comments came after Senate Majority Leader Bill Frist (R-Tenn.) renewed his call for passage of legislation, which is being tacked on to a must-pass defense spending bill and has never been debated or voted on in either the House or Senate.
Frist’s plan is especially troubling because it provides no means for victims who are seriously injured to seek compensation, unlike other federal vaccine programs. Moreover, the industry does not need additional liability protection for the flourishing market for “pandemic vaccines” and antivirals, and the Department of Health and Human Services (HHS) already has authority to exempt drugmakers from liability under the kind of “hazardous” circumstances that would be present during a disease pandemic.
“Under the guise of an impending public health ‘emergency,’ Sen. Frist is inflicting collateral damage on unsuspecting health care workers and consumers,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “It is amazing how far he has strayed from the principles of first preventing harm to patients and is instead pandering to special industry interests.”
The backroom maneuver is such bad news because:
* Frist wants to shield companies from legal responsibility when their negligence, recklessness, deceptive claims – or even intentional failure to warn users about potential dangers – sicken or kill the people who take their pandemic vaccines and pharmaceuticals. Although emergency vaccines and medicines may be rushed to first responders and the public on short deadlines, with reduced scrutiny and less stringent testing, drug companies can rest assured that they will not have to worry about any harmful consequences. Some 4,000 people fell ill after taking the swine flu vaccine in 1976; 500 contracted a paralyzing nerve disorder and more than 30 people died. Some military personnel and first responders who took the smallpox vaccine in 2003 suffered heart attacks, increased risk of heart inflammation and neurological disorders. None of these people would have had any recourse under this bill. Moreover, conferring legal immunity on the drug industry could thwart the public health goals that a pandemic disease program is designed to achieve: ensuring that a critical mass of people are vaccinated or accept prophylactic treatments to stop the outbreak. The 2003 smallpox campaign failed in part because both first responders and ordinary citizens balked once they knew that lawsuits against the manufacturer were barred and they would have no way to get compensation if injured.
* Frist’s scheme gives innocent victims no means of obtaining compensation. Ordinarily, when the government grants liability exemptions to companies, it provides some form of relief for consumers who are injured. For example, the 1976 Swine Flu Act allowed those who had bad reactions to the vaccine to sue the government under an expanded version of the Federal Tort Claims Act. In 2003, the government set up a compensation plan for people injured by the smallpox vaccine after people refused to get vaccinated without it. And since 1986, a National Vaccine Injury Compensation Program has been available for children suffering bad reactions to childhood vaccines. In contrast, Frist’s plan would set up a system whereby injured people could seek compensation only if they could first clear hurdles so high as to effectively bar any chance of recovering damages.
* Frist’s claim that drug companies need the incentive of a liability shield because the vaccine business is not lucrative enough is bogus. The same companies that would benefit under Frist’s plan already are investing heavily in vaccine and antiviral production, lured by the prospect of huge profits driven by global need and the certainty of large government purchases. Established vaccine manufacturer Chiron has been working on an H5N1 vaccine since 1997. Novartis, which already owned 42 percent of Chiron, bought the rest of the company this past fall, offering the company 23 percent above its closing share price at the time of the deal. Roche estimates that sales of its antiviral Tamiflu will reach $1 billion in 2005 – about four times the 2004 level. Biotech firms like Novavax and Vical are competing to develop improved vaccine production techniques –and seeing their stock values soar to new heights.
* Frist is deceiving the public by not revealing that government indemnification of drug companies already is available under existing law and has been incorporated into recent contracts. Under an executive order, HHS can indemnify contractors that may not have sufficient insurance to cover their legal liability for damages. The contract that Sanofi-Aventis signed in September with HHS for $100 million worth of avian flu vaccine contains such an indemnification clause, according to Hill staffers familiar with the deal. Chiron’s contract for $62.5 million worth of avian flu, signed in October, also has the indemnification provision. In fact, the HHS Pandemic Influenza Plan released in November lists in its appendix of legal authorities “Executive Order 10789, as amended by Executive Order 13232” giving the agency the right to indemnify its contractors under the Federal Acquisition Regulations, 48 C.F.R. 50.403, for risks not covered by private insurers. Accordingly, Frist’s claim that immunity from liability is needed so that companies will agree to produce vaccines is unfounded.
“Giving blanket immunity to the drug industry without providing any means for victims or their families to get compensation for serious injury or death is unconscionable,” said Jillian Aldebron, civil justice counsel for Public Citizen’s Congress Watch division. “It looks like Christmas will come early for the drug industry, but consumers will only get a lump of coal.”
Pharma To Republicans - Time To Pay Up Again
Pharma To Republicans - Time To Pay Up Again
By Evelyn Pringle
The generation of children injured by vaccines containing the mercury-based preservative thimerosal is now reaching puberty. Many of these children will require life-long care and support. The cost to their parents by today's standards, will reportedly exceed $2 million dollars for each child.
An ever-growing number of health care professionals point to thimerosal as the culprit behind the explosion in cases of autism and other neurological disorders. The only common thread connecting these damaged children to one another is their exposure to mercury through childhood immunizations.
Accountability from vaccine makers is something that parents of injured children have been seeking for years; but accountability appears more illusive with each year's passage. On October 27 2005, the Hartford Courant reported that "Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people."
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S 1873), is being pushed through Congress without giving voters the chance to make their objections known to their elected officials.
Nicknamed "Bioshield Two," the bill's primary sponsor, Senator Richard Burr (R-NC), claims the Act will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."
Co-sponsored by Senators Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), the Act will in truth, eliminate current regulatory and legal safeguards applied to vaccines.
What kind of profits need protecting? A good example is GlaxoSmithKline, which predicts that some of its new vaccines will become blockbusters with projected sales of more than $1 billion a year, according to Reuters on June 30, 2005. Glaxo aims to launch five major vaccines by 2010, it said.
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Another example, for people who believe there’s no profit in vaccine making, “tell it to Wyeth, a big drug maker whose vaccine Prevnar ... costs more than $250 for the four-dose treatment given to infants,” says Kristine Severyn, PhD, author of the report, Profits, Not Science, Motivate Vaccine Mandates Vaccine Policy Institute.
Despite the price, "the government has recommended that all infants get the vaccine, and insurers generally pay for it - as does the federal Vaccines for Children program for low-income families. Prevnar, with sales expected to top $1 billion this year," says Severyn.
Severyn's predictions were right on. According to Wyeth's 2005 first quarter earnings report, Prevnar achieved net revenue of $391 million, more than double the first quarter earnings in 2004.
Bush’s FY2006 budget proposes to improve access to vaccines by allowing underinsured children to receive Vaccines for Children at state and local health clinics. The Department of Health and Human Services estimates that cost of the proposal will be $140 million in 2006, and $700 million over the 2006-2010 period.
How much does this sort of government protection cost? For starters, according to the Center for Public Integrity, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is the industry's trade organization and it has topped the list of pharmaceutical lobbying spending since 1998, shelling out $74 million. Its members include 16 of the industry's 20 largest companies and their subsidiaries and its current president is Billy Tauzin, is a former Republican congressman from Louisiana.
In the 2002 election cycle, PhRMA gave $3,505,052 with 95% going to Republicans. The top recipient in the Senate was none other than Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics. So far in the 2006 cycle, Gregg has received over $106,000 and Enzi has taken in $21,000 in pharma money.
Frist is a real piece of work. He has been trying to get a law passed to protect the drug companies for years. In 2002, he was behind the dead of night insertion of a provision into the Homeland Security bill that would have immunized vaccine makers from lawsuits related to thimerosal.
Frist has made millions upon millions profiting off human misery. The basis of the family fortune is the Hospital Corporation of America, the largest for-profit hospital conglomerate in the nation. However, the corporation also paid the largest health care settlement in history of more than $1.7 billion in civil and criminal penalties to settle charges of massive Medicare and Medicaid billing fraud.
Until recently, Frist and his wife owned $26 million worth of HCA stock. They are currently being investigated on charges of insider trading in the sale of HCA stock in the weeks immediately before the stock's value plummeted, and conflict of interest charges involving his ownership of HCA stock which he had previously claimed he knew nothing about because in accordance with ethics rules, it was in a "blind trust."
According to the Center for Justice and Democracy, Frist has received more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, raising more cash from health-care interests than 98% of his colleagues. In return, his legislative work in the Senate consists of almost nothing but trying to push through laws to increase profits for his number one backer.
Its worth noting that while Frist was its chairman, the pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee, doling out about $4 million, with Eli Lilly, the company that invented thimerosal, being the single biggest contributor, giving $1.6 million.
The National Vaccine Information Center (NVIC), a watchdog advocacy group, is highly critical of the pending protection legislation. According to the group's President, Barbara Loe Fisher, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades.” The NVIC calls the Act "a drug company stockholder's dream and a consumer's worst nightmare."
According to NVIC, currently there are at least ten different bills pending in Congress that will contain provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.
"This proposed legislation," Fisher told UPI, "is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur."
The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single authority for the advanced research and development of drugs and vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws. In addition, the Act specifically bars citizens from challenging the Secretary's rulings in court.
BARDA will be exempt from the Freedom of Information Act and the Federal Advisory Committee Act, to ensure that no evidence related to injuries caused by vaccines classified as "countermeasures" will become public.
"It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take," Fisher told UPI, "that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."
In a November 15, 2005, letter to Senator Burr's staff director, Fisher describes S 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.
“It is exactly this type of legislation that leads to civil disobedience and many times in the extreme form,” Dr Boyd Haley, a well-known expert on heavy metal toxicity, told this author, “I am very fearful of how certain segments of our society will respond to any mass vaccination program---especially if it does cause a problem like the thimerosal/autism situation,” he said.
As it stands today, if the Bush administration and its puppets in Congress achieve their common goal of protecting pharma profits by shielding vaccine makers from lawsuits, tax payers will have to foot the bill for the life-long costs of caring for millions of injured children.
Tax payers are already funding their special education needs. In a January 14, 2005, letter to a Congressional Subcommittee on Human Rights, the Government Accountability Office (GAO), informed committee members that the number of children diagnosed with autism served under the IDEA has increased by more than 500% in the last decade and that "about 1.5 million Americans are currently living with some form of autism."
In a recent interview with Teri Small published in the journal, Medical Veritas 2 (2005), Dr Geier said that he believes that this may be the greatest iatrogenic epidemic in history. "The damage already done to our society is already in the trillions of dollars," he warns. "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.
"All of us alive," Dr Geier says, "will have to bear its effects both in the lifetime care of the damaged children and the loss of what they otherwise might have contributed to our society."
*************
Evelyn Pringle
epringle05@yahoo.com
By Evelyn Pringle
The generation of children injured by vaccines containing the mercury-based preservative thimerosal is now reaching puberty. Many of these children will require life-long care and support. The cost to their parents by today's standards, will reportedly exceed $2 million dollars for each child.
An ever-growing number of health care professionals point to thimerosal as the culprit behind the explosion in cases of autism and other neurological disorders. The only common thread connecting these damaged children to one another is their exposure to mercury through childhood immunizations.
Accountability from vaccine makers is something that parents of injured children have been seeking for years; but accountability appears more illusive with each year's passage. On October 27 2005, the Hartford Courant reported that "Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people."
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (S 1873), is being pushed through Congress without giving voters the chance to make their objections known to their elected officials.
Nicknamed "Bioshield Two," the bill's primary sponsor, Senator Richard Burr (R-NC), claims the Act will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."
Co-sponsored by Senators Bill Frist (R-TN), Mike Enzi (R-WY), and Judd Gregg (R-NH), the Act will in truth, eliminate current regulatory and legal safeguards applied to vaccines.
What kind of profits need protecting? A good example is GlaxoSmithKline, which predicts that some of its new vaccines will become blockbusters with projected sales of more than $1 billion a year, according to Reuters on June 30, 2005. Glaxo aims to launch five major vaccines by 2010, it said.
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Another example, for people who believe there’s no profit in vaccine making, “tell it to Wyeth, a big drug maker whose vaccine Prevnar ... costs more than $250 for the four-dose treatment given to infants,” says Kristine Severyn, PhD, author of the report, Profits, Not Science, Motivate Vaccine Mandates Vaccine Policy Institute.
Despite the price, "the government has recommended that all infants get the vaccine, and insurers generally pay for it - as does the federal Vaccines for Children program for low-income families. Prevnar, with sales expected to top $1 billion this year," says Severyn.
Severyn's predictions were right on. According to Wyeth's 2005 first quarter earnings report, Prevnar achieved net revenue of $391 million, more than double the first quarter earnings in 2004.
Bush’s FY2006 budget proposes to improve access to vaccines by allowing underinsured children to receive Vaccines for Children at state and local health clinics. The Department of Health and Human Services estimates that cost of the proposal will be $140 million in 2006, and $700 million over the 2006-2010 period.
How much does this sort of government protection cost? For starters, according to the Center for Public Integrity, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), is the industry's trade organization and it has topped the list of pharmaceutical lobbying spending since 1998, shelling out $74 million. Its members include 16 of the industry's 20 largest companies and their subsidiaries and its current president is Billy Tauzin, is a former Republican congressman from Louisiana.
In the 2002 election cycle, PhRMA gave $3,505,052 with 95% going to Republicans. The top recipient in the Senate was none other than Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics. So far in the 2006 cycle, Gregg has received over $106,000 and Enzi has taken in $21,000 in pharma money.
Frist is a real piece of work. He has been trying to get a law passed to protect the drug companies for years. In 2002, he was behind the dead of night insertion of a provision into the Homeland Security bill that would have immunized vaccine makers from lawsuits related to thimerosal.
Frist has made millions upon millions profiting off human misery. The basis of the family fortune is the Hospital Corporation of America, the largest for-profit hospital conglomerate in the nation. However, the corporation also paid the largest health care settlement in history of more than $1.7 billion in civil and criminal penalties to settle charges of massive Medicare and Medicaid billing fraud.
Until recently, Frist and his wife owned $26 million worth of HCA stock. They are currently being investigated on charges of insider trading in the sale of HCA stock in the weeks immediately before the stock's value plummeted, and conflict of interest charges involving his ownership of HCA stock which he had previously claimed he knew nothing about because in accordance with ethics rules, it was in a "blind trust."
According to the Center for Justice and Democracy, Frist has received more than $2.3 million from doctors, health insurers, drug companies and others in the health care industry, raising more cash from health-care interests than 98% of his colleagues. In return, his legislative work in the Senate consists of almost nothing but trying to push through laws to increase profits for his number one backer.
Its worth noting that while Frist was its chairman, the pharmaceutical industry was also the largest single contributor to the National Republican Senatorial Campaign Committee, doling out about $4 million, with Eli Lilly, the company that invented thimerosal, being the single biggest contributor, giving $1.6 million.
The National Vaccine Information Center (NVIC), a watchdog advocacy group, is highly critical of the pending protection legislation. According to the group's President, Barbara Loe Fisher, "It is a big lie that drug companies have been driven out of business by lawsuits in the past two decades.” The NVIC calls the Act "a drug company stockholder's dream and a consumer's worst nightmare."
According to NVIC, currently there are at least ten different bills pending in Congress that will contain provisions to shield drug companies from lawsuits including S3, S975, S1437, S1828, S1873, S1880, HR650, HR3154, HR3970, and HR4245.
"This proposed legislation," Fisher told UPI, "is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur."
The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single authority for the advanced research and development of drugs and vaccines and grants the Secretary of the Department of Health and Human Services, the sole authority to determine whether a drug maker violated drug safety laws. In addition, the Act specifically bars citizens from challenging the Secretary's rulings in court.
BARDA will be exempt from the Freedom of Information Act and the Federal Advisory Committee Act, to ensure that no evidence related to injuries caused by vaccines classified as "countermeasures" will become public.
"It means that, if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take," Fisher told UPI, "that citizen will be banned from exercising the Constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."
In a November 15, 2005, letter to Senator Burr's staff director, Fisher describes S 1873 as "arguably unconstitutional" because it (1) lacks transparency into the research, development, licensure and post-licensure surveillance of vaccines and drugs used in public health emergencies; (2) lacks accountability for either manufacturers of these products or government health officials who mandate their use without informed consent; and (3) lacks justice for those who will inevitably die or suffer chronic illnesses after being compelled to take these products.
“It is exactly this type of legislation that leads to civil disobedience and many times in the extreme form,” Dr Boyd Haley, a well-known expert on heavy metal toxicity, told this author, “I am very fearful of how certain segments of our society will respond to any mass vaccination program---especially if it does cause a problem like the thimerosal/autism situation,” he said.
As it stands today, if the Bush administration and its puppets in Congress achieve their common goal of protecting pharma profits by shielding vaccine makers from lawsuits, tax payers will have to foot the bill for the life-long costs of caring for millions of injured children.
Tax payers are already funding their special education needs. In a January 14, 2005, letter to a Congressional Subcommittee on Human Rights, the Government Accountability Office (GAO), informed committee members that the number of children diagnosed with autism served under the IDEA has increased by more than 500% in the last decade and that "about 1.5 million Americans are currently living with some form of autism."
In a recent interview with Teri Small published in the journal, Medical Veritas 2 (2005), Dr Geier said that he believes that this may be the greatest iatrogenic epidemic in history. "The damage already done to our society is already in the trillions of dollars," he warns. "The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism," he told Veritas.
"All of us alive," Dr Geier says, "will have to bear its effects both in the lifetime care of the damaged children and the loss of what they otherwise might have contributed to our society."
*************
Evelyn Pringle
epringle05@yahoo.com
Pharma's Poisoned Generation
Pharma's Poisoned Generation
Evelyn Pringle
A growing number of professionals in the health care field are reporting that a relationship exists between the epidemic in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay all across the country, and the use of thimerosal, the mercury-based preservative used in childhood vaccines.
Vaccines are the only medicines that Americans are mandated to receive as a condition for attendance in school and day care, and for some types of employment. Parents who receive federal assistance are also required to show proof that their children have been vaccinated.
While the mandate for which vaccines must be included on the vaccine schedule is a state mandate, it is the Centers for Disease Control and Prevention (CDC) and its Advisory Committee that make the recommendations to which the majority of states adhere when determining mandates. The current epidemic actually began in the late 1980s when a large number of new vaccines were added to the schedule.
The blame is at least partially attributable to the failure of government officials to keep track of the cumulative amounts of mercury as they added triple-dose-vaccines to the schedule and the amount of thimerosal was multiplied by three.
Each new vaccine contained 25 micrograms of mercury and according to Professor Lynn Adams, of Radford University, who specializes in autism, by 1999, a study determined that the average child received 33 doses of 10 different vaccines by the age 5.
Elected lawmakers first became aware of the problem in 1999, when the House Committee on Government Reform initiated an investigation into the dangers of mercury exposure. An alarm rang early about the exposure of children to thimerosal.
By October 25, 2000, Committee Chairman, Dan Burton (R-IN), was trying to get the substance out of vaccines as quickly as possible and sent a letter to the Department of Health and Human Services, asking the director to get the FDA to recall all vaccines with thimerosal.
“We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain Thimerosal,” Burton wrote. “Every day that mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk,” he said.
“I implore you to conduct a full recall of these products,” he wrote. “If the only action ... is a gradual phase out, children will continue to be put at risk every day,” Burton warned. “These vaccines will continue to be injected in children for years to come - putting our nation's most vulnerable population ... at risk for mercury poisoning," he added.
The Reform Committee soon discovered that regulatory agencies were still allowing thimerosal to be used decades after the recognition that it was harmful. The Committee was told that the Food and Drug Administration, (FDA), uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency:
"at the heart of all FDA’s product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. The FDA will allow a product to present more of a risk when its potential benefit is great—especially for products used to treat serious, life-threatening conditions."
The argument that the known risks of infectious diseases outweighs any potential risk of neurological damage is one that has continuously been used by officials. The FDA claims that any risk from thimerosal is theoretical because no proof of harm exists.
However, after its review of scientific literature and listening to the testimony of witnesses, the Committee found plenty of evidence to support the fact that thimerosal posed a grave risk. "The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature," the Committee said.
The Committee also discovered that regulatory agencies have never required drug companies to conduct studies on the use of thimerosal. During a June 20, 2002, hearing, Burton questioned officials from the FDA and CDC and said, "You mean to tell me that since 1929, we've been using Thimerosal and the only test that you know of is from 1929, and every one of those people had mennigitis, and they all died?"
In his opening statement at a July 18, 2000, hearing, Burton said:
"We assume that the FDA would protect our children from exposure to any level of mercury through drugs. But that hasn’t been the case. Thimerosal was first marketed in 1930 and has become the most widely used preservative in vaccines. It is present in over 50 licensed vaccines."
"The FDA recently acknowledged that in the first six months of life, children get more mercury than is considered safe by the EPA," Burton noted. "The truth is that sometimes kids go to their doctor’s office and get four or five vaccines at the same time," he added.
"My grandson received vaccines for nine different diseases in one day," Burton said. "He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines."
"According to his weight, the maximum safe level of mercury he should be exposed to in one day is 1.51 micrograms," Burton advised. "This is forty-one times the amount at which harm can be caused," he added.
In his opening remarks at a June 19, 2002, hearing, Burton described the devastation of witnessing the correlation between vaccines and autism.
"My only grandson became autistic right before my eyes – shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing, healthy, grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism."
People often wonder why regulatory officials would protect drug makers. In large part, because the CDC and FDA policy decisions are made through advisory panels whose members have financial relationships with the same companies they are charged to regulate.
The decisions of the 300 experts who sit on the FDA's 18 advisory committees affect billions of dollars in sales. The panel members play a crucial role in determining what drugs will be approved and participate in just about every major decision related to industry regulation.
When it comes to vaccines, the large population in the USA transforms into a lucrative customer base when our government makes vaccines mandatory and keeps adding more and more to the list. Between 2003 and 2006, it was predicted that the annual global market for vaccines would rise from $6 billion to $10 billion, by Mark Benjamin for United Press International on July 21, 2003.
Investors follow the decisions made by the advisory panels closely. A favorable vote by a committee can add hundreds of millions of dollars to a company's stock value which also means the potential for corruption in the panels is enormous.
In a July 18, 2000 hearing, Burton mentioned the problem. "We have a lot of doctors who serve on Federal advisory committees who have serious conflicts-of-interest problems. They’re allowed to vote on vaccines made by companies that they get money from."
An analysis conducted by USA Today, of 159 FDA advisory committee meetings that took place between January 1, 1998, and June 30, 2000, revealed conflicts of interest were wide-spread:
At 92% of the meetings, at least one member had a financial conflict of interest.
At least one committee member had a financial stake in the topic under review at 146 of 159 advisory committee meetings.
At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.
Many parents are now refusing to vaccinate their children because they believe there is an on-going conspiracy by government officials and the pharmaceutical industry to boost profits by mandating unnecessary vaccines, while at the same time, denying their potential for harm. Congressman Burton addressed this issue in a June 19, 2002 hearing:
"Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well."
Burton also noted the need to get honest about the current epidemic. "As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury," he said.
In May 2003, the Reform Committee, released a report that said the "FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule."
As an example the report cited the Hepatitis B vaccine. "When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled." The report identified thimerosal as the cause of the autism and chastised the FDA:
“Thimerosal used as a preservative in vaccines is directly related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal and the sharper eyes of infant exposure to this known neurotoxin. The public health agencies failure to act is indicative of institutional malfeasance for self protection and misplaced protectionism of the pharmaceutical industry.”
Many people have not yet recognized the seriousness of the epidemic, largely because the majority of people have not seen many autistic children due to the fact that parents seldom take their affected children out in public because of the difficulty in trying to control them in a strange environment.
However, the rising numbers in special education classes in the nation's public school system provides a clear measurement of how wide-spread the epidemic has become. State by state statistics for students with autism from the Department of Education for the 12-year period between 1992-93 and 2003-04, are almost unbelievable. For instance, in Ohio in 1992-93, there were only 22 cases of autism, by 2003-04 there were 5,146. In Illinois, there were only 5 cases twelve years ago and 6,005 in 2003-04. Wisconsin had 18 cases of autism in 1992-93 and the numbers rose to 3,259 in 2003-04.
The true reality of these statistics will register in the not too distant future. "With eighty percent of autistic Americans under the age of 18, the dramatic impact of this crisis will be felt by taxpayers in the coming years when these autistic children become adults," says Anne McElroy Dachel, Media Relations Coordinator for the National Autism Association.
Most vaccines on the immunization schedule now are said to be thimerosal-free but some still do contain trace amounts. "An exception is the flu shot, which the Centers for Disease Control and Prevention recommends for pregnant women and for infants 6 to 23 months old,” advises Don Olmsted in United Press International on November 19, 2005.
For 6 to 23-month-old infants, the schedule calls for two flu shots that contain 12.5 micrograms of thimerosal each to be given a month apart. “That total of is the same amount that was in vaccines some parents believe triggered their child's autism," Olmsted advises. "And some of them believe in utero exposure to mercury via the pregnant mother might be the most dangerous exposure of all,” he said.
When deciding whether mercury-laced flu vaccines are safe for children, parents had better think long and hard before rolling the dice.
Evelyn Pringle epringle05@yahoo.com
Evelyn Pringle
A growing number of professionals in the health care field are reporting that a relationship exists between the epidemic in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay all across the country, and the use of thimerosal, the mercury-based preservative used in childhood vaccines.
Vaccines are the only medicines that Americans are mandated to receive as a condition for attendance in school and day care, and for some types of employment. Parents who receive federal assistance are also required to show proof that their children have been vaccinated.
While the mandate for which vaccines must be included on the vaccine schedule is a state mandate, it is the Centers for Disease Control and Prevention (CDC) and its Advisory Committee that make the recommendations to which the majority of states adhere when determining mandates. The current epidemic actually began in the late 1980s when a large number of new vaccines were added to the schedule.
The blame is at least partially attributable to the failure of government officials to keep track of the cumulative amounts of mercury as they added triple-dose-vaccines to the schedule and the amount of thimerosal was multiplied by three.
Each new vaccine contained 25 micrograms of mercury and according to Professor Lynn Adams, of Radford University, who specializes in autism, by 1999, a study determined that the average child received 33 doses of 10 different vaccines by the age 5.
Elected lawmakers first became aware of the problem in 1999, when the House Committee on Government Reform initiated an investigation into the dangers of mercury exposure. An alarm rang early about the exposure of children to thimerosal.
By October 25, 2000, Committee Chairman, Dan Burton (R-IN), was trying to get the substance out of vaccines as quickly as possible and sent a letter to the Department of Health and Human Services, asking the director to get the FDA to recall all vaccines with thimerosal.
“We all know and accept that mercury is a neurotoxin, and yet the FDA has failed to recall the 50 vaccines that contain Thimerosal,” Burton wrote. “Every day that mercury-containing vaccines remain on the market is another day HHS is putting 8,000 children at risk,” he said.
“I implore you to conduct a full recall of these products,” he wrote. “If the only action ... is a gradual phase out, children will continue to be put at risk every day,” Burton warned. “These vaccines will continue to be injected in children for years to come - putting our nation's most vulnerable population ... at risk for mercury poisoning," he added.
The Reform Committee soon discovered that regulatory agencies were still allowing thimerosal to be used decades after the recognition that it was harmful. The Committee was told that the Food and Drug Administration, (FDA), uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency:
"at the heart of all FDA’s product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. The FDA will allow a product to present more of a risk when its potential benefit is great—especially for products used to treat serious, life-threatening conditions."
The argument that the known risks of infectious diseases outweighs any potential risk of neurological damage is one that has continuously been used by officials. The FDA claims that any risk from thimerosal is theoretical because no proof of harm exists.
However, after its review of scientific literature and listening to the testimony of witnesses, the Committee found plenty of evidence to support the fact that thimerosal posed a grave risk. "The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not "theoretical," but very real and documented in the medical literature," the Committee said.
The Committee also discovered that regulatory agencies have never required drug companies to conduct studies on the use of thimerosal. During a June 20, 2002, hearing, Burton questioned officials from the FDA and CDC and said, "You mean to tell me that since 1929, we've been using Thimerosal and the only test that you know of is from 1929, and every one of those people had mennigitis, and they all died?"
In his opening statement at a July 18, 2000, hearing, Burton said:
"We assume that the FDA would protect our children from exposure to any level of mercury through drugs. But that hasn’t been the case. Thimerosal was first marketed in 1930 and has become the most widely used preservative in vaccines. It is present in over 50 licensed vaccines."
"The FDA recently acknowledged that in the first six months of life, children get more mercury than is considered safe by the EPA," Burton noted. "The truth is that sometimes kids go to their doctor’s office and get four or five vaccines at the same time," he added.
"My grandson received vaccines for nine different diseases in one day," Burton said. "He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines."
"According to his weight, the maximum safe level of mercury he should be exposed to in one day is 1.51 micrograms," Burton advised. "This is forty-one times the amount at which harm can be caused," he added.
In his opening remarks at a June 19, 2002, hearing, Burton described the devastation of witnessing the correlation between vaccines and autism.
"My only grandson became autistic right before my eyes – shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing, healthy, grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism."
People often wonder why regulatory officials would protect drug makers. In large part, because the CDC and FDA policy decisions are made through advisory panels whose members have financial relationships with the same companies they are charged to regulate.
The decisions of the 300 experts who sit on the FDA's 18 advisory committees affect billions of dollars in sales. The panel members play a crucial role in determining what drugs will be approved and participate in just about every major decision related to industry regulation.
When it comes to vaccines, the large population in the USA transforms into a lucrative customer base when our government makes vaccines mandatory and keeps adding more and more to the list. Between 2003 and 2006, it was predicted that the annual global market for vaccines would rise from $6 billion to $10 billion, by Mark Benjamin for United Press International on July 21, 2003.
Investors follow the decisions made by the advisory panels closely. A favorable vote by a committee can add hundreds of millions of dollars to a company's stock value which also means the potential for corruption in the panels is enormous.
In a July 18, 2000 hearing, Burton mentioned the problem. "We have a lot of doctors who serve on Federal advisory committees who have serious conflicts-of-interest problems. They’re allowed to vote on vaccines made by companies that they get money from."
An analysis conducted by USA Today, of 159 FDA advisory committee meetings that took place between January 1, 1998, and June 30, 2000, revealed conflicts of interest were wide-spread:
At 92% of the meetings, at least one member had a financial conflict of interest.
At least one committee member had a financial stake in the topic under review at 146 of 159 advisory committee meetings.
At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.
Many parents are now refusing to vaccinate their children because they believe there is an on-going conspiracy by government officials and the pharmaceutical industry to boost profits by mandating unnecessary vaccines, while at the same time, denying their potential for harm. Congressman Burton addressed this issue in a June 19, 2002 hearing:
"Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well."
Burton also noted the need to get honest about the current epidemic. "As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury," he said.
In May 2003, the Reform Committee, released a report that said the "FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule."
As an example the report cited the Hepatitis B vaccine. "When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled." The report identified thimerosal as the cause of the autism and chastised the FDA:
“Thimerosal used as a preservative in vaccines is directly related to the autism epidemic. This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal and the sharper eyes of infant exposure to this known neurotoxin. The public health agencies failure to act is indicative of institutional malfeasance for self protection and misplaced protectionism of the pharmaceutical industry.”
Many people have not yet recognized the seriousness of the epidemic, largely because the majority of people have not seen many autistic children due to the fact that parents seldom take their affected children out in public because of the difficulty in trying to control them in a strange environment.
However, the rising numbers in special education classes in the nation's public school system provides a clear measurement of how wide-spread the epidemic has become. State by state statistics for students with autism from the Department of Education for the 12-year period between 1992-93 and 2003-04, are almost unbelievable. For instance, in Ohio in 1992-93, there were only 22 cases of autism, by 2003-04 there were 5,146. In Illinois, there were only 5 cases twelve years ago and 6,005 in 2003-04. Wisconsin had 18 cases of autism in 1992-93 and the numbers rose to 3,259 in 2003-04.
The true reality of these statistics will register in the not too distant future. "With eighty percent of autistic Americans under the age of 18, the dramatic impact of this crisis will be felt by taxpayers in the coming years when these autistic children become adults," says Anne McElroy Dachel, Media Relations Coordinator for the National Autism Association.
Most vaccines on the immunization schedule now are said to be thimerosal-free but some still do contain trace amounts. "An exception is the flu shot, which the Centers for Disease Control and Prevention recommends for pregnant women and for infants 6 to 23 months old,” advises Don Olmsted in United Press International on November 19, 2005.
For 6 to 23-month-old infants, the schedule calls for two flu shots that contain 12.5 micrograms of thimerosal each to be given a month apart. “That total of is the same amount that was in vaccines some parents believe triggered their child's autism," Olmsted advises. "And some of them believe in utero exposure to mercury via the pregnant mother might be the most dangerous exposure of all,” he said.
When deciding whether mercury-laced flu vaccines are safe for children, parents had better think long and hard before rolling the dice.
Evelyn Pringle epringle05@yahoo.com
December 8, 2005
Guilt
During the DAN! Conference a month or so ago I heard Jaquelyn McCandless speak. She said that the number one thing that pregnant women can do to prevent autism in the child that she is carrying is to avoid milk. My first thought was, "Well there is one more way I screwed my son". I could not get enough milk when I was pregnant, and that was just one more thing I could add to the long list of things that I have done that made me feel like I failed Chandler.
I know that I am not alone in this, as it is a frequent topic of conversation when parents of autistic children gather in a safe place where they can share how they really feel.
If only I had taken better care of myself when I was pregnant.
If only I had not eaten tuna.
If only I had not taken terbutaline.
If only I had breastfeed.
If only I had not vaccinated.
If only I had asked for mercury free shots.
If only I had been paying closer attention.
If only I would have listened.
If only I had not waited so long to get help.
If only I had tried this intervention first instead of last.
If only I had known.
If only I was stronger for him now.
If only....
There is so much guilt to go around, and after more than a year and a half I am only now starting to feel some freedom from it. Surprisingly the freedom from the guilt does not come during the times Chandler makes big improvements, but when I am able to focus on the fact that God had a plan for Chandler to become autistic, has a plan for where Chandler will go from here and has a plan for our family that will make us better people, autism or no autism. Specifically, in that plan, both in the painful parts and in the happy parts, God has something really rich for us, something of true beauty that we would not have been able to see were it not for the specific road he had set us on. It is when I am able to be that person of focus, that I can see our family’s story with perspective, and know that even all my mistakes will be used for beautiful things, if I can yield them to God.
I know that this week is one of those yielded times for me because when I read my email from Children of Destiny this morning I didn't feel that small knife turning in my gut when the subject of my own guilt was brought up. I actually felt joyful and grateful.
I feel like this is one of those moments when I can see the person that I am meant to be, but I know myself well enough to know that I forget all to easily what good things are possible when I really listen to God allow him to give me perspective. So I write this down and publish it out loud so that in six months time when I am freaking out because I am focused on my failures and the failures of others and the insurmountable odds, you, my loyal readers, can cut and paste this blog post into an email and remind me that when I am yielded to God what freedom and humility and joy are possible. Regardless of the circumstances.
If you are a person of faith with an autistic child and you are not currently on the Children of Destiny mailing list, get on it.
I know that I am not alone in this, as it is a frequent topic of conversation when parents of autistic children gather in a safe place where they can share how they really feel.
If only I had taken better care of myself when I was pregnant.
If only I had not eaten tuna.
If only I had not taken terbutaline.
If only I had breastfeed.
If only I had not vaccinated.
If only I had asked for mercury free shots.
If only I had been paying closer attention.
If only I would have listened.
If only I had not waited so long to get help.
If only I had tried this intervention first instead of last.
If only I had known.
If only I was stronger for him now.
If only....
There is so much guilt to go around, and after more than a year and a half I am only now starting to feel some freedom from it. Surprisingly the freedom from the guilt does not come during the times Chandler makes big improvements, but when I am able to focus on the fact that God had a plan for Chandler to become autistic, has a plan for where Chandler will go from here and has a plan for our family that will make us better people, autism or no autism. Specifically, in that plan, both in the painful parts and in the happy parts, God has something really rich for us, something of true beauty that we would not have been able to see were it not for the specific road he had set us on. It is when I am able to be that person of focus, that I can see our family’s story with perspective, and know that even all my mistakes will be used for beautiful things, if I can yield them to God.
I know that this week is one of those yielded times for me because when I read my email from Children of Destiny this morning I didn't feel that small knife turning in my gut when the subject of my own guilt was brought up. I actually felt joyful and grateful.
Thursday, December 8, 2005The idea that God wants me to be free from my guilt, even well deserved guilt, is both humbling and freeing. I want to know that kind of freedom as I walk through life and as I parent my special needs son. I want to have that freedom from the past so that I can be available to make my boys present all that it can be for them.
Let us draw near to God with a sincere heart in full assurance of faith, having our hearts sprinkled to cleanse us from a guilty conscience and having our bodies washed with pure water. (Hebrews 10:22, NIV)
PARENT’S PRAYER:
Heavenly Father,
We thank you for all that you do for us. We especially thank you for cleansing our conscience and our bodies. We pray that you would cleanse us of all guilt that we may feel because of ________’s autism. So often we worry that we may not be doing the right interventions for him/her and sometimes feel guilty. However, as we draw near to you and you show us which path to take, we are set free. So, help us draw near to you. We pray too that our bodies would be washed so that we would be strong and healthy. We again thank you for the destiny that _______ has in you. We pray that your plans for him/her would manifest today. We pray that your anointing would rest on him/her and bring new levels of healing and development to his/her brain. We thank you for each new day, and for the restoration you bring with it.
In Jesus’ name,
Amen
I feel like this is one of those moments when I can see the person that I am meant to be, but I know myself well enough to know that I forget all to easily what good things are possible when I really listen to God allow him to give me perspective. So I write this down and publish it out loud so that in six months time when I am freaking out because I am focused on my failures and the failures of others and the insurmountable odds, you, my loyal readers, can cut and paste this blog post into an email and remind me that when I am yielded to God what freedom and humility and joy are possible. Regardless of the circumstances.
If you are a person of faith with an autistic child and you are not currently on the Children of Destiny mailing list, get on it.
December 7, 2005
CBC Slams Mercury in Flu Shots
Scroll down to Eye on Flu Shot and click "watch the clip".
http://www.airfarce.com/seasons/season13/051202.html
http://www.airfarce.com/seasons/season13/051202.html
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