TACA Talk About Curing Autism - Help, Hope and Support

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Talk About Curing Autism (TACA) provides general information of interest to the autism community. The information comes from a variety of sources and TACA does not independently verify any of it. The views expressed herein are not necessarily TACA’s. TACA does not engage in lobbying or other political activities.

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TACA E-Newsletter

December 2009 #1

Here is your update on TACA (Talk About Curing Autism). If you are new to our site... WELCOME! This newsletter is produced two to four times each month.

We are an autism education and support group. We want to make this e-newsletter informative for you. As always, contact us your thoughts and/or questions so we can improve it.

We focus on parent information and support, parent mentoring, dietary intervention, the latest in medical research, special education law, reviews of the latest treatments, and many other topics relating to autism. Our main goal is to build our community so we can connect, share and support each other.

1. Find a TACA Meeting

Come to a TACA Meeting!

TACA holds monthly meetings in many locations throughout the United States that feature educational speakers on important topics and allow family members to connect with one another and stay on top of the latest information in the autism world. Each TACA group maintains a resource library of the latest autism books, CDs and DVDs that can be checked out by members at no charge.

Check out our group listings: each contains information on TACA meetings and special events as well as a contact form.

Are you wondering what happens at a TACA meeting? Watch our video.

2. Join Us for Coffee Talk!

Come and receive some extra support or to chat all topics related to autism and meet other TACA families at these informal, monthly get-togethers.

› Birmingham, AL
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› Bakersfield, CA
› Burbank, CA
› Long Beach, CA
› Orange County, CA
› Redlands, CA
› Visalia, CA
› Indianapolis, IN
› Glen Burnie, MD
› Gaithersburg, MD
› Hamilton, NJ
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› Tullahoma, TN
› Virginia Beach, VA
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› Milwaukee, WI

3. Capital One Credit Card Benefiting TACA

Support and promote TACA with a Capital One card.
Turn your day-to-day purchases into a real contribution to TACA.

Give back. A $25 donation will go directly to TACA when you make your first purchase, and you'll earn 1% cash rewards on all purchases thereafter, all automatically issued to TACA.
Promote TACA. Share the message and create a buzz while contributing to TACA with every purchase.
Exclusive benefits. Enjoy free online account servicing, special shopping discounts, extended warranty protection, auto rental insurance, and more.

4. TACA 3rd Annual Adopt-a-Family Campaign Update

TACA has received more than double the applications for our 3rd annual adopt family program for the holidays. We are hoping members and friends of TACA can help us help the overwhelming number of families in great need. Several of our regular grants to help this program are not available this year due to a poor economy. How to help? It's simple! Your deadline to be a good citizen: 12/14/2009

Note: If you are a family in need, this request is not aimed at you. How members can help is to ask family and friends to participate in helping TACA members in need. We appreciate your support!

5. Tell Us About TACA's Autism Journey Guide

Families with Autism Journey Guide Do you have a copy of TACA's Autism Journey Guide? If yes, TACA wants to hear from you how the Journey Guide helped your family and how we can continue to improve it.

We would really appreciate if you would provide your input by filling out our online survey about the Journey Guide.

In gratitude for your completed survey, we will send you a TACA car magnet. Thanks in advance for helping TACA to help more families.

Our Autism Journey Guide is given to all parents at their first TACA meeting or can be purchased at Shop TACA.

6. Is the TACA Print Newsletter Coming to Your Home?

This month TACA mailed almost 17,000 printed newsletters. To make sure you receive these printed newsletters twice a year with new content and helpful information - please update your personal information including your address.

7. Pre- and Post-Flu Vaccination Care and Flu Prevention Tips

Flu season is upon us and with the new Swine flu strain, it seems flu is everywhere. We aim to offer you helpful tips to consider to keep your family safe and healthy this flu season, and all year long.

Pre and Post Vaccination Tips

Renowned pediatrician Dr. Bob Sears advises against re-vaccinating any child on the autism spectrum. www.thevaccinebook.com

Doctors recommend that if you are planning on getting a flu vaccine, to follow a “flu-prevention” protocol up until the day of the vaccine. Then 12 hours after the vaccine, start the high dose vitamin A protocol and high-dose Elderberry. Also, give Oscillococcinum if flu symptoms were to arise in the days to follow. (you can print out a coupon at their website!)

Flu vaccines are available in mercury-free formulations. If you choose to give your child a flu vaccine, make sure it’s thimerosal- (mercury) free. We have been hearing from parents that they are having a hard time finding thimerosal-free vaccines and they are being told “take it any way you can get it." We don’t agree. Mercury is a known neurotoxin and should be avoided at all costs. If you are determined to get a vaccine, you should wait for the thimerosal-free version.

Doctors recommend that anyone who has had a vaccine reaction, recent or in the past, try the two days of high dose Vitamin A protocol: for small kids, use 100,000IU twice a day for 2 days, or for large kids and adults to do 200,000IU twice a day for 2 days.

Also consider using Thuja 30C, 3 doses, 12 hours apart.

If your child does get a thimerosal-containing vaccine, then formal chelation with DMSA or DMPS should be considered.

Additional Resource:

Dr. Russell Blaylock’s post-vaccine protocol

Flu Prevention Protocols

The CDC advises that influenza spreads mainly person-to-person through coughing or sneezing of infected people. It recommends the following everyday actions to stay healthy:

Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it. If you do not have a tissue, cough or sneeze into your sleeve.

Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.

Avoid touching your eyes, nose or mouth because germs spread that way.

Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.

Follow public health advice regarding school closures, avoiding crowds and other social distancing measures (keeping a minimum of six feet between people, whenever practical.)

Avoiding contact with people who have had the nasal spray of the vaccine for 11-21 days post-vaccination will reduce your exposure as well because the nasal spray (not the shot) causes viral shedding. See section 14.5 of the FDA’s package insert.

There are many flu prevention supplementation protocols. Most contain the following:

Oscillococcinum - 1 weekly during flu season
Astragalus - 250 mg in am, 3X a week in flu season - if no fever
Echinacea/Goldenseal - 250/175 mg 2X a week
Vitamin D3 - 2000IU/day for small kids, 5000IU/day for older kids and adults
Vitamin C - 500-1000 mg/day
Zinc - 50 mg/day
Probiotics

Additional Resources:

Flu Treatment Protocols

If your child has symptoms of the flu, there are many things you do to help. Cool baths, Motrin, Vitamins D3 and C, Zinc, Elderberry, oscillococcinum, colostrum, probiotics and a low-sugar diet (sugar suppresses the immune system) are general things that help. Below are more specific protocols to consider.

Flu Treatment Protocol:

Sambucus from Quantum Health, it has Sambucus Nigra, Vitamin C, Echinacea, and Mullein, which is great for lungs.
Vitamin D3 - 10,000IU for 3 days
Motrin (NOT Tylenol)
Curcumin (250 mg 2X a day)
Olive Leaf Extract (150 mg, 3X a day)
Gargle with salt water
Hydrate, Hydrate, Hydrate! Water and Unflavored Pedialyte are good choices.

Additional Resources:

8. New Swine Flu Vaccines and Schools

By Holly Bortfeld
November 29, 2009

My children have been homeschooled for a number of years but this year, my 16 year old daughter chose to go back to public school just when schools became vaccine clinics!

Because my daughter has an Autism Spectrum Disorder, she is immunocompromised. I asked her doctor if removing my child from school is necessary and he said, “If they are doing the injections only and not the nasal spray, there is no concern as there is no spread that can happen*. But if they give the nasal spray, either remove her or give her immune booster supplements and have her wear a mask all day, which should reduce the risk about 80%." As you can imagine, the mask did not go over well with my daughter. Nor should she have to be put at risk because the Department of Education decided it was acceptable to perform medical procedures on campus without proper medical monitoring and without regard for immunocompromised children, in my opinion.

My daughter does not have an IEP, but has a 504 plan. Under Section 504, even those without a formal diagnosis or a “504 Plan” but those “regarded” as having a disability are protected.

When I met with the head of special education and the principal before school started, I told them that my daughter would not be getting the flu vaccine and if they chose to give the vaccines on campus, I would remove her each day that they administered the vaccines. Also, if they gave the nasal spray, which has 11 (some research says 21) days of viral shedding because it’s a live virus, that they would have to let her work from home without penalty or put her in "homebound instruction" program during that period.

Our school also was to be implementing a cyber option of the curriculum that they hoped to be ready by October, but wasn’t. If your school district has a cyber option that they can carry on their class work at home which is much more likely at a high school level, you may do that without penalty.

If your school does not have the cyber option and the nasal vaccine is being given on campus, then you will need a doctor’s letter that cites your child’s (and/or his/her siblings) weakened immune system, which if exposed to children who are shedding the virus for those 11-21 days, it would make them even sicker. If they hold a vaccine clinic on campus more than once, this must be repeated each time they hold a clinic. However, if you incorporate this into a “health plan” in the child’s IEP or 504 Plan, you shouldn’t have to repeat these steps as the health plan or IEP will control this matter.

The bad news is that the schools are more likely to use the nasal spray at elementary schools, so they don’t have to deal with all the crying from pointy needles, so parents need to prepare by knowing your state law about homebound instruction and to start boosting those immune systems!!

TIP! Things that boost immune the system are Vitamins C, A, D3, Zinc, Elderberry, Oscillococcinum, Larix, Selenium, Colostrum and Olive Leaf among others. Also remember that sugar is an immunosuppressant so reduce as much sugar, candy, juice and carbohydrates as you can during this time.

About Homebound Instruction

The federal citations for home instruction are: 20 USC Sec. 1412(a)(5) and 34 CFR Sections 300.39 and 300.115

“Because federal guidelines permit children with disabilities to receive an education, even if your child has a temporary disability, the right to continued education is mandated. Under federal guidelines, any child with a disability is permitted to obtain an education in the least restrictive environment possible. For this reason, if your child is unable to attend school, due to a temporary disability, homebound instruction should be considered. Within each school district, there should be a staff of homebound instructors that can provide the delivery of education to your child at home or even in a hospital setting.”

A note about homebound instruction: Please note that if your child is in a 6-hour program at school, that a homebound program will likely provide a teacher for 1 hour a day, not the full 6. Federal law does not set any minimum or maximum hours per day for a homebound program but only says the teacher “will cover the child’s curriculum." States vary in their laws so ask an advocate in your state.

Giving Vaccines on School Campus

Life Health Choices published “An open letter to schools” on their website which you can print off for your school and also has a great primer on the subject.

Another article on giving vaccines in school, from the NVIC.

I checked into my local law (you need to ask about yours) but the vaccine funding only gives the shots to the kids, not the staff. The staff have to get their own shots off campus.

Unfortunately, as you can see from the links below, schools are vaccinating children, even sick children, against parent’s direct wishes and against their consent. To be safe, I have chosen to remove my child from school each day that vaccines will be administered on campus since the schools clearly cannot adhere to the parent’s legal non-consent.

So your choices are to leave your child in school and risk exposure; pull your child out of school and then either

use the cyber option, if available
demand homebound instruction
collect homework for your child to do at home so they don’t fall behind while absent and provide a doctor’s note.

The Legalities of the Situation

Unfortunately the current situation of widespread vaccination on school campus is new and there is no precedent to reference in regards to homebound for children NOT YET ILL. We have kids who will certainly get sick if they attend a school filled with children who are shedding live viruses but since they are not yet sick, do they fall under the legal guidelines for Homebound Instruction? The current law is unclear, but the Courts are required to consider each child’s needs on an individual basis if that child has an IEP in place.

It wasn’t our choice to fill the school with virus shedding kids and leaving our kids in with the vaccinated kids is a risk not worth taking for a lot of people, especially with immunocompromised children, such as those with ASD.

We ask: What legal basis does the school have to DENY your child education during the school’s self-imposed viral outbreak?

Sample Letters From Your Doctor to the School

Here are two samples of the types of doctor’s letters that you may need. The first is if you are requesting homebound instruction.

Letter example #1

I am the treating physician for [insert child’s name]. [insert child’s name] has a weakened immune system and therefore should not be exposed to persons vaccinated with the nasal spray of the flu vaccine, seasonal or H1N1, for a minimum of 11 calendar days after administration. The vaccine manufacturer’s package insert says that immunocompromised people are at risk from the nasal vaccine’s live virus (17.2 Medimmune Insert) therefore, I am recommending for [insert child’s name] be removed from the school campus during these periods of on-campus live virus vaccine administration. I am also recommending that the school district provide home instruction by appropriately credentialed personnel while [child] remains at home. This live-virus blockade also extends to any staff sent to the house to work with [insert child’s name].

Letter example #2 If you are not requesting homebound instruction.

Please excuse [insert child’s name] from school for the period of [enter dates here] due to his/her immunocompromised state.

Why wouldn’t I want my child to get the H1N1 vaccine?

In case you are new to this subject…

Even the FDA says they don’t know if it’s safe for anyone under the age of 18, or pregnant women.

“Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or in persons less than 18 years of age. (8.1, 8.3, 8.4)”

The “safety” study compared a placebo that contained thimerosal, therefore skewing all data from the trial as a placebo, by definition, should not contain known reactive toxins. (Table 1, line 130; Table 1, line 141) section 14.5 discusses viral shedding.

This research paper discusses the viral shedding from live virus vaccines.

Need a Primer on Why Giving Mercury (Thimerosal) to Children is Stupid?

The Dangers of Mercury in the H1N1 Vaccine article

Placement - Homebound

Homebound Education State-by-State Comparison

The following was excerpted from SpecialEdConnection.com, by LRP, a company that advises schools on how to combat parents in the fight for adequate education for their children.

In some cases, a homebound placement is appropriate for a student with a disability.

Key Points:

Circumstances When Homebound Placements are Appropriate

Special education includes specially designed instruction conducted in the home. 34 CFR 300.39 (a)(1).
Although considered the most restrictive placement on the LRE continuum of alternative placements, a homebound placement may be appropriate for some students with disabilities. See generally 34 CFR 300.115 (b).
Homebound placements are often deemed appropriate for students with disabilities who are unable to attend school for medical reasons, whether on a permanent or temporary basis. See, e.g., Walker County Bd. of Educ., 31 IDELR 152 (SEA AL 1999); Northside Indep. Sch. Dist., 33 IDELR 201 (SEA TX 2000); Hawaii v. Katherine D., 555 IDELR 276 (9th Cir. 1983); and Williford Sch. Dist., 29 IDELR 298 (SEA AK 1998).
Some schools require a doctor's recommendation for students who seek homebound instruction due to a temporary disabling condition. This is a wise practice because it documents the need for such an arrangement. See Jefferson City (MO) Sch. Dist., 19 IDELR 437 (OCR 1992); Richmond (VA) City Pub. Sch., 19 IDELR 440 (OCR 1992). However, the LRE presumption would require a return to the typical school setting, if and when it was determined to be appropriate to the student's educational needs.

Entitlements for Homebound Students

Homebound students have the right to receive the same special education entitlements and protections as other students - the only difference is that these special education programs are implemented in the home rather than in an educational facility.

Unilateral Homebound Placements

Parents have been allowed to recover expenses associated with a unilateral homebound placement under the same circumstances where reimbursement has been awarded to unilaterally placed private school students, in accordance with Burlington v. Department of Education for Massachusetts, 556 IDELR 389 (1985). Also see Brad J. v. Commonwealth of Pennsylvania, 22 IDELR 712 (E.D. Pa. 1995).

Participation in Extracurricular Activities by Students on Homebound

For students on homebound instruction who are physically able to participate in school district extracurricular activities and are desirous of doing so, the failure to include students in this regard may constitute discrimination under Section 504 and the ADA. See, e.g., Morris (NJ) Sch. Dist., 31 IDELR 170 (OCR 1999).

9. Surviving the Winter Holidays Advice!

Below are submissions from parents like you who have been there/done that and want to share their advice on surviving this time of year:

We'd also love to hear from you about your experiences and advice!

10. New High School Club Seeks to Eliminate Hate

Sticks and stones can break your bones but names can never hurt you. Right? While children have sung that song since before any of us can remember, a new club at Coronado High School in Coronado, California knows that words can hurt. Voices Against Cruelty, Hatred and Intolerance, known as VACHI for short, seeks to educate students, teachers and parents about the harm caused from hate motivated behavior, including bullying, harassment and name-calling. VACHI hopes that with education they can eliminate hate motivated behavior on campus.

VACHI, the brain-child of junior, Joey Langerman, who was looking for a novel idea for his Boy Scout Eagle Project, is believed to be the first club of its kind. But that fact doesn’t stop Joey from thinking globally. One of the first things Joey did was work with local web designer who donated his time for the project. VACHI now has a web presence that will help to bring the “No Hate” message to other schools around the country.

Joey was motivated when he read about several students who committed suicide after being bullied at their schools. Despite reporting those incidents to school officials, nothing changed and finally several teens killed themselves. While none of those suicides occurred in Coronado, Joey knew that kids at his school were contributing to the spread of hate. He hopes VACHI will spark a change. VACHI created, funded and placed “No Hate Zone” signs (available on their website) in each classroom and teachers made sure that students were aware of the new philosophy. VACHI’s message is clear: every student is entitled to a physically and emotionally safe place to go to school.

VACHI’s hope is to empower students to stop spreading hate and to stand up against hate when it is witnessed. In his research to start this club, Joey learned that most incidents of bullying and harassment are unreported because the victims are afraid and feel powerless. Joey thought that if it became “cooler” to speak out against hate than to side with the abuser, maybe the incidence of hate would be reduced. The message to students is simple: Think before YOU speak and if you see someone bullying, harassing or name calling another student, stand up and say, “Hey, that’s not cool”. If everyone then sided with the victim, the abuser would lose his power. “Hate behavior is about power. If we take the power away, we can stop the hate,” says Joey.

VACHI recognizes that hate behavior is learned. VACHI encourages parents to model tolerance and help teach the “No Hate” message. VACHI is hoping other high school students will start chapters in their school (materials available on their website). The club’s email is hatehurts@vachi.net. VACHI also has a Facebook page. Joey asks that everyone become a VACHI FAN on Facebook. Joey’s final words ring strong: “Together, we can start a movement.”

11. Daily Autism Updates for Families

All news related to autism:

For daily updates to all autism legislative issues: ChangeforAutism.org

AgeofAutism.com

12. The number of adults with autism is growing

ABC 13

The numbers are staggering. One in every 150 babies in the U.S. is now born with autism. The rate for boys is even higher. But what happens to those children when they grow up?

Beth Meyer is a hard worker. Beth has always been good with her hands. But her autism affects her ability to interact with people.

Vicki Obee-Hilty is executive director of Bittersweet Farms in Whitehouse where the focus is on adults with autism.

"It is not an institution. It's not where you've just taken a group of people and isolated them. This is a viable farm."

A farm Beth and 29 other adults call home. Beth has an apartment there and a paying job.

Phil Bartus goes for the day program. He has his own apartment off-site, with some help. Phil makes furniture in the woodshop and is also a ham radio operator.

Phil and Beth are both highly functioning. Yet many autistic adults are unable to work. They live with family or in group homes, and their numbers are growing. In the twenty-six years since Bittersweet opened, autism diagnoses have soared nearly 1,000 percent.

Vicki says, "These kids are coming through the system. You're seeing a bubble in the numbers now. Parents now have teenagers and they're saying 'what is the next step'?"

The next step for Melanie Arend was her first job. Melanie got the job through the Autism Model School where she attends classes.

Tom Peters from George F. Peter Son Inc says, "It's pretty simple, she shows up on time, shows up when she's supposed to be here and she shows up with a good attitude."

Melanie has become a valued employee; getting her name on the marquee for her 17th birthday and earning a steady paycheck.

She says working gives her a sense of accomplishment.

Patrick Sabin is Melanie's classmate. He's also seventeen.

Patrick's mother Barb Sabin says, "He would never grow up and move out. I knew that would never happen. It wouldn't be a so-called normal life like everybody else. It was pretty devastating to find that out. I think you just go through a grieving process like everything else. Then you just accept it and try to move on."

Classes there teach life and job skills. But those who provide adult services say there aren't nearly enough.

"To be able to live and have a job, for many people, it's going to take partnership with society, with their communities to make that happen", says Vicki. "It is possible. I'm very optimistic that is possible. But those for whom that are unattainable, families are going to need support."

Experts say people with autism need lifelong support. The growing number of cases means our country will eventually have to fund more services for autistic adults.

13. Diabetes Cases to Double in 25 Years

Yahoo News

If Americans don't eat better and exercise more, diabetes cases will double by 2034 and costs to care for the patients will triple, according to a new report that paints a bleak picture of the future.

With diabetes, the body fails to metabolize glucose, or blood sugar. Diabetes is the leading cause of amputations, blindness, and end-stage kidney disease.

Obesity, poor diet and lack of exercise are all known factors that have contributed to an already serious increase in type 2 cases, the variety that is largely preventable and comprises about 95 percent of all cases.

One example of how out of control the situation has become: A 1991 study projected U.S. diabetes cases would double, from 6.5 million in 1987 to 11.6 million by 2030. We're already at 23.7 million cases.

"If we don't change our diet and exercise habits or find new, more effective and less expensive ways to prevent and treat diabetes, we will find ourselves in a lot of trouble as a population," said the study's lead author Dr. Elbert Huang, assistant professor of medicine at the University of Chicago.

The study is detailed in the December issue of Diabetes Care.

It projects costs associated with the disease will rise from $113 billion per year now to $336 billion by 2034, even with no increase in the prevalence of obesity. The researchers project that obesity rates will level off. If that doesn't happen, even more cases of diabetes will develop, they say.

Much of the increase in cases and in costs will be driven by aging baby boomers, the 77 million Americans born between 1946 and 1957 who are approaching the age of retirement. Because diabetes is now diagnosed earlier in life and treatments are more effective, people with the disease live longer.

"This leads to a longer history of disease, opportunities for more aggressive therapies, and time to accumulate complications, which are costly to treat," the researchers said in a statement.

Boomers are generally less healthy (and less happy) than the previous generation. Half of Americans aged 55-64 have high blood pressure, a major risk factor for heart disease and stroke, according to a 2005 report from the Centers for Diseases Control and Prevention.

"The public policy implications are enormous," said co-author Michael O'Grady, senior fellow at the National Opinion Research Center at the University of Chicago. "This a serious challenge to Medicare and every other health plan in the country. The cost of doing nothing is the significant increase in the pain and suffering of America's population and a financial burden that will threaten the financial viability of public and private insurers alike."

14. An Autism Mom's Video Response to the Chicago Tribune Story

Age of Autism

“This Too Shall Pass…..”

By Jacey Capurso

I sit here, banging away on my computer, as I continue to reverse the effects of my local hometown rag’s recent articles on biomedical interventions. Family, friends and foes have all emailed me the articles with “Have you seen this?” in the subject box. I have responded to each and every one of them. I reply with one line comprised of one link of one boy who conquered one disorder in the video below.

Living in the Chicago area last week had fired me up once again. Local biomed moms were more than prepared for the articles as emails and yahoo group posts flew around the Windy City. The news of the imminent publishing of, again, some crappy story on biomedical treatments for autism was the hot topic of the week. Honestly, I have resorted to not even justifying the articles as they are absolutely ludicrous. I believe some journal articles justify a healthy back and forth discussion about the treatments, but this series of reporting (if that is what they call it) was not even worth one breath.

Last Saturday night, with husband out of town and kids asleep, my furor continued to burn as I sat at my computer and awaited the “Sunday Paper” to be posted on the Chicago Tribune website. It was “the anger” I had not felt in a long time. In the past 2 years I have been living with some sense of peace as “the anger” was eating me alive. Don’t get me wrong, I am chronically disgusted with the snail’s pace of autism research and the continual run around from our government. I am regularly appalled at the comments from pediatricians and neurologists who have the nerve to look parents in the eye and say, “Find a happy place for you and him. By the time he is a teen, he will be institutionalized.” (An actual quote from a world-renowned epileptologist who diagnosed my son at age 3 with a seizure disorder.) How dare anyone give up hope on my child? Thus, despite my new leaf I have turned, my inner peace had given way to a fiery fit of rage.

However, in light of the upcoming Thanksgiving holiday, my grandmother’s words began to echo in my inflamed brain. “This too shall pass.” Jesus, was I really going to resort to some old fashion maxim when the world is tearing itself apart and destroying our children? Mimi died over 15 years ago when the autism rate was 1 in 10,000. I wondered if she would say this now.

Regardless, I exited out of my biomedical emails and autism yahoo pages. Scanning the screen, I found and clicked on my iMovie icon, which had sat quietly in the corner of my desktop ever since I bought this computer 3 years ago. It had never been touched, yet alone opened. And for the next 5 hours, I worked away at my rebuttal to whatever was coming out of the Chicago Tribune. I watched my final cut at 2 a.m. and had never felt better in my life. My son flickered before me in his You Tube debut and all the anger I had welt up and all the frustration I had harbored earlier that week all faded into a dim memory. I had just witnessed the last 6 years of my life flash before me. All the pain, struggle and sweat had paid off. All the therapy and medical interventions had worked. There is nothing you can say to me that will make me believe otherwise, especially not some flakey words on a piece of newspaper that arrived at my doorstep one morning. The effects of a printed page is nothing compared to my living, breathing recovered son….my recovered son from biomedical intervention.

Thus, remember this of the Chicago Tribune’s Chicago Tribune's articles, “this too shall pass.” Our children are the real story.

At Peace Once Again and Happy Thanksgiving

Jacey Capurso is a mother of a 7 year old son who is recovered from Autism and a 6 year daughter who is recovered from IBS using biomedical intervention. With the tenacity of some dedicated doctors, incredible therapists, and other warrior mothers who have gone before us, her children are incredibly healthy and happy. She now dedicates herself to those who continue to lead the way for real medical interventions for our sick kids....and cried like a baby when her son said the entire Lord's Prayer at the Thanksgiving feast."

Jacey's Quote: "I am tired of hearing how 'the road to recovery (from autism) is not a sprint. It is a marathon.' There is nothing further from the truth! There is no one long, straight, paved road to a finish line. Rather, the path to recovery from autism is more like scaling Mount Everest. It is a climb up a treacherous terrain with jagged edges and loose rocks. You will occasionally have to hold on with your fingertips or stumble back down a couple feet. You always have to look up and reach higher than you ever thought possible, never looking down. You will sweat; you will bleed; and you will scrape your knees along the way. But with others holding your rope, supporting your falls, and lending their hand, you can reach the summit!"

15. Superstar CBS Reporter Blows the Lid Off the Swine Flu Media Hype and Hysteria

Sharyl Attkisson is a CBS News correspondent and investigative reporter. She’s covered Capitol Hill since February 2006 and has been a Washington-based correspondent there since January 1995. She was also part of the CBS news team that received the Edward Murrow Award in 2005 for overall excellence. Additionally, she received an Outstanding Investigative Journalism Emmy in 2002 for a series on the Red Cross.

In case you didn't realize it, Sharyl Attkisson is the investigative reporter behind the groundbreaking CBS News study that found H1N1 flu cases are NOT as prevalent as feared.

In fact, they’re barely on the radar screen.

How did this startling information come about, and why is the U.S. Centers for Disease Control and Prevention (CDC) painting a different picture entirely? I spoke directly with Sharyl Attkisson to find out.
Two Videos

The first video is an amazing interview I did with Sharyl about ten days ago and what the bulk of this article is based on.

The second video is brand new and was done at noon yesterday in which I was videoed in the CBS studio in downtown Chicago. Sharyl was gracious enough to invite me to be on with Dr. Bernadine Healy, the former director of the NIH. We both were in agreement about the swine flu and opposed to the stance the CDC is taking, but we had different views on mammograms.

Please also watch the second interview as it is very entertaining.

Getting Started on the Swine Flu Trail
Ms. Attkisson says:

“The reason I looked into this is a couple of months ago, I got tips from three or four different segments of public healthcare, with folks telling me the CDC has recommended that they go ahead and stop testing for and counting swine flu cases.

Each different entity that contacted me was concerned, thinking that this should not be happening. They really felt that it was necessary for the swine flu to continue to be tracked in some details. So I went about trying to find out why this decision was made and what the ramifications would be.

… I started by contacting the CDC and the HHS and asking some basic questions. I felt like I pretty much got stonewalled with some of the information I really needed to get at, especially what I needed from the states data, and information on the rationale behind this decision to stop counting and testing for swine flu.”

Because the CDC did not initially respond to Attkisson’s requests, she contacted all 50 states directly, asking for their statistics on state lab-confirmed H1N1 prior to the halt of individual testing and counting in July. She also asked states, one by one, to help explain the rationale behind the CDC’s decision to stop tracking H1N1 cases.

Attkisson continues:

“One of my good sources within the government said to me that they’re either trying to, in his opinion, over-represent the swine flu numbers or under-represent by not counting them anymore. He said, “You need to find out which it is.” And so to find out which it might be, I really wanted to see the data that the CDC had at the time it made the decision to quit counting the cases.”

What Her Investigative Report Reveals

If you listen to most media outlets and even to government agencies, you get the impression that virtually every person who has visited their physician with flu-like symptoms in recent months has H1N1, with no testing necessary because, after all, there's an epidemic.

We are all being led to believe that every case diagnosed as “swine flu” or even as “flu-like illness” is, in fact, swine flu.

But Attkisson’s investigation revealed a very different picture right from her first contact with individual states. She explains:

“Across the country, state by state, they were testing [for H1N1] until CDC told them not to bother. They were testing, in general, the cases most likely to be believed to have been swine flu based on a doctor’s diagnosis of symptoms and risk factors such as travel to Mexico.

These special cases were going to state labs for absolute confirmation with the best test -- not the so-called “rapid testing,” but the real confirmation test.

Of those presumed likely swine flu cases out of approximately every hundred of what was tested, only a small fraction were actually swine flu. In every instance, perhaps the biggest number of cases that were swine flu was something like 30%. The smallest number was something like 2% or 3%.

Maybe there’s one state where it was just 1%.

The point is, of the vast majority of the presumed swine flu cases recognized by trained physicians, the vast majority were not flu at all. They weren’t swine flu or regular flu; they were some other sort of upper respiratory infection.”

And here is the clincher that it seems the CDC just doesn’t want the American public to know …

“The CDC explained that one of the reasons they quit counting was because of all the flu that’s out there, most are swine flu. Well, that’s true. Most of the flu that was out there was indeed swine flu, but they failed to say that most of the suspected flu was nothing at all. And I think that’s the caveat the public just didn’t know,” Attkisson explains.

She gives even more striking examples of the numbers the investigative report revealed. For instance:

In Florida, 83 percent of specimens that were presumed to be swine flu were negative for all flu when tested!

In California, 86 percent of suspected H1N1 specimens were not swine flu or any flu; only 2 percent were confirmed swine flu.

In Alaska, 93 percent of suspected swine flu specimens were negative for all flu types; only 1 percent was H1N1 flu.

Freedom of Information and Getting the Truth Out

It is not easy for journalists to access this type of information, and they often have to wait weeks, months or even years for information from the CDC and the FDA -- information that is readily available and supposed to be clearly public.

Attkisson expands on the difficulties she faced in trying to get simple data regarding swine flu cases in the United States:

“They [CDC’s public affairs] quit communicating with me when I pressed on why I couldn’t get certain information. They just wouldn’t answer my emails anymore. So I had to file a Freedom of Information request, which is usually my last choice because I know I was going into a deep black hole many times and I’ll never get an answer.

But in this case, I got an interesting response on October 19 from the CDC when I had asked for some simple, public documents that would have been easy for them to obtain too quickly.

Journalists are allowed to ask for expedited processing of their Freedom of Information request because, for obvious reasons, they’re working on a story that may have public impact or be of public interest. The agencies are not supposed to use the Freedom of Information Law to obstruct or delay the release of this information.

This may be the first time I was denied that expedited processing from Freedom of Information that we’re entitled to as members of the press; a letter from HHS or Health and Human Services (the CDC is under HHS) said to me that one of the reasons they’re denying my expedited processing is because this is not a matter of “widespread and exceptional media or public interest.”

In other words, the CDC doesn’t think these questions about swine flu prevalence and these other things that we’ve been asking are, at least in their opinion in this letter, not a matter of widespread and exceptional media or public interest.”

Yet, while the CDC expressed that questions about swine flu prevalence were not a matter of widespread media or public interest, the President had declared the swine flu a national public health emergency!

The inconsistencies at the CDC are nearly incomprehensible.

The Ramifications of the Swine Flu Policy

According to Attkisson’s CBS News study, when you come down with chills, fever, cough, runny nose, malaise and all those other "flu-like" symptoms, the illness is likely caused by influenza at most 17 percent of the time and as little as 3 percent! The other 83 to 97 percent of the time it's caused by other viruses or bacteria.

So remember that not every illness that appears to be the flu actually is the flu. In fact, most of the time it's not.

Curiously, the CDC still advises those who were told they had 2009 H1N1 (and therefore should be immune to getting it again) to get vaccinated unless they had lab confirmation.

But because very few people have actually had a lab-confirmed case of H1N1 (and in most cases those people told they had swine flu probably did not), this means nearly everyone is still being advised to get the swine flu vaccine.

Attkisson has been one of the few to speak out against this flawed system and point out the serious ramifications that come when a public health agency is secretive about their health data.

Attkisson says:

“From a public and journalistic standpoint, I believe the mistake comes when you don’t fully disclose to the public as you go and discover the mistakes. Try to disclose and fix things that come up.

Everybody understands that there isn’t a perfect system, but I think you need to be upfront with them, explain what you’re doing, and explain what you’re discovering. If you’ve made a mistake or you feel like you need to correct something, say that, too, but don’t just try to keep information from the public.”

I couldn’t agree more, and Attkisson’s CBS News report has stood out like a bright light of truth among all the clouds of misinformation.

If you’d like to learn more about the report and its findings, you can read all the details in the past article CBS Reveals that Swine Flu Cases Seriously Overestimated.

16. Swine Flu Pandemic May Be Less Severe Than Expected

Data indicates that, while serious, virus impact predicted to be mild

TUESDAY, Dec. 8 (HealthDay News) -- A new joint American-British study suggests that the impact of the H1N1 swine flu pandemic during the autumn-winter flu season will be less severe than had been feared.

"As more detailed data have become available, we have been able to improve our estimates of how severe this disease is. Early on, it was difficult to measure the flu's impact and it was crucial to plan for the full range of possible outcomes. Fortunately, the virus now appears to be near the milder end," study senior author Marc Lipsitch, professor of epidemiology at Harvard School of Public Health, said in a news release.

The study authors analyzed the pandemic in the United States by looking at national statistics from the U.S. Centers for Disease Control and Prevention (CDC) and local statistics in Milwaukee and New York City. Researchers chose those two cities because they thought they did a good job of keeping statistics.

In particular, the researchers made their projections by examining the number of people who were hospitalized or in an intensive care unit or on a ventilator, along with the total of those who had died.

"The good news is that, along with previous work by the CDC and others, our work shows that the severity of the H1N1 flu may be less than initially feared," Lipsitch said. But between one in 70 and one in 600 people who get the illness will be hospitalized, he noted.

"This is a serious disease," he added. "The CDC and others have shown that certain high-risk groups, including pregnant women, people with asthma and people with compromised immune systems, should be vaccinated and should seek prompt treatment if they suspect they are sick with H1N1. Even for people outside these high-risk groups, vaccination is an important way to reduce the risk of what can be a serious illness."

The study is published in the Dec. 7 online edition in the journal PLoS Medicine.

17. Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy

Age of Autism, By Dan Olmsted and Mark Blaxill

Paul Offit, vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents, according to a new analysis by Age of Autism. Our analysis also shows that Offit’s future royalty income is strongly tied to Rotateq®’s future sales in domestic and international markets, giving him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.

This new analysis by Age of Autism updates an earlier report in which we detailed Offit’s financial conflicts. Our original report, derived through independent reporting on which Offit and his employer would not comment, was based on information that we have since learned did not reflect recent changes in practices on sharing patent revenues with inventors and a private agreement on revenue sharing between Offit and his co-inventors. Our new estimate of Offit's total profit of $13-35 million through 2019, overlaps the range of our original estimate of $29-55 million. Both those estimates exceed Offit's recent -- and apparently partial -- disclosure that he made "about 6 million.”

The connection between Offit’s public role as an authority on vaccines and autism, and his financial interests, is rarely mentioned when Offit is quoted in news accounts. And although he once received harsh criticism from a Congressional committee for his participation in a government advisory panel while his own patented vaccine, Rotateq®, was undergoing clinical trials, he continues to seek opportunities to influence the public debate without apparent consequence. The magnitude of Offit’s ongoing financial benefit from this public advocacy is described for the first time here.

Offit did not respond to a request for comment. We also asked one of the patent owners, the Wistar Institute, about the arrangement in order to confirm our calculations. “Wistar is one of the owners of the patent” and licensed it to Merck, said Meryle J. Melnicoff, Director of Business Development, referring us to the Wistar Web site for details on how Wistar shares license royalties to inventors. This statement supports the analysis below.

New information from Offit allows more detailed analysis

We previously reported (HERE) that Offit, co-inventor of Merck’s Rotateq® vaccine, sat on the regulatory body that held the authority to create the market for the rotavirus vaccine category, participated in committee deliberations that bore directly on the commercial value of that category and voted in favor of measures that expanded the resulting market; all this while a vaccine formulation protected by his patented invention in the same category was proceeding through clinical trials. We estimated the personal profit Offit made when his own rotavirus vaccine was subsequently approved, marketed and a portion of his royalties securitized in a transaction worth $182 million. We asked Offit and his employer, the Children’s Hospital of Philadelphia (CHOP) to comment on our estimates but CHOP declined comment and Offit never responded to our inquiry.Recently, however, Offit has revealed to others additional information on his personal stake in Merck’s Rotateq® vaccine (for Offit’s public emails on this issue, see HERE). These new disclosures enable us to refine our earlier estimates and present a sharper picture of Offit’s financial interest in the success of the invention his sponsors at CHOP and the Wistar Institute licensed to Merck. Our original analysis estimated Offit’s profits from Rotateq® in a range of $29-55 million, all of which we suggested flowed to him following a single lump sum payment to CHOP from a financial firm called Royalty Pharma. Offit now claims that the one-time payment from CHOP was less than our estimate, revealing to Amy Wallace of Wired Magazine that CHOP paid him “several million dollars” and to others that he received “about $6 million.”

“It was a ridiculous amont [sic] of money…but it is also a far cry from what has been claimed.”

Offit’s recent revelations do little to change our conclusion, that he was “voting himself rich” while sitting on a government vaccine standards body. But they do suggest that our assumptions regarding the way in which cash flowed from Merck’s Rotateq® account to his own pocket were incomplete. And while we have no reason to question Offit’s disclosures regarding his share of CHOP’s securitization deal with Royalty Pharma (or his claim that this lump sum payment was less than we estimated), we also describe here how Offit’s disclosure of this lower payment does not constitute full disclosure of his financial interest in Rotateq®. Instead, Offit’s recent statements have continued his pattern of partial disclosure of his financial relationship with Merck (see HERE for an earlier report from CBS News on this pattern of partial disclosure), failing to mention at least one other lump-sum payment and downplaying the full extent of his ongoing financial relationship with Merck’s vaccine business.

Based on two crucial new disclosures from Offit, we estimate in a revised and more detailed analysis that Offit has received and will continue to receive multiple payments based on Rotateq® licensing revenue, that he may already have earned $10 million from Rotateq® and that he stands to earn between $13-35 million over the lifetime of Rotateq’s key patents (based on different assumptions regarding the product’s future worldwide sales forecasts). In the first of these two disclosures, Offit has revealed that he had an agreement to share the royalty payments with his co-inventors, Stanley Plotkin and Fred Clark; this agreement reduces our estimate of his payout from the Royalty Pharma deal, but since CHOP owned only half of the rights to the patents, we are now able to estimate his share of Wistar’s inventor payments, a source of wealth that we had not previously assigned to him. In his second disclosure (one that reinforces the finding that he has shared in distributions from the Wistar Institute’s royalty revenue), Offit has revealed that he is receiving a “continuing royalty each year” for Rotateq®, a royalty stream that could only come from Wistar. Taken together, these two disclosures provide a clearer picture of Offit’s path to personal wealth while also demonstrating that his ongoing royalty stream gives Offit a large and continuing financial stake in the success of Merck’s Rotateq® business.

If Offit had chosen to reap the benefits of his invention privately, there would be little public interest in publication of his stake in Merck’s Rotateq® revenues: inventors have every right to profit from their inventions and companies have every right to fund the commercialization of innovative new products. But Offit’s ambitions are larger than Rotateq®; he has thrust himself into the spotlight as both a vaccine safety authority and an autism expert, spokesman roles that have little to do with his work on Rotateq®. In these dual roles, he has worked aggressively to diminish public concerns over rising autism rates while deriding those who express concerns over vaccine safety. In effect, he has moved beyond his original rotavirus expertise and taken on a new career as a booster of the American medical industry, writing books on autism and vaccines (with another on what he calls the history of the “anti-vaccine” movement on the way), participating in highly publicized conflicts with several of the world’s leading autism charities and eagerly providing talking points for numerous media articles and books. Because he has approached this new career donning the mantle of a disinterested expert scientist, we contend that Offit’s personal financial connection to the world’s leading vaccine manufacturer is a matter of legitimate public concern, since Offit’s efforts serve both his own and Merck’s ongoing financial interests. Beyond promoting Rotateq®’s worldwide growth, Offit’s advocacy benefits Merck’s ongoing vaccine business, which has confronted controversial issues such as withdrawals, adverse reactions and regressive autism in products like ProQuad®, Gardasil®, and MMR II®.

Our reporting on this issue is also a matter of public interest, since our estimates of Offit’s Rotateq® riches have attracted widespread attention. Offit has commented with bitterness on our coverage of his Rotateq® payments, complaining that “It hurts to watch people slander me the way they do.” Most notably, we have received hostile (and in one case threatening) messages from readers who take issue with our estimates. Although these threats have concerned us, they have also been a useful source of new information, the full implications of which our critics had clearly not grasped. After a thorough new investigation, we decided, in an unusual exercise in financial forensics, to undertake a reanalysis of the Offit’s Rotateq® related finances.

Our financial forensics analysis has led us to investigate of two different types of payments

1. Lump sum payments distributed to Offit and his fellow inventors by both CHOP and the Wistar Institute following transactions in which each institution sold a portion of its royalty streams to a financial investor. We have estimated the size of the distributions in these two deals based on Offit’s disclosures, public descriptions of the terms of each deal and some basic financial analysis.

2. Ongoing distributions to Offit and his fellow inventors based on direct payments from Merck to either CHOP or the Wistar Institute. These distributions include both past payments that we have estimated based on reported Rotateq® revenues and future payments for which we have forecasted ranges of annual payments based on different forecasts of Merck’s future worldwide Rotateq® revenues.

After developing estimates of the size of each lump sum or direct royalty payment, we then add up all the payments to obtain a complete estimate of the wealth that has flowed and will continue flow to Offit from his financial connections to Merck.

Offit’s lump sum payments

1) The CHOP securitization deal with Royalty Pharma Trust. On April 24, 2008, The Children’s Hospital Foundation (CHF, CHOP’s parent company) and Royalty Pharma announced that CHF had “sold its worldwide royalty interest in respect of sales of RotaTeq® from and after October 1, 2007, to Royalty Pharma for $182 million in cash.” This large and relatively simple transaction represented a large financial windfall for CHOP. Two months later, Moody’s Global Credit Research reported that “CHOP's strong investment position continues to be a major credit strength”, in large part because “in April CHOP received $153 million in proceeds from the monetization of royalty rights related to the development of a vaccine for rotavirus.” Although both announcements reported on the same transaction, we have been unable to fully explain the $29 million difference between Royalty Pharma’s reported payment ($182 million) for CHOP’s royalty interest and CHOP’s reported proceeds ($153 million) from the monetization of its royalty rights.

In calculating Offit’s stake in this transaction for our earlier report, the simplest plausible scenario involved two assumptions: 1) that CHOP’s sole inventor was Paul Offit and 2) that the difference between Royalty Pharma’s payments and CHOP’s receipts represented CHOP’s distribution of royalties to the vaccine’s inventor(s). At the time, the information we had suggested this was a likely scenario. With respect to Offit’s standing as CHOP’s sole inventor, we reviewed the file history for the Rotateq® patents and obtained copies of the “assignment agreements” for both CHOP and Wistar (in most American commercial research enterprises, inventors assign ownership rights for their inventive work to their employers). In the case of the Rotateq® patents, these file histories documented two separate assignment agreements: in one, Paul Offit signed the form ceding his inventor rights to CHOP; in the other, Fred Clark and Stanley Plotkin assigned their inventor rights over to Wistar (for copies of the actual assignment agreements see HERE).

Since neither CHOP nor Offit were willing at the time to disclose the payments he received for Rotateq®, in calculating the dollar amount of royalties distributed to the inventor(s) we based our analysis on two sources: CHOP’s current patent royalty policy and the patent royalty policy of a sample of comparable institutions. We learned that CHOP’s current policy provides inventors with a distribution share equal to 30% of royalties; we also learned that in a sample of comparable institutions (including university-affiliated children’s hospitals) reported inventor distributions ranged from 15-35%. Finally, we noted that the $29 million difference between the announced Royalty Pharma payment of $182 million and the reported proceeds of $153 million to CHF was 15.9% of the Royalty Pharma payment.

In the absence of any response from CHOP or Offit, we decided to report a range of possible payments and to estimate the low end of the range using an inventor(s) share of 15.9%: in part because we preferred to emphasize the most conservative estimate, and in part because the difference in reported payments to and receipts by CHOP of $29 million came to 15.9% of $182 million. Based on the evidence from the assignment documents, we assumed that the entirety of this inventor payment went to Offit.

According to Offit’s recent disclosure, it appears now that this scenario was not what actually occurred. In fact, the full inventor team—including Offit, Clark and Plotkin—shared in the CHOP payment. Based on the current CHOP policy, it is clear that such private arrangements between inventors are anticipated. “If there is only one such Inventor, Author, or other creator, the total Inventor Share is payable to that person” reads the “Patent and Intellectual Property Policy” from CHOP’s Administrative Policy Manual. But “where there is more than one such Inventor, Author, or other creator, and all such persons unanimously agree in writing how the Net Income should be distributed among them … then the Net Income will distributed in accordance with such agreement.” According to Offit, he, Clark and Plotkin reached a private agreement to share the inventor proceeds, which resulted in a three way split of the inventor distribution.

But if Offit shared the Royalty Pharma proceeds with Plotkin and Clark, then Offit would also stand to receive a share of any Rotateq® related payments made to Wistar, payments we did not attribute to him previously and that he has not disclosed. In contrast to CHOP, Wistar’s approach to monetizing its patent royalties combined smaller lump-sum payments with a larger ongoing relationship with Merck, a financial structure we will analyze in greater depth below.

Offit has also disclosed that the actual inventor share of the Royalty Pharma transaction was 10%, a number well below CHOP’s current 30% policy, the 15-35% range from comparable institutions and our 15.9% estimate. His claim of a 10% inventor distribution for Rotateq® is supported by a document we received from a critic of our analysis: a January 2007 newsletter from CHOP call “Bench to Bedside” (see HERE). In this newsletter, CHOP announced a change to their patent and intellectual property policy that raised the inventor distribution from a prior share of 10% on all royalties above $5 million (based on a sliding scale that started with a 50% share) to the current share of 30% on all royalties.

Offit has now publicly disclosed both of these terms (a disclosure that Age of Autism Contributing Editor Jake Crosby confirmed in direct correspondence with Offit). So instead of our original range of $29-55 million and our base case of $29 million, we now estimate that Offit received a $6 million lump sum payment from CHF based on the Royalty Pharma deal ($6.2 million to be precise).

But even this revised lump sum estimate likely understates Offit’s total return from the CHOP royalty streams. According to the announced payment terms, Royalty Pharma only purchased the rights to CHOP’s royalty stream “from and after October 1, 2007.” Based on its quarterly financial statements, Merck reported Rotateq ® sales of $537 million before that date. If CHOP retained the royalty rights to Merck revenues before that date, then Offit could have received royalty payments directly from CHOP based on Merck’s early Rotateq® revenues in addition to the lump sum payment he received based on the Royalty Pharma transaction (see our estimate of this additional direct payment below).

It’s also worth noting that CHOP’s current “patent and intellectual property policy” sets the terms not just for direct inventor payments but also includes a provision for direct royalty distribution to the inventor’s laboratory and department (25% of royalties up to $850K) as well as a distribution to hospital research (40%). We have no evidence that this provision was in place during the Rotateq® deal. But since the Royalty Pharma deal was closed just 15 months after the new CHOP policy was announced, it seems likely that Offit’s new interest in autism research has received a boost from CHOP’s Rotateq® proceeds (following Offit’s newfound interest in autism research, we noted with interest that a substantial portion of the new autism genetics program at CHOP’s Center for Applied Genomics was self-funded: see HERE).

So instead of our earlier estimate of a single $29 million payment to Offit from the Royalty Pharma transaction, it appears that single lump-sum transaction “only” netted Offit $6.2 million. In addition, however, our emphasis on a single transaction omitted numerous other payments that Offit has received. One of these was another seven figure lump sum payment from Wistar.

CHOP declined to comment for this article.

2) The Wistar Institute’s securitization deal with Paul Capital. Offit revealed to reporter Amy Wallace that he receives ongoing royalties on Rotateq®. According to Wallace’s report in Wired, Offit “continues to collect a royalty each year. It’s a fluke, he says — an unexpected outcome. ‘I’m not embarrassed about it,’ he says. ‘It was the product of a lot of work, although it wasn’t why I did the work, nor was it, frankly, the reward for the work.’”

Offit’s seemingly modest disclosure to Wallace opens up an entirely new field of financial forensics. For, like CHOP’s transaction with Royalty Pharma, Wistar was also active in negotiating securitization deals for its patent royalty streams. On December 15, 2005, “The Wistar Institute…announced that it has sold a portion of its anticipated worldwide royalty revenues from Rotateq® to an affiliate of the Paul Royalty Fund for $45 million” (emphasis added).

Unlike CHOP, which elected to minimize its risk by trading all of its future royalty payments for a single lump-sum payment, Wistar took a less cautious approach. Instead of selling its entire royalty stream to Paul Capital (the Paul Royalty Fund is run by Paul Capital), Wistar only sold the rights to the first $300 million in worldwide Rotateq® revenues. Beyond that threshold level of sales, Wistar was willing to gamble on Merck’s success in marketing Rotateq® to the world. According to the deal’s announced terms, “Wistar is expected to retain all worldwide royalties on Rotateq® sales in excess of approximately $300 million annually.” In return for giving up its rights to the first $300 million in Rotateq revenues, Wistar received a lump-sum payment of $45 million from Paul Capital, a large payment, to be sure, but one that was substantially smaller than Royalty Pharma’s lump sum payment to CHOP.

Wistar’s immediate receipt of $45 million was subject to the same inventor distribution requirements as the CHOP transaction. So just as Offit received a share of the CHOP inventor distribution, the Wistar deal created an occasion for a second lump-sum payment. According to the “Guidelines for Wistar inventors” (see HERE), Wistar’s current revenue sharing policy sets the inventor share of royalty distributions at 15%. Splitting those proceeds three ways means that Offit would have received 5% of the Paul Capital proceeds, or $2.25 million (By way of comparison, if the operative Wistar royalty rate was 10% instead, the same level as CHOP, Offit’s share would have been $1.5 million).
In his recent disclosures regarding his CHOP payment of $6 million, Offit has consistently neglected to mention that he received another seven-figure payment from Wistar a few months before. Adding these payments together gives Offit a total of $8.4 million from lump sum payments alone.

As we noted above, a cursory comparison of the Royalty Pharma and Paul Capital transactions raises the obvious question: If both CHOP and Wistar shared patent rights equally between them, why was the Paul Capital payment of $45 million to Wistar so much lower than the Royalty Pharma payment of $182 million to CHOP? The answer, of course, is that the terms of each deal were different. In the case of CHOP’s royalty stream, Royalty Pharma purchased the entire royalty stream from CHOP; by contrast, Paul Capital purchased a much less extensive right to a more predictable revenue stream, the royalty rights on the first $300 million of Merck Rotateq® revenues. In a sense, Paul Capital paid for the rights to a security that resembled a bond: a fixed “coupon” based on a relatively certain royalty stream that would last the life of the patents. In the case of Rotateq®, the relevant period of patent protection is just under 13 years: in 2006, CHOP and Wistar applied for a 4.8 year patent term extension on the key Rotateq® patent and their request was granted earlier this year. Patent protection for Rotateq® now expires on February 19, 2019.

From the perspective of Offit’s finances, the difference between CHOP’s $182 million and Wistar’s $45 million means that Wistar chose to hang on to roughly three quarters of the remaining value of the Rotateq® royalty stream. And because Wistar retained the rights to all Merck Rotateq® revenue above $300 million in a given year, Offit gets a share of that too.

Although Melnicoff, Wistar’s Director of Business Development, declined to provide details of the arrangement with Offit, she said, “To my knowledge Wistar has had policies in place, I don’t know exactly when but probably from the early ‘80s if not before, relating to obligating our scientists to assign any inventions that they make in the course of their work at Wistar to the Institute.” She said “our policy is on our website on inventor sharing", a policy that places the inventors’ share at 15%, which was split equally among the three inventors, according to Offit.

Staci Vernick Goldberg, Wistar’s Director of Communications, gave us this statement: “A collaborative scientific research project which began in the 1980s between the Wistar Institute and the Children’s Hospital of Philadelphia, and later Merck, led in 2006 to FDA approval of a vaccine that effectively prevents rotavirus infection. In order to develop the science and bring this lifesaving vaccine to the public, where today it is part of the recommended vaccine schedule for all U.S. babies, the parties entered into a technology licensing agreement. The Wistar Institute is bound to non-disclosure based on confidentiality provisions within this licensing agreement. We respectfully decline to comment for your story."

Since its launch, Rotateq® has consistently been generating a good deal more revenue than $300 million per year, delivering Offit an ongoing interest in global success of the rotavirus vaccine category and raising an obvious question: How much is this ongoing royalty stream worth to him?

Calculating Offit’s income based on direct royalty payments by Merck: past and future

1) Direct royalties to the Wistar Institute. In most cases, the arithmetic of pharmaceutical patent licensing is straightforward: patent owners receive a fixed percentage of product revenues from their licensees. Most such licensing deals involve single digit percentages, i.e., between 1 and 10%, but these rates can be quite variable. In the case of a jointly owned patent, the owners would each receive half of the overall royalty percentage on the patent. The best way to ascertain the royalty rate is to obtain the information from the licensor directly. We contacted Wistar to comment on their royalty rate and they declined to disclose it, citing non-disclosure agreements, so we are forced into a further exercise in financial forensics.

Fortunately, there are numerous sources that can inform an estimate of these Rotateq® royalty flows. The most helpful of these is the Paul Capital deal with Wistar, which requires only one assumption (Paul Capital’s discount rate for the time value of money) to permit calculation of a relatively precise estimate.

To illustrate, in order for Paul Capital to be willing to pay $45 million for a 13 year royalty stream between 2006 and 2019, we calculate that Wistar’s royalties on the first $300 million in Rotateq® revenues would need to fall somewhere between $6-9 million per year, depending on the discount rate Paul Capital applied to the future royalties (for the financially minded among you, just calculate the required annual cash flow to generate $45 million worth of “net present value” on a 13 year royalty stream with a discount/interest rate in the 10-15% range). This calculation would mean that Wistar has a royalty rate somewhere in the 2-3% range. For simplicity’s sake, we have assumed that Wistar’s actual royalty is 2.5%, which after adding an equal amount for the CHOP license brings Merck’s total royalty for its Rotateq® patent license to 5%.

How can we verify that this estimated royalty rate is accurate? Well there are some simple tests one can apply. First of all, we know precisely what Merck’s Rotateq® revenues are, since Merck reports quarterly revenues for all of its biggest selling drugs and vaccines, including Rotateq®. We’ve provided a full accounting of these revenues in Table 1 below.

Table 1: Merck's Rotateq® Revenue: 2006-2009

Year

Fiscal Quarter

Merck's quarterly revenue from Rotateq® ($M)

Merck's annual revenue from Rotateq® ($M)

Merck's Annual Rotateq® revenue above $300M ($M)

2006

163

2007

119

171

149

525

225

2008

190

178

134

162

665

365

2009

134

126

127

>120(est)

>507

>207
(if Q4 revenues >$120M)

Second, we can also look to the Wistar Institute’s Annual Reports, in which their annual income from royalties (also known as “technology transfer”) is provided. Although Wistar doesn’t itemize their Rotateq® royalties, their recent annual reports give great prominence to the vaccine’s development. In order to check the reasonableness of our royalty rate estimate, we took Merck’s annual revenue over $300 million, multiplied by 2.5% and compared the resulting number with the changes in Wistar’s technology transfer income. As the table below shows, using the information about the Paul Capital transaction along with a 2.5% royalty rate for Wistar’s Rotateq revenue quite closely accounts for the increases in Wistar’s technology transfer revenue from 2004 to 2008.

Table 2: The Role of Rotateq® in the Growth of the Wistar Institute's Licensing Income

Year

Wistar Institute's "Technology Transfer" revenues ($000)

Rotateq Revenues ($000, est)

Likely impact of Rotateq® royalties on the Wistar Institute's technology transfer revenue

2003

2004

$1,375

$1,823

Zero. Wistar's pre-Rotateq® revenues provide a rough estimate of their technology transfer income from other sources

2005

$2,985

1,000

Wistar's income increased by $1.16 million in 2005
Wistar received a $1million Rotateq® payment in December 2005.¹

2006

$39,906

44,000
(less investor payments)

Rotateq® was first marketed in the US in 2006.
Wistar received a $44 million payment in Q2 2006.¹
Wistar's 2006 Annual Report: "Principally composed of revenue from a one-time sale of a portion of the future royalty income expected from commercialization of the rotavirus vaccine."²

2007

$8,033

5,600

Merck's 2007 Rotateq® revenues were $665 million
2.5% of the revenue over $300 million equals $8.4 million

1. According to the December 15, 2005 press release, "Under the terms of the agreement with the Paul Royalty Fund, Wistar will receive an up-front payment of $1 million and a second payment of up to $44 million when ROTATEQ is marketed in the United States."
2. As with CHOP, the gap between the $44 million payment and the $38 million revenue item may represent inventor payments.

Although we’re largely focused here on Offit’s income, it’s worth noting how valuable the Rotateq® licensing revenues have been to Wistar. In 2003, licensing represented only 3% of total revenues of Wistar’s revenue of $43 million, most of which came from federal grants. By the time Rotateq® hit its first full year of sales, technology transfer income had risen to 15% of annual income and Wistar’s President took pains to sing the praises of the larger benefits to society of technology transfer in Wistar’s 2007 Annual Report. “Through my work with the CEO Council for Growth”, said Russel Kaufman, “I have come to appreciate the critical role of technology transfer – the process of moving a discovery from a laboratory into commercial development – in growing the economy.” In 2008, rising technology transfer income became even more important to Wistar, reaching 22% of revenues while also providing a lifeline in a difficult financial year; Wistar reported a staggering $25 million in investment losses in 2008.

As we noted above, Wired Magazine reported that Offit “continues to collect a royalty each year” from sales of Rotateq®. This ongoing payment stream can only come from Wistar and we have estimated Offit’s share of these payments based on three inputs: Merck’s revenue in excess of $300 million (see Table 1), Wistar’s royalty rate on those revenues (see Table 2) and the Wistar inventor distribution (we have assumed the current published rate of 15%). If we apply a Wistar royalty rate of 2.5% to the Rotateq® revenue, apply the inventor share of 15% and divide that share by three to get Offit’s personal share, we estimate that Offit receives an eighth of a cent (or .125%) for every dollar of Merck’s Rotateq® revenue above $300 million. If Rotateq® performs well, it can generate a large annual income for Offit: a relationship we have illustrated graphically in Figure 1 (click to enlarge.)

We can apply this formula to Merck’s actual Rotateq® revenues to obtain a precise estimate of Offit’s past royalties from Wistar. But how can we predict where on this payment line Offit’s future royalties will fall? Any prediction, of course, is subjective and necessarily speculative so we have not attempted to make a single estimate ourselves. Instead, we have considered several different approaches, each using a different external source, to provide a range of possible income forecasts.

First, we know that Wall Street analysts are in the business of making such predictions and such estimates were likely available to the parties involved in the negotiations on the securitization of royalties based on these revenues. Supporting this notion is a comment from Wistar’s Director of Business Development, Meryle J. Melnicoff, who stated in a May 2006 presentation that “Wall Street estimates peak revenue at $1 billion annually.” Using that level of sales, Offit’s continuing annual royalty would come to $875,000 over the nine years from 2010-2018.

Second, we can draw a simple inference based on a comparison of the Royalty Pharma payment to the Paul Capital payment. After February 2006, when Rotateq® was first marketed in the U.S., the royalty stream on the first $300 million of revenues was worth $45 million to Paul Capital. In April 2008, Royalty Pharma acquired CHOP’s royalties after October 1, 2007, a year and a half later, for $182 million. In other words, Royalty Pharma acquired the full royalty stream for almost exactly four times what Paul Capital paid for a $300 million portion. (It’s worth noting that Paul Capital received its smaller portion of royalties over the full period of patent protection; by contrast, CHOP paid for royalties “from and after October 1, 2007” and Merck reported Rotateq revenue for six quarters prior to that date, none of which appear to have been included for royalty purposes in the CHOP deal). If Paul Capital’s royalty stream transaction was based on only $300 million in annual revenue (and the least risky portion), then in April 2008, Royalty Pharma appears to have estimated an annual revenue stream of at least four times $300 million, or more than $1.2 billion. That level of sales would place Offit’s continuing annual royalty income at well over $1 million from 2010-2018.

Third, we can look to comparable vaccine products in the market today. The most successful of these is Wyeth’s pneumococcal vaccine, Prevnar®. In 2008, Prevnar®’s domestic revenue was $1.2 billion, similar in magnitude to the forecasts we’ve seen for Rotateq®. But international markets have been a huge source of sales for Prevnar® (well over half the total), reaching $1.5 billion in 2008 and giving Wyeth worldwide revenues of $2.7 billion. Prevnar®’s sales through the second quarter of 2009 have shown continued growth over the prior year, putting Prevnar® in position to break the $3 billion sales barrier by year end. We have therefore used Prevnar®’s worldwide sales performance as the most optimistic benchmark to set an upper limit for Rotateq®’s future revenue of $2.5 billion.

Based on these inputs, we are now in a position to calculate the distributions that Offit would receive based both on Merck’s past Rotateq® revenues and on predicted future sales of Rotateq®.

1. For the period from 2006 through 2009, Offit “continues to collect a royalty each year”, almost certainly based on Wistar’s income from Merck’s annual Rotateq® revenues in excess of $300 million. Using a conservative estimate for the final quarter of Rotateq® revenues (which have not yet been reported), the Merck revenues that would be subject to the Wistar royalty would equal at least $795 million (see Table 1). Assigning an inventor share for these revenues to Offit of .125%, this would mean Offit has earned approximately $1 million so far based on Merck’s license payments to Wistar.

2. For the period from 2010 to 2019 (Rotateq®’s patent protection expires on February 19, 2019), we assume that Offit will continue to receive royalties of .125% on the same qualifying revenues. If Rotateq® meets its annual revenue expectations of $1.2 billion during that period, Offit’s payments would come to $1.125 million per year for 9.1 years, or $10.3 million in total. By contrast, in the most pessimistic scenario, if Rotateq®’s annual revenue during this entire period is only $600 million, Offit’s share would be worth less: $375,000 per year, or $3.4 million. In the most optimistic case, if Rotateq succeeds in reaching Prevnar’s worldwide sales levels of over $2.5 billion, Offit could receive as much as $2.75 million per year and $25.1 million through 2019.

Offit has acknowledged receiving a continuing royalty, but not the extent of his contingent future payments.

2) Direct royalties to CHOP. Although the large majority of CHOP’s benefits from Rotateq® royalties were realized in a single lump sum deal with Royalty Pharma, there was a substantial sum roylaties paid to CHF prior to the securitization deal with Royalty Pharma that began in October 31, 2007. Confirming the effect of these payments, we can observe that before selling its rights to Royalty Pharma, CHF’s royalty income grew rapidly after Rotateq® was marketed in the U.S (see Table 3). Like Wistar, these royalty payments were reported in annual report documents from the Children’s Hospital Foundation (CHF), allowing us to make a direct comparison between the increased licensing revenues received by CHF and our estimates of the Rotateq® royalty payments that CHF received from Merck before selling its ongoing royalty stream to Royalty Pharma.

Applying a 2.5% royalty rate to Merck’s reported Rotateq revenue, we find that we can account for 74% of the increases in CHF licensing income during 2007-8 (using the same approach, as shown in Table 2, we accounted for 92% of Wistar’s increased royalty income in 2007-8). Although it’s possible that other Wistar licensing programs increased at the same time, the clear temporal alignment of the licensing surge in both institutions, the prominence of Rotateq® in both series of annual reports and the close match between our calculated revenues (using a 2.5% royalty rate) and reported revenues suggest that our royalty estimates for Rotateq® are reliable.

Table 3: The Role of Rotateq® in the Growth of CHF's Licensing Income

Fiscal Year (June 30 fiscal year end)

Children's Hospital Foundation's licensing revenues ($000)

Rotateq® royalties
($000, est)

Likely impact of Rotateq® on CHF's licensing income

2005

2006

865

1,189

Before Rotateq®, CHF's licensing revenues were small

2007

2008

7,260

13,299²

13,425¹

After Rotateq® was marketed in the U.S., CHF's licensing revenues grew rapidly³ before they sold their Merck royalty payments to Royalty Pharma

1. Estimate based on Merck's Rotateq® revenues fo $537 million through October 31, 2007 and a licensing rate of 2.5%
2. This was the reported income excluding the "Rotateq monetization." Total licensing income in FY 2008, including the Royalty Pharma deal was $190.8 million. This report provides yet another estimate of CHF receipts from the securitization deal: $177.8 million in cash receipts reported by Moody's.
3.CHF's licensing income for FY 2007-8 increased by $18.2 million over its 2006 annual revenue rate of $1.19 million

Based on our analysis of Wistar’s royalty payments, we are also now able to estimate an additional direct payment from CHOP that Offit likely received. Since the Royalty Pharma deal transferred CHOP’s rights to Rotateq® royalties “from and after October 1, 2007”, any CHOP royalties received before that date would have resulted in an additional payment to Offit.

How do we make this additional estimate? Applying CHOP’s 2.5% royalty to the CHOP inventor share at the time of 10% and dividing that share by three to obtain Offit’s portion, we estimate that Offit received .083% of all Merck Rotateq® revenue before October 1, 2007. For the period from 2006 through the third quarter of 2007, we can add up the six quarters of Rotateq® revenues that should have been subject to the CHOP royalty to obtain a total of $537 million (see Table 1). Based on these two assumptions, we therefore estimate that Offit received $447,000 (.083% x $537 million) in additional CHOP royalty distribution payments before the deal was closed with Royalty Pharma. We asked CHOP to confirm our assumptions and they declined comment.

We are not aware that Offit has disclosed receipt of any such payment, nearly a half million dollars, previously.

The issue of Offit’s ongoing incentives with respect to Rotateq® income

As one can observe in Figure 1, the ongoing financial benefits Offit receives vary quite widely with Merck’s annual sales performance. As we’ve reported above, when Rotateq® was first introduced and the large securitization deals subsequently struck with Paul Capital and Royalty Pharma, the revenue outlook appeared to be quite bullish. In a panel convened in May 2006, Wistar’s director of business development reported that “Wall Street estimates peak sales at $1 B annually”; our own estimates suggest that the parties to the securitization deals placed an even higher forecast on those annual revenues, $1.2 billion or higher. As we’ve shown, a more optimistic forecast based on strong international adoption of Merck’s vaccine could result in annual revenues as high as $2.5 billion or more.

Unfortunately for Offit, Merck’s Rotateq ®revenues have not yet matched those lofty expectations. There are two possible explanations for this. The first is market share losses in the domestic market. After Rotateq®’s approval in 2006, Merck had the U.S. market all to itself for a while, as Wyeth’s Rotashield® had been withdrawn a few years previously. For nearly two years, Rotateq® had an effective monopoly on the American rotavirus vaccine market that Offit had voted to create. But starting in April 2008, Merck faced a new competitor for the US market, when the FDA approved GlaxoSmithKline’s Rotarix® for sale in the U.S. market. This has had the effect of reducing Rotateq®’s domestic market share and sales.

The second reason is that international markets have been slow to develop. Merck has pushed hard to market Rotateq® outside the US. For example, Merck announced “access partnerships” for Rotateq® in developing markets like Nicaragua and is pushing the WHO to expand its recommendations worldwide. Supported by CDC and NIH, their push has been intensifying. Still, the international market for Rotateq® continues to be modest.

As a consequence of these two factors, overall 2009 revenues for Rotateq® are down, driven by U.S. revenue declines of over 25%. Merck’s foreign sales, although growing, remain only a fraction of domestic revenue, less than 11% of total revenue through September 2009.

Adding it all up

As should be clear by now, obtaining a full and accurate picture of Offit’s financial benefits from Rotateq® is quite complex, driven by contrasting practices in separate institutions using different payment methods, each of which involve a range of financial parameters that determine how cash payments flow to Offit. As we have assimilated new information, we have learned that our earlier estimates underestimated this complexity.

Cutting through this complexity, we conclude our analysis by summarizing the payment flows. Although the Wistar and CHOP deals are markedly different, both provide two basic kinds of payments to Offit: either lump sums from securitized payments or ongoing royalties. In the case of ongoing royalties, analyzing past product revenues provides greater certainty than estimating future income based on projected revenues. In addition, there may well be other nuances in the terms of these inventor distributions that we have not identified. Our most important unconfirmed assumptions include the following: a 5% patent license rate paid by Merck, an equal split of that royalty between patent owners that provides 2.5% each for Wistar and CHOP, and a 15% distribution share for Wistar inventors.

The results of our analysis are summarized in Table 4 below. Based on our exercise in financial forensics, we now estimate that Offit has already earned over $10 million from his relationship with Merck and its Rotateq® vaccine. In terms of ongoing royalties, we estimate that he stands to make at least $300,000 per year of annual income, a ten-year flow of payments that would place him solidly in the top 1 percent of American income earners for a decade, and as much as $2.75 million per year.

Furthermore, to the extent that Offit has attempted to create the perception that he only made $6 million from Rotateq®, our analysis shows that he has selectively withheld information on important additional payments. Our calculations show that he has likely received $8.4 million in lump sum payments so far and earned approximately $10 million in total income based on Rotateq® sales through this year, after including ongoing royalty payments he has earned based on Rotateq® revenues through year end 2009.

Put differently, through year end 2009 Offit will have received less than half of his potential return on Rotateq®, and therefore his financial future is clearly tied into the success both of his specific rotavirus vaccine and the reputation of vaccines more broadly, especially worldwide. The increase in royalty payments above $300 million on which Wistar’s royalty payments so strongly depend will be realized most effectively if rotavirus vaccine uptake proceeds expeditiously in international markets.

Finally, although we do not question the sincerity of Offit’s strongly held beliefs on the benefits of all vaccines, we note that his vaccine (not to mention his autism) advocacy is closely tied to his personal financial interests. As foreign governments and health authorities are persuaded to adopt the American policy of intensive infant vaccination, Offit’s personal wealth will increase.

Table 4: Total Payments to Offit from Rotateq over the Life of His Patents
Time Period	CHOP ($000)	Wistar ($000)	Total ($000)
Before 10/01/07	$448	$2,250	$2,698
2007-2009	6,192	994	7,185
2010-2019, or 9.14 years (annual revenue scenario) Maximum estimate: $2.5 billion (Prevnar) Quoted estimate: $1.2 billion Actual attained: $600 million	--	25,127 ($2,750,000 per year) 10,279 ($1,125,000 per year) 3,426 ($375,000 per year)	25,127 10,279 3,426
Total	$6,639	$6,670-28,371	$13,309-35,010
Note: Lump sum payments in bold red font

Dan Olmsted is Editor of Age of Autism and Mark Blaxill is Editor at Large.

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