Extreme Love : Autism

I don't think I've perused this site in a long time......maybe 5 or 6 years.

I watched Louis Theroux's excellent documentary last week (aired in UK on 19/4/2012) and thought there would have been at least one discussion at this site. Unless I've missed it, here's one to get the ball rolling.

These are my thoughts on the current situation. I haven't put any links to my theories but if anyone wants them I'll list them separately.

My son was diagnosed ten years ago with high-functioning autism. Concerns were raised at his 3.5 year assessment as he wasn't speaking. After 6 months of tests, the CDC (Child Development Centre) made their diagnosis. My wife cried on the sofa while I hugged her. I can remember all the 'milestone' dates as if it was yesterday.

Tom did vocalise from the beginning and started to talk around 9 months. By 12 months he had a few words. After his MMR (15 months) he lost those words. He didn't have much shared non-vocal communication either (ie. staring at a cup or a toy that he wanted). It was something we watched for like a hawk in his sister when she came along 4 years later.

Of course, when we underwent an 'Early Bird Training Programme' for parents of newly diagnosed children after his diagnosis, the child psychologist informed us that it was a coincidence that his words should disappear around the same time as the MMR jab. To be honest in those days, I didn't think it was the jab that caused his autism as he didn't have any massive side-effects. Not like some of the parents we met on that course. Over the eight weeks it took place, we swopped stories and some of the parents noticed immediately after the jab a change in their children. Their stories of incessant crying and fits in some cases were heart-breaking even if, from a medical standpoint, they were only anecdotal. I've always wanted to go back and ask the child psychologist where she found the information that says 'autism' begins to show between fifteen and eighteen months of age. Over the years of study, I've never come across a piece of research that covers this. It's only with hindsight now, that it seems a pretty convenient way of covering up any damage that might occur through a much increased vaccination program that we now have.

So there it is. My research over the last ten years has brought me to the indisputable conclusion that the increased rates of autism are down to ONE significant cause, with a myriad of possible results.
That cause is of course the vaccination schedule.

The myriad of possible results I stated above, is because although vaccinations are the trigger for setting the autistic brain in development, I don't think they are acting alone. I think the damage is further fuelled by the food intake of the children and their individual DNA make-up. I actually think the idea that 'autism' has a possible 'genetic' make-up (the inheritence theory), is probably only a small risk factor compared to the massive risk that vaccinations pose.

My silver bullet for making such a bold statement lies in a very, very, simple fact. Take any un-vaccinated population around the world (the Amish community in the USA is a good example). The rate of autism is between 1 in 10,000 - 15,000). The reason why the rate is difficult to assess more accurately, is because the incident rate is so small and because there are not many places left where the actions of Big Pharma have not been steamrollered through (cue the image of Ewan McGregor trekking through the backs of beyond in India and Nepal last Sunday evening to deliver vaccines to a remote village. I do hope he goes back with a film crew when the first cases of 'autism' are reported in the future). Compare that rate to the New Jersey rate which I was absolutely shocked to read as being 1 in 29.

You also have to do your homework where vaccinations are concerned. I am in no doubt we will look back on this period of medical history and consider the actions of some people in authority with the same feelings we have towards the clinicians who experimented on patients with mental health problems in the sixties and seventies. When I ask most people 'how many children do you think died of measles in the UK in the year preceding the introduction of the vaccine?' Most answer in the thousands. They are shocked when I say '30'. And out of those we don't know how many had such 'underlying health problems' (as the BBC News is always keen to point out) that they would have unfortunately died of something else anyway. That isn't to say that measles is a simple disease with no risks. Of course in serious cases, encephalitis can cause serious problems. But we've come a long way since the Second World War and cases of measles and their complications were dropping year on year. Mumps never killed anyone and the same for Rubella.

If it sounds as if I think the MMR jab is the sole cause of autism, I don't. I think it's the combination of everything. The thimerosal (mercury) preservative in the vaccine, the use of animal tissue and other genetically modified material, make vaccines potentially fatal. You never hear about the risks, but search around and you'll find cases of death, paralysis and other debilitating disorders because of vaccines.

You may ask, 'if vaccines are the cause, then why don't they affect everybody?' I think in part, they probably do. If you correlate the rises in asthma, eczema, hay-fever, mouth-ulcers and a whole host of other non-life threatening disorders (actually asthma is life-threatening) between vaccinated and un-vaccinated populations the evidence is once again there to be found. You have to disregard almost 95% of medical research because it often is funded by pharmaceutical companies for the sole purpose of demonstrating the 'safety' of their products. Any negative findings are routinely hidden from the rearch data, thus making the results meaningless.

What I found quite shocking in Louis' film was the visual evidence of what I'd been reading about over the years. The rate of obesity in the States is currently running at 37% of adults and 1 in 2 of every child. The figures are mind-blowing. The States also has been Monsanto's GM playground and coupled with a massive lack of nutritional value to the food results in what I perceived on my TV yesterday. When the young man was collected from the hostel to spend the day with his mum, I was shocked to see him tucking into the fast food. His actions looked entirely like an addict trying to get a fix. I don't mean this in an offensive way, but if the 'fuel' of autism is the action of a diet upon a damaged body, as many clinicians working in the field suspect, then we need to fix these addictions.

I realise my views are probably very controversial, but if anyone is feeling pangs of guilt from subjecting their children to the vaccination schedule, I would advise them to let it go. We can only do what we think is for the best, and I'm in no doubt that we all acted in what we thought was the best interests of our children. I actually think the term 'autistic' is becoming redundant now for the simple reason that I've met too wide a 'spectrum' of children and adults who are termed 'autistic' for it to be meaningful. I think of my child's 'autism' now, as a result of someone else's incompetence on the good days, and down-right evilness on the bad days. I also think we need a term that expresses exactly what these children have ended up with .....a term such as 'government damaged' but with a positive spin.

Tom hasn't had any more vaccinations since the age of about 3. What I've learned about the whole process of vaccinations means I will not subject him or his sister to any further vaccinations until they are old enough to weigh up the evidence themselves and then make their own decisions. Funnily enough, the autism specific advisor who was one of the team who delivered that very first 'Early Bird Programme' I mentioned above ten years ago, told me she had had four children herself. She's since retired but guess what?..........none of her children ever had any vaccinations whatsoever.

Food for thought.

As I said I haven't visited this site in a long time, but I was surprised to find how large the NAS has grown (if the size of the website is anything to go by). What further surprised me was the availability of data concerning everything to do with managing autism (from behaviour to legals, education to work etc). There is a lot of stuff on here. What I could't seem to find easily was any mention of causes of autism.

Where are the voices suggesting what the causes of this 'development disorder' are?

Where are the independent research papers outlining various inquiries into possible causes?

Surely this should be the number one priority for an organisation dealing with autism, shoudn't it?

I know only too well how difficult it is getting any help to deal with my son's autism, but if I could stop one more child and their family going through the journey that we've gone through, I would.

If, as I have claimed, the rise in 'autism' that we've seen over the last thirty years, that correlates perfectly with the increased vaccination schedule, is due to vaccinations then parents need to be informed of the risks involved. Then can they make an informed decision as to whether the risk of 'autism' and the subsequent pressure it places upon the family ( ie.the immense emotional and financial strain, the Extreme Love that Louis talks about) is worth the risk BEFORE accepting vaccinations.

I would have foregone ALL vaccinations for my children if I knew then what I know now.

I welcome your comments and debate.

Al

Parents
  • Jim,

    You do know who Paul Offit is.....read right at the bottom:

    Potential conflicts of interest.P.A.O. is a coinventor and patent coholder of the rotavirus vaccine Rotateq and has served on a scientific advisory board to Merck. J.S.G.: no conflicts.

    Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market

    Thirty pieces of silver By Dan Olmsted and Mark Blaxill

    Dr. Paul Offit of the Children’s Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year, according to an investigation by Age of Autism. Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million.

    There is nothing improper about receiving compensation for a patented innovation; but the extraordinary valuation placed on CHOP’s patents raises concerns over Offit’s use of his former position on the CDC’s Advisory Committee on Immunization Practices to help create the market for rotavirus vaccine -- to effectively vote himself rich.

    Offit has steadfastly refused to say how much he made from the vaccine. Based on the income distribution guidelines set forth in CHOP’s current administrative policy manual (HERE) entitled “Patent and Intellectual Property Policy,” Offit’s share of this transaction -- the “inventor’s share of net income” -- would have earned him a personal distribution of 30%. In a Moody’s report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit’s 30% share at $45.9 million.
     
    Although the royalty transaction amounts and current CHOP inventor shares are publicly known, several factors complicate a precise calculation of Offit’s income. Royalty Pharma paid $182 million for the Rotateq royalty stream, but CHOP reported proceeds of only $153 million. Since most universities calculate income based on net royalties, the lower number might more closely reflect the basis for calculating Offit’s income. If CHOP applied an inventor share of 30% to a transaction value of $153 million they would have then been required to distribute $45.9 million to Offit.

    CHOP’s 30% policy for inventor share is consistent with the current practices of other children’s hospitals. But depending on what standard was in effect when the patents were filed and how it was applied to Offit’s proceeds, the amount could be lower. For example, the $29 million difference between the payment made by Royalty Pharma and the proceeds received by CHOP comprises 15.9% of the Royalty Pharma payment (15% is the lowest inventor share percentage we uncovered in our investigation) and could reflect the distribution to Offit, 

    So although it is clear that Offit’s personal share of CHOP’s royalty transaction was large, the exact amount could range from as little as $29 million to as much as $55 million. Age of Autism chose to feature the smaller amounts in this report.

    CHOP spokeswoman Rachel Salis-Silverman, contacted by Age of Autism about Offit’s income from the vaccine, first said, “I don’t even know. That’s not public information.” She initially refused to provide an e-mail to which Age of Autism could send a detailed account of how it determined Offit’s income, but subsequently sent an e-mail saying she was expecting the information.

     “We are declining comment to your questions,” she then replied after receiving our inquiry. Offit did not respond to an e-mail sent to his Children’s Hospital address.
     
    While refusing to disclose his personal profit from this transaction, Offit told Newsweek reporter Claudia Kalb last year that he got a “small percentage” of the payment and confessed that “it’s like winning the lottery.”

    The $29 million-$55 million range is consistent not only with CHOP’s published royalty arrangements but with typical medical patent standards:
     
    -- At Boston Children’s Hospital, inventors get 25% of “net lifetime revenues” for all income over $500,000. For royalty amounts smaller than $500,000 inventors receive 45-100% of revenues.

    -- At Arkansas Children’s Hospital, inventors get 35% of “net royalties” after the first $200K and 50% before that.

    -- At the University of Virginia, inventors get 15% of “total royalty income” over $1 million and a sliding scale of 25-50%for amounts smaller than that.

    -- At the University of California, inventors get 35% of “net royalties.”

      Offit’s claim to a share of the profits from Merck’s Rotateq revenues is based on his role as a listed inventor on the cluster of patents that protect Merck’s vaccine. These patents share the title “Rotavirus Reassortant Vaccine” and include four granted US patents -- US5626851, US5750109, US6113910 and US6290968 — and two granted European patents — EP323708 and EP493575.

      All of the patents are jointly owned by CHOP and the Wistar Institute. Offit is one of the three listed inventors on the vaccine patents but holds 100% of CHOP’s inventor rights. The other two inventors, Fred Clark and Stanley Plotkin, are both affiliated with the Wistar Institute (in a December 2005 transaction that was similar to CHOP’s deal with Royalty Pharma, the Wistar Institute sold its royalty interest in Rotateq to Paul Capital for $45 million).

    The CHOP policy manual that delineates the distribution of income for inventions owned by CHOP can be found (HERE) (see section III B). Clearly, based on the distribution of income rights outlined in this manual, Paul Offit had a greater personal interest in Rotateq’s commercial success than any other single individual in the world. And more than other individual in the world, he found himself in a position to directly influence that success.
    --

    Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP). In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months. For example, after ACIP approved the addition of Merck’s (and Offit’s) Rotateq vaccine to the childhood vaccination schedule, Merck’s Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008. When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it’s not hard to see the commercial value to Merck of favorable ACIP votes.

    From 1998 to 2003, Offit served as a member of ACIP. Before and during his ACIP term, Offit was involved in rotavirus vaccine development activities, the value of which ACIP influenced. Shortly before his term began in October 1998, Offit’s first two rotavirus patents were granted by the U.S. Patent and Trademark Office, the first on May 6, 1997 and the second on May 12, 1998. During his ACIP term, Offit received two additional patents in 2000 and 2001.

    Receiving a patent provides the potential but not the certainty of financial reward. In most cases, when an inventor’s employer receives a patent, the commercial value of the patent award is highly uncertain. In the case of Rotateq, the business uncertainty revolved around three factors: 1) the creation and eventual size of the rotavirus vaccine market, 2) the market share of competing products such as Wyeth’s RotaShield vaccine and 3) the success of Merck’s clinical trial for Rotateq and subsequent FDA approval. For the first two of these three factors, Offit’s ACIP membership gave him a direct opportunity to favorably influence his personal financial stake in Rotateq.

    Four months before Offit was appointed to ACIP in October 1998, the committee had voted to give the rotavirus category a “Routine Vaccination” status, in anticipation of an FDA approval of RotaShield (oddly, ACIP made this vote before the FDA approved Wyeth’s RotaShield vaccine on October 1, 1998). Shortly after Offit’s term began, there were several additional votes involved in establishing the rotavirus vaccine market and Offit voted yes in every case. In May of 1999, the CDC published its revised childhood vaccination schedule and rotavirus vaccine was included. This series of favorable votes clearly enhanced the monetary value of Offit’s stake in Merck’s rotavirus vaccine, which was five years into clinical trials.

    Nevertheless, Merck’s Rotateq vaccine was several years behind Wyeth’s RotaShield, which stood to be the market leader based on its lead in making its way through clinical trials. But when the widespread administration of RotaShield to infants started producing a high incidence of intussusception reports, including numerous fatalities, ACIP was forced to reverse itself. On October 22, 1999, ACIP voted to rescind its recommendation of the RotaShield vaccine.

    Offit recused himself from this vote, although he participated in the discussion. In the meeting in which ACIP discussed RotaShield, Offit remarked, "I'm not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.” CDC records make it clear that Offit was not silent on RotaShield. By 2001, he was actively advancing a “unique strain” hypothesis, an argument that RotaShield was formulated in a way that did increase intussusception risk whereas other formulations (e.g. Rotateq) would not.

    In commercial terms, Offit had a clear stake in the earlier RotaShield decision. As a competitor to Rotateq, RotaShield’s withdrawal provided a financial opportunity for Offit’s partner, Merck. Not only did RotaShield’s withdrawal give Rotateq an opportunity to gain 100% of the rotavirus vaccine market Offit had voted to create (until April 2008, when GlaxoSmithKline’s Rotarix vaccine was approved, Merck held a monopoly on the rotavirus vaccine market), but the absence of competition enabled Merck to charge a premium price for its vaccine, significantly more than Wyeth had charged for RotaShield.

    With RotaShield out of the market and the favorable rotavirus policy precedent established, when the FDA approved Rotateq on February 3, 2006, the path to profitability for Merck was set. And for CHOP, which had licensed its patent rights to Merck, the valuation of its patent portfolio soared. Faced with this newly valuable asset, CHOP chose not to take their profits in the form of a series of smaller royalty checks. Instead, they opted to sell off their rights to the income stream and receive a lump sum payment in its place. Royalty Pharma -- an intellectual property investment firm that “provides liquidity to royalty owners and assumes the future risks and rewards of ownership” -- stepped in to pay CHOP for the rights to its Merck royalties. CHOP, in turn, paid Offit his inventor share. Although neither CHOP nor Merck has disclosed Merck’s royalty obligation around CHOP’s patents, the fact that Royalty Pharma was motivated to pay CHOP $182 million for the right to receive the Rotateq royalty stream suggests that obligation was significant.

    Other news organizations, most notably CBS News, have asked Offit to disclose the financial details of his Merck relationship. CBS New reporter Sharyl Attkisson wrote last July that, “future royalties for the [Rotateq] vaccine were just sold for $182 million cash. Dr. Offit's share of vaccine profits? Unknown.”

    Offit protested loudly over the CBS News report and went so far as accusing Attkisson of unethical conduct. “Did [Attkisson] lie about whether or not we provided materials? Of course,” Offit claimed in an August interview with the Orange County Register. He argued that in responding to a CBS News investigation of his financial ties to Merck, he readily provided full details of the payments that CBS asked for including: “the sources and amounts of every grant he has received since 1980”; “the details of his relationship, and Children’s Hospital of Philadelphia’s relationship, with pharmaceutical company Merck”; and “the details of every talk he has given for the past three years.”

    A personal profit of at least $29 million seems like more than a small detail to leave out.

    This is the type of 'conflict of interest' that permeates the culture of Big Pharma. We haven't heard the last of Dr. Andrew Wakefield either.

    I presume you've seen this before?

    Al

Reply
  • Jim,

    You do know who Paul Offit is.....read right at the bottom:

    Potential conflicts of interest.P.A.O. is a coinventor and patent coholder of the rotavirus vaccine Rotateq and has served on a scientific advisory board to Merck. J.S.G.: no conflicts.

    Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market

    Thirty pieces of silver By Dan Olmsted and Mark Blaxill

    Dr. Paul Offit of the Children’s Hospital of Philadelphia (CHOP) took home a fortune of at least $29 million as part of a $182 million sale by CHOP of its worldwide royalty interest in the Merck Rotateq vaccine to Royalty Pharma in April of last year, according to an investigation by Age of Autism. Based on an analysis of current CHOP administrative policies, the amount of income distributed to Offit could be as high as $46 million.

    There is nothing improper about receiving compensation for a patented innovation; but the extraordinary valuation placed on CHOP’s patents raises concerns over Offit’s use of his former position on the CDC’s Advisory Committee on Immunization Practices to help create the market for rotavirus vaccine -- to effectively vote himself rich.

    Offit has steadfastly refused to say how much he made from the vaccine. Based on the income distribution guidelines set forth in CHOP’s current administrative policy manual (HERE) entitled “Patent and Intellectual Property Policy,” Offit’s share of this transaction -- the “inventor’s share of net income” -- would have earned him a personal distribution of 30%. In a Moody’s report dated June 2008, CHOP reported net proceeds from the Rotateq transaction of $153 million, a deal basis that would put the value of Offit’s 30% share at $45.9 million.
     
    Although the royalty transaction amounts and current CHOP inventor shares are publicly known, several factors complicate a precise calculation of Offit’s income. Royalty Pharma paid $182 million for the Rotateq royalty stream, but CHOP reported proceeds of only $153 million. Since most universities calculate income based on net royalties, the lower number might more closely reflect the basis for calculating Offit’s income. If CHOP applied an inventor share of 30% to a transaction value of $153 million they would have then been required to distribute $45.9 million to Offit.

    CHOP’s 30% policy for inventor share is consistent with the current practices of other children’s hospitals. But depending on what standard was in effect when the patents were filed and how it was applied to Offit’s proceeds, the amount could be lower. For example, the $29 million difference between the payment made by Royalty Pharma and the proceeds received by CHOP comprises 15.9% of the Royalty Pharma payment (15% is the lowest inventor share percentage we uncovered in our investigation) and could reflect the distribution to Offit, 

    So although it is clear that Offit’s personal share of CHOP’s royalty transaction was large, the exact amount could range from as little as $29 million to as much as $55 million. Age of Autism chose to feature the smaller amounts in this report.

    CHOP spokeswoman Rachel Salis-Silverman, contacted by Age of Autism about Offit’s income from the vaccine, first said, “I don’t even know. That’s not public information.” She initially refused to provide an e-mail to which Age of Autism could send a detailed account of how it determined Offit’s income, but subsequently sent an e-mail saying she was expecting the information.

     “We are declining comment to your questions,” she then replied after receiving our inquiry. Offit did not respond to an e-mail sent to his Children’s Hospital address.
     
    While refusing to disclose his personal profit from this transaction, Offit told Newsweek reporter Claudia Kalb last year that he got a “small percentage” of the payment and confessed that “it’s like winning the lottery.”

    The $29 million-$55 million range is consistent not only with CHOP’s published royalty arrangements but with typical medical patent standards:
     
    -- At Boston Children’s Hospital, inventors get 25% of “net lifetime revenues” for all income over $500,000. For royalty amounts smaller than $500,000 inventors receive 45-100% of revenues.

    -- At Arkansas Children’s Hospital, inventors get 35% of “net royalties” after the first $200K and 50% before that.

    -- At the University of Virginia, inventors get 15% of “total royalty income” over $1 million and a sliding scale of 25-50%for amounts smaller than that.

    -- At the University of California, inventors get 35% of “net royalties.”

      Offit’s claim to a share of the profits from Merck’s Rotateq revenues is based on his role as a listed inventor on the cluster of patents that protect Merck’s vaccine. These patents share the title “Rotavirus Reassortant Vaccine” and include four granted US patents -- US5626851, US5750109, US6113910 and US6290968 — and two granted European patents — EP323708 and EP493575.

      All of the patents are jointly owned by CHOP and the Wistar Institute. Offit is one of the three listed inventors on the vaccine patents but holds 100% of CHOP’s inventor rights. The other two inventors, Fred Clark and Stanley Plotkin, are both affiliated with the Wistar Institute (in a December 2005 transaction that was similar to CHOP’s deal with Royalty Pharma, the Wistar Institute sold its royalty interest in Rotateq to Paul Capital for $45 million).

    The CHOP policy manual that delineates the distribution of income for inventions owned by CHOP can be found (HERE) (see section III B). Clearly, based on the distribution of income rights outlined in this manual, Paul Offit had a greater personal interest in Rotateq’s commercial success than any other single individual in the world. And more than other individual in the world, he found himself in a position to directly influence that success.
    --

    Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP). In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months. For example, after ACIP approved the addition of Merck’s (and Offit’s) Rotateq vaccine to the childhood vaccination schedule, Merck’s Rotateq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008. When one multiplies a price of close to $200 per three dose series of Rotateq by a mandated market of four million children per year, it’s not hard to see the commercial value to Merck of favorable ACIP votes.

    From 1998 to 2003, Offit served as a member of ACIP. Before and during his ACIP term, Offit was involved in rotavirus vaccine development activities, the value of which ACIP influenced. Shortly before his term began in October 1998, Offit’s first two rotavirus patents were granted by the U.S. Patent and Trademark Office, the first on May 6, 1997 and the second on May 12, 1998. During his ACIP term, Offit received two additional patents in 2000 and 2001.

    Receiving a patent provides the potential but not the certainty of financial reward. In most cases, when an inventor’s employer receives a patent, the commercial value of the patent award is highly uncertain. In the case of Rotateq, the business uncertainty revolved around three factors: 1) the creation and eventual size of the rotavirus vaccine market, 2) the market share of competing products such as Wyeth’s RotaShield vaccine and 3) the success of Merck’s clinical trial for Rotateq and subsequent FDA approval. For the first two of these three factors, Offit’s ACIP membership gave him a direct opportunity to favorably influence his personal financial stake in Rotateq.

    Four months before Offit was appointed to ACIP in October 1998, the committee had voted to give the rotavirus category a “Routine Vaccination” status, in anticipation of an FDA approval of RotaShield (oddly, ACIP made this vote before the FDA approved Wyeth’s RotaShield vaccine on October 1, 1998). Shortly after Offit’s term began, there were several additional votes involved in establishing the rotavirus vaccine market and Offit voted yes in every case. In May of 1999, the CDC published its revised childhood vaccination schedule and rotavirus vaccine was included. This series of favorable votes clearly enhanced the monetary value of Offit’s stake in Merck’s rotavirus vaccine, which was five years into clinical trials.

    Nevertheless, Merck’s Rotateq vaccine was several years behind Wyeth’s RotaShield, which stood to be the market leader based on its lead in making its way through clinical trials. But when the widespread administration of RotaShield to infants started producing a high incidence of intussusception reports, including numerous fatalities, ACIP was forced to reverse itself. On October 22, 1999, ACIP voted to rescind its recommendation of the RotaShield vaccine.

    Offit recused himself from this vote, although he participated in the discussion. In the meeting in which ACIP discussed RotaShield, Offit remarked, "I'm not conflicted with Wyeth, but because I consult with Merck on the development of rotavirus vaccine, I would still prefer to abstain because it creates a perception of conflict.” CDC records make it clear that Offit was not silent on RotaShield. By 2001, he was actively advancing a “unique strain” hypothesis, an argument that RotaShield was formulated in a way that did increase intussusception risk whereas other formulations (e.g. Rotateq) would not.

    In commercial terms, Offit had a clear stake in the earlier RotaShield decision. As a competitor to Rotateq, RotaShield’s withdrawal provided a financial opportunity for Offit’s partner, Merck. Not only did RotaShield’s withdrawal give Rotateq an opportunity to gain 100% of the rotavirus vaccine market Offit had voted to create (until April 2008, when GlaxoSmithKline’s Rotarix vaccine was approved, Merck held a monopoly on the rotavirus vaccine market), but the absence of competition enabled Merck to charge a premium price for its vaccine, significantly more than Wyeth had charged for RotaShield.

    With RotaShield out of the market and the favorable rotavirus policy precedent established, when the FDA approved Rotateq on February 3, 2006, the path to profitability for Merck was set. And for CHOP, which had licensed its patent rights to Merck, the valuation of its patent portfolio soared. Faced with this newly valuable asset, CHOP chose not to take their profits in the form of a series of smaller royalty checks. Instead, they opted to sell off their rights to the income stream and receive a lump sum payment in its place. Royalty Pharma -- an intellectual property investment firm that “provides liquidity to royalty owners and assumes the future risks and rewards of ownership” -- stepped in to pay CHOP for the rights to its Merck royalties. CHOP, in turn, paid Offit his inventor share. Although neither CHOP nor Merck has disclosed Merck’s royalty obligation around CHOP’s patents, the fact that Royalty Pharma was motivated to pay CHOP $182 million for the right to receive the Rotateq royalty stream suggests that obligation was significant.

    Other news organizations, most notably CBS News, have asked Offit to disclose the financial details of his Merck relationship. CBS New reporter Sharyl Attkisson wrote last July that, “future royalties for the [Rotateq] vaccine were just sold for $182 million cash. Dr. Offit's share of vaccine profits? Unknown.”

    Offit protested loudly over the CBS News report and went so far as accusing Attkisson of unethical conduct. “Did [Attkisson] lie about whether or not we provided materials? Of course,” Offit claimed in an August interview with the Orange County Register. He argued that in responding to a CBS News investigation of his financial ties to Merck, he readily provided full details of the payments that CBS asked for including: “the sources and amounts of every grant he has received since 1980”; “the details of his relationship, and Children’s Hospital of Philadelphia’s relationship, with pharmaceutical company Merck”; and “the details of every talk he has given for the past three years.”

    A personal profit of at least $29 million seems like more than a small detail to leave out.

    This is the type of 'conflict of interest' that permeates the culture of Big Pharma. We haven't heard the last of Dr. Andrew Wakefield either.

    I presume you've seen this before?

    Al

Children
No Data