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9-172 MMR: The Unanswered Questions

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  • schafer
    SCHAFER AUTISM REPORT Healing Autism: No Finer a Cause on the Planet ________________________________________________________________ Tuesday,
    Message 1 of 2 , Nov 4, 2005
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      SCHAFER AUTISM REPORT "Healing Autism:
      No Finer a Cause on the Planet"
      ________________________________________________________________
      Tuesday, November 1, 2005 Vol. 9 No. 172


      THE AUTISM CALENDAR OF EVENTS IS OUT!
      http://www.sarnet.org/events
      _____________________________


      RESEARCH
      * MMR: The Unanswered Questions
      * Scientists Tie Two Additional Genes to Dyslexia

      TREATMENT
      * ADHD Drugs Might Become Available As Patch

      PUBLIC HEALTH
      * Congress Weakens Organic Labeling

      CARE
      * Minnesota Attorney General To Scrutinize Autism Center

      MEDIA
      * Autism One Radio Special Nov 2 Senate Bill 1873
      * TV: Supernanny Teams With Acclaimed Autism Expert To Help Child

      EDUCATION
      * Asperger Boy Can Not Attend Indiana Catholic School

      COMMENTARY
      * Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan


      RESEARCH

      MMR: The Unanswered Questions

      Daily Mail, UK
      http://www.melaniephillips.com/articles/archives/001468.html

      Since Dr Andrew Wakefield first triggered the furore over a possible
      link between autism, bowel disease and the measles, mumps and rubella triple
      jab in 1998, the controversy has never died away. Now a study by the
      respected Cochrane Library has said, on the basis of 31 pieces of research
      into the possible side effects of MMR, that it found no association between
      MMR and autism.
      Cue a frenzy of gloating by Wakefield's enemies, ripe denunciations of
      those like this newspaper who took his concerns seriously and demands that
      we apologise for creating a scare that left children unvaccinated and at
      risk of measles, mumps and rubella. The Cochrane Library study, they
      shrieked, had found MMR to be 'safe', given it the 'all clear' and declared
      all such fears to be 'unfounded'.
      This is a load of old baloney. These people should start by reading
      the actual study rather than lazily recycling the press release. For the
      study didn't say anything like this at all.
      Certainly the lead Cochrane reviewer Vittorio Demicheli said in that
      press release: 'We conclude that all the major unintended events, such as
      triggering Crohn's disease or autism, were suspected on the basis of
      unreliable evidence.'
      But Wakefield never suggested a link between MMR and Crohn's disease,
      a disorder of the bowel. Wakefield reported instead the discovery of an
      entirely new syndrome, autistic enterocolitis, which produced distressing
      bowel symptoms along with a number of developmental problems resembling
      autism - but which the Cochrane report did not even mention.
      Moreover, it did not conclude that Wakefield's evidence was
      unreliable. On the contrary, it said that no fewer than nine of the most
      celebrated studies that have been used against him were unreliable in the
      way they were constructed. As a result, it said, their conclusions that MMR
      was 'safe' or 'well-tolerated' need to be 'interpreted with caution'.
      Next, the press release said: 'There was no credible evidence behind
      claims of harm from the MMR vaccination.' But the study did not say that. It
      did not even examine those claims of harm, which arose not from the
      epidemiological studies of patterns of disease which Cochrane investigated,
      but from clinical investigations of actual children.
      What the report did say but was not mentioned in that extremely odd
      press notice was this: 'The design and reporting of safety outcomes in MMR
      vaccine studies, both pre-and post-marketing, are largely inadequate'. And
      just as significant, this: 'We found only limited evidence of the safety of
      MMR compared to its single component vaccines.'
      In other words, far from saying MMR was safe the study said explicitly
      that the evidence for its safety was not good enough. Yes, it also said the
      evidence it looked at did not support any association between MMR and
      autism. But that does not mean it said the vaccine was safe. It was rather
      that it didn't find anything to suggest that it was not.
      And that was because the epidemiological studies that it examined are
      intrinsically unlikely to reveal the truth about the effects of MMR. For a
      start, they rely on medical records. But the parents complained that their
      children's doctors dismissed all their concerns about autistic symptoms or
      bowel disease. So they never entered anything out of the ordinary on their
      medical records.
      Furthermore, for the vast majority of children, the vaccine poses no
      problem at all. Only a very small proportion are said to have been badly
      affected, possibly through a combination of environmental or genetic
      factors. But population-wide studies are considered too large and
      insensitive to pick up small numbers like this.
      It is the evidence that Cochrane did not examine that is the only
      material worth studying. This is the clinical evidence obtained not just by
      Wakefield and his associates but by others, which has posed alarming
      questions that have never been answered.
      Wakefield's discovery of autistic enterocolitis as a completely new
      syndrome has now been replicated in studies around the world as a new and so
      far unexplained disease in patients with autism.
      It has also been discovered that autistic symptoms have got far worse
      in a number of children after they received booster jabs - and such booster
      jab evidence has been accepted by the American Institute of Medicine, at
      least, as an indication of cause and effect.
      Most explosively of all, vaccine-strain measles virus has been found
      in the cerebro-spinal fluid of some autistic children - which suggests that
      in those cases the vaccine may have had a catastrophic effect on the brain.
      None of this proves that MMR has caused autism in some children. But
      it does raise questions which need to be resolved as a matter of urgency.
      The only way to do so is to conduct large-scale clinical trials, which the
      government has consistently refused to do.
      Hopes of examining the existing clinical evidence were pinned on the
      legal case being brought by parents claiming compensation on behalf of
      children said to have been damaged by the vaccine. But this case foundered
      when the parents' legal aid was abruptly withdrawn.
      Now Wakefield himself is being arraigned before the General Medical
      Council on eleven counts of serious professional misconduct, including an
      alleged conflict of interest over receiving funding from the parents'
      lawyers, which he has strenuously denied.
      Compare this with the Cochrane paper, where under the rubric
      'potential conflict of interest' Dr Tom Jefferson, who is listed as the
      study's second author, acknowledges that in 1999 he acted as a consultant
      for a legal team advising the MMR vaccine manufacturers.
      Another researcher who helped with the Cochrane paper was one of the
      authors of a prominent study which rubbished Wakefield's research -- a study
      which the Cochrane report itself then investigated.
      And a number of epidemiological studies which the government has used
      to state that MMR is safe have been written by researchers with links to
      drug companies or to governmental bodies with an interest in disproving
      Wakefield's concerns.
      Are these not real conflicts of interest which should be investigated,
      rather than hounding the doctor whose discoveries have raised concerns over
      public health which have never been addressed?
      One of Cochrane's findings should give even those jeering from the
      sidelines pause. This was that the 'Urabe' strain of the mumps component of
      the triple vaccine causes aseptic meningitis.
      Although the current vaccine does not contain this Urabe strain, the
      first batch of MMR vaccine introduced in 1989 did - even though the Health
      Department knew at the time that Canada had already withdrawn it because it
      was unsafe.
      The British vaccine was only replaced years later, after researchers
      discovered to their horror an association with aseptic meningitis in
      Britain. So the idea that MMR was always safe is demonstrable nonsense.
      The MMR scandal is getting worse. Urgent questions about the vaccine's
      safety remain unanswered. The doctor who raised those questions is being
      subjected to what appears to be a witch-hunt. The parents' recourse through
      the courts has been blocked. Now they have to put up with being told yet
      again that the evidence of their own eyes is fraudulent.
      Every responsible person wants to see children vaccinated against
      dangerous diseases. But public anxiety could have been allayed overnight had
      the government permitted single vaccine jabs. Instead, we have clouds of
      obfuscation, an ignorant cacophony of catcalls - and an unresolved public
      health problem.





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      . . .

      Scientists Tie Two Additional Genes to Dyslexia

      Note: We have already reprinted another story on this subject. This
      one is by Sandra Blakeslee for the NY Times.
      http://www.nytimes.com/2005/10/29/science/29gene.html?pagewanted=print

      One year after scientists discovered a gene whose flaw contributes to
      dyslexia, two more such genes have now been identified.
      The findings, described yesterday in Salt Lake City at a meeting of
      the American Society of Human Genetics, support the idea that many people
      deemed simply lazy or stupid because of their severe reading problems may
      instead have a genetic disorder that interfered with the wiring of their
      brains before birth.
      "I am ecstatic about this research," said Dr. Albert M. Galaburda of
      Harvard Medical School, a leading authority on developmental disorders who
      was not involved in the latest discoveries.
      The findings, added to last year's, mean that for the first time, "we
      have a link between genes, brain development and a complex behavioral
      syndrome," Dr. Galaburda said.
      As many as a dozen genes are probably involved in the disorder, he
      said, with each playing a role in the necessary migration of neurons as the
      brain's circuitry develops.
      Researchers said a genetic test for dyslexia should be available
      within a year or less. Children in families that have a history of the
      disorder could then be tested, with a cheek swab, before they are exposed to
      reading instruction. If children carry a genetic risk, they could be placed
      in early intervention programs.
      "Reading ability is a proxy for intelligence in American culture,"
      said Dr. Sally E. Shaywitz of Yale University School of Medicine, a
      pediatrician who is an expert on dyslexia. The findings should help overcome
      stereotypes and get children the assistance they need, she said.
      One of the genes newly linked to dyslexia is called DCDC2. It is
      active in reading centers in the human brain, said Dr. Jeffrey R. Gruen, a
      Yale geneticist who described the discovery at a news conference yesterday.
      Large deletions in a regulatory region of the gene were found in one of
      every five dyslexics tested, making it less active.
      Fluent readers and dyslexics alike have the protein made by this gene,
      Dr. Gruen said, but it is less abundant in dyslexic brains. The function of
      the protein is not known, he said.
      Rats also have the DCDC2 gene, so it should not be misconstrued as a
      spelling or reading gene, Dr. Gruen said. Rather, the gene supports the
      circuitry that underlies reading. When it was perturbed in unborn rats, he
      said, neurons migrated shorter distances, undercutting early brain
      development.
      The second gene, called Robo1, was discovered by Dr. Juha Kere, a
      professor of molecular genetics at the Karolinska Institute in Stockholm. It
      is a developmental gene that guides connections, called axons, between the
      brain's two hemispheres, Dr. Kere said in an interview.
      When the gene's activity is reduced, the number of finer connections,
      called dendrites, is reduced in brain areas involved in reading.
      "You get the right signals going, but they do less well in terms of
      rapid processing," Dr. Kere said.
      Many dyslexia experts believe that reading problems stem from an
      inability to process the fast sounds of spoken words.

      . . .

      TREATMENT

      ADHD Drugs Might Become Available As Patch

      http://abclocal.go.com/wls/story?section=health&id=3577054

      Children who are prescribed ADHD drugs may soon have a choice: the
      patch or the pill.
      A new patch system delivers methylpnenidate, the main ingredient in
      Ritalin, Concerta, and Methyln throughout the day. The patch is made by
      Noven and Shire pharmaceuticals. It is the first ADHD drug that does not
      have to be taken orally.
      Studies have shown the patch works at least as well as the pills. It
      does have similar side effects one of the benefits is the affects appear to
      last longer than the usual 10 to 12 hours.
      The company is now awaiting FDA approval.

      . . .

      PUBLIC HEALTH

      Congress Weakens Organic Labeling

      http://www.freemarketnews.com/Feedback.asp?nid=733

      If you have been shopping carefully, reading all the labels and
      otherwise attempting to ensure that only "organic" substances enter your
      body in the food you eat, your task just got a little tougher. According to
      a release from the Organic Consumers Association, a rider in a bill passed
      by Congress last week has "weakened" the laws defining food, to allow
      "synthetic substances" to be included in foods labeled as "organic." The
      opposition group, the Organic Trade Association, in conjunction with major
      food processing corporations like Smucker's, Dean Foods, and Kraft, have
      lobbied Congress to amend the Organic Foods Production Act to allow for this
      leeway in "organic dairy standards."
      The OCA cites a recent court decision, ruling that the OFPA does not
      allow these "non-natural" ingredients in foods labeled "organic." The
      Congressional action was thus required to bypass this decision, and the OCA
      is not pleased.
      "Congress voted last night to weaken the national organic standards
      that consumers count on to preserve the integrity of the organic label,"
      Ronnie Cummins, OCA National Director is quoted as saying. "The process was
      profoundly undemocratic and the end result is a serious setback for the
      multi billion dollar alternative food and farming system that the organic
      community has so painstakingly built up over the past 35 years. . Industry's
      stealth attack has unnecessarily damaged the standards that helped organic
      foods become the fastest growing sector in the food industry."

      . . .

      CARE

      Minnesota Attorney General To Scrutinize Autism Center

      By Dan Browning and Pat Doyl for the Star Tribune
      http://www.startribune.com/stories/462/5694216.html

      Minnesota Attorney General Mike Hatch said Thursday he would try to
      determine if one of the state's largest programs for autistic children has
      misspent Medicaid money and whether the board of the nonprofit organization
      is formed properly.
      Hatch said he would have Medicaid specialists in his office review
      billings from the tax-exempt Minnesota Autism Center to the state Department
      of Human Services. The center relies on public money for most of its budget.
      "It's very clear that there's been enough controversy involving the
      billing matters ... that it does merit review by the state," Hatch said.
      Staff psychologists at the center have complained of being pressured
      to approve treatment services that may not have been medically necessary for
      the autistic sons of two board members, Ron Carey and Kathryn Marshall.
      Carey and Marshall defended the therapy for their children, saying it
      was proper and necessary and approved by DHS. They deny seeking special
      treatment or overstepping their authority as board members. Carey is
      chairman of the Republic Party of Minnesota; Marshall is a retired lawyer.
      Hatch, a DFLer running for governor, said he was reacting in part to a
      story about the dispute published Thursday in the Star Tribune.
      He said he also was responding to complaints from some employees of
      the center and to conversations in the past week with DHS about the matter.
      The dispute resulted in a lawsuit earlier this year by board members
      Tim Wilkin and Larry Colson against Carey, Marshall and two other board
      members with children in the program. Wilkin, a Republican, is assistant
      House majority leader. Colson is a Republican activist.
      In a settlement of the suit, Wilkin and Colson agreed to resign from
      the board and to say their claims were not factual. The center agreed to
      develop a conflict-of-interest policy.
      A Hennepin County judge overseeing the case asked earlier this year
      that Hatch look into the matter, and the attorney general said he had
      referred complaints about the Autism Center to DHS. "We're unclear whether
      DHS is reviewing it or not," Hatch said in reference to the earlier inquiry.
      DHS said state law bars it from publicly confirming investigations
      unless they are closed.
      However, DHS Commissioner Kevin Goodno said Thursday that the agency's
      "Surveillance and Integrity Review Section routinely works closely with the
      Attorney General's Office Medicaid Fraud Unit and supports its efforts to
      investigate any activity it suspects may be fraudulent."
      The Autism Center provides intensive behavior intervention therapy,
      which involves a team of therapists who work with an autistic child for 40
      or more hours a week. It typically lasts about three years and can cost
      $100,000 a year or more at its most intense periods. The center has 88
      clients and a waiting list of more than 100.
      Glen Sallows, director of the Wisconsin Early Autism Project in
      Madison, said that such therapy generally should start before age 3 and that
      most gains occur in the first year. Results are believed to diminish for
      school-age children.

      Legislators Weigh In
      "If there is a question in terms of its effectiveness, and you're
      spending that kind of quantity of money, then what about the other kind of
      therapies that may not be as expensive but have ... pretty good results as
      well?" asked Rep. Fran Bradley, R-Rochester, who chairs the House Health
      Policy and Finance Committee. "You're not going to have as much money left
      for them."
      Bradley said that questions about the therapy's effectiveness and the
      growing expense of Medicaid to the state will probably reduce support for
      funding a 2001 law that would dedicate money for such therapy in the future.
      Sen. Linda Berglin, DFL-Minneapolis, chairwoman of the Health and
      Human Services budget division of the Finance Committee, said that the
      therapy may help some younger children but that she has concerns about the
      cost and overall effectiveness.
      Berglin said that she might ask the Legislative Audit Commission to
      review the matter.
      [Thanks to Rick Rollens.]

      . . .

      MEDIA

      Autism One Radio Special Nov 2 Senate Bill 1873 A Worldwide, Web-Based Radio
      Station for the Care, Treatment, and Recovery of Children with Autism
      http://www.autismone.org/radio

      Wednesday, November 2nd:

      Special: Senate Bill 1873 & the President's Tuesday avian flu
      briefing.
      12:45 pm - 2:15 ET Why is S.1873: the "Biodefense and Pandemic
      Vaccine and Drug Development Act of 2005," one of the most unfriendly pieces
      of legislation yet to you, your children, your neighbors? What positive
      steps can you take right away? Join Autism One Radio and guests, including
      Barbara Loe Fisher of the National Vaccine Information Center, Jim Moody,
      Esq. of Advocates for a Competitive Economy and SafeMinds, and Laura Bono of
      the National Autism Association for these questions and commentary on the
      President's avian flu briefing of Tuesday, November 1st.

      Note: For more information on this subject see commentary below:
      Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan




      EVIDENCE OF HARM DISCUSSION LIST HEATS UP
      AS MERCURY LINK TO AUTISM QUESTION SPREADS

      An Evidence of Harm email discussion list has
      been created in response to the growing interest
      in the book and the issues it chronicles. Now over
      1,100 subscribers. Here is how to subscribe
      (no cost): EOHarm-subscribe@yahoogroups.com


      . . .

      TV: Supernanny Teams With An Acclaimed Autism Expert To Help A Child Who Is
      An Outsider In His Own Home On "Supernanny," November 4, ABC

      Supernanny Jo Frost teams with world-renowned autism expert Dr. Lynn
      Koegel to tackle the parenting issues faced by a family whose three-year-old
      son is an outsider in his own home. This episode of "Supernanny" airs on
      Friday, November 4 (8:00-9:00 p.m. ET) on the ABC Television Network.
      Deirdre and Trae Facente don't know how to integrate their autistic
      son Tristin into their daily life with their twins, Kayla and Marlana (4).
      Tristin is completely non-verbal, caught up in his own world of
      spinning, jumping, swinging and, often, taking off his clothes. The only
      time he spends with his family is sitting at the dinner table. The twins,
      who demand much of their stay-at-home mom's attention, can't figure out how
      to play with their little brother.
      The parents are at a loss as to how to help Tristin come out of his
      zone and join the family.
      Enter Dr. Koegel and Supernanny. Together they refine the classic
      Supernanny methods and teach all the Facentes Dr. Koegel's inclusion and
      communication techniques to help engage Tristin. For example, when they
      introduce the new daily schedule to everyone, Dr. Koegel uses a picture
      board with Tristin to help him understand in a concrete way.
      In just a week, silent Tristin goes from zero words to speaking
      hundreds of times using over 20 new words. He is bursting with requests to
      play a favorite game, be tickled or eat a treat. Step-by-step, Jo and Dr.
      Koegel help the parents keep Tristin from his disruptive behaviors by
      including him in family chores and activities. These efforts culminate in
      the boy helping his dad set the table, a seemingly mundane task that is so
      miraculous for Tristin, it brings tears to Trae's eyes.
      Lynn Kern Koegel, Ph.D is one of the world's foremost experts on the
      treatment of autism. She and her husband, Robert L. Koegel, Ph.D., founded
      the renowned Koegel Autism Center at the Graduate School of Education at the
      University of California, Santa Barbara. She co-wrote the bestselling book
      on autism, Overcoming Autism: Finding the Answers, Strategies, and Hope that
      can Transform a Child's Life, which was recently released in paperback, and
      also co-authored, with Robert Koegel, the new book, Pivotal Response
      Treatments for Autism.

      . . .

      EDUCATION

      Asperger Boy May Not Attend Indiana Catholic School

      By Olivia Clarke for the NW Times, Indiana.
      http://tinyurl.com/9v3sa

      Munster resident Nancy Wojcik is upset her son can no longer attend
      St. Thomas More Catholic School.
      Wojcik said her son, Joshua, has Asperger Syndrome, a disorder that
      falls under the autism umbrella. She said her son is very intelligent, but
      lacks the social skills many children his age have.
      She said she was told about a week before school started that her son
      could no longer attend St. Thomas More School because it did not have the
      financial resources to properly educate him. She believes the school handled
      the situation poorly and has the money to help him. He now attends Wilbur
      Wright Middle School in Munster.
      "We go to church every week and hear of how racism and discrimination
      are wrong," Wojcik said. "I feel like we are a bunch of hypocrites. You have
      an opportunity to practice what you preach. ... I just think that it's too
      easy for them to pick and choose who to admit."
      Stacey Atwood, principal at St. Thomas More School, said the school
      shares Wojcik's frustrations.
      The school believed Joshua needed to have an instructional assistant
      with him at all times because of previous incidents, but it could not afford
      it, Atwood said. The school decided his needs would be best served in a
      public school, she said.
      Atwood said Catholic schools have limited resources that prevent them
      from offering the same type of special education services as public schools.
      Public schools receive federal dollars for special education students, but
      nonpublic schools do not receive that financial help.
      "We are really focused on trying to meet the needs of these kids,"
      Atwood said. "It is very frustrating to have a lack of funding to support
      what we want to do. It is a very generous church. But what I am looking for
      isn't a quick fix. I would like something in place that would be long-term
      that provides for the needs of children with special needs."
      Private school students are not legally entitled to the same level of
      services as public school students, said Bob Marra, associate superintendent
      of the Indiana Department of Education's Division of Exceptional Learners.
      The public school district where the private school is located is
      required to provide some assistance to special education students in that
      private school, Marra said. Public school districts receive money to provide
      this help, but it isn't always enough to help all students equally, he said.
      + Full article here: http://tinyurl.com/9v3sa

      . . .

      COMMENTARY

      Forced Inoculations Beginning Of Bush's Bad Bird Flu Plan

      By John Hanchette.
      http://www.niagarafallsreporter.com/hanchette179.html

      Last week's column warned of imminent federal legislation that would
      toss powerful pharmaceutical companies billions of dollars and complete
      protection from liability suits in case untested and experimental bird flu
      vaccines damage American recipients. It drew heavy response.
      The bill (S. 1873) -- a big congressional wet kiss to the drug
      industry -- is dressed up in a noble-sounding title: "Biodefense and
      Pandemic Vaccine and Drug Development Act."
      In essence, however, it would force Americans to receive inoculations
      against a disease that has yet to kill one of them, while removing their
      constitutional right to seek redress in our courts in case of injury or
      death from the shots because of company negligence. The proposal, now moving
      its way through the Senate, would also ban citizens from using the Freedom
      of Information Act and other popular informational laws to discover whether
      the new vaccine (when it is finally produced) was effective and safe, and
      even whether anyone had suffered adverse reactions to it.
      Some of the e-mails and letters were laudatory, but sadly and
      predictably, many readers missed the point.
      One wrote that I could only have reached my conclusions if I started
      from the position that the pharmaceutical companies were "evil" and that the
      World Health Organization, the Centers for Disease Control, and "practically
      every virologist and epidemiologist in the world is part of a conspiracy."
      Or was I saying that I have "some sort of privileged information that H5N1
      influenza will never mutate and begin to infect humans and even if it does,
      it won't reach the USA?"
      He ended by quoting some venerable Chinese philosopher's advice to
      "plan for what is difficult while it is easy, do what is great while it is
      small."
      Well, yes, point taken on the aphorism -- but that's exactly the
      philosophical tack I'm following here: identifying a cancerous piece of
      federal business and dissecting it while it is still an undivided cell. If
      this bill -- which is absolutely laden with hidden agendas -- metastasizes
      into actual law, Senate 1873 could further ruin an already devastated
      national health care system.
      Sure, the bird influenza that has killed 62 Asians may mutate into
      easily contractible flu for humans. I acknowledge that. It may soon reach
      the United States. I acknowledge that. But my beef is the thematic hidden
      agenda in this dangerous Senate bill that is designed to protect wealthy
      corporate contributors from any consequences of money-motivated,
      irresponsible scientific research and development. The legal precedent would
      be ruinous and take decades to set right.
      One thing the bill-backer friends of Big Pharma are trying to slip
      through with this legislation is a market exclusivity provision that would
      extend patents on hugely profitable drugs that are about to evolve into the
      category of cheaper generic medicines.
      Further, it would prohibit federal drug buyers from contracting with
      generic medicine makers to save taxpayers billions of dollars -- a current
      admirable practice.
      Further, it would allow federal health officials to purchase
      medicines, vaccines and other palliatives by simple fiat without taking
      bids.
      Further, and most onerously, the bill would vastly broaden the
      definition of products eligible to be characterized as "countermeasures" to
      terrorism -- in other words, potentially classifying commonly purchased
      substances like ibuprofen and aspirin as terrorist-fighting devices.
      I'm not the only one who's noticed the exclusivity aspect of this
      legislative turkey.
      The Coalition for a Competitive Pharmaceutical Market (CCPM) is an
      unusually broad-based national coalition of organizations powerful on
      Capitol Hill in representing employers, health insurers, chain drugstores,
      generic drug makers and pharmacy benefit managers.
      Last week, this huge group urged the Senate to revise the "biodefense"
      bill to remove the broadened definition of terrorism "countermeasures"
      because the proposal allows it to be done "in a way that could grant
      existing everyday medicines -- rather than novel products related to
      (defense) against bioterrorism -- multiple years of additional market
      exclusivity."
      This, contends CCPM chairman Annette Guarisco, "would unnecessarily
      drive up prescription drug costs for private and public payers without
      advancing our nation's bioterrorism preparedness."
      Even the big health insurance companies and pharmaceutical management
      lobbyists were startled by the brazen provisions at the expense of common
      citizens Senate 1873 portends.
      Mark J. Rubino, chief pharmacy officer for Aetna Inc., states, "For
      private and public purchasers seeking to provide consumers with
      therapeutically equivalent, but more cost-efficient generic drugs, the
      market exclusivity provision included in the Biodefense bill takes us in
      exactly the wrong direction."
      Mark Merritt, president of the Pharmaceutical Care Management
      Association, said, "This drug monopoly extension proposal is a sweeping and
      unprecedented measure that would rewrite drug-patenting and force working
      families, the disabled, and seniors to pay more for their prescription
      drugs. Perhaps most troubling of all, this measure has moved forward without
      any regard to the cost (effects) it would have on on Medicare, Medicaid, and
      private payers. America's working families, seniors, and small businesses
      deserve better."
      Some who read the column accused me of overstating the liability
      protections for Big Pharma contained in the bill. Surely, they wrote, I was
      guilty of hyperbole or making things up. Surely, federal legislators
      wouldn't remove the cherished American right to redress wrongs or seek
      compensation for uninvited injury.
      Oh, yeah? The language seems pretty clear to me. It provides
      incredibly broad and iron-clad protection from any American seeking legal
      remedy from Big Pharma and just about everyone else involved in protecting
      against bird flu. Look up the draft bill's Section 319F-3 (a) if you don't
      believe me.
      "Authority -- As provided in subsection (b), and subject to subsection
      (b) (1) C, a manufacturer, distributor, or administrator of a security
      countermeasure, or a qualified pandemic and epidemic product, or a health
      care provider shall be immune from suit or liability caused by or arising
      out of the design, development, clinical testing and investigation,
      manufacture, labeling, distribution, sale, purchase, donation, dispensing,
      prescribing, administration, or use of a countermeasure, or a qualified
      pandemic and epidemic product, described in subsection (b) (1) (a)."
      That just about covers the waterfront, as they say. The only avenue of
      relief an injured vaccine or medicine recipient or survivor could follow is
      requesting an investigation of their allegation by the Secretary of Health
      and Human Services -- who would have to find "clear and convincing evidence"
      of "willful misconduct" that "caused the product to present a significant or
      unreasonable risk to human health and proximately caused the injury alleged
      by the party."
      There are at least seven tough legal tests contained in that one
      paragraph. And if the HHS Secretary refuses to even investigate the
      complaint of injury or death, such decision is completely "within the
      Secretary's discretion and shall not be subject to judicial review."
      If the secretary does find for the complaining injured party -- which
      is extremely unlikely -- the drugmaker or distributor or health care
      provider named in the determination can petition the federal court in the
      District of Columbia for "judicial review" of the HHS ruling. But no
      subpoenas shall be issued, "nor shall other compulsory process apply," and
      no third parties can intervene. The drug company appeal "shall automatically
      stay the Secretary's determination for the duration of the judicial
      proceeding."
      There are six more pages of legal gobbledygook backing this up, one of
      them defining the scope of protection from lawsuit as extending to
      allegations "relating to, or resulting from the design, development,
      clinical testing and investigation, manufacture, labeling, distribution,
      sale, purchase, donation, dispensing, prescribing, administration, or use of
      product" defined as measures against pandemics or terrorism. There, is that
      specific enough for you? Is that an imaginative figment?
      Interpretation of this congressional language: Pigs will fly backwards
      and upside down before the common citizen gets any redress or compensation
      for injury or death resulting from a bird flu vaccine or medicine.
      Why are vaccine safety advocates so adamant that John Q. Public might
      get screwed by all this protect-Big Pharma bird flu legislation? Because it
      has happened before.
      In the 1970s, the panic over swine flu led to an ill-advised vaccine
      push that crippled many recipients and cost the drug makers millions.
      In the 1980s, a dangerously reactive vaccine against whooping cough
      injured and killed thousands when a safer foreign alternative was already
      available but stubbornly unapproved by the FDA.
      In the 1990s, the federal health establishment insisted -- and still
      insists -- there is no connection between toxic mercury preservatives in
      mandated childhood vaccines and the astounding increase in autism (from 1 in
      10,000 births to 1 in 166 births), despite ample scientific evidence to the
      contrary.
      Experimental anthrax vaccine is still being tested on troops without
      informed consent, and was almost tested on infants until a big public fuss
      erupted.
      The yearly hoohah over getting your flu shots to protect against
      contractible human flu results in less than desired protection because the
      scientists are always fighting the previous year's struggle that has already
      mutated or died out.
      + Commentary continues here:
      http://www.niagarafallsreporter.com/hanchette179.html


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