...a.k.a. tardive dyskinesia. Fan-tastic! Reglan is the brand name of the drug, by the way...

http://www.reuters.com/article/companyNews/idUSN2629346520090226

UPDATE 1-US FDA: Stomach drugs need movement disorder warning

Big Pharma, lying? Never! I'll bet we won't see this reported on Reuters, since the CEO of Thomson Reuters is on the Board of Directors of Merck. These guys all stick up for each other...

AstraZeneca Papers Raise Seroquel Issues

ORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representatives to tell doctors that its powerful psychiatric drug, Seroquel, didn't cause diabetes even though a company physician had at one point stated years earlier that such a link was probable in some individuals, documents unsealed in a federal court case here show.

The documents -- ranging from unpublished study results to previously undisclosed depositions -- are among more than 100 the U.K. drug maker agreed to unseal Thursday in lawsuits brought by plaintiffs who allege they were harmed by the multibillion-dollar antipsychotic drug. Many of the cases have been consolidated in the U.S. District Court for the Middle District of Florida.

In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a "weight and diabetes sell sheet" they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug.

"Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile," Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to "refocus the call" away from diabetes to the drug's tolerability, the transcript shows.

The voicemail to the sales representatives raises questions about whether there was a contradiction between Ms. Ney's instructions and an AstraZeneca drug-safety expert's own assessment of Seroquel's link to diabetes years earlier. In a 2000 position paper about the safety of Seroquel sent to Dutch regulatory authorities, an AstraZeneca doctor named Wayne Geller wrote that there was a relationship between the drug and diabetes.

"There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes melliutus in certain individuals," Dr. Geller wrote.

AstraZeneca acted "responsibly and appropriately as it developed and marketed Seroquel," company spokesman Tony Jewell says. "From the time it was first approved, the Seroquel labeling alerted physicians that diabetes mellitus, hyperglycemia and weight gain had been observed in clinical trials. We've continued to update the label as the findings have developed."

Mr. Jewell says the document written by Dr. Geller doesn't accurately reflect the company's position in 2000. "In fact, it was not Dr. Geller's ultimate view either. It was an initial draft for discussion purposes. After rigorous discussion of the scientific evidence, Dr. Geller and his colleagues concluded the evidence did not establish that Seroquel causes diabetes."

Dr. Geller retracted his statement in a May 2008 deposition with plaintiffs' attorneys. In response to a plaintiffs' attorney's question, Dr. Geller responded that the statement was "an artifact of an earlier discussion document." AstraZeneca declined to make Dr. Geller and Ms. Ney, who are both still employed by the company, available for comment. Neither could be reached for comment late Thursday night.

AstraZeneca had argued that the documents should remain under seal because they contained proprietary information that could hurt the company if it was revealed to competitors and could harm the public if interpreted out of context. But the company agreed to make public most of the documents following negotiations with plaintiffs' attorneys that concluded in the early hours of Thursday morning.

"AstraZeneca believes communications from the FDA [Food and Drug Administration] to doctors is the appropriate way to notify patients and the public about a medicine's benefits and risks, not a court proceeding," Mr. Jewell says.

Makers of antipsychotic drugs have come under intense scrutiny over whether they knew early on that the powerful psychiatric medicines -- which are used to treat schizophrenia and bipolar disorder -- caused serious side effects such as diabetes. Most of the drugs were approved for sale in the 1990s, but their side effects didn't become widely known until earlier this decade. The drug makers have also been accused of marketing the drugs outside of their approved indications, which is against U.S. law.

Internal company documents proved damaging to Eli Lilly & Co., which agreed to pay $1.4 billion to settle off-label promotion claims last month with the U.S. attorney for the Eastern District of Pennsylvania. Company e-mails and memos leaked in 2006 showed that Lilly played down the health risks of its antipsychotic drug, Zyprexa.

In 2007, Bristol-Myers Squibb Co. agreed to pay $515 million to settle another federal investigation over its marketing practices for its antipsychotic drug, Abilify.

AstraZeneca faces more than 9,000 lawsuits from patients who allege they have been harmed by Seroquel. Most of the cases have been consolidated into one group being heard in the Florida federal court. The first two of these cases, considered bellwethers that would have helped predict the outcomes of the remaining lawsuits, were supposed to have been tried earlier this month, but the judge dismissed them on the grounds that the evidence failed to prove that Seroquel had caused their diabetes. More than 2,300 other cases have also been dismissed. A separate tranche of state cases is also working its way through the courts, with the first set to go to trial in Delaware, where AstraZeneca has its U.S. headquarters. The company says it will defend itself vigorously against the suits.

Pennsylvania, Montana, Arkansas and South Carolina have all sued AstraZeneca, alleging that they were bilked into paying for the medicine for off-label usage and seeking reimbursement for alleged injuries sustained by individuals as a result of the drug. AstraZeneca acknowledges that the U.S. attorney for the Eastern District of Pennsylvania, Laurie Magid, is investigating Seroquel but wouldn't say when the investigation started or what it involves. A spokeswoman for Ms. Magid declined to comment.

When Seroquel was approved in 1997, it contained information in the "adverse reactions" section of the product label concerning diabetes, hyperglycemia and weight gain that had been observed in clinical trials, says Mr. Jewell. In 2003, the FDA mandated a stricter precaution, upgrading the diabetes risk to the label's "warnings" section -- even though the agency said at the time that it wasn't certain that a causal relationship existed.

Last month Seroquel's label was updated to include data on children and adolescents, including blood-glucose levels, cholesterol, weight gain and increased appetite. It also voluntarily agreed to move information about increased blood sugar to the "warnings" section of the label, according to a company lawyer's testimony in court Thursday.

Among the unsealed documents, another set goes back to the late 1990s and raises further questions about whether AstraZeneca kept a lid on unflattering Seroquel studies.

A document dated Feb. 12, 1997, describes internal company deliberations over how to report "Study 15," a study comparing Seroquel to Haldol, an older-generation psychiatric drug. In the document, an AstraZeneca employee named Richard Lawrence writes to his team that one of his colleagues had done a great "smoke and mirrors job," and another had suggested an approach that "should minimise (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study."

It isn't clear what Mr. Lawrence's comments were referring to. He couldn't be reached late Thursday, and AstraZeneca declined to discuss the emails. Ed Blizzard, an attorney with the Houston law firm Blizzard, McCarthy & Nabers, who is one of the lawyers for the plaintiffs, says the document refers to the fact that "the weight gain data was bad, and that's why we believe the study was buried."

In a series of emails in 1999, AstraZeneca executives discuss withholding the results of another Seroquel study, known as COSTAR. That study compared Seroquel to Risperdal, another antipsychotic drug made by Johnson & Johnson.

On Dec. 6, 1999, an AstraZeneca employee named John Tumas, the publications manager for Seroquel, wrote to his colleagues, "There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried" certain studies. Referring to COSTAR, he added: "We must find a way to diminish the negative findings. But in my opinion we cannot hide them."

Mr. Tumas couldn't be reached late Thursday. AstraZeneca's Mr. Jewell declined to comment about the 1990s e-mails and documents other than to note that the FDA "vetted and substantiated the safety data for Seroquel," including the data from both Study 15 and COSTAR. "The FDA has approved the medicine as a safe and effective treatment for schizophrenia and bipolar disorder," he says. —Jeanne Whalen contributed to this article.

Write to Shirley S. Wang at shirley.wang@wsj.com and Avery Johnson at avery.johnson@WSJ.com

Hahahahaha. No ****. How about taking on the FDA next?

http://www.nytimes.com/2009/02/25/science/earth/25air.html?_r=2&ref=us

E.P.A. Is Told to Reconsider Its Standards on Pollutants

Bush administration standards for pollutants like soot are “contrary to law and unsupported by adequately reasoned decisionmaking,” a federal appeals court said Tuesday.

The court ordered the Environmental Protection Agency to reconsider its standards for the pollutants, fine particulates, which are linked to premature death from lung cancer and heart disease and to other health problems including asthma.

When the agency embraced the standards in 2006, its own scientific staff rejected them as too lax. In Tuesday’s ruling, the United States Court of Appeals for the District of Columbia Circuit said the agency “did not adequately explain” why the standards were adequate.

The decision is “a victory for the breathing public,” said Paul Cort, a lawyer with Earthjustice, who argued the case for environmental groups. The legal effort was joined by health organizations and more than a dozen states, including Connecticut, New Jersey and New York.

In a statement, the E.P.A. said only that the standards for particulate matter are “extremely important” and that the Obama administration would review the matter “to ensure that the science and the law will be properly followed.”

Researchers have drawn direct and immediate links between ambient levels of fine particulates and hospital admissions and deaths. By some estimates, tens of thousands of Americans die each year from exposure to airborne particulates.

Among other sources, fine particulates come from diesel engines, power plants, certain industrial processes and even fireplaces. Perhaps one-thirtieth the diameter of a human hair, they can make their way deep into the lungs and in some cases even into the bloodstream.

These pollutants are regulated under the Clean Air Act, but there is no generally agreed safe level of exposure. So in some ways, setting standards is a value judgment more than a scientific decision.

In 2006, agency scientists and almost all the members of its Clean Air Scientific Advisory Council recommended that the standard for long-term exposure be lowered to 12 to 14 micrograms per cubic meter of air, from 15. But the agency’s administrator at the time, Stephen L. Johnson, said there was “insufficient evidence” linking the particulates to health effects.

In a statement in response to Tuesday’s decision, State Attorney General Andrew M. Cuomo of New York said it “could result in preventing hundreds of premature deaths just in the New York City area annually.”

It could also save “hundreds of millions of dollars” in health care costs, Mr. Cuomo said.

Ambient levels of fine particulates vary by place, season and weather. The Clean Air Act divides the nation into so-called airsheds, and regions that consistently violate air-quality standards are subject to penalties including, ultimately, the withdrawal of federal highway funds, Mr. Cort said.

The case decided on Tuesday also involved coarse particulates, like dust, and particulate contributions to haze. Agricultural groups had challenged the standards for coarse particulates as unnecessarily stringent, but the court rejected their view. And it said the E.P.A. must act to reduce the role of particulates in haze.

It was the second time in two days that the appeals court was in the news for overturning decisions made by the E.P.A. during the Bush administration. On Monday, the Supreme Court refused to consider a challenge to the lower court’s ruling against Bush-era standards on emissions of mercury and other pollutants from coal-fired power plants.

Mr. Cort said the appeals court had in recent years exhibited “an increasing level of distrust” for Bush administration regulations. But he rejected the idea that its recent decisions amounted to law-making. “This was not an activist panel of judges here,” Mr. Cort said. Two of the three were Republican appointees, he said, “and this was a per curiam opinion, meaning unanimous.”

http://www.huffingtonpost.com/robert-f-kennedy-jr-and-david-kirby/vaccine-court-autism-deba_b_169673.html

ANOTHER AUTISM CASE WINS IN VACCINE COURT

By Robert F. Kennedy, Jr.

On February 12, the federal "Vaccine Court" in Washington issued a sweeping ruling in three highly touted "test cases" against families who claimed that their childrens' autism had been caused by vaccines. The Special Masters in those three cases found that Petitioners failed to establish causation between MMR vaccines, the mercury-laced vaccine preservative thimerosal, and autism (the court decision, which is under appeal, deferred any finding on a thimerosal-only theory of causation). The rulings could have a significant precedential impact on some 5,000 families who opted to bring their cases in the Omnibus Autism Proceedings (OAP) hoping that the vaccine court would officially hold that the MMR vaccine or thimerosal had caused autism in their children.

The New York Times joined the government Health Agency (HRSA) and its big pharma allies hailing the decisions as proof that the scientific doubts about vaccine safety had finally been "demolished." The US Department of Health and Human services said the rulings should "help reassure parents that vaccines do not cause autism." The Times, which has made itself a blind mouthpiece for HRSA and a leading defender of vaccine safety, joined crowing government and vaccine industry flacks applauding the decisions like giddy cheerleaders, rooting for the same court that many of these same voices viscously derided just one year ago, after Hannah Poling won compensation for her vaccine induced autism.

But last week, the parents of yet another child with autism spectrum disorder (ASD) were awarded a lump sum of more than $810,000 (plus an estimated $30-40,000 per year for autism services and care) in compensation by the Court, which ruled that <http://big.assets.huffingtonpost.com/BANKS_CASE.pdf> the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder.

The family of 10-year-old Bailey Banks won their case quietly and without fanfare in June of 2007, but the ruling has only now come to public attention. In the remarkably clear and eloquent decision, Special Master Richard Abell ruled that the Banks had successfully demonstrated that "the MMR vaccine at issue actually caused the conditions from which Bailey suffered and continues to suffer."

Bailey's diagnosis is Pervasive Developmental Disorder -- Not Otherwise Specified (PDD-NOS) which has been recognized as an autism spectrum disorder by CDC, HRSA and the other federal health agencies since at least the 1990s.

In his conclusion, Special Master Abell ruled that Petitioners had proven that the MMR had directly caused a brain inflammation illness called acute disseminated encephalomyelitis (ADEM) which, in turn, had caused the autism spectrum disorder PDD-NOS in the child:

The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD [an autism spectrum disorder]. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was... a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

The Bailey decision is not an isolated ruling. We now know of at least two other successful ADEM cases argued in Vaccine Court. More significantly, an explosive investigation by CBS News has found that since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many of these cases, the government paid out awards following a judicial finding that vaccine injury lead to the child's autism spectrum disorder. In each of these cases, the plaintiffs' attorneys made the same tactical decision made by Bailey Bank's lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client's autism.

Medical records associated with these proceedings clearly tell the tale. In perhaps hundreds of these cases, the children have all the classic symptoms of regressive autism; following vaccination a perfectly healthy child experiences high fever, seizures, and other illnesses, then gradually, over about three months, loses language, the ability to make eye contact, becomes "over-focused" and engages in stereotypical head banging and screaming and then suffers developmental delays characteristic of autism. Many of these children had received the autism diagnosis. Yet the radioactive word "autism" appears nowhere in the decision.

Instead the vaccine court Special Masters rest their judgments on their finding that the vaccines caused some generalized brain injury, mainly Encephalopathy/encephalitis (brain inflammation) or "seizure disorders" -- conditions known to cause autism-like symptoms. A large number of the children who have won these judgments have been separately diagnosed with autism. HRSA acknowledged this fact in a recent letter, but told us it does not keep data on how many of these children were autistic.

The Vaccine Court, in other words, seems quite willing to award millions of dollars in taxpayer funded compensation to vaccine-injured autistic children, so long as they don't have to call the injury by the loaded term "autism." That hazard is particularly acute for vaccine victims who appear before the Omnibus Autism Proceedings (OAP). Since that body's decisions are closely watched, published and accorded the weight of precedent, many lawyers consider the burden of proof for petitioners to be impossibly high before the OAP Panel. It was for this reason that Bailey's attorney, Mark McLaren, elected to opt out of the OAP and try his case separately, even though Bailey has been receiving autism-related services in his home state and was eligible to file a case in the Court's Omnibus Autism Proceedings (OAP).

McLaren told us he wanted to avoid the added burden facing petitioners under the media glare and precedential weight attending OAP panel trials. "We considered [the OAP route] because [Bailey] is on the autistic spectrum of disorders, but we thought we could try it separately and apart from the Omnibus, and not as a test case," explained McLaren. "We thought we'd have a better chance if we tried to on its own merit, away from the spotlights and the precedent setting pressures that attend these OAP test cases - and it worked."

Bob Krakow, a leading attorney for vaccine damaged children told that many lawyers are now convinced that filing a claim in the OAP is a losing proposition. "There's a growing conviction that if you have a autistic client who has also been diagnosed with encephalopathy/encephalitis or seizure disorder, you are better off not mentioning the word "autism" if you want to win the case." He recommended instead filing a non autism claim like "mental retardation with seizure disorder" for an autistic client.

Although the vaccine court is mandated to fairly serve the victims of vaccine injuries, their primary purpose and raison d'etre is to protect the vaccine program and vaccine makers. Damages are doled out from a 75-cent tax on every vaccine sold and not from the vaccine makers. "You can understand why special masters, burdened with their duty to protect vaccine programs, might be unwilling to make the direct causal link between autism and vaccines," Krakow observed. "If you ask the big question and answer it in the affirmative, there is a sense that it will damage the vaccine program irreparably."

Vaccine Court judges are equipped with a draconian armory of weapons deployable against plaintiffs intent on proving the causal connection between vaccines and autism. Jury trials are prohibited. Damages are capped; awards for pain and suffering are strictly limited and punitive damages banned altogether. Vaccine defenders have an army of Department of Justice attorneys with virtually unlimited resources for expert witnesses and other litigation costs. Plaintiffs, in contrast, must fund the up front costs for experts on their own. In a cultural choice that clearly favors defendants, vaccine court gives overwhelming weight to written medical records which are often inaccurate -- over all other forms of testimony and evidence. Observations by parents and other caretakers are given little weight.

Worst of all -- plaintiffs have no right to discovery either against the pharmaceutical industry or the government. Since autism is a behavioral affliction rather than a precisely defined biological injury -- epidemiological studies are critical to establishing its causation. But the greatest source of epidemiological data is the Vaccine Safety Datalink (VSD) -- the government maintained medical records of hundreds of thousands of vaccinated children -- which HHS has gone to great lengths to keep out of the hands of plaintiffs' attorneys and independent scientists. Unfortunately the vaccine court has judicially anointed this corrupt concealment by consistently denying every motion by petitioners to view the VSD. The raw data collected in the VSD would undoubtedly provide the epidemiological evidence needed to understand the relationship between vaccines and autism. The absence of such studies makes it easy for judges to say to plaintiffs they have not met their burden of proving causation.

Meanwhile, CDC has actively, openly and systematically suppressed and defunded epidemiological studies that might establish a causal link. CDC has ignored repeated pleadings that it fund peer reviewed studies of unvaccinated American cohorts like the Amish and home-schooled children. At the same time the agency has worked overtime ginning up a series of fatally-flawed European studies purporting to dispute the link. Even a cursory critical examination reveals that the oft-cited Danish, English, and Italian studies are rank tobacco science. Many of them were funded by CDC, a badly compromised agency, performed by vaccine industry scientists, and published in miserably conflicted journals.

Needless to say, the existence of these phony studies, combined with the deliberate dearth of epidemiological evidence makes it easy for the special masters to dodge a politically explosive finding by holding that there is "insufficient evidence."

And, speaking of tobacco, it's worth recalling that for sixty years the tobacco industry successfully defended a product that was killing one out of every five of its customers against thousands of legal actions brought by its victims and their families. Tobacco lawyers protected the cigarette companies by arguing that there was no proven link between tobacco and lung cancer. Bob Krakow sees many parallels. Big tobacco uses the same tactic of manufacturing research that seems to dispute the connection to exploit the burdens on plaintiffs to prove causation. Big tobacco prevailed for six decades even without the help of supportive government agencies deliberately suppressing real science and research. In that sense vaccine victims must leap a much higher hurdle.

Despite the perilous odds stacked against them in vaccine court, the evidence of a vaccine/autism link is so strong that vaccine court judges and government agencies have now recognized at least two theories of how vaccines cause autism: the Vaccine-to-ADEM-to-ASD link in Bailey Banks' case, and vaccine-induced aggravation of an underlying mitochondrial dysfunction that caused full-blown autism in the Hannah Poling case. Both theories are different from those rejected in the three cases last week.

Perhaps, these new disclosures will prompt The Times, with all its influence, to actually make prudent journalistic inquiries into the phony science CDC uses to defend its claims of "vaccine safety." If it does, the paper will realize it has once again been ill used by government agencies in a tragic campaign of public deceit. The Times should make the reasonable demand that the government health agencies finally release the Vaccine Safety Datalink for independent scientific research and that CDC and HRSA lift their opposition to genuine epidemiological studies that might finally provide real scientific answers to this debate.

---

A NEW THEORY OF AUTISM CAUSATION?

By David Kirby

A ruling from Federal Vaccine Court -- that MMR vaccine caused an autism spectrum disorder in a young boy named Bailey Banks -- flies directly in the face of the triple-play decision against a vaccine-autism link issued by the Court on February 12.

The Special Masters in those three cases inferred that the vaccine-autism theory was the stuff of Alice in Wonderland fantasy, and virtually accused the childrens' physicians of medical malpractice. (CNN's Dr. Sanjay Gupta called the Court's language "snide," and we agree).

Meanwhile, the US Department of Health and Human services said the rulings should "help reassure parents that vaccines do not cause autism." But why should parents feel reassured when two out of five autism cases (40%) - that we know of - have won taxpayer-funded compensation in Vaccine Court?

The Ruling

In his decision, Special Master Abell ruled that the MMR vaccine produced a side effect in Bailey called acute disseminated encephalomyelitis (ADEM). ADEM is a neurological disorder characterized by inflammation of the brain and spinal cord. The disorder results in damage to the myelin sheath, a fatty coating that insulates nerve fibers in the brain. ADEM can be caused by natural infections, especially from the measles virus. But it also is a recognized post-vaccination injury, especially from vaccines for rabies, pertussis, influenza, and MMR.

Evidence presented to support an MMR-ADEM link was compelling. It included a 1994 report from the Institute of Medicine that said it was biologically plausible for a vaccine to "induce... an autoimmune response... by nonspecific activation of the T cells directed against myelin proteins."

In fact, both parties in the Banks case agreed "that the IOM has cited demonstrative evidence of a biologically plausible relation between the measles vaccine and demyelinating diseases such as ADEM," the Court wrote.

Most cases of ADEM (80%) are in children. Symptoms usually appear within a few days to a couple of weeks. They include: headache, delirium, lethargy, seizures, stiff neck, fever, ataxia (incoordination), optic nerve damage, nausea, vomiting, weight loss, irritability and changes in mental status.

I know of thousands of parents who witnessed many of these same symptoms afflict their children shortly after vaccination, most typically the MMR. Did these children with autism also suffer initially from ADEM or some subclinical version of the disorder? We may never know (physical signs like myelin damage are transitory).

Bailey Banks was given an MRI when his parents brought him to the hospital 16 days after his MMR vaccine, and that helped confirm his diagnosis. The children I know who were brought in with similar symptoms were instead given Tylenol and told to go home.

(Interestingly, Tylenol can affect production of glutathione, an essential antioxidant and detoxifier. A preliminary study from UC San Diego showed that children who were given Tylenol after their MMR vaccine were several times more likely to develop autism than other children. "Tylenol and MMR was significantly associated with autistic disorder," the authors wrote. "More research needs to be completed to confirm the results of this preliminary study.")

Is vaccine-induced ADEM (and similar disorders) a neurological gateway for a subset of children to go on and develop an ASD? That question will now become subject to debate. Thousands of parents have reported similar reactions and symptoms following vaccination, yet they lack radiological proof of ADEM or related disorders in the form of an MRI. Meanwhile, most children with autism do not present with myelin damage, but many do test positive for antibodies to myelin basic protein (MBP).

Also worth noting is that ADEM causes an inflammatory response in the brain, primarily in the microglial cells. It is also associated with abnormal cytokine levels in the brain, and with autoimmunity. Autism, meanwhile, has been linked to brain inflammation, microglial cell activation, cytokine imbalances, and autoimmunity.

In most cases, symptoms of ADEM disappear within a few weeks or so, and the disorder may be treated with IV cortisone to help reduce inflammation. But none of the children with autism that I know were ever examined or treated for a possible case of ADEM or other acute cases of encephalitis/demyelinating disorder. By now, their myelin damage may have repaired itself, yet the damaging agents, (MBP antibodies), persist.

ADEM is said to be rare, but the disorder may be grossly under-diagnosed (or misdiagnosed). Even the government's chief witness against Bailey's case testified that he sees patients with ADEM "on a fairly regular basis." What's more, Bailey's was the third successful vaccine-ADEM case argued in Vaccine Court (that we know of) so far.

Can ADEM Cause PDD/ASD?

Special Master Abell had no trouble linking MMR to ADEM in Bailey Banks' case. But linking his ADEM to PDD/ASD was more difficult.

There is no medical literature to support an ADEM-PDD link. The government's expert witness, Dr. John MacDonald, testified that "all the medical literature is negative in that regard." Instead, he proposed an alternative hypothesis for Bailey's PDD (he suggested it was caused by glucose transporter 1 deficiency).

But Special Master Abell berated the government's witness in much the same way that Hastings et al. had criticized witnesses for the families in their three cases.

"This (glucose) hypothesis, which (MacDonald) declined to incorporate as a plausible, probable theory of explanation, was used by Respondent to blunt Petitioner's theory of ADEM," Abell wrote. "This hypothesis was not given to a reasonable degree of medical probability or certainty, and Respondent's expert admitted that it was merely 'a possible, not necessarily a probable diagnosis.'"

Abell also chided MacDonald for his assertion that "all the medical literature is negative" in regards to an ADEM-PDD link. "However, soon thereafter, he corrected this statement by clarifying, 'I can find no literature relating ADEM to autism or [PDD],'" Abell wrote. "It may be that Respondent's research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that 'all the medical literature is negative' is incorrect."

The Court also took MacDonald to task for insisting that Bailey's initial symptoms were not 100% consistent with the signs of ADEM. "His distinction seems one of degree, not of type, and strikes as a trifle semantic," Abell sniffed. He also noted that McDonald was having a hard time determining Bailey's current diagnosis. "He ultimately concluded that 'Bailey falls into the large group of children with autism/PDD in which by our current evidence-based medicine we rarely can make a specific diagnosis.'"

Special Master Abell seemed to lend more credence to witnesses for the Banks family.

Chief among them was Dr. Ivan Lopez, a neurologist and psychiatrist. Dr. Lopez testified that "the majority of patients with ADEM improve significantly," but added that "the exception to this rule is when patients have been exposed to measles, just like in the case of MMR vaccine," in which case subsequent brain damage "may occur in up to 50 percent of patients." He said such events include "mental syndromes such as PDD and others," and opined that "up to 50 percent of patients...who have had ADEM will show (PDD) as a consequence."

Dr. Lopez, a member of the US Military, gave his testimony by phone from Mobile, AL where, the next day, he was to ship out for a tour of duty in Iraq.

In his conclusion, Special Master Abell wrote:

The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

And he added this:

Petitioner's theory of PDD caused by vaccine-related ADEM causally connects the vaccination and the ultimate injury, and does so by explaining a logical sequence of cause and effect showing that the vaccination was the ultimate reason for the injury.

Does Bailey Banks Have Autism?

Bailey Banks does not have "classic" or full-blown autism. But he has been diagnosed with PDD-NOS, which is squarely on the autism spectrum of disorders. There was quite a bit of back-and-forth on Bailey's diagnosis in the ruling, whose heading included the term "Non-autistic developmental delay." At several points in the proceedings, witnesses took great pains to say that Bailey does not have "autism" which, technical speaking, is true.

On the other hand, Special Master Abell included notations declaring that "Pervasive Developmental Delay describes a class of conditions, and it is apparent from the record that the parties and the medical records are referring to Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)."

Even so, some will argue that Bailey does not have an ASD. They are simply wrong. The diagnosis of PDD-NOS was added to the list of autism spectrum disorders in the 1980s. It was precisely from the inclusion of these "milder" cases into the total number, that the CDC came up with the estimate of 1-in-150 US children with some form of "autism/ASD."

So, if Bailey does not have ASD, then the number of "autism" cases is well below the 1-in-150 mark and needs to be revised downward (the CDC once estimated that 40% of ASD cases were "non-autistic" in the classic sense).

What's more, Bailey does not have a "mild" form of ASD -- he struggles every day with endless challenges. He receives autism services in his home state and attends a special school for children with autism. Bailey was also completely eligible to file a case in the Court's Omnibus Autism Proceedings (OAP), along with 5,000 other claims.

And besides, if the government chooses after-the-fact to argue that Banks simply has another form of brain damage but not, specifically "autism," is that really any comfort?

This particular theory of causation -- Vaccine-to-ADEM-to-ASD -- is different from the three cases that lost, and different than the theory in the Hannah Poling case (vaccine-induced aggravation of an underlying mitochondrial dysfunction caused full-blown autism).

So we now have two novel theories of how vaccines might contribute to ASD -- both ADEM and mitochondrial dysfunction are recognized by the Court as contributing factors.

And yet the government insists it has never made an award for vaccine induced ASD, just vaccine related ASD.

"The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines," said David Bowman, a spokesman for HHS's Health Resources and Services Administration. "We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures."

"Some children who have been compensated for vaccine injuries may have shown signs of autism before the decision to compensate," he added, "or may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.

Unfortunately, the track record on vaccines is cloudy in this particular Court: Three out of four ADEM cases have been successful; and (at least) two out of five ASD cases have also won.

People will argue that ADEM is rare; that vaccines "only" caused PDD in Bailey; and that this was a legal and not scientific decision. The problem is we don't know how prevalent ADEM is because we never looked; while "PDD" is interchangeable with "ASD" in the language of public health. And, the three cases that lost were also "legal" decisions.

Robert Kennedy, Jr. and I would love nothing more than to reassure parents that the nation's current vaccine program is 100% safe for all kids, and that zero credible evidence has been presented to link vaccines with autism. But that simply isn't true -- as at least two court cases have found.

Too bad it's too late now!

Seriously, though, this confuses me. According to several recent news articles, the FDA frequently allows individuals with financial conflicts of interest onto its panels. In the case of Prasugrel, however, the FDA kicked a guy off a panel because he was skeptical about the drug. Does this make any sense? It's OK to let a guy serve on an approval panel when he owns stock in the company whose drug is being evaluated, but not if he has expressed concerns about the drug? Huh?

http://money.cnn.com/news/newsfeeds/articles/djf500/200902231807DOWJONESDJONLINE000572_FORTUNE5.htm

FDA: 'Mistake' Not To Include Doctor At Eli Lilly Drug Panel

WASHINGTON -(Dow Jones)- U.S. federal regulators on Monday acknowledged it was a mistake to "dis-invite" a leading cardiologist to a panel that was deciding whether to recommend approval for a controversial anti-clotting drug made by Eli Lilly & Co. (LLY).

Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in Los Angeles, was scheduled to participate in a Feb. 3 Food and Drug Administration meeting about Eli Lilly's Prasugrel, an anti-clotting drug that has been linked to dangerous internal bleeding.

Panel members at the meeting voted 9 to 0 to recommend approval of the drug.

Several days before the meeting, FDA managers received a call from Eli Lilly saying it had questions about Kaul's inclusion in the meeting because he had authored several papers that were critical of Prasugrel, FDA officials said. Eli Lilly representatives weren't immediately available to comment. This news was first reported by the blog HeartWire.

Under federal regulation, the FDA can exclude members from participating in a meeting if they have a financial conflict of interest, such as having received consulting fees from a company, or for "intellectual bias." Determining intellectual bias, or whether someone has already made their mind up about whether a drug should be on the market, is difficult, and FDA officials say a series of errors lead to Kaul's exclusion from the meeting.

FDA managers that screen panel members only asked Kaul about his financial conflicts of interest, of which he had none, not about any intellectual bias, said Dr. Janet Woodcock, director of the FDA's drug division.

Managers also didn't alert Woodcock or other top FDA officials until after they had decided to tell Kaul not to fly from Los Angeles to Maryland for the meeting.

"At every step of the way there were errors by multiple parties," Woodcock said.

The FDA hasn't done a formal review to determine whether Kaul was actually intellectually biased, but one FDA official said he would have welcomed the cardiologist's input at the meeting.

"In my own personal opinion I didn't see anything in [Kaul's] writings...that would preclude him from serving on the committee," said John Jenkins, FDA's director of the Office of New Drugs. "I think he would have been a very valuable member."

To be sure, FDA officials described the discussion at the meeting as robust and don't think the kerfuffle invalidates the results of the panel.

Prasugrel isn't on the market yet, and it's unclear when the FDA will make a decision about whether to approve it. The drug, co-marketed by Eli Lilly and Japan's Daiichi Sankyo Co. (4568.TO), is expected to bring in ample sales for the companies.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

Probably in more ways than this, but here is the instance to which I'm referring: the Vaccine Injury Compensation Program, which is a fund (made of your tax dollars) that pays plaintiffs who successfully sue for damages to themselves or their children from vaccines. The big news recently has been the unsuccessful cases of the Cedillo, Snyder, and Hazlehurst families, but the news that you haven't seen is that your tax dollars have been paying families under this program since 1986. Yes, that's right: for more than 20 years, you've been paying for Big Pharma's mistakes. ProQuad leads to seizures? No problem for Merck--you're the one footing the bill. One might reasonably ask just how hard a pharmaceutical firm would try to create a clean and safe vaccine product (if, indeed, one exists), given that you, the taxpayer, will pay the price if the product is not clean and safe.

The WSJ just woke up to this--months after JB Handley wrote his own brilliant piece on it. Links to both are below:

http://online.wsj.com/article/SB123535050056344903.html?mod=dist_smartbrief

When someone talks about a chemical that is corn-based, or a plastic that is plant-based, it makes me laugh. It's still a chemical, so you have to pay attention to whether it's going to get into your body (via food or some other mechanism). Apparently, some lawmakers have just realized this. Why can't kids play with wooden toys, as my kid does? What about glass bottles? They're nowhere near as breakable as the plastics industry would have you believe.

http://ecochildsplay.com/2009/02/20/phthalates-out-and-the-new-chemicals-in-toys-are/

Phthalates Out. And the New Chemicals in Toys Are…?

Written by Cate Nelson

Phthalates are out of kiddie plastic now.  Don’t worry; you can still find the endocrine-disruptor in your makeup and shower curtains and pretty much anything that includes the term “fragrance.”

But have you thought about what they put into the new Barbie dolls instead of phthalates? It’s not like they’re making her ginormous bust size out of wood nowadays.  (Insert Ken jokes here.)

So…what exactly is in your kids’ toys now?

An NPR report seeked out the answer to just that.  Sadly, most toy companies gave the big “No Comment” to my beloved public radio.

But Learning Curve and Mattel, maker of Barbie (and much, much more!), did say they were using citrate-based plasticizers as well as a new chemical called DINCH.

The citrates (citric acid esters) have been used as a replacement for phthalates in Europe since 2005. They’ve been deemed safe after much testing. But really, if the Euros trust ‘em, so do I!

The DINCH that stole Christmas…2009.
Not so much testing for that other chemical. The German company BASF manufactures DINCH (in its odd acronym factory, apparently), and now it’s the most widely used phthalate substitute in the world. And so far, no peer-reviewed, publicly available studies are available.

In the NPR story, California EPA toxicologist Stephen Dizio really eases our worries on this front.

There are 80,000 chemicals in commerce. We know something about toxicity of about 400 of them. That really means that things come and go in the marketplace that you have no idea what will happen.

Umm, great? Early studies of DINCH provided to European regulators by BASF showed that at medium doses, this chemical caused liver damage in male rats. But anything can be problematic in high doses. Europeans set limits on how much DINCH could be used in their plastic products. Well aren’t they brilliant!

So are we…sort of. California, the West Coast’s Europe, has two new state laws that will soon require that manufacturers make a list of the chemicals in their products. That list will be available online to consumers.

Hopefully soon, some other states will follow California’s lead and pass similar laws. Like maybe New England (or “Lower Canada”)?
Then perhaps we can all have some clarity.

* * *

http://www.thedickinsonpress.com/ap/index.cfm?page=view&id=D96H2R0O5

Chemigation rules still debated in ND

By BLAKE NICHOLSON Associated Press Writer
The Associated Press - Monday, February 23, 2009

BISMARCK, N.D.

Water resource advocates have lost a round in the state Legislature but they are not giving up the push for more stringent rules on the use of irrigation systems to apply farm chemicals.

The Agriculture Department plans more public meetings this summer on the issue, called chemigation.

"Even without a legislative mandate, we're going to take a critical look at whether our rules, the way they are written now, adequately protect our (water) resources," said Jim Gray, the Agriculture Department's lead farm chemical regulator.

"It's not dead," said Randy Loeslie, a water district manager in northeastern North Dakota. "This is an issue that's not going to go away."

A bill defeated in the Senate on a 22-24 vote would have set up a permit system for chemigation through the Agriculture Department. Gray said the important aspect of such a system would not be the money it would bring in, but the fact that it would set up a registry to let regulators know where chemigation outfits are located.

Right now, he said, "there is no good data source for us to go to, to find out exactly where chemigating is taking place."

It is not a new issue. Loeslie brought it to the attention of two state senators back in 2007, when irrigators in the region put chemigation tanks within a couple hundred feet of some of the Grand Forks Traill Water District's water wells.

Farmers say applying fertilizer and pesticides through irrigation systems can be easier and cheaper than other methods. Opponents say the practice can contaminate groundwater if the chemical tanks leak or spill.

"We're not against chemigation; we just want it to be done carefully," Loeslie said.

It is difficult to say how widespread chemigation is in North Dakota. The state Water Commission has approved more than 2,200 irrigation permits but does not track how many involve chemigation, said Bob Shaver, the agency's water appropriations director.

The Agriculture Department inspects chemigation outfits - 85 in the past two years - but only when field staff come across them while out doing other inspections, Gray said.

A North Dakota farmer who wants to set up a chemigation system must follow design rules and install a device that prevents the backflow of chemicals into the water well supplying the irrigation system.

The bill defeated in the Senate would have required the agriculture commissioner to study new rules and report back to the Legislative Council - the Legislature's research arm - by July 2010. It made reference to containment systems around chemigation tanks but did not require them. Gray said many other states, including Minnesota, have the requirement.

The Agriculture Department will hold public meetings this summer to gather comments from all sides in the debate and then decide how to proceed, Gray said. Similar meetings were held two years ago, leading to the effort to pass legislation this year.

The Agriculture Department does not need the blessing of state lawmakers for new rules. "But we are very hesitant to put those sorts of burdens on all chemigators unless we know that there is a legitimate concern," Gray said.

Herb Grenz of Linton, who owns land where chemigation has been used on potato crops, said a chemigator would not want to contaminate a water well. "You would contaminate your investment, like setting fire to your house," he said.

"When you start a law, where do you stop, and how broad does it become?" Grenz asked.

Loeslie said some chemigators are large operations with hired help who might not have the attachment to the land or water source that a private landowner would. He said chemigation is widespread in his region, and the water district plans to furnish containment tanks free to any chemigator who will take one, despite the several-thousand-dollar cost.

"If we have to buy five of them, we'll buy five of them," he said. "That will provide us a bit of safety, hopefully."

Loeslie said his board also has given him the task of getting another bill introduced in the 2011 Legislature if the Agriculture Department does not pursue new rules. "And we'll do a lot more legwork to get support, to make sure we pass something," he said.

Gray said he knows of no accidents involving chemigators. Republican Sen. Terry Wanzek, a Jamestown-area farmer who voted against the bill, said he believes farmers are good stewards of the land.

"I believe strongly that education, responsible individuals out there will be much more of a deterrent to an accident," he said. "It can happen (but) we've had no incidents, which to me says there is a lot of responsible people out there."

Sen. Elroy Lindaas, D-Mayville, the main sponsor of the bill, said officials should be proactive. "Regulation is not good until something bad happens," he quipped.

___

The bill is SB2440.

* * *

http://honolulu.injuryboard.com/toxic-substances/landmark-chemical-reform-places-burden-on-industry-to-prove-chemicals-are-safe.aspx?googleid=257244

Landmark Chemical Reform places burden on Industry to prove chemicals are safe

February 22, 2009 - 03:27 AM

Which would I rather have, psoriasis or progressive multifocal leukoencephalopathy? Hmm... One of them is embarrassing; the other one kills. Oh, and Raptiva also causes paralysis (Guillain-Barre Syndrome) and several other pretty awful disorders. Oh, sorry, it's "linked to" these disorders. It's apparently never OK to say a drug from Big Pharma "causes" any problems. My mistake.

http://www.bloomberg.com/apps/news?pid=20601085&sid=aK7VwU1xmZgk&refer=europe

Genentech’s Raptiva Faces EU Suspension on Infections (Update3)

By David Olmos and Catherine Larkin

Feb. 19 (Bloomberg) -- European regulators recommended suspending sales of Genentech Inc.’s psoriasis treatment Raptiva after the drug was linked to four cases of a deadly brain infection.

The U.S. Food and Drug Administration and European Medicines Agency have received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy, or PML, in patients taking Raptiva, the agencies said today. Three of the patients died. The South San Francisco-based company reported its second patient death from the infection in November.

Raptiva’s removal from the market would have a “very limited impact” on Genentech, Geoffrey Porges, an analyst at Sanford C. Bernstein in New York, wrote in a note to investors today. Raptiva is one of Genentech’s smallest products, with U.S. sales of $108 million in 2008, or less than 1 percent of total revenue. Germany’s Merck KGaA, sells the drug outside the U.S.

“It appears increasingly likely that the FDA will ultimately pull Raptiva from the market as well,” Porges said in the note.

The FDA added a boxed warning, its strictest form of caution, to the prescribing information for Raptiva in October. The agency said it’s reviewing the new information and “will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits.”

Merck KGaA Response

Genentech is “working diligently with the FDA to put the right plans in place that will help protect patient safety,” said Tara Cooper, a spokeswoman for Genentech, in an e-mail statement. The company is “evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan.”

Merck KGaA spokeswoman Phyllis Carter said the Darmstadt, Germany-based company “will work closely with the European health officials to undertake all necessary measures to comply.” Merck KGaA said its Raptiva sales were 93 million euros ($118 million) last year.

PML is a rare, progressive disorder that damages the sheath protecting nerves in the brain, and can lead to paralysis and death, according to the National Institutes of Health Web site. The disease, caused by a common virus, most frequently occurs in patients with weak immune systems, including those with cancer and AIDS. Drugs linked to the disorder have the effect of suppressing the immune system.

Raptiva is one of five immune-suppressing medicines linked to PML. The others are Biogen Idec Inc. and Elan Corp.’s Tysabri, Holding AG’s CellCept, Genzyme Corp.’s Campath and Biogen and Genentech’s Rituxan.

Other Side Effects

European regulators urged removal of Raptiva from the market as its benefits for the skin disorder “no longer outweigh its risks.” The agency also said that Raptiva’s therapeutic benefits are “modest” and that the drug is “associated with other serious side effects,” including Guillain-Barre and Miller- Fisher syndromes and encephalitis.

“Prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives,” European regulators said today in an e-mailed statement.

The agency said its recommendations would be sent to the European Commission for consideration of a formal marketing ban.

Genentech shares rose 6 cents, or less than 1 percent, to $84.76 at 4 p.m. in New York Stock Exchange composite trading. Merck KGaA fell 1.31 euros, or 2 percent, to $62.88 in Frankfurt.

Genentech is majority-owned by Swiss drugmaker Roche Holding AG.

To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net; Catherine Larkin in Washington at clarkin4@bloomberg.net. Last Updated: February 19, 2009 17:15 EST

This is a wonderful story from a mom who has recovered her son. Please click through the link and read it on her blog...

http://web.me.com/meaganmm/Site/Blog/Entries/2009/2/16_Autism_101.html

So you have firms that spring up to create vaccines because they know the government makes them virtually mandatory and the manufacturers are shielded from any product liability. Then you have outsourced clinical trials taking place overseas with irrelevant populations (who are bamboozled into participating and are taken advantage of), so no one knows whether the drugs are safe or effective--not really. Then you have the FDA bumbling about, trying to make an ineffective and unnecessary flu shot marginally better. Hahahahahaha! Just say no.

http://www.boston.com/business/healthcare/articles/2009/02/19/cambridge_vaccine_firm_raises_23m/

Cambridge vaccine firm raises $23m

By Todd Wallack Globe Staff / February 19, 2009

Genocea Biosciences Inc., a Cambridge firm trying to develop new vaccines, said it raised $23 million in a series A round of venture capital. The company, founded in August 2006, has 16 employees and previously raised $3 million in seed financing and $5.1 million in grants. The latest fund-raising round was led by SR One, the corporate venture arm of British drug maker GlaxoSmithKline. It also included investors Lux Capital Management, Polaris Venture Partners, and Morningside Ventures. Also, the company plans to say today that it hired Staph Leavenworth Bakali, formerly chief operating officer of ID Biomedical and PowderJect Pharmaceuticals, as its new chief executive officer. He replaces Genocea cofounder and former CEO Robert Paull, who is also managing general partner of Lux Capital Management.

* * *
http://health.usnews.com/articles/health/healthday/2009/02/18/many-clinical-trials-moving-overseas.html

Many Clinical Trials Moving Overseas

Study says trend raises ethical, medical issues

So you have a dictatorship that tankrolls protesters and puts lead into kids' toys and melamine into the food supply, and you have a multinational corporation that developed Agent Orange, rBGH, and Frankenfoods. Why wouldn't they be hooking up?

http://money.cnn.com/news/newsfeeds/articles/djf500/200902180310DOWJONESDJONLINE000367_FORTUNE5.htm

UPDATE:Monsanto Building China R&D Center;Eyes Asia,Americas

SINGAPORE -(Dow Jones)- Monsanto Co. (MON), the world's leading producer of genetically modified seeds, is setting up a genomic research center in China, a country that has been struggling between exorcizing due prudence in growth and consumption of GM crops and rising domestic food demand against shrinking acreage.

"We're doing it right now. The country has a tremendous scientist pool," said the company's executive vice president, Gerald Steiner.

He added that Monsanto will look to the government to seek the best way to proceed.

China, one of the world's biggest consumers of major agricultural commodities, has been cautious in adopting GM technologies in crops that are consumed as food, such as rice, with debate dragging on for years.

However, it has been widely growing genetically modified cotton, given its vast demand from the textile and apparel industries and very high dependence on imports.

The world's most populous country is also the biggest buyer of soybeans from the U.S., Brazil and Argentina, which are mostly genetically modified, for processing into feedmeal for animals. The imports account for more than 70% of the country's total annual soybean consumption.

"The Chinese government has announced very significant investments in biotechnology research in the country's universities and institutes," so they aren't against genetically modified crops, said Steiner.

Expecting Growth In Asia, America

Given the traditionally anti-GM stance of European countries, Steiner said the company would go "where we're needed," when asked which countries Monsanto would be focusing on to either market its products or seek mergers and acquisition opportunities.

Besides the U.S., the list includes Vietnam, India and Indonesia, as well as Canada, Brazil, Mexico and Argentina.

Relatively high global food prices are a wake-up call to the world that if countries want to increase their agricultural output, "it takes consistent long- term investment in crop productivity," he said.

The St. Louis-based company launched an initiative in June last year to double crop yields in corn, soybeans and cotton by 2030 while reducing the required water and fertilizer.

To double the yields, biotech will be one of the major contributors, he said.

"This is going to take lots of investment from us, so it's important that we can form the right relationship with governments. Otherwise, they aren't a good financial bet," said Steiner.

Company Web site: www.monsanto.com

-By Helen Sun, Dow Jones Newswires; (65) 6415-4086; helen.sun@dowjones.com

Another one for the "shocking! (not)" file.

http://www.bizjournals.com/milwaukee/stories/2009/02/16/daily30.html

Pharmacia ordered to pay $9M in Medicaid case

The Business Journal of Milwaukee

Any time you have a research organization begging for money from the government, you know that the subject of the research won't be worth any money, because otherwise, Big Pharma would be paying for the research itself. So is the case with embryonic and fetal stem cells, touted by the Left as the Next Big Thing and the cure for every ailment under the sun, especially Parkinson's and other diseases that afflict celebrities. If you needed to grind up an unborn baby to get them, then they must cure cancer, right? Um, no. They cause cancer. Read on...

http://news.yahoo.com/s/ap/20090218/ap_on_he_me/med_stem_cells_tumor

Report: Fetal stem cells trigger tumors in ill boy

By LAURAN NEERGAARD, AP Medical Writer Lauran Neergaard, Ap Medical Writer – Tue Feb 17, 8:01 pm ET

WASHINGTON – A family desperate to save a child from a lethal brain disease sought highly experimental injections of fetal stem cells — injections that triggered tumors in the boy's brain and spinal cord, Israeli scientists reported Tuesday.

Scientists are furiously trying to harness different types of stem cells — the building blocks for other cells in the body — to regrow damaged tissues and thus treat devastating diseases. But for all the promise, researchers have long warned that they must learn to control newly injected stem cells so they don't grow where they shouldn't, and small studies in people are only just beginning.

Tuesday's report in the journal PLoS Medicine is the first documented case of a human brain tumor — albeit a benign, slow-growing one — after fetal stem cell therapy, and hammers home the need for careful research. The journal is published by the Public Library of Science.

"Patients, please beware," said Dr. John Gearhart, a stem cell scientist at the University of Pennsylvania who wasn't involved in the Israeli boy's care but who sees similarly desperate U.S. patients head abroad to clinics that offer unproven stem cell injections.

"Cells are not drugs. They can misbehave in so many different ways, it just is going to take a good deal of time" to prove how best to pursue the potential therapy, Gearhart said.

The unidentified Israeli boy has a rare, fatal genetic disease with a tongue-twisting name — ataxia telangiectasia, or A-T. Degeneration of a certain brain region gradually robs these children of movement. Plus, a faulty immune system leads to frequent infections and cancers. Most die in their teens or early 20s.

Israeli doctors pieced together the child's history: When he was 9, the family traveled to Russia, to a Moscow clinic that provided injections of neural stem cells from fetuses — immature cells destined to grow into a main type of brain cells. The cells were injected into his brain and spinal cord twice more, at ages 10 and 12.

Back home in Israel at age 13, the boy's A-T was severe enough to require that he use a wheelchair when he also began complaining of headaches. Tests at Sheba Medical Center in Tel Aviv uncovered a growth pushing on his brain stem and a second on his spinal cord. Surgeons removed the spinal cord mass when the boy was 14, in 2006 and they say his general condition has remained stable since then.

But was the boy prone to tumors anyway or were the fetal stem cells to blame? A Tel Aviv University team extensively tested the tumor tissue and concluded it was the fetal cells. Among other evidence, some of the cells were female and had two normal copies of the gene that causes A-T — although that boy's underlying poor immune function could have allowed the growths to take hold.

Using stem cells from multiple fetuses that also were mixed with growth-spurring compounds "may have created a high-risk situation where abnormal growth of more than one cell occurred," wrote lead researcher Dr. Ninette Amariglio of Sheba Medical. She urged better research to "maximize the potential benefits of regenerative medicine while minimizing the risks."

This brain disease wasn't conducive to stem cell therapy in the first place, said stem cell specialist Dr. Marius Wernig of Stanford University, who said it's unclear exactly what was implanted.

"Stem cell transplantations have a humongous potential," Wernig said. But "if people rush out there without really knowing what they're doing ... that really backfires and can bring this whole field to a halt."

Consumers don't want it. Genetically engineered corn isn't better for the average German buying groceries. Amen to that, brother! If only we could get a ban here in the US, where roughly 40% of our corn is Bt corn.

http://www.bloomberg.com/apps/news?pid=20601100&sid=amCdajyrmaq8&refer=germany

Germany May Ban Monsanto Corn, Minister Tells Berliner Zeitung

By Rainer Buergin

Feb. 18 (Bloomberg) -- Chancellor Angela Merkel’s government may revoke a license for the cultivation of Monsanto Co.’s genetically modified corn because neither consumers nor farmers want it, Agriculture Minister Ilse Aignertold the Berliner Zeitung.

Genetic engineering “has so far not yielded tangible benefits for the people,” the newspaper quoted Aigner as saying. Germany has granted a license for the cultivation of MON810 while France and Italy haven’t yet, due to environmental concerns, the newspaper said.

Aigner wants to allow Germany’s 16 states and regions within the states to ban cultivation of genetically modified crops, a view that may clash with European Union law, the newspaper said.

To contact the reporter on this story: Rainer Buergin in Berlin at rbuergin1@bloomberg.net Last Updated: February 18, 2009 02:33 EST

Now, this article is from the Big Pharma newsletter, so of course it's incredibly negative about bioidentical hormone therapy (and ridiculously positive about Premarin, a drug that no one took up until extremely recently), but you can go right to the source and read Oprah's magazine to find out more. Also, you might consider reading this book to learn more about how the FDA is nothing but the personal marketing tool of Big Pharma.

http://therpmreport.com/Free/1b53a81c-48ad-41a5-87c7-846f95dcb26c.aspx?utm_source=RPMel

Tuesday, February 10 2009

Bioidentical HRT: One of Oprah’s “Favorite Things” 

By Brenda Sandburg

In defending Premarin against bioidentical hormone therapy, Wyeth has a new, formidable nemesis: Oprah Winfrey.

 

Wyeth has long fought pharmacies trying to convince women to buy compounded hormone replacement therapies in lieu of Premarin. The company now has a new nemesis: Oprah Winfrey.

The television celeb devoted an entire show last month to bioidentical hormone therapy, announcing that she was “opening a national conversation” about HRT. The dialogue continued two weeks later with guest and perennial pitchwoman Suzanne Somers, a long-time advocate of bioidentical hormone replacement therapy.

The February issue of Oprah Magazine also includes an article on the topic (the cover has the teaser “Hot Women! The stuff nobody’s telling you about hormones”) and a column by Oprah in which she describes her own experience with the treatment.

“After one day on bioidentical estrogen, I felt the veil lift,” she writes. “After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step.”

Oprah’s endorsement cast a spotlight on bioidentical HRT as an alternative treatment for menopause symptoms, and has garnered attention far, far outside her typical audience: the New York State Bar Association’s annual meeting. At the meeting, attorney Irving Wiesen said her endorsement would draw an avalanche of attention to compounding.

That comment prompted Geoffrey Levitt, Wyeth’s chief regulatory counsel, to acknowledge: “It’s really hard to go up against Oprah.”

Several years ago Wyeth filed a citizen petition with FDA asking the agency to take enforcement action against compounding pharmacies that were manufacturing or dispensing bioidentical hormone replacement therapy. And Wyeth won: FDA sent warning letters to seven compounding pharmacies for producing these products with unapproved ingredients and making false and misleading promotional claims (you can read all about that here).

Oprah acknowledged FDA’s concerns about the therapy. FDA said in a statement to the show that it does not recognize the term bioidentical. “Many compounding pharmacies use ‘bioidentical’ as a marketing term to imply that drugs are natural or have effects identical to those from hormones made by the body,” the agency said.

“FDA is not aware of credible scientific evidence to support these claims. There are potentially serious adverse effects associated with long term use of these products--even when consumers use FDA-approved hormone therapy drugs that have been proven safe and effective.”

Blah-de-blah-blah-blah. This is Oprah we're taking about. The woman elected a president, for goodness' sake! She's got far more power than FDA and Wyeth combined!

Maybe some cancer patients in the UK will be allowed to take their medicine, after all.

http://therpmreport.com/Free/2f0c2557-4052-460d-9dd8-60f74f379821.aspx?utm_source=RPMel

Sunday, February 15 2009

NICE Deal, Celgene 

By Melanie Senior

Celgene finds a formula to win coverage for Revlimid in the UK.

 

We imagine that Celgene is pleased with its cost-sharing scheme around multiple myeloma drug lenalidomide (Revlimid), approved, at least provisionally, by the UK cost-effectiveness watchdog NICE.

Having failed to get its GBP4,300-a-month drug past NICE the first time around, Celgene had a re-think, and came back with a plan. The UK's National Health Service, it suggested, should pay for the drug for 26 treatment cycles--that's about two years' worth--in those patients with previously-treated disease. Celgene would fund the drug (used in combination with dexamethasone) in patients benefiting from it thereafter.

Sound fair? The thing is, that the median time to progression figure for patients with this disease, as per trial data presented by Celgene to back up its submission, is 11 months. (TTP is what's typically used to determine whether patients continue to receive a therapy--in other words, whether it's working). So Celgene's onto a good deal, right, since it won't have many patients to fund?

Wrong, argues Celgene. It's just not possible to find the true median TTP or overall survival data from these trials because of limited follow-up and patient withdrawals. So Celgene used a model to extrapolate what is sees as more accurate TTP and survival data. That, is says, reveals that 15-20% of patients may continue to benefit from the drug beyond 26 treatment cycles. Even that estimate, the company argues, might be too conservative, since much existing overall survival data is based on current clinical practice, whereby Revlimid, an immunomodulatory agent, isn't part of the mix at all.

Those arguments were clearly sufficient for NICE (although it's worth mentioning that the agency has been under significant pressure to make a popular decision in recent months). And Celgene had two major tailwinds helping it: (a) Recently-issued NICE guidance on end-of-life medicines, which relaxes the cost-effectiveness criteria for products that extend life for those with terminal diseases affecting fewer than 7000 new patients each year, and (b) simple administration.

Celgene will administer the 'you-pay-then-we-pay' scheme itself, and easily, piggybacking on the drug's existing risk minimization plan, which is a condition of its license. (Since the drug is related to thalidomide, it must not be used in pregnant women.) That's a big deal, since the main barriers to any risk- or cost-sharing scheme in the UK, as we suggested in a previous post, appear to be practical ones.

Some critics say that NICE is bowing to popular pressure, with this and with recent revised guidance around kidney cancer treatment Sutent. That's a shame, they continue, because if Obama does copy it or any aspect of it in the US, he should copy the old NICE, not what some describe as the more submissive new one.

Now sure, with more risk-sharing proposals on the way, its value-assessment methods under scrutiny, plus the bunch of other responsibilities that come with its increased influence on drug pricing, NICE is going to have to be smart. (We'll have more about this in the next edition of The RPM Report.) But it's hard to argue with the ethics of providing end-of-life medicines, and of increasing patient access. It's also hard to argue with the economic benefits that come to Britain if access improves. Besides, at least companies and the UK Department of Health are engaging on such matters, even if the outcomes may appear, to some, to favor one side or the other.

http://www.newswithviews.com/Tenpenny/sherri120.htm

THE MMR VACCINE IS NOT HOLY WATER

 

 

Dr. Sherri Tenpenny, DO
February 17, 2009
NewsWithViews.com

For nearly a decade, the British General Medical Council (GMC), the equivalent of a U.S State Medical Board on steroids, has been taking Dr. Andrew Wakefield to task for daring to suggest that autism could be caused by the measles, mumps and rubella (MMR) vaccine. This week proved that the inquisition continues. The Times UK published a report written by commissioned journalist, Brian Deer, claiming that “confidential medical documents and interviews with witnesses” have established that Andrew Wakefield manipulated patients’ data.[1] Deer claims that Dr. Wakefield’s “misleading and inaccurate” research about the MMR has lead to reduced vaccination rates and a resurgence of measles. And while the bickering about the MMR continues, the number of children who have been lost to autism continues to soar.

Before the 1990s, U.K. researchers estimated four to five cases of autism per 10,000 people in their country. By 2006, the number with autism had escalated to 39 per 10,000 and the number with autism spectrum disorder (ASD) stood at 77 per 10,000, making the total prevalence of all types of ASD 116 per 10,000, or one in every 86 children.[2] Barely one year later (2007), researchers at the Cambridge University's Autism Research Center in London released a report estimating that one in every 58 children in the U.K. (not just boys) suffers from "some form of autism disorder."[3]

The current population of the United Kingdom is estimated to be nearly 61 million.[4] One in every 58 equates to 1.7 percent of the population. The reality of that statistic should make one gasp: more than 1,000,000 citizens in the U.K. will become mentally handicapped adults, living on drugs and in group homes to manage their behavior. In twenty years, more than a million persons will be absent from the ranks of engineers, shop owners, doctors, lawyers, policemen, firemen and teachers. In addition, a significant portion of the population will be needed to care for adults who will be incapable of self care. Who will pay these costs?

Adults with severe autism could live very long lives. Some may have asthma and others bowel disorders, but unlike children with a true genetic disorder such as Down's syndrome, autistic adults could live well into their 70s or 80s. Who will care for them? Feed them? Bathe them? Who will wipe their bottoms? Persons with severe regressive autism have not lost their health; they have lost their minds. What if one in 58 children were suddenly going blind or becoming deaf? If vaccines were the suspected cause, would doctors continue to robotically vaccinate and explain away the travesty -- blaming genetics -- then try to fix the problem by increasing the number of seeing-eye dogs and cochlear implants? How much destruction of human life is necessary before the medical profession stops genuflecting to a methodology that should have become a relic of history, similar to bloodletting and skull trephination to release evil spirits?

The United Kingdom is a relatively small country. What will this society look like, with one million autistic adults in its midst? Imagine this as the opening scene of a movie, set in 20 years from now in 2029:

…The opening camera shot scans a British street, typical and narrow, bustling with activity. As the camera zooms in, it becomes apparent that something is disturbingly wrong. Dozens of adults with blank stares are wandering aimlessly through the streets flapping and shouting frequent, unintelligible words. Shopkeepers are concerned for their safety as these over-sized, unemployed adults, mostly men, bang on doors and nearly break windows, searching for food and shelter. Overwhelmed social workers do their best to keep these strong, frightened souls under control but with little success…

This science fiction story may become a reality show in a few short years. But this won’t be happening only in the UK. Autism rates across the globe are exploding. While the World Health Organization does not maintain global statistics on the prevalence of autism, reports from individual countries indicate the alarming scope of the problem.

Numerous studies have placed the rate of autism in India at approximately 1 in 500, or nearly 1.7 million autistic persons.[5] A report by China Central Television reported at least 1.8 million people (including 400,000 children) have autism in China, a number growing by nearly 20 percent per year.[6] Both of these countries have three times the population of the US but we nearly as many children with autism, nearly 1.5 million.[7] Perhaps Dr. Wakefield could see the future as he tried to stop the triple-vaccine jab from ruining the future of not only his country, but the entire world.

The recent decision on February 13, 2009 by the Special Court of Federal Claims, referred to as the “Vaccine Court,” perpetuates the travesty and once again defends the MMR as though it were Holy Water in a syringe. The ruling stated that claims connecting the MMR vaccine and autism were "speculative and unpersuasive." More than 1,500 news outlets proclaimed that the MMR did not cause autism. And while the paid mouthpiece of the vaccine industry, Dr Paul Offit of the Children’s Hospital of Philadelphia chirped, “It's a great day for science, it's a great day for America's children when the court rules in favor of science," hundreds of children are regressing daily in front of their parent’s eyes after a vaccine. How dare our government – and a doctor who took an oath to do no harm -- call them liars?

Several years ago, Dr. Wakefield and I were speakers at an autism conference in Dallas. On Saturday evening, Andy delivered the keynote speech at a dinner that doubled as a fund raiser for the sponsoring organization. I remember his words, and his stately British accent, as clearly today as the night he spoke them.

He told of his journey from a conventionally trained medical doctor into the world of autism.

Parents implored him to examine their children who had developed autistic tendencies and severe bowel disorders soon after receiving the MMR vaccine. Was there a connection? Colonoscopies were performed and the tissue samples from the each of the children surprisingly contained vaccine-strain measles virus. In 1998, he was the lead author in a paper published in The Lancet which concluded, “We did not prove an association between measles, mumps and rubella vaccine and the syndrome described…Further investigations are needed to examine this syndrome and its possible relation to this vaccine.”[8]

The personal and professional attacks began shortly after his case report was published. It was impossible to predict that this single, observational paper would lead to years of vile phlegm being spewed at him for the mere suggestion of an association between a vaccine and autism. He concluded his story with a reflection that, had he foreseen the onslaught that was to follow, perhaps he would have treated the children without fanfare and without publishing his findings.

Undeterred by the verbal and legal assaults, his research continued. He told of a time when he hand-delivered well-designed studies to a top Merck executive, imploring him to examine the data that strongly suggested an association between the measles virus and autism. In a follow up conversation with this very senior executive, Dr. Andy asked, “Did you bother to read any of those studies I gave you?” The Merck executive flatly replied, “We don’t have to.”

We don’t have to? Does that mean Merck makes the rules about the MMR? Does that mean Merck can deny the research of Dr. Wakefield, and subsequently, many others who have seen a correlation between the MMR and autism? One thing is certain: The good doctor poked a stick in the eye of an unfriendly giant named Merck. The giant joined forces with his powerful buddies in the Public Health Department and British National Health Service. Together, they have worked every angle to ensure that Dr. Wakefield’s reputation would be destroyed and any connection between the MMR vaccine and autism would be negated. Perhaps it is not a coincidence that the renewed attacks on Dr Wakefield began within days of the Vaccine Court’s proclamation that there is no connection between the MMR and autism.

At the close of his speech, Dr. Wakefield directly addressed the conference speakers and the activist parents in the room. He chose his words carefully and delivered them with laser focus. He asserted that those who work tirelessly to expose the truth about vaccines are the last hope for seriously ill, vaccine-injured children. “We must continue,” he said, “no matter how difficult the road, no matter how serious the consequences. We must fight for these children….because if we put down the flag and surrender when the going gets a little bit tough, who else will do it? Who will dare pick up the torch and carry it forward if we quit? There will be no one...not one. And the next generation of children…and the next…will be forever lost.”

The profoundness of his words hung in the air; there was no movement for a very long time. Each person knew, unequivocally, he had spoken truth directly into the heart. Our resolve was strengthened and united. The future of humanity hangs in the balance. One by one, hands slowly came together. The applause crescendoed to a roaring, well-deserved standing ovation.

That was November, 2003. The dogged determination of many who work tirelessly to expose the damage being done by vaccines is making a difference. The world is waking up because the health problems of our children are no longer anomalies. Parents are questioning the once-size-fits-all vaccination policies dictated by the minions of pharma. They are refusing to inject their precious babies with more than 100 vaccine antigens and measureable amounts of carcinogenic chemicals as a pre-requisite for school.

Moms and dads are standing firm, resisting the pressure from White Coats to vaccinate. They have done their homework and they are not frightened by the so-called “vaccine-preventable diseases.”

They are finding caregivers who support their decisions, leaving behind the pediatrician whose primary purpose is to give shots on a schedule decided by medical bureaucrats. Parents are embracing the fact that children can be healthy with plenty of sleep, ample exercise, clean hands, fresh water, good quality food and vitamins.

Whistleblowers and brave hearts are more often executed than honored for their courage. By refusing to recant his scientific findings to save his license to practice medicine, Dr. Wakefield is facing the tyranny of medical power. Barbara Loe-Fisher, co-founder of the National Vaccine Information Center, described it this way: “The spectacle this British Medical Inquisition is creating for the world to see will have repercussions far beyond the martyrs it will make. People are not stupid and they will not soon forget that medical doctors inside and outside of the British government so feared one man's scientific discovery about vaccination that they felt they had no choice but to destroy him and anyone who stands with him.”

Keep up the good work, Andy. Keep going. Your bravery and tenacity is an inspiration for all of us to continue to warn others of the real culprit behind the global autism epidemic. Thanks to your steadfast determination, parents are wiser and children are healthier. And the fight must go on. To thousands around the world, you are a hero.

And as for the Vaccine Court ruling, this is not the end. In fact, the battle is just heating up. After all, if the government can’t tell us the cause of autism, they certainly cannot tell us what doesn’t cause it either.

Footnotes:

1, “MMR doctor Andrew Wakefield fixed data on autism,” by Brian Deer. February 8, 2009.
2, “Autism rate in children has doubled, say doctors,” Sam Lister. The Times Online. July 14, 2006.
3, “New Fears Over MMR Link to Autism,” Stephan Adams. The Telegraph UK. July 8, 2007.
4, The World Fact Book. United Kingdom.
5, Action for Autism, India
6, “China has more than 100,000 autistic children,” China View. December 7, 2006.
7, “Autism and Global Human Rights,” Georga Hackworth.
8, Wakefield, AJ, Murch SH,Anthony A et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 351:637-641.1998.

A deer in the headlights
 
 
Monday, 16th February 2009
 
http://www.spectator.co.uk/melaniephillips/3362116/a-deer-in-the-headlights.
thtml
 
 
Eleven days ago, Brian Deer renewed his onslaught against Andrew Wakefield
in the Sunday Times. I wrote about it here
<http://www.spectator.co.uk/melaniephillips/3346281/the-witchhunt-against-an
drew-wakefield.thtml>  and made the point that, since Deer's allegations
sparked the General Medical Council case against Wakefield which would not
have occurred without his involvement, he was effectively a principal player
in the story he was reporting - a clear conflict of interest and breach of
journalistic standards.
 
After I noted this, an American TV show last week accused Deer of
journalistic misconduct in reporting a story in which he was a major player
without acknowledging this fact. Deer has been trying to deny this ever
since.
 
First he threatened to sue the TV station, denying that he had laid the
initial complaint which formed the bulk of the GMC inquiry and claiming
<http://leftbrainrightbrain.co.uk/?p=1849#comment-56401>  instead that the
GMC had approached him for information about Wakefield following his
stories:
 
I did not lay the initial complaint against Wakefield. This allegation is a
fabrication, albeit rather a small one in the MMR issue. The GMC asked me
for my journalistic evidence arising from published stories. It was my
public duty to supply my findings to this statutory regulator.
 
Well, various people did think that Brian Deer's complaint was the trigger
for the GMC inquiry. One of those people, it appears, was Brian Deer.
Screenshots record that, on his website, Deer previously boasted that he had
instigated the GMC hearing. In May 2007, his website noted:
 
GMC inquiry: After submissions by Brian Deer to the UK General Medical
Council, the doctors' regulatory body announced a public inquiry in to the
affair. Sunday Times December 12 2004.
 
By last week, however, the wording had been changed to:
 
GMC inquiry: After Brian Deer's reports, the UK General Medical Council, the
doctors' regulatory body, announced a public inquiry into the affair. The
Sunday Times, December 12 2004.
 
In May 2007, he wrote on his website:
 
Pending a General Medical Council [GMC] fitness to practice panel hearing -
arising from the investigation set out on this page... (my emphasis)
 
Those highlighted words have now vanished from the website, which uses
instead this  formulation:
 
Following Brian Deer's investigation, and charges laid against Wakefield,
Walker-Smith and Murch by the General Medical Council...
 
The perception that the GMC was investigating Deer's complaints about
Wakefield was shared by no less a person than a High Court judge. In a libel
ruling in November 2006 arising from a Channel 4 Dispatches programme about
the Wakefield affair, Mr Justice Eady noted that:
 
Well before the programme was broadcast [Mr Deer] had made a complaint to
the GMC about the Claimant. His communications were made on 25 February, 12
March and 1 July 2004. In due course, on 27 August of the same year, the GMC
sent the Claimant a letter notifying him of the information against him.
 
Last week, Deer claimed that Eady was 'mistaken' and that he had not been
the 'complainant' in the GMC hearing. In the current narrative of the affair
posted on his website, after noting that on March 6 2004 some of the authors
of the original Lancet paper 'retracted' the interpretation that had been
placed upon it, he goes on:
 
Shortly before this retraction [for the retracted "interpretation" text,
check the opening abstract of the Lancet paper
<http://briandeer.com/mmr/lancet-paper.pdf> ], the General Medical Council
announced its own investigation
<http://briandeer.com/mmr/st-june-2006-1.htm>  into the affair, which it
said raised questions over Wakefield's fitness to practice medicine. GMC
officials then approached Brian Deer and asked if, in the public interest,
he would pass them his findings, and later requested him to supply his
research materials - including pivotal
<http://briandeer.com/wakefield/wakefield-deal.htm>  documents - to the
council's retained lawyers, at the firm of Field Fisher Waterhouse [FFW] in
London. Deer, however, is not
<http://briandeer.com/wakefield/deer-ffw-letter.pdf>  the complainant in the
case - which was brought on the GMC's own initiative - and his information
has been compounded with submissions, including complaints, from dozens of
other sources, including parents directly involved.
 
To prove that he was not the complainant, he cites a latter written to him
in May 2005 by the GMC's lawyers, Field Fisher Waterhouse. This ran as
follows:
 
I write further to your telephone conversation with Peter Swain last
Thursday seeking clarification in relation to your role in the above General
Medical Council ("GMC") proceedings.
 
I have now had the opportunity to review the GMC's files. My understanding
is that further to your articles appearing in the Sunday Times in February
2004 in relation to your investigation into Dr Andrew Wakefield and the MMR
vaccine, you were approached by GMC case officer Tim Cox-Brown, who asked
you to supply the GMC with further information regarding this matter.
 
Your situation as a journalist who has carried out an investigation into the
conduct of the practitioners in question is unusual for the GMC. I note from
the GMC and FFW's correspondence files that there does appear to have been
some confusion in relation to your role in these proceedings.
 
In GMC 'complainant' cases an individual will have approached the GMC with a
complaint against a particular practitioner. If the GMC decides to hold an
inquiry, legal representation is offered to the complainant for preparation
and presentation of the case before the Professional Conduct Committee.
 
As stated in Peter Swain's letter to you dated 16 December 2004, your role
in this matter is that of 'informant' rather than 'complainant'. This is due
to the fact that the conduct of the practitioners in question has not
affected you directly and clearly involves issues of a wider public
interest...
 
But what Deer does not reveal is that on February 25, 2004, three days after
his article attacking Wakefield had been published in the Sunday Times, he
had written to the GMC in these terms:
 
Following an extensive inquiry for the Sunday Times into the origins of the
public panic over MMR, I write to ask your permission to lay before you an
outline of evidence that you may consider worthy of evaluation with respect
of the possibility of serious professional misconduct on the part of the
above named registered medical practitioners. [Andrew Wakefield, John Walker
Smith and Simon Murch.]
 
If Deer had previously been approached by the GMC for this information --
presumably in the two days that elapsed between publication of his article
and this letter -- this was a strange form of words. For he made no mention
that it had thus approached him. Instead, he asked the GMC for permission to
lay out his evidence before it. So how can this apparently direct
contradiction be explained?
 
One possibility is that Deer had not previously been approached by the GMC,
and that there was some other explanation for its lawyers' letter to him (it
does not say, for example, precisely when its case officer had asked him for
further information).
 
But if the GMC had indeed already approached Deer before he wrote to it,
then it follows that his form of words was highly disingenuous - purportedly
asking for permission to present his information while concealing the fact
that it had already asked him to do so. And if this was the case, the GMC
would seem to have been complicit in this contrived fiction.
 
Then consider the timing of all this. Deer says the GMC approached him for
information after it had announced its own investigation into Wakefield and
his colleagues.  Deer's Sunday Times article appeared on February 22 2004.
On February 23, the Times
<http://www.timesonline.co.uk/tol/news/uk/health/article1027465.ece>
reported:
 
Investigators for the GMC would speak to Dr Wakefield before deciding what
action to take. A GMC spokesman said: 'We are concerned by the allegations'.
 
On February 24 the Daily Mail reported that the GMC
 
said it would be considering what action may be necessary.
 
On February 25, Deer wrote his letter to the GMC accusing Wakefield and his
colleagues of serious professional misconduct. At that stage, the GMC had
merely said it was considering what action to take. So whether the GMC
approached him before he wrote that letter or not, it was Deer whose
complaint was fundamental to the eventual GMC hearing and whose allegations
- reinforced by two further letters of complaint to the GMC during 2004 -
have formed the bulk of, if not all, the matters it has been investigating.
 
The GMC itself said Deer's role was confusing; indeed, its lawyers' letter
to him was apparently in response to his appeal to clear up the confusion.
But the question of who actually made the first approach to whom is surely
beside the point - as is the distinction between 'complainant' and
'informant', which is clearly a technicality resulting solely from the fact
that Deer was not himself personally involved with these doctors. By any
standard, his letter of February 25 was a complaint to the GMC.
 
The overwhelmingly important point - reinforced by these letters -remains
that Deer was absolutely central to the GMC's investigation. Deer did not
merely supply information.  His letter laid before the GMC allegations of
serious professional misconduct. Moreover, whatever its technical status in
the eyes of the GMC it was presented as a formal complaint, giving the full
names of the doctors and their registered medical practitioner numbers and
phrased in officialese. The GMC lawyers' letter refers to further meetings
with him on 24 February 2005 and 7 March 2005. None of this involvement was
mentioned in his story in last week's Sunday Times.
 
But what about the GMC's own use of Brian Deer? In his book MMR Science and
Fiction: Exploring the Vaccine Crisis, the Lancet editor Richard Horton
provides the following startling cameo from the political crisis that
engulfed the GMC in February 2004 when, following Deer's Sunday Times
article and the denunciation of Wakefield by the Lancet, the then Health
Secretary Dr John Reid demanded the GMC hold an inquiry into the Wakefield
affair:
 
Indeed, the GMC seemed nonplussed by Reid's intervention. The best their
spokeswoman could say was: 'We are concerned by these allegations and will
be looking at what action, if any, may be necessary'. In truth, they had not
a clue where to begin. At a dinner I attended on 23 February, one medical
regulator and I discussed the Wakefield case. He seemed unsure of how the
Council could play a useful part in resolving the confusion. As we talked
over coffee while the other dinner guests were departing, he scribbled down
some possible lines of investigation, and passed me his card, suggesting
that I contact him directly if anything sprang to mind. He seemed keen to
pursue Wakefield, especially given ministerial interest. Here was
professionally led regulation of doctors in action - notes exchanged over
liqueurs in a beautifully panelled room of one of medicine's most venerable
institutions.
 
Two days after this reported exchange, Deer wrote to the GMC asking
permission to lay out his allegations before it. So if, as Deer maintains,
the GMC had previously approached him for his information, then from
Horton's account it looks as if the GMC found in his claims a way to respond
to the pressure from Reid for an inquiry. This pressure had itself been
occasioned by the Lancet's denunciation, which had in turn been provoked by
Deer's allegations.  So if this version of events is correct, the GMC
solicited Deer's allegations - while purporting to be their passive
recipient - to provide it with the means to throw the book at Wakefield et
al and thus pacify the Health Secretary. If that is true, then the GMC was
party to a deception in the pursuit of a politically driven attack.
 
Now here's another strange thing. Last week there was a big vaccine damage
judgement in the US - the 'Cedillo' case - in which the court said the
Wakefield theory about MMR was out to lunch in la-la land. This is what Deer
posted on the Left Brain <http://leftbrainrightbrain.co.uk/?p=1849>  Right
Brain website in the wake of that case:
 
That said, I'm also very proud that, like the GMC, the US government sought
my help in mounting its case in Cedillo, copiously borrowing pages of
evidence from my website and displaying some in court. I was surprised by
this. I assumed that they would have sophisticated contacts with other
governments and with industry, and could pretty much get what they wanted.
However, on a number of occasions I would come home, find an email from the
department of justice asking me for a document, and see that the next day it
was being run in court. Bit of a seat of the pants job by the DoJ (brought
about by the plaintiffs changing their case at the last minute). Indeed, I
recall supplying a key document on the O'Leary lab business, which the DoJ
didn't seem to know about just weeks before the hearing. Hence the late
surfacing of Bustin and Chadwick. It was me wot done that, and I'm glad. I
don't say these things to boast, only perhaps to wonder why - if there are
all kinds of grand conspiracies behind the defence of vaccine safety -
governments and regulators are so untogether that a mere journalist can get
ahead of them in the game.
 
If his boast is true, it would seem that the US court - whose ruling looks
pretty thin to me - arrived at its conclusion based on Deer's allegations.
In other words, two major quasi-legal hearings relating to Andrew
Wakefield's theory, one of which is being reported by Deer, have depended
significantly or wholly upon a journalist's own allegations. 
 
He also posted up on the same site a bizarre and incoherent riposte to the
critics who have been hammering away at him on the blogs:
 
If I am as central to the GMC's case as the cranks and liars say, why would
I publish a front page and two inside pages story which wasn't true? Indeed,
if it wasn't substantially true it would be a very serious libel indeed, and
bound to be found out. It would amount to professional suicide.
 
If what I published is misleading (and it isn't) the GMC panel (two lay
members and three doctors) would see that I had published a baseless story.
They, after all, have the children's medical records (at least for 11 of
them). Given the number of times they have reviewed this material, the data
probably stalks their dreams.
 
Why would I put my name to something that would defeat myself? Obviously I
wouldn't. Although there is no risk of prejudice to the hearing (GMC panels
are deemed by the court of appeal to be beyond prejudice, providing they are
properly advised), there could be no possible explanation as to why I would
publish gross falsehoods that are open to such intense scrutiny by the panel
of a statutory inquiry.
 
The Sunday Times might be well advised to take a very hard look at its
'objective' reporter and his involvement in his own story. And the GMC has
some questions to answer too.

Paul Offit, the worst person on earth. Check out Dan Olmsted's investigative reporting here. A sample:

http://www.ageofautism.com/2009/02/voting-himself-rich-cdc-vaccine-adviser-made-29-million-or-more-after-using-role-to-create-market.html

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...

and now here's my own reporting--did you notice that whenever there's a quotation needed for how great and safe all vaccines are for all babies, Paul Offit is on the scene with the microphone? In fact, NEJM (see here and here) and Pediatrics (see here and here and also here) can't get enough of Dr. Offit. I wonder how much money Merck spends in advertising in mainstream medical journals... Oh, wait, it's money in a doctor's pocket every time a parent brings a kid in for a vaccine. Everybody wins (except your kids' health)!

You deserve to know how much mercury is in your seafood. Here's a group that's working on making that happen.

http://www.foodproductiondaily.com/Quality-Safety/Mercury-labelling-of-fish-products-is-needed-now-says-NGOs

Mercury labelling of fish products is needed now, says NGOs

By staff reporter, 13-Feb-2009

Related topics: Quality & Safety

A coalition of different environmental organisations, the Zero Mercury Working Group, claims that there are risks associated with eating fish due to its mercury content, and consumers need to be made aware of these through fish and seafood product labelling.