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TOP NEWS STORIES: MONDAY JULY 16th 2007:

Bush sends nuclear terrorism treaty to Senate

Fri Jul 13, 2007 3:59PM EDT

Free practice account at FOREX.comWASHINGTON (Reuters) - U.S. President George W. Bush sent a treaty targeting international nuclear terrorism to the Senate on Friday and urged its approval.

The accord, which Bush signed in 2005, is the first such treaty adopted by the U.N. General Assembly and entered into force on July 7.

The treaty provides a legal basis for international cooperation in the investigation, prosecution and extradition of anyone who threatens or commits acts of terrorism involving radioactive material or a nuclear device.

"This convention is important in the campaign against international terrorism. I recommend, therefore, that the Senate give early and favorable consideration to this convention," Bush said in a message to the Senate.

The accord was approved by the U.N. General Assembly in 2005, seven years after Russia first proposed it, and is the first anti-terrorism convention completed since the September 11 attacks.

Compulsory vaccinations may deter workers: AMA

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Compulsory vaccinations may deter workers: AMA

Posted Tue Jul 10, 2007 6:05am AEST

The Australian Medical Association (AMA) says making vaccinations compulsory among aged care workers could deter people from entering the profession.

The issue was first raised after 10 people died during last year's influenza outbreak at a nursing home in Canberra.

Last week, three children died after contracting influenza in Western Australia.

The chairman of the AMA Council of General Practice, Rod Pierce, says making vaccinations mandatory could prove problematic.

"If you're struggling to get someone to look after patients in an aged care facility, you don't want to make it a confrontation between the union and the workers and employment," he said.

"I certainly believe and we certainly believe that it's important for people to have a professional responsibility to actually be vaccinated."

"It's the same as washing your hands, it's the same as doing basic professional things before you actually care for a patient, this falls into the same category.

"It's not about whether you should or shouldn't for yourself, it's about professionally protecting your patient the best you can."

A Win for Dr. Hurwitz, A Loss for the Pill-Counters

By John Tierney

Tags: opioids, pain, William Hurwitz

Dr. William Hurwitz was sentenced Friday to 57 months in prison for prescribing opioids. That’s more time than his supporters and some of the jurors were hoping for, but it’s still a major victory for him — and for the scientists who testified at the trial. The prosecutors had asked for a life sentence.

The sentence is a distinct reduction from the 25-year sentence Dr. Hurwitz was serving after being convicted in 2004 on drug trafficking and other charges. (The conviction was overturned and resulted in a retrial, at which he was convicted of 16 counts of drug trafficking.) One of Dr. Hurwitz’s lawyers, Richard Sauber, said that, considering the time already served, Dr. Hurwitz could be free in 17 months.

The good news, for doctors worried about the Drug Enforcement Administration’s campaign against opioids, is that U.S. District Judge Leonie Brinkema paid attention to the testimony of scientists instead of the 1,600-pill argument of the prosecution and Karen Tandy, the head of the D.E.A. As the Associated Press reports:

Brinkema said she had read news accounts of the first trial and had seen some of the massive prescriptions Hurwitz had given out, including one patient who was given 1,600 pills a day.

‘’The amount of drugs Dr. Hurwitz prescribed struck me as absolutely crazy,'’ the judge said.

But after hearing testimony from both sides, ‘’I totally turned around on that issue,'’ Brinkema said. ‘’The mere prescription of huge quantities of opioids doesn’t mean anything.'’

The bad news for other pain-management doctors is that they can’t count on getting such a thoughtful judge, or getting the support of experts and lawyers like the ones who defended Dr. Hurwitz. And, of course, despite all the relative advantages he had over other doctors, Dr. Hurwitz still received a 57-month sentence.

While there was no evidence that Dr. Hurwitz was profiting from the resale of his prescriptions — and the jurors I interviewed said they didn’t think he intended the drugs to be resold — he will still spend more time in prison than almost all the patients who admitting lying to him and reselling the drugs. Thanks to the deals they made to cooperate with prosecutors, seven of the nine patients got sentences ranging from 10 to 39 months. Only two got longer sentences than 57 months — and one of them, who got 72 months, was also guilty of armed robbery and arson.

I’ll leave you with a few questions:

Why should a doctor trying to treating patients in pain serve more time in prison than a patient who dupes him and intentionally violates the law by reselling the drugs? Will Judge Brinkema’s words and action today discourage narcotics agents and prosecutors from targeting doctors who prescribe large quantities of opioids?

Will the D.E.A.’s policies change now that Democrats control Congress? At a hearing this week on the hearing on the D.E.A.’s regulation of medicine, Karen Tandy and other D.E.A. officials got an unusually tough grilling from members of House Judiciary Committe like Representative Jerrold Nadler of New York. The legislators asked awkward questions about the D.E.A.’s obstruction of research into medical marijuana and its policies on opioids.

They invited testimony from John Flannery, a lawyer who’s been defending chronic-pain doctors and the author of “Pain in America.”

They heard Siobhan Reynolds, the president of the Pain Relief Network, testify that the D.E.A. is an out-of-control agency “that has demonstrated no respect for the rights of ill Americans, nor for the rule of law itself.” It may seem naive to expect any major change in the D.E.A.’s bureaucratic imperatives. But let the record show one shift by its chief: Today, unlike the day when Dr. Hurwitz was sentenced to 25 years in prison, Karen Tandy did not celebrate by posing for pictures with a bag of 1,600 pills.

UPDATE: I just heard from one of the three jurors in the Hurwitz trial whom I previously interviewed. She spoke with the other two and said they share the following reaction: “As we had previously said, we hoped for a light sentence and had complete confidence in Judge Brinkema. We are pleased with the outcome.”

Genzyme Announces Positive Results from Carticel(R) Study at Major Sports Medicine Meeting

Findings from Four Year, Multi-Center Clinical Study on Autologous Chondrocyte Implantation Presented, Coincide with New Product Labeling

July 16, 2007: 09:00 AM EST

CAMBRIDGE, Mass., July 16 /PRNewswire-FirstCall/ -- Genzyme Corporation announced today findings from the Study of the Treatment of Articular Repair (STAR) which investigated the safety and effectiveness of Carticel(R) (autologous cultured chondrocytes) in patients who had an inadequate response to a previous knee cartilage repair procedure. This landmark study demonstrated that autologous chondrocyte implantation provided sustained and clinically meaningful improvements in knee function and reductions in knee pain in this patient population with significant limitations and knee pain at baseline. Internationally renowned orthopaedic surgeon, Dr. Brian Cole of Rush-Presbyterian-St. Luke's Medical Center, presented the data from the STAR study at the American Orthopaedic Society for Sports Medicine (AOSSM) meeting yesterday in Calgary, Canada.

"This was a well done, rigorous study which provided confirmation of our current treatment options for these types of patients," stated Dr. Cole. "What was particularly compelling is that the study specifically investigated the outcome of patients that were unresponsive to previous surgical treatments. These patients had failed to receive a sustained benefit from another surgery, yet most of them who had a Carticel implant went on to a very good outcome."

Study Results

The study achieved its endpoints and successfully fulfills Genzyme's final post-approval commitment to the FDA. Investigators enrolled patients in 29 clinical centers throughout North America in this open label, prospective 4 year study. Carticel is an autologous cell therapy used for the repair of symptomatic cartilage lesions on the thigh bone portion of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior cartilage repair procedure.

The average patient in the study was approximately 35 years old, had a significantly large articular cartilage lesion in their knee and rated their pre-operative knee pain as quite severe (with a median score of 2 on a scale of 1-10 where 0 is the most severe pain and 10 is normal). The patient population experienced significant reductions in knee pain, as well as improvements in function, including recreational and sports activities. Genzyme's new Carticel labeling, announced on June 25, 2007, incorporates the safety and efficacy data from the STAR study.

"AOSSM provided us with an excellent forum to share the results of the STAR study with leading, national orthopaedic surgeons specializing in sports medicine and cartilage repair," said Ann Merrifield, president of Genzyme Biosurgery, the division that manufactures and commercializes Carticel. "We were pleased to share the Carticel safety and efficacy data which confirms how the product can truly make a lasting positive impact for patients."

A Unique Cell Therapy

More than 13,000 patients in the United States have had Carticel implants. Carticel is used by orthopaedic surgeons to treat patients who have clinically significant articular cartilage lesions on the thigh bone part of the knee caused by acute or repetitive trauma that has not responded to a prior cartilage repair procedure. Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Carticel employs a unique process to grow a patient's own cartilage cells for implantation to correct certain types of damage. The treatment starts when an orthopaedic surgeon trained in the use of Carticel provides Genzyme with a biopsy of healthy cartilage taken from a patient's knee in an arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in Cambridge, MA, use proprietary methods to grow millions of cells from this biopsy. The cells are then delivered to the hospital, where the surgeon implants them into the patient's knee defect in a surgical procedure.

Carticel was the first cell therapy to be approved by the FDA. First introduced in March of 1995, Carticel received accelerated approval from the FDA in August of 1997 after the FDA instituted specific cell therapy guidelines. Under accelerated approval, the FDA required Genzyme to conduct confirmatory post-marketing studies.

To learn more about Carticel please visit www.carticel.com.

Cell Therapy Expertise at Genzyme

Genzyme has more than a decade of experience in developing and manufacturing autologous cell therapy products that have been used to treat thousands of patients. Epicel(R) (cultured epidermal autografts), a cell therapy for treating patients with severe burns, is also manufactured by Genzyme. Together, Carticel and Epicel represent the first such products ever brought to market in the United States, providing Genzyme with superior scientific and commercial expertise in this field.

About Carticel

Carticel is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with Carticel implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with Carticel implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. Carticel is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling Carticel. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of a subsequent surgical procedure, primarily arthroscopy, following Carticel implantation is common. The most common reactions (>5% of patients), derived from the Study of the Treatment of Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800- 905-4369 within the United States or 1-678-999-4572 outside the United States.

U.S. Not Ready for Outbreak, Say Americans

July 15, 2007

(Angus Reid Global Monitor) - Most people in the United States believe their government would not respond properly to a national emergency, according to a poll by Ipsos-Public Affairs released by Associated Press. 59 per cent of respondents express little confidence in the administration’s preparedness to handle a major outbreak of an infectious disease.

Laboratory tests have confirmed the presence of the H5N1 strain of avian influenza in several countries around the world. The World Health Organization (WHO) has warned that the virus could mutate into a form that can be transmitted among people.

Since 2003, 317 cases of bird flu in humans have been confirmed, and 191 fatalities have been reported in 12 Asian and African countries.

In November 2005, U.S. president George W. Bush outlined the federal government’s plan to deal with a possible outbreak of pandemic influenza, saying, "Our strategy is designed to meet three critical goals: First, we must detect outbreaks that occur anywhere in the world; second, we must protect the American people by stockpiling vaccines and antiviral drugs, and improve our ability to rapidly produce new vaccines against a pandemic strain; and, third, we must be ready to respond at the federal, state and local levels in the event that a pandemic reaches our shores."

On Jul. 2, John Lange, the U.S. State Department’s special representative on avian and pandemic influenza, declared: "The H5N1 virus is highly persistent; it is spreading in poultry populations, and the threat that it will mutate to become a human pandemic continues. (...) At least 178 countries have drafted or finalized their national pandemic preparedness plans. (...) One element of such preparedness is the Community Mitigation Guidance prepared by the U.S. Centers for Disease Control and Prevention."

Polling Data

How confident are you that the U.S. government is prepared to handle a major outbreak of an infectious disease?

Very confident 9%

Somewhat confident 32%

Not too confident 33%

Not at all confident 26%

Source: Ipsos-Public Affairs / Associated Press Methodology: Telephone interviews with 1,000 American adults, conducted from Jun. 4 to Jun. 6, 2007. Margin of error is 3.1 per cent.

Scientist Says Avandia Executive Tried To Bully Him

DIEDTRA HENDERSON Globe Staff

c. 2007 The Boston Globe

Distributed by The New York Times Syndicate

An undated portrait of Dr. John B. Buse. Buse, a leading diabetes doctor sent the Food and Drug Administration a letter warning of the heart risks of the drug Avandia seven years ago. And the following year the FDA censured the drug's maker for playing down safety concerns, according to documents from 2000 and 2001. The documents indicated that the agency was aware of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug's maker, GlaxoSmithKline, was seeking to minimize Avandia's risks, long before those concerns were brought to public attention on Monday.

An executive of the company that makes the diabetes drug Avandia said a researcher who was among the first to link it to heart problems would be held liable for the $4 billion GlaxoSmithKline PLC lost in stock value as a result of his findings, Dr. John B. Buse testified before congressional investigators last week.

Buse told the House Committee on Oversight and Government Reform that he raised concerns about Avandia's connection to heart problems in 1999, the year the Food and Drug Administration approved it for sale. He said the Glaxo executive, Dr. Tadataka Yamada, made the "disturbing" comment during a meeting Yamada had with Buse's department chair at the University of North Carolina. Afterward, Buse said, he faxed a letter to Yamada asking him to "please call off the dogs" because he feared he could no longer remain civil "under this kind of heat." Buse, a UNC researcher, is incoming president of medicine and science for the American Diabetes Association's board.

The former Glaxo executive was "passionate about his work," Moncef Slaoui, Glaxo's chairman of research and development, said of Yamada, when questioned by the committee chairman, Representative Henry Waxman. "We regret that Dr. Buse felt pressured."

Yamada, who now works for the Bill & Melinda Gates Foundation, was participating in an all-day retreat, according to a foundation spokesman, and could not be reached for comment.

Buse's testimony capped a day marked by allegations of witness intimidation and an admission from the FDA that Avandia and Actos, a similar diabetes drug made by Takeda Pharmaceuticals North America Inc., deserve the agency's strongest warnings for increasing the risk of congestive heart failure.

Avandia, the world's top-selling oral diabetes drug, has been under increasing scrutiny since May 21 when Dr. Steven Nissen, a Cleveland Clinic cardiologist, reported in the New England Journal of Medicine that patients in trials who took it had a 43 percent higher risk of suffering a heart attack, compared with people who took other diabetes drugs or sugar pills. Glaxo's own analysis of nearly four dozen studies found similar heart risks, as did a statistical analysis that the FDA conducted.

The "black box" warnings the FDA is requesting from Glaxo and Takeda would replace less prominent warnings the drugs already carry. Takeda Wednesday committed to strengthen its warnings. Glaxo's Slaoui declined to comment because the firm is negotiating the change with the FDA.

The FDA's willingness to add a black box warning to Avandia is a sharp reversal that comes after the Senate and House launched inquiries into its handling of Avandia's heart risks and followed, by two days, Nissen's paper highlighting those risks. A supervisor who signed off on a February 2006 internal FDA memo suggesting such a label change for Avandia was rebuked by the agency, according to Senator Charles Grassley, Republican of Iowa.

The same day Nissen's study was published, Waxman, Democrat of California, called for a hearing before the oversight committee. He is trying to galvanize House support for an FDA reform bill he cosponsored. It would give the FDA authority that could have sped its actions on Avandia, including power to force changes to drug labels, greater power to require completion of postmarketing studies, and wider dissemination of clinical trial results.

Some 21 million Americans have diabetes, an ailment marked by the body's inability to properly use or produce insulin. Avandia, which generated more than $3 billion in revenue last year, is taken by 1 million Americans.

The public health impact of Avandia's cardiovascular side effects should have prompted faster action by regulators and the company, Waxman said.

Instead, Glaxo waited 11 months before telling federal regulators about clinical trial results linking Avandia to heart risks, and government officials ignored years of earlier warnings about the treatment, Waxman said. "Avandia is a case study of the need for reform of our drug safety laws," he said. "FDA needs the will, the resources, and the authority to be a more effective watchdog."

At the time of Avandia's approval, the FDA was more concerned about the drug's potential to cause heart failure, as well as the liver toxicity that forced a similar drug from the market.

"In retrospect," Avandia's link to heart attacks has evolved into an equally important cardiovascular side effect, FDA commissioner Andrew von Eschenbach testified. But the postmarketing study that Glaxo conducted, at the behest of the FDA, is not large enough to definitively address the drug's heart attack risks, officials said.

Published July 16, 2007

New test pinpoints deadliest prostate cancers

SCIENCE NEWS

July 16, 2007

New test pinpoints deadliest prostate cancers

By Ben Hirschler

LONDON (Reuters) - Scientists have found a new way to identify a particularly deadly form of prostate cancer in a breakthrough that could save tens of thousands of men from undergoing unnecessary surgery each year.

In contrast to many cancers, only certain prostate tumors require treatment. Many are slow-growing and pose little threat to health. But separating the "tigers" from the "pussycats" -- as oncologists dub them -- is tricky.

Now that is set to change with research published on Monday showing how a genetic variation within tumor cells can signal if a patient has a potentially fatal form of the disease.

"This will provide an extra degree of certainty as to whether a cancer is going to be aggressive or indolent, and that's really what we want to know," Colin Cooper, professor of molecular biology at Britain's Institute of Cancer Research, told Reuters.

"Many people get treated radically but probably two-thirds of them never needed treating," he added.

Radical prostate surgery often causes debilitating side effects such as impotence and incontinence, so any system that minimizes treatment would be a major boon to quality of life.

Cooper, who worked with Jack Cuzick at the Wolfson Institute of Preventive Medicine on the new genetic marker, explained in a paper in the journal Oncogene how a particular genetic change could affect survival rates dramatically.

Researchers knew that prostate cancers commonly contain a fusion of the TMPRSS2 and ERG genes, but the new study found that in 6.6 percent of cases this fusion was doubled up, creating a deadly alteration known as 2+Edel.

Patients with 2+Edel have only a 25 percent survival rate after eight years, compared to 90 percent for those with no alterations in this region of DNA.

"If you get two copies it's really bad news," Cooper said.

Exactly how the duplication makes tumors more aggressive is not clear, though Cooper speculates it could result in higher expression of proteins needed to drive tumor growth or be a more general indicator of genome instability.

Whatever the mechanism, 2+Edel is a clear-cut marker for risk that Cooper hopes will soon be used alongside existing techniques at the time of diagnosis to decide whether men require treatment.

Currently, a system called the Gleason score is used to grade which cancers require treatment and which do not, but it is subject to variability in interpretation.

Doctors also use prostate specific antigen (PSA) blood tests as a screen for early signs of prostate problems, though this test is not always a reliable indicator of cancer risk.

Flawed research on autism-vaccine link lingers

Updated Mon. Jul. 16 2007 1:30 PM ET

Helen Branswell, Canadian Press

At least once a week, Dr. Joanne Langley or one of her colleagues in a Halifax pediatrics clinic carves 90 minutes or so out of a crammed schedule to try to persuade yet another set of anxious parents to vaccinate their baby against diseases that regularly used to sicken, maim and kill.

In Toronto, Marianna Ofner - a university professor with a PhD in epidemiology -- has gone to the effort and expense of travelling to the United States to buy single disease vaccines she can't get in Ontario. Ofner was determined to avoid exposing her young daughter to the combined measles, mumps and rubella vaccine that so frightens the parents Langley sees.

Such is the legacy of the research of British gastroenterologist Dr. Andrew Wakefield, whose purported discovery of a link between the so-called MMR vaccine and autism continues to haunt efforts to protect children against these and other vaccine-preventable diseases in North America, Britain and beyond.

The British body that governs physicians, the General Medical Council, begins a hearing Monday into allegations that Wakefield and two colleagues behaved unethically and dishonestly in conducting their research. The hearing, expected to last months, could result in the trio losing their medical licenses.

The voices of infectious diseases specialists and pediatricians display anger and dismay when the subject of Wakefield and his work comes up.

Dr. David Scheifele, a vaccine expert at B.C. Children's Hospital in Vancouver, dismisses Wakefield's research as "nonsense."

"It shouldn't have been published in Lancet," says Scheifele, referring to the prestigious British medical journal that ran Wakefield's study in 1998.

"It's very interesting how important the responsibility is to speak carefully about risk -- because one paper can just poison so much thinking," adds Langley, a pediatric infectious diseases specialist at Halifax's IWK Health Centre.

In the nearly 10 years since the Lancet publication, scads of studies costing untold millions of dollars have failed to corroborate the link Wakefield still insists exists. Scientific authorities such as the U.S. Institute of Medicine have flatly concluded that Wakefield and his coauthors were wrong.

"I actually feel enormously sad that this has been allowed to go on as long as it has. I think that there's been an enormous amount of wasted effort pursuing a theory that is based on flawed science," says Dr. Brian Ward, an infectious diseases expert at Montreal's McGill University who was approached by but declined to work with Wakefield.

"Gosh, if I were the parent of an autistic child and I were having trouble getting services for my child, those millions of dollars could have been so much better spent on real research or providing real services," Ward adds.

In 2004, 10 of Wakefield's 12 collaborators retracted the Lancet study.

"We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism, as the data were insufficient," wrote the group. "However, the possibility of such a link was raised. Consequent events have had major implications for public health."

A 'fatal' conflict of interest

Indeed they have. At one point MMR vaccination rates sunk to 75 per cent in Britain, well below the 95 per cent authorities say is needed to keep these diseases from circulating. While the rate has since climbed to about 85 per cent, Britain continues to suffer outbreaks of these three diseases and to seed the diseases abroad. The mumps outbreak Nova Scotia and a few other provinces have been fighting since mid-winter seems to trace back to a case from Britain.

The Public Health Agency of Canada says MMR vaccination rates in this country hovered around the 95 per cent rate throughout the period from 1997 to 2004, though no data were collected from 1998 to 2001. Still, in Canada and in the United States, anecdotal reports from pediatricians -- and a perusal of Internet discussions dedicated to the issue -- show the fear sparked by Wakefield's work has taken root here too.

Shortly before publishing the retraction, Lancet editor Dr. Richard Horton declared Wakefield had a "fatal" conflict of interest that would have precluded publication, if the journal had been informed of it.

The doctor was doing paid research for a group of parents of autistic children who were trying to mount a class action suit against the makers of the MMR vaccine. Later it was revealed Wakefield had taken out a patent on a new vaccine while publicly challenging the safety of the existing one.

Despite the allegations of research improprieties, despite the mounds of studies refuting Wakefield's work, pediatricians continue to find themselves facing parents reluctant or unwilling to vaccinate infants against these diseases and others.

Fear can trump science, especially when babies are concerned.

Ofner, who specializes in the spread of hospital acquired infections, knows how to read and assess complex medical studies.

Her oldest child, a seven-year-old daughter, is autistic. The little girl was vaccinated with the MMR shots, which are given at about the age when autism's first symptoms are typically observed.

When Ofner's second daughter was born, she didn't want to take a chance with the combined vaccine, and arranged to purchase individual vaccines against the three diseases. Her second daughter was diagnosed with autism at 18 months. But a reappraisal when the girl was three revealed she no longer meets the criteria for autism.

"I'm totally pro-vaccination," Ofner insists.

"However, when it's your kid and there's a slight chance." she says, leaving the sentence unfinished.

She accepts that studies have proven the shot doesn't cause autism, but worries it might serve as a spark in a small subset of children with a genetic predisposition to the condition. She has a cousin with autism and believes coding for the condition may be contained in the genetic blueprints of one or both of her daughters.

"I've read everything. You know what? Honestly I don't know. So I went to my pediatrician and I said: I don't feel comfortable doing this," says Ofner, referring to vaccinating her youngest daughter with the MMR vaccine.

Still, she points to the experience of a friend who has two sons, both autistic.

"She vaccinated the first one and the second one she didn't. The second one is severe, the first one is mild," Ofner says, referring to where on the scale of autism the boys fall.

"So what's that mean?"