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February 8, 2002        News Morgue Search  www.feat.org/search/news.asp

RESEARCH

·        Reuters Reports British Counter MMR-Vax Study Within Hours Today

·        MMMR Vaccination And Bowel Problems, Autism - Another Study

·        Wakefield Responds to Taylor Study

·        US Congressman MD Urges Pediatricians to Warn Patients about MMR Vax

·        Scandal of Scientists Who Take Money to Front for Drug Companies’ Words

 

 

Reuters Reports British Counter MMR-Vax Study Within Hours Today

British Researchers Debunk MMR-Autism Link

[When Wakefield’s latest paper came out, which strengthens the association of the MMR vacine to autism, last Sunday, Reuters took two full days to report it adding it’s own discounting spin.  No other American press service reported it.

However, within hours of it’s release, Reuters had it’s report out on a different study challenging Wakefield’s finding.  This report (below), fails to mention the deep controversy surrounding Taylor’s work. Wakefield responds to the report after the abstract to the Taylor report also below.] http://www.reutershealth.com/archive/2002/02/08/eline/links/20020208elin024.html - - Address ends here.

London, Feb 08 Reuters - As Britain sought to address growing concerns over the safety of the MMR vaccine, new research released on Friday showed no link between the measles-mumps-rubella jab and autism.

Scientists at London’s Royal Free Hospital and University College Medical School said their study of 473 autistic children born in London between 1979 and 1998 found no difference in the rate of the illness in the years before the MMR vaccine was introduced in 1988 and afterwards.

“We found no change in the proportion of autistic children with bowel problems or developmental regression over a 20-year period from 1979,” Professor Brent Taylor of the Royal Free Hospital said in the report.

He said his team’s research, published on the British Medical Journal’s Web site, is further proof that the MMR vaccine is safe and does not cause or trigger autism.

“These findings provide...further evidence against involvement of MMR vaccine in the initiation of autism,” Taylor and colleagues report.

Fears that the triple vaccine can cause autism and bowel problems have led to a drop in the number of children being vaccinated and outbreaks of measles in various parts of the country.

The uptake of the MMR vaccine has fallen from about 85% last summer to under 65% in some parts of Britain, sparking worries of a measles epidemic.

The study was released as Prime Minister Tony Blair’s office urged parents to have their children vaccinated with MMR because it saves lives.

“The government strongly supports the combined measles, mumps and rubella vaccine (MMR) as the best protection for our children against these dangerous diseases,” Blair’s office said on its Web site (www.number10.gov.uk).

It said MMR was widely used in more than 90 countries around the world and more than 500 million MMR doses had been given.

Blair’s 20-month-old son Leo has been dragged into the controversy because the prime minister, citing the need for privacy, has refused to reveal whether the toddler received the MMR jab.

There has been an increase in demand for single vaccinations, instead of the triple shot.

Britain’s chief medical officer Professor Sir Liam Donaldson has warned that if the MMR is abandoned, children would be vulnerable to all three illnesses.

SOURCE: British Medical Journal www.bmj.com/cgi/content/full/324/7333/DC3.

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MMMR Vaccination And Bowel Problems, Autism - Another Study

‘Measles, mumps, and rubella vaccination and bowel problems or developmental

regression in children with autism: population study’

http://www.ananova.com/yournews/story/sm_516363.html

Brent Taylor, Elizabeth Miller, Raghu Lingam, Nick Andrews, Andrea Simmons,

Julia Stowe

Brent Taylor professor of community child health, Raghu Lingam research

fellow, Andrea Simmons research fellow, Julia Stowe research associate,

Immunisation Division, Public Health Laboratory Service, Communicable

Disease Surveillance Centre, London NW9 5EQ , Elizabeth Miller head, Nick

Andrews statistician, Correspondence to: B Taylor b.taylor@rfc.ucl.ac.uk,

 

Abstract

Objectives To investigate whether measles, mumps, and rubella (MMR) vaccination is associated with bowel problems and developmental regression in children with autism, looking for evidence of a “new variant” form of autism.

Design Population study with case note review linked to independently recorded vaccine data.

Setting Five health districts in north east London.

Participants 278 children with core autism and 195 with atypical

autism, mainly identified from computerised disability registers and born between 1979 and 1998.

Main outcome measures Recorded bowel problems lasting at least three months, age of reported regression of the child’s development where it was a feature, and relation of these to MMR vaccination.

Results The proportion of children with developmental regression (25% overall) or bowel symptoms (17%) did not change significantly (P value for trend 0.50 and 0.47, respectively) during the 20 years from 1979, a period which included the introduction of MMR vaccination in October 1988. No significant difference was found in rates of bowel problems or regression in children who received the MMR vaccine before their parents became concerned about their development (where MMR might have caused or triggered the autism with regression or bowel problem), compared with those who received it only after such concern and those who had not received the MMR vaccine. A possible association between non-specific bowel problems and regression in children with autism was seen but this was unrelated to MMR vaccination.

Conclusions These findings provide no support for an MMR associated “new variant” form of autism with developmental regression and bowel problems, and further evidence against involvement of MMR vaccine in the initiation of autism.

[You can read the full paper at http://www.ananova.com/yournews/story/sm_516363.html .]

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Wakefield Responds to Taylor Study

Andrew Wakefield was interviewed today on the UK’s Channel 4.  The above Taylor paper attempts to refute Wakefield’s own work which surfaced only this Sunday. Wakefield is asked to comment on Taylor’s paper: “It is an epidemiological study and it is a retrospective study. What it does is to take patient records and analyse them to look at the prevalence of gastro intestinal symptoms in these children; regression, MMR. To see if there are any correlations. I have been through some several hundreds sets of records of these children and I have to say the quality of the records is appalling.  Symptoms are not recorded. Particularly if you are a psychologist or a psychiatrist, the recording of gastro intestinal symptoms is not good!  What the study cannot exclude is that there is a bowel disease, a new syndrome, associated with regressive autism and that it may be related to MMR”.

Wakefield’s interview today can still be seen on the Channel 4 website:

http://www.channel4.com/news/home_page.html

 

 

 

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US Congressman MD Urges Pediatricians to Warn Patients about MMR Vax

Rep. Dave Weldon, M.D. Urges Physicians to Give Parents Choice of Separating

the Measles, Mumps, and Rubella (MMR) Vaccine Due to Growing Concern

Washington, D.C.—U.S. Rep. Dave Weldon, a Florida physician, urged the American Academy of Pediatrics (AAP) to fully inform parents of their choice in having the MMR vaccine separated and administered at different times.  There is growing concern among parents and medical researchers that concurrent exposure of the measles virus with other viruses may be linked to serious developmental disorders in some children.  A recent study in the Journal of Clinical Pathology (Ulmann et al.) found persistent measles virus in the intestinal tissue of 75 of 91 patients with developmental disorders (i.e., autism) who also exhibited severe bowel disease.

“I am very disturbed by these findings and believe it is critical that we give children’s health the highest priority,” said Rep. Dave Weldon.  “While the verdict is still out on whether the MMR vaccine causes regressive autism, an association has been demonstrated in this study and others.  I call upon the AAP to urge pediatricians to give parents all the facts about this safety concern and allow parents to make an informed decision about whether or not they want to separate the MMR vaccine for their children.”

“Vaccines have saved millions of lives.  However, there are growing concerns about the safety of the MMR vaccine that must be independently studied,” said Rep. Weldon. “These clinical laboratory findings cannot be dismissed with epidemiological studies.  The Centers for Disease Control and the National Institutes of Health must apply vigorous, independent tests to evaluate the concerns over the MMR.”

There is an epidemic of autism among children in the United States.  Ulmann et al. focus their research on a cohort of autistic children who develop what is known as regressive autism. Children with regressive autism meet normal developmental thresholds, but shortly after receiving the MMR (12-15 months of age) they begin to regress.  Many public health officials have stated that the timing is simply a coincidence.  However, Ulmann’s discovery of measles in the inflamed intestines of 75 of 91 children in this recent study gives serious cause for concern.

It is believed that persistent measles virus in the intestines of these children may be the cause of the severe bowel disease (lymphoic hyperplasia and ileocolitis).  Bowel disease is believed to result in the neurological disorders in these children.  It has been established by other researchers that developmental disorders are associated with severe bowel disease.  Last year the Institute of Medicine urged further study of this issue and the Congress has included language urging the National Institutes of Health to support research in this area.  Additionally, a research paper published in Adverse Drug Reactions in January 2001, showed flaws in the pre-licensing studies of the MMR vaccine.

 

 

 

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Scandal of Scientists Who Take Money to Front for Drug Companies’ Words

Doctors named as authors may not have seen raw data

 

[By Sarah Boseley in the Guardian.]

http://www.guardian.co.uk/Archive/Article/0,4273,4351264,00.html

Scientists are accepting large sums of money from drug companies to put their names to articles endorsing new medicines that they have not written - a growing practice that some fear is putting scientific integrity in jeopardy.

Ghostwriting has become widespread in such areas of medicine as cardiology and psychiatry, where drugs play a major role in treatment.  Senior doctors, inevitably very busy, have become willing to “author” papers written for them by ghostwriters paid by drug companies.

Originally, ghostwriting was confined to medical journal supplements sponsored by the industry, but it can now be found in all the major journals in relevant fields. In some cases, it is alleged, the scientists named as authors will not have seen the raw data they are writing about - just tables compiled by company employees.

The doctors, who may also give a talk based on the paper to an audience of other doctors at a drug company-sponsored symposium, receive substantial sums of money. Fuller Torrey, executive director of the Stanley Foundation Research Programmes in Bethesda, Maryland, found in a survey that British psychiatrists were being paid around $2,000 (£1,400) a time for symposium talks, plus airfares and hotel accommodation, while Americans got about $3,000. Some payments ran as high as $5,000 or $10,000.

“Some of us believe that the present system is approaching a high-class form of professional prostitution,” he said.

Robin Murray, head of the division of psychological medicine at the Institute of Psychiatry in London, is one of those who has become increasingly concerned. “It is clear that we have a situation where, when an audience is listening to a well-known British psychiatrist, you recognise the stage where the audience is uncertain as to whether the psychiatrist really believes this or is saying it because they them selves or their department is getting some financial reward,” he said.

“I can think of a well-known British psychiatrist I met and I said, ‘How are you?’ He said, ‘What day is it? I’m just working out what drug I’m supporting today.’”

Marcia Angell, former editor of the New England Journal of Medicine, wrote a year ago that when she ran a paper on antidepressant drug treatment, the authors’ financial ties to the manufacturers - which the journal requires all contributors to declare - were so extensive that she had to run them on the website. She decided to commission an editorial about it and spoke to research psychiatrists, but “we found very few who did not have financial ties to drug companies that make antidepressants.” She wrote: “Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.”

In September her journal joined the Lancet and 11 others in denouncing the drug companies for imposing restrictions on the data to which scientists are given access in the clinical trials they fund. Some of the journals propose to demand a signed declaration that the papers scientists submit are their own.

The success of Prozac, the antidepressant which became a cult “happy” drug in the 1990s, substantially raised the stakes in psychiatry. Its promotion coincided with the decline of state funding for research, leaving scientists in all areas of medicine dependent on pharmaceutical companies to fund or commission their work. That in turn gave the industry unprecedented control over data and ended with research papers increasingly being drafted by company employees or commercial agencies.

The responsibility of scientists for the content of their papers takes on serious significance in the context of court cases in the US, where relatives of people who killed themselves and murdered others while on SSRIs (selective serotonin reuptake inhibitors) - the class of drug to which Prozac belongs - claimed the drugs were responsible. According to David Healy, a north Wales-based psychopharmacologist who has given evidence for the families, the companies have relied on articles apparently authored by scientists who may in fact have not seen the raw data.

Dr Healy, who had unprecedented access to the data that the companies keep in their archives, said: “It may well be that 50% of the articles on drugs in the major journals across all areas of medicine are not written in a way that the average person in the street expects them to be authored.” He cites the case brought last year against the former SmithKline Beecham (now GlaxoSmithKline) by relatives of Donald Schell. The court found that the company’s best-selling antidepressant, an SSRI called Seroxat, had caused Schell to murder his wife, daughter and granddaughter and commit suicide.

The company’s defence was based on scientific papers which analysed the results of trials comparing Seroxat with a placebo and found there was no increased risk of suicide for depressed people on Seroxat. But the raw data probably does not support that, argues Dr Healy. Some of the placebo suicides took place while patients were withdrawing from an older drug. When the figures are readjusted without these, he says, they show there is substantially increased risk of suicide on Seroxat.

This raises the question of whether the eminent scientists whose names were on the papers ever saw the raw data from the trials - or saw only tables compiled by company employees, he says. David Dunner, a professor at the University of Washington, who co-authored one of the papers in 1995, admits he did not see the raw data. “I don’t know who saw it. I did not,” he said. “My role in the paper was that the data were presented to us and we analysed it and wrote it up and wrote references.” His co-author Stuart Montgomery, then of St Mary’s hospital medical school in London, declined to answer calls and emails from the Guardian. The third name on the paper is that of Geoff Dunbar, a company employee.

The World Health Organisation has expressed concern about the ties between industry and researchers. Jonathan Quick, director of essential drugs and medicines policy, wrote in the latest WHO Bulletin: “If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.”

 

Lenny Schafer, Editor@feat.org    CALENDAR EVENTS@feat.org Michelle Guppy

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