A study in India, comparing a new Prevnar vaccine with the Prevenar just introduced into New Zealand, shows just how far the medical profession has it's head in the darkest, murkiest places possible. The new multi-strain vaccine was compared with a "placebo" which was the Prevenar vaccine. A baby with an underlying heart condition, in the "placebo" arm, died after the vaccine. Perhaps guessing that the term "coincidence" is starting to wear thin with parents, this death was attributed to "supervisory shortcomings", because, according to the Wall Street Journal, babies with underlying conditions are always excluded from all vaccine trials. How many parents realise that vaccines are never trialled in babies and children with underlying health conditions?
This is just the latest in a long line of creative medical data manipulation. Does this excuse mean that the vaccine didn't do it? No. But they are hoping most parents think that. Rule numbers one to ten: Blame the injection technique, the supervision, even the plaster, or the rubber cap if the vaccine is pulled out of a bottle, but NEVER blame the vaccine.
All pre- licensing vaccine trials, use extraordinarily strict exclusion criteria. You just have to go to www.clinicaltrials.gov and look at any phase trials, and read the inclusion exclusion criteria to realise that that effectively eliminates a huge slice of the general population.
Yet, when the vaccine is licensed, suddenly that vaccine become extra important for babies and children with any sort of heart defect, immune problem, or health issue, even though it's never been tested in those babies before the vaccine is licensed. Just recently, a Vaccine article was published looking at Vaccination in adults with auto-immune disease and/or drug related immune deficiency..
The abstract says: There are insufficient data regarding the efficacy and safety of vaccination in patients with auto-immune disease (AID) and/or drug-related immune deficiency (DRID). Funny that. Why might that be? Because these are exactly the sorts of people excluded from vaccine trials. Their solution? obtain professional agreement on vaccine practices in these patients. From doctors who are dedicated to turning everyone into a one sized fits all pincushion. and that's called science.
One day, this will return to bite them on the bum, hard. Hopefully, for the sake of people who have underlying health conditions, that day won't be too far off.
In the meantime, here is the full version of the Wall Street Journal article for you to read:
New Concern for Drug Tests Abroad
By GEETA ANAND in New Delhi and SHIRLEY S. WANG in New York
Supervisory shortcomings, rather than problems with a vaccine itself, led to the death of a baby girl in India last fall during a Wyeth clinical trial, according to an official investigation by India's top drug regulator.
The findings by the Drugs Controller General of India are likely to add to concerns about how well Western pharmaceutical companies oversee human testing of potential new medicines in developing countries.
The 3½-month-old infant received the approved version of Prevnar now in use -- not an experimental version, Wyeth said. But she was sick with a cough and diarrhea and had an underlying heart problem. Her illnesses meant the baby should have been excluded from the clinical trial, which was studying a new version of Prevnar, a vaccine against the bacteria that causes pneumonia and ear infections among other ailments.
The trial, in which 250 infants were enrolled, was halted in India in November after the girl died.
The Indian government, for the most part, has welcomed trials by international drug companies as a business opportunity and because they can provide cheap health care for the needy and give access to experimental medicines sought by some dying patients.
"We're very supportive of what Wyeth is doing," said Surinder Singh, the drugs controller general of India, in an interview. But he expressed concern after the infant's death that "if one of the best multinational companies in the world following the best ethical practices has these problems, what is going on down the line?"
Drug makers increasingly are conducting trials outside of the U.S., especially in developing countries where it is often cheaper and quicker to perform testing with humans. Some 700 clinical trials were being conducted in India, China and Russia last year, up from fewer than a total of 50 in those three countries in 2003, according to U.S. National Institutes of Health figures.
Critics have complained that patients in poorer countries are exploited, serving as guinea pigs to test medicines they may never be able to afford. Some also question whether the trials can be conducted safely and correctly by medical personnel who haven't yet developed expertise in testing potential new medicines in human beings.
Big drug makers say they take concerns about conducting ethical clinical trials seriously and use one global standard for trials. For instance, Pfizer Inc., which in February agreed to buy Wyeth for $68 billion, says it conducts trials only in countries where it plans to market the new drug and doesn't pay patients to enroll in trials. It monitors sites around the world, conducting 69,000 visits of 14,000 sites last year, according to a position paper on global clinical trials the company published this month.
Wyeth declined to comment on the specifics of the Indian investigative report, which hasn't yet been released. But a spokesman said the company is "taking steps to address the issues that have been raised" and was working with regulators to resume the halted Indian trial.
In a Feb. 28 letter to regulators, Wyeth asked to restart the trial at 11 Indian sites where research was being done apart from the Bangalore hospital where the baby died. The company also offered a detailed plan to correct problems identified at the Bangalore hospital, which administered the trial, ensuring that records of all medical exams were placed in patients' files.
India authorities haven't yet decided whether to allow Wyeth to resume testing at any site for the new version of Prevnar.
A political frenzy over drug testing erupted in India last year when there were media reports of the death of 46 children in clinical trials at New Delhi's All India Institute of Medical Sciences. A later investigation by the hospital -- reviewed by regulators -- said the deaths were due to the patients' underlying diseases and weren't related to the trial.
Still, the political outcry led India's regulatory body for clinical trials to pull back from a plan to relax regulations to allow even more clinical trials in the country. At present, drugs discovered outside the country can be tested in India after the first human trials are performed elsewhere.
Supporters say research trials offer many benefits -- with proper oversight. "There's a business opportunity we don't want to lose, but the safety and quality standards need to be met and we can only do that if capacity building is done on a large scale," says D.G. Shah, general secretary of the Indian Pharmaceutical Alliance, an industry trade group.
Because of a shortage of experienced personnel to run the drug trials, Indian officials have ramped up training, setting up partnerships with the U.S. Food and Drug Administration, Health Canada and the World Health Organization, among others. "However many trials are conducted here is fine, but the data should be credible and the safety of subjects should be primary," said A.K. Pradhan, India's assistant drugs controller.
The FDA, which opened an office in India in January, has scheduled another clinical trial workshop in June. David Lepay, senior adviser for clinical studies at the FDA, said the agency has done eight inspections in India and "what we've seen has generally been of the quality seen internationally."
But a research group, the Centre for Studies in Ethics and Rights in Mumbai said in a February report that some trials conducted in India don't meet international standards of good clinical practice even though they don't appear to violate the country's regulations for research.
The Indian regulators' report said the deceased infant's medical file indicated that a sibling had died of a cardiac problem at four months of age, which should be been a red flag to trial personnel to examine the baby girl for cardiac problems before she was enrolled in the trial.
The baby received three doses of vaccine -- on Aug. 5, Sept. 5 and Oct. 10. When the baby arrived for the third dose, medical records indicate the baby had had a cold and diarrhea for two days, according to the investigative report.
She still got the vaccine. Researchers conducting the trial didn't know at the time if she was receiving the approved vaccine or the experimental version, a common practice to assure the validity of results in clinical trials.
On Oct. 16, the baby was admitted to the pediatric ward with a cough and noisy breathing. A chest X-ray revealed an enlarged heart. A day later, she died of cardiac arrest, the investigative report says.
