The following is a reprint of an article taken from minutes from a meeting in 1985 regarding DPT vaccination issues, Wyeth, concerned parents and physicians and representatives from the Bureau of Biologics from the FDA.
Are doctors told enough?
Fresno Bee, DPT report 1984
“Doctors are as much victims as we are. They do what the American Academy of Pediatrics says,” said Ed Hodges, president of California Dissatisfied Parents Together.
“Physicians are innocent victims,” said Los Angeles attorney Andrew Dodd.” It’s a very sad situation and it’s a scandal, in my opinion, of enormous proportions. And I’m ashamed of it. I am ashamed that I know more than a pediatrician [about pertussis vaccine]. That is not right.”
Dr. Kevin Geraghty: “A pediatrician is more likely to believe that the dangers of his stethoscope choking him are higher than DPI causing the degree of damage that I would say it does.”
When Geraghty began studying DPT vaccine 18 months ago, he said his goal was to debunk the critics of the vaccine. “I am a pediatric immunologist; I was trained in immunology. It didn’t take very long for me to know something was very, very wrong.”
But another doctor might not know that. Said Dodd: “When he is administering a mass-immunization product — polio, rubella, DPT — he assumes that the vaccine is almost as sate as water. ‘Mass immunization product’ — that means something to him.
“…He’s not going to take the time to read the medical literature because he knows the reactions. . . are very, very rare. The trouble is It’s wrong. it’s wrong, wrong, wrong.
“If physicians only understood that… they are giving a neurological poison… it isn’t a secret, except it’s not generally known.”
For the most part, physicians learn about DPT vaccine at medical school, in medical journals and in the leaflet manufacturers include with the vaccine. The national Centers for Disease Control provides updated information for parents through public health clinics.
“I tell students very little,” said Dr. Philip A. Brunell, professor of pediatrics at the University of Texas in San Antonio and chairman of the American Academy of Pediatrics’ Red Book committee. “That’s a major problem at medical schools. We are derelict in that. ..
There also are differences in practice in various parts of the world. For example, doctors in Japan, Europe and Soviet-bloc countries generally do not give DPT shots to children with histories of neurologic problems.
U.S. manufacturers have included that caution for years in the leaflets that are shipped with the vaccine. But until two major medical groups made the same suggestion earlier this year, the practice did not become standard in this country.
Manufacturers revise the product leaflet periodically, with necessary approval by the Food and Drug Administration. Over the years, there have been disagreements about what the leaflets should say.
In June 1979, Wyeth Laboratories wanted to include warnings about crib death, based on reports from the CDC.
Wyeth wanted to say the vaccine should not be given when there are signs of fever, acute respiratory or other infection, failure to thrive, neurologic disorders or periodic breathing problems — including those associated with crib death.
“We deem it imperative that these changes be incorporated in our package circular as soon as possible,” wrote Dr. Alan Bernstein, Wyeth’s managing director.
Dr. Harry M. Meyer Jr., then director of FDA’s Bureau of Biologics, replied July 11, 1979. He agreed to insert the crib death information into the section on side effects and adverse reactions, but refused to include it in a section telling doctors when not to use the vaccine.
Meyer wrote, “There is no evidence that such a change would prevent crib death, yet it would certainly deprive many infants of protection against pertussis during the months when exposure to whooping cough is most likely to result in life-threatening or disabling disease.”
Four months earlier, the Bureau of Biologics had heard Dr. Daniel C. Shannon of Massachusetts General Hospital in Boston describe adverse reactions to DPT in 200 infants who already had a brush with crib death and were on breathing monitors.
Twenty percent of those infants had another near-death reaction within 24 hours of DPT shots.
“We do have this data,” Shannon said at the meeting. “It is all recorded
However, those details were not included, in two articles published in medical journals. Shannon explained that they were excluded because “I can’t say there definitely appears to be an association. I haven’t done the kind of study that needs to be done.”
Physicians in general turn to medical journals and other periodicals for up-to-date information. Pediatricians also rely on the American Academy of Pediatrics’ Red Book, as the Report of the Committee on Infectious Diseases has come to be known.
Brunell, the current Red Book chairman, said the list of reasons to defer DPT shots did not change from the 1977 edition until August 1984, when an interim statement suggested that physicians defer immunization of children who have had seizures. (The next regular edition is due in 1985.)
Dr. James Cherry, who was part of a UCLA pertussis research team in 1978-79, was on the Red Book committee from 1977-83. He was asked why physicians did not receive an update sooner.
“There was no reason …,” he said. “The 1984 update said it is wise to wait if there is a history of neurological problems in the family, but that is because doctors now are scared of being sued.”
Brunell was asked the reason for the delay. “We need more money,” he said. “We’re spending $45 million a year on AIDS and less than $1 million a year on DPT. We need 25 times that.”
Geraghty said: “The medical literature has failed to adequately reflect what’s happening. Doctors don’t report cases of adverse reactions because, first, they’re scared it’s going to wind up in a liability case and second, they do not make a connection at all.
“They are not suspicious because there have been no warnings in the medical literature.”
Dr. Kenneth Bart of the CDC said, “Physicians have an obligation to be informed about everything they do.”
He was asked about the two deaths that UCLA researchers reported to the FDA but left out of articles in medical journals.
“What’re they going to say to a physician that he’s going to use?” Bart asked. “That two deaths occurred? Well, what does that mean?”
Said Geraghty; “All I want is for them to tell my fellow doctors what they tell each other.”
[Vaccination] [Fresno Bee report]