In the 1970s Wyeth Pharmaceuticals had sent an entire lot of DTP vaccines to be administered to newborns in middle Tennessee. This caused many, many cases of SIDS all in a close proximity and it was impossible to deny the vaccines were at fault. Because of this, Wyeth changed their policy on how vaccine lots are distributed. Instead of just shipping off each lot manufactured together, they began breaking up the lots and sending them all over the country so the cause of the SIDS cases wouldn't be so obvious... a practice still used by all pharmaceutical companies today. Here is the internal memo discussing this decision.
In 1978-79, eleven babies were found to have died within eight days of a DPT vaccination. Nine of the eleven had been vaccinated with the same lot of pertussis vaccine, Wyeth #64201 and five (four from the same lot) had died within twenty-four hours of vaccination.
"A statistical analysis of the clustering of deaths revealed that the likelihood of observing four or more deaths occurring randomly on any of the first eight days after the use of lot #64201 was 3 in 100. ... E.B. Mortimer later reported that the probability of this being a chance association was even lower -- between 2 and 5 in 1,000.
"The statistical evidence in favor of a connection between the deaths and the DPT shot was strong. Would the medical authorities bite the bullet and admit the vaccine was related to the deaths? Absolutely not."
In the 1970s Wyeth Pharmaceuticals had sent an entire lot of DTP vaccines to be administered to newborns in middle Tennessee. This caused many, many cases of SIDS all in a close proximity and it was impossible to deny the vaccines were at fault. Because of this, Wyeth changed their policy on how vaccine lots are distributed. Instead of just shipping off each lot manufactured together, they began breaking up the lots and sending them all over the country so the cause of the SIDS cases wouldn't be so obvious... a practice still used by all pharmaceutical companies today. Here is the internal memo discussing this decision.
In 1978-79, eleven babies were found to have died within eight days of a DPT vaccination. Nine of the eleven had been vaccinated with the same lot of pertussis vaccine, Wyeth #64201 and five (four from the same lot) had died within twenty-four hours of vaccination.
"A statistical analysis of the clustering of deaths revealed that the likelihood of observing four or more deaths occurring randomly on any of the first eight days after the use of lot #64201 was 3 in 100. ... E.B. Mortimer later reported that the probability of this being a chance association was even lower -- between 2 and 5 in 1,000.
"The statistical evidence in favor of a connection between the deaths and the DPT shot was strong. Would the medical authorities bite the bullet and admit the vaccine was related to the deaths? Absolutely not."
In the 1970s Wyeth Pharmaceuticals had sent an entire lot of DTP vaccines to be administered to newborns in middle Tennessee. This caused many, many cases of SIDS all in a close proximity and it was impossible to deny the vaccines were at fault. Because of this, Wyeth changed their policy on how vaccine lots are distributed. Instead of just shipping off each lot manufactured together, they began breaking up the lots and sending them all over the country so the cause of the SIDS cases wouldn't be so obvious... a practice still used by all pharmaceutical companies today. Here is the internal memo discussing this decision.
In 1978-79, eleven babies were found to have died within eight days of a DPT vaccination. Nine of the eleven had been vaccinated with the same lot of pertussis vaccine, Wyeth #64201 and five (four from the same lot) had died within twenty-four hours of vaccination.
"A statistical analysis of the clustering of deaths revealed that the likelihood of observing four or more deaths occurring randomly on any of the first eight days after the use of lot #64201 was 3 in 100. ... E.B. Mortimer later reported that the probability of this being a chance association was even lower -- between 2 and 5 in 1,000.
"The statistical evidence in favor of a connection between the deaths and the DPT shot was strong. Would the medical authorities bite the bullet and admit the vaccine was related to the deaths? Absolutely not."
INTERNAL Conresvonnrmn
Larry Hewlett from Alan Bernstein
focated Radnor, company WET. tocates
Marietta
DIP Vaccine date August 27, 1979
After the reporting df the SID cases in Tennessee, we discussed the
merits of limiting distribution-of a large number of vials from a single
lot to a single state, county or city health department and obtained
agreement from the senior management staff to proceed with such a plan.
This subject has been discussed with Chariie Young and the following
guidelines were developed by FSRD. I would appreciate your comments
concerning this procedure and the advisability of formalizing these
guidelines.
Interim Measures in Affect
1. Allocation of stock to Distribution Centers is designated by lot
number in a manner designed to leave the maximum variety of lot
numbers in Great Valley and Marietta to service substantial orders.
2. Managers in D.C.'s carrying average inventories of over 3000 packages
(approximate) have been requested to advise FSRD of any orders
exceeding 2000 vials. FSRD will then designate shipment by lot
number, furnishing additional stock as needed.
Permanent Policy Proposal ;
Beeeiepic, wilt not £111 any order with stock exceeding 2000 packages oF
one lot number before clearing with FSRD.
2. When additional stock is needed for compliance, FSRD will make
necessary arrangements.
In the event that the national inventory do,
FSRD will clear exception with Marietta management, oF
‘ments for split delivery.
es not permit compliances