S. Delerme
2005-04-15 08:56:54 UTC
Je suis tombé sur un article du new england journal of medicine
relativement inquiétant : Volume 352:1411-1412 April 7, 2005 Number
14 "The Cutter Incident, 50 Years Later". Il rappelle, dans les années
50, un scandale lié à un laboratoire qui (au début de la vaccination
contre la polio) avait injecté le virus de la polio au lieu d'une
forme atténuée à des centaines de milliers d'enfants, avec quelques
dizaines de paralysés et morts. C"était dù à un problème de
fabrication, et le laboratoire avait été condamné, non parce qu'il
avait été négligent, mais parce que son produit avait causé des
dommages, même si ça n'était pas directement de sa faute.
Depuis les années 80, il semble que des avocats poussent des gens à
porter plainte pour des effets indésirables de vaccins, même si les
études réfutent la relation cause-effet des pathologies (un vaccin
contre la maladie de lyme accusé de causer des arthites sans preuve
scientifique, par exemple). Et c'est aussi vrai pour de nombreux
autres produits (les implants en silicone qui causeraient des
connectivites, un agent "préservatif" qui causerait l'autisme...).
Même quand ils ont raison, les labos dépensent d'énormes sommes en
frais de justice et accords avec les plaignants.
Moralité : ils risquent de se retirer des marchés peu lucratifs comme
les vaccins (les marchés lucratifs étant ceux où le patient doit
prendre à vie une pilule, comme l'HTA, l'hypercholestérolémie,
l'épilepsie...)
Je vous copie-colle l'article car le NEJM n'est pas en accès libre.
J'espère que personne ne m'en voudra de faire le piratin en herbe.
(l'auteur de l'article, c'est Paul A. Offit, M.D)
-----------------------------------------------------------------------------------
On April 12, 1955, Jonas Salk's polio vaccine made by inactivating
poliovirus with formaldehyde was declared to be safe and effective.
The trial of Salk's vaccine had included 1.8 million children who were
inoculated with either vaccine (made by either Eli Lilly or
Parke-Davis) or placebo or were not inoculated but only observed. That
afternoon, an advisory committee to the Laboratory of Biologics
Control (the federal agency that was responsible for licensing
biologic products in the United States) recommended that licenses to
produce the vaccine be granted to five pharmaceutical companies: Eli
Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter. The licensing
process took only two and a half hours.
Two weeks after the release of the vaccine, on April 26, the director
of the Laboratory of Biologics Control, William Workman, received a
series of telephone calls about five children in California who had
become paralyzed after receiving polio vaccine. In each case,
paralysis occurred in the arm that was inoculated, and in each case,
the vaccine had been made by Cutter Laboratories. Cutter's vaccine was
immediately recalled, but 380,000 doses had already been administered
mostly to healthy first- and second-graders.
The Epidemic Intelligence Service of the Communicable Diseases Center
(a precursor of the Centers for Disease Control and Prevention) was
asked to determine whether polio vaccine was causing the paralysis.
The agency's scientists found that two production pools made by Cutter
Laboratories (accounting for 120,000 doses) contained live poliovirus.
Among the children who had received vaccine from these pools, abortive
polio (characterized by headache, stiff neck, fever, and muscle
weakness) developed in 40,000; 51 were permanently paralyzed; and 5
died.1 Cutter's vaccine also started a polio epidemic: 113 people in
the children's families or communities were paralyzed, and 5 died.1 It
was one of the worst pharmaceutical disasters in U.S. history.
Subsequent studies found that cell debris contained in Cutter's
vaccine had prevented adequate exposure of virus particles to
formaldehyde. The federal requirements for vaccine manufacture were
revised, and between 1955 and 1962, a total of 400 million doses of
safe, inactivated polio vaccine were distributed in the United States;
the incidence of polio decreased dramatically.
Two years after the tragedy, the first lawsuit was filed on behalf of
Anne Gottsdanker, a five-year-old girl whose right leg was paralyzed
as a result of Cutter's vaccine. Cutter was sued on two counts:
negligence (that the company failed to exercise ordinary care in the
production of its vaccine) and breach of implied warranty (that it was
implied that a vaccine labeled "inactivated" polio vaccine did not
contain live poliovirus).2
The jury was shown two pieces of evidence that determined the verdict:
all five companies had difficulties in completely inactivating
poliovirus, and Wyeth Laboratories also produced one lot of vaccine
that paralyzed and killed several children in the Northeast.3 The jury
found that Cutter Laboratories was not negligent but was guilty of
breaching an implied warranty.
The ruling in Gottsdanker v. Cutter Laboratories meant that juries
could find companies financially responsible (liable) for their
products without finding them negligent in the production or design of
those products (i.e., liability without fault). In reference to the
Cutter tragedy, an article in the Yale Law Journal stated that
"manufacturers of products for human consumption are liable for
personal injuries caused by their products, not because they are at
`fault' for the injuries, nor because they would have prevented them,
but because they can best distribute this unavoidable cost to all
persons who benefit from the enterprise."4
Since proof of negligence was no longer required, it was easier for
juries to find pharmaceutical companies liable. Decisions could now be
made solely on the basis of the harmfulness of the product and
therefore relied on the jury's capacity to understand the science of
cause and effect. Unfortunately, jurors have been imperfect arbiters
of scientific truth, as they have shown, for example, in deciding that
silicone-filled breast implants caused connective-tissue diseases and
that Bendectin (a combination of vitamin B6 and doxylamine) and
spermicidal jellies caused birth defects.
Initially, vaccines were unaffected by the Gottsdanker verdict. But in
the early 1980s, lawyers in the United States successfully sued
vaccine makers, claiming that the pertussis vaccine caused permanent
harm, despite a series of studies whose results were at variance with
such claims. To raise enough money to pay for increased liability
insurance, the companies hiked the cost of the
diphtheriatetanuspertussis vaccine from $0.17 per dose to $11 per
dose, and the number of companies that made the vaccine dropped from
eight to one.
In 1986, to ensure the continued participation of pharmaceutical
companies in the manufacture of vaccines, the National Vaccine Injury
Compensation Program (VICP) was born. Funded by a federal excise tax
on each dose of vaccine, the VICP remains a model method for ensuring
that all persons harmed by vaccines are compensated quickly and
generously, while also protecting companies that make lifesaving
products from abuses of the tort system.
Unfortunately, as plaintiff lawyers begin to find weaknesses in the
VICP, the viability of vaccines is again threatened. For example, when
the program rejects claims that are not supported by medical or
scientific studies, lawyers can easily opt out of the program.
Hundreds of lawsuits have been filed claiming that the preservative
thimerosal, which was added to many vaccines before 2001, caused
autism. Although this contention is not supported by a recent study by
the Institute of Medicine,5 vaccine makers have spent tens of millions
of dollars defending against these lawsuits and are bracing for
settlements or awards that could threaten their desire to remain in
the vaccine business.
What's more, the VICP does not cover some vaccines. Plaintiffs have
sued makers of the vaccine against Lyme disease on the grounds that
the vaccine caused chronic arthritis, even though these claims were
unsupported by large prelicensure studies. In part because of media
attention to these lawsuits and resultant fears that the vaccine was
unsafe the manufacturer stopped making Lyme vaccine. In addition,
because coverage by the VICP does not extend to the fetus, vaccine
makers have been hesitant to pursue strategies that include immunizing
pregnant women to prevent diseases such as those caused by respiratory
syncytial virus or group B streptococcus.
The Cutter incident resulted in the first coordinated national
response to a medical emergency and in the creation of a better system
of regulating vaccines. But the incident's final ironic legacy may lie
in a court ruling that, although designed to protect children from
harm, has greatly reduced the willingness of pharmaceutical companies
to make lifesaving vaccines.
Source Information
Dr. Offit is chief of the Division of Infectious Diseases, Children's
Hospital of Philadelphia, and a professor of pediatrics at the
University of Pennsylvania School of Medicine, Philadelphia.
relativement inquiétant : Volume 352:1411-1412 April 7, 2005 Number
14 "The Cutter Incident, 50 Years Later". Il rappelle, dans les années
50, un scandale lié à un laboratoire qui (au début de la vaccination
contre la polio) avait injecté le virus de la polio au lieu d'une
forme atténuée à des centaines de milliers d'enfants, avec quelques
dizaines de paralysés et morts. C"était dù à un problème de
fabrication, et le laboratoire avait été condamné, non parce qu'il
avait été négligent, mais parce que son produit avait causé des
dommages, même si ça n'était pas directement de sa faute.
Depuis les années 80, il semble que des avocats poussent des gens à
porter plainte pour des effets indésirables de vaccins, même si les
études réfutent la relation cause-effet des pathologies (un vaccin
contre la maladie de lyme accusé de causer des arthites sans preuve
scientifique, par exemple). Et c'est aussi vrai pour de nombreux
autres produits (les implants en silicone qui causeraient des
connectivites, un agent "préservatif" qui causerait l'autisme...).
Même quand ils ont raison, les labos dépensent d'énormes sommes en
frais de justice et accords avec les plaignants.
Moralité : ils risquent de se retirer des marchés peu lucratifs comme
les vaccins (les marchés lucratifs étant ceux où le patient doit
prendre à vie une pilule, comme l'HTA, l'hypercholestérolémie,
l'épilepsie...)
Je vous copie-colle l'article car le NEJM n'est pas en accès libre.
J'espère que personne ne m'en voudra de faire le piratin en herbe.
(l'auteur de l'article, c'est Paul A. Offit, M.D)
-----------------------------------------------------------------------------------
On April 12, 1955, Jonas Salk's polio vaccine made by inactivating
poliovirus with formaldehyde was declared to be safe and effective.
The trial of Salk's vaccine had included 1.8 million children who were
inoculated with either vaccine (made by either Eli Lilly or
Parke-Davis) or placebo or were not inoculated but only observed. That
afternoon, an advisory committee to the Laboratory of Biologics
Control (the federal agency that was responsible for licensing
biologic products in the United States) recommended that licenses to
produce the vaccine be granted to five pharmaceutical companies: Eli
Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter. The licensing
process took only two and a half hours.
Two weeks after the release of the vaccine, on April 26, the director
of the Laboratory of Biologics Control, William Workman, received a
series of telephone calls about five children in California who had
become paralyzed after receiving polio vaccine. In each case,
paralysis occurred in the arm that was inoculated, and in each case,
the vaccine had been made by Cutter Laboratories. Cutter's vaccine was
immediately recalled, but 380,000 doses had already been administered
mostly to healthy first- and second-graders.
The Epidemic Intelligence Service of the Communicable Diseases Center
(a precursor of the Centers for Disease Control and Prevention) was
asked to determine whether polio vaccine was causing the paralysis.
The agency's scientists found that two production pools made by Cutter
Laboratories (accounting for 120,000 doses) contained live poliovirus.
Among the children who had received vaccine from these pools, abortive
polio (characterized by headache, stiff neck, fever, and muscle
weakness) developed in 40,000; 51 were permanently paralyzed; and 5
died.1 Cutter's vaccine also started a polio epidemic: 113 people in
the children's families or communities were paralyzed, and 5 died.1 It
was one of the worst pharmaceutical disasters in U.S. history.
Subsequent studies found that cell debris contained in Cutter's
vaccine had prevented adequate exposure of virus particles to
formaldehyde. The federal requirements for vaccine manufacture were
revised, and between 1955 and 1962, a total of 400 million doses of
safe, inactivated polio vaccine were distributed in the United States;
the incidence of polio decreased dramatically.
Two years after the tragedy, the first lawsuit was filed on behalf of
Anne Gottsdanker, a five-year-old girl whose right leg was paralyzed
as a result of Cutter's vaccine. Cutter was sued on two counts:
negligence (that the company failed to exercise ordinary care in the
production of its vaccine) and breach of implied warranty (that it was
implied that a vaccine labeled "inactivated" polio vaccine did not
contain live poliovirus).2
The jury was shown two pieces of evidence that determined the verdict:
all five companies had difficulties in completely inactivating
poliovirus, and Wyeth Laboratories also produced one lot of vaccine
that paralyzed and killed several children in the Northeast.3 The jury
found that Cutter Laboratories was not negligent but was guilty of
breaching an implied warranty.
The ruling in Gottsdanker v. Cutter Laboratories meant that juries
could find companies financially responsible (liable) for their
products without finding them negligent in the production or design of
those products (i.e., liability without fault). In reference to the
Cutter tragedy, an article in the Yale Law Journal stated that
"manufacturers of products for human consumption are liable for
personal injuries caused by their products, not because they are at
`fault' for the injuries, nor because they would have prevented them,
but because they can best distribute this unavoidable cost to all
persons who benefit from the enterprise."4
Since proof of negligence was no longer required, it was easier for
juries to find pharmaceutical companies liable. Decisions could now be
made solely on the basis of the harmfulness of the product and
therefore relied on the jury's capacity to understand the science of
cause and effect. Unfortunately, jurors have been imperfect arbiters
of scientific truth, as they have shown, for example, in deciding that
silicone-filled breast implants caused connective-tissue diseases and
that Bendectin (a combination of vitamin B6 and doxylamine) and
spermicidal jellies caused birth defects.
Initially, vaccines were unaffected by the Gottsdanker verdict. But in
the early 1980s, lawyers in the United States successfully sued
vaccine makers, claiming that the pertussis vaccine caused permanent
harm, despite a series of studies whose results were at variance with
such claims. To raise enough money to pay for increased liability
insurance, the companies hiked the cost of the
diphtheriatetanuspertussis vaccine from $0.17 per dose to $11 per
dose, and the number of companies that made the vaccine dropped from
eight to one.
In 1986, to ensure the continued participation of pharmaceutical
companies in the manufacture of vaccines, the National Vaccine Injury
Compensation Program (VICP) was born. Funded by a federal excise tax
on each dose of vaccine, the VICP remains a model method for ensuring
that all persons harmed by vaccines are compensated quickly and
generously, while also protecting companies that make lifesaving
products from abuses of the tort system.
Unfortunately, as plaintiff lawyers begin to find weaknesses in the
VICP, the viability of vaccines is again threatened. For example, when
the program rejects claims that are not supported by medical or
scientific studies, lawyers can easily opt out of the program.
Hundreds of lawsuits have been filed claiming that the preservative
thimerosal, which was added to many vaccines before 2001, caused
autism. Although this contention is not supported by a recent study by
the Institute of Medicine,5 vaccine makers have spent tens of millions
of dollars defending against these lawsuits and are bracing for
settlements or awards that could threaten their desire to remain in
the vaccine business.
What's more, the VICP does not cover some vaccines. Plaintiffs have
sued makers of the vaccine against Lyme disease on the grounds that
the vaccine caused chronic arthritis, even though these claims were
unsupported by large prelicensure studies. In part because of media
attention to these lawsuits and resultant fears that the vaccine was
unsafe the manufacturer stopped making Lyme vaccine. In addition,
because coverage by the VICP does not extend to the fetus, vaccine
makers have been hesitant to pursue strategies that include immunizing
pregnant women to prevent diseases such as those caused by respiratory
syncytial virus or group B streptococcus.
The Cutter incident resulted in the first coordinated national
response to a medical emergency and in the creation of a better system
of regulating vaccines. But the incident's final ironic legacy may lie
in a court ruling that, although designed to protect children from
harm, has greatly reduced the willingness of pharmaceutical companies
to make lifesaving vaccines.
Source Information
Dr. Offit is chief of the Division of Infectious Diseases, Children's
Hospital of Philadelphia, and a professor of pediatrics at the
University of Pennsylvania School of Medicine, Philadelphia.