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Privacy bill could compromise US youth health
POLICY
Privacy
AND
PE
OP LE bill could
compromise US youth health
the US House 1995 and for Senate consideration later this spring could inadvertently imperil continuation of the 20-year-old survey that tracks the use of
A measure passed by in scheduled
tobacco,
alcohol,
illicit drugs among teenagers in the USA. The bill, called the Family Privacy Protection Act, is aimed at ensuring that parents provide written consent before sovernmentfunded researchers may ask children about sensitive issues such as religious beliefs and sexual preferences. "By strengthening the rights of parents, minors and their families will be protected from having to answer embarrassing or offensive questions", said Representative William Clinger (Republican, Philadelphia), one of the measure’s sponsors. But Lloyd Johnston, programme director of the University of Michigan’s Survey Research Center, which conducts the substance abuse study for the National Institute of Drug Abuse, says that requiring prior written consent from parents would reduce the response rate and thus potentially compromise the survey’s results.
The parents who do not respond, Johnston said, are most likely to have children at high risk for the behaviours being tracked, so losing those children "would produce a very biased sample". The requirement
would also drive up
and
survey
costs,
he
said; it would also essentially eliminate the of ability researchers
to con-
surveys by telephone. As approved by a
duct
House committee in March, 1995, the measure had been revised to eliminate the requirement that consent had to be in written form. But on the House floor 2 weeks later, the requirement for written permission was reinserted. The Affairs Senate Governmental Committee approved the Housepassed version of the bill on April 18, 1996. An aide to Representative Steve Horn (Republican, California), the bill’s sponsor, said that while "there are many who believe [the wording] is not as grave a problem as Lloyd Johnston makes it out to be", he nevertheless expects attempts to amend the wording when the measure reaches the Senate floor. Julie Rovner
US court throws out largest-ever tobacco suit
A federal
court
Louisiana victory to the
in
delivered a major
embattled tobacco industry on May 23, rejecting what would have been the largest-ever class-action lawsuit on behalf of every American who claimed to have been addicted to nicotine since 1943. Although the suit may go forward with its original plaintiffs, a three-judge appeals panel said that allowing the suit to encompass all smokers nationwide would unfairly "commit the fate of an entire industry, or indeed, the fate of a class of millions, to a single
jury". The case, named after lead plaintiff Diane Castano, a woman whose husband died of lung cancer, accused the seven major US tobacco firms of concealing knowledge abut the addictive nature of nicotine and of manipulating nicotine levels in their products. The case was considered to be pivotal in
1546
the history of tobacco litigation, because by pooling the resources of literally dozens of lawyers and law firms, tobacco opponents hoped that the first time they could hope to match the collective financial clout of the tobacco industry. Tobacco stocks rose sharply on Wall Street after the court’s decision was announced. But while the tobacco industry has now dodged a potentially fatal bullet, it remains under significant legal fire. Eight states are suing tobacco companies in an effort to the of treating costs recoup tobacco-related illnesses through their Medicaid programmes for the poor. And the attorneys who were pursuing the Castano case have announced that they will instead file separate class-action cases in state courts of each of the 50 states. Julie Rovner
FDA warns Pfizer on failure to report drug
problems letter from the and Drug that it has warning adverse drug experireport
fizer has
received Food
US Administration failed
to
a
(ADEs) on eight drugs: Diabinese, Minipress XL, Feldene, Norvasc, Zoloft, Procardia XL, Diflucan, and Terramycin. By law, a drug maker must report ADEs quarterly to the FDA. A serious, unexpected event must be reported within 15 days. After an investigation, the ences
FDA determined that Pfizer reports were overdue by 70 to 500 days. One involved a patient who died while taking Feldene (piroxicam). It was not reported to FDA until 91 days after the report was due. The FDA uses ADE reports to track post-marketing incidents. If a product has a record of serious adverse events, FDA will suggest a labelling change, or, possibly, a recall. In reviewing Pfizer’s ADE reporting since 1983, the FDA found "that the same or similar problems continue to recur, even though you have made promises to correct them". Although the agency says the history is "a major concern", it has not moved to fine or prosecute Pfizer. Pfizer spokesman Brian McGlynn says that the firm is responding, but claims that the letter "doesn’t raise any new safety issues". The firm responded similarly in November, 1995, saying that the ADEs did not merit a labelling change or have any effect on the safe use of Pfizer drugs, according to the FDA letter. The agency says the firm’s delay keeps the FDA from detecting patterns that could indicate more serious problems. Zoloft (sertraline) seems especially troubled. A quarterly report on the drug’s ADEs due on March 30, 1994, was not submitted until Aug 26, 1994, and included 324 incidents. "The specific violations noted ... may be symptomatic of serious underlying problems", wrote the FDA, which said it may take further action against Pfizer. Despite the tough tone, activitist Sidney Wolfe of the Washington DCbased Health Research Group calls the letter a "slap on the wrist", noting that drugs like Feldene have a troubled history. A 1986 HRG petition to ban use of Feldene in people over age 60 was denied by the FDA. Alicia Ault Barnett
Privacy
AND
PE
OP LE bill could
compromise US youth health
the US House 1995 and for Senate consideration later this spring could inadvertently imperil continuation of the 20-year-old survey that tracks the use of
A measure passed by in scheduled
tobacco,
alcohol,
illicit drugs among teenagers in the USA. The bill, called the Family Privacy Protection Act, is aimed at ensuring that parents provide written consent before sovernmentfunded researchers may ask children about sensitive issues such as religious beliefs and sexual preferences. "By strengthening the rights of parents, minors and their families will be protected from having to answer embarrassing or offensive questions", said Representative William Clinger (Republican, Philadelphia), one of the measure’s sponsors. But Lloyd Johnston, programme director of the University of Michigan’s Survey Research Center, which conducts the substance abuse study for the National Institute of Drug Abuse, says that requiring prior written consent from parents would reduce the response rate and thus potentially compromise the survey’s results.
The parents who do not respond, Johnston said, are most likely to have children at high risk for the behaviours being tracked, so losing those children "would produce a very biased sample". The requirement
would also drive up
and
survey
costs,
he
said; it would also essentially eliminate the of ability researchers
to con-
surveys by telephone. As approved by a
duct
House committee in March, 1995, the measure had been revised to eliminate the requirement that consent had to be in written form. But on the House floor 2 weeks later, the requirement for written permission was reinserted. The Affairs Senate Governmental Committee approved the Housepassed version of the bill on April 18, 1996. An aide to Representative Steve Horn (Republican, California), the bill’s sponsor, said that while "there are many who believe [the wording] is not as grave a problem as Lloyd Johnston makes it out to be", he nevertheless expects attempts to amend the wording when the measure reaches the Senate floor. Julie Rovner
US court throws out largest-ever tobacco suit
A federal
court
Louisiana victory to the
in
delivered a major
embattled tobacco industry on May 23, rejecting what would have been the largest-ever class-action lawsuit on behalf of every American who claimed to have been addicted to nicotine since 1943. Although the suit may go forward with its original plaintiffs, a three-judge appeals panel said that allowing the suit to encompass all smokers nationwide would unfairly "commit the fate of an entire industry, or indeed, the fate of a class of millions, to a single
jury". The case, named after lead plaintiff Diane Castano, a woman whose husband died of lung cancer, accused the seven major US tobacco firms of concealing knowledge abut the addictive nature of nicotine and of manipulating nicotine levels in their products. The case was considered to be pivotal in
1546
the history of tobacco litigation, because by pooling the resources of literally dozens of lawyers and law firms, tobacco opponents hoped that the first time they could hope to match the collective financial clout of the tobacco industry. Tobacco stocks rose sharply on Wall Street after the court’s decision was announced. But while the tobacco industry has now dodged a potentially fatal bullet, it remains under significant legal fire. Eight states are suing tobacco companies in an effort to the of treating costs recoup tobacco-related illnesses through their Medicaid programmes for the poor. And the attorneys who were pursuing the Castano case have announced that they will instead file separate class-action cases in state courts of each of the 50 states. Julie Rovner
FDA warns Pfizer on failure to report drug
problems letter from the and Drug that it has warning adverse drug experireport
fizer has
received Food
US Administration failed
to
a
(ADEs) on eight drugs: Diabinese, Minipress XL, Feldene, Norvasc, Zoloft, Procardia XL, Diflucan, and Terramycin. By law, a drug maker must report ADEs quarterly to the FDA. A serious, unexpected event must be reported within 15 days. After an investigation, the ences
FDA determined that Pfizer reports were overdue by 70 to 500 days. One involved a patient who died while taking Feldene (piroxicam). It was not reported to FDA until 91 days after the report was due. The FDA uses ADE reports to track post-marketing incidents. If a product has a record of serious adverse events, FDA will suggest a labelling change, or, possibly, a recall. In reviewing Pfizer’s ADE reporting since 1983, the FDA found "that the same or similar problems continue to recur, even though you have made promises to correct them". Although the agency says the history is "a major concern", it has not moved to fine or prosecute Pfizer. Pfizer spokesman Brian McGlynn says that the firm is responding, but claims that the letter "doesn’t raise any new safety issues". The firm responded similarly in November, 1995, saying that the ADEs did not merit a labelling change or have any effect on the safe use of Pfizer drugs, according to the FDA letter. The agency says the firm’s delay keeps the FDA from detecting patterns that could indicate more serious problems. Zoloft (sertraline) seems especially troubled. A quarterly report on the drug’s ADEs due on March 30, 1994, was not submitted until Aug 26, 1994, and included 324 incidents. "The specific violations noted ... may be symptomatic of serious underlying problems", wrote the FDA, which said it may take further action against Pfizer. Despite the tough tone, activitist Sidney Wolfe of the Washington DCbased Health Research Group calls the letter a "slap on the wrist", noting that drugs like Feldene have a troubled history. A 1986 HRG petition to ban use of Feldene in people over age 60 was denied by the FDA. Alicia Ault Barnett