E-drug: JAMA on DTC
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E-druggers:
This is an interesting piece on DTC in JAMA [copied under fair use].
A link to the full report mentioned is found at the bottom.
Happy new year!
Staffan Svensson, MD
Dept of Clinical Pharmacology
Sahlgrenska Univ Hospital, Gothenburg, Sweden
staffan.svensson@pharm.gu.se
[snip]
Misleading Advertisements
Brian Vastag
JAMA Tuesday, December 31, 2002.
http://jama.ama-assn.org/issues/v289n1/rfull/jch20003-1.html
Some pharmaceutical manufacturers repeatedly run misleading
advertisements that millions of consumers view or hear before the
Food and Drug Administration (FDA) can put a stop to them, according
to a report from the General Accounting Office (GAO), the
investigative arm of Congress. The violations include unsubstantiated
claims and failure to provide information about health risks.
The report, Prescription Drugs: FDA Oversight of Direct-to-Consumer
Advertising Has Limitations, comes amid a huge increase in
direct-to-consumer advertisements in recent years, which the GAO said
apparently contributes to an increase in prescription drug spending.
Prescription drug spending has increased an average of 18% per year
since 1997, when regulations for the advertisements were loosened.
Several studies have found that television advertising, in
particular, shapes patients' demand for brand-name drugs (Am J Health
Behav. 2002;26:68-75). The GAO report estimates that in 2000, about
8.5 million consumers received prescriptions after viewing
advertisements and asking their physician for a particular drug.
The GAO noted that sales of drugs advertised to consumers increased
faster than sales of drugs not advertised as heavily. For example, in
1999 and 2000, the number of prescriptions dispensed for the most
heavily advertised drugs rose 25%, but increased only 4% for drugs
that were not heavily advertised.
The FDA's effectiveness in reining in misleading advertisements has
been hampered by regulations handed down by the Bush administration
in January 2002, the GAO found. The rules significantly increased the
time between identification of misleading advertisements and
notification to drug makers. It now takes an average of 78 days for
the FDA to notify a drug maker of a violation.
In some cases, the FDA does not send a violation noticewhich
typically requires modification or cancellation of the offending
advertisementuntil after an advertising campaign has ended, according
to the report.
In response, the Department of Health and Human Services (DHHS),
which oversees the FDA, pledged to expedite the time spent reviewing
the violation notices, according to a letter sent to the GAO by DHHS
Inspector General Janet Rehnquist.
The full report can be found at http://www.gao.gov/new.items/d03177.pdf.
[end of snip]
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