E-drug: Lancet editorial on DTCA in Europe
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[Copied as fair use. KM]
http://www.thelancet.com/journal/vol359/iss9319/full/llan.359.9319.editorial
_and_review.21142.1
Lancet 2002; 359: 1709 (18 May)
Europe on the brink of direct-to-consumer drug advertising
Earlier in May, David Kessler, former commissioner of the US Food and Drug
Administration (FDA) made a surprising U-turn about direct-to-consumer
advertising (DTCA) of prescription-only drugs. According to the May 2 Boston
Globe, Kessler, now dean of Yale University School of Medicine, told a
drug-industry conference on DTCA that he had been wrong to oppose such
advertising. While head of the FDA from 1990 to 1997, Kessler had vigorously
opposed DTCA. Soon after he left, the FDA relaxed its rules on DTCA and the
floodgates opened, especially for DTCA on television in the USA. Spending on
DTCA by the pharmaceutical industry increases year on year in the USA, and
reached US$2�5 billion in 2000 compared with $860 million in 1997.
DTCA is only allowed in the USA and New Zealand, but last July the European
Commission proposed changes in EU law to allow DTCA for three disease
areas--AIDS/HIV, diabetes, and asthma--for a 5-year period followed by a
review. This suggested change in the law was driven by DG Enterprise, the
Commission's division with special responsibility for promoting business.
Although the proposal was said to have arisen as a result of demand from
patients' groups, the Commission remains unable to show what groups made the
demand, why these three disease areas were singled out, and what form the
review will take.
Is DTCA such a bad thing? Undoubtedly, everyone should have access to
information about disease and treatment. But experience to date in the USA
and New Zealand raises many concerns. Only new "blockbuster" drugs are
advertised and often in misleading ways. In 2000, according to Health Action
International (a network of consumer health groups), drug companies in the
USA spent over 95% of their DTCA budgets on 50 drugs, giving retail sales of
US$41�3 billion. DTCA is highly cost effective--for the drug industry. A
dollar spent on television adverts returns $1.69 in sales; a dollar on
magazine adverts returns $2.51. The 50 advertised drugs accounted for $9�94
billion (almost half) of the increase in prescription-drug spending in the
USA from 1999 to 2000. US television viewers are saturated by an average of
nine DTCA slots a day.
DTCA is also often inaccurate. The FDA regulates such advertising in the
USA. From 1997 to 2001, the FDA issued 94 notices of violations, mostly
because benefits of the drug were hyped up and risks minimised. New Zealand
uses self-regulation by the drug industry. Last year, five of six television
adverts that had been voluntarily submitted to the Ministry of Health for
scrutiny violated the regulations, as did 20% of printed advertisements.
Nobody knows whether there is any public-health benefit for DTCA, largely
because surveys of visits to a physician and what drugs are requested (and
why) and which ones are prescribed are only surrogates for therapeutic
benefit. Claims are made, mostly by the drug industry, that disease would be
otherwise untreated, but often doctors prescribe expensive new drugs instead
of cheaper generics. For instance, a diuretic is the first-line treatment
for uncomplicated hypertension, but such off-patent drugs are not advertised
to consumers. Instead, the public are exhorted to try calcium-channel
blockers and angiotensin-converting-enzyme inhibitors.
An unusual twist in the USA is the fightback by health-insurers against the
cost of expensive new drugs. General Motors spent $55 million last year on
prescription omeprazole for its employees, although the company found that
over 90% of those given omeprazole had not tried cheaper generics first.
Branded omeprazole is the second-most heavily advertised drug (by DTCA) in
the USA. Both GM and Ford, and a Michigan-based health-insurer, have started
generics-only incentives, and GM claims to have saved $36 million in this
way.
A full benefit-risk-cost analysis has not been done for DTCA, largely
because the task is difficult and will be expensive to do properly. DG
Enterprises' proposals for relaxation of DTCA regulations in Europe,
especially the called-for review, need clarification and open scrutiny.
Until then, the potential disadvantages from DTCA, as judged by experiences
in the USA and New Zealand, outweigh any claimed benefits.
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