Heart disease and passive smoking

1994. The estimate is far higher than those obtained in previous studies. One reason for the higher estimate, said the author of the study, is that instead of starting with relative risks derived from smaller cohort studies and then applying them to the whole US population, he started with the total known ischaemic heart disease deaths in the US and used the Drug Abuse Advisory Committee relative risk figures for passive smoking gives a substantial boost to FDA Commisand active smoking to parcel those deaths sioner David Kessler’s campaign to conout among active smokers, passive smokvince the US Congress that tobacco ers, and those whose deaths had nothing products should be regulated by the FDA. to do with tobacco. Such back calculation But "The panel’s working definition of revealed a higher ischaemic heart deathaddiction was so broad it rate among people who had never smoked everything from heroin to coffee", said than was assumed in previous studies, Tom Lauria of the Tobacco Institute, an Wells said. industry group. Smoking is merely habit, .: The same risk assessment approach was like coffee drinking, Lauria said. : employed in the 1992 US Environmental For a product to qualify for regulation Protection Agency report that concluded under the Food, Drug and Cosmetic Act, passive smoking causes 3000 lung cancer which delineates the FDA’s jurisdiction, deaths annually in the US. the product must affect the function and structure of the body, and it has to be the Michael McCarthy intention of the vendor of the product that it be used as a drug. The committee has 1 Judson Wells A. Passive smoking as a cause of heart disease. J Am Coll Cardiol 1994; 24: confirmed the first criterion, said 545-54 O’Hara, FDA spokesman. But the Ianguage of the Food, Drug and Cosmetic Act presents Kessler with a difficult problem. Because cigarettes are known to be . ’ Canadian interventions in unsafe, if he concludes that FDA regulabreast settlement tion of cigarettes is warranted, he has to ban them outright. Kessler knows that Arguing that Canadian women were such a ban would set off a political denied "fair treatment" in US courts in a firestorm and instantaneously create an US$4-1-billion private classproposed enormous black market, so he is trying to action settlement struck between implant force Congress to draw up special guiderecipients and American manufacturers of lines for tobacco regulation. Under one faulty breast implants, the government of scenario, such regulations would require Canada has asked a US court to increase tobacco companies to decrease gradually the amount of monies set aside for nonthe nicotine content of cigarettes over ten American breast implant recipients. The to fifteen years, until a person could Canadian government is intervening as a smoke 20 to 30 cigarettes a day without "friend of the court", to correct misapprebecoming addicted. In theory, such a prohensions about the Canadian health and gramme would slowly wean current smokjudicial systems, and about the number of ers from their alleged nicotine addiction Canadian recipients. and keep future generations of smokers Under the terms of a settlement from becoming addicted in the first place. reached last February, foreigners are entitled to only a 2-5% stake of the$2-7-bilMichael McCarthy lion disease compensation element of the settlement, not to a share of the separately established medical diagnostic/evaluation, explanation, rupture, and breast implant

: agency with a written plan forPDA on corrective action, including instructions to : sales force and a commitment to prevent addiction recurrence of such violations; and to preCigarettes and other tobacco products are pare a "Dear Healthcare Professional" letand nicotine is the substance in addictive all false ter which "explicitly corrects that causes the addiction, a tobacco andBor misleading promotional messages Food and Administration Drug expert : or other about Axid antisecretory prodlast week. The concluded finding by panel to the has submit letThe ucts". company

provide the

ter to

panel

FDA for

approval

before it

is

by

disseminated to health professionals direct mail and paid advertisements in at least 12 medical journals including Gas-

troenterology, and the American Journal of ; :: Gastroenterology. was to have sent its Lilly expected response to

the FDA this week.

:

Syed Rizwanuddin Ahmad

:

Felbamate and aplastic anaemia

Drug

Last week, the US Food and Administration strongly urged that the use of the antiepilepsy drug felbamate (Felbatol, Carter-Wallace) be suspended because of its association with aplastic anaemia. The drug was approved last year for the treatment of partial seizures that did or did not become generalised in adults, and for partial and generalised seizures associated with Lennox-Gastaut syndrome in children. The FDA is aware of 10 reports of aplastic anaemia (2 deaths) associated with felbamate exposure in about 100 000 patients since the drug was first marketed in September. The manufacturer has sent out 240 000 "Dear Doctor" letters recommending immediate withdrawal of patients from felbamate therapy "unless" such a move "is deemed to pose an even greater risk" to the patient. "We strongly recommend that patients consult their physician as soon as possible, but it is critical that do not discontinue the drug on their own due to the risk of seizures", said Dr David A Kessler, FDA Commissioner. : This has been the second major blow for the company recently. In June, CarterWallace signed an agreement with FDA to discontinue manufacture of its expectorant containing iodinated glycerol (Organidin) because of lack of evidence of

they

efficacy

and its

cigarette

encompassed

Jim

implant

Heart disease and

passive

smoking

carcinogenic potential in Exposure

to secona-nana smoKe in

tne

USA increases by 20-70% the coronary Schering-Plough, the licensee for sale death rate among people who have never outside North America, said it has issued smoked, says a report in Journal of the ; a similar warning for restricted use in American College of Cardiology.’ The report Argentina, Chile, Colombia, and estimates that 62 000 deaths attributed to Venezuela-the only countries where the ischaemic heart disease in 1985 were due to passive smoking and, after taking into drug is marketed. Felbamate has been recommended for approval by the European account such factors as the decline in the Union’s Committee for Proprietary Medinumber of smokers and an increase in cinal Products. smoke-free workplaces in the US, predicts that second-hand smoke will be responsSyed Rizwannudin Ahmad ,ible for 47 000 ischaemic heart deaths in

rats.

:

recipient compensation or to reserve funds, even though as many as 15% of the implants were given to Canadian women. Canada says the monies available for nonAmericans should correspond to the number of implants done abroad and is asking Sam Pointer, chief judge of the district court for the northern district of the state of Alabama, when he convenes an Aug 18 hearing to determine the settlement’s fairness, to increase substantially compensation for foreign breast implant

recipients. The proposed settlement contends that foreigners should be treated differently because they have "national health med-

465