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the USA. Death rates from heart attacks and stroke have declinedspectacularly since 1972, by 42% and 54%. Officials at the NationalHeart, Lung and Blood Institute cannot fully explain this

phenomenon. Asked at a hearing whether changed life stylescontributed to the declines, the Institute’s head, Claude L’Enfant,said he had no "hard data" to support that view.Here again, as in the case of cancer, Congress is impressed with

treatment techniques developed through research. Thrombolytictherapy to dissolve clots in the early hours after myocardialinfarction ranks as a major accomplishment. High priority is nowbeing given to research on the relative merits of bypass surgery andangioplasty.

In view of Washington’s announced determination to reducespending, the appropriations for cancer, heart disease, and otherdisorders seem generous. However, overall expenditures on theAIDS epidemic are already overtaking these sums. RepresentativeWilliam Natcher of Kentucky, chairman of the House healthappropriations subcommittee, reckons that AIDS research,treatment, and care will cost around$3 billion in 1990. That maywell turn out to be a conservative estimate.

115 Blue Hills Road,Amherst, Massachusetts 01002, USA J. B. SIBBISON

CORRUPTION AT THE FDA

A SCANDAL is unfolding at the Food and Drug Administration.Executives of generic drug companies have been caught paying offthree FDA officials to obtain preferential treatment over

competitors on new drug applications. Some generic manufacturersused false test data to win approval. There have been guilty pleas.Prison terms for some of the principals may be in the offing.The investigators in these proceedings are chiefly a House of

Representatives Oversight Subcommittee headed by John Dingellof Michigan, Breckinridge Willcox, the US Attorney in Baltimore,and a grand jury there. As investigators explain it, the stakes arelarge. Generally the first company to get a new generic drug onpharmacists’ shelves is assured of 20% of a multimillion dollarmarket.How a company seeks to influence FDA decision-making can be

illustrated in the case of Charles Y. Chang. Chang was a chemist andsupervisor in FDA’s generic drug division, a key man in thereviewing process. According to what the prosecutors told the WallStreet Journal, a small company named American Therapeutics inBohemia, New York, delivered$10 000 worth of furniture toChang’s home in Potomac, Maryland, an upper-income suburb ofWashington. Chang also enjoyed a trip to Hong Kong at thecompany’s expense. In return, he quietly represented the

company’s interests inside the FDA, expediting its drugapplications and dealing with other company matters within hispurview.Chang has pleaded guilty to accepting travel in aid of

racketeering. Along with two FDA colleagues, David Brancato andWalter Kletch, he has also pleaded guilty to accepting illegalgratuities. Company officials involved in the payoffs have beencharged, have pleaded guilty, or are still under investigation inBaltimore.

Another approach to hurrying a new drug approval along is adeceptive application. The Dingell subcommittee says VitarinePharmaceuticals of Springfield Gardens, New York, did that inobtaining the right to sell the generic equivalent of ’Dyazide’, ananti-hypertensive agent produced by the SmithKline BeckmanCorporation. According to FDC Reports, a newsletter for the drugindustry, Vitarine submitted dyazide in Vitarine capsules to FDA asits test product. Dingell says that the result was that Vitarine’sproduct was sold for more than a year without full safety tests. Thecompany has recalled the product. Investigators say ParPharmaceuticals of Spring Valley, New York, has been involved inboth payoffs and submission of "untrue statements" in new drugapplications.

All this has left FDA Commissioner Frank E. Young, as heexpressed it, "deeply dismayed and outraged". There has been a

personnel shakeup in the generic products reviewing office, and ananalysis of the thirty most prescribed generic drugs and theirbrandnamed counterparts has begun. Although FDA declined toname the company, the Wall Streetloumal says that the agency haswidened its own investigation to include, for the first time, a firmmanufacturing brand-named products, Eli Lilly & Co,Indianapolis.FDA’s performance, however, does not impress Dingell, who

says that two of the companies in this scandal, Par and AmericanTherapeutics, obtained FDA permission to sell new drugs afterbeing cited by the US Attorney’s office regarding bribes to FDApersonnel. "Frivolity", says Dingell, "prevails at FDA."

115 Blue Hills Road,Amherst, Massachusetts 01002, USA J. B. SIBBISON

In England Now

HAVE you noticed the current craze for telephones that playsynthesised "music" when you are left holding on? Music is, Ibelieve, supposed to have charms to soothe a savage breast, softenrooks, and even bend knotted oaks, but I fear it does little to quellmy annoyance as I wait to be connected to the person to whom Idesired to speak-though I must confess it is, perhaps, justpreferable to dead silence and a nagging suspicion you have been cutoff.The range of tunes is limited, so there is no chance of choosing

appropriate music for various professions; I have heard, however, ofa travel agency that regales its customers with There’s No Place LikeHome. Our senior surgeon, at his rooms, serenades callers with thechorus of praise from Judas Maccabeus, best known as the hymnThine be the Glory. Someone (but not me) should tell the seniorsurgeon that the piece was originally written in honour of the Dukeof Cumberland, known by his contemporaries as "ButcherCumberland".

I would think the next step would be synthesised speech.Everything seems to talk these days; in my youth, if a housewife wasfound having a conversation with a washing machine or a vacuumcleaner, you reached for the Section papers and ordered an

ambulance, but not now. Mind, the conversational repertoire islimited (eg, "My hose is blocked", repeated in a monotone with astrong transatlantic accent), but give them time. Even in the presentstate of the art, hospitals could make use of such a system. Thus,while waiting for the geriatrics houseman, one could be given a voicerepeating, "There are no geriatric beds; please replace the receiver",or, if asking for an outpatient appointment, have a voice saying,"The waiting list for new appointments is 3 years and 2 months".Indeed, I wonder if something like this has not been in use for sometime--certainly it would explain the disembodied voice which tells arelative, ringing to inquire about a loved one, freshly subjected tosome heroically major piece of iatrogenic trauma, that the patient is"comfortable".

If cleaners and washing machines can talk, then why not medicalequipment? Take anaesthetic machines; could not a CO2 monitorcause a booming voice to declaim, "The patient is blue at my end,what is he like at yours?", while a device sensitive to muscularmovement could trigger, "Mr Anaesthetist, if the patient has to stayawake, surely you could too". Think, too, how useful it would be if asigmoidoscope could, when necessary, murmur apologetically, "Isay, I think that’s the appendix I’m looking at". Perhaps somethingsimilar could be done with patient monitoring systems-forexample, a voice at the nurse station repeating, "Mr X needs abottle", to be followed, in due course, by, "Too late; Mr X needs asheet change".

But, reverting to telephones, I am waiting for the first model forgeneral practitioners that will, when rung in the hours of darkness,synthetically advise the patient to take two aspirins and call again inthe morning.