Doctors, Drugs & Dollars

Some drugs, widely prescribed by reputable physicians, are worthless. Others have hidden dangers about which doctors are not told enough. Some are inadequately tested in animals before being marketed, so that human patients serve, in effect, as guinea pigs to find out whether they are safe or not. A drug may be so costly, especially if it is a patented, monopoly item, that a patient's drug bill for a single illness can run to thousands of dollars. Almost any drug costs far more if it is prescribed by trade name instead of the generic chemical name.

All these charges, with supporting evidence by eminent medical men, were in the records of the U.S. Senate's Antitrust and Monopoly Subcommittee last week when Chairman Estes Kefauver adjourned its hearings for a summer recess. They were just what the Senator wanted to back up his contention that the laws relating to safety, testing, efficacy, pricing and promotion of drugs are in need of a drastic overhaul.

Share the Patents? Testimony on the drug industry is aimed at building up support for Kefauver's drug-industry antitrust bill (S. 1552). As introduced last April in the Senate (and by New York Democrat Emanuel Celler in the House), the bill is a shotgun blast against everything that Kefauver dislikes in the pharmaceutical industry. It would require drug manufacturers to get licenses from the U.S. Food and Drug Administration and give FDA power to inspect and close their plants. It would prohibit marketing of new drugs until they have been proved effective and make FDA the judge of effectiveness (it is now empowered to pass only on their safety, purity and toxicity). Under the bill, FDA could deny a license for a new drug if it only duplicated the effects of an existing drug without improving on them. The Federal Trade Commission would regulate the promotion material that drug companies send to doctors. And the patent laws would be amended to force a company owning a drug patent to license its rivals, after three years, to make the same drug for a royalty of up to 8%.

"If the drug companies and the drug advertising agencies permit themselves to be outraged by these very modest proposals," says Kefauver blandly, "I submit that they have lost all touch with reality." The Administration is not backing the sweeping Kefauver-Celler bill, mainly because it cuts across the jurisdictional lines of too many Government departments. The bill will not be reported out this session. Likely to replace it is a bill now being drafted by FDA with the more modest objective of regulating the flow of new drugs, testing their efficacy before they get to market, and encouraging prescription by generic names. But with Kefauver regulating the spotlight, a good many unknown and disturbing facts about drugs and the industry have come tumbling out into the open.

Individual Efficacy. Not all the testimony went Kefauver's way. Among the few unfriendly witnesses that Kefauver called in his latest round of hearings was Dr. Hugh H. Hussey Jr., dean of Georgetown University's School of Medicine and chairman of the A.M.A.'s board of trustees. Said Dr. Hussey: "Efficacy" is beyond the FDA's power to judge because it is a misleading term. A drug that works for one patient may be useless for another with what appears to be the same illness, and only the individual physician treating the individual patient can determine efficacy in each case. Dr. Hussey argued further: "The marketing of a relatively useless drug is infinitely less serious than would be arbitrary exclusion from the market of a drug that might have been life-saving for many persons."

But Senator Kefauver was far from bereft of support. To the witness stand he marched a parade of eleven noted doctors, nearly all of whom said that they favored S. 1552 only because they despaired of persuading the pharmaceutical industry to police itself. Outstanding items from their testimony:

sbDr. Charles D. May (New York University; a member of the A.M.A.'s Council on Drugs): "Hectic promotion of unwarranted products subjects patients to illogical and excessive use of drugs. Individual doctors cannot evaluate each drug's usefulness. If they could, they would not have gone on prescribing leeches for so many years."

sbDr. Maxwell Finland (Harvard Medical School): "The argument that the practicing physician is the only one who can determine efficacy . . . is an invitation to all manufacturers to dump into the hands of busy practitioners any and all types of good and bad drugs and devices, and let them learn, at the expense and peril of their patients, whether they are any help. With over 200,000 physicians and their patients as potential prey, the result would be untold harm."

sbDr. Louis Lasagna (Johns Hopkins University) : "Investigators are sometimes offered drugs on which extensive safety tests have been run in animals, but sometimes--perhaps by the same manufacturers--we are offered drugs on which little animal work has been done. It is reprehensible for man to be the first experimental animal on which tests are run simply because bypassing the tests in animals saves time and money."

sbDr. Martin Cherkasky (Director of Montefiore Hospital in The Bronx): "The A.M.A. Journal of March 5, 1960 carried a scientific article by Dr. Lawson Wilkins documenting 36 cases in which girl babies were so masculinized that they would have been reared as boys because their mothers were treated early in pregnancy with a synthetic hormone to reduce the risk of spontaneous abortion.* Yet for months afterward, the Journal carried advertisements for this drug, marketed by Parke, Davis & Co. as Norlutin, which contained no word of warning as to the possible catastrophic effects.

"A diabetic patient with a blood infection was in Montefiore Hospital for 61 days this year, and his bill for drugs alone came to $3,127. Most of this was for a single drug, produced by only one manufacturer under a patent monopoly. Another patient with a heart-valve infection had a drug bill of $1,800.

"Brand names boost the prices of drugs, so wherever possible we do our buying by generic name. A steroid of the cortisone group that costs us $11.50 a hundred tablets is list-priced by brand name at $170; a sedative is $3.50 by generic name, $16.20 list-priced by brand name; a sulfa derivative is $7, as against a list price of $53.32 by brand name. If we could do all our buying by getting bids from manufacturers on a generic-name basis, we could save 40% of our $315,000 annual drug bill."

* An earlier warning was sounded by Dr. Wilkins in Pediatrics (TIME, Aug. 18, 1958).

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