This Date in UCSF History: PR and the Pill

Originally published in Synapse the UCSF student newspaper on March 10, 1981. “Ten Year Study Reassesses Risks of Oral Contraceptive Use” read a banner headline on a public relations news release that went out to the print and electronic media in the United States and Canada last October.

The release proclaimed the results of the Walnut Creek Contraceptive Study, an in depth research effort carried out at the Kaiser-Permanente Medical Center and funded by the National Institutes of Health (NIH).

According to this press release, “Certain health risks which have been linked to use of birth control pills may be exaggerated.”

The release went on to report that “the main conclusion from the study is that in a U.S. population of young, adult, white, middle-class women, the risks of OC (oral contraceptive) use are “negligible.”

Predictably, the media focused on the “negligible,” and omitted the disclaimers. The headline over a United Press International story was typical: “Birth Control Pills Are Called Safe.”

Where did that original press release come from? Not, as one might expect, from the Walnut Creek study or its research director, Dr. Savitri Ramcharan.

Instead, the release was put out by the public relations firm Hill & Knowlton for G. D. Searle and Company, the developers of Envoid, the first commercial Pill.

The release was apparently a capsulized version of a summary report presented at the First Annual John Rock Commemorative Symposium by Drs. Ramcharan and Frederick Pellegrin, Walnut Creek’s principal investigators.

The symposium, which brought together an assortment of past and present oral contraceptive researchers, was funded by none other than G. D. Searle.

Its tone was typified by one doctor’s encomium on the joys of working “in the industrial complex” at G. D. Searle in the first halcyon days of developing a “marketable product.” Ever since that “marketable product” was produced for mass consumption, there has been controversy over its safety.

Dr. Ramcharan, when asked to comment on the Searle release, said, “No easy answers. That’s what I’d like the headlines to say.”

Other health experts echoed her caution or elaborated on it.

Dr. Philip Corfman, director of the Center for Population Research of the National Institute of Child Health and Human Development, described the Searle/Hill & Knowlton press campaign as “smelly.”

“It’s free enterprise in action,” he said. “I don’t think anyone’s doing anything illegal, but there’s sure a lot that’s been unethical.”

Sentence

Corfman also objected to the key sentence in the release calling the risks of Pill use “negligible.”

“It’s full of so many qualifications, that sentence, that it’s essentially useless,” he said.

“I think that kind of conclusion is foolish and dangerous. There is nothing in the Walnut Creek study that makes us feel better about the Pill.”

Barbara Seaman, author of The Doctors’ Case Against the Pill (Dolphon, 1969), the first American expose of the hazards of birth-control pills, was extremely concerned about the implications of the pharmaceutical industry’s new pro Pill press campaign.

With the help of the National Woman’s Health Network, of which she is a co-founder, she prepared and circulated and adversarial press packet, along with a statement charging Searle/Hill & Knowlton with “a carefully orchestrated Machiavellian campaign” to resell the Pill to American women.

(After Seaman’s book was published and the Federal Drug Administration put warnings on Pill packaging, usage dropped from a peak of 14 million women to a low of 4 million.) Along with other specialists and doctors, Seaman also characterized the Walnut Creek study itself as a “grotesquely flawed and incompetent piece of work.”

“The records and the interviews were amazingly shoddy. Almost 4 percent of the women were of ‘unknown status’ when they entered the study. Translated, this means that despite the $4.34 million spent, the researchers didn’t even know whether 4 percent of the subjects had ever taken the Pill.”

Critique Although the third and final volume of the study is still being printed by the NIH, Seaman agreed with Dr. Martin Vesey of Oxford University, the principal investigator in the British study which originally discovered the hazards of the Pill.

Vesey has written a critique in which he differs with many of the conclusions the Walnut Creek authors draw from their data.

He points out that the study provides very little information on women during their years on the Pill.

Of the 107,000 woman/years the study covers, only 20,000 woman/years reflect women currently taking the Pill; the rest are “pastusers” or “never-users.”

Thus, only one out of five woman/years was actually spent on the Pill. Vesey therefore warns against the study’s conclusion minimizing the risk of Pill-related cardiovascular disease, since existing medical evidence links this hazard only to current use, and current use makes up only one-fifth of the data base of the Walnut Creek study.

Dr. Vesey’s critique will be published as an appendix to Volume 111 of the Walnut Creek study.

Dr. Shanna Swan, who teaches advanced epidemiology at the University of California, at Berkeley, was senior biostatistician on the study from 1970 to 1974.

Having read an interim version of the study’s final volume, she too agreed with Vesey.

“When you lump together current users, and past users, and you’re: looking for an effect that is, present only in current use in one case per 100,000 — if you have only 20,000 woman years of current use, you can’t see it.”

Although Dr. Ramcharan said there were “no easy answers” about the risks of oral birth control, in an interview at Walnut Creek she stood by the wording of the Searle/Hill & Knowlton press release.

Her co-author and principal investigator, Dr. Pellegrin, gave the release a more qualified endorsement.

“If you take white females, middleclass, residing in Walnut Creek and they don’t smoke, the risk negligible. lt’s too bad that it sounds like it’s across the board.”

Pellegrin called the Searle financed Hill & Knowlton campaign “a legitimate thing that is done by all the drug companies.”

Deceptive There are those, however, who take issue with this conception of legitimacy. Dr. Peter Rheinstein, former director of the FDA’s Division of Drug Advertising, took a dim view of Searle’s publicity campaign.

“It is deceptive,” Rheinstein said, “for companies to prepare materials and circulate them in a way they expect will result in their being reprinted or broadcast anonymously in the media.”

Barbara Seaman also charges that Dr. Ramcharan had previous financial and other ties with G. D. Searle and Company, which, along with Pill manufacturers, Mead Johnson, Ortho, Parke-Davis and Syntex, contributed $150,000 to the Walnut Creek study in 1975. Ramcharan’s vita indicates that she worked with Dr. Gregory Pincus, a longtime Searle consultant, evaluating Envoid (Searle’s version of the Pill) from 1957 through 1959.

Moreover, Don Buggrabe, a Searle spokesman, admits that Searle paid the travel expenses of both Ramcharan and Pellegrin for the John Rock Commemorative Symposium in Philadelphia, as well as paying for a trip to New York for Dr. Ramcharan to appear in Toronto at a Canadian Fertility Society Press conference.

Wyeth set up the conference, it seemed, in order to refute a recent investigative story in The Toronto Star on the health risks of the Pill.

Canada conference

The headline on the release issued for that Toronto conference was even cheerier than the Hill and Knowlton U.S. version: “The Pill in a New Perspective: Pill Users Healthier than Non-Users.”

Dr. Patrick Taylor of Calgary was quoted as calling the Walnut Creek study “the best news for Canadian women, whether past, present, or future users of oral contraceptives, since the introduction of the Pill in 1960.”

This kind of superlative clearly has more to do with advertising than ir does with medical accuracy.

“The pills are risky,” Dr. Swan reiterated. “For some women they are very risky.”

She estimates that in the 15 years during which the Pill has been widely used, it has been responsible for at least 20,000 deaths — an estimate she calls “conservative.”

She said she believes that if the Walnut Creek data are ever properly and adequately analyzed, they will confirm previous findings of oral contraceptive hazards.

If women are provided with accurate information on the Pill, Swan said, they will be able to make an educated decision about contraception.

But if they are fed misinformation on the Pill, they may make risky or even fatal choices.

What better way to sell your product than to claim it has been endorsed by a federally funded team of experts who researched the problem for more than a decade?

It’s as if the tobacco companies quoted the Surgeon General as saying: “Smokers Healthier than NonSmokers.”

“Most women,” Seaman said, “don’t want to die for love.”

But if pharmaceutical companies continue to mask the dangers of the Pill with excessively optimistic press releases, more will.

At least when the next round of Pill related deaths hits the headlines, women will have a better idea of whom to blame.

Critics say a recent Walnut Creek study is misleading and minimizes the hazards associated with oral contraceptives.