The contraceptive pill, the Pill, came into our lives in 1960. Almost immediately there were reports of young women with deep vein thrombosis (DVT) and pulmonary embolus and in some cases death from thrombosis. As expected industry denied there could be a problem – DVTs happen, women are prone to them, pregnancy leads to more of them than anything else. Many medical and religious experts thought there had been shockingly little research on the Pill and it should be banned until a lot more was known about it. AMA and FDA undertook studies and reviewed the evidence and concluded there was nothing to it. In the middle there were a few experts like Louis Lasagna who said that if a bunch of young women start turning up with DVTs while on the Pill, there were compelling grounds to think the pill could cause thrombosis, but having been told the risks women needed to be let make their own minds up about it. This position probably cost him job in Johns Hopkins.
The original Pill was a high dose Estrogen pill. In 1968 a British study reported that high dose Estrogen pills were linked to far more thrombosis that just introduced low dose pills. There was panic. The British regulator convened meetings. The options were to phase out the high dose pill or begin to insert information for the patient with each package explaining the risks. British medicine was against interfering with the doctor patient relationship and so the regulator effectively banned high dose pills. The change was so rapid that pharmacies didn’t have time to stock up and there was chaos.
The following year Barbara Seaman’s The Doctors Case Against the Pill spread the panic to the United States. Senator Gaylord Nelson convened Hearings on January 4 1970 to review the situation. These hearings gave rise to the photo above – the forerunner of the all male Trump cabinet photo in January this year for the signing of the order limiting access to funding for any organizations having any truck with abortion.
The Nelson experts were all male. One of them John Davis, concealing his financial interests, made a pitch for IUDs and the soon to be introduced Dalkon Shield which had a huge uptake partly because of concerns about the Pill. The Dalkon Shield caused horrific injuries and put the the company marketing it A.H. Robins out of business – in part because they spent so much time denying there could be a problem.
Nelson was pro-generic drugs, pro-consumers and generally progressive. So perhaps he did what he did next on purpose! When two women from the Women’s Liberation Front stood up to protest what was going on, and refused to sit down, he asked the Girls to settle themselves.
All of a sudden a consumer movement that was having difficulties getting heard had hundreds of thousands more followers. Drugs beyond the Pill became an issue for women, who turned up in force at later hearings on tranquilizers.
Bill Haddad’s National Consumer League for Prescription Drugs had women experts and women presenters at hearings, and men began to become a touch more wary about women like Abby Meyer, a self-styled little old housewife from Connecticut, when she began talking about an Orphan Drugs Bill.
Rather than remove high dose Pills, the FDA resolved the Pill controversy by opting for patient inserts to inform women. The AMA objected. It was the role of the doctor to have discussions with his patients. In the end there was a compromise, dispensing an almost unintelligible and opaque insert was left to the doctor’s discretion.
Some years later in 1978, the Carter Administration announced a Drug Regulation Reform Bill, more often thought of as a Kennedy Bill. This planned to extend patient inserts to all medication and make them more intelligible.
It also proposed among other things to let companies post the prices of their drugs. The generic industry was just coming into being and the hunch was that visible evidence of lower prices might help the switch and save costs. The National Consumers Prescription Drug League welcomed these changes. The Carter Bill went nowhere but …..
In 1983, on television in Florida, the Boots Pharmaceutical company ran the first Direct to Consumer Advert for a pharmaceutical. A brief 40 second slot telling consumers that Boot’s own brand of ibuprofen, the original drug, was cheaper than some of the copies they might be sold.
They were instructed to take down the advert, while the FTC considered the propriety of this move. After thinking about it for two years, during which they had representations from companies like Lilly that this was not a good idea – it would be burdensome for industry – FTC sanctioned the move on the basis that consumers had patient information now anyway and had welcomed information about prices.
Before inserts doctors were the fall guys if something went wrong on a medication – it was their duty to warn. Companies had no duties to warn patients. After inserts and DTCA, doctors remain the fall guy – as GSK’s efforts to pin the blame on Dr Sachman in the Dolin case illustrates. You gotta have a fall guy.