In 1937, the pharmaceutical firm S.E. Massengill Company launched a liquid form of the drug sulfanilamide to help fight strep throat infections. They called it Elixir Sulfanilamide. The drug was never tested on animals or humans. Because they didn’t really do that back then. But it did contain a chemical compound related to anti-freeze. The result of the drug’s distribution was a nationwide mass poisoning. Over a hundred people died, mostly children. Thousands more were made violently ill. After the early reports of death and illness, the company tried to recall the elixir. They could not. No one kept records back then. So the FDA had to use the entirety of its field force to track down all the available bottles of the medicine, door to door, to avert further crisis.
At the time, the only law that S.E. Massengill Company violated was the mislabeling of the drug as an elixir. Elixirs contain alcohol. Elixir Sulfanilamide did not; just anti-freeze. The only reason the FDA was empowered to participate in the recall was because of that fortunate mis-labeling. In response to the tragedy, there was a public outcry and Congress passed the 1938 Food, Drug, and Cosmetic Act requiring clinical testing be conducted before any pharmaceuticals go to market, among other sweeping regulatory changes.
Dr. Samuel Evans Massengill, the owner of the company, offered his assessment of the events shortly after the recall. “..there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”
Harold Watkins, the company’s lead chemist who developed the compound personally was more contrite. He committed suicide shortly after.
S.E. Massengill Company survived. It’s one of a half dozen companies that have merged, split or spun into Glaxosmithkline, the massive British pharma company that manufactures household name drugs like Advair.
The Food, Drug and Cosmetic Act of 1938 is hard to poke holes in. It’s pretty difficult to argue that if we can’t manage to not hand out anti-freeze to children with sore throats without government intervention, then perhaps we ought to have some government intervention. So have some we do. Most would agree that we’ve come a long way towards the safety and efficacy of our medicine since the 30’s. For the most part. There’s a gap though. Because the funny thing about regulation, when large sums of money are involved, is that it tends to drive minimal acceptable behavior. Here’s how it works.
For 50 of the 80 or so years of it’s existence, the only people the Food, Drug and Cosmetic Act of 1938 protected, were white men. Because the only people that participated in the clinical testing were white men. And it’s not just because we had a long history of only really meaning white men when we pass laws. There’s actually a slightly better answer for this one.
If you need to test a drug that you think is going to help people, and you have limited time and resources to do it, like everyone does, you probably need to find the most stable, common test subject. Now, from a biology perspective, we men are pretty boring. We don’t have exciting things like menstrual cycles, pregnancy or menopause. We just get horny, then old, then bald and grumpy and dead. But our body chemistry stays pretty consistent. And since we white folks in America have historically been the majority of the population, the safest, most consistent, effective and efficient test subjects to pick were white men.
Additionally, in the early 60’s we had the thalidomide tragedy, where thousands of pregnant women were prescribed thalidomide to help with morning sickness. The outcome was that thousands of babies around the globe were born without limbs. The less tragic but more enduring outcome was a knee jerk reaction to eliminate women all together from clinical testing because they ran the risk of becoming pregnant or being pregnant, and no one wanted to repeat the thalidomide tragedy. So, at first, no one wanted to test women because it was inefficient. And then, no one was really allowed to. At least until the 80’s, when people started to notice.
It sounds like a reasonable excuse. Right? Well it depends. Are you a woman? Are you an African American who is at higher risk for diabetes, heart disease and a litany of auto-immune issues that needs the drugs that weren’t tested on people like you before they were issued to people like you? Are you one of the women who sleep drove off a highway because Ambien metabolizes 15% slower in women then it does in men of equal weight. But no one told you because no one knew. If you are, then I would imagine that the excuse gets less reasonable. Especially since we’ve since found out that sex and race have much more of an impact on a drugs effect than we originally thought. So we’ve had some more regulation regarding the requirements to test women and minorities over the last thirty years.
Now, there’s a chance that you read the last few paragraphs and you were satisfied or at least sympathetic to the biological explanation of exclusion of women and minorities from clinical testing. And though you wish the science of the time had known better, you understood the approach and even appreciated the efficient principles behind it. As a result, you don’t carry too much ill will towards those who were responsible for it. You might say something about those that executed a policy of women and minority exclusion from clinical testing that sounds something like, they were “supplying a legitimate professional demand and not once could have foreseen the unlooked-for results.” As a result, you bristle a bit about government sticking their nose in the industry and forcing things on companies that are just trying to run a business.
That’s how Dr. Massengill felt. Remember?
On the other hand, you could be outraged. Perhaps because you are a woman. Or perhaps because you are one of the tens of millions of ethnic minorities in America. And you feel that an entire industry, one with nearly unending profits and durability decided to focus on efficiency instead of your wellbeing for something as important as the medicine you take to keep you and your family safe. And like the parents of those poor children who were fed anti-freeze that destroyed their kidneys and killed them, you might take offense to the opinion that no one was responsible for bad behavior.
Thats’ how the chemist Watkins felt. Remember?
So are you a Watkins? Or a Massingill? Somehow, history feels somewhat better about Watkins. Even if Massingill did die rich in his bed. But that’s not really the point.
Change is coming in the domain of government regulation. Seek the debates that ask the better questions: Does the regulation in question provide sufficient benefit for the cost? Is your sense of benefit impacted by your own experience with it? Answer those questions, and you’ve got a sound opinion. Anything else is just noise. And it’s about to get really noisy.