Cough Syrup, Dead Children, and the Case for Regulation

Kathleen Hobson was eight years old when her mother unknowingly dosed her with poisonous cough syrup. She’d only taken a couple spoonfuls but when investigators came round, they still found nothing left to test.  After the little girl died, her mother had set the bottle on fire and then thrown it into the trash.

Charlene Canady was just four when she died from the same medication. Her father had carefully packed the cough syrup bottle, waiting for justice to come calling.  I always imagine him silent when he handed the bottle over, grief and his daughter’s name caught like a kind of suffocation in his throat.

Both little girls lived in Tulsa, Oklahoma, both came down with nasty little colds in the fall of 1937,  and both died because they were dosed with a brand new medication, a popular, raspberry-flavored cough syrup.  In all, the syrup would kill 11 people in Oklahoma, within a few weeks. Ten in Alabama. Ten in Georgia. Twenty-three in Mississippi. Nine in South Carolina. Seven in Texas. More in California, Ohio, Illinois, Missouri, Virginia, Louisiana, and more.

More than one hundred dead nationwide, in fact, and most of them children, Charlenes and Kathleens scattered across the United States like so much storm wreckage.  “Nobody but Almighty God and I can know what I have been through these past few days,” a Louisiana doctor later wrote to the U.S. Food and Drug Administration, after six of his patients died in one week.

As FDA scientists would quickly realize, the syrup was lethal because it was sweetened by a compound known as diethylene glycol which kills by causing acute kidney damage. Both diethylene glycol and the obviously closely related compound, ethylene glycol (even more toxic) are best known today for their use as antifreeze agents and  homicidal weapons on more than one occasion.

But at the time that Elixir Sulfanilamide came to be, produced by the S.E. Massengill Company of Bristol, Tennessee, that wasn’t well understood.  There was actually no legal requirement that companies understand their products, much less safety test them.

The company chemist who designed the cough syrup by mixing a sulfa drug into the poisonous sweetener claimed to have no such knowledge. And as the company president, Samuel Massengill responded: “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.”

The resulting  Elixir Sulfanilamide scandal – and it was, indeed, an incendiary, nation-rocking scandal at the time -  is mostly forgotten today. But it shouldn’t be. Those rippling deaths, the feeble government response, the indifference of the manufacturer and its big business allies -  provoked such a passionate outcry that a year later, the long-delayed  U.S. Food, Drug and Cosmetics Act was signed by President Franklin Roosevelt.

The 1938 law was first major upgrade of 1906 legislation. The earlier law established the U.S. government as a guardian of the American people’s safety, set precedents in regulating toxic chemicals in food and drugs. But that turn-of-the century law was in many ways a piece of regulatory lace, full of exceptions and exemptions.  The new law filled many of those holes, gave power to protective rules.

Now, for  the first time,  manufacturers were required to safety test their wares and could be held responsible for consumer death and injury. In the case of Elixir Sulfanilamide, the company could not be held liable for a single death. It could only be charged with mislabeling – elixirs were supposed to contain alcohol and the cough syrup contained none.

The 1938 law also required manufacturers to list ingredients on their labels in some detail – another first. One of my favorite books of the 1930s, 100,000,000 Guinea Pigs, by Arthur Kallet and F.J. Schlink, is basically a litany of the hidden dangers that preceded that rule: the toothpaste that contained so much potassium chlorate that it was possible to commit suicide by eating a single tube; the high levels of lead in hair dye,;and the use of the toxic element thallium in depilatory creams. One of the side effects of thallium poisoning is that hair falls out. Cosmetic manufacturers of the 1930s thus found it handy in hair-removal products. They expressed surprise at the small epidemic of baldness, paralysis and occasional death that resulted. But, as they reminded irate physicians, they could not be held responsible for that.

But although advocates like Kallet and Schlink spent years marshaling such evidence in an effort to persuade the government to give the FDA actual enforcement powers, they were stymied by business opposition until the Elixir Sulfanilamide scandal galvanized the country. In an essay for the Annals of Internal Medicine, toxicologist Paul M. Wax called it “one of the most consequential mass-poisonings of the twentieth century.”

And it’s that case that always comes to mind when I hear politicians trumpeting the wonders of an unregulated marketplace, as with the current Republican party mantra that we don’t need strong environmental protections or – at the most extreme vantage point – even a U.S. Environmental Protection Agency at all. Last year, along the same lines,  conservative legislators were busily trying to defund the FDA as well.

The Washington Post’s Ezra Klein points out that Americans tend to sound anti-regulation when queried. But, he adds, if you press them on which oversight they’d like to give up, the picture becomes more complicated. Klein cites a Pew Research survey done in February which found that 53 percent of respondents wanted food and food product regulation increased – only seven percent thought it should be reduced. For environmental regulation, slightly more – a full 17 percent – argued for relaxing the rules.  The survey was, actually, unable to locate a majority of American citizens seeking to be less well protected.

We hear legislators suggest that hard economic times demand the loosening of regulations. But don’t forget that our country was still mired in the long-reach of the Great Depression when that 1938 law was passed. The government recognized, even then, that protection of American citizens meant more than policing our cities and defending our borders. It meant dedicated protection of public health.

Do we sometimes wish that such protection was smarter, moved faster, was more richly knowledge-based?   Less influenced by politics, on occasion, by corporate lobbyists? Of course, we do. But I see that as a call to keep the process as politics free as possible (dreaming, I know), to  invest more in good risk research and to use that knowledge to improve protection against everything from food poisoning to chemical contamination.

We may not remember by name the Kathleen Hobsons and Charlene Canadays of our past. And as I said, the Elixir Sulfanilamide story, is mostly forgotten as well. But we should be grateful for the way it changed our lives. And we should occasionally acknowledge those lost children;  whether we recognize it or not, their ghosts still walk among us today, reminding us of what is right.

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38 Responses to Cough Syrup, Dead Children, and the Case for Regulation

  1. Janis says:

    We may not remember by name the Kathleen Hobsons and Charlene Canadays of our past.

    It’s okay — if we forget them, nature will obligingly provide us with new names to remember. Until we forget those as well. :-/

  2. Emily says:

    This article is beautifully written and as a history buff I do love the subject. However, your conclusion is poor. Interesting how times change, now the poisoners run the FDA. You can now sell your poorly tested drug as long as you bribe the right person. Articles like this remind me of how ignorant the populace has become. More regulation does not protect it only allows the corrupt to get away with murder legally.

  3. Ronald Yunis says:

    Spot on, Emily.

    This is the slippery slope of Government regulation, aka “mission creep.” You have to try to figure out what’s best with numbers and statistics, not with tear-jerking stories of individuals. This country was founded with the lives of thousands upon thousands who were willing to risk it all to live the American dream. We do not need the FDA or the EPA today because greedy attorneys will make sure that illegal and immoral behavior is punished in the only way the perpetrators understand- cold cash penalties and death by bankruptcy. Penalties imposed by the Government are never designed to kill the goose that lays the golden egg; merely to pluck as many of its feathers as possible without killing it so that they may pluck it again.

  4. Deborah Blum says:

    Oh, agreed that we’ve done a bad job of protecting the FDA from the corporate influence. We can blame that on our political system in large part. Did you see that the GOP is, in fact, pushing to change its mission statement from protection to encouraging commerce? But imperfect as the agency is and imperfect as regulations often are (which is why you saw me arguing for evidence-based rules) we are still better off than in the days of Elixir Sulfanilamide. You may remember a few years ago that the exact poison in that cough syrup – diethylene glycol – was used by Chinese manufacturers to sweeten both toothpaste and cough syrup. Children in Latin America died in that incident and I thought to myself, not again. Didn’t we already learn this. Our FDA moved to block distribution of those products here. And the Chinese are moving (albeit slowly) toward the kind of regulation we see here in part because they recognize how bad such incidents are for business.

  5. Deborah Blum says:

    I’ve tried to answer some of your points in my answer to Emily below. I actually agree that government penalties are often ridiculously low, not for repeated plucking but because corporations successfully lobby against meaningful actions. It’s worth noting that the FDA – as an example – is often able to exert protection without penalties at all though. As an example, you’re probably aware of the long time addition to organic arsenic to chicken feed (it’s an anti-parasitic and it has the cosmetic effect of making packaged turkey and chicken parts look pinker and healthier). For many years, manufacturers have argued that this is not a health risk because organic arsenic is not as dangerous as the inorganic form. But last year, some very dogged FDA scientists were able to show that arsenic can covert to the riskier type within the birds. The company in question then suspended sales in order to do further research. Not a flashy action, you might say, but evidence-based, in the public interest, and in the best interest of the company. And this, I will argue, is what we need more of – not less.

  6. Lee says:

    This is what’s called “regulatory capture” — aka “the fox guarding the henhouse”. And the cure for it is not getting rid of the regulatory agencies, but shutting down the revolving door between said agencies and the industries they are supposed to be regulating.

    In other words, there needs to be MORE regulation, not less, and it needs to include a minimum 5-year cooling-off period before any regulator can take a job in one of the regulated industries, or any industry official can take a job in the regulatory agency.

  7. Deborah Blum says:

    Couldn’t agree more, Lee.

  8. julie says:

    This piece includes some good history of regulations by the FDA. I certainly hope the right people are following these posts because we need more awareness about how outdated so many of our chemical regulations are on a federal level. Yes, they have been updated many times but when research companies are inventing thousands of new compounds and products a year, the regulations should change accordingly.

    I’d like to see companies with regulatory databases that reflect tracking systems relevant to modern products- not databases inconsistently tracking the regulated chemicals.

    This is only possible with a top-down approach from the federal level. We need some smart people to write some comprehensive regulations and some keen regulators to enforce them.

  9. Laura says:

    Hear, hear.

  10. Janis says:

    5 yrs is nothing. Never sounds good to me — what’s wrong with that?

  11. Deborah Blum says:

    Completely agree, Julie. We could still be so much smarter about this than we are.

  12. Kristi says:

    Great Article. Its sad though that so many of your readers have such low regard for the scientists working to apply regulations that ensure the safety of products used by millions of Americans everyday. Naturally there is room for improvement, but vilifying people who work within the system is not the way to seek improvement. Is it that hard to remember that these people are consumers just like everyone else, and don’t want unsafe products on the market either. If people think laws need to be strengthened they should contact their congressman, rather than insinuate that their fellow citizens are so easily corruptible.

  13. Deborah Blum says:

    Completely agree with you, Kristi. Let’s not forget how often overwhelmed, outmatched, out-funded, and outnumbered these regulatory agencies are. And given that they do a remarkable job of keeping the rest of us from harm. And, as you point out, they ARE the rest of us – are exposed to the same dangers as the rest of us and have good reason to do things right.

  14. Mario Fontana says:

    The FDA has lost respect. They seem to have their priorites a little mixed up! They will ban a drug that might affect a very small percentage of people but then give the tobacco companies a pass – I guess making 35 + billion in 2010 will buy the FDA ignoring 6 million deaths in a year! (see link below) I understand that all those deaths are not in the US but what we do seems to have some influence around the world. Why keep people from ‘experimenting’ with medications that might help them, especially if that person signs a waiver to do so, especially if that person is looking at death in 6 months…. What ever happened to ‘it’s my body’? Is that only available to women who want to abort their babies. Why does the FDA suppress all the links to breat cancer, depression, etc.linked to the pill? A lot of double standards/hyprocrisy. I am NOT saying to get rid of the FDA – it does serve a good purpose. Just wish they were more consistent and would give people a ‘choice’ if they wanted to try a possible life saving medication.

    Here’s the article that came out yesterday stating that the ‘Tobacco use killed almost 6 million people worldwide last year and was the top cause of death in China, the world’s biggest cigarette market, a report by the American Cancer Society and World Lung Foundation’

    http://www.courier-journal.com/article/20120321/NEWS01/303210141/cigarettes-tobacco-deaths-2011?odyssey=tab%7Ctopnews%7Ctext%7CHome

    and…..

    http://www.leaderpost.com/health/Smoking+deaths+triple+over+last+decade+tobacco+report+says/6335972/story.html

  15. N says:

    It is a interesting historical article. However, near the end it dives into partisanship. Too bad.

    Unlike 1938 there are vast armies of lawyers just waiting to make their first million on a wrongful death lawsuit. It is not the same environment as it was in 1938.

    More to point both the EPA and FDA are delving into things they were not chartered to do: EPA want to regulate CO2; FDA wanting to limit salt. Both agencies are overstaffed and overfunded because they have the time and resources to involve themselves in things they have no business or little improvement to offer.

    Doing such things are bad for both agencies. It reduces their public support. These agencies need to remember they operate at the pleasure of the public and taxpayers. When they deny people access to their property or look into the lunch sacks of children people are all too willing to reduce their funding and power…

  16. N says:

    Not really. They have unlimited funding from the taxpayer and are able to influence or write their own rules.

    For example, the EPA used it authority to deny property owners use of their property. Further, since the EPA was on shaky grounds at calling the peoples property a “wetlands” they demanded the people convert it to a wetland prior to going to court. The EPA had also unfairly used its administrative power to shield itself from judicial review and coerce acceptance of its judgements. Finally SCOTUS has started to reign them in.

  17. Raker says:

    I find it pretty telling that you had to go back to the 1930′s to find evidence for your argument. What’s next? An essay on how the Great Famine of 1315-1317 was caused by under-regulation of agriculture?

    But seriously, where is your cost-benefit analysis of government regulation now? Or at least in the recent past? How about any cost analysis of regulation? How many people have died in the last ten years waiting for the FDA to approve drugs that might have saved them? Do you have any idea? I don’t, but I know that defending government regulation on the basis of a single anecdote from 85 years ago is poor reasoning.

    For that matter, where is your proof that stronger regulation would have prevented these diethylene glycol poisonings? How many people poison themselves today with so-called herbal remedies, which are not regulated by the FDA even now? Again, I don’t know, but I’m betting that the number isn’t zero. But I do know that if stronger regulation wouldn’t have saved Kathleen Hobson or Charlene Canady, then your argument falls apart.

    These are just the first few questions one would need to answer just to begin to have an informed opinion about the appropriate level of regulation. But you haven’t even raised these questions. All you’ve done is perpetrate classic scare-mongering: ‘We better not deregulate even slightly, or evil corporations will put anti-freeze in your kids’ cough drops!’

  18. Deborah Blum says:

    So, sigh, I’m think you missed the point of my piece. I pointing out that consumer safety was much more tenuous in the pre-regulation era (hence, um, the 1937) example. But if you wonder about diethylene glycol poisonings in a non-regulated environment, you need only look to the scandal a few years ago regarding toothpaste and cough syrup from China sweetened with exactly that compound. Hundreds of children died then too – only not in this country because the FDA confiscated those products. No one, including me, is saying that any regulatory system is perfect. But are we better off with? Absolutely and you won’t find me budging from that point.

  19. Deborah Blum says:

    Really, they don’t have unlimited funding. If they did, we’d have adequate staffing for inspections, for instance, which we don’t. Again, I’m not arguing that any government agency should operate without good oversight and good research behind its actions. I am arguing if we’re going to fund anything, it’s solid research and that will enable us to choose the best possible rules and help inform how to apply them.

  20. Deborah Blum says:

    Well, obviously, whether or not you think CO2 should be regulated depends on whether or not you think it’s helping to drive global climate change (or in some cases, whether global climate change exists). The evidence on salt (sodium chloride) and high blood pressure is pretty solid. But obviously that’s a public health issue in a different way than addition of something like diethylene glycol. And I do think you raise a reasonable point about agency mission – we as a country don’t have the money to regulate everything under the sun. So we need to be smarter (hence my plea for research funding) about our priorities.

  21. Deborah Blum says:

    Yes, I agree that the FDA’s reputation has been tarnished. But I think we have to address that directly by highlighting the problems in public – as you’ve very nicely done here – and keeping the pressure on so that the agency is kept focused on its primary mission – which I think is unbiased protection of American citizens.

  22. N says:

    The FDA may not have unlimited funding but the agencies that will enforce their rules and regulations do. Further the government also has the ability to threaten entities to keep them in a costly venture navigating the bureaucracy. The EPA just had its hand slapped for doing this.
    The problem is that these agencies get so large that in order to justify their large staffs and budgets they have to generate new regulations and requirements. While its hardly unique to government (corporations do this too) it is not the way to run a agency tasked to do the work of the FDA.

    Incorporating another post of yours Ms. Blum, while the link between salt and hypertension is well known, why regulate this substance when the hazards of tobacco products are clear? The same could equally apply to liquors and its impact on diabetes, etc.?
    If people are honest, we know the reasons why.

    The FDA’s job is not to weigh our food and enforce what we eat or drink. That is a personal responsibility and every bit as important as making sure products are safe. Make sure the products are safe, inform us of proper usage, provide advice, good practices of manufacturing and delivery.
    If government is going to save us from ourselves, this world is going to have two spheres: the governing class, and the governed.

  23. N says:

    As far as regulating everything under the sun…even if we had the money that is a bad idea especially where bureaucracies are involved. Once mechanisms of government are established it is very difficult to get them changed. Small wonder…aren’t we still paying for the Spanish-American War on our phone bills?

    Being a technical person I love research. Research sometimes, maybe even frequently makes discoveries that were not part of the original project.

    Unfortunately, it seems that Washington rather than allowing research to go forward on its own merits, funds the research that supports its political aims. It even rewards those that help them reach those aims.

    Research needs to reward that basic curiosity. Researchers need to carefully husband those taxpayer dollars. Let me try not to soapbox too much here, but I think it is a poor use of taxpayer dollars to have the universities to function as patent mills. It use to be their developments were open for development by all.

    If research is to be respected, and revered, than it must firewall itself from the political system. For one, the researchers will be much happier, second they will avoid what politics will try to do to real science.

  24. N says:

    And in support of what Ms. Blum has said, there are even recent examples of drugs approved for use that had to be removed from shelves. Just watch the TV attorney ads for the list. Also how many of us took aspirin as children and the children today do not because of Reyes?

    The FDA has its place. But I have four daughters, one with a serious disease. I hope that something will cure her one day, and allow her to have children too. But I don’t want some drug to be fast tracked and then I only have a granite stone as a reminder of someone’s good intentions.

    The FDA needs to stay focused on its mission, and let us live our lives the way we wish.

  25. Lou Doench says:

    Hi Deborah… loved your piece. Have you thought about spraying for libertarians however? I know they are resistant to most government approved pesticides, but I’m sure the free market would provide a solution if overpaid gubmint regulators would just get out of the way.

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  28. Mary says:

    Hi Deborah,
    Glad to have found your article. My brother (2 months old), was one of the victims of that cough elixer. He had contacted whooping caugh and the Dr. had prescribed the elixer. While I am not for government control, there needs to be control in these areas for our safety.

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  30. We may not remember the names of those victims but what is important is that we need to seek always for the improvement of our daily life’s activities, looking way beyond. This incident before is only a testament that during those time, in drugs in particular may not have equip technologies as we have today, the reason it happens is for we to improve. So in today’s generation, many of our living today, food, medicine technology increases but we still need to seek for more.

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