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First published in Hospitals & Health Networks OnLine, August 7, 2007
With dead pets and contaminated seafood piling up, the Food and Drug Administration claims it is trying to improve. But the challenges, and the risks, are great.
I can't eat, I can't talk,
Been drinkin' mean Jake, Lord, now can't walk,
Ain't got nothing now to lose,
Cause I'm a Jake-walkin' papa with the Jake walk blues.
"Jake Walk Blues" The Allen Brothers Recorded May 5, 1930
The enactment of Prohibition in 1919 had many profound effects on American society, quite a few of which were unintentional. These unanticipated consequences ranged from the rise of organized crime, which capitalized on the demand for illegal alcohol, to the worst mass poisoning in U.S. history. There are lessons in this for us today.
In the 1920s, while wealthier urban Americans were enjoying fancy cocktails in upscale speakeasies, low-income working-class people (especially men) in rural areas in the Midwest and South were hard-pressed to find affordable alcohol. One available product was a patent medicine, Jamaican Ginger, colloquially known as "Jake," which contained ginger extract and 70 percent to 85 percent ethyl alcohol; it was a popular cure for nausea and diarrhea. It was also a popular cure for the Prohibition-induced shortage of booze. Federal authorities soon caught on and required that the amount of ginger in Jake be increased to the point that the stuff was undrinkable except in very small quantities, which was appropriate if it was really only being used as a medication.
However, demand for the more potent and drinkable stuff was still there, so Jake manufacturers tried to find adulterants that would make the product appear legitimate, but would allow for more alcohol and would mask the taste of the ginger. In 1930, a couple of Boston chemists-turned-bootleggers, Harry Gross and Max Reisman, hit upon the perfect adulterant: triorthocresyl phosphate (TOCP). An odorless, colorless, tasteless industrial chemical, it fit the bill precisely. Their firm, Hub Products, churned out hundreds of thousands of bottles of this adulterated Jake, which were widely distributed.
TOCP is a central nervous system poison.Between 50,000 and 100,000 Americans, mostly low-income white and African-American men, drank enough of the bad Jake to develop partial paralysis. They lost control of the muscles in at least one leg, which forced them to walk by lifting the leg and slapping it down as though they were operating a puppet. This became known as the "Jake walk" or "Jake leg." Most victims never recovered, and few, if any, received optimal medical care or even much sympathy because the gait was so distinctive that it was evident in their often-conservative communities how they had become disabled.
In 1931, Gross and Reisman pleaded guilty to conspiracy to violate federal law and were each fined $1,000 and sentenced to two years in prison. They avoided prison time by promising to help find some alleged New York bootleggers whom they claimed had really manufactured the tainted Jake. That claim was eventually proved to be bogus, and Gross was ordered to serve his term; Reisman never did.
The Jake leg calamity became a minor footnote in history; its victims were poor, were violating federal law and in many instances were African-American men, not the most popular group in many places (as is still true, unfortunately). But the story lived on in a large number of blues, ballads and laments in both the white Southern musical tradition and in African-American blues; indeed, a recording of 17 of these songs was released in 1977 ("Jake Leg Blues," Jass Records).
In 1862, Abraham Lincoln appointed a chemist named Charles M. Wetherill to serve in the U.S. Department of Agriculture (USDA) in order to check food safety; his work led to the Bureau of Chemistry within the USDA. By 1880, government scientists were advocating passage of a safe food and drug law, and in 1906, the Food and Drugs Act was passed by Congress. It prohibited interstate commerce in "misbranded and adulterated foods, drinks, and drugs." Its enforcement was the responsibility of the Bureau of Chemistry at the USDA. In 1927, the bureau was divided into a research branch and a regulatory branch, the latter being the Food, Drug, and Insecticide Administration, renamed in 1930 as the Food and Drug Administration (FDA).
In 1933, the FDA urged that the 1906 Food and Drugs Act be overhauled and strengthened, a crusade that later was advanced by a mass poisoning in 1937; 107 people, mostly children, died from ingesting a medication that was tainted with diethylene glycol, a solvent used in antifreeze.
In 1938, Congress passed the Food, Drug, and Cosmetic Act, which greatly extended the FDA's scope of regulatory oversight and power. In 1988, the FDA was officially transferred to the Department of Health & Human Services.
The agency has had something of an up-and-down ride over the years. Its most publicized success was probably its refusal, in 1962, to approve use of the drug thalidomide for pregnant women. The thalidomide refusal prevented the births of thousands of U.S. children without complete limbs, as had occurred in Europe. Frances Kelsey, M.D., Ph.D., the FDA physician who insisted on further testing and research despite heavy pressure from the drug's manufacturer, was hailed as a heroine when the drug's terrible effect on fetuses was revealed. As a graduate student, she had participated in the research that identified diethylene glycol as the culprit in the 1937 mass poisoning.
Seventeen years later, the FDA demanded the recall of dietary supplements containing significant amounts of the substance L-tryptophan, which sickened 1,500 people and killed 38 before the recall.
The FDA also sought to regulate tobacco as a drug, but that effort was ended by a U.S. Supreme Court decision in 2000 that declared the agency did not have such authority.
However, the FDA has not had such a good run of late. As early as 2000, the agency had some knowledge that the Merck drug Vioxx was associated with a much higher rate of heart attacks among its users than among the general public. Eric Topol, M.D., of the Cleveland Clinic, estimates that as many as 160,000 people had heart attacks or strokes as a result of using the drug. David Graham, M.D., an FDA official who had warned the agency about Vioxx and was infuriated by what he saw as the FDA dragging its feet, told Congress in 2004 that the deaths were equivalent to "two to four jumbo jetliners dropping from the sky every week, and no one else at the FDA was concerned."
Earlier this year, some pet foods were found to contain melamine, a chemical contaminant in wheat and rice gluten imported from China; hundreds, if not thousands, of pets died. People for the Ethical Treatment of Animals demanded that the FDA commissioner resign; he refused.
The FDA provided information on a recall, which was repeatedly expanded, on its Web site; however, the Web site was difficult to use, and if you had a pet and weren't on the Internet, well, good luck to you and Fido or Fluffy. Ferret food was also contaminated. It was a pretty horrible outcome for products called Happy Tails, Natural Life and Loving Meals.
The pet food poisoning was followed by a warning that some Chinese-made toothpaste contained diethylene glycol (remember the 1937 mass poisoning?).
The much-touted anti-cervical cancer vaccine Gardasil recently was linked to adverse health events in young women, although that particular debate is colored by some conservative groups' strong opposition to the drug on grounds that it promotes promiscuity.
Even more recently, the hugely popular diabetes drug Avandia has been linked with an increased level of heart attacks -- information that was provided to the FDA years ago. The agency did nothing. Several anemia drugs, including the heavily advertised Procrit, have been associated with cardiovascular and cancer risks. An FDA advisory committee has recommended that their use be limited. The agency did not restrict or end their being advertised to physicians and patients.
And now there's imported Chinese catfish (what, we don't have enough catfish in the American South?) containing antibiotics and antifungals not allowed in U.S. food, and imported shrimp that were fed chicken feces; and now salmonella has been found in the seasonings used in Veggie Booty and other snacks, and … you get the idea.
By the way, although there is no evidence (not yet, anyway) that the United States is at risk, dozens of people in Panama were fatally poisoned in recent months by cough syrup that was contaminated with diethylene glycol (there it is again) that had been shipped from China mislabeled as glycerin, which is a common ingredient in such medications.
Meanwhile, the FDA has been wrestling with a host of internal problems. Some are not of the agency's making; imports of food and additives of all kinds have skyrocketed, and the FDA's staffing and budget have not been augmented to meet the new challenges. Furthermore, Congress has done some curious things to tie the agency's hands, the most stellar of which is its refusal to allow the FDA to stringently regulate "dietary supplements," vitamins and other products (which may well have led to the L-tryptophan debacle); quite a few Hollywood luminaries showed up on Capitol Hill to support this exemption. (Hope they turn out in support of proposals to help the uninsured poor.)
Furthermore, the very structure of the FDA causes a conflict of interest. The agency is supposed to ensure the safety of foods and drugs on the one hand, and approve their use on the other. (Interestingly, the FDA has never been asked to find out if the things work, or if they are better than what is already out there.)
To add to this dilemma, much of the FDA's work is funded by money from the drug manufacturers, who thereby put huge pressure on the agency to approve drugs quickly. This is the result of the 1992 Prescription Drug User Fee Act, which requires that drug makers fund the process.
(The push to get new drugs on the market quickly started before manufacturers had to pay for the approval process; beginning in the 1980s, the AIDS community pushed the FDA to approve any possibly effective HIV drug as quickly as possible. That led to a "fast-track" process, and much mischief has likely resulted. One wonders what would happen if thalidomide came up for approval today.)
The result may well be -- as Curt Furberg, M.D., one of the physicians whose research brought Avandia into question, has said of the FDA-that "safety is just not a high priority for them."
And then there's the leadership issue. Lester Crawford, a veterinarian, was appointed to head the FDA in 2005 after serving as acting commissioner for over a year. His tenure was marked by, among other things, the Vioxx issue, the flu vaccine shortage of 2004-05, the political fight over approval of the "morning-after pill" and other problems.
He got the top job permanently in July 2005. He resigned two months later. Why? There are two schools of thought. One is that he was accused of an improper romantic relationship, a charge that has been largely discredited. The other is that the head of the United States Food and Drug Administration, which is responsible for protecting the safety of the products we ingest, had significant stock holdings in firms over which his agency had oversight. He lied about those holdings.
Earlier this year, Dr. Crawford was given a really harsh penalty: three years' probation, 50 hours of community service and a $90,000 fine.
Almost immediately upon his departure from the FDA, Crawford was named "senior counsel" at a Washington lobbying firm, Policy Directions Inc., which represents clients in the pharmaceutical, biotechnology and food sectors. Because of, shall we say, rather lax federal ethics rules, he had to wait only a year before he could begin directly lobbying federal officials.
Flash to China. Zheng Xiayou was the leader of that country's food and drug safety administration until recently. He was convicted of dereliction of duty and accepting bribes to approve unsafe medicines. Thousands of people died as a result of his corruption.
Zheng Xiayou was sentenced to death. So was Cao Wenzhuang, another high-ranking Chinese food and drug safety official, who also took bribes from drug companies. Zheng was executed July 10.
In 1949, Elvin Stakman, then president of the American Medical Association, told his members, "Science cannot stop while ethics catches up." Well, it certainly didn't; at the time, dying cancer patients were being subjected to massive amounts of radiation so more could be learned about radiation poisoning.
Well, ethics is beginning to catch up with the FDA-maybe. The agency has announced that it will intensify surveillance of all U.S. plants that use certain additives in human food production (I guess pets are still on their own). A new "food safety czar," David Acheson, M.D., has been appointed as the FDA's assistant commissioner for food protection, a new position. FDA consultants and advisors who receive significant money from drug manufacturers will no longer be allowed to serve on FDA approval committees (and just how long was that going on?). The agency's drug oversight process is being overhauled, and post-release scrutiny of pharmaceuticals is being beefed up. The Senate has passed a bill that would force the FDA to keep tracking a drug's effects for a very long time after it has been approved.
But that may not be enough. The Senate bill also makes the FDA even more dependent on pharmaceutical manufacturers for its funding, and more power and responsibility for the FDA was gutted by senators, who, just coincidentally, had received hundreds of thousands of dollars in campaign donations from drug makers. The new FDA commissioner, Andrew von Eschenbach, M.D., former head of the National Cancer Institute, has close ties to the pharmaceutical industry and has long lobbied for faster approval of drugs. Deputy FDA Commissioner Scott Gottlieb, M.D., previously served as a biotech stock analyst on Wall Street, specializing in pharmaceuticals. "Food safety czar" Acheson recently told Time magazine that monitoring every shipment of imported food products would be "too complex and cumbersome," and that the FDA therefore concentrates on "high-risk" items.
I wonder what he eats.All that the FDA faces was nicely encapsulated by a Wall Street Journal OnLine poll released this June, which found that "Half of all adults in the U.S. still believe the FDA is doing a fair or poor job when it comes to ensuring the safety and efficacy of new prescription drugs. Nearly six in 10 give the agency negative ratings on ensuring that truly innovative drugs come to market more quickly." The problem of trying to please everybody persists.
In the meantime, television commercials for the Pfizer pain reliever Celebrex boast, "Prescription Celebrex has never been taken off the market." Why do I not find that comforting?
So what has happened to the agency that protected American mothers and babies from thalidomide? Many things. Political influence and interference. Underfunding and understaffing. Tough calls in terms of what to focus on. Conflicts of interest on the part of its leaders. An economy that shifted to a massive influx of imports with which the agency could not hope to keep up. A political mind-set that the private sector can monitor itself, despite equally blatant conflicts of interest. And greed.
Seventy-seven years ago, tens of thousands of Americans suffered debilitating paralysis because of a confluence of factors: ill-thought-out federal law, profiteering, poverty, racism, lack of accountability, slap-on-the-wrist punishment for the worst offenders and federal oversight that could not or would not do what was necessary.
Have we learned nothing since?
This column is dedicated, with great respect, to John P. Morgan, M.D., who has worked tirelessly to bring the Jake leg poisoning and its lessons to the world's attention.
First published in Hospitals & Health Networks OnLine, August 7, 2007
© Emily Friedman 2007