The Malignant Empire

An excerpt from my documentary proposal about an "Uncensored History of Money, Power and Politics in the Cancer Industry"

One thing all freelance authors and journalists have in common is that we usually have several projects underway at the same time. One might turn into the next book, another ends up as a documentary, and the rest become articles or opinion pieces and sometimes go nowhere.

Projects come up sometimes unexpectedly.

A year after my last book, Pharma: Greed, Lies and the Poisoning of America, my wife, Trisha, was diagnosed with breast cancer. I was with her when the physician did a biopsy and ultrasound that confirmed the dark spot on her annual mammogram was a malignant tumor. That day, Trisha became one of the more than 1.8 million Americans who will get an annual cancer diagnosis; four in ten will hear that during their life.

Cancer has a way of instantly jumping ahead of everything on life’s to-do list.

Trisha and I are partners for over 40 years. We work together on all our book projects. Friends and colleagues know we do pretty much everything as a team. All we wanted was to do whatever was necessary to eliminate Trisha’s cancer. She decided to undergo traditional treatment. That did not mean she would blindly follow every suggestion from her oncologists. “Making uninformed decisions regarding our bodies may be more dangerous than doing nothing at all,” she had written in a book about hormone replacement therapy and menopause twenty years ago (No Hormones, No Fear [Villard]).

Neither of us, however, could have remotely imagined that the treatment journey Trisha was about to start would spark our curiosity to investigate much broader questions about the cancer industry. We came to understand over nearly a year of reporting how the modern cancer cartel is not just a collection of pharmaceutical and biomedical companies. It has powerful allies in the food and chemical industries, patient advocacy lobbies and cancer charities, government regulators, academic scholars, and researchers, as well as health reporters in legacy media and medical journals.

It is an industry focused almost exclusively on treatment instead of prevention. In 2021, Americans spent a record-breaking $176 billion on oncology drugs billed to patients and health insurance companies, a 40% surge from a decade earlier. That was double what was spent on all Covid-19 vaccines and therapeutics. Industry analysts expect cancer drug spending to double to $320 billion by 2026. Since Richard Nixon declared the war on cancer, government agencies and nonprofits have funneled a quarter trillion dollars into research. Although America spends far more per capita on all healthcare, especially cancer treatment, that has not translated into longer lives. Mexico, Brazil, and most of Europe, have lower cancer death rates although they spend a fraction as much.

Last year I submitted a 91-page proposal/pitch to my agents for an eight-part documentary. They are working to find the right documentarian to tackle the project and bring it to cable/television.

In the meantime, the news yesterday from Reuters that the WHO’s cancer research agency is about to declare aspartame sweetener as a possible carcinogen, reminded me of what I already had covered in part of my Malignant Empire draft.

Below are two sections from The Malignant Empire; the first is about how the government dealt with the mother of all artificial sweeteners, saccharine, and the second section about what it has done with aspartame.

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The Sweetest Carcinogen (Harvey Washington Wiley)

The corporate defense to tighter regulations or bans of suspected carcinogens was to muddy the science and lobby regulators to do nothing. They sometimes even rallied public support. It was rare for people to oppose government policies designed to lower their risk of developing cancer, but that is what happened in the late 1970s over saccharin.

Saccharin was discovered by accident in 1879 by a John Hopkins chemistry professor who was looking for new uses for coal tar derivatives. When he forgot to wash his hands before lunch, he tasted something sweet on his fingers. Three hundred times sweeter than sugar, and cheaper to make, saccharin was soon a popular food additive.

Monsanto got its start in 1901 selling only saccharin. Harvey Washington Wiley, the crusading chief of the Department of Chemistry, tested saccharin along with several dozen food additives, on volunteers he called The Poison Squad. Wiley was certain saccharin was toxic and after the Pure Food and Drug Act was enacted in 1906, he tried banning it. President Teddy Roosevelt, whose doctor had recommended saccharin to help Roosevelt lose weight, personally intervened to block the prohibition. Wiley waited until Roosevelt left office. Saccharin was finally banned in 1912 and listed as “a poisonous and deleterious substance.”

The food industry carved out a loophole, however, that allowed sales for those “with special medical needs…who must restrict intake of ordinary sweets.” That exception was considerably relaxed during World War I when sugar was rationed. Saccharin had steady, if unremarkable sales, for decades. It took off, however, when a competitive sweetener, cyclamates, got banned in 1969 when two animal studies showed they caused bladder cancer.

Cyclamates were America’s top selling sweetener, almost 20 million pounds a year. Within weeks of that ban, Sweet’N Low, Diet Pepsi, and Tab, switched to saccharin.

 After the ban, Ralph Nader and other consumer and health activists asked the FDA to further investigate whether saccharin was truly safe. There were a dozen studies dating back to 1948 that raised questions about saccharin’s possible toxic side effects and whether it encouraged tumors. The FDA ignored those pleas and put no restrictions on the use of saccharin. There were more urgent calls for action in 1973 after two studies, one sponsored by the FDA, revealed that saccharin given to lab animals sharply increased the rate of bladder, breast, uterine and ovarian cancers.

That prompted the FDA to remove saccharin from its “Generally Recognized as Safe” food additive list. The food industry, however, led by the biggest American saccharin producer, Sherwin-Williams, succeeded in blocking any further regulation. The standoff lasted until 1977 when Canada’s equivalent of the FDA published a study that showed saccharin given to lab rats dramatically increased bladder cancer and posed a significant risk to embryo development. Ten independent pathologists confirmed the Canadian results. Large-scale use of saccharin in consumer foods was only a few years old and many scientists worried that not enough time had elapsed for a significant-excess in saccharin-induced cancers to be apparent in the general population. Unrestricted use of saccharin was, they argued, a time bomb and by the time the increase in cancers was evident, it would be too late.

 The FDA responded to the Canadian study by announcing in March 1977 that it intended to completely ban saccharin. Sherwin-Williams and its competitors hatched a counterattack at a hastily convened summit in New York. They launched a multiprong assault to undermine the Canadian study. They struck gold when they realized that the Canadian researchers fed the rats the daily equivalent of 800 cans of diet soda. Editorial cartoonists and late-night comedians had a field day. The decade-old Calorie Control Council, an international association that described itself as “representing the low-and reduced-calorie food and beverage industry,” blasted the Canadian study in full-page newspaper and magazine ads as “unscientific” and “biased.” It secretly funded a write-in campaign to Congress complaining about the proposed ban as “an attack on democracy and Americans’ freedom of choice.”

The American Diabetic Association contended that saccharin was “a medical necessity” for treating diabetes. Toxicologists and statisticians who were friends of the food industry signed a public letter stating that it was unlikely saccharin was “a potent carcinogen for humans, if it is one at all.” Even the American Cancer Society protested that “banning saccharin may cause great harm to many citizens while protecting a theoretical few.”

America’s diet soda generation was outraged. A record-breaking number of letters and phone calls to the FDA demanded it reverse course. Congress held public hearings. Editorial boards in the nation’s premier newspapers weighed in.

A new commissioner at the FDA supported the prohibition but offered a compromise to calm the firestorm: saccharin would be available as an over-the-counter drug for diabetics and others who required it for medical reasons. That was the solution Canada had implemented. But it was a non-starter for the U.S. food and chemical industry. They knew such a rule would require them to demonstrate saccharin’s effectiveness in treating diabetes. As a food additive, it only had to be safe, but did not have to prove any efficacy. The food industry’s internal studies showed that a third of a can of diet soda caused about a 15% drop in blood sugar, making people eat more and gain weight faster than those who did not use artificial sweeteners. Since obesity was the primary driver of spiraling diabetes rates, such a revelation would almost certainly block any FDA approval of saccharin as a nonprescription drug.

Teddy Kennedy introduced an amendment in the Senate to postpone the FDA ban for eighteen months and instead put a warning label on saccharin products. Bipartisan support got the extraordinary amendment through Congress in record time and Jimmy Carter signed it into law in November 1977. That speed-record political reaction is evidence of how successful the food and chemical industries were in cultivating the popular belief that a 100-year-old non-nutritive artificial sweetener was safe for weight control and diabetics and that animal tests were inaccurate in predicting human cancer risks.

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Rethinking the “Gold Standard” (Bernard Fisher)

In 1981, the ninetieth “anniversary” of William Halsted coining radical mastectomy, a study was published with results of the first ever clinical trial to determine whether Halsted’s drastic surgery saved lives or prevented cancer from recurring. Since he had developed it at the turn of the twentieth century, it had become the gold standard for breast cancer surgery. Its proponents had ridiculed some surgeons in the 1950s who suggested that less mutilating lumpectomies might be as effective a cancer fighting tool.

It had taken until 1971 to begin the trial. It would never have even happened if it had not been for the persistence of a single surgeon, Bernard Fisher, who had relentlessly challenged the status quo and finally convinced a consortium of academic hospitals to conduct the clinical trial. Getting women with breast cancer to volunteer was not easy. They would be divided in three groups, one getting a radical mastectomy, a second group only the lumpectomy, and the third a lumpectomy followed by radiation. By signing on to the study, there was a good likelihood that many of the women would discover when it was over that they had been randomly assigned to a category that shortened their life or increased the odds their cancer would recur. 

The researchers took ten years to gather the data on 1,765 patients around the U.S. and Canada. When the results were released in 1981, they sent a seismic shockwave through the insular world of surgical oncology. The rates of cancer recurrence, death, and cancer metastasis were “statistically identical” in all the groups.

The sobering realization was that half a million women had undergone a disfiguring surgery during the previous ninety years. In many instances it was unnecessary. Some had been talked into it by their surgeons. Others may have wanted it, hoping it would save their lives. Most, however, never knew they had a choice.

Nineteen eighty-one was by coincidence the same year when the food industry won a relentless campaign to win FDA approval for another artificial sweetener, G. D. Searle’s aspartame. Discovered by accident in the mid-1960s, the FDA had refused for fifteen years to approve it because studies showed that large doses might cause brain cancer. Food companies used the safety questions over saccharin’s safety to open the door to aspartame.

In one year, aspartame replaced more than a billion pounds of sugar in the American diet (it was the sweetener in Diet Coke when that was launched the following year).

All the while, the food and chemical industry continued its battle to remove the warning label from saccharin products. They thought it cast a pall of uncertainty over the safety of all artificial sweeteners. The companies spent millions underwriting other ‘research studies’ designed to show that humans metabolize saccharin differently than animals. A slew of industry-friendly researchers concluded that the increased cancer rates in lab rats had little predictive value for people. Armed with those results, the FDA ultimately eliminated the warning labels and removed saccharin from the agency’s list of known carcinogens.

A series of clinical studies starting in the mid-1990s raised fresh health concerns about artificial sweeteners. In 1996, aspartame was again linked to brain cancer; two years later another trial demonstrated it could destabilize DNA metabolites; in 2008 a review concluded it broke DNA strands in the bone marrow of mice. That was the same year that Italian researchers finished a study showing women were at higher risk of urinary tract cancer if they consumed aspartame or saccharin products for 10 years or more. The most comprehensive meta-analysis ever in 2021 concluded that the data linking artificial sweeteners is “not conclusive” but “more data from large clinical trials are needed to affirm the relationship between artificial sweeteners and cancer.” In March 2022, the French National Institute for Health released a study of 100,000 people over eight years. The conclusion? There was a 13% increased risk of breast and obesity related cancers for those who regularly consumed artificial sweeteners.

What is the position of the most prominent and well-funded advocacy organization, the American Cancer Foundation? On its website: “The evidence suggests that artificial sweeteners (saccharin and cyclamate) found in 'diet' drinks and some foods are unlikely to cause cancer.”

The “large clinical trial” that the meta-analysis called for is playing out in real time with consumers around the globe ingesting tons of mostly unregulated artificial sweeteners in tens of thousands of food products. The Malignant Empire relies on newly declassified documents to uncover the explosive story of how millions in secret food-industry payments have bought the silence of health regulatory agencies and the private cancer-care organizations.

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