2017-02-23

How a toxin became a beauty must-have.



The following is an excerpt from the new book Botox Nation: Changing the Face of America by Dana Berkowitz (NYU Press, January 2017):

The discovery of Botox—a purified and diluted form of the botulinum toxin, the world’s deadliest toxin—followed a series of accidents involving a batch of spoiled sausages, a band of musicians at a Belgian funeral, a pickled ham, and a married pair of Canadian doctors. The toxin is a naturally occurring by-product of the microorganism that causes botulism, a potentially lethal paralytic disease caused by eating contaminated preserved food. Although botulism has likely been around since ancient times, or at least as long as humans have been attempting to preserve and store food, the relationship between spoiled food consumption and the paralytic infection was not scientifically documented until the early nineteenth century.

The first recorded instance of botulism dates back to 1820, when Justinus Kerner, a German poet and medical enthusiast, discovered that a substance in spoiled sausages, which he called Wurstgift (German for “sausage poison”), was responsible for a growing number of lethal food poisonings. Kerner, considered by his contemporaries to be an expert on sausage poisoning, published the first scientific descriptions of what physicians now recognize as the symptoms of foodborne botulism. The next important scientific step in the discovery of Botox came in 1885, when Emile Van Ermengem, a Belgian physician and professor of microbiology, was called in to investigate a massive outbreak of botulism that occurred after a band of musicians who had been playing at a funeral in Belgium became ill from eating pickled and smoked ham, many of whom later died. Through performing a clinical, toxicological, and bacteriologic analysis of the food and the victims, Van Ermengem was the first to successfully isolate the anaerobic bacterium causing the illness, which he appropriately named Bacillus botulinum, after botulus, the Latin word for sausage. Today we recognize the bacterium by the scientific name Clostridium botulinum.

Both Kerner and Van Ermengem found that, even in small doses, the botulinum toxin could be lethal. Early symptoms of botulism, such as blurred vision and difficulty speaking and swallowing, typically appear within eighteen to thirty-six hours after eating contaminated food. Without treatment, the mortality rate ranges from 10 percent to 65 percent, and death usually occurs within a week. An excruciatingly painful experience, untreated botulism paralyzes victims’ bodies from the inside out: their bowels open, their autonomic nervous system fails, and eventually their lungs stop functioning, resulting in death by suffocation.

Only relatively recently has the medical world applied the botulinum toxin—in highly dilute form—for therapeutic purposes. In the 1970s Dr. Alan Scott, an ophthalmologist in San Francisco, began using a form of the toxin, botulinum toxin A, for the treatment of blepharospasm, a disorder of uncontrollable blinking. He branded the new drug with the less-threatening name “Oculinum.” Around the same time, the biochemist Edward Schantz started using the nerve toxin to treat strabismus, the condition more commonly known as “crossed eyes.” By the 1980s, the toxin was widely applied by both ophthalmologists and neurologists as a remedy for crossed eyes, uncontrollable blinking, and other facial, eyelid, and limb spasms.

Jean Carruthers, an ophthalmologist who was using Oculinum to treat crossed eyes and optimal spasms, was the first to discover the botulinum toxin’s cosmetic potential. During a routine procedure in 1987, one of her patients pointed to her brow and told her, “When you treat me there I get this beautiful, untroubled expression.” The next day Jean and her husband Alastair, a dermatological surgeon, decided to inject Oculinum in the forehead of their assistant, Cathy Bickerton Swann. Less than a week later, they observed that the lines on Swann’s brow that used to make her look angry and tired had completely vanished. From that day forward, Swann has been famously known as “patient zero” in the Botox trials.

Even though the Carruthers “discovered” what we know now as Botox in 1987, it took another decade before people could be persuaded to use it. The idea that you could use a poison to paralyze and relax muscles to take away lines was foreign and bizarre, even for dermatologists to grasp. Word about the toxin traveled slowly but steadily; doctors would hear about it at a conference or through colleagues, they would try it on a patient, and then the patient would tell their friends about it. In 1991, Allergan bought Oculinum for about $9 million, rebranding it “Botox.” During the 1990s, as increasing numbers of dermatologists became convinced that the Carruthers had stumbled upon an extraordinary discovery, they persuaded more and more of their patients to give it a try, and Botox slowly became a beauty secret among insiders, celebrities, and socialites. By 2002, when the FDA finally approved the drug Botox for the cosmetic treatment of glabellar lines, word had already been widely circulated about the revolutionary drug.

By 2015 over eleven million people in the United States had used Botox, a derivative of the deadliest toxin on the planet, to smooth their facial wrinkles. As the journalist Alex Kuczynski notes, seemingly overnight Allergan was “transformed from a relatively small potatoes pharmaceutical company that sold acne products and eye drops to a hugely influential player on a billion-dollar global field.” So how did this happen? If we want to understand the roots of Allergan’s sudden transformation from a small pharmaceutical company into a multibillion-dollar giant, we have to go back forty years to the beginnings of the deregulation and commercialization of American medicine.

America’s recent era of deregulation began in the 1970s when the Federal Trade Commission (FTC) filed an antitrust complaint against the American Medical Association’s (AMA) ban on direct advertising and patient solicitation. By 1978 the FTC declared that the AMA ban against soliciting business through advertising and marketing was a violation of the Sherman Antitrust Act, which made it illegal to prohibit certain business activities that reduced competition in the marketplace and restrained trade. In 1982, the Supreme Court upheld the FTC’s ruling.

Then in 1992 Congress passed legislation that sanctioned reductions in the testing time of new drugs by the Food and Drug Administration (FDA), reducing drug approval times by close to 50 percent. As a result of the Federal Trade Commission’s rulings, the FDA’s ability to control the marketing and advertising of drugs has been significantly truncated. This deregulation was further accelerated in 1998, when pharmaceutical companies began to advertise in print media and television and on the Internet, opening the gate for Viagra ads during Monday Night Football and Botox commercials in between nightly reality TV programming. When the FDA approved Botox for cosmetic use in April 2002, Allergan spared no expense and wasted no time. The company began advertising the following month, committing a whopping fifty million dollars to its consumer ad campaign. By May 2002, Botox advertisements ran in twenty-four different magazines, including People, the New Yorker, Vogue, and In Style. By 2007, Botox had its first celebrity spokesperson, the actress Virginia Madsen, and in 2009, the actress, singer, and beauty queen Vanessa Williams became the second celebrity spokesperson for the product.

But advertising alone does not account for Botox’s sudden rise in popularity. In addition to marketing in traditional ways, Allergan used other creative product placement strategies to ensure that Botox was promoted throughout the editorial pages of magazines. Even before Allergan committed to spending a single dollar on marketing, journalists, a group significantly more trusted by the public than advertising executives, functioned as ghost marketers in the public relations campaign for Botox. Nobody seriously trusts advertisements these days, but many of us still believe what we read in magazines. And it is this credibility on which Allergan’s public relations campaign banked.

By 2002, Allergan’s strategic marketing campaign was already skillfully woven throughout the editorial pages of national magazines. In 2002, Newsweek published a landmark article titled, “The Botox Boom.” Pegging it as “the miracle drug for Boomers,” Newsweek wrote that Botox was “helping to make trophy wives out of ordinary ones, turning character actresses back into ingénues, and erasing the stigma of failure from the brows of laid off technology executives.” Similarly, an article in Time said Botox was a “facelift in a bottle... a true miracle drug.” Another 2002 headline from Harper’s Bazaar read, “Imagine looking younger in an instant, with no surgery and no side effects.” Journalists raved that Botox was “easy, reliable and can be administered over a lunch break.” Word was out. We had finally found the fountain of youth, and its waters could be harnessed in a syringe.

Trials and Tribulations

When I asked dermatologists to tell me how they felt when they first learned about Botox, every single one emphasized the drug’s extraordinary properties and wave-making consequences. I heard phrases like “revolutionary” and “transformational.” Ivan Camacho, a Latino dermatologist with a thriving practice in Miami whom I met at the American Academy of Dermatology meeting in 2014, told me, “It is really amazing how a toxin has created a generational change in how we have been able to intervene in the aging process.” And it has.

It has also proved useful for a range of other ailments, including cerebral palsy, carpal tunnel, tennis elbow, migraines, facial tics, incontinence, and chronic anal fissures. In fact, its applications are so versatile that medical authorities have begun comparing it to penicillin. Mitchell F. Brin, a neurologist and senior vice president of development at Allergan, pronounced, “Botox will transform the world the way penicillin has transformed infectious disease.” One German doctor even likened Botox’s significance to that of chemotherapy. If these analogies seem a bit hard to swallow, then how about those studies reporting that Botox could potentially cure depression? In 2013, Dr. Eric Finzi, a dermatologist lauded for his pioneering research on Botox and mental health, made international headlines when he found that more than half the people that he treated for depression with Botox shots showed significant improvement in their mood. A profusion of articles with titles like “Can You Really Botox the Blues Away?” and “Don’t Worry, Be Pretty” littered magazines, newspapers, and digital media that year, shaping a new cultural imaginary about the relationship between aesthetic enhancements and mental health.

Botox has enjoyed some considerable publicity over the last decade and a half. Yet, despite riding high on an unprecedented period of success, there have also been a host of legal problems and public relations scandals with which Allergan has had to deal. Within only one year of Botox’s cosmetic approval, Allergan received a scorching letter from the FDA accusing the company of minimizing the drug’s side effects, for having advertisements that neglected to disclose facts about the product’s use, failing to present all of the serious risks associated with Botox, and omitting the duration and severity of such risks. This initial reprimand generated an outpouring of negative press coverage, stimulating early patient concern about the dangers of the drug.

However, it was not until a year later that the real publicity nightmare started—an acrimonious high-profile Hollywood lawsuit that instantly made media headlines. In a trial that could have easily been the subject of a theatrical melodrama, Irene Medavoy, a former model, actress, and wife of a high-powered Hollywood film executive, sued her dermatologist, Dr. Arnold Klein, after she fell gravely ill when he treated her migraine headaches with over 80 units of Botox. Medavoy had already been going to Klein, a celebrity dermatologist with A-listers like Michael Jackson and Elizabeth Taylor on his client roster, for her Botox Cosmetic injections. When Klein suggested she try Botox to relieve her debilitating migraine headaches, Medavoy saw it as a no-brainer. In addition to injecting her that day for her usual cosmetic routine, Klein injected Medavoy at the base of her skull, behind her neck, and behind each ear. Within one week of the procedure, Medavoy reported being incapacitated by headaches and had fever, blurred vision, ringing ears, respiratory problems, gastric distress, and difficulty swallowing. After her medical problems persisted for months, Medavoy sued Klein for unspecified damages, alleging that Klein committed malpractice by failing to get informed consent from her for use of Botox and its potential side effects, especially those arising from off-label uses such as her migraine treatment. She also sued Allergan for product liability, condemning Botox for being “an inherently dangerous product.” Medavoy sought reimbursement for both her medical bills and her lost wages from a proposed talk show. Throughout the trial, Medavoy was painted as a vain and frivolous opportunist and ultimately lost her case when the jury eventually sided with Allergan, nine to three. Despite the win for Allergan, the trial was not “without wrinkles for Botox,” and neither Allergan nor Klein left the courtroom looking innocent.

One of the most crippling testimonies against Allergan came from Mitchell Brin, a senior vice president at Allergan and neurologist (the same man who compared Botox to penicillin), who confessed under cross-examination that the risks of Botox were unknown in dosages higher than 20 units and that the drug can spread to other parts of the body, affecting neuromuscular transmission. He also confessed that Allergan’s own clinical studies suggested that Botox might be associated with headaches, pain, sinusitis, flu-like symptoms, and respiratory problems. Medavoy’s own neurologist told journalists that he had conducted independent research demonstrating how Botox’s paralysis of facial muscles could potentially cause changes in other muscles around the body. He found that injecting Botox in a person’s forehead could cause changes in muscle function in the hands and the feet—something that Allergan’s product literature gives very little attention.

In addition to exposing the potential risks of Botox, particularly with respect to the off-label uses of the drug, the trial turned the spotlight on the larger issue of the dubious relationships between pharmaceutical companies and doctors. As one of the forty doctors who were trained by Allergan’s public relations experts to act as media spokespeople for Botox, Klein was paid over $100,000 a year by Allergan for his work as a consultant and media spokesman and had not disclosed this conflict of interest to Medavoy. In addition, Klein also received bonuses of $10,000 a day and travel expenses for his attendance at professional meetings where he promoted Botox, championing the drug’s diverse applications. Klein’s company, Minimally Invasive Aesthetics, received a total of $499,000 from Allergan between September 2000 and December 2003. When interviewed about the case, Jerome Kassirer, the former editor of the New England Journal of Medicine, said Allergan was “turning doctors into sales reps”; about Klein, Kassirer alleged, “It is clear he is being paid to promote the drug.”

In his book, White Coat, Black Hat: Adventures on the Dark Side of Medicine, the medical bioethicist Carl Elliott observed how one of the ironic consequences of the American Medical Association’s increased policing of pharmaceutical salespeople at the turn of the millennium was that doctors rather quickly became the new drug reps; after all, doctors are the best people to market a drug to other doctors and to their patients. Physicians are not only given free samples of drugs and encouraged to promote and prescribe them, they are also urged to use them for off-label purposes, as Klein did with Medavoy to treat her migraines. Although in our current age of commercial medicine, these ethically ambiguous relationships between physicians and pharmaceutical companies are routine, most people typically do not know about them. Only recently have they come under public and governmental scrutiny. Some argue that the landscape has changed somewhat since 2002, after the Office of Inspector General in the U.S. Department of Health and Human Services declared that it would crack down on big pharma’s promotional practices. Under the imminent threat of prosecution, the Pharmaceutical Research and Manufacturers of America began to self-regulate more seriously, adopting a “voluntary code of ethics” on their relationships with health-care professionals. However, skeptics have alleged that this new code is nothing but smoke and mirrors.

Even with the increasing transparency of payments from pharmaceutical companies to health care professionals, the vast majority of patients are not aware that their physicians are paid consultants and spokespeople for pharmaceutical companies. To combat this, one consumer advocacy group, ProPublica, has started a website, aptly named “Dollars for Docs,” where patients can see if their physicians have received money from a pharmaceutical company. According to this site, Allergan spent over seventeen million dollars on Botox, paying close to sixty thousand doctors across the globe. Despite the fact that the Medavoy case made media headlines and was a public relations debacle, expenditure of Botox declined only minimally in the months following the trial. Yet it would only be a year before Allergan’s next major scandal—and this time the consequences would be even grimmer.

In November 2004, Bach McComb, an osteopath with a suspended medical license from Florida, got his hands on some black-market Botox and injected himself, his girlfriend Alma Hall, and another couple, Eric and Bonnie Kaplan, with catastrophic amounts of improperly diluted raw botulinum toxin A—a research-grade botulinum not suitable for human use. The outcome was dire. McComb was on a respirator until February 2005, and his girlfriend Alma Hall was in the hospital for seven months, four of which were spent on a respirator. The Kaplans spent over two months on respirators before they were able to breathe on their own. Eric Kaplan had recovered by 2005, but his wife was not as fortunate. Bonnie’s face was still partially paralyzed over a year and a half later, she could still barely walk, and she had lost 50 percent of her hearing. In court, the Kaplans and Hall vividly described their tormenting experience after the poison began to take effect—they were fully conscious, but they were unable to move, speak, or even breathe on their own. At the conclusion of the hearing, McComb’s medical license was revoked, and he was sentenced to three years in federal prison for misbranding and trafficking an illegal drug.

During the trial, it came to light that McComb purchased his research-grade botulinum from a California company called List Biological Laboratories, owned by naturopathic physicians Zahra Karim and Chad Livdahl. A report by federal prosecutors revealed that Karim and Livdahl’s company bought over three thousand vials of the research-grade botulinum for $30,000, reselling it for $1.5 million to over two hundred doctors across America. After pleading guilty to federal charges of illegal drug distribution, Livdahl was sentenced to nine years in prison, Karim to five and a half years, and both were ordered to pay substantial fines. The case made international headlines, exposing the chilling underground industry of black-market Botox. A subsequent 2004 investigation by the FDA uncovered that bootleg botulinum was being imported illegally into America from all over the world. The mid-2000s saw the publication of several magazines articles warning consumers about crooked providers purchasing impure Botox from China, Afghanistan, and the former Soviet Union. Take for example, the following excerpt from Newsweek:

He came for his pinprick like everyone else, lured by the promise of wrinkle-free skin. But for 47-year-old Freddy Borges, the price of vanity was higher than the $300 per injection he paid to a New York City couple, Iris and Eliezer Fernandez. The Fernandezes weren’t doctors, according to law-enforcement officials who charged them with assault and reckless endangerment. (They pleaded innocent.) And the treatments weren’t Botox, the antiwrinkle wonder drug. Whatever they were, they left Borges with ugly purple scars that no injection can fix.

A cultural panic around Botox rapidly ensued, and the editorial pages of magazines were punctuated with horror stories about black-market Botox, cautioning consumers that, in a hurting economy, greedy doctors and other aesthetic practitioners were cutting dangerous corners—they were buying fake Botox, diluting their Botox, and taking advantage of consumers who were vain, insecure, and starved for a quick fix. Magazine articles with titles like “Doctors without Borders” warned readers about the dangers of getting duped by practitioners using bargain, botched, and black-market Botox. Stories about vanity-obsessed women falling prey to unscrupulous providers made for entertaining journalism and were commonly picked up by magazine editors.

Readers were repeatedly advised to choose a physician who was board certified in dermatology or plastic surgery and who had years of experience with injectables. Alongside foreboding allegations like “Qualified doctors don’t go to parties with syringes of Botox,” readers were warned about the risks of going to private residences, Botox parties, hair salons, and medical spas. Yet the arousing concern over bootleg Botox soon subsided. A week after the McComb incident, Allergan’s stock dipped slightly but then quickly rebounded. And although consumers were initially alarmed, the overwhelming majority had not stopped using Botox. Why didn’t the Medavoy or McComb case create a lasting cultural panic about Botox? And why didn’t a discourse on “Botox as dangerous” ever catch on? One reason for this obviously has to do with the millions of people who have used Botox without any major risks or side effects. Another is that Botox appeals to the kind of people who are willing to modify their bodies in order to look younger, and these are people who tend to overlook risks. Much of the reason Botox did not fail, however, stems less from individual people and their choices than from cultural and medical discourses that project Botox’s positive effects. Drawing upon media coverage, advertising, and conversations with Botox providers, I now turn to an analysis of the dominant cultural and medical discourses that have contributed so greatly to Botox’s success.

“Everybody’s Doing It”: The Normalization of Botox

“You are going to have to do it, and not that long from now... not because you hate yourself, fear aging, or are vain. You’re going to get a cosmetic procedure for the same reason you wear makeup: because every other woman is.” These are the provocative opening sentences of Joel Stein’s 2015 cover story for Time magazine, entitled “Nip. Tuck. Or Else,” where he predicts that cosmetic procedures will become even more common than they are today and that those who choose to age without technological intervention will eventually become the minority. Stein shows how the stigma that once accompanied cosmetic procedures has been dramatically reduced and how the notion of “having work done” has lost much of the shame that had accompanied it only a few decades ago. According to Stein, “This is the first generation that thinks about plastic surgery as almost a given.... They’re the first generation to grow up with the idea that plastic surgery is neither superexpensive nor a weird thing that only the maladjusted would do.”

While his argument is problematic and flawed for many reasons—most notably in that many cannot afford such procedures or that some might not even want them—in some respects Stein is not so far off. Survey data have confirmed that Americans have grown increasingly comfortable with the practice of altering their faces and bodies through surgical and nonsurgical procedures. Since 1997, the number of Americans who underwent cosmetic surgical procedures increased from 900,000 to 1.7 million. In 2014, there were over 15 million surgical and nonsurgical cosmetic procedures performed in America. Of these 15 million procedures, 1.7 million were surgical procedures, and nearly 13.9 million were nonsurgical procedures. The growth in cheaper, nonsurgical procedures rose from 700,000 in 1997 to well over 13 million in 2014.53 In less than two decades, there has been a 500 percent increase in the total number of minimally invasive procedures—such as injectables, skin resurfacing, and laser procedures—and nonsurgical facial rejuvenation procedures have experienced more growth than any other cosmetic procedure. In 2014, Americans spent almost 13 billion dollars on cosmetic procedures. Two billion of these dollars were spent exclusively on Botox.

A 2010 survey revealed that almost half (48 percent) of all Americans, regardless of income, approve of cosmetic surgery, and almost a quarter would consider it for themselves. More striking is that 48 percent of respondents with an income of under $25,000 approve of cosmetic surgery, and 23 percent of these respondents would consider cosmetic surgery for themselves. These statistics suggest that feeling good about the way one looks is important to the majority of Americans—even those who can’t easily afford cosmetic surgery without accruing debt. Cutting across gender lines, these ratings show that women’s approval rating for cosmetic surgery is only slightly higher (59 percent) than men’s (51 percent). Despite this almost gender-neutral approval rating, the actual practice of cosmetic surgery and enhancement is nowhere near gender neutral; in 2014 women accounted for 92 percent of the total number of cosmetic procedures. The numbers for Botox injections are similar, with women constituting 96 percent of the total.

Cosmetic procedures are something that Americans no longer keep secret, as 73 percent of women and 66 percent of men said they would not be embarrassed if others knew they had gone under the knife, needle, or laser. Recent analyses of print media revealed narratives of pride among celebrities as they recounted their cosmetic surgeries with a combination of “graphic realism, enthusiasm, and cheerful exclamation.”

Where the normalization of Botox is related to a broader trend in the mainstreaming of aesthetic procedures, the fact that Botox injections are temporary, repetitive, addictive, and marketed as preventive has made it such that these injections are fast becoming regular body upkeep, just like teeth cleaning and haircuts. Rebecca Steinberg, a tall, slim, self-assured Miami dermatologist with enormous brown eyes, told me that Allergan’s success in marketing Botox injections means that they are increasingly becoming a normalized, routine, and casual component of female maintenance for its consumer base: “For these women, it's now like you get highlighted, [you get a] manicure, you get your teeth bleached, and [you get] your Botox. It’s not a big deal. It’s one more thing you do.” According to an article in Vogue, Botox injections had become “an appointment many of us... greet every few months with about as much ceremony as a manicure.” In an article in People, one skin-care expert proclaimed, “I don’t know why people want to make a controversy about Botox—it’s a basic thing, like getting a manicure or getting your hair dyed. It’s on the grooming checklist, its part of the game.” Similarly, soap-opera star Lisa Rinna, who famously underwent surgery to drain her botched lip injections, announced that Botox for her is “like changing the oil in your car.”

The growing nonchalance and mainstreaming of Botox was nowhere more evident than in the slew of candid celebrity narratives that colored the pages of People magazine. One article in this magazine reported that celebrity doctors in New York and Los Angeles estimated that 75 percent of stars over thirty-five get injected with Botox regularly. Declaring that Botox was “not all that different from getting fake tans or teeth whitening,” Hollywood starlet Nicole Richie asked, “Why grow old gracefully when you have the technology to prevent it?” Even men were jumping on the Botox bandwagon. Former Baywatch star David Hasselhoff admitted, “Of course I have had Botox, everyone has,” and TV personality Simon Cowell maintained, “To me Botox is no more unusual than toothpaste.”

Extraordinary interest in the lives of celebrities and, in particular, fascination with their beauty secrets, surgeries, and enhancements has been a vital force in fueling the rise of Botox and cosmetic surgical culture more broadly. It is increasingly more common for celebrities (and even more so for manufactured celebrities such as the Kardashians) to document the amount of time, energy, and money they spend on their appearance. In celebrity culture, vanity and superficiality are celebrated, and obsessing about one’s physical appearance and tweaking it with cosmetic enhancements is now the “cool” and “hip” thing to do. Moreover, with the rise of new technologies like tablets and smart phones, the quest for feminine youth and beauty is made public; women, particularly celebrity women, no longer become beautiful in private. All the creams, potions, lasers, and needles that go into making bodies beautiful are now public for the entire world to witness, emulate, and scrutinize. We watch as manufactured celebrities from reality TV shows like Keeping Up with the Kardashians or The Real Housewives franchise get injected with Botox in their own homes. Even when celebrities do not come forward about their aesthetic enhancements, tabloids and gossip blogs subject celebrity skin to close readings in an attempt to discern whether or not these starlets have gone under the needle or the knife.

This has been an excerpt from the new book Botox Nation: Changing the Face of America by Dana Berkowitz (NYU Press, January 2017).




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