An even more important consideration is whether Adderall actually works to improve grades in children without ADHD. The supposed benefits of Adderall as a study aid in healthy children are largely anecdotal. The causes of poor school performance are multifactorial, and many of those factors are not amenable to Adderall. Prescribing the drug without addressing basic remediable factors, such as parental involvement and improving nutrition, sleep habits, and physical fitness, borders on malpractice.
It would be disingenuous not to acknowledge that some students might benefit from Adderall. Its mechanism in ADHD is unknown, but its effect cannot be ignored. This is where science comes in. Today the trend in medicine is toward minimizing reliance on anecdotal experience and using instead evidence-based practice, studies to determine the safety and effectiveness of medications in selected populations.
If we seriously want to consider the use of Adderall to improve student performance, the government and the pharmaceutical companies should undertake well-designed, large-scale studies with appropriate informed consent for the children involved. This is the best way to maximize the benefit and minimize the harm—and even this is not perfect. Critics might reasonably object to the mind-control aspects of such studies. An understandable concern, but consider the alternative: doctors blindly prescribing these drugs and parents seeking them out for their children on an ad hoc basis.
In 1931 the English writer Aldous Huxley anticipated the Adderall issue in his novel Brave New World, the story of a futuristic society. One feature of that fictional society was the widespread use of a state-sponsored drug called “soma” (not to be confused with the real-life muscle relaxant of the same name). The literary soma was given to citizens to abolish feelings of unhappiness, anxiety, and rage, which had the associated effect of discouraging independent thought. In the story, Huxley described a solidarity service, a meeting where mindless conformity was encouraged through the administration of soma. “By the time the soma had begun to work, eyes shone, cheeks were flushed, the near light of universal benevolence broke out on every face in happy friendly smiles,” Huxley wrote.
Huxley’s brave new world was intended to be a dystopian nightmare. Does the widespread prescribing of Adderall pose a danger of creating a similar but real nightmare?
40
IS “LOW T” AN ACTUAL DISEASE?
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The difficulty of defining disease is implied in the very structure of the word: “dis-ease.” So many different kinds of disturbances can make a person feel not at ease and lead him to seek the aid of a physician that the word ought to encompass most of the difficulties inherent in the human condition.
—RENÉ JULES DUBOS
THE FOOD AND DRUG ADMINISTRATION (FDA) prides itself on taking an active role in protecting consumers from the risks associated with direct-to-consumer testing. Yet the FDA has been notably restrained on the pharmaceutical marketing saturating the media and Internet concerning “low T,” a condition that might be a “disease” or simply just a slick advertising strategy to generate drugs sales.
Low T is the term for the decreasing blood level of the male hormone testosterone in most men over the age of thirty. While extreme testosterone deficiency is an actual inherited or acquired hormonal disease in a small number of men, a gradual drop in testosterone occurs in normal aging men (in contrast to the precipitous drop in sex hormones experienced by women at menopause). Although low T is a campaign to diagnose patients with “below normal” values of testosterone, this is problematic because the “normal” range for testosterone in the blood for males varies widely from age thirty through eighty. The ostensible purpose of diagnosing low T appears to be to create a market to sell testosterone supplements to a significant segment of middle-aged American and Canadian men. And it’s working—in both countries testosterone use has increased exponentially in the past decade.
In a 2012 Colbert Report, Stephen Colbert facetiously, but accurately, described the billion-dollar industry: “A man on TV is selling me a miracle cure that will keep me young forever . . . for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.”
The pharmaceutical marketing of testosterone supplements avoids the scrutiny of the FDA by exploiting loopholes in the advertising laws. The FDA closely monitors prescription medication advertising—witness the fast-talking fine-print patter on television—but a company can circumvent that by creating a “disease-awareness” campaign. Low T advertising becomes part of disease awareness or in the industry jargon, having men take a proactive approach to their overall health. Commercials advise men to see their doctor for a checkup and to get tested for blood pressure, cholesterol—and testosterone. The unstated message being that low T is now a risk factor comparable to high blood pressure or elevated cholesterol.
That’s what is meant by disease awareness. Of course a disease usually has symptoms, especially if a specific treatment is being marketed to the public. So according to the advertising, symptoms of low T include occasional fatigue, weight gain, mood swings, and decreased sex drive. Basically, symptoms endemic in aging baby-boomer males. In this way, low T is essentially transformed into a “quality of life” disease.
None of this means that testosterone supplements in patients with low testosterone levels have no benefit; testimonials to its effectiveness are not hard to come by. But testimonials are not the same as a proven scientific benefit; there is simply insufficient clinical literature on that count. A review article in JAMA: The Journal of the American Medical Association said, “Testosterone therapy results in only small improvements in lean body mass and body fat, libido, and sexual satisfaction, and has inconsistent (or no) effect on weight, depression, and lower extremity strength. Whether these effects are big enough to matter to patients is unknown.”
At the same time, there is no guarantee that treating low T is completely safe. Some cardiologists worry that one important side effect of testosterone supplementation may be accelerated coronary heart disease. As with the benefits of testosterone supplementation, the risks have not received enough scientific scrutiny to date. Since the low T advertisements are careful not to refer to any specific medicine, there is no obligation to mention any downsides to treatment, unlike warnings that must be included for prescription drug advertising.
Today middle-aged men find themselves in a similar position to women of a generation ago. Then, the medical community pushed for estrogen and progestin supplementation in women during and after menopause on the theory that hormone supplementation would confer protection against heart disease. It was not until 2002 that a Women’s Health Initiative long-term study of hormone replacement in 160,000 women failed to demonstrate such protection. In fact it was suggested the treatment might have increased the danger of heart disease and cancer.
If there is a difference between then and now, it is that the pharmaceutical industry has wholeheartedly embraced the modern direct-to-consumer marketing approach that bypasses the physician. While there are undeniably public health benefits to the direct-to-consumer approach in terms of promoting health awareness, there is a fine line between that and a manufactured campaign for a pseudodisease. And as the case of low T illustrates, there is a lot of money to be made straddling that line. That straddle may not be illegal or even unethical. But it’s close, and until greater study is done on the risks and benefits of testosterone supplementation in low T, the FDA should pay special attention to this new disease.
41
JUST BECAUSE YOU ARE RICH DOESN’T MEAN YOU ARE SMART
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I’ll get killed for saying this but I’m not so against steroids if they’re administered under proper supervision and there is no long-term damage.
—MARK CUBAN
AT A SPEECH at the University of Pittsburgh, Mark Cuban, the Dallas Mavericks’ billionaire owner, gave his opinion on steroids and sports by noting that medical
practices like LASIK eye surgery and Tommy John surgery already improve athletic performance. He asked if that’s not considered cheating, why the double standard when it comes to drugs? “You administer them properly and fairly and set the rules strictly, as long as in doing so we recognize there are no negative long-term health-impact issues.”
Cuban, a superrich windbag who lacks a mind-mouth filter, gets more publicity than he deserves. His uninformed pronouncements reflect the sentiment that steroids should be made available to any professional or amateur adult athlete who wants them. And he has support from some experts who claim the harm in steroids is minimal and represents nothing more than a technology advance, no different from fiberglass vaulting poles or specially designed swimsuits.
In analyzing the issue, medical ethicist Norman Fost cited Ben Johnson in the 1988 Olympics, vilified for using performance-enhancing drugs while American swimmer Janet Evans was hailed for winning a gold medal when she wore a top-secret, high-tech fabric swimsuit. The argument is basically the harm of these drugs is overblown and most side effects are either short term or merely cosmetic. The unfair advantage the drugs confer would be minimized if everyone had access to these drugs.
Yet the short-term physical and psychological side effects have been well documented, even if they are occasionally overstated. As for long-term effects, nobody knows since there has never been any long-term evaluation. It took nearly two decades for the incredible performances of East German female swimmers to come under scrutiny. Because so much is unknown, these drugs must be considered far riskier than LASIK or Tommy John surgery. The athlete who accepts the unknown risks will always have an advantage over those who prefer “to play clean.” But there is no basis to compare these drugs to equipment advances like high-tech swimsuits that confer advantage but do not jeopardize athletes’ health.
The most compelling argument is the danger these drugs pose to children. Professional athletes’ success with performance-enhancing drugs is a main reason the drugs are sought by teenagers—and a strong argument for banning them at the professional level. Even Norman Fost acknowledges the risks to young people. He favors testing young athletes. His punishment for those distributing drugs to them is simple and straightforward—“Hanging followed by a fair trial.”
There is no bright line between seeking a competitive edge and “cheating.” But there is such a thing as cheating. Competitive sports are inherently difficult. Even the greatest competitors are humbled by their sport’s limitations. Mark Buerhle, untainted by any drug allegations, pitched a perfect game for the White Sox in 2009 and set a major league record by retiring forty-five consecutive batters. Right after that he failed to win a game for six weeks. Even in his prime, Tiger Woods occasionally failed to make a tournament cut.
Performance-enhancing drugs permit athletes to circumvent the natural limitations of their sport. The drugs confer an unfair advantage, even if unproven scientifically. Athletes using these compounds cheat their fellow competitors and cheat their sport. Many athletes elect not to use performance-enhancing drugs but are reluctant to point out a problem they know exists. This “conspiracy of silence” extends to coaches and others (especially the Major League Baseball Players’ Union), creating a public crisis of confidence in sports. In the case of complicit sports physicians, it’s a clear dereliction of duty.
If today’s situation is disturbing, genetic engineering advances may soon permit scientists to inject genes into target muscles and exponentially increase performance. Gene transfer therapy, already theoretically possible, might allow the body to repair and re-create damaged tissue immediately. Such techniques might be undetectable by testing. Competitive athletics could become caricatured entertainment—sluggers hitting 250 home runs per season, pitchers with 115 mph fastballs, and sprinters running 100 meters in 7 seconds.
The future is problematic for the sports culture and society at large. Performance-enhancing drugs mean greater paychecks for athletes and billionaire owners like Mark Cuban. But they tarnish competition and endanger the lives of athletes and would-be athletes. Mark Cuban’s foolish belief is that he can extract the value from performance-enhancing drugs without realizing the eventual cost.
42
FLYING TOO CLOSE TO THE SUN
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Don’t decide on a dog based on looks, much like with people, looks and first impressions can be deceiving.
—ELIZABETH HOLMES, FOUNDER AND CEO OF THERANOS
IN 2004 ELIZABETH HOLMES, a nineteen-year-old Stanford dropout, created Theranos, a health care start-up that was once valued as high as $9 billion, which gave her a one-time net worth north of $4 billion. Forbes described her as “the youngest self-made female billionaire in the world.” Like other Silicon Valley wunderkind, she was instantly hailed as a genius and transformed into a media darling, her every trivial observation, even about dogs, regarded as wisdom worthy of Confucius.
Unfortunately, a federal investigation of Theranos showed Ms. Holmes that in the matter of looks and first impressions, some witty quotes can be like some dogs—they can deceive, then turn around and bite.
Theranos was developed based on its “breakthrough technology”; the company claimed it could run dozens of blood tests from a fingerstick instead of a sample drawn from a vein. Anyone who has ever experienced difficulty having his or her blood drawn would appreciate the less cumbersome fingerstick approach. In addition Theranos advertised it could make its results available at a far lower price than other laboratories.
The reason blood drawn from a vein has traditionally been used for testing is because the consistent mixing of blood in veins yields dependable sample results; a fingerstick blood sample is not as uniform. Blood from tiny vessels also contains fluid from tissues where the stick is performed. This is not a problem with small molecules like glucose, where fingerstick samples are reliable—that is what home glucose kits do. But the mixture of tissue fluid and blood changes the concentration of larger molecules like proteins and cholesterol, so fingerstick results are less consistent than that of blood from veins. Theranos claimed to have solved this problem with its proprietary laboratory technology.
At the inception, Ms. Holmes did a brilliant job of promoting the mystique of Theranos. In the name of empowering patients, she touted her company’s mission to permit consumers to monitor their own health with inexpensive and easy-to-run blood tests. Theranos’s original board of directors was a “who’s who” of people like Henry Kissinger and George Schultz—long on business and government clout but suspiciously short on experience in chemistry, pathology, and laboratory testing.
With one notable exception, business journalists were charmed by Ms. Holmes’s marketing approach, as were venture capital firms and other Silicon Valley business moguls. She was compared to Steve Jobs. Soon respected health care companies like the Cleveland Clinic and Walgreens cut deals to partner with Theranos, and this only increased the company’s cachet.
But there was always a sticking point, no pun intended. Because Theranos operated in secrecy, it refused to divulge its methodology or allow its laboratory results to be widely tested against industry standards. The Wall Street Journal, the exception among business publications, raised serious doubts about the Theranos technology, the reliability of their test results, and the lack of medical experience of its board of directors.
The company came under scrutiny by the Centers for Medicare and Medicaid Services, which examined whether the Theranos technology actually works. Theranos admitted that thousands of its laboratory tests from 2014 and 2015 were invalid. Other investigations probed the possibility that Theranos misled investors. The company’s chief operating officer was forced to retire, and to assuage the business community, Ms. Holmes reconstituted the entire Theranos board by adding experienced medical and laboratory experts. After a flurry of lawsuits and settlements, Theranos has burned through large amounts of cash and may have difficulty raising more in the future. Walgreens has terminated its partnersh
ip with the company.
At Stanford, when Ms. Holmes first came up with the idea for a cheap, rapid fingerstick approach to blood testing, she decided on the company name Theranos as a combination of two words with ancient Greek derivation, therapy and diagnosis. Perhaps her appreciation for the ancient Greeks did not extend to the myth of Daedalus and his son, Icarus. Daedalus was an inventor and innovator, the kind Ms. Holmes aspired to be. Trapped on an island, Daedalus, undaunted that man had never left the ground before, invented wings made of wax so that he and Icarus could escape by flying away. Despite his father’s warnings, Icarus, enamored of his newfound ability, flew too close to the sun, causing the wax to melt, and he crashed into the sea.
Lessons for young Silicon Valley entrepreneurs: a little more study of Greek mythology never hurts. The promise of a “breakthrough technology” cost Daedalus his most precious possession, and flying too close to the sun can be dangerous.
The Doctor Will See You Now Page 14