But movies “based on true stories” don’t necessarily tell the whole truth. While Dr. Omalu did identify CTE in football players, he did not give the condition its name, as the movie claims. It was identified and named in boxers decades ago by earlier physicians. That is trivial.
More important, scientists, including in this case Dr. Omalu, often have significant conflicts of interest as well.
The brain findings Dr. Omalu described were all postmortem, and there is currently no way to identify CTE before death. Consequently, there are tremendous medical and financial incentives to discover a test that will demonstrate findings of CTE in living patients. And Dr. Omalu is a partner in a company that proposes to do exactly that. The company, Taumark, owns exclusive rights to a radioactive compound that, when injected into the bloodstream, is supposed to show up in brain scans and identify CTE. If successful, the test would be extremely expensive, and the demand would be tremendous.
In 2013 after an initial study of five NFL players, Taumark was deluged by demands from professional athletes and the parents of amateur football players. Unfortunately, right now the technique remains an experimental research tool. Independent experts caution that it has no proven clinical value at present. “The whole field is in a very early state since we don’t even know what CTE is,” said Dr. Douglas Smith, a traumatic brain injury researcher at the University of Pennsylvania. “Instead of having everybody in a mad dash to get a scan, we need to vet these tests so they are validated.”
This did not deter two of Dr. Omalu’s partners from issuing unfounded claims on the company website stating, “Despite the devastating consequence of traumatic brain injury and the large number of athletes, military personnel and other head trauma victims at risk, until now, no method has been developed for early detection or tracking of the brain pathology associated with these injuries.” Shortly after that, the FDA, which has not approved Taumark’s compound for clinical use, forced them to remove that claim. The compound has yet to prove specific for CTE.
Preventing and detecting brain injury in athletes is a huge emerging industry, and Dr. Omalu’s company could reap immense profits (although other companies have begun testing their own compounds). While his company goes about raising millions of start-up dollars, he is notably reticent about the details of going forward. He told a Pittsburgh interviewer, “It’s a business. I cannot reveal the corporate plans. . . . When people say ‘for-profit business,’ I don’t want people to say that as a derogatory [term]. . . . No, it is something good.”
It certainly might be. There is nothing illegal about medical researchers partnering in commercial ventures. As for being unethical, these types of relationships are encouraged by virtually every American university, so much so that issues of conflicts of interest are often glossed over. When I taught medical ethics to students and residents, they saw no problem with doctors partnering, although they were nearly unanimous that it was unethical if politicians did something similar.
As a Taumark partner, Dr. Omalu has an undeniable interest in the successful outcome of his company’s brain trauma research. In no way does this mean Taumark’s work will automatically be biased or invalid. But it does mean there will inevitably be questions about Dr. Omalu’s credibility and even his integrity, which was depicted as unimpeachable in Concussion.
As Dr. Bailes observed, “It’s business.”
36
I AIN’T AFRAID OF NO MEDICAL GHOSTWRITERS
* * *
It was my fault. I should have read it before it came out.
—CHARLES BARKLEY ABOUT HIS AUTOBIOGRAPHY
HOW COULD YOU be misquoted in your own autobiography? Well, it happened to basketball-player-turned-broadcaster Charles Barkley, who gave the matter a simple explanation. In all likelihood, the problem was that Sir Charles employed a ghostwriter, nothing to be ashamed of since it puts him in decent company with the likes of Ronald Reagan (Robert Lindsey) and David Beckham (Tom Watt).
Athletes, politicians, and celebrities are often short on time, not to mention writing ability, and while they may be reluctant to admit it, ghostwriters are indispensable to telling their stories. But what’s commonplace in the publishing industry has permeated the medical profession. In what has become a widespread practice, ghostwriters are substituting for doctors by writing articles for medical journals about important research. In some cases, it has reached the level of outright deception. The Senate Finance Committee investigated “medical ghostwriting” as part of its examination of pharmaceutical company influence on the health care industry. During the probe Senator Charles Grassley (R-IA) was given internal company documents showing that pharmaceutical giant Wyeth hired ghostwriters to write favorable medical journal articles about one of its widely marketed drugs.
According to the documents, a decade ago Wyeth developed in-house concepts for medical articles and hired a company that employs medical authors, who are not doctors, to write the manuscripts. Wyeth then recruited prestigious physicians to put their names on the articles as authors. Once the articles were ready, they were submitted to medical journals as if the doctors had written them. None of this was disclosed to the journals’ editors or readers.
Medical ghostwriting has been an embarrassing issue before. JAMA: The Journal of the American Medical Association revealed that Merck had research studies prepared and written by nonphysician ghostwriters before arranging to have academic physicians put their names on the articles as authors. Recruited authors were frequently listed as primary authors and paid for their participation. Some manuscripts about the pain medication Vioxx were prepared by unacknowledged ghostwriters and attributed to prestigious physicians, who failed to disclose their payments from the company. (In an unrelated matter, Vioxx became the subject of lawsuits and was pulled from the market.) Merck has acknowledged that on occasion it hires outside medical writers to assist the doctors whose names eventually appear on the articles. It maintains the doctors do contribute research and analysis and sign off on the final draft of all articles.
None of this means that published medical research is necessarily inaccurate or biased. Most articles are approved by independent peer review before publication. But it does raise questions for both the scientific and lay communities about the process of medical authorship and the integrity of everyone involved, including physicians who market their names and reputations posing as authors for articles they simply have not written.
The problem is the result of the increasing complexity of medical research. Today medical studies, whether they come from universities or private industry, involve teams of researchers including investigators, statisticians, and writers. In the case of pharmaceutical companies, where there are large sums of money at stake in new drug development and approval, the actual credits for a final paper, if published, might resemble those of a major motion picture.
Unfortunately, many physicians today have neither the time nor the training to write the type of prose necessary to publish these studies. The process of training doctors is in part to blame. Most medical students no longer take writing courses as undergraduates or in medical school. Whereas medical journals were once filled with doctors’ entertaining, well-written accounts, journals today are filled with dense, turgid articles incomprehensible to outsiders (and not infrequently to those in the field).
Enter the medical ghostwriter. Most are professionally trained writers with a scientific background. Of course, as in any field, there are shills among them, but the majority are proud of their contribution to advancing the quality of medical research. Without them, many studies simply would not get published. But full disclosure is the key to ending the current deception. The ghosts must be expunged, and to do so, pharmaceutical companies and physicians must identify those people who actually write the words for them. In addition, as an editorial in JAMA noted, “[Medical] journal editors also bear some of the responsibility for enabling companies to manipulate publications.”
Conflicts of
interest are a serious problem in the medical profession today, but ghostwriting is not necessarily a bad thing—when acknowledged and openly identified. The professional approach to medical ghostwriting should be that of the Ghostbusters theme—“I ain’t afraid of no ghosts.” Even if it is a double negative no self-respecting ghostwriter would ever tolerate.
37
THE BLACKEST OF ALL BLACK MARKETS
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If you think people are inherently good, get rid of the police for 24 hours and see what happens.
—SYLVESTER STALLONE
SNOPES IS A WEBSITE specializing in investigating urban myths. It turns out Walt Disney wasn’t cryogenically frozen after death, and a tooth left in a glass of Coca-Cola won’t dissolve overnight. But the site also investigates more sinister urban myths like the one about people who reportedly have been drugged and had a kidney removed against their will as part of a black market in transplantable organs.
The website diligently tracks the myth’s origins, its perpetuation (including on a 1991 episode of Law & Order), and in a detailed, responsible fashion, debunks the story. There is only one problem—at least in South Asia, the story is not an urban myth. In 2008 an organ transplant ring working out of several Indian states victimized indigent day laborers in poor sections of India. Authorities believe hundreds of people had their kidneys removed and then sold to clients who traveled to India from around the world. A police raid on a covert clinic near New Delhi uncovered a kidney transplant waiting list with forty-eight names, including those of several foreigners (known as “medical tourists”). The police suspect the ring involved doctors, nurses, hospitals, paramedics, and a car outfitted as a tissue matching laboratory. Bioethicists have long suspected organs have also been harvested from prisoners condemned to death in Communist China.
While nothing remotely like this has happened in the United States (although at least two American citizens may have been on the police’s recovered client list in India), this organ black market is an ominous development. The sale of an organ is currently illegal in the United States, with bioethics groups, transplant organizations, and the Vatican all inveighing against putting a concrete price on a kidney. Citing a host of abuses, they envision the exploitation of the poor who might opt for quick cash, as well as recipients reneging on payment agreements, shoddy postoperative care for poor donors, and ultimately the urban myth that has become real in India: a black market in organs.
But there are nearly seventy-five thousand domestic patients with renal failure waiting for kidneys, and each year several thousand of them die before receiving a kidney. Consequently, there is a growing movement in the United States to commodify organs—expand the pool of available organs by offering compensation to people to donate a kidney (a person can live with one healthy kidney). Supporters have proposed changes in the law, including a regulated free market in organs (an “incentive system”), which might save the lives of some of those who currently die awaiting donor organs. They claim a well-regulated federal incentive system would actually prevent a black market of exploited donors. A Nobel Prize–winning economist has even calculated a price he claims would eliminate the current waiting list.
Without putting a price on a kidney, the organ-donation system needs streamlining. Simply relying on altruism, however commendable, does not provide for the number of kidneys needed to eliminate long and sometimes fatal waiting times. The federal government should provide new incentives such as significant tax credits and the assumption of long-term health care costs for those willing to donate a kidney. A radical idea worth discussing—once they have given their gift, perhaps those who donate a kidney should never have to pay either income tax or for their health care. Such a plan would not necessarily mean lost revenue for the government since thousands currently disabled by renal failure would then be able to return to work.
But absolute faith in the free market corrupts absolutely. When kidneys or other organs become simply another commodity, there will be no shortage of those willing to exploit others. That’s why in addition to providing added incentives for organ donation, the federal government should reinforce its vigilance against the unauthorized procurement and sale of organs in light of the Indian experience.
The problem of how to encourage organ donation illustrates an eternal medical dilemma—the conflicting role money plays in health care. The quest for profit drives the research and technology that provide immeasurable benefit to American patients. But the naked edge of the free market also invites exploitation, fraud, and crime, even in medicine. International trafficking in transplantable organs would be the worst conceivable black market. And that’s no urban myth.
38
DOPED: PERFORMANCE-ENHANCING DRUGS KEEP WINNING THE RACE
AGAINST TESTING
* * *
The drug problem has always been with us, and it always will be.
Athletes have always used performance-enhancing substances. . . .
It’s human nature to try to obtain every possible advantage for success. If there were a drug available that would dramatically increase the ability of university faculty to get grants, you’d better believe they’d be injecting their butts with it in front of Old Main.
—CHARLES YESALIS, MPH, LEADING EXPERT ON PERFORMANCE-ENHANCING DRUGS
THE HISTORY OF ATHLETES using performance-enhancing drugs (PEDs) goes back at least two thousand years, when ancient Greek athletes used mushrooms and opioids during athletic competitions, including the first Olympic Games. There are reports of European cyclists using a variety of stimulants during the late nineteenth century. In the twentieth century, German physicians discovered the first injectable anabolic steroids, and these drugs, along with amphetamines, may have been administered to Nazi troops during World War II. After the war, use of these drugs took off in both amateur and professional sporting events.
The drug situation became a reflection of the Cold War—drug use a symbol of the political competition between the East and West. Soviet weight lifters achieved great success in the 1950s using anabolic steroids. While the first Olympic drug testing was established in 1968, the world’s attention was drawn to the incredible performances of East German female swimmers in the 1970s. Many of these young women were selected by the government from an early age, taken from their families, and received intensive training and sophisticated chemical regimens, leaving them with terrible physical and psychological complications years later. Some are infertile or have given birth to deformed children. Others have developed male sex characteristics, and at least one developed so many male sex characteristics, she underwent a sex-change operation.
When East Germany collapsed, these swimmers’ unfortunate stories were revealed, and the world took note of the drug problem in sports. Meanwhile in the West, European cyclists used amphetamines routinely in the 1960s. In the United States, PEDs made their way into professional sports. In 1970 former New York Yankees pitcher Jim Bouton wrote Ball Four, a bestseller about his life in baseball, describing widespread use of amphetamines, known as “greenies.”
Gradually, medical advances made PEDs more accessible to professional athletes, and drug testing could not keep pace with the drug explosion. In the last two decades, drug use has proliferated. Top Olympians, including Marion Jones and Ben Johnson, tested positive for banned compounds, calling their world-class performances into question. Johnson, once “the world’s fastest man,” had his world record one-hundred-meter dash time thrown out and was temporarily banned from his sport. Jones, among America’s top Olympians, was stripped of five Olympic medals and went to jail for events revolving around her use of illegal PEDs.
Following his career, former Oakland Athletics outfielder Jose Canseco publicly charged that steroid use was widespread in baseball. His accusations were first viewed skeptically, but as baseball performances reached new heights, some players confessed to using drugs, lending Canseco’s claims credibility. In 2005 Congress held public hearings, and playe
rs including Mark McGwire and Sammy Sosa, hailed as heroes only several years before, were unconvincing in their denials of steroid use. It’s been disclosed that stars including Alex Rodriguez, Barry Bonds, Andy Pettite, Manny Ramirez, and David Ortiz have all tested positive for PEDs at some point in their careers.
Meanwhile, the abuse of PEDs has crept into college and high school athletics. Surveys indicate more than one million American children between the ages of twelve and seventeen have taken PEDs (including creatine, which falls into a special category). It would be naive to believe the success of professional athletes who have used PEDs has not influenced younger athletes. Since testing is expensive and sometimes impractical at the lower levels, no one knows how serious the problem is. However, the accessibility of these drugs through the Internet and other channels makes PEDs a serious public health issue at all levels of sports.
What are we talking about when we say PEDs? The term is all encompassing and nonspecific. It includes some legal drugs and others that are illegal. Some of the drugs are injected, some taken orally, and others used in skin patches. It includes naturally occurring substances, synthetic compounds, drugs used for other legitimate purposes, nutritional supplements, and drugs used not for performance but to mask or counter the effects of other drugs. This is why it is hard to draw absolute medical conclusions about what drugs athletes ingest.
The Doctor Will See You Now Page 12