My Drug Problem
I think the FDA is too harsh on doctors and pharmaceutical companies!
The American Society of Clinical Oncology (ASCO) held its annual convention in Chicago recently, and I was there. Let me make clear at once that I am not a member of this august body but am instead married to someone who is; I was thus in the logistical position to report (with some admitted bias) on the proceedings.
ASCO is a big organization, and its members engulfed the city. Everywhere I looked, disheveled men and women could be seen carrying over-the-shoulder ASCO satchels and leafing through behemothian ASCO Convention Proceedings. Only Chicago and Orlando have convention centers big enough to accommodate the more than 30,000 doctors, researchers, drug company representatives, and sundry others attached to the cancer industry who attend this meeting each year. And although Orlando has hosted on occasion, there’s a certain dissonance in talking about myeloma in the morning and visiting Mickey Mouse in the afternoon. Chicago, by contrast, is a serious city, more fitting as the site for a serious convention — and what could be more serious than cancer?
One of the salient features of the ASCO annual convention is the large representation of nerds. This is not surprising. If you’re going to treat cancer, you’re going to have to spend lots of time hunched over boring books, drinking stale coffee, and eating fattening pound cake. In other words, you can’t expect oncologists to be buff — in fact, I’d worry if the members of the American Society of Clinical Oncology looked like those of the American Yachting Association.
Not that there weren’t exceptions at this year’s meeting. The Italian female oncologists, for example, were hot in tight skirts and stiletto heels. And the Eastern European oncologists had mullets — not, I have to say, a mark in their favor (would you want to get chemotherapy from these guys?). There were ponytails on the Southern California contingent, who, one might surmise, were spearheading the medical marijuana movement. Finally, of course, there were the French oncologists, a breed unto themselves. The French can bring style to anything, even to cancer, and could be seen in their slippered shoes and pinched-waist suits discoursing coolly about their protocols, with detours into an analysis of “les restaurants de Ćhic-ago” — mispronouncing the name of the windy city in a charmingly French sort of way. Outside the convention center, they could also be found sucking on cigarettes, though sheepishly. It’s hard to carry off smoking at an oncology conference, even if you are French.
As this suggests, ASCO, despite its identification as an American society, attracts a large multinational audience to its annual meeting: vast numbers of Europeans, not to mention South Americans, Africans, and even Chinese. A little investigation reveals why. It seems that the pharmaceutical companies fly in the foreign physicians, lodge them in fancy hotels, and bus them nightly to dinners and shows. This is a great boon both to the advancement of global knowledge and to the vacation plans of foreign oncologists, especially given the weak state of the dollar.
The American oncologists, meanwhile, are excluded from this largess. FDA regulations forbid them from receiving any manner of drug company perk — no travel or hotel subsidies, no dinners or shows, not even a drink or a snack. The principal rationale for this ban is the assumption that American doctors are morally weak and will be seduced into using drugs manufactured by companies that spring for dinner, a drink, or even a refrigerator magnet.
The secondary rationale for the ban is that drug company perks inflate the price of drugs. This may seem logical in theory, but practice shows that the promotional budgets of the pharmaceutical companies have remained unchanged. Money not spent on doctors at home is simply spent on doctors abroad.
Given this two-tiered treatment, it is no wonder that the natives looked irritable. Clutching their ASCO satchels (that seemed to have been redesigned this year to look more like man-purses in deference to the Euro-presence), the Americans had to watch as their foreign compeers were bused off to the Capital Grille, leaving them to gripe about the latest round of reimbursement cuts and malpractice hikes. Even the drug reps appeared to find the situation weird and depressing. “We can wine and dine the foreigners, while we can’t give the Americans stickums, no less steaks,” one rep noted.
I wandered over to the exhibition area, a gargantuan space on one side of the convention center, where the drug companies had their booths. Any money left over from bankrolling the rest of the world’s oncologists seemed to have been lavished on high tech displays, glossy literature, and plush couches and armchairs. The dominant color was orange (the color of cancer?) and there was a plethora of orchids (the cancer flower?). Soft New Age music wafted through the space, and one half expected Dr. Kevorkian to appear and beckon some of the docs to a talk on assisted suicide.
Amid the towering displays were partitioned areas, curtained like seraglios and emblazoned with the warning, “For International Guests Only.” At their entrance were nubile young women who scanned ID cards to make sure that those entering were indeed not American. It seems that a two-tiered system was in effect here, as well: The drug companies are permitted to discourse only to the foreign doctors on “off-label” drug use (i.e., drug applications for types of cancer other than those for which the drugs were formally approved). Once again, FDA rules lie behind the partitioning. They don’t allow the reps to speak to American doctors on off-label use, although the Americans widely and routinely use the drugs this way. Driving the game is the simple matter of time and money: it takes millions of dollars and a dozen or more years for a drug to be approved by the FDA for treatment of one type of cancer, so companies don’t bother to apply for its use on other types, knowing that doctors will learn of these alternative uses from their efficacy in clinical trials. Everyone knows this is standard practice, yet FDA regulators stipulate that the pharmaceutical companies not raise the issue with American doctors — a version of “don’t ask, don’t tell” transferred to cancer treatment. One drug representative explained it all to me, then noted that the FDA had spies undercover to make sure that he abided by the letter of the law.
The problem goes beyond bureaucratic over-scrupulousness. It affects the entire process of cancer research. As an article in The Journal of Clinical Oncology recently noted: “In the work on cancer, progress has been impeded by the regulatory bar having been placed too high and the efficacy bar having been placed too low.” And the article continues: “Clinical trials are analogous to cars speeding down the research highway in the quest for a cure. An accident happens, so the speed limit is reduced. Ultimately, research cars capable of traveling 120 mph are permitted a top speed of 5 mph.”
The slowing down of cars is now occurring in the area of medical education as well. The University of Michigan Medical School recently announced that it would no longer allow its doctors to take part in medical education programs to which drug companies contribute. What is missed here is that the drug companies do not control these programs (required of practicing doctors to keep their licenses up to date), but do contribute to them by teaching about new drugs or off-label uses of drugs (see above) that have become available since these doctors received their licenses. The ban is “a breathtaking sweep to squash something that is really important to us, which is the science that’s going on in the private sector,” explained Dr. Francis S. Collins, director of the National Institute of Health. The infatuation with purity (correspondences to the American temperance movement come to mind) is not only extreme and unrealistic, but it also has practical consequences on patient care by reducing doctors’ access to the full range of medical data.
Wandering through the exhibition area, I noted that one item was ubiquitous: candy. Everywhere you looked, there were bowls of it, as though the oncologists were 10-year-olds in need of a continuous sugar fix. Candy, it seems, is an innocent give-away — unlikely to corrupt American physicians the way previous give-aways presumably did (those insidious refrigerator magnets, for example). Still, I can imagine that the American Dental Association — and the FDA in its war on obesity — will be on the candy case soon enough. One can foresee a day when York Peppermint Patties may be subject to the iron hand of regulation, when only foreigners will be allowed to suck on sour balls.
In the exhibition area, massive drug company ads were everywhere — lit up as though they were marquees advertising big name stars: Pfizer, Roche, Merck. As in Hollywood, there’s a celebrity culture, with the big star of the moment, Genentech (the Gwyneth Paltrow of cancer), inching ahead of the recent big star, Novartis (the Julia Roberts), with the former has-been, Bristol-Myers (Britney Spears back from rehab) gearing up for a comeback with the introduction of its sexy new drugs.
To an outsider, some of the promotional hype was unnerving. A sign picturing a drill with a needle in it superimposed over a large human finger read: “To access the bone marrow this and OnControl is all you need.” Another display had panels with the headings Multiple Myeloma, Chronic Lymphocytic Leukemia, Lymphoma, and Solid Tumors — arranged like items on a Chinese restaurant menu. A large canvas banner announced: “Ask us about DNA Banking” and a rep, with a lack of modesty, had a sign affixed to his derriere: “Do you know the signs of colorectal cancer?”
As each presentation period neared, the exhibition space emptied out. Everyone was eager to get to the poster sessions, special talks, or plenary session. This last was being held in a room with a capacity of several thousand — more like the site of a rock concert than an exposition on malignancy. As I was walking to this space with my husband, we saw an elderly man, bent almost double, shuffling near the side of the bridge connecting the two wings of the conference center. He wore a name tag with multiple ribbons, indicating eminence of some sort. My husband peered over at the tag: “That’s Dr. James Holland, one of the fathers of modern oncology!” he exclaimed: “A giant in the field!” We watched Dr. Holland, clinging to the railing as he made his way slowly across the bridge as hordes of younger oncologists — French, German, and Japanese intermingling with their American counterparts — rushed past, their ASCO man-purses slung over their shoulders, their nerdish ties flapping.
It was an apt image of the march of scientific progress: its global embrace, its steady push forward. The past, so crucial to the present, was being outpaced and quickly left behind. It was a dramatic image — but a day at ASCO is full of dramatic images. It is a peek into the complicated world of the cancer industry with its massive exchange of information, its dense concentration of intellect, its buzz of technological innovation.
With so much being done by so many, one half-expects the big C to hoist a white flag and put up its hands. But this is a wily and intransigent foe. Miracle drugs like Gleevec, that in a stroke conquered one form of leukemia, are the flukes. Despite efforts on the part of the press to make preliminary developments seem like big breakthroughs, success comes slowly and in small increments. Yet there is something truly heartening about watching the ASCO doctors make their way through the vast spaces of Chicago’s McCormick Place. One feels hopeful. This is what civilization is all about: devising new ways to fight the great natural enemies of humanity. That said, shouldn’t we award these nerdish warriors a modicum of trust — which is to say, a few stickums and steaks? • 28 June 2010
Paula Marantz Cohen is Distinguished Professor of English at Drexel University and host of The Drexel InterView, a talk show broadcast on over 275 public television stations across the country. She is author of four nonfiction books and three bestselling novels, including Jane Austen in Boca and Jane Austen in Scarsdale or Love, Death, and the SATs. Her essays and stories have appeared in The Yale Review, The American Scholar, The Times Literary Supplement, and other publications. Her new novel, What Alice Knew: A Most Curious Tale of Jack the Ripper and Henry James, is due out in September. She can be reached at firstname.lastname@example.org.
Photo by © ASCO/Todd Buchanan 2010