Cancer Drugs: The Hype That Dashes Hope


By Amy Tsao In May, the media collectively broke out the champagne over another groundbreaking cancer drug. In one of the speediest drug approvals ever -- a matter of months -- the U.S. Food & Drug Administration had approved Novartis' Gleevec for treating chronic myeloid leukemia. Gleevec, which attacks the defective protein that causes the cancer, reversed the disease in 90% of patients with chronic CML in whom it was tested. The coverage of this discovery, in advance of the American Society of Cancer Oncologists' annual meeting, was breathless.

Then, as as happened too many times before, the cancer proved smarter than the latest superdrug. While the response rate for those with chronic CML hadn't changed, a few weeks after Gleevec's approval and the ASCO meeting, a new analysis emerged discussing why most of the patients in the late stage of the disease saw all of their progress stripped away within six months. The media coverage of this new analysis was largely buried in the back pages.

Gleevec isn't an isolated story. Most observers are quick to say the media fuels exaggerations in its quest for a sexy story. In the case of Gleevec, researchers still think the treatment is a huge advance on the other types of weapons available. But hope too often morphs into hype when it comes to promising cancer drugs, often approved with far less testing than other drugs due to the urgency for alternative treatments. And hyping a drug before long-term data are available can take a significant toll on already desperate patients.

GIANT CONFABS. The media should report on cancer research responsibly. What prompts it to glom on to certain cancer drugs? In part, the circus-like frenzy surrounding cancer research meetings contributes to reporters' fervent approach to the latest data.

Once upon a time, cancer research meetings were attended by a few hundred academics conducting projects at universities or who had backing from the National Cancer Institute. Not any more. The 2001 ASCO meeting attracted some 25,000 oncologists.

Economics dictate this process. Critics like to carp about money from drugmakers being somehow tainted, but there's no getting around it: Funding is the mother's milk of medical research. Even so, the highly competitive drug-development industry has the added motivation of trying to please Wall Street. Says Maurie Markman, director of the Cleveland Clinic's Taussig Cancer Center: "I can see the pressure to say things are really great is high."

Markman thinks these dynamics have changed the annual ASCO confab into "two worlds these days." In one, a deluge of research, late- and early-stage, is presented over several days. In the other, companies use the hours after the meeting as a venue to showcase progress to the media and analysts. "They are talking not to patients, but to the investment community," says Markman. "You've got biotech companies out there -- hundreds, thousands -- all trying to get the same investor dollars. If they can make a claim, they are more likely to get money for development." Getting a "wonder drug" headline doesn't hurt, either.

SPLASHY SHOWS. One way to dispel this money-grubbing atmosphere would be stricter standards on how information is presented at scientific meetings. ASCO doesn't allow media briefings, news conferences, or press receptions on-site unless they're run by the association. But it needs to go further. After hours and off-site, companies can and do hold splashy press events. Attendees can be hard-pressed to draw the line between company-sponsored presentations and those sanctioned by ASCO. "One can make the argument that [research meetings] could require more rigorous statements as to what can be presented or not presented," says Markman.

ASCO and even the FDA have held briefings that unintentionally added to the hype. If nothing else, when "miracle drugs" are unveiled, researchers and companies -- even regulators and scientific trade groups -- should emphasize the need and importance of follow-up studies. Look at Taxol, Bristol Myers Squibb's (BMY) chemotherapy drug for various cancers. When it was first introduced commercially in 1992, the drug, derived from the ewe tree, was heralded as the "Tree of Life." Taxol did indeed provide a potent weapon in taming some cancers, but in the years after its approval, serious side effects came to light. "It was not a wonder drug. It was an interesting drug," says Markman.

Another example: Herceptin, Genentech's (DNA) breast cancer drug targeting cells that make too much of a protein associated with the disease. Herceptin was met with much fanfare when its discovery was revealed several years ago, and today it's an immensely successful and lifesaving drug. However, it comes with serious potential side effects such as heart muscle damage and lung failure. "Targeted therapy seemed to be a much bigger step than it [actually] was," says Susan Levine, vice-president for technology assessment at Hayes, a consulting firm to health insurers. "[Herceptin] didn't translate into a cure."

TAKE CARE, DOCTORS. In all of these examples, Gleevec included, the media rallied around the drugs, using words like "miracle" and "wonder." Some might say the media attention showered on new treatments is essentially harmless, that miracle-cure headlines become forgotten with yesterday's news. But that's no longer the case in this era of intense competition among drug developers for funding from Wall Street.

Many doctors have even succumbed to the lure of the hype that comes with the search for a blockbuster miracle drug. With the vast quantities of money available for research projects, doctors have much more incentive to get involved. "The whole game has changed," says Leonard Zwelling, vice-president for research administration at MD Anderson Cancer Center. "A lot of money is involved, and doctors have to be careful."

Zwelling argues that researchers shouldn't have a financial interest in companies they do work for, since it can skew their objectivity. "I don't think doctors who do work on an issue that will influence a company's value should have a personal interest in that company," he says. Along those lines, he argues that regulators on the federal level should come up with ethical guidelines: "I'd like to see a statement from the government on what they expect us to do."

CONSIDERABLE CAVEATS. No one is questioning the integrity of the vast majority of researchers and doctors working on drug development. But in the three decades since President Nixon declared war on cancer, dozens of new "breakthrough" drugs have raised the hopes and expectations of cancer patients -- only to disappoint or be saddled with considerable caveats after more studies were made available.

Given the history of cancer drug discoveries, the Gleevec setback shouldn't have been totally unexpected. Novartis certainly can't be faulted. The company is simply doing what profit-making ventures do in the quest for treatments aimed at vanquishing cancer -- a noble cause in itself.

So, how should the general public view the next Gleevec? With skepticism. Gleevec and other highly specific cancer drugs will surely have important roles in the future of combating cancer. "Our understanding of the carcinogenic process has brought us to the beginning of an era for individualized treatment," says Zwelling. With help from the human genome map and other drug-discovery technologies, treatments for cancers will continue to be more effective and less toxic.

Still, it's unlikely that any one drug will be a magic bullet for cancer. The media, researchers, drug companies, and doctors have a responsibility to their patients and the general public to drive that message home. Tsao covers biotechnology for BusinessWeek Online in New York


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