Ignoring the big C

Cancer will kill more than half a million Americans this year. Scientists are desperate to find cures, but weak federal funding and high research costs driven by private-company greed are crippling their efforts.

Topics: Cancer, Biotechnology, Iraq, National security, Middle East, Intellectual Property,

Ignoring the big C

The latest artillery in the war on cancer waits, ready for action, in Dr. Susan Mallery’s Ohio State laboratory: the map of the human genome, biological compounds, and all the molecular know-how to take direct aim at a prolific killer. Armed with medical science’s newest precision weapons, Mallery is edge-of-her-seat eager to test a novel way to prevent head and neck tumors from recurring. But for now, her research lacks one thing. The drug. A California for-profit company that sells the experimental compound, a protein called Endostatin, is effectively holding it hostage at $572 per milligram. Mallery and her colleagues need enough of the drug to test it in a time-release model. The experiment requires a gram — about three tablespoons — which will cost $572,000.

“They pretty much have you by the jugular,” Mallery says of the cancer capitalists. “This isn’t something you can just whip up in a back-lab garage.”

In its best and purest form Endostatin can cost as little as $1.36 per milligram, or $1,363 per gram, when manufactured in bulk by industry for tests in humans, says Dr. Judah Folkman of Children’s Hospital Boston, whose lab discovered the protein’s potential to block the growth of some tumors. The research-grade Endostatin sold commercially by San Diego’s EMD Biosciences, is unfit for humans. It’s a lower-grade product made in smaller quantities for preliminary tests in animals and cell cultures — and can be so inexpensive to make that biotech companies have given it away when scientific experiments promise to eventually generate profits.

At the moment Mallery is talking with Alchemgen Therapeutics, in Houston, about just such a deal. But typically, when scientists like Mallery first attempt to hatch cures without industry sponsorship, they are at the mercy of the free market. Society be damned.

Mallery’s early research shows that Endostatin might even inhibit Kaposi’s sarcoma, the most common AIDS-related cancer, made notorious by Tom Hanks’ character in the movie “Philadelphia.” “But it’s not like baking cake: add a pinch of this and a pinch of that. You have to try a bunch of controlled-release formulations,” Mallery says. “It’s not that you can’t get Endostatin. You can buy it, but it is ungodly.”

EMD Biosciences, a boutique seller of compounds used in disease research, would not explain the wildly steep price difference between human- and animal-grade Endostatin. “There is a list of things you are not supposed to tell anybody,” says Cyndy Lane, the company’s product manager.

Steve Schwendeman, a University of Michigan chemist collaborating with Mallery, shrugs it off. Price gouging in wartime is not unusual. “It is not a problem unique to Endostatin,” he says. “This is a problem that goes throughout our industry.”

Declared by Congress three decades ago, the “war on cancer” is today farmed out to 181 drug and biotech companies whose existence depends on profits and investments. Leading cancer scientists in academia and government say their pursuit of the enemy is increasingly shackled to stock quotes, aggressive patent strategies, tightly held trade secrets and the legal wrangling over the spoils of success: more than $60 billion in yearly revenue, according to admittedly “lowball” estimates by the National Cancer Institute.

“I recognize a pharmaceutical company’s need to make back money, but the bottom line is we’re trying to cure cancer,” says Howard Hughes Medical Institute scientist Dr. Brian Druker, who helped discover the cancer drug Gleevec. “Our priorities are wrong when the goal becomes, Let’s make money first, and if it happens to help the health of the population, then good.”

While 1,500 Americans die daily from cancer, scientists are being forced to drag their feet rather than run to the cures they suspect are within reach of today’s newest science. That is the conclusion drawn from an examination of hundreds of patents and lawsuits, and from interviews with more than 40 scientists, stockbrokers, senators, professors, patients, industry executives and government officials. The current fight is not the war that Washington promised. Not even close.

In 2004, cancer will kill 10,000 Americans under the age of 40; about 1,000 will be children age 9 or younger. If Washington truly wanted to wage war on cancer we could do it, and the first obvious step would be to increase funding for the front-line troops. Right now, drug and biotech companies are investing about $6 billion a year in cancer research, according to Fortune magazine. That’s $1.2 billion more than the annual budget for the National Cancer Institute, the government’s lone deep pocket for cancer science, and $5 billion more than all the major charities combined. A few billion dollars more each year could make a huge difference, saving thousands of lives.

In the last 18 months, taxpayers have given $120 billion to a different war: the invasion and consequent reconstruction of Iraq. By the end of next year, that figure is expected to top $200 billion. That’s about three times the total amount given to the NCI by Congress during the 33 years of the war on cancer.

Cancer victims, scientists and the public at large are asking for funding more on a par with a real war. In a USA Today poll published on the front page in 1998, nearly nine in 10 adults surveyed said they would be willing to pay more taxes if the money went toward research for a cancer cure. Four years earlier, Sens. Tom Harkin of Iowa and Mark Hatfield of Oregon had proposed legislation for a 1 percent tax on health insurance premiums to create a medical research trust fund to subsidize disease research. Insurance lobbyists defeated it.

Last year, in a bipartisan survey of 1,000 Americans conducted by pollsters who have worked for President Bush and former Vermont Gov. Howard Dean, cancer ranked as the public’s greatest fear, greater than AIDS, heart disease, car accidents or even acts of terrorism. Two-thirds favored adding billions of dollars each year to the NCI budget; about half wanted to double or triple its budget.

“There is an epidemic of cancer in this country and we are doing damn little about it in the way of public funds,” says Hamilton Jordan, a cancer survivor and chief of staff in the Carter White House. “There is no way to understand it or to justify it.”

With substantial government investment, scientists say, more research proposals — like Mallery’s — would be publicly funded and owned; there could be additional patent and financial incentives for research on the hundreds of minor cancers that go ignored because little is offered in the way of profit; the veils of secrecy that hide clinical trials from the public would be lifted, allowing for the recruitment of more trial patients; and scientific collaboration could be the standard rather than the exception.

Simply, if science were loosed from Wall Street’s leash, its assault on cancer might rain down like bombs on Baghdad.

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Science’s advance on cancer is notoriously slow. That’s why, in 1971, a war on it was launched from the nation’s capital with a political promise of victory by the U.S. bicentennial. In 2004, more than a quarter century past that improbable deadline, at least 550,000 Americans will die from cancer, while the age-adjusted death rate from cancer remains only marginally improved from 1970.

Today, the war on cancer is at a crossroads. Armed with the emerging science of the publicly funded Human Genome Project, researchers are examining cancer anew. Cancer was once an umbrella term grouping together what were believed to be 100 to 200 diseases unique for their organ location — lung, liver, breast, prostate. Now it is being redefined, subdivided into vastly more varieties by advanced research.

There may be thousands of cancers distinguishable only by subtle genetic differences, says Howard Hughes scientist Druker. “Each has its Achilles’ heel and we have to identify that Achilles’ heel in every cancer. Imagine if we could very rapidly sequence the genomes of several hundred of each of the common cancers. It might take a long time and cost billions of dollars, but with today’s technology it is possible.”

But after Congress began doubling the National Institutes of Health budget in the late 1990s — and the NCI’s budget for basic science ballooned to vet the early promise of some cancer drugs — industry attached itself like barnacles to cancer research. As companies invested, they claimed proprietary rights to the results of their research. The effect was double-edged: New and expensive cancer drugs offer negligible benefits while the war is weighted down with patent strategies, intellectual property rights and a collective fixation on NASDAQ.

The ruckus that scientists are beginning to raise about the problem is one of a few hopeful signs. The government official who oversees the cancer-war arsenal admits that the conduct of the war is flawed, but says that the very admission is a move in the right direction.

“One has to recognize the problem before taking concrete steps,” says Dr. Richard Pazdur, director of oncology drugs for the Food and Drug Administration. “People are finally talking about this, and people have realized the problem. That is the first step.”

A review of 78 federal court cases dating to 1962 that deal primarily with oncology and the scientific scuffling among researchers, universities and industry found that nearly 80 percent, or 61 cases, have occurred since 1998, indicating that the struggle to control the fruits of research has become substantially more litigious in recent years. More telling, perhaps, is how the tenor of the lawsuits changed in the 1990s. Straightforward claims of patent infringement became crowded with charges of racketeering and intellectual theft.

“It is sometimes hard to decide who is wearing the white and who the black hat,” says Dr. Robert Cook-Deegan, director of Duke University’s Center for Genome Ethics, Law and Policy. “And a lot of folks are trading hats of different shades during the day.”

During their lifetimes, one in two American men and one in three American women will hear the words that staggered Don Chance. “It’s cancer,” a doctor told Chance after removing a lump in his neck. “The darn thing has spread all over the place.”

That was nine years ago and Chance, 52 and in remission today, vividly recalls his response. The knees weakened, his legs splayed, he sat down. “There are two kinds of people in this world: those who have had cancer and those who haven’t,” says Chance, a Louisiana State University professor. “The ones who have had it no longer have to worry about how they will feel when the doctor says those words. It’s nothing you want to hear.”

Chance’s story can be multiplied a million-fold, which might make one think that the search for a cure would be a potent political issue. But so far, there are few signs that the political will to fully wage war on cancer is present in Washington. The Senate’s latest version of the National Cancer Act, a rah-rah piece of legislation mired in committee for two years, doesn’t ask for any wallops in funding. Bill co-sponsor Sen. Sam Brownback, a 48-year-old Kansas Republican, calls cancer “the polio of our era,” but even he says money isn’t the antidote.

“What we need now is a key top-down focus like what [President] Nixon did when he declared war on cancer” in 1971, he says.

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Brownback wants Bush to set a date for when cancer will be defeated, like a dare to the cancer-fighting industry. NCI director Dr. Andrew Von Eschenbach says science’s goal is to eliminate “the suffering and death” due to cancer by 2015, but Brownback wants a similar charge — and confidence — from the White House. “I think people would fall in line,” he says. “This would be measurable and time certain … like balancing the budget in seven years.”

Prostate cancer survivor Sen. John Kerry shows his support for cancer research by sporting the mustard-yellow wristband of the Lance Armstrong Foundation, but his office offers few details about how the Democrat from Massachusetts would help if elected president. He would “significantly increase federal funding of cancer research,” says Madhu Chugh, the campaign’s director of healthcare policy, but she gives no particular strategy or dollar amount.

Instead she steers discussion toward the politically charged issue of embryonic stem-cell research, a budding science that holds no immediate promise for cancer fighters. There are currently no FDA trials for any drugs stemming from embryonic stem cells, and no medicines are likely for at least 10 to 15 years.

As for Bush, Brownback says his forays into the West Wing have been mostly ignored. Because George H.W. Bush lost a daughter to leukemia and is on the board of visitors at the University of Texas M.D. Anderson Cancer Center, Brownback long ago discussed with the former president his plans for articulating a stand in the cancer war. But, more recently, the idea “didn’t get much reception with Dubya,” Brownback says.

The priorities of the current administration are clear: The war in Iraq is front and center. The more than 1,000 U.S. soldiers killed there have dominated headlines. Cancer’s assault is far less visceral than the bloodshed in Iraq, but its carnage accumulates at an unfathomably greater clip: Since the beginning of the Iraq war, cancer has killed about 3,500 American children and teenagers.

That’s why, in May, 15-year-old cancer victim Sonia Bawa made a pleading request of President Bush. “Put the war in Iraq on hold for one month so we can double the national cancer research budget,” she wrote on her Web site.

Sonia’s impractical appeal is about priorities — and perspective. Congress spends on average about $6.5 billion per month in Iraq. It gives $405 million per month to the NCI. At least two-thirds of the cancer research proposals that are peer-reviewed and approved by the NIH today don’t receive government funding. The ideas are thrown like chum to the free market — where many sink. Industry doesn’t typically invest unless success is shown in preliminary testing, the expensive pre-clinical animal trials supported by charities and taxpayers.

Companies are charged with assessing risk to stockholders, not patients, explains Wall Street biotech analyst Reni J. Benjamin. “At the end of the day,” he says, echoing other analysts, “the most humanitarian company does no one any good if it is bankrupt.”

There is a paradox inherent in the nature of cutting-edge cancer research and the current, mostly corporate, funding structure. Drug development is an expensive undertaking, and the costs are compounded by cancer’s new targeted therapies. Drugs tailored for specific genetic mutations reduce each drug’s population of patients — and thus the potential for profit. For example, non-small-cell lung cancer kills about 140,000 people in the United States each year, but the targeted drug Iressa benefits only about 10 percent of these patients. So even as the state-of-the-art in cancer cures improves, the chances to make money may be decreasing.

When Druker was developing the cancer drug Gleevec, he had to argue with the industry to push it through the FDA pipeline. Industry executives, worried about the drug’s limited market, wanted to wait for other uses to be discovered before investing in expensive human testing, he recalls. “It was becoming a long, dragged-out affair,” Druker says. “Meanwhile, I had patients in the clinic who were dying.”

Washington offers incentives, such as patent extensions, to companies that develop drugs serving relatively small pools of patients. The FDA’s “orphan” drug designation is meant to entice the industry to invest in cures for rare diseases that might offer little profit. But of the 395 cancer drugs in human trial today, only one, a drug tested on an uncommon type of brain cancer, was designated last year as an orphan. Industry isn’t biting, says Dr. Genie Kleinerman, head of pediatric oncology at the M.D. Anderson Cancer Center.

Kleinerman is still frustrated by her attempts many years ago to test a novel therapy for osteosarcoma, a rare bone cancer that strikes about 900 U.S. children and young adults every year. Her idea was to combine two drugs licensed to rival companies, but she says competing lawyers could never agree to each other’s terms. “It didn’t get off the block. It’s nowhere today,” she says. “You are just never going to change the corporate culture.”

Wall Street analyst Alex Zisson says it’s not industry’s responsibility to play the good guy. Stock investors everywhere are culpable; they expect their companies to compete headlong for profits. “We pay taxes so the NCI can fund humanitarian research,” says Zisson, a New York analyst with Thomas, McNerney & Partners.

Pharmaceutical companies are the nation’s most profitable industry, but drugs on average cost hundreds of millions of dollars to develop and market, and only one in every five that advance to human testing is eventually approved. The risks and expense make patent protection “essential to continued innovation and investment,” says Jeff Trewhitt of the Pharmaceutical Research and Manufacturers Association, the industry trade group based in Washington.

The system works, Trewhitt insists: “Clearly progress is being made in the war when there are so many cancer drugs in clinical testing.”

For example, pharmaceutical giant Pfizer, best known perhaps for Viagra, the erectile-dysfunction blockbuster, is spending 12 percent, or $192 million, of its research-and-development budget on 20 cancer medications. Eight of these compounds have progressed into advanced human trials, where a drug’s efficacy is tested, says Dr. William J. Slichenmyer, the company’s vice president of oncology drug development. Pfizer is drawn by the war’s untapped potential, he says, and “huge unmet need.”

“Despite the progress that has been made, some people still prefer to see the glass as half empty,” Slichenmyer says. “But you could also see it as half full.”

And yet, something appears wrong with the system. The treatment of cancer in the United States generated about $13 billion in revenue in 1980, $27 billion in 1990, and in excess of $60 billion today. In today’s dollars, that’s equal to a doubling in yearly revenue while the decrease in cancer mortality has been incremental.

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Some progress has been made. Several new cancer drugs in the past five years have been shown to extend lives by several months and have raised the hopes of cancer victims. But the rate of progress does not match the evolving potential, Druker says. The hallmark of science is selfless collaboration, but CEOs are required to put the interests of their stockholders first.

Between 1995 and 1997, there were 196 patents issued for cancer-fighting compounds, techniques and devices, according to records at the U.S. Patent and Trademark Office. In the past two years, there has been a piling on: 639 patents and counting.

“We seriously have to rethink what we have done with patenting in this country,” says Druker, who testified before the Senate Cancer Coalition last year about the cancer war’s conflicts and triumphs.

On his first day of work 11 years ago at the Oregon Health and Science University, Druker asked permission to test an obscure compound owned by the Swiss drug company Ciba-Geigy. Within hours an agreement was signed between the university and the company, now Novartis. Druker was soon experimenting with STI-571, the drug that became Gleevec, used today in the treatment of chronic myeloid leukemia and some rare stomach cancers.

“In today’s climate if I could get something like that in my lab within six months I would be extremely pleased,” he says from his Portland office.

In an effort to foster teamwork, the NCI began this spring requiring scientists, universities and industries that use its money to sign collaborative agreements. But the NCI is generally involved in less than 20 percent of the cancer drugs in human trials. Of the 395 cancer drugs in clinical trials this year, the NCI was sponsoring or co-sponsoring 69.

This is at a time when the cross-pollination of cancer science is more important than ever. In the war on cancer, doctors will increasingly rely on combinations of drugs aimed at specific molecular targets, says Dinah Singer, the NCI’s director of cancer biology. “A single drug is unlikely to eliminate a tumor target,” she says. “It takes multiple pathways with multiple drugs.”

It takes a singularly minded army.

Which explains why Sonia Bawa wrote to Bush. If the war on cancer were funded like a real modern war, Druker and his cancer-fighting fraternity would not have to negotiate their every step with business — and profits — in mind. The pursuit of a killer might quicken.

Sonia and Bush exchanged polite letters. They are at an obvious impasse. Meanwhile, Congress this summer approved Bush’s request for $25 billion in emergency funds for military operations abroad.

Former Washington insider Hamilton Jordan, 59 and a survivor of lymphoma, prostate and skin cancers, wants to know where Sonia’s emergency funds are. “I’m baffled as to why this isn’t a political issue,” he says from his home in Atlanta. “It affects so many people that it’s easy for me to imagine a presidential candidate saying, ‘This is cancer week … and it’s the only issue we’re going to talk about.’”

Sonia has battled leukemia, a cancer of the blood, for most of her life. She’s endured chemotherapy, two bone-marrow transfusions and a transfusion of her older brother’s healthy stem cells. She’s very much at war.

When a letter dimpled with the presidential seal arrived one Friday this summer at her home in Fort Collins, Colo., she did what savvy teenagers do today. She scanned Bush’s response onto her Web page.

She then stayed home for the weekend. She had hoped to go to the movies, but her mother didn’t want her in a crowded theater. A girl in the trenches can’t risk catching even a cold.

Greg Barrett is a national correspondent for Gannett News Service based in the GNS/USA Today bureau in Washington, D.C.

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