বৃহস্পতিবার, ৭ মার্চ, ২০১৩

Special Report: Behind a cancer-treatment firm's rosy survival claims

(Reuters) - When the local doctor who had been treating Vicky Hilborn told her that her rare cancer had spread throughout her body, including her brain, she and her husband refused to accept a death sentence. Within days, Keith Hilborn was on the phone with an "oncology information specialist" at Cancer Treatment Centers of America.

Hilborn had seen CTCA's website touting survival rates better than national averages. His call secured Vicky an appointment at the for-profit, privately held company's Philadelphia affiliate, Eastern Regional Medical Center. There, the oncologist who examined Vicky told the couple he had treated other cases of histiocytic sarcoma, the cancer of immune-system cells that she had.

"He said, ?We'll have you back on your feet in no time,'" Keith recalled.

Vicky's cancer treatment was forestalled by an infection and other complications that kept her at Eastern Regional for three weeks. In July 2009, when she got back home, things changed. Despite Keith's calls, he said, CTCA did not schedule another appointment. As his wife got sicker, Keith, a former deputy sheriff in western Pennsylvania, was reduced to begging.

The oncology information specialist "said don't bring her here," he recalled. "I said you don't understand; we're going to lose her if you don't treat her. She told me I'd just have to accept that."

Vicky Hilborn never got another appointment with CTCA. She died on September 6, 2009, at age 48.

CTCA is not unique in turning away patients. A lot of doctors, hospitals and other healthcare providers in the United States decline to treat people who can't pay, or have inadequate insurance, among other reasons. What sets CTCA apart is that rejecting certain patients and, even more, culling some of its patients from its survival data lets the company tout in ads and post on its website patient outcomes that look dramatically better than they would if the company treated all comers. These are the rosy survival numbers that attract people like the Hilborns.

BEATING THE AVERAGES

CTCA reports on its website that the percentage of its patients who are alive after six months, a year, 18 months and longer regularly tops national figures. For instance, 60 percent of its non-small-cell lung cancer patients are alive at six months, CTCA says, compared to 38 percent nationally. And 64 percent of its prostate cancer patients are alive at three years, versus 38 percent nationally.

Such claims are misleading, according to nine experts in cancer and medical statistics whom Reuters asked to review CTCA's survival numbers and its statistical methodology.

The experts were unanimous that CTCA's patients are different from the patients the company compares them to, in a way that skews their survival data. It has relatively few elderly patients, even though cancer is a disease of the aged. It has almost none who are uninsured or covered by Medicaid - patients who tend to die sooner if they develop cancer and who are comparatively numerous in national statistics.

Carolyn Holmes, a former CTCA oncology information specialist in Tulsa, Oklahoma, said she and others routinely tried to turn away people who "were the wrong demographic" because they were less likely to have an insurance policy that CTCA preferred. Holmes said she would try to "let those people down easy."

Equally significant, CTCA includes in its outcomes data only those patients "who received treatment at CTCA for the duration of their illness" - patients who have the ability to travel to CTCA locations from the get-go, without seeking local treatment first. That means excluding, for example, those who have exhausted treatment options closer to home and arrive at a CTCA facility with advanced disease.

Accepting only selected patients and calculating survival outcomes from only some of them "is a huge bias and gives an enormous advantage to CTCA," said biostatistician Donald Berry of MD Anderson Cancer Center in Houston.

The company defends its practices. Spokeswoman Pamela Browner White said CTCA's survival data are in "no way misleading, nor do they deviate from best practices in statistical collection and analysis." As for the Hilborns, she said, the company does not discuss individual cases.

Cancer Treatment Centers of America got in trouble with regulators in 1996, when the Federal Trade Commission accused it of, among other things, presenting survival claims it couldn't support. The company entered into a consent decree with the FTC and, without admitting any of the allegations, agreed not to make unsubstantiated outcomes claims. The company also "implemented a voluntary, robust compliance program," White said.

Asked if CTCA's current outcomes claims conform to the consent decree, Richard Cleland, the agency's assistant director for advertising practices, said: "No one at the commission can comment on non-public information."

"A FREE-MARKET GUY"

Cancer Treatment Centers of America, which estimates it treats 4 percent to 8 percent of U.S. patients with complex and late-stage cancer, was founded in 1988 by Richard J. Stephenson, who has served as chairman ever since.

Stephenson, who declined to comment for this article, serves on the board of FreedomWorks, a non-profit group that advocates for small government and low taxes, and he is "very much a free-market guy," CTCA President and Chief Executive Stephen Bonner told Reuters.

He also has a history of pushing limits. A graduate of Northwestern University Law School, Stephenson started out as an investment banker. In 1966 he became a trustee of Americans Building Constitutionally, an organization that helped wealthy individuals set up not-for-profit corporations and personal trusts to avoid paying federal income and inheritance taxes.

In 1969, a California state court found the group's top official and six others guilty of grand theft or conspiring to commit grand theft. Stephenson had pleaded no contest to false advertising, a misdemeanor, and testified for the state, according to media reports at the time.

Stephenson ventured into healthcare in 1975, when he and partners bought Zion-Benton Hospital in Zion, Illinois, renaming it American International Hospital. By the late 1980s, American International was facing financial problems and its "reputation had been severely damaged" by local press reports about its use of unproven cancer treatments, according to a 2004 court opinion on a successful petition by a former CTCA president seeking an increased valuation for his share of the company.

In 1988, Stephenson founded CTCA. He was motivated, said CEO Bonner, by the difficulty he had identifying and obtaining the best therapies for his mother after she developed bladder cancer. She died in 1982.

Stephenson began building what was to become a national network of cancer centers that would uphold "the Mother Standard," described on the company website as "a warm, nurturing approach (that) involves caring for patients as we would want care for our own mothers, fathers, sisters, brothers, and other loved ones."

The hospitals also would seek patients "who were willing to travel to receive treatment" and "who were covered by private commercial insurance and could afford those expenses not paid by insurance," according to the 2004 court opinion.

THE TOUGH CASES

Today, CTCA - with hospitals in Illinois, Oklahoma, Pennsylvania, Arizona and Georgia, plus an outpatient clinic in Washington state and headquarters in Schaumburg, Illinois - is the only hospital system in the country that specializes solely in complex and advanced cancers. It does not release revenue or profit figures.

The company has treated about 50,000 patients since 1988, CEO Bonner said. (By comparison, the non-profit MD Anderson, a leading cancer center, treated about 115,000 patients last year.) CTCA expects 6,000 new patients and 15,000 to 16,000 continuing patients this year, he said, and is considering expanding in the Pacific Northwest, the Northeast and even Asia.

At each facility, the standard cancer treatments - radiation and chemotherapy - adhere to national guidelines, Bonner said. "But because we see mostly patients with later-stage, complex cancers, they often need something else," he added - psychological and spiritual support as well as "holistic" interventions such as yoga, acupuncture and reiki, a laying-on of hands.

More and more academic cancer centers offer such alternative medicine, which some insurers cover.

"Patients who feel they are understood and empowered will have a better outcome," Bonner said. They'll summon the strength to continue therapy, "even if the last thing they want to do is another round of chemotherapy."

The CTCA formula resonates with many patients. According to Healthgrades, a doctor- and hospital-ratings site, CTCA facilities consistently beat national averages in patient satisfaction.

"We were very impressed with the personal attention," said Rose Weistock, whose husband, Harvey, was treated for non-small-cell lung cancer at the Zion hospital, now the Midwestern Regional Medical Center, after his local physician gave him three to five years to live. "You didn't feel like you were just a number," she said.

CTCA flew the couple at no charge from their Maryland home to Chicago - complete with limo from the airport - to tour the hospital and undergo tests. Harvey, an accountant who had medical insurance through his job, began chemotherapy on that 2004 visit. The Weistocks appreciated the emphasis on what CTCA calls a cancer-fighting diet and on boosting the immune system through mind-body and spiritual practices.

Harvey died in a Maryland hospital in 2005. The family sued CTCA, alleging that he died after receiving chemotherapy he couldn't tolerate, and settled out of court. Still, Rose's admiration for the hospital's personal attention remains unwavering.

HOPEFUL PITCH

"They market hope," Gail Robison, a staff nurse at the Zion hospital from 2003 to 2007, said of CTCA.

The marketing typically features CTCA's state-of-the-art care and holistic approach. Ads note that featured patients might not be representative: "You should not expect to experience these results."

The ads also challenge viewers to "compare our treatment results to national averages." Doing so, on the company's website, shows that CTCA's reported survival outcomes regularly beat those averages.

Experts in medical data who reviewed CTCA's claims for Reuters say those claims are suspect because of what they called deviations from best practices in statistics - in particular, comparing its carefully selected patients to those nationwide.

"It makes their data look better than it is," said Robert Strawderman, professor and chairman of biostatistics at the University of Rochester. "So the comparisons used to suggest that CTCA has better survival rates are pretty meaningless."

The selection process begins when a prospective patient first contacts CTCA, by phone or web chat, and speaks to an oncology information specialist. "The first thing you do is be kind and greet them, but you're qualifying them," said Carolyn Holmes, the former oncology information specialist. "You ask, ?How old are you?' meaning, ?Are you Medicare-age?'"

Holmes says she learned to recognize callers with "Cadillac insurance policies" and those from poor zip codes. She said she tried to redirect undesirable patients away from CTCA.

"You don't want them," Holmes said about Medicare patients. Medicaid? "Absolutely not." Other former employees confirmed her account of screening patients based on their means of payment.

Holmes sued Southwestern Regional Medical Center, CTCA's affiliate in Tulsa, in 2012 for terminating her job after she says she experienced symptoms consistent with multiple sclerosis.

CTCA denies any knowledge of Holmes's possible disability and claims she failed to satisfy performance standards, according to court records. The case is pending in Oklahoma federal court.

CTCA spokesman White said that the company has an "insurance-screening process and established criteria" and trains its specialists to direct callers to other resources when CTCA is unable to offer treatment.

CTCA accepts Medicare patients "in some hospitals," said CEO Bonner, and "a tiny bit" of Medicaid. It also has a fund, named for Stephenson's mother, that provides $2.5 million a year in charity care.

SKEWED POOL

The practices Holmes described result in a patient pool that looks very different from the nation's.

At the Zion hospital, about 14 percent of patients were covered by Medicare and 4 percent by Medicaid in 2011, according to data the hospital submitted to Illinois health authorities. Over the previous 10 years, the Medicaid percentage was often in the single digits. Reuters was not able to obtain data from CTCA's other hospitals.

In the database CTCA compares itself to, called SEER and run by the National Cancer Institute, 53 percent of patients were diagnosed at the Medicare-eligible age of 65 or older, and 14 percent are below the poverty level, an indication of those covered by Medicaid or uninsured.

SEER includes patients "with and without insurance, with and without other serious medical conditions, at or not at cancer centers, treated by all types of doctors, not just oncologists, and even including those who never received treatment because the cancer was diagnosed too late," said Celette Skinner, associate director for Population Science & Cancer Control in the Harold C. Simmons Cancer Center at the University of Texas Southwestern Medical Center.

Those factors all depress the survival of SEER patients, making CTCA's results look better by comparison.

For instance, patients without insurance, whom state filings show CTCA rarely accepts, are only half as likely to undergo a screening test for cancer, says American Cancer Society statistician Elizabeth Ward. And screened patients are alive longer after diagnosis than are unscreened patients. That reflects the effect of screening, not treatment.

Poor people, whom CTCA rarely treats, also tend to have worse health, such as heart disease and susceptibility to infection. Those "co-morbidities" are responsible for as many as half of all cancer deaths in the year after diagnosis, said Soneji Samir, an expert on cancer statistics at Dartmouth Medical School in Lebanon, New Hampshire. CTCA's patients "have less risk of other causes of death."

CTCA makes every effort to adjust its data so comparisons to the national database are legitimate, said biostatistician Chengjie Xiong of Washington University School of Medicine in St. Louis, who performed CTCA's survival analysis as a consultant to the company.

But "comparisons cannot be done between CTCA and SEER database on income level," he said in an email. That means "there are some differences" between the two patient populations.

Xiong said he is doing new survival calculations using more recent data from CTCA, trying to make sure the comparison to the national database is rigorous. The new results, Xiong said, are expected to be posted on CTCA's website this month.

For some cancers, CTCA will still have better survival rates, he said. For others, "the survival difference in favor of CTCA is no longer statistically significant" after adjusting for several differences between CTCA's patients and those in the national database.

"VERY RED FLAG"

CTCA also excludes from its survival calculations thousands of patients it does treat but who did not receive "treatment at CTCA for the duration of their illness."

"?The duration of their illness' is a very big and very red flag," said MD Anderson's Berry. CTCA's patients will "tend to be healthier" than those in the general population from which SEER draws its data, he said, adding: "Ability and willingness to travel is an independent factor" associated with longer survival.

No federal or state law requires hospitals to report their cancer outcomes, let alone mandates how to do the calculations. But many healthcare providers voluntarily err on the side of inclusion.

"We follow them for the duration of their illness and still report them even if they were treated elsewhere," said oncologist Alan Campbell, medical director of Spectrum Health, which runs medical practices and hospitals in Michigan. "Doing otherwise could skew your survival numbers."

Other major cancer centers do not report outcomes at all, arguing that the statistics can be manipulated.

CTCA also appears to exclude the vast majority of its patients when it calculates survival data. In survival results from 2004 to 2008 posted on its website, CTCA reported 61 patients with advanced prostate cancer, 97 with advanced breast cancer, 434 with advanced lung cancer, and 165 with advanced colon or rectal cancer. These are the four most common solid tumors. In the same period, CTCA treated thousands of patients at its Zion facility alone, according to filings with state regulators.

"We agree that some of our sample sizes" are small "and have always stated this as a limitation of our study," said Xiong, the consultant to CTCA.

"I'd have some concerns about why and wonder if some cherry-picking was going on," said Spectrum Health's Campbell.

Moreover, while the standard reporting period for cancer survival is five years after diagnosis, CTCA on its website doesn't go that far; for the four most common tumors, it reports survival up to four years at most. And as Reuters found, the company's advantage often diminishes as the five-year mark approaches (see accompanying graphic).

Soon after Keith Hilborn got Vicky back home, her local doctor cleared her to travel. Keith started calling the CTCA oncology information specialist he had first spoken to. "She said things like ?We'll have to get back to you,'" Keith said.

They never did. Vicky "was depending on me, and I couldn't get them to treat her," he said. "She never got a single cancer treatment from them."

Hilborn received a statement from CTCA saying Vicky's care cost $319,902.20. "This was just for treating her infection," he said. "My local hospital could charge like that, too, if they flew you around and sent limos for you."

He refused to pay, keeping the reimbursement Vicky's insurer had sent to him. CTCA sued him for payment and won. A sheriff's sale of his belongings is expected to raise money to pay the judgment.

(Editing by John Blanton)

Source: http://news.yahoo.com/special-report-behind-cancer-treatment-firms-rosy-survival-125342638.html

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