Md. cancer statistics altered

Cases overstated

matter goes to attorney general

July 29, 2008|By Laura Smitherman | Laura Smitherman,Sun reporter

A state contractor tampered with Maryland's cancer registry, a database used by researchers to track the disease's impact, counting hundreds of patients as having cancer when they did not, according to a legislative audit released yesterday.

The company, Macro International Inc., found in an internal investigation that data were deliberately altered between August 2004 and December of that year. The company fired the employee responsible for the cancer registry. State officials said that Macro employees apparently overreported the incidence of cancer to ensure that the database met standards set by a national certification association, which closely monitors registries to ensure that states have a complete count of cases.

The misinformation led researchers to send an estimated 400 women letters beginning in 2005 asking them to participate in a cervical cancer study when they did not have the disease. About 10 of those women called the state Family Health Administration, part of the state's Department of Health and Mental Hygiene - one of the first indications that the cancer registry was inaccurate.

The database is often used by public health officials interested in cancer prevention and by epidemiologists who look for correlations between cases and environmental, lifestyle and other factors in an effort to find potential causes.

The case has been referred to the criminal division of Attorney General Douglas F. Gansler's office, which is looking into the matter. The state health department also sent the results of its inspector general's investigation to the federal Department of Health and Human Services and its office of research integrity.

"We have been forced to go back and make sure that this data is accurate," Maryland Health Secretary John M. Colmers said. "This has delayed getting that information out there and delayed research activities."

Guy Garnett, a Macro vice president, declined to comment, citing company policy not to discuss client issues. The company completed the contract term, earning $1.9 million to manage the registry for 18 months through January. The state hired a new vendor, Westat, beginning in February.

The cancer registry, created in 1982, tracks all new cases of cancer diagnosed or treated in Maryland. Physicians, hospitals and other medical providers are required by law to report information to the database, which includes patient names and addresses as well as a complex system of coding for the types of cancer and treatments.

"Cancer registries throughout the country are just so important for us to understand the incidence of the disease and how we're doing with it," said Dr. Thomas Burke, a professor at the Johns Hopkins University's Bloomberg School of Public Health. "The quality of the data is always important. If you have the wrong reporting, you get the wrong answer."

The Department of Legislative Services produced the audit for a joint committee of the Maryland General Assembly. Bruce A. Myers, an auditor, said the committee is considering whether the problems unearthed at the Family Health Administration deserve more attention. Auditors also found a lack of oversight for several other programs that account for millions in state spending.

"There are some issues here that concern some big dollar amounts," Myers said.

In 2003, when Macro submitted the 2001 cancer database to the North American Association of Central Cancer Registries, it did not receive certification as required under its contract. Auditors faulted the state agency for not taking action, such as terminating the contract.

The next year, Macro did receive certification, but the auditors noted that information was later found to be erroneous. Auditors outlined several red flags that were not raised until years later.

First, the state agency did not review the 2002 data until August 2005, when it found they showed a 90 percent increase in cervical cancer cases and a 70 percent increase in melanoma cases from 1998 to 2002. At the time, auditors said, Macro could not provide an adequate explanation for the staggering rise in cancer incidence.

Around the same time, as part of the state health department's study of breast and cervical cancer diagnosis in Maryland women, about 2,300 patients in the cancer registry were asked to participate in the study. The Family Health Administration later worked with Macro to comb through medical histories, comparing original laboratory reports with data in the cancer registry, and determined that 400 of them did not have cancer. The study was suspended.

Then in May 2006, a former Macro employee informed the state agency that data were deliberately altered. Macro's investigation found that more than 13 percent of all cases in 2002 showed signs of tampering, according to the audit. Macro concluded that the changes were "methodical and were made by one or more persons with broad access to the system," the audit said.

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