The American Medical Group Association is a long way from attracting enough investment capital to complete a slowly evolving national data warehouse that could contain medical information on at least 10 million Americans.
But the Alexandria, Va.-based organization, which represents most of the biggest multispecialty medical groups in the U.S., has made considerable progress in developing the database, which officials say will contain the most comprehensive and commercially valuable index of personal medical information ever compiled on such a scale. Five medical groups already have signed letters of intent to collaborate with the AMGA and its two partners-drugmaker Aventis Pharmaceuticals and Accenture, a worldwide consulting firm, officials say.
"This will be unlike any other source of information in the healthcare industry," says Kevin Brown, the newly appointed chief executive officer of Anceta, the fledgling data warehouse named after a Roman goddess of healing.
AMGA officials say Anceta eventually could include medical information and long-term histories on as many as 35 million patients, providing medical groups, other healthcare organizations and a wide array of potential commercial vendors complete access to richly detailed clinical and operational-performance data. Brown says the AMGA, parent of the for-profit subsidiary, would be able to sell the information to pharmaceutical companies, device manufacturers, government agencies and employer groups interested in "understanding the most cost-effective way to treat diseases."
The database is expected to be up and running sometime this fall.
"I think what will distinguish this from everything else tried before will be the depth of this information," Brown says. "We'll have a database that is unmatched, the kind that has never been put together before."
What about privacy?
Though patients' identities will be encrypted and strictly confidential, Brown says, the AMGA will sell aggregate information to pharmaceutical companies and other customers. He says pharmaceutical companies would be able to work with individual clinics and physicians to identify patients who might be willing to participate in clinical trials. Clinic officials would provide information to pharmaceutical companies if patients approve the release through their physician, he says.
"Pharmaceutical companies could quickly identify target populations for clinical trials," he says. "But the process will solely be in the hands of the doctor treating the patient. The patient-doctor relationship will never be violated. There will never be any contact between the pharmaceutical companies, the AMGA or Anceta, and patients. We would never think of approaching patients that way."
Susan Brooks, a spokeswoman for Aventis, says the database will comply with all privacy guidelines in the Health Insurance Portability and Accountability Act of 1996 and "does not in any way compromise patient confidentiality."
But some privacy advocates and policymakers dismiss these claims, saying that nothing can completely safeguard this information once it becomes part of a database peddled to private firms or the federal government.
"They claim confidentiality, but that's nonsense," said Lisa Dean, vice president of policy at the Washington-based Free Congress Foundation, a not-for-profit think tank that has become deeply involved in privacy issues in the past several years. "If the doctors report this information, the government, for instance, can come back and say, `Well, now we need this because there's an epidemic, or some other major problem.' These groups have made that argument before that they'll only release this information with a patient's approval. Is that patient going to be notified of what's going to be done with the information? And are they truly informed about the issues? Most Americans are not aware of just what this information can be used for."
What's more, in spite of the apparent safeguards detailed by Aventis and AMGA officials, the end result of connecting patients with pharmaceutical companies poses some clear ethical concerns to consumer advocates.
"It's another example of how business is swamping out professional relationships that are supposed to exist between doctors and patients," says Sidney Wolfe, M.D., director of the Washington-based Public Citizen's Health Research Group, who voiced both ethical and privacy concerns about such ventures.
Asked about those privacy issues, Brown says he does not think it is an intrusion for a pharmaceutical company to approach a patient through a clinic about a drug trial. "If the patient is interested, then the pharmaceutical companies get involved," he says. "There's great value in that."
But Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, says any big national database should raise concerns about confidentiality-regardless of whether it adheres to even the strictest federal guidelines on patient privacy. Anceta's database, which ultimately could connect patients and pharmaceutical companies, sounds an even more jarring alarm, he says.
"They say the identities will be protected," Caplan says. "But can the databases be penetrated? To me, anything that can lead back to approaches that identify a person is moral nitroglycerin. It's going to set off an enormous controversy-private medical information getting into third-party hands. Even recruiting for clinical trials is still going to raise all kinds of red flags."
Of course, the AMGA isn't the only healthcare organization hoping to make a profit selling personal medical information. Indeed, databases of all kinds abound in the U.S., where many retailers, for instance, now routinely ask customers for addresses, ZIP codes or telephone numbers to create databases that enhance marketing and advertising efforts.
The Chicago-based American Medical Association earns about $23 million per year selling its list of more than 875,000 physicians to about a dozen vendors. That information often winds up in the hands of big pharmaceutical companies, which use it to profile doctors and market their drugs.
Less than two years ago, the AMA formed a for-profit joint venture with Acxiom Corp., a Little Rock, Ark.-based marketing firm that specializes in database management, to fine-tune its marketing of the nation's most comprehensive database on doctors. With the addition of nurses and other providers, the AMA's expanded Preference Solutions database will include detailed information about more than 1.3 million medical professionals through Acxiom, a major "data integration" company that boasted revenue of more than $1 billion in the year ended March 2001.
Putting the data to work
Advocates say these big databases can help providers reduce paperwork, share general information, fight false claims and identify the most effective treatments. They also can help researchers track diseases and chart the responses of patients, ultimately leading to better, more effective drugs, proponents say.
Premier, a San Diego-based hospital alliance, has collected information on about 60 million patient visits from 380 participating hospitals since 1996, accumulating a massive database that includes operational statistics and a wealth of information on both inpatient and outpatient services. With this information, for example, a drug company can see how a drug is used inside a hospital setting and also spot trends that ultimately will help it focus on certain groups for clinical trials, says Stephanie Alexander, senior vice president of healthcare informatics at Premier.
Patient names remain confidential, but drug companies can locate candidates for clinical trials by spotting trends and contacting hospitals, she says. Many drug companies have arrangements whereby hospitals provide them with information on patients willing to join such trials. Among other clients, the U.S. Food and Drug Administration signed a contract with Premier last September to use the database for drug surveillance, including monitoring adverse drug events. The FDA will pay Premier about $842,000 in the first year of the contract.
In addition to the FDA, all hospitals that participate in the database and a handful of pharmaceutical companies pay fees to use the data, says Ken Inchausti, a Premier spokesman.
Although Premier focuses entirely on hospital information, the AMGA's venture would be the first big database to contain detailed information from doctors who treat patients in their offices and clinics, Brown says. The database would capture information on every medical procedure for every patient, he says, generating data from as many as 100 million patient visits per year.
The next step, says Premier's Alexander, might be coordinating that information. "If we could tie it together, and link the actual patient," she says, "we would get a lot of different information. We could actually begin to look at the entire episode of care-say, for example, what is the cost of treating congestive heart failure? All we can say is what is the cost within the acute-care setting. What (the AMGA) can add to that is the cost of the patient, going each week to their physician's office."
The information would be very valuable to a company such as drug manufacturer Aventis. Accenture is also deeply involved in this market after joining with Merck-Medco and UnitedHealth Group last year to create Montvale, N.J.-based Xceleron Health, which will provide consulting services to technology-based firms in healthcare.
AMGA officials say momentum is building for the database, which was announced at the organization's annual meeting in February 2001 and has remained fairly inconspicuous since. Until Brown was hired for Anceta's top job in March, that role was filled part time by Donald Fisher, the AMGA's president and CEO, who guided the fitful birth of Anceta while juggling his other duties at the association.
"It's been a huge undertaking for an organization like ours," says Fisher, who outlined the database to HHS Secretary Tommy Thompson during a meeting in March. "But we're the right organization to do this. And we've got a commitment from the medical groups. They know this data will never be used in a way that makes them uncomfortable. "
Brown says the AMGA is looking for additional investors to help shoulder the potential $50 million cost of the project. So far, he says, the group has collected about $15 million in cash investment and sweat equity from its two partners. The AMGA, which represents about 250 medical groups with more than 67,000 physicians, is not investing any cash in the venture, he says.
At this point, the AMGA holds a majority equity stake in the enterprise, which officials hope to launch with perhaps more than a million names from at least two of the big multispecialty medical groups. A full rollout with the stated goal of 10 million names could take several years, Brown says. The organization will reduce its stake as investors are added.
"We have lots of work to do before we really understand the full revenue potential," Brown says. "There's no question in my mind that, once we get this done, the value will be there."