June 24, 2011
Improvements in healthcare are impossible without patient outcomes data. So are R&D efforts at pharmaceutical companies. But if providers and drug

Improvements in healthcare are impossible without patient outcomes data. So are R&D efforts at pharmaceutical companies. But if providers and drug companies can throw their energies together, the result may be a giant leap forward in outcomes research.

Like everybody else in healthcare, drug companies need information to compete. But short of undertaking the overwhelming job of following patients around to check their drug regimens, their compliance and their outcomes, drug companies have had no way to get the kind of information that would tell them how to better produce and market their products. Enter healthcare IT.

The pharmaceutical industry’s interest in healthcare IT revved up when the Clinton administration began blaming it for surging costs during the early days of healthcare reform. "Pharma was a major whipping boy back in 1993," says Mark Zitter, president of the Zitter Group, a San Francisco-based healthcare conference, training and publishing firm. In defense, pharmaceutical companies looked for ways to do more than sell pills, especially with managed care threatening to hammer down profits with the dreaded "f" word: formulary. But they needed more information. Specifically, drug manufacturers needed answers to such post-marketing questions as: What exactly were doctors prescribing their products for? Were there new indications to pursue with the FDA? If patients picked up their prescriptions, did they actually take them? Were patients satisfied and getting better with their treatment? And the hardest question of all: Were the drugs cost-effective?

Pharma heavyweights such as Glaxo Wellcome and Pfizer began testing the concept of disease management, bringing to market their knowledge of disease processes in hopes of collaborating with providers or adding value to their products. Others, such as Merck, Smith Kline Beecham and Eli Lilly bought pharmacy benefits management businesses as a way to diversify and sniff out some answers. Forward-thinking companies began exploring the need for a computer-based medical record, often infusing much-needed funds into fledgling companies. Over time, every self-respecting pharmaceutical company had launched a Web site, with widely varying degrees of quality and interactivity.

But now, some five years later, drug companies are still seeking the same information--and still not getting much of it.

Pharma’s perception problems
Part of the problem has been perceptual. "Pharma has been frustrated by its ability to work with the healthcare data world to get information of benefit without being seen as unnecessarily mercenary," says Ronald Waife, president of the Massachusetts-based healthcare consulting firm Waife and Associates. Managed care organizations have been slow to cozy up to large-scale disease management programs crafted by drug companies, often preferring to retain traditional relationships--meaning: "just give us the lowest price on drugs, thank you."

In pharma, one tried-and-true method of changing perceptions has been the decidedly low-tech means of hosting or paying for events--meetings, conferences and seminars. Providers, drug companies have found, will attend pharma-sponsored learning events on such topics as disease management, outcomes and clinical information systems. In fact, Mark Zitter’s Center for Outcomes Information, whose clients include both providers and pharmaceutical manufacturers, has twice been named by Inc. Magazine as one of America’s fastest growing companies. Zitter markets as a strength his firm’s ability to foster information exchange between the two groups.

And Zitter isn’t the only one making the most of IT learning events. Last fall, Hoffman-La Roche together with the Smithsonian Institution sponsored a high-brow symposium entitled "Parallel Revolutions: Managing Improvement and Quality in the Information Age," and invited to it healthcare IT thought leaders and CEOs, CIOs, CFOs and other senior executives of major healthcare organizations throughout the country. The proceedings will be preserved in the Smithsonian’s permanent research collection on information technology at the National Museum of American History in Washington, DC.

Why did Roche go to such lengths? "It’s our bias that data sets and clinical pathways between people are more important than any of the bricks and mortar in healthcare," says Richard Evans, vice president, business policy and account management at Roche. To compete, he says, companies like Roche must deliver quality at the best cost, and "to do that, we feel we can no longer approach every patient without reference to patients of a similar type," which means mega needs for crunchable data."We wanted to check our view," says Evans, "and advance the industry dialogue."

A few months later, Bristol-Myers Squibb sponsored the second annual Conference on Integrated Patient Care in Washington, DC, as part of "an ongoing initiative to transform our current healthcare system with its many disparate and disjointed parts into one in which all sectors work in concert for the benefit of the patient," according to promotional literature. Information technology, of course, is key to such an approach to care.

Should pharma fund healthcare IT?
The quest for credibility may have also been at the root of one pharmaceutical company’s recent offer to give a million dollars to the well-regarded Henry Ford Health System in Detroit for any information system project of the healthcare organization’s choosing. The offer, which came by way of a consulting firm, had only one stipulation, says Frank Palazzolo, Ford’s director for information systems: that the drug company’s name would be associated with the project ifit was successful. While the IS staff liked the idea, says Palazzolo, ultimately the organization’s doctors panned it--viewing the offer as a surreptitious effort to get on Ford’s formulary.

Palazzolo believes Henry Ford popped onto the pharma’s radar screen because it sponsors an annual award called the Healthcare Innovations in Technology Systems (HITS) Partnership in Technology Award, which has been known to significantly boost its recipients’ subsequent sales. The HITS award winner is selected by a high-profile panel of IT experts and is recognized each year at the National Managed Health Care Congress, an event attended by thousands of healthcare management executives--and well-sponsored by pharmaceutical companies.

Still, while such market posturing may boost credibility, it can only yield a pharmaceutical company so much information. Beyond niceties, what’s needed are numbers. And that means connectivity, which raises the larger question: Who pays for the infrastructure needed to connect doctors to doctors, doctors to pharmacists, health plans to doctors, hospitals to doctors--and finally pharmaceutical companies to the real numbers they need?

Says Minneapolis-based cardiologist Spencer Kubo, MD, a senior medical director for Merck & Co.: "The broad view is that the responsibility for IT investment resides within the payor community. Merck recognizes the need and fully supports customers as they implement their own programs."

Merck, which makes and markets lipid-lowering Zocor, offers physicians a handy software program that mashes demographic data, national cholesterol guidelines, risk factors and lab values to produce individualized goals and tracking for each patient. It’s modular, Windows-based, simple to use, and can fit into just about any clinic’s system, says Kubo. What’s more, doctors don’t need to be prescribing Zocor to get the software.

"We view IT as a method to enhance delivery of medical services, which means enhanced use of our products--if we make good products," says Kubo.

Consultant Ronald Waife takes a different view, summing up the debate simply: Pharma says managed care organizations should be researching outcomes to find the most efficient drug treatment, but cost-constrained MCOs say that’s pharma’s responsibility since the drug companies will directly benefit from the resulting information. "It’s gotten to be something of a standoff," says Waife.

Who knows doctors?
Even if a networked computer magically appeared on every doctor’s desktop, there still would be a major impediment to pharma’s and just about anyone else’s getting the information they need: doctors. Doctors have resisted using computers--largely due to workflow considerations--and no one’s figured out quite how to budge them. But therein may lie pharma’s big break in healthcare IT: Having studied physician behavior ad infinitum, having talked to and "detailed" them ad nauseam, and having marketed to them ad hominem, pharmaceutical companies--like it not--know something about influencing doctors. If anyone can motivate doctors to accept IT, it’s pharma.

Indiana-based Eli Lilly apparently bought into this concept several years ago when it purchased IMS Medacom, a networking company that has connected some 70,000 physicians to major hospitals, integrated delivery systems and insurers. In February, Lilly announced plans to fold IMS Medacom into a joint venture with electronic commerce giant EDS. The new company, Kinetra, is owned 49 percent by Lilly and 51 percent by EDS.

Based in Golden, Colo., Kinetra hopes to extend its network of real-time transactions to thousands more office-based physicians--and to hospitals, health insurers, laboratories and pharmacies. What’s the hook for doctors? Within seconds, networked MDs should be able to check a patient’s eligibility for a particular drug, find out what other drugs the patient has been prescribed, receive alerts to any potential adverse reactions, review lab results and much more.

Explains Kinetra’s executive vice president and medical director, Michael Hodgkins, MD, MPH: "We’d like to create an information access opportunity that doesn’t exist today. We want to be the utility, if you will."

Another Lilly subsidiary, Arizona-based pharmacy benefits management company PCS Health Systems, will play a role in the Kinetra venture. PCS already connects 54,000 retail pharmacies nationwide to health plan information, giving them access to patient eligibility and copays. PCS can also adjudicate and pay claims within seconds. PCS offers its customers--mostly health plans-- software called Re:solve that allows them to comb through their own database to examine trends, drug costs, prescribing patterns by physicians, and therapeutic categories of drugs being prescribed.

Yet Lilly is prohibited from access to confidential patient information, as is any user of the information. So what’s the benefit to Lilly? "Lilly’s interest in Kinetra is the belief in the importance and value of pervasive connectivity," says Hodgkins. "The more information and the better the quality of information available, the better for the entire healthcare system as a whole."

Buy a doc a PC
While Lilly through Kinetra works toward widespread connectivity and physician-friendly applications, at least one other pharmaceutical company is taking a different but compatible approach.

Roche’s Evans views the capital costs of computers as part of the obstacle to getting physicians to use them. He believes that once even a small set of doctors overcomes the cost hurdle and discovers the value of going digital, word of mouth will help spread enthusiasm for connectivity. Roche might consider giving computers to 40 to 50 targeted groups of physicians in specialties that place a high value on academic and scientific information. The pitch, says Evans, would be: "Look, we’ll get you over the capital hurdle, and you folks will be able to have access to a data set no one else has."

Actually, it’s a simple formula that has worked quite well in the past for pharmaceutical companies: Give samples, give information, watch business grow. Only this time, such a tactic could move more than drugs--it might help nudge connectivity and physician usage of computers far enough along to give pharma and many others in healthcare the information they need.

Pharma to IT: If You Build it, We Will Come

BRINGING A NEW DRUG FROM laboratory to market takes about 15 years and costs a pharmaceutical company an average of $500 million, according to the Pharmaceutical Research and Manufacturers of America.

During the clinical trials phase, much of the documentation still happens on paper. Ronald Waife, president of the Massachusetts-based healthcare consulting firm Waife and Associates, says a golden opportunity exists for IT developers who have been building electronic patient charts (a term he considers more palatable to doctors than electronic medical record) and practice management products.

The tedious process of checking and rechecking facts and figures to catch potentially dangerous errors during clinical trials could be greatly streamlined if entries were made, sorted and compared on computer. Waife sees significant overlap between the FDA-mandated case report form and the electronic medical record software.

Further, he says, the scheduling and tracking of patients in clinical trials could be vastly improved with the kinds of practice management software being marketed today.

There is some research software available for this kind of work, Waife says, but "it’s quite inadequate" and pharmaceutical companies are generally not happy with it. "Sooner or later, someone’s going to figure this out," says Waife. It may not be the behemoth sell that capturing the entire healthcare market would be, but pharmaceutical companies are spending at least "tens of millions of dollars on it," says Waife.

In a related development, Quintiles, a North Carolina-based contract research organization last November acquired a minority ownership in Physicians’ Online, an MD-only online service serving more than 50,000 individual doctors and largely supported by pharmaceutical sponsors. Contract resource organizations run clinical trials for pharmaceutical companies and need new and better ways to collect and track data to stay competitive.

According to Dennis Gillings, PhD, Quintiles chair and CEO, Physicians’ Online "Internet-based communication systems and secure Intranets provide an excellent opportunity to improve the efficiency of clinical trials."

Quintiles plans include "recruiting investigators and patients for clinical trials, managing investigator sites, and collection and transfer of clinical trial data."

Kathleen Kimball-Baker is a Minneapolis-based healthcare writer.

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