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Credit: Technology Review

A new tool allows entire networks to be scanned efficiently for infection.

MIT Technology Review, April 1, 2009, by Erica Naone — On April 1, a computer worm called Conficker, which has already infected millions of machines worldwide, is expected to do something bad, though no one knows exactly what. Some experts fear that an army of infected machines could be ordered to launch a coordinated attack or send out a barrage of spam. But a tool released today could help lessen the impact by allowing big companies and institutions to quickly weed out infected machines by scanning entire networks for signs of infection.

Analysis of the Conficker worm has previously revealed that infected computers will “phone home” on April 1 to receive a new set of instructions. It is already possible to detect the worm by scanning machines individually, but this is a relatively time-consuming process. It’s also possible to detect the bug by watching for outgoing communications sent across a network, but the latest version of Conficker is designed to stay silent until April 1.

Dan Kaminsky, director of penetration testing for the Seattle-based security company IOActive, helped create the new scanning tool and says that it can identify an infected machine by recognizing the way it presents itself to the wider network. This makes it quick and easy to scan for the worm remotely and does not require any special access to machines. “It’s like driving through a neighborhood looking for houses with big signs on their doors,” Kaminsky says.

The tool was created after Tillmann Werner and Felix Leder, members of an independent research organization called the Honeynet Project, asked Kaminsky to review their research on Conficker. The pair had figured out that the worm changes the way a machine appears on a network. Kaminsky seized on this, suggesting that the researchers create a tool that uses this information to find infected machines. The researchers built such a tool and worked through the weekend to get it ready for broad distribution to suppliers of other security software. “Whatever vulnerability scanner a company is using, it should have support for this by the end of the day,” Kaminsky says.

Bruce Schneier, chief security technology officer at BT Counterpane, says the new tool’s ability to seek out the virus remotely should be useful, since it will let people scan a huge number of machines very quickly. This is important, Schneier says, because the worm is such a nasty pest. “Conficker is an extremely well-written, extremely well-designed, extremely well-executed worm,” says Schneier. “It really is an impressive piece of work, and there’s someone really smart behind it.” But Schneier adds that it’s important for computer users and administrators to protect their machines against a variety of malware, not just a single threat.

“If you’ve been running a good environment, you shouldn’t be worried about this,” says Rich Mogull, founder of the security-consulting company Securosis, who helped connect the Honeynet researchers and Kaminsky with network-security vendors over the weekend. Mogull notes that Microsoft has already released several patches that block the vulnerability that Conficker uses to infect a machine. However, he says that companies worried about Conficker should start scanning for it right away, after checking to see if their network-security tools have been updated.

Kurt Rohloff, a scientist who studies Internet worms at the research and development company BBN Technologies, says that the tool could prove useful, though he doubts that there’s time to find and neutralize every computer infected with the worm. Rohloff says that the new scanner could be used to take preventive action by identifying infected hosts and removing them from the network, though he admits that this approach is “drastic, because you’re removing connectivity.”

Kaminsky notes that the tool is intended for organizations with large networks. For individuals, he says, the best approach is to make sure that the latest security updates are installed and up-to-date antivirus software is running. Since Conficker blocks a computer from accessing certain security websites, users could test for the worm by trying to visit those sites, Kaminsky says. Werner and Leder plan to release a paper within the next day, describing the technical details of their discovery.

WebMD.com/heartwire, March 31, 2009, by Lisa Nainggola — A phase 2 trial described as being the critical first step on the journey to discover whether a polypill could work effectively has shown just that [1]. The pill (Polycap), consisting of three antihypertensive drugs, a statin, and aspirin–developed by the Indian firm Cadila Pharmaceuticals–could cut cardiovascular risk by half in healthy, average people, say the researchers.

Dr Salim Yusuf (McMaster University, Hamilton, ON) reported the findings of The Indian Polycap Study (TIPS) at a late-breaking clinical trials session here at the American College of Cardiology (ACC) 2009 Scientific Sessions today, and they were simultaneously published in the Lancet.

Importantly, those who took the polypill in the study had no more adverse effects than eight other groups enrolled who were taking one of the components of the polypill alone or, in some cases, a combination of two or three of the components. And there appeared to be no drug-drug interactions. But the degree of cholesterol lowering was slightly less with the polypill than in patients who got simvastatin alone, and the reduction in BP was lower than projected from the antihypertensives included. “Our findings emphasize that the effects of the polypill cannot be assumed to equal the combined effects of its individual components,” the researchers caution. Nevertheless, the findings are key, they say. Dr Denis Xavier (St John’s Medical College, Bangalore, India), a coinvestigator of the TIPS trial, told heartwire: “We are encouraged by the results–this trial has demonstrated that the Polycap is well tolerated and does modify physiological parameters as expected at three months and can potentially be given to a large proportion of individuals with cardiovascular risk factors. But what we do not yet know is whether it would reduce mortality and other major cardiovascular events. So prior to its widespread use, we must test it in a large primary-prevention clinical trial with cardiovascular events as outcomes. This has prompted us to firm up plans for the next trial.”

Yusuf told heartwire that the Polycap will be available in India “within a matter of weeks” and that its use in secondary prevention is feasible because large morbidity and mortality trials have already been conducted with the individual components. But he agrees that a large trial is needed before such a pill can be given to apparently healthy people. “The polypill is a wonderful concept, but there are lots of steps before we put it into practice.”

In an accompanying comment in the Lancet [2], Dr Christopher P Cannon (Brigham and Women’s Hospital, Boston, MA) says the concept of a polypill has “obvious appeal and vast implications for global health,” with the possibility of reducing heart disease by 80%. The TIPS trial “moves us one step closer to realizing this dream,” says Cannon.

Following the presentation at ACC, there was a lively debate surrounding the lower-than-expected reductions in LDL cholesterol and blood pressure; compliance, which was not as high as would have been expected; and the ideal target population for such a pill. Dr Steven Nissen (Cleveland Clinic, OH) asked what this would be for, “the developed or the developing world?” Yusuf replied: “It’s for the sensible!”

Moderator of the press conference, Dr Hani Sabbah (Henry Ford Health System, Detroit, MI), was fairly critical of the study. “I think Yusuf way overrated his conclusion based on the data they have, which is not quite ready to go as a primary intervention. He wants to treat the world, or at least everybody over the age of 50, with a polypill. I share his enthusiasm, but I’m not quite ready to jump on the bandwagon of treating nations,” he told heartwire. But Dr Timothy Gardner (Christiana Care Health Services, Wilmington, DE) said he was reassured somewhat by the data: “Some of the concerns about a polypill in the general population were not seen.”

BP Lowering Good and Aspirin Effectiveness Maintained in Polypill

TIPS, a double-blind study, enrolled 2053 patients aged 45 to 80 years without cardiovascular disease but with one risk factor–type 2 diabetes, high blood pressure, smoker within past five years, increased waist-to-hip ratio, or abnormal lipids–at 50 centers in India. They were randomly assigned to one of nine groups for 12 weeks: 412 received Polycap, with hydrochlorothiazide 12.5 mg, atenolol 50 mg, ramipril 5 mg, simvastatin 20 mg and aspirin 100 mg. The remainder were assigned to eight other groups, with around 200 patients in each, including the same doses of aspirin alone, simvastatin alone, hydrochlorothiazide alone, three combinations of two BP-lowering drugs, three BP-lowering drugs alone, and an arm with three BP-lowering drugs plus aspirin. All participants were also counseled on appropriate lifestyle modification.

The polypill lowered blood pressure similarly to the added effects of each of its three BP-lowering components, with an average reduction of 7 mm Hg systolic, with no interference of aspirin with the BP-lowering effects. Heart rate (an indicator of beta blockade) and urinary 11-dehydrothromboxane B2–a measure of aspirin effectiveness–were also lowered to a similar degree with the polypill as with the individual components.

Following the presentation, both Dr Sidney C Smith (University of North Carolina, Chapel Hill) and Nissen questioned what they said was a poor showing of the polypill in terms of antihypertensive-lowering effects. Yusuf reminded them the pill contained only half doses of antihypertensives, and “these data are telling us you can lower BP reasonably safely in this population. With full doses, how well will they be tolerated, and how much more of a benefit will we get? We have to follow this up with further trials to look at clinical outcomes.” Smith agreed: “The true test is not what happens to BP, but whether it affects your rate of events. If you give it to this population, what are the outcomes going to be?”

Cholesterol Lowering Inferior With Polypill, But Tolerability Is Good

The Polycap was well tolerated, with a similar rate of discontinuation in that group compared with the other eight, something Cannon calls “a key and very promising finding.”

But Yusuf admitted that compliance was poor in the study overall, with 18% of patients dropping out within the 12 weeks. However, the reasons for this were likely due to lack of staff in the study centers and the fact that six of the centers hadn’t ever performed a trial before. It’s also possible that generally healthy people stopped taking the pill because they couldn’t conceive any benefit, he said.

This holds tremendous promise but it’s a first step, and we’ve got miles to go before we sleep.

Smith stressed that compliance was a key factor to look at in future trials. “What we need to know now is, will people adhere to a polypill better than they would adhere to five pills? Will they take it? It may just be that they aren’t going to take pills at all. We need to know that putting them together in one pill improves compliance. We have to show that. This holds tremendous promise, but it’s a first step and we’ve got miles to go before we sleep,” he commented to heartwire.

For reasons that the researchers say remain unknown, the polypill did not lower LDL cholesterol to the same extent as simvastatin alone; studies by the sponsor indicate that the drug concentration of simvastatin with the Polycap was 20% lower than with simvastatin alone, they note.

It’s very important that if people take a polypill, this is not a substitute for continuing to smoke and be fat and eat the wrong things.

Cannon says this finding “highlights the importance of a phase 2 study such as TIPS to identify any such issues with the polypill” and suggests that perhaps a dose of 40 mg of simvastatin or a moderate dose of a more potent statin, which should become available generically in a few years, may be more appropriate for future larger trials.

Xavier told heartwire that, based on the results, “We are planning to alter some of the components, especially in specific conditions such as hypertension and diabetes. We also propose to have different combinations for primary and secondary prevention; in the former, without aspirin, and in the latter, with aspirin.”

Safety Must Be Proven; Lifestyle Must Not Be Neglected

“Even the current polypill will lead to important things,” Yusuf told heartwire. But, he said, “Our next step is to test various different formulations, to see if we can improve on the results, to see whether this is still safe and affordable and whether people be willing to use it. My guess is that they will–there are people swallowing pills of ginseng and all kinds of rhinoceros horns and other things.”

However, he cautioned: “It’s very important that if people take a polypill, this is not a substitute for continuing to smoke and be fat and eat the wrong things, so the polypill has to be on top of good lifestyle behavior.”

Sabbah said much more data on safety are needed. “We know that for these patients, for the duration that they were followed (12 weeks), there were no safety issues. But I don’t know if safety issues would begin to rear their ugly heads in a year, two years, or three years. You need a much longer follow-up to assess the safety of the polypill. This would have no legs to stand on in the US through the FDA without a larger trial, powered to be able to look at safety issues as well as efficacy. Drugs do not grow on trees. They are chemicals, and if there is no need for that chemical, if you cannot establish a cause for that chemical, patients should not be swallowing those pills. More studies are needed.”

Yusuf told heartwire: “The company and I will be meeting with the FDA to share our data with them. I don’t know how soon the meeting will be held, certainly it will be in the next few months, and we will try to understand from them what is needed. Maybe what we’ve already got is good enough. We have very good stability data, which I haven’t shown, and we have very good pharmacokinetic data–we’ve really done a proper development here. We’ve tested nine formulations, and, usually these things are meant to be four weeks, and this is 12 weeks, so we’ve done a lot of things that are right, so we just have to wait and see.

“But I think the regulators will be cautious, because when you have something new, they take a while to work things out. The answer is I don’t know,” he added.

Projected 50% Reduction in Stroke, 60% Reduction in MI

The TIPS investigators have projected the benefits of the polypill on the reduction of cardiovascular disease and stroke, which they note are “significantly less” than the risk reductions predicted by Drs Nicholas J Wald and Malcolm R Law (Wolfson Institute of Preventive Medicine, London, UK), the British doctors who first conceived the idea of a polypill in 2003.

Nevertheless, the calculations overall indicate an estimated 62% reduction in coronary heart disease and 48% reduction in stroke, although Yusuf was keep to stress that these really are “just projections”.

Estimated Reduction in CHD/Stroke of a Polypill in Those With Average Risk-Factor Levels

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Asked by heartwire how much the Polycap is likely to cost, Xavier said: “I am unable to comment on pricing at this point. It is the company’s call here, and to the best of my knowledge they have not yet priced it. What I do know for sure is that it will be priced in such a way that the majority of the lower-middle class in India would be able to afford it long term, and the same will apply to other developing countries, too. In developed countries, it will be priced higher.”

Yusuf has received fees for lecturing and research grants from Cadila as well as six other pharmaceutical companies that produce CVD drugs. Xavier and some of the other authors have received research funding for this trial from Cadila. Cannon has received research support from Accumetrics, AstraZeneca, Bristol-Myers Squibb/Sanofi, GlaxoSmithKline, Merck, and Merck/Schering-Plough. He serves as a clinical adviser and holds equity in Automedics Medical Systems. He is a senior investigator on the TIMI study group.

1. The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized trial. Lancet 2009; DOI:10.1016/S0140-6736(09)60611-5. Available at: http://www.thelancet.com.

2. Cannon CP. Can the polypill save the world from heart disease? Lancet 2009; DOI:10.1016/S0140-6736(09)60652-8. Available at: http://www.thelancet.com.

But others were not impressed.

Robert Bonow, M.D., professor of medicine at Chicago’s Feinberg School of Medicine at Northwestern University, cautioned restraint.

“We already have a polypill — it’s called exercise,” Dr. Bonow said.

Dr. Bonow, who is a former president of the American Heart Association, said, however, that he did believe there was a role for a polypill in secondary prevention.

After myocardial infarction, patients should be on multiple drugs to prevent recurrent MI, he said, and “that is when compliance can be a real problem, when the patient needs to take four or five drugs so a single pill could be a big help.”

Steven Nissen, M.D., director of cardiovascular research at the Cleveland Clinic Foundation, didn’t mince words. “I’m not impressed,” he said after listening to Dr. Yusuf’s presentation.

Although he conceded that the polypill “didn’t hurt anyone,” he pointed out that with a mere 12 weeks of data it would be premature to endorse the polypill as safe.

“If a patient does get side-effects, how do you know which drug it is? And, you can’t titrate a polypill,” Dr. Nissen said.

He concluded that the polypill was probably “not approvable” in the United States.

Whether or not Dr. Nissen’s assessment of approvability is accurate, developing a polypill for use in the U.S. would be an arduous and expensive proposition.

Dr. Yusuf estimated that the phase II trial conducted in India cost about $1 million, a drop in the bucket, he said, for a clinical trial.

Attempting such a trial in the U.S. would probably cost hundreds of millions of dollars and tens of thousands of patients would need to be recruited, said Hani N. Sabbah, Ph.D., of Henry Ford Hospital in Detroit. Dr. Sabbah, who is co-chair of the ACC program committee, moderated a press conference where Dr. Yusuf discussed the results of the polypill trial.

Dr. Yusuf said the blood pressure reductions achieved with the polypill — an average reduction of systolic BP by 7.4 mmHg and diastolic BP by 5.6 mmHg compared with controls not taking antihypertensives — were less than the 20 mmHg/11 mmHg reductions that had been projected.

But even those more modest reductions cut the risk of coronary heart disease by 24% and stroke risk by 33%.

The trial recruited 2,053 adults (age 45 to 80) at 50 centers in India. Criteria included no history of cardiovascular disease and just one risk factor. Patients were recruited from March 5, 2007 through August 5, 2008.

Participants were randomized to the polypill — thiazide (12.5 mg), atenolol (50 mg), ramipril (5 mg), simvastatin (20 mg) and aspirin (100 mg), or to one of eight comparator groups: aspirin alone, simvastatin alone, thiazide alone, thiazide plus ramipril, thiazide plus atenolol, ramipril plus atenolol, all three blood pressure drugs, and all three blood pressure drugs plus aspirin.

Some 412 individuals were randomized to the polypill and 200 to each of the comparator arms. Patients were given the study drug for 12 weeks.

To lessen the risk of hypotension, patients randomized to an arm that included ramipril were initiated at a dose of 2.5 mg for seven days then titrated up to 5 mg.

Among the findings:

· The polypill reduced 11-dehydrothromboxane B2 by 283.1 ng/mmol creatinine. This was similar to reductions achieved by aspirin alone (348.8 ng/mmol creatinine) and aspirin in combination with three blood pressure drugs (350.0 ng/mmol creatinine).

· Heart rate reductions with the polypill and in treatment groups taking atenolol averaged 7 beats/min, which was significantly lower than groups not taking the beta blocker (P<0.0001).

· BP reductions increased with the number of drugs used. One drug reduced systolic pressure by an average of 2.2 mmHg and diastolic by 1.3 mmHg. With two drugs the reduction was 4.7 mmHg/3.6 mmHg, and with three, the drop was 6.3 mmHg/4.5 mmHg.

In an editorial that accompanied The Lancet paper, Christopher P. Cannon, M.D., of Harvard and a senior investigator with the TIMI Study Group, said the major appeal of the polypill is its simplicity and low cost.

That could not only translate into “broad applicability in areas of the world with less access to medical treatment”, he wrote, but also “fit well in to more modern medical systems, in which large proportions of patients with risk factors are untreated.”

Dr. Cannon concluded that while TIPS “does not provide all the answers, the study does take a first and crucial step forward and raises hope that, in conjunction with other global efforts to improve diet and exercise, the polypill could one day substantially reduce the burden of cardiovascular disease in the world.

The study was sponsored by Cadila Pharmaceuticals, India, which played no role in data collection, analysis or interpretation.

Dr. Yusuf reported receiving lecture fees and research grants from Cadila for the conduct of this trial. Dr. Yusuf also reported being named on a patent for a urinary assay of thromboxane, with royalties donated to McMaster University.

Dr. Cannon reported research grants/support form Accumetrics, AstraZeneca, Bristol-Myers Squibb/Sanofi Partnership, GlaxoSmithKline, Merck, Merck/Schering Plough Partnership. Dr. Cannon said he was a clinical advisor and equity partner in Automedics Medical Systems.

Dr. Nissen reported that the Cleveland Clinic Coordinating Center for Clinical Research has received research support to perform clinical trials from Pfizer, Astra Zeneca, Sankyo, Takeda, sanofi-aventis, Lilly, Roche, Daiichi-Sankyo, and Novartis. Dr. Nissen consults for many pharmaceutical companies, but says he requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.

Dr. Bonow reported no conflicts of interest.

Medscape.com, March 31, 2009, by Wayne J. Guglielmo — Despite a full plate that seems to be getting fuller all the time, the Obama administration has made healthcare reform a top priority.

In his budget, the President establishes a reserve fund of more than $630 billion over 10 years to finance fundamental reform, while also appropriating billions directly to support more immediate healthcare initiatives. Lawmakers in Congress have already responded with proposals of their own, including one to keep any reserve fund budget neutral. But, whatever happens to the President’s budget priorities in the next few months, Washington has already injected billions of healthcare dollars into the system via the stimulus package passed and signed into law in February.

Of the $787 billion in the American Recovery and Reinvestment Act of 2009 (ARRA), roughly $150 billion is directed to healthcare. A big chunk of this amount is slated for 2 areas that have been placed under tremendous stress by the current economic downturn — Medicaid, the federal-state health program for low-income individuals and families, and COBRA, the law that assists laid-off workers to continue their employer-sponsored healthcare coverage for 18 months or longer. ARRA appropriates $86.6 billion and $24.7 billion, respectively, for Medicaid and COBRA. The aim is not simply to provide relief but stimulus, with the hope of making the road to recovery less long and winding.

But ARRA does something else, too. “Clearly, the stimulus was not purely stimulative,” Paul B. Ginsburg, president of the nonpartisan Center for Studying Health System Change in Washington, DC, told Medscape Medical News. “The thinking among lawmakers was, ‘Let’s use it for some things that will move reform ahead.’ ” Those things include significant new appropriations for comparative effectiveness research, health information technology, and prevention and wellness.

Here is a rundown of both the relief and reform items in the stimulus package, with an eye to what their near- and long-term effect on healthcare is likely to be.

Relief for Troubled Times

With more than 45 million uninsured Americans in 2008, the recession has made a bad situation worse, both for low-income people and for the previously employed who have lost their coverage. The stimulus targets these groups in different ways:

Enhanced federal Medicaid match. The nearly $87 billion that ARRA appropriates to Medicaid is taking the form of a temporary increase — 27 months — in FMAP, the federal government’s share of what it costs a state to run its Medicaid program. With states already struggling with high program costs, “the enhanced match gives them the ability to provide services to an increased number of people,” said Joy Johnson Wilson, the chief federal policy analyst for the National Conference of State Legislatures in Washinton, DC.

All states are receiving a base increase of 6.2%, with the prospect of higher increases for states with significant hikes in their quarterly unemployment rates. The stimulus also ensures that no state’s FMAP will drop for fiscal years 2009 and 2010. Thus, if a state’s federal match was higher in 2008 than in 2009, it would still get the 2008 FMAP in 2009.

To qualify, states may not have eligibility standards in place that are more restrictive than they had in place on July 1, 2008. This stops them from cutting new groups or populations of people — but it also keeps them from adding them. States are permitted, however, to cut benefits or provider payments, which Ms. Wilson thinks some may have to do if unemployment rates keep going up during the next 27 months. “Despite the enhanced federal match, the states under these circumstances may need to cut benefits or do something else to sustain their programs,” she told Medscape Medical News.

COBRA assistance. The law, passed in 1986, enables laid-off workers who might otherwise have to purchase private insurance to stay in the less-expensive group health market, at least temporarily. With the rise in insurance costs, however, COBRA premiums have themselves become prohibitively expensive, totaling nearly $13,000 in 2007 for a family policy, according to the Kaiser Family Foundation.

ARRA provides a 65% subsidy for workers who formerly participated in their employer’s health insurance program and whose income for 2009 will not exceed a certain ceiling — $125,000 for an individual or $250,000 for a family. The program is temporary, so workers terminated involuntarily after the end of this year will not be eligible. Still, Paul Ginsburg of the Center for Studying Health System Change calls it “a bold stroke in policy,” one that it’s not impossible to think “could come back as permanent policy, especially if broader healthcare reform doesn’t succeed.”

Jumpstarting the Reform Process

The stimulus package pushes this process forward in some small and some not-so-small ways:

Comparative effectiveness research (CER). Judging from the reaction to date, the $1.1 billion appropriated to CER is viewed as a small but very significant step forward. “If I’m going to compare the effectiveness of a medication to a medical device, say, I’ll need to have that study funded,” said J. James Rohack, MD, president-elect of the American Medical Association and a senior staff cardiologist at Scott & White Clinic in Temple, Texas. “In our current model, all the device or drugmaker has to show is that its medication or medical device is safe. Neither company has a lot of incentive to fund a head-to-head effectiveness comparison. And so this is a role the government can play — freeing up money to fund such research.”

The ARRA calls for the government to name a Federal Coordinating Council to oversee the research, which it has already done. The ARRA also directs $300 million in effectiveness funds to the Agency for Healthcare Research and Quality (AHRQ), which has promised “to make the most of this additional funding.” Another $400 million of this money is slated for the National Institutes of Health (NIH) and the office of the Department of Health and Human Services Secretary.

Whatever research is developed will not guide coverage determinations for public and private payers; nor will it result in new national clinical guidelines, something Dr. Rohack thinks lawmakers got exactly right: “If you have information that’s valid and credible, the doctor and patient can arrive at the most effective treatment option. Right now, we don’t have that information, except for sporadic literature searches. The hope is that the new research will fill in the existing gaps.”

Health information technology (HIT). ARRA directs a significant $19.2 billion to this area, which the government estimates will lead over time to better quality of care, better care coordination, less duplication of services, fewer medical errors, and, ultimately, more cost savings. The biggest chunk of money — $17 billion — will come in the form of Medicare and Medicaid incentives to entice physicians and hospitals to adopt electronic health records (EHRs). Besides carrots, the government also has penalties for nonadopters. Beginning in 2015, physicians who have not adopted HIT will be subject to decreasing Medicare payments, up to a 3% reduction by 2017 and beyond.

Is this carrot-and-stick approach the way to go? Yes, says Patricia B. Wise, vice president of the Healthcare Information and Management Systems Society (HIMSS), headquartered in Chicago. “If the nation is going to move forward in all the areas that President Obama has called for, that means all Americans should have an [EHR] by 2014, not a portion of them.”

Ms. Wise is quick to add, however, that it is equally critical for the government to make good on another key provision of the stimulus — developing standards for the uses and exchanges of electronic health data. Such interoperability standards, as they’re known, are essential if we’re really going to reap the rewards of HIT, said Ms. Wise, Dr. Rohack, and other commentators. “It’s not enough simply to make an electronic version of the paper record,” Ms. Wise told Medscape Medical News. “We need to be encouraging the data exchange between those records.”

In line with this, ARRA also contains provisions that strengthen — and, in some instances, expand — rules from the Health Insurance Portability and

Accountability Act (HIPAA) that protect patient information. Among other changes, ARRA includes tough new standards for business associates of covered entities, establishes a federal breach notification requirement, and expands the existing accounting rules. On the last point, physicians and other covered entities who disclose protected information in an EHR must account for this disclosure, even if it’s in connection with treatment, payment, or healthcare operation. Will this impede HIT adoption? Right now, it’s too early to tell. “I don’t think we have heard the last on this,” said Jo-Ellyn Klein, an attorney with Akin Gump, in Washington, DC.

The stimulus package makes other down payments on reform, including $10 billion for NIH, which has already directed $60 million to support autism research; $1.5 billion for community health centers; $1 billion for wellness and prevention programs; and $500 million for training primary care providers for medically underserved areas.

In the rush to pass the stimulus, lawmakers in Congress were often vague in how exactly they wanted all this money spent, which Mr. Ginsburg thinks may be a blessing in disguise. “Often bad policy results when Congress tries to micromanage healthcare,” he said.

He also thinks the stimulus had another good effect — it lightened the load of future healthcare reform: “There are some things — like HIT — that such reform doesn’t have to grapple with as much because they got a big jumpstart in the stimulus package.”

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New Benchmarks: “Most consumers assume that everybody does everything right all of the time,” says surgeon Dr. Alfred Casale. | photograph by Kyoko Hamada

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Patient no. 86: Geisinger CEO Glenn Steele, who initiated the ProvenCare guarantee, became one of its early beneficiaries. As a patient, the process “was totally opaque to me,” he says. “And that’s exactly the way I wanted it to be.” | photograph by Kyoko Hamada

How a small network of hospitals in Pennsylvania is defying convention, cutting costs, and improving health care.

Geisinger Health System’s Plan to Fix America’s Health Care

By Peter Carbonara

Here’s a guarantee that will get your attention. Geisinger Health System, which runs three hospitals in central Pennsylvania, not only charges a flat fee on coronary-artery bypass surgery and all of the pre- and post-operative care that goes with it, but it also offers a warranty: If a preventable complication puts you back in the hospital within 90 days, Geisinger will eat the cost.

Geisinger’s doctors and executives — who sound like management consultants with their talk of “unnecessary variation,” “best practices,” and “managing change in complex systems” — are trying to do more than reengineer heart surgery. They’re turning this 92-year-old hospital network/insurance company in Danville, Pennsylvania, into an ambitious laboratory for organizational and financial experiments aimed at fixing American health care. And some of the ideas may actually work.

When CEO Glenn Steele, a surgeon and oncologist, was recruited from the University of Chicago medical school five years ago, Geisinger was recovering from a brief, unhappy merger with Penn State Hershey Medical Center that left it shaken but also open to change. This was ideal for Steele. Because Geisinger had its own hospitals and health-insurance plan, employed 600 doctors directly, and served a stable and therefore easily studied demographic, it was just the kind of place you’d pick if you wanted to test big hypotheses for reforming the health system.

On Steele’s watch, Geisinger has expanded computerized patient records and established a venture unit to develop treatments for possible licensing. But the guarantee program, called ProvenCare, represents arguably the biggest challenge to the status quo.

To Steele, the underlying idea is simple enough: “We shouldn’t get paid if we don’t do the right thing.” Most American health care is provided on a fee-for-service basis. If you have six operations and die, that’s better financially for your hospital than if you have one procedure and go home. How to replace fee-for-service with pay-for-performance (P4P) has been the talk in medical policy circles for some time. P4P is often linked to “evidence-based medicine,” which simply means doing what clinical data say works, rather than relying on habit, hopes, or tradition.

ProvenCare is based on CEO Glenn Steele’s concept that “we shouldn’t get paid if we don’t do the right thing.”

ProvenCare sets a fixed price — which includes a percentage of the historical costs of complications — for a given medical problem. That creates a powerful financial incentive to get things right the first time. Says Dr. Ronald Paulus, Geisinger’s chief innovation and technology officer: “We had to put our money where our mouth was.” Steele decided to start with coronary-artery bypass graft (CABG, pronounced cabbage) surgery because it’s a high-volume, high-margin procedure that’s well studied and has low mortality and complication rates.

“We did this to test whether we could take a very complex system across three hospitals with a huge number of people involved and reliably do something we promised we’d do,” says Dr. Alfred Casale, formerly Geisinger’s chief of cardiothoracic surgery and now chief medical officer of one of Geisinger’s hospitals. Before, he explains, “if the physician’s assistants got called to the bedside of somebody who had developed rapid atrial fibrillation [the irregular heart rhythm that happens about 20% of the time after a heart operation], the first thing they would ask wasn’t, ‘How is he?’ It was, ‘Whose is he?’ Because what they would do next depended on the idiosyncrasies of the surgeon and the cardiologist.”

ProvenCare eliminates that kind of variation. After studying guidelines adopted by the American Heart Association and the American College of Cardiology, as well as mountains of clinical research, Steele’s seven cardiothoracic surgeons developed a list of 40 steps that should be taken — or at least considered — in the treatment of every CABG patient, from the first clinic visit to discharge. “None of the 40 things are new,” Casale explains. “Being certain that they are all being done all the time is the real innovation.” It’s not a question of inventing a secret sauce, he says, so much as guaranteeing “every hamburger that comes out of the place has the secret sauce in it.”

For patients, of course, getting what’s been proven to work is nothing more than we expect from a Jiffy Lube. But according to a 2003 New England Journal of Medicine paper, only 55% of American patients get all the treatment that is generally accepted as necessary for their problems. To make sure the number at Geisinger is near 100%, surgeons, pre- and post-operation, face a computer screen that asks a set of questions: Is the patient on a beta blocker? A statin? Were antibiotics given at least 60 minutes before surgery and discontinued after 48 hours? A staffer sends an email query if there’s no response to any of the 40 steps.

There’s a financial component to ProvenCare — doctors receive bonuses based in part on following the protocol — but Geisinger insists it’s not trying to force its staff to practice what is pejoratively known in the industry as “cookbook medicine.” A doctor who concludes there are good reasons not to do one of the 40 steps simply documents that decision in the patient’s record. “What we’re trying to do,” Casale says, “is avoid the moment of smacking yourself on the head at the end of a procedure and saying, ‘Jeez, I should have used antibiotics!’ ”

The results have been promising. A paper published in the fall of 2007 in the journal Annals of Surgery studied 181 CABG patients subject to the ProvenCare protocol between February 2006 and February 2007. Compared to nonchecklist patients, the ProvenCare group had 16% shorter hospital stays. Their bills were about 5% lower. While Casale admits that the study was small, he insists the results are still significant: “We’ve seen a 45% decrease in readmission rates, 60% decrease in neurologic complications — meaningful changes that you’d certainly be happy to get even if they don’t meet a statistician’s level for ringing a bell.” He says surgeons opted to skip a step in only three cases.

The breakthrough so far hasn’t revolutionized Geisinger’s business; the company’s sales force hasn’t yet been able to attract new employers or insurance customers on the basis of ProvenCare, although it’s in discussions with insurance giant Aetna. “The idea of mistake-proofing specific problems is at the center of the patient-safety movement and care improvement,” says Dr. Troyen Brennan, Aetna’s chief medical officer. “I give them great credit.”

What Geisinger would really like, of course, is Brennan’s business. Chief innovation officer Paulus is optimistic, predicting that new customers will come as the company expands the number of procedures and diseases covered, which now include total hip replacement, cataract surgery, and programs for managing diabetes.

In the meantime, Geisinger continues to compile success stories, including that of CEO Steele, who became patient No. 86 in the ProvenCare CABG program. “I was in and out of the hospital in two-and-a-half days,” he says. Casale, who was Steele’s surgeon, says the case opened his eyes to how complex a routine operation really is: “Two weeks after, the head of our IT group called me and said, ‘Al, I just looked through [Steele’s] chart, and I want to send you a list of everybody that accessed the medical record from the time he was seen in the clinic to two weeks post-op.’ There were 113 people listed — and every one had an appropriate reason to be in that chart. It shocked all of us. We all knew this was a team sport, but to recognize it was that big a team, every one of whom is empowered to screw it up — that makes me toss and turn in my sleep.”

Which makes the value of that 40-step checklist very clear indeed.

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Glenn Steele Jr, MD, PhD

Dr. Steele became President and Chief Executive Officer of the Geisinger Health System on March 1, 2001. In this capacity, he serves as a member of the Geisinger Health System Foundation Board of Directors, ex-officio of all Standing Committees of the Board and Chairman of the subsidiary boards.

Dr. Steele joined Geisinger from the University of Chicago where he served as the Richard T. Crane Professor in the Department of Surgery, Vice President for Medical Affairs and Dean of the Division of Biological Sciences and the Pritzker School of Medicine.

Prior to that, he was the William V. McDermott Professor of Surgery at Harvard University Medical School, Chairman of the Department of Surgery of New England Deaconess Hospital, and President and Chief Executive Officer of Deaconess Professional Practice Group.

Dr. Steele is widely recognized for his investigations into the treatment of primary and metastatic liver cancer and colorectal cancer surgery. He is a past Chairman of the American Board of Surgery and serves on the editorial boards of numerous prominent medical journals.

His laboratory investigations have focused on the cell biology of gastrointestinal cancer and pre-cancer. A prolific writer, he is the author or co-author of more than 450 scientific and professional articles.

Dr. Steele is a member of the Institute of Medicine of the National Academy of Sciences, the New England Surgical Society, a fellow of the American College of Surgeons, the American Surgical Association, the American Society of Clinical Oncology, Society of Surgical Oncologists, The Commonwealth Fund, Healthcare Executive Network, the U.S. Department of Health’s National Advisory Committee on Rural Health, and the Center of Corporate Innovation (CCI). He is a past chair and a current examiner for the American Board of Surgery and serves on several scientific advisory boards including Simon Healthcare (University of Rochester) and the Institute of Medicine’s study of early detection of breast cancer.

He serves on the American Hospital Association Health Care Systems Governing Council and is presently serving as Chair ’05. He also serves on the AHA Strategic Policy Planning and Hospital/Medical Staff Committees. In addition to serving on the boards of Bucknell University and Priority Healthcare Corporation, he most recently became March of Dimes – Honorary Chair of the Pennsylvania Prematurity Campaign.

Dr. Steele was born in Baltimore, Maryland, received his BA degree in history from Harvard College in 1966 and his MD degree from New York University School of Medicine (New York City) in 1970. He completed his internship and residency in surgery at the University of Colorado, where he was also a Fellow of the American Cancer Society. He earned his Ph.D. degree in microbiology at Lund University in Sweden in 1975.