The findings counter a common belief that the drug-approval process by the U.S. Food and Drug Administration is especially slow, according to Yale University School of Medicine researchers.

The study authors reviewed drug-approval decisions made between 2001 and 2010 by the FDA, Health Canada (the Canadian drug regulator), and the European Medicines Agency (EMA). The latter agencies were chosen for comparison with the FDA because they face similar pressures to approve new drugs quickly while ensuring patient safety, the researchers said.

“Among the subsample of drugs approved for all three regulators, the FDA’s reviews were over three months faster than those of the EMA or Health Canada,” study leader Nicholas Downing, a second-year medical student, said in a university news release.

“The total review time at the FDA was faster than EMA, despite the FDA’s far higher proportion of applications requiring multiple regulatory reviews,” he added.

The study also revealed that most new drug therapies were first approved for use in the United States.

“Examining novel drugs approved in multiple markets, we found that 64 percent of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86 percent of medicines approved in both the U.S. and Canada were also approved first in the U.S.,” Downing said.

The study was published online May 16 in the New England Journal of Medicine.

More information

The FDA explains how it approves drugs.

– Robert Preidt

SOURCE: Yale University, news release, May 16, 2012

Last Updated: May 16, 2012

Copyright © 2012 HealthDay. All rights reserved.

Read more: http://www.nydailynews.com/life-style/health/clinical-trials-fall-short-small-offer-adequate-medical-evidence-article-1.1073821#ixzz1uDjO0IrS ]]> http://www.bioethicsinternational.org/blog/2012/05/07/clinical-trials-often-fall-short-too-small-to-offer-adequate-medical-evidence/feed/ 0 http://www.bioethicsinternational.org/blog/2012/05/02/u-s-needs-to-expand-monitoring-after-drug-approval/ http://www.bioethicsinternational.org/blog/2012/05/02/u-s-needs-to-expand-monitoring-after-drug-approval/#comments Wed, 02 May 2012 17:03:08 +0000 Jennifer Miller http://www.bioethicsinternational.org/blog/?p=3032 Pharmaceutical drugs approved by the Food and Drug Administration but later re-called from the market—such as the anti-diabetic drug Avandia and pain-reliever Vioxx—were the impetus for an Institute of Medicine committee report recommending that the FDA take proactive steps to continue monitoring drugs’ safety after initial approval and throughout their time on the market. One of the key recommendations made by the report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, is that upon approval, each drug have a single, comprehensive, publicly available Benefit and Risk Assessment and Management Plan to serve as a central, updateable repository of side effects and other information.

“A drug’s full range of risks and benefits become apparent after it is used widely over time, and so it is crucial that the FDA continue to monitor drugs throughout their market life-cycle with a systematic and transparent process,” says committee co-chair Ruth Faden, Ph.D., MPH, director of the Johns Hopkins Berman Institute of Bioethics.

According to the committee, the BRAMP should include a description and benefit-risk assessment of any safety questions that exist when a drug is approved, as well as any that emerge over the course of its market life-cycle, with details on any regulatory actions taken and their results.

The FDA—which asked the IOM to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs,” already collects much of the suggested information, but the data are scattered across multiple records rather than amassed in one central location. “Decentralized records make it difficult for physicians, policy makers and consumers to easily assess information about risks and benefits that accrue over time,” Faden notes.

The committee recommends postmarket studies when:

• A regulatory decision cannot be made based on existing safety evidence.
• The research can be designed and implemented to sufficiently reduce uncertainties about the benefit-risk balance and help inform a regulatory decision.
• The results of the research will be used to make a decision in a timely fashion.
• The rights and interests of the research participants can be adequately protected.

Another key recommendation in the report addresses the significant ethical issues posed by post-market monitoring. The committee recommends that the FDA establish a new body to provide advice on the ethical challenges that required observational studies and surveillance activities pose. The report also makes recommendations about how post-market research should be conducted. The committee found that while randomized controlled trials remain the gold standard for studying drug effectiveness, observational studies have ethical and practical benefits over clinical trials once drugs are on the market. Results can be obtained more quickly, and thus regulatory action can be taken earlier.

The committee’s recommendations build on the FDA’s increased authority through the 2007 Food and Drug Administration Amendments Act to monitor drugs after approval and to act if there are signals of safety issues, Faden notes. “Our report focuses on how the agency can be proactive, so that when a drug’s risk outweighs its benefit, the FDA will know earlier and respond quickly, while honoring its ethical obligations to protect both public health and research participants,” says Faden.

What is notable about Fearing’s case is not that he eventually got over his depression, or that he had an organ removed after transplantation — those things happen. What is remarkable is the simple, altruistic gesture he made just before his doctors removed his kidney that led to what scientists are describing as a medical first.

Fearing donated his transplanted kidney to another patient, a northern Indiana man, and the organ that had been failing inside Fearing’s body thrived in the new recipient. “When we removed that dysfunctioning kidney from Ray’s environment, it recovered rapidly after being transplanted in a second recipient,” said Dr. Lorenzo Gallon, Fearing’s doctor and medical director of the kidney transplant program Northwestern Memorial Hospital. “It is the first time that has happened.”

“It’s amazing stuff, it really is,” said Dr. Lynda Szczech, a nephrologist and president of the National Kidney Foundation. “I don’t know if this is something we’re going to get into with great regularity, but the fact that these providers were able to think outside the box to save such a precious resource is frankly amazing.”

Fearing’s kidney transplant was in June 2011, using an organ donated by his sister, Cera Fearing. He had been struggling for years with focal segmental glomerulosclerosis, a disease that causes scar tissue to develop in the part of the kidney that filters harmful substances.

A few days after his operation, doctors took a biopsy of the new kidney and found it was quickly becoming damaged by the FSGS. The cascade of problems following the operation was swift.

Fearing said that soon after his operation, “My abdomen was full of blood and very sore and [Dr. Gallon] told me he had to remove the kidney immediately.”

Gallon said the situation, having to remove an organ to which so many hopes were now attached, haunted him. But when he realized the organ could still be viable in another patient, he decided to broach the idea with Fearing.

“I said the kidney is yours, we can do whatever you want,” said Gallon, who consulted with his hospital’s ethics board before approaching Fearing. “But if we take it out, we will discard it. Are you willing to allow us to see if this kidney might work for someone else?”

Fearing did not hesitate.

“There are thousands of people waiting for organs, I couldn’t see myself just discarding one,” said Fearing.

The window of time in which to remove an organ that has been transplanted is narrow, said Dr. Matthew Cooper, director of the kidney transplant program at the University of Maryland Medical Center. Once a kidney is put into place, like any other transplant, it develops scar tissue around it.

“After a period of time, technically it is very difficult to remove it,” said Cooper. “It is equally difficult to think about transferring it to someone else.”

Cooper said he just had scenario similar to Fearing’s: A mother donated a kidney to her daughter, who suffers with FSGS. Ultimately, the kidney had to be removed.

“Hearing about this case, I’m thinking ‘Wow, what a cool idea,’” said Cooper. “I don’t know why we didn’t think of it.”

Of course, the procedure undertaken at Northwestern is not standard; an organ with even marginal functionality would usually stay in the patient.

“In this case we’re not talking about a lack of perfect function,” said Gallon. “We’re talking about a kidney making Ray sicker than it would have been to keep the kidney in.”

But that kidney would ultimately make another patient, 67-year-old Erwin Gomez, better.

Gomez’s kidneys were irreversibly damaged, he said, after 20 years of struggling with hypertension. Once he received the new kidney, whatever damage that had occurred while it was implanted in Fearing was reversed.

“The disease, if captured early enough, is reversible when you remove the organ from the original recipient,” said Gallon. “But another part of the story is that when a patient’s kidney failed, he had the strength to say ‘Let’s help someone else.’ That gesture has more weight than words.”

The reality Fearing faces now is a long, difficult wait for another organ. For Gomez, receiving Fearing’s organ means he could go back to work as a cardiovascular surgeon, and he has more time with his grandchildren.

“I feel bad for him because his misfortune is my gain,” said Gomez, who on Wednesday met Fearing and his sister, Cera. “I’m completely grateful to them for considering re-transplanting that kidney … I owe them eternal gratitude.”

Fearing said that when he thinks about other people (91,836 and counting) waiting for a kidney transplant possibly benefiting from what he went through, it stems the tide of sadness he sometimes feels about his situation.

“It was hell when I went through it,” said Fearing. “It is better that my situation helps people than having it take over my life.”

In a statement, Novartis said it was calling for a judicial review “as a last resort” because it believed patient safety was being potentially compromised. According to the U.K.’s health watchdog, Novartis’ Lucentis is the only drug recommended to treat the eye problem macular degeneration in the country’s state-run National Health Service hospitals.

However, several NHS hospitals have been prescribing the much cheaper Avastin, a cancer drug, for the same problem even though it has not been officially approved. Most doctors only prescribe drugs approved by the health watchdog, but have the discretion to use other treatments if they believe they are warranted.

Last year, four hospitals in southern England decided they would pay for Avastin when it was prescribed by a doctor. 

Both Avastin and Lucentis are made by Novartis. 

In a statement Tuesday, Novartis said it was demanding a judicial review to make the hospitals use Lucentis rather than Avastin. Novartis said it was concerned patients and clinicians were being pushed to use an unlicensed medicine in order to cut costs. Britain’s coalition government has mandated that its National Health Service trim $20 billion ($31 billion) from its budget by 2015 as part of a national austerity drive.

“It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available,” the pharmaceutical company said. Novartis noted there was “emerging evidence” of safety concerns for using Avastin to treat eye problems.

Patient groups called for an independent analysis to determine which drug should be used. “If Avastin is not as safe as Lucentis, no one should be using it,” said Helen Jackman, chief executive of the Macular Disease Society. “If it is as good, perhaps everyone should be using it.”

Jackman said government ministers should hold an appraisal of whether Avastin was safe to use in eye diseases. Eye doctors are divided over whether Avastin is as safe and effective as Lucentis, she said.

Other critics slammed Novartis for their decision to go to the courts.

“Companies like Novartis should not be in the position to block moves to more cost-effective treatments in order to maximize their profits,” said John Harris, of the Institute for Science Ethics and Innovation at the University of Manchester, in a statement. He said it was legitimate for health providers to use treatments that were much cheaper than ones that were already licensed.

The bill, called the “PATIENTS’ FDA Act,” is divided into six titles: (1) improving transparency and accountability in FDA decision-making; (2) recalibrating risk-benefit considerations; (3) reducing unnecessary delays and regulatory burdens; (4) improving the way the FDA gains outside expertise; (5) medical-device regulatory improvements; and (6) improving the FDA’s internal management.

The plan is timely, because it coincides with the every-five-year reauthorization of the Prescription Drug and User Fee Act (PDUFA), which has come to be the main instrument for Congressional reform of FDA policies. Many stakeholders, most notably the big pharmaceutical companies, basically like PDUFA the way it is, and are lobbying for a “clean PDUFA” with minimal modifications to the 2007 version. From their standpoint, they have much more to lose of PDUFA fails to get reauthorized, than they do if the law is revised to improve the FDA’s stance toward innovation.

If the Burr-Coburn proposal were to get incorporated into the 2012 PDUFA reauthorization, it could do a reasonable amount to improve the FDA’s transparency and efficiency. In many ways, the bill requires the FDA to do things that it is already supposed to do—once more, with feeling. Here are some of its notable provisions:

Retract the dumb 2007 conflict-of-interest rules for FDA advisory committees. The bill would repeal the “overly stringent conflicts of interest requirements” that were put in place in the 2007 PDUFA, provisions that prevent clinical thought leaders from participating in FDA advisory committees. The rules bar anyone who has taken any form of compensation from drug companies from participating in these panels. The problem is that nearly all physician experts are involved in conducting clinical trials, which involve receiving compensation from drug companies for the costs of conducting the trials.

More accountability for meeting drug-review deadlines. The FDA has been increasingly failing to meet its PDUFA-mandated deadlines for giving companies approval decisions on new drug applications. The PATIENTS’ FDA Act would require the FDA to “report [to Congress] on a deeper level detail with respect to the performance goals agreed to in the prescription drug, generic drug, and biosimilar user fee agreements,” and hold individual reviewers accountable for their speed in reviewing applications.

Stop forcing companies to do unnecessary and expensive busywork. The bill’s summary notes that “some FDA reviewers request reams of additional information about a drug or device that is beyond the scope of data needed to meet the FDA’s approval standard.” The FDA will be required, under the bill, to “document the scientific and regulatory rationale” for such decisions, and review within one year “the costs and adoption of the least burdensome approaches to regulation.” The bill would also codify the FDA’s “commitment to improve on patient risk-benefit considerations…to ensure accountability for fulfilling…the user fee agreements.”

Take more advantage of clinical trials in other countries. The bill would require FDA to work with “other specific regulatory authorities of similar standing” to encourage uniform standards for clinical trials. (The Geneva-based International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, performs many of these functions.) FDA will also be instructed to help sponsors “minimize the need for duplication of clinical studies, preclinical studies or non-clinical studies.”

Modifications to the Medical Device user fee agreement

The bill also seeks to improve the Medical Device user fee agreement, which was born in 2007. The bill seeks to require that “the reviewer assigned to handle [device] submissions to have prior experience with that type of device or technology,” and prohibits the FDA from “disapproving medical research based on a determination that the device will not meet the standards for approval or clearance.” It would strive to improve and increase the FDA’s use of third-party reviewers of device applications and inspections.

The bill will require FDA to “publish detailed review summaries for 510(k) clearance” so that everyone can learn from the FDA’s thought process: something that would also be quite useful in the drug-development process. It would require the FDA to ensure that a manufacturer would not have to submit an entirely new 510(k) application if a modification to an already-approved device is “validated by the same method…applied to the original device.”

Overall management improvements

The bill would require the FDA to “develop a strategy and implementation plan” to advance regulatory science, and to “track and annually report on their progress against their identified priorities.” The FDA would be required to “contract with an independent management company to conduct an assessment of all of the drug review and approval processes” and issue an “integrated strategy and management plan.”

The bill highlights a 2009 GAO report that found that the FDA has made “mixed progress in establishing IT management capabilities that are essential in helping ensure a successful IT modernization effort.”

The bottom line: A solid effort at addressing an intractable problem

A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.

In these areas, the bill is a good start. It will be interesting to see what kind of reception it gets in Washington and New Jersey.

The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, “Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, their duty is to stop it—and stop it they will.”

It will take far-reaching reforms to meaningfully change this dynamic. But every little bit helps.

Follow Avik on Twitter at @aviksaroy.

UPDATE: Sarah Kliff has penned a nice background of the semi-decadal PDUFA reauthorization, for those who aren’t familiar with it.

An American soldier dies every day and a half, on average, in Iraq or Afghanistan. Veterans kill themselves at a rate of one every 80 minutes. More than 6,500 veteran suicides are logged every year — more than the total number of soldiers killed in Afghanistan and Iraq combined since those wars began.

These unnoticed killing fields are places like New Middletown, Ohio, where Cheryl DeBow raised two sons, Michael and Ryan Yurchison, and saw them depart for Iraq. Michael, then 22, signed up soon after the 9/11 attacks.

“I can’t just sit back and do nothing,” he told his mom. Two years later, Ryan followed his beloved older brother to the Army.

When Michael was discharged, DeBow picked him up at the airport — and was staggered. “When he got off the plane and I picked him up, it was like he was an empty shell,” she told me. “His body was shaking.” Michael began drinking and abusing drugs, his mother says, and he terrified her by buying the same kind of gun he had carried in Iraq. “He said he slept with his gun over there, and he needed it here,” she recalls.

Then Ryan returned home in 2007, and he too began to show signs of severe strain. He couldn’t sleep, abused drugs and alcohol, and suffered extreme jitters.

“He was so anxious, he couldn’t stand to sit next to you and hear you breathe,” DeBow remembers. A talented filmmaker, Ryan turned the lens on himself to record heartbreaking video of his own sleeplessness, his own irrational behavior — even his own mock suicide.

One reason for veteran suicides (and crimes, which get far more attention) may be post-traumatic stress disorder, along with a related condition, traumatic brain injury. Ryan suffered a concussion in an explosion in Iraq, and Michael finally had traumatic brain injury diagnosed two months ago.

Estimates of post-traumatic stress disorder and traumatic brain injury vary widely, but a ballpark figure is that the problems afflict at least one in five veterans from Afghanistan and Iraq. One study found that by their third or fourth tours in Iraq or Afghanistan, more than one-quarter of soldiers had such mental health problems.

Preliminary figures suggest that being a veteran now roughly doubles one’s risk of suicide. For young men ages 17 to 24, being a veteran almost quadruples the risk of suicide, according to a study in The American Journal of Public Health.

Michael and Ryan, like so many other veterans, sought help from the Department of Veterans Affairs. Eric Shinseki, the secretary of veterans affairs, declined to speak to me, but the most common view among those I interviewed was that the V.A. has improved but still doesn’t do nearly enough about the suicide problem.

“It’s an epidemic that is not being addressed fully,” said Bob Filner, a Democratic congressman from San Diego and the senior Democrat on the House Veterans Affairs Committee. “We could be doing so much more.”

To its credit, the V.A. has established a suicide hotline and appointed suicide-prevention coordinators. It is also chipping away at a warrior culture in which mental health concerns are considered sissy. Still, veterans routinely slip through the cracks. Last year, the United States Court of Appeals in San Francisco excoriated the V.A. for “unchecked incompetence” in dealing with veterans’ mental health.

Patrick Bellon, head of Veterans for Common Sense, which filed the suit in that case, says the V.A. has genuinely improved but is still struggling. “There are going to be one million new veterans in the next five years,” he said. “They’re already having trouble coping with the population they have now, so I don’t know what they’re going to do.”

Last month, the V.A.’s own inspector general reported on a 26-year-old veteran who was found wandering naked through traffic in California. The police tried to get care for him, but a V.A. hospital reportedly said it couldn’t accept him until morning. The young man didn’t go in, and after a series of other missed opportunities to get treatment, he stepped in front of a train and killed himself.

Likewise, neither Michael nor Ryan received much help from V.A. hospitals. In early 2010, Ryan began to talk more about suicide, and DeBow rushed him to emergency rooms and pleaded with the V.A. for help. She says she was told that an inpatient treatment program had a six-month waiting list. (The V.A. says it has no record of a request for hospitalization for Ryan.)

“Ryan was hurting, saying he was going to end it all, stuff like that,” recalls his best friend, Steve Schaeffer, who served with him in Iraq and says he has likewise struggled with the V.A. to get mental health services. “Getting an appointment is like pulling teeth,” he said. “You get an appointment in six weeks when you need it today.”

While Ryan was waiting for a spot in the addiction program, in May 2010, he died of a drug overdose. It was listed as an accidental death, but family and friends are convinced it was suicide.

The heartbreak of Ryan’s death added to his brother’s despair, but DeBow says Michael is now making slow progress. “He is able to get out of bed most mornings,” she told me. “That is a huge improvement.” Michael asked not to be interviewed: he wants to look forward, not back.

As for DeBow, every day is a struggle. She sent two strong, healthy men to serve her country, and now her family has been hollowed in ways that aren’t as tidy, as honored, or as easy to explain as when the battle wounds are physical. I wanted to make sure that her family would be comfortable with the spotlight this article would bring, so I asked her why she was speaking out.

“When Ryan joined the Army, he was willing to sacrifice his life for his country,” she said. “And he did, just in a different way, without the glory. He would want it this way.”

“My home has been a nightmare,” DeBow added through tears, recounting how three of Ryan’s friends in the military have killed themselves since their return. “You hear my story, but it’s happening everywhere.”

We refurbish tanks after time in combat, but don’t much help men and women exorcise the demons of war. Presidents commit troops to distant battlefields, but don’t commit enough dollars to veterans’ services afterward. We enlist soldiers to protect us, but when they come home we don’t protect them.

“Things need to change,” DeBow said, and her voice broke as she added: “These are guys who went through so much. If anybody deserves help, it’s them.”

[WSJ Health Blog] Francis Collins, head of the National Institutes of Health, painted a stark picture at TEDMED about the difficulty of translating basic scientific knowledge into applications that could be useful to patients.

We need to “build a bridge across this yawning gap,” Collins told the audience at this gathering in Washington of researchers and other thinkers to discuss the future of health care. Collins first serenaded the crowd with his guitar and a song about the need to knock out disease.

Imagining the gulf between basic science and applications as a body of water, Collins said linking them wouldn’t be like building the Golden Gate Bridge.  Rather, it’s more like a swimmer, a sailboat and a tugboat all attempting to cross the water.  There are sharks and other obstacles in the water, causing the swimmer to die, the sailboat to capsize and the tugboat to run aground.

So what could help accelerate translation research, particularly drug development?

One thing, says Collins, is to encourage all companies to “open their drug freezers” for compounds that were determined to be safe and active — meaning it had an effect on the body — but weren’t found to be useful for the purpose for which it was being developed.

If some of those old drugs could be repurposed — or taught new tricks, as he said — then development could be accelerated because the compound could start at a Phase II trial for the new condition.

Intellectual property is the main concern stopping this from happening, and the NIH is working with companies to figure out an agreement amenable to drug companies. The NIH has a drafted a model agreement and they’re working to get drug companies to sign on, he said.

Stay tuned, he told reporters after his talk.

Funded by the Robert Wood Johnson Foundation’s (RWJF) Clinical Scholars program and the United States Department of Veterans Affairs (VA), the study, which appears today in the April issue of Health Affairs, examines the potential impact of policies to reduce inappropriate imaging for prostate cancer. Such overutilization began receiving national attention, in part, through an article in the New Yorker in 2009. A week later, a New York Times article detailed how the concept had captured government’s attention and highlighted the resulting interest in lowering costs through reducing the over-use of various medical tests, imaging, screening and procedures. Such efforts are beginning to yield results and lead to guideline change, such as last week’s move by nine medical specialty societies to identify the top five overused practices in each specialty for which no evidence exists to support their value.

“We’re in the middle of a huge healthcare debate, where government, hospitals and physician groups are working to lower healthcare costs while still providing quality care,” said lead investigator Danil V. Makarov, MD, MHS, assistant professor of urology at NYU School of Medicine, part of NYU Langone Medical Center, and an assistant professor of health policy at NYU Wagner School of Public Service. “One area being reviewed is imaging use. Changing practices in regions of high use to make them more like those in areas of low use to lower costs may seem like an appealing strategy. However, our study suggests that such an approach might sacrifice quality by depriving patients of needed services.”

The study, performed with colleagues while Makarov was a RWJF and VA Clinical Scholar at Yale, looked at regional patterns of imaging, both appropriate and inappropriate, to stage newly diagnosed cases of prostate cancer. The research was conducted in prostate cancer patients because prostate cancer is a common disease and there are clear, well-established guidelines for the use of imaging to stage it.

“Appropriate imaging” was defined as prostate cancer staging imaging for patients who are at high risk of metastatic spread. These include patients with clearly evident, observable or tangible cancer, for whom National Comprehensive Cancer Network guidelines indicate further screening, in the form of a bone scan, computed tomography (CT) or MRI, to see whether and how far the cancer has progressed. “Inappropriate imaging” was defined as the use of those same imaging techniques in patients without high-risk features, suspected of having only early stage prostate cancer. These men were not at a stage where accepted guidelines indicate the use of imaging.

The researchers found that regions of the country with high rates of inappropriate imaging also had high rates of appropriate imaging. Similarly, regions with low rates of inappropriate imaging also had low rates of appropriate imaging. The investigators dubbed this finding the “Thermostat Model,” and concluded that imaging use appears to be determined strongly by regional practice patterns and affinity for imaging, rather than solely by medical indication.

“Ultimately there appears to be an underuse of important services and overuse of nonessential ones,” said Dr. Makarov. “This forces us to wonder if low use areas, which may spend less money but also provide fewer of the recommended services for those patients who need them, are necessarily the model we should be promoting.”

According to the investigators, simply limiting inappropriate healthcare use may have the unintended consequences of limiting appropriate care for patients who need it.

“New policies aimed at controlling costs can not be a ‘one size fits all’ approach,” Dr. Makarov said. “Instead, policies must be multifaceted to carefully blend cutting inappropriate use while promoting appropriate use.”

Coauthor institutions include Yale University School of Medicine, Duke University School of Medicine, University of Connecticut Health Center, and Vanderbilt University School of Medicine.

About NYU School of Medicine:
NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one of the nation’s premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals – Tisch Hospital, its flagship acute care facility; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; Hassenfeld Pediatric Center, a comprehensive pediatric hospital supporting a full array of children’s health services; and the Rusk Institute of Rehabilitation Medicine, the world’s first university-affiliated facility devoted entirely to rehabilitation medicine– plus NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center’s tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.