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Chemotalk NewsletterChemotalk Newsletter, Vol. 98 June 1, 2016 Hello, Everyone... Off and running... WHAT DRUG ADS DON'T SAY By Richard A. Friedman Drug companies are eager to tell you about their newest medicines. Turn on your TV or go online and there's a new drug -- with a hefty price tag -- for whatever ails you, from antidepressants to painkillers to remedies for erectile dysfunction. The pharmaceutical industry spends lavishly to get your attention: in 2014, drug makers poured $4.3 billion into so-called direct-to-consumer advertising, a 3-% increase over two years. Drug makers claim they are educating the pubic with their ads providing information that will help you make better choices about your medical care. So in the spirit of education, let's consider a recent online ad for Latuda, a new antipsychotic medication. A young woman rides a bike off into the sun as we are told that Latuda has been shown to be effective for many people with bipolar depression, followed by that staccato recitation of potential side effects that most viewers tune out. Fair enough. But the ad omits something that most consumers would like to know: There are may older and cheaper treatments that are just as effective. In fact, Latuda is one of 10 "second generation" antipsychotic medications, many available in generic forms, that essentially work the same way. Of course, the goal of drug companies is not to educate, but to sell products. We could ban the ads, as almost every other country does, and which I'd strongly support. But such a campaign in the United States would face fierce legislative and legal challenges. Instead let's help the drug companies make their ads truly educational. What I propose is a universal scorecard for all new drugs, to be overseen by the Food and Drug Administration, with information on how their cost and effectiveness measure up against similar medications. This could be a simple graphic that would fill the screen at the end of every video ad and be highly visible in every print ad. It should become a routine part of discussions with doctors whenever medications are prescribed, and should be provided by pharmacies alongside basic drug safety information. Think of the scorecard as the batting average for a baseball player. If you want to know how good a player is, you don't just want to know how many home runs he hit, but how many hits per at bat he had. The batting average combines success and failure in one measure. Likewise, drug companies should have to reveal how may total clinical trials were conducted for each drug and how many of these trials were positive and how many were negative. If a new drug does better than a placebo in just two out of six clinical trials, you are going to think very differently about its efficacy than you would about that of another drug that beats a placebo in all six trials. Drug companies might legitimately complain that there are many reasons a drug might fail to outperform a placebo besides ineffectiveness: quirks in the design of a trial; patients who were not typical of those with the disease; a dosage that was too low. But then the company should be happy to explain this to the public, since the goal is education, right? Even savvy consumers cannot easily obtain this information because of the "file drawer effect": Positive clinical trials are much more likely to be published than negative trials. And while drug companies now have to register their clinical trials in a federal database they often don't publish the results in a timely fashion, and it's unrealistic to expect the public to hunt for this kind of data; it should be as clear as the blue sky in those idyllic drug ads. The drug scorecard should also include something called the "number needed to treat," or N.N.T. This is the number of patients that need to be created for one to benefit, compared with a control in a clinical trial. For example, for a drug with a number needed to treat of six, six patient would have to be treated before one would benefit. The lower the number, the more effective the treatment. This is a clear measure that consumers could use to understand the efficacy of drugs that are invariably pitched as the next panacea. But even this isn't enough. What consumers and their doctors really want to know is not just whether a new drug is better than a placebo, which is generally the standard for approval by the Food and Drug Administration. (Typically a drug has to beat a control, usually a placebo, in two randomized clinical trials) We want to know whether the new drug is better than a comparable, older drug. Drug companies have little incentive to make these comparisons. Why? Because a vast majority of "new" drugs are really not new at all; instead, they are minor tweaks and modifications of older drugs, and therefore unlikely to substantially outperform them. For example, there are seven statins on the market that all lower cholesterol by the same mechanism, and eight antidepressants (selective serotonin reuptake inhibitors) that essentially work the same way. Comparing the effectiveness of different treatments is one of the goals of the Affordable Care Act, through a nonprofit it created called the Patient-Centered Outcome Research Institute. But comparative effectiveness research has yet to really take off. When it does, the data it compiles should be added to the universal scorecard. For too long, we've allowed drug companies to tell us only their positive results. Now we're ready to hear the whole story. * * * DOCTORS HIT A SNAG IN THE RUSH TO CONNECT Medical Records Go Digital, but Sharing Them Can Be Costly, or Impossible By Julie Creswell As a practicing ear, nose and throat specialist in Ahoskie, N.C., Dr. Raghuvir B. Gelot says that little has frustrated him more than the digital record system he installed a few years ago. The problem: His system, made by one company, cannot share patient records with the local medical center, which uses a program made by another company. The two companies are quick to deny responsibility, each blaming the other. Regardless of who is at fault, doctors and hospital executives across the country say they are distressed that the expensive electronic health record systems they installed in the hopes of reducing costs and improving the coordination of patient care -- a major goal of the Affordable Care Act -- simply do not share information with competing systems. The issue is especially critical now as many hospitals and doctors scramble to install the latest versions of their digital record systems to demonstrate to regulators that they can share some patient data. Those who cannot will act reductions in Medicare reimbursements down the road. On top of that, leading companies in the industry are bidding on a Defense Department contract valued at an estimated $11 billion. A primary requirement is that the winning vendor must be able to share information, allowing the department to digitally track the medical care of 9.6 million active-duty military personnel around the globe. The contract is the latest boon to an industry that taxpayers have heavily subsidized in recent years with over $24 billion in incentive payments to help install electronic health records in hospitals and physicians' offices. While most providers have installed some kind of electronic record system, two recent studies have found that fewer than half of the nation's hospitals can transmit a patient care document, while only 14% of physicians can exchange patient data with outside hospitals or other providers. "We've spent half a million dollars on an electronic health record system about three years ago, and I'm faxing all day long. I can't send anything electronically over it," said Dr. William L. Rich III, a member of a nine-person ophthalmology practice in Northern Virginia and medical director of health policy of the American Academy of Ophthalmology. Dr. Gelot the ear nose and throat specialist, uses a system made by Practice Fusion. His local medical center, Vidant Roanoke-Chowan Hospital, relies on a program built by Epic Systems. there is no evidence that either company does a better or worse job of sharing information. But Epic and its enigmatic founder, Judith R. Faulkner, are being denounced by those who say its empire has been built with towering walls, deliberately built not to share patient information with competing systems. Almost 18 months after an Epic system was installed at Unity-Point Health-St. Luke's hospital in Sioux City, Iowa, physicians there still cannot transmit a patient care document to doctors two miles south at Mercy Medical Center, which uses a system made by another major player in the field, the Cerner Corporation. Where interconnectivity between systems does occur, it often happens with steep upfront connecting charges or recurring fees, creating what some see as a digital divide between large hospital systems that have money and technical personnel and small, rural hospitals or physician practices that are overwhelmed financially and technologically. he University of California Davis Health System has 22 specialists installing the technology so that doctors can share patient data between its Epic system and other internal systems, like the hemodynamic monitors in its critical care unit, or with some non-Epic systems outside the hospital. "We're a huge organization, so we can absorb those costs," said Michael Minear, the chief information officer at the U.C. Davis Health System. "Small clinics and physician offices are going to have a harder time." Separately, through its maintenance contracts and other agreements, Epic charges a fee to send data to some non-Epic systems. Epic is not alone in charging various fees, nor is there evidence that its fees are more expensive than its peers. But the barrier created by these types of charges "affects the small and rural providers much more significantly," Morgan Honea, executive director of the Colorado Regional Health Information Organization, a public health information exchange, said in recent policy hearings in Washington. While nearly all of the leading companies in this area have come under fire for their inability to easily share information, Epic faced some of the strongest attacks. A research report from the RAND Corporation described Epic as a "closed" platform that me it "challenging and costly for hospitals" to interconnect with the clinical or billing software of other companies. Shortly after, Representative Phil Gingrey, a Georgia Republican and a doctor, assailed the company in public hearings in Washington for the same shortfalls. Executives at Epic rejected the criticism, labeling it as "vendors throwing smoke screens," but for the first time, the company hired a Washington lobbying firm to improve its image. Epic argues that its customers -- some of the biggest hospitals in the country -- share more records than any other. In interviews with nearly 200 providers for a story, executives at the research firm Klas said Epic's scores were "as good or better than most of the other vendors" in its ability to share information with other systems. Moreover, at the request of Epic executives, several customers, including Cedars-Sinai Health System in Los Angeles*, the Yale New Haven Health System and New York's Mount Sinai Hospital, sent emails to the New York times saying they were able to share records through Epic. A sort of Microsoft of the Midwest, built on a sprawling campus on nearly 1,000 acres of farmland near Madison, Wis., the privately held Epic has emerged as a leader in the race to digitize patient medical records. Its systems hold the health records of nearly half the country. The explosion in demand under the technology incentive plan has been a windfall for Epic. Ms. Faulkner is estimated to be worth $23 billion. In a rare interview, Ms. Faulkner said the industry made great strides and noted that Epic's customers were sending increasing numbers of records each month. She and other company executives argued that the company was actually one of the first to create rules around sharing information and a platform to do so. In 2005, when it became clear to her that the government was not prepared to create a set of rules around interoperability, Ms. Faulkner said, her team began writing the cod for Care Everywhere. Initially seen as a health information exchange for its own customers, are Everywhere today connects hospitals all over the country as well as to various public health agencies and registries. "Let's say a patient is coming from U.C.A.A. and going to the University of Chicago, an Epic-to-Epic hospital. Boom. That's easy," Ms. Faulkner said. "These are hospitals that have agreed to the Rules of the Road, a legal contract that says the other organization is going to take good care of the data." Careful in her choice of words, Ms. Faulkner offered muted criticism of regulators for, essentially, failing to create what she did-- a contract to help providers connect to one another and a way to authenticate that only the correct person could view the patient information. "I'm not sure why the government doesn't want to do some of the things that would be required for everybody to march together, she said. Regulators responded that interoperability was a top priority" and that they recently set out a 10-year vision and agenda to achieve it, in a statement from the Office of the National Coordinator for Health Information Technology. The office's spokesman added that achieving interoperability "required stakeholders to come together and agree on policy elated issues like who can access information and for what purpose." Dr. Gelot says he hopes interoperability comes sooner rather than later. "The systems can't communicate, and that becomes my problem because I cannot send what is required and I'm going to have a 1% penalty from Medicare," Dr. Gelot said. "They're asking me to do something I can't control." * From personal experience, in the last month a Cedar-Sinai practice was unable to send my blood work electronically, to City of Hope. It was sent either as a scanned attachment to an email, or a fax. * * * Until July
And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com. Elaine Jesmer
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