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Deadly Drugs – Johnson & Johnson’s Risperdal

Deadly Drugs – Johnson & Johnson's Risperdal

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Overkill

Annals of Health CareMay 11, 2015 Issue
Source: The New yorke

An avalanche of unnecessary medical care is harming patients physically and financially. What can we do about it?

By Atul Gawande May 4, 2015
Photo(s) Source: The New yorker

  • It was lunchtime before my afternoon surgery clinic, which meant that I was at my desk, eating a ham-and-cheese sandwich and clicking through medical articles. Among those which caught my eye: a British case report on the first 3-D-printed hip implanted in a human being, a Canadian analysis of the rising volume of emergency-room visits by children who have ingested magnets, and a Colorado study finding that the percentage of fatal motor-vehicle accidents involving marijuana had doubled since its commercial distribution became legal. The one that got me thinking, however, was a study of more than a million Medicare patients. It suggested that a huge proportion had received care that was simply a waste.
Millions of Americans get tests drugs and operations that wont make them better may cause harm and cost billions.
Millions of Americans get tests, drugs, and operations that won’t make them better, may cause harm, and cost billions.Illustration by Anna Parini

The researchers called it “low-value care.” But, really, it was no-value care. They studied how often people received one of twenty-six tests or treatments that scientific and professional organizations have consistently determined to have no benefit or to be outright harmful. Their list included doing an EEG for an uncomplicated headache (EEGs are for diagnosing seizure disorders, not headaches), or doing a CT or MRI scan for low-back pain in patients without any signs of a neurological problem (studies consistently show that scanning such patients adds nothing except cost), or putting a coronary-artery stent in patients with stable cardiac disease (the likelihood of a heart attack or death after five years is unaffected by the stent). In just a single year, the researchers reported, twenty-five to forty-two per cent of Medicare patients received at least one of the twenty-six useless tests and treatments.

Could pointless medical care really be that widespread? Six years ago, I wrote an article for this magazine, titled “The Cost Conundrum,” which explored the problem of unnecessary care in McAllen, Texas, a community with some of the highest per-capita costs for Medicare in the nation. But was McAllen an anomaly or did it represent an emerging norm? In 2010, the Institute of Medicine issued a report stating that waste accounted for thirty per cent of health-care spending, or some seven hundred and fifty billion dollars a year, which was more than our nation’s entire budget for K-12 education. The report found that higher prices, administrative expenses, and fraud accounted for almost half of this waste. Bigger than any of those, however, was the amount spent on unnecessary health-care services. Now a far more detailed study confirmed that such waste was pervasive.

I decided to do a crude check. I am a general surgeon with a specialty in tumors of the thyroid and other endocrine organs. In my clinic that afternoon, I saw eight new patients with records complete enough that I could review their past medical history in detail. One saw me about a hernia, one about a fatty lump growing in her arm, one about a hormone-secreting mass in her chest, and five about thyroid cancer.

To my surprise, it appeared that seven of those eight had received unnecessary care. Two of the patients had been given high-cost diagnostic tests of no value. One was sent for an MRI after an ultrasound and a biopsy of a neck lump proved suspicious for thyroid cancer. (An MRI does not image thyroid cancer nearly as well as the ultrasound the patient had already had.) The other received a new, expensive, and, in her circumstances, irrelevant type of genetic testing. A third patient had undergone surgery for a lump that was bothering him, but whatever the surgeon removed it wasn’t the lump—the patient still had it after the operation. Four patients had undergone inappropriate arthroscopic knee surgery for chronic joint damage. (Arthroscopy can repair certain types of acute tears to the cartilage of the knee. But years of research, including randomized trials, have shown that the operation is of no help for chronic arthritis- or age-related damage.)

Virtually every family in the country, the research indicates, has been subject to overtesting and overtreatment in one form or another. The costs appear to take thousands of dollars out of the paychecks of every household each year. Researchers have come to refer to financial as well as physical “toxicities” of inappropriate care—including reduced spending on food, clothing, education, and shelter. Millions of people are receiving drugs that aren’t helping them, operations that aren’t going to make them better, and scans and tests that do nothing beneficial for them, and often cause harm.

Why does this fact barely seem to register publicly? Well, as a doctor, I am far more concerned about doing too little than doing too much. It’s the scan, the test, the operation that I should have done that sticks with me—sometimes for years. More than a decade ago, I saw a young woman in the emergency room who had severe pelvic pain. A standard X-ray showed nothing. I examined her and found signs of pelvic inflammatory disease, which is most often caused by sexually transmitted diseases. She insisted that she hadn’t been sexually active, but I didn’t listen. If I had, I might have ordered a pelvic CT scan or even recommended exploratory surgery to investigate further. We didn’t do that until later, by which time the real source of her symptoms, a twisted loop of bowel in her pelvis, had turned gangrenous, requiring surgery. By contrast, I can’t remember anyone I sent for an unnecessary CT scan or operated on for questionable reasons a decade ago. There’s nothing less memorable.

It is different, however, when I think about my experience as a patient or a family member. I can readily recall a disturbing number of instances of unnecessary care. My mother once fainted in the Kroger’s grocery store in our Ohio home town. Emergency workers transported her to a hospital eighty miles away, in Columbus, where doctors did an ultrasound of her carotid arteries and a cardiac catheterization, too, neither of which is recommended as part of the diagnostic workup for someone who’s had a fainting episode, and neither of which revealed anything significant. Only then did someone sit down with her and take a proper history; it revealed that she’d had dizziness, likely from dehydration and lack of food, which caused her to pass out.

I began asking people if they or their family had been subject to what they thought was unnecessary testing or treatment. Almost everyone had a story to tell. Some were appalling.

My friend Bruce told me what happened when his eighty-two-year-old father developed fainting episodes. His doctors did a carotid ultrasound and a cardiac catheterization. The tests showed severe atherosclerotic blockages in three coronary arteries and both carotid arteries. The news didn’t come as a shock. He had smoked two packs of cigarettes a day since the age of seventeen, and in his retirement years was paying the price, with chronic lung disease, an aortic-aneurysm repair at sixty-five, a pacemaker at seventy-four, and kidney failure at seventy-nine, requiring dialysis three days a week. The doctors recommended doing a three-vessel cardiac-bypass operation as soon as possible, followed, a week or two later, by surgery to open up one of his carotid arteries. The father deferred the decision-making to the son, who researched hospitals and found a team with a great reputation and lots of experience. The team told him that the combined procedures posed clear risks to his father—for instance, his chance of a stroke would be around fifteen per cent—but that the procedures had become very routine, and the doctors were confident that they were far more likely to be successful than not.VIDEO FROM THE NEW YORKERHow Will Americans Vote During a Crisis?

It didn’t occur to Bruce until later to question what the doctors meant by “successful.” The blockages weren’t causing his father’s fainting episodes or any other impairments to his life. The operation would not make him feel better. Instead, “success” to the doctors meant reducing his future risk of a stroke. How long would it take for the future benefit to outweigh the immediate risk of surgery? The doctors didn’t say, but carotid surgery in a patient like Bruce’s father reduces stroke risk by about one percentage point per year. Therefore, it would take fifteen years before the benefit of the operation would exceed the fifteen-per-cent risk of the operation. And he had a life expectancy far shorter than that—very likely just two or three years. The potential benefits of the procedures were dwarfed by their risks.

Bruce’s father had a stroke during the cardiac surgery. “For me, I’m kicking myself,” Bruce now says. “Because I remember who he was before he went into the operating room, and I’m thinking, Why did I green-light an eighty-something-year-old, very diseased man to have a major operation like this? I’m looking in his eyes and they’re like stones. There’s no life in his eyes. There’s no recognition. He’s like the living dead.”

A week later, Bruce’s father recovered his ability to talk, although much of what he said didn’t make sense. But he had at least survived. “We’re going to put this one in the win column,” Bruce recalls the surgeon saying.

“I said, ‘Are you fucking kidding me?’ ”

His dad had to move into a nursing home. “He was only half there mentally,” Bruce said. Nine months later, his father died. That is what low-value health care can be like.

I’m a fan of the radio show “Car Talk” (which ceased taping in 2012 but still airs in reruns), and a regular concern of callers who sought the comic but genuine advice of its repair-shop-owning hosts, Tom and Ray Magliozzi, was whether they were getting snookered by car mechanics into repairs they didn’t need.

“There’s no question we have considerable up-selling in the industry,” Ray told me when I reached him by phone. “Quickie-lube places are the worst for this. I won’t name names, but they tend to have the word ‘lube’ in them.” He let out that nyuk-nyuk-nyuk laugh he has. “You can’t make money on a $29.95 oil change. So they try to sell you on a lot of stuff. First level, they sell you something you don’t need but at least doesn’t hurt. Second level, they do some real damage mucking around.”

Even reputable professionals with the best intentions tend toward overkill, he said. To illustrate the point, he, too, had a medical story to tell. Eight months earlier, he’d torn a meniscus in his knee doing lunges. “Doing lunges is probably something a sixty-five-year-old should not be doing to begin with,” he admitted. He was referred to an orthopedic surgeon to discuss whether to do physical therapy or surgery. “Very good guy. Very unassuming. I had no reason not to trust the guy. But I also know he’s a surgeon. So he’s going to present surgery to me.”https://8cda257c87e858baee5380cc65ab1ba3.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.htmlADVERTISEMENT

Sure enough, the surgeon recommended arthroscopic knee surgery. “This is going to fix it,” Ray recalled him saying. “In by nine, out by noon.”

Ray went for a second opinion, to a physical therapist, who, of course, favored physical therapy, just as the surgeon favored surgery. Ray chose physical therapy.

“How’d it turn out?” I asked.

“Amazingly well,” he said. “I feel pretty darn good right now.”

“What did the surgeon say when you told him you weren’t going to do the surgery?”

“He said, ‘No problem, go to P.T., and when that doesn’t work we can schedule the surgery,’ ” Ray recalled. “Who knows? Maybe I will end up having to go back. He wasn’t trying to pull the wool over my eyes. But he believed.”

What Ray recommended to his car-owning listeners was the approach that he adopted as a patient—caveat emptor. He did his research. He made informed choices. He tried to be a virtuous patient.

The virtuous patient is up against long odds, however. One major problem is what economists call information asymmetry. In 1963, Kenneth Arrow, who went on to win the Nobel Prize in Economics, demonstrated the severe disadvantages that buyers have when they know less about a good than the seller does. His prime example was health care. Doctors generally know more about the value of a given medical treatment than patients, who have little ability to determine the quality of the advice they are getting. Doctors, therefore, are in a powerful position. We can recommend care of little or no value because it enhances our incomes, because it’s our habit, or because we genuinely but incorrectly believe in it, and patients will tend to follow our recommendations.

Another powerful force toward unnecessary care emerged years after Arrow’s paper: the phenomenon of overtesting, which is a by-product of all the new technologies we have for peering into the human body. It has been hard for patients and doctors to recognize that tests and scans can be harmful. Why not take a look and see if anything is abnormal? People are discovering why not. The United States is a country of three hundred million people who annually undergo around fifteen million nuclear medicine scans, a hundred million CT and MRI scans, and almost ten billion laboratory tests. Often, these are fishing expeditions, and since no one is perfectly normal you tend to find a lot of fish. If you look closely and often enough, almost everyone will have a little nodule that can’t be completely explained, a lab result that is a bit off, a heart tracing that doesn’t look quite right.

Excessive testing is a problem for a number of reasons. For one thing, some diagnostic studies are harmful in themselves—we’re doing so many CT scans and other forms of imaging that rely on radiation that they are believed to be increasing the population’s cancer rates. These direct risks are often greater than we account for.

What’s more, the value of any test depends on how likely you are to be having a significant problem in the first place. If you have crushing chest pain and shortness of breath, you start with a high likelihood of having a serious heart condition, and an electrocardiogram has significant value. A heart tracing that doesn’t look quite right usually means trouble. But, if you have no signs or symptoms of heart trouble, an electrocardiogram adds no useful information; a heart tracing that doesn’t look quite right is mostly noise. Experts recommend against doing electrocardiograms on healthy people, but millions are done each year, anyway.

Resolving the uncertainty of non-normal results can lead to procedures that have costs of their own. You get an EKG. The heart tracing is not completely normal, and a follow-up procedure is recommended. Perhaps it’s a twenty-four-hour heart-rhythm monitor or an echocardiogram or a stress test or a cardiac catheterization; perhaps you end up with all of them before everyone is assured that everything is all right. Meanwhile, we’ve added thousands of dollars in costs and, sometimes, physical risks, not to mention worry and days of missed work.

Overtesting has also created a new, unanticipated problem: overdiagnosis. This isn’t misdiagnosis—the erroneous diagnosis of a disease. This is the correct diagnosis of a disease that is never going to bother you in your lifetime. We’ve long assumed that if we screen a healthy population for diseases like cancer or coronary-artery disease, and catch those diseases early, we’ll be able to treat them before they get dangerously advanced, and save lives in large numbers. But it hasn’t turned out that way. For instance, cancer screening with mammography, ultrasound, and blood testing has dramatically increased the detection of breast, thyroid, and prostate cancer during the past quarter century. We’re treating hundreds of thousands more people each year for these diseases than we ever have. Yet only a tiny reduction in death, if any, has resulted.

My last patient in clinic that day, Mrs. E., a woman in her fifties, had been found to have a thyroid lump. A surgeon removed it, and a biopsy was done. The lump was benign. But, under the microscope, the pathologist found a pinpoint “microcarcinoma” next to it, just five millimetres in size. Anything with the term “carcinoma” in it is bound to be alarming—“carcinoma” means cancer, however “micro” it might be. So when the surgeon told Mrs. E. that a cancer had been found in her thyroid, which was not exactly wrong, she believed he’d saved her life, which was not exactly right. More than a third of the population turns out to have these tiny cancers in their thyroid, but fewer than one in a hundred thousand people die from thyroid cancer a year. Only the rare microcarcinoma develops the capacity to behave like a dangerous, invasive cancer. (Indeed, some experts argue that we should stop calling them “cancers” at all.) That’s why expert guidelines recommend no further treatment when microcarcinomas are found.

Nonetheless, it’s difficult to do nothing. The patient’s surgeon ordered a series of ultrasounds, every few months, to monitor the remainder of her thyroid. When the imaging revealed another five-millimetre nodule, he recommended removing the rest of her thyroid, out of an abundance of caution. The patient was seeing me only because the surgeon had to cancel her operation, owing to his own medical issues. She simply wanted me to fill in for the job—but it was a job, I advised her, that didn’t need doing in the first place. The surgery posed a greater risk of causing harm than any microcarcinoma we might find, I explained. There was a risk of vocal-cord paralysis and life-threatening bleeding. Removing the thyroid would require that she take a daily hormone-replacement pill for the rest of her life. We were better off just checking her nodules in a year and acting only if there was significant enlargement.

H. Gilbert Welch, a Dartmouth Medical School professor, is an expert on overdiagnosis, and in his excellent new book, “Less Medicine, More Health,” he explains the phenomenon this way: we’ve assumed, he says, that cancers are all like rabbits that you want to catch before they escape the barnyard pen. But some are more like birds—the most aggressive cancers have already taken flight before you can discover them, which is why some people still die from cancer, despite early detection. And lots are more like turtles. They aren’t going anywhere. Removing them won’t make any difference.ADVERTISEMENT

We’ve learned these lessons the hard way. Over the past two decades, we’ve tripled the number of thyroid cancers we detect and remove in the United States, but we haven’t reduced the death rate at all. In South Korea, widespread ultrasound screening has led to a fifteen-fold increase in detection of small thyroid cancers. Thyroid cancer is now the No. 1 cancer diagnosed and treated in that country. But, as Welch points out, the death rate hasn’t dropped one iota there, either. (Meanwhile, the number of people with permanent complications from thyroid surgery has skyrocketed.) It’s all over-diagnosis. We’re just catching turtles.

Every cancer has a different ratio of rabbits, turtles, and birds, which makes the story enormously complicated. A recent review concludes that, depending on the organ involved, anywhere from fifteen to seventy-five per cent of cancers found are indolent tumors—turtles—that have stopped growing or are growing too slowly to be life-threatening. Cervical and colon cancers are rarely indolent; screening and early treatment have been associated with a notable reduction in deaths from those cancers. Prostate and breast cancers are more like thyroid cancers. Imaging tends to uncover a substantial reservoir of indolent disease and relatively few rabbit-like cancers that are life-threatening but treatable.

We now have a vast and costly health-care industry devoted to finding and responding to turtles. Our ever more sensitive technologies turn up more and more abnormalities—cancers, clogged arteries, damaged-looking knees and backs—that aren’t actually causing problems and never will. And then we doctors try to fix them, even though the result is often more harm than good.

The forces that have led to a global epidemic of overtesting, overdiagnosis, and overtreatment are easy to grasp. Doctors get paid for doing more, not less. We’re more afraid of doing too little than of doing too much. And patients often feel the same way. They’re likely to be grateful for the extra test done in the name of “being thorough”—and then for the procedure to address what’s found. Mrs. E. was such a patient.

Mrs. E. had a turtle. She would have been better off if we’d never monitored her thyroid in the first place. But, now that we’d found something abnormal, she couldn’t imagine just keeping an eye on it. She wanted to take her chances with surgery.

The main way we’ve tried to stop unnecessary treatments has been through policing by insurers: they could refuse to pay for anything that looked like inappropriate care, whether it was an emergency-room visit, an MRI scan, or an operation. And it worked. During the nineteen-nineties, the “Mother, may I?” strategy flattened health-care costs. But it also provoked a backlash. Faceless corporate bureaucrats second-guessing medical decisions from afar created an infuriating amount of hassle for physicians and patients trying to orchestrate necessary care—and sometimes led to outrageous mistakes. Insurance executives were accused of killing people. Facing a public outcry, they backed off, and health-care costs resumed their climb. A decade and a half later, however, more interesting approaches have emerged.

Consider the case of Michael Taylor. A six-foot-tall, fifty-five-year-old optician from Ogden, Utah, Taylor threw his back out a year ago, while pulling weeds from his lawn. When he tried to straighten up, pain bolted from his lower back through his hips and down both thighs. He made his stooped way up his front-porch steps, into his house, and called his wife, Sandy, at work.

“For him to call meant it was really bad,” she said later.

Taylor was a stoic guy who had had back issues for a long time. By his early thirties, he had already undergone two spine operations: the fusion of a vertebra in his neck, which was fractured in a car accident, and the removal of a ruptured disk in his lower back that had damaged a nerve root, causing a foot drop—his left foot slapped when he walked. He’d had periodic trouble with back spasms ever since. For the most part, he managed them through stretches and exercise. He had been a martial artist since the age of thirteen—he’d earned a third-degree black belt—and retained tremendous flexibility. He could still do splits. Occasionally, if an attack was bad, he saw a pain specialist and got a spinal injection of steroids, which usually worked for a while. This episode, however, was worse than any before.

“He could hardly walk,” Sandy said. He tried sleeping in a recliner and waiting out the pain. But it didn’t go away. He called his primary-care physician, who ordered an MRI. It showed degenerative disk disease in his lumbar spine—a bulge or narrowing of disk space between two of the vertebrae in his lower back. The doctor prescribed muscle relaxants and pain medications, and said that Taylor might need spinal surgery. She referred him to a local neurosurgeon.

Taylor put off making the appointment. He did his lower-back stretches and range-of-motion exercises, and worked on losing weight. These measures helped a little, but he still couldn’t sleep in his bed or manage more than a shuffling walk. After four weeks with no improvement, he finally went to see the surgeon, who recommended fusing Taylor’s spine where his disk was bulging. Taylor would lose some mobility—his days of spinning kicks were over—and success was not guaranteed, but the doctor thought that it was the best option.

“He said the surgery would be, like, a fifty-fifty thing,” Taylor recalled. “Half of people would see great success. The other half would see little or no difference. And there’d be a few who find it makes the pain worse.” There was also the matter of cost. The vision center he managed was in a Walmart superstore, and the co-payments and deductibles with the company insurance plan were substantial. His bills were likely to run past a thousand dollars.

But Taylor had heard about a program that Walmart had launched for employees undergoing spine, heart, or transplant procedures. Employees would have no out-of-pocket costs at all if they got the procedure at one of six chosen “centers of excellence”: the Cleveland Clinic; the Mayo Clinic; Virginia Mason Medical Center, in Washington; Scott and White Memorial Hospital, in Texas; Geisinger Medical Center, in Pennsylvania; and Mercy Hospital Springfield, in Missouri. Taylor learned that the designated spine center for his region was Virginia Mason, in Seattle. He used to live in Washington, and the back surgery he’d had when he was younger was at the same hospital. He trusted the place, and it had a good reputation. He decided to proceed.

The program connected him to the hospital, and its staff took care of everything from there. They set up his appointments and arranged the travel for him and his wife. All expenses were covered, even their food and hotel costs.

“They flew us from Salt Lake City and picked us up at the airport in a town car,” Taylor said. He said he felt like royalty.

Walmart wasn’t providing this benefit out of the goodness of its corporate heart, of course. It was hoping that employees would get better surgical results, sure, but also that the company would save money. Spine, heart, and transplant procedures are among the most expensive in medicine, running from tens of thousands to hundreds of thousands of dollars. Nationwide, we spend more money on spinal fusions, for instance, than on any other operation—thirteen billion dollars in 2011. And if there are complications the costs of the procedure go up further. The medical and disability costs can be enormous, especially if an employee is left permanently unable to return to work. These six centers had notably low complication rates and provided Walmart a fixed, package price.

Two years into the program, an unexpected pattern is emerging: the biggest savings and improvements in care are coming from avoiding procedures that shouldn’t be done in the first place. Before the participating hospitals operate, their doctors conduct their own evaluation. And, according to Sally Welborn, the senior vice-president for benefits at Walmart, those doctors are finding that around thirty per cent of the spinal procedures that employees were told they needed are inappropriate. Dr. Charles Nussbaum, until recently the head of neurosurgery at Virginia Mason Medical Center, confirmed that large numbers of the patients sent to his hospital for spine surgery do not meet its criteria.

Michael Taylor was one of those patients. Disk disease like the kind seen on his MRI is exceedingly common. Studies of adults with no back pain find that half or more have degenerative disk disease on imaging. Disk disease is a turtle—an abnormality that generally causes no harm. It’s different when a diseased disk compresses the spinal cord or nerve root enough to cause specific symptoms, such as pain or weakness along the affected nerve’s territory, typically the leg or the arm. In those situations, surgery is proved to be more effective than nonsurgical treatment. For someone without such symptoms, though, there is no evidence that surgery helps to reduce pain or to prevent problems. One study found that between 1997 and 2005 national health-care expenditures for back-pain patients increased by nearly two-thirds, yet population surveys revealed no improvement in the level of back pain reported by patients.

There are gray-zone cases, but Taylor’s case was straightforward. Nussbaum said that Taylor’s MRI showed no disk abnormality compressing his spinal cord or nerve root. He had no new leg or foot weakness. His pain went down both legs and not past the knee, which didn’t fit with disk disease. The symptoms were consistent with muscle spasms or chronic nerve sensitivity resulting from his previous injuries. Fusing Taylor’s spine—locking two vertebrae together with bolts and screws—wouldn’t fix these problems. At best, it would stop him from bending where it hurt, but that was like wiring a person’s jaw shut because his tooth hurts when he chews. Fusing the spine also increases the load on the disks above and below the level of fusion, making future back problems significantly more likely. And that’s if things go well. Nussbaum recommended against the surgery.https://8cda257c87e858baee5380cc65ab1ba3.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.htmlADVERTISEMENT

This was not what Taylor’s wife wanted to hear. Had they come all this way for nothing? “I got kind of angry,” Sandy told me later. She wanted his back problem solved.

He did, too. But he was relieved to hear that he wouldn’t have to undergo another back operation. Nussbaum’s explanations made sense to him, and he had never liked the idea of having his spine fused. Moreover, unlike most places, the Virginia Mason spine center had him seen not only by a surgeon but also by a rehabilitation-medicine specialist, who suggested a nonsurgical approach: a spinal injection that afternoon, continued back exercises, and a medication specifically for neuropathic pain—chronic nerve sensitivity.

“Within a couple of weeks, I was literally pain free,” Taylor said. It was six months after his visit to Seattle, and he could do things he hadn’t been able to do in decades.

“I was just amazed,” Sandy said. “The longer it’s been, the better he is.”

If an insurer had simply decreed Taylor’s back surgery to be unnecessary, and denied coverage, the Taylors would have been outraged. But the worst part is that he would not have got better. It isn’t enough to eliminate unnecessary care. It has to be replaced with necessary care. And that is the hidden harm: unnecessary care often crowds out necessary care, particularly when the necessary care is less remunerative. Walmart, of all places, is showing one way to take action against no-value care—rewarding the doctors and systems that do a better job and the patients who seek them out.

Six years ago, in “The Cost Conundrum,” I compared McAllen with another Texas border town, El Paso. They had the same demographics—the same levels of severe poverty, poor health, illegal immigration—but El Paso had half the per-capita Medicare costs and the same or better results. The difference was that McAllen’s doctors were ordering more of almost everything—diagnostic testing, hospital admissions, procedures. Medicare patients in McAllen received forty per cent more surgery, almost twice as many bladder scopes and heart studies, and two to three times as many pacemakers, cardiac bypass operations, carotid endarterectomies, and coronary stents. Per-capita spending on home-health services was five times higher than in El Paso and more than half of what many American communities spent on all health care. The amount of unnecessary care appeared to be huge.

What explained this? Our piecework payment system—rewarding doctors for the quantity of care provided, regardless of the results—was a key factor. The system gives ample reward for overtreatment and no reward for eliminating it. But these inducements applied everywhere. Why did McAllen succumb to them more than other medical communities did? Doctors there described a profit-maximizing medical culture. Specialists not only made money from the services they provided; many also owned stakes in home-health-care agencies, surgery and imaging centers, and the local for-profit hospital, which brought them even bigger returns from health-care overuse.

The test of health-care reform, I wrote, was whether McAllen or El Paso would become the new norm. Would McAllen’s costs come down or El Paso’s go up? Now that it has been five years since the passage of the Affordable Care Act, I thought I’d find out. I returned to the economist Jonathan Skinner, of the Dartmouth Institute for Health Policy and Clinical Practice, who had provided the earlier analysis of the Medicare data, and worked with him to get a sense of what recent data reveal. As it turns out, the cost of a Medicare patient has flattened across the country, El Paso included. U.S. health-care inflation is the lowest it has been in more than fifty years. Most startling of all, McAllen has been changing its ways. Between 2009 and 2012, its costs dropped almost three thousand dollars per Medicare recipient. Skinner projects the total savings to taxpayers to have reached almost half a billion dollars by the end of 2014. The hope of reform had been to simply “bend the curve.” This was savings on an unprecedented scale.

Skinner showed me the details. In-patient hospital visits dropped by about ten per cent—and physicians reduced the mad amounts of home-health-care spending by nearly forty per cent. McAllen’s spending on ambulance rides—previously the highest in the country—dropped by almost forty per cent, too.

I followed up with doctors there to find out how this had happened. I started with Lester Dyke, a cardiac surgeon who was one of many doctors troubled by what they were seeing, but the only one to let me quote him by name in my McAllen piece. (“Medicine has become a pig trough here,” he had told me. “We took a wrong turn when doctors stopped being doctors and became businessmen.”) After it was published, television crews descended on the town. Texas newspapers did follow-up investigations.

“The reaction here was fierce, just a tremendous amount of finger-pointing and yelling and screaming,” Dyke recently told me. The piece infuriated the local medical community, which felt unfairly singled out. And Dyke paid a steep price: “I became persona non grata overnight.” Colleagues said that he would be to blame if they lost money. Cardiologists stopped sending him patients. “My cases went down by ninety per cent,” he told me. He had to give up his practice at Doctors Hospital at Renaissance, the for-profit hospital, after it became clear that he wasn’t welcome there, but he was able to continue doing some surgery at two other hospitals. When I talked to Dyke in the first months afterward, he’d sounded low. The few friends who voiced support didn’t want to be seen in public with him. He thought he might be forced to retire.

Yet he insisted that he had no regrets. Two of his children went into medicine, and in a medical-ethics class his son was assigned the article. The professor asked whether he was related to the Dr. Dyke quoted in it.

“Yes, I am,” he said proudly. “That’s my crazy dad.”

“I don’t think you often get a chance in life to stand up to all the badness,” Dyke told me.

With time, the anger of colleagues subsided. Many of them resumed sending him patients. Within a couple of years, he was back to an annual caseload of three hundred open-heart operations. Meanwhile, it got harder for McAllen physicians to ignore the evidence about unnecessary care. Several federal prosecutions cracked down on outright fraud. Seven doctors agreed to a twenty-eight-million-dollar settlement for taking illegal kickbacks when they referred their patients to specialty medical services. An ambulance-company owner was indicted for reporting six hundred and twenty-one ambulance rides that allegedly never happened. Four clinic operators were sent to jail for billing more than thirteen thousand visits and procedures under the name of a physician with dementia. The prosecutions involved only a tiny fraction of the medical community. But Dyke thought it led doctors to say to themselves, “Hey, we’re under the magnifying glass. We need to make sure we’re doing things strictly by the book.”

Jose Peña, an internist, was a board member at Doctors Hospital at Renaissance in 2009. When we spoke recently, he didn’t hesitate to tell me the immediate reaction his colleagues had to what I’d written. “We hated you,” he said. The story “put us in a spotlight, in a bad way,” but, he added, “in a good way at the same time.” They hadn’t known that they were one of the most expensive communities in the country, he maintained. They knew there were problems, “but we did not know the magnitude.” His hospital did its own analysis of the data and reluctantly came to the same conclusion that the article did: inappropriate and unnecessary care was a serious problem.

The major overuse of home-health-care services proved particularly embarrassing. “We didn’t know that home health was a thousand dollars a month” for each patient, Peña said. People in the medical community had never paid attention to how much of it they were ordering or how little of it was really needed. He led monthly staff meetings with more than four hundred local physicians and began encouraging them to be more mindful about signing home-health-care orders. Within a year, home-health-care agencies started going out of business.

But more interesting was how broad and enduring the cost decline has been. E.R. visits, hospital admissions, tests, and procedures all fell from the Texas stratosphere. And, years after the attention and embarrassment had passed, the costs continued to fall. Bad publicity, a few prosecutions, and some stiffened regulatory requirements here and there couldn’t explain that. I probed for months, talking to local doctors and poring over data. And I’ve come to think that a major reason for the change may be a collection of primary-care doctors who don’t even seem to recognize the impact of what they’ve been doing.

Armando Osio is a sixty-three-year-old family physician in McAllen. In 2009, when the article came out, he did not own part of an imaging center or sleep-testing center or hospital or any other medical money-making venture. He didn’t have any procedures or tests that he made big money from. He was just a primary-care doctor doing what primary-care doctors do—seeing patient after patient every twenty to thirty minutes, for about sixty dollars a visit. That’s what Medicare paid; private insurance paid more, and Medicaid or the uninsured paid less. He earned nothing like the income of the specialists that I’d written about.

Then, later that year, officials at a large medical group called WellMed contacted Osio. They wanted to establish a practice in McAllen, catering to Medicare patients, and asked whether he’d join them. WellMed had contracted with Medicare H.M.O. plans to control their costs. Its pitch to clinicians was that, if a doctor improved the quality of care, this would save on costs, and WellMed would share those savings with the doctor in the form of bonuses. That meant Osio would have to see fewer patients, for longer visits, but WellMed assured him that, if he could show measurable quality improvements, he’d actually make more money.

Osio was skeptical, but he agreed to see some of WellMed’s patients. When he was in training, he’d been interested in geriatrics and preventive medicine. In practice, he hadn’t had time to use those skills. Now he could. With WellMed’s help, Osio brought on a physician assistant and other staff to help with less complex patients. He focussed on the sicker, often poorer patients, and he found that his work became more satisfying. With the bonuses for higher patient satisfaction, reducing hospital admissions, and lowering cardiology costs, his income went up. This was the way he wanted to practice—being rewarded for doing right rather than for the disheartening business of churning through more and more people. Within a year, he’d switched his practice so that he was seeing almost entirely WellMed patients.

He gave me an example of one. That day, he’d seen an elderly man who had taken a bad spill two or three weeks earlier, resulting in a contused kidney and a compression fracture of his lower spine. After a couple of days in the hospital, he’d been sent home. But the pain remained unmanageable. He called Osio’s office seeking help.

If the man had called five years ago, a receptionist would have told him that the schedule was full for days and sent him to an emergency room. There, he would have waited hours, been seen by someone who didn’t know his story, been given a repeat CT or MRI, and then likely have been kept for another hospital stay. Once the doctors were sure that the situation wasn’t dangerous, he would finally have been sent home, with pain medicine and instructions to see his primary-care doctor. Cost: a few thousand dollars.ADVERTISEMENT

Now when the man called, the receptionist slotted him to see Osio that afternoon. The doctor examined him and, being familiar with his case, determined that he had no worsening signs requiring imaging. He counselled patience and offered reassurance, gave him pain medication, and sent him home, with a plan for his nurse to check on him the next day. Cost: at most, a hundred dollars. And the patient got swifter, better care.

I spoke to Carlos Hernandez, an internist and the president of WellMed. He explained that the medical group was founded twenty-five years ago, in San Antonio, by a geriatrician who believed that what the oldest and sickest most needed in our hyper-specialized medical system was slower, more dedicated primary care. “Our philosophy is that the primary-care physician and patient should become the hub of the entire health-care-delivery system,” Hernandez said. He viewed the primary-care doctor as a kind of contractor for patients, reining in pointless testing, procedures, and emergency-room visits, coördinating treatment, and helping to find specialists who practice thoughtfully and effectively. Our technology- and specialty-intensive health system has resisted this kind of role, but countries that have higher proportions of general practitioners have better medical outcomes, better patient experiences, and, according to a European study, lower cost growth. WellMed found insurers who saw these advantages and were willing to pay for this model of care. Today, WellMed has more than a hundred clinics, fifteen hundred primary-care doctors, and around a quarter of a million patients across Texas and Florida.

There’s a reason that WellMed focussed on these two states. They are among the nation’s most expensive states for Medicare and are less well-supplied with primary care. An independent 2011 analysis of the company’s Texas clinics found that, although the patient population they drew from tended to be less healthy than the over-all Medicare population (being older and having higher rates of diabetes and chronic lung disease, for instance), their death rates were half of the Texas average.

This last part puzzled me. I had started to recognize how unnecessary care could crowd out necessary care—but enough that dedicated primary care could cut death rates in half? That seemed hard to believe. As I learned more about how Dr. Osio’s practice had changed, though, I began to grasp how it could happen.

He told me, for instance, about a new patient he’d seen, a sixty-five-year-old man with diabetes. His blood-sugar level was dangerously high, at a level that can signify a full-blown diabetic crisis, with severe dehydration, rising acid levels in the blood, and a risk of death. The man didn’t look ill, though. His vital signs were normal. Osio ordered a urine test, which confirmed that the man was not in crisis. That was, in a way, a bad sign. It meant that his diabetes was so out of control that his body had developed a tolerance to big spikes in blood sugar. Unchecked, his diabetes would eventually cause something terrible—kidney failure, a heart attack, blindness, or the kind of wound-healing problem that leads to amputation.

Previously, Osio would not have had the time or the resources to do much for the man. So he would have sent him to the hospital. The staff there would have done a battery of tests to confirm what Osio already knew—that his blood sugar was way too high. They would have admitted him, given him insulin, and brought his blood sugar down to normal. And that would have been about it. The thousands of dollars spent on the hospital admission would have masked a galling reality: no one was addressing the man’s core medical problem, which was that he had a chronic and deadly disease that remained dangerously out of control.

But now WellMed gave Osio bonuses if his patients’ diabetes was under better control, and helped him to develop a system for achieving this. Osio spent three-quarters of an hour with the man, going over his pill bottles and getting him to explain what he understood about his condition and how to treat it. The man was a blue-collar worker with limited schooling, and Osio discovered that he had some critical misunderstandings. For instance, although he checked his blood-sugar level every day, he wrongly believed that if the level was normal he didn’t need to take his medicine. No, Osio told him; his diabetes medication was like his blood-pressure medication—he should never skip a dose unless the home measurements were too low.

Osio explained what diabetes is, how dangerous it can be, how insulin works. Then he turned the man over to an office nurse who had taken classes to become certified as a diabetes educator. She spent another forty-five minutes having him practice how to draw up and take his insulin, and how to track his sugar levels in a logbook. She set a plan to call him every other day for a week and then, if necessary, bring him back for another review. This would continue until his disease was demonstrably under control. After that, she’d check on him once a month by phone, and Osio would see him every three to four months. The nurse gave him her direct phone number. If he had any problems or questions, she told him, “Llámame”—call me.

Step by deliberate step, Osio and his team were replacing unnecessary care with the care that people needed. Since 2009, in Hidalgo County, where McAllen is situated, WellMed has contracted with physicians taking care of around fourteen thousand Medicare patients. According to its data, the local WellMed practices have achieved the same results as WellMed has elsewhere: large reductions in overuse of care and better outcomes for patients. Indeed, for the past two years, the top-ranked primary-care doctor out of WellMed’s fifteen hundred—according to a wide range of quality measures, such as the percentage of patients with well-controlled blood pressure and diabetes, rates of emergency-room visits and hospital readmissions, and levels of patient satisfaction—has been a McAllen physician.

I spoke to that doctor, Omar Gomez. He said that he’d set about building a strong team around his patients, and that team included specialists such as cardiologists and surgeons. He encouraged his patients to shift to the ones who, he noticed, didn’t subject them to no-value care. He sat with the specialists, and, he said, “I told them, ‘If my patient needs a cardiac cath—by all means, do it. But if they don’t, then don’t do it. That’s the only thing I ask.’ ”

The passage of the Affordable Care Act, in 2010, created opportunities for physicians to practice this kind of dedicated care. The law allows any group of physicians with five thousand or more Medicare patients to contract directly with the government as an “accountable-care organization,” and to receive up to sixty per cent of any savings they produce. In McAllen, two primary-care groups, with a total of nearly thirteen thousand patients, formed to take advantage of the deal. One, as it happens, was led by Jose Peña, the Doctors Hospital at Renaissance internist. Two years later, Medicare reported that Peña’s team had markedly improved control of its patients’ diabetes; patients also had dramatically lower emergency-room visits and hospital admissions. And the two McAllen accountable-care organizations together managed to save Medicare a total of twenty-six million dollars. About sixty per cent of that went back to the groups. It wasn’t all profit—achieving the results had meant installing expensive data-tracking systems and hiring extra staff. But even after overhead doctors in one group took home almost eight hundred thousand dollars each (some of which they shared with their mid-level staff). It was proving to be a very attractive way to practice.

McAllen, in large part because of changes led by primary-care doctors, has gone from a cautionary tale to something more hopeful. Nationwide, the picture is changing almost as fast. Just five years after the passage of health-care reform, twenty per cent of Medicare payments are being made to physicians who have enrolled in alternative-payment programs, whether through accountable-care organizations like those in McAllen or by accepting Walmart-like packaged-price care—known as bundled payment—for spine surgery, joint surgery, and other high-cost procedures. If government targets are met, these numbers will reach thirty per cent of Medicare payments by 2016. A growing number of businesses are also extending the centers-of-excellence approach to their employees, including Boeing, Kohl’s, Lowe’s, and PepsiCo. And a nonprofit in California, the Pacific Business Group on Health, now offers to provide a similar network to any health-care purchaser in the country.

Could a backlash arrive and halt the trend? It’s a concern. No one has yet invented a payment system that cannot be gamed. If doctors are rewarded for practicing more conservative medicine, some could end up stinting on care. What if Virginia Mason turns away a back-pain patient who should have gone to surgery? What if Dr. Osio fails to send a heart patient to the emergency room when he should have? What if I recommend not operating on a tiny tumor, saying that it is just a turtle, and it turns out to be a rabbit that bounds out of control?

Proponents point out that people can sue if they think they’ve been harmed, and doctors’ groups can lose their contracts for low-quality scores, which are posted on the Web. But not all quality can be measured. It’s possible that we will calibrate things wrongly, and skate past the point where conservative care becomes inadequate care. Then outrage over the billions of dollars in unnecessary stents and surgeries and scans will become outrage over necessary stents and surgeries and scans that were not performed.

Right now, we’re so wildly over the boundary line in the other direction that it’s hard to see how we could accept leaving health care the way it is. Waste is not just consuming a third of health-care spending; it’s costing people’s lives. As long as a more thoughtful, more measured style of medicine keeps improving outcomes, change should be easy to cheer for. Still, when it’s your turn to sit across from a doctor, in the white glare of a clinic, with your back aching, or your head throbbing, or a scan showing some small possible abnormality, what are you going to fear more—the prospect of doing too little or of doing too much?ADVERTISEMENT

Mrs. E., my patient with a five-millimetre thyroid nodule that I recommended leaving alone, feared doing too little. So one morning I took her to the operating room, opened her neck, and, in the course of an hour, removed her thyroid gland from its delicate nest of arteries and veins and critical nerves. Given that the surgery posed a greater likelihood of harm than of benefit, some people would argue that I shouldn’t have done it. I took her thyroid out because the idea of tracking a cancer over time filled her with dread, as it does many people. A decade from now, that may change. The idea that we are overdiagnosing and overtreating many diseases, including cancer, will surely become less contentious. That will make it easier to calm people’s worries. But the worries cannot be dismissed. Right now, even doctors are still coming to terms with the evidence.

Other people of a more consumerist bent will be troubled not that I gave her the choice but that she paid virtually none of the expenses incurred by it. The nature of her insurance coverage guaranteed that. Her employer had offered her two options. One was a plan with a high deductible and a medical savings account that would have made her pay a substantial portion of the many-thousand-dollar operation. And this might have made her think harder about proceeding (or, at least, encouraged her to find someone cheaper). But, like many people, she didn’t want to be in that situation. So she chose the second option, which provided full coverage for cases like this one. She found it difficult enough to weigh her fears of the cancer against her fears of the operation—with its risks of life-threatening bleeding and voice damage—without having to put finances into the equation.

Two hours after the surgery, Mrs. E.’s nurse called me urgently to see her in the recovery room. Her neck was swelling rapidly; she was bleeding. We rushed her back to the operating room and reopened her neck before accumulating blood cut off her airway. A small pumping artery had opened up in a thin band of muscle I’d cauterized. I tied the vessel off, washed the blood away, and took her back to the recovery room.

I saw her in my office a few weeks later, and was relieved to see she’d suffered no permanent harm. The black and blue of her neck was fading. Her voice was normal. And she hadn’t needed the pain medication I’d prescribed. I arranged for a blood test to check the level of her thyroid hormone, which she now had to take by pill for the rest of her life. Then I showed her the pathology report. She did have a thyroid cancer, a microcarcinoma about the size of this “O,” with no signs of unusual invasion or spread. I wished we had a better word for this than “cancer”—because what she had was not a danger to her life, and would almost certainly never have bothered her if it had not been caught on a scan.

All the same, she thanked me profusely for relieving her anxiety. I couldn’t help reflect on how that anxiety had been created. The medical system had done what it so often does: performed tests, unnecessarily, to reveal problems that aren’t quite problems to then be fixed, unnecessarily, at great expense and no little risk. Meanwhile, we avoid taking adequate care of the biggest problems that people face—problems like diabetes, high blood pressure, or any number of less technologically intensive conditions. An entire health-care system has been devoted to this game. Yet we’re finally seeing evidence that the system can change—even in the most expensive places for health care in the country. ♦Published in the print edition of the May 11, 2015, issue.

Source: The New yorker
Shidonna Raven Garden and Cook

Atul Gawande is a surgeon, a public-health researcher, and the chairman of the health-care venture Haven. His four books include “Being Mortal” and “The Checklist Manifesto.”

What did you learn from this article? What is your prospective as a patient? Why?

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NO BURNING SECRETS

By Eugene P. TraniJuly 3, 1994
Source: The Washington Post

On June 19, The Post’s Outlook section carried an essay titled “Burning Secrets” by Cliff Honicker, director of the American Environmental Health Studies Project of the Commission on Religion in Appalachia. The article claims that secret and unethical Cold War experiments were conducted in the 1950s at the Medical College of Virginia, now a part of Virginia Commonwealth University.

In an inaccurate portrayal of the archival records, the article falsely alleges that Dr. Everett Idris Evans and a scientific team working in MCV’s burn unit — the first civilian burn unit in the country — took advantage of “unaware human subjects, most of them poor and African American” in burning and radiation studies.

In fact, these not-so-secret studies resulted, during the course of the research project (1949-59), in the publication of 27 articles in nationally recognized scientific journals, a number of presentations before the most prestigious medical and surgical organizations in the world, and local Richmond newspaper coverage.

Funded by grants from the U.S. Army Medical Research and Development Command, Dr. Evans and his team conducted a series of studies involving animal and human subjects to examine the impact of the effects of an atomic blast. The animal study involved whole-body X-ray radiation. Its purposes were to determine the fluid and blood replacement needs following severe burns and to devise approaches to coping with large-scale burn trauma. No such studies were done on humans.

A second, very different study sought to determine the effects of heat radiation and different degrees of thermal injury on healthy human subjects. This study used paid volunteers. They included 44 white MCV students and 22 African American Virginia Union University students. The research team, including two women investigators, also subjected themselves to burns. In this study, subjects received dime-sized “flash” burns of varying degrees on their arms from a 24-inch field Army light — the “intensely hot Army searchlight in a secret lab” noted in the article.

Among the researchers’ conclusions reported in the Richmond newspapers in 1953 and 1954 was that damage from an atomic blast would occur in less than a second, contrary to earlier theory suggesting a longer time lapse. They also learned for the first time that women and African Americans burn more easily than white men. It is interesting to note that the MCV scientists recognized the merit of using women as well as men, African American as well as white, subjects — a major interest of federally funded research today.

The study team also conducted a third study involving burn patients at MCV that was both investigative and therapeutic. It is this aspect of the project that the article attacks most, suggesting these patients were “unwitting” subjects of dangerous radiation.

This study incorporated batteries of diagnostic tests not unlike those conducted nowadays on seriously ill patients in intensive care units. Over the 10-year period of the study, more than 770 patients were treated in MCV’s burn unit, of whom approximately 460 were African American. This study investigated complications resulting from severe burns, particularly fluid loss and anemia.

One test — called the most “chilling part of the experiments” in the article — involved measuring blood volume, red blood cell volume and red blood cell survival. This test involves taking a small sample of the patient’s blood and mixing it with a tiny amount of a labeling agent to tag the red blood cells. This sample is then reinjected into the patient. The labeled cells are identified by subsequent sampling, allowing the calculation of blood volume and red blood cell survival.

Two types of labels were used: phosphorous-32 and glycine containing nitrogen-15. Nitrogen-15 is a stable isotope of nitrogen and is not radioactive. Phosphorous-32, which is radioactive, is on the order of the background radiation to which an individual living in North America would be exposed in a given year. Patients who today undergo a thallium stress test to diagnose coronary artery disease receive six times as much radiation.

It is important to realize that since the work of Nobel laureate George Charles de Hevesy in the early 1940s, phosphorous-32 had already been in use as a diagnostic tool to measure red blood cell volume. The technique of tagging red blood cells with a radioactive isotope is a standard clinical tool used in hospitals around the world.

The net results of the entire MCV project led to several important advances. These included, among others, the most effective use of antibiotics, the development of fluid and nutritional requirements following thermal injury, a universal dressing for burns, and the causes and treatment of anemia — all of which formed the basis for procedures used today to treat burn victims.

Among the major problems of Honicker’s article is that it inappropriately links the whole-body radiation in the experimental animal study to the clinical blood cell studies performed during the treatment of the burn patients. Comparing the former to the blood cell test, however, suggests a gross misunderstanding of the science.

Another grave concern is that the article questions whether the patients who died during this time did so as a result of the tests. It is important to recognize that these were severely ill patients. The top priority of the physicians involved in the study was to try to save their lives, and those who did not survive almost surely died from their condition.

The article also raises the matter of informed consent, implying that patients were victims of self-serving scientific ends. Again, radiation experiments were not conducted on patients. All studies conducted on patients were administered only for the appropriate diagnostic and therapeutic reasons, and they were covered under a general consent for hospital procedures. The volunteers gave verbal consent, the medical and scientific standard being practiced at the time of the project.

In addition, the Atomic Energy Commission served as the oversight body reviewing radiation studies. In fact, the MCV project was approved by an internal faculty committee established under the auspices of the Atomic Energy Commission. It was not until 1971 that federal regulations governing research protocols, including documentation of informed consent, were established through the Department of Health, Education and Welfare.

Finally, the article questions Dr. Evans’s reasons for writing the Atomic Energy Commission requesting information on malpractice and other exigencies of radiation in studies. It would have been natural for Dr. Evans to be concerned about the liability of the institution in studies involving human subjects. Lacking the federal safety net that would come later, Dr. Evans could have been seeking information to help him govern his own study.

This was not the stuff of a top-secret lab nor the work of unethical scientists on a project that lacked therapeutic purposes. Rather, the team embodied the ethic of the basic researcher — that investigative medical studies ultimately should produce new treatments for patients and a better understanding of prevention. Judging by an editorial on the surgeon’s ethics that Dr. Evans published in 1950 in the Annals of Surgery, it also is clear that he was himself a staunch proponent of appropriate medical ethics.

In all, The Post article’s “investigation” of the Medical College of Virginia’s burn unit misreads the record, misrepresents the work of the scientists and moralizes about past research practices.

In attempting to understand the events of yesterday, it is vitally important for journalists, editors and authors to get the facts and their interpretation straight. It is all the more critical when the reputations of individuals and institutions are at stake and when the danger exists that former patients and their families will be misled about their treatment.

The work of MCV’s investigators, the times in which they made their groundbreaking discoveries and the former patients of MCV deserve better.

The writer is president and professor of history of Virginia Commonwealth University.

What other stories of unethical medical experiments are apart of our history? What are the unethical experiments of today? What would you like to see happen with regard to unethical medical experiments?

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A Doctor’s Drug Trials Turn Into Fraud

By Kurt Eichenwald and Gina Kolata
May 17, 1999
Source: The New York Times

See the article in its original context from May 17, 1999, Section A, Page 1
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Editor’s Note Appended

If ever there was a wonder boy in the lucrative business of drug testing, it was Dr. Robert Fiddes.

In just a few years, Dr. Fiddes transformed his sleepy medical practice here into a research juggernaut, recruiting patients for drug experiments at a breakneck pace. His success made him a magnet for an industry desperately scouring the nation for test subjects. Companies large and small showered him not only with more than 170 studies to conduct, but with millions of dollars in compensation for his work.

Life was good. With bank accounts bulging, Dr. Fiddes and his wife could afford to drive matching BMW’s; a Ferrari parked in his garage was ready for special occasions. After a short time in research, the once small-time family practitioner was planning his dream house on a Cayman Islands beach and envisioning the day he would make millions more by selling shares in his business to the public.

But amid the glitter and cash was a fact that no one outside his office knew: It was all a scam.

For Dr. Fiddes was conducting research fraud of audacious proportions, cutting corners and inventing data to keep the money flowing from the drug industry. Fictitious patients were enrolled in studies. Blood pressure readings were fabricated. Bodily fluids that met certain lab values were kept on hand in the office refrigerator, ready to be substituted for the urine or blood of patients who did not qualify for studies.

Monitors for the Government and the industry never noticed any problems with Dr. Fiddes’s bogus paperwork, which they reviewed during routine audits. Even when some of Dr. Fiddes’s employees alerted those monitors to their suspicions, no investigations were initiated. Instead, their warnings were filed away, while Dr. Fiddes’s sterling reputation as a researcher grew.

Finally, in June 1996, the scheme started to unravel when the manager of a neighboring doctor’s office, Dennelle Del Valle, told a Government auditor rumors of crimes, lies and fraud she had heard from Dr. Fiddes’s own employees. Eventually, to prove the claims, Ms. Del Valle slipped a piece of paper into the auditor’s hand. On it was written a telephone number and a single name: Susan. It was the tip that would lead the Government to Susan Lester, a former employee of Dr. Fiddes who not only knew what had happened, but had a few records that seemed to back up her story.

So began the multiyear investigation of Dr. Fiddes’s Southern California Research Institute, a testing operation that was one of the most corrupt research enterprises ever discovered by law enforcement. The case is set to wind to a close this week, with the scheduled sentencing of the last co-conspirator. But in its wake is wreckage: Dr. Fiddes and several accomplices pleaded guilty to fraud, drug-study results for virtually every company in the business were compromised and the reliability of the private system for testing drugs for safety and efficacy has been thrown into question.

Dr. Fiddes ”was putting the health of all these patients at risk,” said Alan Knox, the former chief financial officer of Dr. Fiddes’s research center, who resigned just months after taking the job when the investigation led him to learn of the fraud. ”But he was also skewing samples that could affect the whole American public.”

The abuses of this one doctor point to weaknesses in the new system developed in recent years for testing experimental drugs. No longer does the pharmaceutical industry rely on career researchers at academic medical centers, whose professional reputations are forged on the quality of their data. Rather, the industry has turned to thousands of private-practice doctors, for whom testing drugs has become a sideline for making money.

While the researchers and their incentives have changed, the methods of monitoring what they do remain basically the same even though now, since they are paid for each patient they recruit, researchers have an enormous financial incentive to cheat. The case of Dr. Fiddes underscores the ease with which such a system can be deceived — a situation that has not been remedied since the discovery of his crimes.

The story of the corruption at the Southern California Research Institute was pieced together from memos and other internal documents, investigators’ notes, drug company and court records, personal diaries and affidavits of participants, as well as interviews with Government officials, lawyers and the former employees and consultants at the company, which is now defunct.

The picture that emerges from these documents and interviews is of a research office ruled by a doctor driven by greed. Few employees other than the study coordinators — mostly women of limited financial means — were aware of the magnitude of the swindle. Those bothered by it were repeatedly assured that this was the way the drug industry worked. Faced with that perception, there seemed little they could do without risking their livelihood to stop the influential Dr. Fiddes, a man who believed that the system of monitoring was too poorly designed to ever catch him.

”I don’t think he thought he could be touched,” said Kathryn Davis, a medical transcriber at the research center. ”We just didn’t understand why it had to go down the way it did. Maybe he just wanted too much too fast.”

Through his lawyer, Dr. Fiddes — who is now serving a 15-month sentence for fraud in the Metropolitan Detention Center in Los Angeles — refused repeated requests for an interview. But in interviews with the Government after he agreed to plead guilty, Dr. Fiddes portrayed himself as a man trapped by the dishonesty of others. He maintained that most researchers are forced to cheat because drug companies issue requirements for test subjects that sound good in marketing material, but are impossible to meet in the real world. He said — with no evidence to back up his claim — that anyone successful in the business was skirting the rules.

Still, at his own research center, Dr. Fiddes laid much of the blame for everything that happened on his study coordinators — again, without providing evidence to support the assertion. While he was the beneficiary of the illegal activity, he maintained that it was the salaried employees working for him who devised the frauds, often without his knowledge. The information provided by Dr. Fiddes has not resulted in any additional investigations.

Despite his refusal to accept the blame, Dr. Fiddes was anguished at being labeled a criminal. In a letter pleading for mercy that he sent last year to Federal District Judge Robert M. Takasugi, he described his torment. ”My family has had to endure the humiliation of seeing a husband and father sink from being a widely respected community member to now being visualized as nothing more than a common crook,” Dr. Fiddes wrote. ”My mother often said, ‘The only thing in life that is important is to be able to hold your head up high.’ I now know what that means.”

The Career

From Family Doctor To Drug Researcher

Robert Fiddes always wanted to be a skater. As a teen-ager in his native Vancouver, British Columbia, he rose most mornings before dawn, walking to a chilly ice arena for his 5 A.M. practice. The hard work paid off; he often told of winning Canada’s junior figure skating championship, a victory that set him on the path to going professional.

But when the time came to choose between a career as a figure skater or enrolling in a university, young Robert Fiddes took the academic path. And there he showed that same drive, gaining acceptance to medical school at the University of British Columbia after just three years in college, according to his curriculum vitae.

In 1970, at 25, Dr. Fiddes earned his medical degree and, with his new wife, Rebecca, came to Long Beach, Calif., for a job as a hospital intern. He went on to join a medical partnership, but in 1981 opened his own practice in Whittier with a medical assistant, LaVerne Charpentier, in a converted house with an awning and flower garden. It was the perfect image for an old-time family doctor, and the practice blossomed.

Dr. Fiddes’s wife would later write of those early days in a letter to the judge who sentenced her husband. ”His patients adored them and showered the office with everything from home-baked cookies to hand-crocheted dolls,” she wrote. ”Both Rob and Laverne worked long and hard to provide his patients with the best care.”

Eventually, Dr. Fiddes formed a group made up of several family doctors in the area. But by the late 1980’s, an obstacle emerged that Dr. Fiddes was unable to sidestep. Managed care was sweeping California, and Dr. Fiddes chafed at the new rules. ”He felt his hands were tied in performing whatever tests were necessary to assist in the proper diagnosis of the patient,” Mrs. Fiddes wrote in her letter. Patients ”felt equally frustrated with the new system.”

Growing restless, he decided to pursue a law degree, attending night school. In 1987, he passed the California state bar exam.

But by then, the medical profession had changed so radically that an entirely new specialty presented itself: Doctors were testing the safety and effectiveness of new drugs for pharmaceutical companies, using their patients as subjects. Recognizing the opportunity to get away from managed care, Dr. Fiddes jumped at the chance.

His new clinical-trials business grew rapidly. Dr. Fiddes appointed Ms. Charpentier as his first full-time study coordinator, and raided a private research firm in the area, California Clinical Trials, to build his staff. He began to dream of eclipsing his biggest rivals and taking his new enterprise public, at times doodling his ideas for a corporate logo onto pads of paper.

As the business grew, former employees said, a pattern soon emerged. Dr. Fiddes would meet with patients in his first-floor office, then refer them to the study coordinators on the second floor. Often, the patients who arrived there felt reluctant to take part in the trials.

”They were pushed to go up there,” said Susan Lester, the former study coordinator who blew the whistle on Dr. Fiddes. ”They often would say, ‘I don’t want to participate in this, but I don’t want to make him mad.’ ”

In the early days, Ms. Lester and other coordinators would tell wavering patients to take their time, perhaps by sleeping on the idea, before signing an agreement to participate. But Dr. Fiddes and Ms. Charpentier, who also declined interview requests, quickly put an end to such solicitousness.

”I was told that it was a big mistake to let them think about joining,” Ms. Lester said. ”They said, ‘You don’t tell them they have any choice about it. You put them in.’ ”

The Fraud

Falsifying Records, Endangering Patients

Kimberly Carlon’s interviews for a job at the Southern California Research Institute had been going well. She had only one more hurdle to clear: speaking to Dr. Fiddes himself. If he approved of her, Ms. Carlon, a certified respiratory therapist, would become the research site’s latest study coordinator. Sitting in front of Dr. Fiddes’s desk in early 1996, she listened as he described a hypothetical situation. Suppose, he said, that a patient was available for a study, but was taking medication prohibited by the study protocol. The answer seemed obvious, Ms. Carlon replied: she would send the patient on his way.THE MORNING: Make sense of the day’s news and ideas. David Leonhardt and Times journalists guide you through what’s happening — and why it matters.Sign Up

Well, Dr. Fiddes told her, that was not the way he did things. At the Southern California Research Institute, he said, the patient would be entered into the trial; that would require the center to falsify records so that the violation of study rules could be hidden.

Ms. Carlon got the job. But she would later describe her discussion with Dr. Fiddes as the first moment she should have realized something was wrong.

Like every other study coordinator who passed through Dr. Fiddes’s research center, Ms. Carlon found herself being pushed to break the rules. When she ran a 1996 study for a new asthma inhaler sponsored by Fisons, a British drug maker, she found a patient who had been enrolled even though she had an incurable lung disease that should have disqualified her. When a monitor hired by Fisons asked to see the patient’s medical chart, Ms. Carlon approached Delfina Hernandez, a more senior employee, and asked what to do.

Ms. Hernandez quickly fetched the patient’s medical chart, and pulled out every page that made reference to the lung disease. Then, according to investigative documents, she turned the remaining records over to the monitor. The violation went undetected.

Ms. Hernandez, who later pleaded guilty to fraud, declined to comment.

Again and again, study coordinators were instructed by Dr. Fiddes and his top aide, Ms. Charpentier, to ignore the requirements of the drug studies. The rules called for excluding smokers from an asthma study? The coordinators were told to put the smokers in anyway, and not mention their habit in the medical records. A certain blood pressure was required for patients to participate in a hypertension study? Then the coordinators were expected to write that level into the chart, regardless of the truth. Patients’ medical records contained health histories that precluded them from participating in a test? Then the offending pages were ripped out and destroyed, and the patients placed on the experimental medication despite the dangers.

Over time, the frauds orchestrated by Dr. Fiddes grew ever more audacious. Eventually, according to Government documents, it was not just the records that were being falsified. Instead, medical tests were rigged — and at times, patients simply invented. Outside monitors reviewed the documentation, but since there were real lab records for the rigged tests, they had no clue that they were being deceived.

The office refrigerator became the source of human bodily fluids that met the requirements of various studies. A jug of urine was often found there on Monday mornings, provided by Carol Rose, an employee. Ms. Rose’s urine contained high levels of protein — just the trait patients needed to qualify for certain studies. Dr. Fiddes paid Ms. Rose $25 each time she collected her urine and brought it to the office, where over time it was divvied up among specimen cups labeled with other people’s names and presented for testing.

The refrigerator also proved useful when the research center was conducting studies on hormone replacement therapy for menopausal women. The studies required women with blood serums that showed low levels of estrogen and high levels of follicle-stimulating hormone — signs that a woman is going through menopause. To make sure that the patients’ tests qualified, Dr. Fiddes sent out a memo specifying the hormone levels required for the study. ”We need some serum that scores these numbers in the frig at all times,” he wrote.

Another study on an antibiotic required that patients have a certain type of bacteria growing in their ear. No problem for Dr. Fiddes. He bought the bacteria from a commercial supplier and shipped them to testing labs, saying they had come from his patients’ ears.

Dr. Fiddes’s coordinators, paid bonuses for recruiting patients into studies, soon began improperly enrolling themselves and members of their families. Often, names were changed to avoid detection by drug company monitors. At times, family members took part in several studies at once — a violation of the rules because studies require that participants not be taking other medications, so that the data obtained relate only to the drug under study.

Employees ”were running around doing E.K.G.’s on each other, if the patient couldn’t pass,” said Sloan A. Bergman, a former study coordinator who quit working for Dr. Fiddes after less than a year because of ethical concerns. ”I wasn’t happy, but I needed a job.”

Yet all the while, there were constant reminders that the true cost of the frenzied drug testing was being borne by sick and vulnerable patients.

In the summer of 1995, the research institute began work on a study of Cozaar, a hypertension medication sponsored by Merck & Company. Among the patients enrolled by Dr. Fiddes was Arlene Roberts, a 70-year-old woman with high blood pressure. Instead of dropping, her blood pressure rose dangerously when she took the drug. Dawn Simons, the study coordinator, became alarmed and sent Ms. Roberts to see Dr. Fiddes. Rather than taking her out of the study, Dr. Fiddes prescribed two other hypertension drugs. The triple dosage not only violated the study rules, it made it impossible to gauge the effect of Cozaar.

A few days later, Ms. Roberts returned. Her face was bruised, her speech was slurred and she had trouble walking. She told Ms. Simons that she had passed out over the weekend while bathing. Ms. Simons took her pulse and found that her heart was barely beating — a result, the coordinator thought, of bombarding her body with hypertensive drugs. Worried that Ms. Roberts was headed toward cardiac arrest, Ms. Simons asked Ms. Lester, her fellow study coordinator, for assistance. The two helped Ms. Roberts, who by then could barely walk, to Dr. Fiddes’s office.

”He said, ‘It’s no big deal. She’s probably making more of it than it really is,’ ” Ms. Lester recalled in a recent interview.

Ms. Simons, dismayed at what was happening, thought Ms. Roberts should be dropped from the study. But Dr. Fiddes refused, keeping her on the medications for several more weeks. Ms. Roberts was soon seeing another doctor in a hospital for the problems that emerged during the study. Ms. Simons, the study coordinator, resigned from her job, but not before surreptitiously copying all the medical records and turning them over to Ms. Roberts in case she wanted to bring a lawsuit. Ms. Roberts, who recovered at the hospital, never sued.

Dr. Fiddes received payment in full from Merck — his reward for keeping Ms. Roberts in the study through its completion.

Avoiding Detection

The F.D.A. Ignores An Early Warning

Ilse Beverly finally decided that Dr. Fiddes had to be stopped. While working for him for five years handling laboratory tests like blood work, Ms. Beverly had seen signs of his willingness to cheat on drug studies. And so in January 1995, almost immediately after leaving her job, Ms. Beverly telephoned investigators with the Food and Drug Administration.

She reported her own experiences, such as the time in 1990 that Dr. Fiddes had asked her — without explaining why — to find a way to alter lab values in urine tests. She also provided the names of study coordinators who knew that testing data were being manipulated to enroll larger numbers of patients. With her revelations, the Government had its first solid lead on what was happening in Dr. Fiddes’s office fully 17 months before Ms. Del Valle exposed his crimes to an F.D.A. auditor. Investigators wrote memos about Ms. Beverly’s allegations, and forwarded them from Los Angeles to the clinical investigations branch of the F.D.A.

There, the memos were filed away. No investigation was begun.

Brad Stone, a spokesman for the F.D.A., said that, because aspects of the case have not been finished, the agency could not comment at this time.

Dr. Fiddes had always found it easy to elude detection by the crews of company monitors and Government auditors that visited his offices, even when his employees spelled out their suspicions about what was happening. It was not that he was particularly adept at dodging their questions; rather, they seemed reluctant to challenge such a prominent figure in the drug-testing business. ”This business can be run on words, and I have learned the words,” Dr. Fiddes wrote in a 1995 memo. ” ‘We have no problems’ is our motto, and tell this to every monitor.”

When Dr. Fiddes’s efforts to enroll patients were thwarted by system safeguards intended to insure accurate test data, he often found ways around the problem.

In a 1995 study of an experimental pain reliever for arthritis called PHZ 136 that was sponsored by the Zambon Corporation, Dr. Fiddes faced a particularly difficult impediment. The patients were supposed to have arthritis of the knee, as verified by X-rays.

Dr. Fiddes tried to recruit patients. Again and again, he sent their X-rays to an independent radiologist for review. And almost every time the answer came back the same: The patient did not have arthritis, and so did not qualify for the study. Frustrated, Dr. Fiddes told the coordinator of the study, Ms. Lester, to look through his medical files for patients with arthritis of the knee. Then, he said, she should offer each of those patients $25 to come in and get multiple X-rays, which he could substitute for the X-rays of patients who did not qualify. But Ms. Lester drew the line, and refused.

The ever-resourceful Dr. Fiddes found a way around that obstacle, however. Through his staff, he got in touch with the project manager at Pharmaceutical Product Development Inc., which was managing the study for Zambon, and asked a question: Because he was a doctor, couldn’t he just interpret his patients’ X-rays himself, rather than send them to a certified radiologist?

The company was happy to oblige. Researchers ”may interpret knee X-ray films obtained on candidates,” Julia Dixon, the project manager, wrote in a letter to Dr. Fiddes. ”There is no need for a radiological consult.”

From that moment on, Dr. Fiddes had no trouble finding patients who qualified for the study. ”That kind of opened it up for him right there and then,” Ms. Lester said. ”Everyone understood that if he was going to read the X-ray, he was going to lie.”

Not long afterward, Dr. Fiddes received a letter from one of the testing company’s study monitors. ”CONGRATULATIONS on meeting your enrollment deadline!” the monitor, Cheryl Grant, wrote in a letter dated Feb. 19, 1996. ”I performed a 100 percent source document verification, and found no outstanding issues.”

Through Pharmaceutical Product Development, a testing company, Dr. Fiddes was paid $45,268 for his effort in the Zambon study. The company never detected his fraud. Zambon declined to comment, citing confidentiality of the study, as did Pharmaceutical Product Development. But Nancy Zeleniak, a spokeswoman for the testing company, said its monitoring was of the highest quality. ”We have standard operating procedures for detecting fraudulent or fabricated data,” she said. ”We are helping to set standards in the industry.”

Another company came closer to putting him on the spot. Several former coordinators for Dr. Fiddes said they had reported his unethical conduct to Pat Pryor, an independent study monitor working with Pfizer Inc. Tipped off to the discrepancies, Ms. Pryor sharply challenged Dr. Fiddes and his staff in her reviews of their paperwork.

Dr. Fiddes chafed at the challenges, feigning outrage. ”Our integrity and reputation for performing high-quality clinical trial work has been injured, and we are justifiably upset,” Dr. Fiddes wrote in a July 1995 letter to Pfizer, complaining about Ms. Pryor’s demands. He insisted Pfizer ”have a new monitor assigned to our site immediately.”

Not long afterward, Dr. Fiddes announced the news at a staff meeting: Pat Pryor would not be returning to monitor the Southern California Research Institute.

Pfizer said that the company replaced monitors if there seemed to be a conflict. ”In order to insure the most objective and best monitoring, we generally recommend that if there is personal conflict, and no certainty of irregularities, that a new neutral person is assigned to review all of the data,” said Betsy Raymond, a spokeswoman for Pfizer.

But in the Fiddes case, that policy did not improve the monitoring. ”We have an extensive system of checks and balances,” Ms. Raymond said. ”Even with all of that, we didn’t uncover the fraud.”

Why was Dr. Fiddes able to fool the monitors so easily? Because the oversight system is mostly designed to catch errors, not fraud. To protect patient confidentiality, monitors are forbidden even to know the names of test subjects, meaning that no spot-checks are ever performed by the companies to make sure that researchers are not making up lab values or inventing patients.

But Dr. Fiddes’s luck in avoiding detection would not hold. By May 1996, more than half a dozen study coordinators — including Ms. Simons and Ms. Bergman — resigned, fearful that the fraud would cost them their nursing licenses or certifications. Ms. Lester likewise decided she could take no more, and wrote a letter to Dr. Fiddes declaring that she would no longer participate in fraudulent, unethical work.

A response came quickly. Ms. Lester was ordered to clean out her desk immediately, and was escorted from the building. On her way out the door, she bumped into Kathryn Davis, another Fiddes employee. With tears in her eyes, Ms. Lester made Ms. Davis a promise.

”She told me before she left that she was going to bring Dr. Fiddes to his knees,” said Ms. Davis, a former employee. ”I had no idea that she meant it seriously.”

The Cover-Up

‘You MUST Be Able To Dump Your Files’

Alan Knox, the chief financial officer of the research center, was working in his office in the summer of 1996 when its chief operating officer burst in. The officer, Elaine Lai, demanded that Mr. Knox pull a series of invoices documenting payments to an employee, Carol Rose.

Mr. Knox fished the invoices from a filing cabinet. As he read them, he grew concerned. Written clearly across the $25 invoices were the words ”urine sample.” For the first time, he was seeing the evidence that Ms. Rose was being paid to substitute her own urine for that of patients.

Wary of what was happening, Mr. Knox copied the invoices, and kept the originals. As he handed the copies to Ms. Lai, he asked her and Ms. Hernandez, the longtime senior employee of Dr. Fiddes, what was going on. Well, came back the response, apparently Susan Lester had gone to the F.D.A., and worse, was contacting other former coordinators and trying to persuade them to talk to the Government about the way Dr. Fiddes conducted his research.

”I remember inquiring with Delfina and Elaine and saying, ‘What’s the big deal?’ ” Mr. Knox said in a recent interview. ”They looked at me, they looked at each other and said, ‘We have to tell him the truth.’ ” As he listened to them recount the trickery that had taken place at the institute, he said, ”I was just taken aback by the level of fraud.”

His first thought, he said, was that Dr. Fiddes and his top aides should confess everything to the F.D.A. But unknown to him, they were at that very moment planning a cover-up that would involve destroying incriminating documents and manufacturing new ones that might place the blame for any problems on Ms. Lester.

Dr. Fiddes was most concerned about the urine substitution, out of fear that Ms. Rose would talk, according to notes of investigator interviews. So, in August 1996, he called a meeting at the Hilton Hotel in Whittier with Ms. Lai, Ms. Hernandez and his longtime assistant, Ms. Charpentier.

To solve the Carol Rose problem, Dr. Fiddes told the group, he would create a bogus medical chart and false patient history for her. If asked, he would say that urine had been collected as part of her medical treatment.

The following Saturday, Ms. Lai called a meeting for what she called ”chart review.” The actual mission was to go through the medical charts and destroy any evidence of wrongdoing.

Days later, on Aug. 21, Ms. Lai called for another meeting for strategic planning. In a memo to Dr. Fiddes, Ms. Charpentier and Ms. Hernandez, she made clear the need to move quickly.

”F.D.A. is busting down our door on Monday,” Ms. Lai wrote. ”You MUST be able to dump your files to your car when F.D.A. knocks.”

Ms. Lai added in the letter that they had to agree to scripted responses to all questions the Government might ask.

As Dr. Fiddes and his allies were secretly working on their cover-up, Mr. Knox was reaching out to regulatory experts who he thought could help the company in its talks with the F.D.A. He got in touch with Gretchen McKelvey, a quality assurance consultant for clinical trials, who was quickly hired to help out. Ms. McKelvey was stunned by the magnitude of the fraud she discovered at Dr. Fiddes’s office. But even more incomprehensible was the blase attitude Dr. Fiddes demonstrated as he calmly informed her of his cover-up plans.

”I explained to him that what had happened here was considered criminal, and that he could be prosecuted for conspiracy and fraud,” Ms. McKelvey said in an interview. ”Dr. Fiddes replied that they were going to blame Susan Lester for all of the problems, and he was going to say he had no knowledge of what was going on.”

About that time, Ms. McKelvey learned that Dr. Fiddes had moved all of the patient records off site. When she asked where they were, she said, he replied that they were in storage. Days later, when she pressed for them again, Dr. Fiddes told her the records had been lost.

”I was starting to get really scared,” she said. ”I don’t like to be messed with.”

As the situation deteriorated, Ms. McKelvey decided the situation was too big to handle alone, and required someone with more expertise in dealing with the Government. She sought advice from Michael Hamrell, a consultant who specialized in the F.D.A. Mr. Hamrell arrived at the research site for a briefing from the company’s top executives, including Dr. Fiddes and Mr. Knox. They made no bones about all the protocol violations they had committed. Why would Dr. Fiddes be so open? Because, as Mr. Hamrell learned quickly, he still believed that he could outsmart the system.

”He told me that he knew the law better than the F.D.A., and that the F.D.A. couldn’t touch him,” Mr. Hamrell said. ”He told me he was a lawyer, and he wasn’t responsible.”

Many of those who worked for him, like Mr. Knox and Ms. McKelvey, saw the writing on the wall and resigned soon after being hired. But others who for years had accepted Dr. Fiddes’s repeated assurances that everyone in the industry did the same things were shaken and agonized about whether to confess.

”I want to spill my guts, but what is going to happen to me and my future?” Delfina Hernandez, one of Dr. Fiddes’s top aides, wrote in her diary as investigators closed in. ”God forgive me if you think I did wrong, and punish me if I did anything to hurt these patients.”

She soon found out what would happen to her future. On Feb. 16, 1997, teams of Federal agents swarmed into the Southern California Research Institute’s office. The entire staff was ordered to move to the front of the building, as the agents seized box after box of documents. One agent with a video camera filmed every employee’s face for use in future identifications.

With employees facing such intimidating law enforcement tactics, cracks began to emerge in the conspiracy to lie to investigators. Ms. Hernandez was the first to decide to provide evidence to the Government, and the other dominoes quickly fell. By September 1997, Dr. Fiddes, Ms. Hernandez and Ms. Charpentier agreed to plead guilty. Ms. Lai pleaded guilty soon afterward.

Now, with Dr. Fiddes compelled to cooperate as part of his plea agreement, the Government hoped to learn more from him that would help in the battle against research fraud. On Oct. 10, at 10:30 A.M., Dr. Fiddes met for an interview with William Leitner and Hetal Sutaria of the F.D.A.

For five hours, the agents grilled Dr. Fiddes. He told them that fraud was rampant in the research industry. He named names of doctors he suspected of engaging in practices similar to his own. And he described some telltale signs that should raise suspicions of possible fraud.

But, the investigators asked, what evidence of fraud is there in the records reviewed by monitors and the Government? What could the watchdogs have seen that would have allowed them to detect his fraud?

Nothing, Dr. Fiddes replied. Had it not been for a disgruntled former employee, he would have still been in business.

Editor’s Note: July 2, 1999, Friday An article on May 17 described fraudulent trials of new drugs by Robert Fiddes, a California doctor who operated a company, now defunct, that he called the Southern California Research Institute. Dr. Fiddes had no connection to another company of the same name in Los Angeles, a nonprofit corporation that has conducted research on traffic safety since 1973.

Would you recognize health care fraud if you saw it? What would it look like? Have you seen health care fraud before?

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How Doctors Legally (And Illegally) Cover Up Malpractice

A woman holds a finger over her mouth indicating that she's keeping a secret.

Source: Hampton & King Attorney at Law
Photos Source: Hampton & King Attorney at Law

You made it home. Five long days in the hospital, and home was the only thing you could think of.

But suddenly there’s a sharp pain in your stomach. It’s unlike anything you’ve ever felt before. You wrack your brain…”Did I take my medicine on time? Did I follow her instructions? Maybe I wasn’t supposed to eat yet…”

A few consults later with another physician and the truth comes to light. Your doctor didn’t just make a mistake that injured you. She hid it to protect herself. But the secrets don’t stop there. Did you know that doctors can hide their mistakes legally as well?

The Stats

Because of incredibly long hours and the general stress of the job, medical errors have become increasingly common. Out of fear of legal consequences, many doctors choose to hide their mistakes.

► More than 1 out of 10 patients are harmed over the course of their medical care. *

► Medical errors result in 250,000 deaths each year. *

► More than 7 out of 10 doctors say they’d admit little or nothing if they made a medical error, and most say they wouldn’t even apologize. *

That means we’ll never know precisely how often doctors make mistakes, because many if not most of them will hide it if they can. Or best case, “admit little.” Yikes. Back to your story.

Differences Between Settling & Going To Court

So. You find out about your doctor’s malpractice and decide to do something about it. You find the right lawyer and suddenly, the ball’s in your court. You have strong evidence and a solid case. They know you’ll win, so they offer you a substantial amount to settle. Finally, your doctor will own up to her mistake and you can move on with your life, right?

Well, not exactly.

Settlements, as you may know, are when cases don’t go to trial. They’re instead resolved outside of the courtroom.  Settlements can get the issue decided, put more money in your pocket, and resolve conflict in the shortest amount of time. The thing is, they usually involve a payment made by the defendant without admitting any fault. So you get justice, just not exactly all of it.

Trials represent a chance for more closure, but are a much lengthier, expensive, and are a public process involving more risk (but potentially more reward.) Litigation costs and attorney fees can add up, eclipsing the additional money gained from the jury award.

Two people discuss a legal situation with a document in hand.

The Disturbing Side Of Settling

For starters, settlements keep the issue private. County records will show the case was dismissed, omitting any further details.

The general public is left completely in the dark. Future patients don’t have access to databases like the “National Practitioner’s Data Bank”, which reports settlements and payments made by hospitals and doctors. Since the general public doesn’t have access to this information, malpractice is kept out of sight and out of mind. Future patient’s should know what they’re getting into, right? But how can they?

Settling can also keep you in the dark. No one has to give you the specific details of your own malpractice case.

The flip side, is that settlements can be a great way to end the case quickly and to keep things as drama-free as possible. Plus, there’s no risk of losing the trial. You get compensated, and that’s the biggest thing for many if not most people.

But sometimes, going to trial is the only option.

When To Go To Trial

Trials are when you decide to take your claim to court, allowing a jury of your peers to decide the monetary damages and who is at fault, along with a judge, attorneys, witnesses, and the use of testimonies.

For some, it can be critical to put their doctor’s wrongdoings on public record. It’s the best way to ensure the safety of other patients and the best way to avoid future incidents from happening again.

The fact remains that less than 7% of cases involving doctor malpractice go to a jury. It can also take years to process, which can be a demotivating factor when deciding whether to go to trial or not.

Despite this, taking your doctor or hospital to court over medical malpractice advocates publicly for higher levels of accountability in the professional world, and upholds a standard that is important to maintain.

A person signs a legal document with a pen.

Discerning Your Best Option

You’ve certainly felt the gravity of your physicians mistake. It affects your health, finances, and emotions, among other things. You deserve justice, no matter what form it takes.

If you face the decision to settle or go to court, just know that it’s not always black and white. It’s a deeply personal decision that only you can make. Your lawyer will be there to explain the pros and cons of each decision and to help you select the best option.

If you found this article helpful, be sure to check out the rest of our blog where you can find other informative posts. As always, feel free to reach out to us if you have any questions or would like to discuss pursuing a case.

What does malpractice look like? Would you recognize it if you saw it? What should you do?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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