December 18, 2014

Drug Company Employee Paid for Her Honesty with Her Job

An employee of Sanofi, a major pharmaceutical company, spoke up about the company’s kickback scheme intended to boost sales of its insulin medicines, and was rewarded by being fired.

That’s what Diane Ponte, a paralegal in the French company’s New Jersey office, claims in the whistle-blower lawsuit she filed against Sanofi. According to the Associated Press (AP), Ponte accuses Sanofi and more than 10 of its executives and former executives of spending millions to grease palms in the hope of influencing pharmacists to replace generic prescriptions for insulin with the Sanofi brand name version.

Ponte was fired in October, and a couple of weeks later, Sanofi's CEO was dumped because the board didn’t care for his management style, said AP, and because of slumping sales.

Ponte’s lawsuit alleges that his role in the kickbacks contributed to his ouster.

Ponte worked in Sanofi's diabetes division reviewing vendor contacts for their adherence to federal law. At the time, Sanofi operated under a corporate integrity agreement with the U.S. government mandating that it obey U.S. laws and report illegal activity. That agreement was the result of the company’s earlier failure, the AP story said, to follow federal health-care laws.

Corporate integrity agreements are now common in the pharmaceutical industry, and cases like this seem to show how toothless they are.

A statement by Sanofi, of course, denied retaliating against Ponte. It called her a "disgruntled former employee who is opportunistically attacking our company."

The lawsuit says that in March 2013, Ponte balked at approving nine contracts worth $34 million with two consulting firms, Deloitte LLP and Accenture PLC. Neither is a defendant in the suit. Ponte told her manager that she couldn't approve the contracts because they had been signed before she’d seen them, which was improper. They also called for huge payments although no services were being provided.

Ponte’s attorney, Rosemarie Arnold, told AP that the consulting firms used the money to induce hospitals, pharmacies and doctors to prescribe Sanofi insulin brands, including its top-selling product, Lantus.

"Accenture and Deloitte would make deals with the pharmacies whereby when a patient came in with a generic prescription for insulin, the pharmacist would push the Sanofi insulin," Arnold said. She said that if a prescription specified insulin made by Sanofi competitor Novo Nordisk, the pharmacists would urge patients and even contact their doctors to promote Sanofi’s product as a superior treatment.

Arnold said Sanofi did not report the bribery allegations or the internal probe.

The lawsuit claims that a Sanofi supervisor in the U.S. diabetes marketing division told Ponte that the CEO and the vice-president of the U.S. diabetes business knew she was withholding the consulting contracts and that the CEO was "extremely unhappy."

Arnold said the company conducted a "farce" internal investigation in which no one was disciplined, she said, but after which the supervisor and the VP, two key defendants, "retired" from Sanofi. The suit states that they each received "millions of dollars in severance packages and/or in their pensions," and both landed well-paid consultancies to Sanofi.

But Ponte’s treatment was different. She was criticized, threatened with violence and, the suit claims, physically assaulted by a manager. When she was fired in October, according to Arnold, a manager told her it was because she was a whistle-blower.

If Sanofi is like multiple other drug companies whose bad, illegal behavior we have regularly reported, Sanofi doesn’t perceive Ponte’s suit or any other breach of law as particularly troublesome. If they flout the law, get caught and have to pay, it’s just the cost of doing business in the U.S., where the billions of dollars they can reap in drug sales more than offsets any penalties for being scumbags.

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December 16, 2014

Rousing ICU Patients Shows Benefits

The most seriously ill hospital patients reside in the intensive care unit (ICU), a necessary treatment that nevertheless presents serious risks of its own. (See our blog, “Brain Problems Can Endure Long After Leaving the ICU.”) Recent research shows that waking up ICU patients and encouraging them to breathe on their own decreases both their sedation levels and how long they remain in a coma.

The study, published in the journal Critical Care Medicine, also indicated that these practices reduced the delirium that critically injured people often experience.

The study subjects were 702 ICU patients at least 18 years old. The researchers made no other changes to ICU staffing practices other than those tested in what they called the Wake Up and Breathe program.

As described in a news release issued by Indiana University, one of the participating institutions, patients who are on ventilators (to assist breathing) typically receive both sedatives and painkillers. Excessive sedation can extend the time the patient stays on the ventilator. The longer someone stays in the ICU, the more likely he or she experiences delirium, a state of serious confusion and an inability to focus.

But too little sedation can leave patients agitated and cause them to be disconnected from the breathing machine before doctors believe they are ready. Excessive pain medication and sedation have been associated with acute brain dysfunction characterized by coma and delirium.

"Being on too high a dose of sedation medications or painkillers isn't good for the brain, especially the aging brain. Typically about 80 percent of patients in an ICU develop delirium," said Babar A. Khan, M.D., the pulmonologist and critical care physician who led the study and was quoted in the news release. "In our study … we stopped sedation in the morning and woke patients up to breathe on their own with assistance from an interdisciplinary team of nursing, physicians and respiratory therapists. Only 50% developed delirium, still too high a number, but significantly better than typical."

Every year, about 5 million Americans are admitted to a medical or surgical ICU, and slightly more than 1 in 3 of these critically ill patients receive mechanical ventilation because they are comatose, have lung disease, pneumonia or sepsis (severe, systemic inflammatory response to infection) or for other reasons can't maintain an open airway.

Delirium generally prolongs a hospital stay and carries a risk of developing dementia. Obviously, it’s in a patient’s interest to do everything possible to avoid it.

And, according to Khan, "In addition to increasing the probability of long-term cognitive impairment, we know that assisted breathing over a period of time is bad for the body as it increases muscle atrophy, resulting in physical function problems later.”

If your loved one is an ICU patient, make sure the staff knows you’re familiar with the adverse effects this treatment can have. Ask how much sedation the patient is being given, if it’s the lowest dose possible and when the doctors plan to reduce or eliminate it. Discuss options for minimizing the chances of delirium, and what measures are being taken to encourage the patient to breathe without the ventilator.

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December 15, 2014

More Evidence that Vitamin D Tests May Not Be Needed

Although some people don’t get enough vitamin D, and a deficiency of it can cause problems, a federal panel has determined that the jury is out on whether routine testing for vitamin D level in the blood makes sense.

The U.S. Preventive Services Task Force, (USPSTF) an independent body of experts in prevention and evidence-based medicine, makes recommendations to improve the health of all Americans. It has determined, according to a story on NPR, that there are problems with vitamin D testing as a standard practice of preventive medicine. The USPSTF issued an "insufficient evidence" statement meaning that the evidence is unclear on whether benefits of the test outweigh potential harms.

Yes, most people don’t get enough sunshine, especially this time of year, for their bodies to make vitamin D, and, yes, testing is increasingly popular, but as we blogged a couple of years ago in “Vitamin D — Fashion or Fiction?,” even if you do need the vitamin supplement, how much and for how long depend on why you’re deficient, your diet and other medication you take.

As explained by the National Institutes of Health (NIH), vitamin D is found in small amounts in fatty fish (herring, mackerel, sardines and tuna), and is added to dairy products, juices and cereals — that’s what’s meant when you see labels reading “fortified with vitamin D.” But most vitamin D — as much as 90% of what the body gets — is obtained through exposure to sunlight. And it doesn’t take much time in the sun to get sufficient amounts.

As medicine, vitamin D is used to prevent and treat rickets, which disfigures bones. It’s also used to treat weak bones (osteoporosis), bone pain (osteomalacia), bone loss in people with a condition called hyperparathyroidism and the inherited disease osteogenesis imperfect, in which the bones are especially brittle and easily broken. It’s also used to prevent falls and fractures in people at risk for osteoporosis, and to prevent low calcium and bone loss (renal osteodystrophy) in people with kidney failure.

Vitamin D might be prescribed for conditions of the heart and blood vessels, including high blood pressure and high cholesterol, and for diabetes, obesity, muscle weakness, multiple sclerosis, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), asthma, bronchitis, premenstrual syndrome (PMS), tooth and gum disease, some skin conditions and to boost the immune system.

But it’s far from a one-size-fits-all approach to preventive medicine.

Although some studies have shown a relationship between low levels of vitamin D and various disorders (higher risk of bone fractures, falls, heart disease, colorectal cancer, diabetes, depression and thinking problems), the scientists who evaluated studies for the USPSTF concluded that no direct evidence exists for universal screening as a way to reduce those risks.

"The effect of vitamin D levels on health outcomes is difficult to evaluate," the USPSTF statement says.

According to its report:


  • There is no consensus of what defines a vitamin D deficiency. Different professional societies set different minimum levels, from 20 to 30 nanograms per milliliter of blood.

  • Test results can be tricky to interpret because testing methods aren’t consistent; there is no internationally recognized standard.

  • Adequate levels might vary among ethnicities; African-Americans typically have lower levels, but it's unknown if the difference signifies a problem.


Tests aren’t cheap — they cost between $50 and $220. And the typical vitamin D dose generally is not dangerous. So because the vitamin itself is not expensive, some doctors believe it’s OK just to tell people to take supplements and not bother with a blood test. It’s vitamin insurance, not vitamin deficiency diagnosis.

Too much vitamin D can be unsafe. Some side effects of overdosing are weakness, fatigue, sleepiness, headache, loss of appetite, dry mouth, metallic taste, nausea, and vomiting.

Taking vitamin D for long periods of time in doses higher than 4000 units per day is possibly unsafe, according to the NIH, and might cause excessively high levels of calcium in the blood.

In 2010, the Institute of Medicine (IOM), another nonprofit research outfit that’s not an agency of government, issued a report acknowledging vitamin D’s vital role in bone health, but also said evidence was lacking that low levels of it cause disease. The IOM recommended that adults as old as 70 get 600 milligrams of vitamin D a day, and those who are older should get 800 milligrams.

Whether you should be tested for vitamin D levels should be a decision by you and your doctor. But if you’re generally well, if you don’t have an elevated risk of osteoporosis, it’s probably not necessary, at least on the current state of the evidence.

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December 14, 2014

New Guide for Imaging Tests Aims to Cut Harmful Unnecessary Scans

Regular readers of this blog know that imaging tests — X-rays and MRIs, for example — are frequently used when there’s no need, or when the need is questionable. The Joint Commission’s new campaign, Speak Up, includes guidelines for the use of these tests that should help patients understand when and why they are appropriate, or not.

The Joint Commission is an independent, nonprofit organization that accredits and certifies thousands of U.S. health-care organizations and programs. Its mission is to improve health care by evaluating health-care organizations and offering resources to enable them to provide safe, effective and appropriate care.

Medical imaging tests help diagnose problems and guide their treatment. But they’re not without risk — some involve radiation, some involve uncomfortable preparation, some carry a risk of infection or allergy. To view the Joint Commission’s graphic, link here. It explains the purpose of each imaging procedure — X-ray, ultrasound, computed tomography, magnetic resonance imaging and nuclear scan — what’s involved and the risks.

To learn more about imaging tests, link to our blogs here.

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December 10, 2014

New Labeling Rules for Pregnancy and Breastfeeding Products

The FDA has issued new regulations for prescription drug and medical product manufacturers to better communicate potential risks to women who are pregnant or breastfeeding, and people who are concerned about fertility.

The new rule, according to an FDA news release, “sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”

Lots of people have been waiting a long time for the new rules. As explained on AboutLawsuits.com, for years the feds have used a letter category system — A, B, C, D and X — to describe the risks of drugs and biological products to pregnant women and their doctors. But it was a clunky, insufficient explanation of what patients needed to know in order to make informed decisions.

So the final rule is more complete. Instead of letters, there are narrative sections covering drug and biological product labels, which are broken down into sections on pregnancy, lactation and reproductive potential for both females and males.

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations,” said Sandra Kweder in the news release. She’s deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk. The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

The subsection on pregnancy provides information about potential risks to a developing fetus, dosing information and information about pregnancy registries that might gather information on how the drug has affected pregnant women in the past.

Under lactation, there’s information about a drug’s potential effects on breast milk and children who drink it.

The fertility section concerns how a drug might affect contraception, fertility and pregnancy testing.

According to the FDA, there are more than 6 million pregnancies in the U.S. every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Women who have asthma, high blood pressure or other conditions before they get pregnant might need to continue using prescription drugs to treat those conditions, so they need to know the risks.

Women also might need medicine to treat new or acute conditions that occur during pregnancy or breastfeeding.

As explained on AboutLawsuits, the new rule will affect many drug labels, some of which the FDA and scientists have struggled to classify in terms of their potential pregnancy risks. In many cases, the risks are inconclusive, or yet to be determined. One goal of the new regulation is to illuminate the state of this research.

According to AboutLawsuits, pregnant women and their doctors have been concerned primarily with two classes of drugs — antidepressants, and epilepsy drugs.

Many antidepressants are in a class of medications called selective serotonin reuptake inhibitors (SSRIs). They include Zoloft, Paxil, Prozac, Celexa, and Lexapro. Antidepressant side effects have been associated with an increased risk of birth defects, miscarriage and problems in the children, such as asthma and autism.

But if a woman is depressed and pregnant, and doesn’t treat her mental disorder, the fetus can be at risk as well as the woman.

Antiseizure meds like Depakote and Topamax also might pose a risk of birth defects and developmental problems. But not taking those drugs if you need them puts both mother and developing fetus at physical risk if epilepsy is uncontrolled during pregnancy.

So doctors and patients must figure out whether or not to use these drugs, and if so, how much and for how long. Letter designations aren’t helpful in this analysis, but a summary of the current data or research might be.

One supporter of the new rule is the nonprofit organization MotherToBaby.org. It provides evidence-based information to mothers, health-care professionals and the public about medications and other exposures during pregnancy and while breastfeeding.

“There will be a steep learning curve for clinicians and patients to feel comfortable with more detailed information as opposed to the simple letter category,” said Christina Chambers, director of UC San Diego’s Center for the Promotion of Maternal Health and Infant Development, where the organization conducts pregnancy studies. “The MotherToBaby toll-free service can help.”

You can receive a personalized risk assessment of drugs or other exposures from MotherToBaby’s expert phone counseling service at (866) 626-6847. The organization also is conducting pregnancy research studies about asthma, autoimmune diseases and vaccines. To learn more or to volunteer for a study, call the number above or link to MotherToBaby.org and click on the “Research” tab.

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December 9, 2014

Patient Safety Journal Cleans Up After a Conflict-of-Interest Scandal

Early this year, the world of patient safety was rocked when conflicts of interest by one of its champions were exposed. The effects of the scandal continue to be felt, but also addressed.

In February, we told the story of Dr. Chuck Denham in our blog, “Apparent Conflict of Interest Sullies Panel of Patient Safety Experts,” and how, as a leader of the National Quality Forum (NQF), he faced charges of kickbacks after promoting hospital practices in which he had a financial interest.

Last month, the investigative news site ProPublica, in conjunction with NPR, called that incident "patient safety's first scandal," and detailed how it continues “to reverberate in the medical community, most recently in the current issue of the Journal of Patient Safety.”

The journal, we should make clear, is a peer-reviewed publication not to be confused with the newsletter of the same name, which has an excellent reputation, and which we read and refer to regularly.

Members of the journal’s editorial staff analyzed 10 of its articles written by Denham, who previously served as editor. They determined that nine had potential conflicts of interest, five of which he did not disclose. (Researchers who have any kind of relationship with any companies, materials, technologies or people involved in the study they are conducting are obliged to disclose such associations in any communications and/or papers they write pertaining to that work.)

In its review of Denham’s articles, the journal team concluded that although it's unlikely they resulted in patient harm, his work certainly did not enhance the publication’s credibility.

The Journal of Patient Safety was launched in 2005, but, according to ProPublica/NPR, had not adopted some of the conflict-of-interest standards of the International Council of Medical Journal Editors. But now, conflict-of-interest forms will be published with articles, and editors will publish disclosure statements and recuse themselves from decisions in which they might have conflicts.

Denham, who was not a practicing physician, but was considered to be a leader in patient safety as chairman of Texas Medical Institute of Technology (TMIT), a medical research organization. He also served as co-chairman of the NQF Safe Practices committee from 2006 to 2010. The National Qualify Forum reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care.

As ProPublica/NPR summarizes, Denham’s reputation took the initial hit when the U.S. Justice Department accused him of taking $11.6 million in kickbacks from CareFusion, which manufactures ChloraPrep, a surgical antiseptic. Denham wasn’t a party in the civil case, which the company settled for $40 million, but prosecutors alleged that he was paid to influence the NQF to endorse ChloraPrep.

Denham has denied the allegations. But he never disclosed that his company had been paid by CareFusion while he was advocating for ChloraPrep in NQF's Safe Practices committee.

Both the NQF and the Journal of Patient Safety have severed their relationship with Denham.

After Denham left the journal, a new editorial board was appointed. In their Denham article review, they said they were surprised when he was named editor in 2011, as there had been no formal search process and he lacked the strong resume of published academic articles most serious scientific publications demand for such positions.

The journal’s publisher, Wolters Kluwer Health, told ProPublica/NPR that Denham was appointed because he was a prominent member of the editorial board and that he had been recommended by the previous editor.

The Denham articles reviewed in the journal’s study had no direct references to ChloraPrep, but there were several references to the NQF's Safe Practices guidelines. That’s a potential conflict of interest because CareFusion could have benefitted from Denham's control of the guidelines, the editors concluded.

"This is a clear violation of the standards of the Journal," the editors wrote.

Making lemonade out of lemons, Dr. Albert Wu, the journal’s associate editor, told ProPublica/NPR that the Denham controversy would help the patient safety movement evolve by bringing to light the potential of industry to corrupt medical practice.

"We're now much more aware that we need to be more vigilant," Wu said.

Dr. Eric Campbell, a professor of medicine at Harvard Medical School, lauded the journal’s move to come clean, and said it would go a long way toward building trust.

We agree. As we often say, you can’t prevent every mistake, but you can do the right thing after it occurs.

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December 8, 2014

Feds Report Fewer Hospital Harms, but Still Too Many

A report issued last week by the U.S. Department of Health and Human Services (HHS) was a good news-bad news portrait of hospital care in America.

The report showed that between 2010 and 2013, 50,000 fewer patients died in hospitals and about $12 billion in health-care costs were saved as a result of reduced hospital-acquired conditions (HACs). The HHS report says that progress toward a safer health-care system reflects a better effort by hospitals to reduce the numbers of adverse events.

For a long time, hospitalized patients have been harmed by an unacceptably high rate of problems, including hospital-acquired infections (HAIs).

Patients can contract such infections, as we’ve explained in previous blogs, during surgery, from poor management of IVs and catheters and deficient hygiene by hospital staff. Improved safety, the feds say, has resulted in 1.3 million fewer harms overall to hospital patients.

An HHS official, as quoted by MedPageToday, said, “The 17% reduction ... indicates that hospitals have made very substantial progress in improving safety. We can't precisely determine causality but [the decrease] occurred during a concerted effort by hospitals to reduce adverse events. Financial incentives by payers, public reporting of results and technical assistance offered by quality improvement organizations ... all contributed to these impressive results."

The report reviewed as many as 33,000 medical records each year from the Inpatient Quality Reporting Program at the Centers for Medicare and Medicaid Services (CMS). The report’s improvements included:


  • a 19% drop in adverse drug events;

  • a 28% decline in catheter-associated urinary tract infections;

  • a 49% decrease in central line-associated bloodstream infections;

  • a 20% drop in pressure ulcers; and

  • an 18% decrease in postoperative venous thromboembolisms (blood clots).

The report acknowledged that although things have improved, no one should be satisfied. “The 2013 HAC rate of 121 HACs per 1,000 discharges means that almost 10 percent of hospitalized patients experienced one or more of the HACs we measured. That rate is still too high,” the authors wrote.

Examples of adverse events that could have and should have been avoided aren’t hard find. Last week, the Boston Globe reminded readers about the case of Betsy Lehman, a 39-year-old woman who had been undergoing breast cancer treatment at a prestigious Boston cancer center in 1994 and was administered four times as much of a chemotherapy drug as she was supposed to have. It killed her. The “adverse drug event” led to the creation of the Betsy Lehman Center for Patient Safety and Medical Error Reduction.

“But two decades later,” The Globe reported, “nearly one-quarter of Massachusetts residents say they, or someone close to them, experienced a mistake in their medical care during the past five years, according to a survey released Tuesday. And about half of those who reported a mistake said the error resulted in serious health consequences.”

Sadly, the survey of more than 1,200 people by the Harvard School of Public Health found that many respondents did not report the medical mistakes, “often because they did not believe it would do any good, or they did not know how to report it.”

Robert Blendon, the survey’s director, told The Globe, “When you are trying to reduce incidents, and 20 years later you still have a significant number of people who report a significant event, it sets off concerns.”

The poll was commissioned by the Lehman center. Its mission is to improve quality and reduce health-care costs. It’s an independent agency within the state’s Center for Health Information and Analysis, and is funded through fees assessed on hospitals and insurers.

Collecting patient safety and patient harm data is challenging. Most data collected and reported in Massachusetts regarding serious medical errors come from acute-care hospitals and surgical centers. Changes in how statistics are compiled make it hard to pinpoint whether patient safety has improved or not, according to The Globe.

That’s what prompted the Harvard survey as well as two others. A study by the National Academy for State Health Policy showed that although 26 states have systems to monitor adverse medical events, their number has not increased since 2007.

And although these systems can provide valuable information, defining overall trends in patient safety is limited, the newspaper explained, because most states haven’t integrated their monitoring systems into broader initiatives to improve quality and reduce medical costs.

So although we applaud what the federal government says is progress on the patient safety front, there’s still a long way to go before we even know the scope of the problem, much less how to fix it.

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December 7, 2014

Why Can’t You Talk to Your Radiologist? (And Why Sometimes You Should)

When a doctor sends a patient for an imaging test, it can take hours, days and sometimes weeks for the patient to hear the results from the doctor who ordered the test. That’s nerve-wracking. So why can’t patients get this information sooner, directly from the radiologist?

That’s what Dr. Jennifer Kemp, herself a radiologist, wanted to know when her husband had cancer and got scans every three months while they waited each time for the results.

“I couldn’t believe how anxiety-provoking it was to wait even an hour,” she told the New York Times. “Sometimes he would get a scan I didn’t feel comfortable interpreting and he had to spend 24 hours waiting — and I had connections. That was absolute torture.”

So she did something that should benefit all patients, not just those with medical profession connections. She’s heading a committee of the Radiological Society of North America whose mission is to make radiologists more accessible to patients. That means giving them test results immediately if they are requested. Kemp does it, and gives her patients and their doctors her direct telephone number.

Most of us have had X-rays, ultrasounds or MRIs, and lots of times, the only person you meet is the technician who puts you in the machine. The radiologist, the medical doctor who writes the formal interpretation of the study based on looking at all the images, usually sits in a dark room in the back, or even many miles away. The standard procedure, engraved in stone practically since Marie Curie discovered X-rays, is for the radiologist's report to go to the ordering doctor only, not to you the patient.

The Times reports that the American College of Radiology agrees with Kemp that patients now want to know how and why doctors make decisions about their care. The paper also says that an increasing number of medical facilities and doctors’ practices allow patients to access their medical records online, and such records often include imaging reports.

The move toward access is not about legally mandating radiologists to disclose information to patients, it’s about illuminating radiology practices that have done so successfully. It’s about practitioners informing their peers what patients want.

Still, as The Times points out, it doesn’t occur to a lot of people to ask to speak to a radiologist, and many referring doctors don’t seem to have a relationship with these specialists — they just give their patient a prescription for a scan and send them on their way. Some might recommend certain radiological facilities, but insurance coverage also figures into the choice of whom to use.

As always, some practitioners resist changing their ways. Some radiologists aren’t used to talking directly to patients, and can’t answer questions patients might logically ask after hearing the results of the scan. “A radiologist, despite an M.D. degree,” The Times explains, “cannot answer questions about drugs or surgery and without knowing the clinical history may not know if abnormalities are important. And would doctors even refer patients to a radiologist who blurts out a scan’s results?”

But many patients want to hear about their results, and with the exception of mammograms, how quickly that happens for an MRI, PET, CT or ultrasound, depends on the individuals — doctors and patients — involved.

Dr. Geraldine McGinty, chairwoman of the American College of Radiology’s commission on economics, told The Times that if a scan shows something really serious or unexpected, she tries to contact the referring doctor before telling the patient. “If this is not possible and the patient asks to speak directly with me, I’ll make the call to the other doctor as soon as possible, ideally before the patient leaves my office.”

Mammogram results usually are given to the patient right after the scan because the Mammography Quality Standards Act of 1992 requires women to get their results from the radiologist. The act says that if the scan suggests the patient needs a biopsy, the radiologist must discuss it face-to-face with her.

But many radiologists consider their jobs only to be working in dark isolation, reading scans and sending reports to referring doctors. Dr. Christopher Beaulieu, a radiologist at Stanford, told The Times that patients seldom ask to see their scans or talk to him or his colleagues. And if they do, “there is pushback” from radiologists and referring physicians.

Beaulieu says radiologists don’t have time to meet regularly with patients, and that they worry about having to deliver bad news. He also knows that some referring physicians, he said, “don’t want some radiologist telling them or their patients what is wrong or what to do.”

We understand that’s a difficult part of medicine, and that a radiologist isn’t qualified to address the typical “what’s next?” response a patient might have. But we believe that to demur from patient engagement is patronizing and dismissive, and communicating is part of the delivery of quality medical care.

As McGinty acknowledged, making radiologist-patient consultations routine requires a culture shift. That means radiologists and referring doctors need to establish their own relationships. It means radiology groups must perform some outreach, like posting videos depicting how radiologists should talk to doctors and patients.

If you are having an imaging test, and you want to discuss what the radiologist sees as soon as possible, tell your referring doctor that you want to know, and will ask the radiologist. Make your interests clear when you check in for the test. You also have the right to a copy of the scan, which often can be provided in an electronic format.

Usually, you won’t be able to see the radiologist in person, so ask to make a phone appointment. Otherwise, consider the approach of one source for The Times story. He has lung cancer and has had innumerable scans. At each imaging appointment, he asks for a copy of his scan.

Once, he wanted to discuss a scan report with the radiologist, but could never get the doctor to return his calls. “So I just went there,” he told The Times. “I found the guy’s office and walked in.”

“He seemed physically afraid of me,” he said, believing that the radiologist never saw patients, so, “his immediate reaction was to hit the panic button.”

But it’s your body, and it’s his job to talk to you about it.

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December 4, 2014

People Who Commit Medical Errors Still Don’t Get It

Knowing what is the right thing to do and research supporting the wisdom of doing it still haven’t moved a lot of practitioners who commit medical errors to respond as they should.

The results of a survey conducted by ProPublica, the consumer investigative news site, are pretty well summed up in its headline: “The Two Things That Rarely Happen After a Medical Mistake.” Patients, the story says, seldom are told or get an apology when they are harmed from medical care. Little wonder that they turn to a medical malpractice lawyer to try to figure out what happened.

The study examined responses of 236 patients who completed ProPublica's Patient Harm Questionnaire during a one-year period, and who agreed to share their experiences. The study was led by Dr. Marty Makary, professor of surgery at the Johns Hopkins University School of Medicine, and was published last month by the Journal of Patient Safety.

Why do we still have to report that this survey, like so many stories told in court when harmed patients seek redress for medical mistakes, showed that patients who suffer injuries, infections or mistakes during medical care rarely get an acknowledgment or apology?

Specifically:


  • It was common for health-care providers to withhold information about medical mistakes. Only 9 in 100 respondents said the medical facility voluntarily disclosed the harm.

  • When officials did disclose harm, often it was because they were forced to. Nine in 100 respondents said the harm was acknowledged only under pressure.

  • Apologies were infrequent. Only 11 in 100 patients or their family members reported getting an apology from a provider.

  • More than 3 in 10 reported paying bills related to the harm. The average cost: $14,024.


According to ProPublica, another study in the Journal of Patient Safety estimated that at least 210,000 and maybe as many as 440,000 U.S. hospital patients a year die from medical mistakes. (See our blog, “Protecting Yourself from the Thousand-a-Day Toll of Medical Error.”)

The researchers for the more recent survey suggested that clinicians might see the need to be more honest with patients about the adverse effects of their treatment, but might lack the “moral courage” to do it. As we’ve blogged repeatedly, such acknowledgments go a long way toward heading off litigation and improving patient care.

The researchers said that patient advocates and providers should work together on how to best inform patients, and that medical schools and training programs can introduce the needed skills. Again. This is not a new prescription for correction, so why isn’t the message getting through?

Because the study’s findings come from a self-selected sample of patients, it can’t be considered hard science from which definitive conclusions about patient harm or disclosure can be made. But, really, isn’t there just a whole lot of common sense here?

To share your story about being harmed by medical care, fill out the questionnaire on the ProPublica site, and also consult the Safe Patient project sponsored by Consumers Union.

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December 2, 2014

Warning Against Uterine Fibroid Treatment Is Strengthened

Last week, the FDA updated its warning from earlier this year about the cancer-spreading danger of a surgical procedure to treat uterine fibroids. For most women, the feds now say, power morcellation should not be performed.

Our blog, “FDA Warns of Cancer Risk with Uterine Procedure,” described morcellation, which involves a tool that cuts or grinds tissue into tiny pieces so they can be extracted through a small incision. It can spray bits of uterine tissue or fibroids around the surgical cavity.

The main concern now is that morcellation can spread cancer cells, turning a small hidden cancer from totally treatable and survivable into a killer spread throughout the lower abdomen.

The FDA’s order expanded the contraindications for power morcellation to gynecologic surgery patients with known or suspected malignancy, and to peri- and postmenopausal women seeking treatment for fibroids. It also imposed a so-called “black box” warning on the devices' labels.

The warning, the most extreme type the FDA issues, states that "uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices."

It’s stronger than the earlier advisory that the FDA "discourages the use of the devices during treatment for uterine fibroids.” Since April, when it was issued, many hospitals have stopped doing morcellation procedures, and many insurers won’t cover it.

Although it still might be appropriate for some women, the FDA recommends that women requiring a uterine procedure:


  • Discuss with your health-care provider all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.

  • If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him or her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.

  • If you have undergone a hysterectomy or myomectomy for fibroids, the tissue removed generally is tested for the presence of cancer. If your tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health-care provider.

  • Consider other surgical options, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy (smaller incision than open surgery) and myomectomy without morcellation. All treatments carry risk, and you should discuss them thoroughly with your health care provider.


To read the whole alert, link here. To report an adverse event with morcellation (or any other medical procedure), link to the FDA’s MedWatch program here.

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December 1, 2014

Cost of Cancer Rises as Private Oncologists Affiliate with Hospitals

What if your doctor's office changed the sign on the door, and nothing else about it, except the price of care suddenly doubled? You'd be in the strange new world of cancer treatment.

Insurance companies are reducing reimbursements to oncologists, and the drugs they use for treatment are increasingly expensive. The only way many of these doctors can continue to treat their cancer patients is to sell their practices to a hospital system. But that doesn’t mean cancer treatment is business as usual — it means the same treatment is more expensive.

A story last week in the New York Times told the stories of oncologists who said they were forced into selling their practices because they couldn’t maintain a viable business receiving lower fees while the drugs they buy and sell to patients cost more.

The paper cites figures provided by the Community Oncology Alliance Practices, an advocacy outfit. Since 2008, of the nation’s 1,447 independent oncology practices, 544 were purchased by or entered contractual relationships with hospitals, 313 closed and 395 reported being in financial distress.

When cancer patients move from private to hospital care, “Because of quirks in the payment system,” The Times said, “patients and their insurers pay hospitals and their doctors about twice what they pay independent oncologists for administering cancer treatments.”

Dr. Barry Brooks, one source for The Times story who practices privately in Dallas, explained what’s happening in oncology like this: “Say there was a Costco that had very good things at reasonable prices. Then a Neiman Marcus comes in and changes the sign on the door and starts billing twice as much for the same things.”

The Times said cancer treatment is different from that of other diseases because of unique systems of reimbursement that include what drugs patients may get, and where they’re treated. As we wrote in our, “Calling Out the Corruption in Medical Care,” such systems invite conflicts of interest and put doctors in the position of making treatment decisions based not on what’s best for an individual patient, but on whether and how much he or she will be reimbursed.

Some observers say the Affordable Care Act (ACA) has accelerated private practice sales to hospitals because many people bought relatively spare Obamacare insurance plans that don’t cover the expensive cancer care they need. So doctors, who buy cancer drugs in advance, face budget problems when their patients can’t pay, and the overhead is crushing.

Doctors in private practice often send uninsured and Medicare patients to hospitals for their chemotherapy, and keep them as patients for office visits. As one such practitioner said to The Times, “The disgrace is that we have to treat people differently depending on how much money they’ve got. That we do diminishes me.”

Unlike other doctors, oncologists maintain a wide stock of drugs in their offices, and if the patient requiring one dies or can’t pay, the doctor takes the loss. “That used to be acceptable because insurers paid doctors at least twice the wholesale price of drugs,” The Times explained. “Now doctors are reimbursed for the average cost of the drug plus 4.3%, there are more and more drugs to stock, and drugs cost more.”

For private practitioners, the sale of chemotherapy drugs no longer generates impressive income, but it does for hospitals. They get higher reimbursement for administering drugs, deeper discounts for buying large quantities and many take advantage of the federal program that compensates research hospitals and hospitals serving poor people.

The ACA also requires documentation of efficiencies in medical care that some private practice doctors find onerous and time consuming. If they consolidate with a hospital, the drug purchases and paperwork are someone else’s problem.

Medical centers, of course, tout the advantages of this changing business model. An executive with the American Hospital Association told The Times that patients get tests such as CT scans and MRIs, lab work and pharmacy services all in one place. The convenience, and the facilities’ 24-hour care for everybody, including uninsured and underinsured people, justify the higher fees, he said.

Hospitals really want cancer patients, of course, because they use lots of hospital services. They generate a lot of revenue. But as these patients move from private suite to large medical center, the treatment is less personal and often less efficient. As The Times stated bleakly, “The private practice oncologist is becoming a vanishing breed, driven away by the changing economics of cancer medicine.”

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November 30, 2014

Acing the Health Insurance Test

The second enrollment period for the federal and state insurance exchanges under Obamacare is well underway, and many people also renew or switch job-based insurance plans this time of year. But for a lot of people who must make important coverage decisions, many policy terms might as well be written in Swahili.

The Kaiser Family Foundation (KFF) is a nonprofit outfit that researches health issues and studies health policy, and is affiliated with the Kaiser Health News information service. It has no relationship to the Kaiser Permanente HMO. In advance of this year’s autumn insurance enrollment period, it conducted a national survey of nearly 1,300 adults to see how well Americans understood basic health insurance terms and concepts.

On the whole survey, 52 in 100 respondents got 7 of the 10 questions right, but only 4 in 100 scored a perfect 10.

Six of the questions were relatively easy — 2 in 3 respondents got them right. About 3 in 4 could correctly identify the terms “premium,” “provider network” and “annual deductible.” About 2 in 3 knew what was meant by “annual out-of-pocket limit,” and that if an insurer refuses to pay for a medically recommended service, the insured has the right to appeal.

Health-care literacy involves math, and respondents struggled with the question about out-of-pocket costs (about half got it right). The survey also asked respondents to calculate how much an insured patient would have to pay for a four-day hospital stay with a certain deductible and co-pay, and the amount they’d have to pay for an out-of-network lab test. Only 16 in 100 correctly calculated that last request.

Nearly 3 in 10 respondents correctly answered four or fewer questions, and 8 in 100 got no answers right.

Certain terms were widely misunderstood, including “health insurance formulary” — 1 in 3 got it right, and more than half said they didn’t know. Other gaps highlighted by the KFF survey concerned individual doctors’ care for an in-network hospital stay.

You can test your health-insurance knowledge by taking the quiz here. To read the whole survey report, link here. And for a health insurance glossary of terms, link here.

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