DC Medical Malpractice & Patient Safety Blog

When Congress authorized creation of the Sentinel Initiative in 2007, it was concrete acknowledgment that the failure to follow up on the performance of medical devices recently approved by the FDA was compromising patient safety.

Five years later, medical device followup is still a work in progress, and there’s no reason it can’t be moving along at a friskier pace. In a commentary published in the New England Journal of Medicine, Dr. Robert G. Hauser submits that “patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration … despite multiple recalls and some tragic adverse events.”

He cites one particular case involving an implantable cardioverter-debrillator (ICD) that has been implanted in 79,000 heart patients in the U.S. alone. ICDs are used to treat sudden cardiac arrest with a shock, or electrical impulse, via a small device implanted near the heart. But it’s hardly the only “livesaving” device that can put life at risk.

Hauser names two other ICD components used by more than 350,000 patients that might cause problems that, with a bit of foresight, could be consigned to irrelevance. He asks: “Why are we placing patients at risk when the tools and technology are available to monitor vital medical devices such as ICDs, heart valves and coronary stents? The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed. Consequently, we repeatedly find ourselves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence.”

We need to collect more data, he says, in order to:
1. identify adverse events even if they’re infrequent and;
2. review information as it pertains to certain patient groups.

That means using existing clinical registries and remote monitoring databases to improve surveillance of medical devices. Data should be collected on an ongoing basis, and compared with established medical products that have been shown to be reliable. The point is to detect problems early and collect information to guide patient care toward best practice. “[M]anufacturers,” Hauser writes, “should conduct postmarketing studies of this type for marketed … devices that sustain or support life.”

Seems like a no-brainer, as the creation of the Sentinel Initiatives reflects. It’s supposed to augment the current after-the-fact process of reporting adverse events by implementing a real-time network that’s faster and more efficient, and capable of spreading the word to health-care providers and the public.

The Sentinel Initiative’s ambitious reach is to collect electronic health data from 100 million people by the end of this year. The initiative must set priorities, develop tools to analyze the data and design a public-alert procedure when a safety signal is detected. Hauser says we’re years away from a fully operational Sentinel network.

More than 150,000 U.S. patients rely on lifesaving medical devices, Hauser says, and he wants professional organizations, the medical device industry and the FDA to muster the resources now to improve their surveillance once they’re on the market. We’d add that a rising chorus of patient voices could boost this sense of urgency.

If you think tracking the usefulness and safety of medical devices long after their hosts have been released from the hospital isn’t happening fast enough, make your feelings known to your congressional representatives and to the FDA by linking here.

If you’re interested in the specific projects being reviewed by the Sentinel Initiative at any given time, link here.

File this story under: exporting your problems.

That’s what Johnson & Johnson did after the FDA said the company wasn’t allowed to market its artificial hip in the U.S. because J&J’s own studies showed the device was unsafe.

As recounted in the New York Times, not only did J&J pawn its questionable product off on Europeans, it continued to sell a related model in the U.S. that had been made available temporarily only because of a regulatory loophole enabling it to escape the scrutiny of a safety review. In December 2010, The Times called that device “[o]ne of the most troubled orthopedic implants of the past decade.”

It’s not known how many people overseas got the banished replacement hip after the FDA failed to approve it in 2009, nor how many U.S. patients got the similar implant. The two were on the market for eight years and implanted in about 93,000 patients worldwide; about one-third of them were in the U.S.

The problem for both models was the all-metal hip socket cup. These components have long been problematic, and we’ve written about them before, most recently here and here.

Citing declining sales, the DePuy orthopedic division of Johnson & Johnson began phasing out the “articular surface replacement” device known as ASR in November 2009. They were recalled formally in August 2010 because of high failure rates much earlier than their purported 15-year lifespan.

Generally, regulatory standards in other countries for approving the sale of medical devices are lower than here, so there’s no claim that Johnson & Johnson broke the law. And Britain’s Medicines and Healthcare Products Regulatory Agency told The Times that companies were not required to notify it when the FDA failed to approve a product for U.S. consumption that was used in patients there.

But what’s legal and what’s moral aren’t always the same.

But maybe J&J’s squishy moral standards are coming home to roost. As noted by The Times, the FDA rejection may exacerbate the company’s legal and financial problems surrounding the ASR. In January, J&J took a special $3 billion charge, largely to address anticipated legal and medical expenses associated with the recall. Thousands of lawsuits involving the device are pending, including some from patients crippled by metallosis, a form of poisoning by implants shedding metallic debris.

And let’s not forget that, before the recall, when complaints about the ASR were building, DePuy defended it by claiming that any failures were those of the surgeons, who didn’t properly implant the hip cup. So here we have a company that can’t cop to its own shortcomings, and, worse, ships them overseas in hopes nobody notices.

The lack of transparency in medical device approval remains a real threat to patient safety. The FDA’s process is confidential, a practice it justifies because it might include proprietary business information. But when it comes to developing a product that creates so much harm, is this a business model anyone would replicate?

A recent series of articles published in the New England Journal of Medicine (NEJM) presented a less than clear picture of colon cancer screening. Gary Schwitzer, writing on HealthNewsReview.org took on the muddled message offered by the science journal, and the popular media’s woeful effort to offer context and meaningful advice to consumers. We’ve tackled the topic before as well.

Here's the latest advice from our Better Health Care newsletter on how to sort out your colon cancer screening options.

As Schwitzer notes, one NEJM study championed the benefits of colonoscopy screening, one trumpeted the potential benefits of a blood stool testing procedure called Fecal Immunochemical Testing (FIT) and an editorial pondered both.

Readers interested in seeing how medical journalism grapples with material that requires some depth might enjoy HealthNewsReview’s explanation of who went right, who went wrong and who is wandering around in the middle. But if you’re looking for the best, most concise information to enable you to take care of yourself, Schwitzer, a widely respected health news analyst, points to the Reuters coverage. We agree.

Its take-away message, gleaned from the NEJM editorial and explained with additional interviews, was that the best colon-health practice appeared to be colonoscopy screening for everyone who’s 60. The results would tell you if you're high risk or low risk. High risk people get regular colon follow-ups; everybody else stops worrying.

Here’s how a competent report helps readers objectively judge the information: Reuters was the only news organization that quoted the FIT researchers about their study as much as it allowed the colonoscopy researchers to tout their work. According to the FIT researchers, “the numbers of subjects who needed to be screened to find one colorectal cancer were 191 in the colonoscopy group and 281 in the FIT group, and the numbers who needed to be screened to find any advanced (cancer) were 10 and 36.”

This simple numerical analysis reflects a larger discussion we had in a recent edition of our patient safety newsletter about a concept called “numbers needed to treat”.

As Reuters notes, such objective qualities are important because the FIT test is much less expensive than a colonoscopy. “This simple, noninvasive and cheap test is equally good at detecting colorectal cancer and identifying the high-risk individual that should undergo a colonoscopy.”

Reuters also explained that the complication rate—bleeding, low blood pressure and slow heartbeat—was nearly five times higher in the colonoscopy group.

And just as important is the percentage of patients who follow the advice to get one or the other screening techniques. In both screening tests, the follow-through rate is low -- understandably, because the tests are bothersome and unpleasant at a minimum. But the FIT test was more popular than colonoscopy -- one in three patients went ahead and got the FIT test while only one in four got a colonoscopy.

Schwitzer’s report included further analysis from Harold DeMonaco, director of the Innovation Support Center at Massachusetts General Hospital. Of particular note for people considering colonoscopy or other colon diagnostic measures, he said:

• Early detection and removal of adenomatous polyps (benign tissue with the potential to become malignant) appears to reduce the risk of colon cancer. A considerable minority of adults will have adenomatous polyps on colonoscopy, including as many as 1 in 4 males.


• Colon cancer grows slowly. Good followup for people who have had an adenomatous polyp removed appears to reduce the risk of dying from colon cancer over several decades of observation.


• FIT appears to be as useful as a screening tool for colon cancer, but it’s not as good in detecting existing adenomatous polyps.


• FIT is easier, much less expensive and does not have the rare but important potential complications associated with colonoscopy.


• The right combination of colonoscopy and FIT remains unclear, as does the role of CT colonoscopy.

If a conclusive approach to colon polyps screening remains elusive, at least some things are clearer, and patients can make more informed choices.


Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Cancer , Testing

For a long time, Primatene Mist was the go-to relief for asthma sufferers in the midst of an attack. Known as one of many “rescue inhalers,” Primatene was used during critical moments to deliver epinephrine that opened airways and enabled breathing.

But as of this year, Primatene, the only asthma inhaler that was available over-the-counter, was taken off the market.

The problem wasn’t Primatene’s drug safety or efficiency; it was the adverse effects its spray propellant had on the ozone layer. After its departure, many asthma patients felt cast adrift from the only relief they could get without a prescription. According to a story in the Los Angeles Times, lung doctors and asthma specialists said Primatene wasn’t a good option for asthma patients anyway.

Asthma, these experts believe, is controlled more effectively with prescription medication than any over-the-counter product. "Primatene Mist does not treat asthma — it treats symptoms that can come from asthma," Dr. Kyle Hogarth, medical director of the pulmonary rehabilitation program at the University of Chicago Medical Center, told the L.A. Times.

He said that treating only the symptoms of asthma ignores the fact that repeated attacks can damage the lungs permanently. So the best asthma care prevents attacks, it doesn’t just react to them. That requires daily medication, such as inhaled corticosteroids, which prevent inflammation in the airways. The use of rescue inhalers, Hogarth said, should be limited to twice weekly.

Some asthma patients use prescription inhalers whose active ingredient is albuterol instead of epinephrine, and is delivered via a different propellant. Like Primatene Mist, they're used at the onset of an attack only to relieve symptoms. But they require more priming, have a different cleaning regimen, taste different and offer a less powerful puff.

Armstrong Pharmaceuticals, which manufactures Primatene Mist, is developing its product with the more environmentally friendly propellant, but it will continue to use epinephrine as the active ingredient.

But what if you’re one of the estimated 3 million Primatene users who aren’t sure now what to do, especially if you lack insurance coverage or the financial means to get the more expensive prescription drugs?

Community health centers often have sliding-scale payment options for patients requiring diagnosis, treatment and follow-up care. Your doctor and pharmacist are resources for medication assistance as well, and you can find prescription drug coupons online if you search by the drug or manufacturer’s name. Large retailers such as Wal-Mart and Costco often offer deep drug discounts.

Many pharmaceutical companies also offer patient assistance programs. For more information about asthma and medication assistance programs, contact:

• the Allergy and Asthma Network/Mothers of Asthmatics;


• Partnership for Prescription Assistance, (888) 477-2669;


• RxHope[www.rxhope.com], (877) 267-0517.



Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Medications

Red Bull. Rockstar. Monster.

They could be the names of ultimate fighters or black diamond ski runs, but as any American not living off the grid knows, they are the names of energy drinks, a food category that exploded into consumer consciousness in the late 1990s.

Basically, whether marketed as food or dietary supplements, they all sell caffeine. And while caffeine in moderation isn’t harmful for most people, there’s little guidance about the quantity of caffeine—which some sources define as a drug, others as a food additive and others as a stimulant chemical found in plants—in these drinks. There’s also a paucity of information about other ingredients in these drinks.

As noted in a recent story on NPR, there’s no consensus on exactly what an “energy drink” is. Today, you find canned coffee, tea and even fruit juice spiked with extra caffeine. There’s little research about their effects.

One researcher for the Center on Young Adult Health and Development at the University of Maryland School of Public Health called for better labeling of these products in an article published in the Journal of the American Medical Association (JAMA) titled “The ‘High’ Risk of Energy Drinks.”

The American Beverage Association drafted guidelines for energy drinks, but it’s up to manufacturers to include them on product labels. The guidelines call for caffeine quantity, warnings about mixing drinks with alcohol and noting that they are not intended to be consumed by children, pregnant or nursing women or people who are sensitive to caffeine. A few years ago, we wrote about energy drinks being linked to heart problems.

Still, what is an energy drink? According to Susan Carlson of the FDA’s Office of Food Additive Safety, “They range all over the place, from products that have probably no caffeine to products that do have caffeine and products that have ingredients that may contain caffeine. But there is no regulatory definition for energy drinks, per se.”

Regardless of whether an energy drink calls itself a food or a dietary supplement, the FDA has no regulatory limits for caffeine content. Those apply only to cola drinks. Red Bull has about twice as much caffeine per can than Coke.

By law, the FDA has the right to question a manufacturer's use of an ingredient and its safe use of an ingredient. The agency is concerned about conventional foods being marketed as dietary supplements, and, Carlson told NPR, it has taken public comment to draft industry guidelines.

If you’re sensitive to caffeine, or simply like to be informed about the contents of manufactured food products before you consume them, make your feelings about energy drinks known to the FDA.

In addition, visit product websites, where more information might be forthcoming. If not, let manufacturers know that you’re not likely to purchase their product unless you know what’s in it.

Now that even Minute Maid has introduced juice “enhanced” with caffeine, the energy drink craze really deserves scrutiny.

A recent post on ABC News about an alleged medical misadventure made many readers shudder.

It was the story of a Wall Street billionaire who claimed his doctors told him for a year he had meningitis that turned out to be cancer. Of course, the sooner you diagnose cancer, the better your chances of survival.

We’ve addressed misdiagnoses, and what to do if you think it’s happening to you.

The fear of misdiagnosis is real, and although patients often feel helpless in protecting against it—after all, aren’t medical professionals in the best position to determine what’s wrong?—patients can and should exercise oversight, whether they’re billionaires who can afford the best treatment, or people who barely can afford to pay attention.

One doctor quoted in the ABC story perfectly crystallized the situation: Health care, he said, “is provided by people, to people. So, without taking the human beings out of the system, you're never going to get perfection.”

But pay attention you should, and writing on KevinMd.com, Evan Falchuk of Best Doctors, which advises companies about securing superior care for their workers, offers ways to reduce the chance of a misdiagnosis.

1. Know your family history and remind your doctor of it. Because family history is important in handicapping your chances of contracting certain diseases, learn your family’s medical history, and write it down (here’s a useful tool for doing so, provided by the Health and Human Services Department). Make sure your doctor knows about it—especially if you’re sick and they’re trying to decide what’s wrong.

2. Ask questions. A doctor might see 40 patients a day, spending only minutes with each. But asking questions won’t just make you feel more comfortable, it can disrupt your doctor’s thought process and make him or her think about your case in a new way that may save your life. Write your questions down in advance of your visit. Here, too, the HHS has advice about questions you should ask.

3. Don’t assume technology will save you. Technology is wonderful, but it’s not magic. “If I had to pick,” Falchuk writes, “between getting a high-tech test and a doctor who will spend an hour talking to me thinking about my case and putting all of the pieces together, the research says I should pick the doctor.”

4. Don’t always trust the tests. Readers of this blog will have heard this before. Tests can be wrong, they can signal less a diagnostic priority than a care provider’s insecurity, and they require judgment and experience to interpret.

5. Get a second opinion. A proper second opinion requires that the doctor look at your case from scratch—to hear you talk about your symptoms in your own words, and to assess your case without being influenced by the conclusions of your original doctor. Don’t offer the original doctor’s opinion; instead, describe your symptoms, explain your family history, the tests you’ve had done and help the doctor reach independent conclusions about what’s wrong with you.

We devoted an issue of our Better Health Care newsletter to the subject of getting to the right diagnosis. You can read it here.

The epidemic of overtreatment in U.S. health care is figuring ever more prominently into public policy and private care. We’ve repeatedly discussed how this country medically defaults toward testing, screening, prescribing and treating. We’ve shown how such “over care” isn’t the best practice, nor does it necessarily extend lives or reduce suffering.

A recent post on KevinMd.com perfectly illustrates this point, and makes another abundantly clear: the value of second opinions. Although some practitioners, patients and insurers question the wisdom of getting a second opinion, for serious or complicated diagnoses and procedures, clearly they save time, money and, sometimes, lives.

Writer Rosemary Gibson, author of “The Treatment Trap” and “Wall of Silence: The Untold Story of the Medical Mistakes that Kill and Injure Millions of Americans,” recounts an interview with a former employee benefits executive for a Fortune 100 company. Although his company’s routine second-opinion policy seems expensive and protracted, here are some of the benefits it reaped:

• cases in which transplants were recommended for people who were going to die soon from cancer whether the transplant was done or not;


• a hospital recommended a heart-lung transplant, but when the patient visited the Mayo Clinic (at the company’s expense) for a second opinion, it was discovered that neither transplant surgery was indicated;


• an employee was told he needed a heart transplant, and the surgeon said the patient shouldn’t fly anywhere for a second opinion in his condition. But the employee had flown to see that surgeon. He flew, at company expense, to Mayo, where the second opinion was a small blockage. It was treated successfully with a stent.

Four in 10 of the organ transplants that had been recommended for employees were found not to be medically necessary or appropriate after the company flew them to the Mayo Clinic.

These patients were spared extensive, invasive, prolonged treatment. The company maximized its human resources and everyone saved money.

As Gibson writes, “So far, the work to shine a light on overtreatment is compelling.” She refers interested parties—patients, their caregivers, practitioners and insurers—to the “Top Five” good practices in several medical specialties developed by the National Physicians Alliance.

Wise choices are integral, she says, to medical professionalism. “We need to get to the high hanging fruit where real and immediate harm is occurring,” she writes.

Sometimes the wisest choice is doing more by doing less.

We gave some good advice for getting second opinions in a recent issue of our Better Health Care newsletter. We explained why many of us, even medically sophisticated consumers, hesitate to get second opinions. We discussed the multiple ways second opinions are helpful, even when they result in confirmation that the original plan was a good one. And we described ways to make the second opinion consultation more productive.

Most of the time when a doctor prescribes care for a hospital patient, it involves tests, drugs and other medical interventions. But one physician, self-identified as the Happy Hospitalist, has some decidedly less clinical advice for hospital patients and their loved ones.

Hospitalists are physicians who care only for inpatients; generally, they do not have a private patient practice. We’ve written about this medical specialty before, and although their reviews are mixed, hospitalists are in a unique position to provide perspective about the culture of a hospital.

Courtesy of KevinMd.com, herewith are some of HH’s tips for minimizing the trauma and discomfort of being in the hospital.

• Request a hospitalist. They get you out quicker and less sick (which doesn’t necessarily mean healthy).


• Bring an accurate, current medication list with you. You’re vulnerable to hospital errors if your doctor gave you medication you haven’t taken in months or if you miss medications that haven’t been updated in who knows how long.


• Write down all your questions in advance. Your doctor visits your room only once a day (Medicare pays only for daily visits), so unanswered questions must wait until the following day.


• Be patient. No one knows when tests are scheduled to be performed, not even the doctor doing the procedure.


• You’ll be told things that contradict each other multiple times a day. That’s normal among doctors and nurses with their own perspective and experience. There is no right answer to many of your questions. Choose the answer that makes you feel the best, and believe it.


• When you are admitted, request the highest hospital floor for your room. Most doctors take the elevator to the top and work their way down during rounds. If you don’t want to be last patient seen on rounds, try to be at the top.


• Bring a laptop computer or request one from the hospital. Hospitals all have free wireless these days and some provide a laptop if you ask.


• Bring your own pillow!

So much about the health insurance industry is wrong, so much compromises good care and patient safety, that when an underwriter makes the right decision it deserves attention.

WellPoint Inc., according to a recent AP story, plans to boost primary care reimbursement and initiate payment for care management, a patient-protective practice it previously did not cover. The bottom line should be that patients with WellPoint plans will get more quality time with their doctors.

The WellPoint plan will debut later this year and should be implemented throughout its primary care network by the end of 2014.

Primary care practices often receive such low insurance reimbursements that they’re forced to jam as many patient visits as possible into a workday simply to stay financially afloat. We’ve detailed the plight of primary care practitioners, as well as the value of coordinated care.

Care management includes practices such as preparing care plans for people with complex medical problems. It includes simpler practices as well, such as developing an exercise plan for overweight patients, and following up to ensure adherence to it. Care management is a matter of enabling providers to work for patients all along the health continuum instead of addressing only acute needs, of treating people only when they’re sick.

Spending more time with patients facilitates communication, and when patients and doctors communicate well, outcomes improve.

Best practices like these aren’t just about altruism, they’re about saving money, and WellPoint will offer doctors a share in some of the savings realized when better care results in lower costs. Wellpoint officials said the reformulated payments and coverage should reduce some of the most expensive medical care, such as emergency room visits and hospital admissions.

Similar efforts are underway elsewhere in the health-care industry.

Accountable care organizations (ACOs) are becoming more popular as coordinators of care among multiple providers that reduce redundant testing and minimize medical errors. ACOs also afford professional participants a piece of the savings pie.

Insurers are examining the notion of patient-centered medical homes, which are similar to ACOs but focus more on individual practices. Primary care doctors monitor patients between visits and serve as the nexus of communication among specialists and ancillary caregivers, such as nutritionists and physical therapists.

WellPoint has tested the medical home concept and reported that such programs resulted in an 18 percent decrease in hospital admissions and 15 percent decrease in emergency room visits. The company’s new primary care reimbursement plan, AP reported, plans to build on those pilot programs.

Well done, WellPoint. But the effort will have to be embraced by all other insurers in order to become the cultural norm instead of a curiosity.

Electronic health records (EHRs) hold much promise for reducing medical errors and improving quality of care, but the prospect that patient advocates can use EHRs to do an autopsy of where a patient's care went wrong has some in the medical industry sounding an alarm.

Last week a story (actually a press release, on closer scrutiny) in the Wall Street Journal's Market Watch talked about "Crippling Access to Physician's Actions" allowed by tattle-tale Electronic Health Records. Among the horrors described by IT consultant Dr. Sam Bierbock:

EHRs ... can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

And this is a bad thing?

Fortunately there are patient advocates in the medical informatics industry. One is Scot Silverstein, MD, of Drexel University, who trained as a doctor in intensive care units, which have heavy demands for up-to-the-second monitoring information on the desperately ill patients they care for. Dr. Silverstein wrote a well-informed blog post on the real problems with EHRs and why it won't wash to make plaintiff attorneys and malpractice lawsuits the whipping boy for the industry's troubles.

Our firm represented a patient's family last year in a particularly tragic malpractice case where we used the hospital's "audit trial" of EHR records to show that a nurse was claiming to be in two places at one time. Her neglect led to the stillbirth of our family's child.

The alarm of IT consultants like Dr. Bierbock over the ease of auditing health care brought about by EHR's is really a false alarm. Yes, there will be closer scrutiny of medical decisions. But audit trails will lead to more accurate understanding of what happened in any tragic injury, and that should lead to better care for all.

First published on Technorati.

A rare verdict for punitive damages and fraud against a Florida hospital opens a window on the big business aspects of weight loss surgery, which can be unsafe for patients especially when the surgeon lacks experience. The verdict also has lessons for how patients can protect themselves.

A jury in Jacksonville ordered Memorial Hospital to pay $10 million in punitive damages for what amounted to false advertising about its weight loss surgery "Center of Excellence" designation. The same jury said that Clay Chandler, a county deputy sheriff, should be paid $168 million in compensatory damages for brain damage that happened to him as a result of uncorrected leakage in his abdomen after a weight loss procedure in 2007 with surgeon John DePeri, MD.

DePeri, testimony revealed, had performed at most 21 bariatric surgeries before he operated on deputy Chandler. To meet the standards of the American Society Bariatric Surgery’s Center of Excellence seal, he was required to have performed 50 and to have completed at least 20 hours of bariatric education courses. He had taken one.

Memorial Hospital used that accreditation seal in pamphlets given to potential surgery patients of its Bariatric Surgery Center. The seal also was featured on documents DePeri used when speaking at informational forums at the hospital.

The jury found that use to be fraud. It said that the hospital knowingly allowed DePeri to perform paid surgeries for which he was not accredited.

The malpractice verdict was reported by the Florida Times Union.

Chandler is now brain damaged and confined to a wheelchair. The day after his surgery in 2007, Chandler was placed into critical care with respiratory failure and signs of fluid leakage into his abdomen. Eight days later DePeri operated to repair the leak. Even the hospital’s own expert witness testified that most doctors would have addressed the complication much earlier.

It was too late for Chandler, who suffered a stroke and was comatose for more than two weeks. He also suffered a permanent loss of eyesight from a burned retina because he was not given the basic care of lubricating eye drops while he was on the respirator.

The damage to Chandler, said his attorney, Tom Edwards, “occurred because you had a relatively inexperienced doctor doing this surgery and managing the patient.”

DePeri has since been accredited by the bariatric surgeons' program. But it's too late for patient Chandler.

What are the lessons for other patients who want to prevent this from happening to them?

In this case, deputy Chandler would have had to do a fair amount of research to find the 50-case minimum standard of the bariatric surgeons. If he did, of course, he could have asked Dr. DePeri up front how many he had done, and DePeri presumably would have told the truth.

But even without that level of research, here are the kinds of questions any patient can --and should-- ask any surgeon, as I explained in a recent issue of my firm's Better Health Care newsletter, on the topic: Talking to Your Surgeon: What You Need to Ask.

"Is there anyone at your institution (in your partnership, in my town, etc.) who does these procedures more than you do? If so, would you mind if I speak to him or her?" (A defensive response to this question is a red flag.)

Another question that gets at the experience issue:

"Who would you ask to do the operation on a close family member of yours if you couldn't?"

Surgical volume is important to hone a doctor's skills in the operating room. It's the old idea that practice makes perfect. But with bariatric surgery in particular, one of the key issues is being able to quickly recognize and correct surgical complications afterwards. That is where Dr. DePeri fell down, with the long delay in returning his patient to the OR. Leaks themselves happen sometimes with this surgery, even in the best of hands; it's the response that is key to a good outcome for the patient.

Surgical volume is also important for the hospital, because the more nurses and other caregivers have seen patients just like you, the more equipped they are to make sure the post-op recovery period goes smoothly.

See our newsletter for more important questions up front for your surgeon. I called this issue of the Patrick Malone patient newsletter: "When a Conversation Can Save a Life." The Florida story shows how true that is.

All medications carry risks and potential side effects, but seldom does a pill do precisely the opposite of what it promises.

That’s why Pfizer recalled about 1 million Lo/Orval-28 and generic norgestrel birth control pills. Thanks to a packaging error, women who are taking the contraceptive risk getting pregnant.

As widely reported, the recall announcement Jan. 31 explained that some of the blister packs could contain the wrong number of pills, and that the tablets could be out of sequence.

Properly prepared packages contain 21 tablets with active ingredients, and seven with inert ingredients. Pfizer said some packages involved in the recall contained too many tablets with active ingredients, and some had too few. Although manufactured by Pfizer, the pills were distributed under the Akrimax RxProducts label.

If you use this product, notify your physician and return the tablets to the pharmacy.

For a full list of affected lot numbers, NDC number (National Drug Code) and expiration dates, consult the recall announcement. If you have questions, call Akrimax Medical Information at (877) 509-3935. If you believe you experienced an adverse event, contact the FDA MedWatch Adverse Event Reporting Program.

A large survey of doctors published in the prestigious journal Health Affairs finds that while physicians generally subscribe to the idea that honesty is the best policy, they don't always practice honesty with patients, especially when it conflicts with their self-interest.

The article by Lisa Iezzoni, MD, of Harvard Medical School and others, says:

[A]pproximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year.

The authors conclude:

Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered care is broadly possible without more widespread physician endorsement of the core communication principles of openness and honesty with patients.

In 2013, patients will be able to look up data on their doctors' financial ties with drug and device manufacturers, thanks to the new Affordable Care Act. Tentative regulations setting up the reporting system were published in December by the Food and Drug Administration.

As the New York Times' Robert Pear reported recently, researchers have found that payments can influence doctors’ treatment decisions because they steer patients to more expensive drugs and medical devices.

First published on Technorati.

As health-care expert Lisa Zamosky points out on WebMD, you might not be able to control medical costs, but scrutiny of your medical bills can help you save money. The key, she says, is knowing when and how to take action.

Here are four things to watch.

1. Always review your medical bills. They’re notoriously riddled with errors. Be mindful of even minor charges, especially when it comes to hospital care. For example, one person reported that her grandfather was alone in the ICU and intubated (had a breathing tube and was unable to speak) when he was billed for making phone calls at 4 in the morning.

Make sure you’re billed only for the days you were in the hospital, and that there are no duplicate charges for things such as doctor visits and tests and medicine you didn’t receive. If you find errors or discrepancies, immediately contact your doctor’s office manager or billing department, or the hospital where you received care.

2. Confirm that your insurer paid the provider(s). If doctors or hospitals fail to bill the insurance company, if they do so improperly and/or you have more than one type of insurance, confusion can reign. Before paying anyone, find out if your providers have billed the proper insurance company for the procedure you received, then determine whom and how much the insurer(s) paid.

3. Don’t accept an insurance company’s denial of coverage without a fight. “No” doesn’t always mean “no”; sometimes it means “How willing are you to fight?” Thanks to the national health care reform of 2010, everyone has the legal right to appeal coverage denials. If the insurance company rules against you, it must explain why and provide information about how to obtain an independent review of your case. This right does not apply to grandfathered health insurance plans, which are explained here.

There’s evidence that appeals work: The Government Accountability Office (GAO) found that nearly 6 in 10 health insurance appeals were decided in favor of the patient. About 4 in 10 independently reviewed appeals were reversed in the patient’s favor.

4. Negotiate. Most people are uncomfortable haggling over prices, whether it’s for heirloom tomatoes at the farmers’ market or health services from your doctor. But prices for medical care are not rigid. If you need a break, if you believe the cost is too high and especially if you have a high deductible or lack insurance altogether, seek financial relief directly from the source. Your case is stronger if you research in advance fair prices for the relevant medical service in your area. Many health insurers have website pricing features. The Healthcare Blue Book is another pricing resource.

What is the essential core of a health insurance policy that every insurer should have to offer its customers? The federal government is struggling to come up with a definition, but it's proving to be not so easy.

Most people know that the Affordable Care Act (ACA), the health reform plan that was passed in 2010 and remains under political attack, imposes a series of requirements on health insurers. But most people also remain confused about what’s required of the companies that insure them.

Kaiser Health News helps interpret a recent document released by the Department of Health and Human Services previewing what most health plans must offer by way of insurance-covered services beginning in 2014.

Individual states have some latitude in defining “essential benefits” that must be part of coverage for individuals or small businesses, but the law is clear that 10 benefit categories must be included. States can decide, for example, how many doctor visits are allowed.

The HHS released a list of insurance plans names and network types that states may follow, but the feds’ document doesn’t include the benefits covered by those plans. And it doesn’t express a preference for what it would like to see covered.

Consumer advocates, of course, find that rather wanting.

As quoted by Kaiser Health News, Stephen Finan of the American Cancer Society-Cancer Action Network said that without the complete package, “we remain completely in the dark.” Late last year, consumer groups including the Cancer Society were signatories to a letter to HHS seeking advice about which health plans states could choose as benchmarks.

The list offered last week by the department isn’t exactly what they had in mind.

“We know a little more than we knew yesterday, but we still do not have basic documents to see if the plans are good or not so good for cancer patients, or any other kind of patient,” Finan told Kaiser Health News.

HHS lists the insurance plans in each state with the largest enrollments in the small group market. It also lists the three nationally available health plans with the largest enrollments open to federal employees. The document reads, “Under the state’s intended approach, states would have the flexibility to select an existing health plan to set the ‘benchmark’ for the items and services included.” If the selected plan doesn’t include benefits in the federally defined categories, the state must supplement the benchmark.

States may select a benchmark from four types of plans, but if you don’t know what’s in the plan, how do you make an informed decision? It’s like ordering a full course dinner from a brand name restaurant without looking at the menu.

If you’d like to make your feelings known, contact The U.S. Department of Health and Human Services at 200 Independence Avenue, S.W., Washington, D.C. 20201. The phone number is (877) 696-6775.

It's been known for a while that Minnesota ranks dead last in the nation in the frequency with which its doctors are disciplined by the state licensing board for harming patients. Now we know why.

A new investigative series by the Minneapolis Star Tribune has some dizzying quotes from state officials who are charged with protecting the public.

For example, when asked why Minnesota so seldom took action against a doctor's license when authorities in another state had already done so, Ruth Martinez, supervisor of the board's complaint review unit, replied:

"What's the point of piling on?"

(Earth to Ms. Martinez: If your state is the only one that hasn't restricted a doctor's license to practice after some horrendous harm to patients, where do you think that doctor is going to end up practicing?)

Perhaps even more revealing are the words of the board's executive director, Robert Leach, who is quoted as follows by the Star Tribune:

"I'm satisfied the public is protected in Minnesota -- very satisfied. And remember that part of public protection is ensuring an adequate supply of health care practitioners to the public. You can't take everybody out of practice just because they had a problem. That's why we're not in the business of removing credentials unless absolutely necessary. We want to be remedial."

When the board declines to act against a doctor, patients have no way of finding out that that doctor might be a problem -- because by law in Minnesota, only public discipline is disclosable. So there's a real Catch 22 for patients trying to make sure they are seeing a top notch doctor.

Kudos to Public Citizen's Health Research Group for its compilation of the discipline statistics state by state, on which the Minneapolis newspaper report was based.

Progress is being made in the national effort to let patients know which hospitals do the best job in preventing infections. But patient safety advocates are worried that some of the early reports of hospital-specific data may be overly rosy because of fudging in the way that infections are counted.

Last week we wrote about how infections acquired from intensive care units are more dangerous for children than adults. Most hospitals have made progress in addressing the issue of infection control, and a report issued recently by the Department of Health and Human Services promotes transparency in that effort.

HHS compared hospital ICUs across the country in terms of central line associated bloodstream infections (CLABSIs), which research shows are highly deadly but highly preventable with good care. The information for each hospital is posted on the federal Hospital Compare website, updated quarterly. In the future, infections in addition to CLABSIs will be included.

The Centers for Disease Control and Prevention (CDC) estimated that 18,000 patients developed CLABSIs in the ICU in 2009. As many as 1 in 4 of these patients die. The CDC death toll for all hospital-acquired infections is estimated at 100,000 annually; such infections might cost as much as $45 billion.

Consumer advocates, including the Safe Patient Project of Consumers Union, lobbied for years to enable a hospital infection-tracking system. That organization estimates that 2 million patients a year contract an infection in the hospital.

Since January 2011, hospitals have been required to report ICU-acquired CLABSIs to the CDC in order to receive payment from Medicare. Most states that require infection reports use the same system.

As part of the national campaign, a recent California report was rosy: According to California Watch, rates of infections from catheters are nearly half the national average. But there’s a caveat here that other states embrace as well: Hospitals might be under-reporting the incidence of infections. State authorities are reviewing results of an in-depth infection-reporting audit of four types of infections reported by 100 hospitals. But a lack of funding compromises its ability to fully vet all hospital-generated reports.

As Consumers Union noted, the new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services (CMS) “pay-for-reporting” program for all patients, not just those covered by Medicare. Most U.S. hospitals participate because their Medicare payments are higher.

To determine how well your hospital stacks up in the infection-control department using Hospital Compare, Lisa McGiffert of Consumers Union advised comparing its rank with the national benchmark. “If your hospital is no different than the national benchmark, that means too many patients are still suffering and dying from infections that could have been prevented with better care,” she said. “The benchmark for success that hospitals should be striving to reach is zero.”

Reports on surgical site infections will begin in 2013. The CDC estimates that such infections account for 1 in 5 hospital-acquired infections. Catheter-associated urinary tract infections also will be tallied as of 2013.

For some people, the do-it-yourself movement is a congenital condition.

As reported recently by the Centers for Disease Control and Prevention, after a decline of several years, the number of women choosing to give birth at home boomed from 2004 to 2009. That’s interesting, but the number of women overall who give birth at home remains modest—fewer than 1 in 100.

Why would someone prefer to give birth at home instead of in a hospital? Some women dislike the “medicalization” of the birth experience. They question the wisdom of, for example, inducing labor. Like a growing number of laypeople and professionals, they question if C-sections sometimes are ordered for reasons of expedience instead of medicine.

Other reasons for giving birth at home include the desire to be in a familiar environment surrounded by family and friends. Some women express cultural or religious concerns as the driving force to stay home. Expense also can be a factor: A home birth costs about one-third as much as a hospital birth.

Most at-home births are planned, and are the province of women who are mothers several times over. Generally, women who give birth at home have given birth also are:

• often older than 35;


• white;


• married;


• considered low-risk for complications;

People who give birth at home also have help, generally from midwives, although family members and emergency medical technicians also attend. Midwives are present in only 7 of 100 hospital births.

Physicians attend only 5 in 100 home births; when a doctor is involved, it might indicate an emergency situation. Nine in 10 hospital births are attended by physicians.

Although giving birth at home can meet a lot of emotional and financial needs, it’s not without risk. The American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA) do not support planned home births.

According to WebMD,ACOG says that planned home births are two to three times likelier than planned hospital births to risk newborn death. Former ACOG President Richard N. Waldman said that "… home births don't always go well, and the risk is higher if they are attended by inadequately trained attendants or in poorly selected patients with serious high-risk medical conditions such as high blood pressure, breech presentation or prior cesarean deliveries."

Professionals who take issue with home birth are concerned that if something goes wrong, such as an abnormal fetal heart rate, a quick response is critical. And that’s more difficult if you’re at home. Things can go wrong quickly, and unpredictably. See our web page about birth injuries.

Women who have no particular risk for pregnancy problems and want a home birth must be rigorous about getting full prenatal care. Such care often can identify problems in advance that would preclude a safe home birth.

Apart from having normal blood pressure and a record of problem-free previous births, women should consider home birth only if:

• they are able to carry the baby to full term;


• are well-nourished;


• are carrying a fetus that’s developing normally.

If you’re interested in a home birth, do your homework. Research midwives—some are certified, others aren’t—and their histories. Make sure you have access and quick transportation to a hospital if you change your mind or in the event of a problem, and that your obstetrician can attend at that facility.

Instead of giving birth at home, consider doing so at a birthing center. These facilities are warmer and less intrusive than a hospital and delivery room, but have trained staff affiliated with a hospital. Find out more about birthing centers here.

Like all other medical care choices, women must be very careful in assessing the benefits of home birth against its risks. Remember: You’re deciding for two.

Rick Santorum is not the first politician to be caught in a "Do as I say, not as I did" moment. So when it came out this weekend that Santorum had asked for more damages in his wife's medical malpractice lawsuit than the legal limit he would like to impose on all malpractice victims, it would be easy to shrug off the story as the usual politicians behaving badly. But that would miss the bigger and more interesting story.

All the Republican presidential candidates, this year and stretching back for many campaigns, propose damage caps and other rollbacks to the public's right to sue when injured by medical mistakes.

The idea of imposing a uniform national limit on the amount that victims could sue for -- no matter how bad their injury -- has always been a head scratcher to anyone looking for some minimal level of consistency in their politicians. After all, Republicans are often the first to decry "big government Washington solutions" to local issues best handled by each of the 50 states in their own ways. And with medical malpractice, there has been no shortage of state experiments with damage caps and other ideas that are supposed to make medical care more affordable and accessible, despite the lack of evidence that they do either.

But the Santorum story is interesting for another reason that exposes the Achilles heel in the damage cap idea. Every state already has a mechanism for cutting back on high jury awards when plaintiffs like Santorum's wife overreach, and it worked very nicely in the Santorum case.

Karen Santorum sued a Virginia chiropractor in 1999, asking for $500,000 for a back injury she claimed his manipulation caused, with allegedly permanent restrictions on her ability to move. After a jury gave her $350,000, the presiding trial judge, Arthur Vierreg, noted that she only had $18,000 in actual medical bills. Most of the award was for the kind of general damages that Santorum would like to cap for other victims.

Judge Vierreg said the jury's award was "excessive" and a product of "undue sympathy." He cut the verdict by half to $175,000. That's a power he shares with every trial judge in America. It's called "remittitur," and it's an ancient common law power of judges, who see the actual evidence unfold at trial, to curb the occasional over-enthusiastic jury.

It's one of those small-government, local-control ideas that the GOP is supposed to champion.

Those states that have imposed the kind of cap that Santorum advocated -- a $250,000 limit on all "non-economic damages", other than lost wages and medical bills -- have not seen their medical costs go down. Texas, the most recent state to follow a path first walked by California in 1975, has the same medical cost problem as the rest of the country, and its small towns are just as under-served by doctors as they were before the "reforms" were implemented in 2003. Texas actually added doctors to its population faster before the 2003 law than after, as PolitiFact pointed out recently when it rated as "false" the claim of then GOP candidate Rick Perry that tort reform had boosted its number of doctors dramatically.

There's another problem with damage caps besides that they don't work. They hit hardest at the malpractice victims with the worst injuries, like brain damage and paralysis, that can justify high verdicts. Caps do little to curb middling claims like Mrs. Santorum's; she and her husband testified that she had some numbness in a leg and persistent back pain because of the chiropractor's manipulation.

A White House memo on possible medical malpractice reforms was made public last Friday (courtesy of the New Yorker's Ryan Lizza), making the same point. According to the memo sent to President Obama in July 2009 by two top aides on health care policy, "Evidence shows that caps reduce average damage awards by 20 to 30 percent but do not reduce the frequency of medical malpractice claims. Although some argue that caps may reduce the growth of malpractice premiums, there is no evidence that they improve quality of care or reduce health care costs. Finally (and not surprisingly), caps appear to adversely affect the most severely injured patients."

The Santorums are not alone in thinking that damage caps may be a good idea for other people, but not so much at home. Saddled with a bad injury, most people would rather take their shot with a jury and judge, and not have big brother impose a one-size-fits-all limit on their case.

There are plenty of other reasonable ideas to speed up the malpractice system, improve patient safety and cut health care costs. This just isn't one of them. So isn't it time to inter damage caps into the policy grave that they deserve? Somebody give Rick Santorum a shovel.

First published on Huffington Post.

Created by the health reform legislation of 2010, the Patient-Centered Outcomes Research Institute (PCORI) is charged with helping to determine the most effective treatments using objective, science-based standards. We introduced this agency to our readers last year.

Last week, as reported by Kaiser Health News, the PCORI issued its draft priorities and research agenda. What it didn’t do was enumerate specific diseases, treatments or procedures warranting further study.

The agency, which is composed of health care professionals and is not a governmental body, will oversee billions of dollars in research funding. In declining to cite in the draft specific areas of inquiry, it defines “a set of questions and topics” under five broad categories. They are:
1. comparing medical options;
2. improving the health-care system;
3. improving communication of research findings to patients and clinicians;
4. addressing health disparities; and
5. improving research methods.

We’ve written before about “comparative effectiveness research,” a concept that is the currency of PCORI. It’s about comparing different treatments for a given illness and compiling a body of knowledge from which doctors and patients can choose the best option for a given case.

Unfortunately, comparative effectiveness research is wearing a “kick me” sign for Republican lawmakers, who say it will be used to ration care. By failing to be disease-specific, as Kaiser Health News points out, the PCORI draft “sidesteps controversy that might arise from selecting certain diseases or treatments, but not others.” So instead of setting priorities for which diseases to study, researchers will submit questions they want answered in funding applications.

“If they get 1,000 grants submitted on 400 different topics, who is going to make the decision on, say, whether they should fund a project on low back pain, but not one on multiple sclerosis?” Robert Dubois, chief science officer for the National Pharmaceutical Council, told Kaiser Health News. His organization is a policy research group funded by the drug industry.
Dubois said the PCORI approach lends itself to one of the institute’s goals of creating a self-sustaining and robust research community, but he’s not alone in wanting funding to be directed as well toward “actual, unanswered clinical questions.”

Arnold Epstein, chairman of the Department of Health Policy and Management at Harvard University School of Public Health is a board member of PCORI. He said that the agency’s priorities are to get patients involved from the beginning and to fund research that incorporates solid scientific methods to illuminate the gaps in knowledge. The point is to enable patients and doctors to make informed decisions.

PCORI has $3 billion over the next decade to dole out for comparative effectiveness research. If you want to weigh in on how those funds should be spend, review the draft agenda here. Public comment is open through March 15, then a final version will be adopted. PCORI is staging a series of focus groups and sponsoring a national forum on Feb. 27 in Washington, D.C.