DC Medical Malpractice & Patient Safety Blog

Isn’t it refreshing to read about a medical adventure in which all parties got it right?

“Doing Things Right: Why Three Hospitals didn’t Harm My Wife” is the tale told by Michael L. Millenson on the Kaiser Health News website earlier this month.

“My wife was lying in the back of an ambulance, dazed and bloody, while I sat in the front, distraught and distracted,” he begins. “We had been bicycling in a quiet neighborhood in southern Maine when she hit the handbrakes too hard and catapulted over the handlebars, turning our first day of vacation into a race to the nearest hospital.

"The anxiety when a loved one is injured is compounded when you know just how risky making things better can get. As a long-time advocate for patient safety, my interest in the topic has always been passionate, but never personal. Now, as Susan was being rushed into the emergency room, I wanted to keep it that way. ‘Wife of patient safety expert is victim’ was a headline I deeply hoped to avoid.”

Millenson, a visiting scholar at the Kellogg School of Management, wrote “Demanding Medical Excellence: Doctors and Accountability in the Information Age.” So if this patient-safety expert is happy with the outcome of a medical emergency that could have gone wrong in so many ways, what these providers did should serve as a model for everybody.

Susan, who suffered a fractured vertebra at the base of her neck and broken bones in her elbow and hand, was treated at a 50-bed community hospital, a large teaching hospital and a large community hospital. As Millenson says, “There were plenty of opportunities for bad things to happen—but nothing did. As far as I could tell, we didn't even experience any near misses.”

Millenson notes that preventable errors kill 44,000 to 98,000 people in hospitals every year. His wife wasn’t among them, nor among the tens of thousands more who are needlessly damaged beyond their injuries because of what he calls three variables: consciousness, culture and cash.

1. If a hospital is conscious of its errors and what caused them, it’s less likely to repeat them. When patient advocates (in this case, Millenson) are involved, and ask appropriate questions, mistakes are less likely to occur.

2. Sustained consciousness requires a supportive culture. Hospitals with programs that enumerate efforts to improve outcomes and publicize them are sustaining conscientious efforts on the behalf of patients. Common examples are surgical safety checklists and infection-control procedures.

3. It’s difficult to change an unacceptable culture without money. No surprise that the lowest-rated hospitals often claim the poorest patient populations. Millenson’s wife was lucky to be treated at hospitals in affluent areas.

Not every accident victim has the relative good fortune to experience an emergency in a good place, nor with the perfect patient advocate. But Millenson’s story has helpful take-home messages for anyone who wants to be prepared, just in case.

Last month we wrote about an executive order that renewed attention to the problem of drug shortages and the FDA’s inability to fix them. This month, both the Government Accountability Office (GAO) and a U.S. Senate Committee provided more ammunition for granting greater authority for the FDA to address the problem. There’s no real news, but there are more and louder authoritative voices to prompt positive change.

As recounted on FDA Law Blog, Marcia Crosse, GAO Director of Health, told the Senate Committee on Health, Education, Labor and Pensions that the FDA is “constrained in its ability to protect the public health from the impact of [drug] shortages.”

Bills in both the Senate and House of Representatives, and an FDA interim rule to enable the agency to
improve its collection and distribution of drug shortage information to physician and
patient organizations and to work with manufacturers to respond
to potential drug shortages speak to the government’s interest in solving the problem.

And, the pharmaceutical industry is beginning to step up. The Generic Pharmaceutical Association (GPhA) announced its own Accelerated Recovery Initiative to “reverse current drug shortages and prevent further ones. . . .”

Specifically, the industry initiative calls for:

• an independent third party to gather current and future supply information from stakeholders for products identified as meeting the critical criteria;


• that information to be used to determine current and potential supply gaps, with a focus on those products where a shortage is expected to last longer than 90 days; and


• a high-level SWAT team to be formed within FDA with the ability to quickly respond to critical shortages and work with the current Drug Shortage staff expanded through the president’s drug shortage initiative.

The GAO confirmed much of what everybody already knew or suspected. Between 2006 and 2011:

• Drug shortages have increased by 200 percent.


• The average duration of a drug shortage has been approximately nine months.

The GAO analyzed the causes of 15 drug shortages that had a significant impact on public health. Twelve out of the 15 shortages were caused primarily by manufacturing problems. Other factors contributed, such as having to make lengthy improvements to aging facilities and disruptions in the supply of certain drug ingredients.

Also, some drugs are produced by only a few manufacturers, so if one experiences manufacturing problems or supply-chain issues, there aren’t a lot of options to boost production elsewhere.

As noted, these issues aren’t news, nor the fact that even if the FDA knows in advance about drug shortages, it can’t resolve problems unless it has the muscle—the statutory authority—to require manufacturers to do what’s necessary to prevent, mitigate or end shortages.

As FDA Law Blog summarizes, the interim rule may significantly increase the instances in which sole manufacturers are required to notify FDA of an impending production disturbance. But without action by Congress, the FDA can’t expand the shortage reporting requirements, and will remain, as the GAO indicates, “constrained” with regard to drug shortages.

Last week we reported about the shockingly deficient numbers of hospitals that do not conduct autopsies, and, as a result, miss important diagnostic and/or treatment lessons from the results.

In a related and equally disturbing reality, when elderly people die under suspicious circumstances, the reasons often remain unknown because autopsies are seldom performed on people older than 65. The investigative report by ProPublica and PBS Frontline says that no one knows how many of these suspicious deaths have been ascribed to “natural” fatalities, and how many, in fact, were the result of elder abuse or mistreatment. The report quotes a U.S. Department of Justice researcher describing the situation as “a hidden national scandal.”

The system of investigating the cause of suspicious deaths is compromised by insufficient funds, a shortage of trained medical personnel and lack of national standards that, the writers conclude, sometimes have “helped to send innocent people to prison and allowed killers to walk free. When it comes to the elderly, the system errs by omission.”

Specifically, here’s how the system discourages appropriate scrutiny of senior citizen deaths:

• When treating physicians report that a death is natural, coroners and medical examiners almost never investigate. But doctors often get it wrong: Nearly half the doctors in one study failed to identify the correct cause of death for an elderly patient with a brain injury caused by a fall.


• In most states, doctors can write out a death certificate without ever seeing the body.


• Autopsies of seniors have become increasingly rare. People older than 65 represented about 6 in 10 U.S. deaths and 3.5 in 10 autopsied deaths in 1972. A generation later, seniors accounted for 7 in 10 deaths, but fewer than 2 in 10 autopsied deaths. Of the 1.8 million seniors who died in 2008, post-mortem exams were performed on only 36,000.

The ProPublica/Frontline story reports about one death a doctor attributed to clogged arteries and heart failure, but which, thanks to a tip by a nursing home worker, prompted state officials to re-examine. They concluded that the death was due to a combination of ailments often related to poor care—an infected ulcer, pneumonia, dehydration and sepsis. They said the patient’s demise was hastened by the inappropriate administration of powerful antipsychotic drugs, which can have potentially lethal side effects for seniors.

Prosecutors ended up charging the physician and two former colleagues with killing the patient and two other elderly residents.

In another case, the death was attributed to "failure to thrive" due to "dementia." The physician who signed the death certificate hadn't seen the patient for 13 days before he died. She never saw his corpse.

Only when the director of the funeral home that was preparing his body for burial spoke up was it discovered how wrong was the official cause of death. "I'm no CSI expert, but I've been doing this for 25 years, and I've seen a lot of dead people," the funeral home official said. "He was all bruised up and purple, and his ribs were all broken."

He contacted the coroner's office, and an autopsy showed that some kind of violent impact had snapped five ribs. One of the broken bones had pierced the patient’s left lung, flooding his chest with blood. The damage was fatal. His case, too, resulted in criminal prosecution of a nursing home employee.

The reporters identified more than three-dozen cases “in which the alleged neglect, abuse or even murder of seniors eluded authorities. But for the intervention of whistleblowers, concerned relatives and others, the truth about these deaths might never have come to light.”

State laws rely on doctors to separate extraordinary fatalities from routine ones, principally by what they record on death certificates. When a doctor encounters an unusual fatality—a death that might have been caused by homicide, suicide or accident—the physician must report it to the coroner or medical examiner for further investigation.

But death certificates are frequently erroneous or incomplete; one study published last year found that nearly half of 371 Florida death certificates surveyed had errors in them. Doctors without training in forensics often have trouble determining which cases should be referred to a coroner or medical examiner.

Robert Anderson, chief of mortality statistics for the Centers for Disease Control and Prevention, said some doctors don't grasp the significance of death certificates. "I've had instances where the physician just doesn't understand the importance of what they're writing down," he told ProPublica/Frontline. "I'm appalled when I hear that."

Part of the problem is age bias—the death of an older person is accepted much more readily than someone younger—and part of the problem is a lack of resources. Coroners and medical examiners can’t keep up with the number of bodies to be autopsied as it is. Bringing in more seniors exacerbates the problem.

Article first published as Our Nation's Hidden Elderly Deaths Scandal on Technorati.

Although the consequences of medical malpractice are often clear, devastating and sometimes irreparable, malpractice is not always the result of a mistake a doctor or hospital makes during treatment of disease or disorder. Sometimes, the problem lies in the communication of information, or failure to communicate.

A recent study published in JACR – Journal of the American College of Radiology – concluded that the risk of a malpractice lawsuit can increase when the notification of diagnostic test results breaks down between a referring doctor and a treating doctor.

Let’s say a primary care doctor refers a patient to a surgeon. Standard medical practice is for the surgeon, or treating physician, to ensure that the primary care doc is given the results of examinations and/or diagnostic tests if they yield an urgent or unexpected finding. And, commonly, even if they don’t. After all, a primary care doctor knows the patient best, and is considered the “gatekeeper” of a patient’s overall health-care profile and treatment.

The JACR study showed that in recent years, clinicians have ordered dramatically greater numbers of diagnostic examinations. Between 1996 and 2003, malpractice payments related to diagnoses increased by approximately 40 percent. “Communication failures, the authors said, “are a prominent cause of action in medical malpractice litigation. … [C]laims payments increased at the national level by an average of $4.7 million annually. …[C]laims data for 2004 to 2008 indicate that communication failures played a role, accounting for … 7 percent of the total cost.”

These numbers, the study suggests, might reflect the fact that people assume medical data is being reliably communicated among caregivers when sometimes it isn’t. It might reflect the remarkable growth of diagnostic testing, which generates a lot more test reports, some of which are invariably not going to be sent to every caregiver a patient sees. Whatever the reason(s), researchers concluded, “If notification reliability remained unchanged, this increased volume would predict more failed notifications.”

The researchers advise the implementation of “semiautomated critical test result management systems” to improve notification reliability, workflow, patient safety, and, in the event of a lawsuit, to provide legal documentation.

We advise that any patient who undergoes an examination or diagnostic test—X-ray, CT scan, MRI, lab work, etc.—administered by a doctor other than his or her primary caregiver request that a copy of the report and/or results be sent to the primary caregiver. And any other specialist who has participated in the patient’s care for this particular problem. Call your doctor(s) a week or 10 days after the specialist has your results to ensure they have received them.

And as always, we recommend that patients get copies of any test reports themselves. That is the ultimate preventive measure against communication failures.

If you're facing a hip or knee replacement, today's story in the New York Times is a fresh reminder of something we patient safety mavens see over and over with new drugs and devices: the new ones often work no better, and sometimes worse, than older versions on the market for a long time. But it takes much longer for the safety track record to develop for the new devices, and meantime billions in profits have been pulled down.

Barry Meier of the Times is on top of this story, as he is on so many of the ongoing troubles in the medical device industry.

The new study finds that new technology in hip and knee replacements, such as metal-on-metal hip joints, don't turn out to last any longer than their older cousins. Many Americans who have had early failures of new hip replacements can attest to that.

Another interesting angle is the source of the study: an Australian patient registry. We don't have such mandatory registries in the United States. When all patients are entered into a common database, it's easier to pick up early warning signals of safety issues.

There’s an app for that.

Ever since Apple claimed primacy over the smartphone universe, we’ve all become familiar with that refrain. And as noted in a recent report on NPR, mobile medical applications are hot property. Even the stodgy American Medical Association (AMA) has introduced an iPhone app that keeps track of your medications.

It’s all good. Or is it?

We’ve discussed the benefits of electronic medical records. But when it comes to apps, as convenient as such medical assistants might be, there is reason to be concerned about breaches of privacy. That might not induce worry if your techno assistant is helping you adhere to a healthful diet, but some monitor blood sugar, blood pressure and screen for depression. Are you comfortable with strangers having that information?

Medical apps aren't covered by HIPAA, the federal privacy law that controls how doctors and health-care providers store and share patient health information. "They are offering to store and share some pretty sensitive information," Deven McGraw, director of the health privacy project at the Center for Democracy and Technology, told NPR.

Because of that hole in the law, what you consider private, personal information might be little more than marketing data to a medical app manufacturer. As McGraw said, "If their privacy policy says, 'From time to time we will share your information with advertisers,' they can do that."

And what if you lose your phone? What if it’s stolen? What if you share your phone so someone else can peruse your photos—what’s to prevent him or her from perusing other information you might otherwise choose to keep private?

Some app developers, including the AMA’s, offer password protection. That’s good but not impenetrable. Here’s what the AMA app disclaims:

When you purchase this application, you will be responsible for protecting the privacy and security of the information that you enter, and for deciding who to disclose, and give access to, the information. The AMA assumes no responsibility, and shall have no liability, for protecting the privacy or security of the information entered in the application or shared with others either intentionally or unintentionally.

Some med apps invite users to share their medication info with their doctors, pharmacist, family, etc., via email, but anyone who hasn’t recently moved here from Jupiter knows that email is hackable. And who hasn’t made the mistake of sending an email to the wrong recipient? A survey of doctors’ email habits concluded that most didn’t even follow AMA email protocol.

You’d think oversight of med app privacy would fall to the FDA, but last summer that agency was considering limiting its watch-dogging to apps that “could present a risk to patients if the apps don’t work as intended.” If it’s a consumer convenience and not a medical device intended for treatment, the FDA is going to pass.

That leaves the protection of your privacy up to you. In the era of sharing, of Facebook, of tweeting every thought that crosses your mind, the security of medical information seems awfully vulnerable.

We’ve written numerous times about hospital readmissions—circumstances that prompt a hospital patient to re-enter the hospital within a short time of his or her release. Often, readmission rates are a clue about the overall quality of care provided by a facility: When patients come back too often and too soon, it can be a sign that they weren't fixed right on the first go-round. And because hospital care is notoriously expensive, readmissions can signal the cost-effectiveness of a health-care provider network.

Sometimes a patient’s problems require returning for in-patient care. But sometimes readmitting someone to a hospital is less a matter of absolute need than lax oversight. As noted in a recent report by NPR, WNYC and Kaiser Health News, unnecessary hospital readmissions are associated with worse treatment and health outcomes as well as higher costs to taxpayers.

As the NPR/WNYC/Kaiser report makes clear, paying for avoidable care is undesirable if you're the government or a private insurance company. But for paid caregivers, repeat customers are a lucrative market. “Dr. Eric Coleman of the University of Colorado says for too long hospitals have benefited from a system that rewards them for excessive care. A hospital might get 15 to 25 percent of its revenue from readmissions.”

Assigning a “good” or “bad” label to a hospital depending on how many readmissions it registers isn’t that simple. One doctor writing in the New England Journal of Medicine argues that readmissions aren't the best indicator of unnecessary care — even though they're an easy target for budget-cutters. Many hospitals with the highest readmission rates, he writes, also serve the poorest areas with the biggest health problems.

"Readmissions are caused by what hospitals do, who the patients are and what's happening in the community," Dr. Ashish Jha said. "You want hospitals to fix the things they can, but you don't want to punish them for taking care of poor people, and you don't want to punish them for being located in a poor area."

Regardless of patients’ reasons for being readmitted or the facility’s motivation for accepting them, one hospital is trying to reduce the incidence. Heart failure readmission rates for Mt. Sinai Hospital in New York are among the worst in the nation, according to the report. Its hospital administrator challenges how federal data on readmissions are gathered, but says that getting readmissions down is a top priority even though they have been lucrative for Mt. Sinai.

The hospital is hoping to reduce its readmission rates through its Preventable Admissions Care Team (PACT). The program includes measures such as patients meeting with a social worker and nurse practitioner, and only occasionally with a doctor. Such “transitional care” is designed to make patients more self-sufficient and less likely to end up in the emergency room.

It seems to be working. In the program's first full year, its 500 patients notched a 40 percent drop in readmissions and a 55 percent drop in emergency room visits. For one heart failure/diabetes patient who had 20 visits to the emergency room and overnight admissions in the 12 months before joining PACT, Mt. Sinai billed Medicare almost $140,000. In the last 12 months, as a participant in PACT, he went to the ER and had an overnight admission seven times, which cost taxpayers a little more than $54,000.

Mt. Sinai is covering his twice-weekly PACT visits. The program will cost the hospital about $1 million this year, and it's not clear how long Mt. Sinai can foot the bill for PACT, especially if it turns out to be less expensive just to pay the penalty.

As we’ve advised, any patient who knows he or she is going into the hospital should conduct due diligence about the facility’s record. But be mindful that readmission rates alone are only part of the quality-of-care picture.

Thanks to the proliferation of crime procedural TV shows, most Americans understand the value of autopsies in identifying a catalog of biological factors that add up to being able to nab the perp. But in hospitals, medical mistakes are being buried without autopsies, and that's a problem for safe, high quality medical care.

A recent report from ProPublica, Frontline and NPR makes clear that the autopsy, a valuable tool in posthumous diagnosis, is increasingly ignored.

In the middle of the last century, according to the report, autopsies were an integral part of American health care. They were performed on approximately half of all patients who died in hospitals to pinpoint the cause of death, to assess how effective were the treatments and to identify diagnostic errors. Today, only about 5 in 100 patients who die in hospitals are autopsied. Hospitals are not required to offer or perform autopsies.

The consequences are significant, writes ProPublica’s Marshall Allen.

"Diagnostic errors – which studies show are common – go undiscovered, allowing physicians to practice on other patients with a false sense of security. Opportunities are lost to learn about the effectiveness of medical treatments and the progression of diseases. Inaccurate information winds up on death certificates, undermining the reliability of crucial health statistics. For families that lose loved ones under mysterious circumstances, an autopsy can provide answers that would otherwise remain out of reach."

Most deaths that occur in hospitals are deemed “natural.” If they are unexplained, unobserved or occur within 24 hours of admission, according to some state laws, they must be reported to local coroners or medical examiners. But those agencies rarely accept hospital cases unless foul play is suspected.

That means if someone dies for unclear reasons, it’s difficult to determine if someone or some procedure was at fault and should be held responsible. In addition to a natural aversion to finger-pointing and possible legal ramifications of accountability, the report says, hospitals are reluctant to conduct autopsies because it’s expensive.

"Hospitals have powerful financial incentives to avoid autopsies. An autopsy costs about $1,275. ... But Medicare and private insurers don’t pay for them directly, typically limiting reimbursement to procedures used to diagnose and treat the living. Medicare bundles payments for autopsies into overall payments to hospitals for quality assurance, increasing the incentive to skip them."

If the next of kin consents, a deceased patient’s doctor may order a clinical autopsy to explore the disease process in the body and determine the cause of death. But even at teaching hospitals, which are typically nonprofit and whose mission is education, autopsies are performed only in about 20 in 100 deaths. The rate at private and community hospitals, which constitute the lion’s share of U.S. facilities, can be close to zero. Some new hospitals are being built without a place to perform autopsies.

It’s not only hospitals that decline to conduct what can provide definitive answers to the questions surrounding death; many doctors, too, are autopsy-averse thanks to their growing reliance on and confidence in sophisticated diagnostic tools for living patients such as CT scans and MRIs.

But studies have demonstrated that doctors using these devices, as useful as they are, can make mistakes. The report refers to a review of academic studies by the federal Agency for Healthcare Research and Quality that found when patients were autopsied, major errors related to the principle diagnosis or underlying cause of death were found in 1 of 4 cases. In 1 of 10 cases, the error appeared severe enough to have led to the patient’s death. Critics of such studies claim that cases undergoing autopsy are typically the most complex, so it’s likelier that a doctor would make a mistake in these circumstances.

ProPublica interviewed pathologists who said they often find diagnostic errors. “We often identify things that the imaging study could not,” said one. Other supporters of the procedure said autopsies can help identify and resolve hospital-acquired infections, and improve the treatment of heart disease.

Advocates of more routine use of hospital autopsies have suggested ways in which they could be integrated into medical care and subsidized. Pay pathologists for doing them, pay bonuses to hospitals that reach certain autopsy rates, and penalize them if they don’t. Medicare should encourage more autopsies and use them as a performance standard. Insurance companies and the government could pay for them. But the former reject that notion, saying that autopsy is not reimbursed because it doesn’t prevent or treat a sickness or injury. And everyone is aware of the budgetary constraints on government.

Never mind that the cost of an autopsy is small relative to what’s spent on drugs, treatment and diagnostic imaging; that routine autopsies and the payoff could save lives and money.

Said one pathologist, “We are letting go of something which we could really use tomorrow to improve the health care of patients.”

Article first published as Autopsy-Averse Hospitals Bury Their Mistakes on Technorati.

For a couple of years now, Southern California drivers have become used to seeing
billboards for a medical procedure that promises to turn overweight people into the thin creatures they want to be. By calling 1-800-GET-THIN, you could sign up for a gastric Lap-Band surgery at an outpatient facility and change your life. So they claimed.

Several people who took up the offer did change their life—they died.

Last week the FDA finally noticed. The agency issued a warning letter to eight of the surgical centers promoted on the oversized advertisements. The feds told GET-THIN to stop posting misleading advertisements. It’s a violation of federal law for advertising to minimize significant risks and complications of a procedure. It’s also illegal to fail to make clear that for Lap-Band to be truly effective, it must be accompanied by a significant change in the patient's eating habits and lifestyle.

Los Angeles Times columnist Michael Hiltzik said it was about time. “For nearly two years, my colleagues and I have been reporting on the 1-800-GET-THIN ad campaign,” he wrote. “In my very first column on the topic, in February 2010, I identified the people behind it as brothers Julian and Michael Omidi, and reported that Julian's medical license had been revoked by the Medical Board of California and Michael's medical license had been placed on probation. (Michael's probation has since expired.)”

The L.A. Times has reported the deaths of local patients after their surgeries were performed at advertised clinics, and on the lawsuits and coroners' reports that detailed them. “So far," Hiltzik wrote, “the known toll is four, with a coroner's ruling still pending on the death of a fifth patient, who expired after being rushed to a hospital in September from the surgery center where she had just undergone the procedure.

"We've reported on the shocking sanitary and safety conditions at one of the surgery centers affiliated with the ad campaign, and noted questions about whether the surgery centers' insurance billing has been proper.

"And we've reported that effective oversight of a potentially life-threatening procedure has been hampered by California's patchwork system of medical regulation, in which the medical board and the state Department of Public Health essentially pass the buck to each other over who should keep an eye on non-hospital surgery clinics like these.”

The Lap-Band is a cinch placed around the upper part of the stomach creating a smaller organ that minimizes the amount of food you can ingest. Although the procedure is approved by the FDA, and often is preferable to the more invasive and complicated weight-loss surgery that diverts food from being absorbed in the small intestines, it is not without risks that can be exacerbated if it’s performed in facilities whose personnel are less than vigilant or qualified.

Complications include the band moving out of position and eroding through the stomach wall. Nausea, vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD) and pain can result. One study said as many as 1 in 3 10 Lap-Band patients experience band erosion and almost half will have the band removed.

Still, in some circumstances and for some people, it’s a suitable treatment for obesity.

But not the way GET-THIN promotes it. The billboards have included disclaimers that Lap-Band surgery has certain "risks, side effects, and contraindications," and that you should check with your own doctor before undergoing the procedure. That caution was too feeble for the FDA, especially because the disclaimers appear in such tiny type that they're "illegible."

The California insurance commissioner is investigating the Lap-Band industry for alleged fraudulent billings and misrepresented charges. Patient deaths and injuries have prompted a series of wrongful-death and personal injury lawsuits against GET-THIN, its affiliated surgery centers and doctors who performed the procedures. And a class-action lawsuit accuses GET-THIN of false advertising for failing to adequately disclose risks of the surgery and disciplinary problems of some of its doctors.

Hiltzik reported that the director of the L. A. County Department of Public Health complained about GET-THIN to the FDA, and the Omidis filed an administrative complaint against him, asserting that he was biased against them because he was a shareholder in Johnson & Johnson, which markets a competing weight-loss device they don't use. The director recused himself from matters involving weight-loss devices.

When the county coroner blamed the death of a Lap-Band patient at least partially on the "suboptimal" care she had received at a clinic affiliated with GET-THIN, the clinic accused the coroner's expert of a conflict of interest because she had once worked at UCLA, which they claimed was Lap-Band competitor.

As Hiltzik notes, the Omidis are less concerned about quality of care than they are in suing anybody who challenges their shaky performance. “[T] hey've sued me and my colleagues at The Times for reporting about them. So far, three of these lawsuits against us have been thrown out of court by state and federal judges. The plaintiffs have appealed the dismissals and filed more suits against us and commenters on our website.

"The public record is brimming with material — including complaints of wrongful death, negligence and irregularities in billing practices — that could fall well within the jurisdiction of several state regulatory agencies. It may be that the FDA has fired the first shot in what could be a barrage.”

Although this is a local issue, the fact that the Feds have finally taken notice is a cautionary lesson for anyone in search of an invasive weight-loss treatment. Often, these patients are desperate, depressed and vulnerable to claims that aren’t true, or only under certain conditions.

Always research the procedure to be informed about whom it suits, and what are the risks. Always investigate the background of the surgeon with your state medical board. Always investigate the facility at which it is to be performed with your state health department and insurance provider.

As one year ends and a new one begins, some people think about ways to start over. Be happier. Renew energy. Often, they turn to psychotherapy, and in many cases, it works, or at least provides a roadmap to a more satisfying life.

But mental health is like physical health—some things just don’t change. In an effort to help prospective patients understand what psychotherapy can and cannot do, a recent post on the Psychcentral.com website enumerates five things therapy won’t cure.

The advice isn’t just a reality-check; it’s an effort to help people save time, money and frustration. “Therapists, by their nature, tend to want to help every person who comes through their door,” writes John M. Grohol. “Even well-meaning therapists may not fully appreciate when they are largely going to be ineffectual in treatment because of the type of problem presented. After all, psychotherapy isn’t some magical elixir. Talking about some topics simply won’t do much to help the situation.”

Five Things Psychotherapy Won’t Change

1. Personality

Personality disorders are recognized as mental disorders. Typically, they’re more ingrained and more difficult to change than most other mental disorders. They begin in childhood and are shaped by experiences. “You can’t expect to undo decades of personality development in a few months’ worth of psychotherapy. (Years, maybe.)”

But psychotherapy can help mitigate some of the worst features of the problem. For instance, someone with narcissistic personality disorder may continue thinking he or she is better than everyone else, but awareness can help him or her tone it down in interpersonal relationships to become less of a social and work impediment. Another example: Introverted people will still be introverted, but can learn how to relax in social situations.

2. Childhood

No one can go back and fix a lousy childhood. It’s a piece of personal history.

But through therapy, someone can see how he or she interprets what happened in childhood affects behavior now. Then a choice can be made whether to indulge those issues, or grow through them by understanding their significance. A patient will still have had bad parents, rotten siblings, an unsafe childhood home or neighborhood. But those things are afforded a perspective that renders them less hurtful in the present.

3. Half a Relationship

A healthy relationship is a joint effort. Psychotherapy can help couples through rocky times, but only if both parties approach counseling with an open mind and a willingness to work on the relationship. Attendance counts, but work product is key.

That doesn’t mean it isn’t worthwhile if only one-half of a couple goes for therapy; often that helps the patient cope better with the situation or decide to end it. But if the goal is to maintain and sustain a relationship, it takes two to tango.

4. Broken Heart

The side effects of lost love can be long term. Professional counseling isn’t likely to help much, but talk therapy can if the listener is a close friend. Common activities and shared experiences make the painful time seem shorter.

Psychotherapy might help, however, in situations where someone is “stuck” ruminating over details of an old relationship, even years later. If someone can’t move on, talking to a professional might help bring perspective in the same way it does to childhood issues.

5. Bereavement

Typically, grief isn’t considered a mental illness in need of treatment, but its hallmark is depression. Despite popular common wisdom about the stages of grief, the reality is that everyone’s grief is unique.

Psychotherapy won’t help speed the natural processes of time and perspective. Like lost love, grief needs space for remembrance and reflection. It’s done best mindfully and with patience. And like love, it can help someone who cannot get over the loss, even years later. But for most people, “psychotherapy is both unnecessary and overkill for what is a normal process of life and living.”

In two recent decisions, the FDA determined that the eyes have it. And that’s not a positive outcome.

In November, the agency issued a class I recall of Avaira Toric Soft Contact Lenses, manufactured by CooperVision. (Class I is the most serious of the FDA’s graduated scale; see below for a description.) Last week, the feds issued the same recall for another of CooperVision’s products, the Avaira Aquaform Sphere Soft Contact Lens.

These lenses, the agency determined, put users at risk of serious eye injury because of silicone oil residue. Initial symptoms of the problem include hazy or blurry vision, discomfort and corneal abrasions. If you use either of these products, visit CooperVision’s website to see if the lot number on your lens package is included in the recall. If you don’t have the number, or if you simply want to exercise caution, cease using the lenses immediately and call your eye doctor.

According to AboutLawsuits.com, a class action lawsuit was filed last month by stockholders against CooperVision. They allege that CooperVision’s parent company artificially inflated its stock value by minimizing problems with the contact lenses and failing to take sufficient steps to make sure the public was aware of the initial recall.

The website says that the FDA came down on the company in October for failing to provide detail about the lenses’ problems and for issuing its own recall of the Toric lenses in August in a manner so secretive as to leave consumers unaware of the risk. The company expanded the recall in November, and the increased visibility prompted the stock to decline.

In what certainly looks bad even if it’s legitimate, the company’s chief executive officer and chief financial officer sold off millions of dollars in company shares despite their awareness of the growing problem with the contact lenses, according to the lawsuit. Then, the claim says, they boosted expectations for 2011 revenues by minimizing the recall, artificially inflating the value of the company’s stock.

Here’s a primer on the FDA’s approach to recalling suspect, deficient or dangerous products. “Recalls are actions taken by a firm to remove a product from the market,” according to its website. “Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.”

A Class I recall denotes “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

A Class II recall denotes “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences” or when “the probability of serious adverse health consequences is remote.”

A Class III recall denotes “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

Market withdrawal occurs when “a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.”

A Medical device safety alert is issued when “a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.”

Knowledge, they say, is power. It’s also a necessary tool for crafting cost-effective medical practices and protecting patient safety.

Medicare has an enormous claims database from which valuable knowledge can be mined. Finally, within about one year, employers, insurance companies and consumer groups will be able to unearth its information to produce “report cards” on doctors and hospitals.

This blog has championed this access to information, and the subject also figures mightily in “The Life You Save: Nine Steps to Finding the Best Medical Care and Avoiding the Worst,” my book about patient advocacy and medical mistakes.

As described in an Associated Press story, researching a health-care provider’s history in the Medicare database has not been possible before, thanks to a decades-old court decision. Releasing such information, the ruling read, violates the privacy of doctors. The medical establishment was vigorous and vocal in not wanting the people who pay for and receive its ministrations to know how its members rate.

Congress and the executive branch disagreed. For once, both parties were unified on this issue, and federal law has been revised to authorize access to the Medicare database.

What does this mean to the average patient? Suppose you need a knee replacement. Wouldn’t it be nice to compare potential surgeons by how many such procedures they’ve performed, if there were preventable complications and how many?

Experts who analyze Medicare’s billing records glean critical information that not only promotes quality care, it reduces cost and waste by promoting practitioners who are skilled and responsive. The delivery of health care is more efficient and outcomes improve when complications, readmissions and legal adventures are kept to a minimum.

"This is a giant step forward in making our health care system more transparent," said Marilyn Tavenner, Medicare's acting administrator of the newly accessible Medicare mother lode.

Performance reports could be available to consumers by the end of next year. Although individual doctors will be identified in the files, patient names and personal information will not.

Companies are keen to identify the economies of scale that will emerge from analyzing Medicare’s data as it applies to their insurance coverage. But some employer groups also want their workers to know how well their health-care providers are doing their jobs. An executive with the Business Roundtable, which represents CEOs of major corporations, told AP, "We want to make it understandable and usable by our employees. That has always been the goal."

The American Medical Association, which represents doctors, claimed that this data could be misleading or misunderstood by the average consumer. A surgeon with many patients who develop complications, for example, actually might be a top practitioner. He or she just might be willing to accept difficult cases others reject.

There are accommodations to the medical community—providers have the right to see their information before it is released publicly, and they will have 60 days to challenge it.

And Medicare promises to screen the analytical methods of groups requesting access to the data, which isn’t free—access to the files comes at a cost.

The price for transparency is worth it.

First published on Technorati as Finally, Accurate Report Cards on Doctors' Safety and Quality of Care.

Most of the recent media conversation about breast cancer prevention has concerned the topic of screening, and whether and when mammography is routinely appropriate.

Last week, the Institute of Medicine (IOM), a National Academy of Science panel that advises government and the public on issues of health and medicine, garnered front-page headlines with its study about risks for breast cancer. In comparison to most media outlets, which took a “Now Hear This!” approach, the New York Times’ coverage seemed … underwhelming.

“An exhaustive new report meant to address public fears about possible links between breast cancer and the environment,” it began, “finds evidence strong enough to make only a few firm recommendations, most already well known and none with a large proven benefit.”

Where some media framed the report’s conclusion as—if not revelatory, at least significant—The Times was measured. After enumerating the factors that appear to contribute to increased risk of the disease, The Gray Lady suggested that people in search of definitive information about exposure to chemicals, pollution, cosmetics and drinking water would be disappointed. The report, the paper said, “is based largely on a review of existing research, and its limited advice reflects the lack of solid scientific information in many areas of concern to the public.”

Subsidized by $1 million from Susan G. Komen for the Cure, an advocacy group dedicated to eradicating breast cancer, the IOM committee’s chairwoman said it could not “identify a bunch of environmental factors” that might contribute to breast cancer.

According to the report, data did indicate that women could reduce their risk by limiting or avoiding:

• unnecessary medical radiation;


• hormone treatments that combine estrogen and progestin;


• alcohol consumption; and


• weight gain (especially for postmenopausal women).

Weaker evidence, according to the report, suggested that not smoking and increasing exercise lowered risk for breast cancer, and there were a “possible associations” between breast cancer and secondhand smoke, nighttime shift work and exposures to the chemicals benzene, ethylene oxide and 1,3-butadiene (component of car exhaust, gasoline fumes and tobacco smoke).

Even weaker evidence, defined as “biological plausibility,” was identified in certain substances including the chemical bisphenol A (BPA), found in some plastic containers, can liners, food packaging and other products.

In terms of radiation, the report called out the overuse of CT scans, which deliver relatively higher doses of radiation. But it did say that mammograms, which deliver smaller doses, are not of concern.

Cancer in general is a hot medical topic because of its intractability, its invasive and side-effect inducing treatments, its many varieties and the massive amounts of dollars devoted to its treatment and eradication. So any news that seems to be maybe groundbreaking often is translated by the media as definitely groundbreaking.

This news isn’t.

The Times describes why. The disease is difficult to study because suspect chemicals cannot ethically be given to people to see if they cause cancer, and studying people who were exposed in the past yields unreliable information about the dose and timing. Animal studies don’t always apply to humans. And people are exposed to various mixtures of chemicals that may interact differently and with effects that may also vary according to an individual’s genetic makeup.

Also, the panel noted that the effects of various environmental exposures differ depending on someone’s age. Breast tissue may be affected differently in the womb, during childhood, adolescence and adulthood and before and after pregnancy. To state definitively that a certain chemical in a certain environment will pose a certain risk to all breast tissue is false and irresponsible.

The IOC panel noted that even if a woman is scrupulous in eliminating the outlined risks, her risk is subject to the usual vagaries of cancer. “The potential risk reductions from any of these actions for any individual woman will vary and may be modest.”

And some of the behaviors to be avoided might be helpful if someone is facing a different disorder or disease. Moderate drinking might help prevent heart disease; if someone forgoes a CT scan, she might deny herself a valuable diagnostic tool.

As always in the face of breathless medical “news” reporting, before you swallow the message, read the whole story.

The Obama administration’s effort at health-care reform—known as the Affordable Care Act, or ACA—has an image problem. Virtually every poll asking Americans what they think of its provisions demonstrates not only widespread disapproval, but widespread ignorance.

Some pundits attribute our collective misunderstanding to the administration’s inept efforts to publicize the program’s features, some attribute it to GOP mischaracterizations of its features and some say Americans just aren’t paying attention.

One recent poll, however, was categoric in what Americans like about the ACA: the demand that health-care plans clearly communicate their benefits, coverage and exclusions. The popularity of what seems so simple—transparency—underlies the questionable instincts so common among U.S. commercial interests, whether they’re large financial institutions, Big Pharma or insurance underwriters: You can fatten your bottom line by making consumer safety secondary to obscuring the facts about your product.

The monthly Kaiser Health Tracking Poll examines public opinion and knowledge about specific provisions of the ACA. In November, the “runaway” favorite element of the reform plan was the transparency requirement for health plans. Six in 10 Americans gave this provision a "very favorable" rating, the only such element of the ACA to score that high among more than half the public. Eighty-four in 100 ranked this provision "favorable."

Overall, the plan garnered an "unfavorable" review from 44 in 100 respondents; 37 in 100 gave it a "favorable" rating.

Several better-known aspects of the ACA generated these responses:

• preventing insurers from denying people coverage if they have pre-existing conditions: "very favorable," 47 in 100; "favorable," 67 in 100;


• closing the Medicare doughnut hole for drug coverage: "very favorable," 46 in 100; "favorable," 74 in 100;


• providing tax credits to individuals and small businesses to help pay for coverage: "very favorable," 44 in 100 and 45 in 100, respectively; "favorable," 75 and 80 in 100, respectively;


• the individual mandate (the requirement that everyone purchase health insurance coverage that is subject to Supreme Court review): "very unfavorable," 43 in 100.

It’s troubling that more than half—56 in 100 people—believe the ACA includes a new government-run insurance plan to be offered along with private plans (it doesn’t), and that 35 in 100 believe the law allows a government panel to make decisions about end-of-life care for people on Medicare—the so -called “death panel.” That, too, is fiction.

In reviewing the poll results, an analyst with Kaiser, which has no relationship to the health-care company of the same name, opined, “It is no huge surprise that people are confused by their health benefits. And, unlike many elements of the health reform law, there is no apparent downside to the public from requiring health plans to be more up front about what they do and do not cover; although employers and insurers have objected to the rule as a costly and unnecessary new regulatory burden. What is a surprise, though, is that people feel so lost in the health insurance system that they chose a requirement that insurance companies explain their benefits in plain language as the most popular element of the giant health reform law, and by such a wide margin over the many others we asked about.

“But, our polling shows people don’t know much about its more consumer friendly provisions which are popular even across partisan lines. As long as that remains the case, people will not perceive the ACA as part of the solution to their everyday problems and public opinion will remain split along the familiar partisan divide.”

A new study in BMJ , the British medical journal, has revived interest in the issue of the kind of materials best used for hip replacements.

Problems have long been reported from many quarters when metal is used to refashion both sides of the ball-and-socket hip joint. We wrote about one manufacturer’s defective product last year.

The trouble comes when the metal parts abrade each other, releasing tiny bits of metal into the surrounding tissue. Essentially, it’s metal poisoning, called metallosis, characterized by pain and inflammation that impedes the ability to walk.

In 2009, the FDA initiated a comprehensive evaluation of approved implants. And in May, the agency requested more information from metal hip replacement manufacturers to quantify and address the problem.

Now, the FDA-sponsored study results in BMJ “do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.”

That means earlier technology, which used ceramic or, essentially, plastic, are just as effective as the latest technology—metal. Although metal conferred no advantage, the study showed, it was burdened with more problems that not only left patients uncomfortable and mobility-challenged, but possibly at a greater likelihood of needing follow-up surgery.

Many lawsuits have been filed involving metal-on-metal hip implants.

The study examined 3,139 hip-implant patients and data from more than 830,000 operations worldwide. “Evidence on implant revision did not favor metal on metal implants,” researchers wrote.” There is limited evidence regarding comparative effectiveness of various hip implant bearings, and the results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional bearings.”

More than 700,000 joint replacements are performed every year in the Unites States; about 270,000 are hip replacements, and that number is expected to double over the next decade. The cost of the procedure is expected to rise as well.

Joint replacement, the study notes, is a generally successful operation that addresses a significant health issue. The recent popularity of metal is due in part because it enables the use of larger femoral heads (top of the thigh), which supposedly reduces the risk of dislocation and improves the functional outcomes in younger patients. But its use for older patients, according to one study, was popular as well, with 1 in 3 such patients receiving metal-on-metal implants.

Hip replacement surgery can be a godsend for people suffering from this degenerating joint problem. But if you’re scheduled for the procedure, ask your surgeon which device he or she is planning to use, and research its history. If it’s a metal-on-metal device, at least seek a second opinion.

Unless the patient needs really intensive, round-the-clock care, most hospital-type care can be done in the patient's home -- where it's safer, more comfortable and less expensive. That lesson is so well accepted that it was written into the federal health care reform law -- to provide financial incentives for outfits called Independence at Home Organizations.

The problem is that the rules for the new home care organizations are supposed to go into effect on January 1, 2012, but Medicare is behind on writing the rules. So there will be delay in getting this started. The current rules discourage moving hospital-style care home because, among other things, Medicare won't pay for home visits.

An internist named Jack Resnick, M.D., writing an op-ed in the New York Times, talks about his own practice on New York City's Roosevelt Island, caring for infirm and elderly patients. He makes a persuasive case for the home care organizations, writing:

Patients who are treated at home by a doctor and nursing staff who know them intimately and can be available 24/7 are happier and healthier. This kind of care decreases the infections, mistakes and delirium, which, especially among the elderly, are the attendants of hospital care. And it is far more efficient.

Patients’ rights advocates lost a valuable team member this month.

Dr. Donald Berwick resigned as administrator of the Centers for Medicare and Medicaid Services (CMS) for reasons wholly political. The respected, forward-thinking medical professional opted to leave rather than continue in the role for which President Obama sought Congressional approval, but resorted to a so-called “pocket” appointment when Senate Republicans blocked his nomination last year.

The appointment, which Obama made when the Senate was in recess, was in effect until the end of this year. Berwick, a pediatrician, has served 17 months and is leaving, as opposition among Republicans remains strong. They claim Berwick is a fellow traveler with Obama’s health-care reform movement—the Affordable Care Act, or ACA—and all too willing to ration health care.

They’re not completely wrong, but they’re not right.

As recounted on Medscape.com, when Obama nominated Berwick in April last year, he had headed the Institute for Healthcare Improvement, and various organizations supported the move, including the American College of Physicians, AARP, Walmart and Consumers Union.

In his temporary tenure at CMS, Berwick helped implement several elements of the ACA pertaining to the Medicare and Medicaid programs. Among them were regulations for accountable care organizations (ACOs). Those groups of health-care providers improve outcomes and reduce costs by coordinating the care of Medicare patients and, as a reward, get a cut of the money saved.

Berwick also shepherded a pilot program to effect essentially the same change—and benefits—for physicians, rewarding them for providing better quality versus higher quantity of care for the quality as opposed to the quantity of their services. Known as the Comprehensive Primary Care Initiative, the program assists primary care doctors in:

• helping patients with serious or chronic diseases follow personalized care plans;


• giving patients 24-hour access to care and health information;


• delivering preventive care;


• engaging patients and their families in their own care; and


• working together with other doctors, including specialists, to provide better coordinated care.

Dr. Glen Stream, president of the American Academy of Family Physicians, described Berwick for Medscape as someone "with an impeccable background in quality improvement and a willingness to evaluate healthcare from top to bottom." Stream doesn’t know if the initiatives Berwick supports will succeed in improving the quality of and lowering its cost, but like many of his professional colleagues, he give him props for addressing thorny medical-industrial issues others won’t.

Among them are the president and chief executive officer of the American Medical Group Association and the chief executive officer of the American College of Cardiology. The latter, Dr. Jack Lewin, applauds Dr. Berwick for listening to physicians while trying to reform the health-care system. As Medscape notes, when organized medicine initially gave a thumbs-down to the ACO rules, Berwick "went back and changed them significantly," Lewin said.

"CMS is trying to do its job as a regulatory agency, but facilitate innovation at the same time," Lewin said. "They're partnering with us. That's clearly part of Don's legacy."

"It's been a great era. It's too bad we don't have a few more years of it."

Because of his willingness to accept the limitations of modern health-care delivery, Berwick was scorned in Congress and all over the conservative blogosphere as "Dr. Death Panel," referring to his past statements supporting Britain’s National Health Service and accepting that rationing of healthcare is inevitable.

"The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open," Berwick is quoted as saying in Biotechnology Healthcare magazine in 2009. "And right now, we are doing it blindly."

For people more concerned about the quality, accessibility and cost of health care more than who wins political points making it happen, Lewin summarized Berwick’s situation for Medscape: "Unfortunately, he's been a scapegoat for Republicans who are mad about the ACA."

Here's an interesting interview with Dr. Berwick in the New York Times, where he gets off some parting shots about what's wrong with the politics of our health care system.

In 2009 the U.S. Preventive Services Task Force recommended against routine mammograms for women in their 40s. That caused a political firestorm then, with ill-informed politicians claiming that bureaucrats were trying to hold back a lifesaving test to save money. The truth was, and is, that mammograms cause more harm than good unless the women being tested are already at significant risk.

Now, Canadian health-care watchdogs have echoed the U.S. opinion, and for the same reasons.

As reported in CMAJ, the Canadian Medical Association journal, the Canadian Task Force on Preventive Health Care says routine mammograms for women 40-49 are not necessary if they are at average risk of contracting the disease. Women with a personal/family history of breast cancer, or who have the BRCA1/BRCA2 gene mutations are at higher risk, and should be screened more often.

The report concludes that although mammography screening can reduce death from breast cancer among women aged 40–74 years, “the absolute benefit is small — especially for younger women — and is partially offset by harms caused by unnecessary intervention.”

Those harms include false positives, which prompt additional screening or tests that usually include more radiation exposure, uncomfortable biopsies and high anxiety. The disease is relatively rare in younger women, and their higher breast density compromises the ability of mammograms to be fully useful. So the Canadian report says that for women at average risk, an interval of two or three years is sufficient for mammography screening.

Like the earlier U.S. task force, the Canadians emphasize that providers and patients consider the benefits-harm trade-off when deciding about having a mammogram.

We have repeatedly covered this topic, as well the often-conflicting opinions always generated when a former standard of care gets called into question.

In addition to questioning the wisdom of screening younger women via mammography and magnetic resonance imaging, this task force also said that there is no evidence that “clinical breast examination or breast self-examination reduces the risk of mortality or other clinically relevant adverse outcomes.”

Here’s what the Canadian task force recommends for mammography screening for women at average risk, by age:

• 40–49 years, no routine screening;


• 50–74 years, routine screening every two to three years.