DC Medical Malpractice & Patient Safety Blog

Time and again in U.S. health care, new technologies are hurried into wide use with little testing, scant training of their human operators, and lack of solid evidence that newer really is better. After the flush of optimism has faded, billions of dollars later, we learn how to judiciously use the new equipment, but only after patients have been hurt or killed by the rush to the new.

The latest example is the deployment of new radiation therapy machines on cancer patients with operators who are not properly trained or credentialed and equipment that has not been tested or calibrated. The New York Times' recent investigative series on the subject prompted one knowledgeable reader, Dr. Joseph Imperato, medical director of the Center for Advanced Radiation Medicine at Lake Forest (Ill.) Hospital. to write this:

To the Editor:

As a radiation oncologist practicing for 25 years, I believe that there is a crucial part of the story of radiation mishaps that has not been mentioned: the “nuclear arms race,” in which people want the newest technologies, without stopping to think about who is operating them.

In the past, academic medical centers were typically the first to obtain and use new technologies. The equipment would be thoroughly vetted and reported on in peer review articles before being accepted and used by the smaller community hospitals.

Now the reverse is true. Small community hospitals often far outpace academic medical centers. One example is the proliferation of proton centers run by for-profit companies. Often the staff has limited knowledge and experience with this extraordinarily complex equipment. And new technologies are often assumed by the public to be better, even though there is often little firm clinical data to support that.

As we struggle as a country to come to grips with health care costs, this is one area where there is great opportunity for savings. Clinical reviews can prevent the proliferation of needlessly expensive technology. What the public must come to grips with is that “new” is not automatically “better.”

See the Times' letters section for more.

In my book, "The Life You Save," I have several chapters that speak to this issue, particularly with new drugs. What patients need to understand is that whatever the technology, the early years of use are in essence a continuation of the testing phase. If you are comfortable with being a guinea pig, that's fine, but very often you can get better, safer care with the tried and true. And if the new technology looks enticing, go with an operator who has the most experience using it, because practice does make perfect.

Measured by results -- preventable deaths and injuries due to malpractice, medical errors, preventable infections, misdiagnosis and other events that shouldn't happen -- American health care has a lot of problems. Millions of patients are injured every year, and upwards of 200,000 patients die annually from preventable errors and hospital-acquired infections. The United States also lags far behind other developed countries in basic health outcome measures like life expectancy and infant death rates.

But when U.S. hospitals measure themselves with a different yardstick -- the "process" measures of how often certain important things get done for commonly treated diseases -- the results are astoundingly good. An annual report from the Joint Commission, the agency that inspects and accredits hospitals, finds steady improvement in the "process" quality measures that it looks at -- with most hospitals now performing in the 99% range on things like how often heart attack patients get standard treatments in the ER like aspirin and beta-blocker drugs.

The Joint Commission now measures 31 quality indicators. They cover the most common hospitalizable conditions: heart attack, heart failure (when the pump isn't pumping effectively), pneumonia, surgical care, and children's asthma. You can go to this website to look up information about a particular hospital.

The problems with the report are:

* Data is reported voluntarily by the hospitals, with no independent audit from anyone other than the Joint Commission. The Joint Commission says it's independent from the hospital industry but is often seen by critics as a cheerleader.

* Outcome measures -- deaths and injuries -- are not included in the report. Even infection rates, which could have required reports if Congress ever passes health care reform, are not yet reported.

Consumers Union has a Safe Patients Project. CU says it's high time for the U.S. health care industry to be required to report its results. Patient advocates like me agree wholeheartedly.

What can cancer patients do to protect themselves from malpractice in radiation therapy? This urgent question arises from a lengthy series of investigative reports in the New York Times. The articles exposed serious patient injuries that stem from therapists who are overwhelmed and inexperienced, lax regulation and indifference by hospital administrators.

A key part of the problem is that technological sophistication has outrun the ability of the humans running the radiation machines to monitor the safety of the radiation beams they train on patients' bodies.

Another issue is that no central agency is responsible for inspecting the machines and credentialing the people who run them. Depending on the type of radiation involved, the Food and Drug Administration, the Nuclear Regulatory Commission and various state health agencies could have jurisdiction. Or worse, each could claim that someone else has the jurisdiction, and the patient can slip through the cracks.

There is one simple way that patients can take some measure of self-protection. That is to make sure that the radiation therapy center treating you has significant experience, in years not months, with the specific machine being used on you. Too often, hospital administrators buy a fancy new machine, advertise it heavily in glossy brochures, but don't take the time to make sure the machine is properly calibrated and that the medical physicists who operate the machine are fully trained.

You should also ask if the machine treating you has been inspected recently by an independent agency. One federally funded inspection and testing service is the Radiological Physics Center, operated out of MD Anderson Hospital in Houston. It does inspections for any radiation center that wants to receive federal funding for clinical trials. The Center found in 2008 that nearly three in ten hospitals it inspected failed to accurately irradiate a test dummy using IMRT technology.

The Times also found rampant problems with fake credentials among medical physicists, who are in charge of making sure patients get the right dose of radiation. The American Board of Radiology certifies medical physicists in one of three sub-specialties. You can check if a physicist is certified at the umbrella website for all medical board certifications, the American Board of Medical Specialties. Click here to go to the login page to search for a medical physicist's certification. The same page will let you search for whether a doctor is board-certified in any of the ABMS specialties or sub-specialties.

Also, the American Board of Medical Physics runs some certification programs. Its website has lists of diplomates but lacks any searchable database of qualified physicists. So the ABMS website is a better choice.

I recommend that patients ask questions to find out the qualifications of the persons running your radiation treatment program. If they lack certification, why take a chance?

I discuss the certification issue in detail in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." Many of the most egregious cases of malpractice that I have prosecuted for victims' families have involved doctors who lacked basic board certifications. Click here for more information on the kinds of malpractice cases we work on.

More evidence of the urgent need for "checklists" to protect patient safety in complex medical treatments comes with a long article in the New York Times about terrible injuries from malpractice episodes during radiation therapy. Yet readers have to dive deep into the article to find this key point.

Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions. Why did it happen? The hospital, St. Vincent's in New York, blamed a confluence of tragic coincidences. But I reached a different conclusion, as I wrote in a blog post to the Times' "Well" blog:

Deep in this tragic article is the following paragraph that exposes the reforms that are needed before medical care can become safe for all patients:

"It was customary — though not mandatory — that the physicist would run a test before the first treatment to make sure that the computer had been programmed correctly. Yet that was not done until after the third overdose."

So there you have it. If the physicist had been required to run the test -- better yet, if the equipment had been set so that it wouldn't work until the final test had been run -- Scott Jerome-Parks would not have suffered the hideous injuries so eloquently described in the article.

Medicine needs to adopt standard and mandatory - not merely "customary" -- checklist routines to ensure the safety of patients. This is the thesis of Atul Gawande's new book, "The Checklist Manifesto," and I have a chapter on how patients can enforce checklist protocols before surgery in my own book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

Many medical commenters on the New York Times "Well" blog defensively say, "We're only human," to excuse these kinds of errors. Yes! That's exactly the point of the checklist. It recognizes that we're all only human and that when we are deploying potentially deadly treatments, a final check and double-check is needed, every time, before pressing the button.

The Times also found that the manufacturer of the software that ran the linear accelerator, which delivered the radiation, did not have in place until after the injury a simple "fail-safe" mechanism to prevent the kind of error that occurred.

The entire article by the brilliant reporter, Walt Bogdanich, is worth reading. Here is the Times' own summary of the article:

The Times found that while this new technology allows doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error — through software flaws, faulty programming, poor safety procedures or inadequate staffing and training. When those errors occur, they can be crippling.

I also recommend that readers interested in patient safety issues go through some of the NYT "Well" blog posts on this article.

An effort to overturn Maryland's unfair malpractice damages "cap" has been scotched by Maryland's highest court. The case involved Richard Semsker, a deceased Rockville attorney whose family was represented in a wrongful death lawsuit by Patrick Malone & Associates. The Maryland Court of Appeals has ruled that the jury's verdict must be reduced to account for the damages ceiling imposed by the state legislature.

An article in the Montgomery County Gazette discusses the decision and quotes the Semskers' attorney, Patrick Malone, who said:

"We had the entire Maryland medical establishment against us. While we have the better of the issue on the moral ground — damage caps are a terrible imposition upon victims of proven malpractice — on the other hand the establishment was against us on that."

While little understood by the general public, which often responds to vaguely worded public opinion polls by favoring some forms of "tort reform," including damage "caps," these arbitrary limits on damage awards impose a tax on the most severely injured victims of provable malpractice. Victims who have lesser injuries are not affected by the damage caps.

In the Semsker case, for example, no one challenged as unreasonable the jury's decision to pay Mr. Semsker's widow $1 million for loss of the husband to whom she had been married 21 years, and to pay each of his twin teenaged daughters $500,000 for the loss of their father. The jury heard evidence about how close the Semsker family was and how devoted Mr. Semsker was to his daughters and wife. The jury also ruled that the defendants should have to pay $1 million for Mr. Semsker's suffering in the last year of his life, which included multiple surgeries, radiation, and highly toxic chemotherapy -- all to treat a skin cancer that, according to the undisputed testimony, would have been 100% curable if his dermatologists had caught it in time.

But while the jury acted reasonably based on the evidence, the statutory damage cap required a rollback of the verdict for these "non-economic" damages from a total of $3 million to a total of $812,500. That is the "one size fits all" number that the legislature came up with in 2005 as a limit on all non-economic damages in all wrongful death lawsuits for malpractice.

Even worse, the damage cap discriminates against malpractice victims specifically, as compared to victims of other types of injuries. If the same physicians had run over Mr. Semsker with their car, that would have been a non-malpractice case and the damage cap would have been around $1.6 million instead of $812,500.

The Semsker case is also discussed in Mr. Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, an excerpt of which can be read here.

The Semskers had persuaded the judge who presided over the trial that the damage cap statute was written in such a way that its language excluded their case from imposition of the cap. But this week, the Court of Appeals reversed that decision and imposed the cap.

A new study that concluded that two commonly prescribed antidepressant drugs don't work for people with mild depression has opened an interesting discussion about the quality of mental health care in America. The quality score: C-minus, for lots of reasons.

Judith Warner wrote in the New York Times that the news media reports about the new study (which really wasn't an original study but a number-crunching of selected older studies) were too simplistic. She noted many of the shortcomings of mental health treatment, starting with the fact that general practitioners do a lot of the medication prescribing and aren't as skilled as specialists in screening who really needs the medications.

Ms. Warner concluded: "The trouble is not that the drugs don't work, it's that the care is not very good."

She also said:

This is the big picture of mental health care in America: not perfectly healthy people popping pills for no reason, but people with real illnesses lacking access to care; facing barriers like ignorance, stigma and high prices; or finding care that is ineffective.

Her Op-Ed piece brought a round of thoughtful comments in the letters">letters to the editor column at the Times, including:

* Brown University psychiatry professor Lawrence Price writes:

Medications that work for depression are commonly misused, and types of psychotherapy that work for depression are commonly not used at all. The reasons for this state of affairs include mistrust of authority, stigma, big-stakes health care economics, cross-discipline rivalries and simplistic thinking (within the mental health care field as well as the general public).

* James Brush, a psychologist in Cincinnati, writes:

While researchers can investigate treatments in laboratory conditions, few clients fit into simple categories. Try applying an “evidence-based treatment” for a depressed, sexually abused child from a divorced family in which one parent is alcoholic and the child has a learning disability. Such clients do not tend to show up for laboratory studies and don’t tend to respond to simple bromides.

* Neil Brooks, former president of the American Academy of Family Practice, argues that family practitioners by necessity have to treat patients with depression who might be better off with a specialist. Dr. Brooks writes:

Many of those who need treatment have no access to psychiatrists because of geographical distribution, restrictive insurance coverage, cost or a perceived stigma to being cared for by a psychiatrist. Thus, distortion or misinterpretation of the evidence about the treatment of depression will result in those who desperately need help not obtaining it.

The Times also published a rebuttal to the new study by psychiatry professor Richard Friedman, M.D. of Cornell, who cited a number of caveats that limit the usefulness of the new study. He concluded:

Every once in a while, a landmark study comes along and overturns everyone’s cherished ideas about a particular treatment. But the current study is not one of them. So it would be a shame if it discouraged depressed patients from taking antidepressants.

Experts may disagree about what constitutes the best treatment for depression, and for whom. But there is no question that the safety and efficacy of antidepressants rest on solid scientific evidence.

Bottom line: Don't throw out your antidepressants just yet. But if they don't seem to be helping, do talk to a good therapist about trying another approach.

Memorize the name of this antiseptic wash and make sure your hospital uses it: chlorhexidine.

Research continues to pile up that diligent but inexpensive efforts by hospital staff can greatly cut the annual toll of an estimated 100,000 lives lost to hospital infections. The latest simple step involves greater use of the antiseptic chlorhexidine to wash patients before surgery.

In two studies reported in the New England Journal of Medicine, post-surgical infections were cut dramatically when either of two steps were taken:

* Disinfect the patient's skin just before surgery with a chlorhexidine-alcohol rub -- instead of the usual iodine prep.

* Have the patient shower for several days before surgery with a chlorhexidine-based soap, like Hibiclens.

Read more on this antiseptic at Wikipedia.

See Pam Belluck's article in the New York Times for more details on the new studies.

My book, "The Life You Save," lists simple ways patients can help reduce their risk of getting infections in the hospital, including chlorhexidine soap. So the latest studies are only confirming the wisdom of this advice. But because many hospitals don't yet do this, you should ask questions and make sure they have plenty of chlorhexidine on board.

The deadly MRSA infection, estimated to kill 19,000 Americans every year (more than the toll from AIDS), has been virtually wiped out in Norway, with three simple steps:

As described in a recent Associated Press article:

Norway's model is surprisingly straightforward.

-- Norwegian doctors prescribe fewer antibiotics than any other country, so people do not have a chance to develop resistance to them.

-- Patients with MRSA are isolated and medical staff who test positive stay at home.

-- Doctors track each case of MRSA by its individual strain, interviewing patients about where they've been and who they've been with, testing anyone who has been in contact with them.

Step No. 1, ratcheting back on antibiotic prescriptions and relying more on the old tried-and-true ones, won't go over well in America, where the prescription drug industry pushes all of us into a newer-is-better and more-is-better approach.

But step No. 2 -- test and isolate -- has been proven to work by itself to virtually wipe out the spread of MRSA once it gets into a hospital, by isolating people who are carriers.

The problem is that people can carry the bug on their skin without harm; a deadly infection only happens when it gets into the body of an already vulnerable patient. The answer: do nasal swabs of all incoming patients when admitted to the hospital to see if they are carriers, and if so, isolate them in special units.

Does your hospital do this? If not, you should ask why not. The safest hospitals in the United States do nasal swabs of all incoming patients at the time of admission. It's for their safety and everyone else's.

The political brouhaha that followed the new guidelines on mammograms has now died down, maybe enough so that patients can start to absorb the quiet truth about breast cancer and the role of mammogram screening.

The National Breast Cancer Coalition has worked since 1991 to get Congress to fund research and appropriate treatment for this disease. The Coalition believes in sticking to the facts and analyzing closely the research studies that have been published about what mammograms can and cannot do for women who aren't aware of a lump in their breasts.

Here is an excerpt from their discussion of the US Preventive Services Task Force recommendations:

Has breast cancer screening had a significant impact on mortality from breast cancer?

No, over 40,000 women continue to die of breast cancer each year, despite the emphasis on breast cancer screening in our country. To change this, we must address the facts about breast cancer and not simply accept what we want to believe. The fact is that all breast cancers are not equal and that we don’t currently have tools for “early detection” that are good enough for the life-threatening breast cancers.

But doesn’t early detection save lives?

Not necessarily. Some breast cancers are slow-growing and have a good prognosis, whenever they are found, whether small or large. Other breast cancers are aggressive and fast growing, and we don’t have the tools to catch them early enough or treatments that will work.

Why doesn’t mammography work as well for women in their 40s?

Younger women have more dense breast tissue, making mammography less accurate. Also, mammography is better at detecting slower growing tumors more common in older women, than the fast-growing, aggressive tumors more often found in younger women. And the balance of benefit vs. harm changes as women get older since the likelihood of breast cancer increases with age. The disease is relatively rare in younger women.

But shouldn’t a woman in her 40s have a mammogram if she feels a lump?

Certainly. The Task Force recommendations are meant to be guidelines for broad public health policy for healthy women with no symptoms, and an average risk for breast cancer. These guidelines are not meant for any woman with an increased risk or for any woman who feels a lump or change in her breast. Women who have any concerns need to visit their doctors and may need diagnostic mammograms. Mammograms taken to assess a problem are not the kind of mammograms we are talking about with these guidelines.

What’s the harm in trying to detect breast cancer early, even if our methods don’t work that well?

The harms from screening too early or too often include increased false positives, leading to increased imaging and radiation exposure, biopsies and scarring that can affect the accuracy of future mammograms, and anxiety. There is also the harm of overdiagnosis of breast cancer. This would involve treatment of cancers that would never be life threatening, and treatment of cancers that may regress, or go away on their own. The treatments for breast cancer are not aspirin, they are toxic and can be life threatening; the scenario of overdiagnosis should not be taken lightly.

The cancer coalition supports the Task Force's recommendation that women who are not in a high risk category (from a family history or presence of the BRCA gene) start thinking about mammograms around age 50, not age 40.

Here is another useful summary from the National Breast Cancer Coalition: 31 Myths and Truths about breast cancer. You can read it here.

We have discussed the statistics behind breast cancer screening in several entries on this blog. Read them here and here and here. My belief is that women need to understand the numbers and then make a personal choice. Politicians don't need to enshrine mammograms as some sort of constitutional right, as happened in the US Senate not long ago. We need more compelling evidence before this screening device goes onto the "do not touch" pedestal.