Patient Safety Blog

In a logically designed drug safety system, data from new studies would automatically be pooled so that as more and more patients take a drug, researchers can see potential harms across all the data at one time, rather than looking at individual research studies in isolation. Alas, that is not our world.

A new proposal would change that, but it would take an act of Congress to do so.

As described in the Archives of Internal Medicine, a group of researchers analyzed all the studies published on Merck's anti-arthritis drug Vioxx to see when the risk of heart attack could have first been identified. The drug was first put on the market in 1999 and was taken off the market in September 2004 when Merck said it first realized there were many heart attacks in patients taking it.

The researchers led by Joseph Ross, M.D., now say that their analysis, pooling data from 30 separate clinical trials, shows there was statistically significant increase in heart attacks in Vioxx patients as early as June 2001, three years before the drug was removed from pharmacy shelves. The studies after 2001 only strengthened the statistical association, they say.

If we had a system in place that automatically pooled all safety data on drugs as new studies are published, many safety risks could be identified much sooner.

But the head of drug safety at the Food and Drug Administration, Dr. Janet Woodcock, said Congress would have to authorize a change in the existing monitoring system to make for these automatic updates. Currently, she told the New York Times, the FDA does such combined-study reviews but only when a particular drug catches the eye of FDA safety officers.

Consumers are well advised to hold off on taking new drugs until they have been on the market for seven years. This is the advice I give in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Seven years is enough time for safety experts to see whether the new drug has enough benefits that outweigh its harms. In theory, the approval by the FDA to let a drug be sold should provide that green light, but before a drug is approved, only a few thousand patients typically are studied, while many hundreds of thousands will take a drug in the years after approval.

The new study by Dr. Ross and colleagues is yet another example of how far we have to travel before consumers can be assured that a brand new drug is right for them.

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

Posted In: Medications

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Patients who want to probe beyond the glossy pamphlets and flashy web sites of a hospital or nursing home to see what the real scoop is on the safety track record have one simple way to get the official government inspection report: Ask for it. You have a legal right to a copy.

The report is called a CMS 2567. That's the form from the Center for Medicare and Medicaid Services (CMS) that is filled out by the inspectors. It lists "deficiencies" in one column, and the institution's plan for fixing the deficiencies in the adjacent column. The inspectors work directly for regional offices of CMS or work for the state Health Department. In either case, you have a right to see the institution's report.

Here is a blank sample from the government. Here is an example of a report about a California hospital's deficiencies in counting sponges in an operation.

Consumers Union has an very good web page on how to read these forms. The information is oriented mostly to nursing homes but also applies to hospitals. Click here to read.

If the institution claims it doesn't have a copy of the report readily available, you can write to CMS or your state health department and obtain a copy under the Freedom of Information Act.

Investigative reporters for news organizations have used these reports to expose shocking problems at medical institutions.

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

Posted In: Hospitals

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On November 17, 2009 in Washington, D.C., Consumers Union hosted a forum of patient activists, advocates, doctors, nurses and others who want to reform the dangerous safety practices in the U.S. medical industry. (I attended as a medical malpractice attorney and patient safety advocate.)

You can watch a webcast of the forum here.

The forum included a moving panel of three women -- Helen Haskell, Patty Skolnik and Lori Nerbonne -- who recounted their experiences losing loved ones and what they have done since to try to achieve more openness, honesty and safety in American medicine.

Several journalists gave their perspectives, including

* Maggie Mahar, the author of Money-Driven Medicine and the Health Beat blog,

* Charles Ornstein of Pro Publica, who headed a team of investigative writers who exposed dangerous complacency in the California Board of Nursing, which allowed known dangerous nurses to continue to practice for years.

* Cathleen Crowley, chief writer for the Hearst newspaper project, "Dead by Mistake."

I attended the forum and was both inspired at the obvious dedication of the patient safety advocates in the room, yet frustrated with the lack of traction the safety movement is having in the health care reform in Congress.

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

Posted In: General

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The new breast cancer screening guidelines demonstrate yet again why savvy patients need to understand the numbers behind risk/benefit studies before making the very personal decision about whether and how often to get a cancer screening test.

The recommendations of the U.S. Preventive Services Task Force that women hold off on routine mammograms until age 50, and then get one every couple of years instead of every year, are based on sophisticated statistical modeling that aimed to get the most benefit at the least harm. The benefit is saving lives. The harm is overdiagnosing, overtreating, and needlessly frightening women who receive "false alarms" with mammograms.

The key fact that women -- and all patients -- need to understand is that your risk of a "false alarm" depends on your risk for the disease. The lower your natural risk of disease, the higher the risk of a false alarm, and vice versa. The reason the task force said that women between ages 40 and 49 don't need screening is that with the low risk of disease in that age group, the chance of needless false alarm is much higher, and the benefit of discovering the occasional cancer is much lower.

For example, one statistical model, called the Stanford model, which the task force looked at, concluded that if women between ages 40 and 69 got mammograms every year, there would be on average 2,250 false alarms -- "false positive" results -- in every 1,000 women -- an average of two per woman tested over ten years. On the other hand, there would be a total of 164 years of life gained among these 1,000 women. When the mammograms were reduced to every other year, and only given between ages 50 and 69, the years of life gained were 99 and the false alarm rate went down to 780 per 1,000. That is the tradeoff.

Those extra 65 years (164 versus 99) of life gained among the 1,000 women also come at an economic cost: if 1,000 women have to get 10 mammograms each over 10 years, that cost is around $10 million (assuming $1,000 per mammogram).

We don't like to think about "rationing" medical care, but sensible decisions on both a personal and societal level have to take into account how much we're spending for how much gain, and what else the same amount of money could be spent on.

In my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," I have an extensive chapter on the risks and benefits of breast cancer screening at different ages. Here is an excerpt:

What about saving lives with screening tests intended to catch early cancers? Here is how that statistic of a 25 percent reduction in deaths translates in the real world. If you thought that means that of every 100 women screened, 25 of them would be saved by mammograms, you would be making a natural assumption that many others have made, but you would be very far off the mark. The actual numbers come from a series of studies in Sweden involving some 280,000 women. Of those over age forty who did not undergo mammograms, 4 in 1,000 died of breast cancer over the ten years of the study. Of those over age forty who did have mammograms, 3 in 1,000 died of breast cancer over the same ten years. The reduction from 4 to 3 per 1,000 is where the 25 percent number comes from. Put another way, for every 1,000 women who participate in mammogram screening for ten years, 1 of them will be saved from dying of breast cancer.7 The odds of saving 1 life are a little improved if screening begins only at age fifty instead of forty. Of every 270 women who start screening mammograms at age fifty and undergo one every other year for the next twenty years, 1 life will be saved—or about 4 in 1,000, which is a lot more than the 1 in 1,000 lives saved for starting mammograms at age forty.

The new statistics from the Preventive Services Task Force concluded that the benefit from mammograms in women aged 40-49 was even lower than the Swedish estimates -- more on the order of one life saved for every 1,900 women screened, instead of one in 1,000.

Here's the bottom line, as I put it in my book:

Are those kinds of odds worth it to undergo the trouble of regular screening? That is a personal decision. My only point is that to make that decision rationally and realistically, you need to look at the numbers with eyes wide open.

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

Posted In: Cancer , Medical Error , Testing

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Far more infants die in their first year of life in the United States than in most of the developed world, and new data from the Centers for Disease Control suggests one of the main reasons is premature births, and that could be helped by better access to prenatal care for mothers.

Infant mortality is a standard measure of a nation's health. The most recent numbers show that seven in 1,000 babies die before their first birthday in the United States, compared to about two in 1,000 in Singapore, the best in the world. Twenty-nine countries rank better than the U.S. -- nearly all of Europe, plus Australia, Canada, Hong Kong, Israel, Japan, New Zealand and Singapore.

A new CDC study says the U.S. has a much higher rate of premature births (before the 38th week of pregnancy), and prematurity goes hand in hand with higher death rates, not to mention long-term disabilities.

Twelve in one hundred babies are born prematurely in the U.S., compared to five in one hundred in Ireland. The CDC study says that if the prematurity rate could be cut substantially, much of the gap between the U.S. and the rest of the Western world could be eliminated.

But not all. Even among babies born at full term, the U.S. still has a higher death rate than most of the West, because of a higher risk of dying in the U.S. from sudden infant death syndrome, accidents, assaults and homicides, according to the CDC.

An article in the New York Times quotes Dr. Alan R. Fleischman, medical director for the March of Dimes, as saying

the new report was “an indictment of the U.S. health care system” and the poor job it had done in taking care of women and children. The report, Dr. Fleischman added, “puts together two very important issues, both of which we knew about but hadn’t linked tightly.”

Dr. Fleischman said the smallest, earliest and most fragile babies were often born to poor and minority women who lacked health care and social support. The highest rates of infant mortality occur in non-Hispanic black, American Indian, Alaska Native and Puerto Rican women. But other minorities have some of the lowest infant mortality rates in the United States: Asian and Pacific Islanders, Central and South Americans, Mexicans and Cubans.

The lead author of the CDC study, Marian F. MacDorman, a statistician at the National Center for Health Statistics, said American doctors also increasingly deliver babies at "late pre-term," between 34 and 37 weeks, for conditions like high blood pressure and diabetes that in earlier times they would have waited out. These late pre-term babies also have a higher risk of dying than full-term babies, but not as much as the severely pre-term babies.

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

Posted In: Accessibility of Healthcare

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Did you know that rupture of an Achilles tendon can be fatal? This common injury has one potentially fatal but preventable complication: a blood clot can develop in the calf while the leg is immobilized for healing of the injury, and if the clot gets big enough, it can travel to the heart and cause what is called a pulmonary embolism.

The Achilles tendon is the ligament that connects the calf muscles to the heel bone. When it ruptures, the patient must have the calf immobilized for several weeks. That can cause blood clots in as many as three in ten patients, because calf muscles when they flex act as a pump to help bring blood back toward the heart. Immobilized calf muscles allow the blood to pool in the deep veins of the leg and potentially clot.

Samuel Burton, a retired Coast Guard captain, died of such a clot, and a distinguished federal judge recently decided the death should not have happened. Judge Royce Lamberth, chief judge of the U.S. District Court for the District of Columbia, ruled that orthopedic surgeons at Walter Reed Army Medical Center had committed malpractice by failing to warn Capt. Burton when they were treating his Achilles tendon rupture about the risks of this blood clot and what he should do if he developed any of the symptoms of a clot.

When Capt. Burton died, his widow was shocked to learn from the medical examiner who performed the autopsy that two episodes of chest pain and shortness of breath, which Captain Burton had experienced in the weeks before his death, were signs of a potential pulmonary embolism. None of the doctors at Walter Reed had ever warned Captain Burton or his wife of this possible deadly complication and what to watch out for. She sued the government for medical malpractice under the Federal Tort Claims Act. After a trial, Judge Lamberth issued a verdict in favor of the widow, and he ordered the government to pay her $2,080,000. Judge Lamberth concluded that if the doctors had properly educated the patient and his wife, they were responsible people who would have appreciated the need to get to a hospital for treatment before it was too late. Both Captain Burton and his wife had assumed that his two episodes of pain and windedness were from deconditioning because he had resumed some physical activities after being off his feet for weeks.

The judge rejected Walter Reed's defense that since statistics showed that only about one in one hundred Achilles rupture patients died of pulmonary embolism, they didn't need to be warned about the risk.

Captain Burton's family was represented in their medical malpractice case by Patrick Malone & Associates.

Read the judge's decision here.

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

Posted In: Communication , Doctor-Patient Relationship , Hospitals , Self-care , Standard of Care--Hospitals

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Patients with newly diagnosed cancer often feel that they have been uprooted from home and tossed into a foreign land -- with strange landmarks, foreign language and more than enough fear and anxiety for a lifetime. It's very useful to have guidance from a cancer survivor who has been there. A new article by a cancer survivor and professional advisor does just that.

The article by Kathryn Gurland, "A Survivor's Compass," has eleven helpful tips for negotiating this new foreign territory. She starts with the helpful reminder that a cancer diagnosis is not a medical emergency, and you don't need to rush into treatment before you thoroughly educate yourself on all your options.

Other advice includes:

* Make sure you are memorable to the care providers, and not just "another cancer patient." Small things like wearing distinctive clothing, showing your sense of humor, talking about current events -- all can help make you stand out from the crowd, and thus form a better bond with the providers.

* Never be shy about asking for the help you need, and also making clear what you DON'T need.

Read more here.

Ms. Gurland's advice echoes that in Patrick Malone's book, "The Life You Save," which helps patients understand the vital need to get second and third opinions before they undertake cancer treatment. The heart of good care, as Mr. Malone teaches, is clear communication and complete understanding by the patient and the family of everything that is going on.

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

Posted In: Cancer , Communication

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A new study documents how lack of health insurance can be fatal to sick children -- not because they are denied care once they get to the hospital, but because they get into the care system too late.

Researchers at Johns Hopkins Children’s Center crunched the numbers of two decades' worth of children's hospitalizations -- more than 23 million hospital stays. They found that compared with insured children, uninsured children faced a 60 percent increased risk of dying.

The authors estimate at least 1,000 hospitalized children die each year for lack of insurance.

As quoted in a New York Times account of the study, which was published in The Journal of Public Health, one co-author said:

“If you take two kids from the same demographic background — the same race, same gender, same neighborhood income level and same number of co-morbidities or other illnesses — the kid without insurance is 60 percent more likely to die in the hospital than the kid in the bed right next to him or her who is insured,” said David C. Chang, co-director of the pediatric surgery outcomes group at the children’s center.

The kids without insurance tended to arrive at the hospital through the emergency room, and tended to die in less than a day after admission, suggesting they were sicker than insured children, according to the authors.

Dr. Peter Pronovost, another co-author and a patient safety advocate at Hopkins, said:

“The striking thing is that children don’t often die. This study provides further evidence that the need to insure everyone is a moral issue, not just an economic one.”

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

Posted In: Insurance

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