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.
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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.
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.
]]>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.]]>
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.
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.
]]>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.
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.”]]>
Their refrain [of the AMA leaders] is familiar to anybody following the healthcare reform debate. The only problem is that it's not true. There's nothing "sure or quick" about changing medical liability laws that will improve healthcare or its costs. Defensive medicine adds very little to healthcare's price tag, and rising malpractice premiums have had very little impact on access to care.]]>...
Tort reformers neglect the fact that malpractice reform won't save one extra life. To make that difference, insurers, doctors and their lobbyists like the AMA need to find ways to improve patient safety. So for those who push tort reform as a panacea for a sick healthcare system, working to prevent injuries is a much more noble pursuit than writing up baseless arguments for the back pages of a newspaper [in this case, the Wall Street Journal].
The pilots injured no passengers, and the event didn't even qualify as a "near miss." But because they egregiously violated safety rules by working on their flight schedules on a laptop in the cockpit, the aviation authorities did not hesitate to pull their licenses.
In the medical industry, by contrast, it is well known that a doctor will lose his or her license for only flagrant patterns of drug or alcohol abuse or other criminal behavior, with a trail of dead and injured patients usually lasting years before the practitioner is finally put out of business.
Read my entire post on this in the Huffington Post here.
One of the HuffPost comments on my blog post raised the fair point about what should be firing offenses for attorneys. Here's what I said in response:
A firing offense for an attorney should be any conduct that is unethical or negligent and hurts a client. (That's a short and probably incomplete answer to a complicated question.)In most states, the highest court of appeals of the state has power to revoke attorney licenses. Some do a better job than others. But unlike medicine, everything happens out in the open, for the public to observe.
For patient advocates like me, the frustrating part of the medical discipline system is its secrecy and unresponsiveness. I filed a formal licensing complaint about a Maryland plastic surgeon who put a healthy patient into a permanent coma with a gross overdose of local anesthetic; two years later, I received a one-paragraph response from the state board that he had received a "private reprimand." No details available, because, after all, it's "private."
In another recent case, I complained to the Florida nursing board about a nurse-midwife whose overuse of the uterine-stimulating drug oxytocin caused the uterus to rupture and the baby to suffer terrible cerebral palsy. More than a year later, I received a one-sentence reply that the board had "failed to find probable cause."
In the law world, comparable incidents would have received at least a detailed explanation of why the licensing body was or was not taking action. That's what we should demand of any professional disciplinary system that respects the public's right to know.
The current sorry state of medical discipline is one reason I warn readers of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst," that patients need to go way beyond looking up medical licensing discipline to make sure they are picking the right doctor for themselves.
]]>That hidden influence has occurred far too often for the comfort of patient safety advocates, who want prescribing doctors to receive fair, balanced and neutral advice in the important subject of what prescriptions to write for sick patients.
Now the group that gives the official seal of approval for continuing education courses is taking tentative steps to curb the drug industry's influence on these courses. The group is called the Accreditation Council for Continuing Medical Education (ACCME). Its approval is necessary for a doctor to get official credit for any course taken. The head of the ACCME, Dr. Murray Kopelow, told the New York Times he will:
First, make public in the next few weeks a list of the classes and educational companies that have already been found to have broken the rules against commercial bias. This list was previously secret. Apparently there are less than a dozen names on the list as of now.Second, consider further steps such as requiring the sponsor of a course found to be biased to send out corrective material to the doctors who took the course.
A doctor who is pushing for these and stronger reforms is Dr. Bernard Carroll, who filed a lengthy complaint about an online course on treatment of major depression, which he said was strongly biased by hiding bad information about the drugs of the sponsor, AstraZeneca.
The Times reported:
Dr. Carroll faulted the accrediting council for taking nine months to resolve the complaint, allowing the program to rerun and failing to notify doctors who had taken it. “They’re more interested in protecting the providers than watching what gets put out there as education,” Dr. Carroll said in an interview.
Here is Dr. Carroll's own blog posting on the subject.
The steps taken so far by the accrediting body are modest, but go in the right direction. Let's keep watching. As another industry critic, Dr. Bernard Lo, said, it's okay for the drug industry to support medical education. What's not okay is to create commercial bias in favor of one or another company's products.
]]>A new study in the Journal of the American Medical Association criticizes the benefits of the "minimally invasive" surgery as oversold. The operation does cut the average time in the hospital from three days to two, but brings with it both more short-term complications plus more long-term injuries like impotence.
The lead author is Dr. Jim Hu of Brigham and Women's Hospital in Boston. "There has been rapid adoption of minimally invasive radical prostatectomy, however, outcomes have not been superior," Hu said.
Surgeons are trained to use the robot in a weekend course with the manufacturer. Dr. Hu said that a big part of the problem could be surgeons not getting enough experience with the device. He said he has now done more than 700 robotic prostate surgeries, but "it took several hundred cases before I thought I was doing really well in preserving erectile function and continence."
Articles about the new study can be found here and here
The new study brings home an issue that is discussed at length in Patrick Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst. Choosing the right surgeon is key to success, and patients need to ask about the surgeon's volume of cases exactly like theirs. For robotic prostate surgery, it's easy to find a surgeon with hundreds of cases. If that's an option, why would anyone settle for a surgeon who has only done a few dozen?
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]]>Here is how a new article in the Dallas Morning News opens:
Seven years ago, after a scathing series of stories in The Dallas Morning News, the Texas Medical Board promised to crack down on bad doctors. Patient endangerment would be dealt with severely. And sexual misconduct, one official said, would become "intolerable."It hasn't turned out that way.
After its last meeting, in late August, the board announced decisions on four sex-related cases. Two involved doctors whom judges had already sentenced for crimes against children. Two involved psychiatrists found to have had affairs with adult patients – potentially sexual assault under Texas law, but they've not been charged.
The child abusers were allowed to go on practicing medicine, though not with kids. The other two are working without restrictions.
It's all part of a broader pattern of tolerance for misconduct, a News analysis shows. Others who kept their licenses after the August meeting include two doctors convicted of lucrative federal crimes that put patients in harm's way; a neurosurgeon who operated on the wrong body part four times; a cardiologist found to have performed dozens of invasive procedures with little or no cause; and at least seven physicians linked to a death.
In all, 131 doctors were disciplined at the meeting. Only two had their licenses revoked, and then only because they quit contesting the cases against them. A handful of others were suspended or surrendered their licenses rather than fight.
Readers are urged to look at the entire story.
This is depressingly familiar to patient safety advocates. Thirty years ago, I participated with a team of investigative reporters at the Miami Herald where we uncovered similar attitudes. (See discussion on my bio page.)
One key part of the pattern is that medical boards are dominated by physician members. There is no reason why this needs to be. Any intelligent public-minded citizen can understand issues like sex abuse of patients, drug addiction, wrong-site surgery and the other serious transgressions that the boards deal with.
Yet another problem is that even when boards act, their actions are so shrouded in secrecy that patients often never find out that their doctor has any issues. That is why in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, I counsel patients looking for a doctor not to rely heavily on a "clean slate" when they search for medical disciplinary actions. That can often be meaningless.
]]>Paul Levy posted his hospital's numbers on reducing "central line" infections -- the infections that patients in ICUs get in the large-bore tubes that have to be inserted to monitor activity in the heart and deliver medicines to really sick people. When these infections occur, the already sick patient often dies. Pioneering work by Dr. Peter Pronovost proved that rigorous hand washing and other sanitation practices can reduce these infections to close to zero.
Mr. Levy is justifiably proud of Beth Israel's hard work at getting its infection rate down. But he wrote a blog entry that talked about his disappointment that others have not joined in. Here's an excerpt:
The response to my public and private entreaties in this realm has been silence -- from hospital professionals, from insurance executives who care about a transformation of this industry, and, indeed, from public advocacy groups who care about access to care and the quality of care delivered. Some observers attribute the medical profession's lack of engagement to an underlying fear of transparency. And yesterday, a world expert in this field, whose wisdom and advice I treasure, told me that he has come to accept gradual progress in quality and safety improvement, citing the kind of training doctors get, which does not emphasize these areas. That such a person has become content with gradual changes in the status quo is an indication of what it must be like to beat your head against this wall of recalcitrance for several decades.My advantage, being without medical training and having had but a short tenure in this field, is that I retain a sense of outrage. Our collective failure to approach this problem using well established methods of process improvement -- including publication of current performance results -- represents a moral and ethical lapse by the clinical and administrative leadership of the medical establishment in this city. Why? Simply put, a profession that takes an oath to do no harm is, by inaction or incomplete action, doing harm. We are causing people to die who should not die. What would we call that if we saw it happening in other sectors of society?
Here's the full blog entry, which has comments below it.
I learned about Mr. Levy's blog from Consumer Union's excellent blog at their Safe Patient Project website.
]]>That happened in 2001. Today, Dale and her husband Gary head up a non-profit group called Justin's HOPE, which is dedicated to improving health care for children. She speaks often to medical staff in hospitals. One important message she gives to hospital administrators: When a mistake has happened, deal openly and honestly with the parents.
Any parent who can turn their grief into something positive is a real hero. Especially when that child has died an unnecessary, preventable death due to medical errors, the easier thing would be to retreat into numbness and bitterness. So I salute Dale Micalizzi.
I celebrate a number of heroes of the patient safety movement in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.
You can read more about Dale's advocacy in an article in the Schenectady Gazette.
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