February 27, 2015

Why Can’t Doctors Face Death with Honest Conversation with Patients?

Few things are harder than watching your spouse die, especially when he’s in the prime of life. That sad situation was made worse for one woman because her husband’s doctors never spoke frankly about his prognosis.

Nora Zamichow began her heartfelt essay in the Los Angeles Times simply and directly:

“There is one word most doctors hate to say: dying.

“Many of them will go to great lengths — even subterfuge — to avoid it.

“Sure, nobody likes to deliver bad news. But shouldn't physicians have mastered that?”

Of course they should. The practice of medicine is — or should be — as much about taking care of the whole person as it is about the body part. Communication is key to connection, and without connecting you can’t treat someone fully.

Zamichow’s essay referred to a recent study of doctors whose patients were dying; only 11 in 100 of those caregivers said they personally spoke with their patients about their chance of dying.

End-of-life care should be just as excellent as the delivery of a new life. Good medicine is good medicine. (See Patrick’s newsletter, “Dying in America: A Necessary Conversation.”)

Zamichow’s husband, Mark, died at 58 from an inoperable brain tumor. None of his doctors ever told him that he was going to die. But they did tell him, early on, that he might live another five years.

That was before they clearly saw the handwriting on the wall, and instead of reading it to the couple, they offered euphemisms that, as Zamichow wrote, “even I, a former medical reporter, couldn't decipher. Or they hinted, saying, ‘Treatment isn't going our way,’ without ruling out the possibility that it might go ‘our way.’ Finally, toward the end, doctors said, ‘Soon consider hospice.’”

Zamichow understood that predicting a window of death is difficult. She got that caregivers don’t want to extinguish hope in a patient or his loved ones. And, like everyone familiar with U.S. health care these days, she knows that doctors often don’t have time “for the kind of conversation that must occur when they forecast death.”

Zamichow pointed to the technological advancements that have changed the art of diagnosis so significantly. “Doctors no longer count on in-depth conversations with patients eliciting intimate details about symptoms,” she observed. “Instead, they consult a battery of test results and scans.”

They type notes into an electronic device during discussions with patients, prompting one doctor Zamichow spoke with to comment, "Intangible things get lost, like talking to patients."

Zamichow told her husband herself that he was dying, without any professional support, without anyone on hand to answer questions he might have that his wife wouldn’t be able to answer.

That’s just wrong.

Zamichow had learned that her husband was "failing to thrive" only when she attended a meeting in an intensive care conference room with five doctors, only one of whom she had met, briefly. The purpose of the meeting, she learned, was the treatment plan for Mark.

His tumor had been diagnosed weeks earlier, when the discussion had been about radiation and chemotherapy in an effort to buy him more time. But in the ICU conference room, Zamichow recalled, “no one actually used the word ‘dying.’ They said they could no longer help him. One doctor advised hospice. I felt like the air had been knocked out of my lungs. No one had hinted previously that my husband's situation was so dire. Instead, we had been told about people who managed to live years with a brain tumor.”

How does someone in this situation not feel sandbagged by the very people she’s supposed to trust?

Just two days earlier, the oncologist had been optimistic, mentioning several treatment options, then cheerily telling Zamichow that he was going on vacation and would see them when he returned.

That’s when she called their family doctor, who told her, "Your oncologist has not leveled with you.”

“Those are words, Zamichow wrote, “no one should have to hear.”

The family wondered why they didn’t know Mark was dying until a bunch of strangers in a conference room told Zamichow.

“Was it our obstinate desire to cling to every shred of hope in spite of evidence to the contrary?

“I don't think so.”

Zamichow’s research yielded the shocking fact that the average four-year medical school program devotes only 17 hours of instruction on death and dying; that in 2013, only three of 49 accredited schools of public health offered a course on end-of-life care.

“Students do not learn more about dying,” Zamichow summarized one report, because death is considered “a medical failure.”

“In effect,” she acknowledged, “we have created a medical system that treats death as a separate event having nothing to do with life.”

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February 26, 2015

Gravely Ill People Soon Will Have Faster Access to Experimental Drugs

The FDA is proposing that doctors have easier access to experimental drugs for patients suffering dire illnesses who have no other options for treatment.

An editorial published in the New York Times commended the feds for reducing the time involved in applying for the right to use an experimental drug for an ill person from 100 hours to less than one.

The FDA’s proposal reflects a policy implemented when the AIDS epidemic began. Its intent was to allow “compassionate use” of experimental drugs even though their safety and efficacy hadn’t been proved. The policy has expanded, but, like many regulatory functions, has become too complex.

Currently, doctors must provide 26 separate pieces of information accompanied by seven attachments; the new form seeks only eight kinds of information, including the patient’s clinical history and the doctor’s reason for choosing the experimental drug, and a single attachment.

In a breath of fresh bureaucratic air, the FDA won’t deny doctors who want the drugs now, although the proposed new process, which was announced in early February, won’t be final until the 60-day comment period has elapsed.

But be advised that just because someone wants an experimental drug that doesn’t mean he or she will get it. As The Times wrote, “Patients are eligible only when there is no other product that can diagnose, monitor or treat the patient’s disease or condition and the patient cannot be enrolled in a clinical study testing it. The doctor must determine that the probable risk from the experimental drug is not greater than the probable risk from the disease. And the doctor must ensure that the manufacturer is willing to provide it.”

The feds, of course, can’t force a manufacturer to provide a drug to someone; its role is providing guidance for doing it. But the FDA authorizes most requests, the paper reported, within days or even hours.

Terminally ill people are entitled by law to try experimental drugs that have passed at least the first of three phases of testing required by the FDA to assess safety. Drug trials take a long time, so these patients are allowed access to them when they’re still years away from being marketed. But manufacturers aren’t required to provide the treatment, and insurers are not required to pay for it.

The laws are known as “right to try,” and are intended to get medicine to seriously ill patients by bypassing the FDA’s role in moving drugs to market. “Once a doctor and patient decide that an experimental drug is the right choice,” The Times explained, “the laws let them apply to the drug company directly.”

The “right to try” is legal in five states — Colorado, Louisiana, Michigan, Missouri and Arizona, and 26 others are considering such a law. Delaware is the most recent, having introduced legislation earlier this month.

So far, the editorial said, “right to try” has not helped anyone obtain a drug, but supporters hope some patients will have access and benefit from it soon.

Of course such quick action is not without risk — there’s a reason drug trials take so long, and many manufacturers welcome the FDA’s role in the process. The agency “has more information about potential risks and benefits of drugs under development than a doctor or patient is apt to know,” as the newspaper noted.

But the government’s reliance on drug manufacturers to self-report side effects from their products has been called into question, so even if you’re out of treatment options and desperate for help, know that the effects of even drugs not considered experimental might be unknown.

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February 26, 2015

What Is "Home" for a Mentally Disabled Person?

Letters to the editor in the New York Times come with the provocative headline: "Can There Be Good Mental Asylums?" As the father of a 25-year-old son with severe autism, I think about this a lot.

Our son Brendan now lives in a group home which we helped set up in Silver Spring, Maryland. It seems to work for him, although for a parent, eternal vigilance is required. Brendan is out and about in the community every day: at his day program sheltered workshop, and with his "one-on-one" at weekend activities like Special Olympics, trips to museums, dinner at our house, and all sorts of good fun. That's the ideal for any human being.

But look around you. Huddled in the doorway of an office building, sitting in a prison cell -- lots of mentally disabled people have no real home.

Especially when the issue is chronic mental illness like schizophrenia, instead of a developmental disability like Brendan has, it's far more likely that the disabled person will be out on the street instead of safe in a home.

The large state mental hospitals that used to house such people are now mostly closed or greatly shrunk in size, since the deinstitutionalization movement of the 1950s and 1960s. The intent behind that movement was good. Who should have to live in a prison without a release date, when they haven't done anything wrong except be unable to take care of themselves?

But people who cannot work for a living and cannot speak up for themselves get the short end of the stick from state governments. So the community mental health system and affordable housing subsidies, which were supposed to replace large state hospitals, is overwhelmed and underfunded in most states.

And housing opportunities are spotty, and depend on state budgets and the generosity of the local community.

The debate now is over whether a new kind of mental asylum can be built to house the disabled in a more humane, life-affirming way. The letters in the Times, which responded to an op-ed piece suggesting it was time to develop a 21st century version of the asylum, do a good job of capturing the range of the debate.

One letter writer, Kathy Winer, the director of a documentary about state institutions, said:

[I]t is folly to think that we would do any better today in a time of budget cuts, mounting fear of mental health conditions, and misconceptions about what constitutes effective treatment.

Another, a disability lawyer with the ACLU named Susan Mizner, wrote:

We know that large-scale segregation leads to abuse and neglect. We also know that properly funded community treatment and housing are not only successful, but also more cost-effective. No “mental asylum,” modern or otherwise, is the solution.

Let's face facts. Plenty of non-disabled people would prefer that the disabled stay "out of sight, out of mind." Not long ago outside our local parish church, a woman lectured me that I should not bring Brendan into church because "they have televised Mass for people like him."

I ignored her. But I know that many people are uncomfortable around disabled people. They can be dangerous, for one thing. And they're different.

I have no glib answer. I do know there is no one-size-fits-all solution for what is home for a disabled person.

We as a society need to reflect quietly on what we stand for. Cardinal Roger Mahony (and before him, Churchill, Truman, Pope John Paul II and others) said:

Any society, any nation, is judged on the basis of how it treats its weakest members; the last, the least, the littlest.

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February 25, 2015

Still More Diseases Linked to Smoking

The dangers of smoking cigarettes have been well documented for a long time, but new research shows that inhaling tobacco is even more hazardous than we knew.

Scientists writing earlier this month in the New England Journal of Medicine (NEJM) found that in addition to lung cancer, heart disease and stroke, smoking also raises the risk of dying of several other diseases, including several cancers and infections.

As summarized on MedPageToday.com, smoking-related deaths increased by 17% from several diseases that, until now, didn’t have established relationships with cigarettes. This was impressive research that included data from five large cohort studies involving 1 million adult subjects, although there were some limitations to the study.

Participants, for example, were mostly white and well educated, and smoking patterns were self-reported. Also, the associations could be complicated by other risk factors such as diet, physical activity and access to medical care.

Still, the risk for smokers versus nonsmokers of dying from these disorders ranged from 30% higher for breast cancer to 500% higher for intestinal ischemia, which is injury to the small intestine resulting from inadequate blood supply.

"Although these associations should be investigated further,” the researchers wrote, “our results suggest that the number of persons in the U.S. who die each year as a result of smoking cigarettes may be substantially greater than currently estimated."

According to a report last year from the Surgeon General, 480,000 Americans die of 21 smoking-related diseases each year.

Last year we blogged about the latest (bad) news about smoking, and in 2013, we discussed myths about tobacco use. See these blogs if you want to know more about the emerging science on electronic cigarettes.

As MedPageToday noted, health officials have believed for a long time that many of the diseases newly surveyed are associated with smoking, but data to support their suspicions had been lacking. Dr. Norman Edelman, senior consultant for scientific affairs at the American Lung Association, told the reporters, "What's unique about this study is the data. They have large populations and very large numbers, which provide the statistical power to identify small, but statistically significant effects that couldn't be seen in smaller studies. Most of these [diseases] have been suspected, and now we know that there are many other things related to smoking other than the dozen or so that have already been proven."

"When you run the numbers and add up all the deaths attributable to smoking, you come up with an astonishing increase."

The research included any category that accounted for at least 20 deaths over an 11-year period. Of the 181,377 study participants who died, 16,475 deaths occurred among current smokers. Subjects were all 55 or older. Investigators analyzed data in 52 different cause-of-death categories.

Among gender-specific diseases without previously established associations with smoking, prostate cancer mortality was 40% higher in men who smoked, and breast cancer mortality was 30% higher in women who smoked.

For diseases that affect both genders, researchers found significant mortality associations with current smoking for:

  • infections

  • intestinal ischemia

  • hypertensive heart disease

  • renal (kidney) failure

  • respiratory diseases

  • liver cirrhosis

The risk of dying increased significantly as the number of cigarettes smoked increased, especially deaths from infections, breast cancer and kidney failure. But the good news, if there is any in such a grim report, is that the risk of dying of these diseases among former smokers decreased the longer they went without smoking.

The message is louder and clearer than ever: Stop smoking! You will feel better and save yourself a lot of trouble.

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February 24, 2015

Outbreak Renews Concern about Contaminated Endoscopes

Last week, an outbreak of a superbug known as CRE at UCLA’s Ronald Reagan Medical Center in Los Angeles prompted the FDA to alert hospitals and medical providers to the possibility that a medical device used for gastroenterological problems might be the culprit.

At this writing, two people have died and nearly 200 have been contacted if they recently had a specialized endoscope inserted into their throats to treat cancers, gallstones and other ailments of the digestive system.

CRE (carbapenem-resistant Enterobacteriaceae), as explained in the Los Angeles Times, are difficult to treat bacteria because they are resistant to most antibiotics. As many as half of all patients with CRE bloodstream infections die, according to the Centers for Disease Control and Prevention.

The FDA said that the design of the devices might make them more difficult to clean fully, and that even meticulous cleaning of the duodenoscopes might not eliminate the bug. The feds first warned about the problem of multidrug-resistant bacteria and duodenoscopes in 2013.

One hospital safety consultant interviewed by The Times said regulators and industry officials have been too slow to respond. “Hospitals and manufacturers often take months to assess what to do, with the infected patients being the last to know,” Lawrence Muscarella said.

“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety,” according to The Times. “Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”

Some hospitals using the duodenoscopes quarantine them for 48 hours after the initial cleaning to check for bacterial growth before reusing them on patients. If you are scheduled for such a procedure with an endoscope, make sure that it’s essential to your care, and that you clearly understand the risks as well as the benefits. Make sure that the facility has followed the cleaning and quarantine protocol.

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February 19, 2015

Patient Safety Organization Calls for Greater Transparency

The National Patient Safety Foundation recently issued a sweeping report strongly supporting transparency in health care. Transparency not only is ethical, according to the report, but it promotes accountability, leads to fewer medical errors, increases patient satisfaction and lowers costs.

The foundation’s Lucian Leape Institute held roundtable discussions with a range of health-care stakeholders who defined transparency as “the free flow of information that is open to the scrutiny of others.” The report recommends greater transparency in four areas:

  • between clinicians and patients;

  • among clinicians within an organization (such as a medical group or hospital);
  • between organizations; and

  • between organizations and the public.

“If transparency were a medication, it would be a blockbuster, with billions of dollars in sales and accolades the world over,” the report, “Shining a Light: Safer Health Care Through Transparency,” concludes.

You can read the full report here. To learn more about transparency in specific situations, link to our blogs.

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February 18, 2015

One Woman’s Losing Struggle for Medical Malpractice Relief

Too many medical malpractice attorneys are turning away too many righteous cases because they’re not allowed to play on a level legal field. The result is that people victimized by serious medical errors suffer twice, once in the medical facility and the second time by the law.

A story recently published in the Insurance Journal told the story of Jennifer Eastman, who was admitted to a South Dakota hospital in 2013 to have a dead fetus removed from her uterus. Her loss and anguish were bad enough, but they would get worse, thanks to state law that deters legitimate claims like hers.

In the recovery room after her procedure, Eastman went into shock, and a doctor who examined her failed to notice that the doctor who removed the fetus had perforated her uterus. She was bleeding to death, and not until a nurse notice something was wrong was Eastman rushed back to the operating room for emergency surgery to remove her uterus.

Her dream of having a large family ended, she claimed, because of a medical error. She wanted justice, but couldn’t find a lawyer to take her case.

South Dakota caps noneconomic damages in medical malpractice cases at $500,000. The law passed in 1976 and has no provision for increases due to inflation. If it did, the cap would be more than $2 million today.

We recently blogged about California’s ballot measure last election to address the same statutory medical malpractices limitations. The measure failed, largely due to obscene amounts of medical money poured into a campaign filled with misleading, scary advertisements.

Because lawyers generally accept medical malpractice cases on contingency — meaning they are paid only if they win, from a percentage of the judgment or settlement — they can’t afford to spend the enormous amount of time it takes to try such a case unless they are reasonably assured of winning enough to make a living.

The costs of bringing malpractice cases have become enormous, as the Insurance Journal pointed out. “The cost of each case can run into the hundreds of thousands in time and expert witnesses. And in some cases, insurance companies can swoop in and take money from an award, leaving less for the victim and lawyer.”

So in South Dakota, and other states, providing justice doesn’t pencil out, and many deserving clients won’t get any. Steve Johnson, a top plaintiff lawyer in South Dakota, told the Insurance Journal that he has decided to stop taking medical malpractice cases partly because of the cap on noneconomic damages.

“The cap is a negative in terms of being able to adequately represent people in this particular area,” Johnson said. “It simply is.”

But plenty of people on the other side raise the tired — and demonstrably inaccurate — argument that the cap is necessary to maintain a strong health-care system. Dr. Mary Milroy, president of the South Dakota State Medical Association, still believes that the cap deters frivolous lawsuits despite overwhelming evidence that there are very, very few of those, and that doctors, as she claimed, don’t live in fear of being sued.

“If people judge South Dakota as a dangerous place with no caps, they may not come here to practice,” she told the Insurance Journal.

We’ve heard that before. But in Texas, for example, provider numbers have not diminished despite a draconian damage cap plus other laws that abrogate harmed patients’ rights.

Out of 100 people who have been harmed by medical mistakes, only two or three ever attempt to seek compensation. Still, about 30 states have laws that restrict what plaintiffs can recover in noneconomic losses, which include judgments for pain and suffering, emotional distress, loss of companionship and other injuries without specific dollar amounts.

That means that people with the worst injuries — brain damage, disfigurement — can’t be compensated commensurate with their suffering, Nora Freemana Engstron, a professor at Stanford Law School, told the Insurance Journal.

So lawyers who might want to represent them have to play the percentages. If potential clients don’t have large losses not subject to the cap (such as lost wages), they often can’t take the case. Engstrom said that disproportionately hurts people who are impoverished, including women, children and the elderly, regardless of the merit of their claim.

John Hughes, a South Dakota lawyer who gets more than 100 malpractice case inquiries every year, takes only two or three. He said one consequence of the cap on noneconomic losses is that many of medical error victims end up on Social Security disability, Medicare and other taxpayer-funded programs because they couldn’t access the justice system.

“The public ends up subsidizing the health care industry and their insurance companies,” the Insurance Journal said in summarizing Hughes’ explanation.

“We have the public subsidizing negligence,” Hughes told the magazine said. “I don’t understand a system that works that way. That is not a just society that allows anybody to externalize their negligence.”

The cap effectively creates a privileged class of people and institutions that aren’t held to the same standard for negligence. South Dakota’s cap applies not only to doctors, but to dentists, chiropractors, nurses, dental assistants, nurse midwives, as well as other specialties and their corporate employers.

So people like Eastman are left bereft on many levels. “It’s the justice part that I want,” she said. “I want validation, and I can’t get that.”

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February 16, 2015

Yoga as Scoliosis Treatment? The Evidence Is Thin

ABC News recently ran a story about a woman who treated her scoliosis-related back pain through yoga, fleshed out with information about yoga as a general treatment for low back pain. That might work for some people, but the framing of the story invited readers to choose yoga in lieu of medical care without considering all the factors.

“To suggest, based on one anecdote, that readers with severe scoliosis might look to yoga as an alternative to surgery is misleading and irresponsible,” said Gary Schwitzer on HealthNewsReview.org.

It’s a common media mistake, Schwitzer said. Reporters often use only compelling personal anecdotes, instead of anecdotes plus science, to show an association that might not exist, and that can be dangerous if they spurn evidence in favor of trend in a medical situation.

Two words: measles vaccine.

There is some evidence that yoga can be an effective approach for relief of chronic low back pain, Schwitzer acknowledged, but there is no evidence that it’s a suitable alternative to surgery for people with severe scoliosis.

Scoliosis is an abnormal curvature of the spine. Most of the time, the cause is unknown, and it often presents in childhood, and affects more girls than boys. Sometimes it’s congenital, or present at birth, and it can result from a nervous system disorder that affects muscles, such as cerebral palsy, muscular dystrophy, spina bifida and polio.

According to a survey a few years ago by the Centers for Disease Control and Prevention (CDC), more than 1 in 4 U.S. adults had suffered from lower back pain within the previous three months, so there’s a lot of interest in anything that provides relief.

Readers of this blog and of Pat's newsletters are well aware that one treatment — back surgery — carries high costs and considerable risk. So a noninvasive measure like yoga should be considered, but not without knowing its scientific, as well as anecdotal foundation, and its pros and cons.

The ABC story didn’t mention cost (which even at the toniest yoga classes would be considerably less than surgery) or clinical proof. It described benefits in vague terms — “back pain patients who learned yoga had better back function and were better able to manage their pain” — without saying how often the individuals practiced yoga, how much better their back function was or what is meant by better pain management.

The story did mention one study as a randomized, controlled trial, but didn’t cite the authors, the organizations they were affiliated with or when and where the studies were published.

“While the story is correct in noting that there is a ‘lack of conclusive research,'” Schwitzer said, “we’d need more than that blanket statement to award a satisfactory rating here.”

ABC didn’t adequately explain potential harms of yoga, a physical discipline that can cause injuries, especially for beginners or people suffering from back pain. “Moreover,” Schwitzer noted, “there is no evidence that yoga is safe for patients with severe scoliosis who are considering surgery.”

The network also didn’t compare yoga with other options to treat back pain and scoliosis, and didn’t clearly distinguish between back pain resulting from scoliosis vs. other causes.

What about braces, therapeutic exercises or medications as treatment options? You won’t find them mentioned in that story.

So ABC featured a woman diagnosed with a serious spine disorder who looked like a circus acrobat in the prime of her mobility to encourage You Too! to turn pain into performance by taking your curved spine to yoga class.

It’s an appealing prescription, but an awfully thin one.

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February 15, 2015

Devices Used in Knee Surgery Had No Safety Proof

OtisMed Corporation didn’t have approval from the FDA for its OtisKnee guides before it started selling them. The FDA ultimately rejected the company’s application, saying that OtisMed failed to show that the product was safe and effective.

So why was the device used in the knee replacement surgery on Carla Muss-Jacobs, who suffered a terrible outcome?

A story reported by ProPublica.org and the New York Times explained that the tool was supposed to speed both the surgery and the patient’s recovery, but Muss-Jacobs suffered terrible pain, and had to undergo a second knee replacement.

According to the story, about 700,000 knee replacements are performed every year. It’s the most common elective surgery in the U.S., and the demand will only increase as the population ages, leaving an attractive market for companies that serve the surgical community.

OtisMed’s device was a system of guides directing the angle of the surgeon's cuts to enhance the alignment of the artificial knee. It was supposed to help surgeons tailor bone cuts to a patient's anatomy.

The FDA allows manufacturers to classify their devices, which basically lets them determine whether safety studies are required before they are sold. “That can allow some products that should receive closer scrutiny to slip by,” the reporters said.

The FDA has three classes of medical devices:

  • Class III devices, like pacemakers, require extensive testing because they are implanted or sustain or support life and could put patients at serious risk.

  • Class II devices, like powered wheelchairs or pregnancy tests, are approved if companies assure that they are similar to other devices on the market.

  • Class I devices — bandages, dental floss, forceps, etc. — must be registered but don't require premarket review because they present a low risk. They may be sold without any other FDA involvement.

For OtisKnee, OtisMed told providers that its cutting guides were a Class I device and didn't need FDA approval or clearance.

In 2008, despite an earlier surgery, Muss-Jacobs had a terribly painful left knee. Orthopedic surgeon Ronald Teed told her many doctors were using the OtisKnee device, and their patients recovered faster with less pain, she told ProPublica/Times.

She woke up from her procedure with so much pain that she couldn't stop crying. She hobbled around with a walker and couldn’t work. After six months later, she consulted another surgeon, Dr. Ira Weintraub, who said the new knee had failed and was misaligned. He performed a complex revision surgery. Muss-Jacobs walked the next day, but still had a long, painful recovery.

But the damage was done. Without an income, in 2009 she declared bankruptcy and sued Teed. The case was dismissed. (Teed told the reporters that Muss-Jacobs had refused to comply with her rehabilitation plan. "She didn't do what she was told," Teed said, "and she ends up with a bad outcome.")

Despite her legal loss, Muss-Jacobs learned of other complaints about the OtisKnee, that some surgeons questioned whether the device was safe and that it had not been approved by the FDA.

OtisMed marketed OtisKnee to providers at fancy events of the American Academy of Orthopedic Surgeons promising that it would simplify surgery and boost fees due to additional MRI scans, according to Justice Department case filings. It promised that more of a patient's bone and ligaments would be preserved, improving fit and longevity. But according to the Justice Department, none of the promotional claims had been evaluated by the FDA.

Still, number of surgeons adopting the OtisKnee doubled each month in 2007.

Teed endorsed the OtisKnee, calling the surgery in an informational video a "piece of cake,” that it would reduce the risk of infections and other complications. “Eventually, though,” wrote ProPublica/Times, Teed found problems. “He said he had taken part in an OtisMed study and was one of the first surgeons to discover that the procedures were not always working as hoped. ‘Some did. Some didn't …They weren't perfect.’"

He brought the problems to the company's attention, but said "they seemed like they couldn't figure it out." Later, he heard that OtisMed had revised the materials in the cutting guides, which might have led to them warping when they were sterilized before surgery.

“The FDA should have been sterilizing ‘the crud’ out of those things to test them,” Teed said. But he denied that faulty cutting guides were the problem in Muss-Jacobs' case. Still, he said OtisKnee had taught him a lesson: "Don't jump on the bandwagon too early."

In December, OtisMed and its former chief executive pleaded guilty in federal court to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 OtisKnee devices from 2006 to 2009 without FDA approval.

In September 2009, the FDA notified OtisMed that it had not demonstrated that the guides were safe, and called the device a Class III device and told the company not to distribute it.

The OtisMed board voted to halt shipments, according to the Justice Department, but the company's chief executive directed employees to ship some that had been held up since the FDA denial, and 218 were sent to surgeons, the Justice Department filings state.

Did OtisKnee cause Muss-Jacobs' problems? That’s unknown, but U.S. Attorney Paul J. Fishman announced an $80 million settlement of criminal and civil charges against OtisMed, and said patients "should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved."

It’s not known how many people were harmed by OtisKnee. Finding a number wasn’t part of the Justice Department's case.

An FDA spokeswoman told ProPublica/Times that there are so many Class I medical devices that the agency usually doesn’t check to see if they are properly classified. "It's based on voluntary compliance," she said. "We presume companies know the rules and regulations."

The Muss-Jacobs case illustrates why all surgical patients must carefully investigate the tools their doctors intend to use. They must find out how long the surgeon has been using the procedure or technology, and what was the extent of his or her training. They must confirm that any device has been approved by the FDA. See our backgrounder on surgical errors and our blogs about knee replacement

As ProPublica/Times said, “An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation.”

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February 12, 2015

Report Criticizes FDA’s Drug Safety Tracking

When drug manufacturers are responsible for reporting the potential side effects of the products they develop, is it any surprise that the record is less than complete?

Last week the Institute of Safe Medication Practices (ISMP) issued a report critical of the FDA’s Adverse Event Reporting System (FAERS) because of incomplete information about injuries and harmful effects of prescription drugs. As characterized by the Wall Street Journal’s Pharmalot blog, the database consists of “haphazard reports filed by drug makers.”

The FAERS, a resource within the MedWatch program, is primarily how information is collected about potential side effects of prescription medicines. Consumers and medical providers may report problems to the FDA or a drug maker voluntarily, and the pharmaceutical companies are supposed to investigate and report about side effects their products might cause or be associated with.

But drug makers contribute most of the reports. During a recent 12-month period, the pharmaceutical industry filed more than 9 in 10 of the FDA reports, according to ISMP, a nonprofit organization that follows drug safety issues. That led the watchdog to conclude that, according to Pharmalot, “the integrity of the reporting system rests largely with drug makers, but that drug makers too often file incomplete reports.”

In more than 1 in 3 industry reports, patient age was not determined, and more than 4 in 10 lacked the date of the adverse event. The ISMP said that patient age, gender and event date must be included for a report to be considered reasonably complete. Not even half of reports filed by drug makers with serious events were reasonably complete; of those filed by consumers and doctors, 85% were reasonably complete.

Four drug makers submitted reasonably complete reports only 15% of the time or less. And NO drug maker matched the 85% completeness achievement that the average person did.

The ISMP said the number of death reports associated with drugs were “questionable.” Almost 3 in 10 reported patient deaths by drug makers lacked useful information about the cause of death or the possible role of a medicine in it. The ISMP said that fewer than 7 in 10 such reports were of “limited value,” because they contained only the word “death,” or because they lacked complete information about it.

“It makes no sense for drug manufacturers to be required to spend millions collecting and submitting adverse drug event reports promptly,” according to the report, “when so many reports contribute little to the assessment of drug safety. The FAERS system, for all its flaws, nevertheless remains the primary source for detecting new, serious adverse effects in approved drugs and identifying other risks to patients.”

Thomas Moore, one of the scientists involved in the ISMP report, told Pharmalot, “… if we don’t know how many people are being injured and which drugs are most responsible, how do we go about reducing the number of people who may be harmed every year?”

Moore attributed part of the problem to the way pharmaceutical marketing has changed since 2001. That’s the last time the FDA updated the adverse event reporting system. Consumers, providers and drug makers have so many ways of interacting these days that reports about side effects might not be based on spontaneous complaints about a drug. And that can compromise the quality of the information.

An example, said Moore, is an FDA program called REMS (See our blog, “Doctors Don’t Know Dangers of Narcotics and the FDA Leaves Drug Makers in the Driver’s Seat.”) It requires drug makers to take certain steps to minimize risk, such as restricting distribution. But a patient mentioning a possible side effect during a doctor-patient interaction might end up as incomplete database information if the FDA receives it without the drug maker determining whether the medicine caused it.

“The [FDA] regulations are outdated and haven’t kept up with how drugs are marketed today. The system is being flooded with low-quality adverse events reports and, as a result, we don’t know which drug may be suspected of causing the health problem that was reported,” Moore told Pharmalot. He suggested that the FDA should develop a better way to track contact with patients to make side effect information more definitive.

The FDA told Pharmalot that its ability to gather complete information is limited, but that the feds use “modern data-mining techniques” to identify reports of greatest value and that its Sentinel Initiative is being developed to monitor safety.

That program to collect electronic health data was authorized in 2007, and a few years ago we wondered what the delay was; it’s still not fully engaged?

According to the ISMP report, certain drug makers are regular laggards in reporting side effects of their wares. They include Par Pharmaceutical, a generic drug maker whose products include a generic version of Wellbutrin (for depression) and the stimulant Provigil; it filed complete reports less than 1% of the time, and more than 8 in 10 of those were minimally complete, which it blamed on the fact that most of its reports come from the American Association of Poison Control Centers’ annual report, which doesn’t include event dates.

Pfizer submitted the most reports (more than 35,400), nearly half of which were deemed to be reasonably complete and nearly 7 in 10 of which were minimally complete.

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February 11, 2015

Getting What You Need — and No More — From Cold and Flu Medicine

A lot of people have colds and flu this time of year, and a lot them buy over-the-counter medicine to help them feel better. But the sheer number of remedies is overwhelming, as is the variety of symptoms they supposedly treat. What’s a consumer to do?

A recent article in The Atlantic offered useful information to help people understand what these products promise, how they deliver and how to spend your money wisely if you insist on something other than an aspirin for your headache, chicken soup for your congestion and gargling with warm salt water for your sore throat.

The average drug store, according to The Atlantic, probably sells more than 300 cold-and-flu products. Some are generic, and some are brand names, with increasingly narrow application. “Remember when Mucinex was Mucinex?” the article asks. “You could take Mucinex, and it broke up your mucus, and you expectorated out some mucus and went about your business. Now there is Mucinex Fast-Max DM Max; Mucinex Fast-Max Severe Congestion and Cough; Mucinex Fast-Max Cold, Flu, and Sore Throat; …”

About 1 in 4 people who buys an over-the-counter medicine to treat a headache chooses a brand name product. But pharmacists, the report says, almost always go for a generic. That’s because they know, and trust, that the drugs are identical.

Generic drugs by law must contain the same active ingredient as the brand version they copy. They might be compounded differently, or delivered differently, but they must be “bioequivalent,” which means that the body absorbs, or metabolizes, different formulations of the same drug or chemical in the same way.

In The Atlantic’s comparison, Bayer aspirin cost $6.29 at CVS, and the same amount of CVS-brand aspirin cost $1.99. “The difference in price between brand names and generics accounts for tens of billions of dollars ‘wasted’ every year by Americans in pharmacies,” the story says.

Consider the Mucinex complication. Mucinex Fast-Max DM Max seems to say you’ll feel better faster, but it’s really just Mucinex plus a common cough suppressant, the same one found in almost every other cough-suppressing product: dextromethorphan. So a generic cough medicine will have the same amount of dextromethorphan as a brand name that also relies on that synthetic drug.

Mucinex Fast-Max DM Max has the same active ingredients as Mucinex DM, but the delivery system is different — it’s a liquid, not a pill. Mucinex Fast-Max Severe Congestion and Cough is identical to Mucinex Fast-Max DM Max, but it also has some phenylephrine (also sold as Sudafed), which is a decongestant. Fast-Max Cold, Flu, and Sore Throat is identical to Mucinex Fast-Max Severe Congestion and Cough, but it also has some acetaminophen (also sold as Tylenol), which is a pain reliever and fever reducer.

There are all kinds of Tylenol and Sudafed products, too. They’re all pretty much the same five-ingredient stew, mixed in different ways. Each ingredient can be purchased individually in less expensive generic forms, or in various generic — and less expensive — combinations.

That’s not only more cost-effective, but helps you control the amount of the drug easier. In the case of acetaminophen, that’s critical, because too much can cause liver damage. (See our blog, “Understanding Acetaminophen and How to Make It Safer.”) Lots of cold/flu meds with diphenhydramine make you sleepy, so some people might not want to take it. The decongestant phenylephrine can make you dizzy, lightheaded or shaky. You might want to control how much of that you take, especially if you main complaint is congestion.

Although the FDA has a info sheet on myths and facts about generic drugs, The Atlantic doesn’t think much of it, claiming that it’s 12 years old and offers outdated information. (The site wasn’t available when we last tried it — maybe the feds got the message, and are update it.)

One source of cold medication advice the magazine likes comes from the health-information company Iodine. It’s a user-friendly site where you type your symptoms and get recommendations for meds that address them using a database of common cold-and-flu products. You also get product reviews, dosage forms (liquid or pill), active ingredients and the names of generic versions at various pharmacies.

"I know that people, in large part, just walk into a drugstore when they have a cold and grab DayQuil or Tylenol Multisymptom Cold, or whatever, because they know it's going to cover the symptoms that they have," Dr. Amanda Angelotti told The Atlantic. She’s the company’s head of product. "But I also know that a lot of people are taking more ingredients in these combination meds than they actually need. That's going to put them at risk for side effects or overdose, especially with Tylenol. And there are dangers, like for someone with high blood pressure who is taking phenylephrine."

Say you take NyQuil not necessarily for your cold symptoms but just to help you sleep. What you really want is that product’s diphenhydramine (Benadryl), which you can buy for a lot less money, and a much greater sense of safety.

To learn more about generic and brand name prescription drugs, see Pat Malone’s newsletter, “Becoming a Smarter Buyer of Prescription Drugs.”

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February 9, 2015

Experts Advise How to Prepare for Surgery

Anyone who’s ever had surgery or helped a loved go through it knows it’s scary, even when the outcome is terrific. To help patients wrap their minds around a possible date in the OR, Dr. Edward H. Livingston offered advice in a recent issue of JAMA, “What to Ask Your Surgeon Before an Operation.”

Following these excerpts of his article are notes about a new public service video, “Speak Up: When You’re Having Surgery,” produced by The Joint Commission, the nonprofit that accredits and certifies more than 20,500 health-care organizations and programs in the U.S.

Livingston says all patients should ask their surgeons these questions:

1. Do I need surgery?

Before an operation, Livingston said, you should understand what disease or disorder you have and if there are ways to treat it without an operation. Find out if your problem is common, and if there’s anything unusual about your condition.

2. How do I know if the surgeon and hospital where the procedure is scheduled are a good match for me?

We must note that insurance coverage directs most patients toward certain facilities, so this isn’t an open-ended inquiry. Still, for the providers within your plan’s network, you should ask your surgeon about his or her training for your operation: Where did he/she learn how to do it, and how extensive was the training? How many times has he/she performed this procedure? How many patients with your problem does your surgeon treat? Who are the other doctors your surgeon will work with during your operation?

Physicians must be licensed to practice medicine in the state where they practice, and although they don’t have to be board certified or belong to professional organizations, it’s better if they have these credentials. So ask if your surgeon is board certified and, if not, why not.

If your surgeon plans to use a certain technology, such as laser or robotics, ask why it is better than conventional approaches to your problem and how much training and experience he or she has had with it. “Surgeons learning newer techniques may have learned them during a very brief course,” Livingston wrote, so “ask about this.” And see our blogs about robotic surgery.

Also, discuss your options for anesthesia with your anesthesiologist before the surgery, and make sure you understand the possible side effects, how long they should last and what you can do to minimize them.

3. What can I do before surgery to help get the best outcome?

Should you exercise? Stop smoking? Go on a diet? Achieve better control of your diabetes? Should you stop taking any of your regular medications? You might be advised to bathe the day before surgery with special cleansers to minimize the risk of infection. You might have to fast or cleanse your bowels before surgery.

4. What happens after the surgery?

Ask your surgeon how much pain you should expect, how it can be managed and who’s responsible for it. You should know that surgery often requires short-term restrictions in activity, driving and/or diet. Ask how long you will be unable to work (make sure the surgeon knows what type of work you do). Will you need help after the surgery? From whom? What resources are there to get help if you need it after the surgery?

What type of complications might occur? How often do they occur and what happens if you have some? If you have a problem after leaving the hospital, whom should you call and/or where should you go for help?

How available is the surgeon after the procedure? Can you contact him or her at night or weekend? If not, who’s available for emergency care and what is his or her experience taking care of patients like you?

In closing, Livingston advised patients to get more information from the American College of Surgeons.

The Joint Commission reinforces much of Livingston’s advice, and encourages patients to:

  • Speak up if you have questions or concerns. If you still don’t understand, ask again. It’s your body and you have a right to know.

  • Pay attention to the care you get. Always make sure you’re getting the right treatments and medicines by the right health-care professionals. Don’t assume anything.

  • Educate yourself about your illness. Learn about the medical tests you get, and your treatment plan.

  • Ask a trusted family member or friend to be your advocate (advisor or supporter).

  • Know what medicines you take and why you take them. Medicine errors are the most common health care mistakes.

  • Use a hospital, clinic, surgery center or other type of health-care organization that has been carefully checked out. For example, The Joint Commission visits hospitals to see if they are meeting The Joint Commission’s quality standards.

  • Participate in all decisions about your treatment. You are the center of the health care team.

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