July 28, 2015

Medical Device Bill Needs Greater Scrutiny and Patient Protections

Earlier this month, the U.S. House of Representatives passed legislation that was promoted as a way to streamline the FDA’s process for approving medical devices in order to deliver new treatments to patients sooner.

But some voices have been raised in opposition to the measure because they believe it feeds the worst of commercial instincts while compromising patient safety. Writing in the New York Times, Drs. Rita F. Redberg and Sanket S. Dhruva, both cardiologists, are among those hoping the U.S. Senate takes a more critical view of the 21st Century Cures Act, commonly referred to as Cures.

Although the FDA has regulated approval of medical devices since 1976, the writers noted that the agency has not kept up with technology. “Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials),” they pointed out. “And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).”

That accounts, they said, for the disturbing frequency of the FDA issuing warnings and recalls after products entered the consumer market and were found to be dangerous. We often write about such events.

Redberg and Dhruva alluded to the 2009 recall of Sprint Fidelis defibrillators, which had been implanted in hundreds of thousands of heart patients and had malfunctioned frequently, causing not only harm but numerous deaths. They wondered, in light of the FDA’s weak record, how many other products of lurking danger remain undetected.

Cures, the authors contended, invites medical device manufacturers to submit evidence of safety and efficacy based on sources other than clinical trials, such as case histories. Those aren’t science, but anecdotes that relate the experiences of individual patients.

Is that really how we should be stamping approval on medical treatments? By relying on the experience of people who might not reflect reality, much less majority?

Cures also would promote faster approval for what it refers to as “breakthrough technologies” “that are believed,” the authors wrote, “but not necessarily proved to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk.”

Earlier this year, we wrote about an FDA proposal to grant gravely ill people faster access to experimental drugs, but that’s different from the Cures definition of “breakthrough.” Those people have no other options and limited time for any treatment. In contrast, Redberg and Dhruva believe that this legislative interpretation creates “a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.”

No one familiar with Big Pharma’s and device manufacturers’ habits of hiding bad trial results and working to shape reports to their benefit would doubt that claim.

Basically, the op-ed writers said, Cures would shift the burden of evidence to clinical studies that are conducted only after the new devices have been put on the market. That means delays of months and maybe years, because the lag time of such studies is that long. Many are never completed, the writers commented, and when they are, the results often are not made public.

Cures mentions “timely postmarket data collection,” but in the medical realm, where precision should rule, that’s too vague. You can’t enforce something that’s vague, as history informs. “[A]ccording to a 2014 journal article co-written by one of us,” the writers recalled, “the FDA has never issued a warning letter or penalty for a postmarket study delay.”

Let’s say a postmarket clinical study does conclude that a medical device is dangerous; it’s still difficult to yank it off the consumer shelves. “In 2005, … an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence,” Redberg and Dhruva wrote, “the FDA did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.”

After a medical device is approved by the FDA, its manufacturer still can alter it. For example, it might change to a different gauge wire, or a new material. The FDA is supposed to monitor and approve such changes to ensure the device remains safe and effective. Cures, the writers pointed out, essentially gives this oversight the heave-ho.

“[A]larmingly,” they wrote, “[Cures] would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay [our emphasis] — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.”

It’s one thing, an appropriate and righteous thing, for the government to acknowledge and address the need to expedite medical treatments people need to heal, or to retard their decline. But’s it’s another to take action that appears to do so while actually inviting greater harm and ethical sleaze. Cures, according to Redberg, Dhruva and a whole lot of thinking people who are paying attention, “would subject millions of Americans to unsafe or untested medical devices.”

We and they hope that when the Senate considers the bill that it eliminates the dangerous provisions. “Unlike medical drugs,” they pointed out, “which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the FDA are needed to ensure that innovative medical devices lead to better health.”

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July 27, 2015

Heartburn Drugs and Osteoporosis — A Dubious Connection

Proton pump inhibitors (PPIs) are drugs widely prescribed for gastroesophageal reflux disease (GERD). In recent years, concerns have arisen over a perceived association with PPIs and increased risk of bone fractures.

Commonly referred to as acid reflux, symptoms of GERD include burning in the chest, neck or throat caused by stomach acid moving up into the esophagus. PPIs are prescribed for it, as well as stomach and intestinal ulcers and inflammation of the esophagus. The medicine, whose brand names include Nexium, Prilosec, Prevacid and Protonix, reduces the amount of acid in the stomach.

Alarms have been sounded from some quarters that PPIs can lead to osteoporosis, which occurs when bones become brittle and fragile from loss of tissue, usually because of hormonal changes, such as those associated with menopause, or due to a deficiency of calcium or vitamin D.

Writing on KevinMD.com, Dr. Michael Kirsch, a gastroenterologist, said patients often ask him if their heartburn meds, many of which are available in reduced dosages over the counter, cause osteoporosis.

Generally they are worried because of something they’ve read on the Internet. “Patients today are incredibly informed, and sometimes misinformed, about their medical conditions and their treatments,” Kirsch wrote. “Most of their information is from the Internet, and it’s easy for patients to become unwittingly trapped in the world wide web.

“The information dangling in cyberspace is entirely unregulated. Information can be made to appear authoritative and objective when it actually is a paid advertisement.”

His point is that special-interest blogs can appear as purely informative when their real purpose is to sell stuff. (Our patient safety blog strives for authority and objectivity, even though our website spotlights our legal services; just because a blog has a special interest doesn’t mean it lacks useful, helpful information.) Readers must take care to understand who’s providing the content, and why, and they should understand how it is sourced.

“I personally do not believe that Nexium can break bones,” Kirsch wrote, “although I have read the same articles in the lay press that arouse my patients’ concerns. I understand that a headline such as, ‘Nexium Linked to Hip Fractures,’ will make my Nexium users so nervous that they might get wobbly and slip and chip a hip.”

He said that there is no convincing medical evidence that any given individual who takes Nexium or another PPI has any significant risk of sustaining a fracture. We would note that “your mileage may vary”; that is, some individual medical profiles might put a person at a higher risk, depending on underlying conditions, genetics and lifestyle.

But, according to Kirsch, “The belief that [PPIs] can cause or accelerate osteoporosis is derived from large, pooled medical studies that are not truly capable of concluding cause and effect, a critical point often omitted from your hometown gazettes.”

We’ve written before about the crucial difference between “association” and “causation,” which is not a distinction some popular media bother to make, often because headlines are sexier when you can make sweeping statements the science doesn’t support.

Still, “[N] o patient should be on Nexium, or any medication, unless certain requirements have been satisfied,” Kirsch made clear. Before he prescribes medication for a patient, here’s what he, and any good doctor, considers:

  • Is the drug absolutely necessary?

  • Am I prescribing the lowest dose of the drug necessary for the medical task?

  • Is a safer alternative medication or other treatment available?

To this list, we encourage patients to ask:

  • What are the expected results of taking this drug, and how soon should I experience them?

  • What are the potential side effects, and is there anything in my medical history that indicates I’m more likely to experience them?

“If you want a second opinion on any of this,” Kirsch concludes, “try the Internet. That’s where I go when I need reliable medical information.”

Just remember: Reader beware.

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July 26, 2015

The Potential Cost of Waiting to Name the Baby

Of all the medical mistakes that could be made in the first hours of a newborn’s life, few lay people would think to attribute any of them to a delay in naming the infant. But neonatologists (doctors who treat ill or premature newborns) know that the unnamed wee ones under their care are more likely to be on the receiving end of a medical error.

When a baby is born and the parents are still dithering about what to call him or her, hospitals use a generic gender descriptor on the patient bracelet — Babygirl Smith, for example. Once the kid is entered into hospital records with that ID, it’s often there until the baby is discharged, even if he or she gets a real name in the meantime.

A study in Pediatrics conducted by researchers aware that such anonymity can invite problems tested a new naming method to see if it reduced potential errors.

As reported on NPR, it’s believed that generic baby names increase the risk of the wrong treatment being given to the wrong patient, especially if the baby is in the neonatal intensive care unit, where about 12 in 100 newborns land.

The neonatal ICU, or NICU, is filled with tiny, often fragile beings requiring complicated care. According to the study’s lead author, Dr. Jason Adelman, an internist and patient safety officer at Montefiore Health System in New York, "All neonatologists know [generic naming] is a problem, but weren't able to quantify it."

His team changed naming convention by using a real first name — the mother’s. Instead of Babygirl Smith, that baby would get the ID Donnasgirl Smith. Twins would be 1Donnasgirl Smith and 2Donnasgirl Smith instead of the standard BabygirlA and BabygirlB.

Researchers compared the rate of so-called retract-and-reorder (RAR) events in the years before and after implementing the new ID system. “Retract-and-reorder,” NPR explained, “is a tool that uses the hospital's computer system to flag medical orders retracted by a health-care worker and then placed by the same worker on a different patient within a short time period.”

The study showed that RAR events declined by more than one-third in the year after the intervention compared with the earlier period.

That doesn’t prove that the new ID system is superior to the old one, but it’s food for hospital thought to consider revising clinical practice.

Keep in mind that the RAR tool does not track medical errors, just close calls. As Dr. Gautham Suresh, a neonatologist not involved in the study explained to NPR, "Say I'm driving down the highway and I almost take the wrong exit but then swing back into the right lane and take the correct exit later. RAR is catching those times when I almost took the wrong exit."

The researchers also noted that RAR slightly over-reports wrong-patient errors because it includes some false positives. That’s when a test indicates something amiss that leads to more tests and the possibility of complications (such as infection) when, if nothing had been done in the first place, no harm would have occurred.

Although his study analyzed only computerized orders, Adelman said the new naming system has the potential to lower the rate of other kinds of errors, some as simple as taking the wrong container of pumped breast milk from the refrigerator.

Suresh said the study advanced the body of knowledge, but he didn’t go as far as to advise that the new ID system be widely implemented. But he did advocate for further attention to the traditional way babies are named in the hospital, and noted that other factors contribute to wrong-patient mistakes, such as human distraction or poor lighting. "Patient identification errors are complex, and the name is only part of the puzzle," he says.

The simplest way to avoid them, of course, is to figure out what to call your kid before he or she arrives. Come on, mom and dad … it’s not as if Baby has a vote.

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July 24, 2015

Patient Deaths at NIH Lead to Blood Banking Reforms

July 25 marks the anniversary of a blood transfusion error between two federal health agencies in 2011 that was implicated in the deaths of two patients at the National Institutes of Health (NIH) in Bethesda, Md.

Two patients being treated at NIH received transfusions of platelets from a single donor that were contaminated with the dangerous gram negative bacteria Morganella morganii. Both patients died, one within a few days and the other after six weeks of intense treatment, which never overcame the shock to the patient’s system of receiving a direct injection of bacteria into his bloodstream.

The originating source of the platelets – and where the actual contamination occurred – was the blood bank facility of the former Walter Reed Army Medical Center (WRAMC) in Washington, D.C. The incident occurred as the WRAMC blood bank was in the process of being shut down and activity transferred to the National Naval Medical Center (NNMC) in Bethesda, although the closure did not appear to have anything to do with this event.

As the medical facility receiving the contaminated platelets, the NIH does not routinely test incoming blood products for safety but relies on the originating blood bank to do the necessary testing.

It was not until after the fatal infusion of the contaminated platelets that laboratory testing by NIH revealed that the platelets had been contaminated with the Morganella bacteria.

The two patients receiving the contaminated platelets went into immediate and profound septic shock.

One, Richard H. Bowen, Jr. (age 34 at the time) died 44 days after receiving the contaminated platelets. Bowen was the partner of Darryl A. Wahlstrom, who is co-authoring thisblog with attorney Patrick Malone, who represented Bowen’s estate and Wahlstrom in a lawsuit against the federal government.

The government admitted that the contaminated platelets sent both patients into shock but disputed the role of the transfusion in causing their deaths.

The root cause of this event is publicly documented in the “Joint Statement of Material Facts Not in Dispute” from court papers filed by the government in the Bowen/Wahlstrom lawsuit, Civil Action No. 12-1225, in the U.S. District Court, District of Columbia.

The safety testing of the platelets included two separates tests, one for bacterial contamination and a second test for the presence of viruses.

The platelets tested positive for contamination with the bacterial test. Due to the presence of the Morganella bacteria, the bag of platelets was deemed unsafe and given a quarantine status in the electronic system (database) of the blood bank.

During the testing process, an operator observed that the results from the second (virology) test were incomplete and erroneously attributed the quarantine status of the platelets to the fact that test results were still pending, and thus removed the quarantine status once the virus test came back negative.

Blood bank operators then indicated that the platelets were safe for infusion and released them for delivery to NIH without looking back at the previous positive bacterial testing.

The bag containing these contaminated platelets was then sent from the blood bank at WRAMC to the NIH Clinical Center's Department of Transfusion Medicine. The volume of platelets delivered to the NIH was split and administered separately to two different patients, with terrible consequences for both of them.

Any system intended to protect the health and well-being of patients must be designed to foresee and block the kind of human error that happened here. In this case, blood banking officials at the new blood bank at the combined Army/Navy facility in Bethesda, now known as Walter Reed National Military Medical Center, admitted to Wahlstrom in the course of the lawsuit that the old procedure at WRAMC was deficient.

They changed the procedure so that once any blood tests positive for any kind of contamination, the bag of blood must be labeled with a permanent sticker “contaminated, do not use,” and the bag must be physically isolated from other blood intended for human use.

Under the old policy, the quarantine was in only a computer listing that was easy to overlook. If such a physical quarantine policy had been in place in 2011 at WRAMC, the incident that infected the two patients at the NIH in July 2011 would never have occurred, because the contaminated platelets would have been isolated as soon as the test came back positive for Morganella bacteria.

The study of blood safety is referred to as hemovigilance, from the roots “viligare” (to be watchful) and “hemo” (blood). The reason hemovigilance is so important isbecause lethal repercussions can occur if the system and procedures lead to outcomes (contaminated blood products) that deviate from the ones for which the system is designed (safe blood).

Great strides in the safety of blood products and transfusion procedures have been made. Fatal occurrences are rare. Medical providers, however, must remain vigilant to ensure improvements continue to be made and that systems, procedures, and human involvement are designed and integrated that prevent avoidable errors from occurring in the first place.

Richard Bowen Jr. had advanced, stage IV metastatic gastric cancer at the time he received the contaminated platelets. This was a few days after he had undergone extensive, experimental surgery at the clinical branch of the NIH, intended to measure whether such surgery could prolong life. Some patients in the experimental group were still alive three-plus years after their treatment. Whether that would have happened for Bowen can never be known.

But what is certain is that the contaminated platelets snuffed out any hope he had for meaningful survival.

Patients come to a world-class facility like the National Institutes of Health in search of hope and to receive the best medical care possible for their condition. If any medical institution should stand as an exemplar of quality and safety, it should be the NIH. The associated Walter Reed National Medical Center, across the street from the NIH in Bethesda, also should be a beacon of high quality care for our uniformed service members and all those touched by military medical care.

We hope both the NIH and the military have learned the lessons from this case about the importance of vigilance in protecting the safety of blood supply that sick patients depend on.

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July 23, 2015

Medical Considerations for Buying Travel Insurance

At this time of year, many people are in vacation mode, and some purchase travel insurance. But if you don’t have pre-existing medical conditions, should you insure your trip with medical coverage?

According to KaiserHealthNews.org, “Most comprehensive travel insurance policies cover pre-existing conditions if you buy coverage within 14 to 21 days of making your first trip payment, says Lynne Peters, insurance product manager at insuremytrip.com, a website that offers plans from 25 companies.”

But if you’re traveling sooner than that, you can still get coverage if you haven’t needed medical attention recently for a chronic issue such as diabetes or back trouble.

Most underwriters offer relatively short “lookback” periods, which means that if you file a claim, your medical records will be reviewed for pre-existing conditions usually from 60 to 180 days before the policy became effective.

During that window, if you didn’t get medical treatment or testing, if you had no changes in your medication or recommendations from a physician related to a pre-existing condition, your claim should not be denied because it was deemed to be pre-existing.

As always, read any policy you’re considering thoroughly to ensure you understand its limitations and so that you don’t pay for coverage you don’t need. In addition, see our blogs on travel risks.

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July 22, 2015

Doctor Who Defrauded and Disabled Is Sentenced to Prison

In a particularly offensive and harmful misuse of professional authority, a doctor in Detroit was sentenced earlier this month to 45 years in prison for defrauding insurance companies of millions of dollars and poisoning hundreds of patients with chemotherapy treatments when they didn’t even have cancer.

Those weren’t the only crimes committed by Dr. Farid Fata, whose sordid tale was recounted by the Detroit Free Press last week. Rather than helping terminal patients die peacefully, he ordered unnecessary treatments that prolonged their suffering. And rather than treating true cancer patients properly, he withheld appropriate treatments if he made more money doing that than by addressing their need.

He was arrested two years ago and last year he pleaded guilty to fraud, money laundering and conspiracy to pay and receive kickbacks. His federal prison sentence reflects the violation of more than 550 patients’ trust and a more than $17 million haul from fraudulent billings. Federal prosecutors said it was the most egregious case of medical fraud they had ever seen.

"This is a huge, horrific series of criminal acts that were committed by the defendant," the Free Press reported U.S. District Judge Paul Borman saying before sentencing Fata. The judge said the prominent oncologist "practiced greed and shut down whatever compassion he had."

According to U.S. Attorney Barbara McQuade, "Chemotherapy, as you know, is poison. Dr. Fata gave poison to people who didn't even have cancer ... to make money."

One of his victims was Kenneth Paul Loewen, who died last year at 62. He had esophageal cancer for which Fata started chemotherapy before he even healed from surgery. He also was prescribed Neulasta, a strong drug that proved to be unnecessary and made him sicker. Loewen was scheduled for eight radiation treatments one day after Fata was arrested; when he consulted different doctors, they told him he didn't need radiation.

Testimony in the case included accounts of more than 20 victims who told heartbreaking stories. One healthy person underwent chemotherapy and lost nearly all of his teeth. One patient was diagnosed with lung cancer when he actually had kidney cancer. In some cases, Fata gave patients with no documented iron deficiencies overwhelming amounts of iron; sometimes, he gave patients lower-than-needed doses of chemotherapy drugs.

In court, Fata admitted his crimes. “In some cases,” the Free Press reported, “he gave nearly four times the recommended dosage amount of aggressive cancer drugs; in at least one, a patient was given toxic chemotherapy for five years when the standard treatment was six months, according to former patients and experts who testified in court this week.

‘I misused my talents ... because of power and greed. My quest for power is self-destructive,’ Fata told the court before sentencing. He said he is ‘horribly ashamed of my conduct’ and prays for repentance.”

Fata’s criminal behavior was investigated thanks to an office manager-turned-whistleblower. Among the agencies involved in his prosecution were the FBI, IRS and U.S. Department of Health and Human Services.

Although Fata is in jail and his medical license has been revoked, it may be difficult to find mercy for such a loathsome creature. But the survivors of some of his victims managed to do so. Sydney Zaremba's mother died fewer than four months after Fata started chemotherapy for an early stage tumor in her neck that he overtreated with drugs. Still, Zaremba believed Fata was sincere.

"I actually cried," she told the paper. "I had felt pity the first time I saw him come in in shackles."

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July 21, 2015

A Wise Man Analyzes the Renewed Attention on Statins

A couple of years ago, the American Heart Association and the American College of Cardiology revised the guidelines for prescribing statins, drugs that compromise the body's ability to produce cholesterol, to recommend that many more people take statins to prevent heart disease.

It was a controversial decision, as we described in our blog. Last week, the controversy was renewed when a couple of studies bolstered those guidelines.

When the guidelines for statin use were issued in 2013, one analysis estimated the market for the drugs would grow by 12.8 million more than under the previous guidelines, to about 56 million people, or nearly half of all people in the U.S. between the ages of 40 to 75.

To a lot of people, that sounded like medicating for medicating’s sake.

With the newly released studies in JAMA, (here and here), Dr. Harlan Krumholz, writing on NPR’s health blog, acknowledged, “You may be wondering what to do, if anything, about your cholesterol levels.”

Ya think?

Krumholz, a cardiologist, offers strong cred on the topic. He’s a professor of medicine at Yale and directs the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. He’s known for his patient-centered approach to the practice of medicine. Thoughtful people do well to listen to whatever he has to say.

He summarized the change suggested in the 2013 guidelines as moving the focus for deciding whether to take statins from your blood cholesterol numbers to your overall risk of dying from coronary heart disease or having a heart attack or stroke. “The idea is that the higher your risk, the more you have to gain from these drugs. Conversely, the lower your risk, the less likely you are to benefit,” he wrote.

The controversy was about a change from reaching a target number to reduce risk to a less quantitative assessment of health.

One of the JAMA studies published last week, Krumholz said, compared the new guideline with the old guideline for their ability to identify people who would benefit from statin therapy. “The researchers,” he wrote, “found that the new guideline, with its emphasis on risks instead of targets, was more accurate and efficient in identifying people with an increased risk of cardiovascular disease.

“… they find that the new guideline identifies more people for treatment — but that they are people who are likely to benefit from treatment. This article strengthens the case for the wisdom of the change in approach to the decision to use statins.”

That reinvigorates the problem from two years ago — the definition of what constitutes high risk among people without known cardiovascular disease. “It recommends statin treatment for people with cardiovascular diseases, such as having had a heart attack or stroke, or for those with diabetes even if they have not had prior heart disease. For others, they recommend treatment if a person's risk is greater than 7.5% in the next 10 years.”

The other JAMA study looked at the financial implications of different thresholds for treatment. It found that the 7.5% risk threshold was, as Krumholz put it, “economically attractive compared with many other investments in health care. And, in fact, they found that even a risk as low as 4% was economically attractive for society.

“For people contemplating statin therapy, the cost is quite low anyway. Most statins are generic now, and several can be bought for only a few dollars a month.”

His takeaway, as usual, was patient-driven: “[T]he researchers' findings give further support to the efforts to base the decision on the patient's preferences. It is not unreasonable from an economic perspective to support treatment decisions for even those who have a low risk of cardiovascular disease (lower than 0.5% a year), the researchers are saying.”

Krumholz said that before deciding if statins make sense, people should contemplate known and unknown side effects of the drugs, “which are particularly important for those with low risk of heart disease and stroke and less likelihood of benefit.”

He said the drugs are generally safe. But, as we wrote last month, known side effects may involve muscle problems and impaired thinking among older people. Diabetes also might figure into an individual’s situation.

And, as Krumholz noted, “The unknown side effects are, well, unknown, but there is always a possibility that lifelong therapy will involve some issue that we have yet to discover.”

“In the end,” he concluded, “I don't believe the guidelines should dictate what people should do, but only suggest how they might think about their choices.

“One of the new studies endorses the idea that treating based on cardiovascular disease risk is better than treating based on some target level. The other one suggests that treatment based on risk should be available to even low-risk people if they want treatment. We should also be clear that for them, the benefit is small and could easily be offset by any aversion to taking medications or concern about side effects.

“For anyone, the decision should be about whether the potential benefit is big enough to you, based on your preferences, to make it worth taking a pill every day.”

Amen, doctor.

For more information, see Patrick’s newsletter, “Spotlight on Statins.”

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July 20, 2015

Feds Issue Stronger Warning Against Some Kinds of Pain Relievers

For some people, it’s almost a reflex to reach for the ibuprofen when they’re hurting. But the FDA has strengthened its warning on these over-the-counter (OTC) drugs because they might increase the risk of heart attack and stroke.

Although these popular drugs currently bear packaging that says they “may cause” an increased risk of heart attack and stroke, new data showing stronger evidence of cardiac problems prompted the feds to make the warnings more forceful.

The affected medicine is in a class known as NSAIDs (nonsteroidal anti-inflammatory drugs). Brand names include Advil, Motrin IB and Aleve.

Millions of Americans rely on the OTC pain relievers for a wide variety of soft tissue complaints, such as sore muscles, tendons, ligaments and fascia, which are membranes that sheath muscle and other body parts, as well as joint stiffness. They’re also taken to reduce fever. The prescription versions generally are stronger and are prescribed to treat arthritis and other painful conditions.

As explained in the New York Times, the FDA will request that manufacturers issue new labels that say that the drugs “cause an increased risk” of serious heart failure. The agency also wants them to state that that the risk could occur early in treatment and might increase the longer the patient uses the medicine. The FDA advises people with heart problems to consult their doctor before taking these meds.

People who have heart disease, especially people who recently had a heart attack or stroke, are most at risk, according to the FDA, but the agency said that even people who had never had heart disease were at risk.

The label revision will apply to OTC and prescription forms of the medicine.

The FDA decided the current warning was not strong enough after reviewing a significant number of studies that supported the conclusion that NSAIDs caused increased risk. The studies estimated that the relative risk increased by 10% to 50% percent, depending on which drugs were involved, and at what doses.

In 2005, the FDA first warned of the risk of heart attack and stroke from taking the prescription medicines. Last year, the feds convened a panel of experts to review the studies and evidence that determined its decision this time.

If you’re hurting, before reaching for the ibuprofen, try applying ice or heat. Other options include aspirin, if you’re not at risk for bleeding, or acetaminophen if you have a healthy liver, don’t drink alcohol regularly, and take it in low doses. If you must take NSAIDs, use the smallest dose possible to alleviate your problem, take them only for a short period and check with your doctor if you have any underlying problems.

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July 19, 2015

What's Your Surgeon's Score for 'Complication-Free'?

A newly launched website tracks the complication rates of about 17,000 surgeons across the country. The idea is to help patients choose the person who’s going to operate on them based on his or her safety and performance records in comparison with their peers.

The database, Surgeon Scorecard, was established by ProPublica, the nonprofit investigative news site. It analyzed 2.3 million hip and knee replacements, spinal fusions, gallbladder removals, prostate resections and prostate removals done between 2009 and 2013 on patients in Medicare, which pays for two out of every five U.S. hospital stays.

Complications directly related to the operations included infections, blood clots, misaligned orthopedic devices and uncontrolled bleeding. ProPublica counted only cases in which the patient died in the hospital or had a complication requiring readmission within 30 days.

The analysis factored in patients’ health and age. To qualify for comparison, surgeons had to have performed a certain number of the given procedure within five years, so that apples could be compared with apples, so to speak. The team analyzed only elective surgeries because they typically involve healthier patients with the best odds of a smooth recovery.

About 11 in 100 doctors accounted for about 1 in 4 complications, but the rates for hundreds of surgeons were double or triple the national average. About 63,000 Medicare patients suffered serious harm, and 3,405 died after they had procedures generally considered low risk.

The cost of complications was considerable: Taxpayers paid hospitals $645 million solely for readmissions (inpatients who had to be readmitted within 30 days of discharge due to complications).

Another important finding was that even when hospitals identify problems with doctors' competency or practices, significant barriers impair disciplining the poor performers. Their rights of due process prolong what ProPublica deemed even clear-cut cases.

ProPublica’s analysis has some limitations,” it acknowledged. “Patients covered by private insurance were not included, which in some instances omits a substantial portion of a surgeon’s practice. And our definition of complications does not cover other types of patient harm, such as diagnostic errors or readmissions more than 30 days after an operation.”

Among the site reviewers who considered Surgeon Scorecard’s limitations as problematic was the writer of the Skeptical Scalpel blog He or she is a retired surgeon who said that “big data is not enough” to make sweeping comparisons about surgeon competence and safety.

“It took me less than a minute to discover some interesting omissions from the application,” the anonymous blogger wrote. He/she said that one procedure, laparoscopic cholecystectomy (minimally invasive removal of the gall bladder), was the only general surgery procedure listed, and that approximately one-third of the hospitals in his/her state were not surveyed.

“It looks like the problem is that using Medicare fee-for-service data does not yield enough surgeons performing 20 or more cases in some categories such as laparoscopic cholecystectomy for the five years included in the database.”

At one of the biggest hospitals in his/her state, “apparently only one surgeon performed 20 laparoscopic cholecystectomies on fee-for-service Medicare patients in the five years studied; 23 other surgeons were listed as having performed fewer than 20 laparoscopic cholecystectomies on patients in the target population. I don’t see how patients who want to use that hospital for their gallbladder surgery will benefit from the Surgeon Scorecard.”

But he/she understands why ProPublica chose that procedure to review. “They needed to select a procedure that was done frequently enough to yield a sufficient number of cases for analysis. Unfortunately, because of the limitations of the Medicare fee-for-service data and the low complication rate of the procedure, the Surgeon Scorecard is useless for anyone looking to compare general surgeons.”

He/she finds similar shortcomings with prostate surgery, a procedure also chosen because it’s done a lot. But many surgeons of the blogger’s acquaintance also didn’t perform 20 cases on fee-for-service Medicare patients, so they escaped review.

“Perhaps the next iteration of the scorecard will utilize a data set that contains enough patient and surgeon records to make a meaningful comparison.”

Those are valid points. But that doesn’t mean Surgeon Scorecard lacks value for people who want to know about potentially dangerous surgeons before they commit to their care.

Like the surgeon at Baltimore's Johns Hopkins Hospital, which is renowned for excellence and a commitment to patient safety. He had more complications from prostate removal surgery than all 10 of his colleagues combined even though they performed nine times as many of them.

Like the Florida surgeon who performed spinal fusions at Citrus Memorial, which was rated among the top 100 nationally for spinal procedures, but he had one of the highest rates of complications in the country for spinal fusions. His two colleagues had rates among the lowest for postoperative problems such as infections and internal bleeding.

Like the chairman of surgery and medical director for orthopedics at Chicago’s Weiss Memorial Hospital who had among the nation’s highest complication rates for knee replacement operations.

“It’s conventional wisdom that there are ‘good’ and ‘bad’ hospitals,” according to the ProPublica story, “and that selecting a good one can protect patients from the kinds of medical errors that injure or kill hundreds of thousands of Americans each year.

“But … when it comes to elective operations, it is much more important to pick the right surgeon.”

Many hospitals don’t track the complication rates of individual surgeons, so they can’t exercise any quality control over those who don’t measure up. The government doesn’t track doctors either.

The database reflects the fact that some subpar performers work at elite medical centers considered among the nation’s best, and that some surgeons with impressively low complication rates work at small-town clinics.

ProPublica found that overall complication rates were relatively low, ranging from 2 in 100 to 4 in 100 procedures, depending on the type of surgery. “But experts who reviewed ProPublica’s results say they strongly suggest that the typical surgeon’s rate can and should be significantly lower,” according to the story.

For example, more than 750 surgeons who did at least 50 operations did not record a single complication in the five years covered by the analysis. And more than 1,400 had only one.

Rating sites other than Surgeon Scorecard do exist, but without a report as thorough as ProPublica’s it’s difficult to know exactly how the databases were developed and their shortcomings. One new one was established by Consumers’ Checkbook, a nonprofit whose site enables consumers to type in a Zip code and search for the top-performing surgeons in 14 types of major surgery.

Its ratings also rely on Medicare claims data from more than 4 million surgeries performed by more than 50,000 doctors. Its criteria include death rates, other bad outcomes, such as infections, falls or other complications and recommendations by other doctors

It’s worth a patient’s time to learn about their surgeon’s track record. Certainly George Lynch thinks so. He nearly died from complications after a 2013 knee replacement performed by a surgeon at New York Methodist Hospital who had one of the highest complication rates on knee replacements in New York State.

Lynch contracted multiple postsurgical infections, went into septic shock and almost died. Now, he needs another knee replacement and, as ProPublica reported, “This time, he’s peppering his doctors with questions and said performance data will help guide his choice of a surgeon and a hospital.”

“I’d rather be a difficult live patient,” he said, “than a compliant dead patient.”

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July 17, 2015

Six Reasons You Might Be Feeling Forgetful

Aging brings many unwelcome but normal challenges to health and fitness, including possible lapses in memory. But some such problems can be the result of common behaviors you can alter to improve your brain’s ability to remember things, and retrieve them more easily.

Here, courtesy Harvard Health Publications, are six common contributors to memory impairment.

1. Fatigue

Being tired can dull your memory, and although everybody flags occasionally, persistent, serious fatigue is not normal and could signal a medical condition that needs a doctor’s attention. But if your fatigue falls more toward the annoying than debilitating side, ask yourself: Am I getting enough sleep?

There’s no question that lack of restful sleep can make you more forgetful. If you can figure out the nature of your sleep disturbance, you might be able to fix it. See Patrick’s newsletter, “The Struggle to Sleep” to pin down your problem and how to resolve it. If you sleep an adequate period of time but still feel tired and unrefreshed the next day, discuss it with your doctor.

Some people fail to eat enough protein, which also can cause weakness and fatigue. If you’re feeling tired, make sure your diet is balanced.

2. Medications

Certain drugs can affect memory, especially those that cause sedation. Common medications that affect memory include tranquilizers, antidepressants, drugs taken for urinary problems and over-the-counter (OTC) sleep aids.

If you take any of these and are having memory problems, speak to your doctor about adjusting the dose or changing drugs. Don’t take OTC sleep aids more than three consecutive days.

3. Exercise

Physical activity that gets your heart pumping and oxygen-rich blood flowing to your brain helps you to be more alert and mentally sharper. Preliminary studies show that regular, moderate exercise stimulates brain regions involved in memory function. People who exercise regularly commonly report less memory loss as they age, but research on this topic is ongoing.

Walking, dancing, gardening, cycling, swimming … anything that elevates your heart rate and doesn’t hurt or make you feel woozy is good for you. Just don’t work out too heartily in the evening, as the energy boost can interfere with your ability to get to sleep.

4. Stress

Moods can affect body functions in many ways, including impairing memory. Persistent negative stress or anxiety affects memory because it compromises with your ability to concentrate and solidify new information and skills into memory.

Sometimes stress must be treated medically, but run-of-the-mill difficulties often respond to exercise, meditation, massage and simple social interaction with friends that isn’t locked into rigid schedules or activities. Talking with a friend who’s good at listening and not judgmental can alleviate stress and, therefore, boost memory.

5. Depression

Everyone occasionally gets the blues. Such transient gloom doesn’t normally affect memory, so if you’ve been feeling low for too long, you might need further evaluation.

Memory impairment is one common symptom of clinical depression, along with sadness, lack of motivation, poor concentration, sleep disruptions and diminishing or no pleasure in things that you ordinarily enjoy. If any of these signs of serious depression has lasted more than a couple of weeks, talk to a doctor.

6. Alcohol

Drinking reduces memory performance. It’s that simple. And, as you age, your tolerance for alcohol often diminishes. If you have more than one drink of spirits or more than two beers in a day, and you’re concerned about your memory, cut back. If, after a couple of weeks on a reduced alcohol diet you don’t see a difference, eliminate it altogether, or, if you’re accustomed to imbibing every day, even a little, cut back to once or twice a week.

Dr. David Hsu, a geriatric psychiatrist with the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital, told Health Publications that simply perceiving a change in your ability to remember something or recall it on demand might be due to an age-appropriate slowdown in thinking speed. If you’re past middle age, he advises giving yourself a break, and taking a little more time to recall facts and to commit new ones to memory.

“Getting frustrated with memory slips won’t make them stop,” according to the Health Publications, and “it could make it harder to remember things.

Here are Harvard’s top tips for aiding memory recall:

  • Follow a routine. Leave your wallet, keys, phone, glasses, etc., in the same places every day.

  • Write it down. Use a pocket notebook or small digital voice recorder to take the burden off your brain to remember details, especially names and dates.

  • Do one thing at a time. Multitasking compromises your ability to do anything well because the brain really does only one thing at a time. Overtasking leads to forgetfulness.

  • Seek silence. Noisy or busy environments can make it harder to understand, memorize and recall new information. (Some people are sensitive to smell as well, and strong or certain odors interfere with their brain memory function.)

  • Learn it twice. Memories become more durable when you review new information.

  • Create cues. One example of this memory trick is to put your prescriptions next to your toothbrush to prompt you to take morning or evening medications.

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July 16, 2015

FDA Expresses E-Cigarette Concerns for Kids

The popularity of electronic cigarettes has grown a lot faster than the body of science about their potential health effects. But the toxicity of nicotine is well known, and the FDA is raising concern about how e-cigarette nicotine could affect children.

The agency has put the e-cig industry on notice that it plans to require nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing electronic cigarette liquid products.

The feds also are considering the same alerts for a range of nonsmokable tobacco products, including dissolvables, lotions, gels and drinks.

According MedPageToday.com, “The continuing rise in popularity of electronic nicotine devices (ENDS), such as e-cigarettes, which often use liquid nicotine and nicotine-containing e-liquids, has coincided with an increase in calls to poison control centers and visits to emergency rooms related to liquid nicotine poisoning and other nicotine exposure risks.”

The FDA is particularly concerned about the acute toxicity of nicotine for infants and children, because even small doses can be fatal for them.

E-cigarettes and some other nicotine products including cigars and cigarillos were not among the FDA's initial list of tobacco products to be regulated when that agency gained authority over their class by the 2009 federal Tobacco Control Act. The FDA did not propose regulations for e-cigs until 2014. The initial 75-day public comment period for the draft regulation was extended, but the rule has yet to be made final.

The latest “we’re warning you” announcement is known as an “advance notice of proposed rulemaking,” and it would be followed by a proposed rule, another comment period and then issuance of a final rule.

Anyone who wants to comment on the proposed warnings may do so this month and next by linking here.

People who need to refuel their righteous anger over the scummy behavior of the tobacco industry and its enablers should read Patrick’s recent post, “U.S. Chamber of Commerce Shakes Hands with Death and Evil.”

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July 16, 2015

Research Your Doctor's Payments from Drug and Device Makers

For patients in our home territory of the District of Columbia, Maryland and Virginia, here are some quick links to look up your doctor's payments last year from manufacturers of drugs and medical devices.

District of Columbia.



This comes from the ProPublica database, which has obtained the numbers from the federal government in a newly implemented aspect of the Affordable Care Act.

The big players tend to be doctors who use a lot of medical devices like hip implants. For example, Randall Lewis, a Chevy Chase, Maryland orthopedist, and Charles Engh, a Virginia orthopedist, each received seven-figure payments from device makers last year.

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