January 29, 2015

Suggested Reading: Why Politics Isn’t Good for What Ails You

A couple of years ago, Steven Brill published a series of articles in Time magazine called “Bitter Pill: Why Medical Bills Are Killing Us.” Brill’s work on the subject has blossomed into his new book, “America’s Bitter Pill: Money, Politics, Backroom Deals and the Fight to Fix Our Broken Healthcare System.”

We described the Time articles as an exhaustive examination of how the medical industrial complex inflates the cost of health-care treatment and how reform efforts don’t begin to address the problem. The book explores even farther into the dark corners of American health care, and what it finds is enough to make you swoon.

Brill relates how the U.S. dropped $3 trillion on health care last year, which is more money than not only any other developed country, it’s “more than the next ten biggest spenders combined.”

Health care is the single biggest expense for most American families, and the bang we get for our bucks is appallingly deficient in comparison with other similarly developed countries.

Brill begins his tale from a personal perspective — he’s waiting to undergo emergency heart surgery, and is overwhelmed with a moment of clarity: Apportioning health-care resources is difficult not only because of political pressure and greed, but because human beings are ill-equipped to make objective decisions when they or their loved ones are on the brink of mortality. Or think that they might be.

Add to that state what the Los Angeles Times review called the “parasitic, corrupting interests slowly degrading the legislative process and … the feckless state of American bureaucracy,” and you have to hope that common men and women will find a way to overcome powerful forces that, if they don’t make you sick, can certainly keep you there.

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January 28, 2015

When Advanced Care Is a Step Back

America is a country of newer! Better! Now! More! But in medical care, as readers of this blog know, more is not always better, and the point was driven home recently in a New York Times commentary.

“Doing More for Patients Often Does No Good,” by Dr. Aaron E. Carroll, a professor of pediatrics at Indiana University School of Medicine, explained how our desire to want the latest pharmaceuticals, medical devices and procedures “often does no good. Sometimes, it even leads to harm.”

Carroll understands that when you’re sick, it’s difficult to do nothing. An example of the inability, or unwillingness, to “do nothing,” we suggest, is the millions of healthy people who take vitamins when they’re already getting sufficient nutrition from the food they eat. An example is doctors who prescribe Tamiflu for patients who otherwise aren’t frail, elderly or at risk of complications.

According to meta research (review of many studies) published in the BMJ (British Medical Journal), there’s little evidence that antivirals like Tamiflu and Relenza reduce the risk of influenza complications or hospitalizations among the general population. And even when administered shortly after you start feeling ill, they usually shorten the time you feel the worst by hours, or maybe a day.

Antivirals are expensive, but they’re relatively new, and they’re promoted by the Centers for Disease Control and Prevention. The science is secondary to the popular pitch, and to Americans’ appetite for it.

Carroll cast an eye on emergency services. When someone seems to be in heart trouble, paramedics often proceed with advanced life support — they insert endotracheal breathing tubes, start intravenous lines, deliver sophisticated cardiac drugs and defibrillate patients manually.

“[B]ut steps taken out in the field can make a difference,” Carroll noted. “Basic life support, the kind you might be taught in a CPR class — involving the use of bag valve masks, cardiopulmonary resuscitation and automated external defibrillators — can absolutely save a life.”

Carroll said that usually we assume that advanced life support is superior to basic life support, and that where both options are available, advanced life support almost always wins out. But a recent study in JAMA Internal Medicine, calls that assumption into question. “Researchers examined Medicare patients who were billed for either advanced life support or basic life support before admission to the hospital …,” he wrote. “They looked at how often patients survived to hospital discharge, and then months later.”

They found that about 13 in 100 patients who received basic life support survived and were discharged; only 9 in 100 patients who received advanced life support had the same outcome. Ninety days after discharge, more of the patients who received basic life support were alive than those who got the advanced treatment. The basic life support patients also had better neurological outcomes.

Carroll pointed out the JAMA study’s limitations. It wasn’t a randomized, controlled trial, which is the gold standard for scientific inquiry. And it’s possible that sicker patients received advanced life support while people who didn’t appear as sick received basic life support. “But the authors called all of the state agencies,” he wrote, “and they reported that this can’t really happen. After all, a 911 dispatcher can’t tell if it’s a ‘mild’ or ‘severe’ heart attack from a third party on the phone with no medical training. Dispatchers send out advanced life support if it’s available, and basic life support if it’s not.”

And who knows if there were bystanders with CPR training, and if so, how good they were at the procedure. But the study factored that in, conducting what Carroll called “sensitivity analyses.” There, too, the advanced life support failed to outperform basic life support.

Carroll offered a long list of previous studies that show how less is often more:

  • A study in 2004 found that a cardiac arrest patient’s chances of survival significantly improved if the attack was witnessed by a bystander, and that CPR administered by bystanders improved survival, as did rapid defibrillation — all components of basic life support. The addition of advanced life support made no difference in survival.

  • A 2008 review showed that emergency intubation wasn’t effective.

  • Two studies, one in 2010 and one in 2013, found that inserting an airway tube instead of using a bag mask was associated with decreased survival compared with basic life support.

  • A 2012 study concluded that using epinephrine (which constricts blood vessels to raise blood pressure) was associated with worse outcomes, and a 2008 study found that adding vasopressin (for the same reason) did not improve things. A 2009 randomized, controlled trial of these drugs found no improvement in survival.

So, Carroll asked, why does advanced life support appear not to offer any benefit and is often associated with worse outcomes? Could it be that the advanced life support slows things down and distracts people from providing useful, basic life support measures, and delays a patient getting to the hospital?

Carroll also looked at the outcomes of women with unilateral breast cancer (one affected breast) who underwent breast-conserving surgery and radiation versus women who had a unilateral mastectomy and also those who had a bilateral (both breasts) prophylactic mastectomy — that is, removal of the breasts for preventive reasons, like Angelina Jolie.

“The 10-year survival differences between the groups were negligible,” Carroll reported. “Breast conservation therapy is more tolerable, is much less invasive and costs less.”

Our recent blog, “Bad Advice Abounds Regarding Surgery for DCIS” also addressed conservative versus radical treatment for a certain kind of breast cancer, with the same conclusion.

Despite the fact that breast conservation therapy has become a “standard of excellence” in breast cancer care, Carroll noted, a recent study showed that from 1998 through 2011, the chances that a woman eligible for breast conservation therapy would receive a mastectomy increased, as did rates of bilateral mastectomy.

And even though women with early breast cancer do better if they get less radiation, only 1 in 3 who qualified for a procedure that uses less radiation got it. Observed Carroll, “The rest got more, but not better, care.”

One reason why is money: In a fee-for-service system, which is how many insurance plans are structured, the more often you see a doctor and the more treatments you have, the more the doctor and facility get paid. “Research shows that twice as many women want hypofractionated radiation therapy as want conventional therapy,” Carroll said, “but only half of radiation oncologists offer it.

“But it’s not all money. It’s also probably fear. Many radiation oncologists are concerned that doing fewer treatments will lead to worse outcomes. That’s most likely the concern of women who choose much more invasive surgery than necessary as well.”

Often, fear is much harder to overcome than expense or any other quantifiable factor in medical care. In addition to our cultural lust for new and more, fear drives our choices. The advanced life support trial, according to Carroll, was supposed to be randomized and controlled, but paramedics apparently refused to follow that protocol because they believed that withholding advanced life support was unethical, in spite of evidence that it wasn’t effective.

“More is expensive. More sometimes does no good. Sometimes, more is even harmful,” Carroll concluded. “When our policies and care ignore these facts, we all suffer.”

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January 26, 2015

More Evidence Not to Take Daily Aspirin If You’re Not at Risk for Heart Trouble or Stroke

About once a year, it seems, we caution readers about taking aspirin regularly to guard against heart problems, and now there’s more solid science to reinforce that advice.

A study published this month in the Journal of the American College of Cardiology showed that a significant number of cardiology patients are receiving aspirin primarily to prevent heart disease, despite the risk that the drug outweighs the potential benefit for many patients.

As interpreted by MedPage Today.com, too often aspirin is given to people for whom guidelines suggest no real benefit. The study examined a national registry of cardiology practices, and found that more than 11 in 100 uses of aspirin used preventively by cardiologists were for people outside the recommended risk threshold.

Although most people consider aspirin a gentle treatment for run-of-the-mill problems like headaches and fever, it also can help some people with heart trouble cases because it’s a blood thinner — it interferes with how blood clots by making platelets less "sticky." The heart doesn’t work as hard to pump blood around the body when it’s thinner. But aspirin also makes people more susceptible to bleeding problems and gastrointestinal distress, including ulcers and colon problems. So unless you have a certain heart/stroke-risk profile, preventive use of aspirin is not wise.

Different cardiology practices reviewed in the study used aspirin preventively across a wide range; some cardiologists never used it for that purpose, but some used it for more than 7 in 10 patients.

“The variation across practices was so significant,” according to MedPage Today, “that a patient would be 63% more likely to get aspirin inappropriately at one randomly-selected office than an identical patient at another randomly-chosen practice.”

For patients with low cardiovascular disease risk who have never had symptoms of a heart problem, "aspirin use has not been associated with reduced cardiovascular events," said the journal’s editor in an accompanying commentary. "In fact, in this primary prevention population, the increased risk of gastrointestinal bleeding and hemorrhagic stroke associated with aspirin use outweighs any potential benefit in cardiovascular risk reduction."

MedPage Today referred to a five-year study of seniors in Japan who got a daily low-dose of aspirin, but it had no effect on their cardiovascular or stroke risk.

Last year, the FDA warned that its research review did not support the use of aspirin for primary prevention of heart attack and stroke, and as we blogged, the U.S. Preventive Services Task Force also recommended against its routine use. The American Heart Association and American College of Cardiology say aspirin is recommended only if someone’s risk for cardiovascular disease over a 10-year period is at least 6% to 10%.

That window excludes everyone who’s never had symptoms, family history, lifestyle habits or other demonstrated risks. In other words, don’t take aspirin regularly, even baby aspirin, if you’re healthy. If your doctor advises taking a daily aspirin for preventive purposes, ask why if you do not have an elevated risk for heart attack or stroke. If he or she does not have a clear, good reason — and “just in case” does not qualify — don’t take it.

The study involved more than 68,808 patients receiving aspirin for primary prevention at 119 different practices in the U.S. One positive finding was that the trend toward routine use of aspirin for prevention among low-risk patients declined over time, from 14.5 in 100 in 2008 to about 9 in 100 in 2013. But that’s still too many people taking a drug inappropriately.

Women were three times as likely to take aspirin when they shouldn’t — 16.6 in 100 women took it inappropriately, versus 5.3 in 100 men. And unnecessary risk-taking was more likely among the younger subjects (50 years old) than the older folks (66) in the study.

An editorial accompanying the study pointed out some shortcomings. Exclusively reviewing cardiology practice data might skew results because “the population seen by cardiologists usually differs from those in general practice," it read.

And if patients take a statin in addition to aspirin, which is common, it could change a patient's baseline risk profile. Statins, such as Lipitor or Zocor, lower cholesterol. But, according to MedPage Today, an analysis eliminating the statin users in the database showed similar findings — almost 15 in 100 people use aspirin inappropriately.

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January 25, 2015

How to Get the Right Amount of Vitamin D

Vitamin D is an essential nutrient for maintaining bone health and strength. It also contributes to nerve, muscle and immune function, and helps to moderate inflammation. But ensuring that you get enough vitamin D is complicated by much public misinformation about it.

There has been a lot of discussion lately about testing (well … overtesting) for levels of vitamin D, and whether people who have been diagnosed with a vitamin D shortage are truly deficient or just have doctors engaging in a trendy form of overtreatment. You can read about these issues here and here.

Preliminary studies show that the vitamin might have a role in cancer risk, diabetes, high blood pressure, multiple sclerosis and other disorders. But the science is young, and at this point, only interesting, not particularly helpful in a medical sense.

But there’s no question that you should pay attention to how the body receives and uses vitamin D, and whether your situation makes that possible. A recent report from Harvard Health Publications provides a helpful guideline.

The body makes vitamin D from absorbing sunlight, and the liver and kidneys also play a role in vitamin D production. Food also supplies the vitamin, not because a lot of what you eat naturally contains it (it doesn’t), but because manufacturers supplement lots of foods with it, especially milk, yogurt, breakfast cereals and orange juice. Some people take vitamin D supplements, but doing so without knowing if you’re not getting enough through other means probably isn’t a good idea.

Lots of things can affect your vitamin D level. They are:

Where you live. As the Harvard report explains, the farther away from the equator you live, the less vitamin D-producing light reaches the earth’s surface during winter. So if you live in a more northern region, your body probably isn’t making much vitamin D during winter, and because you’re covering up your body when it’s cold, even when it’s sunny the rays aren’t reaching the skin. In addition to shorter days during the winter, according to the National Institutes of Health (NIH), thick cloud cover also can impair your ability to get enough sunshine any time of year.

Air quality. The carbon particles produced when fossil fuels (cars, factories), wood and other materials are burned absorb the sun’s UVB rays that the skin needs to make vitamin D. Pollution that destroys the ozone layer, however, could promote vitamin D production because ozone absorbs UVB radiation.

Sunscreen use. If you regularly apply sufficient amounts of sunscreen you’re getting less vitamin D because sunscreen blocks UVB light. But as the Harvard report makes clear, very few people use enough sunscreen, or use it often enough, to block all UVB light.

Skin color. How dark your skin is depends on how much melanin it contains. As the Harvard writers put it, melanin “competes” for UVB with the substances in the skin that signal the body to produce vitamin D, so dark-skinned people are more likely to make less vitamin D from sunlight than light-skinned people who get the same sun exposure.

Weight. Body fat absorbs vitamin D, so some people have theorized that fat might store the nutrient so that it can be used when its host doesn’t eat or produce enough vitamin D. But studies have shown that obesity is associated with low levels of the vitamin, and that too much weight might interfere with its bioavailability.

Age. The older you are, the less you have of the substance in skin required to convert UVB light into vitamin D-helper. Some evidence has indicated that older people produce vitamin D less efficiently in all ways than younger folks.

In addition to low vitamin synthesis resulting from these factors, you might be at risk of a deficiency, according to the NIH, if you have inflammatory bowel disease or another condition that prevents you from absorbing dietary fat properly, or if you have undergone a gastric bypass procedure. (Such procedures routinely require nutritional supplementation.)

Some medicines can interfere with vitamin D absorption, including steroids and those for weight loss, to lower cholesterol and to prevent and control epileptic seizures. If you take any of these drugs, discuss with your doctor if you should take a vitamin D supplement.

But you also can get too much vitamin D, primarily through supplementation. The NIH says vitamin D toxicity can cause anorexia, heart arrhythmias and other serious problems. It can raise blood levels of calcium to dangerous levels, leading to heart, blood vessels and kidney damage.

If you take vitamin D supplements and experience vomiting, nausea, poor appetite, weakness, constipation, dehydration and/or frequent urination, call your doctor immediately.

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January 22, 2015

Training IVs Used by Mistake Proved Fatal

A few weeks ago, the FDA learned that intravenous fluids intended to be used for training medical personnel in fact were given to patients as treatment. Last week, the agency announced that many people had gotten sick as a result, and one person died. This preventable situation occurred only because commercial, medical and government interests were not paying attention.

As Reuters reported, the FDA initially instructed physicians not to use the products, manufactured by Wallcur LLC for simulating the administration of an IV, and had reported that serious adverse events had resulted from the use of some of the company’s products. But it certainly didn’t seem overly concerned about patient safety.

Nor did the company, which issued a news release the first week in January recalling its products. In part, it read: “As you know, all of Wallcur’s products are intended for training, simulation, and educational purposes only. Recently some of Wallcur’s training products were not used for their intended purpose. Specifically, despite the fact that the products are intended ‘for clinical simulation’ only, we are aware of reports that these products have been used outside of their intended use and administered to patients. Because these products are not intended for human or animal administration, and are not sterile, administration of these products could result in adverse events.”

But, apparently, either medical practitioners did not know Wallcur supplied drugs only for training, or the products were so poorly labeled as to make their origin or contents unclear. If that’s the case, why would anyone use them on a patient?

In its announcement last week, the FDA said that more than 40 patients had been infused with simulated saline solution sent to medical clinics, surgical centers and urgent care facilities in seven states — Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.

The adverse reactions included fever, chills, tremors and headache. Some patients were hospitalized. Officials at the FDA said they didn’t know if the death of the patient among the group that got the IVs was related directly to the product.

Most medical facilities that received and used the solution as a treatment indicated that they weren’t aware that it was for simulation only, but one clinic did, and returned it to the distributor.

The FDA is trying to figure out how the Wallcur products got into the supply chain, and has urged patients receiving IV saline to check to see that the bag is labeled as sterile.

According to USAToday.com, Wallcur doesn't sell its products to hospitals, only to medical and nursing schools that it has determined are legitimate teaching centers. It also sells to distributors. Company officials said they didn’t know how training products found their way from a distributor to a hospital.

The Wallcur product is Practi-0.9 percent sodium chloride IV solution. Medical-grade versions of 0.9 percent sodium chloride — that is, IV solution intended to treat patients, not to train caregivers — is known as normal saline. Recently, there has been a shortage of the drug, which is used widely to treat dehydration and other medical conditions. That prompted the FDA last year temporarily to allow one manufacturer to distribute normal saline from its manufacturing facility in Norway, and the feds also are OK with the temporary distribution of additional normal saline from other sources.

But no one thought that a needy market for saline treatments might cause so many players to overlook their responsibilities to patients.

Michael Carome, director of Public Citizen's Health Research Group, told USAToday that the situation was "outrageous." He’s a physician, and made clear that injecting someone with a fluid that wasn’t sterile could cause serious bloodstream infections, if the fluids are contaminated with bacteria or the toxins that bacteria produce.

A couple of years ago, contaminated steroid injections manufactured by New England Compounding Center that caused 64 deaths from meningitis.

With regard to the Wallcur products ending up inside human bodies, Carome told USAToday, "The system for protecting patients failed at multiple levels." He said such products should be labeled with bold, red letters to make it almost impossible for anyone to mix up a simulated solution with normal saline.

He also criticized the FDA’s failure to aggressively notify both hospitals and consumers of the problem. Its first alert was released Dec. 30, when the holidays probably prevented many people from noticing it.

Carome said the people responsible for distributing the practice saline put patients at risk, as well as hospital staffers, who should have noticed that the practice bags weren't sterile.

Stay tuned for further developments.

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January 21, 2015

Companies Pay Doctors a Lot to Promote Redundant Unproven Drugs

To paraphrase Calvin Coolidge, “The business of America is business.” Even, we would add, when it should be about medical care.

According to a recent news report, “[T]he drugs most aggressively promoted to doctors typically aren’t cures or even big medical breakthroughs. … they are newer drugs that manufacturers hope will gain a foothold, sometimes after failing to meet Wall Street’s early expectations.”

So said a report earlier this month published by the New York Times and ProPublica.org (NYT/ProPublica). Using Open Payments, the federal government’s new database of drug and medical device manufacturers’ payments to medical providers, the reporters found a disturbing, if unsurprising, pattern of dual self-interest that’s all about sales, not the advancement of medical care.

“In almost all cases,” the story said, “older, cheaper products are available to treat the same conditions [as the drugs being promoted]. Companies typically try to differentiate the new drugs by asserting they are easier to use; carry fewer side effects; work faster than competitors; or have medical advantages.”

Assertion is not science. It’s marketing.

This is such a perennial story in the prescription drug world that longtime drug industry scourge Sidney Wolfe MD developed a "seven-year rule": Patients should avoid drugs until they've been on the market for at least seven years. Otherwise you the patient are really participating in an experiment to see if the drug is truly safe. The only rare exception for the seven-year rule is a new drug that is a genuine breakthrough, which rarely happens.

As an example, the reporters offered the blood thinner Coumadin. For many decades, it was the only drug available for millions of patients at risk for life-threatening blood clots. Today, “a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.”

They are Pradaxa, Xarelto and Eliquis, and their manufacturers entice (some people might say “bribe”) physicians to prescribe them in part by subsidizing meals, promotional speeches, consulting jobs and educational opportunities. In the last five months of 2013, these companies spent more than $19 million on doctors and teaching hospitals.

It’s not about announcing new, cutting-edge treatments, as Dr. Joseph Ross told the reporters. It’s about selling a product to whomever will buy it. “They [the drugs] may have some unique niche in the market, but they are fairly redundant with other therapies that are already available,” said Ross, a professor of medicine and public health at Yale University School of Medicine. “Many of these, you could call me-too drugs.”

The three drug makers claim that their drugs are at least as effective as Coumadin for certain conditions. They claim that patients needn’t undergo regular blood tests as they do with Coumadin, and that patients needn’t limit their diet as much. (People who take Coumadin, or its generic version, warfarin, shouldn’t eat grapefruit or cranberries and they must limit their consumption of green, leafy vegetables.)

But as we’ve blogged, thousands of patients on Pradaxa, which was the first of the three to be approved by the FDA, have been harmed by uncontrolled bleeding, and its manufacturer, Boehringer Ingelheim, has been fined for covering up adverse outcomes in its research for the drug. There are similar concerns about Xarelto and Eliquis.

We recently blogged about the diabetes drug Victoza, which also came under scrutiny in the NYT/ProPublica story. Made by Novo Nordisk, Victoza was responsible for the most payments to doctors, by dollar amount — more than $9 million in the last five months of 2013, despite its questionable benefit/harm balance. Its packaging carries a “black box” warning, which is the most severe alarm about potentially harmful side effects, including an increased risk of thyroid cancer and pancreatitis.

Dr. Todd Hobbs, chief medical officer of Novo Nordisk in North America, told the reporters that the $9 million reflected Victoza’s newness and the need to address such safety concerns. We wonder why that money wasn’t spent on making the drug safer in the first place.

Eliquis ranked No. 2 on the doctor spend-o-meter, at nearly $8 million. Its corporate talking heads (Bristol-Myers Squibb and Pfizer) said such spending helps ensure that providers understand its appropriate use, and how important it is “to have a speaker program that adequately provides robust education to these physicians.”

In what other profession are you paid to learn how to use a tool that is your responsibility to understand?

The No. 3 drug in the doctor payment club was Brilinta, yet another blood thinner. It competes with Plavix, whose generic version is clopidogrel. Brilinta’s manufacturer, AstraZeneca, tabbed it for special promotion attention, noting that doctors are “indispensable partners in our efforts to bring new medicines to patients.”

We get that. We don’t get why being an indespensible advancement in science isn’t more important than being a huckster.

Of the top 20 most promoted drugs on the list, 14 were approved by the FDA since 2010. Some treat similar conditions, including diabetes, schizophrenia and chronic obstructive pulmonary disease, so, as one pharmaceutical company consultant told the NYT/ProPublica, “They’re fighting over the same doctors, I guarantee you.”

A troubling number of highly promoted, doctor-palm-greasing meds have caused harm. Samsca, which treats low sodium levels in the blood, can cause involuntary movements and seizures, side effects that emerged after it was approved by the feds. The manufacturers of some drugs, including Copaxone, Latuda, Xarelto, Daliresp and Humira, have been called out by the FDA for sleazy promotions.

Subsys, which we discussed recently, was approved to treat cancer pain. Its market is tiny (cancer patients who have developed a tolerance to opioids), but it still ranked No. 23 in spending on doctors, and it’s often used for off-label, or unapproved, uses, as you might expect with a drug whose consumer base is so limited.

It’s not only drugs, but medical devices that have hefty doctor promotional budgets. Among the heftiest is Intuitive Surgical’s da Vinci surgical robot system, which has been fraught with problems and lawsuits we’ve tracked. Da Vinci is promoted as less invasive for many procedures, but it’s crazy-expensive, and has caused serious complications and some deaths.

But in the last five months of 2013, Intuitive shelled out almost $13 million for physicians to promote the robot. About half of that amount, Intuitive said, was “pass through” spending: Surgeons or hospitals paid the company for services, and the company, in turn, paid doctors to provide them.

According to Open Payments, one doctor who was paid about $75,000 in the last five months of 2013 gave promotional talks about several of the most heavily marketed anticoagulants and blood thinners, particularly Brilinta.

He’s an emergency room doctor who said he offers a different perspective from the cardiologists and internists who usually prescribe those drugs because he treats complications of blood clots in the emergency room.

He told NYT/ProPublica that he reviews clinical studies before deciding to speak for a drug, and that he no longer speaks on behalf of Pradaxa. But he does get paid to speak for Xarelto, a drug he has taken himself for a deep vein thrombosis.

Well, at least he uses the product he hawks.

But, sadly, “Largely absent from the top of the [promoted drugs] list were drugs that cure disease,” the reporters found, “such as a new class of hepatitis C treatments, or those that significantly extend life, particularly for cancer patients. If a drug is either the first to treat a disease or is much better than existing drugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen’s Health Research Group, ‘they “sell themselves” on the merits of their unique benefits.’”

You can see how much money drug and device companies spend on interactions with doctors, (excluding research and royalties) with ProPublica’s Open Payments Explorer tool here.

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January 19, 2015

Pap or HPV Test — or Both?

The medical community is divided about whether a Pap smear or an HPV test is best to detect cervical cancer. The debate was stoked earlier this month when a committee of gynecologic oncology experts categorically voted for only the HPV test.

As reported by NPR, representatives of the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology reviewed the usefulness of the HPV test for cervical cancer detection, and whether it should be given in addition to, or instead of, the Pap test.

Per the report, published in Gynecologic Oncology, the committee concluded that doctors could consider the HPV test a primary screening test for women 25 years and older.

The human papilloma virus (HPV) is thought to cause most cases of cervical cancer, and last year the FDA approved a test for the virus as a primary screening test for the malignancy. For several years now, an HPV vaccination for adolescents has been recommended before they become sexually active to protect girls from developing cervical cancer later in life and boys from developing genital warts, penile and/or anal cancer.

HPV is the most common sexually transmitted infection.

For decades, women routinely have been given Pap smears to catch any signs of cervical cancer early. It involves scraping cervical cells to be sent to a lab to see if any are abnormal. If so, they can be removed before cancer develops. Lower rates of cervical cancer have been attributed to this routine testing, detection and treatment.

But, according to NPR, "Pap smears are probably missing a fair amount of cancer and precancer in women," said Dr. Warner Huh, the chairman of the committee that issued the report. "The HPV test really outperforms Pap smears when it comes to cancer detection as well as precancerous detection," and that it would enable doctors to "pick up disease in women that could be treated earlier so they don't go on to develop cervical cancers."

Not so fast, said members of the American Congress of Obstetricians and Gynecologists (ACOG), an organization that tends to uphold traditional care and treatment, as we’ve blogged. ACOG believes that it's too soon to supplant the Pap smear with the HPV test.

So does Diana Zuckerman, head of the National Center for Health Research. "So many women get HPV who will never, ever get cancer," she told NPR. Her advocacy group, like ACOG, is concerned that an initially positive HPV result will frighten women unnecessarily and prompt overtreatment.

It’s a fair point, because many screening tests, as we’ve observed, can yield the presence of something concerning but that, in fact, will never develop into something that requires treatment. The detection of something benign not only causes fear, but often additional tests that can be expensive, uncomfortable and cause complications of their own.

As the NPR story noted, many HPV infections are temporary, and resolve on their own without causing any problems. So Zuckerman wants both professionals and consumers to understand that better detection doesn’t necessarily mean better medicine.

She also pointed out that cervical cancer isn’t caused solely by the HPV. So if you substitute the HPV test for a Pap test, you might miss other potential cases of cervical cancer. It’s not a matter of reliance on the HPV test being controversial, only premature. Her solution, at least for now, is to use both tests.

That’s the more-is-more approach to medical care, one that we’ve often called into question. The best approach for women, as always, is individual — the tests you decide to have, and their frequency, depend on your medical history, your family history and your habits.

Making a decision about having either the HPV or the Pap test, or both, should be the result of a frank and full discussion with your doctor. Ideally, that person is informed of all medical points of view, and remains objective for each patient’s concern.

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January 18, 2015

The Health Connection Between Your Teeth and Your Heart

As the old song goes, the toe bone’s connected to the foot bone, the foot bone’s connected to the heel bone… But did you know that the heart is connected to the gums and jawbone? As the Harvard Health Letter recently explained, new research strengthens the association between dental and cardiovascular health.

The American Journal of Preventive Medicine examined health and dental insurance records from nearly 339,000 people with two distinct disorders — periodontal disease, which includes a range of mouth problems from simple gum inflammation to serious soft tissue and jawbone damage — and one of these five conditions:

  • type 2 diabetes;

  • cardiovascular disease;

  • cerebrovascular disease (usually a stroke);

  • rheumatoid arthritis; or

  • pregnancy.

People with gum disease, according to the Harvard report, are almost twice as likely to have heart disease as those without it.

A study published this month in the Journal of Dental Research reinforces the Harvard information. A group of Spanish scientists showed that chronic periodontitis is closely associated to the severity of acute myocardial infarction (heart attack).

They looked at the levels of troponin I, a protein that affects heart muscle contractions, and myoglobin, a protein that carries oxygen, for 112 heart attack patients. The proteins indicate, or are biomarkers of, how much heart muscle has deteriorated from a heart attack. The patients also underwent periodontal tests.

As noted on ScienceDaily.com, the study was small and must be confirmed through additional research. But one of the study’s authors said that the results do indicate that "chronic periodontitis appears as a death risk factor and it plays an important role in the prognosis of acute myocardial infarction," and that if subsequent research supports their study, "[C]hronic periodontitis should be considered as a predictor in the development of myocardial infarction, and be therefore included in the risk stratification scores." Those scores are factors by which a doctor assess a patient’s chances of developing a problem.

As you’ve probably heard from your dentist, periodontal disease starts when plaque, a sticky film loaded with bacteria, builds up around your teeth. The gums pull away from the root of the tooth, leaving pockets that gradually enlarge. Infection and inflammation, which is how the body responds to infection or injury, attack tissue that holds teeth to the jawbone, and they can fall out.

If you have periodontal disease, chewing and brushing your teeth can release bacteria into your bloodstream. Several types of bacteria that cause gum disease have been found in the cholesterol-laden plaque that clogs arteries in people with heart disease.

The reasons why periodontal disease patients are more likely to have a heart condition aren't entirely clear. People without access to good dental care also might not have the resources to protect against heart disease. Some experts suspect that inflammation, which is common to both conditions, is a factor.

The new study suggests that if you have cardiovascular disease, treating gum disease could reduce your hospital visits, and lower your health-care costs.

Except for the subjects with rheumatoid arthritis, the Harvard story summarizes, all the research participants who had at least one periodontal disease treatment had lower medical costs and fewer hospitalizations within four years of the treatment compared with people who weren't treated. Patients with cerebrovascular or cardiovascular disease had lower health-care costs of as much as 40%.

"This is a really solid finding and a testimony to what we've been preaching for years," Dr. Alpdogan Kantarci, a periodontist with the Harvard-affiliated Forsyth Institute, told the Health Letter. He explained that treating gum disease reduces the body's burden of infection and inflammation, and that appears to help people respond better to treatments for other health conditions, like heart disease.

The take-home message here is to see your dentist regularly — your mouth is the doorway to other body systems.

Specifically, the Health Letter recommends:

  • Brush and floss your teeth daily.
    Most people have at least mild gingivitis, the earliest form of gum disease. But if you brush and floss daily, you can head it off, and sometimes reverse it.

  • Have twice-yearly cleanings by a dentist or hygienist.
    Some people need these appointments more frequently — if you have an aggressive response to bacteria and develop plaque more easily, you should have at least three or four cleanings a year. If you don’t pay attention to gingivitis, you’re likely to develop periodontal disease.

Dentists and hygienists clean teeth by scaling and root planing (deep cleaning) — that’s the use of all those sharp tools you see on the dental tray next to the chair where you sit with your mouth wide open. They also might use ultrasound devices to scrape away hardened plaque (tartar).

Scaling cleans teeth above and below the gum line. You might be given a numbing agent for your gums, or a shot of Novocain as a local anesthetic. Before treatment, make sure your dentist or hygienist knows what medications you take. Some might increase your risk of bleeding, such as warfarin, aspirin, or clopidogrel (Plavix).

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January 15, 2015

Proposed Rules Give Drug Companies Less Cover to Hide Harms During Trials

Clinical trials are the scientifically rigorous process by which drugs and medical devices are tested for how well they work and the risks they pose before the products are allowed to be marketed. Recently, the data from a lot of clinical trials sponsored by industry (that is, companies with a stake in the outcome) have come under fire, and now the feds are proposing rules to address that dangerous situation.

Readers of this blog might recall that one drug maker, Boehringer Ingelheim, hid the uncontrolled bleeding it knew was happening during its trials of Pradaxa, a blood thinner. Other industry trials have resulted in reports that were ghostwritten, that deliberately minimized harms and journal stories containing material planted by drug manufacturers.

As reported by AboutLawsuits.com, the rules proposed by health experts are intended to expand significantly how much information resulting from drug trials researchers and drug companies must provide to the public.

The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rulemaking that defines the proposed changes. You can see it here, and the public is welcome to comment until Feb. 19.

As explained by AboutLawsuits, the pertinent law “requires [that] certain clinical drug trials in the U.S. be registered with ClinicalTrials.gov and that summary results be submitted for public access. The site is administered by the National Institutes of Health, part of DHHS. Publication of the information and summary results is seen as a guard against publication bias and other biases that could affect the studies’ conclusions.”

The most significant change is the expansion of how much information must be provided on adverse events detected during the clinical trial. Previously, researchers were obliged to provide only two tables on adverse events that occurred during the trials — one depicting all serious adverse events, and one depicting all adverse events that exceeded more than 5 in 100 subjects within the study group.

The proposal requires much more data on adverse events including:

  • the time frame during which adverse event data were collected;

  • how adverse event data was collected;

  • a table listing participant deaths from any causes;

  • a determination on whether the adverse event was caused by drug being investigated.

Also, summary results must be submitted to ClinicalTrials.gov whether or not a drug has been approved by the FDA. Currently, clinical drug trial results are required only if the drug has been approved, licensed or cleared for marketing by the agency.

The reasons for this provision are, according to the New England Journal of Medicine, “to reduce bias in publicly available information about investigational products stemming from selective disclosure of results, to assist those attempting to assess the benefits and harms of entire classes of drugs or devices, to avoid unnecessary duplication of trials of products shown to be unsafe or ineffective, and to inform the description of potential risks and benefits provided in consent forms for future studies.”

One hopes this would eliminate scenarios like that of Pradaxa. After it hit the market, the FDA was flooded with reports about patients bleeding to death. Data later turned up suggesting that the drug accumulates in patients with decreased kidney function, and that they might need monitoring in order to use the drug safely.

An investigation last year by the British Medical Journal unearthed internal documents from Boehringer Ingelheim noting that the risk of bleeding events could be reduced as much as 40% with more blood monitoring, but in its commercials, the company promoted the drug as requiring less monitoring than competing products.

Boehringer Ingelheim paid about $650 million to settle more than 4,000 Pradaxa lawsuits filed by patients charging that warnings and information about the bleeding risks were inadequate. The company was sanctioned by a federal judge for withholding evidence of bleeding risks.

Although pharmaceutical companies see these adverse legal outcomes as the cost of doing business (they make a lot more in drug sales than they pay out in penalties), there’s no question more rigorous trial requirements must be imposed if for no other reason than to reinforce that such behavior is not only immoral, but illegal.

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January 14, 2015

Certain Knee Surgery Might Increases Chances of Arthritis

One of the most common kinds of knee surgery might not be such a good idea, new research suggests.

Knee cartilage called the meniscus (there are two in each knee) are easily torn when the knee is twisted or rotated forcefully, especially during weight-bearing activity such as basketball or soccer. Surgically repairing the tears in these joint shock absorbers is supposed to reduce pain and improve joint mobility and strength.

But according to HealthDay News, meniscal tear operations might increase the chances of arthritis.

Researchers, who presented their study last month at a conference of the Radiological Society of North America, compared MRI scans of 355 knees with arthritis with a similar number of knees without arthritis. The patients’ average age was 60, and most were overweight.

All 31 knees that were repaired surgically for meniscal tears developed arthritis within a year, compared with only about 6 in 10 knees with meniscal damage that did not have surgery.

More than 8 in 10 of the knees undergoing surgery showed a loss of cartilage, but only about half that many knees with meniscal damage that didn’t have surgery showed a loss of cartilage.

So despite its frequency, surgical repair of a torn meniscus might not be a good idea. If your doctor advises surgery for your torn knee cartilage, you should discuss other options such as icing, anti-inflammatory medicine and physical therapy.

As Dr. Frank Roemer, the study’s author, said in a news release, “The indications for meniscal surgery might need to be discussed more carefully in order to avoid accelerated knee joint degeneration.”

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January 13, 2015

Moderation Seems Smart in Many Cases of Blood Transfusion

Determining whether a patient needs a blood transfusion and, if so, how much blood he or she should be given, can be key to the patient’s long-term well-being. Recently, researchers found that survival rates in heart patients undergoing surgery were similar whether the amount of blood that was transfused was large or small.

Surgeons and doctors performing other procedures must judge whether blood is needed based on their observation of how much blood a patient has lost and by closely monitoring vital signs such as blood pressure. Too much transfused blood can overload a patient’s circulatory system, and cause problems with breathing.

Too much blood also can increase the risk of infection, particularly hepatitis and HIV. Because transfused blood is tested in advance, cases of those infections are rare, but as the lead researcher in a study by Rutgers University said, “why give more blood to anyone if you can’t show it benefits them?”

Dr. Jeffrey Carson, chief of the Division of Internal Medicine at Rutgers Robert Wood Johnson Medical School, led the study, which followed 2,016 patients for as long as four years. Half received large quantities of transfused blood; half received transfusions of much less blood.

The study, which was published in the journal Lancet, measured overall mortality, as well as mortality from cardiovascular disease, cancer and severe infection. The results reinforced the recent trend toward a more moderate application of transfusions.

About 5 million people in the U.S. receive transfusions each year, according to the Centers for Disease Control and Prevention. They are surgery patients, accident, burn and trauma victims, mothers and babies during and after childbirth and people whose low blood counts threaten their health.

In 2011, Carson published a study in the New England Journal of Medicine that showed that fewer transfusions during a 60-day period were safer than more transfusions for the same subjects. This time, the Rutgers team found no evidence of increased mortality from cardiovascular disease, cancer or severe infection after surgery attributed to the amount of the blood given during the operation. The results supported the earlier research that, according to the university news release, “was one of the driving forces behind a change in blood transfusion practice nationally.”

“There has been a steady decline in the amount of blood in transfusions given to patients in the
past three to five years,” Carson said. “I think it is very reassuring that we have found that using less blood is okay not just from a short term perspective, but also a long term perspective.”

Carson was chairman of the American Association of Blood Banks’ official guidelines committee in 2012. He said that fewer transfusions not only are better for individual patients, but also benefit society by preserving the blood supply and preventing shortages.

According to Rutgers, medical experts have been concerned that larger amounts of transfused blood might suppress immune function, which leaves the body more vulnerable to infection and cancer. They also wondered whether smaller transfusions could make a patient’s chronic heart disease worse by depriving the heart of oxygen and other nutrients it might have received if more blood had been pumped. But Carson found no difference in long-term death rates for either scenario, regardless of the number of transfusions.

Some health conditions, like heart attacks, still require further transfusion research, Carson acknowledged. Preliminary evidence suggests that those patients need more blood, not less. But for now, if your problem is not a heart attack, and your care team advises a transfusion, or a series of them, ask why they think this is the best, or only, approach. If the answer is “Just in case,” that might not be a good reason.

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January 12, 2015

When Doctors Don’t Listen, Patients Don’t Thrive

We’ve said it before. We’ll say it again: Doctors provide better, safer care when they listen to — and hear — what their patients are saying.

Some doctors realize this, and one of them wrote about it last week in the New York Times. In an op-ed titled “Dr., Shut Up and Listen,” Dr. Nirmal Joshi said that “A doctor’s ability to explain, listen and empathize has a profound impact on a patient’s care,”

“Interpersonal and communication skills” were recognized as key physician competencies in 1999 by the American Board of Medical Specialties. Medical schools and residency programs then began to train and test students on these skills, but after they’re finished, they’re seldom evaluated further.

Joshi illustrated the problem with the story of one patient, “Betsy,” who saw a series of doctors about her rapid heartbeat and overwhelming stress. Doctor No. 6 finally asked about her use of over-the-counter medicines.

She was taking one to lose weight that contained ephedrine. That’s a decongestant and bronchodilator used to treat asthma and fever, but it’s also a stimulant. But before someone bothered to find out about Betsy’s use of it, she had been referred for psychological counseling to treat her anxiety disorder.

Which she didn’t have. As soon as she stopped taking ephedrine, her problems resolved.

“Asked why she hadn’t mentioned this information before,” Joshi wrote, “she said she’d ‘never been asked.’ Until then, her providers would sooner order tests than take the time to talk with her about the problem.”

Joshi deemed Betsy “fortunate,” because poor communication can have much worse, even dire, consequences than hers. He noted that a report by the Joint Commission, a nonprofit organization that reviews and accredits health-care organizations, found that communication failure, not a provider’s lack of skill, was responsible for more than 7 in 10 serious adverse health outcomes in hospitals.

Listening, empathizing and explaining are part and parcel of what a good doctor does. These skills have what Joshi called “a profound impact on a patient’s care.” But they’re woefully missing in the standard delivery of health care.

A survey Joshi read found that 2 in 3 patients discharged from the hospital don’t even know their diagnosis. Another study found that in more than 6 in 10 cases, patients misunderstood directions after they visited their doctor’s office. “And on average, physicians wait just 18 seconds before interrupting patients’ narratives of their symptoms.”

That’s not just bad manners, it’s bad medicine.

We believe strongly that patients are responsible for their health care, responsible for reading labels and directions, for asking questions about treatments and side effects, and what tests are supposed to measure, their risks and their benefits. But patients taking responsibility does not excuse doctors from helping them do so.

Joshi and his colleagues in Harrisburg, Pa., started a communication program in a large urban hospital challenged by a high poverty rate among its patients, a high rate of childhood obesity and a high rate of uninsured patients. They started by assessing how doctors communicated with their patients, and it wasn’t a happy result.

Physicians introduced themselves in only about 1 in 4 encounters. So of course the overwhelming majority of patients later were unable to identify their doctor. Physician encounters routinely were brief and rushed. Patients had limited opportunity to ask questions. And professional empathy was in short supply: One tearful patient related the recent death of a loved one, right after which the doctor said, “How is your abdominal pain?”

Joshi’s team established a physician training program involving actors as patients in a variety of situations. They had a “physician coach” sit in on real patient interviews to provide feedback.

And it worked. Patient satisfaction with doctors, as measured by a standard questionnaire, rose 40 percentile points on a national rating scale.

Happier patients are healthier patients, Joshi noted; one study published in The New England Journal of Medicine, he said, showed “that higher patient satisfaction was associated with improved outcomes for several diseases, including heart attacks, heart failure and pneumonia.”

Joshi acknowledged that a lot of his peers reject communication programs such as his because they’re too intrusive on their clinical practice, and/or too time-consuming. “But,” he wrote, “we need to move away from the perception that social skills and better communication are a kind of optional extra for doctors. A good bedside manner is simply good medicine.”

To read more about how to communicate with your doctor, read some of our blogs on the subject here, here, and here.

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