DC Medical Malpractice & Patient Safety Blog

Another chapter in the book of “Big Pharma Behaving Badly” is being written, courtesy of a story by Bloomberg News. The news service obtained Bayer company emails reportedly showing executives discussing ways to illegally promote a long-controversial drug.

The suspect drug, Yaz, is a member of the family of birth control pills knows as Yasmin, which several studies suggest carry elevated risks for blood clots, and, possibly, pulmonary embolism, deep vein thrombosis and other life-threatening injuries. As noted on AboutLawsuits.com, an FDA advisory committee is supposed to review the data about the risks of Yaz and Yasmin next month.

The Bloomberg report charges that Bayer may have sought to market the birth-control pills for unapproved—or “off-label”—uses, misleading women about the health risks the drug posed. Specifically, Bayer is alleged to have discussed promoting the contraceptive Yaz to treat several types of premenstrual syndrome (PMS). The FDA has approved Yaz only for the most severe form of PMS.

Doctors are not prohibited from prescribing drugs for off-label uses, but manufacturers are not allowed to promote their drugs for any use other than what the FDA has approved. Earlier this month, we wrote about a large legal settlement paid by GlaxoSmithKline over its off-label marketing of a diabetes drug.

In the Bayer emails, a consultant allegedly suggested how the company’s sales representatives could converse with doctors in a way that invites them to conclude that Yaz is suitable for off-label use: asking doctors, for example, what percentage of their patients had common PMS symptoms, then asking what effect they thought Yaz might have on those situations.

An even bolder, in-your-face repudiation of federal law reflected in another email supposedly came from an executive promising that a doctor under contract to a Bayer unit would promote off-label use of Yasmin on the “Today” show.

According to AboutLawsuits.com, the FDA has warned Bayer at least three times in recent years about problems with Yasmin or Yaz advertisements. Bayer has been busted for its misleading ads overstating the efficacy and benefits, and minimizing the risks of Yaz and Yasmin.

“In 2009, Bayer was forced to run a $20 million corrective advertising campaign to address problems with Yaz advertisements that stressed the potential benefits in treating acne and symptoms of PMS, while minimizing the potential risk of blood clots and other side effects of Yaz,” the website reports.

As additional punishment for its loathsome marketing behavior, Bayer must get any U.S. advertisements for Yaz approved in advance by the FDA.

The legal process of suing someone or some organization involves “discovery,” in which both sides look for evidence from each other supporting their arguments. The Bayer emails were unearthed during the discovery process in numerous lawsuits involving Yaz and Yasmin filed against Bayer by women who took the medicine and suffered blood clots, strokes and gallbladder problems.

If a product is so great, why does its manufacturer have to bypass law and common decency to spread the word?

We’re big believers in “evidence-based” medicine. Most recently, we questioned the fuzzy-science circumstances surrounding the death of Steve Jobs. But a recent article in The Atlantic by Megan McArdle reminds us that, sometimes, the art of medicine should play as large a role as that of science and that, ultimately, striking that balance requires the patient and the doctor to communicate well.

McArdle has lived with a thyroid condition for many years that requires periodic blood tests to determine how well that gland is functioning. For a long time, a normal thyroid was deemed to register between 0.5 and 5 for Thyroid Stimulating Hormone (TSH). But several years ago, the American Association of Clinical Endocrinologists Association of Clinical Endocrinologists lowered that threshold to between 0.3 and 3.

McArdle’s TSH levels were at the edge of the new, narrower range, and she had many of the symptoms associated with “underactive” thyroid—hair loss, fatigue, hoarseness, constantly feeling cold. (Overactive thyroid symptoms include insomnia, nervousness, heart palpitations, increased risk of bone fracture and a host of unpleasant and health-threatening problems.)

Her problem was that the numbers, the science, didn’t indicate how bad she was starting to feel.

The treatment for an underactive thyroid (hypothroidism) is a drug—thyroid hormone. And, like all drugs, it’s not without risk, so practitioners prescribe the lowest dosage possible to avoid them. As McArdle eloquently puts it, “There are real risks to taking too much thyroid hormone—it can cause heart palpitations and increase your risk of fractures. Unfortunately, too little thyroid hormone can leave you fat, bald, constipated, and depressed.”

Conservative TSH guidelines err on the side of hypothyroidism, McArdle writes, because “being hyperthyroid can kill you, while being hypothyroid just, well, makes you fat, bald, constipated, and depressed.” As long as TSH levels are under 5, many doctors believe, you are being treated appropriately, no matter how you feel.

Many primary care doctors have yet to adopt the more stringent levels recommended by the endocrinologists association, McArdle says, and even those whose patients’ blood tests show the new normal of 3 sometimes suggest these overweight, sluggish, cold people should just overcome their vanity or go to the gym more often.

“I can understand why doctors want to stick to the number: it is objective, while ‘I'm tired and kinda blue’ is not,” McArdle writes. “And presumably, you will get idiot patients who want to be thinner than is natural for them, and will lie about their symptoms in order to be prescribed dangerous levels of thyroid hormone.

"But this is not much comfort to the thyroid patient struggling to get enough energy to make it through the day.”

Which brings us back to the limitations of “evidence-based” medicine and the need for respectful, constant communication between patients and their doctors. “Evidence-based medicine works best on things that are very easy to measure, like blood levels.” McArdle says. “It is very easy to tell whether a statin reduces blood cholesterol levels. It took a lot longer to tell whether it actually reduced heart attacks.

“The more we rely on a central board to make decisions for huge numbers of people, the more tempted we are going to be to rely on metrics which can be collected, aggregated and mined for data. Where does that leave the thyroid patient with ‘normal’ blood levels . . . and a collection of vague, frustrating—but nonetheless very real--symptoms?”

McArdle found an endocrinologist willing to treat her more aggressively than mere numbers indicated to many of his colleagues. Three weeks after beginning her hormone regiment, she wasn't so cold any more and her voice lost its scratchiness.

“I don't want to come out against evidence-based medicine; we should always be trying to figure out what works and what doesn't,” she writes. “But I do question what constitutes evidence. Will evidence-based medicine push us even more towards looking at numbers rather than listening to patients?”

There’s ignorance, and then there’s dangerous, irresponsible, willful ignorance.

In a series of posts, the website HealthNewsReview exposed the bone-headed actions of Delta Airlines in showing an onboard video sponsored by an anti-science organization minimizing the importance of flu shots. The video “urges viewers to become informed about influenza and how to stay well during the flu season without resorting to the influenza vaccine.”

As you might imagine, the response has been vigorous, including an online petition to “tell Delta Airlines to stop putting their passengers’ health at risk.” The medical establishment weighed in formally in a letter to Delta CEO Richard Anderson from Dr. Robert W. Block, president of the American Academy of Pediatrics (AAP). He wrote:

“The American Academy of Pediatrics (AAP) objects to the paid advertisement/public service message from the National Vaccine Information Center (NVIC) being shown throughout the month of November on Delta’s in-flight programming….
While hand washing and covering sneezes are parts of a larger strategy to prevent the spread of influenza, influenza vaccine continues to be the best way to protect against the disease. It is especially important in enclosed settings where disease droplets can easily spread to passengers sitting in close quarters, especially infants and children and those with special health care needs.

The AAP and many other child health organizations have worked hard to protect children and their families from unfounded and unscientific misinformation regarding vaccine safety. The influenza vaccine is safe and effective.

By providing advertising space to an organization like the NVIC, which opposes the nation’s recommended childhood immunization schedule and promotes the unscientific practice of delaying or skipping vaccines altogether, you are putting the lives of children at risk, leaving them unprotected from vaccine-preventable diseases. Diseases like influenza can have serious consequences. From September 2010 to August 2011, 115 children died from influenza disease, most of whom were unvaccinated.”

Another physician, Val Jones, blogged about this dereliction of corporate responsibility as well, noting that the airline had ignored the righteous outcry and committed to running the video ads through November.

“Every year the influenza virus kills as many as 49,000 Americans and 500,000 individuals world-wide,” she writes. "… I don't understand why Delta, having been duly informed of their mistake, would continue to run ads from a group that misinforms Americans about vaccine-preventable illness. I wanted to believe that they would do the right thing….”

“Which means that I will NOT be flying Delta in the foreseeable future and I hope you won't either. When US physician organizations are flat out ignored by corporate executives, it leaves us with only one choice—to speak with our feet. Sadly, the bottom line may matter more to them than the health and safety of their passengers.”

If you wish to sign the online petition, link here. You may also Tweet your feelings to #DontFlyDelta hashtag.

When it comes to the green revolution, you’re a conscientious soldier. You care about the effect consumer products have on your health and the health of the planet. You read labels. You understand that chemical use has consequences.

Or you would, anyway, if manufacturers let you. While the law requires that food products list their ingredients on the package, the same rule does not apply to household cleaning products. And sometimes their brand names can be misleading.

A new study commissioned by a nonprofit environmental organization employed an independent lab to test 20 top household cleaning products. As it turns out, Tide’s “Free & Gentle” contained 1,4-dioxane, a solvent and suspected cancer agent. As it turns out, Simple Green is not simple, as it contains phthalates, a chemical suspected in endocrine (reproductive) disorders, especially in children. As it turns out, several products listed as “fragrance-free” contained allergens.

Not long ago, we wrote about potentially dangerous ingredients in antibacterial soap, an even more questionable compound, given its market branding as something that's supposed to ward off disease, not possibly promote it.

The report—“Dirty Secrets: What’s Hiding in Your Cleaning Products?”—was issued last week on the same day a Congressman from New York introduced the Cleaning Product Right-to-Know Act. Rep. Steve Israel wants manufacturers to disclose the chemicals used in products ranging from laundry detergent to air fresheners to furniture polish.

In a news release accompanying the report, Anne Steinemann, one of its scientific reviewers, said, "I've heard complaints from hundreds of people who said that air fresheners and other fragranced household products made them sick—causing headaches, breathing difficulties, seizures, asthma attacks and other health problems." Steinemann is professor of civil and environmental engineering and public affairs at the University of Washington. "This report does a tremendous service by revealing the hazardous chemicals that can be hidden in cleaning products, so that consumers can know to avoid fragrances and other chemicals that are linked to serious health problems."

We can’t speak to the scientific rigor of the report, as it has not been published in a peer-reviewed journal. But its approach and conclusions speak to common sense—people have a right to know what chemicals they are introducing into the environment. And manufacturers, it seems to us, should be obliged to disclose what goes into their products.

If you agree, contact your congressional representatives, and ask them to support the disclosure legislation.

A primary consumer benefit of free enterprise is competition. Not happy with the service/quality/price of something you want to purchase? Compare one merchant’s offer with that of another, and take your business where it makes most sense to you.

A few months ago, we wrote about a Florida law requiring urgent care clinics to post prices. Unfortunately, knowing the cost of a medical service in advance generally isn’t possible in the health-care market. As noted by Merrill Goozner on his GoozNews blog,

“

For all the talk about consumer driven medicine …, why doesn’t anyone talk about pricing transparency in health care? Did you ever walk into a doctor’s office where the prices of various services were posted? A hospital? At the drug store’s pharmacy counter?”

But enabling medical consumers to contrast and compare isn’t as easy as, say, simply legislating that prices be posted wherever people are buying health-care products and services. Goozner says that although that’s a place to start, it’s inherently confusing because the U.S. system of health care is so fragmented. It’s not like buying a pair of jeans, where the only differences might be cost and whether or not you get free shipping.

When you’re buying treatment for a heart attack, as Goozner so deftly describes one hypothetical hospital emergency room patient, “You look up on the wall to learn that Insurance Company A pays $30,000 for angioplasty. Insurance Company B pays $28,000. Medicare pays $26,000. Medicaid pays $24,000. And (for) you, the customer right in off the street without coverage, the charge is $32,000. Don’t want to pay our rack rate? You might want to try down the street at Mother Mercy of the Poor. We understand their rack rate is $26,000, the same as Medicare.”

You still need to compare apples with apples. How many providers are involved in each of these options, what are their credentials, what’s the record for each hospital in terms of infection control and readmission rates? Every price listing begs another question.

Holy sliding scale!

“Pricing transparency” helps medical consumers understand the high cost of medical care, and the inefficiencies and inequities of a multipayer system of financing it, as Goozner notes, and that’s critical to effecting any meaningful change. But unless and until U.S. medical care is priced the same for everybody receiving the same service or product, he says, it won’t address the problem of why Americans pay more for medical care than residents of other countries.

Jason Shafrin, writing on the Healthcare Economist blog, is also a believer in pricing transparency. He promotes a tool consumers can use to help them shop for care. The Healthcare Blue Book, which is recommended by Consumer Reports, estimates costs for specific medical problems.

Armed with pricing information, consumers—especially the uninsured—are then empowered to negotiate, to ask for charges comparable to others they can quantify.

As stated on the Blue Book website, the resource “is a free consumer guide to help you determine fair prices in your area for healthcare services. If you pay for your own healthcare, have a high deductible or need a service your insurance does not fully cover, we can help. The Blue Book will help you find fair prices for surgery, hospital stays, doctor visits, medical tests and much more.”

Shafrin looked into how the Blue Book sourced its pricing information. Using claims and billing data, it averages prices paid by insurance companies to providers in a given market.

If you’re faced with a medical expense, either in full or as a contribution to what your insurance pays, inform yourself if the cost seems reasonable. If not, speak out. When it comes to fair health care costs, ignorance is not your friend.

Some things you just can’t make up.

A website is promoting breast cancer research through sales of its product. So far, so normal. But consider that the site, The Firearm Blog, “is dedicated to all things firearm related. If you are into AR-15 and AK carbines, skeet shotguns, self defense pistols or hunting rifles then there will be something here for you.”

And here’s the “good works” pitch: “DPMS have teamed up with Gun Broker to auction off a pink version of their Lite 16" rifle. 100% of the proceeds with go towards Susan G. Komen for the Cure, an organization which supports breast cancer research.”

Does anyone see anything amiss about an effort to eradicate a disease that kills by promoting a product that kills?

The offer prompted some lively commentary from the site’s readers; well, “lively” is one way to put it:

• "Perfect gun for a shoot-out at the Pepto-Bismal Corral."


• "Girls usually stop dressing all-pink before they’re 12, so what makes these manufacturers think that adult women would refuse to be seen in the woods without a pink gun and matching pink-shaded camo clothing?"


• "If there’s any one organization that hopes they never cure Breast Cancer, it’s the Susan G. Komen for the Cure foundation. These people make money off of every single pink item in the world. Who knew you could make money off of a color and a cause? … I think we should outlaw toy guns so that when children pick up a gun, they know it’s real. Even idiots deserve to live to voting age, apparently."

Which brings us to the topic of when a cause becomes a joke. Has the breast cancer lobby undermined its honor by pinkifying the world so much that people stop paying attention?

Some people think so, and they are calling it “breast cancer pinkwashing.” As noted recently on MedPage Today, several media outlets suggested that the pink ribbon campaign has gone too far; that “pink ribbon fatigue” has set in, and when an arms dealer gets attention by painting a rifle pink, you have to wonder if they’re right.

“Pinkwashing” refers to commercial interests promoting breast cancer awareness while also profiting from pink-themed products. As noted in the Boston Globe last year, “The application of pink—in the name of raising money and steering women toward the radiologist’s office—does seem to get broader and cheerier each year. Now, we have NFL balls decorated with pink ribbons and world landmarks bathed in pink light, from the White House to the Ancient Mayan pyramids of Chichen Itza.”

As Karuna Jaggar, executive director of Breast Cancer Action, told MedPage, “At one time, pink was the means. Now, it’s almost become the end in itself. In its most simplistic forms, pink has become a distraction. You put a pink ribbon on it, people stop asking questions.”

Research is based on asking questions. Cures and treatments for dread diseases are based on research.

According to the National Cancer Institute, more than 230,000 women will be diagnosed with and nearly 40,000 will die of breast cancer in 2011. Barbara Brenner, former executive director of Breast Cancer Action, once questioned all the money being raised during breast cancer awareness promotions. “If shopping could cure breast cancer,” she said, “it would be cured by now.”

Last year, KFC initiated a campaign to donate 50 cents to the Komen Foundation (the largest breast cancer foundation in the world) from every pinkwashed bucket of chicken sold. Now, fried chicken isn’t as lethal as a rifle, but given that obesity is a risk factor for the disease, does it strike you as an appropriate cross-promotion?

If you want to support businesses that do good works without selling out your health-promotion principles, Breast Cancer Action suggests you ask yourself these questions before spending your charitable dollars:

1. How much money from your purchase actually goes toward breast cancer? Is that amount clearly stated on the package?
2. What is the maximum amount a company will donate?
3. How are the funds being raised?
4. To what breast cancer organization does the money go, and what types of programs does it support?
5. What is the company doing to assure that its products are not actually contributing to the breast cancer epidemic?

There’s nothing wrong with wearing a pink ribbon or paying extra for a breast cancer postage stamp. But if colorizing the world prevents it from seeing clearly, it’s time to engage common sense in common cause.

Article first published as Breast Cancer Awareness: Too Much of a Good Thing? on Technorati.

Yes, you read the headline correctly. Transplanting feces from healthy patients into patients with horrible infectious diarrhea is rapidly becoming standard medical practice because of its dramatic positive results.

Contracting an infection from Clostridium difficile (C. difficile) can be deadly. About 6 in 100 hospital patients become infected with the insidious bacterium. People who use proton-pump inhibitors also seem to be at greater risk factor for infection. So says a recent study published in the New England Journal of Medicine.

The study’s authors hope that its findings will promote efforts to prevent this extremely common cause of health-care related infectious diarrhea.

A day after that study hit the news, their wishes seem to have come true.

In a “say what?” solution to the horrors of C. difficile infection, the American College of Gastroenterology reported that transplanting fecal material containing healthy bacteria into C. difficile patients can bring relief even to elderly, debilitated people for whom previous courses of treatment had failed.

As reported on MedPage Today, 9 in 10 “fecal microbiota” transplants were successful. The definition of success was patients who had no recurrence within three months. On average, it took six days for their diarrhea to resolve, and four weeks for their fatigue to resolve.

What seems contrary to common sense – even physicians posting comments on the MedPage story were making bathroom humor jokes – appears to be the new gold standard of care for C. difficile infections. Stool bacterial population of patients with recurrent C. difficile infections, apparently, is completely different from that of normal people. “Therefore,” the study’s lead author said, “it would make sense that if you performed a massive bacterial replacement, that might very well reverse that condition and allow for a cure in people who were otherwise not curable.”

The study is poised to change how gastroentologists – physicians who specialize in disorders of the the stomach, intestines and associated organs – practice.

C. difficile infections are notoriously difficult to treat. Recurrence rates are as high as 1 in 2 patients. Earlier fecal transplant studies showed promise, but their results were derived from only a single treatment center. The new study involved five different U.S. medical centers.

The patient/subjects involved in the new study, according to MedPage Today, had failed an average of five different medication courses before receiving the transplant.

At the risk of someone claiming “too much information!” the question arises: What was the source of the transplanted material? More directly, who were the donors? Most were members of the same household as the patient; only one patient had no relationship with the donor.

One interesting result was that two patients experienced improvement in their pre-existing conditions; one with arthritis and one with sinus allergies. Four patients developed new disorders – peripheral neuropathy (nerve damage involving numbness and pain in hands and feet), Sjogren's syndrome (an immune problem involving various symptoms), rheumatoid arthritis and idiopathic thrombocytopenia (abnormally low blood platelets of unknown origin). One patient, who was in hospice care, died.

Study subjects did not seem to find the idea of a fecal transplant unpleasant. "They're desperate people seeking desperate measures so they didn't have much of a problem with it,” said the study’s primary author. “We have to stop thinking of stool as a smelly inert substance; it's an incredibly biologically active substance."

Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…”

The paper was referring to “Health IT and Patient Safety: Building Safer Systems for Better Care," a report by the Institute of Medicine (IOM) calling for greater oversight of health-care technologies.

The U.S. Department of Health and Human Services (HHS) requested the IOM to evaluate electronic health records in the first place out of concern that some such products raised safety risks for patients. Practitioners were wondering if the boom in digital record-keeping is fostering a rash of medical errors thanks to balky, difficult or malfunctioning technology.

The report doesn’t decry the move – for reasons of both cost and care efficiency – from paper to electronic records, it just emphasizes that oversight must be part of the deal: “To achieve better health care, a robust infrastructure that supports learning and improving the safety of health IT is essential. Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus. If appropriately implemented, health IT can help improve health care providers’ performance, better communication between patients and providers, and enhance patient safety, which ultimately may lead to better care for Americans.”

The IOM said an investigative agency -- like the National Transportation Safety Board, which investigates airline accidents and examines safety issues -- should be established for health-care technology. And that it should include tracking the safety performance of electronic health records.

So far, such efforts have yielded mixed results: There are tales of success, such as hospitals that use computerized, bar-coded prescription systems, but also tales of patient harm, such as delayed treatment due to lost data and/or problems with human-computer communication.

The IOM advised the Department of Health and Human Services (HHS) to devise a plan within 12 months to monitor patient safety risks associated with health IT, and to report on that progress every year. If, within a year, such progress is insufficient, the scientists’ group said the FDA should regulate these technologies, and that the agency should start planning for that now.

The IOM report is big on transparency. It is the government’s job to ensure that the private sector demonstrates concern for consumers by freely exchanging information about product use, “including details relating to patient safety.” You can’t establish a body of knowledge and develop a functioning market of safe products if you don’t share details of their risks.

This is thwarted today by the common practice of including nondisclosure clauses in contracts with vendors of IT health products. Such provisions impede efforts to improve safety by discouraging users from sharing information.

The report notes that clauses that limit liability (known as “hold harmless”) also undermine best-product practice by shifting liability “from the vendor to the users when an adverse event occurs.” As the story in The Times said, “Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.”

No one wants to stifle technological developments or the will to manage health care more efficiently. The key, as the IOM says, is to foster innovation without compromising safety.

Here’s another chapter in our ongoing (never-ending?) story of media complicity in spreading fake health “news.”

As noted on HealthNewsReview, a website that examines, exposes and debunks junk health news, last month MSNBC.com committed an act of disease-mongering in a story headlined “Plastic surgeon wants to fix your ‘runner’s face.'"

Like every human we've met, runners have faces, but there’s no such thing as a disorder whose symptoms are purely aesthetic and ascribed solely to people who run. Tellingly, the term was coined by … a cosmetic surgeon who is marketing a “treatment” for what isn’t a medical problem.

But when you’re selling something, especially something you made up, you have to use florid language that draws attention and stimulates response. But do the news media have to spread the colorful message in mindless repetition completely devoid of critical thinking?

Instead of calling out “runner’s face” for the bogus condition it is, MSNBC promoted the cosmetic surgeon’s treatment for the condition he invented. As HealthNewsReview commented, “This is what is called ‘advertising’ – not ‘journalism.’”

The story offered no information on the potential harm of the surgeon’s treatment, nor any sense of what it costs. The story offered no scientific data to underpin the story because there isn’t any. But it did pretend to be authoritative:

“Runner's face generally occurs in both men and women ages 40+ who exercise to improve their body, and in doing so end up with a skeletal and bony face,” pronounced MSNBC.com. “When exercising, an athlete burns off fat beneath the layers of his/her skin. The marked loss of fatty tissue results in a loss of volume which leads to a prominent appearance of the bones, accelerated development of skin laxity and deepening of wrinkles. Though you may look like a 20-year-old from the neck down--your face will easily give away your age.”

The “treatment” for the non-disorder effects a purely cosmetic result -- inject a combination of Botox-Restylane to smooth wrinkles and plump up the face.

If this is a health-care intervention, if this is a news story, then Kim Kardashian is a marriage counselor. With an advanced degree.

Article first published as The New "Disease" of Runner's Face on Technorati.

Once upon a time an adult physical exam routinely included urinalysis, blood tests, echocardiogram and many other screening tests, such as a bone-density scan. But a new study in the Archives of Internal Medicine adds to the growing body of evidence that many such tests are inappropriate, unnecessary and costly beyond their value.

The study, as described by Kaiser Health News, examined the cost of common primary care practices that had been declared overused by a group of physicians known as the Good Stewardship Working Group. It includes internists, family physicians and pediatricians who are part of the National Physicians Alliance, which advocates universal, affordable health care.
Among that group’s conclusions:

• blood and other diagnostic tests were often ordered even for patients who had no related symptoms or risk factors;


• imaging studies such as CT scans or MRIs for low back pain and Pap tests to screen for cervical cancer in teenagers were unnecessary;


• writing prescriptions for antibiotics for children with sore throats who didn't have a strep infection was unwise;


• recommending cough medicines for children with upper respiratory infections and ordering head imaging tests kids who had fallen but didn't exhibit symptoms such as dizziness or loss of consciousness were unnecessary.

The new study estimated that 12 of the unnecessary treatments and screenings cost $6.8 billion in 2009.

The activity most frequently performed without need was a complete blood cell count at a routine physical exam. In more than half of the surveyed routine physicals, doctors inappropriately ordered such tests that cost $32.7 million.

But the single costliest bad practice was prescribing brand-name statins before trying patients on a generic drug first – that accounts for $5.8 billion of the $6.8 billion total.

Study authors said their cost figures were conservative, given that they didn't factor the cost of follow-up tests or procedures prompted by an abnormal blood test reading result or imaging scan, even though in the absence of symptoms or risk factors the follow-up may be unnecessary and even cause harm.

Doctors order unnecessary and overpriced tests and drugs when there's no reason because it’s ingrained in their training, said one member of the Alliance, because some patients expect them and because doctors practice defensive medicine – you don’t get into legal trouble, goes that thinking, if you cover far more bases than you’ll ever need.

Those reasons are misguided on medical, legal and financial grounds.

The new study concludes that doctors alone can't rewrite these misdirections. Patients must inform themselves about when a test is indicated in order to be better medical consumers. And both doctors and patients must communicate. How often have you asked your doctor what the prescription he just prescribed will cost, and he says “I don’t know”?

If your doctor prescribes a test, make sure you know why, what side effects might result and how much it costs. If medication is prescribed, ask if there's a generic version and, if so, if it will suffice, and how much it costs.

Ignorance in standard medical care is not bliss. It's expensive.

Everybody likes a free lunch. And everybody who pays for health care in America likes a free health screening, so when the Giant Eagle grocery chain started offering free in-store allergy tests, lots of people accepted the offer.

As discussed on HealthNewsReview.org by Kevin Lomangino, editor-in-chief of Clinical Nutrition Insight, allergies are like prostate cancer and breast cancer. They are a public health problem that you simply can't test your way out of, at least based on current knowledge.

It’s important to detect and treat food and other allergies – they can be life-threatening. But as Lomangino says, “indiscriminate testing for allergies may be even worse than not enough testing.”

Dr. Richard Wasserman, an allergist in Dallas, told Lomangino that allergy test panels are being heavily marketed to doctors as a means to boost practice revenue. Never mind that such tests have been shown to generate a false-positive as much as half the time when used to detect food allergies. Wasserman said that many patients probably are being tested in situations in which a careful clinical history would rule out suspected food allergy.

As an allergist, Wasserman acknowledges that he might be biased against primary care docs conducting allergy testing. But his concerns about the overuse of food allergy tests are supported by guidelines from the National Institutes of health (NIH) about food allergies. Lab tests are frequently (and incorrectly) used as the sole basis for a food allergy diagnosis.

Which brings us back to the “Attention Shoppers! Free Allergy Testing On Aisle 2!” approach to health care.

Because so many tests indicate a positive result when there is no allergy, their subjects will avoid foods unnecessarily. These diagnoses require a more careful evaluation.

Wasserman offered a hypothetical Giant Eagle customer with nasal symptoms who received a false-positive test for allergy to ragweed. That person might start taking Allegra in the mistaken belief that it would reduce symptoms. But an expert clinical evaluation might have turned up a more serious ailment whose discovery was delayed because of the false test result. Or that person might experience a side effect of Allegra worse than the symptoms of the nonallergy.

"A positive test does not equal a diagnosis, which is the premise of the testing programs," Wasserman said. "These tests are fundamentally useless without a formal evaluation of the patient."

The NIH guidelines indicate a growing awareness of false, easy-fix allergy diagnoses, but Lomangino says we’re still a long way from implementing an evidence-based standard for allergy testing. One study showed that in 103 out of 111 children who were avoiding foods based on allergy test results had no reaction to the food when they ate it during a carefully conducted food challenge.

Such false diagnoses are disruptive. Special diets can be difficult to follow and restrictive diets can be more expensive. People can suffer unnecessary anxiety about accidentally eating the “wrong” thing.

So if you’re having symptoms of what you suspect is an allergy -- to food, to dust, to plants … whatever -- don’t seek confirmation at the same establishment where you're buying razor blades and Cheez-Whiz. And if your primary care provider gives you an allergy test that’s positive, before embarking on treatment, ask for a second opinion from a board-certified allergist.

Repeat after me: There's no free lunch. Ever.

Article first published as The No-Free-Lunch Lesson in "Free" Allergy Testing on Technorati.

Last year we covered the outrageous spectacle in west Texas when two nurses who were appalled at a doctor's quackish and dangerous treatments of patients got into criminal trouble when they tried to report him to the state licensing board. Eventually the nurses were vindicated, but not before they lost their jobs. Now the doctor and the criminal authorities who did his bidding in Winkler County have had their comeuppance.

But still one question remains. How could this doctor, Rolando G. Arafiles Jr., have moved from town to town in Texas, inflicting harm on patients and ultimately moving on, and the authorities have taken so long to bring him to earth?

The answer exposes the perennial conflict-of-interest flaw in any professional self-disciplinary system, where the authorities bend over backwards to find some reason to let one of their fellow doctors keep practicing.

It's really not too different from the child sexual abuse scandal at Penn State, where a powerful authority figure, an assistant football coach, could continually inflict grievous harm on small children and his fellow football coaches like Joe Paterno looked the other way out of self-interest.

The Texas story is summed up in this Texas Observer story, which has this telling paragraph:

The more we dug into Arafiles' past, the more a troubling circular pattern emerged. In his wanderings across Texas—from Victoria to Crane to his wilderness years as a contract doctor to, finally, Kermit—Arafiles did the same things over and over, with the same results. He moved into town. He charmed the townsfolk. He began practicing medicine that can be charitably described as questionable; less charitably as dangerous. He peddled fringe treatments of dubious medical value. He tried to turn town authority figures against anyone who challenged him. He turned litigious when challenged. Eventually, he was stopped, but not punished. He left town, he moved on to somewhere else, and he did it all over again. And perhaps he would still be doing it today had two brave nurses in Kermit not put a stop to it.

A new research study gives hope that some patients who seem to be in a coma, or persistent vegetative state, may actually be aware of their surroundings and can communicate on a rudimentary level.

The even better news is that misdiagnosis of these patients, which studies suggest may be common, can be corrected by use of a simple, cheap and widely available brain wave test called the EEG, electroencephalogram.

The study was reported in the online edition of the prestigious British medical journal The Lancet.

Many patients who seem to be completely unaware of their surroundings after a brain injury do not show any response to this new kind of testing. But of the 16 patients tested in the new study, three patients did show a response, indicating that they had been misdiagnosed and should be reclassified as "minimally conscious."

The researchers gave the seemingly vegetative patients two simple tasks: imagine moving a right finger, and then imagine moving a right toe. The patients who passed the test were able to generate specific, repeatable brain wave responses in the same area of the brain, the pre-motor cortex, as normal healthy control patients could do with the same testing.

Other researchers have found that putting patients like this into MRI machines for functional MRI (f-MRI) testing also can show results that indicate the apparently unresponsive patient actually has a response deep within the brain. The brains of some of these patients light up in specific places on the f-MRI test when they are asked to imagine some specific athletic activity like playing tennis.

The problem with f-MRI testing is it's expensive and requires the patient to be transported to a radiology center.

Here is the conclusion of the authors of the EEG study:

Despite rigorous clinical assessment, many patients in the vegetative state are misdiagnosed. The EEG method that we developed is cheap, portable, widely available, and objective. It could allow the widespread use of this bedside technique for the rediagnosis of patients who behaviourally seem to be entirely vegetative, but who might have residual cognitive function and conscious awareness.

Brain scientists are excited that if these results hold up, we may have a way to communicate with some of the 25,000 Americans who lie in beds seemingly unaware but actually with something going on inside.

Article first published as New Hope for Communicating with Patients in a "Vegetative State" on Technorati.

As the saying goes, keep your friends close and your enemies closer.

Not that we know for sure that behavioral economist Dan Ariely considers pharmaceutical manufacturers “enemies,” but we know he’s onto their practices that are not exactly in the best interest of patients. He and a colleague recently had dinner with a few pharmaceutical sales representatives to find out the tricks of their trade, which is getting doctors to prescribe their companies’ drugs.

Trick No. 1: “One of [the reps] told us a story about how he was once trying to persuade a reluctant female physician to attend a seminar about a medication he was promoting. After a bit of schmoozing, she finally decided to attend – but only after he agreed to escort her to a ballroom dancing class.” A fine example of, Ariely says, if-you-scratch-my-back-I’ll-scratch-yours.

Trick No. 2: “[B]ring meals to the doctor’s office. … [O]ne office even required alternating days of steak or lobster for lunch in exchange for access to the well-fed doctors.”

Trick No. 3: “When the reps were in the physician’s office, they were sometimes called into the examination room (as ‘experts’) to inform the patients about the drug directly. And the device reps experienced a surprisingly intimate level of involvement in patient care, often selling medical devices in the operating room, while the surgery was going on.” (Comment by Patrick Malone: What's really shocking is that these sales reps have at most a bachelor's degree and a few weeks of training from their employers.)

So, Ariely asks, what should be done about this shocking insinuation of commerce into medicine? “[R]ealize that doctors have conflicts of interest. …[P]lace barriers that will prevent this kind of schmoozing, and keep reps from accessing doctors or patients.”

And have dinner with somebody else.

Last week, GlaxoSmithKline agreed to pay $3 billion to settle several lawsuits over how it creates and markets drugs. It’s not as if anybody needed any more evidence that Big Pharma is an industry desperately in need of watch-dogging, but, from the Reuters report, here's the money quote: "… payments would be funded through existing cash resources."

Who except Lindsay Lohan has $3 billion lying around to pay off their bad behavior?

The settlement relates to several cases filed by the U.S. government, including those related to Avandia, Glaxo’s diabetes drug that has been linked to heart risks; how the company exploited Medicaid to boost drug sales profits; and allegations that Glaxo persuaded doctors to prescribe drugs for uses not approved by the FDA (a practice known as off-label marketing).

The United States has beefed up efforts to address unfair pharmaceutical industry practices. Since 2000, Reuters says, the number of industry settlements with state and federal entities has soared. The government is finally objecting to how pharmaceutical business as usual elevates profits over the interests of patients.

Sales reps often receive bonuses based on reaching target numbers, a practice that encourages off-label promotion, which can result in serious harm to patients.

As reported on the business radio program Marketplace, the government allows doctors the freedom to prescribe as they see fit, but it does not allow sales reps to say anything they want to about the drug.

Pharmaceutical companies are challenging that ban in court, claiming that what sales reps say is a form of free speech and should be protected. The Supreme Court recently ruled that some drug marketing is free-speech protected. And a case now in the federal Court of Appeals could decide whether that protection extends to off-label marketing. Which would mean even larger “cash resources” for Big Pharma.

According to Reuters, Glaxo has promised that it will behave in the future – Chief Executive Andrew Witty said that the settled cases "do not reflect the company that we are today."

Maybe.

But don’t forget that last year Glaxo paid $2.4 billion over patient liability claims relating to Avandia, for an investigation into its former Puerto Rico factory and for anti-trust and product liability litigation over Paxil, an antidepressant.

The whole industry’s character has long been called into question. Several other leading drug manufacturers, Reuters said, have settled U.S. charges for huge amounts, or have been forced to pay significant sums in anticipation of such deals.

• Last month, Abbott Laboratories accepted a $1.4 billion charge in conjunction with a U.S. federal investigation into marketing Depakote, an anticonvulsant drug.


• In 2009, Pfizer shelled out $2.3 billion for marketing Bextra (an arthritis drug that has been withdrawn) and other medicines for unapproved uses.


• In 2009, Eli Lilly cut a check for $1.4 billion after charges were leveled about the improper marketing of Zyprexa, an antipsychotic, for children and elderly patients.

If it makes better business sense to pay billions out of your spare change to make problems go away than it does to expose them to full, legal disclosure, that’s the sign of an industry that requires constant observation by outsiders.

Propofol is a surgical anesthetic safely used only in a hospital operating room or a comparably equipped medical facility with continuous monitoring of the patient's heart rate and breathing. The idea of using propofol as a sleep aid in a private home, with a doctor occasionally looking in? Unthinkable, before Michael Jackson's death.

Now Dr. Conrad Murray has been convicted of manslaughter for his role in Jackson's death. Murray was supposed to be Jackson's personal doctor, a unique physician with only one patient, who was paid $150,000 a month by Jackson's concert agency to keep the singer healthy.

Medical malpractice occurs when a doctor violates basic patient safety rules and causes harm to a patient. But this was much worse. Dr. Murray was guilty not just of breaking rules, but of a fundamental conflict of interest. Apparently seduced by his large monthly salary, he threw his medical judgment out the window and let Michael Jackson wheedle him into dangerous and ultimately fatal behavior with powerful prescription drugs. If he had "just said no," like any ethical, responsible physician would have done, Jackson presumably would have shopped for some other doctor to supply him drugs. But then Jackson's death would have been on some other hands, and Murray would not be facing prison and loss of his medical license.

While this is a particularly egregious example, conflicts of interest are common in medicine, from unnecessary surgery to advocating drugs, surgical devices and other treatments based on the doctor's relationship with the drug or device manufacturer.

Last week’s executive order was the first one in more than 25 years directly affecting FDA operations. That in itself speaks to the gravity of the issue it addresses: shortages of drugs, many of them life-saving.

President Obama’s order had two clear messages:
1. Drug shortages are too critical to ignore.
2. Congress has been derelict in resolving them.

As reported on FDA Law Blog, the number of prescription drug shortages nearly tripled between 2005 and 2010. Among the missing medicines are treatments for child leukemia, breast cancer, colon cancer, anesthetics and antibiotics.

If there isn’t enough medicine to treat everyone who needs it, doctors have to ration. Only patients in the worst circumstances get drugs and others either do without or receive a decidedly second choice. If there even is one.

And when someone must switch medicines in the middle of a course of treatment, the potential for reduced effectiveness is high.

The situation affects not only patient health and survival, it feeds a vicious cycle. Drug shortages create higher prices. They also can delay clinical trials for new, experimental treatments if the “control” group (subjects who are testing the standard treatment in comparison to the new one) is assigned to receive the absent drug.

The causes of drug shortages are many. The FDA has identified “quality/manufacturing issues,” production delays and the discontinuation of older drugs that don’t bring as much profit to their manufacturers as they used to.

Free-marketers say prices of older drugs are low until supply runs low. Industry officials say even the higher prices those drugs would bring if more were manufactured aren’t enough to offset the cost of slicing through the government red tape to increase production.

Once again, Big Pharma’s lust for profit compromises human health.

Congress introduced legislation earlier this year to expand FDA authority to require advance notice of impending drug discontinuations and notice of any circumstances that might cause a drug to be discontinued or its production impeded. But the legislation is languishing in committee, so Obama said, essentially, “enough.”

The executive order directs the FDA to:

• require sole-source drug manufacturers to notify the agency in advance of discontinuation that could lead to shortages of certain critical drugs;


• expedite reviews of new drug suppliers, manufacturing facilities and manufacturing changes if such reviews would avoid or mitigate existing or potential shortages;


• report drug stockpiling and price-gouging for scarce drugs to the U.S. Department of Justice.

These measures won’t necessarily resolve all the problems associated with drug shortages, but the order definitely has brought the problem to the fore and has figuratively kicked butt for legislative relief.

If you believe your care provider has caused serious harm by negligence or malpractice, consult an attorney about legal relief. But that’s using a machete, and sometimes the job requires a butter knife.

If you have a medical procedure – surgery, a screening test – whose outcome is not what you were led to expect, or has made you worse off, there are several ways to lodge complaints. Many of these options recently were spelled out in an article in the Los Angeles Times.

Often, as simple a gesture as writing a letter can have the desired effect, especially if your primary objective is to have your problem acknowledged. If you’ve expressed concern, for example, about enduring, post-procedure pain that hasn’t been addressed, a letter to your doctor seeking the name of another practitioner who can evaluate your symptoms, review the procedure that caused them and suggest how to treat it can be a wake-up call.

As The Times reported, a doctor no longer interested in treating a patient is legally required to notify him or her in writing. The doctor also is obliged to provide references to another physician, and instruct the patient or new provider how to access the records relevant to your treatment.

If you’re trying to get, say, a surgeon, to accept responsibility for an adverse outcome, Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen in Washington, D.C., outlines what to do. “Failure to do so,” he said in The Times, “amounts to patient abandonment, an infraction that would justify an investigation by the state medical board.”

Most state medical boards – the agencies responsible for licensing medical practitioners, monitoring their behavior and imposing discipline – have similar provider requirements. Jennifer Simoes of California’s Medical Board said that a patient should file a complaint if he or she “believes the quality of care that they received was poor or not the standard of care they should have received."

Other state agencies also are appropriate places to report medical mistreatment and misadventure, such as state insurance commissions, which monitor health-care coverage by private insurers. Complain to your insurance company via letter, and copy your state insurance commission.

Medical societies, which range from all-encompassing organizations such as the American Medical Association (AMA) to groups whose membership is limited to certain medical specialties, such as the American Academy of Orthopedic Surgeons (AAOS), are concerned about their reputations. It’s in their best interest to ensure their members are responsive to patient needs and complaints.

To find a state medical society, visit the AMA’s website and click on the “Patients” tab to link to the Medical Societies Directories.

If your problem relates to a surgery or procedure performed in a hospital, file a complaint with that facility’s patient advocate and, if it has one, the ombudsman. Many hospitals are accredited by the Joint Commission, about which we recently wrote. It’s an independent, nonprofit organization that accredits and certifies U.S. health-care organizations and programs.

The Joint Commission also accepts patient complaints, and its Office of Quality Monitoring uses consumer complaints to help assess if a hospital meets its accreditation standards. In The Times’ story, Michael Kulczycki, executive director of the Joint Commission's Ambulatory Care Accreditation Program, said of patient complaints, "We would focus on the continuity of care and appropriate follow-up to the patient."

File complaints at http://www.jointcommission.org. Click on Report a Complaint About a Health Care Organization in the Action Center box on the home page. After reviewing a complaint, the Joint Commission can present your issue to the hospital and ask it to review the doctor’s actions to see if additional action is necessary.

Medicare patients have additional avenues to voice complaints. Contact your regional Medicare Quality Improvement Organization (QIO), which reviews medical care and helps consumers who complain about the quality of their care. Locate a QIO near you at http://www.ahqa.org. Click on QIO Locator.

As always, you have legal rights to safe and responsible medical care. Don’t be reluctant to exercise them if you’re not getting the attention, professional courtesy and resolution you believe you deserve. As Carome said in The Times, "Ultimately another way physicians are held accountable is through litigation."

You can find out more about non-lawsuit options for making a complaint about a doctor, nurse, hospital or other health care provider by reading the Health Care Advocates' Power Kit on Patrick Malone's law firm website. It contains addresses of all the relevant agencies and tips on how to make an effective complaint.

A Kansas neurosurgeon who has been sued at least 16 times for malpractice has been able to enlist one important ally in protecting his privacy: the federal agency that runs the data bank that is supposed to keep track of dangerous doctors so they don't drift from hospital to hospital without their track record becoming known to hospitals who hire them.

The National Practitioner Data Bank (NPDB) is run by the U.S. Health Resources and Services Administration. It has both a public mission and a confidential one. The confidential mission is to allow hospitals to query the data base to obtain the track record of lawsuit payouts and disciplinary actions against doctors so they can make an intelligent decision about whether to bring a doctor onto their staff. The data bank also publishes aggregate data, without individual identifiers, about the doctors it keeps an eye on, so the public can see that it is doing its job.

A reporter for the Kansas City Star used the public data on the NPDB, among other resources, to figure out the lawsuit record of neurosurgeon Robert Tenny.

As shown by newly released documents, Dr. Tenny responded with a flurry of letters to the federal agency, which responded with:

* A threat against the newspaper reporter to punish him with fines for misusing the data bank. (This was later withdrawn.)

* Stern letters to all the 28 hospitals who had queried the data bank about Dr. Tenny to warn them that the information they had obtained on him was confidential and not to be disclosed.

* Shutting down the public access portion of the data bank.

The shutdown of all public data from the data bank has caused the most outcry, with a bunch of journalist organizations demanding that it be reinstated.

Senator Charles Grassley of Iowa released documents this week showing the cozy relationship between Dr. Tenny and the federal agency. You can read the documents by clicking here.

Article first published as Federal Health Agency Takes Side of Multi-Sued Surgeon on Technorati.

Last week, the Federal Trade Commission (FTC) released a report with the boring title “Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement and Modernization Act of 2003.”

But the story it tells is hardly dull, and it has implications for anyone who takes prescription medicine. If you want to read the whole report, spoiler alert! It concludes “pharmaceutical companies continued a recent anticompetitive trend of paying potential generic rivals to delay the introduction of lower-cost prescription drug alternatives for American consumers.”

The Washington Post was less than impressed with Big Pharma’s “pay-for-delay settlements.” As analyzed by FDA Law Blog, there were 43 more of these unsavory brand/generic settlements in fiscal year 2011 than 2010; 28 final settlements involved 25 different branded Big Pharma drugs that both compensated the generic manufacturer and restricted it from marketing the less expensive version of the brand med.

In 2004, the FTC didn’t find a single settlement in a patent litigation matter involving drug makers that raised pay-for-delay concerns.

The commission concluded that fiscal year 2011 “witnessed the continued trends of (a) record numbers of brands and generics resolving patent litigation prior to a final court decision on the merits and (b) significant numbers of such settlements potentially involving pay-for-delay.”

It seems obvious that, as The Post notes, “Such pay-for-delay arrangements hurt consumers and increase costs for federal programs such as Medicare and Medicaid,” but the Generic Pharmaceutical Association (“GPhA”) disagrees. It said that “the FTC continues to miss the fundamental point: Patent settlements speed up the availability of less costly generic drugs and save money for everyone; banning settlements and forcing drugs makers to continue lengthy litigation with uncertain outcomes will be costly.”

It’s saying that when generic companies litigate drug patent cases to conclusion (as opposed to settling the case earlier), the generic drugs are delayed from entering the market at least until the brand patent expires.

This expensive, consumer-averse mess would be eliminated by enacting the Preserve Access to Affordable Generics Act. It would effectively ban patent settlement agreements and empower the FTC to challenge suspicious deals. It would accept certain deals if “clear and convincing evidence” supports the notion that the “pro-competitive benefits outweigh the anti-competitive harms.” The nonpartisan Congressional Budget Office estimates that the government would save $3 billion over 10 years by eliminating pay-for-delay deals.

The FTC and the Obama administration have urged the Joint Select Committee on Deficit Reduction (the “super committee” charged with trying to find federal budgets cuts by the end of November) to include the legislation in its deficit reduction plan.

You wonder if all the zealots keen to limit patients’ right by unreasonably capping medical malpractice awards (euphemistically referred to as “tort reform”) are as eager to put a stop to what looks awfully like pharmaceutical company collusion.