Patient POV

Personalized Medicine: Read the Chart!

Posted on May 16, 2013 by Laura Newman

This is a guest post by Ricki Lewis, PhD, who blogs at DNAScience, part of the PLOS blog network. Ricki is a science writer with a PhD in genetics. The author of several textbooks and thousands of articles in scientific, medical, and consumer publications, Ricki’s first narrative nonfiction book, “The Forever Fix: Gene Therapy and the Boy Who Saved It,” was published by St. Martin’s Press in March 2012. In addition to writing, Ricki provides genetic counseling for parents-to-be at CareNet Medical Group in Schenectady, NY and teaches “Genethics” an online course for master’s degree students at the Alden March Bioethics Institute of Albany Medical Center.

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While we’re busy debating the pros and cons of clinical genome sequencing and tossing around buzzwords like “personalized” and “translational” medicine, I’ve recently caught some health care providers ignoring the archaic skills of communication and common sense. So while we await genome analysis apps on our smartphones and DNA sequence annotators in our doctors’ offices, here are 3 suggestions on how to provide personalized medicine right now:

1. Read the patient’s chart (paper or digital)

2. Listen to the patient

3. Look at the patient

Disclaimer: Today’s blog is anecdotal and non-scientific, but may identify a trend.

MY MISSING THYROID
A few weeks ago, I had a long-overdue check-up, with a nurse practitioner. It was my first visit to the practice, which had provided excellent urgent care.

On the medical history form, I described my circa 1993 thyroid cancer in intimate histological detail: papillary in left lobe, follicular in the right.

The NP spent an impressive 45 minutes asking questions and listening to me – or so I thought. During the brief physical exam, I told her all about my thyroid cancer, my daily Synthroid dose, and even brought her hand to my throat, having noticed that dentists get very excited at my lack of a thyroid gland. No thyroid tests needed, said I. My endocrinologist had recently done them.

So I was surprised when, early the next morning, a Saturday, my cell phone quacked.

“Ricki? This is the nurse practitioner. I’m afraid something very alarming has turned up in your bloodwork.”

I braced myself.

“Your thyroid hormone is very low.”

Imagine that!

“Could that possibly be because I take a pill every morning to account for the fact that my thyroid gland has not been part of me for 20 years?” Had she read the chart, where she herself had typed in the cancer info and I’d written it? Did she recall palpating my glandless neck? And why didn’t my health insurer note the duplicated blood test?

“OK. Let’s move on to your LDL. It’s too high.”

Genetic counselors are experts in listening, documenting, recalling, and making important clinical connections. (NHGRI)

Actually, it wasn’t, considering the family history of zero cardiovascular disease that she had neglected to inquire about.

Happily, my HDL was just fine, but she didn’t appreciate my pointing out that HDL is no longer considered a valid biomarker for everyone — geneticists noticed years ago that quite a few families with perfectly good tickers have low (supposedly high-risk) HDL. I’m not going to link to it because the news is pervasive on the Internet. I’ve already altered my textbooks.

Still, she wanted me on a statin, stat, perturbed at my refusal to sign up for a lifetime on a drug that I didn’t need. (Within a few seconds of ending the call, I found a blog by an MD, from 2007, warning of the dangers of statins and providing cases of exactly who shouldn’t be on them. Minus a few years, the “60 year-old woman who is trim, exercises daily, does not smoke, and has no family history of heart disease = no cholesterol-lowering medication” was me.)

Time to switch gears.

“You should begin an exercise program,” the NP helpfully suggested.

“Is the 60 to 90 minutes a day I told you about not enough?”

“Hmmm. Well, you need a low-fat diet to lower your cholesterol.”

I nicely reminded her that she might require a refresher on basic biochemistry if she thought eating less cholesterol lowers cholesterol. It doesn’t work that way. My 10-year low-carb diet made the most sense. The low-fat diet she suggested was exactly what not to do.

I could have chalked up this forgetfulness to a packed schedule, too many patients to recall details, but she spent 45 minutes with me – she probably saw only a handful of patients a day. And she could have at least opened the chart before she called me with potentially upsetting news.

Burying one’s head in a laptop whilst the patient sits there, in the glamorous paper gown, can be a problem too.

Soon after my encounter with the NP, I took my mother-in-law to the cardiologist. After the requisite long wait, we went into an examining room for another wait, and finally the snazzily-dressed doctor rushed into the exam room, pulled up a stool, and proceeded to become one with his laptop. Tapping away, he fired incomprehensible drug and disease names at his elderly patient. He never looked up. And he yammered on about the importance of high HDL, too. I could have sat there with a water buffalo instead of my mother-in-law and he probably wouldn’t have noticed anything amiss until the 2-minute physical exam.

Look at the patient. Engage.

And then there’s the fictional example of young Dr. Gorgeous on the new medical drama “Monday Mornings” who, in the debut episode, let a boy bleed out on the operating table from an inherited clotting disorder, having forgotten to query the single mom about the father’s medical history. Oops.

IGNORED OUT-OF-CONTROL BLOOD SUGAR
The worst example of physician cluelessness happened to a friend I’ll call Karen, who recently had weight loss surgery. This is not a cosmetic procedure. In many people, the surgery ends years of diabetes, polycystic ovarian syndrome, hypertension, even depression.

Karen checked out several offerings. A program at a local hospital seemed so eager to sign her up that it felt like a drive-through. She finally found a bariatric “center of excellence” near her home in a large, midwestern city. She respected the tough requirements: lose 5% of her body weight, and keep her blood sugar down. Specifically, that meant maintaining her A1C level at 7 or below. A1C measures how much blood sugar is carried attached to hemoglobin, the oxygen-carrying proteins packed into red blood cells. Because a red blood cell lives approximately 3 months, the A1C test is repeated every 3 months.

Karen’s A1C rose a bit last August. Too many barbecues, maybe.

“Oh, don’t worry,” chirped the endocrinologist, clutching the chart, unopened, sitting in front of her laptop, also unopened. “If it’s high again, just let me know, I can help. Meanwhile, take two more meds, and up the other one. I’ll email it to your pharmacy.” Tap tap tap.

No one seemed overly concerned with the A1C, because six weeks later, Karen had the all-important appointment with the surgeon, to get “the date.”

First, an intern flounced into the room and pulled up a stool. She sat down, a paper chart on her lap, unopened. A laptop next to her, unopened. The newbie doctor asked a few condescending questions to determine whether Karen was a moron or not and actually knew what the various weight loss surgeries — band, sleeve, bypass — entailed. She did. So the intern launched into a lecture about how sometimes the doc has to remove the gallbladder during the surgery.

Much as I had to remind my NP that I had no thyroid, Karen had to fill the intern in on that fact that her gallbladder had exited her body some 8 years previously. Karen, realizing the doctor was still in training, suggested that perhaps she consider actually reading a patient’s chart beforehand. What a concept!

Deer-in-the-headlights, the flustered intern raced out, without asking the important questions, for her job was to screen the patients to save the surgeon time. How much weight have you lost? What’s your most recent A1C? It was all there in the chart.

Then the surgeon came in. Very serious. He, too, held a chart, unopened. After a brief speech comparing the surgical options, he gave Karen the thumbs-up, and off she happily trooped to pick the date. She assumed he and the nurse with the scheduling calendar knew her A1C. He seemingly assumed the intern, his screener, had no objections to the A1C. She’d passed!

Karen was so excited. The countdown began to the surgery, which would be in December. The diet and exercise continued.

And then Karen had routine bloodwork, her red blood cells having recycled themselves, the hemoglobin within hopefully free of the offending sugar. Shortly after, the bariatric center called. The surgeon had canceled her surgery. Her A1C was too high.

Her A1C was, in fact, just a drop lower than it had been on the day that the surgeon had given her the go-ahead. Had he, or his biliarily-obsessed underling, so much as glanced at the chart, no date would have been bestowed. No apology for the setback.

Karen was devastated, but at first hopeful. “Remember, the endocrinologist said she’d help!” Karen cried to me over the phone.

So she emailed the doc, called, and tried to get her next appointment moved up. She got nowhere. No answers.

Time passed. Finally, the next endocrinology appointment rolled around, which was, in happier times, supposed to be the pre-op check-up.

After the requisite hour-long wait, for no apparent reason and without explanation or apology, the endocrinologist bustled into the room, holding an unopened chart.

“How are you doing?” Big smile. She sat down on the ever-present bewheeled stool, opened her laptop, and then noticed Karen’s uncharacteristic silence.

“How are things?” she tried again.

“Terrible,” said Karen, starting to cry. Her story spilled out. “Why didn’t you answer my email? Return my phone calls?”

The doctor quickly scanned her email and claimed never to have seen any messages. Not true, Karen later deduced. It’s easy enough to check.

“Oh, but look! This is your pre-op visit!”

The doc was still utterly confused, until Karen pointed out, again, that the problem was the A1C. When the doctor launched into the familiar litany of upping the non-insulin meds, with no obvious concern about the potential dangers of taking drugs for many months that didn’t do anything, a strategy that would delay the surgery at least another three months as a new generation of red blood cells formed from reticulocytes extruding their nuclei, Karen had had enough.

“Give. Me. Insulin. NOW.”

The doctor readily agreed, scurried out of the room purportedly to figure out how she had not known of this disaster, and a nice nurse came in to demonstrate insulin injections. Karen learned more in 5 minutes from the nurse/diabetes educator than she had with any physician she’d encountered during her long journey to weight loss surgery.

READ THE CHART!
Theoretically, electronic medical records are a great idea, having a patient’s information instantly available on a laptop or tablet. But as I’ve learned from writing textbooks, you lose something in being restricted to seeing one page at a time – you learn more when pages are compared on real paper, in real space. At the ob/gyn practice where I do genetic counseling, we switched to electronic records a few years ago – but practically, we still use paper charts. Otherwise, you can miss things.

A timeless type of medical chart, the pedigree. (NHGRI)

In those medical charts, electronic or dead tree, the family history is of paramount importance. This is hardly a new concept, and family histories are certainly stressed early on in medical school, as anyone who’s been examined at a teaching hospital can attest. But somewhere along the way, amidst all the new tests and technologies, the biotech bells and whistles, the importance of the history fades.

Maybe the new genomics will bring back both the family history and the pedigree.

Posed Alan Guttmacher, MD, Francis Collins, MD, PhD, and Richard Carmona, MD, MPH, in “The Family History – More Important Than Ever” in The New England Journal of Medicine, “Will the family history eventually become a relic of antiquated medical practice that has been replaced by more ‘modern’ tools? For instance, in a decade or so, when sequencing a patient’s genome may cost less than $1,000, will it still be worth a practitioner’s time to obtain the less precise information contained in a family history? We think so.”

(NHGRI)

That was written in November 2004, so the decade’s almost up. Genome sequencing is here, arriving faster than expected, with cost plummeting. But our genome information will only be actionable in a piecemeal fashion, until we understand all gene-gene and gene-environment interactions, and all the variations therein. Family history will be crucial to the interpretation, for it provides the context without which identifying gene variants may be meaningless. Even tragic.

Reading the chart, especially the family history, can provide valuable clues – as can what the patient says, and how she says it.

Let’s bring common sense and intuition back to the practice of medicine.

Posted in diabetes, Patient stories, weight-loss surgery | Tagged bariatric surgery, electronic health records, thyroid | 3 Comments

Will Patients Win with Transparent Hospital-Bill Mandates?

Posted on May 8, 2013 by Laura Newman

If you had a chance to read Steve Brill’s enormous piece on outrageous hospital bills in Time earlier this year, you probably found it an eye-opener. Speaking before Physicians for a National Health Program meeting in New York last night, Brill said: “The anger is really building.” Brill is making the rounds now, speaking around the country. He put the blame on hospitals, administrative costs, and device salespeople, who reap excessive profits from patients.

Doctors and nurses (who incidentally accounted for much of the audience) are not the culprits in out-of-control prices, he explained repeatedly during his presentation. Not discussed, though, was the fact that some doctors do receive outrageous compensation from hospitals and medical schools. According to Wikipedia, David B. Samadi, MD, Vice Chair of Robotics and Minimally Invasive Surgery, at Mount Sinai School of Medicine in New York, where the meeting was held, received annual compensation in 2010 of $6,389,585. He was the highest paid person at the medical school. The figure was taken from the medical school’s tax return, according to Wikipedia. You have to wonder how many doctors are on academic medical center payrolls, and to what extent, their pay is transferred into your bill. Surely, Mount Sinai is not paying Dr. Samadi as a loss.

Hospital Charge Stories Take Media by Storm

A slew of articles are out today on hospital cost variation in Medicare that coincide with the federal government’s release of prices for the 100 most common inpatient procedures. The hospital costs published today come from the hospitals’ chargemaster.

Washington Post’s May 8 wonkblog reports several stark charge differences. Costs for joint replacement, the most common procedure for Medicare patients, ranged from a low of “$5,304 in Ada, Oklahoma, to $223,373 in Monterey, California, states the WaPo story. In Philadelphia, a simple case of pneumonia without complications cost $124,051 in Philadelphia, compared with $5,093 in Water Valley, Mississippi.

In California, the Los Angeles Times reports similar price differentials, but also points out that since 2006, California hospitals have been required to publish average charges the most common procedures on a state website. Today’s lead story in the New York Times reports that, according to its analysis, hospitals charge about 3 to 5 times more than what Medicare will pay for a given procedure.

Hospital chargemasters are a set of list prices that hospitals use internally, but it’s impossible to see them, unless they are made transparent, Brill explained. “It’s fiction – except it’s not fiction for the people who get billed, who are uninsured or have lousy coverage,” he said. Importantly, he pointed out that at least 60% of personal bankruptcies are attributable to excessive bills. The nation’s teaching hospitals defend higher cost structure. The hospitals claim that higher costs are necessary for teaching and treating sicker and older patients.

Brill and others see price transparency as an opening for reform. Do you think publishing prices like this will help you? Have you been stunned by charges on bills that you have gotten?

Posted in Medicare | Tagged Centers for Medicare and Medicaid, cost transparency, hospital costs, physician salaries | 2 Comments

U.S. Preventive Services Task Force Backs Routine HIV Testing

Posted on May 2, 2013 by Laura Newman

The U.S. Preventive Services Task Force formally published its recommendation for routine HIV testing for all individuals age 15 to 65 in the Annals of Internal Medicine this week. An editorial and patient materials are all available free to anyone with an Internet connection. Many people who work in HIV hoped that this would finally move HIV into mainstream medicine. With a U.S. Preventive Services Task Force Recommendation, patients don’t need to ask for the test, it would become a routine blood test like many others, stigma would be reduced, and insurance would likely cover it. The evidence backs it. However, within 24 hours of the Task Force Recommendation going up online, the American Academy of Family Physicians questioned age 15 as the logical starting point, instead urging that testing begin at age 18. This is just some of the resistance that the medical community is putting forward now.

Several months ago, I spoke with Roger Chou, MD, MPH, associate professor of internal medicine at Oregon Health and Science University, Portland, Oregon, who headed the evidence review for the U.S. Preventive Services Task Force. “About 25% of people who have HIV are not aware of it,” Chou said. “They have no identifiable risk factors.”

Other reasons why data to back routine HIV testing are in, include that “the screening test is highly accurate, we have direct evidence from randomized controlled trials that we can reduce the risk of transmission by 90%, and that you can’t trust what your patient says, or that patients don’t always think that they are at risk,” said Chou.

Disclosure a Huge Problem

“If we learned anything about the announcement earlier this week that Jason Collins is gay, it ought to be that you can’t just look at someone and put them into a risk category,” said Donna Futterman, MD, Director of the Adolescent AIDS Program, and Professor of Clinical Pediatrics, Children’s Hospital of Montefiore, Albert Einstein College of Medicine, Bronx, New York. “Most people who are gay won’t share that with providers that they are gay.” Notably, two days after Collins’ announcement, his former fiancé went on television to say that she had no clue that Collins was gay. This is not to imply anything about Collins’ HIV status whatsoever.

“People simply don’t volunteer that they are having unprotected male-to-male sex, taking IV drugs with dirty needles, and “we really can’t define what high-risk behavior is,” Chou explained. Therefore, targeted screening to so-called high-risk groups misses the boat.

“Step one of the HIV Treatment cascade – is finding and testing people with HIV,” Futterman told me. “It is the step that involves the non-HIV care system. We need to engage the primary care providers and system in routinely offering testing so as to find those with HIV who don’t know their status.”

Judy Levison, MD, associate professor of obstetrics and gynecology, Baylor College of Medicine, Houston, Texas, works with women with HIV who are pregnant. The USPSTF and many health authorities previously recommended HIV testing for all pregnant women. Levison sees enormous public health value in the medical community adding HIV testing to regular screening panels that patients have done when they see their primary care provider.

Although we all like to think we know the sexual patterns of people we are sleeping with, Levison says that she sees plenty of pregnant women who don’t fit the stereotype for HIV. These are women who have been in longlasting marriages, who get the surprise of their lives when they test positive for HIV. “Sometimes it is a married woman who has no idea her husband is having unprotected sex with men,” she said. “Or someone who slipped up once a long time ago with someone she thought she knew.” Levison remembered a patient quote in the book Mortal Secrets: Truth and Lies in the Age of AIDS, by Richard Klitzman and Ronald Bayer: “What was my crime? I loved someone.”

With antiretroviral therapies proving that HIV can be treated just like many other chronic diseases, enabling people to have a full life, have healthy babies, and see them grow up, Levison sees enormous benefits with HIV testing expanding to adults and teens. “The successes of universal testing in pregnancy — and discovering many women not known to have risk factors do have HIV–is central to the recommendation to test all adults. Currently, those who do not know they have HIV are responsible for a large proportion of newly transmitted infections.”

Michael Saag, MD, Director of the Center for AIDS Research, University of Alabama Birmingham, amplifies this: “The bottom line: Anyone who is sexually active, or has even thought about being sexually active should be tested for HIV at least once…and more often if they remain active, especially with multiple partners over time.” As for an age cut-off, he added: “I don’t know of a specific age cut-off that applies in either direction that would apply to everyone. Therefore, I think age distinctions are a bit of a distraction. This is about function and activity, not age.”

Medical Community Views HIV Differently

When we learn that large proportions of Americans have hypertension, diabetes, or high cholesterol, and don’t know it, what do we do? We view it as a missed opportunity, and mount large campaigns to get people tested, followed, and into care to bring their blood pressure down, and keep it down. Not so for HIV.

“It’s been a very difficult sell for providers,” Futterman told me. Providers resist thinking that their patients could possibly have HIV because they don’t obviously fit into the targeted risk groups and they don’t envisage much yield in their practice. What Futterman thinks is urgently needed is to add HIV testing to routine blood screening panels. But HIV testing is segregated, a “holdover from the early days when pre- and post-test counseling were in place.” Although there were good historical reasons for splintering it aside – patient protections and discrimination especially – that no longer justifies keeping it separate.

“Practice change won’t happen unless we work on physician buy-in, implementation, and evaluation,” said Futterman. What she would like to see is for the test to become streamlined, have HIV testing incorporated as a measure of quality for the Joint Commission on Accreditation of Health Care Organizations. “We need to get rid of the special laws related to consent,” she said. “If it is complicated to do it, it won’t be done.”

Posted in HIV/AIDS, USPSTF | Tagged barriers, screening | Leave a comment

Patient POV Update: Immigration and Abortion News

Posted on April 24, 2013 by Laura Newman

I regret not posting here recently. It’s been a very busy time for me and I am following several issues that will make their way to this blog soon. I can’t give you a rank order of what’s most important, but I think there is a heck of a lot going on out there that warrants an in-depth look.

Immigrants with Mental Illness Need Rights to Counsel

Immigration is becoming a big issue (no surprise) since the Boston bombings.

The US Department of Homeland Security handles deportations. If you can, grab a copy of this week’s New Yorker, I highly recommend reading: “The Deportation Machine.” It’s a horrifying story about what happens when a mentally ill person gets trapped by the Department of Homeland Security. In this case, the person was U.S. born! Authorities had good information and bad information, but whenever they uncovered good information, they wrote it off as being wrong.

On a related note, in California, a class action suit is underway that raises the issue that mentally ill immigrants should have access to counsel before they are hurdled into deportation. It’s a right that has been denied unfairly until now. The case may come to closure in the coming weeks.

Separating the Gosnell Case from Safe, Legal Abortions

Kermit A. Gosnell is a 72-year-old black doctor who performed abortions at Women’s Medical Services, an abortion clinic in Philadelphia. Many women treated there were poor and black. Abortions were done late, many beyond the legal limit of 24 weeks for abortion in Pennsylvania.

It’s the one and only case that I’ve ever heard of since abortion became legalized in 1973 rife with charges of a doctor operating outside the law, aborting viable infants long past legal gestational age for abortions in Pennsylvania, stockpiling infant parts in jars, filthy conditions, using unlicensed staff to do abortions, and practicing outside of the law. I am appalled by the conditions presented related to this case. However, it is noteworthy that the Judge cleared Gosnell of several charges earlier this week, as reported in the New York Times last night.

The case has been on my mind quite a bit. I was active in the movement to legalize abortion. and writing about this case requires attention to detail. The lurid details of the case revolt people, no matter what side of the abortion spectrum they are on.

Concerns I have about this case include the following:

that Gosnell is brought to justice;

that the media makes clear that Gosnell is a renegade, who based all accounts, operated outside the law, with no regard for safety.

that Gosnell does not resemble licensed abortion providers;

Legal abortions are extremely safe, far safer than childbirth;
Restrictive abortion laws do not serve the public’s health, but that make it unacceptably onerous for women to get timely abortions and clinics to operate economically.

I hope that the public and lawmakers put this case into proper perspective because it could unjustly continue policies that already have negatively affected access to timely abortions in many states.

I have serious concerns about the media handling of this story. My points are actually quite different from what you might have read. Expect to hear more from me on this in the coming weeks.

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Posted in Uncategorized | Tagged access to care, access to counsel, contraception, deportation, Dept. of Homeland Security, illegal abortion, Kermit Gosnell, mental illness, women's health | Leave a comment

Wellness at the Workplace: Contested Terrain

Posted on April 2, 2013 by Laura Newman

Wellness workplace programs are growing. The recent flap over CVS’ Workplace Wellness Program, brought the issue into focus. CVS is hardly alone in devising workplace wellness programs, but it offers a case study of many similar programs.

PatientPOV is pleased to host a post by Margaret W. Crane, a New York-based freelance writer specializing in health care, medicine, social policy and human rights. She offers a perspective that has not been out in much coverage of the issue. Her credits appear in the LA Times, New Politics, on abcnews.com and other websites. Crane can be reached on twitter at pegcrane.

Workplace wellness programs are nothing new. From gym discounts to on-site weight-loss programs to lunchtime workouts, many companies offer “carrots” to encourage employees to adopt healthier lifestyle choices. Financial rewards, too, can be part of the typical incentive mix.

According to a 2012 survey of 800 U.S. employers, among the 83% that offer wellness incentives, a majority rely on the carrot approach, with only 5% reporting the use of penalties—mainly health insurance premium increases—to motivate their employees to quit smoking, exercise regularly, and lose weight.

These numbers are expected to shift dramatically in the next few years. In an update of the 2012 survey slated for publication later this month, Aon Hewitt predicts

that 58% of survey respondents plan to impose penalties on employees who “do not take appropriate actions for improving their health.

At CVS, “appropriate actions” translate into two principal requirements: Employees are being asked to fill out a health questionnaire and to undergo biometric screening. Failure to comply will result in higher insurance premiums to the tune of $50 a month.

CVS Caremark’s employee wellness program has continued to generate headlines over the past several weeks, including a recent story in The New York Times. The pharmacy chain is one of a growing number of employers, including Walmart, PepsiCo, and Home Depot, who are using negative incentives to promote healthier behaviors among their employees—the start of an ominous trend.

Punishing the Victim

Most people don’t routinely share their weight, blood pressure, or BMI with their friends, much less their employers. HIPAA was designed to protect such private information, which could otherwise be used to deny coverage, services, and even employment. Even though CVS and others using these strategies claim that there is a firewall, the whole approach seems to be a slippery slope.

CVS insists that its wellness policies will help prevent employees from developing obesity- and smoking-related chronic diseases. But according to Stephen Soumerai, MD, there’s something fundamentally wrong with the entire incentives/penalties paradigm. A professor of population medicine at Harvard Medical School, Dr. Soumerai has been looking at the way negative incentives are being used to penalize hospitals with high readmission rates—a feature of healthcare reform. He finds the approach unfair, whether it’s used to incentivize improved performance on the part of doctors, hospitals, or employees.

“The literature in support of this approach is very weak,” he said. “We seem to be going in the wrong direction.” While voluntary provision of health information “could be useful in helping to identify risk groups,” the requirement to do so will most likely be met with resistance among employees. And rightly so. Why should a CVS store attendant report private information that could be used to raise his or her insurance premiums? Do patients’ rights end at the workplace?

For Their Own Good?

CVS, a chain that’s supposed to be all about promoting health, actually houses aisle after aisle of candy, snacks, and sodas: food products that are known to drive obesity, especially among lower-income families. Seen in this light, the chain’s commitment to employee wellness seems pretty specious.

You can’t dangle chips and chocolate bars in front of people all day long and then blame them for their moral turpitude when they over-indulge. How much temptation are employees, not to mention consumers, expected to resist?

It’s hard enough to bear the multiple burdens that people with obesity are made to endure, from the condition’s impact on health to its painful social and moral stigma. But when an overweight employee is forced to reveal all or face a hefty penalty, that’s cruel and unusual punishment for a non-crime.

CVS and other like-thinking employers are exacerbating the very problems that healthcare reform should be alleviating. Instead of leveling the playing field and broadening access to care, negative wellness incentives are curtailing insurance coverage for those who need it most.

Rising Costs as Rationale

Businesses point to skyrocketing healthcare costs as a major drain on the nation’s economy. It’s common knowledge that costs are continuing to soar, despite the Obama Administration’s efforts to rein them in. In the media and the public discourse, “rising costs” seem like a natural disaster rather than like a series of economic phenomena capable of being analyzed and understood. In the so-called healthcare industry, the marketplace invisibly decides costs in a way that places them beyond scrutiny.

Until costs are rendered transparent, neither businesses nor their government allies should be able to carry out unjust policies with the putative goal of reining in costs.

What’s more, employers should treat their employees like adults, not like naughty children. And anyway, if CVS Caremark is truly serious about wellness, they should prove it by losing the junk food.

Posted in wellness | Tagged CVS, health insurance, health reform, incentives, workplace | 3 Comments

With Prostate-Specific Antigen (PSA) Screening Questioned, Why Not Hurl Out the Next Unproven Prostate Tests?

Posted on March 27, 2013 by Laura Newman

The headline in the New York Times story this morning, “New Prostate Cancer Tests Could Reduce False Alarms,” by Andrew Pollack, had me scratching my head. Had I missed something in the story of advances in prostate cancer screening and diagnosis? The search for finding something better than PSA tests to reduce false positives and unnecessary biopsies has been going on for time immemorial, or more accurately, maybe the last 15 years. Also, separating the lethal from the cancers that amount to no trouble at all has also been a key research question.

Had The Times been bamboozled into a story by industry copywriters and urologists, hoping to bring back attention to the prostate? Clearly, the US Preventive Services Task Force, the American Cancer Society, and other groups stomped on routine prostate screening. Plenty of thought leaders agreed it is not a good prostate cancer screening test.

It’s also not just screening of asymptomatic men that is at issue. What about the men diagnosed with prostate cancer? Can they be better stratified so that men with lethal cancers are separated from those that require no treatment?

The New York Times article waxes poetic about the “more than a dozen companies that have introduced tests or are planning to in the near future.” It moves on to the transformative potential of molecular markers and a high-stakes battle looming ahead between Genomic Health and Myriad Genetics.

Are readers supposed to be wowed? I think so.

My favorite line in the story was this one:

“Some experts say that even if the new tests are not perfect, they are better than what is available now.”

Was The Times in the dark about thought leaders who thought all this is premature, urologic oncologists included? Apparently. Will more men and their loved ones insist on these unproven tests? Most likely.

I don’t dispute that we need a good test that separates the bad cancers, but the test is not here yet. The data is thin.

Posted in Prostate Cancer | Tagged false positives, Genomic Health, molecular markers, Myriad Genetics, PSA, screening, testing, treatment | Leave a comment

Delay of Generics Hurts Consumer,
Taxpayer Wallets, and Patient Health

Posted on March 21, 2013 by Laura Newman

Credit: Federal Trade Commission, downloaded March 21, 2013

To insure patent extensions of high-priced, blockbuster drugs, brand-name drug companies frequently pay generic drug manufacturers to stay out of the market. It makes cheaper, more affordable generic unavailable for years. The strategy is referred to as “Pay for Delay.” The Federal Trade Commission has lots of information on this problem and its legality comes before the Supreme Court this summer. The case is Federal Trade Commission v. Watson Pharmaceuticals.

GUEST POST by Wells Wilkinson, JD, Staff Attorney, Community Catalyst

Wells Wilkinson, JD, Staff Attorney, Community Catalyst, originally wrote the post below, for Postscript, a blog of Community Catalyst’s. Community Catalyst is a national advocacy organization, has been giving consumers a voice in health care reform for more than a decade. It provides leadership and support to state and local consumer organizations, policymakers and foundations that are working to guarantee access to high-quality, affordable health care for everyone. You can follow Community Catalyst on twitter at PostScriptRx.

This spring, the U.S. Supreme Court will decide whether the increasingly frequent practice of brand-name drug companies paying off their competitors to keep new generics off the market is a violation of antitrust law. As former Federal Trade Commission(FTC) attorney David Balto told Politico: “There’s no other case that can have as much impact on reducing health care costs.”

This practice, called “pay-for-delay,” has skyrocketed since an appeals court decision allowed the first such deal in 2005. Since then, over a hundred pay-for-delay deals have delayed generic versions of 20 to 30 brand-name drugs each year, according to federal regulators at FTC.

There is no question delaying access to generic drugs harms consumers. That’s why Community Catalyst has helped consumers and advocacy organizations join legal challenges to pay-for-delay deals that blocked consumer access to generics of Provigil, K-Dur and Tamoxifen for years. We have also filed or joined Amicus briefs, and organized national and state-based advocates calling on Congress to ban pay-for-delay agreements.

Recently, Politico ran another story about how one defendant drug-maker in the case (Solvay Pharmaceutical) claimed that these pay-for-delay agreements don’t harm consumers, a position echoed by the generic drug industry’s trade group GPhA. But the FTC, U.S. Department of Justice, Attorneys-General in 36 states and consumer advocates all disagree. Why? Because access to generic drugs brings big savings for consumers and health plans. Look at GPhA’s own data that estimates access to generic drugs has saved consumers and our health care system more than $1 trillion from 2002 to 2011. That’s because generics cost one-fifth to one-tenth as much as brand-name drugs.

How the System’s Supposed to Work

Traditionally, generic drug companies wait for the patent on a brand-name drug’s active ingredient to expire and then file an application with the FDA to bring the generic version of the drug to market. Then the brand-name drug company sues the generic drug company, claiming some “patent infringement.” But in nearly all cases, the drug itself is off-patent. So the infringement is of a “secondary” or “defensive” patent that addresses some minor detail, like how the drug is formulated into a pill, or some step in the manufacturing process. The generic drug company then defends themselves from the litigation, and if they win, they launch their generic right away.

How Pay-for-Delay Deals Broke the System

Since 2005, generic and “BigPharma” companies have decided to do what the federal and state anti-trust regulators see as collusion. During litigation, the brand-name drug company offers to settle the patent infringement lawsuit they filed by paying tens or even hundreds of millions to the generic company, which then agrees to not to start selling a generic for several years. Pay-for-delay settlements are very suspicious, not only because they are made in secret but also because the payments are going the wrong way. Usually the patent-infringer is forced to pay if they violate someone else’s patent. But in these pay-for-delay settlements, these roles are reversed.

For example, Bayer sued four generic manufacturers, saying, in essence: You have infringed the patent on our blockbuster drug Cipro. To show you how angry we are, we will pay you 400 million dollars. But only if you stay off the market.

As a result, consumers did not have a generic version of the antibiotic Cipro for another seven years, while Bayer made billions in unfair profits. Overall, these so-called settlements have caused consumers and their health plans to pay tens of billions right into the pockets of the brand-name drug companies. This creates a powerful incentive to collude and delay competition as long as possible. For the millions who are underinsured, delaying a generic can force patients to pay thousands of dollars a year, or go without needed medicine.

One story we collected from a consumer from Kansas describes his struggle to afford Provigil, whose generic was delayed from 2006 to 2011 by pay for delay. He reported: “[Despite] paying almost $17,000 in annual premiums for my family [health insurance plan] last year, I was paying around$650/month [for Provigil]… That is out of pocket money I have to come up with until later in the year when I reach my deductible [sic] and I can enjoy a few months of only paying $60/month. I cannot describe to you how much stress and difficulty this has caused for me and my family the last several years…”

The real question is whether the high court will allow these secret deals and legal maneuverings to continue? Or will it restore legitimate competition to this market, lowering health care costs and ensuring better access to affordable medicines for all Americans?

Stay tuned. We will be blogging regularly about this case as it unfolds and calling attention to how pay-for-delay deals harm consumers and increase the cost of health care.

Posted in Drug costs | Tagged brand names, Community Catalyst, generic drugs, out-of-pocket costs, Pay-for-Delay, pharma, Supreme Court, Wells Wilkinson | Leave a comment

Meeting Time, Ethical Issues in Psychiatry

Posted on March 13, 2013 by Laura Newman

I am heading to the annual meeting of the Association of Healthcare Journalists, have been occupied with paying work for a change, and cannot do the usual detailed post I do here. In the meantime, it’s worth flagging some recent health news that patients might want to think about.

Ethical Issues in Psychiatry

Last week, I was proud to post Martha Roberts’ excellent post titled “Mental health medication: is it always A Bad Thing?” She made a persuasive argument for life-saving mental health medications. Too often, anti-psych medication zealots, especially when it comes to psych meds, go overboard in questioning the need for mental health meds. Let’s not throw the baby out with the bath water.

Side Effects (2013) Poster

I’ll admit it is tempting, particularly when you see and recognize #badpharma in regards to clinical trials conduct and safety, psychiatrists’ shilling for the drug companies, and manipulation and release of incomplete data. We’ve seen a lot of this in psychiatry and perhaps because the whole field and medication world revolves around the mind, we find it especially repugnant.

Our antennas go up higher than say, when bad ethics are involved in say, pushing a blockbuster heart failure drug, rheumatoid arthritis biologic drug therapy, or an anti-rejection transplant medication. It’s far easier to relate to a problem with our moods.

A few weeks ago I saw the movie, Side Effects (spoiler alert so don’t look at the link if you plan to see the movie), which I reckon accurately reflects some of the more sinister sides of the pharmaceutical industry in marketing psych drugs and saving its hide. However you feel about the plot line, the psychiatrists in the movie, the pharma folks, and the legal teams, are reprehensible. It’s worth watching.

Then, yesterday, ProPublica released another Dollars for Docs report, implicating psychiatrists more than any other doctor group, spotlighting some who make more than $500K per year in payments from big pharma. People can look up their doctors on the ProPublica site; some may be astounded at the dollars big pharma spends on doctors. Maybe they will look elsewhere.

Surely, these stories are worrisome and things will only change with the public insisting regulators look at this and put policies in place to try to get a grip.

But is that tantamount to all psychiatrists being unethical, psych drugs being thrown at people willy-nilly by anyone you are likely to see, or your very own doctor most certainly being unacceptably on the till, I doubt it. I think we ought to tread very carefully.

What do you think is a reasonable follow-up to this news?

Posted in mental health | Tagged antidepressants, antipsychotics, clinical trials, drug use, medical ethics, psychiatrists | 1 Comment

Mental health medication: is it always A Bad Thing?

Posted on March 6, 2013 by Laura Newman

THIS is a guest post written by Martha Roberts, a journalist and mental health blogger in the UK, who writes the blog, Mentalhealthwise. Martha is on twitter @martharoberts01. Thank you, Martha.

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‘So when can you come off your medication, now you’re feeling so much better?’, someone asked me recently.
‘Well…um, never,’ I replied.
‘It’d be good if you could come off it at some point,’ they said.
‘But I’ll always have bipolar – why would I want to do that?’ I said, trying hard to keep my cool.

I know such questions are asked out of concern and kindness – with a bit of misunderstanding thrown in – but they still get me thinking, ‘Will I always have to explain this?’

pills for bipolar disorder.

Such conversations remind me of how people with conditions like mine (I have mixed affective state, a type of bipolar) still have so much further to go to proper understanding. And one of the big areas that needs to be talked about is medication.

Jennifer Lawrence, who won Best Actress at the Oscars for her role in Silver Linings Playbook (a film about bipolar and mental health), recently said: “It’s just so bizarre how in this world if you have asthma, you take asthma medication. If you have diabetes, you take diabetes medication. But as soon as you have to take medicine for your mind, it’s such a stigma behind it.”

I think I might write this on a postcard, laminate it and dole it out when I’m spent for explanations and ready to tear my hair out.

I think I’ll be handing it out a lot, and it’ll have to be laminated because I’m sure some people will want to tear it up in front of me as I warble on about why I agree with this view. That’s if responses to Rachel Whitehead’s recent article are anything to go by.

Rachel, who works in the Rethink Mental Illness press office, wrote a thought-provoking article in The Independent recently about the demonization of mental health medication.

“What I find worrying,” she says, “is the automatic assumption that a rise in prescriptions, or someone taking medication for a number of years, is necessarily A Bad Thing.

“Medication for mental illness can save lives and give people the stability they need to survive. That may be for a few months, it may be years. While no one wants to be on any kind of medication unnecessarily, for some people, it’s the best option.”

It seems her article has opened floodgates, with one person accusing her of proffering a ‘pro disease model and pro the pharmaceutical industry’, saying that psychiatry, which prescribes these drugs, is based on ‘fear, fraud and force’ rather than ‘health or ‘cures”.

However, others agree with her. One says, ‘I’m so fed up [with] the anti-medication brigade out there’ and another concurs, saying, ‘This medication works for me…I have struggled with this diagnosis for the best part of my life and there were many people telling me not to take [it]…It’s easy to talk for those who have no idea of the suffering of the condition.’

I agree with this. I went on meds after years of ‘talking therapies’ failed to do the trick. Talking therapies definitely have their place – few people seem to dispute that. But drugs have their place, too.

For me, these drugs have been truly health-restoring and life-changing. Of course, these are my views and my experiences. I completely accept that others probably have different ones.

However, it seems to me that if mental health drugs work for you it’s verboden to say so. I want to challenge that (and no, I am not being funded by the pharmaceutical industry) – the enduring view that psychiatric drugs are all ‘bad’ is the stuff that stigma is made of.

It seems it’s permissible to stand up and say, ‘These drugs gave me hideous side-effects and didn’t work for me’, but somehow contemptible and collusive (and suggestive of being ‘in the hands’ of the pharmaceutical companies) to say the opposite, to say, ‘They really helped’.

Why not be allowed to say medication has worked for you without it being implied you’re some kind of misguided prescription junkie?

Listen, I’m not saying mental health drugs are always appropriate – for example, they may be more helpful where there’s a clearcut biological basis like bipolar or psychosis than for other mental health issues.

And I’m not saying my drugs are perfect. How can they be? I would imagine there are very few drugs that have no side-effects. Mine have plenty.

For starters, I now live a ‘Cinderella life’. Every day at 7pm, without fail, an alarm goes off on my mobile and the word ‘Meds’ flashes up, and I know that within two hours of taking said medication, I have to drop what I’m doing and run before I hit the decks (the drugs make me so drowsy you could poke me in the eye with a stick and I think I’d just roll over and snore).

If friends say, ‘Let’s meet up’, I’ll generally vote for an early rendezvous (note: mornings and afternoons are great…). If I take my drugs any later, I get a supreme ‘hangover’ the next day and feel like I’m wading through treacle until sunset allows me to sleep again.

I recently read that Carrie Fisher, actress and fellow bipolar gal, said of her daily drugs regime: “This constantly puts me in touch with the illness I have. I’m never quite allowed to be free of that for a day.”

This is how I feel, too. No matter what I’m doing, no matter how ‘normal’ the task or action I’m in the middle of, the alarm is like a bump back down to earth, reminding me that there’s something different about how I now live my life.

If I don’t take the drugs at all, I feel fine (presumably they have a half-life) but immediately have a shocking night’s sleep where my mind races and my fingers fidget with imaginary touch-typing or piano-playing. In other words, how it always was before meds.

I then worry this will set me on track for what I call a bipolar depressive ‘wobble’ (my drugs have also made me realise how I spent years sleeping fitfully, despite regular attempts at ‘sleep hygiene’).

The drugs also mean I’ve put on a bit of weight, and I can’t drink, smoke or have caffeine. I have to have quarterly ECGs because the drugs could cause prolonged QT intervals in my heart which could lead to my heart just stopping. I also have to have regular blood tests because the drugs are known to raise blood cholesterol which could put me at risk of heart disease. Oh, and I may get cataracts. Great.

I guess this is where the pharma critics find their fodder – ‘How can it be good that this woman is subject to all these side-effects?!’ I understand the anxiety. I also understand that prescribing can be about trial and error, and I can see why people – doctors as well as patients – find this unacceptable.

It’s true to say, too, that psychiatric meds have acquired something of a bad reputation over the years, partly due, it’s true, to inappropriate or indiscriminate use; for example, mass use of benzodiazepines in the 1970s, leading to addiction. Many people also feel that ADHD medications have been over-used in children, especially in the US.

As Dr Ian Drever, consultant psychiatrist at The Priory Woking, tells me: “In time-pressured NHS environments, prescribing a medication may be an easier and more readily-available solution than providing long-term and resource-heavy psychological work. So against that background, it’s possible to see how many people are wary of medication, and see any proponents of medication as being ‘in the pocket’ of big pharma.”

Last year Dr Ben Goldacre, author of The Guardian’s ‘Bad Science’ column, published Bad Pharma, a book in which he describes how there are serious ongoing problems in the pharmaceutical industry, in particular with clinical trials. He says important information from them is still being withheld from doctors and patients and that patients experience avoidable suffering and death as a consequence.

It goes without saying that this needs to change. Thank goodness Ben Goldacre, with his influential voice and dogged determination, is campaigning to do something about it.

But whilst it appears that challenging pharma companies in this way is vital for patient health and safety, it shouldn’t detract from the fact that some people, like me, appear to need medication and seem to benefit from it greatly.

I acknowledge that I was lucky that I found a medication and dose that appears to work for me pretty much straight away (I know many others aren’t so fortunate and take forever to get there, if at all). I’m also aware that the side-effects may come back to bite me in years to come.

In an ideal world it would be marvellous to find a drug that was side-effect free. And maybe, over the next few years, with more R&D by pharma companies who are well-placed to fund this, I may end up with one.

In the meantime, I feel it’s important to acknowledge, where appropriate, that for some people like me the drugs have affected me positively, too.

Before the drugs, I was up and down within the same day, or more precisely, within the same minute within the same hour within the same day. Mostly I was hideously depressed. I was sick and sad whilst also trying to mother, to work, to be a friend and to deal with difficult times. I feel I barely managed it. I don’t think it’s any exaggeration to say I felt like I was hurtling towards my own demise because I felt so unable to function effectively. I felt fractured and with no way of getting fixed, no matter how hard I tried.

And so, I may now be at risk of living a shorter life because of heart problems or other iatrogenic issues, but I’m hoping I’ll live longer than I would have done before meds because I am no longer feeling ill and broken.

It also means that I am better able to utilise therapy appointments because they are now constructive, working towards better ways of managing my condition – before, they were more about crisis intervention, with little space for true change.

Dr Drever, who specialises in depression, anxiety and addictions, says medication can “help to improve mood, or diminish anxiety, thus creating a foundation on which the psychological work can take place to maximum effect.” I agree – my meds and talking therapies are something of a ‘team’, facilitating wellness where talking alone was unsuccessful.

Even my daily 7pm alarm cry has started to become a welcomed interruption. It may be a reminder of my illness but it’s also a reminder of my wellness. It is constant proof that I have a diagnosis and am able to do something about it.

I’m actually one of the lucky ones, not a ‘poor sod’ who has been ‘dumped on medication’. I now have more constancy and stability in my life as a result of medication. In Rachel Whitehead’s words, meds for me haven’t been A Bad Thing.

If more people realised that they might just be a good thing, then maybe people would feel less freaked out by them and the stigma would start to fall away.

Now, where’s my laminating machine? I think I’m going to be busy…

Posted in mental health | Tagged antidepressants, bipolar, clinical trials, medication, pharma | 6 Comments

Mental Health and the Patient Point of View:
More High-Quality Stories Needed

Posted on March 6, 2013 by Laura Newman

I am thrilled that later today, Martha Roberts’ post on her own experience taking medication for mental illness, will run here. I first came across her post through a tweet from Ben Goldacre, author of Bad Pharma. It’s nice to know that he has not oversimplified the “bad pharma” argument into this meme: all drugs are inevitably bad for mental illness, overused, and inappropriate. Yes, there are huge problems with selective publishing of clinical trials data, withholding negative drug trials, and more. But mental health and mental illness are a lot more nuanced than a simple meme.

A lot more ink needs to be written about mental illnesses from the patient point of view, that show the real-life hurdles of people unfairly stigmatized, unemployed, or under-employed. I hope that this upcoming post (I’ll link to it here) is the first of many more.

If you have something to say about this, use the comments, or if you have a longer contribution, email me at patientpov “at” gmail dot com.

Posted in mental health, Patient stories | Tagged patient stories, stigma, treatment | Leave a comment