September 1, 2015

Cancer and Fertility — What Aren’t They Telling You?

When you're diagnosed with cancer, fear of death can overwhelm any other issues. Which is too bad, because cancer treatment can -- but doesn't have to -- take away your ability to have children. There are ways to preserve fertility, but providers too often don’t inform patients of their options.

A study in the journal Cancer showed that young women particularly don’t get enough information, before their treatment begins, to enhance their chances of conceiving.

Depending on the kind of cancer, how advanced it is and the medical profile of the patient, a range of treatments might be advised. Sometimes, decisions about them must be made quickly for the best chance at a positive outcome. Sometimes there simply isn’t time to preserve fertility, but when there is, often discussions are given short shrift when the doctor’s focused on discussing what’s involved in chemotherapy, radiation or both.

The researchers surveyed 459 teenage and young adult cancer patients across the U.S. They asked about what kinds of counseling was offered and what strategies were explained in terms of possibly preserving the patients’ ability to have children after their cancer treatments were completed.

About 7 in 10 subjects said they had learned that cancer treatment could make them infertile, but only about 3 in 10 males and nearly 7 in 10 females said the information included fertility-preserving options.

"It's a brave new world, fertility preservation," Dr. Nicole Noyes told CBS News. She’s a reproductive endocrinologist and director of the fertility program at the Langone Fertility Center in New York. "We've got to get the word out to more oncologists."

As CBS noted, when an adolescent or young adult is diagnosed with cancer, treatment often follows immediately, sometimes within 24 hours if they’re diagnosed during an emergency room visit when they’re already quite ill. That tiny window isn’t really open to fertility-preserving measures, but young cancer patients otherwise have the advantage of a generous biological clock: Young men generally have robust sperm and young women have a large reserve of eggs in their ovaries.

If their treatment doesn’t include radiation to the pelvis or abdomen, or the strongest regimens of chemotherapy, they might not need fertility-preserving intervention. But just because younger women continue to menstruate doesn’t mean they’re fertile.

And preserving fertility is more challenging for women — younger, post-pubescent males with mature sperm can provide samples any time. It’s also not too expensive to freeze sperm.

But women are more complicated and have more choices to consider. Preserving their fertility might require an invasive medical intervention to harvest eggs when they’re already sick. These procedures can delay their treatment for cancer.

Freezing unfertilized eggs is a common option for preserving fertility, and success rates have improved over the years. If a woman has a partner, she might consider freezing a fertilized embryo. These measures are expensive.

CBS reported that some less fraught experimental procedures are showing promise, such as repositioning the ovaries during lower-level radiation, and removing some ovarian tissue for later transplant back into the patient. Hormone blocking drugs can stop the ovaries from producing mature eggs during cancer treatment, protecting them from some harmful exposure.

Because some of these advances for young women are considered experimental, insurance often won’t pay for them unless there’s a medical reason to do so, and Medicaid never covers fertility treatments at all. The case for covering them is more persuasive if fertility and cancer care are coordinated.

Noyes told CBS that if oncology and fertility specialists work together, more women are likely to receive these treatments as part of their overall medical care. Oncologists, she said, aren’t "following my literature; I'm not following what new chemos are there to treat things. Until somebody says, 'Hey, you know they've made a lot of strides in this egg freezing,' and they start sending patients, then they see."

Dr. Margarett Shnorhavorian, the study’s lead author, agreed. She said the two medical specialties should "develop strategies that increase awareness of fertility preservation options and decrease delays in cancer therapy as fertility preservation for adolescent and young adult cancer patients improves."

Until the medical professionals get their acts together, young cancer patients and their families should be aggressive in finding out the impact of their treatment on their fertility. No one relishes the prospect of discussing procreation in such intimate detail, especially if the patient is barely old enough to perform the act usually responsible for it, but because treating the so often is successful, it would be remiss no to think about a future beyond cancer, even if the doctors don’t.

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August 31, 2015

Stanching the Flow of a Dangerous Drug for Kids

For years it’s been known that acetaminophen, the active ingredient in Tylenol, poses risks of overdose, particularly in children. Finally, the FDA has endorsed using a safety device to restrict the drug’s flow from bottles of the children’s medicine to prevent them from accidentally getting too much liquid.

As explained by ProPublica.org, the feds took action nearly two years after ProPublica and Consumer Reports explained how a flow restrictor could prevent the overdoses that can cause liver damage and, in some cases, death.

Every year, about 10,000 children visit an emergency department after overdosing on liquid medicines, many of them containing acetaminophen, a common pain reliever. Many people want to put flow restrictors on all liquid medicines used by children, not just those containing acetaminophen, but that’s been a nonstarter for the authorities and the industry, even though ProPublica found internal FDA documents showing that the agency’s own scientists had lobbied for the adoption of restrictors since at least 2001. The FDA waffled, unsure if it had the authority to require their use.

In 2011, a panel of outside advisors to the FDA was supposed to discuss the use of flow restrictors and other measures, but a month before the meeting, pharmaceutical industry representatives announced that they would start adding the devices to infants’ and children’s pediatric medicine bottles as a voluntary measure.

Companies offered several kinds of devices, and Consumer Reports tested them.

After the reports were published, government regulators and industry reps worked to develop standards to test the efficacy of flow restrictors. Final results are expected to be issued in 2016 by ASTM International, which sets guidelines for more than 12,000 products and services.

“The FDA’s formal guidance,” according to ProPublica, “has the effect of pushing makers to use flow restrictors on acetaminophen products for kids. And the standards will provide makers with a uniform way to gauge the performance of the devices.”

Still, nobody — not the government, not the drug industry — seems willing to require the flow restrictors for other products that can be hazardous to children, such as prescription cough medicine.

Why not?

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August 30, 2015

The Soundtrack for Surgical Healing

Research into the healing properties of music isn’t new, but the field of study recently was launched a bit farther with substantial evidence that listening to music before, during or after a surgical procedure helps patients by reducing pain, anxiety and the need for pain medication.

The results of the research published in Lancet involved about 7,000 subjects, and is considered the most comprehensive review so far of how music helps people cope with medical adventures.

The meta analysis (in which the results of multiple studies are reviewed and analyzed) included 72 published, randomized trials examining the effect of music on postoperative recovery in adult patients undergoing various surgical procedures. It was compared with more traditional forms of clinical care or other nondrug interventions, such as massage.

The impressive, significant review showed that, after surgery, patients were notably less anxious after listening to music and reported less pain and a diminished need for pain meds compared with the study subjects who didn’t tune in.

More than 51 million surgical operations are performed annually in the U.S.

Listening to music at any time was beneficial, but seemed to result in even better outcomes if patients listened before rather than during or after surgery. And, as music therapists have known, when patients listen to music that they choose and that they prefer, the results are even better at reducing pain.

Music is so influential, the study found, that if it was played even when patients were under general anesthetic pain levels were reported as lower, although the effects were more significant when they were conscious.

Although music clearly helped patients heal, it did not reduce the length of their hospital stays. But being in the hospital is usually such a lousy experience that anything that makes it better is welcome, whether it’s bringing your own pillow from home, or your iPod loaded with Taylor Swift (or James Taylor, in my case) and Mozart.

As Dr. Catherine Meads, the study’s lead author, said, "Music is a noninvasive, safe, cheap intervention that should be available to everyone undergoing surgery. Patients should be allowed to choose the type of music they would like to hear to maximize the benefit to their wellbeing. However, care needs to be taken that music does not interfere with the medical team's communication."

A reasonable point, but because many surgeons like to work accompanied by music piped into the OR, it’s equally reasonable to allow the patient to control the remote, so to speak, especially if it improves outcomes.

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August 28, 2015

Q&A on the Female Libido Drug

Last week, the FDA approved the first prescription drug aimed at boosting women’s libido. The process of approval was controversial, as we wrote recently in our blog, “An ‘Astroturf’ Grassroots Campaign for a Female Viagra.”

The reference to the fake grass came from a commentator writing on HealthNewsReview.org, (HNR) whose point, with which we agree, was that people who testified before the FDA panel considering the approval were manufactured witnesses, not scientists. They were political and commercial activists whose efforts HNR called “faux-advocacy.” Their slick presentations snookered the FDA into supporting the idea that women with a low sexual drive should be considered sick and that they suffer discrimination because men have drugs to aid their sexual needs, but not women.

Keep in mind that approval of the drug was denied twice previously because of concerns about the drug’s safety and its negligible benefits.

The pill, whose brand name is Addyi, will be available as of October accompanied by warnings about the risk of dangerously low blood pressure, and fainting, if you drink alcohol while taking it. It’s approved only for younger, premenopausal women, but doctors can prescribe it “off-label” to older women, even though its effects haven’t been studied in them.

The Associated Press (AP) offered a Q&A to help readers understand the drug. Following is an excerpt of its story. But if you want to understand in more depth why Addyi is so controversial and why you might want to avoid it, read the thoughtful discussion that aired on the PBS NewsHour under the heading “Why Some Doctors Are Wary of the New Female Libido Pill.”

Q: How does Addyi work?

A: It acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs, and originally was studied as a treatment for depression before being repurposed into a libido drug. Researchers note its ability to increase dopamine, a brain chemical associated with appetite, while lowering serotonin, which is linked with feelings of satiation.

Q: Who is this drug intended for?

A: The FDA approved it for premenopausal women with hypoactive sexual desire disorder (HSDD), described as a lack of sexual appetite that causes emotional distress. As many as 8.6 million U.S. women might have the condition, but because so many other factors affect sexual appetite, other causes for sexual disinterest must be ruled out before a diagnosis can be made. Relationship problems, medical conditions and mood issues caused by other medications all can affect libido.

And the diagnosis is not universally accepted; many experts say that low sex drive should not be considered a medical condition.

Q: Why is the approval decision controversial?

A: The process was contentious, including two previous rejections by the FDA. Drug manufacturers and some medical experts claim that women need prescription medications to treat sexual disorders, which they consider serious medical problems. Some experts and consumer-safety advocates claim that the drug's side effects are dangerous, and some question whether low libido is a medical condition. Tactics for approval by the manufacturer, Sprout Pharmaceuticals, have been challenged for enlisting outside politicians and women's groups to lobby the feds.

Q: Does the drug work?

A: Experts usually describe Addyi's effect as "modest." Sprout’s studies showed that women taking the drug reported a slight increase in sexually satisfying events each month, and they reported a slight increase in desire and a slight decrease in stress.

FDA scientists described these effects as "small," but enough to meet its effectiveness standards.

Q: What are the side effects?

A: About 1 in 10 patients in Sprout's studies experienced the most common problems: dizziness, fatigue and nausea. The drug will carry a warning label that women should not drink alcohol or take certain types of other medications, including antifungal drugs, because those combinations can cause low blood pressure and fainting.

Q: How much will it cost?

A: Women with health insurance will pay between $30 and $75 for a month's supply of Addyi, depending on their coverage.

Q: Why did the FDA approve the drug this time?

A: Regulators first rejected Addyi in 2010, saying that it failed to achieve a key study goal — increasing desire based on patients' daily journal entries. That deficiency, combined with the drug's negative side effects, outweighed its benefits.

Sprout conducted another study of sexual desire using a different method whose results the FDA found acceptable. The company also conducted safety studies to clarify the drug's risks, which are outlined on its warning label.

“While the FDA is required to make all decisions based on science,” according to AP, “critics say that the concerted lobbying effort by Sprout-funded supporters also played a role in Addyi's approval.”

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August 27, 2015

Unhygienic Scopes Continue to Spread Infection

In the same week in which the FDA issued warnings to companies whose invasive medical scopes are difficult to disinfect and that have spread deadly infections, another hospital’s infectious outbreak is being investigated for the same type of problem.

As the Los Angeles Times reported last week, Huntington Memorial Hospital in Pasadena, Calif., informed health authorities about the possible link between a small wave of infections and bacteria-trapping Olympus duodenoscopes. That company makes more than 8 in 10 of such devices used in the U.S.

As our blog explained when the first outbreaks were reported earlier this year, duodenoscopes are inserted into and down patients’ throats to view and treat a variety of serious, often life-threatening gastrointestinal problems. Although the FDA cited manufacturers for not reporting infections they knew were occurring because their equipment couldn’t be fully disinfected, the feds continue to allow their use because there are no options for the critically ill people who might benefit from them.

But as The Times story made clear, many medical experts say incidents of infection remain unreported, and their number might be quite higher than what we know.

More than 650,000 of these procedures (endoscopic retrograde cholangiopancreatography, or ERCP) are done annually in the U.S. If your doctor recommends you undergo one, make sure you understand why he or she thinks it’s worth the risk.

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August 26, 2015

The Connection Between Medical Malpractice Caps and Medical Harm

We write often about the misguided, unfair movement to cap the amount of money plaintiffs in medical malpractice cases are allowed to receive. We’ve often detailed how these efforts, backed by the medical and insurance industries and conservative lawmakers who claim that they impair the efficient delivery of quality care, in fact do not result in the benefits their supporters pretend they will.

Now, a couple of studies from last year explained in The National Law Review show how such damage caps potentially can cause additional harm to patients, not to mention the health-care industry.

The authors reviewed five U.S. states that have malpractice caps imposed under the description of “tort reform,” as well as their records on what is known as Patient Safety Indicators (PSIs). Using various data, “Do Doctors Practice Defensive Medicine, Revisited” (a Northwestern University Law & Economics Research Paper from October 2014), showed a rise in the rate of PSIs after caps were implemented, and subsequently found “consistently gradual relaxation of care or failure to reinforce care standards over time.”

They also determined that this decline was widespread, that it applied to care that’s more likely to lead to a malpractice suit (for example, “never events” such as leaving an unintended piece of medical equipment inside a surgical patient’s body, operating on the wrong side, etc.), as well as care that’s less likely to cause legal action, such as a central line bloodstream infection.

In addition, the authors found evidence “that reduced risk of med[ical] mal[practice] litigation, due to state adoption of damage caps, leads to higher rates of preventable adverse patient safety events in hospitals.”

So … implementing these damage caps leads health-care facilities to relax their care standards, which leads to an increase of otherwise preventable incidents, which leads to … more malpractice suits.

Good idea, huh?

A study earlier last year, “The Deterrent Effect of Tort Law: Evidence from Medical Malpractice Reform” (Northwestern University Law & Economics Research Paper No. 13-09, July 2014), suggested that physicians might practice riskier medicine in states that have caps. “For example,” according to The Review, “the physician might perform ‘high-risk services or procedures’ that would be otherwise avoided in noncapped states, or in states with common laws where an uncapped tort system would provide further deterrence from such riskier procedures.”

Here we go again: As the authors wrote, “damage caps have long been seen by health policy researchers and policymakers as a way to control health-care costs: We find, in contrast, no evidence that adoption of damage caps or other changes in med[ical] mal[practice] risk will reduce health-care spending.”

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August 26, 2015

A "black box" for operating room mishaps?

Patients who suspect malpractice after they've had an unforeseen injury from a surgical procedure quickly learn that the operating room works on a basic "honor system" for reporting errors. If something goes wrong, the surgeon is required to describe the event in his or her dictated report of the operation. Of course, that lets the surgeon control what gets put on paper.

Now there is a budding movement to have cameras in operating rooms record what happens and save the recordings for possible use later -- both to educate professionals and as potential legal evidence.

The Washington Post has an article describing a bill introduced in the Wisconsin legislature to require such recordings. The man behind the move is the brother of a patient who died from too much propofol, the same anesthetic drug that killed Michael Jackson.

Reporter Tom Jackman's article quotes a Toronto surgeon who has invented a device that synchronizes the vital signs recordings of a patient's pulse etc. with video and audio recordings of what is going on in the OR. Teodor P. Grantcharov, a professor of surgery at the University of Toronto, told the Post:

If we don’t know what we’re doing wrong, we’ll never improve. This is what many other ­high-performance industries have been using for decades.

Lawyers for the medical industry complain that such recordings would "invade the privacy" of surgeons, nurses and others in the OR. But if it could educate surgeons on how to avoid errors and save lives, that seems like a minor quibble that could be worked around. Other practical issues also need to be addressed. But many surgical procedures are already video-recorded, because they are done with tiny cameras inside the body in so-called "minimally invasive" techniques.

So why not just save the recording?

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August 25, 2015

Must We Choose Between Free Speech and Patient Safety?

What do Kim Kardashian, the First Amendment and patient safety have in common?

A few weeks ago, Kardashian promoted a drug called Diclegis on her Facebook, Instagram and Twitter accounts, which, according to the Los Angeles Times, have more than 100 million followers. Kardashian is pregnant, and her post was about the drug’s effectiveness against the nausea and vomiting some pregnant women experience.

Kardashian’s post linked to the safety information page of the drug's website, but the FDA wasn’t happy — it ordered the drug’s manufacturer, Duchesnay, to take down Kardashian’s remarks, for which the company paid, from its social media presence because the feds said they didn’t cover enough drug facts. That violates the agency’s requirements that prescription drug promotions include information about risk and specific use. That’s why all those TV commercials include announcers speed-reading all the drug’s possible side effects.

“These violations, wrote the FDA’s Robert Dean in a letter publicly released, “are concerning from a public health perspective because they suggest that Diclegis is safer than has been demonstrated.”

The letter said any promotion of the medicine also must indicate that it has not been studied in women with a severe vomiting condition.

Kardashian’s representatives said that she had offered only her personal experience, that Duchesnay had signed off on it and that questions should be directed at the company. Still, she was a paid company representative, right?

A week later, a federal court ruling that had nothing to do with Kardashian’s morning sickness or her compensated advice about how to handle it nevertheless might relate. It might help to grease a slippery slope of patient harm. The court said that First Amendment free speech protection allows drug companies to market off-label uses of their medications provided that the information they provide is accurate and not misleading.

Off-label, as we’ve explained, refers to the use of a drug to treat a condition or patient population for something other than what the FDA approved it for. Doctors may prescribe drugs off-label, but drug companies and their representatives may not promote them for these purposes.

The court was talking about Vascepa, a prescription omega-3 fatty acid aimed at patients with severely elevated triglyceride levels. Its manufacturer, Amarin, promoted it for patients whose levels were less extreme, meaning its consumer market would be hugely enlarged if doctors prescribed it for them as well.

One study had determined that the drug helped treat people with lower triglyceride levels. But the FDA declined to approve it for them until the company provided evidence that such therapy actually would reduce the risk of heart attacks for that population.

As explained by MedPageToday.com, the judge ruled that the FDA can't restrict Amarin's First Amendment right to disseminate off-label information about Vascepa as long as the company didn’t say anything false or misleading.

The ruling affirmed and expanded a ruling from 2012 known as Caronia, which first broadened the right of free speech for pharmaceutical company reps. The Amarin judge said that the Caronia right applied "across the board to all truthful and nonmisleading promotional speech.” This “speech” means the statements drug reps make to doctors when they promote off-label uses.

Amarin's case hinged largely on its desire to give “scientific” papers to doctors that seemed to support Vascepa for the off-label population and the prevention of coronary disease. As MedPageToday noted, the judge accepted without question that they were "peer-reviewed ... scientific publications."

Even the FDA said Amarin was within its rights to distribute the papers. But that doesn’t mean they were compelling science. According to MedPageToday, “It has long been clear that ‘scientific publications,’ even when ostensibly ‘peer-reviewed,’ do not always meet the highest, or even minimal, scientific standards.”

Is it cynical to look askance at the fact that three of the five authors of one paper were Amarin employees? That a commercial company was paid for editorial assistance? That some authors were funded by Amarin?

As a recent editorial in the Los Angeles Times pointed out, off-label use can be beneficial for patients whose doctors have investigated such applications and can make informed decisions. “But the FDA takes a dim view of pharmaceutical companies using that information to market their products without the agency's specific approval, and for good reason,” the paper opined. “The companies and their sales staff have a strong financial incentive to expand the possible uses of each drug, whether or not it's particularly helpful. Off-label uses can also have as-yet-undiscovered risks.”

What’s “accurate” and “not misleading” can be interpreted too liberally when the profit motive comes into play. Millions of dollars in settlements have resulted from Big Pharma twisting the facts into commercial convenience, and lots of patients have been harmed by their actions, which they consider simply the cost of doing business, as the judgments often cost less than the money made by off-label use.

The L.A. Times made clear that if the FDA’s authority to regulate how pharmaceutical companies market their drugs to doctors is compromised, “its ability to protect the public will be severely diminished,” and that the Amarin ruling “makes this scenario possible, and it will take a concerted effort by the FDA to continue setting limits on eager pharmaceutical salespeople.”

These restrictions aren’t about people who are famous for being famous blabbing to the people who want to know what they think, even when their thoughts come from the wallet and not the heart. But anyone, a private party, a company, its representatives, must take responsibility for promoting products that might help some people but that have such enormous potential to hurt so many others.

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August 24, 2015

More Evidence that Breast Cancer Overtreatment Does Not Extend Life

An impressive study published last week strongly suggests that when it comes to a certain kind of breast cancer, early, aggressive intervention has no effect on a patient’s survival 10 years later.

The research in JAMA Oncology reviewed the records of more than 100,000 women. After being diagnosed with ductal carcinoma in situ (DCIS), the women’s overall chances of dying were a little more than 3 in 100 over two decades. Survival rates for women who received treatment beyond a lumpectomy (to remove abnormal cells) were no different from those who had no additional interventions.

The results of the study were widely reported last week. One news source, the Washington Post, wrote, “The findings add to concerns that the ability to detect these lesions through mammograms may be leading to unnecessary mastectomies.”

We blogged about the common overtreatment of DCIS late last year, and the fact that because it’s found during a mammogram, which many women routinely have, diagnoses of DCIS have increased dramatically in recent years. Diagnosis is one thing, treatment is another, and the JAMA study shows that too often one automatically follows the other, which isn’t necessarily the best medicine.

Because DCIS is a noninvasive cancer (often referred to as Stage 0), the best treatment often is just a lumpectomy. When radiation follows that, the study showed, survival rates did not increase, although that procedure did reduce the likelihood that the cancer would recur. “Significantly,” according to The Post, “there was no difference in the survival rates between women with comparable tumors who had a mastectomy and those who had a less-invasive lumpectomy.”

But the fear factor continues to be a powerful motivator for overtreatment. Many women opt for breast removal to get rid of the perceived threat. As Steven Narod, a senior scientist at the Women’s College Research Institute in Toronto who led the JAMA study, told The Post, “That’s really what’s happening in the last 20 years in the U.S. We have created a culture of breast cancer awareness, and we’ve created a countercultural response of fear. When you do a mastectomy, you reduce the fear greatly.”

But you also disfigure people, waste money and resources, and overtreatment generally invites other problems, including infection and unnecessary worry, stress and exposure to radiation.

The study did identify certain patients for whom a more aggressive treatment for DCIS might be best because they have a higher risk of mortality — women diagnosed when they are younger than 35 and black women.

Some oncologists who reviewed the study cautioned that it had limitations. First, it didn’t compare cancer treatments against each other, but analyzed national cancer registry data from two decades. So analysis of individual patients’ treatments weren’t possible, and many physicians won’t change their clinical practice with such a broad-based review.

But for patients like Mary Lou Smith, the study reinforced her instincts. She was diagnosed with DCIS 30 years ago, then again eight years ago. Her doctors, according to The Post, advised her to have her breasts removed as the safest course of action. She declined, instead choosing to have the questionable tissue removed. That was not the typical treatment, and although Smith, now in her 60s, acknowledges her bias against aggressive treatment, she also told the paper that she understands why doctors recommend mastectomy, and why some women choose it.

“There’s a lot of uncertainty in cancer,” she said. “…So the more certainty we can have as patients, the more comfortable we’re going to be.”

Other research has found that although nearly 60,000 women annually undergo surgical treatment for Stage 0 cancers deemed to be a precursor to the full-blown disease, the number of invasive breast cancers (the deadliest) has not decreased. Some studies have indicated that even a lumpectomy might not be necessary for the mildest cases of DCIS, that surgically removing low-grade lesions didn’t increase survival compared with patients who did not have surgery.

The new study brings us around to a point regular readers of this blog will recognize: Screening is so advanced that tumors can be found even if they would never become threats to health. Technology doesn’t necessarily enable us to distinguish between what requires immediate attention and a range of treatment options from what doesn’t.

As The Post put it, “That has generated a polarizing debate about whether cancers are being overtreated and how to pull back.”

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August 21, 2015

Protect Yourself Against Medical ID Theft

Earlier this month, the Wall Street Journal published an unnerving story about what can happen to your sense of security, not to mention your actual financial security, when someone steals your medical information.

“How Identity Theft Sticks YouWith Hospital Bills” (behind The Journal’s paywall) makes clear that medical identity theft is a fast-growing crime thanks to the proliferation of electronic medical records. Most people are aware of data being hacked at insurance companies and health-care facilities. When someone has your health records, insurance information and Social Security number, he or she can use it to get medical care, surgery, prescriptions and medical equipment while pretending to be you.

A sidebar accompanying The Journal story provides some background and offers tips to avoid being the star of that horror story.

Medical ID Theft Is Different From Financial ID Theft

If your stolen credit card numbers are used and you report it early, you’re not responsible for most of the illegal charges. But medical ID theft victims can be required to cover costs for health services they never received. “Sometimes,” according to The Journal, “the health plan or health-care provider absorbs the losses, and sometimes they push the consumer to pay. [One survey] found 65% of victims reported they spent an average of $13,500 to restore their credit, pay their health-care provider and correct inaccuracies in their health records.”

Sometimes, It’s an Inside Job

Some health-care providers use patients’ personal data to bill insurers or public agencies such as Medicare for services they never provided. Such fraud costs millions every year and wreaks havoc with the patients whose records were used to commit it.

Some Medical ID Theft Is Tied to Organized Crime

An assistant U.S. attorney who specializes in organized crime drug enforcement told The Journal that criminal organizations including gangs have turned to medical ID theft to obtain prescription drugs that can be sold on the street.

What to do:


  • Keep Tabs on Your Personal Information

    Because major data breaches involving insurers are increasing, consumers must know what to do if such a breach becomes medical identity theft.

    First, be careful about giving out any personal information over the phone or online; don’t carry your Social Security or insurance card in your wallet; keep them in a safe place. Second, review all statements from insurers (they’re known as explanation of benefits, or EOBs) to ensure you actually received the services listed and charged. Contact your carrier if there are entries you question. Third, review your credit reports regularly to detect unpaid medical bills in your name. Each of the three major credit reporting agencies must provide an annual accounting for free, so get one every four months.


  • Review Your Medical Records

    By law patients have the right to access their medical files and receive copies, although there may be a charge and you must complete an authorization form. If someone else’s medical information is included in your files, alert the doctor, hospital or other medical provider as well as your insurance company.


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August 20, 2015

The Greedy Root of Escalating Drug Costs

Last month, the number crunchers at Medicare determined that U.S. prescription drug costs increased last year by 12.6% over 2013. That’s five times as much as the increase from 2012 to 2013 — 2.5%.

What happened?

Blame hepatitis C. Or, more accurately, the availability — finally! — of drugs that not only treat the insidious infection, but for the first time cure it. Per the actuaries’ report in the journal Health Affairs, the increase is "a result of expensive new treatments for hepatitis C."

That would be primarily Sovaldi, manufactured by Gilead Science and sold to patients for a tidy $84,000 for the 12-week treatment. That’s about $1,000 per pill.

As L.A. Times columnist Michael Hiltzik pointed out, the whopping increase in drug costs boosted U.S. health-care spending last year by 5.5%, a noticeable rise from 2013’s 3.6% bump. It was the first time such growth topped 5% since 2007. But if you cut drug spending from the calculation, the overall increase would have been 4.8%.

The analysts said the Affordable Care Act (ACA, or “Obamacare”) was a significant contributor to health-care costs, as you might expect when 8.4 million more people are getting insurance coverage than the previous year. But that expenditure reflects a smart, responsible social investment in both individuals as well as society — people who need care are more likely to get it, and people in their midst are less likely to be adversely affected, in terms of both health and economic concerns.

As Hiltzik wrote, “That expanded coverage had clear benefits to the newly insured: The nationwide growth in out-of-pocket spending slowed to just 1.3% last year from 3.2% in 2013, because so much more health care was covered by health plans or Medicaid.

“The major cloud on spending patterns was drug pricing,” he said.

Sovaldi was followed onto the market by Harvoni and Olysio, two more hep C drugs that also are widely effective and wildly expensive. No question that they are remarkable additions to the global formulary that cure about 9 in 10 people with hepatitis C, which can cause liver failure or liver cancer. In addition to their healing success, the drugs don’t come with the horrific side effects of earlier treatments, which only managed the disease, not cure it.

So a lot of people with hepatitis C, which progresses slowly and often without people knowing they have it, from getting treated. Because the new drugs were so wonderful, Hiltzik reported, new patients went from 17,000 in 2013 to 161,000 last year.

So many people seeking treatment at such enormous expense, of course, caused much consternation among the parties that subsidize it. Many commercial insurers refused to pay for it except for patients with advanced liver disease. That’s dumb, because taking the drug earlier would prevent the disease from progressing and causing who knows how much more expense and grief along the way. Still, despite their restricted use, the hep C drugs sent prescription spending skyward.

As usual, people in the U.S. were subject to much greater expense than people in other countries. Hiltzik called Gilead's profit margins on the drugs “stupendous. In the first half of this year,” he wrote, “it recorded profit of $8.8 billion on $15.3 billion in sales, a net profit margin of nearly 58%. For the full year, the company projects gross profit margins of up to 90%.”

How is that not profiteering?

One Gilead executive complained that "there still are a lot of [payer] restrictions in place in the U.S.," and although the company has given discounts to some payers in exchange for approving more patients to receive the drug, Gilead “plainly has pursued a calculated strategy that the success of its drugs will force insurers to pay for them at a large fraction of the list price,” Hiltzik wrote.

The drug was developed by Pharmasset, which planned to charge $36,000 for a course of treatment. When Gilead acquired Pharmasset in 2011, for $11 billion, it raised the rate. Although drugs are expensive to develop, Hiltzik reported that Pharmasset's R&D costs were estimated to be less than $63 million. He quoted a pharmacy management executive as calling Gilead’s pricing an act of "unmitigated gall."

These costs don’t run amok in Canada or Britain; in those countries, Sovaldi costs $55,000, and in Egypt, it’s only $900. But in the U.S., Gilead can charge what it wants, what it believes the U.S. market will bear.

The new report, Hiltzik said, might pressure Gilead and other manufacturers of high-priced drugs to moderate their prices. The reviewers believe that rebates for the hepatitis C drugs will cut Medicare drug cost growth 9% this year, down from 17.3% in 2014.

But can you imagine what it would be if pharmaceutical company greed, and the infrastructure that enables it, instead was common decency?

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August 19, 2015

Bodybuilding Supplements Might Prompt an Eating Disorder

Eating disorders such as bulimia and anorexia have long been associated with mostly female patients, but research presented at the recent American Psychological Association (APA) convention suggests a certain well-defined, largely male population also might be at risk.

Some men who engage in bodybuilding take legal, over-the-counter dietary supplements to such an extreme degree that it might qualify as an “emerging eating disorder,” according to the paper.

Keep in mind that the study sample was small, and relied on input from the subjects that couldn’t necessarily be verified.

“These products have become an almost ubiquitous fixture in the pantries of young men across the country and can seemingly be purchased anywhere and everywhere — from grocery stores to college book stores,” said Richard Achiro, Ph.D., in a news release from the APA. Achiro and a colleague at the California School of Professional Psychology conducted the research. “The marketing efforts, which are tailored to addressing underlying insecurities associated with masculinity, position these products perfectly as a ‘solution’ by which to fill a void felt by so many men in our culture.”

Once again, it appears as though manufacturers capitalize on insecurities rather than physiological evidence of a health issue to sell a “remedy” that probably no one needs.

The researchers analyzed the behavior of 195 men 18 to 65 years old who, in the previous month, had consumed legal supplements (whey protein, creatine, L-carnitine, etc.) purported to enhance appearance or physical performance. The subjects claimed to work out for fitness or appearance-related reasons at least twice a week. They completed a survey about supplement use, self-esteem, body image, eating habits and gender role conflicts.

More than 4 in 10 participants indicated that their use of supplements had increased over time; more than 1 in 5 reported that they had replaced regular meals with dietary supplements not intended to be meal replacements.

What Achiro found most alarming was that nearly 3 in 10 subjects acknowledged being concerned about their use of supplements, and 8 in 100 indicated that their physicians had advised them to cut back on or stop using supplements because of real or potential adverse side effects. Three in 100 had been hospitalized for kidney or liver problems related to their supplement use.

Like other clinically established eating disorders, the risky misuse of legal workout supplements, Achiro believes, is prompted by a combination of factors — dissatisfaction with one’s body, low self-esteem and gender role conflict. The last refers to someone’s self-perception that he’s not fulfilling society’s notion of masculinity.

“Body-conscious men who are driven by psychological factors to attain a level of physical or masculine ‘perfection’ are prone to use these supplements and drugs in a manner that is excessive and which was demonstrated in this study to be a variant of disordered eating,” Achiro said in the news release. “As legal supplements become increasingly prevalent around the globe, it is all the more important to assess and treat the psychological causes and effects of excessive use of these drugs and supplements.”

Not only are dietary supplements rife for misuse, they can cause harm from hidden ingredients and other manufacturing problems and misinformation. To learn more, read Patrick’s newsletter, “The Truth About Diet Supplements and Sports Drinks.”

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