September 30, 2014

Alzheimer Drug Maker Sued for Antitrust

Here we go again. Another drug manufacturer has been sued for trying to stifle competition from generic drug makers.

We’ve written about how Abbott Laboratories, Eisai and Pfizer used smarmy, anticompetitive practices to protect the profits for their brand-name drugs. This time, according to a story in the New York Times, the manufacturer is Forest Laboratories (owned by Actavis), and the drug is Namenda, which is prescribed for Alzheimer’s patients. Earlier this year, Forest Labs said it would stop selling the current version of Namenda in favor of Namenda XR, a newer version that’s taken once a day instead of twice, and has extended release properties.

The lawsuit, filed by the New York attorney general, seeks to stop what it says is an antitrust practice of forcing Alzheimer’s patients to switch to the newer, more expensive drug and preventing competition from generic versions.

It’s hardly a coincidence that the older version of Namenda is losing its patent protection just as Forest Labs modifies its drug, claiming that patients prefer the newer version. The lawsuit says the company illegally is trying to extend its patent and prolong its monopoly on the drug.

As The Times reported, “A drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessarily, simply to protect corporate profits, is unethical and illegal,” Attorney General Eric T. Schneiderman said.

As you might expect, the company’s weak response was to claim that the once-a-day drug had “significant advantages” for patients and their caregivers.

“Significance” is precisely what the lawsuit hinges on; the complaint is that switching drugs to the newer version does not offer a “significant” benefit. It says that Forest Labs is afraid not enough patients will switch to the new drug voluntarily, so it’s eliminating the option in order to maintain profits.

The tactic, according to The Times, is called “product hopping,” and it’s only one of several ways brand-name drug manufacturers try to hold off generic competition. “Several antitrust cases have been brought against drug companies for product hopping,” the paper reported, “though mainly by pharmacies and health plans rather than government regulators.”

There are many reasons why providers prescribe generic drugs, and why patients take them (see our recent newsletter, “Becoming a Smarter Buyer of Prescription Drugs.”) Chief among them is lower cost.

But as The Times pointed out, state laws allow or require pharmacists to substitute a generic when a doctor prescribes a brand-name drug, and generics compose a much larger percentage of the prescription market than brand-name drugs. But if a brand-name drug is even slightly different — say, a different dosage or how it’s delivered — pharmacists may not substitute a generic without permission. So patent-holding manufacturers seek ways to tweak their drugs to extend their window of exclusivity.

In 2012 the Federal Trade Commission weighed in on a private lawsuit involving the acne drug Doryx, criticizing the practice of a brand company making “modest nontherapeutic changes to its product and effectively prevent[ing] generic competition, not because the reformulated product is preferred by consumers, but simply because it is different.”

For all its cunning avoidance of the law, Forest Labs’ strategy doesn’t seem to be that successful — even though 4 in 10 users have switched to Namenda XR, now there’s a shortage of it that has forced the company to extend the availability of the older tablets beyond its original deadline of Aug. 15. The company’s website now puts the deadline sometime this autumn.

Namenda sales are expected to decline after the generics arrive, but the lawsuit says that Forest Labs is trying to preclude Medicare Part D plans from even including the older tablets on the list of reimbursable drugs.

As The Times noted, “The law on product hopping, however, is not clear. While courts might want to preserve generic competition, they have historically been reluctant to interfere with the ability of a company to introduce new products.”

The paper cited the example of Nexium, made by AstraZeneca. When it was introduced, critics said it was only a slight modification of its previous heartburn drug Prilosec.

A court dismissed a lawsuit against AstraZeneca filed by Walgreens, ruling that even if Nexium’s introduction depressed sales of the generic Prilosec, it didn’t violate antitrust rules.

But Forest Labs’ plan to remove its drug from the market is different from AstraZeneca, which left Prilosec on the shelves, essentially inviting Nexium and Prilosec to vie for market share. Nexium made billions every year.

In contrast, in the Abbott Laboratories case, involving the cholesterol-lowering drug TriCor, a court declined to dismiss lawsuits, partly because Abbott had taken the older versions off the market.

Generic companies, pharmacies, health plans and many states sued Abbott, which settled for an amount estimated to be more than $250 million.

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September 28, 2014

Doctors Aren’t Afraid of Being Sued but Still Want to Limit Your Malpractice Rights

You would think with yet another objective, substantive study showing that defensive medicine — doctors overtreating patients for fear of being sued for malpractice — represents only a tiny fraction of health-care spending that advocates of so-called “tort reform” would get the message.

They do get the message, but they still want to yank your rights away.

Tort reform, as readers of this blog know, is the misguided and disingenuous effort to reduce the monetary damages one may receive in the case of medical malpractice. Supporters of the idea like to say it will take care of the problem of frivolous malpractice lawsuits.

But “‘Frivolous lawsuits,’” wrote Michael Hiltzik in the Los Angeles Times, “[are] a problem that exists mostly in the minds of conservatives and the medical establishment.”

According to the study, published in JAMA Internal Medicine, defensive medicine accounts for only 3%, at the most, of U.S. health-care costs. That adds up to about $78 billion, which is a lot of money, but considering that the total cost of U.S. health care every year is estimated to be about $2.7 trillion, it should hardly be fueling the move to limit the rights of harmed patients.

In addition to curbing your ability to recover damages from malpractice, tort reform actually could increase other costs because limiting court system oversight could boost the incidence of medical mistakes. It costs a lot of money to clean up medical errors, assuming you even can.

The JAMA study authors noted that even doctors might be overestimating the prevalence of defensive medicine. Practitioners might order many procedures partly as a defensive habit, but mostly they do so for what they believe are legitimate diagnostic or therapeutic reasons. So tort reform would address the things they order solely because they fear litigation, a tiny percentage of the total.

Like many people who see the brazen move to take away legal rights, Hiltzik wrote, “Tort reform has seldom been about reducing healthcare spending. For Republicans, it's about de-funding a bloc of reliable Democratic Party supporters — trial lawyers.”

Always a popular target. Who hasn’t heard that the only reason lawyers want to represent you is for their cut of a malpractice judgment? Who hasn’t heard lawyers who represent people harmed by malpractice referred to as “ambulance chasers”?

The conservative agenda, Hiltzik claimed, is what drives the suppression of malpractice lawsuits despite the evidence that its impact on health-care spending would be small. It’s not about righting a wrong, it’s about punishing people you don’t agree with. And tort reformers even admit as much!

Avik Roy, a conservative health-care pundit, acknowledges that defensive medicine accounts for only a tiny percentage of spending, but still wrote, "nonetheless, reform is warranted … [because] the U.S. health care-system is uniquely vulnerable to frivolous malpractice lawsuits."

What does Roy have against math? Science? Proof that his ideas are wrong?

“The minimal impact of defensive medicine on healthcare costs demonstrates the injustice of the stringent limits on malpractice lawsuits advocated by doctors, insurance companies and Republican policymakers,” Hiltzik wrote.

He pointed out that capping the amount of money a harmed patient is legally allowed to receive for "pain-and-suffering" is a common ploy among tort reformers — see our blog, “Florida Stands Up to Anti-Consumer Malpractice Cap.” Such tactics discourage people from filing malpractice lawsuits to the benefit mostly of insurance companies. And their impact, Hiltzik wrote, “falls disproportionately on women and families with infants, because their economic damages, which remain subject to jury awards, are hard to estimate and typically underestimated.”

Hiltzik repeats a truism we, too, regularly write about; that "frivolous lawsuits," or cases that should never have been brought, are significantly rarer than the tort reform crowd would have you believe. That’s because the bar is high for plaintiffs to prove that the harm done to them was the result of negligence, so most people who might have a claim don’t pursue it because of the slim chances it would result in a monetary judgment in their favor.

And even when people have legitimate claims, they often can't pursue them because attorneys know how slim their chances are of winning, and because they work for a percentage of a successful claim, they can't take cases they otherwise would.

A bigger problem than frivolous lawsuits, Hiltzik said, is that genuinely injured patients can't get justice “because the courthouse doors have been shut to them. The victims there are often lower-income or unemployed patients.”

The issue is particularly acute in California, as the upcoming election includes a proposition for voters to lift an antiquated, unfair medical malpractice cap. (See our blog.) It’s all about the Medical Injury Compensation Reform Act (MICRA), which Hiltzik referred to as “the state's shame.” In 1975, MICRA capped noneconomic and nonmedical damages in malpractice to $250,000. In today’s dollars, that’s about $57,000.

To remain current with inflation, the amount should be about $1.1 million, and that’s what Proposition 46 proposes. (Sadly, as Hiltzik and many other advocates of fairness observe, the MICRA increase proposal is accompanied by a silly plan for drug testing of doctors.) Roy proposes that noneconomic damages for patients whose health care is subsidized by the Affordable Care Act (that is, by any of the federal or state health care exchanges established by “Obamacare”) be capped at the same $250,000 it has been for more than a generation. His cap also would apply to anybody with insurance through Medicaid, Medicare or any other federal program.

“Why them?” Hiltzik wondered. “Apparently only because they're within the grasp of federal law. Roy all but acknowledges that there's no legitimate economic reason for this punitive approach. It won't save a significant amount of money. It won't change the direction of healthcare costs. It's just nastiness, and as is usual … punishes the most defenseless members of society. Healthcare policy should do just the opposite.”

Yes, it should. And so should the justice system.

To get the facts about medical malpractice litigation served up as thoughtful entertainment, visit PopTort, a civil justice blog sponsored by the Center for Justice & Democracy at New York Law School. You can review the center’s new briefing book, “Medical Malpractice — By the Numbers!”

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September 25, 2014

Medicare Reverses Decision to Withhold Some Hospital Information … Sort of

Last month we wrote about the Centers for Medicare and Medicaid Services (CMS) quietly deciding to withhold some information about hospitals that make medical errors, but the feds apparently saw the error in that, and corrected their poor judgment. In a way.

As reported by USAToday.com, regulators will resume releasing data about serious hospital mistakes, including incidents of people being given the wrong blood type and foreign objects being left in the bodies of surgical patients. But it won’t be restored to Hospital Compare, the public website where people can look up information by searching the records of hospitals in their area.

The restored data will be used only for other safety ratings and researchers, such as the Leapfrog Group, a nonprofit organization composed of businesses and organizations whose mission is to improve the quality, safety and cost-efficiency of health care. It publishes a hospital safety rating.

The data won’t be back until later this year.

The American Association for Justice (AAJ) said, “This is a positive step by CMS to increase transparency, but there is still no simple way for patients to find out the safety record of a hospital.” AAJ invites consumers to join Take Justice Back, its public education campaign to impress upon Congress the need for more, not less, accountability and safety in the U.S. health-care system.

The effort is gaining in popularity. As USA Today reported, the increasing pressure on regulators and hospitals to be more forthcoming about safety and pricing is being applied by business as well as consumer advocates. Transparency was one of the three health-care policy recommendations recently issued by the Business Roundtable, a prestigious organization of CEOs.

Eight categories of “hospital-acquired conditions” (HACs) were yanked by CMS from Hospital Compare over the summer, although they remained available on a public spreadsheet that generally only data nerds and researchers could make sense of.

Before the HAC data were removed, Hospital Compare showed how often many of these conditions occurred at thousands of acute-care hospitals in the U.S. Acute-care hospitals take care of patients for as long as 25 days to treat severe injuries or illnesses, and/or while recovering from surgery. CMS maintained public information for the rate of occurrence for 13 conditions, including infections such as MRSA and sepsis after surgery, but dumped eight others.

As you might expect, many hospital officials oppose releasing information about the additional hospital mistakes. They believe that some incidents don't occur often enough for the information to be reliable.

Our feeling is that if you provide sufficient information in an appropriate context, people can figure out what they need to know, and can separate possibilities of concern from possibilities so remote as to be irrelevant.

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September 23, 2014

FDA Panel Supports Limits on Testosterone Drugs

After months of concern about the heart risks posed by testosterone drugs, an expert panel formed by the FDA strongly approved placing strict limits on pharmaceutical companies that manufacture the drugs.

As reported in the New York Times last week, the panel advised the FDA to restrict label information to make clear that the medicines are meant only to treat serious medical conditions, not complaints related to normal aging, such as low energy and libido.

Men for whom testosterone might be appropriate are those diagnosed with hypogonadism, a testosterone deficiency — the body doesn’t produce enough of the hormone, which can cause infertility, osteoporosis and enlargement of the breasts.

Although the panel’s decision isn’t binding, the FDA generally accepts the recommendations of its expert panels. Only one of the panel’s 21 members voted against the restriction.

As we’ve written, (see our blog,“FDA to Require Blood-Clot Warning on Testosterone Labels.”) in recent years testosterone has been increasingly prescribed for men to moderate symptoms of aging. The Times pegs the number of testosterone users at more than 2 million.

But the drugs were developed to treat serious, not just uncomfortable, conditions, and studies have shown a higher incidence of heart problems among men who take testosterone.

If the feds adopt the panel’s recommendations, it might reduce the number of men who get the meds, and suppress the over-the-top marketing of them. “Low-T” ads do not address a disease — they’re an effort to expand the drug’s market beyond people who are really ill.

Also, tighter restrictions could prompt insurance plans to deny coverage of testosterone for some patients.

But because doctors are allowed to prescribe medicine for any reason they deem appropriate, the number of testosterone users could remain too high for safety purposes.

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September 22, 2014

States Square Off Against Each Other in Allocation of Livers for Transplant

Rarely does the law of supply and demand have a sadder application than in the world of organ donations, and the latest case of too much need and too few resources has states doing battle with each other.

According to a story on TheHill.com, “A heated redistricting battle has gripped the nation’s heartland this fall, but instead of votes, the debate has centered on livers.” Many congressional representatives from Midwestern and Southern states are disputing how the United Network for Organ Sharing (UNOS) wants to allocate livers.

UNOS is a private nonprofit outfit that manages the nation's organ transplant system under contract with the federal government.

Shortages of transplantable organs are an enduring problem, and transplant surgery is complicated by the need to identify suitable donor-recipient matches quickly and transport organs efficiently. Also, who’s a higher priority recipient is a determination fraught with medical and ethical considerations.

As The Hill recalled, in 2009 then-Apple CEO Steve Jobs traveled to Tennessee from California to receive a liver transplant, raising objections that he had “cut the line.”

According to the Department of Health and Human Services, (HHS), about 15,600 people are awaiting a liver transplant, including 3,000 in California and 1,300 in New York. In Kansas, the waiting list has 129 names, and 252 in Georgia.

As The Hill noted, rates of organ donation vary widely depending on location. The highest rates are in the Southeast and Midwest, which also have the nation’s highest death rates.

“That disparity can lead to vastly different outcomes for patients,” the story said. It referred to a report last year published in the American Journal of Transplantation that death rates for people awaiting liver transplants range from 14 in 100 to 82 in 100, depending on their state.

Currently, the organ network is composed of 11 districts; the new plan could re-map it into as few as four.

Under the UNOS plan, The Hill explained, states with larger supplies of livers, such as Kansas and Tennessee, would share their donations with states with fewer donations, including California and New York.

UNOS claims the plan would “increase equity to access” for people across the country.

Some representatives in states where relatively more people donate organs have called the UNOS plan “political gerrymandering.” (Elected officials see everything in political terms.) They say the reallocation would punish thousands of people in donor-rich states, and some have wondered if these areas would become “organ farms” for coastal states.

A bipartisan group of 52 congressional representatives of Texas, Tennessee, Kansas, Mississippi, Iowa, Ohio, Wisconsin and Indiana signed a letter last week condemning the plan, and 11 representatives from Georgia made their feelings known several months ago. The redistricting, they said in a letter to HHS, “would single out the state of Georgia, making it the only southern state in a region comprised of northeastern states.”

Scores of transplant doctors, mostly in the Southeast and Midwest, also oppose the plan, expressing their feelings in a letter to HHS over the summer calling the plan “the most drastic change in liver allocation ever.”

The realignment would boost the average travel time for a liver from five to eight hours. The Georgia lawmakers said that would increase risks and transportation costs for each transplant. Once harvested, a liver is viable before being transplanted for about 12 hours.

Dr. David Mulligan, a transplant surgeon and UNOS official, said the plan would ensure that people with the greatest need would be the first to receive an organ, and told The Hill that if people with less-urgent needs “just wait a little longer, they’ll be a hero and literally save the life of someone who doesn’t have that extra day.”

That’s reasonable, but “being a hero” probably isn’t foremost on the minds of people who are feeling overlooked and taken advantage of.

Last week, the leader of the multi-state objectors, Rep. Kevin Yoder, (R-Kan.), issued a statement that the solution to the organ shortage isn’t shipping them out of the Midwest or South. “[UNOS] should not adopt proposals that punish successful programs and decrease access to organs where donation rates are highest.”

His solution was to increase donations “where disparities in wait times are the greatest.”

Easy to say, hard to do. Donation rates in coastal states have been about the same for a decade.

Mulligan said the conversation is ongoing, and that nothing will change immediately. “It’s kind of nice to say, ‘Oh, all we’ve got to do is make them donate more in the Northeast or Northwest,’” he told The Hill. “But I don’t know how we’re going to do more than what we’re already doing.”

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September 21, 2014

Women Still Misunderstand Risks of Breast Screening

We’ve regularly blogged about the confusion about breast screening procedures — the risks, the rewards and which women should be screened regularly — and recent research shows that a lot of women still don’t understand the risk-benefit balance.

Researchers writing in the British Journal of Cancer (BJC) said that in a survey of about 2,200 women in that country’s National Health Service (NHS) who were given information about the changes of “overdiagnosis” when they got a mammogram, 1 in 3 didn’t fully understand the risks.

Although 2 in 3 did indicate that they understood that the procedure could detect tumors that would never develop to the point they caused harm, the rest are especially vulnerable to the harm caused by such overdiagnosis; that is, when something suspicious is detected, leading to additional tests that have their own risks, such as infection from a biopsy, radiation exposure, unnecessary anxiety, cost and the wasteful use of resources.

Like previous efforts to clarify the risk-reward balance of mammography, the British study explained overdiagnosis as cancers that grow so slowly that it would take more than a lifetime for them to threaten the host’s health; that for every life saved through screening, approximately three women would undergo all of the additional tests that leave them open to complications.

But even informed women who understand that screenings can find things that aren’t necessarily problems are vulnerable — only 7 in 100 of the women in this study said they would be less likely to get a mammogram despite the risks of overdiagnosis.

Dr. Jo Waller, the study’s author, said, “[T]he study found that many women still struggle to understand the balance of benefits and harms linked to breast screening, so we need to find better ways to communicate the risks as well as the benefits."

Even though this study was limited to British women, we’re sure U.S. women also live in this climate of confusion. And the media can be responsible for much of it, as we blogged in April, citing examples of news outlets that completely misconstrued the results of a JAMA study concluding that the harms of screening might outweigh the benefits for some people. One TV news headline about it, for example, read ““Mammogram benefits outweighs risks, new study says.”

Although many medical organizations are moving toward a greater appreciation of overdiagnosis, and although there's a better understanding of it by consumers, progress can be undermined by well-meaning but misguided efforts by the government. For example, under the Affordable Care Act, among the “preventive” medical procedures insurance plans are required to perform at no cost to their covered patients are mammograms for women older than 40 every 1 to 2 years.

So exactly who should get screened regularly?

If you don’t have a higher than normal risk for breast cancer, you generally don’t need regular mammograms. Women at higher risk:


  • have a family history of breast cancer;

  • have genetic mutations known as BRCA1/BRCA2 ;

  • have dense breast tissue (which makes it more difficult to detect masses).


And if women who aren’t considered high risk have a screening that detects a small tumor, many of them would benefit more from “watchful waiting” than aggressive, premature treatment. “Watchful waiting” means monitoring without invasive procedures something identified on a screening test that may or may not become dangerous.

Women and their doctors must discuss what’s best for them, individually, because breast screening is not like a tetanus shot — not everybody needs one.

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September 18, 2014

Suggested Reading: Profits, Not Health Status, May Be Driving Patients Into and Out of Hospice Care

A recent installment of The Washington’s Post series on “The Business of Dying” is not for the faint of heart. Like an earlier story we blogged about a few months ago, this one is about how hospice care is being abused by the agencies that profit from it.

According to Medicare, to enroll in hospice care, a patient’s life expectancy must be six months or less. Treatment is about comfort, not cure, and it’s intended to last until death.

But, as The Post reports, more than 1 in 3 U.S. patients leave hospice care before they die. “When that many patients are leaving a hospice alive,” the story says, “the agencies are likely to be either driving them away with inadequate care or enrolling patients who aren’t really dying in order to pad their profits.”

Although about 15 in 100 hospice patients are properly released before death because their health unexpectedly improves, that is not what seems to be happening at some such facilities, especially new, for-profit companies, where the release rate is far higher than those figures.

The Post says this might be because:


  • Some hospices forsake patients when their care becomes expensive.

  • Some hospices enroll patients who aren’t actually dying.


Read the whole story here.

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September 16, 2014

FDA Oversight Lags for Consumer Apps, but Improves for Industrial Lab Tests

As consumer interest in medical treatment becomes increasingly gratified with downloadable apps and as industry develops ever more diagnostic tools, the opportunities for misinformation and misadventure increase as well. This summer, the FDA admitted that it could little about the former, but will regulate the latter.

As reported on PBS News Hour, the quantity of new health applications available on the market every year outpaces the FDA’s ability to regulate them.

Some Congressional representatives have advocated for a special department within the FDA to address the proliferation of mobile health apps, and to regulate them, but the idea has been rejected as impossible to fulfill by the agency’s policy advisors.

The feds have reviewed about 100 health apps, and they have published guidelines for the app industry and its own staff that, according to the story, frees developers of health-care information technology to create products free of regulatory oversight, even if they cross the line between medical devices and information. Those guidelines were a follow-up document to last year’s guide to help app developers know if their product would qualify as one that requires oversight.

The latest document pretty much confirms that the FDA’s intention is not to scrutinize all health apps, especially ones deemed low-risk, such as exercise tracking tools. It intends to focus on apps used as accessories for a regulated medical device or those that “transform a mobile platform into a regulated medical device.”

So app users, make sure you understand the difference. To learn more about how the FDA oversees medical apps, link here.

Diagnostic tests are a different kettle of fish, regulation-wise. As MedPageToday.com reported, the FDA will assume regulation of so-called "home brew" diagnostic tests developed and used within individual clinical laboratories. The goal, according to its announcement, is “to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.”

The FDA notified Congress that it will propose a framework for laboratory developed tests (LDTs) designed, manufactured and used within a single laboratory, such as some genetic tests and tests that are used by health-care professionals to guide medical treatment for their patients.

Currently, labs certified under a program managed by the Centers for Medicare and Medicaid Services may develop and use their own diagnostic tests internally without FDA oversight. Many genetic tests and some unique infectious disease diagnostics fall into this category. Reagents — substances or compounds used in chemical analysis or other reactions — are regulated by the FDA, but no clinical data are needed for their approval.

According to MedPageToday, FDA Commissioner Margaret Hamburg said the agency was “very concerned” about the growing use of LDTs for cancer and other serious diseases because their accuracy hasn’t been verified. She professed awareness of faulty LDTs that could expose patients to inaccurate diagnosis, which in turn puts them at risk for getting the wrong treatments.

Until now, the feds pretty much laid off these internal lab tests because LDTs were used only for rare or low-risk diseases. Officials didn’t believe that regulating them would be helpful or necessary. But advances in molecular biology have greatly expanded the ability of clinical labs to develop and market tests for a wide range of disease markers, and that means the potential for risky error is so large it should be monitored.

The agency also justified its expanded authority because all diagnostics should be subject to a common standard. "While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use," its statement said.

As MedPageToday noted, the FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.

The FDA’s proposal for stronger LDT regulation adds a layer of patient protection especially to the burgeoning field of personalized medicine. That’s treatment customized according to a patient’s unique, individual traits and has application, for example to things like what kind of chemotherapy, how often and in what dose should be given to a cancer patient with a certain genetic profile.

Although the additional oversight is welcome for patient safety, it won’t happen overnight — the FDA plans to roll out the complete program over several years. Industry, as well as the public, will have the opportunity to comment on the proposal. To learn more, link here to the FDA announcement.

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September 15, 2014

Breast-Sparing Surgery Shows Better Results in Some Cancer Patients

A preliminary report shows that surgery that spares the breast in patients with a certain kind of early-stage breast cancer has better survival rates than mastectomy.

The study findings, reported Consumer Affairs, “defy the conventional belief that the two treatment interventions offer equal survival, and show the need to revisit some standards of breast cancer practice in the modern era, …”

Breast-conserving therapy (BCT), according to a paper presented at the Breast Cancer Symposium earlier this month, involved lumpectomy plus radiation for patients with early-stage, hormone receptor-positive breast cancer. Lumpectomy is the removal of only the mass with the tumor, not the whole breast (mastectomy). Hormone receptor-positive breast cancer (HR+) is when the cells have receptors for either estrogen or progesterone, which invites growth. Hormone receptor status is a primary factor in how a patient’s breast cancer is treated.

In the 1980s, according to Consumer Affairs, studies concluded that (BCT) and mastectomy were equal in terms of survival among women with early-stage breast cancer. But because those studies were conducted when not much was understood about breast cancer biology — for example, subtypes, how and where it recurs and its potential to metastasize, or spread beyond the original site — they don’t have much relevance in today’s more advanced cancer analysis.

As reported by MedPageToday.com, the study’s data and conclusions haven’t been published in a peer-reviewed journal, so they must be considered preliminary. And the five-year survival rate was significantly different between patients who had only a mastectomy or lumpectomy, regardless of their hormone receptor status.

Patients treated with BCT (lumpectomy plus radiation) showed an unadjusted five-year overall survival of 96 in 100. The rate for the mastectomy patients was 90 in 100. Among women who had no radiation, only breast-conserving surgery (BCS) the rate was 87 in 100.

Dr. Catherine Parker and her colleagues at the MD Anderson Cancer Center in Houston analyzed how the choice of treatment affects survival according to each tumor’s biology. The analysis involved 16,646 patients newly diagnosed with stage I breast cancer who were treated in 2004 and 2005.

More than 11,200 were treated by BCT, 3,587 by mastectomy and 1,845 by BCS. The mean age was 59 in the BCT subgroup, 62 in the mastectomy group and 66 in the BCS group. The follow-up period was nearly seven years.

Tumors were classified by hormone receptor status — HR+ was positive for receptors for estrogen, progesterone or both, and HR- was negative for both types of hormone receptors. The primary outcome was overall survival.

The study made two key points, according to Dr. Harold Burstein of the Dana-Farber Cancer Institute in Boston. One confirms many previous studies showing that in terms of survival, BCS is at least as effective as mastectomy. Two is that the combination of radiation and lumpectomy is very important for overall survival.

Burstein told MedPage Today that the second take-away "has been a controversial point. The benefits in some of the studies have been rather small.

"What's clear in this population-based study of thousands of women is that adding radiation therapy — even for the favorable-prognosis stage I breast cancers — helps women do better in terms of survival down the road."

We would add that any time you can avoid a more invasive procedure in favor of a less traumatic surgery, such as lumpectomy over mastectomy, you reduce your risk of complications, such as infection, and also the psychological fallout from losing part of your anatomy.

To learn more about breast cancer, see our backgrounder.

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September 14, 2014

DEA Will Allow Consumers to Return Unused Prescription Drugs

The federal government is finally addressing this country’s serious abuse of prescription drugs with more resources than just those that regulate health care. The Drug Enforcement Administration (DEA) has agreed to allow consumers to return unused prescription drugs to pharmacies to improve the chances that they won’t be used except for what they were intended for.

As reported last week in the New York Times, of most concern are drugs classified as controlled substances, such as opioids (painkillers) including OxyContin, stimulants including Adderall and depressants including Ativan. The DEA wants to reduce unneeded medicines that are ripe for abuse by the patients’ family, or stolen for resale on the street.

As we’ve blogged, injuries and deaths from dangerous drugs, especially opioids, have risen sharply in recent years, and as The Times noted, more than 7 in 10 teenagers say it is easy to get prescription drugs from their parents’ medicine cabinets.

The new regulation permits patients and their relatives to deliver or mail unused prescription meds to authorized collection centers in packaging that will be available at pharmacies, senior centers, libraries and other public locations. It’s supposed to go into effect next month.

Until now, it was illegal to return drugs — the Controlled Substances Act permitted only patients to dispose of the drugs themselves, or turn them into law enforcement agencies. Twice a year, the DEA sponsored a national “take back” event for people to return drugs anonymously to local police departments, sort of like the gun buy-back programs some communities sponsor, and in the last four years, according to The Times, 4.1 million pounds of prescription medications have been turned in.

But there’s plenty more where they came from: About 3.9 billion prescriptions were filled at pharmacies last year, according to the Kaiser Family Foundation.

The semi-annual events removed only “an infinitesimal fraction of the reservoir of unused drugs that are out there,” Dr. Nathaniel Katz told The Times. He teaches at the Tufts University School of Medicine in Boston and studies opioid abuse. “It’s like trying to eliminate malaria in Africa by killing a dozen mosquitoes.”

But Katz hopes the new effort will have a bigger effect. Having drop-off receptacles for controlled substances in pharmacies offers unlimited disposal opportunities.

Of course, people can always flush medicine down the toilet, or dispose of it in the trash, but those habits are discouraged because of environmental concerns.

Some observers warn that because the program is voluntary there’s no guarantee that a sufficient number of venues will establish take-back programs or set up collection receptacles to make a difference, and that other obstacles might arise.

Police departments, for example, often incinerate the illicit drugs they seize, but a local pharmacy might not be able to do that. So their collections would arrive solely by mail, which is probably asking a lot of consumers these days. Also, who pays for the disposal — communities, pharmacies, insurance companies, patients or pharmaceutical companies — isn’t addressed in the DEA’s new rule.

We believe that because the pharmaceutical companies make the profit on these dangerous products they also should bear the costs of removing them in order to minimize their harm when used inappropriately. Is anyone surprised that they’ve objected to this idea? (See our blog, “Drug Companies Oppose Requirements to Take Back Unused Medicine.”)

MedReturn manufactures steel boxes used by police stations in 49 states to collect prescription drugs. Some people worry about their security, because if they “are available to the public, they have to be under law enforcement eyes, because they are gold at the end of the rainbow for someone with an opioid addiction,” Gary Tennis, secretary of the Department of Drug and Alcohol Programs in Pennsylvania, told The Times. His department has 200 MedReturn boxes and plans to install 100 more.

And last year, the American Pharmacists Association told the DEA it was concerned that pharmacies could be held legally liable if a secure drug drop-off receptacle was broken into and its contents stolen. It cautioned that in such uncharted legal waters, pharmacies might be reluctant to participate in a disposal program.

But the biggest obstacle to getting people into the habit of disposing of their unused and unneeded drugs is the understanding that it’s irresponsible to do otherwise.

Still, the new DEA regulation, Dr. G. Caleb Alexander told The Times, “is big news and long overdue.” He’s co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health. “It’s baffling that it’s so easy to get a prescription for opioids and yet so difficult to dispose of these drugs safely.”

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September 11, 2014

Researcher Is Surprised by Wild Disparity in Cost for Simple Blood Test

File this under “irrational”: At one hospital, a blood cholesterol test cost $10, while another in the same state charged $10,169. That’s a multiple of more than 1,000.

Wildly divergent costs for similar lab tests was the subject of a recent report in the journal BMJ Open, which looked at charges for routine blood tests at California hospitals that were performed in 2011.

The researchers, as noted on KaiserHealthNews.org, (KHN) found no rational explanation for the dramatic different in listed prices, although they did recognize that teaching hospitals and government hospitals generally charged less than other facilities.

Here’s another blow-you-away comparison: for a basic metabolic panel, another common blood test, the average hospital charged $371, but some charged as little as $35 to as much as $7,303, more than 200 times more.

Dr. Renee Hsia, lead author of the study, and a professor of emergency medicine at University of California, San Francisco, told KHN, “When people try to understand why prices are the way they are, we have no ability to explain it. That is the take-home message. That is what is so disturbing.”

Almost as disturbing, in our opinion, is the response of the California Hospital Association, which dismissed the report as irrelevant and said most patients pay discounted rates because of their insurance coverage. “Charges are meaningless data — virtually no one pays charges,” said Jan Emerson-Shea, the association’s vice president for external affairs.

How arrogant. How clueless. How unhelpful in addressing America’s out of control health-care price management.

Hsia is familiar with the “say-what?” aspect of medical pricing. She once studied listed charges for labor and deliveries, and for appendectomies in California, and found that the former varyied by as much as 11 times, and that charges for a routine appendectomy ranged from $1,500 to $182,955.

Earlier studies by Hsia identified variations in listed charges for labor and deliveries and for appendectomies in California, with labor and delivery charges varying eight to 11-fold between hospitals, and charges for a routine appendectomy ranging from $1,500 to $182,955.

But even she was surprised by the variation in cost for a single line item like a blood test.

“There is always some variation in patients, even among young healthy adults, and there are variations in physician practice,” she told KHN. “But these are very basic, standard blood tests. It doesn’t matter if you’re sick or not, a complete blood count is a complete blood count. You draw the blood, send it to the lab and put it in a machine.”

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September 10, 2014

Seniors: Beware of Drugs That Present a Fall Hazard

The older you get, the higher the probability that you take a prescription drug, or several. What’s supposed to help you, however, can pose a risk — half of the 20 most prescribed medications taken by older people might increase the risk of a fall. And falls in older people can be deadly.

According to a study published in the European Journal of Public Health, antidepressants and drugs taken to control pain were most strongly associated with a greater probability of being injured in a fall. Serious injuries were significantly more common with 11 of the 20 medications studied.

The researchers studied prescription drug data on nearly 7 million Swedes older than 65. They counted the number of falls among people taking any of the 20 medications most commonly prescribed to seniors in Sweden, and identified 64,399 cases of such injuries that led to hospitalization.

The researchers acknowledged that some added risk could result from the conditions the drugs are prescribed to treat. But because the older population is large and growing, they say any association of medication and fall injuries must be considered by doctors. We would add our usual advice: When your doctor prescribes a medication, always ask:


  • Why is this the best treatment?

  • What will happen if I don’t take it?

  • Are there alternatives and/or a generic version?

  • When can I expect to see results?

  • What are the side effects, and how likely am I to experience them?

  • What are the risks?

  • Are there foods or other medicines I should avoid when taking this medicine?


Although this was a European study, more than 40 million people in the U.S. are over 65 years old, as noted on Reuters.com, and 1 in 3 of them take eight or more medications daily, according to the National Center for Biotechnology Information.

“Falls are a leading cause of disability and death among seniors,” Reuters reported, “and researchers increasingly suspect that prescription medications play an important role in fall injuries.”

The Swedish study found that men and women taking opioid painkillers as well as men taking antidepressants were more than twice as likely to have a fall injury as those who weren’t taking those drugs. Women taking antidepressants were 75% more likely to have a fall injury.

Drugs for ulcers and GERD (gastroesophageal reflux disease, for which drugs that suppress stomach acid are prescribed), calcium, vitamin B12 and some nonopioid painkillers also were linked to as much as a 75% percent greater risk of fall injuries. Heart medications, generally, were not linked to fall risk.

As Reuters pointed out, “The study cannot prove that medications caused falls in all cases, and for drugs that have not previously been linked to fall injuries — including anticlotting agents, drugs for peptic ulcers and vitamin B12 — the researchers think the underlying conditions the drugs are prescribed to treat may be to blame.”

Telling the difference between a fall resulting from a disorder and one caused by medication can be difficult. Dr. Johan Fastbom, a professor at the Aging Research Center at the Karolinska Institute told Reuters that people should “[pay] attention to other symptoms caused by the drugs.” They include vertigo, dizziness, drowsiness, psychomotor impairment, muscular weakness and cognitive impairment.

Anyone who takes medication and experiences any or several of these symptoms should discuss with their doctor if the risk is greater than the benefit.

Further studies probably will examine how different doses of these medications affect both treatment outcome and fall risk. Doses often vary considerably and often are different for men and women.

Researchers also probably will study potential interactions among medications, including those taken over the counter.

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