Preventing Prescription Drug Abuse: Are You Doing Your Part?

Terri Prof Headshot 0412Do you know what your teen is up to when you’re not looking?  What about your spouse, your parents and your friends?  Hopefully they aren’t rummaging through your medicine cabinet to find something they can take to get high. Many of us would never think to use a prescription drug for something other than its intended purpose, or to take something that wasn’t prescribed for us and absolutely necessary.

Unfortunately, there are a lot of other people who not only consider this, but act on the impulse to misuse and abuse prescription drugs.  Sometimes they work the system and see a doctor, or multiple doctors, and get the prescription for themselves, but often, they are looking through your medicine cabinet when you’re in the other room, getting them for free from friends or buying them online or from dealers.

Prescription drug abuse is a growing problem; according to the Centers for Disease Control it is an epidemic.  Just like any addiction, it can ultimately ruin or even end someone’s life.  (more…)

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Pioneers Do Not Fall Apart

Art by Melissa Brooks- 2004

Today our author, who chose to publish anonymously, provides us with an intimate look inside her life and experience with depression, loss and  the journey to finding herself.

Though I moved to Brooklyn in 2008, I will never be able to shake the Midwest from my bones. I grew up in Detroit, MI, a rather complicated place that I’ll never give up on. In contrast to the razor-sharp headlines that have recently grabbed hold of the collective consciousness, Detroit isn’t the place where dreams go to die. It’s the place where dreams – the American Dream, come to life. My grandfathers were autoworkers, pioneers of the Great Migration. Those men worked hard so that their children could carve out a life for themselves that was maybe a little better than their own. Gene & Sandra worked just as hard as their fathers, earning advanced degrees, getting married and having two children of their own. Meatloaf for dinner. Manicured lawns. Ballet lessons and baseball. My childhood was ideal and I am grateful.

Traversing miles and wrangling steel Mustangs makes for sturdy individuals who raise hearty individuals. Like the Stoics before them, pioneer-stock have perfected the art of the levelheaded countenance in the midst of turbulence. I never saw the sweat on my parents’ brow, the struggle in their eyes. They wore their frustrations on the inside and my brother and I reaped the benefits. And for that I am grateful. I am grateful and also wary. For within these romanticized and stalwart walls of strong, black Americana, there is no room to go to pieces. Pioneers do not fall apart. (more…)

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Sunscreens: True Protection or Just An Invisibility Cloak?

eblacklerAs the weather continues to improve, we will all likely spend more time outdoors. Many of us will venture out without adequate protection from the sun. However, as Melanoma Girl  previously warned, that summer glow may be the difference between healthy skin and melanoma. (more…)

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National HIV Testing Day

NealToday is National HIV Testing Day: a reminder to get tested, get re-tested and to tell everyone you know to do the same. To get tested, call your doctor, use this locator to find a nearby testing center, or search the web to find one of many organizations offering free or reduced-cost HIV testing on June 27th. If none of those options are appealing, you can even test yourself using products like OraQuick In-Home HIV Test, a saliva-based test that yields results in the privacy of your own home in as little as 20 minutes. (more…)

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Saturday mail delivery and the law of unintended consequences

rx_deliveryMost of you have probably heard the news: The U.S. Postal Service plans to stop delivering mail on Saturdays starting in August, barring action from Congress to prevent this. Many people in government and business are concerned about the effect this will have on commerce. The Postal Service has agreed to continue the delivery of packages on Saturdays in order to prevent a major disruption.

But there’s another concern that Congresswoman Tammy Duckworth has brought up: what about prescription drug delivery? (more…)

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The trials and tribulations of electronic medical records and e-prescribing

Leslie RottIn April 2008, at the age of 22, Leslie Rott was diagnosed with rheumatoid arthritis and lupus. This post originally appeared on her blog, Getting Closer To Myself, which she started to create awareness about autoimmune diseases.

* * *

So, every once in awhile, I move away from posts that are extremely personal, emotional, and philosophical, to talk about the more practical aspects of being a patient, with some old-fashioned research thrown in for good measure. (more…)

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One in six: Teen addiction lurking in the medicine cabinet

The Partnership at Drugfree.orgOne in six teens admits to using a prescription drug (when a doctor had not prescribed it for them) in order to get high or change their mood. This makes medicine abuse as common as online bullying, car accidents in new drivers and drinking when visiting a college campus. Parents are much more aware of these issues than medicine abuse, and that must change because stakes are high for teens. (more…)

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  • November 21st, 2011 Unrelieved Pain in Terminal Ill Patients – An End of Life Tragedy
    By Glenna Crooks
  • Buck for the bang: Premium med-tech pricing

    The following originally was featured as a  blog post on Medical Device Daily on October 31st. It is written by Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group.

    Cook Medical’s Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies.

    I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had seen in some time. Cook presented a clear study that met all primary endpoints and showed improvement over percutaneous transluminal angioplasty, the current standard of care. To non-FDA experts like myself, it seemed as though Cook was recognized for setting a new bar for conducting clinical trials and collaborating with the FDA.

    I imagine that Cook Medical’s leadership was able to make all the right clinical trial investments necessary for the long-term viability of the product’s market value, not just the ones that were on display at the advisory panel meeting. (more…)

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    The Battle Over Avastin

    Archelle Georgiou, MD

    By Archelle Georgiou. The use of Avastin for breast cancer was addressed by the U.S. Food and Drug Administration this week. The outcome was devastating for Roche and an emotional one for many women who believe the FDA is subjecting them to a death sentence.  As usual, there are a variety of perspectives to take into consideration.

    The history: In 2008, Avastin was given preliminary approval by the FDA for the treatment of breast cancer on the condition that the company would do more studies to demonstrate its effectiveness. Many women have been successfully treated with Avastin — a billion dollar drug for Roche.

    But when Roche submitted the required follow-up studies in 2010, the data showed that there was no benefit from the drug for treating breast cancer.  Studies did not show significant impact on mortality or  improvement in quality of life.  In addition, the drug was associated with some significant side effects such as high blood pressure and blood clots.

    In December, 2010, an FDA panel voted to withdraw the drug’s approval as a treatment for breast cancer.  Roche appealed the decision, and earlier this week, an FDA panel hearing the appeal unanimously decided, in a 6-0 vote, to withdraw the drug’s indication for breast cancer.  The final decision on whether or not Avastin loses the indication is ultimately up to the FDA Commissioner, Dr. Margaret Hamburg.

    If Hamburg supports of the panel’s recommendation is critical. At the same time, this will fuel even more emotion and protests among patients. Here’s why:

    • From the FDA’s side: The FDA issued a provisional approval with the explicit understanding that the final decision would be based on more conclusive studies. If the FDA maintains the drug’s approval despite the lack of scientific data, this would likely impact all of their future decisions to offer provisional approvals for potentially life-saving drugs.
    • From the patients’ side: Women who have benefited from the medication have clearly voiced their opinion that the doctors and patients, not regulators, should decide whether or not to get potentially life-saving treatment.

    An important fact to keep in mind is that Avastin will remain on the market because it is FDA-approved for certain types of lung, colon, kidney and brain cancers. Therefore, Avastin will still be available “off label” for treating breast cancer when patients and their doctors believe that it is the best option.  In those situations, the only real challenge will be a barrier to access is a financial one since expensive drugs used “off-label” are frequently not a covered benefit and very few women can afford to $80,000 per year out of pocket for Avastin. (more…)

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  • July 4th, 2011 July 4 ‘To Do’ List: Make Picnic Salad, Gather Beach Toys, Gas-Up Car, Take Meds
    By Glenna Crooks
  • Bending the health cost curve by spending more on Rx: adherence can lower costs

    Jane Sarasohn-Kahn

    By Jane Sarasohn-Kahn. For every $1 spent on health care in the U.S., 10 cents goes to prescription drugs, 31 cents goes to hospital care, and 27 cents goes to professionals (doctors, dentists, and other services), based on 2009 health spending reported to the Centers for Medicare and Medicaid Services (CMS).

    There’s evidence that by spending a bit more on medication and bolstering prescription drug adherence among patients, total health spending can be lowered for vascular medical conditions. The study and data which leads to this conclusion is published in Medication Adherence Leads to Lower Health Care Use And Costs Despite Increased Drug Spending appears in the January 2011 issue of Health Affairs.

    The study cites the World Health Organization’s report from 2003 that stated medication compliance rates globally averaged about 50%. This number may be high compared with other newer studies on adherence, such as reports from

    Peoples’ lack of adherence to medication treatment regimes costs: diabetes patients who do not take their medications have a 58% increased risk for hospitalization and an 81% increased risk of mortality. The New England Healthcare Institute (NEHI) calculated that more than half of all Americans currently suffer from at least one chronic disease such as diabetes, heart disease and asthma at a cost to the economy of $1 trillion annually.

    The Health Affairs study, sponsored by CVS (the retail pharmacy chain), established a causal link between medication adherence and outcomes: specifically, hospitalizations and total health costs. The researchers examined four conditions under the umbrella of vascular disease: congestive heart failure (CHF), hypertension, diabetes, and dyslipidemia (high cholesterol). Among these four conditions, bolstering adherence had positive impact (i.e., lowered) health costs across all categories, most markedly for CHF, as shown in the chart.

    The average benefit-cost ratios from adherence for the four conditions were 8:4:1 for CHF, 10:1:1 for hypertension, 6:7:1 for diabetes, and 3:1:1 for dyslipidemia.

    Health Populi’s Hot Points:  Focusing just on CHF, the average cost-savings per patient was $7,893. About 5.7 million Americans have CHF, and there are 400,000 new cases of CHF in the U.S. each year, according to the National Heart, Lung and Blood Institute (NHLBI). Do the math: bolstering medication adherence among CHF patients could save $billions to the U.S., which would positively and directly impact Medicare — the nation’s largest threat to financial security in the not-so-long-term.

    Furthermore, improving medication adherence as described in this study would avert hospital admissions for patients with vascular conditions, which would enhance millions of Americans’ quality of life and productivity. This is one example of how to bend the cost curve in health, and it doesn’t require a lot of new technology – just strong doses of sound communication between patients and doctors, access to prescription drugs and medication adherence programs, and a culture of participatory health where patients feel vested in their own care in partnering with their physicians.

    Posted originally on Health Populi by Jane Sarasohn-Kahn on January 10th.

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    Bending the Cost Curve without Bending the Innovation Pipeline: New Research on Generic Drugs, Innovation and Savings

    Former Congresswoman Nancy L. Johnson

    By Former Congresswoman Nancy Johnson. Too often, when we talk about innovation, there’s a ‘yes…but’ quality to the discussion.  Yes, we appreciate the concept of developing new medicines and technologies to extend and enhance human life, but we increasingly question whether the cost of innovation is commensurate with the value it delivers.

    Logically, if the weight of public and policymaker opinion continues in this direction, that innovation undermines the greater national goal of affordability, then this will inevitably lead to policy actions that reflect this line of thinking.  We’re already seeing this to some degree with the weighty pharmaceutical and device taxes that are part of the new health reform law and the creation of an independent board with the power to slash Medicare reimbursements.  While the intention makes sense, it is not clear this path will yield the intended, and worse, may contribute to unintended and undesirable consequences.

    There’s too much at stake, both economically and in terms of societal well-being, to travel far down this path without having an absolute certainty that innovation does, in fact, make health care less affordable.  Do we just take it on faith that innovation drives costs skyward, or is there empirical evidence that says otherwise? 

    To be sure, the literature includes a wide range of research on the relationship between innovation, costs, prices, and value.  Like almost every aspect of health care policy and research, this one is layered in complexity.  Sound bites can be misleading, definitions matter, and important findings can be misconstrued for political purposes and philosophical positioning.

    So much has been written about the relationship between prescription drugs, costs, and prices. What does the literature say about the drug prices as they relate to health care cost growth?

    Last month, Dr. Ernst Berndt of the Massachusetts Institute of Technology and Murray Aitken of IMS Health published the working draft of a paper that makes an important contribution to this debate.  Berndt and Aitken take on one of the widely accepted statements about the relationship between innovation and affordability – that prescription drugs are getting more and more expensive – and ask whether this thesis is supported by available pricing data.

    The authors took a look at the Hatch-Waxman Act, the legislation crafted by Congress in 1984 that granted drugmakers a period of market exclusivity on their new products and then promoted consumer access to generic versions of those drugs once that period ended.  Some have suggested that the effects of Hatch-Waxman are tilted too far toward the interests of pharmaceutical companies, as exemplified by the regular reports issued by AARP monitoring drug price increases.   In fact, AARP said the prices for the top 217 branded drugs went up 9.3 percent in 2009 even though the consumer price index declined. (more…)

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    May Man of the Month – Thomas Maeder

    Thomas Maeder, our May 2010 Man of the Month, is the author or co-author of twelve books and numerous articles in national publications, and has long experience in the biomedical field as a writer, educator, and consultant. Below, he shares his thoughts on rare disorders and their place in the drug market.

    Orphan Diseases – Bellwether of Health Care

    “The only people interested in rare diseases are those who have them, and that’s not a lot,” an editor once told me when rejecting my proposal for a book on orphan diseases.

    In reality, nearly thirty million Americans – one in ten – suffer from some 7,000 rare diseases, making them collectively very common indeed.  Though they differ wildly in their causes and manifestations, they share many characteristics in terms of the uncertainty, isolation, and costs imposed upon sufferers and their families, the challenges they pose for our health care system and sense of social responsibility, and their potential value to medical research.

    In the United States, orphan diseases were defined by the Orphan Drug Act of 1983 as those that affect fewer than 200,000 people domestically.  This landmark legislation offered incentives – tax credits, a period of market exclusivity independent of patent protection, research grants – for manufacturers to develop clinically valuable treatments that would not be economically viable in the normal pharmaceutical market.  Previously there had been tragic instances of known, potentially useful therapeutics never taken to market, or others of already proven effectiveness that were withdrawn, because they did not meet a drug company’s threshold of profitability.  The definition encompasses some familiar disorders, such as cystic fibrosis, muscular dystrophy, hemophilia, Huntingdon’s Disease, and Crohn’s disease, along with thousands of much rarer conditions, including fibrodysplasia ossificans progressive (FOP), Jumping Frenchmen of Maine, and Sakati Syndrome, or acrocephalopolysyndactyly type III, which for many years was represented by a single patient in Saudi Arabia.

    In less than thirty years since passage of the Act, more than 300 orphan drugs have been approved for market.  Some are produced by large pharmaceutical companies.  The biotechnology industry also benefited tremendously from the orphan drug market and its incentives.  In addition, as one pharmaceutical executive told me, big drug companies may need billion dollar drugs to support not only R&D but also massive corporate infrastructures and the sales and marketing machinery, but a small company aiming at a well-defined population, with a small number of specialized physicians and facilities, patient advocacy organizations, and unusually motivated patients, can get by quite nicely on mere tens of millions of dollars in revenues.

    (more…)

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    “News (Hot) Flash: Sex, Drugs and Menopause” Recap – 2010 Breakfast Series

    Many thanks to our speakers, Phyllis Greenberger, Dr. James Simon, and Susan Wysocki, and to Disruptive Women’s Wendy Grossman for the following summary post.

    Our panel this morning discussed the issues surrounding how the WHI results were interpreted and communicated to women and their health care providers. We recognize that hormones are not appropriate for all women, and look forward to hosting a future panel that highlights alternatives.

    The speakers have a variety of backgrounds and experiences (and genders), and we aim to promote diversity of voices.

    This was not normal breakfast conversation.

    Today was a jolting – and disruptive – talk about what happens to women’s bodies when they age. (Who knew that if you’re menopausal and you don’t take your hormones, your vagina can literally dry up and shrink?)

    The second in Disruptive Women’s 2010 breakfast series, today’s talk was titled, “News (Hot) Flash: Sex, Drugs & Menopause.” The breakfast at Johnny’s Half Shell, was sponsored by Medco – and we’re happy to say there were two men in the audience this month – double last time.

    The breakfast started with a screening of trailer for the upcoming movie Hot Flash Havoc. (Think: Michael Moore tackles menopause.)

    “It’s not available in theaters yet – but it will be,” said Disruptive Women’s Robin Strongin, introducing the film.

    I’m genuinely sad that the documentary isn’t being released until October-ish. Normally, I don’t want to watch anything at 7:30 in the morning, but the little bit that was shown was so funny I can’t wait to see the whole thing. (Seriously, put it on your Netflix queue now.)

    Introducing the speakers, Strongin briefly summed up a woman’s life cycle. “You start out life in this estrogen gel – like a gefilte fish,” she said. “Then you hit puberty, you’re either fertile or you’re not, then you’re pre-menopausal, then menopausal, then post-menopausal. Then you die.”

    The talk today focused on the menopausal portion of the life cycle. Phyllis Greenberger, President and CEO of the Society for Women’s Health Research, started off speaking about the Women’s Health Initiative. “There was a lot of misinterpretation, some of the results reported were incorrect,” she said.

    She quickly explained what they did, what was wrong, and what’s true today. The Women’s Health Initiative was a giant study of postmenopausal women, testing whether hormone replacement therapy could help prevent cardiovascular disease, cancer, and osteoporosis. The results were different for different age groups – women starting hormone therapy in their 70s had generally bad outcomes (increased risk of heart attack, breast cancer, stroke, etc.), while women starting in their 50s had generally good outcomes. But the results widely reported were the negative ones from older participants – so many women never heard about the rest of the research, or anything we’ve learned since!

    The next speaker was Dr. James Simon, a clinical professor of obstetrics and gynecology at the George Washington School of Medicine – and a menopause researcher. (But he will forever be remembered to me as the man who scared the crap out of me about the future health and wellness of my vagina. I may not sleep tonight.)

    The Women’s Health Initiative’s results scared a lot of menopausal women into quitting their hormones cold turkey. That, is a very bad idea, he said. Going off hormones makes women unhappy and unpleasant, but more disturbing, he said, “when women go off their hormones their vaginas dry up and get smaller.”

    (!)

    Which makes sex painful – so women stop having it. And, he says, marriages today have enough problems without eliminating sex (or arguing about it).

    “No one wants to have sex when it hurts…. You can’t have good sex with a dried-up vagina. That’s a fact,” he said. “I can give you a two-hour lecture on why the parts don’t work.”

    Uhm, great. Go on.

    Instead, he told a horrifying story about one of his 55-year-old patients – a prominent writer for the Washington Post, who came to his office for her annual healthy woman exam. He asked her how she was feeling, how were things with her husband, how’s their sex life? Good, good, good, she said. Everything was fine.

    Then she put her feet in the stirrups.

    “I couldn’t even put the speculum in because it’s too shrunk and dry and small,” he said. “I could barely fit a pencil.”

    (I have heard stories about women “drying up” and that if you don’t use it you lose it – but I thought that was just, well, talk. I didn’t think it was true.)

    He asked her if she was having sex.

    She was silent.

    Then she started crying. “She cried and cried,” he said.

    Painful dried up vaginas aren’t something a lot of women talk about. “It’s grin and bear it, tough it out, or give it up,” he says.

    But, being an honorary Disruptive Woman – he laid it on the table.

    And Susan Wysocki, president and CEO of the National Association of Nurse Practitioners in Women’s Health pointed out more menopause-related things a lot of young women don’t know – or talk about. Like, who knew some menopausal women off their hormones are in so much pain they can’t ride an exercise bike, or even comfortably sit down.

    “Here we are,” she said, “saving at least one vagina at a time.”

    She also discussed the fact that some women worry about taking hormones because they don’t want to get breast cancer. She says that sometimes a woman may have a teeny tiny potential tumor that could go un-noticed for years. But, sometimes the hormones can make it grow big enough to show up on a mammogram. And that way a woman can get treatment faster.

    “That can be a good thing,” she said.

    For more about menopause, hormone replacement, and the WHI study, you can read:

    Don’t miss the next Disruptive Women in Healthcare breakfast, “Childhood Obesity: A Big Fat National Challenge.” May 27 at Johnny’s Half Shell. Reserve your spot now!

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