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Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Physicians Grapple With Efficiency, ‘Do No Harm’

Two new books and a news article triangulate some interesting thoughts on improving efficiency in medicine while causing less harm to patients – and what that really means.

IMNG Medical Media reporter Alicia Ault’s feature story on “Can More Be Done with Less?” describes a recent conference on “Avoiding Avoidable Care” that brought medical experts together to strategize on how to avoid unnecessary tests and treatment, which can harm patients.

Dr. Vikas Saini, an organizer of the conference, told her that patients often demand tests or procedures because they seek certainty and want to know that the physician cares. But test results often lead to false knowledge, said Dr. Saini of the Lown Cardiovascular Research Foundation, which cosponsored the meeting. The key for physicians, he said, is to convincingly explain to patients why the test or procedure is or is not a good idea, and to practice evidence-based medicine.

To do that, though, requires an ability to interpret medical research and help patients understand it. That’s where Dr. Marya D. Zilberberg’s new book comes in. Between the Lines: Finding the Truth in Medical Literature is a breezy 170-page primer that spends most of the first half of the book cheerleading for scientific uncertainty. She also reviews the hierarchies of quality in research and touches on heterogeneity, biases, and a few general pitfalls in interpreting studies.

The second half of Between the Lines goes a little deeper in explaining study design, validity, statistical analyses, and more, though never so deeply that a nonstatistician’s eyes will glaze over. Dr. Zilberberg, a consultant, teacher, and blogger at Healthcare, Inc., explains these dry subjects in an eminently readable fashion.

I found it a valuable refresher (especially Part Two) even though I’ve been covering medical news for over two decades, and I imagine it would be a great introduction for the uninitiated. Dr. Kenneth W. Lin, a family physician who teaches a course in evidence-based medicine at Georgetown University, posted an online review that called Between the Lines “a rare book that bridges the gulf between medical publications and the real world of practicing clinicians.” Paul D. Simmons, Ph.D., who teaches family medicine residents in Louisville, Ky., said in an online review that he hopes incorporating the book will decrease the number of residents who finish his rotation thinking that evidence-based medicine is impractical, takes too much time, requires a Ph.D. in biostatistics, and doesn’t apply to their careers.

A separate book approaches these themes in ways that question medicine’s sometimes heavy-handed emphasis on “evidence” and “efficiency.” In God’s Hotel: A Doctor, a Hospital, and a Pilgrimage to the Heart of Medicine, Dr. Victoria Sweet eloquently recounts her 20 years of working at a chronic-care hospital for the ill and indigent (considered the “last almshouse in America”) as it morphs into a “modern healthcare treatment facility.”

Dr. Sweet’s scathing depictions of “efficiency” at the expense of time with patients bolster her call for “slow medicine” and the (missing) research to compare the two.

Disclosure: I’ve known Dr. Sweet for many years and even consider her a friend. I esteemed the book on its merits, and so did neurologist and author Dr. Oliver Sacks, whose book-jacket blurb called it, “A most important book, which raises fundamental questions about the nature of medicine in our time. It should be required reading.”

Dr. Abigail Zuger’s review in The New York Times began, “It is probably pointless to suggest that all the individuals presently shaping our health care future spend a quiet weekend with ‘God’s Hotel,’ Dr. Victoria Sweet’s transcendent testament to health care past. Who interrupts cowboys in the midst of a stampede? But if you’re one of the millions of doctors and patients out there choking on their dust, this is the book for you. Its compulsively readable chapters go down like restorative sips of cool water, and its hard-core subversion cheers like a shot of gin.”

The synchronicity of these three works is a sign of the times. As physicians are asked to do more with less, these writings help us understand what you’ve got to work with.

–Sherry Boschert (@sherryboschert on Twitter)

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Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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VA Adopts Innovative Project Nationwide

An innovative medical project that we reported in April has made the big time — a nationwide pilot program in the immense Department of Veterans Affairs system, the nation’s largest integrated health care system.

Project ECHO (Extension for Community Healthcare Outcomes) has been working wonders in New Mexico, Washington State, and a few other locations to bring specialty care to thousands of people who previously had little access to this care. Created by Dr. Sanjeev Arora of the University of New Mexico, Project ECHO connects primary care physicians with specialists in weekly case-management and educational teleconferences to give primary care physicians the support they need to manage complex patients with hepatitis C, asthma, chronic pain, rheumatic or cardiac disease, HIV, substance abuse, mental illness, high-risk pregnancy, childhood obesity, and more.

Dr. Arora (center, back turned) leads a Project ECHO videoconference. (Courtesy Project ECHO)

The U.S. Department of Health and Human Services awarded Project ECHO an $8.5 million Health Care Innovation grant in May 2012 to expand its operations in two states.

Impressed, the Department of Veterans Affairs cloned Project ECHO and tomorrow will launch a nationwide pilot program in the VA system that could help veterans get care in the local communities instead of traveling to specialists for treatment of heart failure, chronic pain, hepatitis C, etc. In our April 2012 video interview with Dr. Rollin M. Gallagher, deputy national program director for pain management in the Veterans Health Administration, he explains why Project ECHO is so appealing to the VA

The VA’s version, called Specialty Care Access Network-ECHO (or SCAN-ECHO), will kick off officially with a briefing by a panel of experts in Washington, D.C., that also can be viewed by Webcast (how appropriate) on Wednesday, July 11, 2012 from 10 a.m. to 11:30 a.m. Eastern time. Register here to view the Webcast.

The panel will feature Dr. Arora with Dr. Robert A. Pretzel, under-secretary for health in the V.A. system, Dr. John R. Lumpkin, director of the Health Care Group for the Robert Wood Johnson Foundation, which has funded much of Project ECHO’s work, and both specialty and primary care providers from the Cleveland VA Medical Center.

With any luck, the success of Project ECHO will echo across the country as this model of care expands.

–Sherry Boschert (@sherryboschert on Twitter)

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IUD Contraception Cost May Inhibit Use

A copper intrauterine device (IUD) retails for the equivalent of $20 in France. In the United States, it costs $860, Dr. Eve Espey says.

“This is highway robbery. It has to change,” she said during a talk on long-acting reversible contraception at the annual meeting of the American College of Obstetricians and Gynecologists (ACOG). “Honestly,” she sighed, “If you went to Home Depot and picked up the supplies to make yourself an IUD, what would it cost? Like, under $1.” (Not that she’s advocating that.)

Dr. Eve Espey (Sherry Boschert/IMNG Medical Media)

Strong words, and they’re not coming from just any frustrated physician. Dr. Espey is chair of ACOG’s Working Group on Long-Acting Reversible Contraception and a professor of ob.gyn. at the University of New Mexico, Albuquerque.

The high U.S. price may be one reason that only 6% of U.S. women using contraceptives choose an IUD, even though studies show it’s one of the most effective kinds of contraception, along with levonorgestrel intrauterine systems and contraceptive implants, the other two kinds of long-active reversible contraceptives.

Sure, the cost of a copper IUD may be somewhat less than $860 if the physician or patient has access to government prices or other discounts, but it still creates a financial burden for physicians to stock their shelves with IUDs, not to mention inadequate reimbursement from insurers, she said.

“I think that the emerging, biggest barrier to IUD and implant use in this country is price,” Dr. Espey said. “ACOG is really trying to work to make a dent in that, but I think that until we see a cheaper IUD, it’s going to be a barrier to increased usage.”

Dr. Espey reported having no financial disclosures.

There’s only one copper IUD approved for use in the United States, so I contacted the makers of the ParaGard IUD, Teva Women’s Health. The “typical cost” for one ParaGard is $754, according to the company’s vice president for corporate communications, Denise Bradley. She said that the ParaGard’s price is “below most other forms of female birth control,” that most insurance plans cover ParaGard, and that the company offers women whose insurers don’t cover the IUD the option of paying by monthly installments.

She didn’t respond directly to the question of whether ParaGard’s cost is a barrier to use, but said, “Teva Women’s Health believes that increased access to all forms of contraception is of critical importance to all women of reproductive age.” She declined to comment on price differences between copper IUDs in the United States and other countries.

Recent data show that when financial barriers are removed and women receive standardized information about contraceptive choices, many more choose long-acting reversible contraception. The Reproductive CHOICE Project recruited nearly 10,000 women in the St. Louis area who desired contraception, gave them standardized counseling, and provided contraceptives for free.

A copper IUD. (Photo courtesy flickr/+mara/Creative Commons)

Results from the first 4,167 women to complete a year of follow-up found that 71% chose a long-acting reversible contraceptive (45% the levonorgestrel intrauterine system, 13% the copper IUD, and 13% an implant), Dr. Espey said. Others chose contraceptive pills, vaginal rings, transdermal patches, or another method.

After 12 months of use, 80% of IUD users reported being somewhat or very satisfied, compared with 54% of pill, patch, or ring users, she said. Only 55% of pill, patch, or ring users were on the same choice of contraception after 1 year compared with 84% of IUD users, 83% of implant users, and 88% of women who got a levonorgestrel intrauterine system.

The investigators recently reported that there have been 334 unintended pregnancies in 7,486 participants. Those using the pill, patch or ring were 22 times more likely to experience contraceptive failure compared with participants on long-acting reversible contraceptives (N. Engl. J. Med. 2012:366:1998-2007).

Long-acting reversible contraception was equally effective in all age groups, but use of the pill, patch, or ring was strikingly less effective in participants younger than 21 years, who were nearly twice as likely to have an unintended pregnancy compared with older women using those same methods of birth control.

–Sherry Boschert (on Twitter @sherryboschert)

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Do Medical Tattoos Need Guidelines?

Should medical tattoos be standardized? Should there be guidelines pertaining to their design, and where on the body they’re located? Should physicians prescribe tattoos to patients with hidden medical conditions? And if the answer to any of those questions is yes, should medical personnel be the ones doing the tattooing?

Photo by Miriam E. Tucker / Used with permission

Those were among the questions raised by Dr. Saleh Aldasouqi in a poster presentation and at a press briefing at the annual meeting of the American Association of Clinical Endocrinologists.

Some patients with diabetes and other hidden medical conditions are choosing to be permanently tattooed rather than wear a necklace or bracelet to alert emergency personnel of their conditions. This is particularly common among patients with type 1 diabetes, for whom low blood sugar can result in unconsciousness or odd behavior that can easily be mistaken for drunkenness.

“There are a lot of patients with diabetes who are getting tattoos. Just Google ‘medical tattoos’ or ‘diabetic tattoos’ and you’ll find a large number from around the world.  The problem is they’re not consulting their physicians. They could have high sugar, which can affect wound healing. …There are so many issues now being talked about with regard to medical tattooing,” noted Dr. Aldasouqi, an endocrinologist at Michigan State University, Lansing.

He believes these issues should be addressed by professional medical organizations, possibly including those pertaining to diabetes, dermatology, and emergency medicine.

As for tattoo location on the body,  the wrist would be the most logical place since first responders will always check there, he said.

So who should do the tattooing?  Tattoo parlors that are licensed under state or local laws are typically clean and use sterile equipment, and require customers to read and sign consent forms that address medical conditions and risks.  Of course, tattoo artists would need to be educated about any new standard.

But dermatologists or plastic surgeons could do it as well. “We’re not competing with tattoo artists, but at least we can collaborate with them by standardizing at their level, or make it a minor surgical procedure. In fact, this is being done to mark the skin for radiation therapy in cancer patients, and in reconstructive surgery after breast cancer. Some medical tattooing is already being done  by medical specialists. So, it’s open for discussion.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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