Category Archives: Endocrinology, Diabetes, and Metabolism

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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“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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The U.S. Obesity Epidemic and Surging Liver Cancer

If there is one truism that trumps everything else these days about U.S. health, it’s that America is a chubby country that keeps getting fatter.

The consequences seep into every corner of the nation’s medical state, including the surprising fact that obesity and the type 2 diabetes it causes are likely pushing up the incidence of liver cancer—hepatocellular carcinoma—to unprecedented heights.

courtesy Wikimedia Commons

When I covered Digestive Disease Week in San Diego recently, one of the biggest stories I heard was that U.S. liver-cancer rates tripled from 1975-2007, and that the numbers continued to rise from the mid to the late 2000s. (My full report on this is here).

Granted, factors other than just obesity play into the liver cancer surge, notably the sizable number of Americans infected with either hepatitis B or C virus, and the fact that as they age their risk for developing hepatocellular carcinoma rises.

But new U.S. infections by hepatitis B and C are largely under control these days (although people infected elsewhere continue to emigrate to the United States). The part of the booming liver-cancer story that is by no means under control is the obesity part.

Every time I see a new CDC map for U.S. obesity prevalence, the colors on it keep getting redder and darker (the CDC’s code for higher prevalence rates).

courtesy CDC

courtesy CDC

Earlier this year, the CDC reported a 36% obesity prevalence rate for the entire U.S. population–and still on the rise–and just a few weeks ago we heard that obesity among children and adolescents had hit a new high of 17%. With obesity seemingly on an unchanging upward trajectory, one can only wonder what rates of liver cancer it might produce in the future. Obesity carries a special relationship with the liver, and it’s not pretty. Just consider any goose headed to a foie-gras future.

Until now, the evidence linking obesity and liver cancer, and type 2 diabetes and liver cancer has been epidemiologic. Compelling, but just an association. At DDW, a new study provided more observational data on the diabetes-liver cancer link, and while still circumstantial it further supports the notion and also carries an intriguing punchline.

The study, done in Taiwan, examined 97,000 hepatocellular carcinoma patients and 195,000 matched controls. The analysis showed that people with diabetes had a two-fold increased risk for liver cancer compared with those without diabetes. Even more striking, the analysis also showed that people with diabetes treated with the oral hypoglycemic drug metformin had their risk for liver cancer cut in half compared with those not on metformin, and those with diabetes treated with a glitazone drug (such as pioglitazone–Actos) had their risk cut nearly in half.

The best solution would be if people avoided obesity and type 2 diabetes all together. Both conditions cause a lot of medical problems, and this new evidence indicates more strongly than ever before that liver cancer is one of them.

—Mitchel Zoler (on Twitter @mitchelzoler)

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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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Keeping Endovascularists Busy

Renal denervation may be the next big thing in endovascular intervention, and not just because of the many patients it might help.

Renal denervation is a new procedure for lowering blood pressure that involves placing a radiofrequency catheter inside both of a patient’s renal arteries and zapping the tissue four to eight times on each side, gently enough not to cause trauma but firmly enough to damage the renal nerves and block sympathetic activity and the kidneys’ renin release. It remains investigational in the United States, where a 500-patient pivotal trial recently started, but it’s been available on a routine basis in Europe since 2010, and according to Horst Sievert, a German interventional cardiologist who’s done many denervations since then, it’s been taking off both in terms of the number of endovascular physicians offering it and the number of patients with drug-resistant hypertension being treated.

image courtesy Wikimedia Commons

Though still off the U.S. market, the prospect of FDA approval within the next couple of years was enough to win renal denervation a special session at ISET 2012 last week in Miami Beach. My news article on those talks is here.

An apparently safe, relatively easy, 60-minute procedure that can durably cut systolic blood pressure by about 30 mm Hg in patients who remain hypertensive despite treatment with multiple drugs is certainly very attractive. It may be even more appealing if early evidence pans out and the treatment also helps normalize glycemic control and reduce hyperinsulinemia in at least some patients.

But when vascular medicine specialist Michael Jaff said at the meeting that renal denervation “could arguably be the most exciting advance in interventional vascular medicine,” and that “in the near term I’m incredibly bullish,” it was hard not to imagine that it was more than optimized patient care that made his pulse quicken.

Endovascular medicine became a medical growth industry more than 30 years ago, when it started to become a routine part of cardiology, a way to less-invasively treat stenotic coronary arteries. Since then, it’s become a major part of all vascular medicine, but in recent years the coronary part showed a definite leveling off. Just last year in a talk at ISET, Martin Leon, one of the world’s foremost interventional cardiologists, declared that endovascular coronary interventions appeared to have reached a volume plateau that would not change anytime soon. He said his early recognition of this trend was a motivation for him to turn his attention to transcatheter aortic valve replacement, which has now emerged as a new way for interventional cardiologists to ply their trade.

Renal denervation may be the next step along the same path. If the pivotal trial results and further clinical experience confirm the early findings of safety and efficacy, and especially if the very early findings of a beneficial glycemic effect also pan out, it may well fulfill Dr. Sievert’s prediction that “renal denervation will become as important as percutaneous coronary intervention.”

Important not just for patients, but for practitioners too. Busy hands are happy hands.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

©froglegs/Fotolia.com

“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Better Thyroidectomy Outcomes Seen by Mid-Career Surgeons

Surgeons aged 35-50 years tend to have fewer complications during thyroid removal surgery compared with their younger and older peers, results from a multicenter French study show.

Courtesy Flickr/buzzthrill/Creative Commons

The findings “suggest that a surgeon cannot achieve or maintain top performance passively by accumulating experience, which raises concerns about ongoing training and motivation throughout a career that extends several decades,” according to the study, which was published Jan. 11 in BMJ. “Solutions to help surgeons avoid poor outcomes could include simulation and proctoring in the early years of their careers, continuous monitoring of performance, and targeted retraining if appropriate. Individual feedback based on outcome indicators might increase awareness about performance and improve safety in surgical practice.”

The researchers, led by Dr. Antoine Duclos, assistant professor of public health at the University of Lyon, France, evaluated data from 3,574 thyroidectomies performed by 28 surgeons at five French hospitals between April 1, 2008, and Dec. 31, 2009, (BMJ 2012 Jan. 11 [Epub doi:10.1136/bmj.d8041]). The main outcome measure was the presence of two permanent major complications 6 months following thyroid surgery: recurrent laryngeal nerve palsy or hypoparathyroidism.

The surgeons had a mean age of 41 years and had been in practice for a mean of 10 years. After adjusting for patient and surgeon variables, the researchers found that surgical experience of 20 years or more was the only factor significantly associated with an increased probability of recurrent laryngeal nerve palsy (odd ratio 3.06) and hypoparathyroidism (OR 7.56). They also observed what they described as a “concave association between surgeons’ experience and their case mix adjusted performance, suggesting that surgeons aged 35-50 years provided the safest care.”

The researchers acknowledged that other unknown or unexamined factors may explain part of the variation in patient complication rates, including the combination of manual and intellectual skills acquired during a surgeon’s academic and professional training. “Future studies should be conducted with larger populations of surgeons in various settings and other surgical specialties to corroborate the potential link between experience and performance,” they advised. “Since a cross sectional study might be inappropriate to resolve a dynamic phenomenon, a recommended design would be to follow a particular cohort of surgeons over time.”

— Doug Brunk (on Twitter@dougbrunk)

Image courtesy buzzthrill’s photostream

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A ‘Health Shock’ for Youth with Diabetes

While the financial impact of diabetes on the delivery of medicine and related health care is a popular area of research, the nonmedical implications for young adults “have gone virtually unexplored,” lead author Jason M. Fletcher, Ph.D.,  associate professor of public health at Yale University, declared in the January 2012 issue of Health Affairs.

Jason M. Fletcher, Ph.D./Photo courtesy Yale University

According to results from a study Dr. Fletcher conducted with his associate Michael R. Richards, a doctoral candidate at Yale, the nonmedical consequences of diabetes can occur early in life and are associated with certain adverse effects. For example, a person with diabetes can expect to earn significantly less income over his or her working life compared with one who does not have the disease. Diabetes patients also more likely to drop out of high school and less likely to attend college.

The study was based on a survey of nearly 15,000 youth in grades 7-12 who participated in the National Longitudinal Study of Adolescent Health in 1994 and 1995 and who completed follow-up surveys in 1996, 2001/2002, and in 2008, when most were about 30 years old (Health Aff. 2012; 31:27-34). The researchers found that the high school dropout rate among people with diabetes was 6% higher than the rate among people without the disease. In addition, people with diabetes were 8%-13% less likely to attend college compared to their peers without the disease. Interestingly, having a parent with diabetes lowered the chances of attending college by another 4%-6%.

Over a 40-year work lifetime, people with diabetes can expect to earn $160,000 less in wages compared with people who do not have the disease. The researchers termed the double-whammy of adverse impact on schooling and wages as a “health shock” to people with diabetes.

“These results highlight the urgency of attacking this growing health problem, as well as the need for measures such as in-school screening for whether diabetes’s impact on individual learning and performance begins before the classic manifestations of clinical diabetes appear,” the researchers concluded.

— Doug Brunk

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Can Pill Color Prompt a “Nocebo” Response?

What’s the opposite of a placebo? An active drug, of course. But what’s the opposite of a placebo response? That would be a “nocebo” response, in which placebos produce adverse side effects.
 
“It’s somewhat hypothetical, but you can imagine that if somebody feels they will get better, they will get better, and if they feel that they’re taking something that’s not good for them, they might get worse,” according to Dr. Allan Krumholz, professor of neurology and director of the Maryland Epilepsy Center, Baltimore.

Image courtesy of Dr. Tricia Y. Ting

Pill color and appearance have been identified as a potential source of “nocebo” response, and differences in appearance between brand-name and generic drugs have been postulated to explain why some patients experience increased adverse events when they switch from brand-name to generics.

In response to this growing concern, in August 2010 the Food and Drug Administration solicited proposals for bioequivalence studies of the impact of switching from brand-name antiepileptic drug lamotrigine (Lamictal) to generic among patients with epilepsy in the outpatient setting.

This is a new way of conducting such trials. “Pharmacokinetics trials across all areas of medicine have traditionally been highly controlled single-dose studies in healthy volunteers dosed in the laboratory setting,” said lead investigator Dr. Tricia Y. Ting, a neurologist who works with Dr. Krumholz at the UMD epilepsy center.

Because the brand-name Lamictal and its generic counterparts look very different, the investigators decided to over-encapsulate the pills with identical coverings in order to “blind” the patients to which formulation they were taking.

But in order to do that, they first needed to determine whether the color of the pill would impact the patients’ perception of safety and efficacy. A group of 80 adult epilepsy patients were shown standard AA size capsules in five “global colors” (white, yellow, gray, caramel, maroon) and asked to select any color(s) considered “unacceptable” and to rank their preferences.

More patients deemed gray, caramel and maroon colors “unacceptable” (21%, 19%, and 20%, respectively) compared with the white and yellow (5% and 4%, respectively). There was a clear preference for white and yellow pills over the other, darker colors, without much difference between white and yellow.

But, there were patients who selected maroon as their “preferred” color. “Some people didn’t have any preference. Some had a very strong preference. One patient, an artist, liked the darker colors. It was different for different people,” noted Dr. Karen M. Aquino, a neurology fellow who worked on the nocebo study.

So what pill color will the bioequivalence study use? “To optimize drug adherence, white colored capsules will be used for over-encapsulation,” Dr. Ting wrote in her poster, which was presented at the American Epilepsy Society’s annual meeting in Baltimore. Dr. Krumholz and Dr. Aquino presented the pill color preference data in a separate poster at the meeting. The bioequivalence results are expected in 2013.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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