Tuesday, November 30, 2010

Vitamin D and calcium supplements

It didn't surprise me one bit when an article appearing on the front page of the New York Times nixed the benefits of megadoses of vitamin supplements. Out of nowhere everyone seems to be getting bloodwork for vitamin D levels and prescribed supplements for low levels. Today's article makes us reconsider whether all these supplements are indicated. It's been known for some time now that megadoses of calcium contribute to kidney stones.

Report: Skip the Megadose of Vitamin D

Lisa Flam Contributor

(Nov. 30) -- Dietary guidelines being released today call for a slight increase in the amount of vitamin D people need every day for good health but warn against megadoses of the "sunshine vitamin," saying there's no proof they prevent cancer and that they could in fact be harmful.

"More is not necessarily better," Dr. Joann Manson of Harvard Medical School, who co-authored the report, told The Associated Press.

The report from the prestigious Institute of Medicine says most people in the U.S. and Canada from ages 1 to 70 need 600 international units of vitamin D daily. That's up from the 400 IUs under today's government-required food labels and above the 1997 guidelines from the institute that called for 200 to 600 IUs, AP noted.

Most people are getting the amount of calcium they need from their diets, the report found, and supplements are not needed, The New York Times reported. Calcium and vitamin D work together to help build strong bones.

"For most people, taking extra calcium and vitamin D supplements is not indicated," Dr. Clifford J. Rosen, a member of the panel, told The Times.

The guidelines could slow the vitamin D craze. The sale of supplements has soared as some scientists recommend 2,000 IUs a day amid studies suggesting low vitamin D levels increase the risk of cancer and heart disease, AP said. The report out today suggests an upper limit of 4,000 a day.

"This is a stunning disappointment," Dr. Cedric Garland of the University of California, San Diego, who was not part of the study, told AP. The risk of colon cancer could be cut if people got enough vitamin D, he said.

Low levels of vitamin D have also been linked to stroke, diabetes, breast cancer, auto-immune diseases, infections and depression, and studies have suggested many Americans don't get enough vitamin D because they spend time inside and wear sunscreen when they go out, according to The Wall Street Journal.

But the institute didn't find enough evidence to prove a link to those chronic diseases, the newspaper said. The new guideline was created solely to promote bone health, the Journal said.

The new guidelines will affect the recommended daily allowances listed on food packages and the makeup of school lunches and other federal nutrition programs, according to the newspaper.

Some experts were disappointed.

The recommended 600 IUs of vitamin D is "way too low," Creighton University professor of medicine Robert Heaney told USA Today. Heaney, who has studied the benefits of D, says people should consider getting about 4,000 IUs daily.

"For me, it's a no-brainer," he told the newspaper. "There is a large body of evidence for benefit at intakes above the IOM recommendations. There is no risk, and very little cost, so why not take a chance of a benefit if there's any possibility?"

The latest study to report no cancer protection from vitamin D, and the possibility of a greater risk of pancreatic cancer, came last summer from the National Cancer Institute, AP said. A megadose of more than 10,000 IUs daily is known to cause kidney problems, AP said.

Tuesday, November 2, 2010

New FDA warnings about Lupron and related meds

FDA Requiring GnRH Agonists To Carry Warnings About Potential Risk For Heart Disease, Diabetes.

The Wall Street Journal /Dow Jones Newswire (10/21, Dooren) reports that to shrink prostate tumors, the medical community relies on a group of products that reduce male hormone levels, but these gonadotropin-releasing hormone (GnRH) agonists may also increase the risk of diabetes and cardiovascular problems. Thus, the FDA is now requiring the drugs, marketed under generic and brand names like Zoladex (goserelin), Lupron (leuprolide), Trelstar (triptorelin), Vantas (histrelin), and Synarel (nafarelin), carry labels that highlight the potential risks.

In February, "the American Heart Association, the American Urological Association, and the American Cancer Society issued a joint advisory warning of the increased risks of diabetes, myocardial infarction, stroke, and sudden death among men who use androgen deprivation therapy (ADT) to treat prostate cancer," MedPage Today (10/20, Walker) reported. "GnRH is the most common form of ADT. However, the groups did not offer specific guidelines for clinicians on when to employ ADT therapy or when to avoid it."

Thus, the FDA stepped in May and "announced...that it was reviewing the" GnRH agonists, HealthDay (10/20, Reinberg) reported. "Speaking after the FDA's announcement earlier this spring," Dr. Nelson Neal Stone, of the Mount Sinai School of Medicine, "said studies have shown that men with advanced prostate cancer who take hormone therapy face a twofold increased risk of developing metabolic syndrome, a cluster of symptoms tied to the development of heart disease." And, "once patients understand that, Stone hopes they will be motivated to watch their diet and exercise." For the time being, however, "men should not stop taking their hormone therapy, but do everything they can to reduce their risk of developing cardiovascular disease and diabetes with lifestyle changes, he said."

Still, the "relationship between heart disease risk, diabetes, and androgen deprivation therapy has not been without controversy," Medscape (10/20, Mulcahy) pointed out. "A medical oncologist specializing in prostate cancer treatment recently defended the safety of the therapeutic approach in an interview with Medscape Medical News." Mark Scholz, MD, of the California-based Prostate Cancer Research Institute, said, "There is no convincing evidence that hormone blockade shortens life or causes excess heart attacks if weight gain is attended to and blood sugar levels are kept in check."

Nevertheless, even though "all of the drugs will stay on the market," they "will be required to carry new label warnings," WebMD (10/20, DeNoon) reported. "The risk that the drugs will trigger diabetes or heart disease/stroke appears small, the FDA says," but again, "recent studies suggest that doctors should monitor blood sugar levels and watch for signs of heart disease in men taking these drugs." Reuters (10/21, Richwine) also covers the story.

From the AUA

Claim Your AUA2010 Credits Online
Attendees of the 2010 AUA Annual Meeting may claim their credits and/or print a CME certificate by clicking here. All 2010 Annual Meeting credits must be claimed by December 31, 201

Tuesday, October 12, 2010

Testosterone replacement

It is clear that we still don't have all the answers regarding the risks and benefits of replacement therapy. More studies are needed to clarify the issues. See the following article from the New York Times Science section.

Personal Health

Hormone Replacement for Men? Perhaps

By JANE E. BRODY

Published: October 11, 2010

Women are way ahead of men in knowing the benefits and risks of hormone replacement. There has yet to be a large study spanning years, comparable to the Women’s Health Initiative, of the safety and effectiveness of hormone therapy for aging men who have signs and symptoms of testosterone deficiency.

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Yvetta Fedorova

Times Topic: Testosterone
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Despite beliefs based on observational evidence that estrogen therapy enhanced the health and well-being of menopausal women, when a definitive study was finally done, clinicians and researchers were shocked to discover that the risks of long-term hormone replacement could outweigh its benefits.

Would a similar study of testosterone therapy for men experiencing “andropause” likewise reveal more hazard than help? The answer would be welcomed by an estimated four million men in the United States who have subnormal levels of this important hormone, a common result of advancing age.

But these men, as well as those already receiving testosterone therapy and the baby boomers who may soon develop symptoms of low testosterone, may never know whether adding to their bodies’ waning supply will improve or detract from the quality and length of their lives. Rather, they may have to base a decision about therapy on confusing and conflicting evidence.

Late last year, for example, a six-month federally financed study of a testosterone gel put a surprising hitch in efforts to improve the lives of aging men who experience a decline in energy, mood, vitality and sexuality as a result of low testosterone levels. The study, conducted among 209 men 65 and older who had difficulty walking, was abruptly halted when those using the hormone had an unexpectedly high rate of cardiac problems.

The researchers, who published their findings in The New England Journal of Medicine, noted that the deck might have been stacked in favor of a hazardous outcome because study participants, especially the group that received testosterone, had high rates of high blood pressure, diabetes, obesity and elevated blood lipids. Then again, this may be a realistic population to study, given that many candidates for hormone therapy are likely to have such health issues.

Advisement ‘in Limbo’

A $45 million study financed by the National Institute on Aging is under way at 12 medical centers to see if a year of treatment with testosterone will help 800 men aged 65 and older with low levels of the hormone and problems with physical functioning, fatigue and sexual or cognitive performance. The study, in which the men are being randomly assigned to receive the hormone or a look-alike placebo, will also evaluate the hormone’s effects on cardiac risk factors.

Still, this study will not answer the question of whether it is safe to use the hormone for years, even decades, which would be necessary to maintain any benefits. A major concern is whether long-term use would promote the growth of prostate cancer, which is present but hidden in as many as half of older men.

“There are not many good studies of testosterone in older men,” Dr. William J. Bremner, a urologist at the University of Washington in Seattle, said in an interview. “The studies are small and the longest of them lasted only three years. We need the same kind of study for testosterone as the Women’s Health Initiative — several thousand men followed for maybe 10 years. Currently, we’re in limbo as to how to advise patients.”

He acknowledged that the need for such a study for men is “less compelling” because, in contrast to women, who experience an abrupt drop in estrogen at menopause, often with disruptive symptoms, hormone decline in aging men is far more gradual, and symptoms, when they occur, are commonly viewed as normal signs of aging, not hormone deficiency.

A large European study published in the same issue of the journal sought to better determine who, among middle-aged and elderly men, might be candidates for testosterone replacement. Among a sample of 3,369 men aged 40 to 79, researchers at eight European medical centers found that “limited physical vigor” and three sexual symptoms — diminished sexual thoughts and morning erections and erectile dysfunction — were most closely linked to low levels of testosterone.

Although low hormone levels are widely thought to increase a man’s risk of depression, the researchers found that “psychological symptoms had little or no association with the testosterone level.”

There are four main approaches to testosterone therapy available in this country: intramuscular injections every one to three weeks; skin applications through a patch or gel; and pellets implanted under the skin that last for months. The patch can cause skin irritation, and the gel can be transferred to others through skin contact unless care is taken to cover the area where it is applied. But oral administration is rarely used because of toxic effects on the liver.

Weighing Help vs. Harm

The most common reason men seek testosterone therapy is waning sexual desire or performance, although the ability of the hormone to relieve sexual symptoms is unpredictable. More than one-quarter of men with normal testosterone levels have such symptoms, and many men with subnormal levels do not. Dr. Bremner said he typically suggests a trial of therapy for up to a year to see if sexual function or other symptoms improve.

Citing the results of many small studies, Dr. Bremner said, “There is good evidence that testosterone administration can improve muscle mass and strength and increase bone density” in men with subnormal levels. Dr. Abraham Morgentaler, a urologist at Harvard Medical School and author of “Testosterone for Life” (McGraw-Hill, 2009), said in an interview that other noted benefits include a decrease in body fat and total cholesterol and improved blood sugar metabolism.

In a report on the risks of testosterone therapy, written with Dr. Ernani Luis Rhoden and published in 2004 in The New England Journal of Medicine, Dr. Morgentaler noted that testosterone has widespread effects throughout the body, but he and Dr. Rhoden concluded that with proper monitoring, any looming hazards can be readily detected.

Before the most recent study, at doses considered normal, the testosterone gel showed little or no effect on cardiovascular risk, the two doctors reported. Injections could result in harmful thickening of the blood, however, especially if above-normal blood levels of the hormone result.

Although testosterone can cause overgrowth of the prostate, studies have not shown harm to urinary function, Dr. Morgentaler said. The risk of prostate cancer is of greater concern, given that suppressing the body’s natural production of testosterone can cause this cancer to regress. Men considering treatment should first undergo a full prostate exam and PSA

Tuesday, September 7, 2010

BRCA2 gene mutation and prostate cancer

A recently reported study in the British Journal of Cancer reported a higher rate of survival in prostate cancer patients who are non-carriers of the BRCA2 gene mutation compared to carriers. These findings may have important prognostic decision-making implications in stratifying patients for treatment once diagnosed with prostate cancer. Those expressing the gene mutation would not be advised to proceed with surveillance because of the poorer prognosis. Genetic testing for BRCA2 gene may become important part of the evaluation in patients with newly diagnosed prostate cancer.

Breast cancer is the cancer most commonly linked to BRCA1 and BRCA2 gene mutations.

Monday, September 6, 2010

Concierge medicine. Will urology or specialty services move in this direction?

I found an interesting article debating the pros and cons of "concierge" medical care. It is clear that the delivery of medical services is rapidly evolving. I was wondering whether this model might move into the specialty services realm. The following article from the New York Times looks at some of these issues.

Doctor and Patient

Can Concierge Medicine for the Few Benefit the Many?

By PAULINE W. CHEN, M.D.

Published: August 26, 2010

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Earlier this summer a friend revealed that for the last nine years she has been a patient in a concierge, or boutique, primary care practice. For $350 each month, she is guaranteed around-the-clock access to her doctor, appointments within 24 hours of calling, longer office visits and the kind of personalized attention and care coordination she felt was missing with all her previous doctors.

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“I love this doctor,” she said. “He really knows me.”

She recounted the details of a recent emergency room visit when a call from the doctor saved her from an unnecessary CT scan and admission to the hospital. “I feel like I have a doctor who’s actually thinking about me and talking to other doctors on my behalf,” she added.

But over the course of our conversation, I also discovered that her husband does not share her enthusiasm. He goes to a doctor in a more traditional primary care practice because he’s uncomfortable with the idea that those who can afford it get better care, while those who cannot pay do not. “I just don’t think it’s right,” he told me.

The two of them had agreed to disagree.

Agreeing to disagree has been what most of us, doctor and patient, have done since concierge, or retainer, practices first appeared in the mid-1990s. Developed as an alternative to the constraints of traditional practice, this new model allowed doctors to offer more personalized care that in turn increased patient and professional satisfaction. By decreasing the total number of patients seen in an office from well over 2,000 to as few as 500, doctors could offer longer visits, increased and immediate accessibility, personalized coordination of hospital care and, in some cases, even house calls and accompanied visits to specialists. In return for these services, patients would pay retainer fees, ranging from just under $2,000 to as much as $15,000 per year.

By 2003, according to a national survey, the number of doctors practicing concierge medicine numbered fewer than 200. And while critics raised ethical concerns about the “abandonment” of patients left without primary care physicians while their doctors downsized and the creation of a “two-tiered” system that exacerbated disparities in health care access, little was done to address those concerns. These boutique practices were a relatively rare curiosity, and practitioners were left alone.

But over the years and particularly in recent months, the debate about the ethics of concierge doctoring has grown more heated, with more and more physicians unabashedly lining up to take sides. An editorial in the Annals of Internal Medicine this spring, for example, questioned not only the ethics but also the quality of care delivered in such practices. The writer went on to urge other physicians to abandon “the neutrality with which the medical community has addressed” this issue thus far.

A month later, over a hundred doctors at a national meeting eagerly attended an event billed as a debate on the ethics of retainer medicine. But they weren’t jostling for places to argue the ethics; they wanted to hear about the experiences of physicians who were already successfully practicing concierge medicine and to solicit advice.

As this issue becomes increasingly divisive, it’s hard not to wonder whether it is possible to practice in a way that reconciles concierge medicine with all the ethical concerns.

One group of doctors in Boston believes it is possible. And in an article published this summer in the journal Academic Medicine, they argue that it can be done to the benefit of doctors and all patients, boutique or otherwise.

Since 2004, the primary care physicians at Tufts Medical Center have offered patients the option of being part of either a traditional general medical practice or a retainer practice. Patients in the retainer practice have longer visits, around-the-clock access to one of five physicians, comprehensive wellness and prevention screenings and on-time office appointments within 24 hours of a request. But unlike other boutique practices, the retainer fee of $1,800 per year that these patients pay does not go directly to the doctors’ coffers. Instead, it is used to support the traditional general medical practice, the teaching of medical students and trainees and free care to impoverished patients.

“I feel comfortable that this practice has been set up ethically,” said Dr. David G. Fairchild, senior author of the article and chief medical officer at Tufts Medical Center, who as a primary care physician sees patients at both the retainer practice and the more traditional general medicine practice. “No matter what practice patients are from, we treat them based on their medical need. But we also recognize that there may be a place for a higher level of service.”

That higher level of service, Dr. Fairchild points out, already exists across the country. Many hospitals, for example, have long offered “V.I.P.” rooms or suites or have concierge wards for patients who are willing to pay more during their stay. In the case of the Tufts primary care retainer practice, the differences come down to “add-ons and the environment” that do not affect the quality of care. “Maybe you have a fish tank in one office and not in another,” he said.

This consistency in care across both practices was highlighted in a survey that Dr. Fairchild and his colleagues conducted last year. With responses from more than 300 patients, they found that patients rated the quality of interactions with their doctors similarly regardless of their affiliation. The only significant differences in responses had to do with the services offered — care coordination, physician access and interactions with office staff.

“It’s like going first-class in an airplane,” Dr. Fairchild said. “The experience of people in coach is a little different, but everyone gets to the same place at the same time.”

And at least in this model, more people may be able to board that plane as a result of increased practice revenues. The retainer fees from each new patient can support the physician costs for as many as 50 patients in the traditional practice; and retainer practice patients know from the start that their fees will be used to support teaching, service and free care in the community practice. “Some patients almost feel guilty about wanting this higher level of service,” Dr. Fairchild said. “Using their retainer fees for this type of support helps them see that they are actually making a contribution to teaching and community service, which are the mission of this hospital.”

While Dr. Fairchild is confident that the Tufts retainer practice addresses the ethical concerns of critics, he also acknowledges that concierge medicine is emblematic of larger problems in the health care system.

“This is not how any of us doctors wanted care to be set up,” Dr. Fairchild said, “but the system, as it is now, is broken. Patients are asking for more, doctors are under huge pressures, and there is not enough money in primary care.”

He added, “For the time being, this is a solution that seems to be working for doctors and patients.”

Wednesday, September 1, 2010

Provenge (Sipuleucel-T) revisited

Unique Treatment Raises Tricky Bioethical Issues
Vaccine for advanced castration-resistant(hormone resistant)prostate cancer prolongs life by a median of four months, but at an extremely high cost

The question is whether it is worth it?

The typical patient might be an "active, mentally acute man with prostate cancer..... twenty-two years after a radical prostatectomy, the man now has extensive disease, including liver metastasis, but continues to enjoy a good quality of life. The man is a strong and eager candidate for a brand-new treatment that could extend his life by several months with relatively few side effects that will allow him to maintain a pleasant existence."

"The treatment is administered in 3 doses-one intravenous infusion approximately every two weeks-at a cost of about $31,000 per infusion, or $93,000 for the full regimen, and yields a 4.1-month median improvement in survival(25.8 months for treated patients vs 21.7 months in controls"

"Balancing the cost to some degree is Provenge's favorable risk profile: The most common complaints are chills, fatigue, fever, back pain, nausea, joint ache, and headache, although more serious respiratory or cardiovascular disorders are possible."

Medicare CMS is likely to issue a decision sometime around early summer 2011. Private insurance will likely respond similarly. The results will certainly be affected by the available dollars allocated for healthcare in this rapidly changing healthcare environment.

Renal and Urology News August 2010 Volume 9, Numer 8

Lupron

Abbott Laboratories has announced the upcoming release of LupronDepot as a 6 month 45mg preparation. It should become available soon.

Tuesday, August 24, 2010

Cranberry juice and urinary infections

Cranberry Juice May Prevent Bacteria From Developing In The Urinary Tract.

WebMD (8/23, Woznicki) reported, "Scientists report that within eight hours of drinking cranberry juice, the juice could help prevent bacteria from developing into an infection in the urinary tract." Scientists at the Worcester Polytechnic Institute made that observation after growing "strains of E. coli in urine collected from healthy people before and after they drank cranberry juice cocktail." In short, investigators "discovered that in petri dishes, cranberry metabolites in the juice prevented E. coli from sticking to other bacteria, limiting its ability to grow and multiply."

Wednesday, August 4, 2010

Occupational risk for bladder cancer

Something I suspected all along (see article below)

Painters Found to Have Increased Bladder Cancer RiskAnd risk appears to increase along with more time in occupation

TUESDAY, July 20 (HealthDay News) -- Occupational exposures in painters are associated with an elevated risk for bladder cancer, a risk that increases with years on the job, according to research published in the August issue of Occupational and Environmental Medicine.

Neela Guha, Ph.D., of the International Agency for Research on Cancer in Lyon, France, and colleagues conducted a meta-analysis of 41 studies encompassing more than 2,900 incident cases or deaths from bladder cancer, including two cohort studies, nine record linkage studies, and 30 case-control studies. The researchers pooled data and adjusted for smoking and other occupational exposures. Results were stratified by study design, gender, and study location.

Compared to unexposed subjects, the researchers found that painters had an overall 25 percent increase in bladder cancer risk (based on all 41 studies), a 28 percent increased risk after adjusting for smoking (based on 27 studies), and a 27 percent increased risk after adjusting for other occupational exposures (based on four studies). After the researchers stratified by gender, study design, and study location, the results were still robust. They also found that bladder cancer risk was higher for those employed as a painter for longer periods of time.

"Because several million people are employed as painters worldwide, even a modest increase in the relative risk is remarkable. It is important for cancer control and prevention to design studies with more specific exposure assessment that quantifies individual agents or classes of agents to identify the underlying carcinogenic agents encountered in painting," the authors write.

Wednesday, July 21, 2010

PCA3

The PCA3 urine test is becoming a useful test for the diagnosis of prostate cancer. See article below. Refer to the website www.PCA3.org for the most up-to-date information.

Cleveland Clinic To Use Progensa PCA3 Test For Prostate Cancer Screenings.

The Cleveland Plain Dealer (7/20, Townsend) reports that even as "the quest for a better, more accurate prostate cancer screening test continues," the Cleveland Clinic "is the latest of a dozen centers across the country to offer the Progensa PCA3 test," which is "one of the latest, more accurate, such tests." PCA3 detects the presence of the gene of the same name, "which shows up in urine only when a man has prostate cancer." The gene is found "in more than 90 percent of prostate cancer cases," the paper says. Over 30 men have received the test and "about half of those tests" have indicated the need "for a follow-up biopsy." Clinical trials for the test "have ended," and Gen-Probe Inc., one of the developers, is preparing to file its regulatory application with the FDA by fall.

Friday, July 16, 2010

provenge

Several patients have inquired about Medicare coverage for the recently approved drug, sipuleucel-T(Provenge) for the treatment of metastatic castrate-resistant prostate cancer. The Centers for Medicare and Medicaid is performing a "national coverage analysis to determine whether autologous cellular immunotherapy is reasonable and necessary under certain sections of the Social Security Act". More information will be forthcoming as it becomes available

Thursday, July 15, 2010

TOP DOC

Dr. Frank was recently named one of New Jersey's Top Doctors in the urology category by New Jersey Monthly magazine. Watch for the listing in the November 2010 edition.

NEW for 2010 continued

PCA3 urine test A specific urine test to stratify patients having elevated PSA's at risk for prostate cancer. The specimen is collected and prepared in the office before it is processed at a specialized laboratory. The results are returned to our office usually within 48-72 hours.

Gardasil vaccine for men. In 10/09, the FDA approved Gardasil for boys and men 9-26 years of age for the prevention of genital warts. The vaccine is available in our office for administration.

Greenlight laser for BPH (benign prostate enlargement) The numbers of procedures for this successful outpatient modality continue to increase as patient satisfaction and "word of mouth" are the guiding forces directing patients away from the traditional TURP (transurethral resection of the prostate).

Bladder outlet and prostate enlargement Medications to treat the prostate continue to enter the market offering patients more options to treat non-invasively. Flomax, Uroxatral and now Rapaflo, a new entry is available in the pharmacological treatment of poor urinary flow secondary to prostate enlargement.

Urgency incontinence The market is flooded with a range of choices. Older medications include ditropan, oxytrol, enablex and detrol. Newer entries include Vesicare, Sanctura and now Toviaz and Gelnique offer patients more options.

NEW for 2010

It is clear that the overall trends in urology continue in the direction of non-invasive, in-office and outpatient treatment of many urologic conditions.

Vasectomy My personal observation is that there is a definite increased interest in couples choosing vasectomy as a mode of permanent contraception. I suspect this may be partially impacted by the economy and the expense of having additional children.

Prostate cancer screening The recommendations for an annual PSA have been revised. A baseline PSA is now recommended in men beginning at age 40 (formerly a PSA blood test was performed on men starting at 50 years of age). Our in-office blood test can provide a result in an astounding 11 minutes.

NMP22 urine test The only non-invasive, in-office urine test approved by the FDA for the diagnosis of bladder cancer in patients with blood in the urine. The result is obtained in 30 minutes.