Category Archives: Urology

Whose Rights Are at Stake?

The Supreme Court heard arguments Tuesday in support of the 2007 Vermont statute limiting the release of the information detailing which drugs doctors prescribe. This information is maintained by pharmacies, which sell it to data-mining agencies, that in turn sell it to drug companies, for marketing purposes. Patient information is excluded from the data, doctor’s information is not.

Under the Vermont law, this information can be released only with the consent of the doctor. However, once data collection firms like IMS Health and interested parties like Pharmaceutical Research Manufacturers of America, challenged the statute, the issue became a question of free speech.

In the case of Sorrell v. IMS Health Inc., data-mining firms claim they have First Amendment rights to buy and sell the information for their marketing use.

However, the state’s attorney’s office likened the release of the confidential information to disclosing a doctor’s tax returns, patient files, or a competitor’s business information, arguing that First Amendment rights in the case apply to protecting doctor’s information. But since the information is given away to parties including insurance companies, journalists, and law enforcement, the court wasn’t too convinced.

” … just don’t tell me that the purpose is to protect their privacy,” said Justice Antonin Scalia. “[A doctor's] privacy isn’t protected by saying you can’t sell it but you can give it away.”

Justice John Roberts said Vermont is trying to reduce health care costs by “censoring” information doctors hear about brand-name drugs, with the intent that they will prescribe more generics, a measure Justice Scalia added was a restriction on free speech.

Vermont Assistant Attorney General Bridget Asay responded that “the purpose of the statute is to let doctors decide whether sales representatives will have access to this inside information” on the prescribing habits of physicians.

Attorneys general of several states, the federal government, AARP, medical associations, privacy groups, and the New England Journal of Medicine have filed briefs in support of the Vermont statute, according to a brief by Cornell (N.Y.) University Law SchoolThe National Association of Chain Drug Stores, the Association of National Advertisers, the Associated Press, and Bloomberg have filed in support of the data mining firms.

In an age in which personal data can mined through social networks and search engines, this case could set the precedent concerning how much personal information can be used for marketing. A decision is expected by June.

 Tell us what you think. 

–Frances Correa (@FMCReporting on Twitter)

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Get More Mileage from Erectile Dysfunction Drugs: Tadalafil for Raynaud’s?

When it gets chilly, but not freezing, my right index finger starts to turn white and numb. I’m told this is Raynaud’s syndrome, and the numbness goes away without much disruption to my life.

 But Raynaud’s phenomenon is a whole different problem: structural damage to the blood vessels that can be serious enough to cause ulcers and gangrene. Raynaud’s phenomenon is common in people with scleroderma, and it can be tough to treat, Dr. Vikas Agarwal, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, said at the annual scientific meeting of the American College of Rheumatology
.

courtesy of flickr user littlelupie (creative commons)

Dr. Agarwal and some fellow rheumatology researchers theorized that a vasodilator that improves blood flow in one extremity might do the same for other extremities. They randomized 53 patients (50 of whom were women) to a placebo or tadalafil (Cialis), a vasodilator better know for its use in treating erectile dysfunction. All participants reported at least four episodes of Raynaud’s per week despite taking other vasodilators.

 So, did it work? In this study, 20 mg of tadalafil every other day for 8 weeks significantly improved the frequency, duration, and severity of the Raynaud’s episodes.

But wait, there’s more. At the start of the study, 18 patients in the tadalafil group and 13 in the placebo group had ulcers on their fingers. At the end of the study, these ulcers had healed in 14 of the 18 patients in the tadalafil group, vs. 5 of the 13 patients in the placebo group.

This is a small study, and none of the researchers disclosed any financial conflicts. Will we see more research if some erectile dysfunction drug makers decide to expand their horizons to a different population? 

–Heidi Splete (on twitter @hsplete)

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Urology Goes to the Dogs

Here at Elsevier Global Medical News, we aim to report stories with direct clinical relevance. We rarely cover Phase I trials, and virtually never report on test-tube or animal studies. Here is an exception: This study is not so much about research on animals but on research by animals.

Here at the annual meeting of the American Urological Association, there are always many studies on detecting and treating prostate cancer. Existing screening methods leave a great deal to be desired. The popular PSA test, for example, is very non-specific—it flags many men who do not have prostate cancer.

Yet a group of French researchers have reported success at training a Belgian Shepherd (Malinois) owned by the French Army to detect prostate cancer by sniffing urine samples.

Here’s a video of the dog in action. The samples are in the drawers.

Presented with urine from 33 patients with confirmed prostate cancer and 33 with elevated PSA levels but without prostate cancer, the dog correctly identified every cancer patient and correctly excluded all but three of the non-cancer patients. Thus the sniff test had a sensitivity of 100%  and a specificity of 92%, a truly remarkable result.

Now you’re not going to see lab-coated pooches in your local doctor’s office any time soon. For one thing, an attempt to train a second dog was unsuccessful. The French investigators hope to figure out which volatile organic compound the dog is detecting, and develop an “electronic nose” to do this automatically.

One question remains: Will the electronic nose be cold and wet? Only time will tell.

—Bob Finn
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Hospitals Moving “Moo” Off the Menus

(Courtesy NASA Goddard Space Flight Center)

Here’s a happy Earth Day item: Four hospitals in the San Francisco Bay Area reduced their meat purchasing for menus by 28% in a pilot study, thereby avoiding significant amounts of associated greenhouse gas emissions and saving hundreds of thousands of dollars in costs.

Most of the drop in greenhouse gases came from reduced purchases of beef, which is a notorious producer of gases that contribute to global warming.

The study is the first attempt to evaluate the “Balanced Menus” program, which was created by the San Francisco Bay chapter of Physicians for Social Responsibility and has been rolled out to 32 hospitals across the United States by the nonprofit organization Health Care Without Harm. The Johns Hopkins Center for a Livable Future partnered with Health Care Without Harm to conduct the study.

A hospital meal (not in one of the study hospitals) by flickr user VirtualErn (Creative Commons).

Two hospitals reduced meat (beef, pork and chicken) in its cafeterias or cafes, one hospital reduced meat in inpatient menus/meal services, and one hospital did both. The Balanced Menu program also had them try to replace the remaining meat on their menus with purchases from sustainable and grass-fed meat producers instead of industrialized meat sources.

The study estimated that in a year’s time, the reduced meat purchases would avoid a total of 1,004 tons of carbon dioxide-equivalent greenhouse gas emissions. That’s roughly equivalent to not using 102,454 gallons of gasoline, or growing 23,354 tree seedlings for 10 years. Although the study did not account for greenhouse gases associated with whatever food replaced that meat, no food makes gas like beef, so there’s no doubt the planet came out ahead.

They also calculated that the less-meat, better-meat program saved the four hospitals $21,080 per month in costs even after including increased purchases of fish and vegetable sources of protein. My calculator suggests that’s $252,960 per year.

What about the patients? No complaints there, only anecdotal reports of compliments. Plus changing the meat-heavy U.S. diet could help combat rising rates of diabetes, obesity, and some cancers. According to Department of Agriculture statistics, the U.S. food supply contains 58% more red meat and chicken (8.7 ounces per person per day) than is called for in dietary guidelines that cover meat, poultry, nuts, beans, and eggs (5.5 ounces per person per day).

One of the lessons learned in the pilot study, the investigators noted, is that hospitals should involve clinicians early in the process of menu development. If you’re a clinician who is looking for one small, achievable Earth Day action that could make a big difference, consider showing this study to your hospital team. They (and the planet) may thank you.

–Sherry Boschert (@sherryboschert on Twitter)
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It’s Not Easy Being Clean

Photo courtesy of Flickr Creative Commons user Moria

Some of the rules seem simple. To prevent health care–associated (formerly called “nosocomial”) infections, hospital staff should wash their hands, use gloves and gowns, and disinfect the patients’ physical environment. But as I learned last week in Atlanta at the Fifth Decennial International Conference on Healthcare-Associated Infections, it takes far more than that.

About 1 in 20 patients in U.S. hospitals develop a health care–associated infection (HAI), leading to 99,000 deaths at a cost of up to $33 billion annually, numbers that Dr. Thomas R. Frieden, chief of the Centers for Disease Control and Prevention, deemed “unacceptable” in his opening remarks at the conference.

Dr. Frieden outlined the U.S. Health and Human Services’ Action Plan, launched in June 2009, which establishes measurable national goals for reducing HAIs. Five-year targets range from 25% reductions in methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and surgical site infections to 50% reduction in all bloodstream infections to 100% adherence to central-line insertion practices.

“What is acceptable? Changing the norm so HAIs are viewed as preventable events,” he said.

The trick is finding exactly what works and successfully implementing those measures. A big debate in the field is whether universal MRSA screening and surveillance of hospital patients is necessary to prevent that organism’s spread. The practice is common in Europe and has been mandated in at least one U.S. state, Illinois.

However, in a study conducted at Virginia Commonwealth University, Richmond, “conventional” infection control measures including hand hygiene, chlorhexidine bathing of ICU patients, and use of central line and “ventilator bundles” resulted in significant reductions in device-related MRSA rates without the need for screening. But other studies suggest universal screening may be necessary to meet infection control targets.

Meantime, as many efforts to reduce MRSA have been successful over the last decade, a study of 28 community hospitals in the Southeastern United States found that Clostridium difficile has now surpassed MRSA in prevalence.

Another seemingly simple infection control measure—vaccinating all hospital employees against influenza—evidently requires a mandate to actually happen. Two studies presented at the conference—one from Nashville-based Hospital Corporation of America, the other from Children’s Mercy Hospital of Kansas City—found that nearly 100% compliance could be achieved only after requiring employees to receive flu vaccine with very limited opportunity for exemption.

I asked renowned infectious disease expert Dr. William Schaffner of Vanderbilt University, Nashville, Tenn., whether he believes that HAIs can ever be reduced to zero. Realistically, he said, they will never be completely eliminated because patients today are more frail and immunocompromised and because current treatments are “more elaborate, invasive, and compromising of the immune system.”

But, he does believe HAIs can be dramatically reduced: “The adoption of checklists and many of the research findings presented at the Decennial meeting will enable us to cut the frequency of [HAIs] at least in half over the next decade. In addition, we will collaborate with our partners around the globe to extend those benefits worldwide.”

–Miriam E. Tucker (@MiriamETucker on Twitter)

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Why The Limp Sales?

After years of go-go growth, it appears that the market for erectile dysfunction drugs in the U.S. and overseas is flat.

Courtesy Flickr user fhwrdh

That’s according to Eli Lilly, which told investors this morning that the global market for ED drugs grew just 1% over the first 9 months of this year. Will this market shrinkage cause primary care doctors to find themselves in the crosshairs of promotion?

Lilly crowed that its Cialis (tadalafil), dubbed “le weekend” by randy Frenchmen because of its reputed 36-hour effect, had 4% sales growth overall (17% in the U.S.).  Some $1.1 billion worth was sold from January to October — nothing to sneeze at, but not a blockbuster like Zyprexa, which had $3.5 billion in sales over the same period.

Cialis has edged ahead of Pfizer’s Viagra (sildenafil) among prescribing urologists in the U.S., the company said. But it has a tougher sell with primary care physicians, who write for Viagra for about 55% of prescriptions.

Bayer’s Levitra (vardenafil) is a distant third.

But overall, in the U.S. and Europe, even Lilly’s own charts show a straight, flat line of sales growth for these drugs.

Meanwhile, in the U.S. at least, ED drugs continue to be promoted like flat screen TVs on Black Friday.  According to a recent report from the Congressional Budget Office, ED drugs were the most heavily promoted class to consumers in 2008.  The three ED manufacturers spent $350 million on television, print, and Internet efforts. Another $175 million was spent promoting the drugs to physicians.

Only those ubiquitous Sally Field ads for Boniva and promos for other osteoporosis ads came close, clocking in at about $250 million in direct-to-consumer spending and $250 million on physician promotions.

So what’s with the slowdown in the ED market? Are there no more men (and their partners) out there who could benefit from these drugs?

Lilly may have an answer for that. According to its presentation, the company is making inroads in China.

How do you say “le weekend” in Mandarin?

— Alicia Ault (on Twitter @aliciaault)

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To Cut or Not to Cut

from the American Academy of Pediatrics National Conference and Exhibition in Washington, D.C.

Photo by K. Wachter

Photo by K. Wachter

We had protesters today here at the AAP meeting.  Three of them.  They were urging pediatricians not to perform circumcisions, likening the procedure to torture.  Given my gender (that’s Ms. Wachter, thank you very much) and my lack of male offspring, it’s not a subject that I had ever given much thought. 

So I did a little research.  Both AAP and the American Academy of Family Physicians seem to take the path of least resistance: the potential health benefits of circumcision–reduced rates of STDs and urinary tract infections, prevention of certain penile problems, and reduced risk of penile cancer–are not sufficient to recommend routine circumcision.  Instead, parents should make this decision in light of available information and cultural/religious considerations. 

Opponents of circumcision argue that the procedure inflicts unnecessary pain on newborn boys and may result in surgical complications.  And then there’s the sexual pleasure argument.  Purportedly, uncircumcised men enjoy greater sexual sensation than their clipped comrades.  At a purely scientific level, a more definitive answer would require studying men who have experienced both conditions.  A quick search on PubMed confirmed my suspicion that this sample size is fairly small.  But I defer to the medical professionals–yea or nay on circumcision?

—Kerri Wachter, @knwachter on Twitter

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It’s a Guy Thing

from Internal Medicine 2009, the annual meeting of the American College of Physicians in Philadelphia

When the first two prospective, controlled studies to ever examine whether prostate cancer screening saves men’s lives came out in late March, and showed in one case that screening did not produce any survival benefit, and in the second case that the benefit was absurdly small, you could almost hear the collective, testosterone-laced sigh of relief.

Prostate cancer may be a scary prospect for men, but the various treatment alternatives stoke their own terror with their significant risk for causing urinary incontinence, fecal incontinence, and impotence.

The findings from these two major studies dramatically shook the prostate landscape. “Based on the information we have now, I think that prostate cancer is an investigational disease for which we don’t have the right answer of how to treat,” Dr. Marc B. Garnick said during a session on the topic.

Dr. Marc B. Garnick/photo Mitchel Zoler

Dr. Marc B. Garnick/photo Mitchel Zoler

Dr. Garnick, a medical oncologist who has spent his career studying prostate cancer, and a professor at Harvard and Beth Israel Deaconess Medical Center in Boston, recommended that men who continued to get their prostate specific antigen (PSA) level tested and find it rising and eventually receive a cancer diagnosis seriously consider the active surveillance approach. This strategy is designed for men with PSA levels of 10 ng/mL or less, a moderate Gleason score of 6 or less, and an early tumor stage of T2a or less–criteria that apply to about half of newly diagnosed prostate cancers, and defers treatment in favor of frequent surveillance. He also stressed that physicians need to clearly spell out to men the pros and cons of prostate-cancer screening (and of treatment when applicable) and let each patient decide for himself what course to follow.

Postate cancer screening and treatment are issues that strike home for men. It was why, in the waning hours of the meeting, on a balmy, late-Saturday afternoon Dr. Garnick’s talk was full of upper-middle aged men (and a few women) who hung on his words. Not many other medical topics elicit the “What would you do?” question. When one guy posed it during Q&A, Dr. Garnick replied that he wouldn’t get his PSA tested.

Then there was another fellow who came to the mic to pose the case of a 78-year old with a moderately rising PSA and some other medical issues. Is he even a candidate for a biopsy, another prostate procedure with a substantial risk for adverse effects? After hearing several medical details about this older man, Dr. Garnick said in his opinion even a biopsy wasn’t needed. “My father thanks you,” replied the physician at the mic.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Get Rrrrready to Rumble!

From the Second Annual Joint Surgical Advocacy Conference, Washington, DC

It’s increasingly obvious that a line in the sand is being drawn, and we’re not talking about one in the desert.  Primary care physicians and specialists appear to be headed for a smackdown, aided and abetted by a Congress that’s going to have to figure out how to fund health care reform and also avoid the statutory 21% cut in Medicare physician fees coming later this year.  

From Flickr Creative Commons user EdBob

From Flickr Creative Commons user EdBob

Chest-beating was on vivid display at the Second Annual Joint Surgical Advocacy Conference earlier this week.  Eighteen specialty groups — from neurosurgeons to ophthalmologists to urologists to plastic surgeons to thoracic surgeons — banded together to hear rousing speeches from congressional allies and then to hop on buses to take their message directly to Capitol Hill.  Last year, there were only a handful of sponsors at the first annual conference. 

They’ve got reason to be worried.  From the Medicare Payment Assessment Commission to many Democratic congressional leaders, there has been a growing drumbeat of support for a redistribution of federal and private monies to prop up primary care, which is relatively underpaid — relative to specialty medicine, that is.

The specialists made it clear that they don’t want to open up their wallets to subsidize primary care. 

Rep. Roy Blunt (R-Mo.) stoked the specialists’ fire by asserting that no foreigner comes to America in search of primary care — rather, they’re looking for top-notch specialty services, he said.  He promised to protect specialists’ interests in his role as head of the Republican task force on health reform.

During question and answer sessions, more than one audience member chimed in that the primary care support should not come out of specialists’ hides.

A day later, specialists and primary care docs were going head to head during a House Energy & Commerce Health Subcommittee hearing.  The fun has just begun. 

– Alicia Ault
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Growth Hormone No Fountain of Youth

From the UCSF Diabetes Update and Advances in Endocrinology and Metabolism meeting, San Francisco

Image courtesy of Whole Wheat Toast under a Creative Commons license.

Image courtesy of Whole Wheat Toast under a Creative Commons license.

Lots of people assume that some bulked-up athletes or actors like Sly Stallone may be taking human growth hormone (HGH), but your grampa too? Illegal use of HGH as a longevity elixir in anti-aging clinics may be the most common use of HGH in the United States, Dr. Andrew R. Hoffman says.

Problem is, that while there’s no evidence it benefits normal elderly people, there is some evidence it can harm them, and let’s just say the cost could exceed most people’s now-depleted 401K funds.

The only legal use of HGH in adults is to treat growth hormone deficiency syndrome caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. In these patients, growth hormone use does seem to provide cardiovascular benefits, longer life, increased strength and exercise capacity, and improved quality of life, says Dr. Hoffman, who has received funds or owned stock in seven companies that market growth hormone products.

The whole craze for using it in normal elderly adults started with a 1990 study that has been cited in potentially misleading advertisements. Subsequent studies by the National Institutes of Health found that higher growth hormone levels are associated with shorter lifespans, not longer ones, and that increasing someone’s growth hormone levels can trigger insulin resistance  and may cause prostate cancer in men or breast cancer in premenopausal women, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University.

A 2007 review of randomized, controlled trials of HGH given to healthy elderly people found high rates of side effects and “absolutely no data in the elderly that suggests that there’s any significant clinical improvement by giving growth hormone,” he said.

—Sherry Boschert
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Filed under Cardiovascular Medicine, Endocrinology, Diabetes, and Metabolism, Family Medicine, Geriatric Medicine, Internal Medicine, Oncology, Uncategorized, Urology