MANHATTAN (CN) - In a federal antitrust complaint, a competitor claims that Davita, the second-largest provider of dialysis in the United States, is monopolizing the industry through "exclusive, long-term, illegal, or predatory contracts" with doctors, drug companies and managed-care companies.
     IHS Dialysis, which operates in New York City and Massachusetts, claims that Davita has monopolized, or tried to monopolize, the market for dialysis since 2007.
     IHS claims Davita has done this by "(a) entering into exclusive, long-term, illegal, or predatory contracts or agreements with nephrologists and other referral sources or other these [sic] referrals to lock-up a significant number of patient referrals on a long-term basis; (b) entering into exclusive, long-term, illegal or predatory contracts or agreements with managed care companies to lock-up a significant numbers of covered lives on a long-term basis; (c) entering into exclusive, long-term, illegal or predatory agreements with pharmaceutical companies to give them needed pharmaceutical products at extremely favorable, and, in some cases, predatory pricing that is not available to HIS Dialysis or other competing outpatient dialysis services providers; ... and (e) engaging in inappropriate and predatory business conduct designed to prevent the potential new entrants to gain any foothold in the market."
     IHS claims DaVita violated antitrust laws by preventing it from establishing dialysis clinics in the Bronx, Manhattan, Queens and Westchester, N.Y., and in Quincy, South Shore and south Boston, Mass.
     IHS, based in Boca Raton, Florida, claims that "there are ... significant barriers to entry in these markets, the most significant of which is locating a nephrologist with an established referral base to serve as the facility's medical director."
     According to the complaint, "In order to achieve or maintain their market, or in some cases, monopoly power in various local outpatient dialysis services markets throughout the country - including the markets in which IHS competes or currently is in the process of planning for or opening facilities - DaVita has entered into exclusive, long-term, illegal, or predatory contracts or agreements with nephrologists and other referral sources ... to lock-up a significant number of patient referrals on a long-term basis."
     IHS claims DaVita has entered into similar predatory contracts with managed care companies, which "typically provide coverage for the first 33 months of a ... patient's course of outpatient dialysis treatment at rates significantly higher than those provided by the Medicare and Medicaid program," leaving IHS with no foothold in the market.
     IHS claims that pharmaceutical companies make with DaVita "at extremely favorable and, in some cases, predatory pricing that is not available to IHS or other competing outpatient dialysis service providers."
     And it claims that finding places from which to operate its dialysis clinics is difficult because "DaVita has inappropriately and without legitimate business justification warehoused space and licenses so as to prevent other potential competitors from entering the local market."
     HIS claims that DaVita, whose profits exceeded $7.63 billion in 2010, is being investigated for antitrust violations and "is currently the subject of three pending federal law enforcement agency investigations into inappropriate and potentially illegal practices in connection with their physician contracting practices."
     IHS wants Davita enjoined from its allegedly predatory practices.
     It is represented by Roy Breitenbach, with Garfunkel Wild, of Great Neck.

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Published: April 04, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

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SAN DIEGO -- Patients with Clostridium difficile infection and underlying impaired renal function who were treated with fidaxomicin fared better than those given vancomycin, a researcher said here.

Patients with toxin-positive C. difficile infection and creatinine clearance below normal (90 mL/min/1.73 m²) were half as likely to experience a recurrence of diarrhea if treated with fidaxomicin (OR 0.46, 95% CI 0.32 to 0.66, P<0.001), reported Kate Mullane, MD, of the University of Chicago.

In addition, patients with moderate to severe renal impairment who received fidaxomicin (Dificid) had almost twice the likelihood of experiencing a 4-week sustained response compared with those given vancomycin (OR 1.89, 95% CI 1.41 to 2.53, P<0.001), Mullane reported at the annual meeting of the Society of Hospital Medicine.

Fidaxomicin and vancomycin are similar drugs, in that they are non-absorbable antibiotics, and they usually have similar initial response rates, she explained.

"However, patients with renal impairment are more immunocompromised and often are unable to fully clear infections and maintain a sustained response," Mullane told MedPage Today in a poster session.

To determine the effects of the drug in this population of patients, she and her colleagues analyzed data from two randomized trials comparing 400 mg per day of fidaxomicin with 500 mg per day of vancomycin for 10 days.

Of 1,031 patients in the two studies, 27% had mild impaired renal function, 21% had moderate impairment, and in 9% the impairment was severe.

Overall cure rates were 91% for patients with normal renal function and 92% for those with mild impairment, but decreased to 80% for those with moderate impairment and 74% for those with severe impairment.

Mortality in both treatment groups also was greater with increasing degree of renal dysfunction, rising from 2.9% with normal creatinine clearance to 17.4% for severe impairment (P <0.001 for trend).

Following initial cure, the overall recurrence rates increased from 16% with normal renal function to 25% with severe dysfunction.

However, the absolute difference in recurrence rates differed between the treatment groups at 21% with vancomycin and 11% with fidaxomicin among those with normal renal function, and 35% versus 15% for severe dysfunction in the vancomycin and fidaxomicin groups, respectively.

On multivariate analyses, having moderate to severe renal impairment was associated with recurrence (OR 1.80, 95% CI 1.80 to 2.98, P=0.024) and inversely associated with sustained response (OR 0.51, 95% CI 0.34 to 0.77, P=0.001).

An important factor contributing to the superiority of fidaxomicin in this patient group is its greater selectivity for C. difficile, according to Mullane.

"This treatment allows the gut microbiota to repopulate, which contributes to the sustained response," she said.

In addition, spore counts are reduced and there is less toxin production, she noted.

The study was supported by Optimer Pharmaceuticals. One investigator is an employee of the company.

Primary source:Society of Hospital Medicine
Source reference:
Mullane K, et al "Renal impairment and responses to fidaxomicin versus vancomycin in patients with Clostridium difficile Infection" SHM 2012; Abstract 86.

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Choosing Wisely®campaign improves care by targeting wasteful interventions

Newswise — Washington, DC (April 4, 2012) —The American Society of Nephrology (ASN), the world’s leading kidney organization, joins the American Board of Internal Medicine (ABIM) Foundation, eight other leading national medical specialty societies, and Consumer Reports in the new Choosing Wisely® campaign that helps health care professionals and patients avoid wasteful and sometimes harmful medical interventions. Unnecessary or redundant tests and procedures account for nearly one third of the medical care delivered in the United States.

ASN President Ronald J. Falk, MD, FASN said, “ASN is honored to participate in ABIM Foundation’s Choosing Wisely campaign. ASN and its nearly 14,000 members work daily to cure kidney disease.”

Each Choosing Wisely partner created lists of five common, but not always necessary, tests or procedures in their fields that patients and physicians should question and discuss. “In developing its list, ASN focused on aligning patient care with evidence-based medicine,” said Dr. Falk. “ASN’s list and the Choosing Wisely campaign emphasize the critical partnership of patients, families and kidney professionals in providing optimal patient care,” he added.

The following make up the “Five Things” list developed by ASN:

1. Routine cancer screening—including mammography, colonoscopy, PSA testing, and Pap smears—of dialysis patients who have limited life expectancies and no signs or symptoms of cancer is not cost effective and does not improve survival in these patients.

2. Administering erythropoiesis-stimulating agents—drugs that are commonly used to prevent anemia—to chronic kidney disease patients who do not experience symptoms of anemia, even if they have low levels (

3. Non-Steroidal Anti-Inflammatory Drug (NSAID) use in individuals with high blood pressure, heart failure, or chronic kidney disease can raise blood pressure, make antihypertensive drugs less effective, cause fluid retention, and worsen kidney function. Other medications such as acetaminophen, tramadol, or short-term narcotic pain relievers may be better options for these patients.

4. Using a peripherally inserted central catheter (PICC)—which allows access to the blood for prolonged treatments such as long chemotherapy regimens and extended antibiotic therapy—should not be done in patients with stage III to V chronic kidney disease before consulting a kidney specialist. A PICC is typically inserted into a vein in the upper arm and advanced until its tip reaches a large vein in the chest near the heart. In some cases, it can cause blood vessel complications that destroy the potential to most effectively access patients’ blood for dialysis.

5. Long-term dialysis should not be started without ensuring that kidney disease patients, their families, and their physicians all participate in the decision to do so. Patients should express their individual goals and preferences and have full knowledge of their prognosis and the expected benefits and harms of dialysis.

Dr. Falk noted that millions worldwide have kidney disease. “Improving outcomes for these patients requires early involvement of kidney professionals. ASN and its members are committed to treating pain and other medical conditions in ways tailored to the needs of patients and their families. ASN commends ABIM Foundation’s efforts to align patient and professional interests with the best medical outcomes.”

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How ASN’s list was developed: ASN maintains a Quality and Patient Safety (QPS) task force, chaired by Amy W. Williams, MD. This task force advances ASN’s commitment to providing high-quality care to patients and to raising awareness of patient safety issues for all professionals administering care to kidney patients. Each of ASN’s 10 advisory groups contributed expertise to the task force to ensure it addresses all areas of nephrology practice, and the society’s president, public policy board and council also provided insights. The QPS task force centered its focus on five items most likely to positively impact and influence optimal patient care. The final list of five items was unanimously approved by the ASN public policy board and council. For complete detail on ASN’s work on the Choosing Wisely campaign, and future updates, go to www.asn-online.org/choosingwisely. ASN’s disclosure and conflict of interest policy can be found at www.asn-online.org.

In addition to offering various lists of “Five Things Physicians and Patients Should Question,” the ABIM Foundation and its partners will develop tools to help physicians discuss these issues with their patients.

Joining ASN and the ABIM Foundation in Choosing Wisely are:

• American Academy of Allergy, Asthma & Immunology
• American Academy of Family Physicians
• American College of Cardiology
• American College of Physicians
• American College of Radiology
• American Gastroenterological Association
• American Society of Clinical Oncology
• American Society of Nuclear Cardiology
• Consumer Reports

About the American Society of Nephrology: Founded in 1966, and with more than 13,500 members, the American Society of Nephrology (ASN) leads the fight against kidney disease by educating health professionals, sharing new knowledge, advancing research, and advocating the highest quality care for patients

To learn more about Choosing Wisely, visit www.ChoosingWisely.org

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The nine organizations that are part of the “Choosing Wisely’’ campaign - American Academy of Allergy, Asthma & Immunology, American Academy of Family Physicians, American College of Cardiology, American College of Physicians, American College of Radiology, American Gastroenterological Association, American Society of Clinical Oncology, American Society of Nephrology, and American Society of Nuclear Cardiology - each reviewed medical evidence over months and settled on a list of five tests and procedures that are often overused.

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