Recently in Health care Category

By now, pretty much everyone has seen the June 19 videotape of Esmin Green, 49, dying on the waiting room floor of Brooklyn's Kings County psychiatric facility, aka G Building, while others―including security guards―saw the prostrate woman and did nothing. Until it was too late.

But reports of inhumane psychiatric care at Kings County Hospital (dubbed "Killer County" by online wags) are nothing new. A search of the NYT archives reveals that repeated and gross deficiencies in treatment existed there at least as far back as the 1960s. On a least 2 occasions, the facility lost its accreditation status, according to the paper. The remarkably dubious history of the public facility, culminating in Green's death, suggests that blame could go as high up as possible, arguably to city hall.

Last year, the Mental Hygiene Legal Service (MHLS) and the NY Civil Liberties Union, on behalf of patients, filed suit against the NYC Health and Hospital Corporation (HHC) and others, alleging that the Kings County facility is a "chamber of filth, decay, indifference, and danger where individuals...are subjected to overcrowded and squalid conditions often accompanied by physical abuse and punitive injections of mind-altering drugs." The plaintiffs cite lack of basic sanitation and laundry services, inadequate food, no wheelchair accessibility, vermin infestation, and neglect alternating with verbal or physical abuse from healthcare staff and security personnel.

The HHC, the largest city hospital and healthcare system in the United States, comprises more than a dozen hospitals, including Kings County, in the city's 5 boroughs. The HHC Chairperson, Charlynn Goins, along with HHC President and CEO, Alan D. Aviles, are named defendants in the lawsuit. Goins and Aviles, both lawyers, were appointed to their positions by Mayor Bloomberg in 2004 and 2005, respectively. Yesterday, Aviles provided a written statement to new sources on the death of Green: "We are shocked and distressed by this situation. It is clear that some of our employees failed to act based on our compassionate standards of care."

The suit also names the following defendants, at least 2 of whom are longstanding employees of Kings County:

• Jean G. Leon, RN, Executive Director, Kings County Hospital: Leon, a native of Trinidad, has evidently held her position for at least 13 years (see 2005's "10 years of inspired leadership"). A PR-type video on YouTube featuring Leon was posted April 2008.
• Kathie T. Rones, MD, MPH, Medical Director, Kings County Hospital: Rones, a 1980 graduate of the Brown University School of Medicine and a board-certified internist, has held her position since 1996. She received a tribute for her services from the NY House of Representatives on April 3, 2006.
• David K. Dailey, MD, Chief of Psychiatry, Kings County Hospital: According to the NY State Department of Health, Dailey is a 1981 graduate of the Loyola University Chicago, Stritch School of Medicine and has been licensed in the state since 1998.
• Joseph A. Charlot, MD, Comprehensive Psychiatric Emergency Program, Kings County Hospital: Charlot received his medical degree in 1968 from the State University of Haiti and has had a NY medical license since 1979.
• Ellen B. Tabor, MD, Medical Director, Adult Psychiatric Inpatient Services, Kings County Hospital: Tabor is a 1983 graduate of the Rush University School of Medicine in Chicago. She has held a NY medical license since 1990.
• Jacqueline Purser, Captain, Hospital Police
• Oswald David (or David Oswald), Assistant Director of Nursing/Product Line Manager, Comprehensive Psychiatric Emergency Program, Kings County Hospital
• Elsa P. Bush, Associate Executive Director of Nursing, Kings County Hospital

According to today's NYT, the hospital fired the director of psychiatry, the doctor on duty, and the director of security at Kings County on June 20, the day after Green died.  It is not clear if the "director of psychiatry" refers to Dailey, Charlot, Tabor, or someone else. According to Esmin Green's medical records, provided by the NYCLU, a "Dr. Estes" was on duty at the time of her death. Two nurses and one security guard were also "suspended pending union-mandated hearings."

The NY Daily News provides earlier coverage and more background on Esmin Green and Kings County:

June 27 "Shocking death on Kings County Hospital psych ward stirs reform call"

June 22 "Video shows staff ignored patient later found dead"

June 21 "Patient dies waiting for bed at Kings County Hospital"

June 21 "Video shows Brooklyn hospital staff ignore patient later found dead"

May 17 "US Attorney probes claims of patient abuse at Brooklyn psych ward"

In addition to a Federal investigation of civil rights violations at Kings County, the latest reports indicate that criminal charges are being considered in the case of Green's death.

07/03/08 update: The NY Daily News reports that Pierre R. Arty, MD, the head of psychiatry at Kings County, was 1 of 6 people fired after Esmin Green's death. The others included Kenneth Jones, the hospital's director of security, and the 2 security guards (not 1, as previously reported) seen in the waiting-room videotape.

Actually, maybe something. The Disease Management Care Blog ambushes us with a quiz, plus an extra-credit question.

P.S. Rhinoliquorrhea is CSF rhinorrhea.

It isn't. The former is a hat-trick recitation of known, memorizable numbers in sequence (albeit a very long sequence), with no practical purpose. The latter is an enduring health insurance program for the elderly, with budgetary problems and unknown solutions—other than more money. 

But AMA President Ronald Davis believes that one should follow the other. In an appealing-sounding, but really illogical, statement made at the annual meeting of the AMA house of delegates, Davis claimed, "If a person with autism can recite Pi to more than 22,000 digits, we ought to be able to...figure out how to get off the [Medicare] hamster wheel."* Cue: rousing applause accompanied by sprinkled thoughts of "huh?"

*On March 14, 2004, autistic savant Daniel Tammet recited Pi to 22,514 decimal places, breaking the European record. Davis's "hamster wheel" refers to cyclic Medicare cuts in physician reimbursement for services.

On the basis of criteria promoting the treatment of global diseases, GlaxoSmithKline and Novo Nordisk ranked highest according to a newly released index from the Access to Medicine Foundation. The foundation, which encourages pharma's role in the healthcare of third-world citizens, assessed the philanthropic activities of 20 of the world's largest drug companies.

The following table lists the 8 criteria used by the foundation, with examples of commendable policies or programs. Leaders and losers in each category are also provided. By holding up examples, the foundation hopes to 1) motivate lower-ranking companies to establish practices which promote healthcare in developing countries and 2) urge higher-ranking companies to maintain and expand their social responsibilities.

Assessment Criteria	Leading Examples	Leader	Loser
Access-to-medicine management	·     sanofi-aventis: Access to Medicine division within Corporate Affairs; separate from philanthropic activities, drug-donation programs ·     Pfizer: Global Health Fellows Program, in which employees volunteer for 4-6 months at nonprofits in developing world	Novo Nordisk	Teva
Public policy influence and advocacy	·     Eli Lilly: Grant Registry, with disclosure of cash grants to US organizations*	Eli Lilly	Teva
R&D reflecting global disease burden and neglected diseases	·     Dedicated neglected diseases divisions:  GSK, AZ, Novartis, Eli Lilly ·     Tropical-disease vaccine departments: GSK, Novartis, sanofi-aventis ·     Wyeth/WHO collaboration on treatment of onchocerciasis (river blindness)	GSK	Teva
Patents and licensing	·     GSK: licensing agreement with Apotex to produce Apo-Triavir for distribution in Rwanda ·     sanofi-aventis: with DNDi, development of fixed-dose artesunate/amodiaquine	GSK	Pfizer
Drug manufacturing, distribution, and capability advancement	·     Merck: Global Pharma Health Fund and Minilabs ·     Roche: Technology Transfer Initiative	Merck	Schering-Plough
Equitable pricing	·     GSK: "Tearing down the barriers" ·     Merck: tiered pricing policy for HIV drugs based on UN Human Development Index and adult HIV/AIDS prevalence ·     Novo Nordisk: "Base of the Pyramid" pricing initiatives for diabetes	GSK	Schering-Plough
Drug donations	·     Merck: donation of ivermectin (Mectizan) for treatment of onchocerciasis (river blindness)	GSK	Schering-Plough
Philanthropic activities	·     Abbott Lab: Tanzania Care ·     AZ: breast-cancer program with Axios in Ethiopia	Merck	Schering-Plough

HT: Pharmalot.

*As stated elsewhere, Lilly provides a highly itemized (and therefore, very difficult-to-synthesize) online registry report for each financial quarter of 2007.

Are pretty much the same.

1. Know exactly why you're going in.
2. Have an exit strategy (other than death, if possible).

Photo of Cook County Hospital originally from Paul Goyette at Flickr.

Image of Iraq from Wikimedia Commons.

If you're at a loss to understand the slogan of yesterday's anti-vaccination march on Washington, DC—led by Jenny McCarthy and Jim Carrey—you're not alone. The costar of Witless Protection* and the star of Horton Hears a Who! evidently want to promote "cleaner" vaccines (whatever that means—more bacteriocidal Thimerosal?). But what they really want to do is alter the current CDC-recommended schedule for vaccinating children...to God only knows what.

Orac dives into the mess and provides commentary.

*You know, the vehicle for Larry the Cable Guy.

Photo: Jenny McCarthy playing with garden hose in kiddie pool.

Executives at managed care companies anticipate fewer prescriptions for Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe) but no immediate changes in coverage for these medications. These conclusions are based on data generated by Cognet-X, a healthcare market research firm, after negative results from Merck's and Schering-Plough's overly scrutinized ENHANCE study were presented at the annual meeting of the American College of Cardiology in March.

According to a Cognet-X press release, more than 75% of pharmacy and medical executives surveyed earlier this month expect prescriptions to shift from Vytorin to generic simvastatin and, to a lesser extent, AstraZeneca's Crestor (rosuvastatin) and Pfizer's Lipitor (atorvastatin). But approximately two thirds expect few changes in coverage for Vytorin or Zetia because of formulary rules already in place, like tier placement and step therapy.

The NIH's National Institute of Child Health and Human Development is offering a calculator to estimate the outcomes for very preterm infants, reports the NYT. The calculated outcomes are based on gestational age (22-25 weeks), birth weight (401-1000 g), sex (girls inexplicably fare better than boys), singleton or multiple birth status, and the mother's receipt of antenatal corticosteroids within 7 days of delivery (to boost infant-lung development). Outcomes are provided for all infants and those who receive mechanical ventilation and include chances of survival with various grades of anticipated neurologic impairment.

The calculator is based on a study of nearly 4500 very preterm infants at a network of hospitals and is intended to aid the decisions of healthcare workers and families regarding levels of care.

The question is raised by the government's recent decision to award compensation to the family of Hannah Poling, who experienced autistic symptoms after a concentrated series of vaccinations at the age of 19 months. The simple answer is the National Vaccine Injury Compensation Program (VICP), a no-fault federal program established in 1988 by the National Childhood Vaccine Injury Act of 1986. Poling's case is evidently the first petitioned case of autism to receive compensation from the VICP since the program's inception.*

According to the VICP web site, the program—which is overseen by the Health Resources and Services Administration (HRSA)—was created "to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines." Compensation for petitioned cases is decided by the US Court of Federal Claims, and awards are taken from the VICP Trust Fund. But how is the trust fund funded?

Here's a bit more explanation: The VICP trust fund, which is managed by the Department of Treasury, is supplied by a 75-cent excise tax on each dose of purchased vaccine, depending on the number of diseases that vaccine prevents. For instance, the tax on a polio vaccine is 75 cents; the tax on a DPT vaccine is $2.25 (75 cents each for diphtheria, pertussis, and tetanus). The covered vaccines and related injuries are listed here and here, and the public- and private-sector vaccine costs^† are provided by the CDC. According to the January 2008 compensation report at the Treasury web site, the fund holds nearly $2.7 billion.

The VICP web site also provides the number of petitions filed and adjudications. Since 1998, 5280 of 8127 (65%) petitions have claimed vaccine-related autism. Two thirds of autism-related petitions were submitted during 2003 and 2004; this petition spike may be related to the heated public attention directed at the proposed (but unproven) link between autism and the vaccine preservative thiomersal. To date, 354 autism claims have been dismissed, and 1165 of 2113 (55%) of the non-autism claims have been dismissed. According to the VICP, "On average, it takes 2-3 years to adjudicate a petition/claim after it is filed." Clearly the backlog for adjudicated autism claims is substantially greater than that for non-autism claims.

The following bar graph, created with data from the VICP web site, shows the petitioner's average award per compensated claim by year, from 2000 to the present. The awards do not include attorneys' fees and costs (which can also be found at the web site, along with the attorneys' fees and costs for dismissed claims). The average award per compensated claim since 2000 is approximately $900,000; the average attorney fee/cost per compensated claim is approximately $40,000.

*In a March 3^rd press release, the HRSA stated that it "found no credible evidence to support the claim" that vaccination causes autism and "has never concluded in any case that autism was caused by vaccination." The HRSA further states that it will elaborate on its views at an 'omnibus' autism proceeding in May.

†It is unclear if the public-sector vaccine costs include excise taxes. The CDC did not respond to an inquiry at the time of this post.

On Friday, the WSJ reported that Merck agreed to pay out more than $650 million in its settlement of two qui tam (ie, “whistleblower”) lawsuits. In the suits, Merck allegedly used a historically exploited exception to the 1990 Medicaid Drug Rebate Program, which otherwise requires drug makers to report the lowest prices they charge to any entity not excepted by the law. The law’s exception—originally intended to foster deep drug discounts to charities and certain state-run facilities—specified that drug discounts of 90% or more (ie, "nominal prices") do not have to be disclosed to the government or included in the seller's best-price calculation for Medicaid reimbursement.

 

The qui tam lawsuits were specifically directed at the widespread practice of loosely applied nominal pricing, in which drug companies offered extreme medication discounts to health care facilities in exchange for formulary preference, and thus a sizeable market share for the drug. According to a 2003 report by the WSJ, the suit brought by qui tam relator and New Orleans geriatrician William LaCorte, MD, alleged that, from 1996 to 2001, Merck sold each tablet of then-prescription famotidine (Pepcid) to some New Orleans hospitals for $0.10, while charging Medicaid approximately $1.65 per tablet.

 

In its February 7 press release, Merck acknowledged the settlement, while asserting that it did not constitute an admission of guilt. The company also clarified that it believed "its pricing and sales and marketing policies and practices were consistent with all applicable regulations and contracts during the relevant time." The company also claims that it "voluntarily began to put in place substantial compliance initiatives in 2001," which raises the question If Merck’s pricing practices were consistent before 2001, why did it have to initiate compliance initiatives in 2001?

 

A December 2006 clarification of nominal pricing is provided in a DHHS document to state Medicaid directors, which defines nominal prices as those offered to 1) a covered entity described in section 340B(a)(4) of the Public Health Service Act; 2) intermediate-care facilities for the mentally retarded, and (3) state-owned or -operated nursing facilities. The document further clarifies that "[n]ominal sales to other entities must be included in the drugmaker’s best price."