The week in review, August 5-11
MedWire News: This week's headlines included a boast about the economic benefits of generic drugs from the folks who make them, evidence for why it's a bad idea to put cosmetics on babies, progress and backsliding in tobacco control efforts, safety-net hospitals find their groove, a major drug company gets taken to the woodshed, and the American College of Physicians (ACP) takes government interference to heart.
Generically good news
Generic drugs saved US consumers $ 1 trillion-plus from 2002 through 2011, a study asserts.
By substituting Brand X drugs for name brands, the US healthcare system saves about $ 500 million daily, according to an independent study commissioned by the Generic Pharmaceutical Association, a Washington, DC-based trade group.
The Generic Drug Savings Study, conducted by the IMS Institute of Healthcare Informatics, shows that savings from generic substitutions in 2011 were $ 192.8 billion, a 22% increase from 2010.
The report cites a recent study from the National Health Expenditure Account of the Centers for Medicare and Medicaid Services, showing that the growth in drug spending is slowing, and attributing the slowdown to increasing use of generics.
More than half (57%) of the annual savings comes from increasing use of generic cardiovascular drugs and central nervous systems agents, including antidepressants and anticonvulsants.
The IMS analysis also found that of the 4 billion prescriptions written in the USA in 2011, nearly 80% were for generic drugs.
Folk remedy cosmetic does more harm than good
A 6-month old boy of Nigerian descent was found on a well-child visit to Boston Children's Hospital to have blood lead levels of 13 µg/dL, more than double the current reference value of 5 µg/dL as established by the Centers for Disease Control and Prevention (CDC).
After ruling out food and environmental sources of lead exposure, investigators from the hospital and the CDC's National Center for Environmental Health (NCEH) traced the source of the poisoning to a Nigerian cosmetic that had been applied to the child's eyelids three or four times each week since the age of 2 weeks. The product, known as "tiro" in the Yoruba language of Nigeria, was found to be composed of 82.6% lead.
"A single application of 10 mg of tiro would deliver 8 mg of lead to the infant's eyelids. The most likely routes of exposure were eyelid-hand-mouth and absorption from the conjunctival surfaces of the eyes or in ingested tears," write Behrooz Behbod (NCEH, Atlanta, Georgia) and colleagues in Morbidity and Mortality Weekly Report (MMWR).
Despite the high lead levels, the child appeared to be growing well, and had met all developmental milestones. At a visit 3 months after the parents stopped painting the boy's eyelids with the toxic compound, his blood lead level had decreased to 8 µg/dL.
Cigars and pipe tobacco the new 'coffin nails'
Although cigarette smoking in the USA declined by one third over the past decade, consumption of cigars and pipe tobacco soared, possibly because of tax changes, study results show.
By looking at tobacco taxes as a marker of consumption, investigators from the CDC estimate that from 2000 to 2011, total consumption of all combustible tobacco products - rolled and loose - declined from 450.7 billion cigarette equivalents to 326.6 billion, a decrease of 27.5%. Over the same period, per capita consumption fell from 2148 cigarette equivalents annually to 1374, a decrease of 36.0%.
But while cigarette-only consumption waned by 32.8% over the study period, use of loose tobacco and cigars increased by a whopping 123.1%. Those latter forms of tobacco accounted for 10.4% of all combustible tobacco consumption in 2011, compared with 3.4% in 2011.
"The data suggest that certain smokers have switched from cigarettes to other combustible tobacco products, most notably since a 2009 increase in the federal tobacco excise tax that created tax disparities between product types," write Michael Tynan (Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Atlanta, Georgia) and colleagues in MMWR.
Safety-net hospitals clean up their act
Safety-net hospitals in some US communities are starting to catch on to the advantages of coordinated care, a new study suggests.
The analysis of 12 US communities shows that safety-net hospitals - the institutions of last resort for the poor and uninsured - are increasingly taking advantage of centralized referral networks, managed care programs, and care coordination among many different providers, report Peter Cunningham (Center for Studying Health System Change, Washington, DC) and colleagues.
The authors, writing in Health Affairs, say that care in safety-net hospitals has traditionally been subpar.
As part of the Community Tracking Study, the investigators looked at health system changes in 12 randomly selected US communities from 1996 through 2010. They found that "efforts to enhance coordination and collaboration among safety-net providers have increased substantially during the past decade. Nine of the twelve communities we studied had some type of organized safety-net program in 2010, compared with only three communities in 2000."
Additionally, whereas none of the communities had a centralized referral network in 1996, four had them in 2010. The networks vary in design, but consist of a central clearinghouse where patients can get referrals and schedule appointments with physicians - primarily specialists, who agree to treat uninsured patients for free or at a discount.
Furthermore, uninsured patients were enrolled in managed care programs in two of the communities (Boston and Indianapolis) in 1996; by 2010, Cleveland had also embarked on a managed care plan for the uninsured.
Pfizer gets spanked
The US Securities and Exchange Commission (SEC) and Department of Justice have slapped Pfizer Inc. with a total of $ 60 million in fines for violating the Foreign Corrupt Practices Act (FCPA).
"The SEC alleges that employees and agents of Pfizer's subsidiaries in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia made improper payments to foreign officials to obtain regulatory and formulary approvals, sales, and increased prescriptions for the company's pharmaceutical products. They tried to conceal the bribery by improperly recording the transactions in accounting records as legitimate expenses for promotional activities, marketing, training, travel and entertainment, clinical trials, freight, conferences, and advertising," says a press statement issued by the agency.
Wyeth LLC, now owned by Pfizer, was also charged with FCPA violations; the combined settlements add up to $ 45 million, plus a $ 15 million penalty imposed on Pfizer by the Department of Justice to defray the costs of investigations.
ACP tells government to back off
The American College of Physicians (ACP) has called for a more hands-off approach to government regulation of the physician-patient relationship.
The College has issued a statement outlining the principles it believes should underpin such regulation, placing a greater emphasis on the ethical responsibilities to the patient and freedom for doctors to treat patients according to best practice.
Recently passed and proposed laws at the state level threaten to undermine evidence-based clinical practice and tamper with the patient-physician relationship, according to authors Jack Ginsburg and Lois Snyder, writing on behalf of the Health and Public Policy Committee of the ACP.
The ACP statement highlights the responsibility of all healthcare providers to support the patient-physician relationship and to recognize the ethical obligations of physicians towards their patients. It also stresses that legislation should not mandate the provision or withholding of information or care in a way that goes against the physician's clinical judgment and clinical evidence. In addition, it observes that medical evidence evolves over time and both clinical practice and legislation must change to reflect this.
By Neil Osterweil, MedWire reporter