Wednesday, July 18, 2012

FDA Bans BPA From Baby Bottles, Sippy Cups

HealthDay – 2 hrs 1 min ago TUESDAY, July 17 (HealthDay News) -- The controversial plastics chemical bisphenol A (BPA) is now banned for use in baby bottles and sippy cups, the U.S. Food and Drug Administration announced Tuesday.

The move was prompted by a request in October from the American Chemistry Council, which represents industry, as a way to clarify for consumers that BPA will not be found in these items.

BPA has a checkered history, with many consumer advocate groups pointing to studies suggesting the chemical might disrupt hormones and trigger a host of unhealthy changes in children and adults, including cancer, obesity and developmental/reproductive problems.

In its ruling, the FDA said that, effective Tuesday, it is now banning BPA-containing resins in "infant feeding bottles

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U.S. Doctors Embracing Electronic Health Records: Survey

HealthDay – 2 hrs 1 min ago TUESDAY, July 17 (HealthDay News) -- A majority of U.S. physicians have now adopted an electronic health record system as part of their routine practice, a new national survey reveals.

The finding is based on responses provided by nearly 3,200 doctors across the country who completed a mail-in survey in 2011. The survey was conducted by the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics as part of an ongoing three-year effort (continuing through 2013) designed to assess perceptions and practices regarding electronic health record systems.

Specifically, the poll found that 55 percent of U.S. doctors have embraced some type of electronic health record system. And roughly 75 percent of those who have done so reported that the type of system they took on meets the criteria of playing a "meaningful" role in their practice, according to the terms of 2009 federal legislation (entitled the Health Information Technology for Economic and Clinical Health Act) designed to promote the use of electronic health records.

What's more, 85 percent of those doctors who now have an electronic health record system in place said they are either "somewhat" or "very" satisfied with its day-to-day operations (47 percent and 38 percent, respectively). And three in four said patient care has improved as a result of electronic health record adoption.

The poll also indicated that among those who have yet to embrace an electronic health record system, almost half said they plan to do so in the coming year.

Physician age seems to have played a role in how likely a doctor was to have already brought an electronic health record system into their practice, the findings showed. While 64 percent of those under the age of 50 have done so, the poll revealed that the same was true of only 49 percent among those aged 50 and older.

Office size also seems to matter, with larger physician practices being more likely to have incorporated an electronic health record system into their administrative infrastructure. Specifically, 86 percent of offices with 11 or more physicians on site had taken on such a system, compared with roughly 60 percent to 62 percent of those with two to 10 physicians and just under 30 percent of single-doctor practices.

But although some kinds of specialists (such as surgeons) were somewhat less likely to have implemented an electronic health record system, race, gender and physician location did not seem to play a role in the likelihood that a doctor's office would or would not bring the technology into their workplace.

Eric Jamoom, of the health care statistics division of the U.S. National Center for Health Statistics, and colleagues published their findings July 17 in the NCHS Data Brief.

More information

For more on electronic health records, visit the U.S. National Library of Medicine.



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Forest Labs profit plunges; Icahn renews his attack

Reuters – 1 hr 33 mins ago (Reuters) - Forest Laboratories Inc, which is bracing for a proxy fight with activist investor Carl Icahn, said on Tuesday quarterly earnings tumbled 79 percent as generic competition ate into sales of its antidepressant Lexapro.

But the company also said efforts to diversify its product portfolio were paying off, with its three newest drugs selling well. New drug sales as well as signs that two new products could be approved by year-end pushed the company's shares up 1.7 percent on Tuesday, an analyst said.

Forest, which also makes the Alzheimer's drug Namenda, said net earnings in the fiscal first quarter ended June 30 fell to $55.3 million, or 21 cents a share, from $258.14 million or 90 cents a sharer a year earlier.

Analysts were expecting 24 cents a share, according to Thomson Reuters I/B/E/S.

The results did nothing to placate Icahn, who launched another broadside against the company in the form of a public letter to the board. In it he defended his nominees against claims by Forest that Icahn's nominees have conflicts of interest.

"Perhaps in your zeal to preserve the status quo at Forest you have failed to recognize that a lack of alignment with management is not a conflict of interest."

A spokeswoman for Forest said she was not immediately able to comment but would do so as soon as possible.

Net sales fell 31.9 percent to $751.8 million, hurt by competition from cheaper generics for Lexapro, which lost patent protection in March. Total revenue fell to $821.1 million from $1.15 billion.

The company last month cut its forecast for the year, saying it expects earnings of 65 to 80 cents a share, which would represent a decline of about 80 percent from 2012.

Icahn, Forest's second-largest shareholder, is seeking four seats on Forest's board. The annual meeting is set for August 15. Icahn failed to get his nominees elected to the board in 2011, but warned that his failure last year should not make the board complacent.

"Forest has underperformed your self-chosen peer companies by 21 percent since last year's meeting," he said. "Given that underperformance, it wouldn't surprise me if many shareholders vote differently this time around."

NAMENDA SALES RISE

Net sales of Namenda rose 15.2 percent to $368.4 million, missing the consensus estimate of $388 million.

While sales of blood pressure drug Bystolic rose 38.2 percent to $107.8 million, sales of the older drug Lexapro fell to $110 million from $585.7 million.

The company launched two new products last August: Daliresp, a drug to reduce the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD), and Viibryd for depression. Daliresp posted sales of $17.8 million in the first quarter, and Viibryd had sales of $37.4 million.

"The new products are the bright side, in particular the growth of Bystolic and Viibryd," said Aaron (Ronny) Gal, an analyst at Sanford C. Bernstein. "These are very nice numbers in largely generic markets."

He noted that management's long-term compensation is tied to the growth of the recently launched products.

Sales of Teflaro, a broad-spectrum antibiotic to treat community-acquired bacterial pneumonia, generated sales of $9.4 million. Teflaro was launched in March 2011.

Howard Solomon, Forest's chief executive, said in a statement that the company has "deliberately and strategically" diversified its product portfolio so that it will not be dependent on any single product or therapeutic area.

"We are pleased with the performance this quarter of three of our most recent product launches, Teflaro, Daliresp and Viibryd," he said. "It is still early days for these products but they are performing well in line with our expectations."

The company said it expects to hear from the U.S. Food and Drug Administration in the coming weeks on the approval status of its drug aclidinium for the long-term maintenance treatment of COPD, and later this summer it expects to hear whether the agency will approve its drug linaclotide for the treatment of irritable bowel syndrome with constipation and chronic constipation.

Assuming approval for both products, the company expects to launch them during fiscal 2013.

Forest shares were up 1.7 percent at $35.78 on Tuesday afternoon, just off the day's high at $35.82.

(Reporting by Toni Clarke in Boston; Editing by John Wallace, Sofina Mirza-Reid and Matthew Lewis)



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Colo. Dental Patients Advised to Get HIV Testing



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UNESCO awards Equatorial Guinea prize despite outcry

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U.S. busts $108 million black market in Medicaid drugs

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FDA: BPA no longer allowed in baby bottles

The federal government announced Tuesday that baby bottles and sippy cups can no longer contain the chemical bisphenol-A, or BPA.

The U.S. chemical industry's chief association, the American Chemistry Council, had asked the Food and Drug Administration to phase out rules allowing BPA in those products in October, after determining that all manufacturers of bottles and sippy cups had already abandoned the chemical due to safety concerns.

It is illegal for companies to use substances not covered by FDA rules.

"Consumers can be confident that these products do not contain BPA," FDA spokesman Allen Curtis said in a statement, adding that the agency's action was based on the bottle industry's phase out of the chemical. "The agency continues to support the safety of BPA for use in products that hold food."

The chemical industry's request may help curb years of negative publicity from consumer groups and head off tougher laws that would ban BPA from other types of packaging because of health worries.

Legislation introduced by some members of Congress would ban BPA nationwide in all canned food, water bottles and food containers. Chemical makers maintain that the plastic-hardening chemical is safe for all food and drink uses.

BPA is found in hundreds of plastic items from water bottles to CDs to dental sealants. Some researchers say ingesting the chemical can interfere with development of the reproductive and nervous systems in babies and young children. They point to dozens of studies showing such an effect from BPA in rodents and other animals.

But the FDA has repeatedly stated that those findings cannot be applied to humans. The federal government is currently spending $30 million on its own studies assessing the chemical's health effects on humans.

About 90 percent of Americans have traces of BPA in their urine, mainly because the chemical leaches out of food and beverage packaging. The vast majority of canned goods in the U.S. are sealed with resin that contains BPA to prevent contamination and spoiling. Canned food manufacturers have used the chemicals since the 1950s. The practice is approved by the FDA.



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States saying no to 'Obamacare' could see downside

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Small study: Drug may help stabilize Alzheimer's

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Taiwan finds H5N1 virus in birds smuggled from China

"File picture of a man (right) giving his pet budgerigars a shower to cool off from the summer heat in Beijing on July 2010. Dozens of pet birds smuggled from southern China into Taiwan tested positive for the deadly H5N1 avian flu virus and were destroyed, Taiwanese authorities said Tuesday. (AFP Photo/)" title

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Tuesday, July 17, 2012

S. Africa recalls 500,000 HIV test kits: ministry

"A used HIV test kit at a roadside AIDS testing table in Langa, a suburb of Cape Town, on World AIDS Day on December 2010. South Africa is recalling 500,000 HIV test kits it ordered from a South Korean company despite a World Health Organisation (WHO) warning over inconclusive results, the health ministry said Tuesday. (AFP Photo/Rodger Bosch)" title

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US regulators to decide on new weight loss drug

"US regulators decide Tuesday on whether to approve the second new anti-obesity drug in 13 years, Qnexa, which studies have shown may help some people lose up to 10 percent of their body weight. (AFP Photo/Paul Ellis)" title

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