HEALTH

Scientists find additive found in plastics harmful to women’s heart health

BY Michael Johnsen

CINCINNATI New research by a team of scientists at the University of Cincinnati released last week found that bisphenol A — an additive in many plastics — may be harmful for the heart, particularly in women. BPA, an environmental pollutant with estrogen activity, is used to make hard, clear plastic and is common in many food product containers. It has been linked to neurological defects, diabetes and breast and prostate cancers.

A research team led by Scott Belcher in the department of pharmacology and cell biophysics found that exposure to BPA and/or estrogen caused abnormal activity in hearts of female rats and mice.

“Low doses of BPA markedly increased the frequency of arrhythmic events,” Belcher said. “The effect of BPA on these cardiac arrhythmias was amplified when exposed to estradiol, the major estrogen hormone in humans. These studies have identified new and important potential cardiac risks associated with BPA exposure that may be especially important for women’s heart health.”

Results of several studies were presented in Washington at ENDO 09, the Endocrine Society’s annual meeting, June 10 to 13.

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CHPA: OTC medicines should remain eligible expenses under FSA

BY Michael Johnsen

WASHINGTON Congress is looking into possibly removing over-the-counter medicine reimbursement from flexible spending accounts, according to a U.S. Senate Finance Committee report released last month, if not eliminating FSAs altogether.

In the May 20 report, the Committee wrote around not including OTCs as eligible expenses under FSA: “Under this option, with respect to medicines, the definition of medical expense for purposes of employer plans (health reimbursement arrangements and health flexible spending arrangements) and health savings accounts could be conformed to the definition for purposes of the itemized deduction for medical expenses. Thus, for example, under the proposal, the cost of nonprescription medicines would not be reimbursed through a flexible spending arrangement.”

The suggestions are being made as one possible way to help raise the revenue that will supplement the expected costs associated with healthcare reform. Reversing the Internal Revenue Services’ decision to include OTC medicines as eligible expenses under FSAs, or eliminating the FSA program entirely, effectively makes those medicinal purchases taxable again.

In response to the report, CHPA sent a letter May 26 to U.S. Senate Finance Committee Chair Max Baucus, D-Mont., urging the committee to not consider eliminating FSAs and to preserve the current gross income exclusions for reimbursements for OTC medicines, the association announced in its e-newsletter Friday.

“Rather than limit these important tools for making health care more affordable, they should be encouraged and expanded,” CHPA wrote in its letter. “OTCs represent more than $20 billion in annual health care spending that is paid directly by consumers, not covered by health insurance. Reducing, or even eliminating, current support for consumer health care spending is bad policy both because of the additional fiscal burden it would impose on consumers and because it would discourage consumers from utilizing important medicines for prevention, treatment and symptomatic relief.”

According to CHPA, the Senate committee has not indicated when it will take up consideration of proposals to finance healthcare reform. Any committee action would be followed by action by the full Senate. The U.S. House of Representatives also would have to agree to the provisions before they could be sent to President Barack Obama. The president has indicated that he wants to sign healthcare reform legislation before the end of the year.

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Novartis completes first batch of influenza A(H1N1) vaccine

BY Michael Johnsen

BASEL, Switzerland Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, the vaccine against the novel H1N1 influenza virus responsible for the current pandemic, weeks ahead of expectations, the vaccine manufacturer announced Friday.

The quick turnaround was made possible through cell-based manufacturing technology, which allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production, Novartis stated.

“The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak,” stated Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.

This first batch of 10 liters of wild type influenza A(H1N1) vaccine monobulk will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials. It demonstrates the value of the cell-based production approach, that is also being used by Novartis with reassortant influenza A(H1N1) seed.

Based on this success with the wild type, Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed, which was provided by the Centers for Disease Control and Prevention on May 27. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall 2009.

More than 30 governments have made requests to Novartis to supply them with influenza A(H1N1) vaccine ingredients, including a $289 million order made by the U.S. Department of Health and Human Services.

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