Category: OMG

Hormonal Contraceptives Linked to an Increased Risk of Rare Brain Cancer

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Long-term use of contraceptive pills may double the risk of developing brain cancer, according to a new study.

Scientists say that taking hormonal contraception, particularly progesterone-only methods, for five years more than doubles the chance of developing glioma, a rare type of brain cancer which affects roughly five in 100,000 people.

Researchers used health data from Denmark to compare 317 women diagnosed with glioma and 2,126 who were free of the disease. The scientists evaluated females, aged 15 to 49 years old. According to the Danish study, women who had used an oral contraceptive or hormone-releasing intra-uterine device were 50 percent more likely to develop brain cancer than those who had not.

The difference in risk almost doubled for women who had used contraceptives for five years or more compared with women from the general population with no history of brain tumor, with a 90 percent increase. When taken for five years or more, progestin-only contraceptives increased the risk almost threefold, with a 2.4 times higher risk than the control group. In terms of type of brain cancer, the risk was greatest for glioblastoma multiforme, the most aggressive type of primary brain cancer.

 

Lead researcher, Dr. David Gaist from Odense University Hospital and University of Southern Denmark noted that it is important to keep the increase in risk in context. Only five out of 100,000 Danish women between the ages of 15 and 49 develop glioma each year, and this number includes women who take contraceptives.

The progesterone hormone is known to increase proliferation of high-grade glioma cells called astrocytomas in the laboratory. Additionally, it is thought to raise levels of growth factors, natural substances that stimulate cell growth. However, the scientists said that it was impossible to come to a conclusion regarding how progesterone-containing contraceptives may influence brain cancer development.

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Ten Breakthrough Drugs will Cost the US Nearly $50 Billion Over Ten Years

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There has been heavy debate over the high cost of prescription drugs, and an analysis by Avalere Health estimates that the federal government will spend nearly $50 billion over the next decade on ten breakthrough drugs.

The US Food and Drug Administration’s (FDA) new Breakthrough Therapy program is designed to expedite drug review periods for drugs that treat serious or life-threatening diseases where no drugs exist or that are considered more effective than treatments currently available. Drugs designated as breakthrough therapies include Gilead Sciences’ hepatitis C drug Sovaldi and Bristol-Myers Squibb’s lung and skin cancer drug Opdivo, drugs with high price tags.

The report was commissioned by America’s Health Insurance Plans (AHIP) and offers a first look at estimated state and federal spending on breakthrough drugs for certain cancers and chronic conditions. According to AHIP, these ten drugs represent a small subset of the more than 5,400 drugs in the pipeline.

The high price tags for these breakthrough drugs lead to significant increases in health care spending. Last year, spending on prescription drugs increased by 13 percent from 2013, the largest percentage in over a decade. In 2014, prescription drug spend reached a record-breaking $374 billion. Nearly half of this spending increase was a result of breakthrough therapies and specialty drugs.

Among these ten breakthrough drugs over the next decade, Medicare would absorb the largest expense at $31.3 billion. This will be followed by Medicaid with an estimated spending of $15.8 billion and another $2.1 billion in spending resulting from subsidies provided through Exchange plans under the Affordable Care Act (ACA). The report notes that total US spending may exceed these numbers when accounting for spending by other government agencies, such as Veterans Affairs and Defense, costs to private sector payers, patient out-of-pocket costs, and the significant spending increases associated with off-label use.

These new, innovative drugs offer significant promise for patients with serious health conditions, however the price that comes with these drugs often make treating large patient populations unsustainable.

Often times, breakthrough therapies have a period of market exclusivity, which can last for several years. Because of the lack of competition, drugmakers may significantly markup the price of the drug, making it unaffordable for patients and private payers.

 

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FDA approves treatment for fat below the chin

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The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.

Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.

“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.

The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.

Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.

Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.

Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.

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Cease all the Unadulterated Fish

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At the request of the U.S. Food and Drug Administration, a judge has ordered L.A. Star Seafood Company Inc., located in Los Angeles, and its owners, Sima and Sam Goldring, to halt operations until they demonstrate to the FDA that they can process food in compliance with food safety laws and regulations.

In 2012, at the FDA’s request, the company recalled some of its products due to potential contamination. In 2013, the FDA inspected the L.A. Star facility, and sent the company a warning letter detailing steps the company must take to comply with the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice requirements. In 2014, another inspection of the L.A. Star facility documented the company and its owners’ continued failure to comply with the law.

“The FDA takes legal action to protect the public’s health when it is necessary,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “This consent decree represents an agreement between the FDA and L.A. Star to ensure that if and when they reopen for business, they will be producing food that meets food safety requirements.”

The consent decree of permanent injunction requires L.A. Star to control for the presence of Listeria monocytogenes (L. mono) and Clostridium botulinum (C. bot), two disease-causing bacteria. The consent decree also requires the company to devise and implement Hazard Analysis Critical Control Point plans and Sanitation Standard Operating Procedures, and train staff in both.

L. mono is a foodborne pathogen that can cause serious illness or even death in vulnerable groups such as newborns, elderly adults and those with impaired immune systems. C. bot, a bacterium that can grow in seafood products, causes botulism, which is rare, but can cause paralysis and death without prompt treatment. The purpose of food safety regulations is, in part, to prevent the growth and spread of L. mono, C. bot and other microorganisms that cause foodborne illness.

No illnesses have been reported to date in connection with L.A. Star Seafood Company, Inc. products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Can Technology replace Doctors?

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It’s true.

Health care technology is transforming at record speeds, almost at pace with Apple’s release of a new iPhone. A digitally globalized world means more power than ever is in the hands of the patient.

Around one in 10 Americans wear some form of technology on a daily basis, whether it’s a smart–phone or a device to track medical information. It may sound like the premise of a science fiction film, but Mark Benden, C.P.E., Ph.D., associate professor at the Texas A&M Health Science Center School of Public Health, director of the Texas A&M Ergonomics Center and member of the Center for Remote Healthcare Technologies and Systems, believes wearable technology is rapidly approaching the point where devices become omniscient about a patient’s needs and personal habits. “We see wearable devices on a daily basis.

The most common devices – like the Fitbit – are built–in mechanisms that communicate with your cell phone. Soon, we will have devices in all environments – they will monitor us in our homes, while we’re at work and during our personal lives.

As these different devices ‘talk’ to each other, they will be able to know people’s habits and practices. Essentially, they will coach and motivate patients,” Benden said.

And in health care, this type of scientific advancement is powerful. With more than 140 million Americans living with at least one chronic medical condition, these devices could keep patients out of the hospital and monitored on a routine basis.

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