Posts Tagged "FDA"

Is Theranos as great as it seems? The blood test company Theranos, which has received widespread acclaim for its development of a cheaper test mainly relying on finger pricks, might not be all that it’s cracked up to be. According to a report published by the Wall Street Journal, based on interviews with anonymous former Theranos employees, only a fraction of the blood samples Theranos handles are actually processed with the company’s proprietary analyzer, which the Journal’s sources referred to as the “Edison” device. The rest, according to the report, are processed with traditional machines. The article’s sources also suggest that the small samples Theranos uses, whether collected by finger stick or by venipuncture using smaller than ordinary needles, do not always produce accurate results.

Theranos released a statement Wednesday calling the report “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.” The release did not address the WSJ’s reporting that only a portion of the company’s tests were actually performed on its proprietary systems. According to Theranos, the Journal declined an opportunity to try out the “Edison” devices and compare the results to those of traditional tests.

A former senior employee told the WSJ that by the end of 2014, only 15 of the company’s more than 240 offered tests were run through the “Edison” technology. Theranos disputed that claim, though it did not specify how many tests are performed with the technology.

The report said that some employees were concerned about the accuracy of Theranos’ results. Some former employees told the Journal that Theranos may have cheated on proficiency testing of its equipment, processing samples through traditional test machines instead of the “Edison” systems. In other cases, employees alleged that Theranos’ use of small blood samples, diluted for use with the traditional machinery, increased the chance of incorrect results.

Theranos has received FDA approval to perform a test for the herpes simplex virus and has submitted paperwork to approve many more, even though the company is not legally required to do so. “We received our first FDA clearance this summer based on the very proprietary systems the story is asserting don’t work, and have submitted almost 130 pre-submissions at FDA for tests run on those proprietary systems,” Theranos’s statement said.

Source: WSJ

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) gave the thumbs-up today to recommending, for the first time, approval for a new class of medications: proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors.

They voted 13 to 3 in favor of alirocumab (Praluent, Sanofi/Regeneron) for lowering LDL cholesterol in patients with hypercholesterolemia, citing likely benefit especially for patients with heterozygous familial hypercholesterolemia (HeFH). Other groups predicted to get special benefit to include those at high CV risk or who don’t tolerate statins. Although there was a lot of debate without consensus about these latter groups, the vote just focused on whether the drug’s benefits exceeded its risks to support approval “in one or more patient populations.”

The biggest discussion of the day was whether the drug should be approved based only on its effect on LDL-C—even before its CV-outcomes trial has been completed. Many panel members, including chair Dr Robert J Smith (Alpert Medical School of Brown University, Providence, RI), did not agree that LDL-C lowering is sufficient for establishing effectiveness for reducing CV risk. “I just don’t think it predicts clinical outcomes. I would need to see the clinical outcomes,” he said.

However, Smith was among the “yes” votes today, noting that patients with HeFH really need this drug—a point that came out throughout all discussions. During the public-hearing session, 14 of 16 speakers gave strong approval for the medication, with most sharing stories of how they and/or family members have struggled with this disorder.

Source: Medscape

Veterinarians have long warned that pain medications like ibuprofen are toxic to pets. And it now looks like merely using a pain relief cream can put cats at risk.

That’s what happened in two households, according to a report issued Friday by the Food and Drug Administration. Two cats in one household developed kidney failure and recovered with attention from a veterinarian. But in a second household, three cats died.

When the veterinarians performed necropsies on the three dead cats, they found physical damage in the cats’ intestines and kidneys, evidence of the toxic effects of nonsteroidal anti-inflammatory drugs, or NSAIDs. NSAIDs include ibuprofen, like Advil and Motrin, and naproxen, which is in Aleve.

Ibuprofen is the most common drug that pets eat, according to the American Veterinary Medical Association, perhaps since many of the pills are candy-coated. In pets, the drugs can cause stomach or intestinal ulcers and kidney failure.

But these cats died by flurbiprofen, another NSAID. In the case of its most recent victims, the cat owner applied a lotion or cream containing flurbiprofen to treat muscle or arthritis pain.

Source: NPR

Companies have added thousands of ingredients to foods with little to no government oversight. That’s thanks to a loophole in a decades-old law that allows them to deem an additive to be “generally recognized as safe” — or GRAS — without the U.S. Food and Drug Administration’s blessing, or even its knowledge.

The loophole was originally intended to allow manufacturers of common ingredients like vinegar and table salt — when added to processed foods — to bypass the FDA’s lengthy safety-review process. But over time, companies have found that it’s far more efficient to take advantage of the exemption to get their products on shelves quickly. Some of these products contain additives that the FDA has found to pose dangers. And even ingredients the agency has agreed are GRAS are now drawing scrutiny from scientists and consumer groups that dispute their safety.

Critics of the system say the biggest concern, however, is that companies regularly introduce new additives without ever informing the FDA. That means people are consuming foods with added flavors, preservatives and other ingredients that are not reviewed at all by regulators for immediate dangers or long-term health effects.

Source: NPR

The US Food and Drug Administration (FDA) is warning consumers that fraudulent treatments for Ebola virus disease are being marketed online.

Although some experimental therapies and vaccines are in early phases of development, no products for treating Ebola infection have been approved by the FDA.  So far, only limited data are available about the safety and effectiveness of the products being tested, and only small supplies are available, according to the agency.  Experimental therapies were used to treat 2 US health care workers who were moved to Atlanta after they became infected by Ebola virus while caring for patients in West Africa, where there is an ongoing outbreak.

The US Center for Disease Control and Prevention says there is little threat of Ebola spreading in the United States.  But some online marketers have seized on global concern about the illness to sell fraudulent products, according to the FDA.  It is illegal for companies to market unapproved products claiming to cure or prevent disease.  The FDA is asking the public to report suspect claims about Ebola-related products (https://1.usa.gov/1mS3T3P).

(JAMA)
Read more here.

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