Archive for the ‘fda’ Category

Healthcare industry spends $30B on marketing—most of it goes to doctors

January 11th, 2019
Healthcare industry spends $30B on marketing—most of it goes to doctors

Enlarge (credit: Getty | Media for Medical)

Talk with your doctor… It’s a common refrain at the end of any drug advertisement or disease awareness campaign. Ostensibly, it seems like a responsible suggestion. Talking with your own, trusted doctor can help determine if a new drug really is right for you, or if you may be suffering from an undiagnosed disease. You shouldn’t just take the word of the drug company behind that drug ad or awareness campaign, of course.

But the suggestion to consult with your doctor may not be as innocent as it seems. The drug company likely got to your doctor first.

Of the nearly $30 billion health companies now spend on medical marketing each year, around 68 percent (or about $20 billion) goes to persuading doctors and other medical professionals—not consumers—of the benefits of prescription drugs. That’s according to an in-depth analysis published in JAMA this week. The study broke down exactly how health companies convinced us to spend enormous sums on our care between 1997 and 2016. In that time, health companies went from spending $17.7 billion to $29.9 billion on medical marketing. Meanwhile, US healthcare spending hit $3.3 trillion, or 17.8 percent of the GDP, in 2016.

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Posted in drug advertisements, drug prices, fda, Health policy, medical marketing, Pharmaceutical industry, science | Comments (0)

Halted inspections amid gov’t shutdown “puts our food supply at risk”

January 9th, 2019
A man shops for vegetables beside Romaine lettuce stocked and for sale at a supermarket in Los Angeles, California, on May 2, 2018, where the first death from an E coli contaminated Romaine lettuce outbreak was reported.

Enlarge / A man shops for vegetables beside Romaine lettuce stocked and for sale at a supermarket in Los Angeles, California, on May 2, 2018, where the first death from an E coli contaminated Romaine lettuce outbreak was reported. (credit: Getty | FREDERIC J. BROWN)

After a year plagued by deadly E. coli outbreaks linked to widely distributed romaine lettuce, 2019 is off to an anxiety-inducing start.

With hundreds of food inspectors furloughed in the ongoing government shutdown, the Food and Drug Administration has suspended all routine inspections of domestic food processing facilities. That’s according to FDA Commissioner Scott Gottlieb, who revealed the news in an interview with the Washington Post published Wednesday.

Gottlieb said that the agency, which oversees about 80 percent of the food supply, is continuing to surveil foreign manufacturers and imported food, as well as any domestic producers involved in a current recall or outbreak.

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Posted in E. coli, fda, food safety, foodborne illnesses, romaine, science | Comments (0)

“Scary” reality: Meds tainted with germs, glass, carcinogens, mystery particles

January 7th, 2019
What else is in there?

Enlarge / What else is in there? (credit: Getty | Bloomberg)

An investigation by Kaiser Health News into thousands of recent drug recalls reveals a frightening record of medicines in the US being tainted with dangerous bacteria, mold, glass shards, rubber bits, cancer-causing chemicals, mysterious powders, and worrying metal particles. There were also cases of medications with too much or too little ingredients—or simply the wrong ingredients entirely.

Digging deeper, the investigation discovered that a startling number of the drug makers who issued the recalls had received an all-clear from Food and Drug Administration inspectors within a year of their recalls. FDA records and lawsuits suggest that drug makers can easily game the inspection system, mislead inspectors, lie about where drugs are manufactured, or outright sabotage inspections.

For instance, FDA enforcement documents reveal that employees at one drug-making facility in Japan stood “shoulder-to-shoulder” to physically block an FDA inspector from looking around, and another drug maker in India faked a worker strike and cut the lights at its facility to foil an inspection. In a different case, whistleblowers alleged in a lawsuit that Gilead Sciences told the FDA that it used a facility in South Korea to make an ingredient for HIV drugs Truvada and Atripla, but in reality, Gilead was using an unregistered facility in China. The civil suit claimed that the Chinese ingredient contained “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”

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Posted in bacterial infection, contamination, Drug Safety, fda, kaiser health news, Pharmaceutical industry, science | Comments (0)

FDA slams more homeopaths for playing fast and loose with toxic chemicals

August 17th, 2017

Enlarge / Contains belladonna, aka deadly nightshade. (credit: Homeolab)

The Food and Drug Administration sent a sharp letter this month to a Canadian-based homeopathic pharmaceutical manufacturer named Homeolab USA. The letter warned of “significant violations” the agency found during a recent inspection and poor quality control of the company’s infant teething products that contain the deadly poison, belladonna, aka deadly nightshade.

The letter, dated August 2 and posted on the agency’s website Wednesday, includes a lengthy list of quality and manufacturing process failures that renders Homeolab’s products “adulterated,” the agency concluded. These include failing to test the quality of ingredients or ensuring consistent levels of belladonna in the products.

Homeolab is just the latest homeopathic company slammed by the FDA for problems related to belladonna-containing products. For years, the agency has been investigating reports of infants having seizures, losing consciousness, and, in some cases, dying after using such products. The symptoms were all consistent with belladonna poisonings. Last September, the FDA warned consumers to avoid the homeopathic teething gels and tablets distributed by Hyland’s, CVS, and others.

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Posted in fda, homeopathy, science, teething | Comments (0)

Supplement maker on FDA blacklist after deadly bacteria found in water system

August 14th, 2017

Enlarge / A scanning electron microscopic image of Burkholderia cepacia. (credit: CDC/ Janice Haney Carr)

The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Florida after finding dangerous Burkholderia cepacia bacteria in the water system used to manufacture its products. Those products include liquid drugs and dietary supplements labeled under Rugby Laboratories, Major Pharmaceuticals, and Leader Brands.

An outbreak of B. cepacia infections affecting at least 60 people in eight states led the FDA and Centers for Disease Control and Prevention to PharmaTech. Late last year, the agencies tracked the source to more than 10 lots of PharmaTech’s oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the company’s other products, and this month PharmaTech issued a voluntary nationwide recall of its other liquid products, such as its liquid vitamin D drops and liquid multivitamins that are marketed for infants and children.

PharmaTech described the recall as a “precautionary measure,” but the FDA seemed to suggest that the problem required more urgency and issued an additional advisory.

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Posted in CDC, fda, Infectious disease, outbreak, science, supplements | Comments (0)

Pacemakers patched against potentially lifethreatening hacks

January 12th, 2017

Potential exploits are ‘the fuel of nightmares’, say experts

Posted in DHS, fda, Law & order, medical devices, pacemakers, Security threats, St. Jude Medical, USFDA, Vulnerability | Comments (0)

FDA, DHS Investigating St. Jude Device Vulnerabilities

September 12th, 2016

The FDA and DHS are jointly investigating cybersecurity vulnerabilities in St. Jude Medical devices.

Posted in DHS, fda, Government, health care device security, Medical device security, MedSec, Muddy Waters, St. Jude Medical, vulnerabilities | Comments (0)

FDA releases draft guidelines to improve cybersecurity in medical devices

January 29th, 2016

Hacking medical devices is a scary prospect – think pacemaker – so it’s good to see the FDA weighing in on the problem.

Posted in diabetic pump, Dick Cheney, fda, Law & order, medical devices, pacemakers, safety, Security threats | Comments (0)