USA v. Mira

Defendants have a history of violating the act,” the complaint said. “Several of the dietary supplement cGMP deviations observed during the July 2013 inspection ... are the same as, or similar to, those observed by FDA during inspections of defendants’ facility between March 13-23, 2012, and between March 18-22, 2013.

Here's the FDA action versus Mira. More later.

Producer of tainted dietary supplements sentenced in Federal Court

Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.

From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of this product, called “Nikki Haskell’s StarCaps” (StarCaps).

BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician.

In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy.

Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement from the market.

“There is a strict regulatory process in the United States for the distribution and dispensing of prescription drugs, and dietary supplements cannot legally contain such drugs,” said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “Consumers rely on the labels of dietary supplements to inform them about any potential health risks. The FDA will continue its vigilance over the dietary supplement market.”

Use of bumetanide is banned by certain professional sports organizations, including the National Football League, in part because bumetanide can mask the presence in the human body of steroids and other banned doping agents.

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, and products that give off electronic radiation, and for regulating tobacco products.

Doctor's Best Red Yeast Rice Recalled

Doctor's Best is a well known vitamin supplement manufacture, so there is big news that the company is recalling more than 7,300 bottles of its "Best Red Yeast Rice" supplement because FDA testing revealed it contains lovastatin, a cholesterol-lowering medication. 

The supplement can be dangerous for people already taking medications to treat their cholesterol or may cause drug interactions.

In rare cases, using the supplements that contain lovastatin could result in serious muscle injury, particularly in people already taking prescription "statins" such as lovastatin, simvastatin (known by brand name Zocor), or atorvastatin (known by brand name Lipitor). The supplements also pose a risk to pregnant women, and patients with pre-existing liver disease, who may be at an increased risk for liver injury following chronic use of statins, according to the release.

The company has not yet received any reports of illness related to use of the supplement. 

Red yeast rice, a traditional Chinese culinary and medicinal product, can contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin (known by the brand name Mevacor). Other red yeast rice products contain little or no monacolin K, but the amount of the substance is not disclosed on the supplement's label and consumers have no way of distinguishing between them, according to the National Center for Complementary and Alternative Medicine (NCCAM).

Link here: http://www.cleveland.com/healthfit/index.ssf/2014/06/doctors_best_recalls_red_yeast.html

Are you a Jerk to the Invisible People in Office Buildings?

NYC: Empire State Building (Photo credit: wallyg)

I work in a tall building in Atlanta. I also travel a lot and go into and out of of tall buildings. My personality is such that I almost always smile, greet, and say hello to those who make those big buildings run. You know the people - the security person at the door, the folks who clean the bathrooms, the company that cleans offices. Because I speak spanish (but don't "look" it) I almost always surprise a hispanic person cleaning during the day or evening.

A simple hello, or holding the door for one of them, or a smile is just the decent thing to do.

Then you have the self important assholes.

I see these types a lot - are you one of them? This morning I used the service elevator, loaded with workers. A guy in a suit, on the phone, pushed his way in. Became angry when his suit brushed up against a stationary moving cart. He snarled something, all the while on his phone. He exited, and all was quiet. I said "pendejo" after he left, and the folks started laughing and smiling. The folks on that elevator were invisible to the asshole, until he felt annoyed.

It's not very hard to do the simple things for the people around you.To me, how a stranger treats someone like the cleaning people - in that brief snapshot of time - tells me a lot of what that person is usually about.

So I watched all of this unfold on some non descript day. I was in jeans and a golf shirt, not the usual business wear. I saw three people decide that each didn't want to hold the elevator for a worker. I saw folks decide that it was not worth the effort to hold the door open for a person with a cleaning cart. I saw a guy be a total asshole to a diminutive person who was from Uruguay ( I asked her where she was from after he left- her name is Clara and she has 2 kids in summer school).    I even saw a woman dressed to the nines look me up and down, disapprovingly because I "appeared" to be just a worker.

I know that for many people each day is a battle. I know it's hard sometimes to be polite, but making someone else feel as if she is a human with dignity, and worth acknowleding, if even just for a brief second, is the right thing to do. Best of all, it's free.

FDA calls for testosterone products to carry blood clot warning

The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. The regulator cited post-market reports of such clots for the warning.

The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia.

 

In January, the FDA said it has been monitoring the stroke and heart risks posed by testosterone products but in light of two recent studies has "decided to reassess this safety issue," prompting an investigation.

 

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.

 

 

 

Read more: FDA moves for more warnings on testosterone products - FiercePharma http://www.fiercepharma.com/story/fda-moves-more-warnings-testosterone-products/2014-06-20#ixzz35Z6yNsJM
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A tragedy in Hooper Nebraska

Here is a compelling blog post from my good friend Chris Welsh...

The small town of Hooper, Nebraska is grieving over yet another heartbreaking loss at the intersection of US Highway 77 and Nebraska Highway 91.

In 2011, 16 year-old Bryn Dirkschneider died in a crash at the intersection. Today, his memorial cross is joined by two more memorials for young boys, Bryan Huff, 17, and Dalan Brandt, 15.
*http://www.jrn.com/kmtv/news/Teens-Killed-in-Crash-near-Fremont--2619559...

Both young men were students at Logan View High School in Hooper. They had just met at their work for the summer. Huff was driving with passenger Brandt on a lunch break around 1:00 pm when they crashed into a semitrailer. The driver, Byron Morrow, 51, of Tekamah, was not physically injured.

Local news investigation by KMTV News 3 laments that the memorials are not slowing traffic at the dangerous intersection. The station inquired to the Nebraska Department of Roads about traffic lights and improved safety in response to the tragedies. They have not received a reply.

Dalan Brandt’s grandfather, Jim Brandt, asks what can be done to fix the issue, "I would love to see traffic lights there but it's not going to happen.” Many fear that another accident will happen before the Department of Roads re-evaluates the intersection.

Trucking safety is another concern involving the crash and a potential cause in all trucking accidents. Fatigue and distracted driving are serious problems for drivers, who are paid by the mile. This payment system encourages drivers to make long trips in order to meet delivery deadlines and make more money. In the rush to do so, safety regulations and careful driving are neglected. This is especially concerning considering that for every semi on the road, the risk of accident increases (http://www.tandfonline.com/doi/full/10.1080/.U5c2m5RdVg8#.U5imIpRdVg8). In dangerous intersections like that of Highway 77 and 91, it is necessary for drivers to be awake and driving responsibly.

In 2012, there were 333,000 large truck crashes that claimed the lives of 3,802 Americans ( http://www-nrd.nhtsa.dot.gov/Pubs/812032.pdf ) If you or a loved has been injured in a car accident, or you believe that a road in your community is unsafe, speak out for support. Every concern should be heard, especially when it means that your family is safer on the road.

A tragedy in Hooper Nebraska

Here is a compelling blog post from my good friend Chris Welsh...

The small town of Hooper, Nebraska is grieving over yet another heartbreaking loss at the intersection of US Highway 77 and Nebraska Highway 91.

Wed, 06/11/2014 - 16:30 - webmaster
In 2011, 16 year-old Bryn Dirkschneider died in a crash at the intersection. Today, his memorial cross is joined by two more memorials for young boys, Bryan Huff, 17, and Dalan Brandt, 15.
*http://www.jrn.com/kmtv/news/Teens-Killed-in-Crash-near-Fremont--2619559...

Both young men were students at Logan View High School in Hooper. They had just met at their work for the summer. Huff was driving with passenger Brandt on a lunch break around 1:00 pm when they crashed into a semitrailer. The driver, Byron Morrow, 51, of Tekamah, was not physically injured.

Local news investigation by KMTV News 3 laments that the memorials are not slowing traffic at the dangerous intersection. The station inquired to the Nebraska Department of Roads about traffic lights and improved safety in response to the tragedies. They have not received a reply.

Dalan Brandt’s grandfather, Jim Brandt, asks what can be done to fix the issue, "I would love to see traffic lights there but it's not going to happen.” Many fear that another accident will happen before the Department of Roads re-evaluates the intersection.

Trucking safety is another concern involving the crash and a potential cause in all trucking accidents. Fatigue and distracted driving are serious problems for drivers, who are paid by the mile. This payment system encourages drivers to make long trips in order to meet delivery deadlines and make more money. In the rush to do so, safety regulations and careful driving are neglected. This is especially concerning considering that for every semi on the road, the risk of accident increases (http://www.tandfonline.com/doi/full/10.1080/.U5c2m5RdVg8#.U5imIpRdVg8). In dangerous intersections like that of Highway 77 and 91, it is necessary for drivers to be awake and driving responsibly.

In 2012, there were 333,000 large truck crashes that claimed the lives of 3,802 Americans ( http://www-nrd.nhtsa.dot.gov/Pubs/812032.pdf ) If you or a loved has been injured in a car accident, or you believe that a road in your community is unsafe, speak out for support. Every concern should be heard, especially when it means that your family is safer on the road.

FDA: New advice on mercury levels in Seafood

English: Logo of the . (Photo credit: Wikipedia)

The U.S. Food and Drug Administration is updating its advice for pregnant women on the appropriate levels of mercury in seafood. Commissioner Margaret Hamburg says the agency won't require mercury labels on seafood packages.

In a wide-ranging interview last week with The Associated Press, Hamburg said the agency will update guidance on mercury in different varieties of seafood and what that means, a long awaited move aimed at helping women better understand what to eat when they're pregnant.

http://www.thestarphoenix.com/health/issues+advice+mercury+levels+seafood/9905526/story.html

Driven Sports and lawsuit over Craze pre-workout supplement

Driven Sports, a New York-based business, is part of litigation involving its Craze pre workout supplement. The company lists items like creatine, citrulline and caffeine in the supplement facts for Craze, but does not list N,α-dimethylphenethylamine, or N,α-DEPEA.

N,α-DEPEA has “a potency somewhere between methamphetamine and ephedrine, both of which are banned substances,” according to a lawsuit.

Craze’s inclusion of this compound was reported earlier in an article by NSF International, Harvard Medical School and the National Institute for Public Health and the Environment in the Netherlands in the journal “Drug Testing and Analysis.”

The authors of the article call the compound a potentially dangerous. Regarding the report, 

 “Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements. “The health risk of using supplements adulterated with a drug should not be underestimated.”

In separate testing, NSF International scientists also detected N,a-DEPEA in a different supplement called Detonate by Gaspari Nutrition. Regulators may want to consider taking action to warn consumers.

“We urge consumers to remain vigilant about the dietary supplement products they choose, especially since products including Craze and Detonate are available in stores and online, and encourage them to look for certification as a sign that the product has been tested and certified to be free of harmful levels of contaminants,” said Ed Wyszumiala, General Manager of NSF International’s Dietary Supplement Certification Program, which helps protect consumers by verifying what is on the dietary supplement label is in the package and that the product does not contain unsafe levels of contaminants.

This collaborative testing project was developed in response to several failed urine drug tests by professional athletes after taking an over-the-counter workout product called Craze marketed by Driven Sports, Inc.  After extensive testing and a review of the product’s label at NSF International’s laboratory in Ann Arbor, Mich., scientists at NSF International, HMS and NIPHE confirmed that the substance N,N-diethylphenylethylamine was listed on the label but N,a-DEPEA, an emerging and potentially harmful designer stimulant, was found.  A review of this substance shows that N,a-DEPEA is likely less potent than methamphetamine but greater than ephedrine.

http://www.nsf.com/newsroom/emerging-and-potentially-harmful-adulterant-depea-found-in-supplements/

Tanning Beds get a New Warning

The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

https://www.federalregister.gov/articles/2014/06/02/2014-12546/general-and-plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to

Viagra Poses Skin Cancer Risk For Men, Researchers Say

 (Photo credit: Wikipedia)

According to a new study published inJAMA Internal Medicine, researchers have identified a link between sildenafil (more commonly known as Viagra) and melanoma. Not only is there an association between the two, but the authors of the study say the drug may increase a man’s risk for melanoma by up to 84%.

From the study:

Importance  The RAS/RAF/mitogen-activated protein kinase and extracellular signal–regulated kinase (ERK) kinase/ERK cascade plays a crucial role in melanoma cell proliferation and survival. Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk.

Objective  To evaluate the association between sildenafil use and risk of incident melanoma among men in the United States.

Design, Setting, and Participants  Our study is a prospective cohort study. In 2000, participants in the Health Professionals’ Follow-up Study were questioned regarding sildenafil use for erectile dysfunction. Participants who reported cancers at baseline were excluded. A total of 25 848 men remained in the analysis.

Main Outcomes and Measures  The incidence of skin cancers, including melanoma, squamous cell carcinoma (SCC), and basal cell carcinoma (BCC), was obtained in the self-reported questionnaires biennially. The diagnosis of melanoma and SCC was pathologically confirmed.

Results  We identified 142 melanoma, 580 SCC, and 3030 BCC cases during follow-up (2000-2010). Recent sildenafil use at baseline was significantly associated with an increased risk of subsequent melanoma with a multivariate-adjusted hazard ratio (HR) of 1.84 (95% CI, 1.04-3.22). In contrast, we did not observe an increase in risk of SCC (HR, 0.84; 95% CI, 0.59-1.20) or BCC (1.08; 0.93-1.25) associated with sildenafil use. Moreover, erectile function itself was not associated with an altered risk of melanoma. Ever use of sildenafil was also associated with a higher risk of melanoma (HR, 1.92; 95% CI, 1.14-3.22). A secondary analysis excluding those reporting major chronic diseases at baseline did not appreciably change the findings; the HR of melanoma was 2.24 (95% CI, 1.05-4.78) for sildenafil use at baseline and 2.77 (1.32-5.85) for ever use.

Conclusions and Relevance  Sildenafil use may be associated with an increased risk of developing melanoma. Although this study is insufficient to alter clinical recommendations, we support a need for continued investigation of this association.

http://archinte.jamanetwork.com/article.aspx?articleid=1857095&resultClick=3