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Simply Thick, Simply Risk

By On · Add Comment · In dysphagia, FDA, necrotizing eterocolitis, simply thick, Uncategorized, warning

Listen up parents, particularly parents of preemies: if you’ve been giving your infant Simply Thick to help with swallowing, be warned that the product could increase their risk of developing a life-threatening illness. The FDA has issued a warning that 22 infants developed necrotizing enterocolitis (NEC) after being fed baby formula or breast milk mixed with Simply Thick. Seven of them died.

The product is used for children that have difficulty swallowing (dysphagia), and although a direct link to NEC has not been yet confirmed, authorities do want to put parents, caregivers and healthcare practitioners on high-alert.

NEC is generally seen in premature infants where portions of the intestinal tissue goes through necrosis or tissue death. The FDA, however, has extended the warnings to all infants being fed the formula thickener. And parents should be on the lookout for NEC symptoms, which include a bloated stomach, greenish vomit, bloody stools and lack of interest in feeding.

According to Dr. Ari Brown, a pediatrician Austin, Texas, and co-author of Baby 411, if reflux and spitting up continues to be an issue, parents do have other options. “They can try doing smaller, more frequent feedings; keeping infants upright for at least 20 minutes after eating; and placing them at a 30 percent incline for sleeping,” she said. “In severe cases, your pediatrician may prescribe medication to help treat.”

And to ease some worries, Dr. Brown adds, “If you’ve already stopped using the product for a while and your baby seems fine, there’s no need to worry.”

Just some food for thought here, but Formula feeding increases the risk of NEC by tenfold compared to infants who are fed breastmilk alone. Breast milk protects the premature infant not only by its antiinfective effect and its immunoglobulin agents but also from its rapid digestion. For women that do not produce breastmilk, human milk from a milk bank or donor can be used. I am a big proponent of using human milk over formula, and this latest news is just another reason why. Am I implicating Simply Thick before all the information is in? No, just stating my belief that the human body knows better than man’s educated, and often arrogant mind. Again, just food for thought. Be safe.

Warning: Recall on Pine Nuts.

By On · Add Comment · In CDC, FDA, food-borne illnesses, listeriosis, Salmonella enteritidis, Turkish pine nuts, Wegmans Food Markets

The FDA has issued a recall on Turkish pine nuts from bulk containers at Wegmans Food Markets, and also food items such as pesto, salads or baked goods that may have been prepared with the pine nuts.  Agency officials report that the pine nuts are imported from Turkey, and have sickened at least 42 people with Salmonella in seven states including California, Maryland, New York, New Jersey, Pennsylvania, Virginia and Washington.  Two people have been hospitalized for salmonellosis.

The CDC has reported 42 people sickened in five states–Maryland, New Jersey, New York, Pennsylvania and Virginia–and implicated pine nuts purchased in Wegmans bulk bins and prepared foods that included Wegmans pine nuts as an ingredient as the source of the outbreak.  The CDC mentioned Caprese salad and asparagus with pine nuts sold at Wegmans stores as possibly being contaminated with Salmonella.

A recall by the Wegmans grocery store chain was limited to 5,000 lbs of pine nuts sold in the bulk foods department of most of its stores in Maryland, New Jersey, New York, Pennsylvania and Virginia between July 1 and Oct. 18, 2011.  The CDC said labs in Virginia and New York have isolated the Salmonella Enteritidis outbreak strain from retail samples of Turkish pine nuts collected from a Wegmans store and from pine nuts and homemade pesto at outbreak victims’ homes.  Federal, state and local health authorities are continuing to use the national PulseNet monitoring system to identify other reports of Salmonella infection that may be part of this outbreak. 

As I’ve reported in this blog, we’re seeing increases in the number of food-borne illness every year, and they will continue to rise.  This latest recall of pine nuts on the heels of a cantaloupe listeriosis outbreak that has been the deadliest in modern U.S. history.  As of this writing, the 26-state outbreak is still in effect, and it might be some time before we can assess the final damage.  But, I digress–today, we’re talking pine nuts.  Make sure to check your cupboards for the Wegmans brand, and if you unsure…toss ’em.  It ain’t worth the puke.

FDA Makes Good

By On · Add Comment · In 17P, compounding pharmacies, drug, FDA, KV Pharmaceutical, Makena, progesterone
As a follow-up to a story I posted on earlier, the FDA has said it will not stop the sale of a cheaper version of a drug used to prevent premature births in women.  The drug, called Makena is a progesterone synthetic, which has been made cheaply for years, mixed in compounding pharmacies that are not federally approved.  The FDA said previously that it would enforce regulations against any compound pharmacies mixing the drug, upholding a federal order to allow one company, KV pharmaceutical, to be the sole producers of Makena.

This news comes as a relief for both women and doctors, as previous reports disclosed that the price would jump from $10-$20 to $1,500 for the once-a-week shot.  The FDA released a statement today saying, “In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies” that compound the drug, also known as 17P.

What makes this story unique is that when pharmaceutical companies usually develop a new drug, some pharmacies may try to make a version of the licensed drug after it comes on the market. But in this instance, pharmacies were making it before KV Pharmaceutical.  It was only the government mandate allowing KV sole manufacturing rights that changed things.  What’s more, the FDA’s regulation of special pharmacies is “a gray area” based on agency policies, not laws, noted Alvin J. Lorman, a respected Washington, D.C.-based food and drug lawyer.

Well bravo to the FDA for holding out on enforcing a bad policy.  And shame on the feds for scratching the back of a solitary pharmaceutical company at the expense of at-risk pregnant women.  Thank goodness there was enough of a public outcry to prompt good decision making by the FDA.  Sometimes our voices can be heard, and this is definitely one of those cases.  Good job, people!

Our Civil Liberties Being Challenged Once Again

By On · Add Comment · In Avandia, cervical cancer, disease, FDA, health, HPV, human papilloma virus, illness, lifestyle choices, mandate, mandatory, sexual behavior, Thalidomide, vaccinate, vaccinations, vaccine, Vioxx
Mandatory HPV vaccinations are once again at the top of the legislative agenda. California is the latest state to introduce a bill requiring girls entering sixth grade to receive the three standard doses of the HPV vaccine.

HPV stands for the human papilloma virus, a sexually transmitted organism that is the cause of genital warts and 70% of all cervical cancers. On the surface, this may seem like a good idea to protect the lives of young women of our society. However, forcing people to vaccinate themselves against a disease that results from lifestyle choices is simply preposterous. This is no morality trip – I don’t think this mandate, in any way, is going to encourage young women to engage in sexual behavior as some suggest. But, I do think that when it comes to our health, the choice should be ours alone.

Now, this is very different from the scenario of being at risk of developing illness by being in the same room as someone who, say, has measles, or tuberculosis or even the flu. You cannot catch HPV without sexual contact, so the public health is not threatened in any way. Using the argument that mandatory vaccination will save lives is using the ends to justify the means. It would be like vaccinating people against drugs and alchohol – a la A Clockwork Orange – to prevent drunk driving deaths.

Sound like an exaggeration to you? It’s not. Consider this: I have a beautiful, healthy and happy 14-month-old daughter, Delilah, who is the apple of my eye. I don’t know anything about this vaccine other than the government (i.e. the FDA) says it’s safe. Do you know how many substances the FDA has deemed safe that we found out later were not? Here are a few:

So why would I want to give a vaccine to my daughter that hasn’t been comprehensively tested? I’m never the first to try out the new version of Internet Explorer, either. Quite frankly, I’d rather take my risk with my daughter contracting HPV, then inject her with something I know very little about. That’s just my opinion. If you want to vaccinate your daughter, go ahead. Nobody wants to stop you. If I, or she, decide down the road that we should do it, then we will – just don’t force it down our throats.

Natural Cures “They” Don’t Want You to Know About

By On · Add Comment · In Biotape, calcium citrate, Coral Calcium, Dr. Nick Show, FDA, health, health book, infomercials, Kevin Trudeau, Natural Cures "They" Don't Want You to Know About, supplements

This month, on the Dr. Nick Show podcast, I review the mega best selling health book, Natural Cures “They” Don’t Want You to Know About by Kevin Trudeau. Boy, what a blast. This guy is a trip. Read this fantastic article about him from the Washington Post.

Trudeau was banned from selling supplements by the FDA for his false claims about the product Coral Calcium. From what I understand, Coral Calcium is not better than calcium citrate as far as absorption goes, and anyway, Trudeau said it could cure cancer. Dummy! You can’t say that. One, because it’s just not true. And two…well, because it’s not true, and furthermore, people might believe you.

He was also banned from selling any health product on infomercials for both his claims on Coral Calcium and his product Biotape. Biotape, according to Trudeau could cure chronic pain. I don’t think it worked very well. Hmm, I see a pattern here.

So, on to the health book publishing biz. Natural Cures has sold over 5 million copies. Very impressive. And it has been proclaimed the greatest selling health book of all time. Wow! Kudos, man.

Anyway, I don’t think the book is totally useless. Check out my review on the Dr. Nick Show.
Here are some real Natural Cures books:
Enjoy.

Time for the Vitamin Industry to Raise the Bar

By On · Add Comment · In Dietary Supplement Health and Education Act, FDA, L-tryptophan, regulation, supplement, vitamin
Well, it’s about time. The FDA has finally set new manufacturing standardsfor the vitamin and supplement industry. Makers of vitamin and herbal supplements will now have to meet government standards to show that their products are free from contamination and contain exactly what the label says, U.S. health officials said on Friday.Some supplements have been recalled in the past, like the contaminated L-tryptophan that killed or injured hundreds of people in 1989. Other companies are selling supplements that contain undisclosed drug ingredients while still others sell products with less than advertised levels of vitamins A, C and folic acid.

I’ll say it again – it’s about time. The vitamin and supplement industry has for too long escaped regulation, opening it up to scheisters and crooks to scam the public. I applaud the FDA for seeing the need to step in and do something. Granted it’s taken thirteen years to finally implement the rule set forth by the Dietary Supplement Health and Education Act of 1994 (DSHEA), but any action in this area is welcomed.

Take it from a health care practitioner who is inundated by advertisements touting one miraculous supplement after another. I sometimes scan through these marketing materials just to see what the latest gimmick is – it really is quite amusing. And I especially love that every company says they have the research data, all of which was compiled by – their own labs! Har har har…does that one really still slip by consumers?

Here’s what I want as a clinician recommending supplements to my clients – high quality vitamins offered singly (as in vitamin C or E), in a complex (as in vitamin B complex) or with a few other ingredients that are known to enhance absorption, assimilation or function (as in vitamin C with bioflavanoids) – that’s it. I don’t want the heart function formula, or the women’s formula, or the male enhancement formula – just the isolated vitamin, mineral or multivitamin that has, well…vitamins. I don’t need rhinoceros horn or bovine adrenals or magic mushroom tops from Belize (um…no, no I don’t want those either) or Chinese herbal mixes. No thank you. Just the vitamins, please.

If I’ve said it once, I’ll say it again: vitamin supplementation is absolutely necessary if you want to live in Optimal Health. But we need some group to watch the rats who’ll sell us ground oregano and tell us it’s as good as eating a whole week’s worth of vegetables.

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