The FDA approves a combination of drugs for breast cancer
Source: U.S. Food & Drug Administration
Breast cancer is the second leading cause of death among women. An estimated 192,000 women will be diagnosed with breast cancer this year.
Not all breast cancers are the same, however. Some breast cancers are hormone positive meaning that the presence of certain hormones (estrogen for example) contributes to cancer and its rate of growth. Breast cancer may also be protein based with HER2 being a common protein positive breast cancer.
Two chemotherapy drugs which have been effective in treating cancer, Tykerb (lapantinib) and Femara (letrozole) have now been approved for use in combination with one another. When a drug receives FDA approval it is typically for a “labeled use” only, meaning that it was developed to treat one specific disease or condition in a specific manner. While medications are used “off label” at times at the discretion of physicians, the explicit approval of the FDA results in wider adoption and use.
Accordingly when the FDA permits the extension of approvals for the use of breast cancer drugs it is a big deal. It is hoped that the combination of the two medications will be twice as effective in slowing the progression of this killer of women.
~Posted by D.M. Schwadron, Esquire
ADHD and Ambidextrous Children? Um…
Source: BBC Health; Pediatrics.
Okay, okay…confession time. I throw “righty” and bat “lefty” and I can punt around on the pitch with either foot. Shocking, I’m sure.
A study performed at the Imperial College London and published in Pediatrics journal has linked ADHD (Attention Deficit Hyperactivity Disorder) with mixed handedness. Why? Damned if I know, read on…
Apparently one in every 100 children are ambidextrous (I’m a semi-rare one!). Quick anatomy lesson…Your brain is divided into 2 hemispheres. More accurately, a longitudinal fissure connected by the corpus callosum separates the brain into 2 distinctly identifiable cortical parts. While very generalized, modern psychology still accepts the notion of brain function lateralization, meaning that one side of the brain does one thing well while the other does something else. Typically it is felt that the right side of the brain is responsible for math and spatial reasoning while the left side of the brain is responsible for creativity and language.
Enter the ambidextrous child. It is believed that right hand dominance corresponds with the left hemisphere of the brain. Accordingly a lesser preference for the right hand might mean more difficulty with learning language.
So is there any validity to any of this? Well you can count the study of 8,000 Finnish children (those that are from Finland, not those that are “done”) 87 of whom were mixed-handed and who at ages 6-7 were twice as likely as their right handed peers to be singled out in school as having ADHD and learning “difficulties.” I’m reserving opinion at this point. <whistles and walks away slowly>
~Posted by D. M. Schwadron, Esquire
Antidepressants linked to preterm birth?
Source: Reuters Health; American Journal of Obstetrics & Gynecology, December 2009
Remember that post about the safety of prescription medications for pregnant women? http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=528
Well, researchers in Washington (State not the Nation’s capital) have found in a study of 3,000 women, those taking selective serotonin reuptake inhibitors (SSRIs) into their 2nd and 3rd trimesters had an increased risk (14%) of giving birth prematurely.
Medications such as Zoloft, Paxil and Prozac were felt to have no appreciable impact during the 1st trimester, however benzodiazepines, such as Ativan and Xanax were linked with preterm labor, low birth weight, respiratory distress and low Apgar Scores.
Among the women in the study who did not take any such medications, only 9% gave birth prematurely as opposed to nearly half of the women taking benzodiazepines.
One might very well question why, with the prevalence of such prescriptions, studies such as this were not published earlier.
~Posted by D.M. Schwadron, Esquire.
Woah, listeria in my cheese balls and now salmonella in my nuts? I can't make this stuff up.
Contact:
Chris Hines or Deborah Hines
214-939-0253
Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The recalled product was sold in 8 oz foam trays wrapped in cellophane and carry the UPC code 0 72036 88121 0. The Pine Nuts were distributed solely to Harris Teeter Markets in North Carolina. Consumers who purchased this product between December 30, 2009, and January 14, 2010 should contact Hines Nut Company for information on how to return the product for a refund.
There have been no complaints or any reported illnesses related to the products to date. The problem was discovered through routine sampling by the supplier, Red River Foods. Consumers with questions may contact Hines Nut Company at 214-939-0253 (M-F, 6:30 AM to 3:30 PM CDT).
And quitting while I am marginally ahead. . .
~Posted by D.M. Schwadron, Esquire
It's Friday, which means…yes! More FDA Alerts! My cheese balls have listeria?
Source: U.S. Food & Drug Administration
That title could have gone terribly wrong. Never combine the words “cheese” and…well…in the same sentence…
Company Contact:
Lindsey Decker
608-837-5166, ext.364
Customer Service Contact:
800.698.1751
The Wisconsin Cheeseman® announced that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010. Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria.
Nine of the recalled products are cheese logs/cheese balls purchased from Parkers Farm, Inc. and then distributed by The Wisconsin Cheeseman®. These products bear the Parkers Farm logo. None of the other recalled products at Parkers Farm, Inc. was purchased or distributed by The Wisconsin Cheeseman®.
The Wisconsin Cheeseman® Food Gifts Impacted by Recall:
Sausage ‘N Cheese Logs – Gift #11
Cheese Logs & Cutting Board – Gift #87
Smorgasbord – Gift #325
Cheese Log Trio – Gift #365
Cheese Logs – Gift #411
Cheese Ball Trio – Gift #441 (WAIT, WHAT?! )
Cheese Logs – Gift #509
Snacker Pack – Gift #751
Cheese Balls & Sausages – Gift #876 (A PERSONAL FAVE!) : P
Consumers who have these products in their possession should not consume them. (Then they would be “purchasers” and not “consumers”, no?) Product should be returned to The Wisconsin Cheeseman® for a refund or replacement. Consumers who believe they may have become ill after consuming these products should contact their health care provider. The Wisconsin Cheeseman® has not received any complaints or reports of illness associated with these products.
Listeria monocytogenes bacteria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Listeria monocytogenes bacteria often experience fever, severe headaches, stiffness, diarrhea, nausea and abdominal pain. In rare circumstances, infection with Listeria monocytogenes bacteria can result in miscarriage or stillbirth among pregnant women.
Yeah, I’ve got nothing left on this one.
~Posted by D.M. Schwadron, Esquire
I'm not a medical doctor, but this sounds like a bad idea…
Source: BBC Health; The Lancet
All it takes is one editorial…or something like that. The respected Brit Medical journal The Lancet has published an editorial tied to a current study by physicians in the U.S. and in Greece on obesity and antibiotic dosage. The argument? With rising waistline sizes, the doses of antibiotics currently administered to patients need to rise as well.
Why? Simple really. The size and density of body fat can significantly alter the efficacy (that’s a fancy word for how well it works) of antibiotics. More fat creates the need for more antibiotics which brings me back to our current theme –antibiotic resistance. More antibiotics being administered creates the potential for more resistant bugs.
Europe you aren’t immune either (Yes, pun intended), currently 1 in 4 adults in England are classifiable as “obese”. This is up 15% from 1993 numbers according to the BBC. You gave us law and language and we gave you fast food. Ahh…the beauty of cultural exchange.
At any rate, I’m not following the call for higher doses of already powerful and very prevalent antibiotic and antimicrobial medications. We’ll see if I’m right in the long term.
~Posted by D.M. Schwadron, Esquire
Friday FDA Alerts, declare your dairy!
Source: U.S. Food & Drug Administration
San Bernardino, California (January 9, 2010) – Rudolph Foods is recalling 39 cases of Pepe’s Louisiana Hot Gigante Cracklins, 3,537 cases of 7-Select Louisiana Hot Onion Rings and 420 cases of Rudolph’s Louisiana Hot OnYums, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. (Personally, I like a nice glass of milk with my Hot Cracklins, but then I don’t have lactose “issues.”)
Pepe’s Louisiana Hot Gigante Cracklins were distributed in Southern California. Rudolph’s Louisiana Hot OnYums and 7-Select Louisiana Hot Onion Rings were distributed in California, Nevada, Oregon, Arizona and Washington State. (Oddly none are actually distributed in product namesake, Louisiana…)
The products being recalled are the 3.5 oz. Pepe’s Louisiana Hot Gigante Cracklins with UPC # 0-24622-51131-7 and code date March 19, 2010; 1 5/8 oz. 7-Select Louisiana Hot Onion Rings with UPC # 0-52548-05785-5 and code dates February 26, 2010 through April 30, 2010; and 8 oz. Rudolph’s Louisiana Hot OnYums with UPC # 0-24622-57079-6 and code dates February 5, 2010 and March 12, 2010. Please reference 4-digit manufacturing codes that include an “s”, located beneath the sell by date, for affected products.
No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the manufacturer inadvertently placed the wrong packaging on these products that did not reflect the presence of the milk ingredient.
Consumers who have purchased any of the above are urged to return them to the place of purchase for a full refund. (Really? Just throw them out. How much could Craklins cost?) Consumers with questions may contact Todd Zwiebel, Corporate Quality Assurance Manager, Rudolph Foods at 800-342-7546 ext.112.
~Posted by D.M. Schwadron, Esquire
Friday FDA Alerts, your Listeria is in my cheddah…
Source: U.S. Food & Drug Administration
It may be Heluva good, but right now it’s heluva contaminated.
Lynnfield, MA – HP Hood is recalling select Heluva Good branded 8 oz. plastic cup containers of Cold Pack Cheese Food because they may contain Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness and nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
No illnesses have been reported to date in connection with the product and codes listed below.
8 oz. plastic cup containers of Heluva Good Port Wine Cold Pack Cheese Food
UPC 73570 55503
Sell by date between 11/15/2010 through 12/15/2010
8 oz. plastic cup containers of Heluva Good Sharp Cheddar Cold Pack Cheese Food
UPC 73570 55501
Sell by date between 11/15/2010 through 12/15/2010
The recalled products were distributed in stores in the following states: New York, Pennsylvania, New Jersey, Maryland, Delaware, Ohio, Virginia, West Virginia, Maine, New Hampshire, Connecticut, Massachusetts, Vermont and Rhode Island.
The recall is being done as a precaution and is the result of a sampling done by the state of Wisconsin (from the facility that co-packs products under the Heluva Good brand) which revealed that some finished products contained the bacteria.
Consumers who have purchased these products are urged to return the products to the place of purchase for a full refund. Consumers with questions can call Heluva Good Consumer Affairs at (800) 242-2423.
~Posted by D.M. Schwadron, Esquire
Why you should use a fork…
Source: AP News; Stuff.co.nz
Shangdong (no, I’m not making that up) Province China. Li Jingchao (aren’t you happy we have child privacy laws now haters?) a 14 month old toddler is in recovery at Bo Ai Hospital Beijing. Swine flu? MRSA? No, chopsticks. Wait…what?!
Little Li was apparently “playing” with the chopsticks when he somehow fell onto one of them, lodging it 4 mm (about a foot for the metrically challenged -Like they’ll know) into his brain through his nostril. Mom, was washing dishes at the time. Due to inadequacies of the local hospital (welcome national health care) the family traveled over 10 hours by car for the removal procedure. He’s said to be resting comfortably with only slight bleeding and an infection. Yeah, I’ve nothing else to say.
~Posted by D.M. Schwadron, Esquire.
From the 'how cool is that?' file, bone from rattan?
Source: BBC News
Okay before you get all grossed out a little information for all of you, bone used for transplant currently is either your own (taken from a portion of your leg or spine) or from a cadaver donor (yes, that’s from a dead person. “That’s Frankensteen.”) So wood isn’t looking so bad now, huh?
Italian scientists, having completed their new tanning and hair products for the Jersey Shore, (I kid) have turned their attention to replacing bones with pieces of rattan, yes the same as in your wicker furniture. Well, not entirely the same.
After cutting the rattan they add carbon (for all you counting your carbon credits, bear in mind we are carbon-based life forms) and calcium under intense heat and pressure to create…bone. The rattan has a similar structure to bone allowing blood vessels and nerves to create pathways through it to keep it nice and healthy.
So far the product has been used on sheep (no shepherd jokes please) with promising results. Apparently with months it becomes difficult to distinguish the faux bone from the real. So with advance apologies to environmental groups and PETA, this really is an impressive and potentially helpful advance in human medical science.
~Posted by D.M. Schwadron, Esquire