Tuesday, August 23, 2011

Dangerous Supplement? Pai You Guo Poses Risk

In 2009, the Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo and issued 
alerts about the supplement's potential health risks.

The new study found nearly a quarter of Brazilian-born women surveyed in Boston use Pai You Guo. No one who took the supplement was aware of the recall, and most experienced side effects.

The article shows once again how ineffective the FDA is when it comes to any recall. Nearly 25% of those women in the study were still using the product. 

Read more: http://www.foxnews.com/health/2011/08/16/dieters-may-unknowingly-buy-dangerous-weight-loss-supplements/#ixzz1VrBaztel

Analysis Continues of Fallout From FDA's SSRI Warning

From Psychiatry Online:

The “black box” warning on antidepressants appears to have affected the likelihood of making an outpatient visit for depression, but not of receiving an antidepressant prescription following a diagnosis of depression.
The number of children's outpatient office visits for depression and visits during which an antidepressant was prescribed dropped in the wake of the 2003 U.S. Food and Drug Administration (FDA) advisory linking an increased risk of suicidality with antidepressant use among pediatric patients.
Yet children diagnosed with depression appeared no less likely to be prescribed antidepressants than before the warning, according to an analysis appearing in the July Psychiatric Services.
Read more at the source:http://pn.psychiatryonline.org/content/46/15/18.1.full

Wednesday, August 10, 2011

Georgia: Actos and Cancer Claims = Lawsuits

From various sources including the  AP and Yahoo.

This summer, Takeda Pharmaceuticals Co. Ltd. stopped sales of Actos in both France and Germany. After that decision  FDA issued warnings about the cancer risk based on new research, but they have allowed sales to continue. 

Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.

In the past week, the first of what lawyers predict will be thousands of lawsuits were filed in courts across the country. It is claimed that Actos triggered bladder cancer, in some cases fatal, in clients who took the pills 

Thursday, August 04, 2011

Georgia High Schools Fail to Protect Players from Oppressive Heat

A guest post from a well respected lawyer in Georgia. I'm angry today. Angry that two high school teenagers died this week while exercising in heat that exceed 100F in some parts of Georgia. The article on these needless deaths is found here:


Take a read and tell me what you think.

By: Buddy Morrison
Butler, Wooten & Fryhofer, LLP

  Football is the South's favorite fall tradition.  While the games are usually played on cool autumn nights, high schools begin their preparation in August, during the most brutal heat of the year.  Unfortunately, practicing this fall sport in the dog days of summer is a dangerous and often deadly mix.  Already this year two Georgia high school students have died from heat exposure during football practice - two deaths that were entirely avoidable and treatable.

Georgia high schools were allowed to begin "mandatory" outdoor football practice on Monday, August 1, in the middle of an oppressive heat wave.  On Tuesday, two Georgia teenagers died after practicing in that heat.  On Tuesday morning, Fitzgerald High School defensive lineman DJ Searcy, 16, died after practice with his team's football camp in Lake CityFlorida.   Later in the evening, Locust Grove High School offensive lineman Forest Jones, 16, died after passing out and spending a week in a coma after a voluntary workout with his team.

These two deaths come on the heels of a report by the CDC that nearly one-fourth of all emergency room visits for heat illness are attributable to football, and that August is the most common month for heat illness to occur.  Over the past fifty years, hundreds of football players have died from heat-related illnesses - with most of those deaths coming in the first couple of days of practice. 

Unfortunately, Georgia schools are not doing nearly enough to protect students.  The Georgia High School Association (GHSA) and its member schools have failed to properly regulate practice in the heat in order to prevent the onset of heat-related illness.  Even after these two recent deaths,Georgia high school coaches are still subjecting children to overexertion in dangerous heat conditions.  Even worse, schools are not taking adequate steps to diagnose heat illness.  Finally, even when heat illness is diagnosed, schools are not taking simple steps that would make death from heat illness entirely preventable.  August football practices at Georgia high schools are unreasonably dangerous. 

In response to Tuesday's deaths, the GHSA shifted responsibility by noting that it requires individual schools to submit their own written policies for practicing football in the heat.  The GHSA has also been conducting a study with Michael Ferrara, Ph.D. at the University of Georgia, to study the relationship between heat levels and heat illness, but that study has not yet been completed.  The GHSA stated that it may implement a uniform heat policy in the future.

The GHSA began requiring heat policies from its member schools five years ago, when a RockdaleCounty football player suffered a heat-related death.  The policies must specify the time of day practices may be held and the amount of time allotted to rest at various heat/humidity levels, as well as set a maximum heat/humidity level where outdoor practices must be terminated.  Essentially, the school must implement a sliding scale related to the heat index - when the heat index is X, practice must start before Y.  When the heat index reaches Z, practice must be canceled altogether or moved indoors.

The "sliding scales" drawn up by the individual schools vary widely from district to district.  Dr. Frerrara noted that "we have seen some policies that have been conservative while others have allowed practice to continue in extreme conditions."  More importantly, the policies do not apply to "voluntary workouts" during the summer - only to "mandatory" workouts.  So long as the players are not required to be at the workout, the coach can hold the workout in any manner he chooses regardless of the heat index.  According to the GHSA, both of the players who died this week were participating in "voluntary workouts" not subject to the GHSA or school regulations.

Even for the "mandatory" practices, including the critical first week of practice beginning August 1, GSHA schools are not required to submit written guidelines for the total amount of time spent practicing, the type of equipment worn, or procedures for diagnosing and treating heat illness. Instead, the GHSA practice rules simply provide that "mandatory" practice may begin on August 1, and that in the first five days of practice, at least two days must have "players dressed in shorts, helmets, shoulder pads, mouthpieces and shoes only."   For the other three days, players may wear full pads.  Further, schools can have "voluntary workouts" at any time, where the players may only wear helmets and mouthpieces. 

The GHSA and its member schools need not apply such a haphazard set of rules - uniform, comprehensive guidelines for practicing football in the summer are not hard to find.  In 2009, the National Athletic Trainers' Association (NATA) issued comprehensive guidelines for beginning football practice that are stricter than even the GHSA practice-time rules.  The NATA recommends that the first two days of practice be helmets-only and that the next three days be limited to helmets and shoulder pads.  The NATA further recommends that an athletic trainer be present at every practice, only one practice per day during the first five days of practice, a maximum of three hours of practice during the first five days, and no consecutive "two-a-days" (two practices in one day) during the second week of football practice. 

It is clear that, even in the wake of these two deaths, some Georgia coaches are not taking the risk of heat illness and death seriously.  This week, Temple High School and West Hall High Schoolkicked off their football camps with three-a-day workouts, and continued doing so even after Tuesday's tragic news.  Schools throughout the state are still conducting two practices a day.   Although many schools, including Atlanta public schools, have canceled outdoor afternoon practices during the heat wave, other schools around the state have not altered their practice plans in response to the oppressive heat. 

Other coaches mistakenly place the responsibility for proper heat acclimatization on the players themselves.  The coach of Mt. Zion High School attributed heat issues to players "laying on their couch all summer."  The coach of Carrolton High School suggested that players participating in the "voluntary workouts" handled the heat better than other players.  (The NATA guidelines call for proper heat acclimatization for all players - even those who do not participate in the "voluntary workouts" throughout the summer.)  Marion County High School actually depended on the voluntary workouts to get players acclimated to the heat.  Coach Mike Swaney observed: "If you let the kids stay home in the air conditioning and let them play video games and watch TV -- if they don't do anything all summer -- they will be in a situation where they'd be in a state of shock to come out in this kind of heat."

Not only are Georgia high schools failing to take adequate measures to prevent heat illness, they are also failing to adequately diagnose and treat symptoms.  Although most coaches now allow players to take a break and rehydrate whenever necessary, "sometimes coaches confuse heat stroke with goofing off, so they push the players harder," said William Roberts, M.D., former president of the American College of Sports Medicine. 

The most effective way to determine if a particular athlete is suffering from heat illness is with a rectal thermometer.  A body temperature of over 104 degrees Fahrenheit is considered to be heat stroke.  High schools are not using the best objective method to diagnose heat stroke.  Depending on the athlete to volunteer that he is experiencing symptoms is not enough - first, athletes often fail to report symptoms to exhibit their "toughness," and second, an elevated core temperature decreases the athlete's cognitive ability and judgment. 

Even when a player does show symptoms of heat illness, teams often fail to take adequate steps to protect their players from further damage.  Water, rest, and shade are not enough.  Death from heat stroke is 100% preventable, but it requires immediate and correct medical attention.  "You have to diagnose [heat stroke] quickly and treat it quickly or a cascade of bad events starts to happen," Dr. Roberts said. Players who show signs of heat illness should be placed in a tub of ice water, which can reduce body temperature from above 108ºF to below 102ºF in 20 to 40 minutes.   Rehydration alone cannot stop heat stroke quickly enough.  According to Douglas Casa, Ph.D., director of athletic training education at the University of Connecticut, if teams kept a "kiddie pool" of ice water available at practices, they could prevent heat-related deaths.  Even in August's sweltering heat, most football teams fail to take this simple precaution.

While heat illness is more prevalent in high school football than other sports, no student-athlete is immune from its effects.  Baseball, soccer, and cheerleading all have their share of heat-related illnesses, as confirmed by the CDC report.  Also during this time of year, the marching band practices alongside the football team in the blazing heat.  Notably, these sports and activities lack even the superficial safeguards that have been implemented for football. 

This week has reminded us that mixing fall football with August heat is a deadly combination.  Unfortunately for Georgia's student-athletes, schools are making football unreasonably dangerous by requiring too much practice in the heat and failing to properly care for players who suffer from heat illness brought on by that over-exertion.  Two sixteen-year-old boys died on Tuesday from a condition that was both 100% avoidable and 100% treatable. 

Tuesday, August 02, 2011

August 2, 2011 Transvaginal Mesh News: Ethicon Gynecare Study

News on the mesh failures continues. 
The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems were first brought to market in the fall  of 2005 and Gynecare Prolift+M variations were introduced in  2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus, the rectum the top of the vagina or the bowel.

A conducted by European researchers suggested that most of the reoperations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.
Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh between January 2005 and January 2009. At a median follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. About 6.9% of those reoperations were due to urinary incontinence, 3.6% due to mesh-related complications and 3% due to recurring prolapse, which the mesh is designed to treat. 

Antipsychotic Meds Not Effective for Combat PTSD

Worth a read from ABC News.com:

Risperidone, antipsychotic medication normally prescribed to treat symptoms of schizophrenia and bipolar disorder, may not be effective in treating symptoms of chronic post-traumatic stress disorder, according to a study published Tuesday in the Journal of the American Medical Association.

Risperidone is commonly prescribed as an add-on treatment for veterans with the more severe forms of PTSD who do not respond to antidepressants.

FDA calls ‘Lazy Larry’ Brownies Unsafe

The FDA has warned the manufacturer of melatonin-laced brownies called “Lazy Larry” that the government considers them unsafe and could seize them from store shelves.

The brownies contain melatonin. The FDA wrote: We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders

Here is the letter:

The Food and Drug Administration (FDA) has reviewed the regulatory status of your product, “Lazy Larry” (formerly “Lazy Cakes”). Your “Lazy Larry” product is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170. You can find copies of the FDCA and these regulations through links on FDA’s home page at http://www.fda.gov.
Your “Lazy Larry” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)].  Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:
- the product is marketed alongside snack foods;
- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
- the appearance and packaging of the product as a brownie.