Monday, November 08, 2010

November 2010 Georgia Reglan News




The U.S. Solicitor General has asked the U.S. Supreme Court to reject an appeal by pharmaceutical companies in a generic Reglan lawsuit, in a case known as the Mensing decison.

The manufacturers of the generic Reglan, metoclopramide, are seeking a reversal of an appellate court decision that holds them liable for failing to warn patients about the risk of tardive dyskinesia, a rare movement disorder linked to the drug. The Supreme Court asked the U.S. Solicitor General for an opinion on the accountability of generic Reglan manufacturers.

The Solicitor General supported the appellate court ruling in an amicus brief that had been filed a week ago.  “The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the brief said. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”

Thursday, November 04, 2010

FDA Receives Complaints Associated With the Use of Brazilian Blowout

Logo for the United States Occupational Safety...Image via WikipediaTheFDA has recently received a number of inquiries from consumers and salon professionals concerning the safety of “Brazilian Blowout” and similar “professional use only” hair care products. The following information is intended to answer questions people may have on this subject.
Has FDA received reports of problems related to these products?

FDA has been notified by some state and local organizations of reports from salons about problems associated with the use of Brazilian Blowout, a product used to straighten hair. Complaints include eye irritation, breathing problems, and headaches. State and local organizations with authority over the operation of salons are currently investigating these reports. FDA has recently received some adverse event reports on
Brazilian Blowout from salon personnel or consumers. These reports included symptoms similar to those in the reports received by state and local organizations, as well as symptoms such as rashes and fainting.

What is FDA’s role in regulating these products?
Although FDA does not have authority over the operation of salons, we do have certain authority over hair straighteners and similar cosmetic products. To learn more, please see "FDA Authority Over Cosmetics."

Who regulates salon safety?
Workplace safety in general, including air quality issues, is regulated by the Occupational Safety and Health Administration (OSHA). Salons are generally subject to state and local authorities as well, which may specify safety practices such as assuring proper ventilation.

What is FDA doing?
FDA is working with state and local organizations, as well as OSHA, to determine whether the products or ingredients would be likely to cause health problems under the intended conditions of use. The composition of the products and the labeling, including use instructions and any warning statements, will be factors in this determination. One safety issue we’ll be evaluating is whether formaldehyde may be released into the air after the product is applied to the hair and heated.

Link: http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm228898.htm
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Chelation Products Warning Letter from FDA to Dr. Rhonda Henry

From the FDA site,  a follow up to my prior post. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm229243.htm

October 12, 2010
Dr. Rhonda Henry
247 La Costa Ave.
Dayton, NV 89403
Dear Dr. Rhonda Henry:                                                                                 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.drhenry.com in July 2010 and has determined that the products, “Pure Heart,” “Melatonin,” “Flaxseed Meal,” “DHEA” and “Cardio Chelate (H-870)” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].
The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website include:
On a webpage at the Dr. Rhonda’s Health Store entitled, “Lose Weight Permanently By Eating”:
Pure Heart
• “[T]here is a completely safe … therapy that can prevent and even reverse heart disease”
•  “The results showed a superior clinical improvement in the Pure Heart group including:
o Decrease of LDL cholesterol
o Increase of HDL cholesterol
o Moderate to Dramatic decrease in angina
o Increase in total blood flow through previously occluded vessels
o Improvement in feeling of depression
o Recovery of myocardial function in previous ischemic and necrotic areas
o Reduction in tachycardia upon stress exercise”
• “The ingredients in Pure Heart appear to be capable of partially or completely reducing ischemia.”
•  “Pure Heart was created to help prevent the changes in the blood vessels which result in heart disease.”
Melatonin
• “Melatonin boosts the immune system reducing the likelihood and severity of infectious diseases, it is a super antioxidant that protects cells from free radical damage, slows the growth of tumors, regulates blood pressure, wards off heart disease, prevents cancer....helps control Parkinson’s Disease, stops or delays the formation of cataracts….”
Flaxseed Meal
• “The dynamic health benefits [of Flaxseed Meal] include: lowered blood pressure … and anti-cancer benefits.”
DHEA
• “Research has found DHEA to have significant anti-obesity ... anti-cancer effects.”
• [L]ow DHEA levels correlate to increased risk of cancer, heart disease, osteoporosis, obesity, diabetes …”
• “Scientific research has linked increased levels of DHEA with reduced risk of most degenerative diseases ….”
Cardio Chelate (H-870)
• “Oral Chelation Formula Removes Plaque that Clogs and Hardens Arteries.”
• “Ayurvedic Herbs Work on the Cause of Heart Disease.”
• “This balanced herbal formula displays the following properties:
o “Pushkarmul and kut have beta blocking like activity.”
o “Arjuna has antihypertensive calcium channel blocker activity.”
o “Gugul has hypolipidemic and antithrombic properties.”
o “Shankhpushpi, arjuna and jalneem are … antihypertensive.”
o “Kut has antidiabetic properties.”
o “Gugul decreases obesity … ”
• “[B]romelain, an enzyme from pineapple, and Papain … cleanse the arteries.”
• “These enzymes break down fibrin, inhibit clotting and promote normal healing of surface lesions.”
Your website also contains disease claims in the form of personal testimonials. The following are excerpted from a webpage entitled “Dr. Rhonda Henry’s Health Test”:
•  “Recently, an excruciatingly painful arthritis flare up in my knees …. Dr. Rhonda heard of my pain, she came in like an angel, bearing a bag of supplements ….  Within 24 hours, my condition turned around.  The inflammation left, the mobility increased.”
• “8 years ago, I was a very sick person.  I had battled colitis, diverticulitis, Epstein-Barr virus and low blood sugar.  I spent thousands of dollars on tests and doctor bills trying to find an end to all my health problems.  I picked up parasites in the Yucatan Peninsula …. I was down 93 pounds, couldn’t digest food, and was weak
• and dizzy all the time … I now eat and digest my food, lift weights 3 times a week, and have energy to spare.”
The claims quoted above are supplemented by the metatags used to bring consumers   to your website through Internet searches.  The metatags include “diabetes”, “arthritis”, “depression”, “menopause”, “peri-menopause”, “Candida”, “digestive disorders”, “osteoporosis”, and “infections”.
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an inclusive list of deficiencies in your products and their labeling.  It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Juliane K. Jung-Lau, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.  If you have any questions regarding any issues in this letter, please contact Ms. Jung-Lau at 510-337-6793.
Sincerely,
 /S/
Barbara J. Cassens
Director
San Francisco District

FDA issues warnings to marketers of unapproved ‘chelation’ products

The FDA has warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.
 
The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.
 
The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.
 
In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood.  Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.  
 
“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”
 
The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.
 
The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.
 
Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.
 
"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.
 
Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.
 
The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:
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Wednesday, November 03, 2010

Purple Glove Syndrome

An advisory committee of the Food and Drug Administration will consider whether IV phenytoin, marketed as Dilantin, should be relabled or even suspended because of the threat of Purple Glove Syndrome.




PGS is a rare condition first noted in the 1980s, when patients who received IV Dilantin were developing painful, swollen hands that turned a deep shade of violet. Some 43 cases of PGS have been documented, according to the FDA. However, it's very likely the disorder is under reported.

The condition is often caused when the toxic drug doesn’t go directly into a vein, but instead seeps into the underlying tissue of the hand. Often, the damage is permanent.

Another drug, fosphenytoin, marketed under the brand name Cerebyx, appears to control seizures as well as phenytoin, but without the same risk of PGS. Both drugs have similar risks of other side effects.

Source: http://bodyodd.msnbc.msn.com/_news/2010/11/03/5398283-purple-glove-syndrome-leads-fda-panel-to-review-drug

FDA tests confirm Listeria at Texas food plant

CeleryImage via WikipediaTests conducted by the FDA have found Listeria monocytogenes bacteria at a San Antonio Texas Fresh Cut Produce food processing plant after state health officials linked four deaths to contaminated celery from the facility.

A recall was issued on October 20, 2010 citing packages of chopped celery from the facility that had been sold to hospitals, restaurants and schools since January. Although the Fresh Cut Produce products were not sold directly to the public, investigators said they had linked tainted celery to at least six cases of listeriosis.

The listeria bacterium can cause severe illness, with symptoms that include fever, muscle aches, diarrhea and vomiting. Symptoms can occur up to 70 days after exposure. The disease affects primarily older people, pregnant women, newborns and people with weakened immune systems.

Link:http://www.examiner.com/fda-in-national/fda-tests-confirm-listeria-at-texas-food-plant





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Tuesday, November 02, 2010

A Disgraceful/Dangerous Stat: FDA fails to inspect 2,390 Foreign Drug Factories

Logo of the United States Government Accountab...Image via WikipediaThe General Accountability Office has just released a report that the FDA miserably failed to follow through on suggestion to inspect manufacturing facilities outside the USA. The folks at the GAO writes that there is an  “urgent need” to better protect public health.

Some stats from the GAO: In the FDA completed 424 foreign inspections. That more than the 324 inspections conducted in 2008. Also in 2009, 1,015 domestic inspections were completed. That is less than half of all USA run facilities. The GAO report says that equals one inspection every two and half years. Is that acceptable?

There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Is that acceptable?

Find the report here (PDF). Most damning conclusion? The GAO wrote: " Among other things, we determined that, because of inaccurate information in FDA’s databases, the agency did not know how many foreign drug establishments were subject to inspection."




 


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Monday, November 01, 2010

Merck: $950 Million Fine to US Regarding Vioxx

RofecoxibImage via Wikipedia
Merck booked a $950 million reserve in the third quarter to cover an anticipated resolution of a government investigation of the company's former pain drug Vioxx.

Merck, Whitehouse Station, N.J., withdrew Vioxx from the market in 2004 after it was linked to a higher risk of heart attacks and strokes. The company previously settled thousands of personal-injury lawsuits filed by Vioxx users and their families for about $4.85 billion.

The latest matter stems from a Justice Department probe of Merck's research, marketing and selling activities surrounding Vioxx. Merck previously disclosed the government was conducting a criminal investigation of the matter.

The U.S. Attorney's Office in Boston last year sent Merck a letter identifying the company as the target of a grand jury investigation regarding Vioxx.

"The company's discussions with the government are ongoing," said Merck spokesman Ron Rogers


Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201010290807dowjonesdjonline000408%20&title=merck-books-950-million-reserve-to-settle-us-vioxx-probe#ixzz144IpwqIb
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Friday, October 29, 2010

Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)

Another Recall to report:


Product: Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)
This recall pertains ONLY to the 5mL fill in 6mL prefilled saline flush syringe with Normal Saline (0.9% Sodium Chloride), with the following product code numbers:
  • E0100-50
  • 10056-1000
  • 10056-240
  • 14056-240
  • 910056-1000
  • S5
The product code number can be found in the barcode on each syringe as well as on the carton label.
These devices were distributed from August 8, 2008 through August 10, 2010.
Use: The Excelsior Disposable 5mL fill in 6mL prefilled saline flush syringes are intended for the flushing of venous access devices (such as, inserted central catheters) and intravenous (IV) lines.

Recalling Firm:Excelsior Medical Corporation
1933 Heck Avenue
Neptune, New Jersey 07753

Reason for Recall: There is a potential for leaking and loss of sterility. The device failure may result in an infection in the bloodstream which may result in serious injury or death.


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FDA MedWatch - Heparin Sodium (B. Braun): Recall - Trace Contaminant

FdaImage via WikipediaFrom the FDA:

AUDIENCE: Pharmacy, Risk Managers
 
ISSUE: B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.

BACKGROUND: Heparin is a blood thinner used to treat and prevent blood clots.

RECOMMENDATION: Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration dates, and recall instructions are listed in the Press Release.
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source:http://www.spinics.net/lists/fda/msg03307.html 
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Novedex XT Recall News

Gaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced
that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase. Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

Potential adverse events associated with the use of anti-aromatases could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Gaspari has received no serious adverse events in over five years of marketing Novadex XT.

Novedex XT had been sold internationally and domestically, to distributors, wholesalers, retail stores and direct to consumers, but was discontinued by Gaspari Nutrition for domestic sales on October 4th 2010. The product was sold in blue bottles with a black cap, containing sixty (60) capsules.


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Injectable Methotrexate Recalled

The maker of injectable methotrexate is recalling the drug after small flakes of glass were found in some of the medication. The company says this has the potential to damage patient’s blood vessels or lead to swelling and even death, although the company isn’t aware of any reported problems so far.


Methotrexate is a disease-modifying antirheumatic drug, or DMARD. It is one of the most commonly prescribed medications for rheumatoid arthritis, or RA, a disease in which an overactive immune system attacks the joints and other tissues and organs. Methotrexate is taken to slow the progression of RA. It is also used for juvenile arthritis, severe psoriasis and some forms of cancer.

Sandoz, the generic pharmaceuticals division of Novartis in Princeton, N.J., is one of several suppliers of generic methotrexate. The company is voluntarily recalling all of its 50mg/2mL and 250mg/10mL vials of injectable methotrexate that are part of the Sandoz and Parenta brands and have expiration dates ranging from December 2010 to March 2012.

Source here

FDA Questions Diet Pill Qnexa

On Thursday, the FDA sent drugmaker Vivus "complete response letter," detailing the shortcomings in the company's application to sell a prescription diet pill called Qnexa.

What were the potential issues with Qnexa? There were claimed risks ranging from birth defects for babies conceived when women were taking the drug to an increased heart rate common among people taking Qnexa.
Even though people taking the highest doses of Qnexa had lost more than 10 percent of their weight a year after starting the medicine, the risks were too high, the a panel of FDA folks concluded.

For me, the area of prescription diet pills, with their history or problems (Fen Phen and Meridia) is a real worry. Diet and exercise is a lifetime commitment. For some people, a pill may be the only or last resort. Losing weight will never be easy for most folks, and to me it is unrealistic to think that a magic pill will be devised to address real weight loss.       

Similac Recall News for Georgia

A class action lawsuit alleging deceptive business practices has been filed against Abbott Laboratories over claims that the pharmaceutical giant sold millions of tubs of infant powder formula that was contaminated with beetles and beetle larvae.


The lawsuit, which was brought in federal court in Chicago, was filed on behalf of  a mother of a newborn baby boy.  The suit alleges that Abbott knew that its baby formula was tainted for at least six days prior to announcing it to the public.  As a result, the suit claims that the named plaintiff's son, like thousands of babies throughout the country, suffered gastrointestinal health issues as a result of ingesting the tainted formula.

Stay tuned.

Source.

Thursday, October 28, 2010

FDA Asks for Tougher Warnings on GnRH Agonists

The FDA has asked manufacturers of gonadotropin-releasing hormone (GnRH) agonists -- a class of drugs used primarily to treat prostate cancer -- to add new warnings about the potential risk for heart disease and diabetes.


Earlier this year the FDA recommended that the risks of GnRH agonists be carefully considered before beginning treatment, but Wednesday's announcement solidifies the FDA's growing concerns with GnRH agonists.
Earlier this year, the American Heart Association, the American Urological Association, and the American Cancer Society issued a joint advisory warning of the increased risks of diabetes, myocardial infarction, stroke, and sudden death among men who use androgen deprivation therapy (ADT) to treat prostate cancer. GnRH is the most common form of ADT.

The groups did not offer specific guidelines for clinicians on when to employ ADT therapy or when to avoid it.

Clinical trials have shown that ADT increases body weight, decreases lean mass and increases fat mass, reduces insulin sensitivity, and triggers or worsens dyslipidemia.

Source: http://www.medpagetoday.com/Urology/ProstateCancer/22887 

FDA Warns Makers of Enfamil

Enfamil FormulaImage via WikipediaThe FDA has warned Mead Johnson Nutrition Co.  about the packaging for some of the company's Enfamil infant formulas.

In a letter dated Oct. 18 that was posted to the agency's website Tuesday, FDA said Mead Johnson didn't give the FDA product specifications about a new plastic tub and lid that is used to store certain types of Enfamil powdered formula.

Earlier this year, Mead Johnson introduced a reusable tub for Enfamil formula that allows consumers to buy refill packages of formula to store in the container.

The FDA said the plastic tub is a "food contact surface." This would require the company to "evaluate the effect of changes in processing conditions that could affect the level of nutrients in the finished product," FDA said.

The FDA said Mead Johnson did notify the agency in February about its plans to start making powdered formula in "multi-serve pouches," but didn't provide an evaluation of the plastic used for the tub and lid.
In a statement, Mead Johnson said the company had believed that it had submitted all required information and had been received a notice from the FDA that indicated the agency had no additional questions.

Source: http://online.wsj.com/article/BT-CO-20101026-713901.html
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Study Suggests that Gene Mutations May Limit the Effectiveness of Plavix

A box of PlavixImage via WikipediaPeople with certain gene variants who take the blood-thinning drug Plavix (clopidogrel) may be at increased risk for serious complications after coronary stent placement, a new study finds.


Having the gene variants seems to reduce the effectiveness of Plavix and put patients at higher risk of developing blood clots in the stent, suffering a heart attack or stroke, or even dying, according to the research.
"Clopidogrel is one of the most commonly prescribed medications worldwide," said lead researcher Dr. Jessica L. Mega, an instructor in medicine at Brigham and Women's Hospital and Harvard Medical School in Boston.

Source: http://www.nlm.nih.gov/medlineplus/news/fullstory_104812.html
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Wednesday, October 27, 2010

Elections 2010: Shame on the Campaign Spammers

2010 United States Senate electionsImage via WikipediaThis election has - at least for lawyers- spawned the worst of all election campaigns - the constant barrage of unwanted, unwelcome, and automated emails that have angered many. What am I talking about you say?
 It seems that some lawyer groups I belong to have their membership emails harvested by campaigns. Perhaps it's because I voted  a certain way, or filled in a survey somewhere, or perhaps my email address was passed along by a (so-called) friend.

Here's what happens: My email gets on a list, like "Georgians for Electing JoeBob Smith" or some other group. They send one email updating me on some campaign for some person I can't vote for b/c I'm not in that district. So, I send an email telling the campaign to stop. Next  week,  more JoeBob emails. And, now there are 2 more groups that have my email - "Friends of JoeBob" and "Independents for JoeBob." Add an email a day from each one. Folks, we don't care.I even called a campaign  and asked to be removed from the email list - the same day? Another campaign email. 

It's no longer enough for me to get emails like that for candidates  in my state (Georgia). I somehow got on a list for Florida candidates, Alabama, and lastly, South Carolina. I was asked to "max out" - contribute the maximum allowed under a State's election laws - for someone I never heard of in S.C.I have even resorted to sending an irate email with a "RE" line that says "stop the damned emails" and they still keep coming.




I've moved emails to spam, only to be thwarted by a work around email


I've been asked to contribute --via email only mind you --$25,000 to one group, $5,000 to a Florida candidate, and more to others down the ballot. In the last three days, I have more than 150 emails from candidates I don't know, people I don't like, and groups for ballot initiatives in states I have not visited.

The internet has one massive failing - it allows  for senseless email solicitations that completely lose effectiveness. Worse, they are automated. I did contribute to one candidate in Georgia, a decent sum, and the next day I got an email asking me to donate.

So, my message to candidates now and in the future  - spare us. Don't become a spammer we detest. Pick
 up the phone. Raise money the old fashioned way. Mind the email accounts so when you see someone complaining, you respond. Because I have to tell you, if you can't respond to an email when you want my money and my attention, do you think I will vote for you? What happens when I need you after you are electeD?
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Tuesday, October 26, 2010

GA Lawyers: Scam Alert

This is a scam similar to the one that has ensnared lawyers in Florida. Be aware of this one, either by the named person, or something similar. Copy of a 'contact' that come to my website:


Name:Paulina Risto
Email:paulinaristo@live.com
Phone: Phone
Comment:Dear Counsel,

My name is Ms Paulina Risto. I was married to my ex husband Matthew Risto for 7 yrs and in Dec 2008, We mutually agreed under a Collaborative Participation Law Agreement to go our separate ways. Dino had agreed to pay me $700,000.00 under terms of the agreement so that I can settle down and to his credit; he has paid me $50,000.00 but with an outstanding balance of $650,000.00. I am hereby seeking your legal assistance in collecting the balance or helping me enforce the agreement, and have him honor the agreement in entity.

I will be providing further information upon your request. I believe that one of the reasons he has refused to pay is because I deaf. Prior to our separation due to irreconcilable differences, we were married for 12yrs of which by his instruction, I was a full time house wife to carter for our two children.

Please get back to me if this is a case you can undertake. I would love to contact you via telephone but i am deaf. I will not hear any you say on the phone. The only means of effective communication is via emails. I am hereby seeking your firm to assist in collecting the balance from him. He has agreed already to pay me the balance but have failed several times to keep to his promise of making the payment. it is my belief that a Law firm like yours is needed to help me collect payment from my ex-husband or litigate this matter if he fails to pay me this time around.

I have contacted you because my ex husband reside in your jurisdiction.

Also note that i am a poor woman who is trying to settle debts that i have owed people. I can only work with on contingency basis because i can't pay lawyer fee.














Four Loko under Scrutiny

Drinks that mix alcohol and caffeine are under scrutiny once again after dozens of Central Washington University students got sick and nine were hospitalized after claiming they had been drinking Four Loko.
alcoholic energy drinks

The maker of Four Loko says it's upset about the products being abused and consumed illegally by underage drinkers, according to a statement on the company's website.
Also on the website, a description of Four Loko's lemon-lime flavored drink:
A wild blend of tart Lemon flavor, with a sharp Lime twist, 12% alcohol and modern day ingredients such as Caffeine, Guarana and Taurine, all packed into a huge 23.5 ounce can.

 From Wiki:



Four Loko 'a $2 blackout in a can', is made from mixing a stimulant (caffeine) with a depressant (alcohol). When people combine the two, they tend to not feel the alcohol as much since the caffeine is keeping them more alert.

However, when the caffeine wears off, then the person feels the full effects of the alcohol. This often causes the consumer to drink more than they normally would because of the delayed 'drunk' feeling. [7]
A study done at the University of Florida in Gainesville, Florida found that students who mixed caffeine and alcohol tended to think they were capable of driving more often than those who drank non-caffeinated alcoholic drinks. http://en.wikipedia.org/wiki/Four_%28drink%29



 More info here: http://www.8newsnow.com/story/13386629/attorneys-general-look-to-ban-alcoholic-energy-drink
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