A recall that began in August with 804,000 full-size pickup trucks and SUVs in 14 states has been extended to include an additional 553,000 vehicles and six more states as well as the District of Columbia, according to General Motors Corp.

The problem involved is the unwanted application of the anti-lock brake system that can cause increased stopping distances during low-speed braking. More than 200 crashes and some minor injuries have been linked to the problem described in the recall.

All of the affected vehicles are from the 1999 to 2002 model years. The specific vehicles being recalled include the Chevrolet Avalanche and Silverado pickups and the Chevrolet Suburban and Tahoe SUVs. The GMC Sierra pickup and Yukon and Yukon XL SUVs are also affected.

As of January 1, 2006, the Food and Drug Administration (FDA) is requiring all foods containing any ingredients that include protein from the eight major allergenic foods be clearly labeled as such.

This new labeling regulation has been implemented pursuant to the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which requires manufacturers to clearly state (in plain English) the presence of ingredients that contain protein derived from:

1)    Milk
2)    Eggs
3)    Fish
4)    Crustacean shellfish (like shrimp)
5)    Tree nuts
6)    Peanuts
7)    Wheat
8)    Soybeans

The label must either list the ingredients or say “contains” and then name the food allergen source.
According to Robert E. Brackett, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition: "The eight major food allergens account for 90% of all documented food allergic reactions, and some reactions may be severe or life-threatening. Consumers will benefit from improved food labels for products that contain food allergens."

The agency believes the new labeling practice will help children learn to recognize the presence of food they cannot tolerate. The labels will not only list the food itself, but the specific protein it is derived from that may trigger an allergic reaction.

The FDA release states that and estimated 5% of infants and children and 2% of adults in the U.S. have food allergies. Food allergies are dangerous and potentially fatal. They can be triggered by even trace amounts of the allergen. According to the FDA, each year 150 Americans die and some 30,000 are treated in emergency rooms because of allergic reactions to food.

Consumers are warned that during the transition period, products may still carry old labels. Thus, they should be cautious with respect to food items that have been in stores or at home since they may have been labeled before the effective date of the regulation.

This lag is to be expected. Moreover, the ruling does not require food manufacturers or stores to remove targeted food items from shelves or to re-label products that were labeled before January 1, 2006.

For more information about FALCPA, visit FDA’s food allergy page at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.

A comprehensive investigative report by the Boston Globe has found that, even though they fail to meet voluntary patient-safety guidelines, at least five Massachusetts hospitals continue to perform obesity surgery. But starting in 2007, Blue Cross and Blue Shield of Massachusetts, the state’s largest health insurer, will no longer pay for the procedure at hospitals that do not meet these and other standards.

In the wake of a highly publicized patient death, the state-appointed committee of health officials urged (in August 2004) that the medical community in Massachusetts adopt strict standards for gastric bypasses and other popular obesity surgeries.

The committee offered several suggestions to hospitals, one being that they handle more than 100 cases per year, and that individual surgeons perform a minimum of 50 operations per year.

The Globe surveyed hospitals that did not meet this volume standard in 2004 and found that at least five hospitals still perform obesity surgery, even though they treat fewer patients than recommended by the committee: Caritas St. Elizabeth’s Medical Center in Boston, Morton Hospital in Taunton, Beverly Hospital, Tobey Hospital in Wareham, and Winchester Hospital.

Although the hospitals did between seven and 70 of the surgeries during the fiscal year that ended Sept. 30, 2005, they defended their programs.  Several said they expect to exceed 100 cases by the time the Blue Cross payment policy takes effect in 2007.
The panel had other recommendations for hospitals and doctors, including how to train surgeons, the level of hospital staff expertise, and how to select patients. The Globe did not ask hospitals whether they comply with these recommendations, however.

According to state officials, 22 Massachusetts hospitals performed 3,040 obesity surgeries in the fiscal year that ended Sept. 30, 2004.  Just 402 obesity operations were performed in 1998.

On average, obesity surgery carries a 1% risk of death and a 1% to 15% risk of complications, according to the panel. A recent study found that the risk of death is elevated for the elderly: 2% within 30 days of surgery and 4.6% within a year.

Blue Cross spent $20.5 million to cover obesity surgery for 1,214 members in the year ended June 2004. Executives at Blue Cross believe that the surgery should be done only at hospitals that demonstrate high-quality care and a good performance record.

"We know there is a significant variability in care across Massachusetts," said Dr. John Fallon, Blue Cross’s chief physician executive and a member of the committee that developed the surgery guidelines.

Hospitals will receive applications from Blue Cross next month, asking for detailed information on obesity surgery programs. The hospitals will have one year to comply with the panel’s recommendations.

The Consumer Product Safety Commission, in cooperation with Simplicity Inc., of Reading, Pennsylvania, has announced a voluntary recall of some 104,000 Aspen 3 in 1 Cribs, sold under the Graco Trademark. Consumers should stop using recalled products immediately.

The screws on the wooden mattress support can come loose allowing a portion of the mattress to fall, posing a suffocation hazard to young children. Simplicity Inc. has received 14 reports of the mattress support coming loose, including eight reports of entrapment. Five injuries have been reported including scratches and bruises to the face and head, a strained neck and a report of a child turning blue.

The recalled cribs were manufactured in China and are made of wood and have a wooden mattress support. Only cribs with wooden mattress supports and with model number 8740KCW SC and serial number 2803 SC to 1605 are included in this recall.

The model and serial number are printed on the envelope attached to the mattress support.

The cribs were sold at department stores, and children’s product stores from August 2003 through May 2005 for about $130. Consumers should call Simplicity Inc. to receive a retrofit kit.

For additional information, contact Simplicity Inc. at (800) 784-1982 anytime or visit the Web site at www.simplicityforchildren.com.

As far back as the late 1930s, intranasal zinc sulfate solutions were used to prevent polio. The products were removed from the market because they proved unsuccessful and due to that some users suffered a loss of smell. Since that time, a number of medical researchers have claimed there is a link between products containing zinc and possible nerve damage.

Neurotoxins act specifically on nerve cells (neurons) usually by interacting with membrane proteins and ion channels. Environmental neurotoxins are known as exogenous and include gases (carbon monoxide), metals (mercury, lead, zinc), liquids (ethanol) and a multitude of solids. When exogenous toxins are taken in, the effect on neurons is largely dependent on dosage and duration.

Of course, since the senses of smell and taste (like the other senses) rely on a sophisticated network of neurological processes, any neurotoxin has the potential to interfere with or even damage or destroy them.

It is because of these facts that there a serious controversy over the safety of over-the-counter (OTC) zinc-based, homeopathic medications like Zicam that claim to shorten the duration of the common cold.

The maker, marketer, and seller of Zicam (R) Cold remedy nasal gel, Zicam, LLC (a wholly owned subsidiary of Matrixx Initiatives, Inc. an OTC drug developer, manufacturer, and marketer) has steadfastly defended its product as being safe.

Only last year, in a press release, Matrixx claimed that any reports alleging anosmia (loss of smell) associated with Zicam(R) Cold Remedy zinc products “are completely unfounded and misleading.”

Matrixx asserted that any research linking nasal products containing zinc to the onset o f anosmia were erroneous because the compound found in the 1930s products was concentrated zinc sulfate as opposed to the zinc gluconate found in Zicam. Zinc sulfate “is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide,” while “zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate, a naturally occurring, non-toxic compound found in all human tissue.”

Unfortunately, the FDA does not test cold remedies containing soluble zinc for safety or efficacy and, thus, it was not until late 2004 that the agency only began to take notice that there might be a serious risk posed by the products.

By that time, however, researchers at University of Colorado Health Sciences Center Taste and Smell clinic had already documented the loss of smell among Zicam users for over a year. In addition, a number of lawsuits had been commenced around the U.S. alleging anosmia as an injury that could occur with as little as one application of the Zicam nasal gel.

The problem had also been presented for discussion at the September 2003 meeting of the American Rhinologic Society. Clearly, there was much more to this than the simple denial issued by Matrixx.

Now, a major plaintiffs’ personal injury firm has announced it has filed suit against Matrixx Initiatives, Inc. Zicam, LLC, and Botanical Laboratories, Inc., on behalf of a woman who claims to have lost her senses of smell and taste after using Zicam Cold Remedy nasal gel.

The lawsuit was filed Tuesday in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana, by Parker & Waichman, a New York based firm that is heavily involved in pharmaceutical litigation throughout the country.

The suit alleges that in December 2003, the plaintiff began using Zicam Cold Remedy nasal gel to relieve her cold symptoms. After using the product as directed, however, she began to experience a loss of her sense of smell and her sense of taste and has never regained these senses completely.  She has been diagnosed as having a permanent partial loss of the senses of smell and taste.

The loss of the senses of smell and taster can have very serious consequences aside from the obvious loss of the enjoyment and pleasure associated with the exercise of those senses. Danger areas documented by studies of people suffering from the loss of these senses include: cooking related accidents; exposure to undetected fires, smoke, or gas leaks; eating spoiled foods or toxic substances; and other situations where either of the senses is a primary method of detection of sensory information.

In addition, the loss of these senses can cause collateral damages such as to anyone engaged in a profession where smell or taste is a critical requirement (chef; taste tester; cosmetics and perfume industry; wine, beer, or spirits industry).

Jerrold Parker, managing partner of Parker & Waichman stated: “Despite numerous reports that Zicam Cold Remedy nasal gel causes anosmia, Matrixx continues to market this product at the expense of consumers’ health. Furthermore, there is little evidence to suggest that Zicam is effective at relieving the symptoms of the common cold.  Because the product has few benefits and poses major health risks, Matrixx should promptly remove it from the market.”
 
In addition to alleging the dangerous nature of the zinc-based gel itself, the lawsuit claims the product label, promotional materials, and advertisements used in conjunction with the sale of Zicam Cold Remedy Nasal Gel did not provide sufficient warning and instructions about the risks and adverse side affects associated with the use of the product.

As far back as the late 1930s, intranasal zinc sulfate solutions were used to prevent polio. The products were removed from the market because they proved unsuccessful and due to that some users suffered a loss of smell. Since that time, a number of medical researchers have claimed there is a link between products containing zinc and possible nerve damage.

Neurotoxins act specifically on nerve cells (neurons) usually by interacting with membrane proteins and ion channels. Environmental neurotoxins are known as exogenous and include gases (carbon monoxide), metals (mercury, lead, zinc), liquids (ethanol) and a multitude of solids. When exogenous toxins are taken in, the effect on neurons is largely dependent on dosage and duration.

Of course, since the senses of smell and taste (like the other senses) rely on a sophisticated network of neurological processes, any neurotoxin has the potential to interfere with or even damage or destroy them.

It is because of these facts that there a serious controversy over the safety of over-the-counter (OTC) zinc-based, homeopathic medications like Zicam that claim to shorten the duration of the common cold.

The maker, marketer, and seller of Zicam (R) Cold remedy nasal gel, Zicam, LLC (a wholly owned subsidiary of Matrixx Initiatives, Inc. an OTC drug developer, manufacturer, and marketer) has steadfastly defended its product as being safe.

Only last year, in a press release, Matrixx claimed that any reports alleging anosmia (loss of smell) associated with Zicam(R) Cold Remedy zinc products “are completely unfounded and misleading.”

Matrixx asserted that any research linking nasal products containing zinc to the onset o f anosmia were erroneous because the compound found in the 1930s products was concentrated zinc sulfate as opposed to the zinc gluconate found in Zicam. Zinc sulfate “is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide,” while “zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate, a naturally occurring, non-toxic compound found in all human tissue.”

Unfortunately, the FDA does not test cold remedies containing soluble zinc for safety or efficacy and, thus, it was not until late 2004 that the agency only began to take notice that there might be a serious risk posed by the products.

By that time, however, researchers at University of Colorado Health Sciences Center Taste and Smell clinic had already documented the loss of smell among Zicam users for over a year. In addition, a number of lawsuits had been commenced around the U.S. alleging anosmia as an injury that could occur with as little as one application of the Zicam nasal gel.

The problem had also been presented for discussion at the September 2003 meeting of the American Rhinologic Society. Clearly, there was much more to this than the simple denial issued by Matrixx.

Now, a major plaintiffs’ personal injury firm has announced it has filed suit against Matrixx Initiatives, Inc. Zicam, LLC, and Botanical Laboratories, Inc., on behalf of a woman who claims to have lost her senses of smell and taste after using Zicam Cold Remedy nasal gel.

The lawsuit was filed Tuesday in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana, by Parker & Waichman, a New York based firm that is heavily involved in pharmaceutical litigation throughout the country.

The suit alleges that in December 2003, the plaintiff began using Zicam Cold Remedy nasal gel to relieve her cold symptoms. After using the product as directed, however, she began to experience a loss of her sense of smell and her sense of taste and has never regained these senses completely.  She has been diagnosed as having a permanent partial loss of the senses of smell and taste.

The loss of the senses of smell and taster can have very serious consequences aside from the obvious loss of the enjoyment and pleasure associated with the exercise of those senses. Danger areas documented by studies of people suffering from the loss of these senses include: cooking related accidents; exposure to undetected fires, smoke, or gas leaks; eating spoiled foods or toxic substances; and other situations where either of the senses is a primary method of detection of sensory information.

In addition, the loss of these senses can cause collateral damages such as to anyone engaged in a profession where smell or taste is a critical requirement (chef; taste tester; cosmetics and perfume industry; wine, beer, or spirits industry).

Jerrold Parker, managing partner of Parker & Waichman stated: “Despite numerous reports that Zicam Cold Remedy nasal gel causes anosmia, Matrixx continues to market this product at the expense of consumers’ health. Furthermore, there is little evidence to suggest that Zicam is effective at relieving the symptoms of the common cold.  Because the product has few benefits and poses major health risks, Matrixx should promptly remove it from the market.”
 
In addition to alleging the dangerous nature of the zinc-based gel itself, the lawsuit claims the product label, promotional materials, and advertisements used in conjunction with the sale of Zicam Cold Remedy Nasal Gel did not provide sufficient warning and instructions about the risks and adverse side affects associated with the use of the product.

A study conducted at McGill University (Montreal) and lead by Dr. Sandra Dial has found that people taking heartburn drugs are at increased risk of developing Clostridium difficile (C. difficile or CD) infections which, in turn, can cause severe diarrhea. It appears in Wednesday’s issue of the Journal of the American Medical Association.

CD is a common bacterium first discovered in 1935 as bacteria and in 1978 as a disease. The infection, in its common form, mainly affected the elderly and causes severe diarrhea and colon inflammation. CD bacteria are naturally present in the intestine and are kept under control by other bacteria. When antibiotics kill some of the controlling bacteria, however, CD can take hold and spread.

Now, however, it appears that antibiotics may not be the only precipitating cause of CD. The research suggests stomach acid may also help protect people from C. difficile infection. Heartburn medication (antacids) reduces stomach acid. Thus, according to Dr. Dial: “We hypothesize if your stomach acidity was less, that maybe …you’d be a bit more susceptible to develop the infection, if you were exposed.”

The researchers analyzed data on more than 18,000 patients in the UK from 1994 to 2004 looking for people diagnosed with CD. They then checked to see if those patients were taking heartburn drugs. The ones who took drugs such as Nexium and Losec showed three times the risk of being diagnosed with CD than those not taking the drugs. Zantac users were twice as likely to suffer CD-related diarrhea.

Dr. Dial does not advocate patients stopping their heartburn medications since all drugs have side-effects and CD is still a relatively rare occurrence.

As far back as the late 1930s, intranasal zinc sulfate solutions were used to prevent polio. The products were removed from the market because they proved unsuccessful and due to that some users suffered a loss of smell. Since that time, a number of medical researchers have claimed there is a link between products containing zinc and possible nerve damage.

Neurotoxins act specifically on nerve cells (neurons) usually by interacting with membrane proteins and ion channels. Environmental neurotoxins are known as exogenous and include gases (carbon monoxide), metals (mercury, lead, zinc), liquids (ethanol) and a multitude of solids. When exogenous toxins are taken in, the effect on neurons is largely dependent on dosage and duration.

Of course, since the senses of smell and taste (like the other senses) rely on a sophisticated network of neurological processes, any neurotoxin has the potential to interfere with or even damage or destroy them.

It is because of these facts that there a serious controversy over the safety of over-the-counter (OTC) zinc-based, homeopathic medications like Zicam that claim to shorten the duration of the common cold.

The maker, marketer, and seller of Zicam (R) Cold remedy nasal gel, Zicam, LLC (a wholly owned subsidiary of Matrixx Initiatives, Inc. an OTC drug developer, manufacturer, and marketer) has steadfastly defended its product as being safe.

Only last year, in a press release, Matrixx claimed that any reports alleging anosmia (loss of smell) associated with Zicam(R) Cold Remedy zinc products “are completely unfounded and misleading.”

Matrixx asserted that any research linking nasal products containing zinc to the onset o f anosmia were erroneous because the compound found in the 1930s products was concentrated zinc sulfate as opposed to the zinc gluconate found in Zicam. Zinc sulfate “is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide,” while “zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate, a naturally occurring, non-toxic compound found in all human tissue.”

Unfortunately, the FDA does not test cold remedies containing soluble zinc for safety or efficacy and, thus, it was not until late 2004 that the agency only began to take notice that there might be a serious risk posed by the products.

By that time, however, researchers at University of Colorado Health Sciences Center Taste and Smell clinic had already documented the loss of smell among Zicam users for over a year. In addition, a number of lawsuits had been commenced around the U.S. alleging anosmia as an injury that could occur with as little as one application of the Zicam nasal gel.

The problem had also been presented for discussion at the September 2003 meeting of the American Rhinologic Society. Clearly, there was much more to this than the simple denial issued by Matrixx.

Now, a major plaintiffs’ personal injury firm has announced it has filed suit against Matrixx Initiatives, Inc. Zicam, LLC, and Botanical Laboratories, Inc., on behalf of a woman who claims to have lost her senses of smell and taste after using Zicam Cold Remedy nasal gel.

The lawsuit was filed Tuesday in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana, by Parker & Waichman, a New York based firm that is heavily involved in pharmaceutical litigation throughout the country.

The suit alleges that in December 2003, the plaintiff began using Zicam Cold Remedy nasal gel to relieve her cold symptoms. After using the product as directed, however, she began to experience a loss of her sense of smell and her sense of taste and has never regained these senses completely.  She has been diagnosed as having a permanent partial loss of the senses of smell and taste.

The loss of the senses of smell and taster can have very serious consequences aside from the obvious loss of the enjoyment and pleasure associated with the exercise of those senses. Danger areas documented by studies of people suffering from the loss of these senses include: cooking related accidents; exposure to undetected fires, smoke, or gas leaks; eating spoiled foods or toxic substances; and other situations where either of the senses is a primary method of detection of sensory information.

In addition, the loss of these senses can cause collateral damages such as to anyone engaged in a profession where smell or taste is a critical requirement (chef; taste tester; cosmetics and perfume industry; wine, beer, or spirits industry).

Jerrold Parker, managing partner of Parker & Waichman stated: “Despite numerous reports that Zicam Cold Remedy nasal gel causes anosmia, Matrixx continues to market this product at the expense of consumers’ health. Furthermore, there is little evidence to suggest that Zicam is effective at relieving the symptoms of the common cold.  Because the product has few benefits and poses major health risks, Matrixx should promptly remove it from the market.”
 
In addition to alleging the dangerous nature of the zinc-based gel itself, the lawsuit claims the product label, promotional materials, and advertisements used in conjunction with the sale of Zicam Cold Remedy Nasal Gel did not provide sufficient warning and instructions about the risks and adverse side affects associated with the use of the product.

Following the FDA’s request, Palatin Technologies Inc., the makers of NeutroSpec, an imaging agent used to diagnose appendicitis, are withdrawing the product from the market.

There have been now been two deaths and 20 “serious and life-threatening” complications linked to the use of the agent, according to the FDA. Those complications occurred within minutes of injection of the drug and have included cardiopulmonary failure, central nervous system reactions, and infusion reactions.

Some patients have required admission to intensive care. There have also been reports of 46 similar but less severe adverse reactions.

According to an FDA official, the “company made the decision to suspend marketing based on the events being life-threatening and the availability of other means to diagnose appendicitis that don’t carry these risks. They are urging health-care providers to stop using existing stocks, and to contact the company regarding their return."

The FDA deputy director of the Office of New Drugs, Dr. Sandra Kweder stated: "Most of the patients, but not all of them, did have some sort of underlying cardiac or lung condition that might somehow have placed them at high risk for an event but they may not have been ill at that time. We don’t know the specific way that NeutroSpec and these adverse events are related, but the consistent characteristics of events in the patients make it likely they were due to NeutroSpec.”

NeutroSpec (Technetium 99m Tc Fanolesomab) is described as a murine or mouse monoclonal antibody tagged with Technetium, a radioactive molecule. The Technetium allows the agent to be seen on an imaging scan by binding to white blood cells thereby producing a hot spot on the image that identifies the site of the infection.

NeutroSpec was approved in July 2004 by the FDA to help diagnose appendicitis in patients aged 5 years and older who don’t have the typical signs of appendicitis. The drug is manufactured by Palatin Technologies Inc. and marketed by Mallinckrodt.
The approval was based on a rather limited study of 523 individuals. In that small sample, very few patients suffered shortness of breath or declines in blood pressure. According to Kweder, "None of the cases were severe."

The FDA is urging all health-care providers to stop using NeutroSpec and to contact either Palatin Technologies Inc. or Mallinckrodt about returning existing stocks.

The FDA plans to take information about NeutroSpec to an advisory committee meeting in 2006. Kweder expects NeutroSpec to be available as an investigational new drug in cases where there are no alternatives until the FDA’s advisory committee meeting takes place.

On August 10, 2001 a sightseeing helicopter crashed into a cliff in the Grand Canyon killing the pilot and David Daskal and three of his traveling companions.

The only survivor of the crash was Daskal’s wife, Chana, a 29-year-old mother of two.

In a lawsuit against the tour company, the pilot, and the helicopter manufacturer, Mrs. Daskal alleged all of the defendants were responsible in some way for the tragic crash that left her near death.  She is still recovering from her injuries that included a broken back, burns over 80% of her body, and the amputation of both of her legs.
Her attorney, Gary Robb of Kansas City, Missouri, stated that:   "Chana is delighted to have this part of her life over with. She’s pleased she doesn’t have to travel to Las Vegas for trial. The important thing is now she can address her needs."     

The $38 million settlement, approved by Judge Nancy Saitta last week in Clark County District Court, is to be paid in a lump sum within 30 days and is ranked by a jury verdict tracking system as the largest pretrial cash settlement in a personal-injury case in U.S. history. The settlement details are sealed and cannot be disclosed.
The settlement resolves all claims against the defendants that included Papillon Grand Canyon Helicopters in Las Vegas; American Eurocopter Corp. and Turbomeca Engine Corp., of Grand Prairie, Texas; Washington-based helicopter retailer Zuni LLC; and the estate of the pilot.