Cigarette companies claim they are not targeting young smokers and they even run ads declaring “there is no such thing as a safe cigarette.” A new study by the Harvard School of Public Health, however, indicates that tobacco companies are enticing children and teenagers by developing flavored cigarettes.

Although the companies claim they are no longer marketing to children, the research, published in the November/December issue of Health Affairs, reveals that attractive packaging and candy flavors are being employed to market to specific racial and ethnic groups.

Harvard researchers compiled the information by consulting a database of more than 7 million internal tobacco industry documents created over the course of more than 30 years. They paid specific attention to the discussion of alternative flavors and flavor technology as a method to attract young smokers.

One internal document from 1993  stated, "Growing interest in new flavor sensations (i.e. soft drinks, snack foods) among younger adult consumers may indicate new opportunities for enhanced-flavor tobacco products that could leverage [a brand's] current strength among younger adult smokers."

The researchers suggest that the companies used new product technology, for example a flavor pellet imbedded in a cigarette filter, to create fruit and liqueur flavors such as Mandarin Mint, Mocha Taboo, Mintrigue, Kauai Kolada, and Margarita Mixer.

Gregory Connolly, senior author of the study and a professor of the practice of public health at HSPH, emphasized that these practices deceptively concealed the harmful effect of cigarettes.

"Tobacco companies are using candy-like flavors and high tech delivery devices to turn a blowtorch into a flavored popsicle, misleading millions of youngsters to try a deadly product. Adding candy flavors to a toxic product (cigarettes) isn’t any different than adding sugar to contaminated meat a century ago. The only difference is that today one is regulated by the FDA and the other is not."

Ford Motor Company, the National Highway Traffic Safety Administration (NHTSA), and the Consumer Product Safety Commission (CPSC) have announced the recall of nearly 226,000 Ford vehicles in the United States and Canada, including the new Ford Five Hundred sedan and Freestyle wagon, because of fire risks.

The recall affects 127,493 Ford Five Hundred and Mercury Montego sedans and Freestyle wagons because the straps that secure the fuel tank to the vehicle body may break, causing the fuel tank and fuel tank heat shield to drop onto the driveshaft or exhaust system, according to the NHTSA.

The problem could cause a fuel leak and result in a fire in the recalled vehicles. So far no injuries or accidents have been reported.

Ford is also recalling 98,444 Crown Victoria, Lincoln Town Car, and Mercury Grand Marquis sedans because on certain vehicles the battery cable may scrape on an attaching bolt and could lead to a fire.

After several years of legal wrangling, Michelle DiLieto has been awarded $5.2 million by a Connecticut jury against Yale School of Medicine and her gynecologist, Dr. Scott Casper.

In 1995, DiLieto was diagnosed with a form of uterine cancer known as endometrial stromal sarcoma, a rare but often fatal cancer. Her gynecologist suggested that she see Dr. Peter Schwartz, a professor at the School of Medicine practicing at Yale-New Haven Hospital.

Although a Yale pathology report confirmed the diagnosis, a 1997 Harvard pathologist report determined that DiLieto never had cancer. Plaintiff’s medical experts, however, testified that tissue samples, released by a court order in November 2004, showed no indication of cancer.

According to DiLieto’s attorney, his client underwent surgery during which Dr. Casper removed her uterus, ovaries and fallopian tubes. Dr, Schwartz was supposed to extract the surrounding lymph nodes, but delegated that operation to Dr. Babak Edraki, a first-year fellow in gynecologic oncology.

DiLieto’s experts also believe Yale knew all along that she didn’t have cancer.  

As a result of the surgery, DiLieto reports she suffered substantial nerve damage and was in terrible pain and unable to walk for months. The doctors attributed the pain not to the surgery but to the fact that she could not take estrogen as hormone replacement therapy for menopause because she was a "cancer survivor," she said. "They were all very arrogant with regard to me," she added.

Although the jury in the recent trial found no negligence on the part of the Yale pathologists, they found in favor of DiLieto for $2.5 million against Yale and $2.7 million against Dr.Casper’s practice at the County Obstetrics and Gynecology Group in Connecticut.

The verdict in plaintiff’s favor follows a long legal battle wherein a jury originally found in favor of Yale in 2000. That verdict was reversed on appeal in 2003 by the Connecticut Supreme Court. According to a hospital spokesman, Yale intends to appeal the verdict.

Baxter Healthcare announced Tuesday that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the market over the next 12 months.

This pump delivers intravenous medications to patients who are primarily in alternate care settings or at home. There are approximately 34,000 pumps currently in use worldwide, including 30,000 in the United States.

In a letter to customers, Baxter stated that it had received reports of one death and two serious injuries due to malfunctions in the pump. The pump may deliver drugs when they are not requested or fail to deliver drugs when they are requested. These product failures can result in an unsafe situation for patients.

Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion pumps from the market. During the transition period, Baxter will continue to provide service and sets for the 6060 pump. Baxter has entered into an agreement with Smiths Medical to provide alternative infusion pumps and products during the transition.

This is not the first time that Baxter has had a problem with its medical pumps. In September, there was a recall of the company’s Colleague Infusion pumps due to battery problems, and in October, the U.S. Food and Drug Administration (FDA) seized 6,000 pumps from Baxter’s manufacturing facilities in Illinois because the firm had continually failed to follow medical device manufacturing requirements.

    A study presented last week at the 18th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas found a possible link between the sustained elevation of the suicide rate in a North Carolina county and releases of hydrogen sulfide and other airborne chemicals from a nearby paper mill and perhaps other industrial locations in the area.

This is not the first time that a link has been proposed between elevated suicide rates in a North Carolina community and exposure to industrial chemicals. In fact, many authors of the latest study also worked on previous research that showed a possible link between an elevated suicide rate in a Salisbury community and exposure to hydrogen sulfide and other potential neurotoxins released from local asphalt plants and petroleum remediation sites.

In the prior study, the researchers found that between 1994 and 2003, the annual suicide rate in two Salisbury neighborhoods was 38.4 per 100,000, which is around triple the North Carolina’s average.

Those findings were presented to the 17th Annual U.S. Psychiatric and Mental Health Congress in 2004 and at the National Institute of Mental Health New Clinical Drug Evaluation Unit meeting in June 2005.

The new study, which focused on CDC data regarding suicides in the rural North Carolina county of Haywood, found that the rate had nearly doubled from an age-adjusted 11.8 per 100,000 in 1990 to 1996 to around 21.1 per 100,000 in 1997 to 2002.

Salisbury’s age-adjusted suicide rate has now remained elevated since 1997, peaking at 29.7 per 100,000 in 2000. The statewide age-adjusted average suicide rate for 1997 to 2001, however, was only about 11.4 per 100,000 per year.

"We clearly know there have been increases in suicides during this time period when there were also operational changes at the paper mill," said Dr. Richard H. Weisler, lead study author. "The 1997 spike in suicides in Haywood County corresponded to a switch to Bleach Filtrate Recycle in late 1996. Whether there is a connection between the increased suicides and operational changes has yet to be determined."

The Haywood County paper mill uses Bleach Filtrate Recycle, or BFR, to remove chlorine and other toxins from the waste discharged into the Pigeon River. Dr. Weisler and his team wonder whether dirtier air has been the price of a cleaner river.

According to Weisler: "The burning of chlorinated compounds that BFR potentially entails, as well as a possible increase in plant volume, may have led to increased releases of dioxins and other harmful compounds into the air. The switch to BFR, which involves burning of black liquor, may have resulted in an increase in air quality problems."

"Black liquor" is a wood and chemical waste byproduct produced in the manufacturing process of turning wood into paper pulp. The Haywood County mill, like many others, burns black liquor to produce electricity.

The Haywood County mill releases many chemicals such as carbon disulfide, dimethyl disulfide, dimethyl sulfide and methyl mercaptan.  In 2003 alone, for example, it released more than 93,000 pounds of hydrogen sulfide.

Research has shown that exposure to occupational levels of hydrogen sulfide (10 parts per million for a 10-minute ceiling) can result in dementia, nervousness, mania, and violence. Hydrogen sulfide has been shown to be a neurotoxin in studies of animals. It alters levels of serotonin, norepinephrine, dopamine, aspartate, GABA and glutamate.

"We speculate that hydrogen sulfide may serve as a marker for other potentially neurotoxic compounds being released in this mountain valley," Weisler said.

Haywood County is located within a series of mountainous valleys that often have temperature inversions trapping colder, dense air in the valley. This has the potential for preventing pollutants from dispersing, and increasing air quality problems. Both studies noted complaints of odor and air quality problems. For this reason, formal studies are needed to trace the flow of air pollution from the plant while also monitoring the amounts of the various chemical pollutants released by the mill.

Weisler stated that he and the team "hope there will be relevant and sensitive air monitoring, as well as a whole reassessment of whether or not burning the black liquor and using Bleach Filtrate Recycle is really the best approach to clean up the Pigeon River.”

Co-author Dr. Jonathan R.T. Davidson believes it is very important for people to remember that effective treatments exist for suicidal depression. He also stated: "Given that suicide can be a tragic consequence to depression, people who are experiencing persistent symptoms of depression should contact their health-care provider for a professional evaluation," he said. "The findings of this study may suggest another potential risk factor for suicide, but this needs to be confirmed in future studies."

Approximately 17,960 current and former female employees of Boeing Co. will share a settlement fund of $72 million to dispose of their sex-discrimination class-action against the aerospace giant.

The payouts will range from $500 to $26,000 depending on seniority and position.

Legal fees and costs of approximately $15 million will be deducted from the proceeds of the settlement. Originally, about 20,000 claims out of a pool of 29,000 were filed against Boeing. Those claims were based upon alleged acts of sex discrimination that took place at the company’s Seattle-area plants between 1997 and 2000. Approximately 2,400 claims were dismissed as a result of various filing irregularities.

Although the settlement did not require Boeing to admit any wrongdoing, the company did agree to change a number of practices related to hiring, pay, promotion, and the investigation of complaints by employees.

According to the lead attorney for the class, it was remarkable that 60% of the female employees filed claims; usually, a 30% response rate is typical in such cases.

Documents obtained from Boeing during the litigation, which started in 2000, showed that women generally earned $1,000 to $2,000 less than men in similar positions. Company promotion and pay-raise policies magnified these discrepancies as an employee’s tenure with Boeing increased.

In addition to the rather cryptic press release issued by Ortho-McNeil concerning the serious risks associated with its Ortho Evra birth control patch, the FDA has published its own information for consumers wishing to learn more about those potentially fatal side-effects.

A series of “Questions and Answers” and other information can be found on the agency’s web site. For the benefit of our readers, we are reprinting some of that information and the links at which it can be found:

Questions and Answers

Ortho Evra (norelgestromin/ethinyl estradiol)

(http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm)

1. What is FDA announcing today?
FDA is announcing a revision to the label for the drug Ortho Evra, the only skin patch approved for birth control. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots. When thinking about prescribing or using Ortho Evra, healthcare professionals and women need to balance the increased exposure to estrogen against the chance of pregnancy if a birth control pill is not taken daily.
2. Why is the FDA making this announcement?
A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.
3. How does the increase in exposure of estrogen affect me when taking Ortho Evra?
In general, a woman may be at higher risk for getting side effects if she takes higher doses of estrogen. However, it is not known if a woman using the Ortho Evra patch is at higher risk for serious side effects than if she is using a typical birth control pill. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.
4. Can a woman decrease the amount of estrogen from the Ortho Evra patch by cutting the patch and applying only a part of the patch?
No. The patch should not be cut. If cut or altered, Ortho Evra will not protect against pregnancy.
5. If a woman wants to change from the Ortho Evra patch to a birth control pill, what should she do?
Talk to her health care professional. The health care professional will help her make this change.
6. Where can I find more information on this?

If you have further questions regarding any medications, please contact the Center for Drug’s Division of Drug Information at: 888-INFO-FDA (888-463-6332), or email us at: druginfo@cder.fda.gov

FDA Updates Labeling for Ortho Evra Contraceptive Patch

(http://www.fda.gov/bbs/topics/news/2005/NEW01262.html)

The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control.

It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses.

The addition of this new warning is a result of FDA’s and the manufacturer’s analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills.

FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen.

The new labeling information is available along with additional information for healthcare providers and consumers online at:

www.fda.gov/cder/drug/infopage/orthoevra/default.htm

Newsinferno.com published a lengthy article regarding Ortho Evra and the dangers associated with its use in yesterday’s edition. We recommend that article to anyone wanting to learn about the troubled history of the “Patch” and the evidence offered by its critics to support their demands to have it banned.

A study in the November issue of the journal Obstetrics & Gynecology advises postmenopausal women that taking (estrogen plus progestin) hormone replacement therapy (HRT) can increase the risk of urinary incontinence after only a few months of treatment.

Currently over 40% of postmenopausal women are afflicted with urinary incontinence. Urinary incontinence includes both stress incontinence, when the bladder leaks urine as a result of pressure on it from exercise, laughing, or coughing and urge incontinence, where there is a frequent urge to urinate.

The study conducted by Dr. Jody Steinauer and her colleagues from the University of California at San Francisco relied on data from a Heart Estrogen/progestin Replacement Study to evaluate the side-effect of urinary incontinence.

The 4-year observational study followed 1,200 women who reported no episodes of incontinence in the week prior to starting HRT or a placebo.

Results showed 64% of women using HRT reported weekly incontinence compared with 49% of those taking a placebo. The symptoms began at 4 months and continued for the duration of the hormone therapy, regardless of age.

HRT was found to elevate the risk of both urge and stress incontinence by 50% and 70%, respectively. The excess risks of weekly urge and stress incontinence attributed to HRT were 12% and 16%, respectively.

According to researchers, these findings contrasted with physiologic data which indicated HRT might have a beneficial impact on incontinence.  The results did, however, confirm previous randomized trials that found postmenopausal women taking HRT might develop urinary incontinence or experience exacerbated symptoms if they already had the condition.

According to government data, some 2 million U.S. adolescents (12 to 19) have a pre-diabetic condition called “impaired fasting glucose” (IFG), which puts them at risk for developing cardiovascular problems and full-blown diabetes.

IFG manifests itself in the form of abnormally high blood-sugar levels even after several hours without eating. Research done by the National Institutes of Health and the Centers for Disease Control and Prevention (CDC) indicates that one in 14 children (boys and girls) in a nationwide sample had the condition. In overweight children, the ratio was even higher at one in six.

Average levels of triglycerides and bad cholesterol were also higher in children who had IFG.

The study, which appears in the November issue of Pediatrics, is based on data from 915 children who were involved in a 1999-2000 national health survey.

Currently, some 20 million Americans have diabetes. The majority of them are adults, who have Type 2 diabetes, which hinders the body’s ability to use insulin. Type 2 diabetes is closely linked to inactivity and obesity.

Although most American adolescents with diabetes (some 177,000) have Type 1, in which the body produces little or no insulin, Type 2 is on the rise.

The American Diabetes Association defines IFG as fasting blood-sugar levels of least 100 milligrams per deciliter. A fasting blood sugar level above 125 is considered diabetes.

Among tested youngsters, the average level was 89.7, which is within normal range. However, 7% of the children studied were in the pre-diabetic range. That percentage translates to roughly 2 million U.S. youngsters. About 16% of the subjects were obese; a figure that parallels the current nationwide estimate.

Although IFG has no symptoms, it represents a serious metabolic problem which, in time, usually develops into Type 2 diabetes. According to the researchers, significant lifestyle changes, such as exercise and improved diet, have shown to stop pre-diabetes from progressing in adults, so it is likely that the same program can help children.