Despite the claim by government officials that an effective plan for dealing with possible bird flu (or other) pandemic will be completed by the end of the summer, several experts have accused the Bush administration of moving far too slowly. They are also calling plans to stockpile antiviral drugs inadequate.

Lawmakers have been told that the possibility of bird flu mutating into a form that is capable of human-to-human transmission is extremely alarming since humans lack immunity to the disease. There is additional concern that the U.S. stockpile of drugs is terribly inadequate. While Britain and France have ordered enough doses of the drug Tamiflu to treat 25% of their populations, the United States has a stockpile of only 2.3 million doses which would only treat less than 1% of the population. The drug, which may lessen the severity of the disease if taken wit 48 hours of the onset of symptoms, however, is not a cure and no study has shown that it improves a personís chances of survival. An experimental bird flu vaccine is currently under development at the National Institutes of Health and the results of safety and effectiveness trials are expected soon.

In a related story, Nature Magazine reported this week that up to half of the pig population in some areas of Indonesia may be infected with bird flu (H5N1 virus) but without causing symptoms. Experts fear that infected pigs pose a greater threat than poultry of spreading the disease to humans. Testing done on pigs in both other countries and other locations in Indonesia has not shown such high infection rates..

Personal Injury & Side Effects News

Although stories of dramatic weight-loss results associated with various surgical procedures have been widely publicized, studies indicate that patients would be wise to consider the potentially serious risks of these procedures more carefully. In 2004, 145,000 bariatric procedures were performed at an average cost of $25,000 each ($3.5 billion). Complications, however, may not only increase that cost to $100,000 but, also, leave the patient with very serious medical problems in addition to their obesity.

In the case of bariatric surgery, for example, one new study reports that almost 20% of the patients experienced complications after surgery. For approximately 5% of the patients, the complications were serious (including heart attacks, strokes, and severe high blood pressure). Another recent study reported a mortality rate (within 30 days of surgery) for gastric bypass surgery at .5% (1 in 200) which is higher than the death rate associated with coronary angioplasty..

Personal Injury & Side Effects News

Between 1993 and 2003, there was a 14% decrease in the number of emergency departments in the United States. During that same period, however, emergency room visits increased by over 26% from 90.3 million to 113.9 million. This combination of circumstances has lead to crowded emergency rooms throughout the country.

The figures released by the Centers for Disease Control and Prevention show that 15% of the visits were classified as emergencies (treatment required within 15 minutes), 35% were urgent (treatment required within 1 hour), and 13% as non-urgent. While children had the highest rate of emergency department (ED) visits, the greatest rate increase was among adults. Those 65 and older had an ED visit rate increase of 26% in the past ten years.

In a press release, Dr. Robert Suter, president of the American College of Emergency Physicians, stated: "As Americaís elderly population continues to grow, we expect to see even more elderly patients in the coming years." Dr. Suter also expressed concern that proposed Medicare cuts will force more and more elderly patients to seek medical care at their local emergency department.

The introduction of various devices that permit listeners to record Internet radio streams and then convert them into MP3 files are making Web radio and streaming services more and more popular with the public. In the opinion of many legal and media experts, this type of recording software may violate digital copyright laws and simply promote piracy. The record industry will be faced with yet another challenge to the proprietary rights of artists, song writers, and record labels.

The Digital Copyright Millennium Act prohibits duplication of copyrighted material from a computer hard drive. Such material may only be recorded from a digital or analog device and only for personal use and not redistribution. Current software such as Replay Radio, however, permits users to perform all types of sophisticated editing functions and turn streaming music services into perfectly tagged MP3 song files.

Entertainment lawyers see this technology as a law suit just waiting to happen. Some Webcasters have already warned at least one software manufacturer to stop advising its customers that their streaming music services work with the recording software..

Personal Injury & Side Effects News

Chemotherapy and radiotherapy may save a female cancer patientís life but these therapies may also cause infertility. While freezing a womanís eggs before cancer therapy begins offers one possible option, the thawing process often renders the eggs incapable of being fertilized. Now, a team of researchers from the University of Michigan Comprehensive Cancer Center has studied a freezing technique called vitrification which freezes an egg instantaneously thereby preventing the formation of damaging ice crystals which destroy about 50% of frozen eggs. In trials using mouse eggs, vitrification has achieved a 98% egg survival rate.

The concept of a money-back guarantee has been around for a long time and has worked with respect to all types of consumer products. Now, the idea of getting a refund for a product that does not perform as advertised is gaining momentum. Professor Claus Moldrup of the Danish University of Pharmaceutical Sciences in Copenhagen believes that such a system would be a benefit to both patients and manufacturers.

Presently, a high percentage of prescription drugs do not have the desired effect when prescribed to various individuals. The reasons for this include genetic factors, interactions with other drugs, or the drug may not be the correct choice. Speaking in the British Medical Journal, Professor Moldrup stated that: "A no cure, no pay strategy creates a win-win situation for the authorities as well as the drug industry, and thus the patients, because in a competitive environment only the best drugs will win." Although a few companies, like Novartis, Eli Lilly, and Bayer have incorporated the idea into promotional campaigns for specific drugs, the industry as a whole has been slow to embrace the concept. In fact, only eight such promotions have been offered in the past ten years. It is hoped that stiffer competition, greater scrutiny by the FDA, the move by the government to control healthcare costs, and doctors being more reluctant to be influenced by sales pitches will cause a shift in favor of refunds.

It is not unusual for a pharmaceutical manufacturer to have an occasional problem with testing practices or quality control. When this occurs, the typical solution is to recall one or two drugs or to close down the offending plant until the deficiencies are corrected. This happened in March of this year when Glaxo-SmithKline was ordered to halt temporarily the distribution of Paxil CR and Avandamet as a result of failing to meet federal production standards. Glaxoís plant in Cidra, Puerto Rico was temporarily closed in order to correct the problems.

It is highly unusual, however, for a pharmaceutical company to recall its entire product line, suspend all manufacturing, withdraw seven approved applications to market various medications, and have its Chairman and CEO resign all at the same time. That, however, is precisely what has occurred at Able Laboratories Inc., a manufacturer of several generic drugs. With no products to sell and no manufacturing being done, the value of Ableís stock plummeted 85%.

Over the past 14 years, Able has had many problems with the FDA including: over 10 drug recalls; charges of selling medications which were either adulterated, mislabeled, or with incorrect potency; failure to report serious adverse reactions with respect to at least five drugs; improper extension of drug expiration dates without proof the drugs would still be effective; and selling drugs with the wrong package insert. Able has received a number of FDA warnings with respect to these deficiencies and it is unclear what measures the agency will impose with respect to the companyís latest revelations concerning deviations from proper manufacturing practices. A full list of the recalled drugs can be found at www.fda.gov and consumers may obtain addition information concerning Able Laboratories by calling 1-888-463-6322. .

Personal Injury & Side Effects News

For the past seven years, the jubilation surrounding the availability of drugs like Viagra, Cialis, and Levitra has been remarkable. No other drugs since oral contraceptives have had such a dramatic impact on sexual practices and expectations. As with every other powerful prescription drug, however, the day of reckoning regarding potentially dangerous side-effects was always lurking in the shadows. That day has now arrived.

The FDA has disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra). To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists is enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION. Pfizer (Viagra) is considering a label change while Eli Lilly (Cialis) has already added a reference to the reports of NAION. GlaxoSmithKline (Levitra) has not made any public Statement on the matter. .

Personal Injury & Side Effects News

Since 2001, the NHTSA has warned that 15-passenger vans pose a serious rollover risk. The vans have a high center of gravity and tend to be unstable when operated at high speeds, with more than 10 occupants, or with improperly inflated tires. Federal law prohibits the sale of these vans for school-related transportation involving children of high school age or younger. This prohibition does not apply to college students or other passengers.

A new research report confirms that improper tire maintenance on 15-passenger vans is a significant cause of rollover accidents. Mis-inflated tires change the handling characteristics of the vehicle. Surprisingly, 74% of all 15-passenger vans were found to have significantly mis-inflated tires as opposed to only 39% of passenger cars. Failure to use available seat belts also contributes to the high number of injuries and deaths associated with this type of van. Thus, operators are strongly advised to insist that all passengers buckle-up before taking to the road..

Personal Injury & Side Effects News

As we reported on May 24, phthalates, a group of chemicals found in cosmetics, personal care products, and other common items have become the subject of debate with respect to their potential effect on humans. Products containing phthalates include hair sprays, deodorants, shampoos, nail polish, perfumes, body washes, skin creams, toys, vinyl flooring, inks, paints, Clingfilm, and medical equipment.

Until now, an indication that these chemicals might be harmful in some way to humans were test results that showed rats exposed to phthalates have a higher rate of birth defects related to the male reproductive system. Other studies only suggested possible links to early puberty in girls and decreased sperm counts in men. The Centers for Disease Control and Prevention found that phthalate levels in young women were much higher than average.

A new study, however, indicates that when four particular phthalates are found above certain concentrations in the urine of pregnant women, the reproductive systems of their infant boys are adversely affected. The abnormalities detected include smaller penises and scrotums, and less developed testicles. It appears that the chemicals suppress production of the male sex hormone testosterone. The researchers found 25% of the women in the United States have concentrations of these four phthalates at this concentration level.

The study involved scientists and doctors at a number of universities and the Centers for Disease Control and Prevention. It was funded by the National Institute of Environmental Health Sciences and the United States Environmental Protection Agency and was published in the journal Environmental Health Perspectives. Many experts, environmental groups, and consumer advocates have expressed concern over these findings and have called for the immediate implementation of strong regulations to eliminate this serious health threat.

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