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

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

In the United States, battle lines have long been drawn over the issue of gun control. In Britain, however, where gun-related crime is not a significant problem, knife reform is suddenly a hot topic. An editorial in the British Medical Journal argues that the sale of "long, pointed kitchen knives" should be banned since "the knives are being used to stab people as well as roasts and the odd tin of Spam." The solution, which the authors of the essay suggest, is a law requiring knife manufacturers to redesign their products with rounded, blunt tips.

While some, like Wayne LaPierre of the N.R.A., looked on the proposal with amusement, others, like incredulous chefs, were more critical of the attempt to do away with a "tool of the trade." The researchers, however, are quite serious and have data to back up their argument. From 2003 to 2004, violent crime rose 18 percent in Britain and in the first two weeks of 2005, 15 killings and 16 non-fatal attacks involved stabbings. In fact, one of the daily tabloids (the Daily Express) reported that "Britain is in the grip of knives terror ñ third of murder victims are now stabbed to death." Whether the proposal is taken seriously remains to be seen.

The death of six organ transplant recipients from a viral infection known as LCMV (lymphocytic choriomeningitis virus), or rodent virus, within six months has health officials concerned with the adequacy of current testing procedures used on donated organs. The recent discovery that this virus, as well as other diseases like rabies and West Nile virus, could spread through donated organs and blood transfusions has experts worried that this may have been going on without detection for some time.

While the rodent virus deaths in Wisconsin, Rhode Island, and Massachusetts are rare occurrences, the fact that they happened at all is a matter of concern that brings into question the scope of the tests done on donated organs. Routine testing is already done for many, but not all, viruses. There is no commercial test for LCMV.

Since donor organs may be dispersed to many recipients throughout the country as part of a nation-wide donor-organ network, the problem can be especially serious. For example, if two kidneys, two lungs, a heart, a liver, and two corneas are harvested from one donor in New York City, they might be tested and then immediately dispersed to eight different hospitals around the country. If the donor was suffering from LCVM, a life and death medical emergency might unfold as to eight unsuspecting transplant recipients in eight widely separated cities. As in the Wisconsin, Rhode Island, and Massachusetts cases, by the time the problem is discovered it might already be too late.

The Canadian Adverse Drug Reaction Information System (CADRIS) is now directly accessible online at http://www.hc-sc.gc.ca/. The database, which will be updated quarterly, contains information on adverse drug reactions that have been reported by consumers, medical personnel, and drug makers since 1965. Searches made be made by product name, active ingredient, date a report was received, patient age and gender, and the nature of the adverse reaction. No confidential patient information is posted. The site contains information on prescription and non-prescription medications, natural health products, biological products, vaccines, and radiopaharmaceuticals.

The establishment of the website "is a major step forward in Health Canadaís transparency agenda" stated Canadian Health Minister Ujjal Dosanjh. Being able to monitor adverse reactions "helps ensure that the benefits of a health product continue to outweigh the risks. It also helps us update product labeling and information."

Over a dozen medical journal editors have warned that the might refuse to publish drug studies which do not adhere to their disclosure demands. Leading the list is Dr. Jeffrey Drazen, editor of the prestigious New England Journal of Medicine and one-time paid consultant for a pharmaceutical manufacturer. The editors suspect that drug companies may be exerting more influence over so-called independent academic investigators they hire to conduct drug trials than previously believed. For example, of 107 medical school research centers surveyed half would permit drug company sponsors to draft the manuscripts of medical journal articles reporting trial results while limiting revisions by the investigators themselves. About a quarter of the research centers surveyed would even allow the sponsoring company to supply the trial results. Dr. Drazen is has also been critical of the practice by companies of suppressing negative information concerning drug trials.

Until recently, medical journals were wary of directly criticizing drug companies for a number of reasons. The journals rely on the companies for substantial advertising revenue as well as subscriptions. In addition, the journals are always interested in being the first to publish new findings which may come out of the trials. Now, however, "converts" like Dr. Drazen see their sole mission as being to "help physicians do their jobs better and help patients get better information."

Although an industry spokesperson claimed that the criticisms were "unfair," drug (and medical device) manufacturers have only hurt themselves recently with revelations concerning their suppression and intentional withholding of negative, unflattering, or damaging information about their products. (Consider the revelations with respect to Vioxx, Bextra, the safety of COX-2 inhibitors in general, the Guidant internal defibrillator, as well as highly publicized examples of misleading direct-to-consumer advertising.) There is also the fact that certain drug manufacturers have not provided the NIH database with information necessary to conduct meaningful data searches. The journal editors have warned that they will not continue to publish articles on studies and trials which are not registered with this publicly-available database (www.clinicaltrials.gov) before the first patient was enrolled.

Following the Red Sox victory in the American League Championship Series last October, thousands of exuberant fans rallied outside of Fenway Park. When the crowd became unruly, police officers fired several pepper spray balls at the revelers. One of those balls struck a 21-year-old college student in the eye killing her. At the time she was shot, she was simply standing on the sidewalk and waiting for the crowd to disperse so that she could retrieve her car from a nearby garage. The City of Boston has agreed to pay the girlís family $5.1 million as compensation for her death.

A report issued yesterday by an independent commission strongly criticized the police department for a number of flawed decisions including: having a deficient plan for crowd control; improper use of the pepper ball weapon by several officers; a failure to appreciate the fact that a person could be seriously injured or killed by the weapon; permitting inadequately trained or uncertified officers to use the weapon; and an undermined chain of command. Five officers face disciplinary charges.

None of the 22 officers trained to use the weapon had been adequately instructed as when the weapon should be fired. The panel recommended a national study on the safety of the weapon and certification standards for its use. The weapon is sold in the United States by FNH U.S.A., a subsidiary of Herstal S.A. in Belgium.

The FDA has announced that a coordinator at a pediatric practice involved in an FDA approved clinical study has been charged with falsifying data with respect to follow up contact information she was supposed to obtain directly from the parents of children vaccinated with an experimental rotavirus vaccine. Rotavirus causes severe diarrhea in infants.

The woman, Anne Butkovitz, worked as the clinical study coordinator at the pediatric practice enrolled in the study and was responsible for required follow-up contacts with the parents of the children after each of three vaccinations. The purpose of the follow-ups was to determine if there had been any serious adverse experiences (SAEs). It is alleged that Ms. Butkovitz did not make the required contacts and yet claimed that she had on report forms. In one case, she is accused of having actually falsified information with respect to the SAEs of a patient enrolled in the clinical study.

As a result of Ms. Butkovitzís actions, the pharmaceutical company involved removed the pediatric practice she was employed by from the study and disregarded the data it had generated.

Guidant has confirmed that it is "working with the FDA" regarding the agencyís investigation of Guidantís belated admission concerning its knowledge of a flaw which could cause its internal heart defibrillator to short-circuit. On May 24, Guidant disclosed for the first time that it had waited three years before disclosing that it was aware of an electrical problem that had caused some 26 defibrillators to malfunction. The revelation came when Guidant learned that The New York Times was about to publish a story on the defibrillator.

The battle lines could not be more clearly drawn. On one side are the experts who claim autism is not linked to mercury exposure (from childhood vaccines and other sources) and who agree with the position of the Centers for Disease Control (CDC) that autism is permanent and not treatable. On the other side are the experts, parents, and attorneys who maintain that autism is directly related to mercury exposure and can be prevented and even reversed by removing mercury from the bodies of autistic children.

nicotinell

A series of recent studies and investigations indicate that mercury is at the heart of the growing autism epidemic. This has lead a number of doctors to employ chelation therapy to remove the extremely toxic substance from affected children. Now, a group of parents of autistic children have founded a nonprofit organization known as Generation Rescue to get the message out that there are biomedical treatments that can effectively treat and reverse autism. The group and the doctors who advocate such treatments are confident that many, if not a majority, of autistic children can make a full recovery from the debilitating disorder. Generation Rescue can be reached at www.GenerationRescue.org.