Florida Personal Injury Attorney Blog

Earlier this month, Dr. Diane Harper stirred up discussion with her remarks about Gardasil, a vaccine manufactured by major pharmaceutical company Merck used to prevent the human papilloma virus (HPV) at the 4th International Public Conference on Vaccination. According to a report by The Bulletin, Dr. Harper, who was the lead researcher for Gardasil and Cervarix and is the director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, stated that the drugs will do little to reduce the risk of cervical cancer. She went further to say that despite the fact that the drugs were recommended for young girls, there have been no clinical trials for girls under the age of 15.

What was surprising was that while Dr. Harper was speaking at the conference to promote the vaccine, many of her statements casted doubt on the utility of the drugs. According to Gardasil, there are four types of HPV. HPV 16 and 18 cause 70 percent of cervical cancer cases, while HPV 6 and 11 cause 90% of genital warts cases. While Gardasil has been promoted as an effective against HPV, Dr. Harper stated that 70 percent of all HPV cases treat themselves within a year, and 90% after two years. Only half of the remaining 10 percent develop into cervical cancer. Dr. Harper went further, stating that the incidence of cervical in the U.S. is very low, with four out of five women with cervical cancer living in developing countries. She also revealed that while Merck followed a group of girls under 16 years of age, it did not follow them long enough to draw conclusions as to the sufficiency of the presence of HPV antibodies.

The subject of vaccinations has been a hot topic lately, and in this case, one that South Florida women should be mindful of. The Bulletin article noted that since Gardasil’s inception in 2006, 15,037 girls reported adverse effects to the Vaccine Adverse Event Reporting System (VAERS), including lupus, paralysis, brain inflammation, and blood clots. The Center for Disease and Control Prevention (CDC) stated that there have been 44 reported deaths.

When considering taking a vaccine or any kind of medication, it is important that you always gather as much information as possible. Talk to your physician about your concerns and the possible side effects of taking certain vaccinations or medications and pay attention to reports and studies, both positive and negative, on these medications.

Posted by Gary T. Lazarus | Permalink | Email This Post

Posted In: PHARMACEUTICAL NELIGENCE

Bookmark:

Pfizer, Inc. is under fire for a hormone-replacement drug produced by Wyerth, a company which it acquired earlier this year for $68 billion.

According to Daily Finance, a jury awarded a Philadelphia woman $3.75 million in compensatory damages and an undisclosed sum of punitive damages, finding a link between Pempro, a hormone drug taken for menopause treatment, and her breast cancer. The jury also found that Wyeth hid evidence of Pempro’s potential cancer risk. The woman took Pempro for five years before being diagnosed with breast cancer in 2002. Daily Finance stated that there are 9,000 more lawsuits pending across the U.S., with about 1,500 in Philadelphia alone.

Stories such as this raises concerns for South Floridians and other consumers around the country. Can we trust that pharmaceutical companies will do business responsibly and ethically with the care and safety of its customers in mind without negligently putting a defective and potentially harmful product on the market? Booster Shots, from the Los Angeles Times’ Health Section, reported on French researches who conducted a study on 133 clinical trials which were published throughout 2006 in major medical journals. Besides finding that 55 percent of the studies were funded by for-profit companies, about 11% of the studies did not report on the adverse effects of their trials.

The researchers also found that some of the reporting was distorted. For example, 36 of the studies did not distinguish between severe and mild side effects. Sixteen studies only included the most severe side effects, while 17 reported only common side effects and another 63 did not report on withdrawals of volunteers from the studies. So while the Consolidated Standards of Reporting Trials was amended back in 2001 to emphasize the importance of reporting all adverse effects and events, the French researchers concluded that from their study, more needs to be done to rectify these inadequesies. Booster Shots noted an editorial accompanying the study by Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece, who saw the under-reporting by the companies as their intent on “silencing the evidence” of the potential harm.

Continue reading "Pfizer’s Prempro Brings Attention to Pharmaceutical Reporting Issue" »

Posted by Gary T. Lazarus | Permalink | Email This Post

Posted In: PHARMACEUTICAL NELIGENCE

Bookmark:

St. Mary’s Medical Center in West Palm Beach, Florida is being sued by a pregnant woman for injuries her baby suffered when the hospital mistakenly gave the woman a drug which speeds up labor. The Miami Herald reports that the woman, Tesome Sampson, gave birth two months early and her baby suffered brain damage as a result of the drug. She and baby's father, Frank Guy, filed suit for negligence against the hospital, its owner Tenet Healthcare, and other hospital personnel, claiming $3.5 million in medical costs.

In the hospital's statement, it apologized and acknowledged that Sampson was given the wrong medication, and that the mistake was “an unfortunate error”. The drug, Prostin E2, has been approved by the FDA , and is commonly used for the termination of pregnancies and expelling uterine contents, and can be used to induce labor.

Sampson was admitted to the hospital on August 25, 2008, 24 weeks pregnant. She was put on bed rest, but ten days later was given the wrong drug and suffered severe cramps. Sampson was given a portable toilet, where the baby was delivered.

Hospitals are not impervious to error. In 1999, an Institute of Medicine study found that about 98,000 people die every year from medical errors. These errors can be attributed to a number of factors such as miscommunication or failure of communication between hospital personnel and inefficient safety systems. Human error also plays a part, sometimes due to hospital staff work long hours.

However, the consequences of such mistakes can be life-altering, or even lead to death. Our firm has handled cases such as this where a careless error, one that could have been easily avoided, has taken the most precious of life away- a child. Furthermore, medical errors can attribute to millions of dollars spent on additional care needed to treat medical errors, rehabilitative treatment, increased medical malpractice insurance costs, and litigation expenses. Hospitals must do their part at all levels of administration to implement appropriate measures to ensure safety of their patients.

Posted by Gary T. Lazarus | Permalink | Email This Post

Posted In: HOSPITAL NEGLIGENCE , MEDICAL MALPRACTICE , PHARMACEUTICAL NELIGENCE

Bookmark:

The Journal of Neurology has reported that common forms of Hormone Replacement Therapy (HRT) can shrink the brains of post-menopausal women. Researchers performed brain scans on 1,400 women aged 71 to 89 who participated in the Women’s Health Initiative, A major American Study.

The Study found that women who were being administered HRT had smaller brain volumes in two key areas than those given a placebo. Brain volume was lower in the frontal lobe and in the hippocampus. Both of these areas of the brain contribute to thinking and memory skills. Shrinkage of the hippocampus is a known risk factor for dementia.

This Study was ironically renowned for finding a link between long term HRT use and increased stroke risk. The question that must be examined is whether the Pharmaceutical Industry is going to continue to be allowed to obtain approval of their products without greater scrutiny.

The conventional wisdom is that the American F.D.A., which regulates the Pharmaceutical Industry, has the most stringent and arduous approval process on the planet. However, conventional wisdom appears to be nothing more than American Corporate propaganda as the overwhelming number of drugs that have been recalled or that have caused significant health problems has been staggering over the past ten years.

Too, often, we learn of the politicizing of the F.D.A., which is given its marching orders to treat the pharmaceutical industry with kid gloves. Former industry personnel end up working for the agency that is supposed to regulate the very same industry they just left, and are going to return to after this government stint.

We are supposed to have a government for the people, not for the corporations. Hopefully, the pendulum will be shifting back.

Posted by Gary T. Lazarus | Permalink | Email This Post

Posted In: PHARMACEUTICAL NELIGENCE

Bookmark: