Category: Health

FDA Sued For Its Failure To Regulate Shellfish Bacteria

BacteriaThe US Food and Drug Administration (FDA) is bracing for a legal battle after public attorney Julie Murray filed the complaint at the Center for Science in the Public Interest (CSPI). The case was filed late May at the U.S. District Court for the District of Columbia. The agency’s failure to regulate the vibrio vulnificus bacteria found in shellfish, a violation of the Food Safety Modernization Act.

The FDA’s failure to regulate the deadly bacteria can result to the death of approximately 30 people who can suffer serious illness and eventually die. The figures were cited from the FDA itself and the Centers for Disease Control and Prevention. Vulnifucus is the main cause of seafood-associated deaths in the United States.

The lawsuit alleges that the FDA’s failure to implement safety standards for controlling the deadly bacteria is unacceptable. With the technology for elimination and decreasing vulnificus while maintaining the texture and flavor of raw oysters is already in place, the only thing lacking is the resolve to act upon the public health hazard.

The CSPI is pushing for a Federal court order that will force the FDA to decide within 30 days on the 4-year old petition calling for the implementation of testing regulations for oysters and other shellfish desigend for raw consumption. CSPI cited a provision in the FSMA requiring the FDA to review and evaluate relevant health data and other relevant information in order to determine the most significant contaminant.

In addition, the provision also mandates the Secretary to issue contaminant-specific and science-based guidance documents regarding action level or regulation. It has been four years since CSPI’s petition and three afters the first deadline of the FSMA but still there is no response from the FDA.

Since the FDA has become aware of the potential hazard, at least 300 people have been killed of contamination from 1989 to 2010. The number of deaths has increased since then. The lawsuit claims that since then the FDA has not implemented a safety standard requiring companies to reduce vulnificus to nondetectable levels.

People who get infected with vulnificus die from poisoning within a few days. The fatality rate is 100 percent if the patient is not treated within 72 hours. The only chance of survival is to have the limbs amputated.

Medical Mistakes: The Third Leading Cause of Death in the U.S.

surgeonsIn May of 2015, Deborah Craven underwent surgery to have a mass removed from her eighth rib. According to a statement filed by Yale-New Haven hospital with the Connecticut Department of Public Health, the incorrect rib, however, was removed.

In a different news story published in February 2016, a 46-year old female doctor in Southern California was said to have been convicted of second-degree murder for the deaths of three of her patients for recklessly prescribing opiate-based painkillers. According to John Niedermann, a Los Angeles County Deputy District Attorney, the deaths of the three patients, who were all in their 20s, were not the only patient deaths blamed on the 46-year old female doctor; in 2007 and 2008, three other patients of hers also died due to an overdose of the drugs that she prescribed.

In the U.S., like in any part of the globe, medical malpractice due to mistakes committed by health professionals and providers is nothing new, thus the thousands of lawsuits (filed by patients or their families) every year. Based on their review of four different studies, all on death rates in the U.S., doctors at Johns Hopkins say that at least 251,454 deaths are caused by medical errors in the U.S. annually. The doctors, however, believe that the number is much higher as many medical errors are never officially reported, and deaths occurring in nursing homes are not included in the count.

Doctors Martin Makary and Michael Daniel, who made the review, state that medical errors seem to kill more people than lower respiratory diseases. This would put medical mistakes in the third spot on the list of the leading causes of death in the U.S., placing it right after heart disease and cancer.

Though the doctors are hopeful that their study will result to improvement in a health care system which, they say, is letting patients down, Dr. Makary, in particular, believes that many hospitals never invest in technology that could help prevent and lessen errors because these hospitals do not realize just how big the problem is: neither do these hospitals make it a priority to understand the cause of the problem.

Removing the wrong body part is not the only basis of lawsuits filed against medical professionals, by the way. There are also lawsuits against surgeons who operate on the wrong patient, a surgeon who accidentally leaves a piece of medical equipment in a patient’s body, a doctor who prescribes the wrong medicine or an opiate-based painkiller, or a doctor who fails to correctly diagnose a serious illness.

When Birth Control Pills Fail to Prevent Pregnancy

woman_holding_birth_controlOf the 177 women who took contraceptive pills made by the manufacturers of Qualitest Pharmaceuticals, 113 still got pregnant with 94 of these women deciding to deliver their child. Qualitest and its manufacturers committed the mistake of having the pills packed in a reversed order, causing the women who used them to take placebo pills during the week instead of the hormone pills.

Due to damages, which include loss of income, medical expenses and cost of raising a child to age 18 (these children being born from unplanned pregnancies), Qualitest Pharmaceuticals, which is a subsidiary of Endo Pharmaceuticals Inc., and other companies which either made or distributed the pills under different brand names, now face lawsuits that can amount to millions of dollars.

The contraceptives, sold under the brand names Tri-Previfem, Previfem, Orsythia, Gildess, Emoquette and Cyclafem, each had 28 days’ worth of pills; 21 of these pills contained hormones that are supposed to prevent pregnancy, while the other seven are placebos. The pills should be taken in order – this means not mixing the placebos with the active pills.

It was found out by a US District Judge, however, that of the half-million packs of pills that were recalled, about 53 packs had the order of the pills reversed. The recalls, which were made in September 2011 by Qualitest, included eight birth-control pills brands.

The head of the National Women’s Health Network knows that the lawsuit filed by the affected women will be a tough battle to fight (part of this is proving that they got pregnant due to the packaging mistake). She believes, though, that it should be the duty of the company, which made the mistake, to do the right thing, which is to compensate those who suffered damages and losses.

Ebola Victims May Recover Using Tobacco-Plant Drug

EbolaDeadly biological agent rears its head abroad, and infected U.S. citizens throw caution to the winds by using an experimental drug not yet approved for human testing.

The Ebola virus claimed the lives of more than 900 people in West Africa, while twice that is infected. An American missionary Nancy Writebol was evacuated to medical isolation in Atlanta together with Dr. Kent Brantly for treatment. Dr. Brantly is the physician who exhibited symptoms of the disease after treating Patrick Sawyer, the first American to die of Ebola. Both are undergoing treatment with the use of an experimental drug derived from tobacco plants that has yet to be approved by the U.S. Food and Drug Administration (FDA) for human applications.

The virus spreads from host to host through contact via bodily fluids. The Centers for Disease Control and Prevention have dispatched 50 infectious disease specialists to contain the outbreak in West Africa.

The spread of disease has become much more a matter of concern because of the ease of air travel. Ebola is fortunately not passed through the air, and has a 55% mortality rate, but experts caution that the virus is tricky and unpredictable. Containment is the best option. There is no confirmed treatment of the virus.

The use of the experimental drug ZMapp on Writebol and Brantly was done so without the sanction of the FDA which is required by law. However, it was first administered in Liberia, thus beyond the jurisdiction of the FDA. Despite the first positive signs of recovery, the efficacy of the drug is not yet confirmed, and the legal ramifications of such a move are also somewhat nebulous, though both patients who received the drug were aware that it was an experimental treatment.