An FDA advisory committee has recommended against the use of Avastin in breast cancer treatment. The decision was based upon new drug trials that demonstrated no demonstrable benefit in the treatment of breast cancer.
The recommendation is a set back for those who believed Avastin would prevent the disease's progression. The FDA should make a final decision by Sept. 17. It is not required to follow the recommendations of advisory panels, but generally does.
CNN posed the question yesterday citing a recent University of California study which found that there's a 10% increase in deaths from medication errors in hospitals in July. While not drawing a definitive conclusion, CNN noted that July is also the month when medical school students become residents in hospitals.
According to CNN, researchers from the University of California study examined 240,000 death certificates from 1979 to 2006 and found a consistent spike in the number of deaths each July. The spike was most significant in counties which have teaching hospitals.
"No one has been able to suggest anything else besides the appearance of new medical residents. That's the first month they start their new jobs and have expanded autonomy," says David Phillips, a professor of sociology and lead author of the study. He says although it's possible that the increase can be linked to administrative or other events specific to July, the most notable link is the start of new medical residents.
The connection between the July influx of residents and the increase in deaths is controversial and not everyone agrees with it.
Regardless of the reason for the spike in deaths, every patient needs to be proactive about health issues, especially when hospitalized. The following are a few tips everyone should keep in mind when entering the hospital:
1) Ask questions
2) Don't assume the medication you're receiving is correct, ask and check
3) If you're not satisfied with your level of care, ask to speak with a supervisor or an attending physician
You have to take responsibility for your own health. Be an advocate and be safe!
With an FDA hearing looming next month, two new studies were released today that bolsters the argument that Avandia is a dangerous drug that should be removed from the market. The new research points to the diabetes drug as a risky drug for those suffering with diabetes. Both studies suggest that Avandia significantly increases the risk of heart attacks and strokes.
The new data adds to the mounting evidence that Avandia may be removed from the market by the FDA when government officials meet next month to decide the diabetes drug's fate.
It also marks a precipitous plummet for GlaxoSmithKline, the manufacturer of the diabetes drug. Avandia, approved in 1999, was once a best selling diabetes drug whose worldwide sales exceeded $3 billion annually.
According to the Washington Post, "One analysis, involving more than 35,500 patients, found Avandia significantly raises the chances of a heart attack. The second, a federal analysis of more than 227,500 Medicare patients -- the largest such study to date -- found the drug boosts the risk for strokes, heart failure and death."
One of the earliest Avandia critics, a prominent Cleveland Clinic cardiologist reaffirmed his commitment to have the drug removed from the market noted, "There's no reason to keep this drug on the market. This is a harmful drug."
With such strong evidence against Avandia, it's hard to imagine the drug will survive FDA scrutiny in July. However, not all industry insiders feel so confident about Avandia's demise. GlaxoSmithKline has not been deterred by the negative attention from the new research. GlaxoSmithKline officials remain confident that the drug is safe and effective in treating diabetes.
The Post concluded by noting, "In a paper released online by the Journal of the American Medical Association, the researchers found those who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took Actos. Based on the findings, the researchers estimate that there would be one heart attack, death, stroke or heart failure in every 60 patients who took the drug for one year."
Ultimately, what should be paramount in the FDA decision is patient safety. If the drug is unsafe, remove it before more patients are injured.
This week has been a tragic one for motorcycle enthusiasts in New Hampshire. As Laconia Bike Week draws to a close, three motorcyclists have lost their lives on NH roads. Yesterday, Christopher F. Magistro of Bradford NH was killed when he lost control of his motorcycle and struck a utility pole. Police noted that alcohol was not a factor in the crash. Magistro was not wearing a helmet at the time of the crash.
Another serious motorcycle accident occurred in Winchester. A motorcycle was heading west on Rte. 10 when a car unexpectedly made a left turn as the motorcycle was attempting to pass the vehicle. Both the driver and the passenger of the motorcycle were thrown from the bike. Both sustained serious injuries. The driver was later flown to University of Massachusetts Memorial Medical Center with very serious head injuries.
The third motorcycle crash in as many days happened in Meredith, NH when a group of bikers was heading north when a vehicle made a sudden U-turn. The lead cyclist hit the driver's side door and flew over the vehicle. The bike's driver was airlifted to Dartmouth Medical Center with serious injuries.
These motorcycle accidents underscore the importance of defensive driving for both motorcyclists and those who operate motor vehicles. During the summer months, motorcycles are everywhere. It only takes a split second of inattention or distraction for a fatal motorcycle accident to occur. Be careful out there!
A new study from the University of Montreal published in the Canadian Medical Association Journal suggests that pregnant women taking antidepressants may be prone to miscarriages. The studies, the first of its kind to delineate certain antidepressants in particular, noted that Paxil and Effexor are associated with the greatest risk of miscarriage.
According to TIME Magazine, "The study included 69,742 women from the registry, 5,124 of whom had had a clinically recorded miscarriage. Among the women who had miscarried, 5.5% had filled at least one prescription for an antidepressant during pregnancy, compared with 2.7% of the control group. Researchers calculated that antidepressant users had a 68% higher risk of miscarriage than nonusers, after controlling for other influences that could potentially confound the association."
The study does not suggest pregnant women suffering from depression abandon pharmaceutical therapy. However, it does offer more data for obstetricians to consider when treating pregnant women who present with depressive symptoms.
We've blogged previously about the dangers of the weight loss drug Alli. Now, the Food and Drug Administration has issued a warning concerning Alli and its risk of severe liver injury. The popular weight loss drug has been taken by an estimated 40 million consumers. Xenical, which is available in prescription form, has also received an FDA warning concerning liver injury. Both Xenical and Alli contain 60 mg of orlistat. The FDA first approved Xenical in 1999, and Alli was approved in 2007.
Last year, the FDA began reviewing orlistat over safety concerns. At the time, the FDA had received 32 reports concerning serious liver injury.
Patients taking Alli or Xenical who've experienced symptoms of serious liver injury should call their healthcare professional. Symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.
When Vermont Governor James Douglas signed the legislation last week, the Green Mountain state became the latest to ban the chemical from use in the manufacturing of plastic bottles and food storage containers.
BPA or bisphenol A is a chemical that has been linked to a variety of diseases including damage to the human endocrine system. BPA has been linked to cardiovascular disease, intestinal disorders, an increased risk to the reproductive system, and liver function.
BPA has been widely used in the hardening of plastic materials used in baby bottles, food containers, beverage containers, nautical paint, and thermal paper.
A Las Vegas jury has ordered Teva Pharmaceutical Industries and Baxter International to pay a combined $500 million in punitive damages in a medical malpractice case. This is a highly unusual jury finding. The case involve a man who contracted Hepatitis C due to an unsafe medical procedure. However, the jury found the pharmaceutical companies liable in the medical malpractice case due to the drug companies' marketing practices that encouraged the reuse of vials through their marketing practices and ambiguous labeling.
According to www.dailyfinance.com, "Health officials have put the blame for infecting patients with the incurable liver disease on reuse of the vials. 'Each of the 63,000 possible patient exposures identified in this investigation were entirely preventable, and would not have occurred if clinic staff had adhered to well-established, safe, and common sense injection practices,' the report concludes. More than 100 cases of Hep C infection were traced to these incidents."
The jury finding was largely based upon their conclusion that the drug makers were responsible for selling the health clinic 50 ml vials of propofol, four to five times the necessary dosage for a colonoscopy. Yet, through their marketing practices, the companies encouraged the re-use of the vials.
According to the 2009 Health and Human Service Department's quality report to Congress, the rate of hospital related infections has shown little improvement. In fact, rates of illnesses from three of five of the major hospital related infections have seen an increase. Rates of bloodstream infections following surgery increased 8%. Urinary infections from the use of a catheter following surgery increased 3.6%. Overall incidence for a series of common infections due to medical care increased by 1.6%. More than 98,000 patients die each year from preventable medical errors. It's been a decade since the Institute of Medicine launched a campaign to raise awareness concerning this issue but little improvement has occurred. Hospital related infections can be prevented by following proper procedures and good nursing care.
This disappointing trend can be corrected. The Wall St. Journal noted that 100 emergency rooms in Michigan have reduced the rate of central catheter infections to near zero by following good medical care procedures.
Documents submitted to the National Highway Traffic Safety Administration (NHTSA) show that Toyota knew about defective floor mats and "sticky" accelerator pedals in 2006. Since 2006, approximately 50 people have been injured or died due to these Toyota vehicle defects. According to the Associated Press, Toyota chose to monitor the safety situation rather than publicly disclose the public safety hazards concerning the floor mats and accelerator pedals.
The NHTSA has decided to fine Toyota $16.375 million, the maximum penalty allowed by law, for Toyota's failure to timely disclose the defects.
“We now have proof that Toyota failed to live up to its legal obligations,” Transportation Secretary Ray LaHood said. “Worse yet, they knowingly hid a dangerous defect for months from U.S. officials and did not take action to protect millions of drivers and their families. For those reasons, we are seeking the maximum penalty possible under current laws.”
Toyota class action lawsuits will now be consolidated and heard in Orange County CA. 8.5 million Toyota vehicles have been recalled because of the defects.
23-month-old Almariah Duque was born with a birth defect. In December 2009, she underwent transplant surgery of her small intestine, pancreas, and liver. Almariah was readmitted to the Nebraska Medical Center in February after an infection developed. On March 31, the toddler died of an apparent heparin overdose.
Heparin is a blood thinner commonly used in transplant surgeries, dialysis, and to prevent blood clots.
A hospital statement after the toddler's death noted that a heparin overdose may have contributed to the death.
"It appears an overdose of the blood thinner heparin may have contributed," said the statement, which called the death "a deeply troubling and emotional incident" for hospital personnel. "We all want to extend our deepest apologies to the Duque family for their tragic loss," it added.
Heparin overdoses are not that uncommon due to medical errors involving dosage errors and failure to comply with hospital dosage protocols.
In 2007, actor Dennis Quaid’s infant twins suffered a Heparin overdose at Cedars-Sinai Hospital in Los Angeles. In 2008, a dozen premature babies were given an overdose of heparin, two of whom died, at Christus Spohn Hospital South in Corpus Christi, Texas.
The FDA issued a heparin safety alert in 2007 advising healthcare professionals of the potentially fatal consequences of mistaking 10,000 unit vials of heparin with 10 unit vials. The FDA encouraged hospitals to review dosage procedures and protocols in the wake of three Indiana infants died after given adult dosages of heparin.
In the mid 1980's there was no single repository of information concerning a doctor's disciplinary record, medical malpractice claims filed, or a history of suspensions or license revocations. In 1986, the US Congress passed the Health Care Quality Improvement Act in order to rectify the situation. As a result of the new law the National Practitioner Data Bank was established, which serves as a database that includes malpractice payments, loss of clinical privileges, and medical license revocations. The database keeps records on physicians, dentists, nurses, pharmacists, physical therapists and other professionals.
The problem with the database concerns public access to the information contained therein. Thanks to the American Medical Association's lobbying efforts, the public can only access general statistical information. Individuals cannot access information on individual doctors. Doctors may access their own files and hospital administrators and other "authorized users" have access to the files of individual doctors.
What good is such a database if it isn't transparent? It seems that the public's right to know should trump the lobbying efforts of the AMA.
During the healthcare debate, we've witnessed those who want to restrict consumer access to the courts talk about the medical malpractice crisis. In their arguments, they'd often cite doctors fleeing the practice of medicine and insurance premiums being raised as a direct result of medical malpractice lawsuits.
But the facts don't support these hyperbolic rants. In 2009, fewer medical malpractice claims were paid than any previous year, according to the National Practitioner Data Bank. While medical malpractice payments fell 8% last year, healthcare spending rose 83%.
This doesn't seem like a crisis to me.
A new study published in the New England Journal of Medicine suggests doctors may be ordering unnecessary angiograms thus exposing patients to radiation that is not warranted. The study of 400,000 patients concluded that nearly 40% of them did not need an angiogram. According to Manesh Patel, a cardiologist at Duke University and one of the study's authors suggests better diagnostic tools are needed in order for a reduction in unnecessary procedures such as angiograms.
“We need to improve all the things we do before we get to the cath lab,” Patel said in a telephone interview. “But we need more large-scale studies to give doctors the guidance they require to make these calls.”
The spike in imaging tests exposes patients to more radiation than ever before. According to David Brenner, director of the Center for Radiological Research at Columbia University in New York, Americans are exposed to twice as much radiation today as they were 30 years ago.
The increase in such invasive procedures such as angiograms has also led to an increase in healthcare costs without the benefit of improved outcomes.
A surgical tech with an admitted drug problem has been sentenced to 30 years for placing countless patients at risk for various bloodborne diseases. Kristen Diane Parker, whose shoddy medical practices fueled by drug seeking behavior led to the infection of at least 3 dozen patients, was originally thought to be sentenced to 20 years in prison. However, the judge rejected the plea agreement and has sentenced her to 30 years in prison.
Parker was charged with stealing Fentanyl syringes for her own use. While she says she intended to replace the used syringes with new ones, she instead filled the used syringes with saline solution infecting at least 36 patients with hepatitis C which is transmittable through bodily fluids, especially blood.
There is no known cure for hepatitis C and the disease can be fatal. The regulation and monitoring of surgical techs such as Parker are an issue that has gained more attention with the Parker case.
Last week, we reported a disturbing case in which a Texas nurse faced a prison term for reporting a doctor she suspected of practicing bad medicine. We've just learned that a jury has acquitted her of any wrongdoing.
Fortunately the jury agreed with those who believe in medical accountability and transparency.
"Fulfilling your duty as a nurse shouldn't get you an indictment," said Joyce Cunningham, spokeswoman for the Texas Nurses Association, which called the prosecution unprecedented and launched a legal fund that she said has swelled to almost $50,000. "It's about patient safety, and patient safety won the verdict."
A new study conducted by the Center for Health Services Research at Henry Ford Hospital and published in the February issue of the Journal of Clinical Endocrinology & Metabolism, suggests that a certain class of diabetes drugs known as thiazolidinediones may increase the risk of bone fracture in women. While most consumers couldn't identify thiazolidinediones, they surely would recognize brand name drugs such as Actos and Avandia, two of the more popular members of the diabetes drug class.
The Henry Ford study was restricted to those with Type II diabetes. The findings were striking in that women who took the thiazolidinedione for one year were 50% more likely to experience a bone fracture. Interestingly, thiazolidinedione use in men, regardless of age, did not impact the likelihood of bone fracture.
An administrative nurse faces a trial and a ten year prison sentence if convicted of reporting a doctor for practicing bad medicine. The official charge is "misuse of official information" a third degree felony in Texas. The prosecution will argue that Anne Mitchell has a history of making inflammatory statements about Dr. Rolando G. Arafiles, Jr. Mrs. Mitchell has stated that as a nurse, she had a professional obligation to report the doctor for improper prescribing and surgical errors-including a failed skin graft that Dr. Arafiles performed without surgical privileges. According to the NY Times article, Arafiles also sutured a rubber tip to a patient's crushed finger which was later flagged as inappropriate by the Texas Department of State Health Services. When informed of the complaint, Arafiles complained to his friend who happened to be the Winkler County Sheriff. The Sheriff obtained a search warrant and seized the nurse's computer. He found the letter and she was arrested. It's not clear from the article how the sheriff determined Mitchell to be a suspect.
The case has received attention from the legal and medical communities in Texas and across the country. Legal experts have argued that Mitchell appears to be protected under Texas whistle blower laws.
While Dr. Arafiles has friends in high places, the law would appear to side with a healthcare professional who reports a doctor for questionable medical practices.
Supposedly, the state of medical practice in Tennessee was so bad that the American Medical Association had declared a crisis in the state. So in 2008 the residents voted to pursue tort reform legislation. However, those efforts have proven fruitless in lowering malpractice insurance for healthcare professionals.
In President Obama's meeting with Republicans in Baltimore last Friday, Obama said he was open in reviewing tort reform efforts even though the Congressional Budget Office had noted that such efforts would do little to lower healthcare costs.
When will the insurance industry and other lobbying groups stop pushing this myth? So-called tort reform isn't healthcare reform.
Yaz birth control lawsuits have been filed across the country because of their association with an increased risk of strokes, blood clots, and heart attacks. However, the Yaz birth control pills are now being linked to an increased risk of gallbladder disease. These Yaz side effects seem to be caused by the higher level of estrogen related to Yaz contraceptive use.
In 2001, FDA approved Yasmin, which contains drospirenone, a progestin that can increase the body's potassium levels. According to the drug's label, the potassium increase may put women with liver and kidney problems at higher risk for serious side effects including blood clots, strokes, and heart attacks. Yaz, which also contains drospirenone and a lower dose of estrogen, was approved in 2006 as both a contraceptive and a treatment for premenstrual dysphoric disorder and moderate acne. Bayer, which manufactures both contraceptives, has aggressively marketed the contraceptives resulting in nearly $2 billion in worldwide sales in 2008.
In 2008, the FDA sent Bayer a warning letter about its Yaz marketing campaign. The FDA noted that Bayer had overstated its efficacy and its promotion for uses (premenstrual syndrome) which the FDA had not approved. In August 2009, Bayer received a second FDA warning letter concerning its quality control practices in its manufacturing plant in Germany.
The head of the Consumer Products Safety Commission, Inez Tenenbaum, has told US consumers to throw away any children's jewelry that was manufactured in China. Tenenbaum's reaction has come in the wake of studies that have found unsafe levels of lead and cadmium in the jewelry. The CPSC warning was published in a blog post after the Associated Press reported the dangerous levels of lead and cadmium in the jewelry. The report included the most contaminated piece analyzed for its investigation contained a whopping 91 percent cadmium by weight. Other pieces of jewelry tested at 89 percent, 86 percent and 84 percent by weight. Overall, 12 percent of 103 pieces of jewelry contained at least 10 percent cadmium.
This poses a serious public health risk to our children. Cadmium is a known carcinogen that may interfere with neurological development in children. Presently, there are no restrictions in the use of cadmium in the manufacturing of children's jewelry.
The Yaz birth control lawsuits may exceed 20,000 as they head to US District Court for the Southern District of Illinois. The number of Yaz lawsuits underscores the popularity of the birth control as well as the aggressive marketing campaign of their manufacturer Bayer. In spite of 3 separate FDA warnings, consumers continue to purchase and use the birth control.
Unlike other birth control pills, Yaz and its precursor Yasmin contain a type of progestin called drospirenone which have been associated with numerous adverse side effects including heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.
Many of the lawsuits already filed in federal court claim that Yaz and Yasmin have caused blood clots and other serious side effects which were never mentioned in the onslaught of television advertising promoted by Yaz manufacturer Bayer.
Judge David R. Herndon (MDL No. 2100) is presiding over the MDL involving the Yaz birth control lawsuits. In anticipation of the onslaught of birth control lawsuits, Judge Herndon has hired a law clerk to help manage the cases.
As a new year dawns, there is hopeful news regarding patient safety. That is the case in at least two states, Washington and Ohio, both of which took significant steps in improving patient safety by making public hospital safety data.
In Washington state, the state Department of Health has developed a website where the state's hospitals' infection records and medical safety records are made public. The new website has already benefited the hospitals as well as the patients. When Washington's Swedish Medical Center, one of the largest hospitals in the state, was shown to have unusually high infection rates linked to central lines (tubes inserted into patients), the hospital responded to the bad news and began to correct the problem. Updated state health data shows that the hospital has responded to the issue and is making corrections to resolve the infection issue. Perhaps, this would not have happened if this data was not made public.
In Ohio, the state Department of Health launched a website that tracks mortality rates for certain hospital procedures, compliance rates in treating common conditions, and provides three patient safety indicators.
These new measures are positive signs that at least in some states, the fight for transparency and improvement in patient safety is making progress.
Lawsuits concerning Bayer's Yaz and Yasmin birth control products continue to mount as more women come forward after having suffered strokes, heart attacks, pulmonary emboli, and gall bladder problems as a result of taking the birth control. The lawsuits have been consolidated in a multi district litigation in U.S. District Court for the Southern District of Illinois. Thus far, there have been approximately 300 such lawsuits filed across the country.
Both Yaz and Yasmin are manufactured by Bayer Pharmaceuticals containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. The unique progestin has been implicated as the likely cause of the
issues surrounding both Yaz and Yasmin.
According to an August 2009 study published in the British Medical Journal, the drospirenone contained in Yaz and Yasmin carry 6.3 times increased risk of developing blood clots, deep vein thrombosis, or pulmonary embolism than other forms of birth control.
Harrington and Sons of Williston Vermont has recalled 68 pounds of ground beef because it may be contaminated with E. coli O157:H7 bacteria. The announcement was made in conjunction with the US Department of Agriculture's Food Safety and Inspection Service.
The recall is Class I which means that the health risk is high for those who consume the ground beef. Class I food recalls involve serious risks to health including death in some instances. The beef affected by the recall was produced on December 15, 2009 and was distributed to local restaurants and one retail business.
E. coli O157:H7 is a dangerous, potentially lethal bacterium that may cause bloody diarrhea, dehydration, and in the worst cases, kidney failure. Those who are most at risk for serious illness are the very young, the elderly, infirm, and those with compromised immune systems.
Those who have questions or concerns about this recall can contact “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0:00 a.m. to 4:00 p.m. Eastern Time, Monday through Friday. Recorded food safety messages are available 24 hours a day.
A class of bone-building drugs known as bisphosphonates may actually reduce the instances of breast cancer. While researchers aren't clear about the causal relationship between bisphosphonates and a reduction in breast cancer, new studies point to a reduction in the occurence of the cancer.
According to a Wall St. Journal report, "In one study, researchers analyzed data from the huge National Institutes of Health-sponsored Women's Health Initiative and found that users of bisphosphonates had nearly a third fewer cases of breast cancer compared with nonusers.
A second study involving more than 4,500 postmenopausal women in Israel with and without diagnoses of breast cancer found that those who reported using bisphosphonates for at least five years were about 30% less likely to receive a breast-cancer diagnosis, even after controlling for risk factors such as family history and use of other medications."
Now, there is a cautionary note to be considered with this class of drugs. Hundreds of Fosamax lawsuits have been filed by those who've taken this particular bisphosphonate drug and suffered necrosis of the jaw bone.
More research is needed before women begin taking bisphosphonates as a breast cancer prevention drug. However, the initial results presented at the San Antonio Breast Cancer Symposium are interesting and worthy of further study.
The once popular birth control pills Yaz and Yasmin have been linked to an increased risk of blood clots, strokes, and a potentially deadly gallbladder disease. The Yaz and Yasmin birth control pills utilize a different type of hormone than previous birth control pills which has been associated with an increased risk of blood clots, strokes, and now, gallbladder disease. Drospirenone is the new type of hormone utilized in these birth control drugs and is perhaps boosting the level of cholesterol in bile and limiting the movement of the gallbladder associated with gallstones and gallbladder disease. Drospirenone has also been associated with a dramatic increase in blood clots.
Yaz and Yasmin lawsuits continue to be filed against their manufacturers Bayer and Schering.
The FDA is warning consumers not to mix certain heartburn drugs like Prilosec with Plavix, an anti-clotting drug. Tests have shown that Prilosec (available over the counter) and Nexium (available by prescription) interfere with Plavix's ability to block platelet aggregation (it's anti-clotting effect). Studies have shown that the drug interaction may cause Plavix's effectiveness to be reduced by 50%. Plavix, an anti-clotting drug, is used to prevent the blood clots that typically lead to heart attacks and strokes.
The FDA noted that Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of a liver enzyme. Prilosec, which is a proton pump inhibitor designed to block acid build-up in the stomach, blocks that enzyme, thereby reducing the effectiveness of Plavix.
Yaz and Yasmin lawsuits continue to mount as more strokes, heart attacks, and blood clots are reported in those women taking the birth control pill manufactured by Bayer. All the lawsuits allege that the progesterone used in the Bayer formulation is dangerous and causes the strokes and blood clots. Studies of Yaz and Yasmin point to the fact that the ingredient used in these birth control pills, drospirenone, causes a potassium buildup which leads to a drop in heart rate. The drop in heart rate may lead to clot formation. Other studies have noted that drospirenone may also lead to an electrolyte imbalance which may trigger strokes.
In spite of the drugs' initial popularity due to Bayer's aggressive marketing of the products, Yaz and Yasmin face mounting lawsuits. Presently, the drugs remain on the market. The FDA has not commented yet on the dangers of the birth control pills.
One million Maclaren baby strollers have been recalled by the company in conjunction with the US Consumer Product Safety Commission. The recall was prompted by 15 reports of children placing their fingers in the hinge mechanism resulting in 12 finger amputations. The affected models included Volo, Triumph, Quest Sport, Quest Mod, Techno XT, TechnoXLR, Twin Triumph, Twin Techno and Easy Traveller. The high-end stroller retails for $100-$360.
The popular stroller is manufactured in China and is sold in the United States at Target stores as well as Babies "R" Us. The strollers have been available for purchase on the US market since 1999.
A California hospital program has found a new way to drastically reduce medication errors in hospital settings, and it has nothing to do with purchasing expensive technology. Healthcare officials UCSF implemented a program in which nurses who dispense medication were left uninterrupted while on rounds dispensing prescribed medications. The result was fascinating. The simple procedure reduced medication errors by 88% in 36 months.
"Medication errors make up the largest slice of the medical error pie," said Julie Kliger, director of UCSF's Integrated Nurse Leadership Program, which developed the medication errors' program. "Improving these numbers is a huge benefit to patient safety and, secondarily, it reduces costs." Read more: http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2009/10/28/MNIM1AB9DB.DTL#ixzz0VNjTLYP3
Medication errors result in approximately 400,000 preventable injuries each year at an annual cost of $3.5 billion in additional medical costs.
The low-tech strategies implemented in the program included nurses wearing bright colored vests or establishing "quiet zones" in the hospitals that indicate a nurse is not to be disturbed while administering prescription drugs.
An apparent domestic dispute turned deadly this afternoon in the Queen City. The shootings in the 200 block of Jewett St. left one dead and at least one other person injured. Since the incident took place near several middle and high schools, the schools were on lock down and all students were kept inside their school buildings.
According to the Union Leader, a Manchester SWAT team was dispatched to the scene and quickly cordoned off the area. The shooting was the second such incident in Manchester in the last 24 hours.
Medical errors account for an estimated 98,000 deaths each year in the United States. These deaths are preventable. However, they are rarely reported and not tracked. These unfortunate facts remain major stumbling blocks to significant reform in healthcare today.
The Centers for Disease Control and Prevention estimate that an additional 99,000 hospital patients die from hospital acquired infections.
Because there is no national medical error reporting system, we can only rely on estimates. However, these figures are alarming. These estimates point to 200,000 Americans dying each year from preventable medical errors and infections.
Yet, the insurance lobby will have you believe the real problem in healthcare reform is medical malpractice. However, the estimated statistics paint a different picture. Medical errors and malpractice can't be addressed and resolved if there is no transparency in the system.
The national investigation undertaken by Hearst newspapers, which is available online at http://www.chron.com/deadbymistake chronicles the safety issues at the heart of the healthcare crisis in this country.
Pharmacy errors can be multi-faceted and can cause great injury to the patient. Errors may occur in the processing or preparation of the prescription. These pharmaceutical errors include preparing and dispensing the wrong drug or dispensing the correct drug but the wrong dosage. The most common of these errors occurs when the wrong drug is dispensed. Other pharmacy errors include: prescribing recalled medication, prescribing medication with known harmful effects, and mislabeled prescriptions. Other errors may occur when pharmacy technicians are not properly monitored and supervised by pharmacists and are allowed to prepare and fill prescriptions without adequate supervision. In some pharmacies, the sheer volume of prescriptions to be filled leads to medical and pharmaceutical errors.
These pharmaceutical errors can lead to serious injury and death. Pharmacies and pharmacists are liable for such errors, since they have a duty of care to ensure that a prescription is properly and safely filled.
The Swiss government has begun a probe into the safety of birth control pills Yaz and Yasmin after a young woman died of a pulmonary embolism after taking the birth control pill for 10 months. In the United States, the FDA has received 50 reports of deaths associated with Yaz or Yasmin since 2004.
Yaz was approved for use in 2006 and is made with drospirenone which may increase potassium levels in certain users. Both birth control pills, Yaz and Yasmin have been linked to an increase in high blood pressure, blood clots, and strokes.
Currently, there are 74 Yaz and Yasmin lawsuits pending across the United States.
Children's Tylenol, manufactured by McNeil Consumer Healthcare, has issued a recall of 21 of its products in cooperation with the FDA. The recall concerns certain Tylenol products manufactured between April and June 2008. The company explained its recall decision in a letter posted on its website,
"The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements.Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications."
The 21 Tylenol products include:
Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Strawberry
Children’s Tylenol Suspension 4 oz. Bubble Gum
Infants’ Tylenol Suspension 1/2 oz. Cherry
Infants’ Tylenol Grape Suspension Drops 1/4 oz.
Children’s Tylenol Dye Free Suspension 4 oz. Cherry
Children’s Tylenol Suspension 4 oz. Cherry
Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1/2 oz. Grape
Children’s Tylenol Plus Flu 4 oz. Bubble Gum
Children’s Tylenol Plus Cold Suspension 4 oz. Grape
Children’s Tylenol Plus Cough/ST Suspension 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Grape
Infants’ Tylenol Dye Free Suspension 1 oz. Cherry
Children’s Tylenol Pediatric Suspension 1 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Cherry
Children’s Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
Infants’ Tylenol Grape Suspension Drops H/G 1/2 oz.
Infants’ Tylenol Drops 1 oz. Grape
Children’s Tylenol Suspension 4 oz. Cherry, Hospital Govt.
The first Paxil birth defect lawsuit will commence today in Philadelphia. The drug has been linked to birth defects in pregnant women who used the drug in the first trimester of pregnancy. There are more than 600 other Paxil lawsuits pending against the drug's manufacturer, GlaxoSmithKline PLC.
According to the results of two scientific studies, women who were taking Paxil during the first three months of pregnancy were 1.5 to 2 times as likely to give birth to a child with heart malformations than those who had taken other antidepressants. Another study showed evidence that babies born to mothers who took Paxil were susceptible to persistent pulmonary hypertension, a rare but life threatening condition that could potentially lead to multiple organ failure and death.
In 2005, the FDA warned consumers of the potential Paxil side effects. The studies showed cardiovascular damage such as atrial and ventricular septal defects. Other side effects include:
Difficulties with breathing
· Seizures
· Vomiting
· Low blood sugar
· Tremor
· Irritability
Court papers submitted by the plaintiff show that Paxil's manufacturer knew about the potential side effects as far back as 1980 but did nothing about it.
“There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.
The first Fosamax trial may end in a mistrial if the jury is not able to reach a unanimous verdict by Friday, a judge told the jury yesterday. The trial is the first of 900 lawsuits brought against the manufacturer of Fosamax, Merck. The lawsuits allege that Fosamax leads to osteonecrosis of the jaw or jaw rot.
Fosamax was manufactured by Merck in order to treat osteoporosis. However, soon after Fosamax was introduced to the marketplace, Fosamax users began complaining of jaw problems including deterioration of the jaw bone.
While US District Court Judge John Keenan warned of a possible mistrial, he also ruled in favor of the plaintiffs in Merck's attempt to dismiss 24 other Fosamax lawsuits. Keenan will allow the testimony of two doctors who will testify that Fosamax may cause jaw necrosis after less than 3 years of continuous use.
Approximately 220,000 Jeep Wranglers are being investigated by the National Highway Traffic Safety Administration for fire hazards. NHTSA is investigating 2007 and 2008 Jeep Wrangler models for transmission defects. In 3 cases, the transmissions overheated causing transmission fluid to leak and catch fire.
According to preliminary reports from the NHTSA investigation, the transmissions were manufactured at the Chrysler plant in Kokomo, Indiana. No injuries have been reported due to the transmission defect. It is unknown if the Jeep Wranglers will be subject to a recall at this time.
Drug manufacturer Eli Lilly settled its lawsuit with the state of West Virginia for $22.5 million. The lawsuit was prompted by the manner in which Eli Lilly marketed Zyprexa for uses that had not been approved by the FDA. The lawsuit also claimed that Eli Lilly downplayed such Zyprexa side effects as weight gain and the onset of diabetes.
Zyprexa is approved to treat schizophrenia and bi-polar disorder. However, Eli Lilly had aggressively marketed its best-selling drug for unapproved uses such as dementia and depression.
Physicians may prescribe any drug for off-label purposes. Drug companies are prohibited from marketing their products for uses other than those approved by the FDA.
Eli Lilly still faces lawsuits from seven other states over its Zyprexa marketing practices.
The West Virginia settlement is not the first lawsuit to be settled by Eli Lilly. In January, Eli Lilly agreed to pay $1.42 billion, including $362 million to 30 states to settle claims against the company for its prohibited marketing practices.
The Journal of the American Medical Association published two articles raising questions about Gardasil's safety and effectiveness as well as the way it has been marketed.
Researchers at the Centers for Disease Control and the FDA analyzed more than 12, 400 reports of adverse events related to Gardasil. Approximately 6% of those adverse events resulted in hospitalization, permanent disability, or death. However, the study's lead author Dr. Barbara Slade, a medical officer in the immunization safety office of the U.S. Centers for Disease Control and Prevention, stated that the study did not suggest the deaths were caused by Gardasil. The primary adverse reports concerned a higher incidence of fainting and blood clots than those receiving other vaccines.
Perhaps more troubling was the article concerning Merck's marketing practices regarding Gardasil. The study's authors criticized Merck for funding education campaigns that didn't provide the public with a balanced view of the drugs benefits and risks. According to the Wall St. Journal, "Doctors have questioned how effectively the vaccine prevents cervical cancer, given that its regulatory approval was for protecting against two strains of human papilloma virus, or HPV, that can cause cancer, but not all cancer-causing strains. Also, the vaccine was tested in only a few hundred 11- and 12-year-old girls, which some doctors said was too small a number to declare it safe for that age group. Critics assailed Merck's efforts to get states to require HPV vaccination, a push Merck backed away from in 2007."
In its critique of Merck's marketing practices, the authors noted that Merck emphasized the threat of cervical cancer in adolescents and minimized the sexual transmission of HPV.
Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association, wrote an accompanying editorial in this week's JAMA calling Merck's marketing of Gardasil "pushy" and "disturbing".
The National Cancer Institute estimates that there will be 192,370 new cases of breast cancer among women this year. 40,170 women will die from breast cancer, according to the Institute.
In spite of these statistics, breast cancer remains one of the more treatable forms of cancer if it is detected early through breast examination and mammography. It is estimated that between 85-90% of all breast cancer can be detected by mammography. The American Cancer Society recommends a baseline mammography before a woman reaches the age of 40 and an annual mammography every year thereafter.
Still, breast cancer is the second leading cause of cancer deaths among women today. Some of these deaths occur because of a breast cancer misdiagnosis or a late diagnosis of breast cancer. A misdiagnosis may occur when a radiologist misreads a mammogram. Additionally, the rate of false negatives for mammograms is 10%. If a routine breast examination reveals a lump or mass in the breast but is not detected by mammography, the standard of care warrants follow-up diagnostic exams and testing including an ultrasound or biopsy.
In cases where a breast biopsy is ordered, errors in diagnosing are an unfortunately all too common malpractice claim.
In cases where the healthcare professional failed to timely diagnosis breast cancer the consequences can be fatal. The survival rate between Stage I breast cancer and Stage IV plummets 80% according to some studies. Since breast cancer is a progressive disease, any delay can have serious negative consequences.
Breast cancer is one of the most commonly misdiagnosed forms of cancer. If you are presenting symptoms of breast cancer, see a doctor immediately. If you are not satisfied with your doctor, make an appointment to see another one, preferably a specialist. Be proactive.
In May 2006, Dr. David Polly testified before a U.S. Senate Committee concerning the importance of developing new medical devices to treat Iraqi war veterans, especially Medtronic’s Infuse Bone Graft. He told the committee that he was speaking on behalf of the American Academy of Orthopedic Surgeons. During his testimony, he spoke about his work at Walter Reed Army Medical Center as well as his work as a spine surgeon at the University of Minnesota. He didn’t mention that Medtronic Corp. had paid for the trip to Washington as well as his consulting services.
According to the Wall St. Journal, Dr. Polly was paid $1.14 million by Medtronic from 2004-2007.
Polly is a paid Medtronic consultant who is one of the doctors paid to promote Medtronic’s Infuse Bone Graft. In July 2008, the FDA issued an Infuse safety warning. Since that time, the federal government has been investigating the relationship between doctors and Medtronic.
Dr. Polly is not the first paid medical consultant to come under FDA scrutiny. Dr. Timothy Kuklo, an Army surgeon, has been accused of falsifying Infuse research as well as plagiarizing the signatures of other doctors on a favorable Infuse medical journal article.
These conflicts of interest demonstrate a safety concern for the general public as well as healthcare professionals who rely on scientific testimony to determine if a medical device is safe and effective. Doctors who are paid to promote a particular medical device and do not disclose such financial relationships to the public constitute a public health hazard. Scientific research on pharmaceutical drugs and medical devices must be objective and free of influence from financial gain.
Consumer watchdog group Public Citizen announced this week that diabetes drug (Rosiglitazone) Avandia increases the risk of liver failure. Avandia has already been linked to an increase in risk for heart attack.
Public Citizen has called for the FDA to ban Avandia. A review of adverse events reported to the FDA found 11 deaths due to liver toxicity between 1997 and 2006.
"Because of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug," said Dr. James Floyd of Public Citizen. He estimated that 1 in every 44,000 patients who take the drug develops liver failure.
The concern about liver failure adds to the list of problems associated with Avandia. Studies have shown that Avandia use increases the risk of heart attack by 40%, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss.
No such adverse events have been associated with the older, cheaper diabetes drugs Metformin (Glucophage) and Glipizide (Glucotrol).
Morgantown West Virginia is a sleepy community of nearly 30,000 residents and is best known as the home of West Virginia University. It’s also home to the world’s third largest manufacturer of generic drugs.
Earlier this spring, Mylan Inc. halted production of its generic drugs. The May 11th discovery involved violations of government mandated quality control procedures. An internal company report obtained by the Pittsburgh Post-Gazette details reports about employees overriding computer generated warnings concerning problems with drugs they were manufacturing. The report noted that quality control procedures had been circumvented and products were adulterated. To make matter worse, the report indicated these were not isolated issues. They were happening on all shifts for the last two years.
Mylan Inc. manufactures approximately 19 billion doses of medications annually that are prescribed to treat high blood pressure, diabetes, cancer, depression, among other diseases.
According to an article in the Pittsburgh Post Gazette, "I've never before seen anything like this, that has reached this level of cheating," said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. "It certainly indicates a significant problem within their company."
While Mylan officials contend that their products remain safe, government officials remain skeptical.
"The batch record is there to tell the story, the good, bad and ugly," said Robert Lewis, a regulatory consultant in Georgia and former FDA investigator who also reviewed Mylan's report. "Whenever there is a problem [during production] it should be noted and discussed and evaluated."
Experts said there was not enough information in the report to judge whether any drugs going out the door had been compromised.
The report described "serious [FDA] violations, no question about that," Ms. Bennett said. "To cheat, if you will, with an electronic record and say it is pervasive on all three shifts ... is very, very serious.
"But I can't determine from this report whether it's catastrophically serious," she said, meaning whether the breaches resulted in tainted medications.
Read more: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MbY2isLQ
Pfizer Inc. will go to trial this Monday concerning its epilepsy drug Neurontin. It is the first case to be tried among an estimated 1,200 Neurontin lawsuits that allege the epilepsy drug increases the risk of suicide among users.
In spite of the looming trial date, Pfizer hasn’t taken financial reserves to deal with litigation expenses. US District Judge Patti B. Saris stated in a July 20 pretrial hearing that the plaintiff’s case will be a tough one because of the plaintiff’s personal history of drug use and previous suicide attempts.
The Neurontin trial stems from the 2004 suicide of Susan Bulger, a 39 year old woman who had ingested the drug hours before her suicide. Pfizer lawyers contend that Bulger’s suicide stems from a long history of drug use and multiple suicide attempts.
Bulger’s family believes that Pfizer downplayed the drug’s dangers and its increased risk of suicide. Bulger’s lawyers cite the December 2008 FDA ruling ordering all epilepsy drugs to carry a warning label associated with the increased suicide risk as supporting evidence of its claims against Pfizer. The Neurontin lawsuit also contends that Pfizer marketed the epilepsy drug for off-label use, which is illegal. While doctors may choose to prescribe drugs for off-label use, pharmaceutical companies are forbidden from marketing drugs in such a fashion. In 2004, Warner-Lambert paid $430 million to resolve US Justice Department allegations of off-label use involving Neurontin.
While Pfizer lawyers will attempt to demonstrate Susan Bulger’s past drug use and history of suicide attempts as the cause of death, the judge has refused to dismiss the case. She has described the relationship between Neurontin and the increased risk of suicide as “biologically plausible”.
Industry officials and those who have legal claims against Pfizer will watch the proceedings closely. The outcome of this trial may provide an indication of the fate of the remaining Neurontin lawsuits.
The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.
In spite of a 2002 FDA Consumer Advisory, kava drinks continue to be popular in the United States. In some states, kava bars have opened for business and are doing quite well. Kava users tout the calming effects of the herbal supplement while manufacturers expound on the all natural qualities of the product.
Kava(piper methysticum) is an ancient herbal supplement derived from the root of a crop that grows naturally in the Pacific Islands.
Kava is normally taken as a tea but may be ingested in pill form.
In spite of its all natural ingredients and tranquilizing qualities, the supplement has come under scrutiny for its association with hepatoxicity.
In some countries, the supplement is banned because it has been associated with liver injury including liver failure. In its March 2002 advisory, the FDA noted 25 such liver injuries around the world. In the United States, there have been reported injuries including at least two deaths associated with the ingestion of kava products. These two deaths were preceded by failed liver transplants.
Kava is still under FDA scrutiny and several pending lawsuits may reveal more about the potential dangers of this all natural herbal supplement.
The makers of the highly popular cholesterol drugs Zetia and Vytorin have agreed to pay $5.4 million in legal costs to 35 states and the District of Columbia.
The legal probe conducted by the states' attorneys' general centered on allegations that the drug companies' attempt to conceal the results of an unfavorable study concerning the effectiveness of the expensive cholesterol drugs.
In January 2008, Merck and Schering-Plough released the results of the study and were criticized for not releasing it in 2006 when the findings had been completed. The study showed that Zetia and Vytorin were less effective in fighting plaque build-up in the neck than the older, much cheaper drug Zocor. Later studies have called into question Zetia and Vytorin's effectiveness and safety in comparison to the older cholesterol drugs.
In addition to the $5.4 million, the drug companies must do the following: obtain preapproval from the FDA for all DTC advertisements, comply with FDA suggestions to modify their drug advertising,register their clinical trials and post the trials’ results, reduce the possibility of conflicts of interest involving external Data Safety Monitoring Boards for company-sponsored trials,and comply with other detailed rules to prevent the deceptive use of clinical trial results.
