Doctor Is Pressed Again on Ties to Device Makers By BARRY MEIER
Published: September 21, 2009
Two leading senators have charged that a well-known heart doctor affiliated with Columbia University may have failed to tell the university about millions of dollars in payments and other income he received from medical device makers.
In a letter sent Friday, the lawmakers, Herb Kohl, Democrat of Wisconsin, and Charles E. Grassley, Republican of Iowa, said that their review of financial data subpoenaed last year from device makers and physicians indicated that the cardiologist, Dr. Martin B. Leon, might have failed to tell Columbia about significant amounts in consulting fees, speaking fees and other payments.“Dr. Leon appears to have failed to report millions of dollars that he has received in outside income,” their letter stated. >learn more
Levaquin Side Effects - Tendon Ruptures Prompt Black Box Warning A leading antibacterial drug has come under increased scrutiny by the Food and Drug Administration following reports of serious injuries to tendons and ligaments linked with its use. Levaquin manufactured by Ortho-McNeil/Janssen is one of the antibiotics known as flouroquinolones, a class of commonly used antibacterial drugs. >learn more
Senator Moves to Block Medical Ghostwriting By NATASHA SINGER
Published: August 18, 2009
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products. Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account. Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington. >full story
Medical Papers by Ghostwriters Pushed Therapy
By Natasha Singer
Published: August 4, 2009, The New York Times
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. >full story
Fleet Lawsuit: Kidney Failure (Acute Phosphate Nephropathy) Important update: C.B. Fleet Company has announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.
May 5, 2006 —The Food and Drug Administration (FDA) is warning health care professionals and patients that a rare but serious form of kidney failure (acute phosphate nephropathy) has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. OSP products are commonly used for bowel cleansing prior to colonoscopy, radiographic procedures, and surgery. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (such as Fleet Phospho-soda and Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol).
Acute phosphate nephropathy, a type of acute renal failure, is a rare, but serious adverse event associated with oral sodium phosphate bowel cleansing. When acute phosphate nephropathy occurs, renal impairment is often permanent and may require chronic dialysis. Read more about Fleet kidney failure. Individuals at increased risk include: those of advanced age, those with decreased intravascular volume or kidney disease, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)].>full story
FDA says Zicam nasal spray can cause loss of smell 6/16/2009, 1:46 p.m. EDT
MATTHEW PERRONE The Associated Press (AP) —WASHINGTON - Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs. >full story
Glaxo's Emails on Avandia Reveal Concern When a study linking GlaxoSmithKline PLC's diabetes treatment Avandia to increased heart-attack risk was published in 2007, the pharmaceutical giant publicly responded by denouncing the researchers' conclusions. But internal emails indicate some of the company's own scientists were concerned that Glaxo's data were showing the same thing. >full story
As you may have heard or read in the news, Avandia (generic rosiglitazone) – a drug made by GlaxoSmithKline to treat Type 2 diabetes, has come under fire since 2007.
Studies published in the New England Journal of Medicine and Journal of the American Medical Association, and an analysis of 42 clinical trials published by the Cleveland Clinic, all conclude that patients taking Avandia had at least a 43% higher risk of having a heart attack or heart failure. Avandia has also been cited as causing blindness, and bone fractures in women.
Despite this alarming information, in July 2007, instead of issuing a recall the FDA voted to simply issue a “black box” warning on Avandia, meaning it will carry a warning label similar to the one on cigarette packs. This vote came after one of the FDA’s own scientists, Dr. David Graham, said Avandia should be removed from the market due to its serious health risks.
Same Old Song and Dance
As expected, GlaxoSmithKline has gone into “crisis mode” to protect its number two money-maker, stating that results from other Avandia studies have not reached the same conclusions. In addition, they’ve allegedly tried to quiet the first Avandia critic, Dr. John B. Buse, by contacting his employer – the University of North Carolina – and attempting to silence his outspoken criticism of the drug.
Byetta (exenatide) is a type 2 diabetes drug used to help reduce blood sugar levels. Recently, Byetta has been linked to serious cases of pancreatitis and in some cases death.
All lots of the heart medication (digoxin) have been recalled because some have been found to contain twice the approved levels of active ingredient than is appropriate. Unfortunately, this recall comes too late for the families whose loved ones ingested the potentially deadly dose. According to the Food and Drug Administration, several reports of illnesses and injuries have been received. Digitek is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digoxin toxicity in patients with renal failure.
Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive intake of digoxin.
Fosamax the brand name for alendronate, a type of bisphosphonate drug that is used in the treatment of a number of bone diseases, notably osteoporosis and osteitis deformans (Paget's disease).
Approved by the Food and Drug Administration (FDA) in 1995, Fosamax is manufactured by Merck & Co. With 2005 revenues exceeding $3 Billion, Fosamax is Merck & Co's second best-selling drug on the market. The fact that the drug has recently been linked with the onset of a serious bone condition called osteonecrosis of the jaw (ONJ) could spell disaster for Merck, who are currently involved in litigation surrounding Vioxx.
Osteonecrosis of the Jaw
In addition to the somewhat common and relatively mild side effects (headache, nausea, abdominal discomfort, rash, etc.) that are associated with the use of Fosamax, users face the risk of developing a serious condition called osteonecrosis of the jaw, or "dead jaw." Fosamax users suffering from ONJ are susceptible to severe infections that can cause facial discomfort, numbness or extreme pain. Swelling of the gums and poor gum health can also be caused as a result of ONJ.
Osteonecrosis (avascular necrosis, aseptic necrosis, ischemic necrosis) is a type of bone disease that affects approximately 10,000 to 20,000 Americans each year. It commonly results from a temporary / permanent loss of blood flow to the bones. Without an adequate supply of blood, bone tissue cannot survive and will eventually die and lead to joint collapse.
Osteonecrosis Symptoms
The process of diagnosing osteonecrosis typically begins with a number of painful symptoms that lead a sufferer to consult an orthopaedist, a doctor specializing in the diagnosis and treatment of a variety of musculoskeletal conditions. The most common osteonecrosis symptom is severe and chronic joint pain that is not unlike that suffered by arthritics. Although the time period between the initial onset of joint pain and the loss of joint functionality varies from one osteonecrosis sufferer to the next, it usually takes no longer than one year.
Diagnosing Osteonecrosis
If a case of osteonecrosis goes undetected and/or untreated, it can eventually cause a great deal of arthritic pain while the joint surface erodes and the bone gradually collapses.
In order to determine whether someone eliciting symptoms of osteonecrosis is in fact suffering from a case of the rare bone disease, a complete physical examination is performed (functional evaluation of the bone) in addition to an evaluation of a patient's medical history. Any number of bone imaging techniques (X ray, MRI, CT scan, bone scan) are eventually employed in order to determine whether signs of osteonecrosis are present. In addition to bone imaging techniques and physical functionality examinations, an orthopaedist may also request the surgical biopsy of bone tissue to determine whether it is receiving an adequate supply of blood.
Fosamax Lawsuits
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for personal injury litigation.
Gardasil is a vaccine developed by Merck & Co for certain strains of human papilloma virus (HPV). The vaccine has recently come under scrutiny as a result of studies linking it with a number of potentially fatal side effects.
Heparin sodium is a blood thinner that is commonly administered into the vein of patients. Baxter Healthcare had a voluntary recall of several of its vials due to a potential contamination.
Levaquin Black Box Warning
Levaquin is a third generation flouroquinolone, which was touted as an improvement and safer alternative to Cipro, an older second generation flouroquinolone.
In light of the increased risks of tendon ruptures and ligament damage, the FDA has issued a black box warning, the most urgent and severe type of safety warning imposed by the agency. Public Citizen petitioned the FDA for nearly two years following reports of Levaquin tendon rupture risks and other flouroquinolones.
Levaquin Ruptures
Tendon injuries most often result from some type of trauma or over-activity. Tendon tissue is located throughout the body; however, the most common tendon linked with flouroquinolone-based rupture is the Achilles tendon. Reports indicate that the injury often occurred without pain or warning, suggesting a potential toxicity issue. Typically, flouroquinolone injury victims reported pain and swelling prior to rupture, leading experts to believe that injury may be avoidable in such instances by halting use of the drug.
Levaquin tendon injuries have been shown to occur more often in patients over 60 years of age, taking steroids (corticosteroids), or who have undergone a kidney, heart, or lung transplant. While the most common tendon injury associated with Levaquin has been an Achilles tendon rupture, there have been many reports of tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb. Cases have also been reported which occurred up to several months after taking Levaquin.
Levaquin Lawsuits
If you or a loved one has been injured as a result of using Levaquin, you may be entitled to compensation. Drug manufacturers have a responsibility to ensure the safety and efficacy of their products before marketing them for public consumption. Failure to adequately measure a drug’s effects or alert doctors and consumers to any potential side effects is considered negligent and grounds for personal injury litigation.
According to an article published on Bloomberg.com in October 2007, approximately 2,400 women currently taking birth control patch Ortho Evra plan to sue its maker, Johnson & Johnson.
The reason? It is believed that the transdermal contraceptive, a combination of estrogen and progestin hormones, causes serious health conditions including blood clots, pulmonary embolisms, strokes and even fatal heart attacks. The truly tragic aspect of this whole scenario is that teenagers have died as a result of taking Ortho Evra.
Depression and anxiety are debilitating mental illnesses. If you or a loved one suffers from either, you know exactly what I mean. Unfortunately, some medications used to treat these conditions can produce side effects that are as bad as, if not worse than, the condition they’re supposed to treat.Paxil seems to be one of those medications. It’s an anti-depressant prescribed to treat depression, various types of anxiety and obsessive compulsive disorder. However, studies have shown that the side effects of Paxil can cause serious physical and psychological problems, including suicidal tendencies in adults and teenagers. In addition, Paxil has recently been linked to an increased risk of birth defects in infants born to women who took the drug during their first trimester of pregnancy.
Frightening Statistics
As if all of that weren’t bad enough, up to 85% of patients who want to stop taking Paxil often go through painful withdrawal symptoms. Even more frightening to me is that, according to an article in late 2004 on Washingtonpost.com, one in ten women was taking an antidepressant Recently I read that as high as one in 20 people currently take an antidepressant. One in 20! How many people do you think experience additional pain and suffering as a result of these dangerous side effects and don’t even know why?
Remember: Although you may have legal grounds for seeking compensation, you should not stop taking Paxil unless your doctor advises you to do so.
Reglan® (metoclopramide) is a drug prescribed to treat a variety of symptoms, including heartburn, nausea, vomiting, and loss of appetite in some patients.
Reglan Linked to Severe Neurological Disorder
Reglan use has been linked to the development of a severe neurological disorder known as tardive dyskinesia (tahr-div dis-ki-nee-zhuh). "Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with metoclopramide. There is no known treatment for established cases of tardive dyskinesia..."
According to the National Institute of Neurological Disorders and Stroke, tardive dyskinesia is characterized by:
• repetitive involuntary movements of the arms, legs, fingers, or toes
• uncontrolled grimacing
• sticking the tongue in and out (tongue protrusion)
• smacking, puckering, and pursing of the lips
• rapid eye blinking
• swaying movements of the trunk or hips
Tardive dyskinesia is often extremely embarrassing for the affected person, as the related movements are uncontrollable and unintentional.
Black Box Warning
Update: The U.S. Food and Drug Administration announced in February 2009 that Reglan manufacturers must add a black box warning--the strongest warning possible--to the class of drug's label regarding the risk of its long-term or high-dose use. Chronic use of the drug has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drug is no longer taken, according to the FDA.
When Trasylol is used druing heart surgery, people have suffered from kidney failure, stroke and death.
Many people who have had heart surgery do not know they were given Trasylol during their operation. But if they have suffered from kidney failure, stroke or death and did receive this drug, they may have a claim.
Trasylol, observed to be linked to more than 5,000 patients in September 2006, was finally removed from the market in November 2007 months after Dr. Dennis Mangano presented his report. In that time it is estimated that 22,000 lives could have been saved had Bayer and the FDA acted to remove Trasylol then.
In September 2004, pharmaceutical company Merck announced a voluntary recall of Vioxx, a prescription drug developed to relieve the symptoms of rheumatoid arthritis, osteoarthritis, acute pain in adults, and pain experienced during menstrual cycles.
The reason for the recall stems from clinical studies that identified an increased risk of cardiovascular conditions, including heart attack and stroke, in patients who took the drug for longer than 18 months.
An FDA study has estimated that more than 27,000 people may have suffered a heart attack between 1999 and 2003 as a result of taking Vioxx. To make matters worse, it appears that Merck and the FDA knew that there was cause for concern way back in 2000. Merck submitted its own study to the FDA and that study found an increased risk of serious cardiovascular events in patients taking the drug. What did the FDA do? Two years later, the agency issued label changes to the packaging! No other action was taken at that time.
Zicam Side Effect - Loss of Smell
The Food and Drug Administration (FDA) released an announcement in July 2009 urging consumers to discontinue use of Zicam Cold Remedy nasal gel and related products after reports emerged linking the homeopathic treatments with permanent loss of smell. The FDA received more than 130 reports of anosmia (loss of smell) since the products' debut in 1999.
Zinc, one of the main components of Zicam's cold remedy treatments, is believed to cause permanent nerve damage in nasal tissues and affect consumers' ability to smell. Loss of the sense of smell could lead to life threatening situations, including the inability to detect gas leaks or fires. In 2003, Matrixx Initiatives, Inc., the manufacturer of Zicam products, came under fire after consumers stated Zicam products caused anosmia. The company dispelled the link claiming their products boast naturally occurring compounds and a neutral pH. However, many consumer reports mentioned that application of the product may cause a sensation of pain, an indication that the products caused damage.
Zicam Cold Remedy nasal gels and products are considered homeopathic treatments and are not subject to FDA approval before being released on the market. Upon reviewing consumer reports, the FDA now requires Zicam products meet formal approval. Matrixx Initiatives Inc. is considering withdrawing Zicam products from the market, a decision that could cost them almost 40 percent of their total sales.
Zyprexa (olanzapine) has been associated with several glucose abnormalities including diabetes, diabetic ketoacidosis, diabetic coma and hyperosmolar coma.
