Can Vytorin cause cancer?
Millions of Americans suffer from high cholesterol, which clogs the arteries and reduces life expectancy. A poor diet, lack of exercise and genetic factors can cause high cholesterol. Drugs, along with diet and exercise, as the TV commercials say, can lower it. But Vytorin, an oft-prescribed drug of TV commercial fame, may pose another risk. A study known as SEAS indicates it not only may fail in fighting cholesterol, but also could lead to cancer. The Food and Drug Administration has yet to agree.
So, is this a matter of he said, she said? Not so fast. The New England Journal of Medicine at first insisted that the study linking Vytorin to cancer was likely based on chance. But in an unusual reversal, the Journal’s editors conceded last week that it’s too early to dismiss such cancer concerns. “Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug,” the Journal reports.
Selling in the billions of dollars, Vytorin is produced and sold jointly by Merck & Co. and Schering-Plough Corp. Merck is the same pharmaceutical giant which produced the discredited drug Vioxx.
Filed under Defective Drugs | Comment (0)Killer Drug|Blood Thinner|Heparin
Wonder Blood Thinner Turned Killer Drug
A team of scientists led by MIT professor Sam Sasisekharan on April 24, 2008 formally announced that they had identified the contaminant in the blood-thinning drug Heparin, imported from China. Contaminated batches of the Baxter International-produced blood thinner slipped through a series of safety screens leading to death and injuries to scores of patients in the U.S.
The contaminant is a synthetic compound known as “oversulfated chondroitin sulfate” (OSCS). Based on the findings of two studies conducted by the scientists, the U.S. Food and Drug Administration (FDA) has now put screening methods in place to detect contaminated heparin.
Studies Published in Respected Medical Journals
The results of the two studies conducted by Professor Sasisekharan’s team were published in the British journal Nature and the New England Journal on Medicine. The study published in Nature, reported that heparin is only tested for contaminants such as protein, lipids or DNA. OSCS consists of long, complex chains of repeating sugar molecules that are almost impossible to detect. The MIT scientific team used the latest technology developed for analyzing complex sugars to find a method for detecting OSCS. The study in the New England medical journal revealed that OSCS activates two “inflammatory pathways” in the body: one that triggers blood clotting and dilation of blood vessels, resulting in dangerous blood pressure decreases while the other generates toxins that produce severe, and often deadly, allergic reactions.
U.S. Trade Officials Cite Need for China Reforms
China’s pig industry has a sordid history. Heparin, produced from Chinese pig intestines, is critical to the U.S. health care delivery system because the blood thinner is used by millions of patients during kidney dialysis and heart surgery to prevent blood clotting. U.S. commerce officials are now seriously concerned about health products from China. Reuters reported on April 25, 2008 that Christopher Padilla, U.S. Undersecretary of Commerce for International Trade, told a group of businessmen that Chinese regulators lack both the ability and will to monitor the nation’s pharmaceuticals and chemical industries. Padilla said that China’s State Food and Drug Administration (SFDA) has no authority to regulate the production of pharmaceutical ingredients not considered to be of medicinal use. He added that the Chinese manufacturer of the ingredients imported by Baxter to produce heparin was not registered with SFDA as a maker of active pharmaceuticals.
U.S. Officials to visit China
Padilla is leading a group of healthcare executives to China with hopes of introducing the concept of healthcare reform to the Chinese. Healthcare services and products have become one of the America’s fastest growing exports to China. Foreign investors, especially from America, have now become more cautious about Chinese products as the country continues to produce and export dangerous products. This acknowledgement provided little comfort to American drug consumers, especially since China did not inspect SPL because it was listed as a chemical producing plant, not a pharmaceutical plant.
Filed under Defective Drugs | Comments (7)FDA Failure|Consumer Watch Dog
What’s up with the FDA?
A lot of criticism, that’s what. The consumer watch dog is taking a beating for a process of drug approval that has ended up killing Americans. The FDA failure has attracted harsh attacks from the press. The Boston Globe, USA Today and The Reader’s Digest, among others, have published articles slamming the federal watch dog. The April 2008 edition of The Digest features a scathing assessment of the agency that is supposed to protect Americans from bad drugs, devices and products.
Spreading the bad word
The Reader’s Digest has 38 million U.S. readers and 100 million worldwide. But foreigners are no strangers to media criticism of the FDA. In 2005, The Lancet, a highly respected British medical journal, called the federal agency “ruthless and irresponsible” because it failed to take VIOXX off the market in 2000 despite evidence that long term use of the painkiller was risky for cardiac patients.
Internal critics slam the FDA
In early 2004, the white hot light of publicity caused headlines around the world when an FDA scientist testifying before congress attacked the agency for its handling of VIOXX. Dr. David Graham, a senior FDA scientist accused it of “ignoring its own safety experts.” Its manufacturer pulled the drugg off the market voluntarily after that. By then, the highly touted drug had been sold in the U. S. for more than five years and experts had linked it to more than 27,000 heart attacks or sudden cardiac deaths nationwide between 1999, when it appeared on the market, through 2003.
Where there is smoke, is there fire?
The Reader’s Digest assessment of the FDA is damning. As the April edition of the magazine reports: “The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy - and, sniff out any food borne terrorist plot” on the budget of a large school district! Pressures on the FDA by patients who want to speed up the approval process for life-saving drugs; by drug manufacturers interested in profits, some of whom have hidden evidence of defects from the FDA; and by the FDA’s own sloppy record keeping and sometimes deliberate suppression of evidence that a drug is bad, is a recipe for continuing trouble.
Is the public helpless against killer drugs?
What can the public do? That’s a tough question since defective drugs and devices could be on the market for years before there’s enough evidence to recall them. Meanwhile, a new federal law gives FDA staffers the right to publish critiques of the agency; Congress has “created a new office within the FDA to improve the quality of research” and increased its budget. But lawsuits against drug manufacturers, and the media coverage they generate about the continuing FDA failure to properly regulate drugs, are crucial to protecting the public. VIOXX victims have won millions, keeping the story in the headlines, as crusading lawyers teach this malfunctioning federal agency a well deserved lesson.
Filed under Defective Drugs | Comment (1)Drug Company Sales |Unsolved Mystery|One Thousand Lives A Month
Drug Company Sales|Unsolved Mystery
The story of Trasylol isn’t an unsolved mystery anymore. But it reads a lot like a crime story about corporate greed, hidden evidence, and a whistle blower who exposed a major drug company that allegedly hid bad information about one of drugs to protect its profits. The company - Bayer AG - denies any improprieties and maintains that its drug is safe when used according to labeling.
Evidence hidden from FDA The Federal Drug Administration approved Trasylol in 1993 for use in patients at high risk of bleeding with some types of heart surgery. The FDA noted that kidney toxicity could be a problem when it approved the drug. What the FDA did not know then, according to a 60 Minutes report in February 2008, is that Trasylol’s manufacturer had evidence from a German doctor that it caused severe kidney damage in laboratory animals. The 60 Minutes report, One Thousand Lives A Month, featured the researcher, Dr. Juergen Fischer. He told CBS that Bayer AG, the drug’s manufacturer, wasn’t interested in examining “these side effects” when he revealed them to the company in the 1980s. By 1998, the FDA expanded the use of Trasylol, allowing it to be used in all heart bypass surgeries.
Study Says Many Deaths Linked to Trasylol
In 2006, a prominent American researcher, Dr. Dennis Mangano, the man who discovered that aspirin reduces the risk of heart attack, published a study in the New England of Medicine showing that Traslylol was severely damaged kidneys and causing thousands of death. By then, Bayer’s Trasylol sales had soared to $300 million a year.
Whistle Blower Reveals Trasylol Findings
eacting to the 2006 report, the FDA held hearings. Since the Mangano study was not conducted according to the strict medical protocols that the FDA favors - it tracked actual hospital records – the federal agency left the drug on the market.But the FDA didn’t get all the information about Trasylol at that hearing from senior Bayer AG representatives who knew that a study they commissioned confirmed Mangano’s findings. A week later the Harvard doctor who did the Bayer study went to the FDA and blew the whistle.
Trasylol Still Used
In November 2007, the FDA asked Bayer AG to remove the drug from the American market for safety reasons. But it is still available. The FDA suspension includes a “slow phase out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs,” according to a statement from an FDA spokesman in U.S. News & World Report. Bayer maintains that Trasylol ”has a favorable risk benefit profile when used according to labeling.”
Levaquin 500mg|Bad Effects of Drugs
Levaquin 500mg|Bad Effects of Drugs
Patient complaints about Levaquin 500mg (Levoflaxin) read like horror stories. The bad effects of drugs meant to cure patients jump out in the words of those who say they suffered severe side effects after taking Levaquin and other quinolone antibiotics. Many reported damage to Achilles tendons that required surgery. The complaints, aimed mainly at Levaquin and that drug’s side effects, include other quinolone antibiotics - Cipro, Tequin, Maxaquin, Inimed, Noroxin and Floxin, among others.
Patients Stories Detail Suffering
Patient posts on a web site about the drug’s effects include stories of tendon ruptures, double vision, severe rashes, insomnia, nausea, anxiety, ringing in the ears, and psychotic episodes. The comments warn others not to take the drug under any circumstances. A few, however, praise it. Levaquin is an antibacterial drug used to treat bronchitis, urinary tract infections, prostatitis and sinus infections, among others.
Official Complaints about Levaquin
Complaints about the drug and tendon ruptures received national attention in 2005 when the Attorney General of the State of
FDA New Safety Warning
The FDA recently added a new warning about Levaquin. It alerts patients to the potential of photosensitivity and phototoxicity from exposure to the sun when taking the drug. The warning joins existing warnings about tendonitis and other side effects of Levaquin. So far, the FDA has not elevated the tendonitis warning to “black box” status (the highest alert the FDA can put on a drug) as requested by the State of Illinois and Public Citizen.
FDA warnings | Botox And Myobloc
The FDA reported in early February that Botox and Myobloc, a similar drug, have been linked to deaths in children with cerebral palsy and that they can cause severe side effects even when used for cosmetic purposes. According to the FDA, the drug has never been formally approved to relieve muscle spasms in children with the paralyzing condition even though it has been used for that purpose. Botox and Myobloc are distilled from the botulinum toxin. It blocks nerve impulses to muscles, causing them to relax. The drug is wildly popular among women and men, who use it to smooth out wrinkles. Even in cosmetic applications, which use far less of the drug, side effects have occurred. Public Citizen, an advocacy group, formally petitioned the FDA to strengthen warnings in January about the drugs, “citing 180 cases of patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.”
Filed under Defective Drugs | Comment (0)
Avandia | Heart Attacks In Diabetics
If you are a Type- 2 diabetic, you could be taking a drug that will kill you, or make you seriously ill as you do all you can to improve your health! Avandia, one of the most popular drugs for diabetics on the market in years, may affect the heart, causing angina, chest pain, fluid retention, shortness of breath, coronary artery blockage and other symptoms of heart failure. In November 2007, the U.S. Food and Drug Administration advised doctors to closely monitor patients with Type-2 diabetes who were taking the drug to lower their blood sugar levels, alone or in combination with other drugs. The FDA voted 22 – 1 not to take the drug off the market, but asked its manufacturer, GlaxoSmithKline to increase warnings about it to the highest level by adding “ …new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.”
One Million Americans On Avandia:
The drug was first approved in 1999, along with diet and exercise to lower blood sugar levels. But
serious alarms were raised in May 2007about its potential to cause heart failure when the nationally respected Cleveland Clinic reported in The New England Journal of Medicine that patients taking Avandia were 43% more likely to have a heart attack or be hospitalized for blockages of the coronary arteries. By August 2007, the FDA had posted black box labels on prescriptions warning that the drug might cause heart failure. Now the drug carries the FDA’s highest warning.
Why Is “Heart Attack” Drug Still Sold?
The FDA asserts there is no definitive proof yet that Avandia causes heart attacks in diabetic patients. It points to other
studies that do not show a connection between the drug and heart failure in diabetics. The FDA has ordered a trial to compare the drug’s heart attack risk with other oral diabetes drugs. It expects results in 2014. Meanwhile, patients taking the drug may be playing Russian Roulette with their health. In a USA Today story about the drug, an FDA scientist who recommended taking the drug off the market, said the FDA warning did not go far enough. David Graham said it should include information about alternative drugs that “work as well and… don’t have this cloud hanging over them.”Meanwhile, patients taking Avandia are advised not to stop the drug without seeing a doctor. But those on the drug when they had a heart attack might do well to consult an attorney.
