Profit Before Health - Bayer Hid Information About Deadly Drug Trasylol

"Good medicine demands that you protect the patient. That's the issue here, and not the drug, and not the profit margin," stated Dr. Dennis Mangano, the San Fransico doctor who conducted the largest study to date concerning the dangers of the anti-bleeding drug Trasylol. Dr. Mangano offered these comments during a scathing report featured on 60 Minutes which revealed that Trasylol's manufacturer, Bayer, hid studies from the FDA which showed a clear link between the drug and heart and kidney failure. Other doctors interviewed by CBS suggest that Bayer was aware of dangerous side effects from Trasylol as early as the 1980's.

Trasylol is an anti-bleeding drug that is given to approximately 1/3 of patients undergoing heart surgery. Trasylol was heavily marketed by Bayer and was projected to be the next billion-dollar drug in 2008. Fortunately, Dr. Mangano's efforts set into motion a chain of events that would eventually put a stop to Bayer's ability to profit (and profit a lot) from other's misfortunes.
After following 5,065 patients in 17 countries, Dr. Mangano found that patients given Trasylol were more likely to experience death and kidney failure after heart surgery.

This study was then published in the New England Journal of Medicine, which prompted other doctors to speak out regarding the deadly drug. According to Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, Bayer was not interested in his results from studies conducted in the 1980's that showed severe kidney damage in animals given Trasylol. Dr. Nicholas Kouchoukos also received the cold shoulder from the pharmaceutical company for his human study in 1992 that showed that patients given Trasylol were more likely to experience kidney failure after surgery.

Kouchoukos called this study a "red flag", but explained that safety studies are generally not taken seriously until they involve thousands of participants. Since Bayer did not conduct a large-scale investigation of the drug following these complaints, the proof was not available to pull the drug from the market. Consequently the FDA approved Trasylol in 1993--noting kidney problems as a potential side effect from the drug.

Thankfully, Dr. Mangano's 5,065 patient study in 2005 was sufficient to finally catch the FDA's attention. The FDA scheduled a meeting with Bayer executives to discuss the issue eight months after the report was issued. As a result, Bayer went on the defense and set out to conduct a study of it's own to dispute Dr. Mangano's study. Their plan backfired. Bayer's study confirmed Dr. Mangano's findings that Trasylol may have been responsible for thousands of deaths and serious injuries in the United States.

What Bayer decided to do with this information next, in my opinion, proves the company's clear disregard for patient safety. Bayer hid their study from the FDA. They acted as though it never took place. It wasn't until a whistleblower from Bayer contacted the FDA regarding the proven dangers of Trasylol that the true findings from the report were made public. Following this disclosure, Canadian researchers attempted to perform their own Trasylol study, but had to stop because too many people were dying.

So what are the consequences of Bayer's lack of scientific testing and honesty regarding Trasylol? According to Dr. Mangano, "Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market."

Sad. And while the story reads like a bad novel, real people's lives have been ruined by this drug. Loved ones have died or were forced to go on dialysis after otherwise routine procedures. Livelihoods were stolen as injured patients struggle just to pay the bills with their meager disability check. Ironically, Bayer walks away with millions of dollars and no consequences from the FDA. And I can almost guarantee that the politicians in Washington will turn a blind eye as well. After all, they need a paycheck too and who do you think funds the campaign that allows them to stay in office? The pharmaceutical companies of course. What politician in his right mind would bite the hand that feeds him?

Clearly, the only remedy for patients that have experienced side effects from Trasylol is to file a lawsuit against Bayer. It's more than just money-it's the only way to change the system. Complaints to the FDA do not work. Letters to Washington do not work. Pharmaceutical sales are big business driven by the desire for profit at any cost. To change the system, the American people have to take what matters the most from these companies-their profit. When they finally realize that they will have to pay for hurting people, maybe they will invest some of their billions into better scientific testing and personnel to handle investigations before drugs like Trasylol, Vioxx and now Heparin take the lives of trusting people who depend on this medicine to make them better, not worse.

About John R. Mininno, Esquire

Attorney John R. Mininno is a licensed New Jersey and Pennsylvania attorney who represents clients in medical malpractice and other serious injury claims. His offices are in Collingswood, NJ and Philadelphia, PA. He also writes on patient safety issues and encourages patients to be their own "patient advocate." If you or a loved one has experienced heart or kidney failure from Trasylol, click here for further information on how to file a trasylol lawsuit

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Las Vegas Hepatitis Scare Linked To Unsafe Medical Practices At Clinic

Because of unsafe medical practices uncovered by investigators at two Las Vegas clinics, more that 50,000 colonoscopy patients may have been exposed to hepatitis C, hepatitis B, HIV or other blood-borne illnesses. So far, more than 850 former patients of the Endoscopy Center of Southern Nevada and the Desert Shadow Endoscopy Center have tested positive for hepatitis C.
During the investigation, health authorities discovered that staff at the two clinics were commonly reusing medical equipment, including syringes, single-use medicine vials, biopsy forceps and the bite blocks used to hold open a patient's mouth during a colonoscopy.

Several staff members who were interview said that they were told to reuse medical equipment by the doctors who owned the Las Vegas clinics. These practices created a risk that an infection could be spread from one patient to another if any of these items became contaminated with the blood of an infected patient.

In addition, investigators discovered that doctors were sometimes performing two colonoscopy exams at the same time, and sometime completing the procedure in as little as two minutes. Experts say that a colonoscopy should take between 15 and 30 minutes, including six minutes alone just to withdraw the endoscope used to perform the exam from a patient's colon. When a colonoscopy is performed this quickly, doctors can miss the signs of serious conditions such as colon cancer which the exam is designed to catch.

Former co-workers say that Dr. Dipak Desai, the main owner of the Gastroenterology Center of Nevada, which oversaw the two clinics, frequently bragged about his "two-minute colonoscopy skills." Staff members say that he and other doctors at the Las Vegas clinics were responsible for the practice of re-using single use medical equipment.

In addition staff members say that they routinely over-billed patients for anesthesia times or ordered unnecessary biopsies in order to drive-up patient costs. Dr. Desai is currently being investigated on possible criminal charges for medical malpractice and insurance fraud.
Health officials have informed the public that anyone treated at either the Endoscopy Center of Southern Nevada or the Desert Shadow Endoscopy Center between March 2004 and January 11, 2008 should visit their doctor in order to be tested for hepatitis B, hepatitis C and HIV. However, since several patients treated before these dates have already tested positive for hepatitis C, other patients who underwent a procedure may also wish to undergo blood tests in order to check for these diseases.

Several former patients of the Endoscopy Center of Southern Nevada and the Desert Shadow Endoscopy Center have filed lawsuits against Dr. Desai and the two Las Vegas clinics. These patients have alleged that in an attempt to boost profits at the facilities, Dr. Desai and other staff members engaged in unsafe medical practices which may have caused hundreds of patients to become infected with hepatitis C, and thousands more to be exposed to the disease.

Several patients who have not yet become ill but who may have been exposed to hepatitis C or another illness have also filed lawsuits alleging that they suffered emotional strain as a result of potentially becoming infected with a serious blood-borne illness.

Hissey Kientz, LLP is currently accepting cases involving people affected by mesothelioma and asbestos, AMO Complete, ReNu with MoistureLoc, Medtronic defibrillator lead wires, the Las Vegas hepatitis scare, Fosamax, Zelnorm, heparin, heart devices, the Kugel hernia patch, hormone replacement therapy and other defective drugs.

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