cialis online

Brain Study Subjects Received Impure Drugs at Columbia University’s Kreitchman PET Center

AddThis Social Bookmark Button

The New York Time’s is reporting that Columbia University’s Kreitchman PET Center is in trouble for injecting mental patients involved in brain studies with dangerously impure imaging drugs.

To perform a PET scan, patients must first be injected with a drug called a radiotracer. According to The Times, such drugs are considered very safe, but degrade quickly. As such, many labs make these drugs themselves, following strict protocols which regulate the allowable radiation levels and the purity of the drugs. Drugs that contain impurities can have effects in the body that are unpredictable.

Kreitchman PET Center, located in Manhattan, New York City, is considered the nation’s leader in the use of positron emission tomography, or PET, for psychiatric research, according to The Times. Pharmaceutical companies provide millions of dollars to the center every year to study drug actions and the biology of brain disorders.

According to The New York Times, a Food & Drug Administration (FDA) investigation found that researchers at the Kreitchman PET Center routinely injected mental patients with drugs that contained potentially dangerous impurities, repeatedly violating agency regulations over a four-year period. The FDA first wrote to Columbia in December 2008, citing lax internal quality control and sloppy procedures for formulating drug injections. It warned that: “Failure to promptly correct these violations may result in legal action without further notice.”

Then in January 2010, FDA investigators returned and found that many of the Kreitchman PET Center’s lab practices had not changed. The agency cited a long list of specific violations, including one instance in which the staff hid impurities from auditors by falsifying documents, The Times said. One former lab worker told The Times that the FDA “raided the place like it was a crime scene, seizing hard drives.”

According to The Times, during its last investigation, which took place from Jan. 5 to Jan. 21, the FDA cited six categories of violations. Since 2007, “at least 10 batches” of drugs had been “released and injected into human subjects” with impurities that exceeded the level the lab had agreed to set, investigators said. At least four injections “had impurity masses that more than doubled the maximum limit implemented.” Agency investigators also found a forged document, a hard copy record that had been altered to hide a drug impurity that showed up clearly in the computer records, The Times wrote

The FDA did not make its investigation public.

According to The New York Times, Columbia University has since quietly suspended research at the Kreitchman PET Center and reassigned top managers there as a result of an FDA investigation.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com