Sabatini and Associates, LLC

An article in the New York Times outlines how LeRoy Hubley lost his wife and son from an allergic reaction to contaminated heparin.  The FDA believes the contamination was deliberate but they have been prevented from inspecting the Chinese plants that made the drug.So far, 81 deaths have been linked to a contaminant in the blood thinner, Heparin.  Dr. Janet Woodcock, director of the FDA said a third of the material in some batches of Heparin was the contaminant.  David Strunce, the CEO of Scientific Protein Laboratories, the company that supplied the Heparin said it was an “insidious act that seems to us an intentional act upstream in the supply chain.”

Based on internal company documents revealed in Vioxx litigation,  JAMA authors uncover how the company, without disclosing it, compensated ghostwriters who aren’t even doctors, to create articles for professional journals that have the potential to influence doctors and popularize drugs prescribed to the public.  In the 250 documents reviewed by the authors, Merck employees either working by themselves or in collaboration with a medical publishing company helped create the study on Vioxx. They would then recruit academics or leaders in the medical field to lend their name as the lead author. For scientific review papers, Merck would outline the plan for the manuscript then ghostwriters were hired from medical publishing companies, which typically pay about $20,000 per submission to the ghostwriter.

The scientist then recruited to be the named author would be offered “honoraria” for their participation.

This review in JAMA finds that among 96 published articles, 92 percent of clinical trials disclosed Merck’s financial support.  But only half disclosed Merck’s involvement in the creation of the publication or whether the author had received compensation. In another JAMA article in the same issue, the documents suggest the company’s control of the data allowed it to downplay the risk of death from Vioxx in patients with Alzheimer’s disease.

Vioxx was taken off the market in 2004 but not before it was linked to an increase in heart attack and strokes. The FDA says the drug lead to up to 139,000 heart attacks, 30-40 percent of them fatal.

Litigation followed and ultimately resulted in a $4.85 billion settlement against Merck to settle U.S. cases. The internal company documents were released as part of the settlement.

The FDA announced that an unidentified contaminant was found in batches of the active ingredient used in Baxter’s recalled blood thinner Heparin.  The FDA still does not know how the substance got into the drug.  The drug is being investigated after hundreds of patients reported bad reactions.  There have been 19 fatality reports. 

On November 5, 2007 the FDA issued a marketing suspension for the anti-bleeding drug Trasylol. Trasylol (aprotinin injection) is approved for use in cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery.  The drug has been approved for use since December of 1993.  It has been used in surgeries around the world.  The FDA is investigating reports that 235 people died in the United States after receiving Trasylol in surgeries from 1993 to February 2006.The marketing suspension was issued after a study was suspended early after test data showed that Trasylol increased the risk of death by 50 percent compared to two other drugs in the same class.  The study was performed by researchers in Canada.  The study analyzed data from over 3,000 cardiac surgery patients since 2002.  The results were so drastic that the study was halted, and no new patients were enrolled pending further analysis.  Trasylol has been linked to an increased risk of kidney failure, heart attack and stroke.   

The BART studied prompted the removal of Trasylol from countries around the world.  The European Union, Great Britain, China and many other counties all joined the United States in the marketing suspension.  The FDA has recommended that surgeons weigh carefully the use of existing stock of Trasylol on high risk patients. 

More lawsuits have been filed over bacteria-tainted syringes.  Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines.  In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago.  14 of those patients required hospitalization from five to nine days.   All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria, Serratia marcescens.  On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.  Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens. The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.