Questions Regarding Columbia Medical Center Clinical Trial Study of Hetastarch and Hextend Prompt FDA and OHRP Investigation: Heart Surgery Patients Treated at Hospital in 1999-2001 May Be Able to Seek Compensation.

Hetastarch and heart information: The U.S. Food and Drug Administration (FDA) is the federal agency that has responsibility for making sure that the thousands of prescription and over-the-counter (OTC) drugs in the nation are properly tested and safe.

Before any drug can be sold or prescribed, the companies that will manufacture these drugs must supply the FDA with important information about the drug, their research, and the potential health risks for the patients who will eventually take the medications.

Part of the research process involves clinical trials, where physicians and researchers study how the drug will work to help patients with the condition the drug has been developed to treat. Before someone can give their consent to be part of a clinical trial study, they must be provided with important information about the study, the drugs they may be given and the potential health risks involved in participating.

In cases where patients who, because of their age, general health, or other problem that would cause them to not be able to make an informed consent, a family member or an approved healthcare advocate must also be made aware of the purpose of the study and the potential risks.

Surgical Use of Hetastarch
Hetastarch, which is manufactured by Abbott Laboratories, is a solution that contains salt, starch and other ingredients that is administered by IV to patients undergoing surgery to help prevent problems associated with blood and fluid loss. The use of Hetastarch must be carefully monitored, as it can interfere with normal blood clotting.

Hextend, also manufactured by Abbot, was developed as a form of Hetastarch that could be administered in larger dosages. The Columbia clinical trial was developed to test the two drugs and whether larger doses of Hextend could be administered safely.

Overdoses of Hetastarch can have serious health consequences, causing patients to hemorrhage, suffer cardiac arrest or other organ failure, brain damage and death.

OHRP Investigation Into Consent Issues During Columbia’s Hetastarch/Hextend Study
During the period of the clinical trial, Columbia became aware of concerns regarding whether the patients in the study had been properly informed about the purpose and health risks involved. After an internal hospital review resulted in disciplinary action against the study’s lead researcher, the Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) began an investigation about whether more than 200 patients documented in the clinical trial had been properly advised of the health risks and other important information about the clinical trial.

Of particular concern to the OHRP investigators was reports that a number of the patients in the study were from a low-income neighborhood near the hospital, and that many of these individuals were Spanish speakers. Also of concern was that the Spanish-speaking patients in the study did not come from a referral from the patient’s private physician, but rather, they were admitted directly from the Columbia emergency room.

As a result of their investigation, the OHRP issued a letter to Columbia Hospital in June 2009 ordering them to contact all of the patients involved in the study to inform them they may not have been properly informed of the nature of the study, the risks and consequences involved.

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