More Pharmaceutical News

Two good articles compliments of The Alliance for Human Research Protection (AHRP)

Media and Pharmaceutical companies mislead safety of drugs with advertising hype. An article from the Columbia Journalism Review reports on the media and pharmaceutical companies benefit in profits while misleading the safety and effectiveness of new drugs along with interference of investigative reports.

This article below is very important. Any medical experiments causing death, including subscribing drugs for non-approved uses by Health Canada, should have the doctors and researchers charged for criminal negligence causing death.

Research scandal forces Israel to tighten up supervision State
controller Eliezer Goldberg accused the health ministry of negligence - AP
Sharmila Devi reporting from Jerusalem

Israel is considering legislation to tighten up supervision of the health system after the country’s main government watchdog found that elderly patients and children had been used in thousands of hospital medical experiments, often without permission from their legal guardians.

The report, issued on May 8 by Eliezer Goldberg, the state controller, found the health ministry guilty of negligence and carelessness. A bill to control such experimentation is still unfinished after 8 years of work. The violations were found to be worst in geriatric, rehabilitation, and psychiatric hospitals, where some children had their eardrums deliberately pierced so that a drug could be applied. In another painful procedure, a needle was used to draw urine from the bladder for testing without health ministry approval.

“Further supervision has been undertaken to ensure that the general procedures imposed by the health ministry more than a year ago are being followed”, said a spokesman for Danny Naveh, the health minister.

Israeli hospitals are party to the 1964 World Health Organization’s Helsinki Accord, formulated in response to human experiments conducted by the Nazis in World War II.

Under the accord, patients must be fully informed about the risks involved in a medical experiment. A leading Israeli physician has called for the prosecution of doctors involved in the unauthorised experimentation.

Jacques Michel, the retired director of Jerusalem’s Hadassah Hospital and head of the Hadassah Medical Organisation’s Helsinki committee on medical experimentation, triggered the state controller’s investigation of 39 hospitals with a lecture he gave in 2001.

No fault was found at any of the Hadassah institutions. “Those doctors who violate the Helsinki Declaration guidelines should be punished. They should have their medical licences suspended or taken away”, Michel told the daily Jerusalem Post.

“Anyone who performs a medical experiment on someone who doesn’t or is unable to give his informed consent should be tried for physical assault.”

The controller’s report said the experiments, conducted by physicians, included genetic experiments and research studies involving drugs not certified for use in western nations.

Under Israeli law, these studies should be authorised by national Helsinki committees and the health ministry. In addition, unusual occurrences or deaths should be reported immediately to hospital authorities and within 48 h to the hospital committee that oversees experiments. The controller’s report found many deaths were reported too late. In 2003, for example, 90% of the 37 deaths of patients involved in medical experiments were reported after the required time.

The Sheba Hospital committee was unaware of, or did not report to the health ministry, 25 unusual incidents or deaths in 88 drug experiments in 2003.

Three deaths and three serious incidents took place involving congestive heart failure and two deaths involved experimental chemotherapy. The committee also authorised an experimental drug for breast cancer after doctors failed to report there were 31 unusual incidents with the same drug in other hospitals. The Ichilov Hospital was also cited in the report for faulty death reporting.

Among the faults listed in the report were: use of unapproved medicines on young children through the piercing of their eardrums and several incidents involving patients 80 years and older who were subjected to suprapubic aspiration.

This was done after a Hartzfeld director refused approval in her unit because of the risks of bleeding and infection. Two women died after the experiments.

In addition, geriatric patients had their fingers inked to give fingerprints authorising the tests even though they suffered from senile dementia. At the Wolfson Hospital, experiments were performed on the placentas of 50 new mothers without consent.

“This is a failure of a system that involves the ministry and the hospitals”, Naveh told the Jerusalem Post. “We need significant reorganisation to correct it.”