Officials Investigating Fake Avastin Production

Chinese health officials and police are investigating a pharmaceutical plant, Cancer Center, hospital employees and pharmaceutical dealers for the use and production of fake Avastin that harmed 61 patients last month.

Caj Wenjun in the October 23rd edition of the Shanghai Daily reports on the Chinese State Food and Drug Administration (SDFA) and the Shanghai Public Security Bureau investigating a Beijing pharmaceutical plant for allegedly producing a counterfeit version of the drug Avastin.

The fake Avastin caused eye infections in 61 patients at the Shanghai No. 1 People's Hospital last month according to officials from the Shanghai Health Bureau.

Shanghai No. 1 People’s Hospital illegally treated patients with Avastin on people with eye complaints, though its key component is believed to have a positive effect on some eye conditions, it is only officially approved for treatment of certain cancer conditions.

Roche, Avastin's producer, said the drug is only approved for colorectal cancer treatment in China. It is used in the treatment of five types of cancer in the United States, but is not permitted for use on eyes.

Avastin was not officially approved for use for colorectal cancer until October 22nd nearly a month after the incident at the hospital.

According to the Shanghai Daily story:

• Local police will also investigate the Avastin case.

• The Shanghai Ruijin-AmMed Cancer Center is under suspicion as it allegedly purchased the bogus Avastin and sold it on to hospitals.

• Several employees at the cancer center, along with some pharmaceutical dealers, have been detained. The relevant head of Shanghai No.1 People's Hospital will be charged with poor management and negligence, said health bureau officials.

• Only three patients from the case remain in the hospital. Many of those discharged have received compensation.

This incident features many culprits and plenty of criminal activity. The production of dangerous fake medications, dealing in counterfeit drugs and unofficial medical treatment to name just a few.

In this incident, each member of the supply chain perpetrated some level of criminal, fraudulent and unethical behavior with the consumers suffering serious injury.

It is critical for all members of the global pharmaceutical supply chain to protect their inventories by deploying best practices, solutions and technologies to authenticate and verify the efficacy of the products that flow through their operations.

To read the entire Shanghai Daily article, visit: http://www.shanghaidaily.com/article/?id=452464&type=Metro#ixzz13SEBnJZr

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin

In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."

The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.

To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

AP: Chinese Drug Regulator Fired For Suspected Violations

The Associated Press is reporting that Zhang Jingli, the "deputy head of China's food and drug regulator, is being investigated and has been dismissed from his post, a state news agency said Sunday, citing an anti-corruption agency."

Xinhua, a state news agency, "cited the Communist Party of China Central Commission for Discipline Inspection, an anti-corruption body, in a brief report that offered no details on what the suspected violations were."

Highlights of the Associated Press story include:

· The move comes three years after the former chief of the drug agency was executed after a bribe-taking scandal in which several deaths were blamed on medicines the agency approved.

· Zhang Jingli, deputy director of the State Food and Drug Administration is under investigation for suspected "serious disciplinary violations," the official Xinhua News Agency said. The term is a standard party reference for graft and abuse of power.

· In 2007, Zheng Xiaoyu, the former head of the drug and food watchdog was executed after he was convicted of taking bribes to approve flawed medicine blamed for several deaths.

· Zheng was sentenced to death for taking bribes to approve an antibiotic blamed for at least 10 deaths and other substandard medicines.

· China said in April it would step up monitoring of a faulty rabies vaccine that was recalled last year but could have still been on the market. It was the latest in a series of quality problems in China in recent years, including tainted infant formula and other milk products that sickened children.

· China's pharmaceutical industry is lucrative but often poorly regulated. Local manufacturers and other players along the drug supply chain have been blamed in recent years for deaths linked to counterfeit or shoddy medications at home and abroad.

To read the entire Associated Press story: http://www.google.com/hostednews/ap/article/ALeqM5gHqNTMIPOepIIcWUsEuBqru23vrAD9GA86VG0

Given all of the issues with fraudulent, adulterated and counterfeit medications that have emanated from China internal regulatory scrutiny seems a very wise course of action.

Secure Pharma Chain Blog endorses all within the pharmaceutical supply chain to protect their receivables and inventories by deploying authentication technologies which allow for their validation within their unit-of-sale container.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

Chinese SFDA Official Arrested in Rabies Vaccine Scandal

In an online story, written by Phil Taylor in Securing Pharma, the Chinese newspaper 21st Century Business Herald is reporting that an official with the SDFA, the Chinese State Food and Drug Administration has been arrested in connection with an investigation into the adulteration of rabies vaccine.

Wei Liang an official with SFDA's Drug Registration Department has been charged with taking nearly $145,000 in bribes.

The arrest is related to the adulteration and substitution of raw materials used in the manufacturing of thousands of doses of rabies vaccines at a vaccine manufacturing plant operated by Jiangsu Ealong Biotech Co.

According to SFDA officials the adulterated vaccines will not provide the appropriate protection against the disease but are unlikely to cause adverse effects.

SDFA’s have investigated another rabies vaccine-producing company - Hebei Bioforwell Co - but have to find any evidence of criminal activity.

The entire investigation was precipitated by the December 2009 discovery by the SFDA that more than 215,000 doses of rabies vaccine supplied by the Jiangsu Ealong Biotech and Hebei Bioforwell had quality problems.

The SDFA is concerned that some of the adulterated and sub-potent vaccine may still be in the Chinese supply chain.

This particular healthcare scandal apparently contains the gamut of premeditated fraud, raw material adulteration, medication quality control issues, official bribery and official corruption all at the expense of the health of the Chinese population.

This incident, much like the Heparin scandal that cost thousands of lives several years ago, should encourage all members of the pharmaceutical supply chain to authenticate and verify medications within their control to avoid liability, protect their business brand and make certain that the healthcare consumer is protected from potentially deadly consequences of fraudulent, adulterated or counterfeit drugs.

To learn more about authentication technologies, visit: www.xstreamsystems.net.

To read the Securing Pharma online story, visit: http://www.securingpharma.com/.