Fake Drugs Mean Prison for St. Louis County Man

Man to be sentenced for trafficking in bogus erectile dysfunction drugs that were purchased on-line.

Robert Patrick in the St. Louis Post Dispatch reports about a St. Louis County man who has pleaded guilty to federal charges and admitted to selling thousands of counterfeit erectile dysfunction pills over the last several years.

According to the St. Louis Post Dispatch story:

• Mark Hughes, 47, ordered counterfeit versions of the drugs Viagra and Cialis online from China and India, and sold them either in an illegal and unlicensed pharmacy or via word of mouth, Assistant U.S. Attorney John Bodenhausen said in court.

• Hughes' last shipment, of 1,000 pills, was intercepted by U.S. Customs and Border Protection in 2009 and delivered by investigators. Hughes house was then searched and he admitted buying roughly 11,000 pills. He sold them for $5 each, roughly one-third of the wholesale price, Bodenhausen said.

• Bodenhausen said that the pills either did not contain the correct drug or contained a less potent dose of the drug.

• In court, Hughes pleaded guilty to trafficking in counterfeit goods and misbranding a drug, and could face at least two years in prison under federal sentencing guidelines when sentenced in January, depending on a number of factors.

This is an excellent cautionary tale regarding those who set out to scam people by buying bogus goods online.

Mr. Hughes is fortunate that the bogus drugs that he sold did not adversely effect the health or kill someone or he would be facing a far more serious consequences.

Bogus drugs are becoming one of the more significant health care issues of the 21st century. 11,000 doses of a potentially lethal, fraudulent or adulterated drug could poison and create a huge health care disaster within a communities population.

Kudos to U.S. Customs and Border Protection for intercepting these bogus medications.

To read the entire story, visit: http://www.stltoday.com/news/local/article_0ac42318-dad5-11df-a1ce-0017a4a78c22.html

To learn about pharmaceutical anti-counterfeit solutions, visit: http://www.xstreamsystems.net/.

State of Connecticut Medicaid Program to Receive Part of GSK Settlement

GlaxoSmithKline will pay Connecticut $1.72 million as part of a larger nationwide settlement related to selling tainted, sub-standard and defective prescription drugs.

Related to a post earlier this week regarding GSK's huge financial settlement, the money will be paid to Connecticut's Medicaid program as a small fraction of a $750 million overall settlement.

"GlaxoSmithKline's dumping of defective drugs on Connecticut Medicaid recipients is shocking and shameful," said Attorney General Richard Blumenthal. "Such a massive failure to follow formulation and sanitation standards is unacceptable and inexplicable. The company endangered patient health -- and pumped up profits -- by providing tainted tablets."

GlaxoSmithKline allegedly sold four drugs to Medicaid that were contaminated at the company's plant in Cidra, Puerto Rico. Those drugs were:

-Paxil CR, an antidepressant that had either no active ingredient or only the active ingredient without the controlled-release aspects of the pill.

-Avandament, a diabetes medication that had too much or too little of the active ingredient.

-Kytil, an anti-nausea drug that had some impurities.

-Bactroban, antibiotic ointments and creams that contained microorganisms.

The company's head of global litigation, Elpidio Villarreal, said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes."

Secure Pharma Chain is noticing an influx of quality control or poor manufacturing issues that are not just related to overseas contract manufacturing.

The dangers that these incidents pose to consumers all over the globe are serious and significant.

It is important that all members of the pharmaceutical supply chain authenticate and verify the quality and efficacy of their inventories to avoid liability and to protect their individual brands.

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

B Braun Recalls Possibly Tainted Heparin

Recall linked back to the 2007/2008 Heparin crisis that poisoned hundreds.

Andrew Zajac from the Los Angeles Times is reporting about the recent announcement by B. Braun Medical Inc., of a recall of seven lots of the anticoagulant heparin because of concerns they may be contaminated with trace amounts of oversulfated chondroitin sulfate, or OSCS, the same substance implicated in the 2008 heparin crisis that killed or seriously sickened dozens of people.

According to the Mr. Zajac’s report:

• The company said in a statement that based on current information, the recalled lots did not pose a significant health risk, but they're being pulled from the market "with the support of the U.S. Food and Drug Administration."

• "There is not a significant public health threat," FDA spokeswoman Karen Riley said.

• The active ingredient in the suspect heparin was manufactured by Scientific Protein Laboratories Inc. of Waunakee, Wis., the same company that supplied the active ingredient for the heparin distributed by Baxter International that poisoned hundreds of patients in late 2007 and early 2008.

• Riley said B. Braun's announcement reflected a decision by Scientific Protein to recall three lots of the heparin ingredient that were distributed to manufacturers in the United States, Canada and Japan. It was not immediately clear how many, if any, other manufacturers are affected by the recall.

• Both the heparin in the poisonings and in the B. Braun recall were manufactured with raw material – pig intestines – from China. An FDA-led inquiry at the time of the heparin crisis identified OSCS as the contaminant. The substance apparently was added in an effort to stretch heparin, which is subject to significant fluctuations in supply because of changes in the Chinese pig population.

• The FDA has not identified who was responsible for the adulteration, or where in the lengthy Chinese supply chain it occurred. The heparin in the B. Braun recall also is from the same batch discussed in a recent FDA inspection that found that Scientific Protein waited a year to investigate a complaint about possible OSCS contamination.

• Riley said the heparin ingredient was manufactured by Scientific Protein in 2006 and was determined to contain traces of OSCS by one of the company's medical industry customers, which called it to the company's attention in October 2008.

• Scientific Protein's "quality department did not initiate a formal investigation into this complaint until 9/9/09," according to the FDA inspection report. It's not clear whether the complaining customer was B. Braun.

Many of the facts of this incident remain to be seen and or made public. It is anticipated that there will be more voluntary recalls and information over the next several days.

Secure Pharma Chain is puzzled with this recent turn of events given the amount of scrutiny that the 2007/2008 Heparin crisis elicited within the government, industry and consumers world wide. It would appear that not all the bases were covered within the supply chain following the deaths of some many back in 2007/2008.

Secure Pharma Chain encourages all within the supply chain to avoid the issues of fraudulent, adulterated, sub-standard and counterfeit drugs by deploying authentication technologies to verify that their inventories are safe and efficacious.

To read the entire story, visit: http://www.chicagotribune.com/health/la-heb-heparin-recall-braun-20101027,0,2834227.story

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

New York Times: Glaxo to Pay $750M for Sale of Bad Products

Regulators say that GlaxoSmithKline, the British drug giant, knowingly sold tainted baby ointment, an ineffective antidepressant and contaminated drugs.

In an article written by Gardiner Harris and Duff Wilson which appeared in the New York Times-GlaxoSmithKline, the drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant.

The following are the highlights from the New York Times article:

• This settlement is the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.

• Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.

• Cheryl D. Eckard, the company’s quality manager, asserted in her whistle-blower suit that she had warned Glaxo of the problems but the company fired her instead of addressing them.

• Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflex drug.

• No patients were known to have been sickened, although such cases would be difficult to trace.

This is the latest in a string of quality control issues at pharmaceutical manufacturers both domestically and abroad.

Most troubling is that the contamination's impact to consumers is difficult to trace. No one can be certain if bad product may have had a significant or even lethal impact on its consumer.

While the financial settlements to GSK and others is large, overiding these amounts is the cost to their brands in lost trust and consumer confidence.

It is critical that all members of the pharmaceutical supply chain utilize technologies to protect their products, inventories and ultimately the consumer from poor quality, adulteration, fraud and counterfeiting.

To read the entire New York Times article, visit: http://www.nytimes.com/2010/10/27/business/27drug.html?_r=1&th&emc=th

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

Healthcare Fraud Costing EU €56bn a Year

In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

Euractiv.com posted a story about a study stating that €56 billion is lost to healthcare fraud each year in the EU.

In the October 6th post, Euractiv.com claims that experts say conflicts of interest in the pharmaceutical sector mean that the true extent of expenditure being directed away from patients remains unknown.

The study by The European Healthcare Fraud and Corruption Network (EHFCN) was done to determine “the burden healthcare fraud places on society and facilitate the exchange of best practice on its detection.”

The research was conducted in the countries of Belgium, France, the Netherlands, Northern Ireland, Norway, Poland, Slovenia and Scotland and was presented at the EHFCN conference in Brussels in September.

According to the EHFCN report:

• The vast number of parties involved in the healthcare sector and the subsequent potential complexity of fraud schemes means that special fraud detectors - professionals already working in health care - have to be employed in order to carry out investigations into bills, patient notes and medication receipts.

• Trade in counterfeit medicines has exploded and it is now estimated that global counterfeit drug sales will reach €60 billion this year. In Europe alone, the fake drugs market is estimated to be worth more than €10.5bn every year.

• Low quality treatment - including from unqualified practitioners, forged receipts and sickness certificates, price cartels and the provision of counterfeit medicines - were identified as contributing to a phenomenon difficult to measure but ringing alarm bells at a time when austerity measures are being undertaken across the EU.

• 4,188 instances of suspected fraud were identified in the study, which was carried out in seven member states. The Netherlands and Belgium - working under a 'pay for service' system where doctors have an incentive to provide as much treatment as possible - hold the highest rates.

Hopefully this study will bring awareness to government, industry leaders and consumers to the negative impact that fraudulent, adulterated, sub-standard and counterfeit drugs have on health care and populations as a whole.

Secure Pharma Chain believes that it is important that all members of the pharmaceutical supply chain take proactive measures to deploy solutions to protect their inventories and provide themselves with a competitive edge as consumers begin to understand the potential risks of counterfeit and fraudulent medications.

To read the entire Euractiv.com story, visit: http://www.euractiv.com/en/health/healthcare-fraud-costing-eu-56bn-a-year-news-498480

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

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/.

Securing Pharma: Cambodian Study Finds Only 3% of Medicines are Counterfeit

Low figure compares to historical estimates of 4% to 90% in studies reported since 2000, according to the researchers.

Phil Taylor in an October 22nd post in Securing Pharma writes a blog about a recent study by Japanese researchers that shows a low percentage of counterfeits as it relates to past studies.

This research is significant because at face value the study paints a very different, more positive picture of the Cambodian pharmaceutical supply chain from previous studies which may lead to a false sense of the totality of the problem.

Highlights from the Securing Pharma post include:

• The results of a medicine sampling study in Cambodia reveals that just 3% of products were counterfeit, although between 5 and 9 % failed HPLC or dissolution-based quality testing.

• That relatively low figure compares to historical estimates of 4% to 90% in studies reported since 2000, according to the researchers, who were from Kanazawa and Nagasaki Universities in Japan and Cambodia's National Health Product Quality Control Center.

• A total of 710 samples of a wide range of commonly-used medicines were collected by the researchers in three tranches (in 2006, 2007 and 2008) at pharmacies and other forms of retail outlet in both rural and urban areas.

• A little over half (55%) of the samples collected had their packaging intact, but in 45% of cases it was open. Counterfeits were 20 times more likely to be encountered among open containers than closed one, were more likely to fail quality testing and were encountered more often in rural outlets, according to the researchers.

• Four of the counterfeits were labeled as originating from China, six were from India, two were from Malaysia and there was one each from Hong Kong, Cambodia and the UK.

Clearly the outcome of this research needs to be followed up given the apparent disparity between the results of this testing and what has been found in the past.

After one looks at the data however it would appear that although 3% were found to be specifically counterfeit there was a significant amount of issues with up to 9% of the sampling as to leave doubts to its efficacy. Simply put Cambodia has a huge health care issue as it relates to the safety of its pharmaceutical supply chain.

Adulterated, sub-standard, fraudulent and counterfeit drugs impact the health and safety of entire populations in developed and underdeveloped nations by poisoning the consumer, not properly treating diseases, creating drug resistant disease or at best scamming the patient out of his or her intended treatment.

Secure Pharma Chain encourages all within the pharmaceutical supply chain (regulatory agencies, manufacturers, distributors and dispensers) to use best procurement practices when purchasing their raw materials and inventories and to deploy technologies and solutions that will interdict these potentially lethal fakes from reaching the consumer.

To view Phil Taylor’s Securing Pharma article, visit: http://www.securingpharma.com/40/articles/624.php

To view the research published in Pharmaceutical Research, visit: http://www.springerlink.com/content/kj17835007x13471/

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