Showing posts with label GlaxoSmithKline. Show all posts
Showing posts with label GlaxoSmithKline. Show all posts

Friday, October 29, 2010

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/.

Thursday, October 28, 2010

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/.



Wednesday, September 15, 2010

Washington Post: India Becomes a Hub for Fake Medicines


India, the world's largest manufacturer of generic drugs, has become a busy center for counterfeit and substandard medicines.

Rama Lakshmi, in the September 11th issue of the Washington Post writes and outstanding expose regarding the state of the pharmaceutical supply chain in India.

Beyond the borders of India, this has become a significant concern given that India is the world’s largest producer of generic drugs and now has the dubious distinction as the largest exporter of counterfeit drugs around the globe.

India currently legitimately exports $8.5 billion of pharmaceuticals, mostly to African and Latin American countries, each year.

Lakshmi does an excellent job in personalizing the Indian counterfeit drug problem with stories of locals fighting and participating in the illicit trade, along with macro industry insight.

Highlighted in the Washington Post article:

• India, the world's largest manufacturer of generic drugs, has become a busy center for counterfeit and substandard medicines. Stuffed in slick packaging and often labeled with the names of such legitimate companies as GlaxoSmithKline, Pfizer and Novartis, the fake drugs are passed off to Indian consumers and sold in developing nations around the world.

• An expert says the global fake-drug industry, worth about $90 billion, causes the deaths of almost 1 million people a year and is contributing to a rise in drug resistance.

• Estimates vary on the number of these drugs made in India. The Indian government says that 0.4 percent of the country's drugs are counterfeit and that substandard drugs account for about 8 percent. But independent estimates range from 12 to 25 percent.

• Indian officials say the clandestine industry has hurt the image of India's booming pharmaceutical industry and its exports.

• The number of people arrested for manufacturing and selling fake drugs rose from 12 in 2006 to 147 last year, and drugs worth about $6.5 million were seized over this period.

• The tricks of the trade include sticking fraudulent labels on expired products, filling vials with water, stuffing small amounts of real ingredients in packages of popular licensed brands and putting chalk power in medicine packets.

• In June, officials at Nigeria's Abuja airport caught a shipment of fake antibiotics, containing no active ingredients, with a "Made in India" label. Nigerian investigators later said that a Chinese company shipped the drugs via Frankfurt. In a similar incident last year, a shipment of fake anti-malaria drugs from China arrived in Nigeria with an Indian tag.

• Last year, Sri Lanka banned imports from four Indian companies after officials discovered substandard medicine in shipments.

• Over the years, drug companies have used holograms or embossed their logo on the packaging to protect their brands, but these have also been counterfeited in India.

• Co-writing a report on a recent survey, Barun Mitra, Director of the New Delhi-based think tank Liberty Institute said that 12 percent of sampled drugs from the capital's pharmacies were substandard. "We are behaving like ostriches with our heads in the sand and pretending that nothing is amiss even as the problem keeps growing and affecting Indian patients."

Lakshmi ends the piece with a story about an encounter with a local drug counterfeiter:

On a recent morning in the northern city of Varanasi, a young man named Ashish waited for a shipment of painkillers and postpartum pills to arrive by train.

He said his order of pills that controlled postpartum bleeding contained chalk powder but came with the brand name Methergine in a Novartis package.

The painkiller had insufficient ingredients and carried a Bidanzen Forte label inside a knockoff GlaxoSmithKline package.

"There is a lot of profit in this," said Ashish, 28, describing the extent of counterfeit drugs in Varanasi. He declined to give his surname because his operation is illegal.

"I do not think about right or wrong," he said. "I am not killing anybody. The worst is that these medicines will not show any result and the patient may have to check into a hospital."

In a growing global supply chain and with India's pivotal role in it, it is imperative that the regulatory and the individual members of the pharmaceutical supply chain's become proactive in dealing with drug counterfeiting a criminal act that impacts the health and well being of millions all over the globe.

As this story illustrates, because of their sophistication, drug counterfeiters can easily adapt to packaging centered anti-counterfeiting solutions, what they cannot do is account for authentication of the product while it is in its packaging.

Verification of the product inside its sealed container is the most effective way of protecting the supply chain and the consumer from this deadly crime.


To read the entire Washington Post story, visit: http://www.washingtonpost.com/wp-dyn/content/article/2010/09/10/AR2010091006700.html.

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


Monday, August 16, 2010

SecuringPharma: German Pharmacies Infiltrated by Fake Medicines




Phil Taylor wrote and posted a story August 12th in SecuringPharma about a scandal that involves dozens of pharmacies in the northern portion of Germany that are being investigated about the distribution of illegal medicines, including counterfeits.

Mr. Taylor reports that “the case suggests that far from being mainly a risk associated with purchase of medicines over the Internet, in some parts of Germany counterfeit and otherwise illegal drugs may be on pharmacy shelves and getting into the hands of patients.”

Also included in the posted story:

· Prosecutors have brought charges against one pharmacist from the Braunschweig region who is accused of handling €1.68m-worth and are investigating several others, according to a report by German business magazine Markt.

· The affairs of other pharmacies in Hamburg, Celle, Verden and Kiel are also being probed, according to the report, which notes that the counterfeit goods being traded included not only lifestyle medicines such as impotency drugs and bodybuilding products, but also painkillers, antibiotics and cancer treatments.

· Among the practices alleged to have been carried out by the pharmacists is mixing of illegally-acquired medicines with legitimate, genuine product.

· Last year, Germany suffered other high-profile cases in which counterfeit versions of GlaxoSmithKline's Combivir (lamivudine and zidovudine) and Boehringer Ingelheim's Viramune (nevirapine) - both used to treat HIV infection. The fakes were discovered in the legal supply chain, Combivir in Bremen and Viramune on the island of Sylt in northern Germany.

The suspected introduction and mixing of counterfeit medications into the trusted supply that consumers rely upon to be safe, make this a very troubling story.

When one of the most trusted health care professionals, pharmacists, poison their own supply chain with fraudulent, counterfeit medications, the only protection is in the members of the supply chain routinely verifying the safety and clinical efficacy of the product through authentication technologies.

Secure Pharma Chain encourages everyone within the pharmaceutical supply chain to deploy a variety of technologies, specifically authentication solutions to protect their inventories from fraudulent, adulterated and counterfeit medications. Authentication solutions go beyond pedigree or track and trace solutions and verifies to the end user what is inside the box within their inventories.

Knowing where the box has been is important but knowing what is inside the box is critical.

To read the SecuringPharma post, visit: http://www.securingpharma.com/40/articles/548.php.

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

Friday, July 30, 2010

Stolen in 2009, GSK Inhalers Showing Up in Pharmaceutical Supply Chain

The FDA and GlaxoSmithKline have recently announced that some of the Advair Diskus inhalers stolen from a GSK distribution warehouse in 2009 have been found in some pharmacies.

According to the GSK press release:

• The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

• The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and GSK continues to work with the FDA to aggressively investigate the matter.

• Medicine in the stolen cartons could represent a health risk because it has been removed from the legitimate supply chain. The product may have been tampered with and the storage conditions under which the stolen products were held are unknown. Inhalers from these lots should not be dispensed, sold, or used.

• The lot numbers, doses, and expiration dates of the stolen Advair Diskus inhalers are:
Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose – Exp: Sep 2010
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose – Exp: Sep 2010



The discovery of the stolen products within the legitimate supply chain magnifies the commercial gaps that exist within the legitimate pharmaceutical supply chain and the ability for those with a nefarious intent to exploit them.

As Secure Pharma Chain continues to report, there is a vast network of criminal elements that are taking advantage of the huge profits in dealing with stolen, sub-standard, adulterated, fraudulent and counterfeit medications. This criminal element imperils the legitimate industry and victimizes the consumer, sometimes with deadly consequence.


In this particular incident, the danger to the consumer is the efficacy of the drug and the unknown as to the conditions that it has been stored and if it has been somehow altered, diluted, adulterated or the contents counterfeited by the criminal element which could harm the end use consumer.

Secure Pharma Chain endorses that all members of the legitimate supply chain deploy a variety of solutions and technologies to close these commercial gaps, protect their inventories and make certain that the products that they are passing onto the consumer are safe and efficacious.


To learn more about pharmaceutical supply chain solutions, designed to protect and authenticate materials, visit: http://www.xstreamsystems.net/.

Sunday, July 18, 2010

SecuringPharm.com: Thieves Make Off with Two GSK Shipments



Phil Taylor in a July 14th story in SecuringPharma.com updates and provides detail to the recent in-transit cargo theft of GlaxoSmithKline products in Pennsylvania late last month.

The thefts of the two trailers had a combined value estimated at about $400,000. One trailer load of products was recovered, thanks to an on-board GPS tracking device.

According to the SecuringPharma.com story:

  • The two trailer loads contained personal care products such as Aquafresh mouthwash and Sensodyne toothpaste and were taken at a logistics provider terminal in York. The thieves moved the loads to another logistics provider site, stole a tractor fitted with the GPS device, and drove one of the trailers away. It was subsequently recovered with about two-thirds of its contents in New Jersey. The other trailer remains unaccounted for, according to an update from the Pharmaceutical Cargo Security Consortium.

The SecuringPharma.com piece also included some news on two other pharmaceutical cargo thefts:

  • The Florida TOMCATS - a specialist police group focusing on cargo theft - has recovered a load of around 35,000 albuterol 3ml vials worth around $500,000 which had been stolen back in August 2009. The theft occurred whilst in transit from a manufacturing site in South Carolina to a distribution centre in Texas.

  • Proctor & Gamble lost a shipment of its products (assorted razors and related items) worth over $600,000 from a truckstop in Iowa on July 3. The load was being carried by shipping firm Schneider National.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.


To read all of Phil Taylor’s story, visit: http://www.securingpharma.com/40/articles/522.php


To learn more about pharmaceutical supply chain security verification solutions, visit: http://www.xstreamsystems.net/.

Saturday, July 10, 2010

FDA: Counterfeit Alli Contains 3 Times Daily Dose


The U.S. Food and Drug Administration is announcing that recently confiscated Counterfeit pills of the diet drug Alli contain up to three times of an active ingredient, which may be harmful to consumers.

Earlier this month, the FDA warned consumers about the counterfeit Alli pills circulating on the Internet and for sale in online auction sites. Alli is the brand name for the drug orlistat, but the counterfeit drugs being passed off as Alli contain a different stimulant drug, sibutramine.

The bogus drugs discovered were counterfeits of Alli 60 mg capsules sold in 120-count refill packs, officials said.

Alli is an FDA-approved over-the-counter weight loss drug made by GlaxoSmithKline.

Following laboratory testing, the FDA now has determined that the counterfeit Alli pills contain up to three times the usual daily dose of sibutramine if they are following the dosing instructions for Alli.

According to the FDA, that much sibutramine may cause health individuals to develop anxiety, nausea, heart palpitations, accelerated heart beat (tachycardia), insomnia, and increased blood pressure.

Also, such high levels of sibutramine can be fatal for patients with histories of cardiovascular disease and can cause high blood pressure, stroke, and heart attack.

Consumers first began reporting their suspicions of the counterfeit Alli to GlaxoSmithKline in early December 2009, officials said.

The bogus Alli product looks similar to the authentic product, but there are a few notable differences:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.


Secure Pharma Chain Blog encourages all consumers to only purchase pharmaceuticals through internet sites that are affiliated with a reputable pharmacy or that are sanctioned by the National Boards of Pharmacy through their VIPP accreditation. Never buy from an internet site that does not require a prescription from your individual physician.

In addition Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain use authentication technologies to verify and secure their inventories to protect both their brand and all health care consumers.

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

Monday, March 29, 2010

Two Men Charged for Illegally Importing Counterfeit Medications


The U.S. Department of Justice (DOJ) announced the arrest of two people for illegally importing counterfeit weight loss products including GlaxoSmithKline’s alli.

According to the DOJ, the two Chinese born men, imported weight loss products they claimed were cheaper versions of FDA approved medications.

Sengyang Zhou, a Chinese national was arrested in Hawaii last week. Zhou, during the course of the investigation implicated himself as the maker of the counterfeit Alli.

Qin Ming Hu, a U.S. citizen, born in China was arrested in Plano; Texas last week. According to the DOJ the charges could result in nearly 20 years of prison time and hundreds of thousands in fines for Zhou and several years in prison and fines of nearly $250,000 for Hu.

"The Food and Drug Administration will work together with other government entities to aggressively target those individuals who put the public's health at risk by selling counterfeit drugs," FDA Commissioner Margaret Hamburg said recently in a published statement.

The two men were apparently successful in marketing their bogus products over the Internet to consumers seeking less expensive medications online. The counterfeit medications, identical to the packaging of the branded medications, reportedly contained dangerous levels of the active ingredient used in the authentic drugs.

XStream Systems encourages all members of the pharmaceutical supply chain to use an authentication process to verify their inventories and protect healthcare consumers from dangerous adulterated, fraudulent, sub potent and counterfeit medications.

To learn more about an anti-counterfeiting technology which is being used to discover fraudulent, adulterated and counterfeit drugs in the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

Thursday, March 25, 2010

FDA Asks Physicians To Suspend Use Of Rotarix Due To Contamination


The FDA has asked the nation’s physicians to stop giving their patients Rotarix, a vaccine used to protect against rotavirus.

The recommendation came after the FDA became aware of an independent U.S. research team finding an unauthorized substance, porcine cirovirus 1, or PCB-1 DNA, in multiple samples of Rotarix.

According to CNN: "Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said 'a substantial amount' of the DNA was found in the vaccine. But, he stressed, 'there is no evidence that it causes any disease. ... There is no evidence that it ever does anything.”

According to the New York Times: “For now, the decision is unlikely to disrupt routine immunizations in children since a second vaccine, this one made by Merck and called RotaTeq, remains available. RotaTeq was approved for use in the United States in 2006 and is still the more popular vaccine. Rotarix was approved in 2008 and has been used to vaccinate about one million children.”

The discovery of this virus, hastens the need for more robust Quality Control testing at all lengths of the supply chain, raw materials, manufacturer, distribution and the point of dispense to properly protect the healthcare of the global consumer.

A variety of news sources are reporting on the story including the New York Times, CNN, Wall Street Journal, Washington Post and USA Today.

To view the New York Times story, link to: http://www.nytimes.com/2010/03/23/health/policy/23fda.html.

To learn more about supply chain protections against contamination, adulteration, fraud or counterfeiting, visit: http://www.xstreamsystems.net/.

Wednesday, February 10, 2010

FDA News: GSK Works With eBay to Stop Online Counterfeit Alli Sales


The following news release was posted online at FDANews.com:

GlaxoSmithKline (GSK) is working with eBay to remove online auctions of counterfeit Alli and inform consumers about potentially counterfeit product sold on similar websites.


eBay is removing auctions of the weight-loss drug Alli (orlistat) covered by the alert and asking sellers to review FDA communications to make sure they have legitimate Alli before relisting it for sale, Jack Christin Jr., eBay associate general counsel for government relations, said.

Pictures of counterfeit Alli samples of the packaging and product provided by GSK can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm

To learn more about technologies that can verify drugs in their unit of sale container without degradation or destruction, visit: http://www.xstreamsystems.net/.

To read the entire FDANews news release, visit: http://www.fdanews.com/newsletter/article?articleId=124314&issueId=13409.

Monday, January 25, 2010

FDA News Release: Counterfeit Alli



As reported earlier in Secure Pharma Chain Blog, the FDA Warns Consumers via a press release about Counterfeit Alli.

The counterfeit products contain controlled substance sibutramine. The following is the press release from the FDA.

The U.S. Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.

The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

  • Outer cardboard packaging missing a “Lot” code;
  • Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);

  • Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;

  • Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;

  • Contains larger capsules with a white powder, instead of small white pellets.
Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).


Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.


Pictures of counterfeit Alli samples of the packaging and product provided by GSK can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm


To learn more about technologies that can verify drugs in their unit of sale container without degradation or destruction, visit: http://www.xstreamsystems.net/.

Tuesday, January 19, 2010

FDA: Counterfeit Version of Alli May Harm Consumers


Three separate media outlets are reporting the Food and Drug Administration’s announcement about a counterfeit version of the GlaxoSmithKline OTC drug Alli.


The following are web links to stories from CNNMoney.com, the Wall Street Journal and MedPage Today.


CNNMoney.com reported, "A counterfeit version of the over-the-counter weight-loss product Alli being marketed online could be harmful to dieters, the US Food and Drug Administration warned." The agency "said the counterfeit Alli was sold in 60 mg capsules as part of a 120 count refill kit." Alli manufacturer GlaxoSmithKline "said tests showed the falsely packaged and labeled products contained a controlled substance called sibutramine."


The Wall Street Journal reports that sibutramine is the active ingredient in Abbott Laboratories' prescription weight-loss treatment Meridia. The FDA said that "sibutramine...should not be used in certain patient populations or without physician oversight." Glaxo noted that while patients should take Alli three times a day, Meridia should only be taken once daily.


The agency said the fake products are missing a "'Lot' code on its cardboard packaging," MedPage Today reported. In addition, the counterfeit has "an expiration date that includes month, day, and year...instead of month and year," and contains "plain foil inner seals as opposed to the genuine articles printed, 'SEALED for YOUR PROTECTION.'"


To learn more about technologies used to detect counterfeit medications, visit: http://www.xstreamsystems.net/.

Monday, November 16, 2009

Fox News: Gangs Making 'Millions of Dollars' Selling Fake H1N1 Drugs Online


The Reuters new story was posted on Fox News on November 16, 2009 and deals with the ever increasing issue of counterfeit, fraudulent and adulterated drugs related to the H1N1 pandemic.

Criminal gangs are making millions of dollars out of the H1N1 flu pandemic by selling fake flu drugs over the internet, a web security firm said on Monday.

Sophos, a British security software firm said it had intercepted hundreds of millions of fake pharmaceutical spam adverts and websites this year, many of them trying to sell counterfeit antiviral drugs like Tamiflu to worried customers.

Tamiflu, an antiviral marketed by Switzerland's Roche Holding and known generically as oseltamivir, is the frontline drug recommended by the World Health Organization to treat and slow the progression of flu symptoms. GlaxoSmithKline makes another antiviral for flu, known as Relenza.

Sophos said many of the gangs behind the sites were based in Russia and the top five countries buying fake Tamiflu and other medicines on the internet were the United States, Germany, Britain, Canada and France.

Sophos spokesman Graham Cluley said a "worrying trend" toward stockpiling Tamiflu had already been seen in Britain — Europe's worst-hit country in the H1N1 pandemic so far.

"As more and more cases of swine flu....come to light, it is essential that we all resist the panic-induced temptation to purchase Tamiflu online," he said.

The criminal gangs working behind the scenes at fake internet pharmacies are putting their customers' health, personal information and credit card details at risk."

The Geneva-based WHO, which declared H1N1 swine flu a pandemic in June, updated its guidance to doctors last week to say that antiviral drugs should be given even before tests conclude that an at-risk patient has the pandemic virus.

Sophos said criminal gangs were operating medicines websites branded as the "Canadian Pharmacy" to try to appear genuine.

It said its research showed that on one network operated out of Russia, called Glavmed, it was possible to earn an average of $16,000 a day promoting pharmaceutical websites.

"But the criminals can be members of more than one affiliate network, and some have boasted of earning more than $100,000 per day," it said in a statement.

The pandemic H1N1 flu virus has now spread to 206 countries since it was first discovered in March. There have been more than 6,250 deaths to date, mostly in the Americas region, according to the latest WHO toll.

To view the story on-line visit:
http://www.foxnews.com/story/0,2933,575327,00.html?test=l

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

Friday, August 28, 2009

GSK Advisory: Warehouse Theft of Advair

GlaxoSmithKline is advising that two lots of Advair Diskus medication were stolen from the company’s distribution facility near Richmond, Virginia on August 2nd. The stolen medicine, could represent a health risk because it has been removed from the legitimate supply chain and storage conditions. Inhalers from these lots should not be dispensed, sold or used.

The lot numbers and quantities are:

  • Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose (14,400 inhalers)
  • Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose (11,200 inhalers)

These lots were awaiting distribution to retail pharmacies at the time of the theft. Neither of these lots are part of the legitimate pharmaceutical supply chain. GSK has alerted its distributors and customers to the stolen lots.

Anyone who has information regarding this incident, has received suspicious or unsolicited offers for the Advair Diskus lots in question, or has received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989. Patient or customer inquiries for the company should be directed to GSK's Customer Response Center at 1-888-825-5249.

GSK discourages patients from purchasing any medication sold outside of legitimate channels.

XStream Systems encourages all members of the pharmaceutical supply chain to use pedigrees and authenticate their receiving and returns by using authentication technologies like the XT250 system which verifies materials inside its sealed unit-of-sale container without destroying or degrading the medication.

To view entire article click here.