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/.

J&J Unit Recalls More OTC Drugs

Late Tuesday, Johnson & Johnson's McNeil Consumer Products division announced the inclusion of several other of its hugely popular brands to its massive OTC recall. It is now recall four lots of Benadryl allergy tablets and one specific lot of its Extra Strength Tylenol gel pills.

Including this recent recall announcement Johnson & Johnson’s McNeil Consumer Products division has issued four recalls over the past twelve months.

Various media outlets are reporting on this development:

The New York Times: "The Johnson & Johnson unit whose recall of liquid children's Tylenol and other pediatric medicines is under Congressional investigation said on Tuesday evening that it was recalling additional over-the-counter drugs." Specifically, McNeil Consumer Healthcare "said that it was recalling four lots of certain Benadryl allergy tablets and one lot of Extra Strength Tylenol gel pills." According to a company statement, "'the products were inadvertently omitted' from an earlier recall -- one preceding the children's drug recall -- involving medicines made at a company plant in Puerto Rico." Although the drugmaker maintains that the chances of experiencing serious side effects are nil, it began recalling products from the Las Piedras plant in November after consumers were reportedly overcome by a mildew-like odor.

The Wall Street Journal: The smell purportedly prompted stomach pain, diarrhea, and nausea. The unit has since identified the manufacturing issue.

Bloomberg News: "the odor has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets."

Reuters: US House of Representatives Oversight and Government Reform Committee Chairman Edolphus Towns (D-NY) said, "This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson." He added, "I am troubled by what we have learned so far in our investigation, and this latest development adds to my concern."

The recent proliferation of recalls generated from pharma manufacturers due to poor quality production, inadequate quality control, cargo theft and various other adulterations to the consumer product strengthens the concept of material authentication by all members of the pharmaceutical supply chain. Material authentication, inside the products unit-of-sale container protects the members of the suppy chains inventories and the end use consumer.

To read the various reports on this recent announcement and the J&J recall from The New York Times, Wall Street Journal, Bloomberg News and Reuters, visit these sites:

http://www.nytimes.com/2010/06/16/health/16drug.html.

http://online.wsj.com/article/SB10001424052748704009804575309132577939048.html?mod=googlenews_wsj.

http://www.bloomberg.com/apps/news?pid=20601202&sid=awltXaS.MHl4.

http://www.reuters.com/article/idUSN159754220100615.

To learn more about pharmaceutical supply chain security solutions that protect the supply chain and consumers from poor quality, fraudulent, adulterated and counterfeit drugs, visit: http://www.xstreamsystems.net/.

New York Times: GAO Study Reveals Contaminants In Herbal Supplements

According to a New York Times article, published on May 26th, the General Accounting Office published a study that finds contaminants, some in high amounts, in all herbal dietary supplements tested by investigators.

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

· "Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found."

· Although the "levels of heavy metals -- including mercury, cadmium and arsenic -- did not exceed thresholds considered dangerous," almost half of them "contained pesticide residues that appeared to exceed legal limits." Notably, "Dr. Joshua M. Sharfstein, principal deputy commissioner of the Food and Drug Administration, said in an interview that he was not concerned about the safety of the supplements tested by the GAO investigators."

· Sharfstein added that "the FDA had increased enforcement actions against supplements spiked with prescription drugs."

To read the New York Times article, visit: http://www.nytimes.com/2010/05/26/health/policy/26herbal.html.

Secure Pharma Chain Blog, endorses that all members of the pharmaceutical and herbal supplement supply chain utilize authentication technologies to verify the authenticity and quality of their inventories and protect the consumer from fraudulent, adulterated and counterfeit materials.

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

Johnson & Johnson Faces Possible Criminal Charges

Widely reported by most media outlets, pharmaceutical giant Johnson & Johnson and its McNeil Consumer Products division may face a variety of charges including criminal for what was described by FDA officials in a May 27th Congressional hearing as “a pattern of violations in manufacturing and quality control practices (which) led to a number of recent recalls.

The following are some of the media highlights from yesterday and today:

• ABC World News George Stephanopoulos reported, "Government officials said today they are considering criminal charges against Johnson & Johnson, stemming from last month's huge recall of Tylenol and other popular over the counter children's medicines."

• NBC Nightly News Brian Williams reported, "Johnson & Johnson insists it has taken dramatic steps to clean up the plants where the recalled products are made. Meanwhile, the FDA says it has referred the matter to its criminal division for consideration."

• The New York Times reports, "The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines last month may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday." Notably, the "agency is considering further actions against McNeil Consumer Healthcare...after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls," Sharfstein "said at a Congressional hearing on Thursday."

• The Washington Post states, "When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term 'recall,' according to documents released by the House Committee on Oversight and Government Reform." Then, "after the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product." And, in the last year, there have been "four recalls of McNeil products...including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name."

• The Los Angeles Times reports that following the revelations at the hearing, "Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, apologized 'to the mothers and fathers and caregivers for the concern and inconvenience' caused by the April recall."

Securing Pharma Chain Blog, supports the inclusion of authentication and verification of pharmaceuticals at all members of the pharmaceutical supply chain to protect against poor manufacturing practices, fraud, adulteration and counterfeiting and avoid consumption of bogus materials by consumers.

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

To read the major media stories, visit:

http://www.nytimes.com/2010/05/28/business/28drug.html?src=busln.

http://www.washingtonpost.com/wp-dyn/content/article/2010/05/27/AR2010052705484.html?hpid=moreheadlines.

http://www.latimes.com/news/nationworld/nation/la-na-tylenol-hearing-20100528,0,1137250.story.

FDA Issues Second Warning Letter to Apotex

The Food and Drug Administration has posted on their website a March 29th warning letter to Apotex, Canada’s biggest drug company citing lapses that included charred particles in a diabetes drug, contamination of an antihistamine and a drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.

The FDA letter also claims that Apotex had failed to notify regulators in a timely fashion about such problems.

This is the second warning letter by the FDA to Apotex is less than a year which is highly unusual for the agency.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

The New York Times has an excellent article about this FDA letter, written by Natasha Singer and published on April 15th.

To view this article, visit: http://www.nytimes.com/2010/04/16/business/16generic.html.

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

New York Times Op/Ed: Are You Buying Illicit Drugs?

In a New York Times Op/Ed published on March 31st, author Katherine Eban and Aaron Graham, former DEA Agent write about the recent pharmaceutical thefts and how this trend is made possible by “our haphazardly regulated pharmaceutical supply chain and the dangerous gray market that intersects it.”

According to the Op/Ed, “As soon as medicines leave manufacturers' loading docks, they enter a market teeming with middlemen, many legitimate, but some not. The drugs may move through a dozen hands, through small secondary wholesalers and repackagers. With so many middlemen involved, thieves can easily unload stolen drugs, which may be resold to pharmacies and hospitals and dispensed."

Ms. Eban and Mr. Graham then go onto detail to describe some of the more egregious recent incidents of pharmaceutical theft, diversion and counterfeiting.

Ultimately Ms. Eban and Mr. Graham conclude that the most effective way to deal with this growing epidemic which threatens the healthcare of consumers everywhere is through technologies that Track and Trace drugs throughout the supply chain. While Track and Trace technologies are important, they are limited in their effectiveness in that they were initially designed and implemented as inventory management tools. Basically these tools tell the supply chain where the box has been.

We at Secure Pharma Chain Blog believe that while it is important to know where the drug has been, ultimately knowing what is inside the box properly protects both the supply chain and the consumer. Track and Trace technologies require a comprehensive and complex, daisy chain of data flow while Authentication Technologies like XStream Systems’ XT250 can tell you what is inside the box and if it is safe to consume without maintaining an elaborate transaction pedigree.

The best solution is a multi-layered approach of a variety of solutions that thwart the opportunity for criminal organizations to profit from their deadly activities.

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

To read the New York Times Op/Ed, visit: http://www.nytimes.com/2010/04/01/opinion/01eban.html?scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt.

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/.

New York Times - Millions Disappear With Fake Technology

In probably one of the more creative and egregious examples of war profiteering in a war that has hundreds of examples of waste, corruption and excess, the New York Times writes about the now infamous ADE 651 "technology".

Basically the technology known as ADE 651, which is a hand-held wand, wielded by Iraq’s security teams at hundreds of checkpoints, is supposed to detect car bombs and weapons. However this technology which is a battery-free device — supposedly powered by the static electricity of a soldier’s body — turns out to be a very expensive hoax.

After widespread doubts, including warnings by American military officials who never used ADE 651's, Britain finally banned the devices’ export and arrested the manufacturer for fraud. But not before Iraq bought more than 800 wands, which cost $250 each to make but drew up to $60,000 each from the Baghdad government.

This boondoggle cost the Iraqi government $48 million, most of which probably came directly or indirectly from the US taxpayers.

The ridiculously obvious hoax is very frustrating to many within the technology sector who are developing very real and useful technologies that can be used in security, industrial and consumer applications.

The question is, how can such a crude and obviously fraudulent tool, fool an entire process, while very useful technologies, languish for years as they slog through a bureaucratic procurement process that seemingly rewards inaction over innovation?

Apparently greed and corruption in certain situations have little to impede their progress...

To read the New York Times Editorial, visit:

http://www.nytimes.com/2010/02/01/opinion/01mon4.html?th&emc=th


To learn more about a very real and effective technology that is being deployed around the globe that will protect millions, visit: http://www.xstreamsystems.net/.

New York Times: In Recall, a Role Model Stumbles

Natasha Singer writes an excellent article in the January 17th issue of the New York Times regarding the recent management of a sweeping product recall by McNeil Consumer Healthcare, a division of Johnson & Johnson.

In this article, Ms. Singer explores how a company with the reputation of Johnson & Johnson, who is seen as the “gold standard” of crisis management, seemingly botches this most recent issue of product contamination within the supply chain.

Secure Chain Pharma Chain Blog has reported extensively on this particular recall and believes that this incident, which is based on onsite product contamination, energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products.

The following is an excerpt of the Ms. Singer’s article:

The Harvard Business School teaches future executives the gold standard in brand crisis management. The model dictates that a company should communicate clearly with the public about a crisis, cooperate with government officials, swiftly begin its own investigation of a problem and, if necessary, quickly institute a product recall.

The template is based on Johnson & Johnson’s conduct in 1982, when several people died after taking tainted Tylenol pills. The company’s reaction to the crisis is widely regarded as exemplary.

But last week, Johnson & Johnson appeared to abandon its own template, stunning a few business school professors. Its conduct also drew harsh criticism from federal officials.
On Friday, McNeil Consumer Healthcare, a division of Johnson & Johnson, announced the recall of several hundred batches of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

According to a federal inspection report, the response was anything but swift. The recall came 20 months after McNeil first began receiving consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to a warning letter sent by the Food and Drug Administration to the company on Friday. Since then, a few people have also reported temporary digestive problems like nausea, vomiting and stomach pain, the agency said.

To read the entire article, visit:

http://www.nytimes.com/2010/01/18/business/18drug.html?th&emc=th

To learn more about technologies which will protect inventories within the supply chain, visit:

http://www.xstreamsystems.net/.

Using Scientific Tools in an International War on Fake Drugs

The July 20th edition of the New York Times published an excellent article written by Thomas Fuller about using mass spectrometers and other forensic laboratory technologies to identify and interdict fraudulent and counterfeit medications.

The article is an excellent source of information on counterfeit drugs and the efforts to use authentication technology as an effective tool in finding and securing international pharmaceutical supply chain.

Laboratory instruments are an excellent resource in gaining granular and exact information on suspect materials and fake medications.

XStream’s XT250 Material Identification solution like these laboratory technologies has proven to be an effective tool in identifying fake medication but has been developed to be deployed within the supply chain and used by a non-technical resource for instant and exact information on suspected product. The XT250 does not require the destruction of the material and allows the testing of the material inside its sealed unit-of-sale container so that material found to be good can remain in the supply chain and go onto the consumer. To find out more about XStream’s revolutionary technology visit our website at www.xstreamsystems.net.

XStream endorses all technologies used in the fight against counterfeit drugs because we realize that there is no one solution to protect the vital health care supply chain.
To read the Thomas Fuller’s article please follow the link:

http://www.nytimes.com/2009/07/21/science/21coun.htl?pagewanted=1&_r=1&emc=eta1

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.

Weekend News Highlights International Epidemic of Counterfeit Medications

XStream Systems found an op-ed article in the New York Times regarding the health epidemic in the third world regarding poor quality and counterfeit medications and a story reported by Bloomberg News about the seizure of millions in counterfeit malaria, HIV and tuberculosis drugs in SE Asia.

The phenomenon of counterfeit, adulterated and contaminated pharmaceuticals continues to grow and flourish as our global economy declines.

Until technology solutions such as XStream’s XT250 become ubiquitous, this malady will continue to proliferate and impact those beyond the third world.

Op-ed: More needs to be done to ensure safety, quality of drugs in the developing world.

In an op-ed in the New York Times (11/15, A21), Roger Bate, author, director of the health advocacy group Africa Fighting Malaria, and resident fellow at the American Enterprise Institute, wrote that, "if aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs."

According to Bate, the importations of counterfeit medicines "are only part of the problem." Bate explained that in order "deal with the scarcity of drugs, many poor governments have turned to local production." Still, "local producers often make low-quality" medicines. "Many poor countries," he wrote, "lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the" Food and Drug Administration (FDA).

Bate concluded that aid organizations must first "give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards." Second, they should "always refuse to subsidize any low-quality drugs." And finally, organizations need to "insist that only brand-name and generic products approved by stringent drug agencies like the FDA be distributed."


Interpol seizes more than $6.65 million of counterfeit medicines in Southeast Asia.

Bloomberg News (11/17, Bennett) reports, "Interpol seized more than $6.65 million of counterfeit medicines against malaria, HIV, and tuberculosis in Southeast Asia and made 27 arrests, disrupting the region's fake drug trade for the second time in three years."

According to Aline Plancon, an officer involved in the "five-month investigation called Operation Storm," officials "seized more than 16 million pills, including fake antibiotics for pneumonia and child-related illnesses." Operation Storm "involved almost 200 raids" conducted across "Cambodia, China, Laos, Myanmar, Singapore, Thailand, and Vietnam."

Health officials were particularly concerned by "copies of a class of malaria drugs called artemisinins." Fake "artemisinin-based treatments containing small amounts of the medicine are helping the parasite responsible for malaria to evade authentic drugs in patients near Cambodia's border with Thailand, a recent study showed."