Friday, December 10, 2010

Pharmalot: The Sorry List of Johnson & Johnson Troubles


“We now see a strong likelihood of near-term FDA enforcement action.”


Once again Ed Silverman in his Pharmalot blog outlines the issues that have plagued the pharmaceutical industry giant over mandated recalls, “phantom recalls”, other regulatory misdeeds that have impacted their venerable brands including Tylenol, Mylanta, Motrin, Rolaids and Benadryl.

In his blog, Mr. Silverman cites Wells Fargo Securities analyst Larry Bigelsen regarding the potential impact of continued FDA scrutiny on their operations and to J&J stock.

This blog presents some interesting, whimsical insight into the depth of the problem and the potential impact operationally and financially to J&J.

Secure Pharma Chain sees this as a cautionary tale to the pharmaceutical supply chain- protect the production, quality, efficacy and distribution of your product and inventories within the supply chain or risk the reputation and viability with the consumer. The stakes are high and the consequences to the brand and the consumer can be lethal.

It is vital that all members of the pharmaceutical supply chain deploy and utilize technologies that protect consumers from adulterated, fraudulent, sub-standard, poor quality and counterfeit drugs.


To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/12/the-sorry-list-of-johnson-johnson-troubles/




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

Thursday, December 9, 2010

Court Told of Multi-Million Pound Medicines Scam


“This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,”

The Tuesday, December 7th edition of the Bath Chronicle reports on the court case of five accused of a multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

According to the Bath Chronicle story:

• A jury was told the people behind Europe’s biggest ever scam of its kind were motivated by “pure greed.”

• The court was told that as a result of the scam, medicine watchdogs ordered a recall of all suspected drugs – taken by heart and cancer patients and people with mental health problems – resulting in shelves being cleared in pharmacies all over the country.

• “They were prepared to make profits by feeding duff drugs to people with serious illnesses, prostrate cancer, heart disease and psychiatric issues,” prosecutor Andrew Marshall told Croydon Crown Court.

• All five have pleaded not guilty to conspiring between January 1, 2006 and June 30, 2007 together and with others to defraud pharmaceutical wholesalers, pharmacists, the public and holders of intellectual property rights in pharmaceuticals by dishonestly distributing for gain counterfeit medicines.

• Charges were brought following a two-year investigation by the Medicines and Health Care Products Regulatory Agency, part of the Department of Health, into Consolidated Medical Supplies Ltd.

• The company, of Unit 14, Sherrington Way, Lister Road, Industrial Estate, Basingstoke, had its wholesale dealer’s licence revoked by the agency on January 8, 2008.

• “This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,” Mr Marshall told the jury.

• “The most serious in the European Union, with far-reaching effects for pharmaceutical companies, patients and the confidence of the general public.

• “The purpose is just greed. To obtain the profits of buying illegal goods cheaply.”

• The charges relate to ‘Casodex‘, used to treat advanced prostate cancer, ‘Plavix‘, a drug prescribed to prevent blood clots and prevent heart attacks for angina patients and ‘Zyprexa’ a anti-psychotic drug prescribed to schizophrenic and bipolar patients.

• “They are just importing danger,” Mr Marshall told the jury. “The drugs imported are not extensively and expensively tested, but instead have been smuggled into the EU and distributed regardless of their chemical qualities.”

• The drugs were said to be manufactured by a notorious Chinese pharmaceutical counterfeiter currently serving a prison sentence for a similar scam in the United States.

• “No one pretended these were cheap counterfeits, they were pretended to be real. These men are not a charity importing cheaper drugs, it is I am afraid, pure greed in order to make money, working totally outside the system.

Hopefully the pharmaceutical supply chain and consumers will use this story to educate themselves about the danger that counterfeit drugs pose, even in sophisticated health care delivery systems within developed nations.

There are bad guys everywhere that realize that huge profits with little risk are involved in the sale of bogus medications.

Secure Pharma Chain encourages all within the regulatory and supply chain to take measures to protect their constituents from fraudulent, adulterated, sub-standard and counterfeit medications.

To read the Bath Chronicle article, visit: http://www.thisisbath.co.uk/health/Court-told-multi-million-pound-medicines-scam/article-2976972-detail/article.html

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

Wednesday, December 8, 2010

‘Made in India,’ Faked in China

China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Roger Bate a Legatum Fellow at the American Enterprise Institute and Tom Woods President of Woods International write an excellent article in The American, the Journal of the American Enterprise Institute about the huge role that China is playing in polluting the pharmaceutical supply chains around the globe by producing massive amounts of fake drugs that often times with lethal consequences.

Mr. Bate, a long time favorite of Secure Pharma Chain, along with Mr. Woods once again provides insightful analysis into one of the most insidious and deadly crimes of the 21st century.

Highlights of The American article include:

• Chinese manufacturers are faking drugs, endangering patients' lives, and undermining legitimate brands, especially those from India. Indian companies provide vast amounts of generic drugs to mid-income and developing nations. By some estimates, 80 percent of HIV drugs for the developing world come from India, and probably half the anti-malarials and antibiotics, too.

• From the counterfeiters' perspective, faking Indian drugs makes sense. Even in those categories where Indian products do not dominate the market, they may still be copied. In part this is because Western brand owners are more likely to go after those faking their brands, whereas Indian drug makers have smaller margins and hence spend less on brand enforcement.

• Criminals often manage to bypass… inspections by inserting their fake versions further along the distribution chain. So more often tip-offs from underworld contacts, probably disaffected parts of criminal networks, provide the greatest likelihood of intercepting fakes.

• Of course, sometimes the fakes make it to market, often with lethal effect. In 2009, our Nigerian colleague Thompson Ayodele came across another fake of an Indian drug in a Lagos pharmacy, this time an antibiotic. Later, we found out it too had been made in China. It is impossible to know how many patients had taken this fake antibiotic before authorities were alerted.

• Chinese gangs do not discriminate—every major drug company and every country has probably had drugs faked by the Chinese. China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. In fact, Chinese operators will fake in or for any location and they will fake anything popular. Take Artesunat, the brand of a Vietnamese anti-malarial made by the Ho Chi Minh–based company Mekophar Chemical Pharmaceutical, which is also widely faked. Ongoing research shows that fake Artesunat was found in Nigeria, Ghana, Kenya, Uganda, Tanzania, and Thailand; and it was all the handiwork of Chinese counterfeiters.

• Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Clearly China has become the primary incubator and exporter of the counterfeiting drug trade which now stretches beyond the globe. China must do more to protect supply chains from a criminal act that can cause death and create health care catastrophes among entire populations. All members of the pharmaceutical supply chain must take proactive steps to interdict and eradicate these deadly fakes and protect the consumer.

To read Mr. Bate and Mr. Woods article, visit: http://www.american.com/archive/2010/december/made-in-india-faked-in-china



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


Monday, December 6, 2010

Pharmaceutical Counterfeiting: The Effect of Technology, Regulation, and Legislation on Manufacturer Liability

“As more technologies become available and affordable, plaintiffs will contend that companies not employing technological protections—especially for drugs highly likely to be counterfeited—breach some duty to consumers.”

Caitlin Blanche an Associate with Snell & Wilmer out of Orange County, writes an outstanding essay in the American Bar Associations Mass Torts, Winter 2010 edition regarding the legal and liability perspective of the pharmaceutical supply chain stakeholder and the overall issue of pharmaceutical supply as it relates to fraudulent, adulterated, sub-standard and counterfeit drug.

While clearly written for a pharmaceutical industry General Counsel, Ms. Blanche’s article should be a must read for all industry insider’s as they look at dealing with one of the most insidious threats to the pharmaceutical industry and health care consumers at large.

Ms. Blanche outlines the issue, discusses relevant technologies/solutions and reports on regulatory initiatives while concluding with:

"Now, more than ever, attorneys should counsel clients about supply chain management, internal audits, the careful analysis and adoption of track-and-trace and anti-counterfeit technology, remedial measures, and monitoring of all relevant legislation introduced. Although courts have not yet imposed common-law liability for drug counterfeiting, there are a number of evolving variables in play, and plaintiffs could use any one of them to allege a new standard of care for manufacturers."

Secure Pharma Chain endorses Ms. Blanche's conclusions and encourages all within the supply chain to take proactive steps to secure their inventories from adulterated, fraudulent, sub-standard and counterfeit medications.

To read Ms. Blanche’s essay visit: http://www.swlaw.com/assets/pdf/news/2010/12/01/ABAMassTortsPharmaceuticalCounterfeiting_Blanche.pdf

To learn more about anti-counterfeiting solutions for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/


Friday, December 3, 2010

42 Police Raids In Argentinean Counterfeit Drug Probe

In Argentina, 42 raids were conducted as part of continuing investigations into counterfeit and illegal drug distribution by organized crime.

According to the Argentinean news organization, Momento 24, Argentinean authorities are continuing their two year investigation of counterfeit drug sellers that operate within workers' unions that involve the use of expired drugs, counterfeiting and murder.

Last week Judge Norberto Oyarbide ordered over 40 raids on suspected workers’ union sites in Capital Federal, Avellaneda, San Justo and other interior locations within Argentina.

As reported by Partnership for Safe Medicines: Among the organizations raided were employment organizations for truckers, metalworkers, air navigators, lottery, port, petrochemical, turf, post and telecommunications, teachers and automotive industries.

In Argentina, healthcare including doctor care and prescription drugs are distributed to the majority of Argentineans’ through their employment union organizations.

According to Momento 24:

• Police collected documentation on the purchase and distribution of cancer drugs, hemophilia medication and AIDS drugs.

• Police are looking for possible connections with drug companies, including San Javier of businessman Nestor Lorenzo, previously arrested and prosecuted for organized crime medicine distribution in 2009.


In earlier reports by Momento 24, Mr. Lorenzo has testified in the investigation for the murders of Sebastián Forza, Damian Ferron and Leopoldo Bina. He testified on the chain of suppliers and creditors of Forza, who, allegedly, sold a shipment of counterfeit hemophilia medications to the National Drug and Technology Agency (Anmat).

According to an earlier Momento 24 story, one of Mr. Lorenzo’s previous business partners in a small chain of drug stores, Luis Marcelo Tarzia died in jail after his arrest for allegedly being the local manager of a Mexican drug gang that set up a methamphetamine lab in Ingeniero Maschwitz.

This is a cautionary tale to industry stakeholders and consumers of pharmaceuticals within developed countries over the possible interdiction of dangerous medications within the legitimate supply chain.

Unfortunately this type of crime is becoming commonplace within the legitimate supply chain in the UK, Germany and even the United States.

Because of its high profit and low risk, counterfeiting or dealing in adulterated, fraudulent or sub-standard medications has become a lucrative trade and has drawn the attention of organized criminal elements. The real danger however is that it not only impacts those involved with the transaction but has potentially lethal implications for unsuspecting consumers who take these dangerous knock offs.


All members of the pharmaceutical supply chain must proactively take measures to protect their inventories.

To read the entire Momento 24 story, visit: http://momento24.com/en/2010/11/26/at-least-42-police-raids-on-the-case-of-counterfeit-drugs/

To read the entire story on Partnership for Safe Medicine, visit: http://www.safemedicines.org/2010/12/argentina-federales-investigate-fake-drug-crime-ring-60.html


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


Thursday, December 2, 2010

Chinese Court Jails Four for Fake Medicine

Chinese gang sentenced to jail for selling expired and bogus medications.

According to a story in the Shanghai Daily, four members of a group that sold expired medicine and produced fake prescription drugs without a license were given jail sentences ranging from eleven months to five and a half years yesterday.

According to the Shanghai Daily story:

• The drugs produced by the gang were tested and found to be fake. Fortunately, none of them were sold thanks to quick action by the police.

• The Putuo District People's Court heard that the gang collected expired medicine around the city at low prices and then sold them outside Shanghai, after changing the production and expiration dates on the labels.

• Zhang Dezhi, 45, from Liaoning Province, and Zhang Wenzhong, 48, from Anhui Province, who do not have licenses to sell or produce drugs, began to collect medicines around the city last year, the court heard.

• Police seized more than 3,100 boxes of medicine in Zhang Dezhi's home in Shanghai on February 3 and intercepted more than 20,000 boxes on their way to Shen-yang. They were estimated to be worth around 550,000 yuan (US$82,614).

• Police later confiscated medicine valued at 230,000 yuan from Wang's home in Shenyang, and drugs in Zhang Wenzhong's residence in Shanghai valued at more than 400,000 yuan.

• In addition to collecting and selling the drugs, Zhang Dezhi also produced fake drugs by buying in cheap and inferior medicines and attaching false labels of more expensive brands.

Hopefully this is a sign that as reported previously in Secure Pharma Chain, Chinese officials are becoming proactive and more diligent in aggressively prosecuting a lethal crime that impacts the lives of their population and that they export around the world.

China and India have become the epicenter of a global counterfeit drug issue that is worth billions annually and is estimated to kill and impact the health of millions.

To read the entire Shanghai Daily story, visit: http://english.eastday.com/e/101126/u1a5572554.html

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

Wednesday, December 1, 2010

China Launches New Product Piracy Crackdown

According to Bloomberg News and the Associated Press, China's government is launching a new six-month crackdown on rampant copying and counterfeiting of software, medicines and other goods.

According to the reported announcement:

• The announcement comes amid complaints by industry groups that piracy of software and some other goods is growing despite repeated government pledges to stamp it out.

• Cabinet officials said the crackdown will target a wide array of products from illegally copied computer software to corn that is falsely labeled as organic.

• Fake or illegally copied music, designer clothes, medicines and other goods are widely available in China. Industry groups say Chinese piracy costs legitimate producers billions of dollars a year in lost sales.

China leads the way in fraudulent, adulterated, sub-standard and counterfeit medications that is exported to the developed and underdeveloped nation’s pharmaceutical supply chains.

Hopefully this announcement is a serious effort on behalf of the Chinese government to protect consumers around the globe from this potentially lethal crime.

To read the entire Bloomberg News story, visit: http://www.bloomberg.com/news/2010-11-30/china-launches-new-product-piracy-crackdown.html

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