Policy/Enforcement News
LD 171 and LD 449 will expose Mainers to counterfeit drugs
Two proposals in the Maine legislature (LD 171 and LD 449) to import drugs from all over the world would endanger Maine patients without saving them any money. Maine patients would end up having their prescriptions filled by foreign companies that aren’t licensed pharmacies and sell drugs that aren’t even FDA-approved, assuming they didn’t get counterfeit drugs with either chalk or toxins.
For a serious condition, such as high blood pressure, asthma, and blood clots, even medicine made of chalk is a dangerous pill.
[...]Operator of Canada Drugs Subsidiary Pleads Guilty in Counterfeit Drugs Case
When counterfeit cancer medication was found in US distribution at doctors’ offices throughout the country, the source of the fake drugs was traced to Canada Drugs affiliate, Montana Healthcare Solutions (MHS). Now the Wall Street Journal is reporting that a man who marketed the fake cancer drugs to US doctors is due to plead guilty to felony charges in the case.
On March 21, 2013, Paul Bottomley, a UK citizen and founder of Montana Healthcare Solutions, signed a plea agreement wherein he accepted his guilt for his role in the distribution of counterfeit cancer medication, reports the Wall Street Journal. According to the Plea Agreement, Bottomley waved the right to a jury trial and agreed to plead guilty to misprision of a felony, or aiding in the commission of a felony. The plea agreement also states that Bottomley “maintains he can provide substantial assistance to the United States” and in so doing, further reduce his sentence.
Bottomley had previously agreed to forfeit the proceeds of his business to the Federal Government, including land and an ostentasiously expensive Aston Martin, sold at auction for $110,000, reports the Missoulan.
Bottomley initially denied any connection to the fake Avastin distribution, telling CBS news via text that Montana Healthcare Solutions had shut down in 2010, and that he “knew nothing of this Avastin matter.” Subsequent investigations however linked him to the sale of the fake Avastin. CBS reports further that a doctor they spoke to received a price sheet in 2011 from MHS with Bottomley listed as the “Business Development Director.”
Back in February 2012 when the FDA first reported that counterfeit Avastin had been found at US doctors’ offices, they identified Montana Healthcare Solutions as one of the suppliers. At that time MHS’s links to online pharmacy giant Canada Drugs were not as yet understood. In July of 2012, the Wall Street Journal linked the two companies in print for the first time. Montana Healthcare Solutions has since been identified by the FDA as “owned and operated by Canada Drugs.”
In related news, The Winnepeg Sun is reporting that Canada Drugs has laid off hundreds of employees in the wake of the FDA’s efforts to shut down their US operations.
To learn more about the safety of purported Canadian Internet pharmacies, and to insure that your medicine stays safe read “The 5 Secrets Canadian Web Pharmacies Don’t Want You To Know.”
To learn more about the counterfeit Avastin case, and check to see if your doctor received a warning letter from the FDA about fake cancer medication, read our Update on Fake Avastin.
[...]United Nations Report on East Asian Organized Crime: Criminal Made $5 Billion in Fake Drug Profits
The United Nations Office on Drugs and Crime (UNODC) has just released their report on organized crime activities in East Asia. It shows counterfeited/ fraudulent pharmaceuticals are a growing source of profit for criminal gangs, and countries with lax enforcement are the biggest market fraudulent medicines.
[...]2 Rhode Island Men Plead Guilty in International Fake Internet Pharmacy Scheme
Rhode Island pair pleaded guilty to being part of an international criminal enterprise based in Israel that imported steroids and misbranded pharmaceuticals into the United States for sale via the Internet. The drugs were repackaged and shipped from their facility in Rhode Island.
The US Department of Justice (DOJ) reported on March 13th that two Rhode Island men, Edmond Paolucci, and Patrick Cunningham have pleaded guilty to receiving, repackaging and shipping steroids and misbranded prescription drugs to Internet customers who placed orders with the Israel-based Internet pharmacy.
[...]Justice Department Dismantles Fake Online Pharmacy Conspiracies & Convicts 9
On March 27, the US Department of Justice announced the sentencing of 9 people involved in distinct but interrelated fake online pharmacy conspiracies. The ringleaders were sentenced to 4-5 years apiece, while other members of the broad organizations got less jail time or probation. All told, the defendants forfeited more than $94 million in profits. UPS & FedEx shipping records were used as evidence in this case.
The Department of Justice (DOJ) has concluded the successful prosecution of two different fake Internet pharmacy conspiracies. As they describe it, “these convictions were the result of a lengthy investigation by the Drug Enforcement Administration, San Francisco Field Division’s Financial Investigative Team. The prosecution is part of the Northern District of California United States Attorney’s Office’s Health Care Fraud program and was initiated as an investigation with the Organized Crime and Drug Enforcement Task Force. Substantial assistance was provided by the North Carolina Board of Pharmacy. Assistant United States Attorneys Kirstin Ault, Thomas Stevens, and Tracie Brown, with assistance from Denise Oki, Maryam Beros, Rawaty Yim, and Rayneisha Booth, prosecuted this case on behalf of the United States.”
Pitcairn Internet Pharmacy
Michael Arnold, founder of Pitcairn Internet Pharmacy was given a 5 year jail term for his role in distributing controlled substances and prescription drugs through a maze of illegal Internet pharmacy websites. From 2003-2007, he earned more than $69 million via websites such as ezdietpills dot net, pillsavings dot com, and doctorrefill dot net. Arnold used accounts in several countries including Canada, Switzerland, and the Netherlands to launder profits from his illegal drug sales. In addition to his jail term, he has been ordered to forfeit the $69 million in profits from his fake online pharmacy business, reports the DOJ.
SafeScripts/PharmacyUSA
Christopher Napoli, the founder of SafeScripts (also known as PharmacyUSA) was sentenced to 4 years in jail and required to forfeit almost $25 million in profits from his illicit online pharmacy business. Napoli ran his fake Internet pharmacies from November 2004 to December 2006. During that time, Safescripts sold more than 13 million doses of controlled substances. Napoli’s Safescripts operation was rather sophisticated, paying affiliates in several foreign countries to market his drugs, and utilizing a call center in the Dominican Republic to handle customer calls, according to the sentencing document.
[...]FDA Uses Portable Rapid Testing Devices to Insure Patient Safety
The FDA has released photographs of a portable XRF analyzer designed to screen dietary supplements for toxic metals. The device is one of a new generation of portable screening tools, which will allow investigators to discover and seize adulterated drugs before they are available to consumers. The FDA’s new efforts rely on spectroscopic technologies that “analyze the dispersion of an object’s light determine the object’s chemical or molecular composition.”
[...]UNODC Conference Highlights Fake Drugs Distributed by Organized Crime
Last month, the United Nations Office on Drugs and Crime (UNODC) held a conference in Vienna to discuss the the production, distribution and trafficking of fake drugs by organized crime networks. The conference, which was held February 14-15, gathered an international group of experts from governments, law enforcement agencies, NGOs and the private sector to share information about the scale of the problem, which has significant impact worldwide. UNODC has found that in parts of Asia, Africa and Latin America as much as 30 percent of available drugs are fraudulent, and that the trafficking of unsafe or ineffective medicine is “a multi-billion dollar activity.”
[...]Recent Efforts by Chinese Government to Crackdown on Counterfeit Drugs Show Progress
Though China has long been linked to the manufacture of counterfeit drugs, the last two years have shown that Chinese authorities are taking counterfeit drug crime much more seriously. China’s Food and Drug Administration (SFDA) cracked over 14,000 cases last year, a major toxic gel capsule ring was broken up, and Chinese authorities are working in concert with both the FDA and major drug manufacturers to track down counterfeit drug manufacturers and prosecute them. The founding of Partnership for Safe Medicines China also demonstrates China’s stakeholders’ commitment to improving patient safety both at home and abroad.
China made great strides in the last year in their efforts to combat pharmaceutical counterfeiting. Their cooperation with the US Food and Drug Administration on inspections is helping to safeguard both US and Chinese consumers. The founding of Partnership for Safe Medicines China underscores a new commitment to ensuing drug safety within their borders. Partnership for Safe Medicines China is the latest branch of the leading advocacy organization dedicated to fighting the global threat posed by counterfeit and misbranded drugs.
[...]UK’s Medicine Regulatory Agency Warns of Dangerous Ingredients in Herbal Remedies
On February 19th, 2013 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) posted a press release warning of dangerous heavy metal contamination in unlicensed Chinese herbal medications produced in Hong Kong and sold internationally online. The herbal compounds are reported to contain mercury and lead, which can lead to health side-effects ranging from dizziness to kidney and brain damage, reports the MHRA.
The MHRA, which is the UK counterpart to the US Food and Drug Administration (FDA), states that the following products: “Bak Foong Pills – used to relieve menstrual discomfort, Fung Shing Paij Tian-Ma Wan – used to relieve arthritis and headaches, and Shi Hu Ye Guang Wan and Nai Chang Ming Yan Pills – both used to improve vision in adults” are all contaminated with either lead or mercury.
[...]Institute of Medicine Releases Report on Falsified and Substandard Drugs
On February 13, 2013, the Institute of Medicine (IOM) released
their report, “Countering the Problem of Falsified and Substandard Drugs” that
reviews the current state of substandard and falsified drugs globally, and offers
a series of recommendations to combat drug falsification and to encourage
global cooperation on drug safety.
Food and Drug Administration Commissioner Dr. Margaret
Hamburg commends the FDA commissioned report because it “spotlights a critical global public health
issue. Falsified and substandard medicines adversely affect the lives of
millions around the world, and the issue must be elevated to the highest levels
of international discourse.”