News Coverage
The Partnership for Safe Medicines has been publishing information about the counterfeit drug problem around the world for more than a decade. With experts leading the organization and a committed and passionate set of writers and editors, our content is more in-depth than many other sources, which simply copy links to the news from other websites.
Between 2009 and 2014, 35 doctors in 7 states were prosecuted for exposing women to non-FDA approved IUDs. Doctors have been accused of purchasing IUDs from “Canadian” fake online pharmacies and importing untested IUDs from Mexico, then billing Medicare for the cost of genuine, FDA-approved IUDs. Over the same time period, authorities estimated that over 450 women were implanted with misbranded, black-market IUDs.
Learn more about black market cancer drug cases by downloading this resource. While many pharmacists act as custodians for their patients’ safety, three different pharmacists in California, New York, and Pennsylvania have either been indicted or pleaded guilty to charges ranging from prescription drug smuggling and money laundering, to heath care fraud and illegal diversion…
Graphic from PwC’s report, “Younger consumers are more concerned about the safety and quality of their medications” A recent survey by Pricewaterhouse Coopers found that people 18-24 had the greatest concerns when it comes to medicine safety. Greater numbers of young consumers express concern about the quality and safety of their medications than those 65…
A news channel conducted their own investigation into purchasing prescription drugs online. Testing of the drugs they received proved they were counterfeit, and in some cases contained dangerous banned compounds. A Colorado news station, 9 News Colorado, shared with their viewers the disturbing experience of their sister news station, WKYC in Cleveland. WKYC’s investigation in…
Download What Kind of Businesses Are Fake Online Pharmacies New campaign, “Counterfeit: Don’t Buy Into Organized Crime” addresses the dangers posed to consumers who purchase medicine that turns out to be counterfeit. “Counterfeit: Don’t Buy Into Organized Crime,” the new consumer awareness campaign launched today by the United Nations Office on Drugs and Crime…
Download BlackMarketCancer_Long.pdf (881.4K) Dr. Eduardo Miranda, an oncologist practicing in Laredo, Texas, was accused of illegally importing non-FDA approved cancer medications from a known source of counterfeit Avastin. In December 2013, the U.S. Department of Justice (DOJ) reported that Dr. Eduardo Miranda had pleaded guilty to charges that he imported non-FDA approved cancer medication into…
Ms. Arnold spoke at Interchange 2013 about the events in her state that resulted in the passage of a controversial law that allows non-FDA approved medication to be imported from unregulated sources into the state of Maine. At the heart of this recent law is a Canadian business called CanaRX that Ms. Arnold stated “came into…
In August 2013, the Department of Justice announced indictments of eleven people involved in running an unlicensed pharmaceutical wholesale business out of suburban Virginia. To date, seven employees of Gallant Pharma International, along with one of its co-owners have pleaded guilty to charges of importing and distributing non-FDA approved injectable medications via their unlicensed wholesale…
Download FSA.pdf (493.3K) As we approach the end of the year, people seeking to empty their flexible spending accounts or avoid new prescription deductibles in the new year will order prescriptions and other medical supplies online.But the convenience of purchasing online shouldn’t prevent you from ensuring that your…
The Federal Bureau of Investigation announced on December 11, 2013 the indictment of Salim Yusufov, owner and operator of Healthway Pharmacy in Pikesville, MD. Yusufov is charged with illegally providing unapproved prescription drugs for customers from Germany and Eastern Europe. The medication, Corvol, contains large amounts of phenobarbital, and is used to treat elevated blood…
Turkish police in Istanbul have arrested 56 as part of an organized crime ring in the business of manufacturing and distributing counterfeit cancer drugs for sale in Turkey and other countries, including the United States. The Hurriyet Daily News has reported that police in Istanbul have broken up a conspiracy operating throughout Turkey that manufactured…
On Thursday, December 12, 2013 a federal jury concluded deliberations on U.S.A. vs. Dr. Anindya Kumar Sen and Patricia Posey Sen. Dr. Sen is an oncologist practicing in Greeneville and Johnson City, Tennessee. Patricia Posey Sen is his wife, who manages Sen’s medical practice, East Tennessee Cancer and Blood Center (ETCBC). The doctor, his wife…
PSM’s Black Market Cancer Drug Cases 2007-2013 looks back through the past 6 years at the numerous cases of fake or misbranded cancer drugs that were sold by shady black market drug sellers and purchased by doctors and clinics throughout the United States. Since 2007, 16 physicians and drug distributors have been prosecuted for their…
As part of PSM's continuing efforts to publicize the dangers posed by counterfeit medications, two representatives from PSM spoke at last week's National Association of Drug Diversion Investigators Conference. On November 20th, 2013, two speakers from the Partnership for Safe Medicines spoke to an audience of 400 drug diversion investigators in Saint Louis Missouri at…
President Barack Obama talks with Chief of Staff Denis McDonough, National Economic Council Director Gene Sperling and Miguel Rodriguez, Director of Legislative Affairs.Image courtesy of The White House via Flickr. On November 27, 2013, President Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA). The new law established a national track-and-trace system to…
U.S.Attorney Samuel Louis speaking at Interchange 2013 We were fortunate enough to have US Attorney Samuel Louis share details from the counterfeit medication cases he has prosecuted at the Interchange 2013. During the course of his presentation, he described how master drug counterfeiter Kevin Xu was finally brought to justice. Kevin Xu was a businessman…
Dr. David Fishman of Euclid, was one of 7 oncologists prosecuted for purchasing imported cancer medication from websites that claimed to be Canadian. Dr. Fishman and his co-defendant Dr. Hassan Tahsildar had already pleaded guilty to charges related to illegally purchased non-FDA approved cancer medications, according to a report from the News Herald at the…
PSM applauds the members of the Senate for passing HR 3204, "Drug Quality and Security Act." The securing of the supply chain through establishing track-and-trace requirements for medicine manufacturers, wholesalers and repackagers will provide Americans with greater security over our prescription drugs. When the supply chain is breached by someone mistakenly purchasing a substandard drug…
At the 2013 Interchange, PSM Board Member Dr. Marvin Shepherdoffered an explanation of how drug diversionsubverts the securesupply chain and endangers patient health. Three pharmacists from the now shuttered Kentwood Pharmacy have been sentenced in Federal court, and stripped of their right to practice as a result of their guilty pleas on charges of reselling…
USP has launched the Center for Pharmaceutical Advancement and Training in Accra, Ghana.Learn more about USP’s efforts to improve the quality of medicines globally at http://www.usp.org/around-world We were most fortunate to have Patrick Lukulay, PhD, Vice President of Global Health Impact Operations for the US Pharmacopeial Convention (USP) as a panelist at this year’s Interchange.…
Download Rabies Vaccine Information from CDC. Chinese authorities seize more than $3.28 million in counterfeit drugs and vaccines. Counterfeit rabies vaccine was sold to hospitals in Shandong province since 2009. China Daily reports the arrest of 17 drug counterfeiters who specialized in counterfeits of blood products as well as counterfeit rabies vaccine. Authorities discovered that two…
On October 24th, the Partnership for Safe Medicines gathered stakeholders in the efforts to combat counterfeit medicine in Washington D.C. for a one-day conference at the Newseum’s Knight Conference Center. This was our 4th annual conference, focused on U. S. drug supply chain security and the safety of American patients. Speakers and panelists were drawn…
Many feel Switzerland is a safe country when it comes to drug importation, however even the Swiss authorities are forced to search for counterfeit drugs. There is in fact, no “safe” country for importation. Last week, 1 million fake anti-anxiety pills were seized by Swiss customs. The counterfeit Xanax was in transit via Switzerland, and…
You can count on it. The criminals who counterfeit drugs and endanger American patients haven’t stopped making and selling fake drugs during the shutdown. There is more need for a counterfeit drug conference now than ever. The 2013 Interchange will include: Patient advocates who represent patients whose lives depend on getting genuine medication Journalists who…
2013 Interchange will feature new research from Carl L. Alsberg Fellow, Tim K. Mackey, and in-progress research from PSM Board member Marv Shepherd. As part of the Partnership for Safe Medicines continuing effort to inform the both the public and medical professionals about the dangers of counterfeit medication, we’re presenting two new research studies on…
The Partnership for Safe Medicines is pleased to announce Deputy Director Ilisa Bernstein as the keynote speaker of the 2013 Interchange on October 24, in Washington, DC. Dr. Ilisa Bernstein is the Deputy Director of Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She…
Partnership for Safe Medicines India brings together pharmaceutical, patient safety, and government enforcement organizations for their training workshop focused on protecting patients from false or spurious medicines. Bejon Misra, founder of the Partnership for Safe Medicines India will be our luncheon speaker at the 2013 Interchange October 24th in Washington D.C. Register today! On August 23rd 2013,…
PSM Executive Director Urges Greater International Cooperation in Major Address to the Japan Medical Association TOKYO, JAPAN (September 19, 2013) – Partnership for Safe Medicines Executive Director Scott LaGanga stressed the urgent need for greater global education and collaboration to fight the growing health threat posed by counterfeit and substandard medicines in an address to…
Click image to download G-8 Infographic (pdf) The countries of the Group of 8 (G8) have begun to work together to try and fight the global scourge of counterfeit medications. Their efforts are important, as most of the G8 member countries are having their own problems with counterfeit drug crime. In May 2013 leaders from…
We are pleased to welcome Dr. Lukulay as a speaker at PSM’s 2013 Interchange, happening October 24th in Washington D.C. Register now to hear about the achievements of the U. S. Pharmacopeial Convention and Dr. Lukulay in combatting counterfeit medication in Africa. In May 2013, the US Pharmacopeial Convention(USP) achieved their long-held goal of opening…
It is safe for Americans to order life-saving medicine from online pharmacies overseas? No. Like the U.S., other countries are plagued by illegal Internet pharmacies.
Russian Programmer Responsible for Millions of “Canadian Pharmacy” Spam Emails Lands in Moscow Court
Igor Artimovich utilized a “botnet” program called Festi, to infect computers all over the globe, turning them into automated spamming servers. His arrest and court appearance has exposed Russia’s shadowy underworld linking spam servers, identity theft, and counterfeit drug criminal organizations. The ubiquitous “Canadian pharmacy” advertisements that regularly appear in consumer email inboxes seem innocuous…
Click image to download Simple Steps for Safe Sourcing (pdf) This month, prescription medication was stolen from an unattended courier van in Modesto. Why would anyone steal prescription drugs? Because they can be sold on the black market and also used to “salt” batches of counterfeit drugs to fool inspectors. On August 22, a batch…
Seven oncologists in six different Ohio cities have been charged with illegally importing misbranded, non-FDA approved cancer medication. The U.S. Department of Justice (DOJ) is reporting that seven Ohio cancer doctors are facing allegations of importing non-FDA approved cancer medications. The seven were each charged with a misdemeanor, “causing the shipment of misbranded drugs.” The…
11 people have been indicted in an $8.6 million prescription drug importation scheme. Gallant Pharma International allegedly imported non-FDA approved drugs into the United States, then repackaged the drugs with US labels. Gallant Pharma posed as a Canadian pharmaceutical company shipping low-cost drugs from Canada to the U.S. The drugs sold by Gallant Pharma, including…
Images of bogus diabetes treatments courtesy of the FDA. The U.S. Food and Drug Administration (FDA) is warning diabetics to beware of illegal “natural” remedies for the treatment of diabetes. They pose a serious health danger to diabetics, and are part of the growing trend amongst drug counterfeiters pushing fake natural medications. The FDA has…
In a two-part series, Clinical Oncology takes a look at the recurrent counterfeit cancer medication scares that have occurred in the last year. The impact on oncologists has been dramatic, with sentencing announced for one doctor, with more prosecutions possibly looming on the horizon. They note that to date, 155 medical practices in the United…
The new NABP report warns that a fake online pharmacy collective is posing as individual, but fake, Canadian pharmacies. In their latest quarterly report, the National Association of Boards of Pharmacy calls for strong consumer outreach in response to ever-more sophisticated efforts by fake online pharmacies in disguising the illegal nature of their operations. The July progress report from…
Click here to download stories of medicine counterfeiters including James Newcomb (pdf). On July 11 in Saint Louis, a British citizen was convicted of distributing counterfeit Avastin, sentenced to jail and asked to forfeit close to $4 million in counterfeit drug profits. Richard J. Taylor, a British citizen, has been sentenced to 18 months in…
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has produced a short video starring an animated “genuine” pill warning consumers and doctors of the dangers of counterfeit drugs. In a post on the Global Health Matters blog, editor Mario Ottiglio explains the reasons for the campaign: “Every day, fake medicines find their way into…
In the last year, there were several cases of counterfeit medication entering the secure U.S drug supply chain via orders made by healthcare professionals. The safety dangers to patients are implicit, but the legal problems healthcare providers face in these cases are not. On Thursday July 18th, the Partnership for Safe Medicines hosted Counterfeit Drugs…
Libby Baney speaking at the 2012 Interchange on online pharmacy patient safety issues. The Alliance for Safe Online Pharmacies (ASOP), an informal advocacy coalition started in 2009, has now become a charted nonprofit organization. Focused on online pharmacy safety, it is dedicated to protecting patient safety through legitimate online pharmacies. ASOP’s President is Diane Darvey,…
The United States Government Accountability Office (GAO) has just released a new report on the growing threat of fake Internet pharmacies in the United States. Its findings underscore the difficulty of enforcing US laws on foreign-based Internet pharmacies, and the imperative need for public outreach to educate consumers about the dangers of counterfeit drugs. Internet…
PSM’s Member PSI Aids Investigators in Largest Global Operation of its Kind Washington, D.C. (June 27, 2013) – The Partnership for Safe Medicines (PSM) applauds INTERPOL and the nearly 100 countries who took part in Operation Pangea VI, the largest global sting operation to date targeting the online sale of illegal prescription medicines. One of PSM’s…
Interpol-coordinated global operation targeted fake online pharmacy trade, netted over $41 million worth of counterfeit medication, and shut down more than 9,600 fake online pharmacies. Fake versions of drugs used to treat diabetes symptoms, arthritis, and schizophrenia were seized as part of the operation. 58 arrests have been made. On June 27, 2013, Interpol announced…
A recent WUSA-9 story looked at the growing problem of American teens who are buying prescription medication online from foreign-based online pharmacies that demand neither proof of age nor prescription. The growing problem of fake online pharmacies is of particular concern for parents trying to protect their children from dangerous drugs and toxic fakes. In…
On June 10th, 2013, Global Pharmacy Canada, a fake Internet pharmacy based in Belize, was forced by the Ontario Court of Appeal to shut down offices in Toronto for violating Ontario’s professional pharmacy rules. Global Pharmacy Canada was originally cited by Health Canada for marketing drugs to Canadians that were not of Canadian origin on…
A second Johnson City doctor was charged with purchasing misbranded cancer drugs just days after Dr. William Kincaid was sentenced to 2 years for his role in purchasing & administering questionable cancer medication from non-FDA approved foreign suppliers. According to the indictment (Download Sen Indictment) released on June 11, 2013 by the U.S. District Court in Greeneville,…
A Kentucky doctor is facing numerous charges including Medicare fraud for purchasing misbranded IUD contraceptive devices from a pair of fake online pharmacies and dispensing them to unsuspecting patients. Canh Jeff Vo, of Elizabethtown, Kentucky was charged with 13 counts including illegal drug importation, Medicaid fraud, health care fraud and mail fraud for deceiving his…
Two Pakistani nationals have been extradited to the United States for their alleged role in importing misbranded pharmaceuticals and controlled substances worth approximately $780,000 into the United Sates by offering them for sale via the Internet. The drugs were packaged and shipped from locations in the United Kingdom as well as Pakistan.
The U.S. Department of Justice (DOJ) released a report May 20th on the extradition and arrest of Sheikh Waseem Ul Haq, and Tahir Saeed of Karachi, Pakistan. The two men are charged with “conspiracy to import controlled substance pharmaceuticals into the United States; conspiracy to distribute controlled substance pharmaceuticals; conspiracy to introduce misbranded pharmaceuticals into interstate commerce; importation and distribution of controlled substance pharmaceuticals; introduction into interstate commerce of misbranded drugs, and conspiracy to commit international money laundering. It also includes a forfeiture allegation seeking all proceeds that can be traced to the scheme.”
View larger map On June 10, 2013, Dr. William Kincaid of Johnson City, Tennessee was sentenced to two years in prison for his role in purchasing misbranded and possibly counterfeit cancer drugs. Kincaid was a physician and managing partner for McLeod Cancer and Blood Center of Johnson City, Tennessee. The clinic was set up to…
Chronic Obstructive Pulmonary Disease (COPD) is a disease that obstructs airways, limiting breathing and causing cardiopulmonary issues. Patients with COPD are likely to suffer severe shortness of breath and are more susceptible to upper respiratory infections, including flu and pneumonia, both of which can be deadly for them. Chronic conditions like COPD are often expensive to treat, and COPD patients may seek to find cheaper medications from risky fake online pharmacies which would provide them with substandard and unapproved medication and poor treatment. But patients can shop safely online and find affordable authentic medicines.
According to a report just published by Men’s Health Network “Breath Easy, Your Lungs and COPD” COPD is “the third leading cause of death in the United States, with 12 million Americans diagnosed with COPD, and another 12 million who suffer from the disease without knowing they have the disease.” Additionally they report that 120,000 men and women die of COPD a year in the United States, and approximately 85-90% of COPD deaths are the result of cigarette smoking.
The symptoms of COPD as outlined in the Men’s Health Network Report are: shortness of breath (Dyspnea), a chronic cough, and wheezing. COPD occurs in two main forms, chronic bronchitis, and emphysema. There is no cure for COPD, but symptoms can be ameliorated by careful treatment. Unfortunately COPD sufferers are particularly endangered by common illnesses that are easily treatable in a healthy patient. Colds, influenza, pneumonia, and other lung infections can be a death sentence for a COPD sufferer.
Flu season can be a dangerous time for COPD patients. The illness, which can range from mild to serious for the average adult, can be lethal for a COPD sufferer. Because of this, those with COPD should seek vaccination for seasonal flu, and medical treatment if they become ill with the flu.
However, if a COPD sufferer makes the mistake of turning to a fake online pharmacy to seek a flu vaccination or flu cure, they could be signing their own death warrant. Drug counterfeiters regard flu season as an opportunity to make money selling fake vaccines and flu treatments. In February 2013, during the height of flu season, the FDA posted a public warning concerning fraudulent flu treatments and vaccines for sale on the Internet. As Gary Coody, the FDA’s national health fraud coordinator said in the warning “As any health threat emerges, fraudulent products appear almost overnight. Right now, so-called ‘alternatives’ to the flu vaccine are big with scammers.”
A new study
in the May 2013 Journal of Medical Internet Research illustrates just
how easy it is for fake online pharmacies to advertise via social media outlets
such as Facebook and Twitter.
Researcher Tim Mackey and co-author Dr. Bryan
Liang set up dummy, no-prescription-required pharmacy websites, then created
advertising for the dummy sites on Facebook, Twitter, MySpace, and
Google+. They found that in the 10
months that their fake ads were running, close to 3,000 unique visitors went to
the dummy sites in search of drugs that required no prescription. Surprisingly, though they had visits from all
over the globe, the highest percentage of web traffic to their fake sites (54%)
came from the United States.
PSM applauds the members of the House of Representatives for passing HR 1919, “Safeguarding America’s Pharmaceuticals Act of 2013.”
Today, our system of prescription drug distribution heavily relies on trusting the entity you’re dealing with and their judgment. If a mistake is made, or anyone farther back in the supply chain makes a mistake in purchasing a substandard drug product, there is no ability for a good actor down the line to know this. Criminals have taken advantage of this fact, and such incidents are growing in number every year. Life-saving medications that treat osteoporosis, cancer, heart disease, and many other serious medical conditions have been faked just in the last few years, as the rules of the road have failed to keep up with the innovative nature of the criminals that prey on American patients.
Robert Harshbarger
Jr. of Kingsport, TN pleaded guilty to charges he replaced FDA-approved iron
sucrose for use in kidney dialysis with
cheap foreign versions of the drug. Patients
in Kansas were unwittingly exposed to the misbranded drugs.
Harshbarger was originally charged by the FDA in March
2012. In the indictment, he was charged
with one count of selling misbranded drugs, one count of mail fraud and five
counts of health care fraud, for substituting cheap Chinese-made iron sucrose
for the FDA approved Venofer he claimed to be filling prescriptions with,
reported the Department of Justice at the time of Harshbarger’s indictment.
The Partnership for Safe Medicines recently gained access to a RFP submission from a foreign drug broker, purporting to save money for a Maine employee union. We studied the top 30 medications purchased by this union and price-compared black market foreign pharmacies to pharmacies who possessed a pharmacy license in Maine.
Using legitimate, FDA approved generic saves more than 80% of the cost of the name-brand medication, while purchasing from the black market foreign pharmacy saves less than 50%, while exposing patients to the dangers of substandard, misbranded and counterfeit drugs.
View larger map On May 25, 2013, France’s Ministry of Economy announced the largest seizure of counterfeit medication ever made by France and the European Union. French customs agents in Le Havre discovered 1.2 million doses of counterfeit aspirin hidden in a shipment of tea originating from China. The goods in the shipment were destined…
May 28 2013 is World Anti-Counterfeiting
Day. The
Global Anti Counterfeiting Network has announced Interpol and the Malaysia Health Service as the winners of their 15th
Annual Global Anti Counterfeiting Awards. While
not an event traditionally widely observed, this day gives us a chance to try and highlight our work to protect
patients from counterfeit drugs. If
you’re reading this, you probably care about protecting patients, but you
haven’t done anything to prepare for the event. The Partnership for Safe Medicines has made
it easy for you to highlight patient safety on this day, by giving you easy
resources for writing tweets, posting to Facebook, sending email, or writing a
letter to the editor on this day.
If you’re planning to help, please send us a note and we’ll keep an eye out for your messages!
Quick links:
- Campaign homepage: http://www.safemedicines.org/patient-and-doctor-tips-shareable-content.html
- TIPS for American patients: http://www.safemedicines.org/drug-safety-tips-for-patients.html
- TIPS for American physicians: http://www.safemedicines.org/drug-safety-tips-for-doctors.html
What we have planned
We are launching our patient and physician TIPS campaign on
World Anti-Counterfeiting Day. The
campaign includes 25+ tips on how patients can avoid counterfeit drugs, and
physicians can avoid unauthorized distributors selling counterfeit drugs. The tips have short versions that can fit in
a tweet or Facebook message, or longer versions that can fit in an email or
print newsletter. Each one contains an
original illustration like this one:
Ways you can help
Post a tip to Facebook or Twitter.
Post a note of support for the campaign recognizing PSM’s efforts on Twitter.
Send a tip to your mailing list, with links to more.
Post a blog post on your website.
Post a link to our campaign on your website, either in text or with one of
the tips graphics.
Write an op-ed.
Dear Speaker Boehner and Chairman Upton:
On behalf of the Partnership for Safe Medicines (PSM), we write today in strong support of H.R.
1919, the “Safeguarding America’s Pharmaceuticals Act”.
PSM is a not for profit, consumer focused organization that seeks to
keep Americans safe from counterfeit drugs through patient and healthcare
provider education and awareness. In
the US we work with a coalition of over 70 healthcare professional and patient
groups to improve patients’ and their
healthcare providers’ knowledge about where they obtain their medication, how
they can save money safely, and how to safely identify licensed pharmaceutical
distributors.
PSM strongly supports the creation of a national uniform track and trace
or pedigree system that would allow all participants in the supply chain to
verify a product’s history of sale.
Chinese pharmaceutical manufacturer Guilin Pharmaceuticals is rolling out SMS-text message codes on packaging to ensure authenticity of its antimalarial medication in Nigeria.
Guilin’s artesunate meets world-wide quality assurance standards and has been pre-qualified by the World Health Organization (WHO). The Prequalification Programme applies unified standards of quality, safety and efficacy to medicinal products and includes manufacturing inspections, and evaluation of ingredients. Though the program is mainly used by UNAIDS and UNICEF to guide procurement, other agencies use it as a guide to determine safety at an international level, reports the WHO.
Now, purchasers of the medication can guard against purchasing counterfeit versions by scratching off a hidden identification code on drug packages. Patients can send the code via text message to a computer that will send back a safety message if the package is authentic, reports The Financial Times.
The FDA has released more information about their new counterfeit drug detection device, Counterfeit Detection Device 3 (CD-3). In this newly-released video, Nico Ranieri, the FDA research biologist who developed this new technology talks about how important such innovations are to patient safety.
In
2005, it first occurred to Nicolas Ranieri to try to use the type of
ultra-violet light devices deployed in crime scene investigations in a
hand-held counterfeit drug detection device.
Up to that point, drug testing equipment was both delicate, expensive, and
also required highly-trained scientists to
perform the tests for fakes. Says
Ranieri, “We wanted to find counterfeits, and we wanted to find them as fast as
possible,” reports the FDA.
Rx360 has launched a new campaign educating healthcare providers to the risks of buying diverted and suspect products advertised directly to doctors’ offices via fax blast, direct email and online marketing.
Lewis T. Kontnik, team lead for the education campaign, says, “Some of the recent
problems with counterfeit and diverted medicines in the US, including
the counterfeit versions of Avastin, resulted in part from a lack of
awareness by physicians and medical practice administrators
of the risks of counterfeit and diverted medicines. The ads of the
professional diverters can appear tempting when they promise ‘genuine’ medicine and substantial discounts, however the facts are different and
the consequences can be very serious.”
When London police raided an apartment in west London last month, they were looking for visa cheats. What they found instead was over $750,000 worth of counterfeit medications stored in deplorable conditions.
A raid by Home Office Immigration Enforcement officers in West London that was aimed at catching people who had overstayed their visas instead found a vast quantity of unlicensed prescription medications, reports the MHRA. Investigators from the MHRA believe the drugs, which were mostly ED, weight loss, and hair loss treatments, were manufactured in India. Anabolic steroids were also found in the raid.
In 2012, the FDA sent over 350 warning letters to doctors advising them they may have purchased fraudulent or misbranded injectable drugs, including fake versions of Avastin, Botox, and two different osteoporosis treatments. Now the FDA has identified another batch of fake Botox that is currently being marketed to doctor via fax blast.
On April 26, 2013, the US Food and Drug Administration (FDA) posted a drug safety warning for healthcare practitioners, warning them that fraudulent versions of the anti-wrinkle treatment Botox are being marketed and sold in the US. The Botox is being sold by unlicensed suppliers, and has not been vetted within the secure U.S. supply chain. They state that the FDA “cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.“
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.
In light of the threat of illegal online pharmacies, the National Association of Boards of Pharmacy (NABP) announced their application to the Internet Corporation for Assigned Names and Numbers (ICANN) to own and operate a secure and vetted .PHARMACY domain for licensed Internet pharmacies.
The April 2013 report from the National Association of Boards of Pharmacy (NABP) illustrates the patient safety threat from illegal online pharmacies by showing that of more than 10,000 Web sites they analyzed, nearly 97% operate out of compliance with pharmacy laws and practice standards established in the US. To combat that threat, they have announced their application to ICANN for .PHARMACY, which will be available only to legally operating online pharmacies, who follow the rules and regulations in the jurisdictions in which they are based.
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.
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.
The Oklahoma Male Clinic offered treatment specifically tailored for men, but with little regard for patients’ health or medical history. The two owners of the clinic chain have now been sentenced to probation for selling misbranded drugs, and their business shuttered by Federal agents. On March 19, 2013 two men, Michael Schueter and Thomas…
4 Wales residents were sentenced in a counterfeit drugs case spanning Europe. The four accepted delivery of counterfeit & illicit drugs from Pakistan, which they then repackaged and shipped to online customers in the European Union.
On March 27, 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom announced the sentences of 4 defendants in a counterfeit drug operation spanning from Wales to Pakistan.
CanaRX on the Ray Richardson show on Mon 4/15/2013 @ 7am EST This coming Monday morning 4/15/2013 @ 7am EST the Ray Richardson show is going to talk about importing drugs and have, as a guest, CanaRX, the company that fills Mainers prescriptions by passing them along to unlicensed pharmacies in other countries to be…
Over the last year the FDA has sent our numerous warnings about the dietary supplement “Mojo Nights” for containing unacknowledged prescription medication. Now four people who marketed and sold Mojo Nights have been indicted for distribution of misbranded drugs.
The FDA first warned the public about the Mojo Nights dietary supplements in May 2012, advising consumers to “stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.”
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.
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.
United Parcel Service has agreed to pay a $40 million fine for their failure to stop fake online pharmacies from using their service. They have also agreed to implement safeguards in the shipping systems going forward to prevent drug counterfeiters from using UPS to ship their products.
On March 29, 2013, the US Department of Justice announced a non-prosecution agreement with United Parcel Service (UPS) in which UPS agrees to pay a fine of $40 million to the Federal government, and also implement compliance procedures to ensure they no longer ship illicit and counterfeit drugs for illegal online pharmacies, reports Fox Business.
According to the Department of Justice (DOJ), “UPS has cooperated fully with the investigation and has already taken steps to ensure that illegal Internet pharmacies can no longer use its services to ship drugs. These voluntary improvements will be strengthened by the compliance program UPS will implement as a condition of this NPA.”
Billing Insurance Companies for Imported Drugs is a Crime In November 2012, Tennessee oncologist William Kincaid pled guilty to purchasing cancer drugs from unauthorized distributors who were hawking counterfeit drugs with no active ingredient. Dr. Kincaid deprived his patients of needed cancer treatments and endangered their lives, but–as with Al Capone–the Federal government’s case against him…
Special agents with the US Immigration and Customs Enforcement Homeland Security Investigations (ICE-HIS) seized approximately $ 4 million worth of counterfeit goods and pharmaceuticals in South Carolina.
The seizure was the result of an investigation that began February 19th. Investigators from ICE-HSI, the South Carolina Secretary of State’s Office, Blazer Investigations and Pfizer found a stockpile of counterfeit goods in a warehouse in Columbia. The bulk of the seized counterfeit items were counterfeit pharmaceuticals, according to the ICE.
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.”
The Mexican Senate voted on March 12 to increase penalties to counterfeit drug sellers to nine years in prison and fines of up to 3 million pesos.
The Senate approved an amendment to article 464 of The General Health Law to increase penalties with 90 votes in favor. Senate Health Committee President Maki Esther Ortiz Dominguez said, “Anyone who sells or offers for sale, trades, distributes or transports medicine, drugs, raw materials that are falsified, altered, contaminated or adulterated, either in stores or in any other place….will be subject to the same penalty,” reported The News.
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.”
March
12, 2013 (Washington, D.C.) – The Partnership for Safe Medicines
(PSM), the leading advocacy organization dedicated to fighting the spread of
counterfeit drugs, applauds today’s
announcement of a bold new initiative between INTERPOL
and the pharmaceutical industry to combat the global health threat of
counterfeit and fake medicines.
This new initiative broadens the scope of the
successful Medical Product Counterfeiting and Pharmaceutical Crime Unit through
the creation of a Pharmaceutical Crime Program to assist and enhance worldwide
law enforcement efforts. Thomas Kubic, PSM Board Member and CEO of the
Pharmaceutical Security Institute, released the following statement hailing the
new agreement:
How Did That Canadian Web Pharmacy Medicine Get to Me?
So called “Canadian” online pharmacies pretend to sell non-Canadians price-controlled medications for citizens. Evidence collected by the U.S. Food and Drug Administration questions their claim.
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.
The National Association of Boards of Pharmacy (NABP) has released their 5th annual report on Internet Drug Outlets. Published each year, it is a progress report for state and federal regulators that illustrates the state of online drug sales in the United States and the overwhelming dominance of fake online pharmacies in the global Internet marketplace.
As of March 4, 2011, NABP surveyed 10,275 internet pharmacies and found that 9,938 or 97% were classified as “Not Recommended”, meaning they did not comply with NABP patient safety and pharmacy practice standards, or state and federal laws.
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.
Before buying the next miracle cure for weight loss, joint pain, or intestinal distress, ask yourself, is it heart-smart to take a dietary supplement you know nothing about?
Heart disease is the number one cause of death in the US for both men and women.
In the last few years, some truly unexpected drug compounds that cause heart ailments have turned up in herbal dietary supplements despite claims to be “safe and all natural.” To honor American Heart Month, take the pledge to guard your heart by being a smart shopper and only taking dietary supplements when you know the ingredients are safe.
Learn more about the top three herbal supplement ingredients that are neither natural nor herbal.
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.”
On February 15, 2013 at the India Habitat Centre in New Delhi, the Partnership for Safe Medicines India proposed an initiative “to study the extent of spurious and not-of-standard medicines in India and adopt policies to ensure safety and quality in the supply chain.”
An unprecedented pilot program supported by the PSM India will provide low-cost medicine evaluation for patients at accredited government approved laboratories. The goal of the pilot program is to “establish trust on the quality and existing regulatory standards between the manufacturers and the consumers,” said P. D. Sheth, VP, International Pharmaceutical Federation.
Breaking News: US Food and Drug Administration (FDA) has identified a third batch of counterfeit cancer medication in the United States. On February 5, 2013, the FDA posted a health practitioner warning about this latest counterfeit version of the cancer treatment Avastin.
According to the FDA “lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the United States contains no active ingredient.” The counterfeit drugs allegedly have been distributed by New York-based supplier, Medical Device King/Pharmalogical, reports the FDA warning. This is the first time a US drug supplier has been implicated in the distribution of counterfeit cancer drugs.
7,224 hospitalizations for laboratory-confirmed flu cases have occurred in the United States since October 1, 2012, according to the US Centers for Disease Control (CDC) Weekly Flu Update. Additionally, a January 25th CDC news release reports that influenza infection rates have been running at least 2 percentage points above epidemic classification for the past three weeks. While the CDC and other public health entities are encouraging consumers to be vaccinated, drug counterfeiters look at the US flu epidemic as a cash-making opportunity, warns the US Food and Drug Administration (FDA).
The FDA’s February 1 consumer update warns “As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.”
This is a reprint of an FDA Alert. Purchasing Unapproved Drugs is Risky Business [2/5/2013] The Food and Drug Administration is committed to protecting the supply chain against counterfeit and unapproved medicines that enter the United States through fraudulent sources. As part of this vigilance, FDA is alerting health care professionals that an unapproved cancer…
On February 12, 2012, the FDA sent out a public warning that counterfeit versions of the injectable cancer medication Avastin, had been found in the US drug supply chain. Since that time, a second warning was issued on counterfeits of the Turkish version of Avastin, Altuzan had also been found in the US, five US citizens, including three doctors have been prosecuted for selling or purchasing misbranded cancer medication, and an additional 134 doctors in 28 states have been sent FDA warning letters concerning their dealings with the foreign supplier that was the source of the counterfeit Avastin.
In the last 12 months, the US Food and Drug Administration (FDA) has issued warning letters to 134 US doctors informing them that they may have purchased counterfeit cancer medication. They were warned about purchases of unapproved medications, including unapproved versions of the injectable cancer treatment, Avastin, from wholesale drug distributors operated by foreign suppliers outside US jurisdiction. Each letter sent explained that the foreign drug wholesaler the doctors did business with were the source of the counterfeit Avastin that had infiltrated US drug supplies.
The first warning letters were sent out February 10, 2012 to 19 doctors. In April, two sets of letters, one dated the 5 and the second dated the 23rd, were sent to an additional 59 doctors. On June 28th, 55 more doctors received warnings, bringing to current total to 134 doctors in 28 states. California leads the pack where 57 California doctors were warned by the FDA about counterfeit cancer drug purchases.
The current warnings about counterfeit versions of Avastin or Altuzan were issued on June 28th, 2012. The FDA letter states “The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor named Clinical Care, Quality Specialty Products (QSP), Montana Healthcare Solutions, or Bridgewater Medical. Most, if not all, of the products sold and distributed by this distributor have not been approved by the FDA and may include counterfeit versions of Avastin or Altuzan.”
These most recent warnings were sent to doctors in Alaska, California, Colorado, Florida, Georgia, Illinois, Kentucky, Michigan, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and West Virginia.
A Puerto Rican man who acted as a distributor for a counterfeit drug criminal gang was sentenced in Federal court this month. Originally facing 10 years, he has been sentenced to 2 years in prison for his role in a massive counterfeit drug ring operating in the United States
Francis Ortiz Gonzalez was convicted of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals in August of 2012. According to the U.S. Immigration and Customs Enforcement (ICE) news release on the occasion of his sentencing, “federal agents executed a search warrant at Ortiz Gonzalez’s residence in Trujillo Alto, a suburb of San Juan, Puerto Rico. Inside the home, investigators found more than 100,000 pills that resembled a variety of popular prescription medications.” Ortiz Gonzalez shipped more than 140,000 counterfeit pills from China to individuals throughout the United States, found the investigators.
In an effort to stem the tide of fake drugs being produced in their country, China’s Food and Drug Administration (SFDA) offers a bounty of $50,000 US to those who report counterfeit drug production. This comes on the heels of recent success by the SFDA in shutting down counterfeit drug websites catering to Chinese-speakers.
China’s Food and Drug Administration has begun offering an increased bounty to anyone who reports counterfeit drug production to the agency. On January 17th the SFDA (on their English-language website site) stated “To encourage the public to report illegal activities so as to discover, control and eliminate potential safety risks concerning food and drug in time, and to crack down on illegal and criminal activities concerning food and drug, the State Food and Drug Administration (SFDA) and the Ministry of Financial of China recently jointly issued the Reward Measures for Reporting Illegal Activities Concerning Food and Drug.”
The US Food and Drug Administration (FDA) has issued warning letters to 20 US doctors that they have possibly purchased unapproved medications, including unapproved versions of the osteoporosis treatments Prolia and Aclasta, from drug wholesalers owned by suppliers operated by foreign entities outside US jurisdiction. The medical practices were warned that the wholesalers are selling drugs that not approved for sale in the United States and that they may be counterfeit.
The current warning about unapproved versions of the osteoporosis treatments Prolia and Aclasta were issued on September 10, 2012. The FDA letter states “The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor owned and operated by Canada Drugs, known as Montana Healthcare Solutions, Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Infusion Options, UK Pharmacy Services, or Clinical Care. Most, if not all, of the products sold and distributed by one of these distributors, including versions of Prolia and Aclasta, have not been approved by the FDA.”
Canadian online pharmacy pioneer, Andrew Strempler, was sentenced January 9th, 2013 to 4 years after he pleaded guilty to one charge of conspiracy to commit mail fraud. Initially, Strempler faced 4 charges relating to the case with each carrying a possible sentence of 20 years.
Strempler’s current legal woes stem from the FDA investigation of his Internet pharmacy business Mediplan Health Consulting Inc, also known as RX-North. According to the Wall Street Journal, FDA investigations of Strempler’s business discovered that 90% of the drugs they had seized from a Mediplan shipment were counterfeit. The shipment contained fake versions of Arimidex, a breast cancer treatment, and Lipitor, the cholesterol drug.
The FDA has issued warning letters to over 350 US medical practices that they may have purchased unapproved medications, including unapproved versions of Botox from wholesalers owned by foreign suppliers. The medical practices were warned that the suppliers sold drugs not approved for sale by the FDA that may be counterfeit.
In this latest incident of US doctors buying prescription medication for patients from questionable and unapproved sources, doctors in 38 states, and one hospital have received warnings that they have made purchases from an unapproved foreign supplier of medication.