Politifact ignores the world of criminal counterfeiters
We recently ran an ad in Florida about the dangers of attempting to import medicine from Canada, and the risk of getting medicine from other countries like China where much of the world’s counterfeits come from. The website Politifact.com emailed us with questions about our ad and labeled it negatively.
We noticed that they ignored certain facts that didn’t fit the conclusion they had already come to. In the interest of fairness, we’ve published below both the email from Politifact and our heavily sourced response. Judge for yourself if legislators in Florida are being naive about the risks of importation in a world with a highly evolved criminal counterfeit scheme.
Shabbir Imber Safdar
Executive Director, Partnership for Safe Medicines
PSM's April 2019 ad warns that there are serious safety problems with Florida's plan to import medicines from Canada.
On April 25, 2019, WESH 2 News political reporter Greg Fox looked at what healthcare experts say about this proposal and found our ad to be truthful.
Politifact's Email
XXX XXXXXXX <XXXXXXXX@poynter.org> Tue, Apr 23, 2019 at 1:46 PM
To: XXXXXXXX@safemedicines.org, editors@safemedicines.org
Hi XXXXXXXX:
For PolitiFact we are going to fact-check your TV ad.
"State senators are pushing a new government program that allows prescription drugs from China without FDA inspection. An FDA commissioner warned these drugs comes from "unreliable parties and counterfeiters." The WSJ calls it "unpractical, unsafe and unlikely to reduce prices." Too many have died from counterfeit drugs -- are you willing to take that risk?”
In which media markets has this TV ad been running and when did it start?
SB 1528 says it would establish a Canadian importation program -- it makes no mention of China. What evidence of you have that the program would allow drugs from China?
SB 1528 says that it would require “ The drug meets the United States Food and DrugAdministration’s standards related to safety, effectiveness misbranding, and adulteration;” and 3.Accept a current inspection report from the United States Food and Drug Administration conducted pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.
What evidence do you have that the program would allow the drugs from China (or anywhere?) without an FDA inspection?
Please send me the full back up for the claims in the ad including the WSJ editorial and the comments by the FDA commissioner by noon Wednesday EST.
Thanks - XXX
Our Answers
Question: Where did the ads run?
Our response:
We published this in a press release when the first set of ads were released:
"The campaign will include a broadcast and cable television campaign in key markets including Miami, Ft. Lauderdale, Tampa, Orlando, Jacksonville, Ft. Myers, and Tallahassee, as well as print and digital ads in the state." [source]
Question: How do you know these drugs won’t come from Canada? What evidence do you have that the program would allow the drugs from China (or anywhere?) without an FDA inspection?
You wrote:
SB 1528 says it would establish a Canadian importation program -- it makes no mention of China. What evidence of you have that the program would allow drugs from China?
SB 1528 says that it would require “The drug meets the United States Food and Drug Administration’s standards related to safety, effectiveness misbranding, and adulteration;” and 3. Accept a current inspection report from the United States Food and Drug Administration conducted pursuant to the federal Drug Quality and Security Act, Pub. L. No. 113-54.
Our response:
The last twenty years of the story of counterfeit medicines in America is a story of people getting fooled into thinking they were getting Canadian medications but instead were getting subtherapeutic and outright placebos from countries all over the world including China.
China is a source of counterfeit medicine and the current fentanyl fake pill crisis
Today’s fentanyl crisis has been caused by counterfeit medicines made with fentanyl, as well as raw fentanyl coming from China. PSM has documented the presence of counterfeits made with fentanyl in 46 American states previously. This issue has been well covered in the media but here are three incidents of Chinese counterfeit medicine entering America:
- Three Texans smuggled at least 43 shipments (106,000 pills) from China to Texas, including Xanax, Valium, sibutramine, Cialis, Viagra. and Stilnox (marketed in the United States as Ambien). None of the pills that were seized and tested were legitimate. Some were sub-potent, but most contained entirely different active ingredients from their legitimate, approved versions. Read more about the sentencing of one of the ring.
- The Department of Justice has indicted two Chinese citizens with operating a conspiracy that manufactured and shipped deadly fentanyl analogues and 250 other drugs to at least 25 countries and 37 states. These allegedly included counterfeit Adderal adulterated with "bath salts." The indictment also charges that the organization had agreed to make counterfeit cancer medication, replacing the active cancer-fighting ingredient with dangerous synthetic drugs. Read about their indictment here.
- Chinese drug counterfeiter Kevin Xu received more than $1.5 million in just 2007 when he sold fake versions of drugs such as Plavix, Zyprexa, Casodex,Tamiflu and Aricept to people all over the world, including in the U.S. He was caught by a multi-agency undercover investigation during which he offered to supply agents with 25 different medicines. He also managed to infiltrate the legitimate UK drug supply, causing a massive drug recall. Read about his eventual arrest and sentence after he was lured to America.
Even more cases are found in the attached spreadsheet. The Florida legislation would make the problem so much worse by creating a legal pathway for these counterfeits and the illusion of safety.
Regulators, healthcare professionals, and officials on both sides of the border have warned of this danger
Many regulators, from FDA Commissioner Scott Gottlieb to Canadian regulators themselves (see attached NAPRA letter), have said that buying from entities claiming to be Canadian is risky because there’s no guarantee you will get a Canadian medical product. Four other previous commissioners have cited the dangers of these importation programs as well.
Furthermore boards of pharmacy from across Canada as well as the United States oppose importation because of the danger of not getting Canadian medication. Patient groups in America and Canada oppose importation. Pharmacists in both America and Canada oppose importation. Medicine wholesalers in both America and Canada oppose importation. https://www.safemedicines.org/opposing-drug-importation-2000
They’ve all warned that Canadian drug importation risks getting counterfeit, non-Canadian product just as we’ve identified in our ad.
Canada is not a willing partner in this endeavor either. With 37 million residents and over 1,700 medicines currently in shortage, they are not on board with being the drugstore to America’s 300+ million citizens. James Moore, former Canadian Minister of Industry, just made this clear with regards to Florida’s proposal:
17 states now have drug import proposals. This is a policy non-starter. 1) Canada will not ship medicines out that are intended for Canadians. Canadians come first. 2) Canada & the US don’t have a customs union, so any deficiencies on transshipments...won’t be caught. And with millions/billions of possible dosages/transactions, this would greatly endanger the trusted Canada-US trading relationship. This policy won’t work. https://twitter.com/jamesmoore_org/status/1119673019301941248?s=12
When drug importation was tried before in other states, Americans got medicine not from Canada
When Minnesota tried drug importation over a decade ago, this is one of the safety issues among many that the FDA cited in a warning letter the US Food and Drug Administration sent Gov. Pawlenty:
Many drugs obtained through at least one of the pharmacies were apparently not even of Canadian origin, and many of the drugs were obtained from a difficult-to-follow path of writing and rewriting prescriptions across multiple Canadian provinces.
More recently Maine tried drug importation in 2013. Within a few months of the program turning on, one vendor immediately started violating the law. Canada Drug Center put full page ads in Maine papers advertising the “Canadian” medicines they sold. But the medicines weren’t from Canada, as Professor Kenneth McCall found out. He ordered three medications, including a blood thinner, and received medicines manufactured in India and shipped directly from Turkey, India and Mauritius. Two of them tested as significantly sub-potent, and the third had a notable impurity. https://www.safemedicines.org/2015/11/maine-importation-2013-2014.html
Fraud is business as usual for online Canadian retail and wholesale pharmacy vendors selling to Americans
Criminal entities in Canada have a long history of selling fake Canadian medicine to Americans, sometimes even with a Canadian pharmacy retail or wholesale license.
- Andrew Strempler RXNorth / Mediplan
Andrew Strempler’s RXNorth business possessed a Manitoba pharmacy license and sold medicine to Americans and claimed they were Canadian. But they were sourced from other countries besides Canada and contained insufficient active ingredient. Strempler eventually fled to central and south America to avoid US prosecution. https://www.cbc.ca/news/canada/manitoba/internet-pharmacy-pioneer-loses-licence-1.869449 - Operation Bait and Switch
Under FDA Commissioner Andrew von Eschenbach in 2005, Operation Bait and Switch found an enormous quantity of medical products being sold as Canadian were originating in other countries. Lab testing also showed 32 different counterfeit medical products as well.An FDA operation found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit. - Quantum Solutions
In 2017, Canadianpharmacymeds.com, a company in Canada and their parent Quantum Solutions, operated a pharmacy licensed by the board of pharmacists of Manitoba. They were caught sourcing medication from lots of places besides Canada and selling it to American patients and doctors. Again, Americans were put at risk because they didn’t get the medicine they thought they were getting, and of unknown purity. They ended up getting probation and a fine because it’s so difficult to extradite Canadians for giving Americans counterfeit medications. https://www.legitscript.com/blog/2018/08/operators-of-so-called-candian-pharmacy-sentenced/ - Canada Drugs Wholesale
And of course CanadaDrugs Wholesale was indicted in 2014 for their role in trafficking counterfeit cancer medication to physicians into America. They had a wholesale license in Canada in Manitoba, and kept that license even after they were indicted for these crimes in 2014. There is no way to know today how many American patients died as a result of the counterfeit medicine they received during the fake Avastin scandal. https://www.safemedicines.org/policymakers-media/canada-drugs-case
With all of this as the history of crime associated with the danger of Canadian pharmacies, you would have to be truly naive to think that importing drugs from Canada would actually bring you any volume of Canadian medicine. There’s twenty years of criminals and scores of warnings from regulators that this is not a safe idea.
Ad Sourcing
Below is our sourcing for every sampled video or image we've used in our ad.
Ad Content
Source
"State Senators are pushing a new government program that allows prescription drugs from China without FDA inspection."
“The Senate Appropriations Health and Human Services panel approved the measure Tuesday. The House has scheduled floor consideration Wednesday on its version, which would expand the countries from which drugs can be imported beyond Canada.”
"An FDA Commissioner warned these drugs come from quote 'unreliable parties and counterfeiters.'"
“We've seen too many cases where intermediaries purporting to import Canadian drugs really source drugs from unreliable parties and counterfeiters.” -Scott Gottlieb, 23rd Commissioner of the Food and Drug Administration https://twitter.com/ScottGottliebMD/status/1117113434397650944
"The Wall Street Journal calls it 'impractical, unsafe and unlikely to reduce prices.'"
“The latest example is a GOP plan in Florida to import prescription drugs from Canada, which is impractical, unsafe and unlikely to reduce prices at the pharmacy.”
https://www.wsj.com/articles/importing-bad-ideas-on-drug-prices-11555369066
"Too many have already died from counterfeit drugs. Are you willing to take that risk?"
“We are currently facing a global counterfeit drug epidemic and it’s already affecting too many Americans. In more than 40 states, law enforcement officials have identified counterfeit pills containing highly lethal fentanyl, a few grams of which can kill someone instantly. In fact, in 29 of those states, there have been fentanyl-related deaths from counterfeit pills.”
"Tell your State Senator. Vote NO on SB 1528."
