Bloomberg Misses The Mark In Its Article About Drug Importation Advocacy

October 23, 2019 :

In case you missed it, Bloomberg’s Ben Elgin has published an “in-depth” piece on the connection between PhRMA and the Partnership for Safe Medicines. However, this has been public and widely reported on for years. More concerningly, the story misses the broader point about the clear safety concerns of foreign drug importation.

Over the past several months, we heard from PSM partners that had been contacted by Bloomberg for this story, and a disturbing pattern emerged of attempts to find partners, former employees and consultants to speak negatively about PSM. From what we heard, the reporter was particularly focused on funding and not interested in people’s concern about the safety of importation.

We provided the reporter a straightforward quote prior to publication. However, the quote was not included.

The piece claims that none of the existing policy proposals would allow unregulated drugs into the U.S. This is wrong and the reporter’s decision not to sufficiently report on the policy arguments is evident throughout the piece. Let’s look at the facts:

Licensed Canadian vendors have sold Americans counterfeit medicine

Case in point: A licensed wholesaler in Canada, the exact kind that Florida politicians pushing importation think would be safe, was caught sending counterfeit cancer drugs to American cancer clinics. By the time the FDA’s Office of Criminal Investigation wrapped up this wave of counterfeits being sold into America by these and other rogue wholesalers, hundreds of U.S. medical clinics had to be warned of the danger.

When writing about this issue, the outbreak of hundreds of cancer clinics warned by the FDA because they were doing business with dangerous suppliers selling fake cancer medication should be front and center.

This isn’t even a new problem. PSM has been warning of the dangers of Canadian importation since its founding in 2003. That same year convicted Canadian online pharmacy criminal Andrew Strempler was opening multiple shipping warehouse in Manitoba. Soon after that, the US FDA would intercept American-bound medicine shipments from Mediplan, Strempler’s company, and find that they contained counterfeit breast cancer treatment Arimidex.

Previous government attempts at importation have endangered patients

This isn’t even the first time importation programs have endangered patients. Illinois, Minnesota, and Maine have all experimented with importation over the last decade, and they’ve all had documented drug safety incidents. A story about the policy of Canadian drug importation should have mentioned these failed prior attempts at trying to make importation safe.

Law enforcement’s concern about counterfeits and importation is broad

Since the Bloomberg story focused on law enforcement’s concerns about counterfeits, it might have mentioned that PSM has documented counterfeit pills made with fentanyl in 49 states, a fact that PSM’s own research has covered. We’re not alone here. The Drug Enforcement Administration has been warning law enforcement and the public since 2016 of the dangers of deadly counterfeit pills. And FDA Director Carol Cave, in recent testimony to Congress, stated that for 99.1% of all drug products inspected at international mail facility for FY 2019 were non-compliant, since they were either counterfeit, substandard or otherwise not authorized by the FDA.

This is why law enforcement is so concerned about counterfeits and future policies, like Canadian importation, that could weaken the supply chain. They see the problem in their communities and they don’t want it to get any worse. We stand with the members of law enforcement who have to deal with the firsthand effects of counterfeits in their communities every day. We thank them for their vocal opposition to this dangerous policy and are proud to be their unwavering supporters.

Canadian importation breaks Track-and-Trace

In 2013, Congress passed the Drug Supply Chain Security Act, which mandated factory floor to pharmacy tracking and tracing of everyone who handles your medication. Experts broadly agree that there’s no way to implement Canadian drug importation without upending America’s Track and Trace system or violating U.S. law.

This was also missed.

Canadians, currently fraught with their own drug shortages, are terrified of US drug importation

From what we can tell, Bloomberg didn’t ask any Canadian patient advocates what they think about drug importation. They are dealing with massive and terrifying drug shortages today. With the U.S. being 900% bigger than the population of Canada, they are concerned that any efforts by the U.S. could drain the supply of medicine for their own people. Because they have no manufacturing capacity, there’s no easy way for them to replenish once they’ve lost their medicine to Americans.

However, the history of counterfeit medicines in the U.S. suggest that if you create a market demand for cheap Canadian medications, someone, usually with criminal intent, will sell them to you.

It’s not the critic who counts.

PSM has spent 16 years advocating for policies that secure the supply chain, and we are proud of our members and partners that see the danger counterfeits pose. Those members include everyone who touches medicine from the factory floor (manufacturers), to the wholesalers and distributors who form the backbone of the safe supply chain, to the pharmacists who dispense it and the patient advocates who receive it. Our members have always been listed on our website and our affiliations to them have never been a secret.

We respect good journalism (it’s needed now more than ever), but the thousands of concerned families and patients that we’ve met and worked with over the years deserve more from Bloomberg. When real people have already been harmed by imported counterfeits, it’s irresponsible to focus months of research on funding and process at the expense of public safety.

GL Holdings Issues Voluntary Worldwide Recall Of Green Lumber Products Due To Presence Of Undeclared Tadalafil

October 22, 2019

This is a reprint of an FDA Alert.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Company Announcement Date: October 22, 2019

FDA Publish Date: October 22, 2019

Product Type: Drugs

Reason for Announcement: Contains Tadalafil

Company Name: GL Holdings

Brand Name: Green Lumber

Product Description: Dietary supplements for male sexual enhancement

Company Contact Information

Consumers:

GL Holdings

(949) 426-8622

recall@greenlumber.com

Company Announcement

FOR IMMEDIATE RELEASE – Newport Beach, California. GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.

Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, GL Holdings has not received any reports of adverse events related to this recall.

GL Holdings is recalling the lot that tested positive for tadalafil and, out of an abundance of caution, GL Holdings is also recalling all previous lots, thus this recall encompasses all Green Lumber products sold on or before August 10, 2019. Tadalafil is an FDA approved drug for the treatment of erectile dysfunction. The presence of tadalafil in the Green Lumber products renders them unapproved drugs for which safety and efficacy have not been established, and therefor subject to recall.

The Green Lumber product is marketed as dietary supplements for male sexual enhancement and is packaged in 2-, 4-, and 10-capsule blister packs.

The Green Lumber lot that tested positive for tadalafil was sold between June 10 and August 10, 2019. Some of the blister packs are marked with “XC06 EXP 06/2022.” It is sold in a white wrapper with a green Green Lumber logo on the front and has one of the following UPC codes:

2 pack: X0020TSV4R

4 pack: X0020TRRHJ

10 Pack: X0020TUJLZ

Other lots that are being recalled were sold between April 1, 2018 and June 10, 2019 and may have a different UPC code on the package. Some of these blister packages are marked with one of the following “XC12EXP12/2020,” “XC06EXP06/2021,” “XC10EXP10/2021,” “XC02EXP02/2022,” or “XC04EXP04/2022.”

This product was distributed in the United States and Canada via internet sales.

GL Holdings is notifying its distributors and customers by email and is arranging for replacement of recalled products, at the request of the customer. Consumers with questions regarding this recall can contact GL Holdings via email at recall@greenlumber.com at any time or by phone at 949-426-8622 on Monday through Friday between the hours of 9 a.m. to 5 p.m. Pacific Time.

Consumers who purchased the product should stop consuming it and return any unused product to GL Holdings. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.