ABC 20/20 Factual Errors and Misrepresentations

This note is being shared with ABC’s 20/20 team, on behalf of the millions of Americans who purchase medications at government regulated prices from pharmacies around the world that those individuals could not afford to purchase here in the US.  A recently aired (and re-aired) ABC 20/20 show on counterfeit products presented a dizzying number of factual errors and misrepresentations to the viewing public, street peddlers and counterfeiter’s aside.  We hope in the interest of quality and factual reporting, a standard to which ABC prides itself, you will stop airing and/or correct the record regarding the factual errors broadcast in your show.

Errors and Misrepresentations

1.            Error: The program indicated that a medication ordered and shipped from Spain was expired upon arrival by mail in the US. 

Fact:  Dates in Europe, including Spain, begin with the day followed by month and end with the year.  (DD/MM/YYYY).  By contrast, in the US, dates are written with the month first, followed by the day, and ending with the year.  (MM/DD/YYYY).  The date you referenced as the expiration date was on a product made for sale in Europe, and thus the date was in the DD/MM/YYYY format.  Thus you misinterpreted and misrepresented the date as being in the past, when in fact the expiration date was months in the future!

2.            Error:  Inaccurate use of the word “counterfeit” with respect to medications regulated and manufactured for sale in countries outside the US. 

Fact:  When it comes to individuals manufacturing fake medicines with forged company logos and selling those products to the public, all would agree that is counterfeiting.  There is a big difference between a counterfeit medicine and one properly and legally labeled for sale by licensed pharmacies in a particular country.  If a Spanish citizen came to the US and purchased medicine from Walgreens, then took that medicine to a lab in Spain for testing.  Would or should the Spanish lab say that medication is counterfeit?  Even if they did, would that be accurate by US FDA and Walgreens perspective and standards?  The products ordered and received by 20/20 staff were all regulated products manufactured for sale in country.  The same products sold in pharmacies in those countries every day, to local residents.  To classify those as counterfeit is disingenuous certainly to your audience and very misleading.

3.            Error: You tested the generic for Propecia ordered and shipped from India and reported to have found impurities and unknown substances in the product (along with the correct active ingredient in the correct amount). 

Fact:  Unless the “impurities” and “unknown substances” came from another galaxy perhaps, they can’t be unknown.  If they did come from another galaxy, that would have been reported presumably since that would be high profile news; if found on Earth, they would easily be identified by the simplest of chemical analyzing equipment.  Perhaps they were simply not identified or not reported, but not unidentifiable. The FDA refers to ingredients other than the active ingredients in medicines as impurities.  Impurities include binders, fillers, color dyes, etc. widely used in manufacturer of medicines and recognized worldwide and by the US regulators as “Generally Regarded As Safe” (GRAS).  Your report failed to indicate whether the “impurities” or “unknown substances” were in fact GRAS ingredients often used in the manufacturer of medicines?  Did the labs that tested the products indicate they found anything that might reasonably be considered unfit for human consumption or unusual to find in a medicine?   If the labs stopped short of identifying all but the active ingredient, perhaps ABC should commission those labs to characterize the other ingredients for clarity.  If the labs did find harmful or unusual substances in any of the products received by ABC staff, THAT would certainly be news and a fact that the foreign regulators of those products need to know for the safety of citizens in their own countries.  No such claims were asserted by ABC, which leaves one to conclude that no such harmful or unsuitable products were found.  The opposite of the message ABC delivers in the 20/20 episode.

4.            Error:  The report stated that the generic for Propecia purchased from India failed a lab test.  

Fact:  It appears that ABC asked the lab to compare the generic form of Propecia to the original brand product.  If so, then the test would accurately show a difference, since inactive ingredients vary widely among generics, including generics sold in US pharmacies.  If you had tested the generic form of Propecia sold in US pharmacies, you would have obtained the same “failed” result and also found “impurities”.  In fact, the exact same generic ABC purchased from India is sold by the same manufacturer to US pharmacies.  Did ABC compare the US generic to the India generic from the same manufacturer to see if they match up?  If any generic sold in US pharmacies also “fails” the test conducted by ABC, what then does the test mean?  Should the FDA and public be concerned and warned?

5.            Error: Your report implied that US residents must purchase their medications from US pharmacies at high US prices, or break the law and risk their health. 

Fact: There is no prohibition against an individual traveling abroad, purchasing medications in a foreign country for their own personal use, and bringing those medications back home in their bag or suitcase.  Bus-loads of US residents living near the Canadian border have been visiting Canadian pharmacies for years and bringing their pills back over the boarder to the US without repercussion or legal concern.  Should it make a difference, realistically, if those same medications were shipped to the same individuals from the same pharmacy by mail?  What about individuals who don’t live on the Canadian border, or can’t afford to fly to a foreign country to purchase their drugs?  Why should they not be able to purchase the same medications and have them delivered to their home, for their own personal use, particularly if they can get them at much lower cost than in the US? 

6.            Error:  Your report indicated that the products orders and shipped from foreign pharmacies did not meet FDA standards.

Fact:  Simply having a label designed for a different country automatically means it does not meet FDA standards, regardless of the medication’s actual safety.  You may recall the CNBC program that aired last year on the same subject.  They too were told that the product they ordered from New Zealand did not meet FDA standards.  That product was then shown to Pfizer, the original brand manufacturer, and they too told CNBC that the product was not legitimate product.  On further investigation and pressing of Pfizer by CNBC, Pfizer admitted on camera that the product was in fact made by Pfizer in a Pfizer owned factory in Turkey.  Their own lab confirmed the product was theirs.  When asked why they had told CBNC that the product was not legitimate, Pfizer stated that is was not labeled for sale in the US.  When subsequently asked if they a different and inferior product in New Zealand compared to the US, Pfizer of course said “No”.  When the FDA says, it “does not meet their standards”, that does not mean the product is counterfeit, it just means the product is not labeled for sale in the US.  In reality the products are labeled and regulated for sale in country, which does not by default make them illegitimate, safe or fraudulent.

7.            Error:  Medications for sale in Canada are better and safer than medications for sale in England, or New Zealand, or India.

Fact:  The country of origin for each and every medication ordered by ABC, appeared to have been communicated to each ABC representative at the time the order was placed.  A combination of weak Canadian dollar and supply limitations in Canada caused by drug manufacturer threats against wholesalers selling products to international pharmacies, consumers have looked to pharmacies in other countries around the world for years.  Prices vary widely from country to country on individual products; therefore, consumers may purchase their needed medications from multiple countries.  India has achieved an eminent global position in pharma sector.  Indian pharmaceutical manufacturing facilities registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country outside the US.  According to the Wall Street Journal in May 2014, Indian drug makers accounted for 40 percent of U.S. generic drug imports, based on volume, and 39 percent of total generic drug approvals by the agency.

 

Entities like the storefronts profiled on the 20/20 program (often in conjunction with pharmacies in Canada), provide a consolidator role to simplify and quality control the shopping experience for their customers in person and in English.  A much better and safer experience for the consumer, than hoping for the best buying their medication through an unknown website owned by someone off-shore that the customer can’t meet, find, or speak with.   In contrast, these storefront owners are performing a much needed service out in the open with nothing to hide and helping their customers connect with vetted pharmacies overseas to safely obtain the medications they need at a price they can afford.

Recommendation:         

If ABC is truly interested in learning about and reporting factual information about the common practice of US resident purchases of medicines from licensed pharmacies in other countries, direct dialogue with professionals in the industry would be best.  The approach ABC took instead, did a disservice to ABC journalistically, to the public ABC is trying to inform, and to the local store operators assisting individuals locate and purchase medications safely from pharmacies around the world.  Learnings and information exchange suffered on all counts.

ABC might consider running a story on the history of inter-country barriers relating to prescription drug sales.  Prior to the formation of the EU, those same barriers existed.  Subsequent to the formation of the EU, those barriers were abolished.  Any pharmacy in the EU can purchase drugs from any wholesaler in Europe and sell those drugs to their local customers.  Pharmacies in Spain can sell drugs made and labeled for sale in Germany.  Pharmacies in England can sell drugs made and labeled for sale in Spain.  If the European’s can figure out how to safely manage imports and exports across border throughout Europe, why is this such a problem in the US?  Of course, drug manufacturers fought to prevent abolition of parallel import laws in Europe, and lost that fight.  Drug manufacturers continue the fight to retain parallel import laws in the US, because profits from US drug sales account for over 60% of world-wide profits for manufacturers.  The US is subsidizing the World when it comes to prescription drugs.  

ABC might want to profile Gilead’s new drug Harvoni for treatment of Hepatitis C.  A 12 week course of therapy in the US costs over $90,000.  The same course of therapy costs less than $1,000 in Egypt.  How can that be?  And how is that justifiable or sustainable for the American public and our healthcare system.  These are the truly news-worthy stories that need attention and focus.