Something unexpected happened at a dog and pony show staged at the National Press Club on April 4, where the Partnership for Safe Medicines (PSM) gave its campaign against prescription drug importation and international online pharmacies the imprimatur of technocratic expertise. Former FDA Commissioner Dr. Andrew Von Eschenbach, in opposing importation as unsafe, and “frightening” said that 29 countries have regulatory systems for drug safety comparable to the U.S. Was that a mistake? No. We need to get that list of 29 countries and create standards for distribution and refine guidance for consumers to help more Americans import lower cost medications from those countries.
I derived the number 29 because Dr. Eschenbach said: “of the 96 countries around the world that can supply drugs only 30% have a functional regulatory infrastructure that’s comparable to the one that we have at the Food and Drug Administration.” Simple math showed 30% of 96 is 28.8. I rounded to 29!
Granted, Dr. Eschenbach would say that I was taking his words out of context. (more…)
This week, LegitScipt’s John Horton blogged with apparent glee about charges by the U.S Attorney’s Office for Western Pennsylvania implicating several Canadian individuals and their company, Quantum Solutions, for allegedly exporting wholesale quantities of medications manufactured for foreign markets to U.S. pharmacists between 2007 and 2011.
Horton makes the mistake of saying that the case involved charges against an internet pharmacy certified by PharmacyChecker, but this is not the case. No online pharmacy is charged in the case, let alone any online pharmacy verified by PharmacyChecker.
Horton also states that the case involved the shipment of “bad” medicine, but there is nothing in the court documents indicating a problem with the quality of any of medications. Their labeling was apparently for the countries where they were being sold, which makes them “misbranded” if sold in the U.S. but not “bad” medicine. The drugs involved were expensive brand name drugs like Abilify, Zyprexa, and Plavix, costing hundreds of dollars per month in the U.S. but normally 80-90% lower in price outside the U.S. — which is likely what motivated the U.S. pharmacists to allegedly purchase the medication from abroad.
John Horton’s blog shows that in the world of online pharmacies, one party you can’t trust for reliable information is John Horton.
A very strange thing about the government’s filing in this case is an attachment listing website domains, a few of which are for international online pharmacies verified in our program. There is no claim of wrongdoing by any of these sites. The filing explains that these website addresses are property which the U.S. government seeks to have forfeited by the defendants in the event of a conviction, as the addresses may have been purchased with proceeds of the alleged offense. Certainly there are other assets owned by the defendants that our government could seek, so why focus on these uninvolved websites? It would seem that if these websites were taken by the government, the public would lose access to several safe, low-cost pharmacies.
Not surprisingly, John Horton misrepresents at least one of these pharmacies as being “the subject of today’s criminal charges” (more lies). Horton goes further by posting this list of websites to his blog in what we see as an attempt to smear the reputations of these uninvolved sites and part of his ongoing tactics to scare Americans away from safe and affordable medication and keep us hostage to inflated drug prices at home.
The executive director of Prescription Justice, Jodi Dart, published an op-ed in Morning Consult earlier this week called The Rx Rip-Off. The piece does contain Ms. Dart’s opinions but there are also some facts reported, ones based on a Zogby poll on drug prices commissioned by Prescription Justice. The poll shows that 90% of Americans are united on the need for the government to take action to make medication more affordable! As an incredible coincidence, President Trump tweeted just hours after the op-ed was published that “Pricing for the American people will come way down!”
There’s a lot in this poll that I look forward to writing about but let’s consider some of the broad findings of the poll:
75.5% of Americans agree with President Trump that the “drug companies are getting away with murder:
29.6% of Americans say they have not filled a prescription because of cost.
4.2% say they currently get prescription medication from a Canadian or other international online pharmacy.
77% of respondents who had an opinion on the issue of importation laws (522 out of 674) supported reforms so that consumers could lawfully purchase medicines from Canada or other countries.
Only 15% of respondents were actually against legalizing personal drug importation (23% of those who had an opinion).
Yesterday, a bill was introduced in the U.S. Senate called the Affordable and Safe Prescription Drug Importation Act, which, if passed, would legalize the importation of lower cost medications from Canada, by wholesalers for re-sale and individuals for personal use. I support this bill as a great step in the right direction to reign in drug prices. The bill’s sponsors, Senators Bernie Sanders (I-VT), Cory Booker (D-NJ), and Bob Casey (D-PA) are to be commended. Congressmen Elijah E. Cummings (D-MD) and Lloyd Doggett (D-TX) introduced a companion bill in the House. You can watch the press conference announcing the new importation legislation above.
If passed, the new bill directs the FDA to finally help Americans do what they do already, but they would have new FDA assurances, which is purchase lower cost medication from safe international online pharmacies. It also would allow wholesalers in the U.S. to buy medications at lower cost from FDA-registered Canadian wholesalers, so that U.S. retail pharmacies can charge lower prices, too, which will mean fewer international, online retail sales.
For the last 15 years, we’ve been verifying international online pharmacies, ones that extend beyond Canada, and comparing their prices. Empirical and peer-reviewed literature studying online pharmacies demonstrates the significant savings consumers find through safe importation. We know for a fact this works. (more…)
Since Americans started importing medications for personal use in larger numbers at the beginning of the last decade, the Pharmaceutical Researchers and Manufacturers of America (PhRMA), Big Pharma, has engaged in media and government relations scare tactics to try and stop them. Apparently, when it comes to foreign versions of the new FDA-Approved Emflaza, which treats Duchenne Muscular Dystrophy, one board member of PhRMA supports importation!
Last week, I wrote about the decision of drug company Marathon Pharmaceuticals to postpone selling Emflaza over pricing concerns and how the issue shines a bright light on the benefits of personal drug importation. To summarize: some folks are outraged because Emflaza (deflazacort) was launched at a price of $89,000 for a one year supply. This seems insane when foreign versions of deflazacort, which cost 1% that amount (less than $1000), are already imported for personal use.
PhRMA is trying to distance itself from Marathon, just like it did with Martin Shkreli, former CEO of Turning Pharmaceuticals, when the price of Daraprim jumped from $13.50 to $750 a pill overnight. The CEO of Marathon, Jeff Aronin, however, sits on PhRMA’s Board of Directors! Last week, John Carroll of Endpoints News predicted last week that Aronin might be dropped. As of today, he’s still there.
Mr. Aronin wrote a letter to the Duchenne community that fully acknowledged American kids were already being treated with an unapproved foreign version of deflazacort. In his words: “As we all know, deflazacort was being used without FDA approval — and without ever having been approved anywhere in the world for Duchenne — by a very small group of patients (roughly 7 to 9 percent) in the Duchenne community who imported it from overseas.”
But does he support it? I mean, after all, the “score” for Marathon is that once it’s available for sale in the U.S., it will be purchased here. At least for the time being, this PhRMA board member does support it and seems to have no concern whatsoever whether the foreign version is safe and effective, not should he, since, like other medications, it was approved for safety and efficacy elsewhere. In noting that Marathon will “pause our commercialization” of Emflaza,” maintain its Expanded Access Patient Assistance Program, Aronin also state: “Patients currently receiving deflazacort from other sources may continue to have that option.” Damn right.
Is it hypocritical of PhRMA to diss Marathon? After all, brand drug companies jacked prices 130 times the inflation rate in 2015. Forty-five million Americans didn’t fill a prescription in 2016 due to cost. PhRMA will continue its practice of legal bribery and unleash a new, shiny PR campaign about life sciences and innovation — to prevent legislative and regulatory reforms that would lower drug prices. It’s going to take an unpredictable, unexpected populist wave of American anger at drug companies to bring their house down. In the meantime, maybe the people will take a hint from one PhRMA board member and import unapproved and lower cost medications.
Personal drug importation works! This week, drug company Marathon announced it is postponing the launch of Emflaza, its recently FDA-approved version of an off-patent drug called deflazacort, in the face of heavy scrutiny by Senator Bernie Sanders and Congressman Elijah Cummings over its price tag – $89,000 a year. This drug, which treats Duchenne Muscular Dystrophy (DMD), is available under the brand name Calcort in the United Kingdom at about 99% less (about $750) than the current U.S. “postponed” price. Generic versions of deflazacort are also available internationally among verified online pharmacies at an annual price tag of about $650.
For some background on the disease and treatment: DMD is a “genetic disorder characterized by progressive muscle degeneration and weakness.” It mostly afflicts boys, with onset ranging from ages 3-5. It’s caused by the absence of a protein called dystrophin. For more, see the Muscular Dystrophy Association’s (MDA) website. According to the MDA, corticosteroids, including deflazacort, help slow the disease’s progression.
For a critique of the Emflaza price read Sanders and Cummings’ letter. No one could do better than that. Marathon CEO Jeff Aronin attempts to rationalize the price here but it almost reads like an apology. They argue that no consumer will deal with the $89,000 price tag because health insurers only charge a $20 co-pay and they have patient assistance programs to help the uninsured. It’s never that perfect, at all: people always slip through the cracks and we’re not forcing people to go without needed medication or go into bankruptcy to get it. Right?
So now a fist full of truth about this medication and safe online access to affordable medicines to shine a bright light on the lifeline that is personal drug importation… (more…)