In late March, drug giant Bayer Pharmaceuticals, out of the goodness of its heart, agreed to donate three million tablets of chloroquine phosphate to help the Trump administration get this drug into U.S. pharmacies. That’s according to an investigative article in Vanity Fair by Katherine Eban, called:
How inflammatory?! For Trump lovers, that title has the ring of just more biased, liberal media Trump-bashing. For Trump haters, it’s another reason to hate Trump. This post isn’t about our constant partisan divide or even Bayer or other evil drug companies, although they are referenced. It’s also not about unproven treatments for Covid-19 (that was last week). All parties should be interested in the story behind the story: independent drug testing and its potential importance to determine if a drug is safe and effective.
I’m a big fan of testing prescription drugs to see if they have the right stuff (to put it eloquently). Here’s why: lots of pharma-funded groups and some people at the FDA say don’t buy medicine online from foreign countries because it’s allegedly unsafe. Yet, independent testing of about a thousand prescription drug orders has shown that personal drug importation can and is done very safely. Periodic testing of foreign online pharmacy medication orders over the last decade has proven the efficacy of brand name Celebrex, Lipitor, Nexium, Viagra and Zoloft; generic ciprofloxacin and atorvastatin; and, just last month, hydroxychloroquine and chloroquine phosphate.
If you choose to buy from PharmacyChecker-accredited sites (or other organizations and companies that properly credential online pharmacies), you will get the right drug, according to the aforementioned testing.
If you don’t, then you’re much more likely to get a counterfeit or otherwise substandard drug. Peer-reviewed journals are so convinced of this safety that they are not interested in similar studies.
Now, the lead scholar and policy wonk on the online pharmacy testing is Roger Bate, PhD, an economist affiliated with the American Enterprise Institute who specializes in drug quality and public health. I have never given a penny to AEI and, honestly, disagree with their policy positions on almost all issues. So, hey, it’s pretty convenient that I agree with Mr. Bate about his online pharmacy drug testing! But my belief extends to testing that has nothing to do with online pharmacies. We need to do more of it now.
The FDA has recently suspended its overseas inspections of drug establishments that manufacture products for the U.S. market. Albeit there are some new hellish supply chain issues due to the coronavirus, drug importation from those plants is still happening. Mr. Bate extols the FDA’s relative capacity to inspect drug manufacturing plants to help ensure they are operating in accordance with Good Manufacturing Practices, crediting the agency with finding problems at plants more than its foreign counterparts.
On the other hand, countries of the European Union rely more on quality testing of drug imports than on inspections – and it does a better job than the U.S. In view of the fact that the FDA can’t inspect overseas, Mr. Bate recommends independent testing – like they have in the European Union. You see, we have testing in the U.S., but it’s based on the honor system: trusting the drug companies to test their own products. Really – the honor system. Mr. Bate writes:
“In the EU, this certification has to be provided by a EU qualified person, meaning a EU citizen. But we don’t have that system here. Instead, we essentially use an honor system from the manufacturer. Many manufacturers have not always acted honorably, so the system doesn’t work too well. Today, the way it works for the most duplicitous firms is that even if they find that the product they are shipping fails microbial contamination testing for example, they just make up data on the CoA and ship it anyway.”
One of the reasons he knows all about this is from talking to celebrity whistleblower Dinesh Thakur and getting his advice. Mr. Thakur blew the whistle on criminal and dangerous acts by Indian drug company Ranbaxy. One such act was falsifying manufacturing and testing data. Essentially, the honor system doesn’t always work when it comes to be drug companies (who knew?). For more details on what Bate and Thakur are recommending: read this post. But the gist is really to create requirements for independent labs to test imported drug products at the batch level. I bet people think we do that already.
So, how does this relate to Trump-love for chloroquine phosphate, Bayer Pharmaceuticals and Pakistan?
Back in mid-March, before the publicity, Trump was bullish on chloroquine meds. The administration set about trying to increase our emergency supply, which led to an outreach from the lovable Bayer. Bayer said it would donate the drugs. That’s easy to corroborate because the drug company bragged about it in a press release:
“Bayer announced it is joining the U.S. Government’s fight against COVID-19 with a donation of 3 million tablets of the drug Resochin (chloroquine phosphate)… Bayer in recent days has been in talks with the White House, HHS, CDC, and the FDA, offering any assistance we can provide with a focus on donating Resochin to help in the government’s efforts to combat the virus.”
Gives you the warm fuzzies. [An aside: I still hope these anti-malaria drugs pan out for Covid-19, but it doesn’t look good from the recent data. The FDA is wisely cautioning people against trying to get this medicine for themselves without medical supervision.]
Bayer’s “pat-on-the back” press release did not mention where Resochin is made. It’s made in Pakistan. As readers of my epistolary and research efforts know, I can’t get enough of talking about how “American drugs” are anything but since most drugs sold in U.S. pharmacies are imported. But not Resochin: Bayer’s beautiful chloroquine pills have never been sold in the United States. Why not? Ms. Eban points out that “normally [its importation] would be prohibited since the FDA had never inspected the plant in Karachi, Pakistan, where Resochin is made.” As it happens, FDA inspections of foreign drug establishments are not required by the FDA as a basis for importing pharmaceuticals: we have an increasing number of mutual recognition agreements with countries through which we rely on their drug regulatory authority inspections. Pakistan is not one of those countries.
How can the FDA check safety where it can’t inspect or rely on the inspections of other regulatory authorities?
In the case of Bayer’s Resochin, Eban reports: “…the FDA set aside its usual safeguards and approved the donation, after sampling and testing the drugs to make sure they met U.S. standards.”
Roger Bate and Dinesh Thakur are recommending that we do more such testing for drug imports for sale in the commercial U.S. market since we are not doing inspections now. But as far as I see it, we should simply be doing more independent testing even in the absence of a global pandemic. Katherine Eban’s book Bottle of Lies: The Inside Story of the Generic Drug Boom was scathing in its criticism of FDA drug inspections – overly so in my opinion – but a great book nonetheless for exposing all that is wrong with the drug safety system. Mr. Bate’s appreciation for FDA inspections compared to other drug regulatory authorities is well placed, but the FDA has made many mistakes and even intentionally overlooked lapses in drug manufacturing. All the more reason to test, test, test.
To add irony in concluding this post: two fun facts.
- Federal law actually calls for more stringent testing of imported, lower-cost Canadian drugs, per the FDA’s proposed rule to implement Section 804. See Horvath Health Policy public comments on Section 804 importation. In other words, if the U.S. moves forward to permit wholesale drug importation from Canada, because of supplemental testing requirements, those imported cheaper drugs may have greater safety guarantees!
- Since the pandemic, the FDA has been seizing more medicines personally imported through international mail facilities by Americans trying to afford their meds. The FDA’s announcement about suspending inspections of foreign drug establishments does not mention more independent testing in the pipeline but references that sample testing can be a basis to refuse drug imports! FDA boss Stephen M. Hahn M.D. states:
“We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.”
Well, they have been good at seizing safe and effective drugs that “may violate other applicable legal requirements;” testing, not so much.Tagged with: Bayer, Donald Trump, Katherine Eban, Roger Bate