Trial by Data Podcast: The Truth Behind Generic Drugs
Featuring Katherine Eban, investigative journalist and best-selling author, and Dr. Sam Volchenboum
This week we welcome Katherine Eban to Trial by Data to discuss the need for global whistleblower protections, as well as why the industry needs to incentivize drug quality across both name brands and generics. During our time together, we also touch on how companies were able to jump the line for FDA review during the pandemic — and how we can stop such behavior in the future.
Katherine Eban is an investigative journalist and Vanity Fair contributor. Her articles on pharmaceutical counterfeiting, gun trafficking, and coercive interrogations by the CIA have won international attention and numerous awards. Her first book, Dangerous Doses: a True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply, was named one of the Best Books of 2005 by Kirkus Reviews and was a Barnes & Noble Discover Great New Writers pick. She lectures frequently on the topic of pharmaceutical integrity.
Her second book Bottle of Lies: The Inside Story of the Generic Drug Boom is a New York Times bestseller and a New York Times 100 Notable Books of 2019. Based on a decade of reporting, the book reveals endemic fraud and dire conditions in the overseas manufacturing plants where the majority of our low-cost generic medicine is made.
You can find her on Twitter here.
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Each episode, we pull out some of the key themes of the conversation for our listeners.
Here are the highlights from our conversation with Katherine:
Ideally, the FDA has just one front door. In an ideal world, every therapeutic and diagnostic test would go through this front door of the FDA and be evaluated in an orderly system of review. However, during the pandemic, we saw that companies that wanted their “miracle COVID tests” rapidly reviewed found the backdoors and metaphorically breached the windows of the FDA to jump the line. These companies were able to circumvent traditional channels by leveraging recommendations from congressmen, white house staffers, and even Mark Meadows. Looking ahead, the question is: How can the FDA insulate itself from political pressure like this in the future?
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Medical pressure, not political pressure, expedited the COVID vaccines. This distinction is important because political pressure can cut both ways — serving as either a positive or negative accelerant. One of the things we saw this year was Steven Hahn sharing a podium with Donald Trump to discuss product-specific announcements. This caused a lot of people to raise the question, is that appropriate? And how is this impacting the scientific procedure?
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Whistleblowers need global protection. In most countries around the world, there are no legal protections for whistleblowers, and this has serious implications for the US pharmaceutical industry. More than half of the manufacturing for the US drug supply is overseas, which means that whistleblowers who are witnessing fraud and other criminal activity in these unprotected countries find it extremely difficult to report their findings and observations safely.
Katherine notes that some say that the Ranbaxy fraud could not have happened in the US, because, in a way, fraud was Ranbaxy’s business model. Were a similar situation to happen in the US, there would be hundreds of whistleblowers running to the FDA because there are legal protections and financial rewards for whistleblowers in the US.
However, even with our culture of whistleblowing, it’s worth asking whether this is a system that is truly working. Even in the US, how many executives go to jail when there has been corruption or negligence? The resolution to these cases is a financial cost but people rarely spend time in jail. The risk-reward equation ends up skewing in favor of fraud. As an industry, we would need to seriously examine these systems of deterrents for these crimes.
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Company data does not cut it when it comes to verifying drug quality. Due to the pandemic, the US is no longer doing overseas inspections. Instead, we are now 100% reliant on company data from overseas factories for quality and safety checks. This means that our whole drug supply is built on an honor system — which is simply not good enough.
For example, there is no routine system for checking that drugs are what they say they are when they come into the US. The approvals are instead based on company data and inspections, which for overseas plants, are preannounced. As a result, we are left with this stage set of compliance, which does not reflect what is really going on in these manufacturing plants.
Referenced:
- These pills could kill you
- Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan
Generic drugs are not all created equal. Our entire drug supply is built around the false notion that there is no difference between a drug and its generics, so long as they are approved by the FDA. The assumption is that approval means they are wholly equivalent. However, as an FDA consultant put to Katherine, “Every cheddar-cheese buying consumer understands that there is a difference between Cheez Whiz, Kraft, and artisanal cheddar. Yet consumers who go to a drug store do not understand that there is a Cheez Whiz generic, a Kraft generic, and an artisanal cheddar brand. There are differences between generics.”
If this is the case, it’s up to patient advocacy groups to take on this issue. Additionally, we as an industry need to create incentives for drug quality. There needs to be market reward. However, this can’t be implemented unless you have a baseline understanding of whether drugs are producing good outcomes. So where is the Yelp of consumer ratings for generic drug brands? After all, low cost drugs are not a bargain if they don’t work.
During COVID especially, there is an ideological impact on the federal response. In the Trump administration, there was a deep belief that markets can solve all problems, which led away from a coordinated federal response. Instead, there was a belief that the federal government should let the states solve it and the markets sort it out. However, there are many reasons why, in a global pandemic, where everyone is vying for the same resources, ordinary market mechanisms fail us. We saw this failure with PPE supplies, and we’re now seeing it with the vaccine.
COVID itself as vaccine. There are two lines of thought regarding the pandemic.
The first is as Professor Scott Galloway noted — that COVID has been devastating, but it’s interesting to think about the pandemic as a forcing function for us to truly face the logistical issues, ethical issues, and issues of data standardization and drug approvals that the pandemic has brought up. Hopefully, all of these issues mean that the next time this comes around, we’re ready. We will have already built up organizational and civic immunity.
On the other hand, this pandemic has been preceded by an infinite number of tabletop exercises and war games. So many of the problems that we have faced or are now facing were anticipated problems.
The bottom line may be that in order for the tabletop exercises and prep to work, you have to believe in science. And more than that, you also have to believe in the government in order to launch a response that works.
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Trial by Data, presented by Litmus Health, is a podcast exploring the data-driven technologies and strategies shaping the future of clinical trials. We cover the most pressing issues and questions facing researchers and clinicians today, in an ever-changing landscape. Listen in as we interview leaders and innovators in the field who are at the forefront of developing and using these data-driven approaches.
