The Philip DeFranco Show - MS 5.25 How This Big Pharma Company Conned Doctors and Addicts, and Made MILLIONS

Starting point is 00:00:00 Sup, you beautiful bastards. Hope you have a fantastic weekend. Welcome to another Weekend Deep Dive. My name is Philip DeFranco, and today we're gonna be talking about the opioid epidemic. Now, over the last few months, we've covered several disturbing stories on the main show concerning the role of pharmaceutical companies

Starting point is 00:00:13 in creating this crisis. And while the word crisis, yes, is thrown around a lot in the media, there is really no other way to describe just how bad this problem has become. A new CDC report has some staggering statistics about drug overdoses. 72,000 people died last year, just last year.

Starting point is 00:00:29 And that is a 10% increase in overdose deaths over the year before. New CDC research shows fentanyl is now the most common drug involved in drug overdose deaths in the United States. The National Safety Council puts the odds of dying from an opioid overdose in America at 1 in 96. That's a higher chance than dying in a car accident. And while provisional data from the CDC shows that overdose deaths have finally stopped rising

Starting point is 00:00:52 and may in fact be leveling off, we are still looking at more than 67,000 deaths between September 2017 and September 2018, with the vast majority of those deaths as a result of opioid use. And while pharmaceutical companies like Purdue, McKesson and Insys have received the majority of the attention for flooding communities with opioids like Oxycontin and Fentanyl, there's actually another company that has largely fallen below the radar. And it's a company that was supposed to help solve

Starting point is 00:01:14 the opioid epidemic. And so to go down this rabbit hole, we had Rogue Rocket's Cody Snell jump into it. The origins of the opioid crisis have been well documented by media outlets across the country. Two million Americans are hooked on prescription painkillers. And in 2012, 259 million prescriptions were written. That's one bottle for every American adult. Williamson, West Virginia. Population 3,200. But investigators say in little more than a decade, more than 20

Starting point is 00:01:46 million prescription pills were sold here, an average of 6,500 per person. We have to know the truth. Why did these companies act in this way? What did they know? Who are the decision makers? Why did they decide to flood this country with millions and millions of pain pills? That's a question that's still being answered as state lawsuits against pharmaceutical companies continue to pile up. But only in recent weeks have we seen a spotlight put on a company that is claimed to be the world leader in addiction treatment. Indivior is not a household name when it comes to some of the biggest pharma giants. The company used to be part of Reckitt Benckiser, a massive multinational consumer goods company that sells everything from Lysol to Durex condoms.

Starting point is 00:02:30 But in 2014, Indivior spun off into its own separate corporation and has been raking in the profits ever since, earning more than $1 billion in net revenue last year, with the vast majority of that money coming from just one product, Suboxone. It's a medication you may have heard of if you've ever seen a commercial for a drug treatment center. Medication-assisted treatment is the proven most effective for opiate addiction recovery,

Starting point is 00:02:54 utilizing medications such as methadone, suboxone, and subutex. Suboxone has been around in the US for more than 15 years after being approved by the FDA in 2002 as a treatment for opioid addiction. It contains two active ingredients, buprenorphine and naloxone. Buprenorphine is an opioid itself, but gives off a much weaker euphoric effect compared to stronger drugs like oxycodone and heroin,

Starting point is 00:03:17 essentially satisfying the patient's physical need for opioids without providing the same intense high. Studies have shown that buprenorphine in particular can be extremely effective at weaning opioid addicts off stronger drugs. At the same time, naloxone is supposed to provide an additional safety measure. If a patient tries to abuse the buprenorphine by snorting or injecting it to get high faster, naloxone causes them to experience withdrawal effects. Dr. Richard Blondell, the vice chair for addiction medicine at the University at Buffalo, told us that while Suboxone still has the potential for abuse, it's a realistic solution for

Starting point is 00:03:50 addiction. You're substituting one drug for another. That's how this works. People can take a stable dose of buprenorphine or methadone, have their mood improve, have their personality revert back to what it was, it might become employed, they might go back to school, they might take care of their family, they might be a good parent, they might be a good spouse, they might be a productive citizen, all while taking methadone or Suboxone. Nonprofits like the Partnership for Drug-Free Kids even feature countless testimony from recovering opioid addicts

Starting point is 00:04:24 highlighting the difference that Suboxone has made in their lives. Sometimes when I wake up in the morning, I have the, I wouldn't say withdrawal, but I would say uneasy feelings. But after I take the Suboxone, it really normalizes me, makes it so that I can just do everything that I need to do in the day. One study done in Sweden found that over the course of a year, 75% of patients given buprenorphine remain clean from other drugs, compared to 0% who are given a placebo medication. But while Suboxone has been lauded by many as an effective treatment, Indivior's method of marketing this medication has not, largely because of a

Starting point is 00:05:02 tactic known as product hopping. Ed Silverman, a senior writer for Stat News, a medical and health news website, explained exactly what this tactic entails. A drug is about to lose patent protection and therefore the ability to forestall competition. And so what a company might do is come up with a slightly different version or some different version of that existing product. Get the patent on that new product and look to market that. And to fully understand how Suboxone was product hopped, we have to go all the way back to 2006. In December of that year, Indivior began developing a new form of its Suboxone pill called Suboxone Film. Suboxone Film is a strip that dissolves when you put it under your tongue, similar to a Listerine breath

Starting point is 00:05:49 strip. There was nothing particularly wrong with Suboxone in its tablet form. It was selling well and seen by many as a major breakthrough in addiction treatment. But in less than three years, the patent on Suboxone pills was set to expire, opening it up to generic competition. So executives knew they had to make sure that doctors and patients would abandon the pill and embrace the new patent-protected film. So it was time to get creative. On June 9th, 2009, Indivior's medical director

Starting point is 00:06:16 allegedly told his staff, "'We need to develop a story about childhood exposures "'to set the stage for switching patients to Suboxone film.'" So that's exactly what the company did. In October 2009, Indivior wrote to the FDA asking if the agency agreed that a child would be less likely to accidentally ingest the film than the tablet because it contained more secure packaging.

Starting point is 00:06:36 The FDA responded saying, "'No, we do not agree that the packaging for Suboxone film "'provides meaningful incremental protection "'against pediatric exposure. Because the film cannot be spit out, unlike a tablet, it is possible that a child who obtains access to even one dose might be more adversely affected than a child who obtains access to a single tablet. But that response fell on deaf ears.

Starting point is 00:06:58 Indivior went full speed ahead, launching an all-out marketing blitz once the film version was approved by the FDA. Even though the Suboxone tablets were still on the market, Indivior only wanted to push the film, with its sales and marketing team telling physicians things like, Suboxone film offers increased protection against misuse slash abuse and pediatric exposure.

Starting point is 00:07:17 It would be unethical or inappropriate for us to promote the tablet now that we have a better, safer product. Suboxone film is preventing pediatric death in graphic terms. Dr. Jeffrey Junig, a psychiatrist who runs his own clinic in Wisconsin and prescribes Suboxone to his patients, told us he was suspicious about the claims he was hearing

Starting point is 00:07:35 from Indivior sales representatives about the packaging of the tablets. It just seemed just ironic that right at the time their patent is running out, they make the claim that the drug that they've been selling for the last seven years is unsafe. And in 2012, just as the FDA was set to approve generic Suboxone tablets, Indivior went even further in attacking its own product, declaring that it would be withdrawing its Suboxone tablets from the U.S. market,

Starting point is 00:08:02 and releasing what's called a citizen's petition to the FDA. In the petition, Indivior claimed that based on a study it had funded, it found that the risk of unintentional pediatric exposure to tablets is eight and a half times greater than for film. But a closer look at the company's own data showed that compared to widely sold pills like Tylenol, pediatric exposure was minuscule. Christopher Moraf, a freelance journalist who writes about the pharmaceutical industry, explained just how small of a threat Suboxone pills were for children. Like any medication, it's pretty easy for a child to get a hold of anything. We have more fatalities in this country, I think, from acetaminophen than certainly I would think from Suboxone.

Starting point is 00:08:48 In fact, for every million tablets of Suboxone dispensed, just six children had accidentally ingested it, compared to roughly 4,100 accidental ingestions per million tablets of acetaminophen or Tylenol. The company also had no problem continuing to sell Suboxone tablets in Europe, where they were still protected by a patent. And if its motives for pulling the pill were still in question, one key sentence in its petition said it all. FDA may not approve a generic drug if the reference-listed drug has been voluntarily withdrawn from sale and the agency has not determined whether the withdrawal is for safety or effectiveness reasons. Essentially warning the FDA that it could not approve generic Suboxone tablets for at least a year. Silverman explained the impact of preventing a generic drug from reaching the market.

Starting point is 00:09:32 89% of prescriptions written in the United States are for generic drugs as opposed to the brand name drugs. They're a better deal. And so if that generic drug that could save you money is delayed from getting to the market by the company manufacturing the brand name drug, well, that's a loss of savings to both the individual patient, their health plan, and the entire US healthcare system on a cumulative basis. Dr. Junig told us that the attack on generics was particularly devastating for the opioid addict population, as Suboxone could cost up to $600 a month before generics were released. This is a patient population that's often unemployed or underemployed.

Starting point is 00:10:20 Often before they seek treatment, they've hit a rock bottom of sorts. They've used up all their spending. You know, they're impoverished. And so when the prices are that high, the only patients that really have a chance at treatment are the ones who are lucky enough to still be covered by an insurance plan, a pharmacy plan. The scheme to stop Generics from making it to the market was only the tip of the iceberg. The company also set up a telephone and internet hotline called Here to Help.

Starting point is 00:10:50 It guided patients to doctors prescribing Suboxone and other opioid addiction treatment medications. Silverman told us why this hotline is now receiving scrutiny. They used a telephone and internet program to connect patients who are struggling with addiction to doctors who as it turns out were inappropriately prescribing opioids and related medicines and at particularly high rates. In order to prevent clinicians from over-prescribing opioids,

Starting point is 00:11:19 federal law only allows doctors to treat a certain number of patients at any given time with buprenorphine and other opioid medications. But Indivior was allegedly including law-breaking doctors in the Here to Help program. One of the doctors involved with Here to Help was even prescribing opioid medication to more than 800 patients, eight times the legal limit at the time.

Starting point is 00:11:39 The doctor was also suspected of allowing Suboxone to be trafficked by their patients in the parking lot of their practice. Despite Indivior was also suspected of allowing Suboxone to be trafficked by their patients in the parking lot of their practice. Despite Indivior's alleged efforts, generic Suboxone tablets started being sold in 2013, and generic Suboxone film just started being sold this year. But that hasn't stopped the Department of Justice from bringing a federal indictment against the company. The company is now facing multiple counts of wire, mail, and healthcare fraud, the forfeiture

Starting point is 00:12:02 of $3 billion in cash, and the loss of all its business divisions, bank accounts, and patents. Indivior has responded, saying in a statement that the charges are almost exclusively based on years-old events from before Indivior became an independent company in 2014. And they are wrong. Dr. Junig says he understands that these companies need to make money, but that this case went beyond normal business practices. You know, a certain percent of the money that pharmaceutical companies has, has to go to research and development and some has to go to marketing.

Starting point is 00:12:34 But you know, they're given seven years of the absence of competition. And when you look at the stock price of Reckitt Benkiser, which eventually spun off in Divior, Suboxone was a very profitable drug for them. And at some point, you know, the question becomes, how much profit is necessary? It's a question the pharmaceutical industry can't answer soon enough. Now that you've heard more about this individual case and how it fits into the overall opioid crisis, we'd love to hear from you. In general, what do you think? What do you think the priority should be for the Justice Department when it comes to the opioid crisis? Should authorities

Starting point is 00:13:14 be spending more time targeting prescription painkiller companies instead of focusing on treatment manufacturers? Or do you think that going after these companies for these kinds of tactics is just a band-aid solution? Do you think that the entire marketing and approval process for prescription drugs doesn't need to be overhauled? And if you or someone you know has had experience with Suboxone and you feel comfortable sharing your story, we'd love to hear from you as well. Also, if you like this video, you wanna support the channel,

Starting point is 00:13:34 we'd love if you took a second to just hit that like button, maybe even go to roguerocket.com slash support, you can use one of our fantastic subscribers, maybe get a paid subscription instead. Also, if you're new here, you wanna make sure you don't miss any of these daily videos, be sure to hit that subscribe button. Also, if you're not 100% filled in today, maybe you missed one of the last two videos we put out. You can click or tap right there to watch those. But with that said, of course, as always, my name's Philip DeFranco. You've just been filled in. I love your faces and I'll see you tomorrow.

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The Philip DeFranco Show - MS 5.25 How This Big Pharma Company Conned Doctors and Addicts, and Made MILLIONS

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