I have been wondering if I should write about the opioid drug epidemic, an epidemic brought to us by the pharmaceutical and medical industries, the advertising industry and the legal-judicial cartel who have aided them so recently after the overdose of one of my nephews, a child I took care of sometimes when he was young. It was his second overdose, they hadn't told me about the first one. It happened in New Hampshire, the police where it happened have been given training in injecting overdose victims with Narcan, I'm not sure of the status of the police in Maine, where the degenerate governor was opposed to first responders having that ability to save lives. It's quite possible, though I haven't been told the details, that if it had happened across the border, he'd be dead. As it is I'm not expecting him to live much longer as the 28 day spin cycle he's currently in is probably not going to break his addiction.
I was paying attention to the regulatory agencies and the courts as they took the decision to allow big Pharma to advertise directly to consumers even as some doctors and their professional groups were warning that it would lead to terrible results. I was sufficiently disillusioned with the free-speech industry by that time to notice they had a role in supporting the right of big Pharma to advertise dangerous drugs to people with no more knowledge of them than they would gain from the ads they saw on TV, no matter how theoretically available that information was to them. Most people don't know how their cars or their kitchen appliances really work, to expect they were going to master a level of the science behind high power drugs in order to make "informed" consumer choices about whether or not to "ask their doctor" to give them a prescription was obviously a ruse of the kind that do so much to bring lawyers and the law into disrepute.
People who have read my blog will be unsurprised that the sacred cow of what I've started to think of as The Stupid Left, the ACLU took the Pharma industry favoring line on that, with enough fig leafs to cover their asses. Here, from the official ACLU line taken in the early years of what would lead to the drugged up nation we are, today.
The agency has solicited comments regarding whether it should regulate some types of products more extensively than others, i.e. drugs versus dietary supplements. The FDA should not regulate certain products' advertising and labeling more comprehensively than others simply due to product type, because such an approach does not constitute the least restrictive means. Nor is it the most narrowly tailored way to achieve the agency's objective of furthering public health. Regardless of what legal test is applied, at a minimum, regulation governing commercial speech must be no more extensive than necessary. Thus, the government cannot just apply a blanket solution that is not targeted to further its substantial interest.
The FDA could protect consumers from potentially harmful effects of dangerous drugs by requiring measures other than restrictions on speech in labels and advertisements. For example, it could require a doctor's prescription for both dietary supplements and drugs that are powerful or have dangerous side-effects. This would promote public health by providing additional guidance and monitoring to consumers without restricting speech.
Well, that's certainly not how things worked out. The lawyers of the ACLU, clearly didn't include enough control on commercial speech so as to prevent the flood of patients browbeating their doctors into giving them drugs as advertised on TV and elsewhere, even when some of them carried warnings delivered in unintelligible speeded up talk that the toe-fungus meds might kill you. I encourage you to read the whole document because it is clear that they knew where the stand they took could lead and it has, despite their reassurances, led there. They were certainly aware of the doctors and medical professionals and scholars who warned against their position as were the regulators and, later, judges and justices who enabled the drug industry and the media in their part of producing the epidemic.
It's especially telling how enabling the ACLU has been in the creation of this crisis when you consider some of its other briefs and stands on, not only the direct marketing of drugs to consumers but the promotion of off-label uses of drugs directly to doctors, something which has played a huge role in the industry-advertisement-court created pandemic we are in, today. Here from Gabe Rottman, Legislative Counsel, ACLU Washington Legislative Office, in 2012, Selling Drugs and the First Amendment, notice the fig leaves and weasel words.
A few folks have asked me about the recent Second Circuit decision in United States v. Caronia, in which the court found that criminalizing the promotion of “off-label” pharmaceutical uses by a drug company sales representative violated the First Amendment. I cover a lot of commercial speech issues in the legislative context, so let me try to explain why I think the decision is probably right (“probably” being the operative term), and significant.
That was how Rottman began. And from the end,
For most people, advertising is a bad word. But sometimes commercial speech can help inform the “marketplace of ideas” as well as just the marketplace. This case highlights how, again assuming the speech is not misleading, pharmaceutical sales can actually help inform physicians’ medical decisions. By hampering the free flow of ideas, even profit-seeking ones, the government’s theory in Caronia could directly impair the values the First Amendment exists to further.
Two things do continue to bother me, however. First, does the government have an interest in preventing pharmaceutical company representatives from making statements about off-label uses when physicians have not separately determined that such uses might be therapeutic? The dissent is very concerned that the majority decision opens the door to precisely that. This is a completely different question than the one presented by the government in Caronia, and may very well change the analysis.
Second, does the analysis also change when you’re talking about actual advertising campaigns for an off-label use, rather than in-person informational meetings with physicians? Hopefully these questions will be addressed in future litigation, or by others following the case.
Given what the regulators acting under political coercion due to the then and still fashionable market libertarian ideology, big drug money in our politics and the Supreme Court which, with the ACLU's help, put that money directly into are politics have allowed by way of drug advertisement and the results of that, his "hopeful" hope that further litigation is going to address the catastrophic results of this legal regime are disingenuous and stupid.
You can contrast the legal bull shitese of the "free speech" advocates with this, from The National Institute of Drug Abuse.
How did this happen?
In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.3,4 Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1 That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).5 Here is what we know about the opioid crisis:
- Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.6
- Between 8 and 12 percent develop an opioid use disorder.7–9
- An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.7–9
- About 80 percent of people who use heroin first misused prescription opioids.7
This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.
You can also compare Pressure on the FDA to Loosen Restrictions on Advertising, a section of a paper A History of Drug Advertising * republished by The National Institute of Health.
Significant counterregulatory pressures during the mid-1990s moderated the efforts to restrict drug promotion (Epstein 1996; Hilts 2003). In 1994, with the Republican Party's takeover of Congress, the FDA encountered conservative opposition on many fronts. House Speaker Newt Gingrich called the FDA the “no. 1 job killer,” charging that it discouraged innovation and prevented profitable products from coming to market (Hilts 2003, 196). Conservatives also charged that the FDA's new drug approval process placed so much emphasis on keeping potentially bad drugs off the market that it unnecessarily delayed the introduction of important therapeutic advances. This criticism was echoed by a new and vocal breed of consumer advocacy organization that urged the FDA to reconsider its standards for approving drugs to combat HIV/AIDS (Epstein 1996). A parallel criticism was leveled against the FDA's approach to regulating drug advertising. Some argued that the FDA was so heavily focused on prohibiting misleading advertising that it prevented valuable information about prescription drugs from reaching consumers and physicians (Keith 1992).
In this environment of greater consumer involvement in health care, increased spending on consumer-directed promotion of prescription drugs, and scrutiny of the FDA's regulation of advertising, the agency held hearings on DTCA (FDA/DHHS 1995b). Officials heard testimony from pharmaceutical and advertising industry representatives, consumer organizations, medical societies, and academics. The pharmaceutical industry sought clarification of the provision in the 1969 advertising regulations that obviated the need for broadcast advertisements to contain the brief summary of the approved product label when “adequate provision” was made for dissemination of the product labeling in conjunction with the advertisement (FDA/DHHS 1969). In 1995, roughly 15 percent of DTCA spending was for television advertising (Kreling, Mott, and Wiederholt 2001). In order to circumvent the brief summary requirement, pharmaceutical companies ran reminder or help-seeking advertisements, which either included the name of the drug or discussed a particular condition, but not both. Reminder ads, which were originally designed for physicians and medical journals, led to some confusion among consumers who did not know what condition the drug was supposed to treat.
Some people who testified at the hearings noted that consumers' involvement in health care had expanded dramatically since the first DTC ads were aired in the early 1980s (FDA/DHHS 1995a). Participants in the hearings pointed to two divergent approaches to communicating risk information to consumers. Advocates of the first model proposed by critics of DTCA believed that the best method of educating consumers about prescription drugs was through something akin to patient package inserts. This model assumed that consumers needed to be educated after the prescribing decision had been made and that the package insert would help make the product safer. Consumer groups like the Health Research Group, which focused on product safety, adhered to this view.
The other model of information dissemination, supported by representatives of the advertising and pharmaceutical industries, proposed replacing the brief summary with a general risk statement like “prescription drugs could be harmful to your health and should not be taken without consulting a physician.” Advocates of this view considered advertising as a way to get the consumer—not the physician—to initiate the conversation about a prescription drug and so wanted to give consumers information about a drug well before the prescribing and purchasing decisions were made. The brief summary requirement was therefore seen as a barrier to direct communication between the pharmaceutical manufacturer and the consumer.
By 1997, those FDA officials who were reluctant to open the floodgates to prescription drug advertising on television felt increased pressure from a variety of sources to ease the regulations and permit broadcast advertising (Feather 1997). In August, a few months after David Kessler left the FDA, the agency released the Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements. It outlined the ways in which pharmaceutical manufacturers could meet the brief summary requirement in broadcast ads by clarifying the ways in which the product labeling could be adequately provided (FDA/DHHS 1997, 1999). Instead of airing the entire brief summary, the ads could refer consumers to (1) a toll-free telephone number, (2) print ads, (3) a website, and/or (4) their pharmacists or physicians, from whom they could obtain complete information about the product's risks and benefits. Consumers' confusion over the reminder ads for prescription drugs on television was a major factor behind the policy change (Woodcock 2003). Although whether the guidance was intended to loosen restrictions or to clarify existing provisions of advertising regulation has been debated, it nonetheless made broadcast advertisements of prescription drugs more feasible.
I am sure, from experience of the true believers in "free speech" as defined by the ACLU and, now the far right of the Republicans on the Supreme Court, that those definitions of "free speech" and "rights" they pretend that the consumers of TV commercials will get sufficient information to "act as their own advocates," "exercising agency" or whatever slogans and buzz words will be used to lie about it, and so protect themselves against dangerous drugs.
But that's an obvious lie as even the scientists of the regulatory agencies either can't discern so many of the dangers of the drugs that will be recalled after a lot of people die carry. That whole line of crap invented by lawyers trying to make a name and career from themselves out of "free speech" "First Amendment" and "civil liberties" advocacy is refuted as it runs straight into the reality of how people really are in the real world where even people who have been to medical school and have extensive post-doc training can't get it right. Sometimes they run pill-mills such as have led to local and even state drug addiction epidemics, having an education in science and medicine is no guarantee of morality and telling the truth.
There will never be a real life possibility in the general population having sufficient knowledge to make drug advertising safe or anything but a guarantee of drug abuse and addiction epidemics. When you tie the lying of drug promotion into the modern mass media that the people who wrote the Bill of Rights couldn't imagine, you will get the national crisis that the libertarian interpretation of that has brought us. I doubt it will be the last one caused by legalized lying in the mass media by corporate interests.
The next time you see a psycho-active drug advertised on TV, the next time you read of the opioid epidemic, the next time you read about an overdoes death or, as I sincerely hope you never experience, have someone in your family OD, consider the role that the advocates of "free speech" really and demonstrably have played in bringing it about.
* The subtitle of the paper is, The Evolving Roles of Consumers and Consumer Protection. It is an interesting paper to consider because it goes into the role that the mixed bag of "patients rights" as both something to protect people and as a propaganda opportunity that it was to the people who brought us the drug epidemic. As with the advocacy of the ACLU, what was supposed to be something to protect people from commercial predators who would rob and kill them, was used by those very crooks who adopted the language, adapting it for their own ends. It is no accident that the ACLU has used the language of the First Amendment to enable Nazis, the KKK, the billionaire boys club, .... and, as can be seen above, the pushers of addictive and dangerous drugs of big phrama and that the Nazis who would destroy much more than just free speech of their opponents have adopted it as their slogan, as well as such others as David Horowitz and Dinesh d' Souza.
There is something very wrong with the current interpretation of the First Amendment as well as other amendments of the Bill of Rights. But don't expect the lawyers coming from elite law schools to even acknowledge that. They're too busy bilking you for feel-good donations so they can go to court for the Nazis and big Pharma.
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