Intro to Marketing Chapter In O'Donnell's Drug Injury--Just Published
The Ultimate Reference For Those In Pharmacology-Related Fields
The Role Of Investigative Journalism In Improving Drug Safety
The years between the debut of direct-to-consumer drug (DTC) advertising in the 1990s and passage of the Physician Financial Transparency Reports (Sunshine Act) in 2010 were a kind of “Wild West” for the drug industry. Hollywood-handsome drug reps saturated hospitals and medical centers with lunch, gifts and free drug samples for doctors and their staff. Statins, PPIs, asthma drugs, antipsychotics and ADHD meds became blockbusters. But the "Wild West" was not to last for drug makers.
For one thing, the public was becoming aware of––and infuriated by––drug maker price gouging. In 2016 Martin Shkreli, founder of Turing Pharmaceuticals, refused to justify the company’s price hike of the anti-parasitic drug Daraprim from $13.50 to $750 on Capitol Hill and took the "fifth."
Months later, the drug giant Mylan raised the price of EpiPen, the emergency allergy injection, to $600 from $100 with no warning.
Also, many top-selling drugs went off patent, lucrative psychiatric drug franchises peaked and financial incentives to doctors like "speakers fees" were frowned upon. Still, greater awareness of conflicts of interest between medical leaders and drug makers did not mean those financial relationships stopped. In 2018, ProPublica reported:
"Top researchers at Memorial Sloan Kettering Cancer Center have filed at least seven corrections with medical journals recently, divulging financial relationships with health care companies that they did not previously disclose. The hospital’s chief executive, Dr. Craig B. Thompson, disclosed his relationship with companies including the drugmaker Merck, and Dr. Jedd Wolchok, a noted pioneer in cancer immunotherapy, listed his affiliations with 31 companies.
The corrections followed the resignation in September of Dr. José Baselga...the cancer center’s chief medical officer, who had failed to disclose his company ties in dozens of articles in medical journals...totaling millions of dollars."
CEO Thompson sat on the boards of Merck and Charles River Laboratories and actually founded a cancer start-up said news reports.
In response to the developments, drug makers launched a love affair with biologics– –larger proteins, peptides, nucleic acids and cells administered parenterally replaced the huge revenues6 drug makers had enjoyed for orally administered "small molecules."7 Monoclonal antibodies, man-made proteins that behave like human antibodies, were used to create blockbuster TNF blockers such as AbbVie's Humira which became the best selling medication in the U.S. year after year.8 But the medications' costs and safety profiles were alarming.
In addition to the TNF blockers, drug makers also launched expensive, specialty and disease-specific biologic drugs, some priced so high and without clear benefit that the House Committee On Oversight and Reform conducted continual investigations. In fact, according to a 2019 article in JAMA Internal Medicine, only 19 of 93 cancer drugs approved since 1992, were shown to increase survival.
Other noteworthy biologics that emerged once small molecules began to disappoint were hepatitis C virus (HCV) medications like Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) which we discuss later in this chapter. Their prices ranged from $78,000 to $87,000 per round of treatment.
Before the Covid-19 pandemic put a halo on drug makers' heads in 2020 as the world craved a vaccine, revelations had emerged that opioid makers deliberately created the opioid addiction and overdose epidemic for profit. In 2020, OxyContin maker Purdue Pharma agreed to plead guilty to a three-count felony charge which included a criminal fine of $3.544 billion and $2 billion in criminal forfeiture.12 Other popular and widely-used medications were also beset with new safety concerns though the Covid-19 pandemic tended to eclipsed other pharmaceutical news.
Direct-To-Consumer Advertising Increased With the Pandemic
Direct-to-consumer (DTC) advertising debuted at the same time as the World Wide Web and both had the immediate effect of giving the patient more information about diseases, symptoms and drugs than they ever had before, fostering "cyberchondria." DTC drug advertising enriched drug makers and media outlets and for some magazines and TV shows, DTC ads were the primary revenue drivers, explaining the lack of coverage about safety concerns.
While some people say they enjoy ads, other TV viewers have their guard up. They know the butterflies, sunsets and puppies in the ads are designed to distract from the listing of alarming side effects that could be reasons to not "ask your doctor" about the advertised drug. Since only brand drugs are advertised, DTC marketing also sell expensive drugs when cheaper drugs would work just as well.
It was no surprise to media or industry watchers that drug advertising increased during the Covid pandemic with a greater potential audience of millions now isolated at home. A month after the Covid pandemic was declared, drug makers' TV ad expenditures for the top 10 prescription drugs increased to $183 million from $156 million in March according to FiercePharma.13 Overall spending on prescription drug ads rose 123% 14 In the first six months of 2020, Pfizer's digital advertising was up 532 percent while Amgen's was up 216 percent and GlaxoSmithKline was up 151 percent.
Unbranded DTC Advertising Sells Hypochondria
Another kind of popular marketing from drug makers which persisted during Covid is called "unbranded" advertising. Its purpose is to "raise awareness" about a disease or condition and the drug that is really being promoted is never mentioned.
The hallmark of unbranded advertising is fear. It implies that even though someone may feel healthy, they may be ill or even have a "silent killer" disease. Unbranded advertising often sends people to online "symptom checkers" which then circuitously lead a person to the drug being sold. Risks of diseases are also peddled though patients were symptom-free and; clearly if patients take the med, they can't know if the drug is working or if they ever even needed it.
Unbranded advertising can fly under the public's radar because it appears to be official information from the CDC or the government. Even radio and TV stations have been known to wave unbranded ads through to run free as "public service announcements" because producers do not see drug makers' fingerprints on them but rather "altruistic" ads. Unbranded advertising has sold everything from depression and bipolar disorder to obscure conditions like exocrine pancreatic insufficiency and non-24-hour sleep-wake disorder. END
Read more here! https://www.taylorfrancis.com/books/edit/10.1201/9781003615323/donnell-drug-injury-james-donnell-iii-james-donnell-gourang-patel-jennifer-splawski
And Now For Something Funny
What Would Tom Wolfe Say About GLP-1 Agonists?
Who remembers writer and social satirist Tom Wolfe?
In addition to his 1979 book "The Right Stuff and the 1983, related Oscar-winning movie (about military test pilot Chuck Yeager) he was a merciless social critic.
His 1970 book, Radical Chic & Mau-Mauing the Flak Catchers, skewers New York composer Leonard Bernstein's fundraising party for the Black Panthers and his 1987 novel, The Bonfire of the Vanities, continues his offensive against liberal hypocrisy and early Woke ideology.
Wolfe famously coined the term, the "Me Decade"--Let's Talk About Me; The Most Important Person in the Room--for the licensed social narcissism that characterized the 1980's. Everyone was a star and, later, their own "brand"-- winning friends and influencing people
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Today, social media and journalists-turned-bloggers/diarists have ushered in a new "Let's Talk About Me" Decade, often characterized by detailed, victim tales of "ADHD" and "Neurodivergence," and pass-the-hanky books called "One Woman's Story." ("Now that you've told me about your depression, I'll tell you about mine.")
Boys With Boobs
Wolfe was most caustic when it came to rich women dieters who he described as "Social X-rays." Such women, in their efforts to diminish the size of their hips, abdomens and butts yet still retain their "female" card, looked like "boys with boobs," he wrote. The veins on the dieters' hands stood up as high as rings.
"The women came in two varieties," he wrote in The Bonfire of the Vanities. "First, there were women in their late thirties and in their forties and older (women 'of a certain age'), all of them skin and bones (starved to near perfection)." Their dieting had given them "juiceless ribs and atrophied backsides."
"Lemon Tarts," he continued, were "women in their twenties or early thirties, mostly blondes (the Lemon in the Tarts), who were the second, third, and fourth wives or live-in girlfriends of men over forty or fifty or sixty (or seventy)." They had a "round bottom (something no X-ray had)" but likely were on the way to the former variety.
Oh Oh Oh Ozempic
What could Wolfe say about the fat drug (GLP-1 agonist) craze which has conferred billions if not trillions on drug makers and Wall Street and enlisted millions of Americans into an expensive diet "journey"?
First, Wolfe might ask the etiology of the US obesity epidemic--how did the average size of a US woman's waist became bigger than the average size of her hips when he was writing social critiques? (That's not dressmaking that's upholstering say fashion designers.) Didn't anyone notice the amassing of adipose? Didn't anyone care?
Then he would likely highlight the role of ads for fattening food and its availability--drive-through outlets, deliveries, vending machines--and ask why people believe a pill is the answer to their obesity instead of better eating? (Do fattening food makers get a kickback?)
Finally, he would address the beauty trade-offs of the new, pill-produced svelteness. The emaciated "Ozempic face"--which creates a market for plastic surgeons but new shame for the less well-off. The GLP-1 agonist-related muscle loss, which, again the rich can treat with more drugs but the less well-off must accept--and regret
Wolfe might highlight the dental side effects of the new fat drugs--"Ozempic mouth"--such as dry mouth-caused cavities, gum disease and bad breath. And the growing reports of hair loss now linked to the drugs. He would not omit the eye risks linked to the popular new drugs--non-arteritic anterior ischemic optic neuropathy (NAION) linked to vision loss.
"I might be bald, blind and with dentures but my butt is small," Wolfe might joke the new social X-rays would say.