By Kimberly J. Soenen
Abilify, Advair, Cialis, Depakote, Enbrel, Diovan, Humira, Lantus, Lexapro, Lipitor, Nexium, Plavix, Seroquel, Singulair, Viagra, Vioxx, Xanax, Zyprexa, and other drugs have all became household names over the last three decades. Like Tampax, Frisbee, Jell-O, Xerox, Q-Tip, Saran Wrap and Kleenex, during the commercial breaks of Seinfeld, In Living Color, Friends, The Fresh Prince, Mike and Molly and Roseanne, Americans willfully took media hits, audio snorts and visual injections of these brand names like unsuspecting children walking towards candy offered by The Joker. These drug brand names—brainstormed by Madison Avenue pharmaceutical marketing teams while dining at Daniel, La Grenouille and The Oak Bar—became as recognized by American households in the 1990s as Alka-Seltzer and Life Cereal.
Direct-to-Consumer (DTC) advertising of pharmaceutical drugs has been legal in the United States since 1985, but it skyrocketed exponentially in 1997 when the Food and Drug Administration (FDA) loosened a rule mandating that companies offer a detailed list of side-effects in their drug TV commercials. As healthcare access became increasingly unaffordable in the United States along with the shift to Commercial Health Insurance Managed Care, people began to rely on their TVs, desktops and cell phones for medical advice. Risk? What risk?
Today, the broadcast, Out-of-Home and digital drug ads continue, only now, we have a Prescriber-in-Chief— yet another reckless, ill-informed, greedy pharmaceutical drug sales rep: the President of the United States, Donald J. Trump.
Once a drug is approved by the FDA for a specific use, it may also be prescribed for any use that a physician sees fit. The only restriction on that “off-label” use is that manufacturers cannot advertise or otherwise promote the drug to a physician for that untraditional use. But the President of the United States advertised the drug hydroxychloroquine (HCQ) aggressively from the loudest podium in the world—the Rose Garden and the White House press room.
“It is never a good idea for someone other than an individual’s treating healthcare provider to make treatment recommendations. This is especially true now, when people are scared and looking for magic bullets and so little is known about this coronavirus (Covid-19). The fact that the President of the United States was promoting the off-label use of a drug is both unprecedented and dangerous,” said Dr. Julie A. Pryde from Champaign, Illinois.
Alternative Medical Facts
As of May 2020, President Trump has made more than 18,000 entirely false or misleading claims while in office. Not surprisingly, “Alternative Facts,” just like Alternative Medical Advice, are unregulated.
So, when DTC-like medical recommendations are coming from a proven liar, how should Public Health professionals, physicians and pharmacists respond to Trump’s aggressive and unrelenting promotion of, and professed use of, the drug hydroxychloroquine?
The news cycle has already moved on from Trump’s promotion of hydroxychloroquine to his war with social media industry titans and his directive to shoot American protestors. But, scientists and physicians are still addressing the harm Trump imposed by promoting the drug aggressively on television. By speaking with numerous physicians, pharmacists and Public Health professionals across the country over the last week, I’ve learned that HCQ is a very complicated drug and carries with it several serious risks that can lead to severe adverse reactions and death. In addition, physicians are losing their patience with the harm imposed by the televised advertisement of drugs.
“Trump is no different than a carnival barker selling snake oil. His reckless and ill-informed promotion of hydroxychloroquine likely has resulted in the death of some patients and benefited no one. Given the drug’s well-documented toxicity, no patient should be given the drug outside of a carefully monitored, randomized clinical trial,” said Dr. Michael A. Carome, Director of the Public Citizen Health Research Group.
For those of you who do not practice medicine and wish to understand the risks of HCQ in simplest terms, this is a drug with very strong effects on the body: HCQ is traditionally used to treat symptoms of rheumatoid arthritis and lupus, among other illnesses, but Trump has said he used it as a preventative against Covid-19.
After prescribing HCQ, a physician would typically monitor electrolytes such as sodium and potassium levels, baseline heart tracing, kidney function and may administer liver tests. Physicians are aware that the drug can cause QT prolongation, which is a measure of delayed electrical signals passing through the heart’s large ventricles. This means the heart muscle takes longer than normal to recharge between beats. This electrical disturbance can only be seen after an electrocardiogram test (EKG). Excessive QT prolongation can trigger a very rapid, irregular, and potentially fatal, heart rate. HCQ may increase insulin levels which, in turn, may contribute to an increased risk of severely low blood glucose. HCQ has also been linked to kidney failure.
“The medication that Donald Trump has elected to use to stave off Covid-19 may not work any better than his hair dye to prevent contraction of this deadly virus. As we all know from watching the endless warnings that are contained in each drug advertisement we see on television, every drug has considerable side effects,” said Dr. Peter Orris, Professor and Chief of Service in the Occupational and Environmental Medicine Public Health School at the University of Illinois Hospital and Health Sciences System in Chicago. “This is why a physician’s prescription is needed to assure that the benefits and risks to patients are taken into account when taking a medication for a specific purpose. As physicians, we can only hope that this unproven therapy [promoted by Donald Trump] will not cause any harm to people who trust his words and actions,” Dr. Orris added.
Despite the deafening lack of unified response from the American Hospital Association (AHA), the American Medical Association (AMA) and other organized medical associations, physicians and pharmacists across the United States have been both alarmed and angered by the President’s unrelenting promotion of hydroxychloroquine and other medical advice.
“Trump’s [self-reported] use of hydroxychloroquine to prevent illness from Covid-19 is clearly not consistent with the advice of national health officials and experts and is just another example of his refusal to respect and believe science and its experts,” Dr. Susan Rogers, President-Elect of Physicians for a National Health Program said. “His critique of the United States Department of Veterans Affairs’ (VA) clinical study to defend his use of the drug is so totally inappropriate for anyone to do who is not familiar with scientific protocols,” Rogers continued. “Doing so as President is particularly dangerous. I can only speculate on his motivation to promote the use of the drug again, but whatever it is, it is clearly not in the best interest of the people in this country.”
How Big Pharma Got “Big”
In the late 1980s, pharmaceutical marketers began to promote natural human experiences like shyness, hair loss, melancholy, high-energy children and diminished sexual function as diseases. “That’s me,” Americans responded. “I need to get an erection at the age of 80,” they said from their rocking chairs. “I need to feel happy all of the time,” they squawked as they watched E! News while drinking cosmos from their tanning beds. “I need to be skinny,” they said while reading US Weekly and PEOPLE Magazine. Puppies in wheat fields, heterosexual couples holding hands in bathtubs in Tahiti, wives skipping down the street with balloons in the sunny suburbs with a clearly reliable spouse… “all of this, and much more, could be yours—with one pill,” the TV said. Just “talk to your doctor.”
When the Pharmaceutical Research and Manufacturers of America (phRMA) finally received a greenlight in 1987 to advertise their drugs (and so-called diseases) directly to the consumer on television, just like that, they made the “Plop Plop Fizz Fizz” Alka-Seltzer antacid pain reliever ad campaign launched in 1931 look like a Go-Kart compared to today’s rocket-propelled grenade-like ad campaigns. This is the timeframe when the word Big was added to “phRMA.”
Overnight, the opiate of the masses literally, became the opiate of the masses.
In the early 2000s, I began to notice that everyone I knew over the age of 50 seemed to be on Lipitor. After September 11, 2001, I learned people in my own professional and personal circles were ingesting alprazolam (Xanax) like aspirin. SSRIs and mood stabilizers were increasingly prescribed for pain caused by athletic injuries and to kids who were under-stimulated at school—even though these are not the originally- intended uses for medications such as Carbamazepine (Carbatrol, Equetro, Epitol, Tegretol), Valproic acid (Depakene), Divalproex sodium (Depakote), Lamotrigine (Lamictal) and others with similar drug properties.
Pharmaceutical sales reps lapped up lobster bisque in San Francisco, Boston, New Jersey, Basel, San Diego and Chicago while the brain chemistry of the unsuspecting masses who had grown up conditioned to trust their doctors were now irreversibly being altered and, in many cases, addicted to, or killed by “Blockbuster Drugs.”
Drug manufacturers were handing out brand name pens, brand name notepads, and dinners for entire hotel ballrooms of physicians and pharmaceutical company sales reps who promised to upsell the Blockbuster Drugs in exchange for beach vacations, Michelin Star meals and weekends in Aspen. Peers of mine in their late 20s who were pharmaceutical sales reps were suddenly vacationing in Switzerland, clubbing in Dubai and buying homes in Santa Barbara and La Jolla.
My own physician in the early 2000s began handing out “samples” of drugs to me. I would walk out of the hospital clinic with tiny boxes of 4-6 pills in each box wrapped in a brown paper bag like I had just popped into a 7-Eleven or Circle K for a bottle of Mad Dog or Funyuns. “Try it, You’ll like it! He likes it!” the makers of the Blockbuster Drugs shouted. And just like Little Mikey’s brothers in the Life Cereal ad, physicians enthusiastically waited for their patients’ responses.
According to the Milbank Quarterly, spending on Direct-to-Consumer advertising of prescription drugs increased dramatically from an estimated $166 million in 1993 to $4.2 billion in 2005. The correspondingly increased TV advertising of prescription drugs since 1987 is extremely controversial, especially when the drug is suggested for a non-traditional ailment. Two decades of high time have been riddled with class action lawsuits about off-label prescribing, mostly organized by relatives of patients who have died from ingesting the drugs that had been recommended to them as a promising new treatment.
Despite Black Box warnings required by the FDA for certain medications that carry serious safety risks and dangerous side effects, between 2004 and 2020 the increase in off-label promotion settlements under the False Claims Act has been astonishing. Numerous high profile examples of off-label drug prescribing, and uses that initially appeared to be valid but were subsequently determined to be dangerous—and in many cases fatal, include: Adalimumab (Humira), Fenfluramine and Phentermine (Fen-Phen), Neurontin, Calcium Channel Blockers (CCBs), Rofecoxib (Vioxx), Escitalopram (Lexapro), Quetiapine (Seroquel), Encainide and Flecainide, and Anturane to name just a few.
The most recent cases of harmful off-label marketing are Celgene’s off-label promotion of Revlimid and Thalomid in July of 2017 and Aegerion Pharmaceuticals’ off-label promotion of the cholesterol medication Juxtapid, in September of the same year.
In 2018, California Insurance Commissioner Dave Jones sued drug manufacturer AbbVie, the spin-off of Abbott Laboratories, alleging that the company offered kickbacks to health care providers to prescribe the popular arthritis drug Humira, resulting in health insurers paying $1.2 billion in Humira-related pharmacy claims. This case is said to be the largest health insurance fraud case the California Department of Insurance had ever seen. The illicit plan to “pump up” the sales of Humira in California is the most recent example of how TV advertising and aggressive off-label promotion of drugs by healthcare professionals and physicians imposes harm.
According to the California Attorney General: one scheme involved “classic kickbacks” in the form of substantial cash payments, gifts, trips and vacations, meals at restaurants and wineries, and other bribes given to California healthcare providers…. The other scheme took the form of AbbVie’s “Ambassador Program” —a network of nurses AbbVie made available at no cost to those healthcare providers who prescribed Humira for their patients. This scheme “dramatically increased the number of prescriptions for Humira that are filled and refilled” in California, a practice that was “particularly pernicious because Humira is an expensive drug with serious potential health hazards.” The case will soon return to the Superior Court.
Pharmaceutical companies frequently pay government agencies and the United States Department of Justice legal case settlements in the millions—sometimes billions—to side step conviction and incarceration. Charges of gross negligence and malicious intent just don’t seem to stick.
Viagra is another example of how aggressive DTC drug marketing impacts health. Men have been turning to the little blue pill to treat their “Erectile Dysfunction” (ED) for over 20 years. Since sildenafil (Viagra) first came onto the scene in 1998, the number of men diagnosed with Erectile Dysfunction has shot up by more than 250%. The marketing on television drove Viagra’s widely spread use, and even made it a sought-after street drug. But taking Viagra or other similar meds such as tadalafil (Cialis) or vardenafil (Levitra) can be dangerous. For example, Viagra’s side effects include increased blood pressure, stuffy nose, intense headaches, stomach pain, nausea, diarrhea, memory problems, back pains, loss of hearing, ringing in the ears and dizziness.
Physicians and nurses who utilize Best Practices pushed back on the aggressive television marketing of Viagra, and activists joined in passing legislation that would eventually force phRMA to verbally list drug side effects and risks in their television ads. Soon, these side effects were written in unreadable tiny print on the television screen and verbally read on television ads at a speed so rapid, it is almost impossible to hear clearly. But, even with the warnings, between 1998 (the year Viagra was approved for market) through 2007, Viagra was implicated in at least 1,824 cardiac arrest-related deaths.
Dr. Ronald Wyatt said in more than 20 years of clinical practice as an Internal Medicine Specialist, he had never prescribed or managed a patient on hydroxychloroquine without the guidance of a Rheumatologist or Hematologist.
“The possibility that a White House physician would prescribe this medication to the President of the United States is inexplicable, especially after April 24, 2020, when the Food and Drug Administration (FDA) issued a Drug Safety Communication about the known side effects of hydroxychloroquine and chloroquine – the antimalarial drugs being used to treat Covid-19,” said Wyatt. “These side effects include serious and potentially life-threatening heart rhythm problems reported with Covid-19 patients, which has led to controversy with the off-label use of these drugs.”
White House physician Dr. Sean Patrick Conley published confirmation that he did proactively prescribe hydroxychloroquine for off-label use to the President of the United States. Yet the question remains for organized medical associations: why would a physician prescribe hydroxychloroquine to an obese, asymptomatic, elderly male? Off-label use is not a violation of federal law or FDA regulation because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive legal realm of individual states. That said, Dr. Conley should undergo a review by the state licensing board.
“When prescribed by a doctor or another certified clinician, hydroxychloroquine can offer therapeutic benefits for people living with diseases like lupus. But, like all drugs, it has side effects, some of which can be life-threatening. Taking hydroxychloroquine may increase the risk for dangerous cardiac arrhythmias, and evidence is lacking to support the use of hydroxychloroquine to prevent Covid-19,” said Dr. Hope Ferdowsian, President and Co-founder of The Phoenix Zones Initative.
Reached by email, Dr. Georges C. Benjamin, Executive Director of the American Public Health Association said, “The American Public Health Association (APHA) believes that hydroxychloroquine should only be used as permitted by FDA regulations, which includes appropriately approved clinical trials. Like all medications, it has risks and benefits which should be considered when prescribed by authorized prescribers.”
Could the muted response and silence from organized medical associations be from fear of being personally discredited by the President in a public statement? Is it that many physicians who support the current United States presidential administration are personally invested in the companies he promotes publicly?
On May 25, the World Health Organization (WHO) temporarily suspended its trial of hydroxychloroquine over safety concerns and resumed clinical trials the first week of June. WHO Director General Tedros Adhanom Ghebreyesus told reporters at a news briefing. “Numerous clinical trials are looking to see if it’s effective in fighting Covid-19, but it is not a proven treatment,” he said.
Researchers reported on June 3 that following a rigorous study of 821 people who had been exposed to Covid-19, hydroxychloroquine did not prevent the virus. The study was the first of controlled clinical trial of hydroxychloroquine.
On May 29, Donald Trump announced he was terminating the United States’ membership in the World Health Organization (WHO).
Plop Plop Fizz Fizz.
“CANDY SHOP” video produced by Animation Artist and Director Patrick Smith of Blend Films Animation. Smith is known for his metaphorical hand drawn short films, as well as his experimental stop motion films. He is a member of the Academy of Motion Picture Arts and Sciences, and a fellow of the New York Foundation of the Arts. His latest award winning animated short film “GUN SHOP” recently qualified for entry into the 2020 Academy Awards / Oscars. Smith resides in Montauk, New York. https://vimeo.com/blendfilms