pharma marketing

Birth Control and Crohn’s Disease: Doctors Have It All Wrong

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It’s funny how clearly some mundane memories stick in your mind. I still recall the first time I took my car in for an instant oil-change. The shop’s marketing had spoken to my heart with a promise to have me in-and-out in under 10 minutes. If I wasn’t already hooked, something about navigating my car over the huge hole in the floor appealed to the little boy inside me, and, in fact, the entire experience was pretty pleasant… right up until the technician approached my window at the eight-minute mark.

“You’re going to need a new valve soon, and you’re air filter is really dirty. Would you like for me to replace these today?”

He was carrying the dirty filter and PCV valve as proof. I thought to myself, “They’ve been riding in a car engine. Of course, they’re dirty!” After he told me the cost, I politely declined. I’m not really a car guy, but I suspected I could get them cheaper elsewhere.

I’m skeptical anytime I know someone is trying to sell me something. That doesn’t make me unique; it makes me human. That’s why word-of-mouth advertising is so effective. If a friend (or even a stranger on Yelp) tells us something is great and we know they aren’t being paid to say so, it carries much more weight than that same message coming from someone who stands to benefit from it.

That air filter, though. It was nasty! So, I drove directly to a parts store, and it was indeed about half the cost. My inner imp felt justified.

A few thousand miles later I returned to the same shop for another oil change. (The sacrifices we make in the name of ‘instant’). Imagine my surprise when the eight-minute interlude again included the same air filter I had just replaced. On the Scale of Betrayal, the technician was hardly Judas, but I still vowed never to take my car there again.

In my opinion, that’s the definition of a healthy skepticism, one that steers us clear of people who don’t have our best interests in mind.

What’s Behind the Message?

“Life is pain, Highness. Anyone who says differently is selling something.”

Granted, the Man in Black was more than a little bitter when he uttered those famous words to Buttercup in The Princess Bride, but filter out the resentfulness, and you still have a grain of truth. In the oil change shop, it’s easy to spot the salesman’s motivation, but in some scenarios it’s difficult to spot the salesman, much less his/her motivation.

That healthy skepticism may never be more absent than when we visit the doctor. Ironically, because of the odd paradigm of the medical industry, that is precisely when it should be at its sharpest. I can’t think of another scenario where the consumer of the product relies completely on someone else to make the purchase decision. Perhaps our skepticism is alleviated because we believe the physician has taken a non-binding oath to ‘first do no harm.’ However, about one out of every five medical students actually reports taking no oath at all.

With or without the oath, we, the consumer, will be the ones taking the treatment they prescribe. We will be the ones living with the consequences, good or bad. Given that those consequences are all too often chronic or deadly, we should absolutely question a doctor’s reasoning and motivation.

Questioning Consensus

Crohn’s Disease affects absorption on the surface of the intestine, which can diminish the effectiveness of hormonal birth control. In this scenario, the prevailing consensus among doctors is to counter the affect Crohn’s has on The Pill by switching the patient to a higher dosage. In the long run, this can be devastating for the patient.

Unfortunately, this often the MO for dealing with problems in the medical industry. You either increase the dosage, or you prescribe something ‘off-label,’ especially when it comes to The Pill.

Hormonal contraceptives are prescribed off-label to treat everything from acne and irregular periods to PCOS and Multiple Sclerosis. But, think for a moment about what ‘off-label’ means. It means the prescribed drug hasn’t been clinically proven safe or effective for this particular use. It means treatment by consensus, rather than sound science. Alarmingly, a recent study published in Obstetrics and Gynecology revealed that a full two-thirds of practices in their specialty were based on consensus rather than ‘good and consistent scientific evidence.’

Proactive in the Wrong Direction

Recognizing the effects of Crohn’s Disease on the intestine and boosting a young woman’s birth control may seem very proactive, but it doesn’t take into account the big picture. In fact, it’s like admiring the mountainous road behind the Mona Lisa while missing her smile.

Surprisingly few doctors recognize that birth control could have actually triggered her disease despite the fact that the number of Crohn’s Disease cases exploded since the introduction of birth control pills.

In 2015, Harvard researchers conducted a massive study of nearly a quarter-million health records and discovered that women who took hormonal birth control for five years, more than tripled their risk of developing Crohn’s Disease.

But really, it shouldn’t have taken a major Harvard study for doctors to consider the link to irritable bowel disease. After all, nausea and upset stomach are among the most common complaints after starting birth control.

Estrogen is known to modify permeability and inflammation of the gut, and synthetic estrogen’s affect is unquestionably deleterious. Interestingly, the same study found women who take hormone replacement therapy face a 74% increased risk of ulcerative colitis, another irritable bowel disease.

Nothing New Under the Sun

News outlets hailed the Harvard study as groundbreaking. Any health periodical worth its weight in feathers ran an article on the study’s new findings. However, one only needs to read the study’s references to see how little ground it broke.

Citations and the year they were published, include (Condensed titles): Regional enteritis: possible association with oral contraceptives, 1969; Small intestine disease and oral contraceptive agents, 1973; Intestinal complications during the use of oral contraceptives, 1976; Colonic Crohn’s disease and use of oral contraception, 1984; The risk of oral contraceptives in the etiology of inflammatory bowel disease, 2008.

After a 1999 study associated hormonal contraceptive use as a high risk factor for a relapse in Crohn’s disease, Gut British Medical Journal published evidence that not only supported these findings, but also demonstrated a significant change in gender ratio, the incidence of female diagnoses compared to males jumped dramatically after the introduction of birth control pills.

Ultimately, the Harvard study was a massive population based study that did little more than confirm what researchers had known (or at least suspected) since 1969.

In his testimony at the Nelson Pill Hearings (1970), Dr. Philip Ball detailed how The Pill affects nearly every tissue in a woman’s body, and then offered this food for thought:

“I believe that we physicians are so used to administering very potent medications to very serious disease problems, we have not really yet learned it is a totally different circumstance to administer powerful but nonessential drugs chronically to healthy young women, as is done in contraceptive pill administration. It is of no relevance to say that the pill causes less trouble than cigarette smoking – doctors do not prescribe cigarettes. In fact, I take women off tobacco also. It is not sensible to say that birth control pills are safer than pregnancy – we don’t prescribe pregnancy. The question is simply, are the pills safer than the diaphragm or safer than the foams or rubber prophylactics? And the answer is clearly no.

“We have had much talk in our land about preserving our environment or improving our quality of life or preventing pollution of our country. The administration of birth control pills…may be termed an internal pollution by chemicals (that will) interfere with a woman’s quality of life.”

Let Those with Crohn’s Beware

Common sense and science tell us that hormonal contraceptives probably aren’t a great idea for someone with Crohn’s Disease (or someone with a family history of Crohn’s). Yet, we’ve already seen that the consensus is to increase the dosage of synthetic estrogen for these patients.

How can this be? And, what does it have to do with a speedy oil change?

Clearly, physicians aren’t receiving a commission or bonuses for prescribing drugs, but that’s not to say they aren’t influenced by pharmaceutical companies in much the same way the oil change technician was influenced by his employers. Let’s consider the commonalities of training, incentives, and pressure to perform.

Training – Drug manufacturers begin exerting influence on medical professionals early in their academic careers. These unwitting students are typically unaware of the biases that could be shaping the way they approach their future practices.

In her wonderful book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, Marcia Angell, M.D. writes extensively about Big Pharma’s influence on medical education. She described the industry’s relationship with universities this way:

“The Reagan years and Bayh-Dole also transformed the ethos of medical schools and teaching hospitals. These nonprofit institutions started to see themselves as “partners” of industry, and they became just as enthusiastic as any entrepreneur about the opportunities to parlay their discoveries into financial gain. Faculty researchers were encouraged to obtain patents on their work (which were assigned to their universities), and they shared in the royalties. Many medical schools and teaching hospitals set up “technology transfer” offices to help in this activity and capitalize on faculty discoveries… One of the results has been a growing pro-industry bias in medical research—exactly where such bias doesn’t belong.”

As a former editor of the prestigious New England Journal of Medicine, Dr. Angell became keenly aware of the pharmaceutical industry’s influence on medical education, and it doesn’t end with the medical schools. Her book offers a comprehensive explanation of how the industry moved to virtually lock down control of continuing medical education, which doctors are required to take each year in order to maintain their licenses.

Incentives – Just for fun, watch an hour of television and don’t skip the commercials. In fact, count them. What percentage do you think will be prescription drug commercials?

I know it sounds more nausea-inducing than fun, but here’s the point. Big Pharma spends $3 billion dollars-per-year advertising to consumers. (We can also thank Reagan-era deregulation for direct-to-consumer marketing). As you think about those ubiquitous commercials and how far $3 billion dollars will go, consider this – Big Pharma spends 8 times as much on marketing directly to healthcare professionals, $24 billion annually.

The Food and Drug Administration, American Medical Association, and (PhRMA) Pharmaceutical Research and Manufacturers of America have all established guidelines and regulations in an attempt to limit gifts from the drug industry to healthcare professionals. The thought is that strictly limiting gifts will eliminate the influence drug companies have over those who write the scripts. A pharma sales rep bringing lunch to the doctor’s staff on Tuesday couldn’t possibly motivate him/her to prescribe more of their drug, right?

A recent study published in JAMA Internal Medicine found that, indeed, even a single $20 meal sponsored by a drug company can influence a doctor’s prescribing habits, and the impact increases with each meal. According to NBC News:

“Those who got four or more meals relating to the four drugs [in the study] prescribed Crestor nearly twice as often as doctors who didn’t get the free meals; Bystolic more than five times as often, Benicar more than four times as often and Pristig 3.4 times as often.”

These small gifts translate to a huge return on investment. The study found that when a drug company spends $13 on a doctor, they see 94 additional days of prescriptions for brand-name anticoagulants and additional 107 days for brand-name drugs to treat diabetes.

The Centers for Medicare and Medicaid Service track industry payments to healthcare professionals, and have made their database accessible to the public. You can discover if your physician receives payments from pharmaceutical companies and, if so, how much, by visiting: https://openpaymentsdata.cms.gov. ProPublica also created an interesting search tool using the same data, which you can utilize by visiting: https://projects.propublica.org/docdollars/.

Pressure to Perform – You may feel happy for Joe Mechanic when he gets Employee of the Month for selling the most air filters, but how would you feel about drug companies tracking your doctor’s performance? In fact, that’s exactly what’s happening.

Pharmaceutical companies buy physician prescribing data from companies like IMS Health. These weekly lists track every prescription written by healthcare professionals in the United States. Physician and patient names aren’t included, but each prescription does include the doctor’s Drug Enforcement Administration ID number. Interestingly, the American Medical Association makes about $20 million per year selling the master file of its physician database, which includes their DEA number.

By combining these two databases, the drug companies can see precisely how frequently each doctor prescribes their drug compared to the competition. Then, the sales reps can tailor their pitch and the amount of pressure to apply to each doctor.

Most doctors seem to realize that the gifts and pressure are influential but think that they are immune. Shannon Brownlee offered this perspective:

“Most physicians make “I’m OK, you’re not” assumptions about their profession’s susceptibility to such tactics. In one survey, 61 percent of the residents at the University of California, San Francisco Medical Center reported that they themselves are unmoved by drug company gifts. But when asked if they thought their colleagues were swayed, 84 percent said yes.”

Signs of their influence over healthcare professionals are everywhere. How else would you explain raising the dosage on birth control for Crohn’s patients as the consensus? Does it seem reasonable that seven out of ten people you meet today are taking a prescription, and 20% of them are taking at least five prescriptions?!

I suppose we should just be thankful humans don’t need air filters.

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Last updated on October 21, 2023 at 9:38 pm – Image source: Amazon Affiliate Program. All statements without guarantee.

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This article was first published in December 2017.

 

Lipstick on a Pig: Stelara’s Unethical Ads

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This 2014 commercial for Stelara is deplorable:

This commericial a disgusting example of everything that is wrong about pharmaceutical advertisements. It appeals to viewers’ vanity and insecurity – which we all possess – in order to sell a dangerous drug. The drug advertised, Stelara (a Johnson & Johnson product), causes cancer. The FDA warning label for Stelara notes that it can cause cutaneous squamous cell carcinoma, prostate, melanoma and breast and cancers, each of which can lead to death. It suppresses the immune system and leaves those who take it susceptible to dangerous infections, which can also lead to death.

Apparently it needs to be said, because there isn’t uproar and disgust in the general public over this wretched ad (and others like it for immunosuppressive drugs)–it is WRONG to utilize the same slimy sales techniques used to sell cosmetics in order to sell dangerous drugs that can severely hurt people and lead to their death. It is wrong to prey on people’s vanity and insecurity in order to sell them something that can hurt or even kill them. It is wrong to promote the frivolous and inappropriate use of a dangerous drug.

A drug like Stelara, that suppresses the immune system and can cause cancer, should not be used lightly and it is not even remotely appropriate to use it in order to have clearer skin. Just listen to the ad, “In a medical study, seven out of ten Stelara patients saw at least 75% clearer skin at twelve weeks.” Look at the model living a glamorous lifestyle, being adored, and flaunting her perfect skin, hair and body. This ad isn’t about helping people with plaque psoriasis, it’s about vanity and aspiration. It’s about selling a product and greed. It is not appropriate, and it even crosses the line of being wrong, to use manipulation and vanity to sell pharmaceuticals–especially pharmaceuticals that can cause cancer and death.

As is the case with all pharmaceutical ads, the risks associated with using Stelara are downplayed. At the end of the ad, after the marketers have thoroughly convinced the viewers (at least on a subconscious level) that if only they took Stelara they would look like the glamorous model in the commercial, a list of the most severe adverse effects is given. These risks include lowering one’s ability to fight infections, increasing one’s risk of cancer, headaches, seizures, vision problems, serious allergic reactions, and it is also stated that patients should, “tell your doctor if you, or anybody in your house needs or has recently received a vaccine.”

Do other people find that warning about not being around people who have recently been vaccinated to be concerning? It certainly piqued my interest when I first heard it. It made me wonder, “What is THAT about??” It made me wonder WHY people who are on Stelara shouldn’t be around those who have recently been vaccinated.

The written warning label for Stelara goes into a little more detail. It states, “People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®.”

Live vaccines include MMR (measles, mumps and rubella combined), chickenpox, nasally administrated flu, and rotavirus vaccines.

Additionally, recent studies have revealed that the whooping cough / pertussis vaccine can be spread from those who are vaccinated to those who are not vaccinated. A story published in the New York Times noted that, “’When you’re newly vaccinated (with the whooping cough / pertussis vaccine) you are an asymptomatic carrier, which is good for you, but not for the population,’ said Tod J. Merkel, the lead author of the study, who is a researcher in the Office of Vaccines Research and Review in the Food and Drug Administration.”

There is nothing okay about a vaccine spreading the disease that it is supposed to protect against. It is entirely indefensible. If a vaccine spreads disease it should be removed from the market. Try again, pharma companies that make live and whooping cough / pertussis vaccines. Not all vaccines spread the diseases that they are trying to prevent, so there must be some techniques and technologies that can keep that from occurring. Make it so, because endangering those who have suppressed immune systems is not acceptable.

Immune system suppressing drugs like Stelara, Humira, Enbrel, Remicade and others, are used by millions of people every day (it is estimated that 20% of the American population has an autoimmune disease, the diseases that these cancer-causing drugs are supposed to make more manageable). Everyone on an immunosuppressive therapy has a weakened immune system and is susceptible to catching a disease from someone who has recently received a live vaccine (or the pertussis/whooping cough vaccine). However, the people taking immune-suppressive drugs like Stelara aren’t the only ones who have compromised immune systems. Pregnant woman have compromised immune systems, so do people who are HIV positive or have AIDS, people going through chemotherapy, and many others.

The combination of live, virus containing, vaccines, along with a large portion of the population taking immunosuppressive drugs, may make the spread of diseases throughout the US population more common in the future. Unvaccinated people will be blamed, but perhaps more of the blame should sit with the pharmaceutical companies that are making billions off of suppressing people’s immune systems ($6.1 billion in immunosuppressive drugs like Stelara were sold in 2012 alone) and selling live virus vaccines.

Projections of diseases being spread through a population that is immune-suppressed are conjecture. It is not conjecture, however, that dangerous drugs are being sold via immoral marketing techniques. If it were demanded that there be truth in advertising, Tony’s story would be the advertisement one would see for Stelara:

Though Tony’s story is tragic, at least it is real. Pharmaceutical advertisements are not real. We all know, on some level, that pharmaceutical advertisements are not real. Perhaps it’s time we get angry about these types of commercials. Anger may even lead to change. At the very least, it’s time to get educated about the real risks associated with heavily marketed medications. The risks are real. The ads are not.

About the Author: Lisa Bloomquist was “Floxed” on her 32nd birthday by Cipro, a fluoroquinolone antibiotic. After 2 years of battling the mysterious health ailments that come with an adverse reaction to a fluoroquinolone, she has fought her way back to health. She is now fighting for recognition of the harm that these drugs can cause and hoping to help those who are suffering from them through their fluoroquinolone induced illness to find recovery. Her web site, Floxie Hope, highlights stories of hope and recovery. Mito Madness, also started by Lisa, focuses on the absurdity of ignoring the role of mitochondria in forming disease models.

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