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Danger of Safety Deafness to Pharma DTC Ads

Pharma ads are a relatively “new” phenomenon. In the late 1990s, the FDA allowed pharma companies to advertise directly to consumers (DTC). These DTC campaigns were reviled by physicians who believe that the ads would create pressure on them from the patients and disrupt that physician patient relationship.

Pharma companies do not have “free speech” because they operate under “commercial speech”. They are therefore dictated by the Food and Drug Administration (FDA) on what they are allowed to say and they are required to provide the information about the safety of the drug as part of “fair-balance”.

This is why you will see the disclaimers built into the ad, as the narrator smoothly go from talking about how the drug works and to ask your doctor about the drug to the standard —

“…WonderDrug is not for everyone. Women who are pregnant or nursing should not take WonderDrug. Your doctor may do routine liver testing when you are on WonderDrug. Do not take WonderDrug if you are also taking IncrediblePill. Patients who experience big toe palpitations should stop WonderDrug immediately and call their doctor….”

From an industry perspective, one of the arguments *for* DTC is that diseases and conditions become educational opportunities.

For example, depression is a stigmatized condition — then Pfizers happy little marshmallow cartoon (or pill? or cloud? I don’t know what that Zoloft character was meant to be) showed up on screen and it was a way to encourage consumers to talk to their doctors about conditions they may otherwise not discuss. For erectile dysfunction, it used to be an uncomfortable topic, but it is one of the side effects of diabetes and patients care about sexual function (compliance on meds) — so you have ads that break the ice of conversation that patients need to have so that doctors can work with them on adhering with medication regimen for best outcomes.

So there are definitely positives as a result of DTC.

On the other hand, when a DTC for restless leg syndrome came out, I didn’t like that campaign very much. I felt this was such a specialized population of patients, that having a DTC campaign may cause patients to start diagnosing themselves, erroneously, based on seconds of soundbite.

In the past when pharma companies have been sued for not disclosing safety risks and full side effect profile, their DTC ads have usually been part of the lawsuit where the charges would be that patients have not been properly informed of the full risks of the drug and that the time spent on effectiveness tips the fair balance to make the drug appear “safer than it should appear”.

Image by of the concerns I have is that over time, patients may begin to ignore those safety statements. This can be a real danger.

It’s not unlike how many of us have grown “blind” to online ads. We go to the website and our eyes are hit by ads all over the place, but we’ve trained ourselves to selectively ignore them. Ad-blindness is a real phenomenon and internet marketers talk about this and how to bypass or overcome them.

In pharma DTC, we may become so used to those safety disclaimers that we may become selectively deaf to those statements. Many of those statements are also repetitive and similar — such that we may begin to downplay the real risks that “need for liver monitoring” may pose.

Here’s an example from real life:

We’ve all seen various statin drug commercials — these are widely used blockbuster drugs. There are always safety statements about muscle weakness — sign of serious adverse event that can result in death.

One of my relatives was on a statin drug and he watches a lot of TV, he no doubt has seen ads for these statin drug commercials including the one he was taking. One afternoon when he visited and we were sitting at a picnic table he casually mentioned that he had trouble walking very far because he seems to have very low energy.

I knew he must be on a statin drug but he’s been on several drugs for several years: this person is a chronic smoker who still wouldn’t give up smoking or horrible fat-laden diet after multiple surgeries including a quadruple bypass (I am not kidding! Quadruple bypass! One of the most serious heart surgeries you can get). He’s always complaining of aches and pains — but still:

I asked him if he had switched meds recently and sure enough, he had been taken off an old statin in favor of “a newer” statin. I told him that he needed to call his doctor immediately and make sure that his “weakness” isn’t due to a serious adverse event like rhabdomyolysis, which can cause fatalities because of kidney over-burden.

He called his doctor and was taken off that statin to another statin and his “weakness” improved dramatically.

In other words, patients who are watching these commercials may grow deaf to these statements that sound very clinical but they don’t know what this looks like in real life. We aren’t thinking “oh I’m feeling this way because the drug is causing my muscle fibers to massively break down” — we think “I’m feeling really weak.”

“I saw a nurse – Where’s the doctor?”

You went to see the doctor and then realized that you talked to the nurse practitioner who ordered some tests — but you never saw the doctor! What’s going on?

In some states, a nurse practitioner (NP) has the same prescribing authority as the doctor, and may even act as a patient’s primary care “doctor” — thus I wouldn’t rule this out as a case of negligence, but more a prevailing norm of healthcare in a particular geographic area.

That said, you should absolutely be comfortable with the care you are receiving. If you want to see an MD instead of an NP, that is within your right as a patient!

I’ve heard of patients complain about their doctors not scheduling enough tests to rule out possible conditions associated with their complaint, so “test ordering” may depend on the context of the appointment. Often, physicians are not financially rewarded for ordering tests (costs the insurance companies too much) when compared to prescribing a drug (cheaper for insurance companies to pay for pills than an expensive scan).

For example, I had an acquaintance whose doctor was writing prescription drugs for her diabetic elderly father without doing any blood tests or monitoring. Her father began vomiting on a regular basis, and this doctor simply switched to writing other prescription drugs without figuring out why the patient was vomiting and becoming increasingly lethargic. She took her father to another doctor, who promptly ordered a series of tests to look at what was happening, and determined that the vomiting was mostly likely a serious adverse reaction to one of the diabetes medication. This doctor used the results of the tests to make a more informed clinical decision on which drug may keep the patient’s diabetes under control while minimizing the side effects that would prevent the patient from taking the drug regularly to keep symptoms at bay.

How you can still coach with compassion in pharma biotech

Most people in the pharmaceutical industry want to play by the rules and meet all compliance standards. I haven’t ever met any employee or managerial leader who has told me, “I want to bend the rules as much as possible then get the hell out of here, I can’t care less what happens to patients.”

However, where behavior and ideals collide, is when people observe inconsistencies with preached rules and prevailing behaviors that are rewarded.

Thus, pharma managers and executives must coach their teams on at least 2 levels:

Level 1 Tap into the Ideal Self

Coaching with compassion level may be done by tapping into the person’s ideal of how he and she wants to work in the role and in industry; that person’s vision of why s/he matters in the job s/he is doing.

Many people in industry do this for personal reasons, whether they’ve been a patient themselves or have had family and friends go through a health crisis that propelled them to want to get into the industry. Connecting with these ideals and catalytic events can rekindle that vision the employees held when they entered the industry.

Level 2 Navigate those risky gray areas

Discussing the inconsistencies that arise, and from the person’s positive emotional attractor state, to look at these inconsistencies and ask that person what s/he think is happening and then what s/he thinks about it.

This creates concrete examples that the leader/coach and team member can discuss, rather than generalities about “what we should and shouldn’t do, what we could and couldn’t do.”

Why Consumers aren’t Buying “High Cost-of-Developing Drugs” Argument

The Economist recently published an article on the government of India denying Novartis the patent for its cancer drug, Glivec (in the U.S. marketed as Gleevec).

In reading the reader comments, it is obvious that a sense of fairness violation was perceived by readers who felt that the government was correct in denying Novartis this patent, given that the readers perceived the company should have “made back its R&D losses” in developing this drug and beyond.
Image by Chris Holder
Pharma companies cite R&D development costs as well as the pitiful yield in its success rate in developing novel drugs as the reason why drugs cost so much. Thus patent is given as a way for companies to recover overall losses in this risk-intensive business as well as remain sustainable over the long term.

Yet companies are also known to go for patent extension strategies that do not represent truly novel contribution to market, by creating slightly different forms – or formulations of the drug – and then gaining patent on that slightly different form. Then companies use their sales and marketing arms to then keep patients on the “newer” (in patients’ mind, “better”?) version of the drug instead of the cheaper generic.

Those who argue for patent protection speaks about the risk and astronomical costs in bringing a drug to market. This is true, especially during human clinical trials, which consumers are rarely given the full picture of just how much “each patient” in a clinical trial actually costs the company to run the complete trial, especially when there is tremendous overhead in setting up these trials across different clinical settings within the country.

But consumers also perceive the unfairness of the pricing and when it comes to healthcare and medicine, emotions run high and it is common to conclude that pharma companies are greedy and being unfair given that they should have had already recuperated on their fixed costs and now they are using strategies to boost their bottom-line when they aren’t really investing in that drug (but they have to keep investing in their pipelines of drugs, many of which will fail, rendering huge losses to the companies).

Drug companies try, and its advocacy arm (PhRMA in the u.s.) tries, but the approach and message don’t seem effective. These messages are often very abstract and statistics-driven, which do not lend well to personalization. Statistics aren’t stories the average consumer can relate to.

Medical Decision Making and Conflicts of Interest

Dr. Peter Ubel is a professor at Duke University and gave a guest lecture for Dan Ariely’s (also a professor at Duke) Coursera class on Irrational Behavior economics. Ubel’s lecture talks about a colleague who told a leukemia patient that the patient’s chance of recovery if he undergoes chemotherapy was 20%, which was an overstatement of the 5% benefit of chemotherapy for leukemia, especially considering the side effects:

“In Mr. Andrews case, a 5% chance that his leukemia would respond to chemotherapy and yet the oncologist told him that it was 20% odds. Is that a lie? Well here I want just tell you. It’s not just patients who are prone to strange decisions in medical contexts. We physicians are prone to those too. And I don’t think that that oncologist lied. I think that oncologist when asked straight up front what are my odds of getting benefit from the chemo had that 5% number in her head. And immediately started recalculating because it’s so hard to give someone such dismal news.” [Source: Coursera week 3 on Dishonesty

One of the students in the course was outraged that Dr. Ubel did not come right out and confront his colleague as well as tell the patient that his colleague “had lied.” I was troubled that Dr. Ubel did not have a conversation with his colleague about his concerns, because this must happen not just with this one oncologist, but many others who pull numbers out of their own “clinical judgment” hats. However, Dr. Ubel did go back to challenge the patient’s decision, but in a way that also elicited the patient to reveal why he had chosen to go with the most aggressive treatment (the patient revealed that his partner had passed away of AIDS and was a fighter and that his partner would have wanted the patient to fight as well).

I believe that if Dr. Ubel had learned that the patient was swayed primarily by the oncologist’s judgment and nothing else, then he would make sure that the patient understands the “true statistics” and what aggressive chemotherapy or radiation therapy entails. This is the reason why Dr. Ubel did have that follow-up conversation with the patient, and based on the patient’s own explanation, knew that the patient was truly making an informed decision that respects the patient’s own wishes, not just relying on what the oncologist claims.

It is indeed true that the medical profession upholds a certain “code of brotherhood” where physicians don’t call out each other’s biases, and that this poses a major problem in deciding in the “best” interest of patients. However, I personally didn’t perceive this to have happened in Dr. Ubel’s example. I perceived that he felt as troubled by the oncologist’s claim as we all did when we knew the conflict of interest in the oncologist’s claim.

Part of the office hour video, which I wasn’t able to watch completely, included Dr. Ubel talk about how “hope” is important to patients and therefore physicians must also take into consideration the effect of hope and not necessarily give patients false hope, but also not to dash hope by quoting death statistics. Yet this oncologist who had overstated the chemotherapy’s benefit of 20% instead of the truthful 5%, had done so by calculating her own biases of hope (these may not necessarily be false hope, it may very well reflect her own hope for the patient).

We don’t like physicians to give us cold, clinically calculated statistics that may or may not be true for us as individual patients. But we also don’t like physicians to overstate and give us false hope. This is the kind of balance that makes medicine more an “art” than science even when we have all this scientific data at our fingertips.

More from Dr. Ubel

Whatever Ethics We Are Legislating, Money is Overriding

Back in 2003 when I worked in pharma, this would have been major mind-boggling news (when Pfizer paid over $400M in fines). Now, almost 10 years later, pharmacos “set aside money” for penalty and this sort of news is no longer news. Whatever ethics we are legislating, it is obviously not working against financial incentives that drive this behavior.

Patients Shouldn’t be Trusted with Their Own Vital Data

I was reading a recent issue of The Economist that talked about possible innovation of something akin to a medical tricorder, and there was a paragraph about the amount of resistance from the medical establishment because it does not believe that patients could be trusted with their own data:

Not everyone is excited about patients taking matters into their own hands. Health care is a very paternalistic industry, and “physicians don’t want patients to become independent and too empowered,” says Mr Wasden of PwC. “The medical community has always been very conservative,” says Yan Chow, director of innovation and advanced technology at Kaiser Permanente, a non-profit health-care provider. “It’s very hard to change things.”

Moreover, doctors may be reluctant to use data collected by patients. Instead of measuring vital signs at an annual check-up, they could find themselves being asked to examine huge data sets created by patients—raising the question of legal liability if something is missed. “The irony is that a doctor is more comfortable with the liability in a system that does not have rich data than in a system that does have rich data,” says Mr Wasden. Another difficulty is that electronic health records are not designed to allow for the inclusion of patient-generated data, says Dr Chow.
“As medicine becomes more of an information science, some tasks could be taken on by patients.”

Some of the new diagnostic tools may be financially threatening to doctors, especially in disciplines such as optometry, dermatology and paediatrics, says Dr Topol. Why would you visit a specialist, he asks, when a mobile device lets you test your eyes, diagnose skin lesions or determine whether your child has an ear infection? But as medicine becomes more of an information science, some mundane and simple tasks could be taken over by patients, which could free up doctors for more demanding problems, argues Mr Jones.

I’m wondering how long the stronghold of the establishment can keep.

One of the upside of social media and technology is that patients are beginning to self-educate AND self-advocate (instead of only “self-medicate” as in days past) — and once we have a level of awareness, we start asking questions about what’s happening with our care and what’s happening with our vital data.

Even infants grow up one day to expect a level of self-reliance from their fathers.

Dear medical establishment, you can’t infantilize patients forever, even in the name of “patients’ own good.”

Can pharma really afford to “be more human”?

The recent hullabaloo with some pharma companies pulling out of Facebook got me thinking about whether it is even probable for pharma companies to come across as “more human” and therefore viewed as willing to connect with consumers/patients beyond the PR and marketing scripts.

For example, can pharma companies — whether on Twitter or Facebook — afford to respond with “I don’t know” when asked a question*?

*They are free to follow up with, “I’m not the best person to give you this advice, your doctor is, how may I help you engage your doctor so that you can get meaningful dialog going?”

Can pharma companies afford to say, “we have seen this side effect in our clinical studies that we’ve submitted to the FDA” when patient complains about a certain side effect?

Can pharma companies afford to say, “I’m sorry”?

Is this the problem? — That pharma companies believe they simply cannot afford to come across as more human because of what it will cost?

What do you think?

Entrepreneurs? Please — Disrupt Healthcare!

I was inspired to write this post to answer a question on Quora: “Can a consumer internet entrepreneur cross over into the healthcare space with limited domain expertise?”


But you will need —

A compelling motive.
I know of a CEO who was trained as a lawyer. Her child had a rare disease and current treatments weren’t cutting it. Instead of getting frustrated, she founded a life science company to focus on this disease. She had a compelling motive, which is almost always personal in nature.

A compelling vision.
I agree with you that healthcare is ripe for disruption. It’s been ripe for years. So why hasn’t anyone disrupted it? Because the constituents in the system need to “get on board”. Depending on who you’re targeting, you will need to have a compelling vision to get them to “buy into” what you’re trying to do, rather than opting for the status quo. Because I’m telling you right now — the status quo is very, very comfortable. People like to be comfortable.

A compelling set of competencies.
If you don’t have the subject matter expertise, hire it. If you don’t have the management prowess to herd all the cats you need on board to make this thing happen, hire it. Whatever competencies you lack, you can always fill it with persons who live and breathe these competencies. You may even need to hire the right people who know how to hire the right people.

Never underestimate the importance of hiring the right people who must execute on your leadership vision. That CEO who went ahead and built that company I talked about earlier? She hired the wrong person (he had great interpersonal skills, just not the right subject matter expertise) and as a result, he almost bankrupted the company by screwing up critical decisions. People skills are critical yes, but in healthcare, depending on what you’re dealing with, you’d better hire the right subject matter experts where it counts.

You focus on what you do best — but don’t assume that your motive or vision can carry you all the way through. I’d hate nothing more than to see a grand vision or disruption get systematically drained by lack of competencies needed to execute on motive and vision.

You can do it.

74% of Medical Students Believe Pharma Sponsored Grand Rounds are Biased

PLoS medicine did an analysis of medical students’ attitudes toward pharma marketing to them, and not surprisingly, they’re skeptical and confused.

I say not surprising because that attitude translates to how physicians feel about pharma, except they are more indignant:

“What, Me, corruptible?! How dare you! Sir, I am a PROFESSIONAL!”

I’ll let Robert Cialdini, author of the definitive book on Influence, respond for me, “Please excuse me while I, a scientist, Laugh.” But I digress.

Rather than read the paper, look at the data, which is what you would want to do anyway as a critical, discerning observer/consumer.

Look at the data table of what medical students say about their interactions – 74% say that industry supported grand rounds and CMEs are “biased”.

This matches up with physicians’ attitudes about how CMEs supported by pharma are “biased”.

Yet they keep accepting pharma supported events and food. Why?

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