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Case 1: A 48-year-old female with a 10-year history of left-sided Ulcerative Colitis (UC) has been well controlled on an injectable biologic for 5 years. Her last colonoscopy one year ago was normal without erythema or friability. She presents for an interim visit due to an increase in stool frequency from 2 to 4 bowel movements a day. She denies urgency, nocturnal bowel movements, or blood in her stool. She is concerned about a disease flare and wonders if she is on the right medication. She just saw a TV ad for a new oral UC medication and wants to switch because she prefers an oral medication to an injectable one. Physical exam was normal and in-office flexible sigmoidoscopy demonstrates no change in her colon appearance. You advise her to stay on the biologic because she is still considered well-controlled. She insists on being switched to the new oral medicine. When you probe her more, she says that the TV ad she saw shows people getting the medicine leading normal lives, which has enormous appeal to her.
Case 2: A 52-year-old healthy male is referred for colonoscopy evaluation. He reports no change in bowel habits with rare blood in his stool and thinks his uncle had colon cancer at age 48. He is anxious and not very receptive to having a procedure. He recently saw a TV advertisement promoting non-colonoscopy-based colon cancer screening. You recommend a colonoscopy based on his family history, but he insists on stool-based screening.
Case 3: A 32-year-old female with moderately to well-controlled IBD asks you to review a new “multi-omic” profile of her gut microbiome that she saw advertised on social media. The test report she provides contains a snapshot of her microbiome including abundances of single species and predicted functions for these bacteria from a single stool sample collected and submitted 6 months ago. You counsel her on the role of the gut microbiome in IBD and explain that currently there is not enough knowledge or technology to incorporate these test results into clinical care yet. The patient is frustrated and wants to know why you’re “behind the times.”
These cases may sound familiar to a practicing gastroenterologist. The platform driving all three of these clinical encounters, direct-to-consumer advertising (DTCA), is a legal mechanism by which a commercial entity can communicate directly with the consumer about a medicine or device, bypassing a health care professional.
In the 1960s, Congress granted the Food and Drug Administration regulatory authority over prescription drug labeling and advertising. This included ensuring that ads (1) were not false or misleading, (2) presented a “fair balance” of drug risks and benefits, (3) included facts “material” to a drug’s advertised uses, and (4) included a “brief summary” of all risks described in the drug’s labeling.
Direct-to-consumer advertising increased dramatically in the late 1990s after the FDA eased regulations around risk information by requiring ads to include only “major risks” and provide resources directing consumers to full risk information.
In 2022, the top 10 pharmaceutical ad spenders combined for a total of about $1.7 billion in TV ad spend, with the two top categories being inflammation and diabetes.
The role of the FDA in regulating DTCA of at-home tests is still evolving and largely depends on the intended use of the test results and the health claims used to market the test (that is, whether the test is designed to simply return general information, as in case 3 where DTCA regulations may not apply, or is marketed with specific medical claims or diagnostic interpretations, as in case 2 with clear applications for DTCA regulations.).
It has both potential benefits and potential risks. DTCA can serve to increase disease awareness (e.g., the need for colon cancer screening). It may also prompt patients who might otherwise disregard “red flag” signs and symptoms to seek medical evaluation (e.g., rectal bleeding). DTCA can also alert healthcare providers to new treatment options for diseases within their scope of practice and encourage them to expand their armamentarium.
In bioethics terms, DTCA can be beneficial in facilitating patient autonomy and promoting justice. For example, DTCA can “even the playing field” by ensuring that patients have equitable access to information about available treatments regardless of their socioeconomic status. In doing so, it can empower patients and allow them to have more meaningful discussions with their health care providers and make more informed decisions. In addition, patients may be introduced to alternative testing modalities (i.e., stool-based CRC screening) that, while not necessarily the best screening modality given individual risk (as in Case 2), may offer benefit with greater acceptance compared to inaction (i.e., no screening). Last, the idea of direct-to-consumer “omics” profiling has empowered patients as “citizen scientists” and led to the advent of “biohacking” among the lay population. In doing so, it has challenged the previous bounds of patient autonomy in healthcare by broadening the types of personal health data available to individuals, even when the clinical utility of this data may not yet be clear.
On the flip side, it is undeniable that DTCA of medical products is driven by commercial interests. Branded drugs are primarily, if not exclusively, promoted in DTCA, but these drugs may not always align with standard of care treatment recommendations. A study published in February 2023 in JAMA found that drugs with lower added clinical benefit and higher total sales were associated with higher DTCA spending.
With patients entering medical encounters with preconceived notions of what drugs they want to be prescribed based on media exposure, the ability of health care providers to provide sound medical advice regarding treatment may be circumvented. A patient’s preferred therapy based on exposure to DTCA may sharply contrast with their provider’s recommendation based on their experience and expertise and knowledge of the patient’s unique clinical history.
Unreasonable expectations
An additional potential downside of DTCA is that it can instill unreasonable expectations on the part of patients that the advertised product will benefit them. While DTCA is required to be fair and balanced in reporting benefits and risks, it is difficult to meaningfully address nuanced clinical risks in a brief TV ad and patients may come away with a skewed view of the risk-benefit equation. Furthermore, social media advertising and associated formats may not provide the same level of digestible information as other forms of media and are targeted to individuals likely to identify with the product. Finally, as stated above, only branded products (vs. generics) are advertised. Branded products are generally more costly, and where less expensive and equally effective therapies exist societal costs need to be considered. This can lead to inequities in distributive justice which is the societal allocation of resources. The more the healthcare market is driven towards higher costs in one segment, the less resources are available in another. This may affect regions where healthcare resources are limited.
Shared decision-making
Returning to the 3 cases above, in case 1 the UC patient’s awareness of new treatment options has prompted a shared decision-making discussion. She has a renewed interest in exploring a different route of medication administration because of DTCA. In spite of the patient seemingly well-controlled on her current IBD therapy and minor fluctuations in symptoms that might otherwise be a reason to observe more closely, the patient sees this as a reason to change her treatment based on her impression from the DTCA.
Regarding case 2, disease awareness and CRC screening acceptance is itself a positive outcome. Although commercially driven, the outcome/benefit to society leads to a decrease in disease burden and is a ready alternative with established benefits compared to no screening.
Regarding the proactive “omics-curious” IBD patient in case 3, despite the patient’s disappointment with the DCTA-promoted test’s limited clinical utility at this time, the patient may be communicating a general openness to novel approaches to treating IBD and to advancing her understanding of her disease.
So where does that leave you as a clinician?
As of today, if you live in the U.S., DTCA is a reality. As you navigate day-to-day patient interactions, it is important to keep in mind that your first obligation is to your patients and their best medical interests. Having a well-informed and engaged patient is a positive effect of DTCA over the past 30 years despite the challenging discussions you sometimes are forced to have. In many cases, patients are more self-aware of and engaged in their health and are acting on it due to direct acquisition of information from DTCA platforms. As a clinician, you have an ethical obligation to educate your patients and manage expectations, even when those expectations may be formed on the basis of DTCA with inherent conflicts of interest for promoting a product. Moreover, though certain products may be trendy or promoted on a popular science basis, the underlying technology (i.e. stool-based screening or metagenomics) and/or resultant data are likely not well understood by the typical lay patient, such that it may be difficult for a patient to comprehend how the product may not be particularly informative or inappropriate with respect to their personal medical history without additional counseling. Despite the potentially awkward clinician-patient dynamic precipitated by DTCA, these moments do offer an opportunity for you to gain rapport with your patients by taking the time to fill in the gaps of their understanding of their treatment plans, alternatives, individual risk factors and/or disease while gaining a greater appreciation for what they may personally prioritize with respect to their own health. Ultimately, as we transition further toward precision medicine approaches in healthcare, shared interest in individualized health decisions, at least partially informed by DTCA, is a positive outcome.
Dr. Sloan is a chief medical officer at Abivax. He is a member of the AGA Ethics Committee for COI. David A. Drew, PhD is assistant professor of medicine, Harvard Medical School, Boston. He is director of the Massachusetts General Hospital Biobanking, Clinical & Translational Epidemiology Unit, Boston. He is a member of the AGA Ethics Committee.
Case 1: A 48-year-old female with a 10-year history of left-sided Ulcerative Colitis (UC) has been well controlled on an injectable biologic for 5 years. Her last colonoscopy one year ago was normal without erythema or friability. She presents for an interim visit due to an increase in stool frequency from 2 to 4 bowel movements a day. She denies urgency, nocturnal bowel movements, or blood in her stool. She is concerned about a disease flare and wonders if she is on the right medication. She just saw a TV ad for a new oral UC medication and wants to switch because she prefers an oral medication to an injectable one. Physical exam was normal and in-office flexible sigmoidoscopy demonstrates no change in her colon appearance. You advise her to stay on the biologic because she is still considered well-controlled. She insists on being switched to the new oral medicine. When you probe her more, she says that the TV ad she saw shows people getting the medicine leading normal lives, which has enormous appeal to her.
Case 2: A 52-year-old healthy male is referred for colonoscopy evaluation. He reports no change in bowel habits with rare blood in his stool and thinks his uncle had colon cancer at age 48. He is anxious and not very receptive to having a procedure. He recently saw a TV advertisement promoting non-colonoscopy-based colon cancer screening. You recommend a colonoscopy based on his family history, but he insists on stool-based screening.
Case 3: A 32-year-old female with moderately to well-controlled IBD asks you to review a new “multi-omic” profile of her gut microbiome that she saw advertised on social media. The test report she provides contains a snapshot of her microbiome including abundances of single species and predicted functions for these bacteria from a single stool sample collected and submitted 6 months ago. You counsel her on the role of the gut microbiome in IBD and explain that currently there is not enough knowledge or technology to incorporate these test results into clinical care yet. The patient is frustrated and wants to know why you’re “behind the times.”
These cases may sound familiar to a practicing gastroenterologist. The platform driving all three of these clinical encounters, direct-to-consumer advertising (DTCA), is a legal mechanism by which a commercial entity can communicate directly with the consumer about a medicine or device, bypassing a health care professional.
In the 1960s, Congress granted the Food and Drug Administration regulatory authority over prescription drug labeling and advertising. This included ensuring that ads (1) were not false or misleading, (2) presented a “fair balance” of drug risks and benefits, (3) included facts “material” to a drug’s advertised uses, and (4) included a “brief summary” of all risks described in the drug’s labeling.
Direct-to-consumer advertising increased dramatically in the late 1990s after the FDA eased regulations around risk information by requiring ads to include only “major risks” and provide resources directing consumers to full risk information.
In 2022, the top 10 pharmaceutical ad spenders combined for a total of about $1.7 billion in TV ad spend, with the two top categories being inflammation and diabetes.
The role of the FDA in regulating DTCA of at-home tests is still evolving and largely depends on the intended use of the test results and the health claims used to market the test (that is, whether the test is designed to simply return general information, as in case 3 where DTCA regulations may not apply, or is marketed with specific medical claims or diagnostic interpretations, as in case 2 with clear applications for DTCA regulations.).
It has both potential benefits and potential risks. DTCA can serve to increase disease awareness (e.g., the need for colon cancer screening). It may also prompt patients who might otherwise disregard “red flag” signs and symptoms to seek medical evaluation (e.g., rectal bleeding). DTCA can also alert healthcare providers to new treatment options for diseases within their scope of practice and encourage them to expand their armamentarium.
In bioethics terms, DTCA can be beneficial in facilitating patient autonomy and promoting justice. For example, DTCA can “even the playing field” by ensuring that patients have equitable access to information about available treatments regardless of their socioeconomic status. In doing so, it can empower patients and allow them to have more meaningful discussions with their health care providers and make more informed decisions. In addition, patients may be introduced to alternative testing modalities (i.e., stool-based CRC screening) that, while not necessarily the best screening modality given individual risk (as in Case 2), may offer benefit with greater acceptance compared to inaction (i.e., no screening). Last, the idea of direct-to-consumer “omics” profiling has empowered patients as “citizen scientists” and led to the advent of “biohacking” among the lay population. In doing so, it has challenged the previous bounds of patient autonomy in healthcare by broadening the types of personal health data available to individuals, even when the clinical utility of this data may not yet be clear.
On the flip side, it is undeniable that DTCA of medical products is driven by commercial interests. Branded drugs are primarily, if not exclusively, promoted in DTCA, but these drugs may not always align with standard of care treatment recommendations. A study published in February 2023 in JAMA found that drugs with lower added clinical benefit and higher total sales were associated with higher DTCA spending.
With patients entering medical encounters with preconceived notions of what drugs they want to be prescribed based on media exposure, the ability of health care providers to provide sound medical advice regarding treatment may be circumvented. A patient’s preferred therapy based on exposure to DTCA may sharply contrast with their provider’s recommendation based on their experience and expertise and knowledge of the patient’s unique clinical history.
Unreasonable expectations
An additional potential downside of DTCA is that it can instill unreasonable expectations on the part of patients that the advertised product will benefit them. While DTCA is required to be fair and balanced in reporting benefits and risks, it is difficult to meaningfully address nuanced clinical risks in a brief TV ad and patients may come away with a skewed view of the risk-benefit equation. Furthermore, social media advertising and associated formats may not provide the same level of digestible information as other forms of media and are targeted to individuals likely to identify with the product. Finally, as stated above, only branded products (vs. generics) are advertised. Branded products are generally more costly, and where less expensive and equally effective therapies exist societal costs need to be considered. This can lead to inequities in distributive justice which is the societal allocation of resources. The more the healthcare market is driven towards higher costs in one segment, the less resources are available in another. This may affect regions where healthcare resources are limited.
Shared decision-making
Returning to the 3 cases above, in case 1 the UC patient’s awareness of new treatment options has prompted a shared decision-making discussion. She has a renewed interest in exploring a different route of medication administration because of DTCA. In spite of the patient seemingly well-controlled on her current IBD therapy and minor fluctuations in symptoms that might otherwise be a reason to observe more closely, the patient sees this as a reason to change her treatment based on her impression from the DTCA.
Regarding case 2, disease awareness and CRC screening acceptance is itself a positive outcome. Although commercially driven, the outcome/benefit to society leads to a decrease in disease burden and is a ready alternative with established benefits compared to no screening.
Regarding the proactive “omics-curious” IBD patient in case 3, despite the patient’s disappointment with the DCTA-promoted test’s limited clinical utility at this time, the patient may be communicating a general openness to novel approaches to treating IBD and to advancing her understanding of her disease.
So where does that leave you as a clinician?
As of today, if you live in the U.S., DTCA is a reality. As you navigate day-to-day patient interactions, it is important to keep in mind that your first obligation is to your patients and their best medical interests. Having a well-informed and engaged patient is a positive effect of DTCA over the past 30 years despite the challenging discussions you sometimes are forced to have. In many cases, patients are more self-aware of and engaged in their health and are acting on it due to direct acquisition of information from DTCA platforms. As a clinician, you have an ethical obligation to educate your patients and manage expectations, even when those expectations may be formed on the basis of DTCA with inherent conflicts of interest for promoting a product. Moreover, though certain products may be trendy or promoted on a popular science basis, the underlying technology (i.e. stool-based screening or metagenomics) and/or resultant data are likely not well understood by the typical lay patient, such that it may be difficult for a patient to comprehend how the product may not be particularly informative or inappropriate with respect to their personal medical history without additional counseling. Despite the potentially awkward clinician-patient dynamic precipitated by DTCA, these moments do offer an opportunity for you to gain rapport with your patients by taking the time to fill in the gaps of their understanding of their treatment plans, alternatives, individual risk factors and/or disease while gaining a greater appreciation for what they may personally prioritize with respect to their own health. Ultimately, as we transition further toward precision medicine approaches in healthcare, shared interest in individualized health decisions, at least partially informed by DTCA, is a positive outcome.
Dr. Sloan is a chief medical officer at Abivax. He is a member of the AGA Ethics Committee for COI. David A. Drew, PhD is assistant professor of medicine, Harvard Medical School, Boston. He is director of the Massachusetts General Hospital Biobanking, Clinical & Translational Epidemiology Unit, Boston. He is a member of the AGA Ethics Committee.
Case 1: A 48-year-old female with a 10-year history of left-sided Ulcerative Colitis (UC) has been well controlled on an injectable biologic for 5 years. Her last colonoscopy one year ago was normal without erythema or friability. She presents for an interim visit due to an increase in stool frequency from 2 to 4 bowel movements a day. She denies urgency, nocturnal bowel movements, or blood in her stool. She is concerned about a disease flare and wonders if she is on the right medication. She just saw a TV ad for a new oral UC medication and wants to switch because she prefers an oral medication to an injectable one. Physical exam was normal and in-office flexible sigmoidoscopy demonstrates no change in her colon appearance. You advise her to stay on the biologic because she is still considered well-controlled. She insists on being switched to the new oral medicine. When you probe her more, she says that the TV ad she saw shows people getting the medicine leading normal lives, which has enormous appeal to her.
Case 2: A 52-year-old healthy male is referred for colonoscopy evaluation. He reports no change in bowel habits with rare blood in his stool and thinks his uncle had colon cancer at age 48. He is anxious and not very receptive to having a procedure. He recently saw a TV advertisement promoting non-colonoscopy-based colon cancer screening. You recommend a colonoscopy based on his family history, but he insists on stool-based screening.
Case 3: A 32-year-old female with moderately to well-controlled IBD asks you to review a new “multi-omic” profile of her gut microbiome that she saw advertised on social media. The test report she provides contains a snapshot of her microbiome including abundances of single species and predicted functions for these bacteria from a single stool sample collected and submitted 6 months ago. You counsel her on the role of the gut microbiome in IBD and explain that currently there is not enough knowledge or technology to incorporate these test results into clinical care yet. The patient is frustrated and wants to know why you’re “behind the times.”
These cases may sound familiar to a practicing gastroenterologist. The platform driving all three of these clinical encounters, direct-to-consumer advertising (DTCA), is a legal mechanism by which a commercial entity can communicate directly with the consumer about a medicine or device, bypassing a health care professional.
In the 1960s, Congress granted the Food and Drug Administration regulatory authority over prescription drug labeling and advertising. This included ensuring that ads (1) were not false or misleading, (2) presented a “fair balance” of drug risks and benefits, (3) included facts “material” to a drug’s advertised uses, and (4) included a “brief summary” of all risks described in the drug’s labeling.
Direct-to-consumer advertising increased dramatically in the late 1990s after the FDA eased regulations around risk information by requiring ads to include only “major risks” and provide resources directing consumers to full risk information.
In 2022, the top 10 pharmaceutical ad spenders combined for a total of about $1.7 billion in TV ad spend, with the two top categories being inflammation and diabetes.
The role of the FDA in regulating DTCA of at-home tests is still evolving and largely depends on the intended use of the test results and the health claims used to market the test (that is, whether the test is designed to simply return general information, as in case 3 where DTCA regulations may not apply, or is marketed with specific medical claims or diagnostic interpretations, as in case 2 with clear applications for DTCA regulations.).
It has both potential benefits and potential risks. DTCA can serve to increase disease awareness (e.g., the need for colon cancer screening). It may also prompt patients who might otherwise disregard “red flag” signs and symptoms to seek medical evaluation (e.g., rectal bleeding). DTCA can also alert healthcare providers to new treatment options for diseases within their scope of practice and encourage them to expand their armamentarium.
In bioethics terms, DTCA can be beneficial in facilitating patient autonomy and promoting justice. For example, DTCA can “even the playing field” by ensuring that patients have equitable access to information about available treatments regardless of their socioeconomic status. In doing so, it can empower patients and allow them to have more meaningful discussions with their health care providers and make more informed decisions. In addition, patients may be introduced to alternative testing modalities (i.e., stool-based CRC screening) that, while not necessarily the best screening modality given individual risk (as in Case 2), may offer benefit with greater acceptance compared to inaction (i.e., no screening). Last, the idea of direct-to-consumer “omics” profiling has empowered patients as “citizen scientists” and led to the advent of “biohacking” among the lay population. In doing so, it has challenged the previous bounds of patient autonomy in healthcare by broadening the types of personal health data available to individuals, even when the clinical utility of this data may not yet be clear.
On the flip side, it is undeniable that DTCA of medical products is driven by commercial interests. Branded drugs are primarily, if not exclusively, promoted in DTCA, but these drugs may not always align with standard of care treatment recommendations. A study published in February 2023 in JAMA found that drugs with lower added clinical benefit and higher total sales were associated with higher DTCA spending.
With patients entering medical encounters with preconceived notions of what drugs they want to be prescribed based on media exposure, the ability of health care providers to provide sound medical advice regarding treatment may be circumvented. A patient’s preferred therapy based on exposure to DTCA may sharply contrast with their provider’s recommendation based on their experience and expertise and knowledge of the patient’s unique clinical history.
Unreasonable expectations
An additional potential downside of DTCA is that it can instill unreasonable expectations on the part of patients that the advertised product will benefit them. While DTCA is required to be fair and balanced in reporting benefits and risks, it is difficult to meaningfully address nuanced clinical risks in a brief TV ad and patients may come away with a skewed view of the risk-benefit equation. Furthermore, social media advertising and associated formats may not provide the same level of digestible information as other forms of media and are targeted to individuals likely to identify with the product. Finally, as stated above, only branded products (vs. generics) are advertised. Branded products are generally more costly, and where less expensive and equally effective therapies exist societal costs need to be considered. This can lead to inequities in distributive justice which is the societal allocation of resources. The more the healthcare market is driven towards higher costs in one segment, the less resources are available in another. This may affect regions where healthcare resources are limited.
Shared decision-making
Returning to the 3 cases above, in case 1 the UC patient’s awareness of new treatment options has prompted a shared decision-making discussion. She has a renewed interest in exploring a different route of medication administration because of DTCA. In spite of the patient seemingly well-controlled on her current IBD therapy and minor fluctuations in symptoms that might otherwise be a reason to observe more closely, the patient sees this as a reason to change her treatment based on her impression from the DTCA.
Regarding case 2, disease awareness and CRC screening acceptance is itself a positive outcome. Although commercially driven, the outcome/benefit to society leads to a decrease in disease burden and is a ready alternative with established benefits compared to no screening.
Regarding the proactive “omics-curious” IBD patient in case 3, despite the patient’s disappointment with the DCTA-promoted test’s limited clinical utility at this time, the patient may be communicating a general openness to novel approaches to treating IBD and to advancing her understanding of her disease.
So where does that leave you as a clinician?
As of today, if you live in the U.S., DTCA is a reality. As you navigate day-to-day patient interactions, it is important to keep in mind that your first obligation is to your patients and their best medical interests. Having a well-informed and engaged patient is a positive effect of DTCA over the past 30 years despite the challenging discussions you sometimes are forced to have. In many cases, patients are more self-aware of and engaged in their health and are acting on it due to direct acquisition of information from DTCA platforms. As a clinician, you have an ethical obligation to educate your patients and manage expectations, even when those expectations may be formed on the basis of DTCA with inherent conflicts of interest for promoting a product. Moreover, though certain products may be trendy or promoted on a popular science basis, the underlying technology (i.e. stool-based screening or metagenomics) and/or resultant data are likely not well understood by the typical lay patient, such that it may be difficult for a patient to comprehend how the product may not be particularly informative or inappropriate with respect to their personal medical history without additional counseling. Despite the potentially awkward clinician-patient dynamic precipitated by DTCA, these moments do offer an opportunity for you to gain rapport with your patients by taking the time to fill in the gaps of their understanding of their treatment plans, alternatives, individual risk factors and/or disease while gaining a greater appreciation for what they may personally prioritize with respect to their own health. Ultimately, as we transition further toward precision medicine approaches in healthcare, shared interest in individualized health decisions, at least partially informed by DTCA, is a positive outcome.
Dr. Sloan is a chief medical officer at Abivax. He is a member of the AGA Ethics Committee for COI. David A. Drew, PhD is assistant professor of medicine, Harvard Medical School, Boston. He is director of the Massachusetts General Hospital Biobanking, Clinical & Translational Epidemiology Unit, Boston. He is a member of the AGA Ethics Committee.