Direct-to-consumer advertising (DTCA) refers to the
marketing and advertising of
pharmaceutical products
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...
directly to consumers as patients, as opposed to specifically targeting
health professionals. The term is synonymous primarily with the advertising of
prescription medicine
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The rea ...
s via
mass media
Mass media refers to a diverse array of media technologies that reach a large audience via mass communication. The technologies through which this communication takes place include a variety of outlets.
Broadcast media transmit informati ...
platforms—most commonly on
television
Television, sometimes shortened to TV, is a telecommunication medium for transmitting moving images and sound. The term can refer to a television set, or the medium of television transmission. Television is a mass medium for advertisin ...
and in
magazines, but also via
online
In computer technology and telecommunications, online indicates a state of connectivity and offline indicates a disconnected state. In modern terminology, this usually refers to an Internet connection, but (especially when expressed "on line" o ...
platforms.
Direct-to-consumer advertising is only completely legal in New Zealand and the United States, but are subject to regulations regarding the balanced disclosure of a prescription's benefits in comparison to its risks (including but not limited to
side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s and
contraindication
In medicine, a contraindication is a condition that serves as a reason not to take a certain medical treatment due to the harm that it would cause the patient. Contraindication is the opposite of indication, which is a reason to use a certain tre ...
s), among other factors.
Regulations regarding DTCA are typically applied to advertising materials that describe a prescription's
indications and benefits, and may be more lenient to advertising materials which do not discuss uses. Many countries ban any advertising of prescription drugs directly to consumers.
There are
ethical
Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns ma ...
and regulatory concerns regarding DTCA, specifically the extent to which these ads may unduly influence the prescribing of the prescriptions based on consumer demands when, in some cases, they may not be medically necessary, or there are cheaper options available. Critics of DTCA have argued that too much is spent on marketing medications, rather than into research and development; in the United States, ad spending by drugmakers reached
US$
The United States dollar (symbol: $; code: USD; also abbreviated US$ or U.S. Dollar, to distinguish it from other dollar-denominated currencies; referred to as the dollar, U.S. dollar, American dollar, or colloquially buck) is the official ...
5.2 billion in 2016.
Types
The U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) defines several common types of DTCA for prescription medication:
* A "product claim" advertisement identifies the
nonproprietary and
trade names
A trade name, trading name, or business name, is a pseudonym used by companies that do not operate under their registered company name. The term for this type of alternative name is a "fictitious" business name. Registering the fictitious name w ...
of the medication, and contains at least one approved
indication, and claims surrounding its benefits.
* A "reminder" advertisement is designed to build
brand recognition
Brand awareness is the extent to which customers are able to recall or recognize a brand under different conditions. Brand awareness is one of two dimensions from brand knowledge, an associative network memory model. Brand awareness is a key consi ...
for a medication. Reminder ads cannot contain any information or imagery that pertain to the medication's approved uses, but may have themes that vaguely allude to them;
for example, a reminder commercial for the
erectile dysfunction drug
Viagra
Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by ...
featured the showtune "
Good Morning
"Good morning" is a common greeting in the English language. It may also refer to:
Television
* ''Good Morning!!!'' (Australian show), a children's show
* ''Good Morning'' (New Zealand show), a daytime talk show
* ''Good Morning'' (Russian ...
" and scenes of a man happily walking to work, emphasizing a sexual
innuendo
An innuendo is a hint, insinuation or intimation about a person or thing, especially of a denigrating or derogatory nature. It can also be a remark or question, typically disparaging (also called insinuation), that works obliquely by allusion ...
in the lyric "it's great to stay up late".
They may still contain a
call to action
Call to Action (CTA) is an American organization that advocates a variety of changes in the Catholic Church. Call To Action's goals are to change church teachings in such areas as mandatory celibacy for priests, the male-only priesthood, the selec ...
urging viewers to ask their doctor or seek an external resource (such as a website or phone hotline) for more information.
* A "help-seeking" advertisement is not presented as marketing for a drug first and foremost, and instead resemble an awareness campaign for a specific medical condition. They do not specify any specific product or treatment, and direct the audience to ask their doctor or seek an external resource for more information. These outlets are, in turn, used to promote specific prescription options. Help-seeking campaigns are sometimes used as preliminary marketing for new drugs.
Reminder and help-seeking ads are often used by drugmakers to bypass the more onerous restrictions (such as the required listing of side effects), or outright prohibitions on product claims advertising, as neither of them are focused on promoting the drug itself.
Sometimes, a campaign may mix both of these ads, with one ad discussing the condition, and another, similarly-styled ad, mentioning the product but not the condition, seeking to have the viewer infer the association between the ads.
Legality
Brazil
In 2008 a new resolution from
ANVISA
Brazilian Health Regulatory Agency ( pt, Agência Nacional de Vigilância Sanitária, links=no, italics=yes, ''Anvisa'', literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during Presi ...
(Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals.
Canada
The
Food and Drugs Act
The ''Food and Drugs Act'' (the ''Act'') (formal title ''An Act respecting food, drugs, cosmetics and therapeutic devices'') is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of f ...
prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when
Health Canada began to allow ads containing names, quantities, and prices only, so that
pharmacies
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links healt ...
could display their prices for comparison purposes.
In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited.
Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad.
There are no regulations requiring direct-to-consumer marketing prohibited under Canadian law to be removed or substituted from U.S. television channels and print publications distributed in the country.
In 2014,
York University
York University (french: Université York), also known as YorkU or simply YU, is a public university, public research university in Toronto, Ontario, Canada. It is Canada's fourth-largest university, and it has approximately 55,700 students, 7,0 ...
professor and physician Dr. Joel Lexchin, and
University of British Columbia
The University of British Columbia (UBC) is a public research university with campuses near Vancouver and in Kelowna, British Columbia. Established in 1908, it is British Columbia's oldest university. The university ranks among the top thre ...
associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations "
ackedaccountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement".
Europe
In October 2002, the
European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body ...
voted against a proposal to selectively allow advertising of "disease education information" in relation to
AIDS,
asthma
Asthma is a long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wheezing, co ...
, and
diabetes
Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...
. Despite insistence otherwise due to its selective and controlled nature, the
assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information. UK
Labour Party MEP
Catherine Stihler
Catherine Dalling Taylor Stihler (née Taylor; born 30 July 1973) is a Scottish former politician who is chief executive officer (CEO) of Creative Commons. A member of the Scottish Labour Party, she was a Member of the European Parliament (MEP) ...
argued that the proposal was a "slippery slope" towards U.S.-style advertising practices promoting expensive "wonder drugs", and that "we don't want consumers sitting on their couches bombarded with a hard sell from big drug companies in the advertising break between ''
Crossroads
Crossroads, crossroad, cross road or similar may refer to:
* Crossroads (junction), where four roads meet
Film and television Films
* ''Crossroads'' (1928 film), a 1928 Japanese film by Teinosuke Kinugasa
* ''Cross Roads'' (film), a 1930 Brit ...
'' and ''
Coronation Street''."
Hong Kong
Under the Undesirable Medical Advertisements Ordinance, advertising of medications is only legal for "minor" diseases, such as coughs and colds, headaches, indigestion, and others. Ads may not include depictions of treatment, medical professionals, or dramatizations of symptoms.
New Zealand
Under the Medicines Act of 1981, and regulated by the Therapeutic Products Advertising Code and a self-regulatory code by the industry group Medicines New Zealand, New Zealand is one of the only countries beside the United States to allow direct-to-consumer advertising of prescription medications.
An ongoing review of the Act to develop a replacement, the Therapeutic Products Bill, has faced lobbying efforts for and against the continued legality of DTCA.
United Kingdom
Advertising materials directed towards the general public are prohibited from containing any references to prescription-only medications, under the basis that they are not to be presented as a consumer's choice.
The
home page
A home page (or homepage) is the main web page of a website. The term may also refer to the start page shown in a web browser when the application first opens. Usually, the home page is located at the root of the website's domain or subdomain. ...
of a drug manufacturer's website also constitutes advertising material, and thus may not include references to prescription products either.
In a 2005
Health Select Committee
The Health and Social Care Select Committee (abbreviated to HSC, HSCC and HSCSC) is a Departmental Select Committee of the British House of Commons, the lower house of the United Kingdom Parliament. Its remit is to examine the policy, administra ...
hearing,
GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept.
United States
Under the regulations of the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major
side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s and
contraindication
In medicine, a contraindication is a condition that serves as a reason not to take a certain medical treatment due to the harm that it would cause the patient. Contraindication is the opposite of indication, which is a reason to use a certain tre ...
s in the main body, with a "fair balance" in its coverage of benefits to risks. Unless they are given "adequate provision" via a variety of different outlets, ads must also include a "brief summary" of all risks associated with the medication. In print ads within magazines, this summary is typically given on a second page.
Print ads must contain a standard notice that instructs patients to report negative side effects and
adverse events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...
to the FDA's
MedWatch program. In ads carried on broadcast media, such as television commercials, only the major side effects are typically listed, and the ad directs viewers to consult a website or current magazine issue for more information (the aforementioned "brief summary"). If the drug is subject to a
boxed warning from the FDA (which indicates a serious risk), the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited.
If an advertisement does not contain health claims, it does not fall under the FDA's jurisdiction, but can still be regulated by the
Federal Trade Commission.
Early history
In 1962, the
United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washing ...
gave the FDA the authority to regulate prescription drug labeling and advertising, but the FDA did not establish regulations until 1969. These required that ads for prescriptions include information on their major
side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s and
contraindication
In medicine, a contraindication is a condition that serves as a reason not to take a certain medical treatment due to the harm that it would cause the patient. Contraindication is the opposite of indication, which is a reason to use a certain tre ...
s, and unless they have "adequate provision" via different outlets, a "brief summary" of all side effects and contraindications.
Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine.
However, a larger movement towards
autonomy in health care decisions prompted the first prominent examples of direct-to-consumer advertising.
Merck
Merck refers primarily to the German Merck family and three companies founded by the family, including:
* the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668
** Merck Serono (known as EMD Serono in the Unite ...
published the first print DTC ad for a pneumonia vaccine (with a particular focus on those aged 65 years or older), and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription
ibuprofen Rufen. The advertisement promoted it as a cheaper alternative to the leading brand Motrin, and did not contain health claims. The FDA briefly demanded that the Rufen ad be pulled, but it was restored after minor amendments.
As its guidelines were not written with
mass media
Mass media refers to a diverse array of media technologies that reach a large audience via mass communication. The technologies through which this communication takes place include a variety of outlets.
Broadcast media transmit informati ...
in mind, these early campaigns prompted concern from the FDA, especially after the arthritis drug
Oraflex (whose release had been backed by a significant PR campaign) was recalled after only five months on the market, following reports of adverse reactions and deaths. FDA commissioner
Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations. The moratorium was lifted in 1985.
The industry felt that the requirement for a "brief summary" of all side effects was designed with print media in mind, and that their increasing length and technical language (often taking up an entire separate page of
fine print
Fine print, small print, or mouseprint is less noticeable print smaller than the more obvious larger print it accompanies that advertises or otherwise describes or partially describes a commercial product or service. The larger print that is us ...
when published in a magazine) made television advertising of prescriptions unfeasible. By the 1990s, there were calls for the FDA to loosen its regulations to make the concept viable.
Partial deregulation
A 1996 marketing campaign for then-prescription allergy medication
Claritin found a loophole, by intentionally excluding information about the medication itself from its advertising. Claritin's television commercial contained only imagery, slogans such as "Clear days and nights are here" and "It's time for Claritin", and asked viewers to call a phone number or consult their doctor for more information.
In 1997, the FDA issued new guidelines that were intended to make DTCM on radio and television less burdensome. In particular, the FDA clarified that informing the audience of where the "brief summary" can be obtained (such as a magazine ad, phone hotline, or website) constituted "adequate provision" of risk information, and thus relieved them from being included in the ad. The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not contain claims or statements regarding the indications and benefits of the medication.
The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $1.12 billion.
Despite this growth, there were concerns that some ads had an insufficient focus on properly discussing the product, while concerns were also shown for the advertising of erectile dysfunction medications during programming that may be widely watched by children. In 2005,
Pharmaceutical Research and Manufacturers of America
Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ...
(PhRMA) instituted new voluntary guidelines for DTCA, including requirements to voluntarily submit ads to the FDA for review and educate health professionals on new medications before an advertising campaign commences, use clear language in advertising, obtain appropriate age targeting for advertisements involving subject matter that may be inappropriate to certain audiences, and to not use "reminder" ads. By 2011, spending on pharmaceutical advertising had grown to approximately US$4.5 billion per year,
and increased to $5.2 billion by 2016.
With the increasing spending, DTCA began to face opposition. In 2015, the
American Medical Association
The American Medical Association (AMA) is a professional association and lobbying group of physicians and medical students. Founded in 1847, it is headquartered in Chicago, Illinois. Membership was approximately 240,000 in 2016.
The AMA's sta ...
's house of delegates voted in favor of a motion supporting the prohibition of DTCA, arguing that these marketing efforts contribute to the high cost of drugs, and "inflates demand for new and more expensive drugs, even when these drugs may not be appropriate". On March 4, 2016, Senator
Al Franken
Alan Stuart Franken (born May 21, 1951) is an American comedian, politician, media personality, and author who served as a United States senator from Minnesota from 2009 to 2018. He gained fame as a writer and performer on the television comed ...
introduced the Protecting Americans from Drug Marketing Act, which proposed the removal of tax breaks for pharmaceutical companies who engage in DTCA. Franken similarly showed concerns that the industry was spending too much on marketing. In a similar move, representative
Rosa DeLauro
Rosa Luisa DeLauro (; born March 2, 1943) is an American politician who has been the U.S. representative for since 1991. She is a member of the Democratic Party. The district is based in New Haven and includes most of its suburbs. DeLauro is ...
called for a three-year moratorium on advertising of newly-approved prescription drugs.
Proposed display of list prices
On May 8, 2019, the
Department of Health and Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is ...
(HHS) approved a mandate for
list price
The list price, also known as the manufacturer's suggested retail price (MSRP), or the recommended retail price (RRP), or the suggested retail price (SRP) of a product is the price at which its manufacturer notionally recommends that a retailer ...
s to be displayed in advertising for any prescription that costs $35 or higher for 30 days of treatment. Ads could also include price comparisons against competitors.
PhRMA objected to the rule, arguing that prominent display of list prices would cause confusion because they do not reflect what patients would typically pay under insurance coverage (the rule did require display of a disclaimer stating that those with health insurance may pay a different amount). When the rule was proposed in October 2018, PhRMA stated that its members would commit to publishing detailed pricing information online (including possible out-of-pocket costs, and information on financial support options), and directing viewers to this information within their advertising. However, the HHS disputed their arguments, arguing that list prices would help patients calculate how much they would pay, especially if they have not yet met their insurance
deductible
In an insurance policy, the deductible (in British English, the excess) is the amount paid
out of pocket by the policy holder before an insurance provider will pay any expenses. In general usage, the term ''deductible'' may be used to describe o ...
, or the drug is not covered by their insurance.
Secretary of Health and Human Services
The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...
Alex Azar
Alex Michael Azar II (; born June 17, 1967) is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the United States secretary of health and human services from 2018 to 2021. Azar was nominated to his p ...
compared the proposed requirement to similar regulations involving list prices for automobiles.
On July 8, 2019, shortly before it was to take effect, the rule was struck down by
DC district judge
Amit Mehta, who ruled that it overstepped the HHS' authority.
Impact on drug prices and patient care
Direct advertising of prescription drugs to consumers in only legal in the US and
New Zealand
New Zealand ( mi, Aotearoa ) is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and over 700 smaller islands. It is the sixth-largest island count ...
. With the introduction of the Therapeutic Products Bill in
New Zealand
New Zealand ( mi, Aotearoa ) is an island country in the southwestern Pacific Ocean. It consists of two main landmasses—the North Island () and the South Island ()—and over 700 smaller islands. It is the sixth-largest island count ...
, the US will likely be the only country in the world where prescription drugs can directly be advertised to consumers. Health insurance providers have long argued how DTC pharmaceutical advertising and "drug detailing" have increased marketing costs for the pharmaceutical industry while bolstering the sale of certain newer prescription drugs. Consumer organisations likewise had advocated a ban of DTC in order to curb the negative effects of pharmaceutical marketing to consumers. Pharmaceutical ads on television and Internet had hurt patient care, according to health care providers, and increased costs for health care rather than lowering them. Prescription drugs covered by health insurance should be prescribed "based on evidence and value" rather than on "splashy commercials".
Reception
Supporters of direct-to-consumer advertising argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 and 2001, spending on research and development in the U.S. increased 59% while spending on promoting drugs directly to patients increased 145%. However, other experts have asserted that funding for R&D is determined by several other factors.
Direct-to-consumer advertising, among other patient education initiatives, can educate consumers and patients about new treatments and therapeutic options that may not have been proactively mentioned by their healthcare professional. Proponents of DTCA claim this provides a vital opportunity for the public to be aware of what is available to them and to engage in an educated discussion with their doctor. A study observed that direct-to-consumer advertising promotes communication between patients and their doctors about medications. Thirty percent of Americans indicated they talk with their doctor about a medicine they saw on TV.
In addition, surveys showed that increased advertising has had a positive impact on the degree to which people adhere to a given course of treatment – but only among those who were already on medication prior to exposure to direct-to-consumer advertising. Among this population, a 10% increase in exposure to drug advertising increases the rate of adherence between 1% and 2%.
Some studies have asserted that direct-to-consumer advertising misleads patients into demanding heavily-advertised drugs, leading to superfluous or sub-optimal treatment. Doctors may feel pressured to prescribe specific brand-name medications because they were mentioned by a patient.
[Metzl, Jonathan. “Selling Sanity Through Gender.” ''Ms Magazine'', Fall, 2003.] In 2016, the
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
reported that 47% of all antibiotics prescribed in the United States were unnecessary.
Another study of young people living in West Palm Beach, Florida found that a 10% increase in advertising expose increased the total number of prescriptions by 5%; a higher percentage change than in Denver, Colorado – where DTCA expenditures per person are lower.
Market impact
It has been argued that direct-to-consumer advertising can influence the
doctor–patient relationship
The doctor–patient relationship is a central part of health care and the practice of medicine. A doctor–patient relationship is formed when a doctor attends to a patient's medical needs and is usually through consent. This relationship is bu ...
, including patients bringing up their need for an advertised, name-brand drug as their primary concern during a doctor visit, and becoming interested in newly-introduced medications that may not have undergone sufficient
postmarketing surveillance Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of phar ...
. It has been demonstrated that direct-to-consumer ads have contributed to the frequency of requests made by patients towards their physicians to prescribe
analgesic drugs
An analgesic drug, also called simply an analgesic (American English), analgaesic (British English), pain reliever, or painkiller, is any member of the group of drugs used to achieve relief from pain (that is, analgesia or pain management). It ...
, including
opioid
Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid use ...
s. A patient's request for a specific medication dramatically increases the rate at which physicians prescribe usually more expensive, branded drugs even when treatment for existing indications does not warrant such use.
Pharmaceutical companies have also faced allegations of "
disease mongering
Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses and aggressively promoting their public awareness in order to expand the markets for treatment.
Among the entities benefiting from selling a ...
"—the process of promoting awareness of minor conditions such as
balding and skin wrinkles in such a way that it encourages the sale of treatments for them.
Critics also argue that resources spent on advertising could otherwise be spent on research and development for new drugs and medical therapies. Danish physician
Peter C. Gøtzsche
Peter Christian Gøtzsche (born 26 November 1949) is a Danish physician, medical researcher, and former leader of the Nordic Cochrane Center at Rigshospitalet in Copenhagen, Denmark.
He is a co-founder of the Cochrane Collaboration and has writ ...
indicated that pharmaceutical companies will advertise for their most profitable products, many of which are unnecessary
"me-too" drugs. He maintains that "there is no need for marketing, as the products should speak for themselves."
Drug safety
Advertisements generally begin within a year of drugs entering the market, before
postmarketing surveillance Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of phar ...
is available to see if adverse effects emerge, which increases the risk of harm.
[ In the early 2000s, the FDA's resources to screen DTC ads were not keeping pace with the number of ads being produced, raising the risk that the inappropriate ads were not removed.][ ]Vioxx
Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea. Rofecoxib ...
was heavily marketed and was widely-prescribed after its approval in 1999. When the drug was withdrawn for safety reasons in 2004, Merck, its developer, and the FDA were criticized for the campaign.[ ]
Several DTC ads have faced criticism or FDA warnings over containing depictions of activities that are part of a prescription's contraindications, such as an advertisement for the blood thinner
Anticoagulants, commonly known as blood thinners, are chemical substances that prevent or reduce coagulation of blood, prolonging the clotting time. Some of them occur naturally in blood-eating animals such as leeches and mosquitoes, where th ...
Xarelto which featured scenes of a patient spokesperson among motorcycles (despite a disclaimer stating that the spokespatient had to stop riding her motorcycle whilst taking the medication), and a print ad for the Factor IX
Factor IX (or Christmas factor) () is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. It was discovered in 1952 after a young boy named Stephen Christmas ...
treatment Idelvion containing an image of a soccer player (with the FDA warning that soccer was a "moderate to dangerous high-risk activity for hemophilic patients", and that the ad falsely implied patients could engage in such activity without consequences).
Gender stereotypes
Some drug ads have "gendered" diseases in ways that do not reflect actual epidemiology. Women's bodies have also been objectified to mask or distract from unpleasant aspects of diseases. The marketing of drugs for inflammatory bowel disease have been called out on both counts. Similarly, the marketing of Gardasil
Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledge ...
was primarily aimed at young women, when sexually transmitted diseases are carried by, and affect, both genders.[
]
References
Further reading
*
*
External links
Educating the Consumer about Advertising: Some Issues
– from the Education Resources Information Center
The Education Resources Information Center (ERIC) is an online digital library of education research and information. ERIC is sponsored by the Institute of Education Sciences of the United States Department of Education.
Description
The missio ...
Clearinghouse on Reading and Communication Skills, Bloomington, Indiana
Bloomington is a city in and the county seat of Monroe County in the central region of the U.S. state of Indiana. It is the seventh-largest city in Indiana and the fourth-largest outside the Indianapolis metropolitan area. According to the Mo ...
.
40 years of DTC by Matthew Arnold/Medical Marketing and Media
* ttps://ethoseo.com/blog/pharma-social-media-advertising-rules-restrictions Pharmaceutical Social Media Advertising Rules and Restrictions
OPDP Complaints
FDA
Prescription Drug Advertising
FDA
{{Unnecessary health care
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Drug advertising
Pharmaceutical industry
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