In January 2009,
the pharmaceutical industry adopted new marketing guidelines aimed at improving
the effectiveness of their products. Billy Tauzin, PhRMA's president and CEO,
stated that the organization's goal is to ensure that the medicines are
marketed in a way that benefits patients.
These guidelines
were issued at a time when the public is becoming more aware of the various
marketing practices that influence the prescribing of certain medicines. The
complexity of the relationship between the medical profession and the
pharmaceutical industry has raised concerns about the independence of
physicians.
Due to the
complexity of the situation between the pharmaceutical industry and the medical
profession, the guidelines were issued at a time that the government and the
public are engaged in a vigorous debate about the role of marketing in the
treatment of patients. The various policies that have been put forth by the
government and the medical profession raise important questions about the
potential role of government intervention in preventing the influence of
marketing.
Although the scope
of pharmaceutical marketing is wide, this commentary focuses on the various
activities that are directed toward physicians. One of these is the use of
industry gifts, which are often associated with the marketing of certain
medicines. In this article, I review the efforts of the government and the
pharmaceutical industry to limit the influence of these gifts (this is somewhat different from the kind of gifts from salespeople that I mentioned here).
Attempts At Self-Regulation
During the 1960s,
there was a debate about the appropriate relationship between the
pharmaceutical industry and the medical profession. In 1991, the American
Medical Association issued ethics guidelines aimed at restricting the use of
industry gifts and marketing techniques.
Due to the
increasing number of marketing activities, the attention of the public has also
increased. In response, the pharmaceutical industry issued voluntary guidelines
in 2002. The AMA then updated its guidelines in the same year. Under the new
guidelines, gifts valued at less than $100 are allowed to be given to
physicians if they are related to a patient's practice.
In line with the
new guidelines, the pharmaceutical industry is still allowed to provide meals
for physicians that are modest and are accompanied by an educational component.
However, it is not allowed to provide non-educational gifts such as pens.
Several academic
medical centers have started to restrict the activities of pharmaceutical
companies in their facilities. These changes were made following a policy proposal
by a group of academic leaders. The American Medical College Association also
supported a set of policies aimed at restricting the activities of
pharmaceutical companies in their facilities.
Despite the efforts
of the pharmaceutical industry and the medical profession to limit the
influence of gifts on the prescribing of certain medicines, policymakers in the
U.S. are still questioning if the industry and the profession have gone far
enough. A recent scorecard revealed that only nine of the country's medical
centers have adopted a model policy.
Despite the various
steps taken by the medical profession and the pharmaceutical industry to limit
the influence of gifts on the prescribing of certain medicines, a survey
revealed that almost all physicians still accept payments and gifts from the
industry.
A survey also
revealed that physicians are less likely to believe that industry gifts are
very influential compared to their patients. Only 9% of the physicians said
that a small textbook is very influential compared to 37% of the patients.
Despite the various
steps taken by the medical profession and the pharmaceutical industry to limit
the influence of gifts on the prescribing of certain medicines, a survey
revealed that almost all physicians still accept payments and gifts from the
industry. This suggests that the implementation of the ethics guidelines issued
by the AMA has not yet brought about substantive change.
Although large
gifts are still considered to be an example of commercial influence, evidence
shows that small gifts, as well as other non-educational items, are also
influential. Given these shortcomings, the government should play a leading
role in further restricting the influence of marketing.
- Government Approaches To Regulating Pharmaceutical Gifts To Physicians
In response to the
growing concerns about the influence of marketing on the prescribing of
medicines, state legislators have enacted various laws aimed at restricting the
activities of the pharmaceutical industry. The Office of the Inspector General
also issued a guidance to the industry that explains how to avoid breaking the
law.
In 2003, the OIG
endorsed the industry's voluntary guidelines aimed at limiting the influence of
gifts on the prescribing of certain medicines. The agency noted that compliance
with these guidelines offers substantial protection.
One of the most
effective ways to improve the professional behavior of healthcare practitioners
is through government regulation. This strategy can motivate changes in the
industry and the professional conduct of individuals. In addition to being able
to prevent illegal activities, strong legal enforcement can also encourage the
industry to follow the regulations.
Despite the various
steps taken by the medical profession and the pharmaceutical industry to limit
the influence of gifts on the prescribing of certain medicines, a survey
revealed that almost all physicians still accept payments and gifts from the
industry. This suggests that the implementation of the regulations has not yet
brought about substantive change. One of the most challenging factors in
regulating the activities of the pharmaceutical industry is the implementation
of the laws.
The government
should carefully consider the various aspects of the regulation to address the
issue of influence, while also minimizing unintended consequences.
- Disclosure of Physician Payments and Gifts
In response to the
growing concerns about the influence of marketing on the prescribing of
medicines, state legislators have enacted various laws aimed at restricting the
activities of the pharmaceutical industry. Some of these laws require companies
to disclose the gifts and payments that they make to physicians. In Minnesota
and Vermont, for instance, the disclosure requirements apply to gifts that are
over $100.
Although the laws
require companies to publicize the details of their transactions with
physicians, in Vermont, they can also classify certain payments and gifts as
trade secrets. Other states, such as Massachusetts, have also enacted laws that
require companies to disclose the gifts and payments that they make to
physicians.
The legislation
introduced in the last Congress aimed to establish a comprehensive framework
for the disclosure of payments and gifts made to physicians. However, when the
bill was reintroduced in 2009, it was modified to reduce the reporting
threshold to $100. This new law was supported by the pharmaceutical industry.
Several companies
recently indicated that they would begin voluntarily disclosing the details of
their transactions with doctors by using the $500 threshold. This move seems to
be a preemptive step to limit the scope of regulation.
The concept of
disclosure is attractive, as it can help address the conflicts of interest that
arise from the activities of the pharmaceutical industry. However, it is also
not always effective. For instance, the reporting requirements of the law may
reduce the administrative burden of the pharmaceutical industry.
Studies have shown
that even small gifts can influence the decisions of doctors. Patients also
have a hard time using the information provided by the law to make informed
decisions.
In addition, the
law provides for the possibility of moral licensing for physicians, as long as
the gifts and payments are disclosed.
In experiments, it
has been shown that disclosing the details of transactions with doctors can
increase the level of bias that they display in their reports.
Despite the
shortcomings of the law, it has been found that it has been beneficial to the
public by allowing the media to access the details of transactions with
doctors. The data collected through the public disclosure has led to heightened
scrutiny of the relationships between the pharmaceutical industry and doctors.
A study conducted
in Vermont and Minnesota revealed that the laws' provisions on the trade secret
and the accessibility of the data were not ideal. In addition, some companies
have used the trade secret provision to classify certain gifts and payments as
trade secrets. These provisions can limit the effectiveness of the law and its
benefits.
To ensure that the
law is effective and is made more transparent, policymakers should require drug
companies to make the necessary disclosures regarding all gifts to doctors.
- Bans on Physician Gifts
Although several
states have enacted laws aimed at restricting the activities of the
pharmaceutical industry, Minnesota was the first to implement a comprehensive
ban on industry gifts to doctors. The law prohibits pharmaceutical companies
from giving doctors gifts that have a total value of over $50. The ban does not
apply to certain types of gifts, such as drug samples and educational
materials.
In the state of
Massachusetts, the Department of Public Health has recently issued regulations
that are the most stringent restrictions on industry gifts. The regulations,
which take effect on July 1, 2009, prohibit all types of gifts, except for
modest meals provided in the providers' practice setting.
The implementation
of the law in Minnesota has been a challenging task due to the various
exemptions and loopholes in the law. According to reports, the number of visits
by pharmaceutical representatives to the state's primary care physicians
decreased significantly following the enforcement of the law.
The reduction in
the number of visits by pharmaceutical representatives to the state's primary
care physicians is believed to be related to the increasing number of
patent-protected medicines that have already been approved for sale. The ban on
gifts also has a positive effect on the quality of care by reducing the likelihood
of doctors discussing the use of new drugs with their patients.
Despite the various
laws that have been enacted in response to the concerns about the
pharmaceutical industry's activities, only a few states have adopted a similar
legislative strategy.
- Limits on the Sale of Prescribing Data for Marketing Purposes
In 2005, New
Hampshire enacted a law that prohibits the sale of prescription data to third
parties for commercial purposes. Currently, pharmacies are able to sell their
patients' de-identified records to data aggregators, which then create
customized profiles for physicians. These profiles are then used by
pharmaceutical companies to develop marketing messages and improve the
effectiveness of their marketing efforts.
Although it is not
clear how much of a marketing influence physician profiling has on the uptake
of new drugs, a study conducted by an industry research firm claimed that it
could increase the likelihood of new medications being taken by 30%. Although
it is still not possible to eliminate the influence of marketing on doctors,
the ban on the sale of prescription data should be enforced.
Although a federal
court ruled that the law was unconstitutional, New Hampshire was able to
successfully appeal the case. Similar laws have also been enacted in Maine and
Vermont. Despite the various initiatives that the American Medical Association
has launched to promote the use of opt-out programs, it has still experienced
low participation and awareness.
The increasing
number of data sources has raised concerns about the potential impact of
marketing on doctors. Although the court ruled that the government has the
right to restrict the use of data collected by healthcare providers, it did not
go as far as to ban the sale of prescription data.
- Licensing of Pharmaceutical Sales Representatives
Several states have
also introduced legislation that requires the licensing of pharmaceutical
detailers. In the District of Columbia, the Department of Health established
regulations that require all pharmaceutical detailers to follow a code of
ethics and meet certain educational requirements.
One of the main
concerns about the licensing of pharmaceutical sales representatives is the
potential for conflicts of interest. For instance, if the activities of sales
representatives are considered a professional activity, then it could be
interpreted as a requirement that they follow ethical guidelines. However,
these individuals are not bound by any ethical obligation to patients.
Pursuing a
professional status for sales representatives would be challenging due to the
complexity of the issue and the potential conflicts of interest. Also, granting
this status could increase the credibility of these individuals as educators
and encourage physicians to rely on industry sources for their information.
If a sales
representative's license is revoked due to a violation, then this could be a
powerful tool to ensure that they follow the regulations. It would also require
them to complete educational requirements designed to help them understand the
various aspects of pharmaceutical products.
- Public Funding of Academic Detailing Programs
Despite the various
laws that have been enacted in response to the concerns about the activities of
pharmaceutical detailing, many states have also launched their own programs to
counter the influence of this industry. These programs are designed to help
physicians follow evidence-based guidelines.
One of the most
common programs that state agencies have established is the Independent Drug
Information Service. This program is administered by Harvard University and is
funded by the Pennsylvania Department of Aging.
A review conducted
by the Cochrane Collaboration revealed that academic detailing does not have a
significant effect on the compliance of physicians with evidence-based
guidelines. However, the cost savings that public insurance programs can
provide may be enough to offset the program's costs.
According to the
statistics released by the pharmaceutical companies, there are around 1 million
sales representatives working in the US. In Pennsylvania, the program only
employs 10 academic detailers. It is unlikely that the state could have a
similar level of success in curbing the influence of the industry on the
physicians. Academic detailing programs can help states improve the quality of
their prescribing, but they are not enough to address the larger issue of
preventing pharmaceutical gifts from influencing the decisions of doctors.
A Way Forward for The Profession, Pharmaceutical Industry, And Legislators
Despite the various
steps that have been implemented to address the issue of pharmaceutical gifts,
the industry and the medical profession still have a long way to go in reducing
the influence of these gifts on the decisions of doctors.
It is possible that
the various factors that have been identified as contributing to the increasing
number of pharmaceutical gifts and the diminishing importance of academic
detailing will eventually decrease the significance of these activities over
time. However, this doesn't lessen the significance of the issue.
Aside from the
various factors that have been identified as contributing to the increasing
number of pharmaceutical gifts, the impact of the decreased profit margins on
the decisions of pharmaceutical firms has also not been thoroughly discussed.
The goal of
pharmaceutical detailing is to increase the sales of a company's products. It
is not ethical for financial exchanges such as these to continue. The
government should therefore ban all gifts related to the pharmaceutical
industry.
According to the
evidence collected regarding the influence of pharmaceutical gifts, states
should follow the lead of Massachusetts and not set financial thresholds that
will determine the permissibility of these gifts. Instead, they should ban all
gifts from the pharmaceutical industry.
One of the most
important factors that have been identified as contributing to the increasing
number of pharmaceutical gifts is the lack of transparency regarding the nature
of the relationships that are involved in the promotion of the industry. This
is why it is important that the public is informed about the details of the
relationships that are involved in the industry.
A $25 reporting
threshold for financial transactions would most likely capture most of the
financial relationships between doctors and the pharmaceutical industry. This
would also help the public to monitor the activities of the industry and the
decisions of the doctors.
Despite the various
policies that have been implemented to address the issue of pharmaceutical
promotion, the public should still support academic detailing programs to
promote the use of evidence-based medicine. The pharmaceutical industry has the
ability to influence the decisions of doctors and improve the quality of
patient care.
Despite the various
policies that have been implemented to address the issue of pharmaceutical
promotion, the public should still support academic detailing programs to
promote the use of evidence-based medicine. This is because the government's
regulations will likely contain loopholes that will allow the pharmaceutical
industry to continue its operations. Strong professional norms and ethical
practices can help improve the quality of patient care and reduce the influence
of these gifts on the decisions of doctors.
The medical
profession has to start cleaning its own house of ethical problems related to
the industry. Although the American Medical Association has issued guidelines
aimed at preventing the unethical activities of doctors, they do not seem to be
able to make a significant impact on the issue. It is time for the
organizations to develop incentives and enforcement mechanisms to help improve
the standards of their members.
One of the most
effective ways to improve the standards of doctors is by implementing
professional recognition programs that will allow the public to see how their
practices are being conducted. In addition, medical societies should start to
reduce their dependence on the pharmaceutical industry.
Despite the various
steps that have been implemented to address the issue of pharmaceutical
promotion, the public should still support academic detailing programs to
promote the use of evidence-based medicine. This is because the lack of trust
in the medical profession has threatened its future. Although the government
can play a significant role in regulating the industry, it is still up to the
individual physicians to clean their own house of unethical activities.
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