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Ask your doctor: This drug might be right for you

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By: Jennifer Patterson-West, Ph.D.

20180326_Essay

source: Mike Licht via flickr

Direct-to-consumer advertising (DTCA) of prescription drugs is currently only legal in the United States and New Zealand.  In the United States, DTC advertising is regulated by the Office of Prescription Drug Promotion (OPDP) within the Food and Drug Administration (FDA).  The stated mission of the OPDP is to “protect public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated.”

From patients to consumers

The first DTCA was a print ad for Pneumovax vaccine in 1981. A couple years later, the first broadcast advertisement aired for Rufen, a prescription brand ibuprofen.  In 1985, in response to initial DTCA, the FDA published a notice claiming jurisdiction over the regulation of DTCA. The FDA’s authority would hold DCTA to the same standards as previously established for advertisements to health care providers.  These standards required that advertisement contain a “fair balance” and “brief summary” that notes every risk described on the drug’s label.  Following the release of these standards, DTC print advertisements became prevalent with annual DTCA spending rising from $12 million (1980) to $340 million (1995).

The FDA loosened standards in 1997 by replacing the requirement of a “brief summary” with a “major statement” that only requires inclusion of the major risks associated with a drug and an adequate provision for consumers to obtain additional drug information, such as a toll-free number or website.  By no longer requiring drug companies to buy enough air-time to read the fine print, these new standards removed the fiscal constraint previously restricting the use of broadcast DTCA.  In fact, by the following year, annual spending on DTCAs increased to $1.2 billion annually and peaked at $5 billion in the mid-2000s.  It has been estimated, that on average, Americans now watch 9 drug advertisements per day, which equates to approximately 16 hours per year.  This level of contact far exceeds the amount of time patients typically spend with medical professionals.

Persuasive or informative? Are DTCAs truthful, balanced, and accurate?

Surprisingly, the debate around DTCA is balanced with respect to advocates and critics with considerable evidence supporting both positions.  However, the focus of those on the two sides of the debate differ considerable.  Advocates focus on the benefits associated with DTCA, whereas critics highlight examples of DTCA that are in direct subversion of established regulations and the stated mission of OPDP.

Advocates assert that DTCA empowers consumers by informing them about different treatment options, reduces associated stigmas, prompts dialogue with health care providers, and improves patient compliance.  Improved dialogue with healthcare providers is supported by a 2004 FDA survey in which 73% of physicians reported that they thought DTC advertisements helped patients ask more thoughtful question.  In the same survey, 77% of physicians declared that DTCA improved awareness of new drugs, whereas 33% of physicians agreed that the advertisements increased patient adherence.  In addition to these advantages, proponents suggest that DTCA drives competition, thereby reducing prescription costs.  However, no verifiable evidence is available to support this claim.

In contrast, critics proclaim that DTCA misinforms patients, medicalizes natural conditions, and strains patient-physician relationships.  In the same survey mentioned above, 60% of physicians believed that DTCA did not provide sufficient information regarding risks and 58% of physicians thought DTCA inspired patients to overestimate the efficacy of a particular drug.  These sentiments indicate that advertisements did not adequately communicate a balance of risk and benefit related information.  A recent study by Klara et al. found that 13% of ads within their study section suggested off-label uses, which are prohibited under current regulations. None of the evaluated ads quantified risk.  Another major critisim, is the medicalization of normal conditions such as hormonal changes associated with menopause or variability in sexual performance.  Proponents claim that medicalization heightens patient discontent with “symptoms” ultimately promoting the over utilization of pharmaceutical interventions that consequently contributes to rising medical costs.  Manufacturing of disease states is another example of advertisement practices that are in direct opposition of the stated OCPC mission which promotes the communication of truthful and accurate information.

The argument outlined by critics is likely contributing to the overall sentiment of physicians toward DTCA despite stated benefits.  In a 2013 survey by CMI/Compas that probed the opinion of physicians with respect to the current levels of DTCA, 52.9% supported a scale back, 18.3% felt it should be eliminated, 26% indicated that it should continue as is, and only 2.9% agreed with the expansion.

Maximizing benefit, while limiting risk

The unfavorable effects of DTCA can be lessened by the strict enforcement of current regulations and a careful assessment of advertisement strategies that interfere with truthful, balanced, and accurate communication of drug infomation.  However, since 2010, there has been a sharp decline in enforcement activity by the OPDP.  This decline follows the 2011 Supreme court ruling in Sorell v. IMS Health, which established that pharmaceutical marketing is protected under the Freedom of Speech Clause of the First Amendent.

Despite extensive critisms, it is unlikely that broad restrictions will be implemented in light of this and other juridical rulings that favor increased protection of commercial speech.  Additional measures have been proposed to minimize the risks associated with DTCA and maximize the benefits of engaging and educating consumers.  These include: (1) restricting advertisement of new drugs for a set number of years following approval, (2) pre-clearance of DTCA materials by the FDA or an unbiased entity, (3) mandating that all materials be presented at an 8th grade literacy level, and (4) requiring the inclusion of quantitative information regarding both the potential benefits and risks.  However, additional guidelines that focus on restricting or controlling the messaging of DTCA are unlikely to be upheld when they are challenged in court, due to the recently set precident.

An alternative approach to restrict DTCA has been focused on increasing the associated financial burden.  In 2002, U.S. Representative Jerrord Nadler (D-NY) introduced a measured called Say No To Drug Ads Act that would eliminate the use of tax deductions by pharmaceutical companies for DTCA costs.  Ultimately, this bill was not passed.  Recently, U.S. Representative Rosa DeLauro (D-CT) introduced the Responsibility in Drug Advertisement Act with a similar aim.  Although financial restrictions of DTCA are not in opposition to the constitution or current juridical rulings, this bill is also not expected to progress due to the current political climate.

Based on established precedents within the courts and the current political climate, mitigating the risk associated with DTCA may fall to consumer advocate groups or a public education campaign that informs patients about how to properly evaluate the risks and benefits of prescription drugs.  The success of FDA’s “The real cost” campaign emphasizes the potential benefit of public health campaigns and their impact on consumer behavior.

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Written by sciencepolicyforall

March 26, 2018 at 11:20 am

Posted in Essays

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Science Policy Around the Web – June 23, 2017

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By: Saurav Seshadri, PhD

Drug Policy

Trump’s New Policy to Tackle Sky-High Drug Prices Makes Sense — Sort Of

Tackling high prescription drug prices was a repeated promise of the Trump campaign. The Trump administration has now taken its first step towards fulfilling this pledge, outlined in a blog post by Food and Drug Administration (FDA) commissioner Scott Gottlieb. The agency will pursue a Drug Competition Action Plan, whose goal will be to eliminate obstacles to the development of cheap generic drugs – particularly those caused by loopholes in existing FDA policies, which are exploited by pharmaceutical companies to extend their patent exclusivity period and maximize profits. An example of such ‘gaming’ the system, cited in the post, is the practice of limiting access to branded products for comparative testing by generic developers. Ultimately, the FDA will work closely with the Federal Trade Commission (FTC) to address such issues, since directly regulating business practices is outside its mandate.

On its face, the FDA’s effort is a step in the right direction. Availability of generics reduces the cost of medications by over half within the first year, and according to a recent Congressional report, manufacturers state that ‘competition…is the primary driver of generic drug prices’. However, it ignores evidence that the real driver of increased drug spending is new, branded medicines, not overpriced generics. In fact, early indications are that Trump’s policies will favor the pharmaceutical companies that produce such medicines, by reducing regulations and apparently abandoning his promise to enable the government to negotiate drug pricing through Medicare. Overall, these actions signal a commitment to promoting free market mechanisms in the pharmaceutical industry; time will tell whether this approach will actually lead to more affordable drugs. (Julia Belluz, Vox)

Cancer

In a Major Shift, Cancer Drugs go ‘Tissue-Agnostic’

With the landmark approval of Keytruda in May, the Food and Drug Administration (FDA) appears to have ushered in a new era of cancer drug development.  So far, cancer treatment and drug evaluation have largely used the tumor’s tissue of origin as a starting point. Keytruda (an immune system enabling drug developed by Merck and approved for melanoma in 2014) marked the first departure from this approach, receiving priority approval to treat any solid tumor containing a mutation in the mismatch repair pathway, regardless of context. Recently released data suggests that another tissue-agnostic cancer therapy is on the way: larotrectinib (a cell growth inhibitor developed by Loxo Oncology) showed high efficacy for any tumor with a certain biomarker (TRK fusion). Several other such drugs, whose indications will be based on tumor genetics rather than location, are in the clinical pipeline.

Although these advances have generated significant excitement in the cancer community, some caveats exist. First, identifying the patients that could benefit from tissue-agnostic treatments will require individual initiative and depend on the cost of screening, particularly when considering markers that are rare for a certain tumor type. A potential solution is suggested by the NCI-MATCH trial, part of the NIH’s Precision Medicine Initiative (PMI) – in it, patients can enroll in one of several parallel clinical trials if a corresponding drug-targeted mutation is found in their tumor’s genome. If these trials prove effective, patients could eventually be regularly matched with a personalized, tissue-agnostic, biologically valid treatment, based on a standardized screen.  Second, researchers caution that tissue-agnostic studies should have a strong scientific rationale and/or breakthrough-level efficacy. Otherwise, such efforts ‘could actually slow drug development if there are differential effects across tumor types by diverting resources from enrolling patients in a predominant population or in the tumor type most likely to respond’.

Despite these concerns, the tissue-agnostic paradigm offers great promise for cancer patients. NIH-funded resources such as The Cancer Genome Atlas could be invaluable to this field moving forward. (Ken Garber, Science)

Scientific Publishing

US Court Grants Elsevier Millions in Damages from Sci-Hub

A New York district court has awarded academic publishing giant Elsevier $15 million in damages from Alexandra Elbakyan, founder of the website Sci-Hub, for copyright infringement. Elbakyan, a 27-year-old neuroscientist turned programmer, started Sci-Hub in 2011 with the goal of ‘remov[ing] all barriers in the way of science’. The site allows users to download research papers that would normally be blocked by a paywall, by obtaining credentials from subscribing institutions and using them to access publisher-run databases like ScienceDirect. Over 60 million papers are posted on Sci-Hub, and users downloaded 28 million articles in 2016.

Elbakyan’s case is reminiscent of Aaron Swartz, another high-profile champion of open access to scientific research. Faced with federal charges related to his hacking of journal archive JSTOR, Swartz tragically committed suicide in 2013. Both Elbakyan and Swartz found publishers’ ability to profit from restricting access to scientific literature, effectively withholding knowledge from anyone outside of a privileged inner circle, as well as the legal protection provided to this system, to be deeply unethical. Their willingness to act upon these convictions has earned each a sizable following in the scientific community.

For their part, publishers claim that fees go towards overhead, and point to significant efforts to expand free and open access programs. While judges have so far been sympathetic, Elsevier’s legal battle has been largely one-sided. Elbakyan has been ignoring rulings requiring her to shut down Sci-Hub since 2015, opting to simply change domains instead, and since she is currently based in Russia and has no American assets, she is unlikely to pay any damages. (Quirin Schiermeier, Nature News)

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Written by sciencepolicyforall

June 23, 2017 at 11:00 am