Life Science Compliance Update

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October 29, 2013

Impacts of Pharmaceutical Marketing and Healthcare Services in the District of Columbia: Focus on Antipsychotics in the Elderly

In April of last year, we wrote about Washington, DC's AccessRX Act, which requires pharmaceutical companies that market products in the District to file annual reports on marketing expenditures.

In 2011, 158 pharmaceutical companies reported spending a total of $83.7 million on marketing activities in DC, including $57.9 (69.2%) million on employee and contractor expenses, $18.9 (22.5%) million on gifts and payments, and $6.9 (8.2%) million on advertising. A 2009 report addressed pharmaceutical marketing and healthcare services more broadly in DC. Additional reports were then published in for 2010 and 2011.

Hospitals, medical societies, and other nonindividual recipients received a total of $9.7 million in payments from these companies; payments to individuals totaled $9.2 million. Physicians received 81% of all payments, for a total gift value of $8.6 million (46% of the value of all reported payments).

More recently, the SafeRx Act requires the licensure of detailers (pharmaceutical sales representatives) and establishes an academic detailing program that provides unbiased drug information to prescribers.

Consequently, the DC Department of Health (DOH) recently released a report entitled, "Impacts of Pharmaceutical Marketing on Healthcare Services in the District of Columbia-Focus on Antipsychotics in the Elderly."

The report addresses the health of DC's senior population, with a focus on the use of antipsychotics, and investigates the ways that pharmaceutical marketing may affect the cost, utilization, and delivery of healthcare services in DC. Data submitted by manufacturers regarding marketing expenditures was analyzed by researchers at the George Washington University School of Public Health and Health Services (SPHHS).

In 2008, the most recent year for which data are available, the District’s Medicaid program spent $91.5 million on pharmaceuticals. The drug groups accounting for the largest expenditures were antivirals ($31 million), antipsychotics ($16 million), and anticonvulsants ($6 million).

One of the main reasons for conducting the report was in response to the "soaring rates" of off-label prescriptions for antipsychotics. The report notes that antipsychotics were prescribed off-label in 9 million visits in 2008, compared to 4.4 million visits in 1995. In 2007, 83% of antipsychotic prescriptions for the elderly were written off-label. Finally, the authors noted that while "some off-label uses are supported by scientific evidence, … in 2008, 91% of prescriptions for off-label use were backed by 'uncertain evidence.'"

In addition, The issue of excessive antipsychotic prescribing has been receiving national attention. A 2012 report by DOH focused specifically on the use of antipsychotics in children, particularly those enrolled in the District's Medicaid program. Most recently, the Office of the Inspector General (OIG) for the US Department of Health and Human Services (HHS) launched an examination of antipsychotics prescribed to Medicaidenrolled children in California, Florida, Illinois, New York, and Texas.

For those Sunshine Act stakeholders, this is the kind of report we can expect journalist organizations and other entities to publish once the Open Payments data is made public in September 2014, if the contractors hired by CMS are able to manage that deadline.

Executive Summary

Given the concerns over the use of antipsychotics in nursing homes, the authors analyzed the pharmaceutical marketing reports submitted to DC to evaluate whether nursing home medical directors appear to be "preferentially targeted for marketing efforts." The authors obtained a list of DC nursing home medical directors and searched for records of pharma-company payments to these individuals using the AccessRx database.

Importantly, the authors conducting the analysis "found no indication that pharmaceutical companies are heavily targeting their marketing efforts at District nursing home medical directors, or that those receiving drug company gifts have higher average costs for their Part D prescriptions as a whole."

The report found that the "majority of District nursing homes have antipsychotic prescribing rates below the national average." Additionally, "thirteen (13) of the District's 19 nursing homes receive above average ratings for overall quality from the Centers for Medicare and Medicaid Services' (CMS) Nursing Home Compare website.

After searching the AccessRx database (which covers 2007 through 2011) for records of pharmaceuticalcompany payments (the report calls all payments gifts) to physicians who currently serve as nursing home medical directors, the authors found:

  • About half (nine of 19) of these physicians received no payments from pharmaceutical companies between 2007 and 2011.
  • Seven (7) of the physicians received singleyear payment totals of less than $100, all in the form of food.
  • Six (6) of the physicians received payments totaling $100 $800 in at least one year. Most of these payments were in the form of food; some took the form of books.
  • Only four physicians received pharmaceuticalcompany payments totaling more than $1,000 in at least one of the years studied. Three received cash or checks for speaking or consulting, which totaled $34,639 over five years. All four of these physicians received food from pharmaceutical companies.

Of the ten medicaldirector physicians to whom pharmaceutical companies reported giving payments in 20072011, two received payments in one or two years; four received payments in three or four years; and four received payments in all five years.

The total value of reported pharmaceuticalcompany payments to District nursing home medical directors during these years "is relatively low compared to the total value of gifts to physicians who received the greatest total amounts during that time period."

The authors also stated that "no statistically significant differences in overall ratings or antipsychotic prescription rates were found between nursing homes whose medical directors received gifts between 2007 and 2011 and those who did not receive gifts."

The authors of the report also used ProPublica's online Prescriber Checkup database to examine prescription patterns by DC psychiatrists to Medicare Part D beneficiaries, the majority of whom are seniors.

Their search found 41 psychiatrists in DC (specialties are selfreported by prescribers) who prescribe antipsychotics to Medicare patients. The 44,828 claims for Part D prescriptions written by these psychiatrists had a total cost of $7.5 million and an average cost of $162.

Using the AccessRx database, the report found that 31 of 41 District psychiatrists appearing in the Prescriber Checkup database received payments from the manufacturers of six commonly prescribed antipsychotics in 2010—Clozapine, Geodon, Risperidone, Seroquel, and Zyprexa. Their giftvalue totals ranged from $89 to $52,903, with a median value of $533. Thirteen (13) psychiatrists received fewer than five payments from antipsychotic manufacturers in 2010, and nine received 10 or more. The ten psychiatrists receiving the highest total gift amounts from antipsychotic manufacturers collectively received 161 payments totaling $66,613.

As a group, the 31 psychiatrists listed in both Prescriber Checkup and the AccessRx database received 244 payments from antipsychotic manufacturers totaling $70,556 in value in 2010. While that is a large sum, it is far lower than the $446,530 these antipsychotic manufacturers gave to the ten District psychiatrists who received the largest gift amounts in 2010.

These 31 psychiatrists wrote 36,079 prescriptions that were filled by Part D beneficiaries; these claims had a total cost of $6.3 million and an average cost of $166. That compares to an average cost of $149 for the ten prescribing psychiatrists receiving no payments from antipsychotic manufacturers in 2010.

The difference in average prescription costs is not statistically significant; i.e., "this analysis does not indicate that receiving payments from antipsychotic manufacturers corresponds to higher average prescription costs for Part D prescriptions written by District psychiatrists," the authors concluded.

Most of the top prescribers of six commonly used antipsychotics in the Prescriber Checkup database were psychiatrists, including nine of ten prescribers with the highest Part D antipsychotic claims totals. The percentage of these prescribers' Part D patients receiving antipsychotics ranges from 7% to 92%.

Background

The authors maintain that, "Pharmaceutical marketing can influence providers' decisions about which patients need drug therapies and which drugs to prescribe." Such influence can be "problematic when it results in patients taking drugs whose risks of adverse events and costs are too high relative to the benefits the patients receive," the authors maintain.

Nevertheless, the authors also acknowledge that "Prescription drugs play an important role in improving District residents' quality of life," and "can allow patients to prevent, cure, and manage health problems that could otherwise be disabling or fatal, from hypertension to HIV to mental illness."

"Many healthcare providers lack the time to keep up on medical literature for a growing list of prescription drugs, and so rely on information from pharmaceutical companies." Unfortunately, the authors only portray the potentially negative aspects of information from manufacturers, frequently citing documents from settlements and litigation. For example, the authors maintain that information from companies "may downplay or fail to disclose adverse effects or drug interactions while exaggerating the effectiveness of the company's newer products."

Additionally, without providing evidence to support their claim, they note that, "marketing efforts may also encourage offlabel use of drugs, whether or not such uses are supported by strong evidence of safety and efficacy." 

The report also raises the argument that when companies provide "free food"; samples; compensation for travel and lodging; or hire physicians as speakers or consultants, such relationships "may create a sense of obligation in prescribers." Finally, the authors point to new research that used ProPublica's Prescriber Checkup database to support their concerns about improper industry influence of physician prescribing.

The research, used a sample of 334,086 Part D prescribers, 58% of whom received at least one payment from the 12 companies. The authors found that the industrypaid physicians generated 14.7 claims per patient, compared to 13.7 claims per patient for the average doctor in the sample. How is that statistically significant? Doctors who received at least one payment submitted one (1) more claim than those that did not?

Are we really wasting hundreds of millions of dollars collecting this information and threatening physician-industry collaboration for one claim?

The research did show that "Doctors in the top 20% of those who received the payments from pharmaceutical companies prescribed twice as many branded drugs as those in the bottom 20%." It also found that "physicians who were paid by a particular firm were twice as likely to prescribe drugs made by that firm, compared with doctors who received no money from that firm."

This should not be shocking. Doctors with fewer options are more likely to prescribe brands when there are no alternatives or when generics are not a sufficient or available substitute. Moreover, doctors who are familiar with drugs because of truthful and nonmisleading information would not prescribe a medicine because of a bagel or pizza at the risk of being sued for malpractice and losing their license. These doctors analyze the information they receive knowing it comes from the manufacturer and make an informed decision based on the patients history, diagnosis and other scientific factors. To suggest that the primary factor driving these prescriptions are $10 meals is shortsighted.

In addition, this data does not analyze what kind of doctors are making these prescriptions or what diseases they were treating or curing. These facts are particularly important because primary care physicians must treat a wide array of diseases that might make it more important for them to discuss new treatments and options with manufacturers and to request information. Likewise, specialists may need to consult more regularly with manufacturers to learn about updates, modifications or changes to a device or treatment based on adverse events or post-market clinical data.

Furthermore, the background section of the 2013 DOH report is also problematic because to support their claims about improper influence into physician prescribing, the authors cite to their own previous research and reports from the DOH. Moreover, several of the authors are outspoken critics of industry and have their own conflicts of interest and lack of objectivity, making the assertions and this report problematic.

Nursing Homes and Part D Prescribers in the District

For the District's elderly, use of antipsychotics puts seniors at increased risk of serious adverse events, including extra pyramidal symptoms, cognitive decline, neuroleptic malignant syndrome, weight gain, hypothermia, hip fractures, and death. While the risk-benefit ratio may be acceptable for patients with schizophrenia or bipolar disorder, "elderly patients suffering from dementia, agitation, anxiety, or insomnia may be dosed with antipsychotics for their sedative qualities, bringing the patients few overall benefits while putting them at risk for serious adverse events." The US Department of Justice (DOJ) has taken action against drug companies for inappropriate promotion of antipsychotics to nursing homes (US DOJ, 2009; US DOJ, 2010).

In 2009, Eli Lilly reached a $1.4 billion settlement with the DOJ for its "5 at 5" campaign suggesting that 5 mg of Zyprexa at 5pm would help patients sleep (US DOJ, 2009). Research suggests that alternative treatments for dementia and agitation may improve symptoms with fewer risks.

However, the report found that the majority of District nursing homes have antipsychotic prescribing rates below the national averages. In the US as a whole, 2.7% of shortstay nursing home residents receive new antipsychotic prescriptions and 22.4% of longstay nursing home residents receive an antipsychotic medication (CMS Nursing Home Compare, 2013).

In the District, seven out of 18 nursing homes have aboveaverage prescribing rates for shortstay patients, and six out of 19 have aboveaverage rates of longstay patients taking antipsychotics.

Ultimately, the report concluded by noting that while prescription drugs play "an important role in the health of the District's seniors, inappropriate use of antipsychotics for seniors brings an increased risk of serious adverse events, including death, without a commensurate benefit." Nevertheless, their "analysis of pharmaceutical marketing data did not find evidence of extensive marketing targeted at nursing home medical directors."

The authors emphasized the important role and value that "publicly accessible databases such as Nursing Home Compare and Prescriber Checkup, combined with the AccessRx pharmaceutical marketing database, can play. Researchers, payers, healthcare providers, and individuals choosing doctors or nursing homes can all benefit from the information they contain."

They recommend making AccessRx data available to the public to "complement and advance this beneficial transparency."

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