Conflict of Interest for Nuedexta Drugmaker

Just weeks after CNN released the results of an investigation into the drug Nuedexta, new conflict of interest claims have arisen for the drugmaker, Avanir.  According to a new report published early in November 2017 by CNN, one of the leading Alzheimer’s advocacy groups has halted funding from Avanir while investigations into the company’s marketing and prescribing recommendations continue.

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Readers may remember our previous posts and information posted about the potential dangers of Nuedexta, including an increased fall risk among those taking the medication.  Nuedexta has not been extensively studied for use in elderly patients or those with Alzheimer’s or dementia, and is not FDA approved for such patients.  Nuedexta is FDA approved to treat patients with pseudobulbar affect (PBA), a rare disorder causing laughing and crying outbursts.

Conflict and Ethics

A number of questions about conflicts and ethics arose after CNN’s initial report was published.  Shortly after the publication was released, the Los Angeles city attorney launched an investigation of its own aimed at examining if Avanir broke state or federal laws during its marketing, sale, or prescribing of Nuedexta.

Avanir has supported several nonprofit organizations financially, as well as supporting educational and medical events hosted by advocacy groups and nonprofits.  Many of these groups are aimed at awareness and treatment of dementia and Alzheimer’s.  The conflict of interest questions arise out of the fact that Avanir has specifically targeted nursing homes and patients with Alzheimer’s or dementia, even though the drug is not approved or studied for those patients.

Further casting doubt on the drugmaker’s motives are the fact that many doctors and professionals presenting at events have financial ties to Avanir, with some receiving hefty compensation for their efforts.

Shortly after the Los Angeles city attorney initiated its investigation, the Alzheimer’s Association – one of the leading advocacy groups for patients – announced it would halt all funding from Avanir pending the city attorney’s investigation.  This fiscal year, Avanir reportedly gave the Alzheimer’s Association $200,000, accounting for .056% of the organization’s annual revenue.

It is not surprising for a drugmaker like Avanir to tie themselves to nonprofits because the relationships and information gained are tremendous.  What some believe is surprising, however, is the fact that nonprofits would allow themselves to be sponsored by drugmakers where a conflict of interest may reside.

Another issue involving Avanir is the fact that a great deal of funding for Nuedexta has come from the U.S.  federal government.  In 2015, the Medicare Part D program spent $138 million on Nuedexta, an increase of 400 percent from three years prior.

Avanir Claims Research and Support is Ongoing

The CNN investigation highlighted the fact that Nuedexta has been specifically marketed to nursing homes and patients with Alzheimer’s or dementia, even though the drug is not approved for such use.  Now, Avanir claims that the company is actively researching “ways to help patients with a variety of neurological conditions, including Alzheimer’s disease”.  Avanir also claims that their efforts are careful to comply with FDA regulations, as well as state and federal laws.

Throughout the investigation, Avanir has cited the difficulty of understanding PBA and how misunderstood the disorder is.  PBA can affect patients with Alzheimer’s or dementia, but experts contend that the percentage of such patients is extremely low.  Still, in 2016, over half of the $300 million in Nuedexta sales went to patients in nursing homes.

Since the CNN report, more information about Avanir has come to light.  Whether in an honest attempt to support the Alzheimer’s community, or in an effort to cover unethical marketing practices, Avanir appears to be spearheading a variety of research and support.  Avanir is a member of the Leaders Engaged on Alzheimer’s Disease (LEAD) Coalition.

The drugmaker is also launching a training program at New Jersey’s Camden Community College titled the “Alzheimer’s Journey Coordination Certificate Program.  The program is designed to help families affected by Alzheimer’s make appropriate decisions about housing, transportation, and medical treatments.  New Jersey Congressman, Donald Norcross – who was an earlier supporter of the program – has come forward stating that the CNN investigation is “deeply troubling”, and that the joint board will not allow any inclusion of education around Nuedexta or PBA in the curriculum.

Why it is Important to Keep an Eye on Nuedexta

Anytime this much concern is raised over the safety, effectiveness, and proper prescribing of a medication, it is important for consumers to keep a keen eye on how the situation develops.  Nuedexta has been shown in research to increase fall risk in elderly patients.  Without being approved for use in patients with Alzheimer’s or dementia, there is little additional information known about the risks and possible side effects.

Families concerned about their loved one taking Nuedexta, or being improperly prescribed the medication, should contact their doctor or seek a second opinion.  Many families also find it helpful to contact an attorney who is knowledgeable in medical malpractice and nursing home abuse.  Only an attorney can help patients and their families understand their legal rights and ensure that they are not being victimized by unethical or negligent actions.

 

Sources:

http://www.cnn.com/2017/11/02/health/avanir-nuedexta-nonprofits-invs/index.html

http://www.cnn.com/2017/10/12/health/nuedexta-nursing-homes-invs/index.html