The drug Nuedexta, a little red pill, was created initially with the aim to treat mental and mood disorders. The pseudo-bulbar effects or the PBA, which can induce often uncontrollable and abrupt laughter and crying, can be treated with the help of Nuedexta.
The problem of PBA affects less than one percent of Americans and is known to be a somewhat rare issue. However, hundreds of millions of dollars are still spent on Nuedexta every year. The medication is being commonly provided to the elderly in American nursing homes, for whom this red pill might be mostly unnecessary. In many cases, Nuedexta for old people may be unsafe and even life-threatening.
Meteoric success in a short time
The drug Nuedexta has gained tremendous financial success over a short period primarily because aggressive marketers have been pushing it for use for the elderly to address diseases such as Alzheimer’s and dementia.
Although the drug is not specifically designed for the neurological conditions the elderly in nursing homes typically suffer from, some doctors are extensively prescribing the medicine for them. Furthermore, they even seem to be receiving payment checks from the drug manufacturing companies. A California based physician recently received thousands of dollars in payment from Avanir, the company that manufactures Nuedexta.
Numerous studies have revealed that over 50 percent of the red pills manufactured is provided to long-term care homes and facilities. The number of Nuedexta pills sold rose to almost 14 million in 2016. This represents an astounding escalation of about 400 percent in only a short time period of four years. The total sales for the red pill in the US last year reached approximately $300 million.
Since Nuedexta is aggressively prescribed to elderly, for whom the red pill is not really meant, both Avanir and the red pills have been garnering a lot of attention in recent times. The critics have even called it as irresponsible experimentation. A study on Alzheimer’s patients showed that more than half had used Nuedexta.
No comments from Avanir
Under persistent questioning from the critics of the red pill, the manufacturer Avanir appears to have entirely isolated itself. They have steadfastly declined to interact with the media or the public. According to sources from Avanir, who speak in defense of the company, the medical condition PBA is misunderstood by most people. They suggest that the condition can also affect people suffering from various neurological diseases, including dementia.
According to Avanir’s website, the PBA can affect about 40 percent of the people who have dementia. The figures on their website, however, have been vehemently contested by medical experts.
No scientific rationale
Geriatric physicians, medical researchers, and other experts say that PBA is a disorder only rarely seen in patients with dementia. The percentage of people being affected by these two conditions at the same time is less than five percent. State regulators have found in their inquiries that many nursing homes are even using Nuedexta for patients with agitated and weird behavioral symptoms.
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There is no concrete scientific evidence to justify the use of this little red pill for elderly residents of nursing homes who suffer from neurological disorders. Critics of this treatment believe that elderly in the nursing homes are a vulnerable group and become easy targets for marketers who are under pressure to meet their sales goals.
In a nursing home in California, a psychiatrist received about half a million dollars in payment over a period of just three years from Avanir and its parent company Otsuka. He also received separate perks for traveling and food. The psychiatrist had prescribed the Nuedexta drug to many patients.
In another case in Los Angeles, the red pill was given by a psychiatrist to residents in a local nursing home. The psychiatrist was a paid speaker there, on behalf of Avanir. In Southern California in 2015, a nursing home employee admitted to inspectors about the usage of Nuedexta on people who were not in need of the drug.
In Ohio, a physician paid by Avanir recently came under the scrutiny of the government. He was allegedly receiving substantial payments and kickbacks for prescribing Nuedexta to patients who were “suddenly diagnosed” with PBA. The doctor denied these accusations, of course.
Misuse of Medicare funds
The federal government has noted that a considerable chunk of finances was spent on Nuedexta from the Medicare funds. The drug was found to have been prescribed mainly for people who are aged 65 and above. The available data from 2015 reveals that of the total Medicare funds, $130 million was spent on just Nuedexta.
Medicare funds were created to pay for the use of drugs that are safe for patients. The Nuedexta drug, the first one of its kind, has been approved by the FDA. But the approval has been given with specific condition to only cater to the needs of the patients suffering from PBA. The doctors prescribing it as an off-label drug to patients not suffering from PBA is technically not covered under Medical funds. A key reason for Avanir’s soaring success has Medicare funds.
Gifts and perks
Medical professionals known to prescribe Nuedexta receive large amounts of money and gifts from Avanir. Even though this practice is legally acceptable, it is still a controversial one. In a blatant use of this practice, Otsuka, the parent company of Avanir, recently spent $4.6 million on “traveling and dining expenses” of doctors. Many doctors prescribing Nuedexta to their patients have been enjoying their share of monetary and other benefits.
Side effects of Nuedexta
Nuedexta is suspected to have various side effects. Ever since its introduction to the market, there have been reports of patients suffering from side effects. Some of the cases have been reported to the FDA. According to these reports, the side effects patients experienced after consuming this drug include:
- Abdominal pain
- Muscle spasms
- Peripheral edema
- Urinary tract infections
Side effects such as rashes and dizziness were the most common ones. However, some of the more severe side effects may have also contributed to elderly patients suffering from severe or life-threatening consequences. This has given rise to more controversies about Nuedexta, with critics questioning the approval granted to this drug. The FDA has, however, declined to comment on these negative reports as yet.
But one of the reports by the FDA has noted that Nuedexta has resulted in the following consequences:
- 113 hospitalizations (including deaths)
- 51 deaths in total
- 102 people being sedated
- 101 cases of dizziness and eventual falls
The plight of the sufferers
Avanir received its FDA approval in 2011. The company quickly grew into a pharmaceutical giant, which has raised many eyebrows. The reality, however, may be that for every family that suffers the consequences of Nuedexta, the company gains. The manufacturer appears to be oblivious to the plight of the patients and their families who see their loved ones suffer.Related: 9 Secrets Your Nurses Know
Family members of the sufferers have regularly reported how Nuedexta made their condition worse. A few even reported their elderly patients becoming comatose after taking the drug.
There was a case of an 86-year old woman whose health worsened quickly after she received Nuedexta. The drug’s dosage for her was increased later, which led to further deterioration of her condition. Even after the drug was stopped, she was unable to recover back her health. Eventually, her kidneys failed, leading her to death.
In another case, an 88-year old woman living in a nursing home was placed on Nuedexta dosage. Her family still questions why she was she even prescribed the drug. The family suspects money is the motivation behind this. They took matters into their own hands and discovered that their doctor had received $100,000 during the time the woman was in the nursing home. For two years the old woman has been taken off the drug. Though she is doing slightly better than before, she has still not completely recovered.
Will there ever be an end to the ordeal of vulnerable patients and families who continue to suffer at the hands of aggressive pharmaceutical businesses and doctors who may be willing to compromise medical ethics in return for financial benefit?