The U.S. Department of Justice announced that it is has launched a probe into a new psychosis drug that is marketed for the treatment of Parkinson’s disease. The investigation is targeting the sales and marketing techniques used by the drug manufacturer.
Nuplazid’s Quick-to-Market History.
The drug is called Nuplazid, and it is manufactured by Acadia Pharmaceuticals, who disclosed the DOJ investigation in its recent filing with the U.S. Securities and Exchange Commission. It is intended to combat the debilitating delusions and hallucinations that Parkinson’s patients suffer.
The U.S. Food and Drug Administration approved Nuplazid back in 2016. Citing the desperate need to treat those patients suffering from Parkinson’s, the FDA approved the drug despite evidence that the risks of the antipsychotic drug might outweigh its risks. At the time, the FDA called it a “breakthrough” drug, a designation that indicates that the agency felt it demonstrated substantial improvement in patients in comparison to other treatments and drugs already available on the market.
But because of a significant number of deaths of patients taking the drug, medical researchers and physicians raised alarm bells about the safety of Nuplazid. Some health care professionals asserted that the drug was approved too quickly, and without enough evidence to determine its effect on patient health and safety.
Thereafter, the FDA performed a new safety evaluation into whether Nuplazid was causing higher risk of mortality rates in Parkinson’s patients. That evaluation, which completed in September 2018, concluded that there were no new or unexpected additional risks that were inconsistent with the “black box” warning label—the FDA’s most severe warning level—that was already required to be included with the drug’s prescription.
The DOJ’S Investigation of Fraud.
Acadia admitted in its SEC filings that it received a “Civil Investigative Demand,” a type subpoena, for documents from the DOJ in September 2018, which requested documents and information from the pharmaceutical company. The DOJ’s subpoena cited the False Claims Act, a federal law that the government uses to prosecute and recover fraudulent gains.
The DOJ did not issue a comment, so the focus and the basis of the DOJ’s investigation remain unknown. However, False Claims Act experts and attorneys specializing in health care fraud say that most false claims investigations like this one start from a whistleblower complaint. In the health care industry, False Claims Act cases can involve pharmaceutical companies offering illegal “kickbacks” to doctors—or when the drug manufacturer unlawfully pays doctors extra money in exchange for prescribing the drug. Some False Claims Act cases end with criminal and civil penalties, as well as settlements for millions of dollars.
Investigations into public government data that track prescriptions shows a connection between doctors who were paid promotional fees by Acadia and those doctors who prescribed Nuplazid the most. Although it is not illegal for pharmaceutical companies to pay doctors to promote a drug to colleagues and other medical health professionals, it is illegal to pay doctors to prescribe it to their patients. This information, collected and analyzed from public government Medicare data, shows that there may in fact be a connection between the payments to doctors and the actual patient prescriptions. According to CNN, this data shows that more than 10% of all Medicare-based claims for Nuplazid (or more than $2.1 million) came from the physicians who were on the bankroll of Acadia.
In total, Acadia spent more than $8 million in payments to doctors in its marketing support of its sole drug, Nuplazid. Twenty-six individual doctors received payments—which include compensation for food, drink, travel and financial compensation for marketing efforts—in six-figure sums.
Acadia responded that its payment and marketing interactions with physicians are all for legitimate and legal purposes. In response to the large sums paid to doctors for marketing the Nuplazid drug, Acadia asserted that most of the money was for speaking events to spread awareness about the drug and its benefits in treating Parkinson’s.
Acadia also says that it is cooperating completely with the DOJ’s request.
In the meantime, Nuplazid remains the only drug on the market that is FDA-approved to treat Parkinson’s Disease Psychosis.
Interstitial Cystitis Patient Suffers Progressive Visual Deterioration from Elmiron Treatment
After being treated for bladder pain syndrome with pentosan polysulfate sodium (sold under the brand name Elmiron) for two years, a woman in Texas says she experienced progressive vision problems that eventually led to blindness.
According to court filings, the patient began taking Elmiron in 1997 and less than two years later began to experience blurred vision and having trouble with her eyes adjusting in dim lighting. In 2002, she was diagnosed with maculopathy. Additional medical notes showed that pigment changes were also present on the macula of both eyes.
Unfortunately, in 2010, doctors determined the patient was legally blind from macular degeneration and in 2013, she was further diagnosed the eye disease pigmentary retina dystrophy, which is typically characterized by colored spots on the retina.
Elmiron Research Warns of Potential Eye Damage Complications
The patient and her physicians did not know that Elmiron could cause vision damage, as there were no warnings indicating adverse vision events and the first major study connecting the bladder pain drug to vision damage wasn’t published until 2018.
In that study, published in 2018 in the Journal of Urology physicians from the Emery Eye Center noted eye damage and vision problems in six patients who had been treated with Elmiron. More studies followed regarding the association between eye damage and use of Elmiron.
Elmiron Warning Label Changes Delayed in the U.S.
In 2019, the European Medicines Agency required Elmiron maker Janssen to update the label to warn of the potential for eye damage. Health Canada required the same warning label update later the same year. However, it wasn’t until June 2020 that Janssen updated the U.S. warning label to alert the medical community that pigmentary maculopathy had been identified in Elmiron patients.
In October 2020, the Texas patient was diagnosed by a retinal specialist with chorioretinal degeneration and noted significant pigment changes to the retinal tissue and diffuse outer retina atrophy, elements of Elmiron toxicity.
The patient and her husband are seeking damages for the serious injuries the wife allegedly suffered due to use of Elmiron. The claim was filed in the U.S. District Court for the Eastern District of Pennsylvania.
Elmiron Linked to Vision Damage
New studies indicate that the drug Elmiron, a medication already linked to health issues, may also cause vision problems in women with long-term use. The medication is often prescribed as treatment for urinary tract infections as well as osteoarthritis and other conditions.
Studies on Eye Damage
Several studies have been done on the side effects of Elmiron with more investigations underway. Information links Elmiron and vision damage. The amount of damage correlates with the quantity of the medication taken.
Elmiron was approved by the US Food and Drug Administration (FDA) to treat interstitial cystitis, which is a chronic condition of the bladder. It can cause pressure in the bladder along with pain. With long-term use, research indicates that it may be possible for Elmiron to cause pigmentary maculopathy.
This condition impacts the part of the retina known as the macula, which is the central part of the eye. It can cause issues with changes to light. The job of the macula is to protect the retina from UV light, which allows the person to see details better.
The Emory Eye Center, based in Atlanta, GA, made a report that showed that patients who had been taking the drug for about 15 years had changes in their macula. Another 10 patients had a diagnosis of interstitial cystitis and had been prescribed Elmiron. They also showed symptoms that corresponded with pigmentary maculopathy.
Another study was done by Kaiser Permanente which showed that about 24 percent of patients who had been prescribed Elmiron for a minimum of five years had damage to the eye.
Signs of Damage to the Eye
Symptoms associated with this condition include the following:
- Vision loss
- Difficulty with reading
- Vision that is distorted
While the condition can be preventable, it may not be treatable if it develops. This condition is just the latest to be related to Elmiron. Other conditions include the following:
- Optic neuritis and
- Retinal hemorrhage
Even after the patient discontinues the mediation, damage may occur. They may have difficulty adapting to an environment with low lighting. The condition can mimic macular degeneration in its later stages.
Anyone experiencing these symptoms after taking Elmiron should talk to their doctor about treatment. While it is never advised to stop taking prescription medication without consulting with their doctor first, it is important to arrange an appointment to discuss their symptoms with a medical professional right away. If they have taken Elmiron in the past and are experiencing vision changes, they will want to present that information to their doctor.
As the only FDA-approved treatment for IC, it must be continually taken, which means that thousands of patients may have been using Elmiron for years or even decades without knowing about the potential for vision damage. Even with the studies being conducted, Janssen Pharmaceuticals failed to warn the public until regulatory agencies applied pressure. Even when warnings were required in Europe and Canada, no changes were made to the labels in the US until June 2020. It is expected that more people will come forward with evidence of vision damage as the public becomes aware of the situation.
Changes in Priority List for COVID-19 Vaccine
Supplies for the COVID-19 have been limited in California. At this time, only health care workers, staff and residents in long-term care facilities have been getting it as well as people who are age 65 and older. However, the list for who may be top priority in the future could be changing in the state.
Governor Gavin Newsom has announced who will be top priority for the next phase of vaccination. The plan is to switch to an approach based on age. This is a change from the earlier tier plan where workers who were in commercial and residential settings as well as those who were in transportation and manufacturing would be the next priority. It also included homeless people and those who are incarcerated.
No details about how the groups would be divided by age have been given. Some speculate that it may start with those age 50 and up. Many groups have pushed to have these changes made. However, there are other groups who don’t support the age-based approach. Labor unions are critical because they say essential workers should be protected by getting access to the vaccine right away since they are put at risk for doing their jobs.
Groups that support people with disabilities say that those who are at highest risk aren’t being prioritized. The changes don’t consider those who have the most risk for complications with the virus.
When Vaccinations Will Occur
California state officials have indicated that it may be June before everyone who is 65 and older have been able to get the vaccine. The state is getting about 300,000 to 500,000 doses per week. For Los Angeles County, that many doses would be needed each week just to get the adult residents vaccinated by the middle of summer. It is expected that it will be mid-2022 before everyone is vaccinated.
When it comes to priority by industry, healthcare workers are the top priority. Teachers come next because they are the key to getting schools open again for in-person learning. After teachers, it is workers based in the food and agriculture industries with those in emergency services coming next. There is no current timeline for when those workers are able to sign up for vaccinations.
Vaccinations are going slow in part because a significant portion are going to people getting their second dose. That takes away from those who are seeking their first dose. Adding to the complications is the weather. In Orange County, strong winds caused the Disneyland vaccine site to close, which made thousands of people have to reschedule.
Right now, residents age 65 and older are able to sign up for appointments for vaccination in the state. The goal for Orange County is to get all residents their vaccinations by July 4th. Ventura County is allowing residents age 75 and older to sign up for the vaccine. Other counties have their own restrictions for the vaccine and vaccination sites set up for administration based on the number of doses they receive.
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