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.
Claims of Gilead Scheme with Bristol-Myers and Johnson & Johnson
A new lawsuit against drug manufacturer Gilead Sciences claims that the company created a monopoly on certain HIV medications while keeping the cost of drugs high. Gilead is supposed to have achieved this monopoly with the help of Bristol-Myers and Johnson & Johnson.
Claims of Monopoly
AIDS activists and supporters of those who have been diagnosed with HIV have filed a class action lawsuit against Gilead. Allegations claim that the three companies worked together to stick with ingredients that were protected by a patent for the drugs rather than developing lower-cost generic medications. This continued even when patents had expired on specific parts of the drugs.
The result of this strategy, according to the lawsuit, is higher prices even after exclusivity had expired. One drug, Complera, costs $35,000 per year per patient. Claims made against the manufacturer say that another version which has generic ingredients would cost about half.
This situation is just the latest in a string of lawsuits and claims about Gilead’s practices with HIV medications. The drug manufacturer also faces lawsuits about keeping lower-cost drug alternatives from the public while garnering as much revenue as possible from other older drugs. This lawsuit claims that Gilead was focused on revenue at the cost of patient safety.
The newest accusations against Gilead and the other companies focus on a scheme to reduce competition claiming they limited patient access to drugs while charging the government and insurance companies as well as patients more for expensive drugs.
According to the lawsuit, everyone suffers, from health insurance providers to state and local government programs to the individuals. Many aren’t even able to obtain the drugs because of the cost. Allegations cite a “no generics” clause in the agreements made between the companies as well as other agreements with manufacturers that wanted to put copycat drugs on the market.
Gilead continues to maintain the claim that every decision was made to bring important therapies to patients who needed them. Partnerships with Bristol-Myers and Johnson & Johnson were made with this goal in mind. Bristol-Myers is reviewing the claim, and Johnson & Johnson has not responded to the accusations.
The manufacturer made a deal with the government to provide as many as 2.4 million free bottles of Truvada to those who are at risk for the disease. Generics are expected to be on the market for this medication by the end of 2019 instead of 2021 as originally expected.
Critics say that more needs to be done to ensure everyone benefits from reasonably priced medications designed to treat a deadly and life-changing disease. Highly recognizable activists are part of the plaintiffs in this case, and they are hoping to incite change to give people who need the drugs access.
Gilead continues to deal with multiple lawsuits regarding its practices and pushes for claims to be dismissed in various cases. A recent request was denied against Gilead in a claim which accused the manufacturer of delaying the release of other drugs which are safer and less expensive.
Fournier’s Gangrene Tied to Diabetes Medications
Multiple cases of Fournier’s gangrene have been tied to diabetes medications. This condition is serious and can even be fatal. However, it is a rare condition which usually happens to men past middle age. In fact, lawsuits are being filed for the victims.
What is Fournier’s Gangrene?
Also known as necrotizing fasciitis, it affects the genital area – mainly of men. The condition is a bacterial infection that is found in the tissues under the part of the skin which is surrounding the blood vessels, fat, muscles and nerves of genitalia.
The most common people to suffer from this condition is males between the ages of 50 and 79. Only about 1.6 of 100,000 are diagnosed each year. It’s known as flesh-eating bacteria because that is what it does.
Fournier’s gangrene or genital gangrene as it’s often referred to develops when bacteria gets into the system from a tear or cut in the skin. It will spread quickly and destroys any tissue it comes into contact with. People who have diabetes are already more susceptible to gangrene because of a lower immunity system and reduced blood flow.
The Link Between Diabetes and Fournier’s Gangrene
In August of 2018, the Food and Drug Administration (FDA) provided a warning that people who were taking type 2 diabetes drugs were at an increased risk for developing this type of gangrene. The type of drugs, which are known as SGLT2 inhibitors will carry new warnings. The drugs included are:
And any generic versions.
These drugs work to lower blood sugar levels. They take away any extra glucose in the system by moving it through the kidneys and out of the body in urine. While the medications are designed for people who have been diagnosed with type 2 diabetes, they have shown to be helpful with those who have type 1 diabetes as well.
While the natural incidence rate is low, the number of people diagnosed between March 2013 and May 2018 was significantly higher with 12 cases. All were taking SGLT2 inhibitors. Five of the cases were female and seven were male. The patients were between the ages of 38 and 78 years of age. Fournier’s gangrene is rarely diagnosed in women.
According to reports, the patients developed the condition at an average of about 9 months after they began taking the medication. The actual development was from just seven days all the way to 25 months.
All of the cases required surgery for treatment with one needing skin graft surgery. All needed the infected tissue removed and five had multiple surgeries to take care of the condition. Out of the 12, four of the patients had complications from the condition. These complications included kidney injury, diabetic ketoacidosis and septic shock. One of the patients died. Two others had to go to a rehabilitation hospital.
Data was looked at for other patients who took alternative medications to reduce their blood sugar. During the period between 1984 and 2018, only six cases of the disease were diagnosed. All of the cases were men.
Treatment of the Condition
If a person is taking one of these SGLT2 inhibitors, they should pay attention if they notice swelling, redness or even tenderness of the genital area. If they have a temperature above 100.4 degrees Fahrenheit, they should seek medical attention right away. The condition can worsen quickly.
If the patient is diagnosed with Fournier’s gangrene, they will be treated with antibiotics and may need surgery. They should stop taking the diabetes medications but still monitor blood sugar levels.
The FDA has asked people who experience these or other side effects while taking the inhibitor to contact them and provide information about their case. The agency now requires a warning be included in medicine guides for patients and other information for medical personnel. It was estimated that 1.7 million patients received prescriptions for one of these drugs in 2017.
While genital gangrene has garnered attention with the SGLT2 inhibitors, this is not the only condition to be linked with the medication. Diabetic ketoacidosis is another disease which may be caused by taking the medication. It is another life-threatening condition, which requires treatment right away.
Since diabetics are more susceptible to many health conditions, experts say it is imperative that doctors are aware of these risks and educate patients on them. They need to provide information about recognizing and treating the conditions and advise them of the risk so the patient can make an informed decision about whether to take the medication.
The Diabetes Drug and Gangrene Scare
August 2018 the Food and Drug Administration alerted diabetic patients of the dangers of the SGLT2 inhibitor medications for a specific type of gangrene. This is not just one drug but a class of medications. The condition, commonly called genital gangrene, is serious and can even be fatal.
This type of drug is used to treat type 2 diabetes, but it has also seen some effectiveness in type 1 diabetes. Type 2 diabetes results in a high blood glucose level because the body cannot use the insulin up. It’s most common in middle-aged adults and seniors, but it can occur in other ages as well. This type of diabetes is known as hyperglycemia and is the most common form.
SGLT2 inhibitors work by moving the excess insulin out of the body through the kidneys and in the urine. They work in conjunction with diet and exercise to help the person be able to regulate their glucose levels.
Medications are used to control the diabetes unless the condition is too severe and requires other treatments. Since diabetes drugs are the most common form of treatment, it’s important for patients to understand the risks.
Gangrene and Diabetes
The type of gangrene the FDA warns of with the SGLT2 inhibitors is called Fournier’s gangrene or genital gangrene and is necrotizing fasciitis. It is a rare form of gangrene that only affects the genital areas of patients, mostly men.
In fact, most of the people diagnosed with this condition have been males between 50 and 70 years of age. It affects 1.6 men out of 100,000 each year, which shows how rare it is even for diabetics. A total of 1.7 million people received prescriptions for SGLT2 inhibitors in 2017.
To develop this condition, bacteria must enter a cut in the body. The bacteria then attack the tissue under the skin around the genital area. It causes an infection in the tissue and swelling or tenderness and redness around the genitals. If left untreated, it can cause a severe infection and loss of tissue as well as death.
The Link Between Genital Gangrene and Diabetes Medications
Studies indicate that taking the SGLT2 inhibitors can increase the risk for developing this condition. Between 2013 and 2018, 12 people were diagnosed with the condition, five of which were women. It’s extremely rare for a woman to develop this type of gangrene and at double the normal rate.
Anyone with diabetes is at a greater risk for developing gangrene than someone who doesn’t have the condition because of limited circulation and reduced blood flow. With the addition of the medication, the risk goes up even more.
The drug increases the amount of glucose in the urine, which helps to feed any infection in the body. It can slow down the healing process even if the cut is small. This allows the bacteria to continue to grow and develop into a serious situation.
Supporters of the medications say that 12 cases indicate a minimal risk for those who rely on the drugs to help them control their glucose levels. However, the FDA now requires manufacturers of these drugs to label them with the new warning. This ensures that they are aware of the risk if they choose to take the medication.
Of those 12 who were diagnosed with Fournier’s gangrene, one person died. Four others suffered various complications from the condition and all needed multiple surgeries to remove the dead tissue.
While genital gangrene is certainly one of the most serious results of taking these SGLT2 inhibitors, it is by no means the only risk. Anytime a medication causes additional glucose to move through the kidneys and urine, it puts the person at risk for other infections, such as urinary tract infections. Because diabetics heal at a slower rate in many cases, they can develop other complications and have a more severe reaction to the symptoms.
Anyone who is taking SGLT2 inhibitors should talk to their doctors about the risks and potential side effects. They not only need to know about genital gangrene but other conditions. They need to ask their doctor what symptoms to look for and what to do if they notice signs of problems.
While these inhibitors have shown some positive results for diabetics who are trying to control their type 2 diabetes, they do not come without some level of risk. Many patients may be able to take the drugs with no concerns, but they need to be aware of those risks and make an informed choice.
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