Jeff Sheppard, Attorney in New Jersey Asks: Is a New Parkinson’s Drug Deadly?
Posted on: May 3, 2018
NEW JERSEY. When Nuplazid was introduced to the market, it was heralded as a major breakthrough. The drug showed promise in helping patients who were suffering from the psychotic symptoms associated with Parkinson’s Disease. When drugs are given a “breakthrough therapy” designation, they may be sped through the FDA’s approval process to get the drugs into the hands of the patients who may need them the most. Some doctors believed that Nuplazid showed enough promise in helping Parkinson’s patients with psychosis, that they asked the FDA to fast-track the drug.
However, according to CNN, when clinical trials were performed, some patients were experiencing bad outcomes at double the rate of the placebo group—the group that had not received the drug. In some cases, the medical complications were so severe that patients died. Yet, despite just a six-week study of only 200 patients, the drug was approved.
Based on the reports about the drug’s effects, many families put their loved ones on it. Initial reports indicated that the drug may have resulted in as many as 244 deaths, with other patients reporting that the drug was not effective in treating Parkinson’s related psychosis. Yet, the FDA is not required to take action after initial reports are filed. In general, the FDA reviews reports and determines whether other actions need to be taken. Reports of deaths associated with the drug have since climbed to over 700.
Some doctors believe that the FDA’s fast-track process puts patients at risk. Others believe the fast-track process is too slow. Some families of the chronically ill are asking the House to pass a bill known as the “Right to Try.” According to the New York Times, the bill would allow terminally ill patients the right to try new drugs before they are approved by the FDA.
Few people have traditionally been able to get early-access to newly-developed drugs that showed promise. The passage of the law would likely make it easier for terminally-ill patients to access new drugs. Yet, the law could also have the unintended consequence of letting drug companies bypass essential testing and development processes that ensure that drugs are safe. Individuals are concerned that if patients can access drugs before they are approved by the FDA, the FDA’s authority might be reduced. Companies may also be shielded from lawsuits if they let patients know that a given drug has not been approved by the FDA.
Nuplazid’s manufacturers claim that the high death rate may be due to the fact that Parkinson’s patients are already in the late-stages of the disease. It can be difficult to distinguish the natural progression of the illness from the drug. In fact, in many reports, doctors listed advanced stage Parkinson’s as the cause of death.
The use of antipsychotics to treat elderly patients has been controversial and the FDA has required all antipsychotic medication for the elderly to carry a “black box” warning. Early studies have indicated that the use of antipsychotics in the elderly increases their risk of death. Yet, for some patients, the benefits of reducing psychotic symptoms outweighs the risk. At the end of the day, this may be a quality of life and hospice issue—a question of medical ethics.
If you or a loved one has suffered an adverse event due to taking certain medications, or due to nursing home abuse or neglect, or due to poor treatment after receiving worker’s compensation, consider speaking to the New Jersey personal injury attorney, Jeff Sheppard, Esq. Visit our firm at https://jeffsheppardesq.com/ to learn more about your rights and options, if you’ve been hurt due to taking a medication that was fast-tracked by the FDA.