Tag: opioid painkillers

  • Are American Drugmakers Pushing Pain Pills In India?

    Are American Drugmakers Pushing Pain Pills In India?

    “Painkillers are part of the daily routine. They have become more normalized,” says one social worker in India. 

    At home, major drug manufacturers like Purdue Pharma and Johnson & Johnson are facing declining sales and a plethora of lawsuits. Which is—at least in part—why they have turned their attention to India, a country with a growing middle class population and newly relaxed restrictions on opioid pain medications. 

    When Dr. GP Dureja founded the Delhi Pain Management Centre, people told him, “Nobody has time to complain about pain in our country.”

    Now, that mindset has changed, Dureja said. “I’m getting five to seven new patients per day,” he told The Guardian

    For decades, Indian law tightly controlled access to opioids, because the country historically had issues with opioid abuse.

    Normalization Of Opioids

    However, in recent years, in part due to lobbying by palliative care advocates, the regulations have been relaxed. Fentanyl and methadone are now readily available for pain relief and are beginning to be abused. 

    Alfiya Mulla, a social worker in India, said, “Painkillers are part of the daily routine. They have become more normalized.”

    American companies are moving in to profit from the change. Mundipharma, controlled by the Sackler family, sells buprenorphine in India, while Johnson & Johnson sells fentanyl patches. 

    Indians—like Americans of the early 2000s—see pain relief as a right. 

    Dr. Dureja summed up the changing mindset: “Don’t listen to your forefathers. They said you should tolerate pain, you should not complain, you should not take painkillers. Now, everybody wants to get rid of pain early.”

    Public health expert Dr. Bobby John is concerned that with public opinion on their side, drug companies will find ways to flood India with opioids. “Are people going to figure out every trick in the game to make [opioid painkillers] widely available? Of course it will happen,” he said. 

    Although Dr. Dureja works in pain medicine, even he is concerned by the proliferation of opioids. “General practitioners have started prescribing these drugs, and we’re not educating the population on when to use and not to use,” he said. 

    Opiophobia

    Yet, people who are in favor of expanded access to opioids argue that reducing regulations is important to providing palliative and end-of-life care to Indians who are living—and dying—with chronic pain. 

    “This is a rather horrible country to die in,” said Dr. MR Rajagopal, an Indian physician who speaks out against what he sees as “opiophobia.”

    Rajagopal shared the story of one patient with lung cancer, who came to get morphine tablets. Rajagopal’s clinic was out of the medication. 

    The patient “told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree,’” Rajagopal said. “He pointed to the window. I believed he meant what he said.”

    View the original article at thefix.com

  • FDA Issues New Opioid Guidelines, But Critics Say They’re Not Enough

    FDA Issues New Opioid Guidelines, But Critics Say They’re Not Enough

    The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options.

    The Food and Drug Administration has issued new guidelines about how it should consider applications for approval of new opioids, but some critics are questioning whether the new plan does enough to restrict the harm of potentially deadly medications. 

    The FDA issues the new guidelines on June 20. The guidelines are meant to give a risk-benefit analysis over how new opioids will help patients who use them correctly, but also how they may affect people using opioids illegally. This is a departure for the agency, which usually only considers a drug’s safety when it is taken as prescribed. 

    “Opioids present unique challenges: they have benefits when used as prescribed yet have very serious risks and can cause enormous harm when misused and abused,” the agency said in a statement released at the same time. 

    Still, some people don’t think that the guidelines are enough to prevent the FDA from approving drugs that could worsen the opioid epidemic. One consumer advocacy group, Public Citizen, has demanded that the FDA halt approval of all new opioids until stricter guidelines are in place. 

    Sidney Wolfe, a former member of an FDA advisory committee and a policy expert for Public Citizen, told Pacific Standard that she was not satisfied with the new guidelines. 

    “If this is their view of what should go into a opioid framework, that is not acceptable,” she said. 

    The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options. However, the guidelines don’t require that the agency reject approval for medications that do not work better than existing options, Wolfe said.

    In addition, the guidelines say that the agency will consider how opioids could be misused, but it does not require companies to provide information on potential misuse before they are given FDA approval. The guidelines are not legally binding. 

    Despite the shortcomings, some people who are in favor of stricter oversight over opioids are happy to see the guidelines issues. 

    “What I can say is that we are pleased that the agency has taken this first step in implementing our recommendations,” said University of Virginia professor Richard Bonnie, chair of a National Academies panel that called on the FDA to develop a special process for approving new opioids. 

    The FDA has come under fire for its role in the opioid epidemic. 

    “The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced,” a spokesperson for the agency told Vanity Fair for a recent article. “Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.” 

    View the original article at thefix.com