Tag: public hearing

  • FDA Discusses Using Drug Therapy To Help Teens Quit Vaping

    FDA Discusses Using Drug Therapy To Help Teens Quit Vaping

    The FDA recently held a public hearing to discuss the vaping epidemic among teens. 

    Many consider vaping to be a big problem, and many still don’t realize its potential harm. Now the FDA is so concerned about the popularity of vaping, they’re even considering drug therapy to help wean young people off vaping.

    Matthew L. Myers, who is the president of the Campaign for Tobacco-Free Kids, told CNN, “The FDA has concluded that the level of addiction it is seeing among youthful e-cigarette users is so disturbing and so unprecedented that it needs to at least ask whether we need a solution that goes beyond what we ever did with cigarettes.”

    Even with the partial government shutdown in effect, the FDA held a public hearing on Friday, January 18, to address the problem. One of the biggest problems with the vaping epidemic among young people is that more research needs to be done. There’s a different kind of chemistry that goes into vaping, and previous research on teens and cigarette addiction clearly doesn’t apply the same way.

    As Dr. Susanne Tanski, who is an associate professor of pediatrics at the Geisel School of Medicine, explained, “Clinicians urgently require new solutions to safely and effectively help stop [adolescents] using these and all tobacco products for good. There is unfortunately virtually no data on how to treat an adolescent with e-cigarette dependence.”

    But then the conversation switched to a different tactic, which is trying to keep young people from starting vaping at all. Tanski conceded that “preventing youth use in the first place should be FDA’s primary goal. We must all recognize that if an adolescent has developed a nicotine addiction as a result of vaping, we’ve already failed.”

    Several teens who got hooked on vaping also spoke at the public hearing. One teen first started Juuling in eighth grade, and he stated, “I see so many of my friends who had the same problem I did … and have no idea how to stop it.”

    One possible solution that was proposed at this meeting was having the FDA conduct a “pre-market review” of e-cigarettes, which would include a ban on flavors, one of the most appealing factors of e-cigarettes to young people.

    And while medication is being considered to help wean adolescents off vaping, non-drug therapy was strongly urged at this public hearing as well.

    Nonprofit tobacco control group Truth Initiative has a program that helps young people quit through text messaging. An executive for Truth Initiative said in a statement, “E-cigarette users don’t identify as smokers. They have different barriers to quitting, and, especially in the case of teens and young adults, many want an anonymous way to go about quitting without involving their parents or friends, which texting provides.”

    View the original article at thefix.com

  • Frustrated Pain Patients Meet With FDA About Opioid Access

    Frustrated Pain Patients Meet With FDA About Opioid Access

    A group of pain patients met at FDA headquarters to share their personal stories in a bid to get the agency to ease opioid restrictions.

    The FDA called a meeting in Washington, D.C. to listen to pain patients’ experiences of lacking access to opioids to manage their symptoms.

    A group traveled to the FDA’s headquarters outside the nation’s capital to ask the agency to ease restrictions that they say has made it harder for them to obtain opioids.

    NBC News reported on the stories of some of those who urged the FDA to consider what it is like to have acute or intractable pain and be unable to find relief.

    Dr. Sharon Hertz, director of FDA’s Division of Anesthesia, Analgesia and Addiction Products, told NBC of the informal meeting, “We don’t have expectations for what we are asking. If we thought we knew, we wouldn’t be asking.”

    The Patient-Focused Drug Development Meeting included harrowing stories of suffering. Sandra Flores has a condition called adhesive arachnoiditis, which is an inflammation of membranes in the brain, spine and nerve endings. She has repeatedly attempted to obtain the correct drugs for her pain.

    “I am seeing the true face of medicine,” Flores said. “Now they are throwing me in the trash.”

    FDA Commissioner Scott Gottlieb made an emphatic statement on the plight of pain patients without access to relief. 

    “Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide. This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies,” said Gottlieb, according to PatientEngagementHIT.

    The FDA does not regulate physicians’ prescribing habits; states do. As of now, 28 states enforce limits on opioid prescriptions, says data from the National Conference of State Legislatures.

    Although the FDA, CDC and most major medical institutions agree that limiting access to opioid prescriptions is a necessary step in fighting the opioid epidemic, they do not want intractable pain patients to suffer.

    Under the new regulations, many doctors have simply stopped prescribing out of fear of lawsuits. Flores has been unable to find a doctor that will take her on as a patient. “No doctors will fight. They just don’t want to get into trouble. They have forgotten the people that these drugs were made for.”

    Rose Bigham, speaking on behalf of the Alliance for the Treatment of Intractable Pain, said in the Washington meeting, “To the FDA—we are begging you. Correct the CDC’s egregious mistakes. The CDC recommendations have done irreparable harm to people in pain.”

    View the original article at thefix.com