Opioid Epidemic: Lawmakers Seek Answers from Manufacturers

In a response to the growing opioid epidemic, the Senate will question five of the biggest opioid drug manufactures.  The Senate is looking for reports regarding marketing practices that may have underplayed the seriousness of opioid addiction.  Some of the allegations include misrepresentation about addictiveness of certain drugs.

From CNBC, “Opioid epidemic: Senate committee opens probe of five big painkiller makers:

Excerpt from the Article: “The investigation will explore whether pharmaceutical manufacturers — at the head of the opioids pipeline — have contributed to opioid over-utilization and over-prescription as overdose deaths in the last 15 years have approached nearly 200,000,” said a press release announcing the probe.

 

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An Increasing Demand For The Right-To-Try

In recent years, thirty-three U.S. states have passed “right-to-try” laws aimed at increasing access to experimental treatments for terminally ill patients. Many such patients feel it is their right to try experimental medications, which have not been fully approved by the Food and Drug Administration (“FDA”) and are otherwise unavailable. On the other hand, some doctors and medical ethicists stand firm in their belief that FDA procedures and clinical trial processes should be adhered to as they were put in place for good reason – to ensure that drug manufacturers are producing a safe product. Furthermore, some argue that “right-to-try” laws do not expand patients’ access to effective drugs since pharmaceutical companies are not obligated to distribute experimental medications.

Excerpt from Article:

Right-to-try laws offer patients an alternative to the compassionate-use, or expanded-access, program the FDA has had in place for more than two decades. As many as 1,821 applications are filed each year, and about 99 percent of them are approved, according to the [FDA].

 

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Use of Social Media to Recruit Participants in Clinical Trials Raises Ethical Concerns

Difficulties faced by researchers in recruiting participants to clinical trials has resulted in the increased use of social media as a research tool. Although recruitment through social media is akin to traditional methods in many aspects, online recruiting raises several additional ethical and regulatory issues, such as privacy concerns and online security risks. However, little guidance has been provided to investigators and Institutional Review Boards to facilitate the review and use of social media as a recruitment mechanism. In light of the many benefits this form of recruitment has to offer to increasing participation in clinical trials, Harvard scholars published an article in the American Journal of Bioethics, offering practical recommendations to assist investigators and Intuitional Review Boards with the implementation of explicit policies for social media recruitment.

Excerpt from Article:

One issue that is specific to the online platform in regards to transparency is whether investigators are required to let people know that they are collecting data. Depending on the nature of the research study, investigators could reasonably obtain information just by “lurking” on the group page. 

 

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Making Health Insurance More Portable: GOP’s Plans for Insurance

In an article dated February 28, 2017, the author discussed a GOP plan to make health insurance more portable by allowing consumers to take their plans with them if they move, retire, or change jobs.  Although a popular idea for many, it does present some structural concerns due to the  setup of insurance markets and networks.

From NPR, “What If You Could Take It With You? Health Insurance, That Is”

Except from the article:

“To be truly portable, consumers must be offered plans regardless of their health status, age or other considerations. Before the health law was enacted, insurers could reject people with medical conditions. But the ACA prohibits insurers from redlining sick people or charging them higher premiums. Although popular in opinion polls, those Obamacare provisions may face some changes under the GOP plans.”

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New Genetic Testing Bill: Potential for Progress or Potential for Discrimination?

According to a recent article published in The Atlantic, the House Committee on Education and the Workforce recently approved H.R. 1313, a bill that would allow employers to pressure their employees to undergo genetic testing and share the results as part of an employer’s “workplace wellness program.” If an employee opts not to share the results, he or she could be forced to pay significantly more for health insurance.

Proponents of the bill note that it simply builds on programs already in place from the Affordable Care Act; however, critics are worried that the bill will take away many of the privacy, discrimination and insurance protections of the Genetic Information Non-Discrimination Act (“GINA”).

From The Atlantic, “The GOP’s New Bill Would Seriously Disrupt Genetics Research”

Excerpt from article:

“‘People are already being discriminated genetically without mandatory genetic testing—that’s what sexism and racism is . . . . This [bill] would result in a higher resolution of discrimination and more individualized ways of targeting people.’ The dark mirror of personalized medicine is personalized discrimination.”

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Researchers Restore Hearing in Deaf Mice by Inserting a Normal Copy of the Mutated Gene

Two recent publications in the Nature Biotechnology journal show that researchers were able to help deaf mice hear again after inserting a gene, Ush1c, into their ears. Initially, the mice were given Usher Syndrome type IC, which also causes deafness in humans. To combat the deafness this caused in the mice, the mice were then given a normal copy of the mutated gene. The mice, who were profoundly deaf, began to hear. This research has important implications for humans with hearing loss, in that approximately half of the cases of hearing loss in humans has a genetic component.

From wired.co.uk, “Biologists help deaf mice hear again by inserting healthy genes into their ears”

Excerpt from article:

“[T]he work – and the field in general – is trying to answer one big question: ‘Can you manipulate the system to cure things that are wrong?’”

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Heroin Deaths Outpace Gun Deaths Last Year

 

Heroin deaths have quadrupled since 1999, making it a bigger killer than guns in the United States. While addiction is a disease that health professionals are familiar with, the average American still believes addiction is a character flaw rather than a chronic disease. Over 20 million Americans have addiction issues and over 12 million abuse prescription opioids. With the number of Americans suffering from drug addiction rising, politicians are paying more attention to this crisis, with Congress recently allocating $1 billion to address the opioid epidemic.

From huffingtonpost.com, “Heroin Deaths Topped Gun Homicides Last Year, Depressing CDC Data Shows”

Excerpt from article:

  “It doesn’t take long for prescription use to evolve into misuse.  According to a new Washington Post-Kaiser Family Foundation survey, a third of Americans who took a prescription opioid for two months or longer became addicted to or physically dependent on painkillers.”

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Is Medicaid Expansion Good for State Economies? A Michigan Case Study says so.

In 2017, the federal government is expected to cover 95% of Medicaid costs in states that have expanded their Medicaid programs pursuant to the ACA.

One study in Michigan highlighted three major trends: decreased state level spending on health services, increased economic activity in areas such as construction and retail services, and increased spending in consumer goods (the less Medicaid recipients spent on healthcare costs, the more they spent on other items).  Although the researchers concluded that the expanded Medicaid program benefited Michigan, the study did point to some potential limitations including new spending that actually results from cost shifting from states and consumers to the federal government.

From The New England Journal of Medicine, ” Economic Effects of Medicaid Expansion in Michigan”

Excerpt: “Similar economic benefits are almost certainly accruing to the other 30 states that have expanded Medicaid, but not to the 19 states that haven’t done so. State policymakers can consider these benefits along with health and financial effects for enrollees as they decide whether to continue or initiate Medicaid expansion.”

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Cuba Discovers Cancer Treatment, Yet Embargo Keeps It Out of Reach for U.S. Patients

The fast-growing biotechnology industry in Cuba has created a new cancer drug called Cimavax. The drug targets epidermal growth cells and allows the body to attack the cancer on its own. Cancer patients who use the drug are expected to live 3 to 5 months longer.  Yet, patients in the United States have limited access to the new treatment. The United States has imposed a trade embargo on Cuba that prevents the importation of goods such as medication and, therefore,  requires patients to travel to Cuba in order to receive the new treatment.

From NYTimes.com, “A Souvenir Smuggled Home From Cuba: A Cancer Vaccine”

Excerpt from article:

“The trial could take years, but American cancer patients are not waiting. Over the past couple of years, dozens have slipped into Havana and smuggled vials of the vaccine in refrigerated lunchboxes back to the United States, sometimes not even telling their doctors. Talk about Cimavax on cancer patient networks online has been escalating steadily as relations between the two countries have warmed and more patients are making preparations to go…”

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Tags: Cancer, Treatment, News, Research

Transgender Men Fighting Breast Cancer: The Difficulties in Accessing Care

In an article dated October 16, 2016, Eli Oberman, a transgender man discusses the social and medical difficulties he faced when diagnosed with breast cancer, including discrimination by health care providers. There are roughly 1.4 million transgender individuals in the United States and only recently has the federal government lifted the ban on Medicare coverage for transgender healthcare. New York State lifted a similar ban under its Medicaid program. However, there is still a lack of trust in health care providers among the transgender community, and a lack of knowledge of transgender health care needs among the medical community, that create barriers to accessing much needed health care.

From NYTimes.com, “Living as a Man, Fighting Breast Cancer: How Trans People Face Care Gaps”

Excerpt from article:

During one procedure, when Mr. Oberman had his shirt off, a male technician, seeing that he was transgender, exclaimed: “Why would you do this to yourself? It’s disgusting.”

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