Researchers have been studying the effects of Cannabidiol (“CBD”), a marijuana extract claimed by some to be a “wonder drug” for treating children who suffer from severe epilepsy. CBD, which has also been used in to treat many different conditions including schizophrenia and anxiety, has been legalized in many states and others are considering legislation.
Early research of CBD has revealed mixed results. For example, Dr. Kevin Chapman, a neurologist at Children’s Hospital Colorado conducted a study of 75 children treated with CBD. He found a drop in seizures by at least half in 33% of the children. But, also found that 44% of the children had a negative response that included an increase in seizures.
However, GW Pharmaceuticals (“GW”) conducted a study focused on a “purified CBD extract” known as Epidolex as part of their program to treat resistant childhood epilepsies. The study revealed that of 58 participants, 40% had a decline in seizures, 10% of which became completely seizure-free, while one patient had an increase in seizures. (read more about Epidiolex and GW Pharmaceuticals follow the link http://www.wsj.com/articles/PR-CO-20150108-905340)
Prominent “gene editing” scientists have called for a freeze on genetic experiments that alter the DNA of human sperm, eggs and embryos. Concern in the scientific community spread following publication of an article in the MIT Technology Review that chronicled efforts of three groups to genetically alter human embryos.
The concerned scientists published a plea titled “Don’t edit the human germ line” in the journal Nature (the article can be viewed at http://www.nature.com/news/don-t-edit-the-human-germ-line-1.17111). This group of scientists is involved in experiments involving genome-editing in non-reproductive cells. They fear that unlike their work, the implications of editing the DNA of human embryos will have irreversible repercussions that could be passed to future generations. They note that modifying the DNA of human reproductive cells could be used for cosmetic rather than therapeutic purposes. This raises ethical and safety concerns.
The scientists call for an agreement within the community to ban modifying the DNA of human reproductive cells.
The last known Ebola patient in Liberia has been discharged from a treatment center in Monrovia, potentially marking the end of an epidemic that according to the World Health Organization, claimed 4,117 victims in Liberia alone. On April 4 the epidemic will be considered officially over as long as no new cases emerge. The date was selected because it would mark 42 days (double Ebola’s 21 day incubation period) after the last known infection.
Even though the number of known Ebola cases in Liberia has dropped to zero, officials are warning people to remain cautious. Within Liberia, authorities are still monitoring roughly 100 people who may have been exposed to the virus. Furthermore, Sierra Leone and Guinea have seen a recent spike in the number of known cases — increasing in the last week of February from 99 to 132.
In early March 2015, the Food and Drug Administration (“FDA”) approved Zarxio, the first “biosimilar” drug, to be introduced into the U.S. market. Biosimilars are expected to offer cheaper versions of existing biologics. They are nearly identical to the originals, and are used to treat the same conditions. Biosimilar drugs are expected to create a more competitive market by providing people with comparable, less expensive prescription medication.
Zarxio, the first of what is likely to be many biosimilar drugs to receive FDA approval, will compete with Neupogen, a drug prescribed to chemotherapy patients. Zarxio promises to be cheaper than Neupogen and similar enough to serve all five of Neupogen’s current uses. However, questions remain as to how effective biosimilars will be in lowering the cost of drugs. In fact, the makers of Zarxio have not announced how much cheaper the drug will be. Secondly, there is no telling whether clinicians will embrace biosimilars.
Amgen, the makers of Neupogen, asked a California federal judge for an injunction blocking the launch of Zarxio. They allege that the makers of Zarxio failed to follow the rules in seeking regulatory approval. A court hearing is set for March 13, and Novartis, the maker of Zarxio, has agreed not to sell Zarxio until the hearing or April 10, whichever is earlier.
Months after the Food and Drug Administration (“FDA”) warned against using laparoscopic morcellators, a gynecological tool used to remove fibroids during hysterectomies, many doctors have continued to use the device. The FDA warned that the tool, used to slice uterine tissue into fragments for removal, may leave behind benign and undetected malignant cancers. In fact, the FDA has assed the risk of the device spreading cancer at 1 in 300 to 1 in 1000. of.
Gynecologists who have decided to continue using the morcellator argue that the FDA’s data has been exaggerated, and it is getting in the way of patient treatment. They believe the benefits of using the tool outweigh the risks, claiming patients who undergo a morcellator procedure have lower bleeding risks, less infection, and recover more quickly than those undergoing other minimally invasive procedures.
Since the implementation of the Affordable Care Act (“ACA”), millions of Americans have enrolled in Medicaid. However, the government has not ensured that the new beneficiaries will have access to doctors. In fact, many Medicaid recipients are finding that they have to wait months due to shortages of doctors who accept Medicaid. Daniel R. Levinson, the inspector general of the Department of Health and Human Services, blames the lack of access on variations in standards between states. More specifically, most states rely on private insurance companies to comply with Federal rules in providing Medicaid beneficiaries with “adequate access to all services covered.” However, “adequate” is defined by each state. Some states opt for a “time and distance” standard for access, others set a maximum number of days a patient may have to wait to see a doctor, and some base the standard on a doctor/patient ratio. The result has left many Medicaid patients waiting up to 60 days to see a specialist, while others are forced to travel great distances because their state only requires one primary care provider for every 2,500 beneficiaries.
Mr. Levinson believes that the federal government should be more involved in developing and enforcing state standards of access. However, insurance companies worry that if the federal government forces a larger pool of doctors who accept Medicaid, it will upset the low premiums resulting from insurers limiting access.
Liver transplants are usually available for patients who are deemed the sickest on the national transplant waiting list. Currently, the United Network for Organ Sharing (“UNOS”), divides the country into 10 regional transplant boundaries. This means that sometimes geography, and not the severity of illness, determines the recipient of a liver. The Midwestern and the Southern regions have more organ donors per capita but less demand for transplants than people living in coastal regions. As a result, patients with “means” often avoid the wait in high demand regions by traveling to low demand regions, but the poor are left to wait. This has prompted UNOS to consider new regional boundaries which incorporate parts of high demand transplant regions into lower demand regions. Some lawmakers oppose this reorganization plan fearing that their regions will become “organ farms” for other parts of the country. They blame high demand on a failure to run effective grassroots campaigning to increase rates of donation.
Currently, the Department of Health (“DOH”) has authorized three medical marijuana licenses for the entire state of New York. State Senator Diane Savino has been pushing DOH to issue additional licenses believing insurance companies and customers would benefit from more locations to fill marijuana prescriptions. She asserts that marijuana is a cheap alternative to many costly drugs and that each drug substituted is one less co-pay to be paid.
The Global Commission on Drug Policy, a 21-member commission made of former world leaders, has been pushing for the decriminalization and regulation of most illegal drugs. Among the commission’s members are former United States Federal Reserve Chairman Paul Volcker and former United States Secretary of State George Shultz. The commission’s report focuses on the failure of the so-called “War on Drugs” and the commission aims to introduce the report to the United Nations General Assembly in 2016.
The report proposes a shift from the current law enforcement/criminalization approach toward decriminalization and regulation. The commission asserts that the new focus should be on drug trafficking rather than drug users, pointing to the fact that the War on Drugs has not effectively reduced drug trafficking. The report contends that drug lords have become powerful enough to destabilize entire regions of the world, resulting in violence and human rights violations. However, the commission does not go as far as to say that all drugs should be decriminalized. In particular, it provides that crack cocaine and other potentially lethal drugs should remain illegal.