Pharma Cash Cow: Old Medications, Lucrative Opportunities

In August of this year, the rights to the decades old drug Daraprim were purchased by pharmaceutical company Turing Pharmaceuticals.  Daraprim is the standard of care for treating toxoplasmosis and is used as well in treating HIV infections, cancers, and malaria.  Although the drug was previously sold at $13.50 per tablet, upon its purchase by Turing Pharmaceuticals, the drug’s price increased by over 5,000% to $750.00 per tablet, sparking mass outrage across the internet.

The CEO of Turner Pharmaceuticals, Martin Shkreli, a former hedge fund manager, responded to the widespread criticism of the price increase by providing several reasons for the pricing structure change.  In particular, Mr. Shkreli cited the need to keep the company’s manufacturing costs competitive and to raise capital for the development of new medications to treat toxoplasmosis.  However, medical professionals indicate that there is no need to develop new pharmaceuticals to treat toxoplasmosis and that the former price was profitable, albeit at a much smaller margin.

In response to the public outcry against the price hike, which included criticisms from former Secretary of State Hillary Clinton and presidential candidate and Vermont Senator Bernie Sanders, Turing Pharmaceuticals has reversed the price increase. However, Turing Pharmaceuticals is not the only pharmaceutical company to acquire an old medication and subsequently increase its price to boost profits.  Other drugs, such as Sovaldi, used to treat hepatitis C; Harvoni, a follow-on formulation of Sovaldi for hepatitis C; Retrophin, used to reduce kidney stones; and Cycloserine, used to treat drug-resistant tuberculosis, have also been subjected to similar price increases. Congress is poised to inspect the recent trend in drug price increases, but until congressional action is taken, it appears public outcry will be the primary means of keeping more excessive increases at bay.

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Doctors Continue Use of Tool Which FDA Claims May Have 1 in 300 Chance of Spreading Cancer

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.

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FDA Approves New “At Home” Colon Cancer Screening Test

The FDA recently approved a new “at home” colon cancer screening test known as Cologuard after it outperformed fecal immunalchemical testing (FIT), which was previously “the most reliable stool test on the market.” In a study comparing the two tests, Cologuard “accurately detected cancers and advanced adenomas” more often than FIT, and is the first test that detects “DNA mutations, as well as blood” to screen for cancerous growths. However, Cologuard detects more abnormalities that end up not being cancer than FIT. In fact 13% of those who used Cologuard received a false positive compared to FIT’s 5%.

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Medical Marijuana for New Yorkers?

The Compassionate Care Act, a bill that would allow for a regulated medical marijuana program in New York, has support from New York City Comptroller John Liu. Mr. Liu released a report that over 100,000 NYC residents with serious, debilitating illnesses could benefit from the use of medical marijuana. Currently, twenty states, as well as the District of Columbia, have implemented programs that allow for regulated distribution of medical marijuana. According to a Siena poll conducted in May of 2013, approximately 82% of New York citizens support medical marijuana.

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Research May Lead to New Treatments for Lethal Cancers

Neuroblastoma is a cancer of the nervous system that occurs in children, and is almost always fatal. Fifteen percent of cancer deaths in children result from neuroblastoma. Often, in the most severe cases of neuroblastoma, the gene CHD5 is inactive. A study conducted by Johan Holmberg, PhD, at the Ludwig Institute for Cancer Research Stockholm, examined CHD5’s role as a tumor suppressor in order to learn how it operates in healthy tissue.  The researchers thwarted the activity of CHD5 in the brains of fetal mice; their findings indicate that, in order for a cell to transition from a stem cell into a mature neuron, CHD5 must be active. The findings could lead to new and more effective ways to treat neuroblastoma, as well as gliobastoma multiforme, which is the most common and lethal form of brain cancer in adults.

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World’s Largest Single Cancer Database Established in the UK

The UK seeks to use data to personalize care for cancer patients by setting up the world’s largest single cancer database, which will contain detailed medical information for the 350,000 types of cancer diagnosed across its population. The government maintains that the database will deliver “real-time” data on cancer patients to researchers and clinicians. The instant dispatch of information will give cancer specialists access to information on how varieties of tumors respond to treatment, as well as other detailed clinical information that will help physicians individualize cancer treatments.

The database will also include historical cancer records from the last 30 years, which includes upwards of 11 million records. The combined registry is the result of a five-year project to merge England’s cancer registries into one registry that is centrally managed and subject to the same processes and standards.

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