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.

To read more about, this click on any of the following links:  LA Times, NBC, NBC News, CBS News

Marijuana Extract: Miracle Drug for Children With Epilepsy?

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)

Source

http://www.wsj.com/articles/marijuana-extract-for-children-with-epilepsy-is-questioned-1427148386

FDA Approves Cheaper Version of Popular Drug Prescribed for Chemotherapy Patients

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.

http://www.wsj.com/articles/fda-approves-first-biosimilar-drug-1425651840

Doctors Stop Offering Costly Immunizations

The Affordable Care Act mandates that childhood immunizations be covered at no “out-of-pocket” cost. However, many people are finding it difficult to receive immunizations because doctors have stopped offering them. This is due to the high cost of vaccines and the poor reimbursement from insurers. For example, Prevnar 13, which prevents pneumococcal bacteria diseases, has increased in price at “an average of 6 percent each year” since 2010.  Currently at $136 per dose, many states require children receive up to four separate shots of Prevnar 13. Because of this, more and more doctors feel that they are left with little choice but to stop providing immunizations.

Read more here.

SAIC Seeks to Curb Corruption in China’s Pharmaceutical Industry

China’s State Administration for Industry and Commerce (SAIC) is increasing its investigatory efforts into the Chinese pharmaceutical industry and medical services sector. The SAIC is focusing on the price of medicine, and whether companies are in violation of anti-trust legislation. The SAIC will severely punish those engaged in acts of bribery in the bidding process for pharmaceuticals and medical services because bribery inflates prices artificially and hurts consumers.

Read more here.

New Vaccine Protects Against Four Strains of Flu

GlaxoSmithKline created a vaccine to protect against four strains of the flu virus. Prior to its advent, vaccines protected against only three strains. More comprehensive viral protection is important because providers never know which strain will predominate in a given year. The vaccine is called Fluarix Quadrilivalent (Fluarix). Recently, the FDA approved Fluarix for shipment to health care providers, and the largest order for the vaccine came from the U.S. Centers for Disease Control and Prevention (CDC). The CDC ordered 4 million doses for initial distribution to local and state health care providers.

Read more here.

Strategy Memo Leaked from Big Pharmaceutical Companies

Pharmaceutical companies publish a small portion of the results collected from drug trials; however most of the information collected is not made public. European regulatory bodies wish to increase the efficacy and safety of pharmaceuticals by requiring the companies to publish all of the data from their clinical trials. Regulators claim that increased transparency would allow independent researchers to verify that the results reported by these companies are accurate. Though some companies have agreed to share data, others have launched a campaign against the proposed regulations. Two groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), formed a strategy to mobilize patient advocacy groups to protest the regulation. The strategy was outlined in a memo, which was leaked to the public by an employee.

To read more click here.

 

FDA Safety over Sequestration (SOS) Bill Introduced in the House

A substantial portion of the budget for the Food and Drug Administration (FDA) is comprised of user fees, collected from the industries that the agency regulates. The FDA spends the money collected from the user fees for specific purposes, such as the expedited review and approval of drugs or medical devices. At present, the user fees are not exempt from the sequester, which went into effect in January of this year. Rep. Anna Eshoo, (D-Calif.), is a lead sponsor of a bipartisan House bill, the FDA Safety over Sequestration (SOS) Act, which would exempt the user fees from sequestration. She stated that “private dollars” should not be sacrificed in the name of policy. Proponents of the Act maintain that applying the sequester to the user fees would stifle medical innovation and patient access to “timely therapies.” The SOS Act has found support amongst prominent medical device groups as well.

To read more click here and here.