The Most Publicized and the Most Ignored

A list of drugs having greatest public attention last year appeared in the article Drugs that made headline in 2015

By: Julio César Hernández


2016-02-01 | 16:34:51 EST
The Most Publicized and the Most Ignored The Most Publicized and the Most Ignored Photo: Juventud RebeldeZoom
A list of drugs with greatest public attention last year appeared in the article Drugs that made headline in 2015, published last December by the renowned American magazine Nature Medicine.

Some of those mentioned have been successful and will leave a legacy for having impact on the treatment of cancer and cardiac diseases. These medicines came out with positive results from clinic trials and proved to be effective.

This victory has secured them a spot in the American market after receiving the required authorization granted by the US Food and Drug Administration (FDA). 

Almost half the few more than ten drugs receiving the highest interest within the scientific community are a genetic engineering and biotechnology spin-off. Chief among them are the monoclonal antibodies.

These biotechnological products have become one of the pharmacological products of greatest growth since late 20th century. In fact, since 1992 the Health World Organization (HWO) have warned the existence of more than 300 international common names for monoclonal antibodies; most of them with names hard to be pronounced and quickly learned. 

The rare names, rather than a whim, make sense by giving much pharmacological and clinical information. The “mab” ending, for instance, indicates a monoclonal antibody (MAb abbreviation which stands for monoclonal antibody). The words preceding that ending respond to other meanings depending on the origin (if it is human or animal), and the therapeutic target (bacteria, virus, or the cardiovascular, nervous, or bone system, etc.).

These substances have proved to be successful in the diagnosis and treatment of infectious, immunological and neoplastic disease, among others. They are so called –monoclonal antibodies- being a group of very specialized proteins, also known as immunoglobulin making part of the immune system, produced by the lymphocytes B which are able to recognize very specific molecules (antigens) with well-defined functions.

The most publicized

Among the winning drugs in 2015, approved by FDA, we could mention two monoclonal antibodies: alirocumab and evolocumab. These are able to reduce effectively hypercholesterolemia (high blood cholesterol) through inhibition of the PSCK9 enzyme.

They are essentially useful in those patients with non-tolerance to astatine, and its use has been associated to a reduction of cardiovascular disease dealing with the blood-fat change. These drugs, have been targeted for criticism due to their high prices: a year of treatment costs more than 14,000 dollars.

Nivolumab (popularly known as Opdivo) is another praised product. It had been previously approved for the treatment of melanoma (a type of skin cancer) in advanced stages. Now it will be prescribed for the treatment of a lung cancer known as non-small cell lung carcinoma, also in advanced stages.

It achieves its therapeutic effect by binding to a protein called programmed death cell 1 (PD-1). Unfortunately, it also affects normal cells causing adverse effects which are not insignificant.

Another accepted monoclonal has been the secukinumab. It was approved in January 2015 for the treatment of serious psoriasis, a disease which can affect over 40 million people in the world.

Levetiracetan commercialized by Aprecia Pharmaceuticals by the name Spritan and authorized by FDA last August is among the great creations: it is expected to hit the market in 2016. This drug is prescribed in the treatment of convulsions crisis in patients with epilepsy and swallowing disorders.

Its “major novelty” consists in being the first pill impressed in 3D. It was produced  with a porous structure which is quickly dissolved in the mouth when drinking.

We’ll find in this group of novelties other drugs like Entresto, combination destined for the treatment of cardiac insufficiency; Orkambi for the treatment of cystic fibrosis; Jardiance (empagliflozin) against diabetes mellitus type 2, with which trials have been performed trying to reduce mortality in 40 percent of the patients with cardiovascular and cerebrovascular diseases; and other medicines (Technivie and Daklinza), which are used in the treatment of chronic hepatitis C without using Interferon.

The first generic product approved for commercialization in the United States from Sandoz Corporation is named Zarxio. This is a stimulating factor for granulocyte colonies (white corpuscle production stimulator) used in patients with immunodeficiency, disorder often associated to other (chemotherapeutic), as it happens in cancer and medulla transplants and in regenerative medicine.

This consent have seen a lot of controversy in the US after Amgen tried to block FDA as they held supremacy in this therapeutic field with Filgrastim. By the way, our pharmaceutical and biotechnological industry have produced for some years two similar products of top quality, Hebervital and Leukocim, produced at the Center for Genetic Engineering and the Molecular Immunology Center, respectively. As a result of the blockade, these are banned in the United States.

The Most Ignored

In the last few years a debate has sprung from the reestablishment of diplomatic relations between Cuba and the United States: the blockade is the main obstacle for important Cuban advances in the drug development with mutual benefits for the US population and Cuba.

As an example, we can mention Cimavax, a therapeutic vaccine produced by the Center for Molecular Immunology, which restrains the development of some cases of lung cancer resulting in the patients’ survival and improvement in the quality of life.

Another medicine is the renowned Heberprot-P, a biotechnological product developed by our Center for Genetic Engineering which has been proved efficient in a 70 percent of the diabetic foot ulcer prevention, main cause of non-traumatic amputation in the United States. According to statistic facts, there are around 26 million diabetic patients in that country and amputations are estimated to be over 70,000 due to complications caused by this disease.

Heberprot-P, another Cuban medicine, has been used in about 20 countries of the world. Photo: Juventud Rebelde                        
Other estimates forecast the number of diabetics to be around 36 million in 2030. Nowadays, the treatment of diabetes and its complications adds up to 116 million dollars in direct costs. At least a third of this figure is related to the treatment to the diabetic foot ulcer.

The follow-up cost, during two years, of an amputated foot ranges between 80,000 and 110,000 dollars.

The Heberprot-P has been used in about 20 countries of the world with 165,000 being treated. But it cannot be used in the United States as a consequence of the blockade.

Science and mankind lose a lot, when medicines of proven quality are ignored. The advertising lists seem to include only those products borne out by research conducted by great powers. And on that runway where other breakthroughs of the planet are overlooked, due to that unfair competition, the chances for saving millions of lives are made more and more expensive.

The list makes sense, but not completely, since it is reflecting a partial victory, tainted with power and walls as absurd as the blockade Cuban, science suffers.

At the end, there’s only one victim because of the publicized and ignored antagonism: human species.

Consulted References:
Chradddha S. Drugs that made headlines in 2015. Nature Med. 2015;21:1382-3.
Berlanga J. Heberprot-P: un nuevo tratamiento de las úlceras complejas del pie diabético. Medicc Rev. 2013; 15.

Translated by ESTI

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