FOSTER CITY, California– Because many cases of Hepatitis C exhibit minimal symptoms for the first six months of infection, the virus can take its toll on the human body without providing any hint to the infected that treatment needs to be sought. According to the World Health Organization, more than 130 million people around the globe suffer from a chronic Hep C infection, a diagnosis highly correlated with liver cancer and cirrhosis later in life. The developing nations of East Asia and Northern Africa are most affected by the blood-born virus, as many are infected by unsterilized needles and unsafe blood transfusions. Consequently, these regions bear a substantial percentage of the 400,000 hepatitis C-related deaths each year.
However, Gilead, a biotechnology company based in California, has recently developed a revolutionary treatment course that offers some hope of reducing these figures. Although similar to other treatments that inhibit the virus’ ability to replicate its RNA, Sovaldi is orally administered and only requires a 12-week treatment plan. In comparison, Interferon, the most prevalent Hep C treatment before Sovaldi, requires injections and requires a timespan of nearly 12 months to fight off the infection. The side effects of Sovaldi are significantly less severe than those commonly associated with Interferon, which often can lead to problematic respiratory responses that are difficult to medicate in the developing world. In addition, specialists and doctors are encouraged by the overwhelmingly positive reviews doled out by respected health organizations.
So why is Sovaldi disproportionally absent in the developing world? First and foremost, the cost of the medication is astronomically high. In the United States, Sovaldi costs close to 1,000 dollars per pill. Although the drug cost more than twice the amount of Interferon across the globe, the company continues to vouch for the price line, arguing that their product will help Hep C victims avoid the enormous expenses incurred by future liver damage. However, as demonstrated by the previous release of nnovative medicines, the free marked does not account for humanitarian need. Consequently, a majority of third world citizens remain unable to afford the new drug.
Yet, pharmaceutical companies who understand the vast healing potential of the Sovaldi are fighting back. In the United States, pharmaceutical giant Express Scripts is boycotting the Gilead product in hopes that a viable competitor will emerge to drive down the price of the revolutionary biotechnology.
“What they have done with this particular drug will break the country,” Miller told Bloomberg L.P. “It will make pharmacy benefits no longer sustainable. Companies just aren’t going to be able to handle paying for this drug.”
In addition, countries abroad are employing creative solutions to provide treatment to those in need. India has a history of rejecting big drug companies’ patents in order to sell more affordable generic brands to its population. NATCO pharmaceutical has recently filed a “Pre-Grant Opposition” in hopes of doing just this to Gilead. If successful, the 12 million Indians living with Hepatitis C will have greater access to a viable, affordable treatment plan.
However, holdouts and patent-busting have significant shortcomings. Gilead continues to make ample profits by supplying Sovaldi to other pharmaceutical companies, and Express Scripps may have to accept the reality that a viable competitor may not emerge in the foreseeable future. In addition, patent-busting has been subjected to considerable scrutiny by the international community, and many countries, including the United States, are attempting to revise the WTO’s Trade Related International Property Rights contract to prohibit this practice from continuing.
More consistent long-term solution needs to be devised. Otherwise, the developing world will continually be the odd man out when revolutionary drugs are introduced to the market.
Sources: Reuters, World Health Organization, FiercePharma, IRIN, Drugs.com
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