UM SOM at forefront to develop vaccine for Ebola virus

As the number of lives taken by the Ebola virus in West Africa quickly approaches 1,000, and the US prepares as rapidly as it can, it is clear that little is known in the medical community about the virus. In fact, some experts point out that the number of medical professionals who can properly diagnose and recommend the next steps for treatment is alarmingly small.

Some scientists, however, like Alan Schmaljohn, Ph.D., Professor of Microbiology and Immunology at the University of Maryland School of Medicine (UM SOM), have spent decades studying the Ebola virus and similar viruses identifying key characteristics that have aided in the development of vaccines, antivirals and treatment methods.

As a leader of research and Chief in the Viral pathogenesis and Immunology Branch with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Dr. Schmaljohn was able to help identify three of the key antibodies that are used currently in combination with each other to treat patients infected with Ebola.

Dr. Schmaljohn is now one of the scientific leaders in the UM SOM partnership with Department of Defense contract recipient Paragon Bioservices in the manufacture of an Ebola virus vaccine for initial safety testing in humans.

“Several vaccine candidates for Ebolavirus are proceeding through initial manufacture toward safety testing in human volunteers,” Dr. Schmaljohn said. “Different vaccine candidates are based upon different ‘platforms’ in which selected viral proteins may be made ‘in the test tube’ and purified for injection, or may be added genetically as passengers of a different variety of virus that is weakened. Only human trials will provide the final answers as to which vaccines are best on the basis of many criteria, foremost being safety and efficacy,” he said.

MNC's - Images

GSK is not the only MNC which has been found to be indulging in such unethical and illegal activities in recent years. In mid 2011. Pfizer agreed to pay $14.5 million to the US government to resolve False Claims Act allegations related to its marketing of the drug, Detrol. This was the last of the 10 whistleblower suits filed in the District of Massachusetts and two other districts against the company beginning in 2003.

The other nine suits against Pfizer including the one on painkiller, Bextra, were settled or dismissed in 2009 as part of the US government’s global resolution with Pfizer, under which the company agreed to pay $2.3 billion to resolve civil claims and criminal charges regarding a few other drugs. Eli Lilly and Abbott were also reportedly involved in illegal marketing of certain drugs and agreed to make payments to the US government in the recent past.


Apart from the financial implications caused by the government actions, the MNCs have also suffered major dents to their credibility after these incidents. In India, a large number of essential drugs are being imported and sold by MNCs at very high prices as the country has not yet imposed any control on prices of patented drugs. Considering good track record of most MNCs in discovering modern drugs for several human ailments in the past should they adopt such a disgraceful path for maintaining high profits? This is a question to be pondered by the top managements and shareholders of these corporations.

Ban Policy - Drugs

The move is part of a stringent drug ban policy being prepared by the ministry. The report further said that over a dozen drugs, including anti-allergic Buclizine and anti-asthma doxofylline, have been recently removed from the markets of some developed on grounds of safety. Buclizine and doxofylline are not allowed for sale in countries such as US, Canada, Britain, Australia. Formulations of both buclizine and doxofylline are widely prescribed by physicians in India and marketed by a number of top Indian companies.

The government is also planning to set up an expert committee to weed out such harmful drugs and irrational fixed dose combinations including certain muscle relaxants, painkillers, anti-depressants and antispasmodics from the market. It is estimated that almost 45 per cent of all the drugs marketed in the country today are FDCs.

The move is in the background of the Ranjit Roy Chaudhury committee’s recommendation that India should have a list of drugs not approved in the country of origin and those which have been banned or withdrawn in several countries.

The safety of drugs sold in the Indian market has been an issue of great concern for the health ministry for some time now. Ensuring safety of drugs in the market is the prime responsibility of a regulatory authority in any country and India has been striving to achieve this goal for some years now with not much success.

The matter has come to the notice of the health secretary of the Union Territory and action is being taken against the offenders. It is possible that in other states and Union Territories where drug administration is weak, more such violations must be taking place. Therefore, formation of a Central Drug Authority can only possibly guarantee a uniform policy in the matter of issuing drug licenses and availability of safe drugs in the country.