Corrupt officials and vested commercial interests sabotage indigenous production of economically priced Interferon

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Do we need to conduct research if its fruits cannot reach the patients?

Corrupt officials and vested commercial
interests sabotage indigenous production
of economically priced Interferon

Hepatitis-C which is highly prevalent continue to take many lives as
majority of the patients cannot afford expensive medication therapy

Criminal silence of Gastroenterologists, Hepatologists on this issue
in general and their professional specialty organizations
in particular is also very meaningful

By Shaukat Ali Jawaid

KARACHI: Corrupt officials and vested commercial interests have sabotaged the indigenous production of economically priced Interferon used for the treatment of Hepatitis-C which is more infectious than AIDS virus. At present the average carrier rate of Hepatitis-C in Pakistan is about  7.5% which varies considerably from location to location  as in some areas the prevalence is between 20- 30%. The result is that a vast majority of patients suffering from Hepatitis-C who cannot afford expensive medications are dying and it appears they will continue to die in the days to come as well thanks to the inefficient and incompetent health officials and government functionaries. The prevalence of Hepatitis-C is increasing and since no vaccine is available, interferon along with other medications i.e. supplemented with Ribavarin and boceprevir or teleprevir (triple therapy regimen) remains the only ray of hope. But the cost of treatment is beyond the reach of common man as only less than 2% patients can afford this treatment at present. More recently an oral medication has also become available but that too is highly expensive.

Commercial vested interests are so powerful that they have always managed to block, sabotage indigenous production of essential drugs so that we remain at the mercy of sources overseas and Pakistan remains a lucrative market for import of finished drugs notwithstanding our national interests. Hence the question being asked these days are “Do we need any research in Pakistan if its fruits cannot reach the people of Pakistan”?  Instead of encouraging, honouring , patronizing and  awarding the  research scientists, they are being humiliated, defamed and pressurized to give up their plans of going for indigenous  production of life saving drugs, while the government functionaries continue to do lip service saying they wish to promote research culture in Pakistan. Lt. Gen. Mahmud Ahmad Akhtar former Surgeon General of Pakistan has written a lot on the subject of Essential Drugs and their non-availability in Pakistan but he has failed to wake up the concerned authorities from deep slumber. Currently many brands of Interferon are available in Pakistani market which has come from Argentina, Brazil, China, Cuba, India, South Korea etc. Current Interferon market in Pakistan is estimated to be over Rs. 2.5 Billion per annum. By the Year 2020, it is expected that Pakistan will have to import Interferon worth over Five Billion Rupees.

If one traces the history of efforts to start indigenous production of Interferon, it is sad as well as very painful. Since Hepatitis is very much prevalent in the country, one would have expected that the Gastroenterologists and Hepatologists in general and their professional specialty organizations in particular would take interest in this issue to put pressure on concerned authorities to accelerate the indigenous production of economically priced  Interferon which was to be made available at a cost of Rs. 37.00per 3mIU injectionso that a vast majority of patients could benefit but their criminal silence is also very meaningful. This also highlights another bitter fact that perhaps they are not at all interested in welfare and treatment of Hepatitis patients but are quite content with holding meetings in Five Star Hotels sponsored by the pharmaceutical industry importing and making available expensive Interferon preparations. If economically priced indigenous interferon becomes available, the MNCs won’t take the Gastroenterologists and Hepatologists on pleasure trips abroad.  Hence, they are happy; their patrons the importers of expensive interferon preparations are happy and let the Hepatitis patients go to hell. Some of the companies also provide Interferon to the Federal & Provincial Governments on subsidized rates but continue to fleece the patients in the market.

How the allocated funds for Hepatitis control are misused is evident from the report appearing in Daily Nawa-e-Waqat of June 28th 2015 which states that “Sindh High Court has directed the Sindh Chief Secretary to ensure that the record pertaining to the purchase of Hepatitis-B and C  drugs worth twenty five crore rupees should be  saved and make sure that no changes are made in it. The provincial government had floated a tender on November 28th 2014 for purchase of Hepatitis B and C drugs which was declared non-transparent by the Court. The Sindh Government did not take any action but started purchasing drugs from two multinational companies at a much higher price which was challenged by two local pharmaceutical companies. The case is now in the court and the next date of hearing is fixed as July 15th 2015 on the request of provincial NAB and provincial government.

According to reports realizing its importance, ECNEC is reported to have approved a Five Year Development Project in 2005 at a cost of Rs.  2.59 Billion rupees with the main goal to reduce the incidence of Hepatitis-C to 50% by 2010. Governments of Punjab and Sindh started Free Interferon supply to the needy patients. However, determination of viral genotype, viral load and liver histology is important but in many hospitals, experience and infrastructure for determining viral genotype and viral load is not satisfactory. It was Dr. S.Riazuddin and his group at CAMB/CEMB at University of Punjab Lahore launched a project for indigenous production of therapeutic quality interferon which could be made available at a price of Rs. 37/- per 3mIU injection. This locally produced interferon was certified as “biologically equivalent to World Health Organization (WHO) standards” as evidenced from the results of comparative studies on biosafety, bioactivity and molecular analysis carried out in Germany. This discovery was patented in Pakistan Patent Office. (Patent No. 140574).

It may be mentioned here that all the brands of Interferon available in the market are imported   as finished products. Some companies have formulation/filling facilities for packaging Interferon imported under contract from companies in Argentina, Cuba, Brazil and China making us dependent on import of this active ingredient. Interferon is a “cold-chain-product” which requires a temperature of 4°C during transportation. Dr. Riazuddin had proposed to establish a cGMP protein purification set-up at the CEMB campus which was to be jointly operated through public-private partnership which could have met all the needs of Prime Minister’s as well as Chief Minister’s programmes on the preventon of Hepatitis C and 15% needs of all interferon in Pakistan.  But it was not to the liking of corrupt officials and vested commercial interests.

It was in 2008 that Federal Health Ministry allowed “one time” formulation for one lac injections of indigenously produced Interferon injections for clinical trials. However, some officials in the same ministry for reasons not difficult to understand refused permission to undertake clinical trials with the result that the first lot of one lac injections was lost. Not only that purified interferon protein i.e. raw material for additional one million injections was also lost for lack of permission.  In 2009, Secretary MoST requested Secretary Health to expedite the process of clinical trials. He also mentioned in the same letter that “some companies with vested interests could be creating difficulties in the venture which otherwise is likely to prove extremely helpful   on relatively much lower cost”. Consequently a road map for clinical trials and for local production of interferon was developed but as usually happens in Pakistan,  minutes of the said meeting were deliberately lost, hence no further action to implement that decision could be taken. National press has highlighted this issue quite a few times but it also failed to wake up the concerned quarters. The Parliament’s Standing Committee on Health also discussed this issue in its meeting held on January 11, 2011. In the meantime efforts were intensified to harass, humiliate and defame Dr.Riazuddin and his Group through various means in which some elements in the institutions where this project was being established also played a dirty role. However, an enquiry by FIA reported that “there is absolutely no evidence of embezzlement of any funds and no evidence of personal use of Government funds for personal gains by Dr. Riazuddin.  The FIA report further identified that Dr Riazuddin was working to expand his laboratory research efforts into developing life saving medicines, and diagnostic procedures for general public needs. This was obviously not acceptable to multinationals and their supporters in the government. This report further identified that   Dr.Riazudidn’s appointment letter, authorizing him to establish interferon production programme/facility at CAMB was stolen which provides convincing evidence that local production of interferon was indeed the main bone of contention. The FIA report recommended a separate enquiry into loss of one lac interferon injections, loss of raw material for one million interferon injections, disintegration of interferon production group/facility and closure of all work on the production of interferon. This issue also came up for discussion in Public Accounts Committee in its meeting held on October 30, 2012. After thorough discussion, the PAC members approved and issued a letter of commendation to Dr. S.Riazuddin. It also approved a plan of action for the local production of interferon as already contained in the decisions in the Second special Meeting of CEMB-BOG held on August 16, 2008 and the Sixth meeting of CAMB Board of Governors held on August 28, 2009. The PAC report containing plan for local production of interferon was presented to the National Assembly which approved it on February 28, 2013 vide letter no. 8(10)/2012-ASA (P&C) dated April 18, 2013 by the Additional Secretary MoST. However, to make sure that this project does not take off, the corrupt officials maneuvered and all locally generated funds, frozen during FIA inquiry proceedings, were transferred to Finance Division to deprive the project of interferon production of its immediate financial needs.  The former Chairperson PAC complained to the Speaker National Assembly about the illegal transfer of funds as well as loss of important records/files related to local production of interferon but alas no action was taken. In view of the above, can any research scientists motivated with a national spirit work on any such project of indigenous production of essential drugs?

This whole sad state of affairs also highlights yet another important fact. In all civilized countries the political parties have their Experts Committees and Opposition has Shadow Cabinet consisting of experts in their respective fields. They keep themselves not only abreast of the national issues but also find out their solutions which could be implemented when they come to power. In Pakistan, the situation is altogether different. Here first most of the political parties do not have any such committees and the idea of having a shadow cabinet by the opposition, less said the better. In fact what happens is  that the winning party first identifies the members of the parliament who have to be accommodated in the cabinet and then they are handed over different portfolios irrespective of the fact  whether they have any expertise in that particular area or not.  Those who are vested with the authority themselves do not know nor they seem to be interested to get some feed back, advice from independent experts with the result that they are at the mercy of bureaucrats and other government officials who start playing with them. While there is no dearth of some honest, kind hearted, committed professionals in the bureaucracy but our system is such that even if they wish to do something, they find it extremely difficult which is evident from the fact that minutes are misplaced, files are stolen and so on. How all this happens is an open secret. The corrupt officials continue to thrive, progress and prosper thanks to their patrons among the corrupt politicians and supporters, well wishers in the commercial vested interests.  Pakistan will eventually become a country totally dependent on Import of finished drugs including Essential Drugs while our neighboring countries continue to make tremendous progress.  Since Prime Minister Mian Nawaz Shareef and his team, as it looks, has no time to look into these issues pertaining to the health of the Nation, they being too busy with Energy projects and Metro Bus projects, poor patients will continue to suffer. If this is going to be our fate, let us give some exemplary punishment to research scientists like Dr. Riazuddin so that in future motivated by national spirit, no one commits a sin and crime of thinking of establishing some facility for indigenous production of ecumenically priced Essential Drugs.

It will be of interest to know for the readers that Dr. Riazuddin is currently working as Dean Postgraduate Studies, AIMC, and UHS Lahore. He assumed this honorary position after twenty five years distinguished service as Founding Director CEMB at University of Punjab. He is Professor Emeritus at SZABMU Islamabad and University of Lahore. He is HEC distinguished Professor. He was Rockefeller Foundations Biotechnology Career Fellow (1989-2004), Visiting Professor at  University of Washington, Seattle (1989-2005).He has over three hundred scientific papers to his credit (with a cumulative impact factor of above 1400) He has authored  four books, twenty book chapters and proprietorship of his research discoveries are protected in the form of eight National and three international patents. He has made outstanding contributions in the field of genetics and infectious diseases, cloning and expression of pharmaceutical protein genes.  He was decorated with Prix Isabelle De Case De Nue Swiss Prize in 1978, earned Gold Medal from Johns Hopkins Society of Scholars in 1989, Carlos J. Finlay Prize for Microbiology in 1997. At home he was decorated with Tamga-e-Imtiaz in 1984, Sitara-i-Imtiaz in 1994, Izaz-e-Kamal in 1998 and Hilal-e-Imtiaz in 2004. He is also the recipient of Life time Achievement Award by HEC in 2005 and COMSTECH Award in Biology in 2005.