FIA probe: Govt bars low-cost hepatitis vaccine
The federal government has banned locally manufactured low-cost hepatitis medicine from reaching the market, allegedly on the influence of multinational pharmaceutical firms, a Federal Investigation Agency (FIA) report available with The Express Tribune revealed.
The Ministry of Science and Technology, instead of encouraging microbiologist Dr Sheikh Riazuddin, initiated an inquiry against him through the FIA.
Dr Riazuddin, the former director of the Centre of Excellence in Molecular Biology (CEMB) of the Centre of Applied Molecular Biology (CAMB), had developed the low-cost interferon injection used for curing hepatitis C and proposed to sell it for Rs70 per injection – almost 100% below the prevailing market price.
Undoing its own initiatives
Earlier, the health ministry had not only approved the interferon produced by the CEMB, but also sanctioned funds for the purpose. The product was even validated by German laboratories.
The research work was undertaken six years ago at the CEMB of the CAMB and the Allama Iqbal Medical College (AIMC).
In the phase-I trial, 10 volunteer medical students were injected the drug without any serious adverse effect; however, permission for the clinical trial has been pending with the health ministry for about three years, sources said.
Dr Riazuddin
Sources said that Dr Riazuddin obtained a PhD in Biochemistry from Reading University, England. He had produced 70 PhDs and published over 150 research papers in international journals with a cumulative impact factor of over 700 — the highest among biology institutes across the country.
Dr Riazuddin had proposed to sell the products of the research to the general public at throw-away prices. This, however, was obviously not acceptable to the multinational pharmaceutical laboratories and their supporters in the government, as evident from a letter issued to the Ministry of Health secretary from the Ministry of Science and Technology, the report said.
‘No evidence of embezzlement’
The FIA report concludes that there is absolutely no evidence of embezzlement of funds and no evidence of personal use of government funds for personal gains. “Therefore, this report recommends to close the inquiry,” the document read.
The FIA report recommends to initiate a separate enquiry into the loss of 100,000 interferon injections worth of Rs7 million, as well as a loss of raw material relating to interferon worth of Rs1 million.
The FIA investigators stated that the entire batch of interferon has expired.
Published in The Express Tribune, October 14th, 2012.
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By looking at the report this is very obvious that interferon produced in CEMB worked very well but because of our bureaucratic usual laziness, they didn’t approve the phase II and phase III trials on time, while phase I trial, on ten medical students was successful. No scientist affords to wait for years and years to publish his invention and success story especially if it is in the benefit of public. This is not 1st time that CEMB has doing something in favor of masses to serve the humanity. CEMB/CAMB has set an example for our other institutions to follow it. Many other institutions are using public funding and not benefitting the public any ways. No research is useful if it is not benefitting the public while all institutional researches are funded by the tax money of public. In this particular case it is equally important to know why someone cancelled the research than just, who cancelled it; to know the situation behind the scene. As reported “Earlier, the health ministry had not only approved the interferon produced by the CEMB, but also sanctioned funds for the purpose. The product was even validated by German laboratories.” The biggest dilemma of our country is we don’t keep our eye on goals. We don’t want to acknowledge and appreciate the other people success, if we are not part of it. Multinational national companies must be earning millions of dollars and Pakistan is one of the biggest consumers of these companies. Some local nationals are also part of it. We should recognize those locals who are involved in making money by selling expensive medicines in the market while they can be produced locally and will be in the reach of poor people. We need to induct good scientists in the bureaucratic set up who should deal with these kinds of cases and they will be in better position to understand the work and working conditions of a scientist. We all equivocally encourage Dr Riazuldin and all scientists who are working in his team to continue his work because this is a time to return to the country by serving the nation that is already in many other crises. Keep it up
I congratulate Respected Dr Riazuddin for this great success. It is really sad and tragedy that instead of utilizing qualities and experience of such distinguished scientist, some peoples not only wasted Dr riazuddin precious time but also create hurdles for producing IFN drug for poor peoples of PAKISTAN. We should respect him as founder of Molecular biology in pakistan. I always found him working day and night for progress of science.I request the concerned authorities that we should take benefits of such great scientist in field of molecular biology.
This news gave me immense pleasure. Dr. S. Riazuddin is an eminent scientist of Pakistan. We should condemn those who tried to defame the "Asset"of Pakistan. Thumbs up for Dr. S. Riazuddin and his future researches. I congratulate Dr. S. Riazuddin for coming out of this mess successfully. I also appreciate the FIA for conducting impartial inquiry, clearing him from all financial embezzelment and to declare him "Ä National Asset".
Dr Riazuddin is an eminent and dedicated scientist; it is honour to work under the supervision of such eminent scientist. The corrupt mafia not only targeted the Dr. S Riazudin but also victimized the interferon group incharge and members who worked days and nights to developed the upstream and downstream processing strategies for the commercial production of interferon. The facility that was developed under the supervision of Dr. S Riazuddin was the only facility for the production of bulk concentrate of recombinant human Interferon in the country. The group has also established the first bioactivity /potency checking lab for interferon products. Unfortunately the mafia disintegrated the group and spoils the programme of national interest. Back in 2009-10, I wrote many times to the higher authorities that a group is making propaganda against the interferon programme, rather than to protect and support the programme; authorities used the mafia against Dr. S Riazuddin and interferon group members. Replace me from my position. In addition, the present acting DG, CAMB section, not allowed to provide the testing facility for imported interferons. Hope for sincere and dedicated management.
Dr Riazuddin is an eminent and dedicated scientist; it is honour to work under the supervision of such eminent scientist. The corrupt mafia not only targeted the Dr. S Riazuddin but also victimized the interferon group incharge and members who worked days and nights to developed the upstream and downstream processing strategies for the commercial production of interferon. The facility that was developed under the supervision of Dr. S Riazuddin was the only facility for the production of bulk concentrate of recombinant human Interferon in the country. The group has also established the first bioactivity /potency checking lab for interferon products. Unfortunately the mafia disintegrated the group and spoils the programme of national interest. Back in 2009-10, I wrote many times to the higher authorities that a group is making propaganda against the interferon programme, rather than to protect and support the programme; authorities used the mafia against Dr. S Riazuddin and interferon group members. Replace me from my senior most position. In addition, the present acting DG, CAMB section, not allowed to provide the testing facility for imported interferons in private sector. Hope for dedicated and sincere management.
@Dr. Tayyab Husnain: I completely agree with you. Although we cannot compensate for the pain Dr. Riazuddin has gone through due to these false acquisitions but still nominating him for a civil award like Nishan-i-Imtiaz can be a nice gesture to show how bad we felt about all this mess he has gone through, and as true Pakistani we are highly thankful to his life long devoted efforts for Science in Pakistan. Like majority of the Pakistani scientists, he could have stayed in Europe and America and easily gotten 100 times more salary and benefits but he came back to Pakistan after his training and devoted all his life for developing a world class institute in Pakistan. As a Pakistani, I feel ashamed that we put him through these baseless acquisitions and shameful tactics just to destroy a good cause (interferons). We could have use these golden years of his life to strengthen more of Science in Pakistan and get these interferon to a stage where it could really benefit the people. We could have used his wisdom to strengthen our next generation of Molecular Biologist but no, we are too busy in doing politics for money and position and the last thing we worry about is our country Pakistan. I wish we can learn lessons from the history and could repair the damages we have already done. Dr. Riazuddin, as a Pakistani and a scientist, I sincerely apologize. Please do not stop your good work on interferons due to our poor judgement, bad attitude and misbehavior.
Every one should appreciate the efforts of Dr. S. Riazuddin and his team and the chief justice of Pakistan is requested to take suo moto notice of this issue because this is the matter of publc interest.
The development of interferon by Dr. Riazuddin and his team is a marvelous achievement. I know as a part of CEMB, they worked day and night for interferon production. They also devised an excellent system and workflow for the low price interferon production equally competent to any international laboratory. Low price of interferon makes it ideal for country like Pakistan, where HCV is most devastating health risk. We should encourage these things and think beyond our personal interests. However, It is very easy to criticize and blame any person. But it is very difficult to deliver something for a good cause. If someone has concerns regarding the use of locally made interferon on humans then it can be tested by foreign researchers/companies. I am not expecting any good response in this case from our totally incompetent and corrupt government. In my opinion, this is a great achievement and it will help in HCV prevention in our population.
Its really astonishing to read some of the comments and the way we all think...certainly reflecting the society and gives a negative impression. The question here in not the personality of Dr. Riazudin rather it is that Dr. Riazuddin has produced Interferon which is very very cost effective and can assist us in treating the poor's of our country at worthy just Rs: 70 then whats fun we are achieving by stopping the procedure of clinical trials and bringing hurdles in the process. The worst part of this story is, instead of helping and encouraging Dr. Riazuddin to complete the work quickly he has been interrogated and investigated by FIA and has be proved innocent. Bureaucracy of this country never allow any person to bring peace at any level to people of Pakistan, I am pretty sure some of the secretary would have asked his due share which being a researcher not an industrialist Dr. Riazuddin is not up too.
Absolutely there is a needs of investigation from unbiased body including the scientists from international community, if some issues with the quality of interferon is raised, rather than banning, is’nt it additional validations and tests should be done for it. From all above its feel that its the personality which is problematic not the interferon....so it better now to start thinking beyond the personalities, its the right time in changing Pakistan. The crust of all this is whether there is potential local interferon produced which could reduce the cost tremendously then we should validate it as early as possible and make it available to the poor community in Pakistan. Infection rate of Hepatitis C is souring on daily basis and reaching and alarming point in Pakistan and over most of our population cannot afford the current interferon available from multinational companies. Apropos above, I feel that instead of beating the bushing (debating and arguing about CEMB and its former Director), we should focus on the potential benefit to the public. Let’s put interferon validation and testing up front and make suggestions and recommendations, if any, to validate these locally produced interferons before clinical trials. Being a researcher, I think every scientist do its utmost to prove its idea and hypothesis and same is the case with Dr. Riazuddin, so my request to all honorable persons involved in this whole story is that without having any scientific evidence and supportive data in our hands we should not judge or make comments about the quality of the interferon. We all scientists work with experimental evidence to support our hypothesis and not with rumors.
Reading the news article fills me with satisfication as finally justice has been done and Dr Riazuddin's name has been cleared by the FIA from the false allegations and is without doubt one of the most impeccable scientists in this country. Yet this article greatly saddens me as it tells me of the dismal nature of science in Pakistan. Scientists like Dr Riazuddin, who have devoted their entire lives for the well-being of Science in the country, have a track record of numerous National and International awards, founded the National Center of Excellence and directed it to become one of the top institutions not only in the country but in the whole Islamic World are subjected to such baseless, shameful and disrespectful allegations. As a Nation, we have a history of dishonoring our most brilliant minds going back to the Nobel laureate Dr Abdus Salam. Clearly this attitude cannot persist if the country has to move forward. We must learn to honor, encourage and cherish the effort of our own scientists and researchers.
Interferon has been in the market for a long time and is administered to patients with Hepatitis C as a preventive therapy and is definately not the cure. However the real issue here is that currently interferon in the market is available at exorbitant prices making it extremely hard for the thousands of poor patients to afford it. Dr Riazuddin and his team of scientists at CAMB produced the interferon locally and wanted to sell it for throw away prices for patients who cannot otherwise afford the drug. Instead of admiring Dr Riazuddin for this remarkable feat, various "influentials" try to block interferon and in the process falsely accuse Dr Riazuddin of financial embezzelment. It is really important to understand the background and the motives of people involved. Even if some people believe that there are questions in the efficacy of the drug in question, is banning it going to do any good or wasting the entire lot that actually had cost millions of public money to produce would make any sense?
Aruguably, this could not have been the way forward. Responsible agencies should have carefully evaluated the preliminary data, could have held their own independent varification and then allowed clinical trials to go ahead. That is how drugs get approved all around the world. Scientists like Dr Riazuddin always base their proposals on logical results and data and the best way to analyze the efficacy of the drug is to do a careful scientific evaluation. Blocking the drug altogether does tell you a lot about the ulterior motives of the agencies involved in drug regulation in Pakistan who simply will not let go of their own interests and incur suffering to millions of poor patients in the country.
Hopefully, this report by the FIA will lead to resurrection of the research leading to interferon production and allow future efforts to be directed to help out the millions of poor patients of Pakistan. We must all congratulate Dr Riazuddin in this achievment and support him in future so that he can carry on the good work for the well being of Pakistan and its people.
It is painful to yet learn yet another time that whenever Pakistan has breakthroughs, its within fleas start to infest it. Why are we always seeking a negative news to stretch our passim comments.Since its about Pakistan, we are not even willing to testify the testings by the German laboratories. We will never have "Change" until we act upon it. "Success favors prepared minds". In my opinion we should wait and see, lets the product claimed put to further trails, rather than banning it, criticizing it, and exhausting the time and resources. According to the report above, if FIA has also declared the research to be transparent with no embezzlement of funds, then what stops us to accept the facts and at least appreciate the work. We readily applause at any ground breaking findings happening anywhere else in the world including India. But about Pakistan we cant see beyond drones and corruption, even in the presence of the authorized and reliable proclamations. Everybody quick to point fingers, but slow to reach out a helping hand!! Thats our apathy, alas!!
Dr Sheik Riazuddin is a respectable scientist with international fame and reputation. He has dedicated his career and life for the country. Ministry of Health has the right to make sure the safety of their masses, infect it is a positive thing to do, but if the locally made IFN is equally safe and potent in humans as the one developed by multinational companies, it should have equal rights to the market. We should celebrate that someone in our country is capable of doing the job. But unfortunately, the dilemma of our nation is that they will pay for things that are labeled with foreign trademark even though if it was made through a third party in under developed countries....
In the era in which majority of world is shining with the discoveries/inventions of their scientists work, we are discouraging our scientists to do so, if they did or try to do any marvelous scientific achievement. Dr Riazuddin is an eminent scientist and blessing of Almight Allah for Pakistan, many Scientists of the advanced countries know Pakistan due to contribution of Dr S Riazuddin to scientific community, who has established one of the best research institute of the country from nowhere and brought many noble laureates of world to this centre (Pakistan). His research findings has published in high quality journals' New England journal of medicine, Science, Nature, American Journal of Human Genetics, Eurpeon Journal of Human Genetics, Journal of Human Genetics, Human Mutation and a lot more. Publishing article in these journals is always dream for any scientist. As for as interferon is concerned, it is an other marvelous achievement of Dr S Riazuddin's team and i will highly recommend this achievement should be tested at animal levels because this is the way through which majority of the landmark has achieved in the field of medicine in the past.
It is so unfortunate that the poor people of Pakistan were denied from cheap drug so that international drug companies can make money. Dr. Riaz is an outstanding scientist, he should not have to go through this. All he is trying to help the poor people of Pakistan who are suffering and cannot afford expensive treatment. I have written several letters to MNAs and other higher authorities in Pakistan encouraging them and informing them that the locally produce interferon is as good as the imported one and it should be made available to the suffering people of Pakistan. Unfortunately, there was no response. I think the Chief Justice of Pakistan should look into this issue and punish the individuals so that no other government official can robe the people of Pakistan.
It's really unfortunate situation. If interferon can be locally produced and has been tested from German labs then why it is getting banned? Certainly fishy and needs investigation from unbiased body including the scientists from international community and with Judicial support. If there are any issues with the interferon then it should be recommended for additional validations and tests rather than banning, is'nt it? We should start thinking beyond the personalities. I feel what is important is whether there is potential local interferon which could reduce the cost tremendously then we should validate it as such as possible and then make it available to the poor community in Pakistan. Hepatitis C infection rate is rising with alarming rate in Pakistan and over 70% of the population cannot afford the current interferon available from multinational companies. We need to focus on the stuff which has potential benefit to the public rather than debating and arguing about CEMB and its former Director. Let's put interferon validation and testing up front and make suggestions and recommendations, if any, to validate these locally produced interferons before clinical trials.
As a scientist, I think without any scientific evidence and supportive data in our hands we should not judge or make comments about the quality of the interferon. Scientists work with experimental evidence to support their hypothesis and not with rumors."
Wow, corrupt and what type of agency is operating, rather mafia that wants to kill it's own people for money.UNBELIEVABLE and pathetic.People of pakistan should get together against this evil and inhumane act of governmant and FIA against this DR./scientist and the ban on helping mankind!
Dr Riazuddin might not have done any financial embezzelment but he is still guilty of Inetellectual embezzelment. It is very well known to Pakistan's scientific community that he didn't allow any other scientist at CEMB to publish his research if Dr Riazuddin was not included as an author of that article. This is how he published 150 articles. As far as Locally produced Interferon is concerned, it will harm the patients because it is inefficient and is being propagated by a few individuals for personal gains (not necessarily financial). I hope that Dr Riazuddin shall not get an NOC for clinical trials because it will endanger the life of many poor patients.
@Tribune
Interferon is not a vaccine, it is a drug to treat hepatitis. Actually, to date, there is no vaccine to prevent HCV infection.
A simple correct... interferon is a drug used to treat hepatitis C, it is not a vaccine and will not prevent hepatitis C...
btw, there is no vaccine for hepatitis C. Interferon is used to treat the infection (it is not a vaccine) and it was discovered long time ago.
He injected medical students with interferon????
This is the level of corruption. A man of dignity who put his 6 years of research is ready to provide vaccination (approved by German Health Board) not digested by so called MNC.
Will CJ take a suo moto on this issue of which is of public interest???