Friday, April 20, 2012
Wednesday, April 18, 2012
Interview of Ghooi sir
Posted on March 1, 2012 by Author & Editor in Expert Interviews
Dr. Ravindra Bhaskar Ghooi, experienced in Preclinical Industry, Pharma Industry, Clinical Research and Drug Discovery.
Dr. Bhaskar Ghooi
Q. Can you share about your career journey?
A. I have done my BSc. Chemistry, MSc. Pharmacology and PhD in Medicine. I started my career in Preclinical Industry worked for 11 years then I worked for few Pharma industries as Medical Advisor, then I was into teaching Clinical Research and Drug Discovery in ICRI for 6years, then I was vice president for CliniRx CRO, Gurgaon. At present am working as Professor in Symbiosis International, Pune.
Q. What are the challenges you faced in Preclinical Industry and clinical Research?
A. The first important challenge in Preclinical Industry is shortage of jobs. Honestly, there are few jobs and it’s not easy to get. After I left and when I enter in to medical department in Industry, the first challenge I faced is “no industry allows a non-medical person to become medical advisor”. So, there is a lot of unfair competition where non-medicals suffer very badly. So far, I haven’t seen any medical advisor who is a non-medical degree holder. The job of Medical advisor is not looking for this structure, it involves in more teaching activities, delivering the matter, interacting with regulatory authority, in which none of these doesn’t require a medical degree. But which is essential in terms of medical then it should have a medical degree. This has become a major rude block and major block. These are my challenges.
Q. As you said, it is difficult for a non-medical person to enter as Medical Advisor. How did you get opportunity for Medical Advisor?
A. I don know what opportunity I got but it was decided to take as Medical Advisor. The company looks for good and efficient person and it didn’t bother about the qualification. If every where the companies look for such kind of good and efficient people there would be less unemployment.
Q. why there are less opportunities in Pharma Industry?
A. since, last 1970, they changes the Patent law in India, since that time the drug discovery has not been done in great fashion except for few companies who are doing basic drug research and no body were doing preclinical research. Obviously when nobody was doing preclinical research then there are no opportunities. After that they have started doing research during 1990, the number of companies involved in doing basic drug research and Preclinical research Is handful and majority of the companies are working on chiral compounds or either combination products and still bringing the molecules from abroad and they are doing co marketing and there is greater amount going on clinical research rather than preclinical research in India. Then that’s all the opportunities in preclinical research.
Q. Now a days every one from life science back ground are entering in to Clinical research. Post graduate degree holder of Clinical Research and M.Pharm degree of some specialization, both want to enter into Clinical research and still M.Pharm degree holders are in imagination that there are more jobs in clinical Research though they can go for Pharma industry where Post graduate degree holder in Clinical Research cant enter into a Pharma Industry nor Preclinical Industry. Even though he has adequate knowledge on Clinical research he is less weighed than other degree holders. In such condition what is the use of holding a degree?
A. Clinical Research course is implemented to teach, to create awareness and to train the students who want to enter in to Clinical Research. It is not the problem with the course. Course is giving you the knowledge and the institutions are more starting clinical research without approval from government. There are few institutes with government approval and running the course. Now it is over supply. Because of job scarcity, if every one is choosing clinical Research and when jobs are very less, it gets polluted. That every one should understand. Ultimately, who is having efficient knowledge on clinical research, he will be absorbed, no matter of qualification. If a company has one post two hundred applications will be there, then the company look for people who work for very low salary. So, there shouldn’t be too many people for any course. Most of the institutes just doing business by starting the courses without government, there are no good teachers in Clinical Research and they are trying to cheat students and companies by highlighting placement assurance. This is an unfair requirement. It’s because of many institutes clinical Research has become more famous and fashion.
Q. Based on your experience is Clinical Research is benefit to the society or not?
A. Absolutely beneficial. There is no doubt about it.
Q. Do Investigators are really dedicating their roles and responsibilities to Clinical Trials?
A. Most of the Investigator’s are dedicating to the best of their ability and capabilities. If the Investigator is not dedicating it mean that he hasn’t been trained further properly. In such condition no matter of blaming him.
Q. Is Investigator is getting benefits and challenges in Clinical Trial?
A. Obviously, Investigator is benefiting. He is getting advantages and there are no disadvantages. He is benefiting with funding but still he will not spend any amount on patient serious adverse event (SAE). He needs to collect amount from his birth rate. Conventionally in India, the doctors are not ready to spend anything and they expect their requirements to be done free by some one else. This is due to pamper by Pharma Companies because they want their trial to be done and they want their product to be marketed. The Pharma Companies are bribing the Investigators. The challenges of Investigator should understand properly about clinical trial and he should conduct the trial according to the compliance of rules and regulations. Untrained people shouldn’t be encouraged. The truth today in India, the common people and media, every body against Clinical Research and more connectivity media has played an unfair role in pointing only the negative aspects rather than positive aspects, making very foolish comments without understanding the issues. As a result, the common man doesn’t have a good opinion on Clinical Research and the Clinical Research Professionals done nothing to correct the opinions. They are discussing among themselves and forgot to interact with public. So, because of that people are looking us suspiciously and no one is interested to take part in Clinical Research industry. Most of the clinicians are not recording the documents properly. So, these are major challenges to Investigator.
Q. The Government is involved in giving approval to a new drug why not the Government involves in bribing Investigator from Pharma Company?
A. Approval of the drug is later issue. Before that the drug is to be experimented. So that the Pharma Companies are pampering the Investigators. Government can’t be expected to do this thing because Government itself can’t do its job properly. How can we expect it to involve…!
Q. If the trial is delegated to Investigator. How many hours is he dedicating to the Clinical Trial?
A. He dedicate hardly TEN minutes. The entire work is done by Clinical Research Coordinator and the doctor is spending minimum of ten minutes. If he is popular investigator, he look after 10 or 15 trials but he is supposed to look for only 5 trials. Here every thing is overlooked and he is not ready to pay anything to Clinical Research Coordinator and he want the work to be done free. Because of this, lot of fraud is take place.
Q. How to increase employment rate in Clinical Research?
A. This is difficult question. We can’t expect increase in employment rate but there can be decrease in outcome of students. There should be smart choice of selecting course and institute. No institute can stop their false claims on their advertisement and no company guarantee’s to hire lot of students from institutes. Honestly, if institutes stop their false claims then nothing can be happened and outcome of students will not be more.
Wednesday, January 25, 2012
Criminal trials
PUBLIC HEALTH
Criminal trials
Criminal trials
| Questionable drug trials on mentally challenged persons by doctors in Indore emphasise the need for strict enforcement of medical ethics. |
SOME WOMEN BELONGING to Piduguralla of Guntur district in Andhra Pradesh, who underwent clinical trials by a pharmaceutical company in Hyderabad, at the Government General Hospital in Guntur. A June 2011 picture.
IN what appears to be a page out of Robin Cook's medical thriller, government and private doctors in Indore, Madhya Pradesh, reportedly carried out clinical trials of various medicines on some 233 patients who had gone to them seeking psychiatric treatment. As in Cook's famous book Coma, in which a medical student uncovers the unethical practices in a hospital and is targeted, a resident doctor with a prominent government hospital in Indore attempted to expose the unethical trials and was removed from service. The trials, using humans as guinea pigs to test medicines produced by pharmaceutical companies, were conducted between January 2008 and October 2010 without following proper guidelines.
Following a huge public and media uproar over the trials and the related deaths, 12 doctors, including six involved in the trials on mentally ill patients, were fined just Rs.5,000 each for not informing the parent hospital about the conduct of the trials and for ignoring protocols. The doctors had apparently obtained the approval from independent ethics committees attached to private hospitals. Five doctors were hauled up by the Economic Offences Wing (EOW) of the State government in 2011. But no action was taken against them. On January 1, the State government imposed a small fine on the 12 doctors. Responding to media reports on the trials conducted on mentally ill patients, the National Human Rights Commission (NHRC), which addresses matters concerning morality relating to clinical trials, issued a notice to the State government on December 23, 2011, and demanded a report within four weeks.
The matter pertaining to the drug trials on mental patients in contravention of Schedule Y of the Drugs and Cosmetics Act, which has explicit guidelines for clinical trials involving the mentally ill, and the Indian Council of Medical Research's (ICMR) Ethical Guidelines for Biomedical Research on Human Participants, was raised by Anand Rai, a former resident doctor of MGM Memorial Medical College in January 2011. Anand Rai wrote to the NHRC, which in turn referred his complaint to the State Human Rights Commission. Even after several months, no action was taken. The media then began to report the issue, following which the NHRC took suo motu cognisance of the trials.
No one took notice of his complaint, Anand Rai told Frontline. Things were moving but not fast enough.
In the third week of November 2011, the Union Ministry of Health and Family Welfare proposed amendments to the Drugs and Cosmetics Rules, 1945, relating to regulations in clinical trials. The amendments, it said, had been approved by the Drug Technical Advisory Board, a statutory committee under the Drugs and Cosmetics Act, 1940. The notification dated November 18, 2011, pertaining to the draft rules called the Drugs and Cosmetics (3rd Amendment) Rules, 2011, seeks to strengthen the regulations in favour of trial subjects but has many loopholes. Moreover, it was not given adequate publicity to elicit responses.
Public health experts noticed only recently the notification, posted on the website of the Central Drugs Standard Control Organisation (CDSCO), seeking comments from the public within 45 days. “ Not everyone visits the website regularly. More time should be given for responses as the proposal is beset with problems,” said Anand Rai. The deadline of 45 days for sending responses has expired, but given the concerns raised, the government could consider extending the deadline in order to get more feedback on the rules.
The draft rules claim to have incorporated effective provisions to provide financial compensation to trial subjects in case of trial-related injury or death; enhance the responsibilities of the ethics committees, the sponsor and the investigator to ensure financial compensation and medical care to trial subjects who suffer injury or death; and amend the format for obtaining consent to include details such as address and occupation, and annual income of the subject so as to have information of the socio-economic status of the trial subjects.
Public health groups such as the Low Cost Standard Therapeutics (LOCOST) and Sama have criticised the proposed amendments. They have requested more time from the government so that all concerned groups can articulate their views. Under the proposal, the ethics committees have been given the responsibility of deciding the clinical trial relatedness of an injury as well as the quantum of compensation. Sama representative N.B. Sarojini and LOCOST spokesperson S. Srinivasan argued that it was not correct to hand over both issues to the ethics committees. At present there are no clear guidelines about the constitution of the ethics committees and their monitoring. Members of the ethics committees were found to be biased as they themselves conducted the trials. The so-called independent ethics committees looked into issues of protocol instead of assessing them objectively, they said. They were not part of any hospital but were often owned and operated by powerful private commercial interests, the critics pointed out.
A DEMONSTRATION IN February 2011 in front of the Bhopal Memorial Hospital & Research Centre against unethical drug trials on victims of the 1984 gas leak.
They said a very large number of trials took place in private clinics. The ethics committees did not have the expertise required to determine the quantum of compensation based on the extent of injury, the age of the sufferer, and liabilities in case of death and, overall, had very little training in issues of ethics. Conflict of interest issues as well as institutional biases were matters that were yet to be resolved, they said. The committees had a complete say over compensation issues, including a review of disputes relating to compensation. “The decision of the ethics committee after the review shall be final,” the draft rules state.
Registration of clinical trials was voluntary before November 17, 2008. But the ICMR made it mandatory to register such trials with full disclosure of trial data with its Clinical Trials Registry from June 15, 2009.
In response to a question in the Rajya Sabha in March 2011 relating to the total number of clinical trials and deaths caused by such trials between 2007 and 2011, the Health Ministry gave the following information: 1,622 clinical trials were conducted between July 2007 and February 2011, and there were 288 deaths in 2008, 637 in 2009, and 597 up to August 2010. They were definitely not insignificant numbers.
The matter of trials being conducted clandestinely was raised in the State Assembly more than once where an independent legislator claimed that 1,883 persons, including children and mentally challenged persons, were subjected to drug trials between 2006 and 2010. No action was taken against any doctor during all those years. No names came out. The matter came up in Parliament. On December 20, 2011, replying to a question in the Rajya Sabha on the regulation of clinical trials, the Minister of Health and Family Welfare spoke of six cases of violation of the Drugs and Cosmetics Rules in the context of clinical trials and the action taken during the last three years.
The Minister said that following news reports about drug trials in the MGM Memorial Medical College and Maharaja Yashwantrao Hospital involving the drug Tadalafil for pulmonary arterial hypertension, the CDSCO and the State Drugs Controlling Authority conducted investigations and found that two doctors had used the drug without permission from the Drugs Controller General of India (DCGI). The Minister informed the House that the study with the drug had been initiated on September 18, 2005, when the drug had not been approved for the said indication in the country. It was approved for another indication, male erectile dysfunction, on June 10, 2003. On November 2, 2011, the Ministry directed the two doctors to stop the clinical trial of Tadalafil in pulmonary arterial hypertension and restrained them from conducting any clinical trial for a period of six months.
That was all the punishment handed out. Barring the occasional warning or temporary suspension of permission to conduct trials, the Ministry did not cite a single instance where strict action had been taken against the doctors in the last three years. Consider this. Last year, a Hyderabad-based research firm was reported to have conducted clinical trials of an anti-cancer drug at a multi-speciality hospital on poor people without their informed consent. It transpired that it had conducted bio-equivalence study on an already approved anti-cancer drug and there were certain irregularities with respect to the process of informed consent, review and the decision-making process of the ethics committee.
The firm was punished by withdrawing the permission granted for equivalence on June 22, 2011. But when it submitted “corrective” actions for the subject recruitment process and other procedures, it was granted a no-objection certificate to conduct the bio-equivalence study, subject to the fulfilment of certain conditions such as informed consent process, including documentation of the process through audio-video means, and conditions about the functioning of the ethics committees and the investigators. It was business as usual again.
The Indore and Hyderabad episodes are not isolated ones. Issues of informed consent involving the poor and vulnerable sections of society have always posed a problem. The compensation paid by pharmaceutical majors in case of death during trials is paltry compared with the profits they make. It was not very long ago that post-licensure clinical trials on tribal girls in Khammam in Andhra Pradesh and Vadodara in Gujarat to test the efficacy of the human papillomavirus (HPV) vaccine came under severe criticism over consent-related issues. The ICMR and the two State governments were the collaborating partners in the trial. Following reports of the death of seven girls, the ICMR suspended the trials on April 7, 2010. An inquiry committee found certain discrepancies in the conduct of the trial.
In response to a Right to Information application on November 27, 2010, seeking information about drug trials conducted by the Chacha Nehru Children's Hospital and Research Centre, Indore, over the last six years, doctors used the smokescreen of confidentiality between the sponsor and the principal investigator in order to evade an answer to the queries raised. A doctor in the medicine department of the MGM Memorial Medical College and Maharaja Yashwantrao Hospital, in response to an RTI application filed by Anand Rai, wrote that clinical trial agreements could not be publicised as that would affect scientific and business interests. He argued that the sponsoring pharmaceutical companies and the clinical research organisations (an individual or an organisation to which the sponsor may transfer or delegate some or all of the tasks and duties in a clinical trial provided such obligations are defined in writing) would be reluctant to undertake new research in the State and in the government hospitals if such information was made public.
Compared with other States, he wrote, Madhya Pradesh lagged behind in medical research. Particularly, government hospitals were far behind private clinics in this area. Delineating the benefits of medical research through drug trials, he said it encouraged foreign investment, improved scientific skill, generated employment and brought international contacts for the medical community. He stated that information could be given under limited conditions to the investigating authorities such as the EOW.
The State EOW launched an investigation only as the matter refused to die down. It found that 73 trials were carried out at the Maharaja Yashwantrao Hospital on nearly 3,300 patients, of whom 1,800-odd were children. The trials were carried out by six doctors who received pecuniary benefits from drug companies. Eighty-one trial subjects, including 18 children, suffered from serious side effects. Sixty trials were carried out in the private sector by some 40 doctors; the details of the patients were unknown. Eight Indian companies and 22 multinationals had sponsored the trials.
Anand Rai brought out some more interesting details. He said that the MGM Memorial Medical College had 27 members on its ethics committee, of whom 22 were professors in the college. The chairpersons of the committees of at least two government hospitals were veterinary doctors. The members of the ethics committee of the MGM Memorial Medical College were the principal investigators in many cases, he said. The secretary of the committee himself failed to follow the Good Clinical Practice (GCP) and ICMR guidelines, he said.
“At the moment, we are discussing drug trials sponsored by large pharmaceutical companies and conducted on vulnerable sections of the population. The research subject is typically less powerful than the sponsors and investigators conducting the research. Hence, any compensation should address this imbalance and not be directed to short-term harm or injury,” he said. All trial subjects should be given cashless health insurance for the rest of their lives, Anand Rai suggested. (He is now serving as a medical officer with the Health Department.)
On January 5, Brinda Karat, Communist Part of India (Marxist) leader and a former Rajya Sabha member, submitted a memorandum to V.G. Somani, the DGCI, requesting action against the clinical trials in Indore. She reminded him that it was more than a year since the trials and the violations had been exposed but the DCGI had failed to act against those involved. She said that an inquiry conducted by the EOW had found clear violations for which the licences of the doctors should have been cancelled. The State government's inquiry report had specifically recommended that the DGCI and the ICMR conduct investigations into the violations of the Drugs and Cosmetics Act and the ICMR and Medical Council of India guidelines.
Barring certain weak and cosmetic changes to the Drugs and Cosmetics Rules, relating to compensation in case of injuries to and death of trial subjects, no measures have been taken to strengthen the system in favour of those undergoing trials. Notwithstanding the Ethical Guidelines for Biomedical Research on Human Participants framed by the ICMR in 2006, norms continue to be flouted by both the public and private sectors in health care. The framework to deal with issues of compensation, consent and transparency is considered very weak, leading to several allegations, many of which seem to be well-founded, of exploitation of the poorer sections. After all, it is not the well-to-do on whom the trials are conducted. And often on the grounds of confidentiality (clinical trial agreements), agreements between the pharmaceutical company, the principal investigator and the organisation, information regarding drug trials is not given out freely. It requires dogged efforts by people like Anand Rai to bring these aspects into the public domain.
Friday, January 6, 2012
Tuesday, January 3, 2012
A beautiful site for medical writing with tutorials
http://owl.english.purdue.edu/
The Online Writing Lab (OWL) at Purdue University houses writing resources and instructional material, and we provide these as a free service of the Writing Lab at Purdue. Students, members of the community, and users worldwide will find information to assist with many writing projects. Teachers and trainers may use this material for in-class and out-of-class instruction.
The Online Writing Lab (OWL) at Purdue University houses writing resources and instructional material, and we provide these as a free service of the Writing Lab at Purdue. Students, members of the community, and users worldwide will find information to assist with many writing projects. Teachers and trainers may use this material for in-class and out-of-class instruction.
European Medical Writers Association
EMWA is the European Medical Writers Association. EMWA is the network of professionals that represents, supports and trains medical communicators in Europe. It is a not for profit organisation that is run for and by its members
Link to website:
http://www.emwa.org/
Link to website:
http://www.emwa.org/
Monday, January 2, 2012
Final Thoughts from A Dying Cancer Researcher
I recently received word that Alessandro Liberati, the Head of the Italian Cochrane Network, passed away from multiple myeloma, a cancer of the bone marrow. The Cochrane network is a worldwide collaboration committed to conducting comparative analyses of medical interventions. In a recent letter to The Lancet, Liberati noted his own experience in searching the medical literature in hopes of identifying what would be the best treatment for his own disease. He noted:
I looked at the “epidemiology” of myeloma studies on ClinicalTrials.gov. On July 31, 2011, a search using the term “multiple myeloma” identified 1384 studies. Of these, 107 were phase 2/3 comparative studies. However, in only 58 of these studies was overall survival an endpoint, and in only ten of these was it the primary endpoint. No trial was a head-to-head comparison of different drugs or strategies.
Multiple myeloma is just one of many cancers that researchers at pharmaceutical companies believe will be susceptible to “targeted” drugs, some of which are now in clinical trials. But those trials aren’t designed to prove them superior to existing therapies. They usually are tested in addition to existing therapies. That leaves patients and physicians in the dark about what drugs to use first or in what combinations to maximize a patient’s chance of survival.
Liberati concluded one of his last communications this way: “Patient advocacy groups in myeloma spend millions to support research, hoping to promote better care. With public support they should be in a strong position to call for a redefinition of the research agenda, in the interests of patients.”
Patient groups should be, but will they be? A quick perusal of public filings for the leading U.S.-based advocacy group, the Multiple Myeloma Research Foundation, shows that the bulk of its funding comes from pharmaceutical industry sources. All are intimately involved in MM treatment. Millenium (Velcade or bortezomib for MM); Onyx (carfilzomib for MM, now in clinical trials) and Celgene (Revlimid or lenalidomide for MM) last year donated $1.1 million, $3 million and $1.2 million, respectively, to the group’s $25.7 million budget. The single largest donation ($5 million) came from William Bowes, the 82-year-old general partner of U.S. Venture Partners in Silicon Valley and until a few years ago was considered one of the 400 richest men in America, according to Forbes Magazine. He is a long-time investor in biotechnology companies whose major venture capitalist “wins” over the years included Amgen and Xoma Ltd., where he sits on the board. Xoma is developing a lymphoma therapy.
If the pharmaceutical industry’s narrow research agenda is the problem, can a patient advocacy group primarily funded by pharmaceutical companies effectively advocate for changing that agenda? I wouldn’t count on it.
http://gooznews.com/?p=3475
Original article by researcher in lancet: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2961772-8/fulltext#aff1
Center for Information and Study on Clinical Research Participation
It is an NGO which helps clinical research participants by way of crating awareness.
The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process
Link : http://www.ciscrp.org/
The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process
Link : http://www.ciscrp.org/
Sunday, January 1, 2012
Biosoteria
This is a website which gives training in many areas one of which is - pharmacovigillance
http://biosoteria.com/
http://biosoteria.com/
Hi everybody
Hi everybody.
On this blog i plan to put Clinical Research study martial.
It is a need to get material at a place where you can use it easily, from anywhere.
Thanks
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