Political India: Engaging America

From The Hindu

Last year archival research by Professor Susan Reverby of Wellesley College revealed that during 1946-48 United States scientists had conducted a series of macabre human experiments on vulnerable Guatemalans. The experiments, now widely acknowledged to be a gross violation of modern-day bioethics standards, saw a U.S. team headed by John Cutler, a U.S. Public Health Service medical officer, clandestinely infect Gatemalan prison and mental hospital inmates with sexually transmitted diseases such as syphilis, gonorrhoea, and chancroid to purportedly test the effectiveness of penicillin.

Following the publication of Professor Reverby’s research, the Obama administration issued an apology to Guatemala and subsequently Mr. Obama constituted a Presidential Commission for the Study of Bioethical Issues to delve into what happened in Guatemala and, equally importantly, what the current status of protections for human subjects of medical research is, and how those protections could be enhanced. The Commssion reported its findings earlier this month, and while it could not identify any risks that a Guatemalan-type operation would be conducted again, it did highlight several areas where protections could be strengthened.


The ideas emerging from the Commission’s report will influence the course of the growing debate around bioethics standards in developing countries such as India, where pharmaceutical companies and other institutions are expanding their clinical trials operations and not all subjects in such human experiments may be able to provide informed consent. In this context a member of President Obama’s high-level commission, eminent Indian-American scientist Raju Kucherlapati, spoke to Narayan Lakshman about the principles that the Commission outlined as comprising a basic framework for protecting participants in human-subjects research.


As the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School, Professor Kucherlapati is not only considered an expert on questions of U.S. bioethics issues but has also played a vital role on the frontier of medical research in the Human Genome Project. Originally from Andhra Pradesh, Professor Kucherlapati received his B.S. and M.A. in Biology from universities in India, and his Ph.D. from the University of Illinois at Urbana. Edited transcript of the interview:

You are a member of President Obama’s Commission for the Study of Bioethical Issues and part of the team that produced this week’s report. Could you put the report in the context of the 1940s Guatemalan human experiments and explain how serious it is that the Commission found gaps in the current state of human subject protections?

As you probably know, the history of how the report came about was that Professor Susan Reverby from Wellesley College published a paper describing some of the events that happened in the late 1940s in Guatemala, which were done by one United States Public Health Service physician John Cutler. When those revelations came out President Barack Obama apologised to the Guatemalan government about the unfortunate events that happened and asked the Presidential Commission to do three things.

First, he wanted to have a full accounting of what happened in Guatemala. Second, he asked the Presidential Commission to consult with the international community and based upon those deliberations he wanted to ask whether we have adequate safeguards to protect human subjects in research studies conducted in the U.S. and abroad with federal support. So those were the charges for the Commission.

Commission first wrote a report in September called Ethically Impossible, in a task to describe in detail what the Commission had been able to find out about the events that occurred between 1946 and 1948 in Guatemala. Then it also produced a report that came from the international commission that was established by the Chair of the Commission and that is called Research Across Borders. The report that you are referring to, which came out yesterday, was the Commission’s deliberation on aspects of protecting participants in human subject research.

The most worrying finding by the Commission in some ways seemed to be the fact that federal agencies do not even have the capability to track the involvement of human subjects in research conducted on a vast scale, over 55,000 projects worldwide. How do you think such a serious structural flaw could be rectified?

I don’t know if I would characterise it in the way you have. First of all, the Commission felt that to be able to fully assess whether there are any issues it would be important to understand the scope of clinical research studies conducted with federal funds. It sought intervention from various governmental agencies to provide that information. It indeed received that information from all of the agencies from whom it sought information and that information is summarised in the report.

One other thing was that the degree of detail of the information that each of the agencies was able to provide was different. Of course the format of all of the reports data from the different agencies was also somewhat different. That suggested that the public has no easy access to all of the information of federally-funded human-subjects research.

Based upon that the first recommendation that the Commission makes is that each department or agency that supports this sort of research should make publicly available the specific data elements of each programme. That would include what the title of the programme is, who the investigator is, where that study is done and what amount of funding is provided for that.

Although that information is revealing it is not exactly in a single database. But if each of the agencies has that information then somebody within the U.S. government could provide a portal through which all of this information would become available.

But having said that the Commission has not found any specific instances in which there have been any problems with the protection of human subjects in any of the studies that it has conducted.

Do you have any sense of how the Commission’s findings are going to be taken forward and whether they will be translated into actual policy changes by the Obama administration? What comes next?

First of all, this is done at the request of the President and the report has been submitted to the President. The President and his staff would read the report very carefully. Representatives of the Commission will brief the appropriate staff with more details and background as needed.

The second thing that happens when these types of reports are released is that there is a significant amount of public interest in them. There are many public fora where the results are discussed extensively. Whether or not the President and the executive branch would take on all the recommendations or not, that is up to the President to make that decision.

But in many of these things the Commission has recommended that if the executive branch does not adopt these recommendations then at least it [should] provide a reason and a rationale as to why that is the case. We will see how far the recommendations will be accepted by the President.

In the context of the human experiments in Guatemala, which members of the Commission have described as “chillingly egregious” could you comment on the Commission’s view on compensation to the victims and their families? More generally, what are the guiding principles for such compensation in your view?

I think the issues with regard to compensation were not studied in the context of Guatemala and that is under litigation right now, so I do not have anything to say about compensation in the case of the Guatemala studies.

But as I mentioned the report called Research Across Borders, that is the proceedings of the international research panel of the Presidential Commission, discusses the particular issue of compensation. That group felt that the compensation mechanisms in the U.S. and the rest of the world are different, and they recommended that the U.S. think about compensation mechanisms that [are similar to the kinds of mechanisms] used in the rest of the world. That aspect has been studied very carefully by the Commission and discussed in public fora.

Despite all of that, the one clear consensus is, first of all, the idea that all of the individuals who agree to participate in research are making a significant contribution to society as a whole. The Commission felt that despite every kind of effort that one might take to mitigate risk or harm, if anything happens, the individual participants should not be left alone to pay for the cost of treating injuries that directly relate to that research.
But having said that it is not clear whether the systems that we have in the U.S. are inadequate. There is no reason to suggest or evidence to support, except for the international panel’s view, the idea that in the U.S., how individuals are compensated within the system is inadequate.

One of the recommendations that the Commission makes is that the U.S. government should first evaluate whether the systems that we have in place for compensating research-related injuries to participants is adequate or not adequate. If that study reveals that it is not adequate then [the Commission would recommend that the U.S. government] conduct a pilot study [through] the National Institutes of Health – because that is the agency which provides the majority of support for this human-subject related research – to evaluate different types of methodologies and say which might be the most appropriate.

Could you explain whether the Commission’s findings have any implications for human experiments conducted by the private sector, rather than government-funded research? What is the scale of private sector research and is there a risk that the commercial motive heightens the risk of unethical treatment of human subjects?

The President’s charge to the Commission is to look at whether we have adequate protections for research supported by the U.S. government, whether it is in this country or elsewhere. But the Commission felt that many of the ethical principles that are dealt with are not specific to publicly-funded research and that they would apply equally to privately-funded human-subjects research. So the principles apply everywhere.
he second question is what are the kinds of regulations that are currently in place for privately-funded research in the U.S.? Many of them are research efforts that are supported by pharmaceutical companies or biotechnology companies trying to develop drugs for a variety of different conditions.

In this country any private entity that is seeking approval for a new drug or treatment would have to go through the Food and Drug Administration. The FDA has rules. The FDA rules are very similar, if not identical, to the rules established by many other federal agencies which follow a set of rules called the Common Rules, which [in turn] define the criteria and conditions under which human-subjects research can be conducted. In a way anything that goes to the FDA would have to follow guidelines and regulations which are very similar to the ones that the Commission has talked about.

In addition, of course, in the studies that are conducted outside of the U.S. each of the countries has their own rules and regulations and [companies] may have to follow those regulations as well. There have been discussions as to whether some of these privately-funded research efforts do or do not take advantage of research that is done in other countries. The report deals with some of those types of issues. Regarding those aspects the Commission really recommends that any research that is done outside of the U.S. should take into consideration the local interest, that is, whether it would benefit the communities in which the research is conducted. The benefits could be any one of many different things but nevertheless the Commission recommends that those types of things should be taken into consideration carefully.

There are other sorts of issues with regard to how publicly-funded research outside the U.S. should be conducted and we all felt that the same principles apply whether it is supported by public or private funds.

According to the World Health Organisation the clinical trials industry in India was valued at over $1 billion in 2010 and is growing fast. Given this booming industry, there may be some risks for human subjects there. Based on the experience of the United States, including the most recent debate engendered by the Commission, what reforms are necessary in developing countries like India to have a sufficiently robust bioethics framework?

First of all I think that one of the most important things that the report [by the Commission] talks about is that each country should have the appropriate amount of infrastructure and people who are knowledgeable about the protection of human subjects or the ethical aspects of protecting human subjects. [This infrastructure] should either be in place or before such studies are initiated [there should be an expectation] that such infrastructure can be put together. So that’s number one – there has to be a significant number of people who are knowledgeable about these things.

The second, very important thing is that in making decisions about proper research there should be a significant amount of community involvement. When we say “community” the Commission refers to local communities because the needs of the community in which the research is conducted must be very different [across communities]. The studies that are conducted should not harm but should be of benefit to the community. The only way that you would be able to make sure that that is the case is through engagement with that community.

The third aspect is that there have been lots of discussions on the nature of the trials that should be conducted. For example placebos can be used in such studies and obviously one cannot make a generalised statement about whether a particular type of study is appropriate or not appropriate, but those or all decisions that have to be made on a case-by-case basis by informed people that include the local community.

On a different but related note, you have been closely involved in the Human Genome Project. Could you update us on where it stands now and whether its ultimate benefits in terms of new treatments for some diseases are likely to be realised in the near future?

There are dramatic changes occurring in our ability to sequence the human genome. I was part of the human genome mapping and sequencing efforts. When those efforts were completed in 2003 it was estimated that we had spent approximately $2.5-3 billion to sequence a single human genome. This year several companies in the U.S. have begun to offer whole genome sequencing for less than $10,000. So the cost of sequencing has gone down very significantly over the last eight years or so. It is anticipated that this cost would go down even more in the next few years.
Second, in the case of some disorders, especially cancer, it is becoming increasingly clear that when we examine the total genome of cancer tissues we are able to obtain a tremendous amount of information that is helping us define the ideology of cancers. But it is also in many instances providing knowledge on how we might be able to use that information immediately to treat that patient.
So these types of methodologies are already revolutionising the way that we care for patients and I anticipate that in the next five to ten years there is going to be an increase in the utilisation of sequencing technologies to, first, assess individual risk for different disorders, second, to diagnose that disease more accurately, and third, to use that information to help physicians make informed treatment decisions. All of those aspects are beginning to right now revolutionise the way medicine is practiced and that will continue for the next many years.

As an eminent Indian-American and a leading thinker in your field, can you tell us about your background including your connection to India?

I was born in a town in Andhra Pradesh and I went to undergraduate school in India. I left when I was 23 years old and came to the U.S. to do my PhD and I stayed here. I was rather young when I left India so I don’t have intimate knowledge of India but several years ago I was a member of the Scientific Advisory Committee for the Department of Biotechnology of the Government of India. During the time that I served on that committee I had an opportunity to understand about the nature of investments that the government was making in biotechnology and how that is being utilised. I advised the government at that time about new approaches that might benefit the Indian population.

Do you think those investments were of the kind that might make India a global player in this field?

I think that India has made very, very significant strides and clearly they are not behind anybody in terms of the ability to use these types of technologies. For example there is an international consortium to understand cancer and India is a part of that consortium. Each member of the consortium is looking at cancers that are relevant to that particular part of the world’s geography. India is doing studies on cancers that are much more important [to it].

Indian scientists have also been actively involved in understanding genetic factors that are important in human disease and those are again being applied to diseases that are much more important to India. So I think they are indeed part of the international community and they are embracing new technologies and new ideas and incorporating them into the way that is appropriate to practising medicine in India.

From The Hindu

 

From The Hindu

 

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

From The Hindu

At least two individuals were killed on Wednesday afternoon in a shooting at Virginia Tech University, which in April 2007 was the site of the deadliest single-man gun rampage in the United States’ history.

One victim, police officer Deriek Crouse (39) was shot at near-point-blank range by the gunman, who police said to have approached the officer as he was making a traffic stop in a campus parking lot. Officer Crouse was an Army veteran with five children, officials added.

Staff confirmed via the university website that shortly past noon gunshots were reported in a parking lot. “Stay Inside. Secure doors. Emergency personnel [are] responding. Call 911 for help,” the site warned at the time.

Further updates from the university noted that the suspect, described as a white male wearing gray sweat pants, gray hat with a neon green brim, a maroon hooded jacket and backpack was “at large.”

Officials confirmed early on that a police officer at the university had been shot dead. According to witness reports received by the police, the shooter fled on foot heading toward a parking lot and at that parking lot, a second person was found. “That person is also deceased,” the university confirmed in an update to its website.

University officials also said that that a weapon was recovered near the second body found in a parking lot on campus, although at the time it was not clear if the second body was that of the gunman.

Media reports of a conference call with Virginia Governor Bob McDonnell said “The evidence was strong that the gunman was the second dead man... It was unclear, however, whether his wound was self-inflicted.”

On the call Rick Jenkins of the Virginia State Police said, “We have recovered clothing items that would lead us to believe that he would be one and the same,” however adding, “We are not in a situation to say that definitively at this point.”

By 4:30 pm the university announced that Virginia Tech Police, in conjunction with other law enforcement agencies, have determined that there is no longer an active threat or a need to secure in place. Resume normal activities.”

The event echoed the now-infamous shooting spree of Cho Seung-Hui, an English major at Virginia Tech, who on April 16, 2007 unleashed two separate attacks several hours apart and killed 32 people and wounded 25 others. He then turned the gun on himself.

Following that incident there was also criticism of slow reaction time of university authorities to reports of Cho’s killing spree underway. In Wednesday’s shooting, however, the university went into lockdown mode with minutes of the first reports of gunshots. Law enforcement officers, including a heavily-armed local SWAT team, were seen searching the campus for the shooter.

At a press conference held in the afternoon university authorities defended their response on this occasion saying, “Communication systems we have in place today did not exist in 2007.”

However according to reports the deaths came on the same day that Virginia Tech officials were appealing a fine levied upon them by authorities in Washington over the university’s response in 2007.

Coming in the wake of numerous other such shootings carried out by youth, including the Columbine massacre, the Virginia Tech killings of 2007 sparked off a round of nationwide soul-searching on gun control, particularly the question of firearm bans on college campuses.

The event also sent shockwaves abroad. The slaying of G.V. Loganathan, a Professor in the Virginia Tech Department of Civil and Environmental Engineering drew much attention to the case in India and, in particular, in Tamil Nadu.

From The Hindu

Milorad “Rod” Blagojevich, former Illinois Governor and Democrat, was slapped with an unprecedented 14-year jail sentence in a federal corruption case after a jury found him guilty on 17 out of 20 charges earlier this year. He was convicted of wire fraud, attempted extortion, soliciting bribes, conspiracy to commit extortion and conspiracy to solicit and accept bribes.

Mr. Blagojevich’s time in prison, which will be a minimum of 12 years before he can be considered for parole, will see him reach the age of at least 67 before he is a free man. He has been asked to report to federal authorities on February 16.

Speaking after his sentencing U.S. District Judge James Zagel was said to have made it clear that “the former Governor’s position and the relentless history of corruption in Illinois” required a harsh message. “When it is the governor who goes bad, the fabric of Illinois is torn and disfigured and not easily repaired,” Judge Zagel said to Mr. Blagojevich, adding, “You did that damage.”

Possibly sensing that a tough sentence was coming his way Mr. Blagojevich had struck a penitent tone during the final hearings in court, saying, “I'm here convicted of crimes. The jury decided I was guilty. I am accepting of it. I acknowledge it and I, of course, am unbelievably sorry for it.”

Continuing the dubious tradition of Illinois Governors being sent to jail for wrongdoing – Mr. Blagojevich is the fourth since the 1970s – his arrest in December 2008 and two subsequent trials in 2010 and 2011 transfixed the nation.

Disbelief at the scope and scale of his crimes was centred on the disgraced Governor’s blatant attempt to solicit bribes for the “sale” of the Senate seat that then-Senator Barack Obama vacated when he left for the White House.

For months before his arrest police investigators had tapped his phones and, according to reports, “recorded profanity-laced conversations between the Governor and his advisers about their alleged plans to profit from his authority.”

While a first trial in the federal case against him saw him escape with a guilty verdict on only one of 24 charges, it was ruled a mistrial. A retrial in case was conducted in June this year, and on that occasion the jury found Mr. Blagojevich guilty of 11 counts related to the Senate seat and 6 counts related to fundraising extortion of a hospital executive.

After the first trial Mr. Blagojevich claimed victory saying, “This jury shows you that the government threw everything but the kitchen sink at me... They could not prove I did anything wrong – except for one nebulous charge from five years ago.”

Famed for his media showmanship Mr. Blagojevich will however face a different, bleaker reality in February.

While authorities were said to not yet have decided on where Mr. Blagojevich will serve time, reports said that he would certainly be “largely cut off from the outside world... will have to share a cell with other inmates and work a menial job, possibly scrubbing toilets or mopping floors, at just 12 cents an hour.”

From The Hindu

Syed Ghulam Nabi Fai (62) , a Kashmiri-origin U.S. citizen arrested by the Federal Bureau of Investigation on July 19, 2011 for allegedly acting as an unregistered lobbyist of Pakistan's Inter-Services Intelligence, pleaded guilty on Wednesday to conspiracy and tax violations.


Fai’s guilty plea pertained to a decades-long scheme to conceal the transfer of at least $3.5 million from the government of Pakistan to fund his lobbying efforts in America related to Kashmir, the U.S. Department of Justice said in a statement.

Specifically Fai pleaded guilty on two counts of “criminal information,” the DOJ reported, explaining that the first count was conspiracy to falsify, conceal and cover up material facts he had a duty to disclose; and to defraud the Treasury Department by impeding the lawful functions of the IRS in the collection of revenue. The second count to which he admitted guilt was the charge of endeavouring to impede the administration of tax laws.

Following a hearing before U.S. District Court Judge Liam O’Grady in the Eastern District of Virginia, it was noted that Fai faces a maximum potential sentence of five years in prison for the conspiracy count and a maximum three years in prison for the tax violation. Sentencing has been set for March 9, 2012. Further as part of his plea agreement, Fai has agreed to forfeit his interest in $142,851.32 seized by the government in July 2011, the DO said.

In a case that rocked the already dismal U.S.-Pakistan relationship over the summer the arrest of Fai was followed by revelations that he had served as the director of the Kashmiri American Council, a non-governmental organisation in Washington, D.C According to court documents, the KAC was “secretly funded by officials employed by the government of Pakistan, including the ISI.”

Commenting on the case Neil MacBride, U.S. Attorney for the Eastern District of Virginia, said, “For the last 20 years, Mr. Fai secretly took millions of dollars from Pakistani intelligence and lied about it to the U.S. government,” adding that as a paid operative of ISI, Fai did the bidding of his handlers in Pakistan while he met with U.S. elected officials, funded high-profile conferences and promoted the Kashmiri cause to decision-makers in Washington.

Casting a light upon some of the details of Fai’s scheme,the DOJ said in a statement that to prevent the Justice Department, FBI, Department of Treasury and the IRS from learning the source of the money he received from officials employed by the government of Pakistan and the ISI, Fai made a series of false statements and representations, according to court documents.

“For example, Fai told FBI agents in March 2007 that he had never met anyone who identified himself as being affiliated with the ISI and, in May 2009, he falsely denied to the IRS on a tax return for the KAC that the KAC had received any money from foreign sources in 2008,” the DOJ said.

From The Hindu

From The Hindu

From The Hindu

From The Hindu