Archive for January 30th, 2011

Drug Row Sets Pakistan Scientists Against Ministries

By A A Khan for The Science and Development Network

Efforts to produce a cheap local version of a hepatitis B drug have ground to a halt in Pakistan amidst a row between a leading scientist and senior officials from two government ministries.

Officials claim to have evidence that scientists involved in the drug’s production have cut corners in carrying out trials, abused resources and misused research funds.

But two of the scientists said they feel they are being deliberately prevented from launching the drug, interferon, because it could undermine the lucrative contracts for supplying it currently held by international pharmaceutical companies.

Viral hepatitis B is endemic in Pakistan, with an estimated seven million people infected,according to research published by the Pakistan Journal of Medical Sciences in 2009.   

The government’s claims relate to scientists at the Centre for Applied Molecular Biology (CAMB) in Lahore. The ministry of science and technology commissioned an audit of the centre, carried out by a committee of officials and external auditors, according to sources.

The ministry referred the findings to the Federal Investigation Agency this month (8 December) which will decide whether to proceed with charges. In the meantime, the centre’s accounts have been frozen.

Meanwhile, officials in the ministry of health said they are refusing to approve use of interferon produced by CAMB because of alleged irregularities in the clinical trials.

And, in a separate development, an independent petitioner, Batish Mahmood Tipu, filed a petition in the High Court this month (13 December) which has led to the court issuing notices to both ministries.

The notices require them to explain before the court why they are not allowing the use of locally produced interferon that, according to the petitioner, costs 70 Pakistan rupees (around 82 US cents) per injection, compared with the imported version, which costs around US$11.

CAMB trains molecular biologists and specialises in recombinant DNA technology. The centre has a good record of achievements related to Bt (Bacillus thuringiensis) rice, Bt cotton and Bt pesticide formulations. It has obtained more than ten patents. 

The centre received regular funding from the ministry of science and technology for the interferon project and, from 2004 onwards, it also received financial support from Pakistan’s Higher Education Commission (HEC).

CAMB also received prize money of US$100,000, in 2008, from the Islamic Development Bank for its outstanding contribution to molecular biology.

Clinical trials criticised

Sheikh Riazuddin, one of five scientists targeted by the government’s investigation, was director of CAMB from its establishment in 1985 until June 2009.

Riazuddin was working on a project entitled ‘Local Production of Interferon’, headed by Javed Akram, a professor at Jinnah Hospital, Lahore, which began in 2000.

According to Riazuddin phase III clinical trials of the local version of the drug were conducted at Jinnah Hospital, a teaching hospital of the Allama Iqbal Medical College, Lahore, and it was ready for final approval in December 2008.

By January 2009, CAMB had patented the drug and produced 100,000 vials of it — which have still not been used.

Sources from the ministry of health said they have not approved the drug because of the omission of two key stages normally conducted in clinical trials: phase I (laboratory testing of the drug) and phase II (safety testing on humans).

But Riazuddin said these stages are not necessary in the case of a ‘biosimilar’ drug — an exact copy of a drug for which these trials have already been conducted. 

Rauf Khalid, drug registration controller of the ministry of health, told SciDev.Net: “The approval of hepatitis interferon for commercial release can only be granted when CAMB completes all the requirements, including tests, and shows the capability of its production facilities”.   

The ministry of science and technology’s audit committee, whose findings have not been made public, has, according to sources, found among other alleged irregularities that Riazuddin had been using CAMB facilities, such as transport and phone, even after he had left the organisation.

The committee has also said it can find no satisfactory answer about where the bulk of the prize money from the IDB has gone.

Khalid Siddiqui, joint secretary of the ministry of science and technology, said: “Irregularities have taken place at CAMB for the last many years and all the findings by our committee have formally been sent to the Federal Investigation Agency for verification.

“We respect them [the CAMB scientists] as researchers but any irregularities identified by the fact-finding committee have to be dealt with according to law.” 

Allegations have ‘no substance’

Riazuddin confirmed to SciDev.Net that he has been contacted by the [FIA] which informed him that it had received a case against him involving corruption, to the tune of millions of rupees, and misuse of authority — charges he denies.

“There is no substance in the allegations,” he said.

He agreed that, even after leaving CAMB, he continued to direct the team and spent most of his time at CAMB.

“I did that not for my sake but to see my brainchild become a reality. I assumed if I do not look after the research I started, that might vanish, rendering many years’ effort futile.”

Riazuddin and Akram claimed that there have been government moves to try to block the development and production of their drug.

“Some sections in the ministry of science and technology and in the health ministry are playing into the hands of multinational companies who do not want a local launch of this medicine as Pakistan is importing hepatitis drugs worth Rs 4 billion (around US$47 million) annually from those multi-nationals,” Riazuddin said.

“This all is to force us into saying goodbye to the local production of interferon,” Akram told SciDev.Net

“At every step, from release of funds to the approval stages, we faced bureaucratic hurdles so much so that we felt that they do not want local production of hepatitis interferon,” Akram added.

Anwar Nasim, patron of the Pakistan Biotechnology Information Centre (PABIC), told SciDev.Net: “It is not shocking to know about corruption allegations in research when the menace of corruption is all around us. An external investigation by the FIA would soon help us know who was in the wrong — the ministry or the researchers”.

Egypt Protests Continue as Government Resigns

By David Kirkpatrick for The New York Times

CAIRO — Egypt was engulfed in a fifth day of protests on Saturday but an attempt by President Hosni Mubarak to salvage his 30-year rule by firing his cabinet and calling out the army appeared to backfire as troops and demonstrators fraternized and called for the president himself to resign.

While some protesters clashed with police, army tanks expected to disperse the crowds in central Cairo and in the northern city of Alexandria instead became rest points and even, on occasion, part of the protests as anti-Mubarak graffiti were scrawled on them without interference from soldiers.

“Leave Hosni, you, your son and your corrupted party!” declared the graffiti on one tank as soldiers invited demonstrators to climb aboard and have their photographs taken with them.

“This is the revolution of all the people,” declared the side of a second tank in downtown Cairo. Egyptian men all serve in the army, giving it a very different relationship to the people from that of the police.

The feared security police had largely withdrawn from central Cairo to take up positions around the presidential palace, with their places taken up by the army.

Following Mr. Mubarak’s demand in his late-night speech, the Egyptian cabinet officially resigned on Saturday. But there was no sign of letup in the tumult. Reports from morgues and hospitals suggested that at least 50 people had been killed so far.

In Ramses Square in central Cairo Saturday midday, protesters commandeered a flatbed army truck. One protester was driving the truck around the square while a dozen others on the back were chanting for President Mubarak to leave office. Nearby, soldiers relaxed around their tanks and armored vehicles and chatted with protestors. There were no policemen in sight.

In another sign that the army was showing sympathy for the demonstrations, in a different central Cairo square on Saturday a soldier in camouflage addressed a crowd through a bullhorn declaring that the army would stand with the people.

“I don’t care what happens,” the soldier said. “You are the ones who are going to make the change.” The crowd responded, “The army and the people will purify the country.”

Workers at the Alexandria morgue said they had counted more than 20 bodies from the last 24 hours of violence. Meanwhile, protests had started up again in the city. But there too, the demonstrators and the soldiers showed sympathy for one another. Demonstrators brought tea to the troops and had their pictures taken with them. Protesters walked by armored carriers unmolested with few signs of animosity. People gathered outside the morgue looking for their relatives. In the main hospital, there were a number of people lying wounded from live fire.

Cell phone service, cut off by the government on Friday, was partially restored although other elements of the communication shut down remained in force. On Friday, with much of the nation in open revolt, Mr. Mubarak deployed the nation’s military and imposed a near-total blackout on communications to save his authoritarian government of nearly 30 years.

In the early hours of Saturday, protesters continued to defy a nationwide curfew as Mr. Mubarak, 82, breaking days of silence, appeared on national television, promising to replace the ministers in his government, but calling popular protests “part of bigger plot to shake the stability” of Egypt. He refused calls, shouted by huge, angry crowds on Friday in the central squares of Cairo, the northern port of Alexandria and the canal city of Suez, for him to resign.

“I will not shy away from taking any decision that maintains the security of every Egyptian,” he vowed.

Whether his infamously efficient security apparatus and well-financed but politicized military could enforce that order — and whether it would stay loyal to him even if it came to shedding blood — was the main question for many Egyptians.

It was also a pressing concern for the White House, where President Obama called Mr. Mubarak and then, in his own Friday television appearance, urged him to take “concrete steps” toward the political and economic reform that the stalwart American ally had repeatedly failed to deliver.

Whatever the fallout from the protests — be it change that comes suddenly or unfolds over years — the upheaval at the heart of the Arab world has vast repercussions for the status quo in the region, including tolerance for secular dictators by a new generation of frustrated youth, the viability of opposition that had been kept mute or locked up for years and the orientation of regional governments toward the United States and Israel, which had long counted Egypt as its most important friend in the region.

Many regional experts were still predicting that the wily Mr. Mubarak, who has outmaneuvered domestic political rivals and Egypt’s Islamic movement, the Muslim Brotherhood, for decades, would find a way to suppress dissent and restore control. But the apparently spontaneous, nonideological and youthful protesters also posed a new kind of challenge to a state security system focused on more traditional threats from organized religious groups and terrorists.

Friday’s protests were the largest and most diverse yet, including young and old, women with Louis Vuitton bags and men in galabeyas, factory workers and film stars. All came surging out of mosques after midday prayers headed for Tahrir Square, and their clashes with the police left clouds of tear gas wafting through empty streets.

For the first time since the 1980s, Mr. Mubarak felt compelled to call the military into the streets of the major cities to restore order and enforce a national 6 p.m. curfew. He also ordered that Egypt be essentially severed from the global Internet and telecommunications systems. Even so, videos from Cairo and other major cities showed protesters openly defying the curfew and few efforts being made to enforce it.

Street battles unfolded throughout the day Friday, as hundreds of thousands of people streamed out of mosques after noon prayers on Friday in Cairo, Alexandria, Suez and other cities around the country.

By nightfall, the protesters had burned down the ruling party’s headquarters in Cairo, and looters marched away with computers, briefcases and other equipment emblazoned with the party’s logo. Other groups assaulted the Interior Ministry and the state television headquarters, until after dark when the military occupied both buildings and regained control. At one point, the American Embassy came under attack.

Six Cairo police stations and several police cars were in flames, and stations in Suez and other cities were burning as well. Office equipment and police vehicles burned, and the police seemed to have retreated from Cairo’s main streets. Brigades of riot police officers deployed at mosques, bridges and intersections, and they battered the protesters with tear gas, water, rubber-coated bullets and, by day’s end, live ammunition.

With the help of five armored trucks and at least two fire trucks, more than a thousand riot police officers fought most of the day to hold the central Kasr al-Nil bridge. But, after hours of advances and retreats, by nightfall a crowd of at least twice as many protesters broke through. The Interior Ministry said nearly 900 were injured there and in the neighboring Giza area, with more than 400 hospitalized with critical injuries. State television said 13 were killed in Suez and 75 injured; a total of at least six were dead in Cairo and Giza.

The uprising here was also the biggest outbreak yet in a wave of youth-led revolts around the region since the Jan. 14 ouster of President Zine el-Abidine Ben Ali of Tunisia — a country with just half Cairo’s population of 20 million. “Tunis, Tunis, Tunis,” protesters chanted outside the Tunisian Embassy here.

“Egyptians right now are not afraid at all,” said Walid Rachid, a student taking refuge from tear gas inside a Giza mosque. “It may take time, but our goal will come, an end to this regime. I want to say to this regime: 30 years is more than enough. Our country is going down and down because of your policies.”

Mr. Mubarak, in his televised address, said he was working to open up democracy and to fight “corruption,” and he said he understood the hardships facing the Egyptian people. But, he said, “a very thin line separates freedom from chaos.”

David Kirkpatrick talks about the close call he had while with Nobel laureate, Mohamed ElBaradei, the kinds of police on the streets in Egypt and the possible prospects for the Mubarak government.
 

His offer to replace his cabinet is unlikely to be viewed as a major concession; Mr. Mubarak often changes ministers without undertaking fundamental reforms.

A crowd of young men who had gathered around car radios on a bridge in downtown Cairo to listen to the speech said they were enraged by it, saying that they had heard it before and wanted him to go. “Leave, leave,” they chanted, vowing to return to the streets the next day. “Down, down with Mubarak.”

A bonfire of office furniture from the ruling party headquarters was burning nearby, and the carcasses of police vehicles were still smoldering. The police appeared to have retreated from large parts of the city.

Protesters throughout the day on Friday spoke of the military’s eventual deployment as a foregone conclusion, given the scale of the uprising and Egyptian history. The military remains one of Egypt’s most esteemed institutions, a source of nationalist pride.

It was military officers who led the coup that toppled the British-backed monarch here in 1952, and all three Egypt’s presidents, including Mr. Mubarak, a former air force commander, have risen to power through the ranks of the military. It has historically been a decisive factor in Egyptian politics and has become a major player — a business owner — in the economy as well.

Some protesters seemed to welcome the soldiers, even expressing hopes that the military would somehow take over and potentially oust Mr. Mubarak. Others said they despaired that, unlike the relatively small and apolitical army in Tunisia, the Egyptian military was loyal first of all to its own institutions and alumni, including Mr. Mubarak.

“Will they stage a coup?” asked Hosam Sowilan, a retired general and a former director of a military research center here. “This will never happen.” He added: “The army in Tunisia put pressure on Ben Ali to leave. We are not going to do that here. The army here is loyal to this country and to the regime.”

One of the protesters leaving a mosque near Cairo was Mohamed ElBaradei, an Egyptian who won the Nobel Peace Prize for his work with the International Atomic Energy Agency and has since emerged as a leading critic of the government.

“This is the work of a barbaric regime that is in my view doomed,” he said after being sprayed by a water cannon.

Now, he said, “it is the people versus the thugs.”

%d bloggers like this: