Tuesday, November 30, 2004

Drug companies too can kill

From The Statesman

Drug companies too can kill

ND Batra

Drug companies might have killed more people than all the terrorists put together. But who is counting? Raymond V Gilmartin, CEO of the pharmaceutical giant, Merck & Co., said in an open letter the company “is continuing to offer to refund patients for their unused Vioxx.” But Gilmartin didn’t say what kind of refund would Merck give to children whose mothers have been killed by Vioxx, an arthritis painkiller.

After a study established that patients taking the arthritis drug Vioxx for 18 months had twice the risk of heart attacks and strokes than those placed on a placebo, Merck pulled the drug off the market in September. Memos and e-mails leaked from the company to the media indicate that Merck had some knowledge about the side effects of the drug long before it was taken off the shelf. Did the company use its corporate power to choke the bad news? That would be for the lawyers to prove when they pursue class action suits, which might cost the company billions of dollars in settlement.

The US Drug and Food Administration, which approved the drug in 1999, now reports that Vioxx might have been responsible for causing an additional 27,785 heart attacks or deaths from 1999 through 2003. How much is the FDA culpable for not supervising the drug properly? Dr David J Graham, the researcher who led the Vioxx study for the FDA told the Senate Finance Committee Vioxx is a “national disaster” and that the FDA embodies “a profound regulatory failure” and is “incapable of protecting America against another Vioxx.” The drug, Dr Graham said, should have been removed from the market four years ago, alleging some people in the company knew the drug was not very safe but kept quiet. This is nothing but reckless disregard of the truth, what one might call as actual malice against the public, if the whistleblower scientist is proven correct.

But can any drug be totally safe? What are FDA’s safety standards? Sandra L Kweder, the FDA’s deputy director in the Office of New Drugs said, “Unless a new drug’s demonstrated benefits outweighs its known risks for an intended population, FDA will not approve the drug. However, we cannot anticipate all possible effects of a drug during clinical trials that precede approval.” But Dr Graham in his testimony before the Senate Finance Committee compared FDA drug warnings with weather forecasting. He told the Committee that if a weather forecaster said that there’s 80 per cent chance of rain, naturally a person would take an umbrella to his office. But the FDA believes that an umbrella won’t be necessary unless there is a 95 per cent probability of rain.

The analogical criticism of the FDA, however interesting, does not answer the question of acceptable risk for a drug. If a drug kills five patients but saves or makes the lives of a million livable, should that drug be put on the market? Should the FDA obligate the pharmaceutical company that manufactures the drug to put a label, such as: Five in a million users of the drug will die or develop some other serious problems?

Many people wonder whether the FDA has become a promotional arm of the pharmaceutical industry or is intrinsically incapable of doing its work properly. Dr Jerry Avorn, an associate professor of medicine at Harvard Medical School, has authored a new book, Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. Talking with Ray Suarez of PBS NewsHour whether the FDA was doing a good job of protecting the public, Dr Avorn said, “I think it’s fair to say in light of both the Vioxx experience and also the experience we’ve had with other drugs in the recent past that, no, the system is not working well at all. There’s an enormous focus within the FDA about approving drugs quickly and getting them on to the market. And that’s okay if it’s done well. But then the attention of the FDA really drops off. And the vigilance disappears when it comes to requiring and analysing the data that we need to be able to learn about the safety of the drugs once they’re in widespread use.”

It is difficult to say whether the FDA suffers from a short attention span or is intimidated by corporate power, but Congress and the media can’t ignore the problem of drug safety any longer. In the meantime, Merck has begun its public diplomacy to win the hearts and minds of its shareholders if not the American public. Apparently the three full-page ads in major newspapers were not meant to assure the millions of people who have used Vioxx. Like the rest of corporate USA, Merck is interested in the bottom line; and that’s what Gilmartin said, “Our business prospects are strong and we are well prepared to address the challenges posed by the withdrawal of Vioxx.”

There is nothing wrong in Merck’s interest in delivering “returns to shareholders,” provided it also includes the welfare of the American patient. Now that Merck stands on trial in the court of public opinion and before Congress and faces class action suits, it would be its burden to prove what the ad claims: “Our ethical standards are the foundation of our company. Merck has consistently been recognised as one of the world’s ethical companies.” Who has conferred such a high distinction upon Merck? Where did the company executives learn their ethics? Are they confusing ethics with technical standards and profit making?

Saturday, November 27, 2004

Corporate greed

Consider what Arthur Levitt Jr., a former chairman of the SEC, said in a recent piece in WSJ entitled “Money, Money, Money.” “Exorbitant compensation feeds the worst instincts and egos of powerful CEOs, fueled by their desire to win at all costs and resulting, too often, in the cutting of ethical corners.“

Wednesday, November 24, 2004

If Condoleezza Rice were a mother

If Condoleezza Rice were the mother of young children, would she have looked at Iraq differently?

What would Lady Macbeth have done?

“I have given suck, and know

How tender 'tis to love the babe that milks me:

I would, while it was smiling in my face,

Have pluck'd my nipple from his boneless gums,

And dash'd the brains out, had I so sworn as you

Have done to this.''

Tuesday, November 23, 2004

Dr Rice is in and the whole world is watching

From The Statesman


America’s face to the world

ND Batra

Condoleezza Rice, the new US secretary of state, has a world to heal, without giving up the fight against global terrorism. As a most trusted confidante of President Bush, whom she is said to have helped form a vision of the world based on freedom and democracy, she could launch a new phase of American diplomacy. A broken and wounded world expects much from her. She brings to the job greater clarity and more credibility than Colin Powell, about whom the world was not sure whether his voice was authentic.

In spite of his well-articulated magnificent presence, Powell was an over-rated diplomat. His domestic reputation rested on the fact that the son of Jamaican immigrants, raised in the Bronx, a Vietnam vet, rose to become chairman of the joint chiefs of staff, national security advisor and finally the secretary of state. He celebrated his Horatio Alger kind of rags-to-fame and riches achievements in his best selling book My American Journey. The Powell Doctrine –attack only when absolutely essential but with an overwhelming force and know how to get out – was nothing but a distillation of the best practices of some of the past great generals.

Powell’s international reputation rested on a dubious premise that in spite of the fact that he differed with the Bush administration on its policy of pre-emption in general and the war against Iraq in particular, he heroically continued exercising his moderating voice among the hawks like defence secretary Donald Rumsfeld and Vice-President Dick Cheney. If the chief function of a diplomat is to persuade others, Powell persuaded no one; not the President; not his own Cabinet colleagues; not the public; and not the international community. Using satellite imagery on 5 February 2003, he tried to convince the UN Security Council that Iraq had weapons of mass destruction. Technically brilliant and highly oratorical, it was nonetheless a disastrous performance.

By giving the impression that he was trying to give a moderate face to the Bush administration’s policy of pre-emption, Powell raised false hopes abroad. Last year on his visit to Islamabad, he declared Pakistan to be a non-Nato ally, which made no sense to anyone and pleased none. It was a diplomatic blunder of sub-continental proportion. His defenders say as a loyal soldier, he has continued supporting the commander-in-chief, President Bush, in spite of fundamental differences, but that is a deceptive behaviour. He would have served the country better by being a man of conscience rather than a blind follower of something he did not believe in. May be he would write another book about his experiences in living with contradictions in an atmosphere of cognitive dissonance. Diplomacy is not deception. It is not a charm offensive; nor a point-counterpoint game of chess. In the ultimate analysis, it is building alliances by creating shared meanings and common goals. It is persuasion using all the available means, short of war.

With Powell’s departure, it falls upon the shoulders of Condoleeza Rice to give a new tone and set up a new structure for the US foreign policy, which must go beyond pre-emption. Much is being talked about her past; how she grew up in the segregated South; how her father, a priest, imbued in her an unshakable faith in the ultimate goodness of American society; her self-discipline and dedication to whatever she chose to do, whether it was concert piano, ice skating or being a provost at Stanford University.

The most remarkable thing about Rice is she won the confidence of George Bush, who graciously introduced her at the time of appointment as secretary of state as “America’s face to the world.” Her relations with Bush, which began during the 2000 presidential campaign when she became his foreign policy advisor, grew into mutual admiration and trust. Bush admires Rice’s sharp analytical mind; she is captivated by his uncluttered vision, his habit of cutting through verbiage and getting to the heart of the matter. Probably she understood that behind the occasionally mangled English and malapropism, there lies a clear-headed and determined person with a vision.

What is expected of her? In what way would she be different from Colin Powell? As the President’s trusted person, she would speak with an authentic voice and in that sense she would be a true face of the Bush administration to the world. With so much credibility, she must dust up the roadmap for Israel-Palestine peace process and instigate earnest negotiations for the establishment of a genuine Palestinian democratic state that lives in peace with Israel, an indispensable first step in winning over the Arab-Muslim world. Lessons of Iraq must not be forgotten; though hopefully peace would return some day and Iraqis would have their own democratically elected government. Although Iran and North Korea cannot be ignored, any attempt to force a regime change would unleash forces that the USA might not be able to control. Dr Rice of course understands all that and much more.

Saturday, November 20, 2004

Recent columns published in The Statesman

Revisiting Bush’s policy of pre-emption

Section: Perspective Date:Nov 17,2004Cyber Age/ ND Batra

The USA needs deeper engagement with the world through international economic aid, building up democratic institutions and strengthening weaker or failing states so that they don’t become havens for terrorists. It cannot depend

Bush unbound?

Section: Perspective Date:Nov 10,2004

The US presidential election ended gracefully and with clarity. It was a celebration of democracy. And if, as they say, the end is the beginning of something new, Bush’s second term could be more productive at home and less destructive abroad. But that wo

Outsourcing healthcare and other American problems

Section: Editorial Date:Nov 03,2004A few days ago

I shocked one of my colleagues when I showed him a Washington Post story how a 53-year old man Howard Staab, suffering from a life-threatening heart problem, could not afford $200,000 for heart surgery and instead went to New Delhi’s

America’s most (un)civil war

Section: Perspective Date:Oct 27,2004 by ND BATRA

The USA is a fierce democracy; non-violent may be, but brutal. Democratic presidential candidate Senator John Kerry said the “W” in George W Bush’s name stands for wrong – wrong on war, wrong on peace, wrong on budget, wrong on social securit

Democracy’s work is never done

Section: Perspective Date:Oct 20,2004 by ND Batra

The continued insurgency in Iraq has unfortunately distracted our attention from some positive developments in Afghanistan. The election in Afghanistan held under the auspicious of the United Nations and international observers is the first sm

Seductions of cyberspace

Section: Perspective Date:Oct 13,2004

As the legend goes, on the Internet nobody knows whether a person is a dirty old man trying to seduce teenagers; a gender-swapping woman playing with big boys in a virtual MUD room; or a teenager posing as an expert. As a New Yorker cartoon by Peter Stein

cyber age: ND Batra: Who would do a better job in Iraq?

Section: Perspective Date:Oct 06,2004

The political war about war in Iraq has heated up to the point that other domestic issues including economy, jobs, social security, education and health care have been sidetracked. The daily flow of images of car bombs and suicide explosions in Baghdad, i

cyber age: ND Batra: Doing away with business patent methods

Section: Perspective Date:Sep 29,2004

Vivius, Inc., based in Minneapolis, is a most recent example of companies rushing to patent their unique methods of doing business, thus creating impenetrable walls to hide ideas that should be tested and debated in public. The company, according to Busin

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Thursday, November 18, 2004

Discussion: Internet privacy and e-commerce

Discussion: Internet privacy and e-commerce

What is your position on collecting and distributing consumer information collected through the Internet? Should companies be allowed to collect this data and sell it to third parties? Why or why not?

Tuesday, November 16, 2004

Revisiting Bush's policy of pre-emption

From The Statesman

Wednesday 17 November, 2004


Revisiting Bush’s policy of pre-emption

Cyber Age/ ND Batra

The USA needs deeper engagement with the world through international economic aid, building up democratic institutions and strengthening weaker or failing states so that they don’t become havens for terrorists. It cannot depend solely upon its firepower and modern war technology to subdue a restive people. Consider what happened at the funeral of Yasser Arafat, where Palestinian authorities could not control frenzied, hysterical mourners, who jumped barbed wires, climbed over the walls of Muqatta, descended on the compound, and raised passionate chants to grieve the passing away of their beloved leader. Such street-battle scarred people, whether in Palestine or elsewhere, need to be engaged culturally, economically and politically to wean them away from Islamic militant ideology. Pre-emptive policy needs revisiting.

During the 2002 brinkmanship between India and Pakistan, the USA by sharing selective military intelligence with both countries played a low-profile but significant role in defusing the crisis; and since then Washington has been unobtrusively supporting the process of normalisation. Today, the Indian sub-continent is a more hospitable place for business and investment than it was a few years ago. Although this does not diminish the bold foreign policy initiatives taken by the Vajpayee and Singh administrations, the quiet diplomacy of the USA has begun to bear fruit.

The only way the USA can exercise its influence is through the use of diplomatic power, the power of persuasion through cooperation, commonality of national interests and developing common goals such as economic growth, fighting terrorism and eliminating AIDS. Diplomatic power arises from the attraction of a nation’s culture and values, apart from its economic and military prowess. Most people around the world perceive American culture as a culture of Hollywood, pop music, blockbuster movies and steamy television programmes, but that’s only partly true. American culture is a culture of openness, of freedom and open roads that lead to the free marketplace of goods and ideas. It is a culture of optimism that holds the possibility of expanding human horizons. The Arab-Muslim world needs to be informed and educated about.

India like China has understood the power of US openness, the free marketplace, and has become one of the fastest growing world’s economies. If the USA, for example, were to shut its doors on India by blocking outsourcing, India’s technology-driven export economy would receive a setback. Bush’s Democratic opponent Senator Kerry talked against outsourcing. From economic and diplomatic point of view, Bush is a better choice for India. China has benefited tremendously by opening its economy and eventually would open itself to other cultural influences including free expression and democracy. By opening its markets to China, the USA has exercised its diplomatic power and changed a hostile nation to a friendly global power. A similar phenomenon has begun to take place in Pakistan, where the economy is picking up steam and foreign currency reserve is swelling. Americans may be resented and even disliked in some places, but they are also a most admired and envied people in the world. India and China aspire to catch up with the USA one day.

Joseph Nye of Harvard’s Kennedy School of Governance says that a country can become attractive by “co-opting people rather than coercing them.” He suggests that international influence “comes from an effective aid and information programme abroad. What is needed is increased investment in soft power, the complex machinery of interdependence, rather than in hard power – that is, expensive new weapons system.” Although fighting terrorism requires both hard and soft power, attraction of the soft power, “is much cheaper than coercion, and an asset that needs to be nourished.” Just as trade with China and rising prosperity has co-opted the Chinese people and has given them new hopes and new dreams, a similar policy might transform Iran too.

The Bush administration must explore new directions in international relations instead of using pre-emptive power. For example, it is important that the USA uses media power to present an alternative view of reality to the Arab and Muslim world. Unlike the quick catastrophic victory in Iraq, the results of such cultural engagement would not be immediately visible but they would be long lasting. All battles ultimately have to be fought and won in the minds and hearts of the people. “Effective broadcasting,” wrote Edward Kaufman in The Battle for Hearts and Minds, “strengthens the traditional triad of diplomacy, economic leverage, and military power and is the fourth dimension of foreign conflict resolution… Perceptions change when outside information challenges certain assumptions.” International broadcasting done in local languages, for example, as done by BBC, must become part of the larger front of public diplomacy, the deployment of soft power of culture, to win the war of ideas.

More than anything else it is corporate America that makes the USA attractive. If American apparel makers were to open factories in Palestine, for example, they would create new hopes and dreams for the Palestinian people. The USA should encourage corporate America, through economic incentives and other means, to invest in West Asia to raise and sustain democratic dreams, the kind of dreams about which Bush talked about in his recent joint press conference with British Prime Minister Tony Blair.

Wednesday, November 10, 2004

Internet porn and the First Amendment

Internet porn and the First Amendment

Pornography has been proliferating on the Internet and is obviously a serious problem, especially for parents of computer savvy children. What should be done? Should porn be controlled? Can it be controlled somehow when the Internet is boundless? Should Congress regulate it legislatively? Or is it better to leave its control to programmers, software companies and the marketplace?

Tuesday, November 9, 2004

Bush unbound?

From The Statesman


10 November, 2004

Bush unbound?

ND Batra

The US presidential election ended gracefully and with clarity. It was a celebration of democracy. And if, as they say, the end is the beginning of something new, Bush’s second term could be more productive at home and less destructive abroad. But that would depend upon how creatively he accommodates or co-opts others’ ideas.

As Democrats and Republicans assimilate the causes of their respective defeat and victory, the bitterness and ugliness of the campaign would hopefully diminish, if not disappear altogether. Some are already planning for the future. After all, political power is never static. The election divided the map of the USA into a vast red territory that went for Bush and three disjointed puddles of blue that voted for Kerry, giving a totally misleading impression of homogeneity in each division. Underneath every red state, there is blue and vice versa. And as consciousness changes, the blue would surface up and dominate the red.

Terrorism and the question of legalising gay marriages that became a test of character and moral values drove many voters to Bush. While the Bible-thumping voters might have helped Bush get re-elected, the rich would more likely reap the economic benefits of his second term. The stock market rose 3.5 per cent in two days after the election.

Though magnanimous in victory, Bush was nonetheless quick to assert that his ambitious agenda cannot wait. People have spoken and Congress must listen up, he admonished during his first post-election press conference held in the White House. He seemed in a hurry to accomplish his agenda, the social political and economic platform that he set up during his election campaign. Knowing that the last 18 months or so of his second term would be the time for the next presidential poll campaign, he can’t afford to be a lame duck President too soon. Bush does not want to not end up simply building his legacy in the form of a presidential library or writing a bestseller memoir. Bush seems to have established a tryst with destiny. He has put the country on notice. “I earned capital in the campaign, political campaign, and now I intend to spend it,” he said. The decisive victory over Senator Kerry has given him a tremendous sense of power, especially when he sees that both houses of Congress are now under Republican control. He said he would tell Congress that the people have spoken and embraced his political platform, and so should they; especially regarding social security, taxation, health care, medical liability reforms and other initiatives. But of course when the reality sets in, he would know that his fellow Republicans in the Senate and the House too have their own political agendas to safeguard their political future.

Bush also knows that 48 per cent of voters who did not vote for him were not limited to the North-east, the upper lake region and the West; that underneath the vast swath of red states, there is a thick layer of the throbbing blue, the enduring Democratic sensibility that sees the USA differently. Although the election has left Democrats weak and humbled, he is aware that for any meaningful work to be done he might have to compromise. As he said, “My goal is to work on the ideal and to reach out and to continue to work and find common ground on issues.” But how far would he deviate from the ideal, his political platform regarding social security, taxation, health care, stem cell and other contentious issues remains to be seen.

The most contentious issue is of judicial appointments, especially for the US Supreme Court, where many justices are old, some too old. The influence of the Supreme Court justices extends beyond their graves. In many ways, they have shaped American society. Like most Americans, the justices of the Supreme Court too have conservative and liberal ideologies. And it is the President who, with the approval of Congress, appoints them.

One way of setting the agenda for generations to come would be to appoint justices who reflect the conservative philosophy of Bush. Recently, the 80 year-old Chief Justice Rehnquist underwent surgery for thyroid cancer. He may be the first to go. For Democrats and Republicans, whoever becomes the next Chief Justice of the Supreme Court is no less crucial than who sits it the White House. Presidential deeds and misdeeds can be undone but what the Supreme Court does lasts for generations. The Court’s influence comes from its exclusive power to interpret the Constitution, which shapes the culture, whether a woman can have an abortion, public school children can recite the Pledge of Allegiance that includes “under God” or a man can say to another man, I do.

The presidential election ultimately pivoted on values and Bush was able to convince a substantial majority of the American people that without values the nation can’t battle terrorism abroad and cultural anarchy at home.

Tuesday, November 2, 2004

Outsourcing healthcare and other American problems

From The Statesman

3 November, 2004

Outsourcing healthcare and other American problems

ND Batra

A few days ago I shocked one of my colleagues when I showed him a Washington Post story how a 53-year old man Howard Staab, suffering from a life-threatening heart problem, could not afford $200,000 for heart surgery and instead went to New Delhi’s Escort Heart Institute and Research Centre. At a meagre cost of $10,000 which also included round-trip fare, a visit to Taj Mahal and great food, Staab had his defective heart valve replaced by Escort surgeons.

Staab is one of the 150,000 foreigners who visited India last year for medical problems. Of course the uppity-nose correspondent John Lancaster of the Post could not resist his condescending remark: “Staab is one of a growing number of people known as medical tourists who are travelling to India in search of First World healthcare at a Third World prices.”Apollo Hospital’s founder Prathap Reddy was quoted saying: “If we do this, we can heal the world.” My colleague’s reaction was: Who would heal India, Mr Reddy? India might have to be satisfied with trickle-down benefits from the medical tourist industry that is projected to grow to $2.2 billion by 2012. But that is beside the point. Skyrocketing healthcare costs are making Americans desperate. State governors in defiance of the federal government are reaching out to foreign countries for cheaper prescription drugs.

If US healthcare providers and the insurance industry want to reduce healthcare costs, they might offer the American patient a choice: Go to India for surgery or pay up the bill, which might be ten times higher in the USA, and swallow up a the retirement nest egg. That presents a policy dilemma. If universal healthcare is the goal, how do you make it affordable? How much of it could be outsourced to countries like India and how much should be handled by the US healthcare industry? This year the flu vaccine shortage has made authorities think about the need for setting healthcare priorities. Should the limited healthcare opportunities be given to those who can afford it or those with the most need?

Until last year, most employers in the United States of America offered their employees free flu shots before the onset of the flu season. They did so in their own enlightened self-interest. It is more economical to keep workers healthy than let them fend themselves in the flu season and the work be disrupted due to sickness.For rest of the community, family health clinics offered flu shots at affordable rates. Since each year there are new strains of the flu virus, the vaccine has to be tailor-made, as it were. There used to be enough for everyone who wanted it. But no one ever thought what might happen if the production of flu vaccine was disrupted due to some catastrophe or even sabotage. Flu vaccine never entered into the calculus of the Homeland Security colour alert system.

Not long ago only most vulnerable people, children, senior citizens, and nursing home residents were advised to go for a flu shot. But since newer flu strains came to be associated with sources of foreign origin — China, Hong Kong, Thailand — most people thought what is good for older people must be good for younger people too. It is just like Viagra, which was initially meant for people with erectile dysfunction but later on even normal healthy people began to use it, thanks to the aggressive advertising push by the pharmaceutical company, Pfizer, and later on sby other manufacturers (Ciala, Levitra). Need was created. Market expanded.

Although widespread fear has made flu shot a universal choice, the market does not drive its demand and supply, unlike that of Viagra. In fact liability claims and low profits might have discouraged its production. Nonetheless, the supply managed to keep pace with the demand. But this year, one of the major vaccine manufacturers, Chiron, expected to provide 48 million doses against a total US demand of 100 million, had its licences suspended due to the problem of bacterial contamination in its plant in Liverpool, England.Most of the people, according to a survey reported by USA Today blamed drug companies and federal health officials. It has not become a serious political issue in the presidential campaign, though one Bush advertisement blamed trial lawyers associated with his Democratic opponent Kerry’s running mate, John Edwards.

But the shortage has created a national scare and an ethical dilemma for the medical profession. Although all healthy people have been excluded from receiving flu shots this year, how do you prioritise the limited supply among the vulnerable population? How do you decide who is the most vulnerable when in some cases a person needs more than one shot to get full protection. One after the other, healthcare facilities have struggled with the ethical dilemma and issued public statements limiting shots to high risk categories; for example, people suffering from asthma, diabetes, immune deficiency, children less than two-years-old and pregnant women, but not necessarily in that order.

The question is: If healthcare is everyone’s basic right, how do you ration it? The next President of the USA might find that outsourcing healthcare and buying cheaper drugs abroad may be the best solution. Another door might open for India.