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?

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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.“

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.''

Dr Rice is in and the whole world is watching

From The Statesman

http://www.thestatesman.net



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.

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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?