Topic: Three-card Monty
Pass legislation to force disclosure of drug info

Many consumers are still reeling from the recent run of frightening news about the safety of prescription drugs in the U.S.

The parents of children taking the antidepressant Paxil were stunned last year to learn not only that the medication was not effective in children but also that it may increase the risk of suicide in children and teenagers. In September, millions of Americans taking the arthritis-pain drug Vioxx saw it pulled from the market after its link to heart-attack risk was firmly established. A few months later came the news that Celebrex, the most widely prescribed arthritis-pain medication, raised similar concerns.

How can drugs approved by the federal government and heavily advertised sometimes do more harm than good?

The answer lies primarily in gaps in our nation's drug-safety system. Before new drugs are allowed on the market, pharmaceutical companies must test them on individuals for safety and effectiveness, and the information is submitted to the Food and Drug Administration. But after a drug is approved, neither the drug company nor the FDA is required to make details of clinical-trial results public; how the drug was tested, its effectiveness, and information on possible side effects can remain hidden from the public for years.

This can lead to situations such as the one involving Paxil. GlaxoSmithKline, the maker of Paxil, had a study of the drug published in a psychiatry journal, but it referred to the increased suicide risk as mere emotional instability. Two other studies showing that the drug was ineffective were never published. Those three studies circulated at the FDA for close to a year and a half before the agency required that the strongest warning be placed on Paxil.

Reports show that the drugmaker Merck and the FDA were aware of the heart-attack risk of Vioxx for years; Merck changed the package-insert information but did not publicize the change.

Critics inside and outside the FDA say that after drugs are approved, the agency does not adequately monitor or effectively address subsequent safety problems. The public needs an independent, effective, and vigorous office to follow and act on ongoing studies, one that is not stymied or influenced by the office of drug approval.

The results of all clinical drug trials should be available to the public in an easily understandable format. Ensuring that consumers, doctors, and researchers know about possible safety problems will help ensure that drugmakers and the FDA quickly address any negative finding raised in a study. These drug trials should be registered as they begin, in a central, public location, perhaps on the Internet.

Pharmaceutical industry trade groups have said that they will voluntarily register and release results of some of their trials. But without a legal requirement for disclosure, the incentive to hide or downplay safety information is too great.

Consumers Union supported legislation last year in Congress that would require registration of clinical trials and make their results public. This session, there has been a renewed bipartisan call for these reforms, and we will work to ensure their passage. Look for updates on legislation and other drug-approval and safety developments in a future issue.



What you can do

For more information on this issue and on Consumers Union's other efforts to make prescription drugs safe, effective, and affordable, go to our public-policy Web
site at www.ConsumersUnion.org.

The median salary for a Clinical Research Associate at the FDA is $50,946. When you consider that the CEOs of the top eleven HMOs make $15.1 million on the average, you have to wonder---Is the FDA a stepping-stone to a corporate job???

Now Playing: Lynn Samuels on Sirius
Topic: Three-card Monty

Post-Election Buzzkill: Why Iraq Is Still A Debacle

February 02, 2005 [ Printer-friendly version ]

Quick, before the conventional wisdom hardens, it needs to be said: The Iraqi elections were not the second coming of the Constitutional Convention.

The media have made it sound like last Sunday was a combination of 1776, the fall of the Berlin Wall, Prague Spring, the Ukraine's Orange Revolution, Filipino "People Power," Tiananmen Square and Super Bowl Sunday -- all rolled into one.

It's impossible not to be moved by the stories coming out of Iraq: voters braving bombings and mortar blasts to cast ballots; multiethnic crowds singing and dancing outside polling places; election workers, undeterred by power outages, counting ballots by the glow of oil lamps; teary-eyed women in traditional Islamic garb proudly holding up their purple ink-stained fingers -- literally giving the finger to butcher knife-wielding murderers.

It was a great moment. A Kodak moment. And unlike the other Kodak moments from this war -- think Saddam's tumbling statue and Jessica Lynch's "rescue" -- this one was not created by the image masters at Karl Rove Productions.

But this Kodak moment, however moving, should not be allowed to erase all that came before it, leaving us unprepared for all that may come after it.

I'm sorry to kill the White House's buzz -- and the press corps' contact high -- but the triumphalist fog rolling across the land has all the makings of another "Mission Accomplished" moment.

Forgive me for trotting out Santayana's shopworn dictum that those who forget the past are doomed to repeat it but, for god's sake people, can't we even remember last week?

So amid all the talk of turning points, historic days and defining moments, let us steadfastly refuse to drink from the River Lethe that brought forgetfulness and oblivion to my ancient ancestors.

Let's not forget that for all the president's soaring rhetoric about spreading freedom and democracy, free elections were the administration's fallback position. More Plan D than guiding principle. We were initially going to install Ahmed Chalabi as our man in Baghdad, remember? Then that shifted to the abruptly foreshortened reign of "Bremer of Arabia." The White House only consented to holding open elections after Grand Ayatollah Sistani sent his followers into the streets to demand them -- and even then Bush refused to allow the elections until after our presidential campaign was done, just in case more suicide bombers than voters turned up at Iraqi polling places.

And the election doesn't change that.

Let's not forget that despite the hoopla, this was a legitimate democratic election in name only. Actually, not even in name since most of the candidates on Sunday's ballot had less name recognition than your average candidate for dogcatcher. That's because they were too afraid to hold rallies or give speeches. Too terrorized to engage in debates. In fact, many were so anxious about being killed that they fought to keep their names from being made public. Some didn't even know their names had been placed on the ballot. On top of that, this vote was merely to elect a transitional national assembly that will then draft a new constitution that the people of Iraq will then vote to approve or reject, followed by yet another vote -- this time to elect a permanent national assembly.

And the election doesn't change that.

Let's not forget that many Iraqi voters turned out to send a defiant message not just to the insurgents but to President Bush as well. Many of those purple fingers were raised in our direction. According to a poll taken by our own government, a jaw-dropping 92 percent of Iraqis view the U.S.-led forces in Iraq as "occupiers" while only 2 percent see them as "liberators."

And the election doesn't change that.

Let's not forget that the war in Iraq has made America far less safe than it was before the invasion. According to an exhaustive report released last month by the CIA's National Intelligence Council, Iraq has become a breeding ground for the next generation of "professionalized" Islamic terrorists. Foreign terrorists are now honing their deadly skills against U.S. troops -- skills they will eventually take with them to other countries, including ours. The report also warns that the war in Iraq has deepened solidarity among Muslims worldwide and increased anti-American feelings across the globe. Iraq has also drained tens of billions of dollars in resources that might otherwise have gone to really fighting the war on terror or increasing our preparedness for another terror attack here at home.

And the election doesn't change that.

Let's not forget the woeful lack of progress we've made in the reconstruction of Iraq. The people there still lack such basics as gas and kerosene. Indeed, Iraqis often wait in miles-long lines just to buy gas. The country is producing less electricity than before the war -- roughly half of current demand. There are food shortages, the cost of staple items such as rice and bread is soaring, and the number of Iraqi children suffering from malnutrition has nearly doubled. According to UNICEF, nearly 1 in 10 Iraqi children is suffering the effects of chronic diarrhea caused by unsafe water -- a situation responsible for 70 percent of children's deaths in Iraq.

And the election doesn't change that.

Let's not forget the blistering new report from the special inspector general for Iraq reconstruction, which finds that the U.S. occupation government that ruled Iraq before last June's transfer of sovereignty has been unable to account for nearly $9 billion, overseeing a reconstruction process "open to fraud, kickbacks and misappropriation of funds."

And the election doesn't change that.

Let's not forget that we still don't have an exit strategy for Iraq. The closest the president has come is saying that we'll be able to bring our troops home when, as he put it on Sunday, "this rising democracy can eventually take responsibility for its own security" -- "eventually" being the operative word. Although the administration claims over 120,000 Iraqi security forces have been trained, other estimates put the number closer to 14,000, with less than 5,000 of them ready for battle. And we keep losing those we've already trained: some 10,000 Iraqi National Guardsmen have quit or been dropped from the rolls in the last six months. Last summer, the White House predicted Iraqi forces would be fully trained by spring 2005; their latest estimate has moved that timetable to summer 2006.

And the election doesn't change that.

And let's never forget this administration's real goal in Iraq, as laid out by Cheney, Rumsfeld, Wolfowitz, and their fellow neocon members of the Project for the New American Century back in 1998 when they urged President Clinton and members of Congress to take down Saddam "to protect our vital interests in the Gulf." These vital interests were cloaked in mushroom clouds, WMD that turned into "weapons of mass destruction-related program activities," and a Saddam/al-Qaida link that turned into, well, nothing. Long before the Bushies landed on freedom and democracy as their 2005 buzzwords, they already had their eyes on the Iraqi prize: the second-largest oil reserves in the world, and a permanent home for U.S. bases in the Middle East.

This is still the wrong war in the wrong place at the wrong time. And the election, as heart-warming as it was, doesn't change any of that.

This is from "Arianna Online"

Encore!!!
Topic: Three-card Monty

Isn't it funnny how history seems to repeat itself???