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Pharming for Profit - by Jeffery Light

Mandatory HPV Vaccinations - SftP's DC Town Meeting - by Jane Zara

Dallas to Review Decades of Convictions - by John Kelly

The Ethanol Bubble - by Peter Caplan

Military Getting Worried about Climate Change - by Juliet Eilperin, reprinted from Washington Post, 4/15/2007

A Cure Worse than the Disease, I - by John Kelly

A Cure Worse than the Disease, II - by John Kelly

The CIA, the Irradiation of Brains and the Dirty Bomb - a History Lesson - by John Kelly

The Green Scare and Operation Backfire- by Peter Caplan

Books of Interest

Ask Dr. Science


Pharming for Profit
   Monsanto Patents Supposedly Safe Method for Growing Food Crops Containing Insulin, Other Drugs
           - by Jeffery Light, Executive director, Patients not Patents

On May 10, 2005, the United State Patent and Trademark Office (USPTO) issued patent 6,891,086 for "Plastid Transformation of Brassica". The patent issued to Calgene, a Monsanto company. The patented technology allows for the "production of human biological proteins (pharmaceutical proteins) from the plant plastid." Examples given include the DNA coding for Human Growth Hormone (hGH), aprotinin (Trasylol), and insulin or insulin precursors. (Trasylol is used to reduce blood loss in patients undergoing heart bypass surgery.) This technology differs from other means of genetically modifying plants because it only modifies plant plastids, and not the plant's nuclear, or primary, DNA. Plant plastids, such as chloroplasts, are biosynthetic centers that are responsible for photosynthesis and can be used industrially to produce amino acids, complex carbohydrates, fatty acids, and pigments.

The patent is specifically aimed at modifying plants of the genus Brassica. The family of Brassica plants is large and diverse, covering radishes, turnips, rutabagas, cabbages, cauliflower, canola, and kale. Significantly, these are crop plants, as opposed to non-food plants like tobacco which are easier for scientists to manipulate. The inventors assert that genes expressed in plastids "are not pollen disseminated, therefore, a trait introduced into a plant plastid will not be transmitted to wild-type relatives." In theory, this would alleviate the concerns of many environmental protection groups.

However, according to a study published in Nature Biotechnology, the inventors' claim may not be well-founded. "This supposition [that Brassica plastids cannot be transmitted through pollen] seems reasonable but requires that the maternal parent and environmental conditions have no effect on transmission." The study further suggested that empirical testing is needed to assess the risks of this technology. No such data is cited by the patent.

Dr. Doug Gurian-Sherman, Senior Scientist at the Center for Food Safety, also disagrees with the claim that plastid engineering is environmentally safe. Dr. Gurian-Sherman told Patients not Patents that "many crops transmit chloroplasts or plastids in pollen." Although it is a relatively rare phenomenon, potential contamination could have devastating effects. Pollen contamination may occur through a process known as recombination. In recombination, genes in the plastid spontaneously migrate to the cell's primary DNA code. After recombination has occurred, the artificially introduced genes can be transmitted to the wild through pollen. Although the significance of recombination in genetically engineered plastids is the subject of debate, at least one case has already been documented. (CY Huang, "Direct measurement of the transfer rate of chloroplast DNA to the nucleus." Nature, 422, 72-76, 2003.)

Our lack of understanding of the biology of plant plastids is not the only problem. Human error can also be a source of contamination. According to a UK study published in Nature Biotechnology, "Seed spillage is inevitable from the oilseed rape (canola) crop during transportation, planting, and harvest." (SE Scott, et al., "Low probability of chloroplast movement from oilseed rape (Brassica napus) into wild Brassica rapa." Nature Biotechnology, 17:390-92.) For example, Prodigene, Inc. was fined more than $3 million in 2002 when its corn, which contained an animal vaccine, contaminated soybean crops in Iowa and Nebraska.

Some biotechnology companies, however, see little danger in the technology. The web site for Chlorogen, Inc. touts the company.s plastid engineering method. "Chlorogen is able to greatly increase the availability of proteins without concern that genes will transfer to other plants via pollen." Perhaps they should be more concerned. Chlorogen creates genetically modified tobacco with human proteins, despite a publication by Chlorogen founder Dr. Henry Daniell which notes that "species such as tobacco have been reported to have ~0.1-0.5% pollen transfer of chloroplast traits." (H Daniell, "Molecular strategies for gene containment in transgenic crops". Nature Biotechnology, 20:581-86, June 2002.)

Mandatory HPV Vaccinations - SftP's DC Town Meeting - by Jane Zara

After emergence of the proposed HPV (Human Papilloma Virus) Vaccination and Reporting Act, DC Metro Science for the People organized a town meeting at the DC Social Forum on March 3. It was attended by healthcare practitioners, parents, young women, public health experts, minority and women's rights advocates and other political activists, all searching for more information about the proposed vaccine's efficacy for its target population, and compensation for adverse effects. The concerns which emerged are listed below.

List of concerns by members attending the town meeting concerning the HPV Vaccination and Reporting Act of 2007, on March 3, 2007, at the DC Social Forum, Catholic University, Washington, DC

Dallas to Review
Decades of Convictions - submitted by John Kelly
              from Wade Goodwyn transcribed from Morning Edition, February 23, 2007

Dallas' new district attorney, Craig Watkins, says he will open his files to the Innocence Project and work with the group to examine hundreds of cases over the past 30 years. The goal is to see whether DNA tests might reveal wrongful convictions.

The move reflects the enormousness of the change that has occurred in the Dallas DA's office over the last six weeks. Watkins was elected the first black district attorney in Texas. "It's a whole different world in the Dallas criminal justice system," says defense attorney Gary Udashen. "It is a world where if a client of ours is innocent, we feel like there's openness in the District Attorney's office to hear what we have say, to look at what we have to show them, where we don't anticipate resistance every step of the way."

Udashen's firm alone has had seven Dallas clients who were convicted, sent to prison, exhausted their appeals and then ultimately - with the pro bono help of Udashen and his colleagues - were found to be innocent. Udashen says Dallas used to be like many other cities in Texas when it came to the DA's office. If it got a conviction, it defended that conviction to the bitter end, even if strong scientific evidence was later uncovered that the convicted was wrongly convicted. This occurs most often in cases that are brought to trial built solely on the testimony of a single eyewitness, often the victim.

But Udashen says that Watkins has decided that defending wrongful convictions is not going to be part of the job. "Well, he has taken a completely different approach to questions of innocence... where he is going to cooperate with these innocence projects reviews of these cases, give them the information they need," he says. "And that active involvement in proving people innocent is something I've never seen a district attorney do before." Watkins puts it this way: "I am cut from a different cloth." At 39, he says he's seen both sides of the criminal justice system in Dallas, good and the bad. Dallas has already released 12 men convicted of sexual assault, and that was with the previous DA fighting it every step of the way. That's more than any other county in the nation, and more than all but two states.

"And when you tested 36 people and 12 of them came up to be not guilty as a result of DNA testing, then, yes, a red flag is raised," Watkins says. "So we need to look at what we've been doing in the past and try to right those wrongs." So Watkins is opening his files to the Texas Innocence Project. North Texas law students supervised by seven veteran former prosecutors and criminal defense lawyers will begin deciding which cases merit further investigation.

"In a state that is a national hotspot, Dallas is the hottest of the hotspots in state right now," says Jeff Blackburn, the Innocence Project's Texas director. "What'd happened in Dallas is that a lot of samples, unlike other any other parts of the state, were preserved, and they're still there." In a twist of irony, Dallas has long outsourced its lab work. And instead of destroying evidence post-conviction like many law enforcement labs, the private labs preserved all the evidence. Blackburn says as a result, Dallas has a treasure trove of potentially exonerating DNA evidence. "It would be safe to say that right now Dallas is on the edge of opening up in a very revealing way what the system in Texas is really all about," Blackburn says.

The Ethanol Bubble - by Peter Caplan


Writes Robert Zubrin, in American Enterprise Online:

“To liberate ourselves from the threat of foreign economic domination, undercut the financiers of terror, and give ourselves the free hand necessary to deal with Middle Eastern extremists, we must devalue their resources and increase the value of our own. We can do this by taking the world off the petroleum standard and putting it on an alcohol standard.”

   Alcohol has arrived.  The safe-driving slogans used to warn us metaphorically that “Alcohol and Gasoline Don’t Mix”.  In the last few years however, alcohol began literally to be mixed into the world’s gas tanks and hybrid cars have been arriving in the U.S. as the status symbol of the ecologically correct glitterati.  During the last year all the pieces began to fall into place: the IPCC reports were finally accepted – even in Washington - ; the age of cheap, plentiful and secure sources of oil was pronounced finished (peak oil studies; threats from Iraq, Iran Russia, Venezuela); demand would accelerate(China, India) and fossil carbon-based alternatives to oil would just as surely lead to climate catastrophe. The green element continued its struggle to be heard – what about conservation?   More public transportation?  Good ideas for the future, but let’s get real, guys - was the response.  This is a crisis.  What we have to do now is to protect the America’s inalienable right to continue to have almost 8 cars for every 10 people (including infants) – a rate 30 % higher than any other country – according to 2006 DOE figures -

and, that those vehicles must remain over-powered and inefficient - the U.S. driver uses over 1600 liters/year, Canada 1200, and Japan and the advanced economies of Europe about 450 (2003 figures from World Resources Institute))

How can America keep 230 million cars on the road without having to fight perpetual wars against uncooperative oil suppliers?  Alcohol. It’s been coming for a long time and now it’s here: Alcohol will save us!  George Bush’s State-of-the-Union address  and sudden discovery of South America, highlighted by the recent exchange of chummy visits with once-leftist President Lula of Brazil was a clear sign that something serious was in the air (besides CO2).

   The March memorandum of understanding between the two nations to promote biofuels and shared technology, while omitting any mention of U.S. trade barriers against ethanol, was largely a gesture; but it was intended and served as a symbol for the world, not only of the Bush regime’s intention to move toward major use of ethanol, but also to use Brazil as a wedge against the influence of Chavez on the continent.. As seen from the sharp responses from Castro, who predicted mass starvation if land were to be used to grow fuel instead of food, and from Chavez who moved quickly to spearhead anti-Bush rallies in Bolivia, Ecuador and Argentina even as Bush was touring in South America. And, in response, Jeb Bush dangled the lure of an eventual reduction of the tariff to entice a still closer approach from Brazil.

    Fidel’s first article in Granma on March 29, “Biofuels and World Hunger”, followed next week by a widely-quoted second article, raised the specter of the starvation of 3 billion, according to the mass media. The number was mentioned only in the first  headline which said “More than 3 billion people… are being condemned to a premature death from hunger and thirst.” and  the article went on to raise important points about multinational control of land and about the effects of climate change: “let the poor countries receive some financing to produce ethanol from corn or any other foodstuff and very soon not a single tree will be left standing to protect humanity from climate change”.  This was of course was quickly dismissed by both Bush and Lula, and National Security Advisor for the Western Hemisphere Dan Fisk added “if there's anyone that knows how to create starvation, it's Fidel Castro”.  However, by coincidence a well-documented study by U of Minnesota professors C.F. Runge and B. Senauer (R&S) backed up most of Castro‘s key points.  Let’s take a look..  

   The paper, by R&S, “How Biofuels could Starve the Poor”, in Foreign Affairs (May-June issue), indicates that, thanks to generous government subsidies, by the end of 2006, there were 110 ethanol refineries in operation in the U.S., many of these undergoing expansion and another 73 under construction, so that by the end of 2008 capacity would reach around 11.4 billion gallons per year (as against 4.4 bgy for 2005 and 5.6 bgy for 2006).  Bush has called for 35 bgy by 2017.

.  The effect of this tremendous growth has been a very large diversion of corn from food to fuel which is bringing corn reserves to record low levels and may soon turn Iowa into a net corn importer.  Since the U.S. accounts for some 40% of the world’s corn production and half of its exports, the rapidly-rising corn prices (highest in 10 years) are having global effects.  But the effect is not limited to corn.  As more land becomes devoted to corn, less is devoted to wheat and rice which are sought as substitutes, leading to decade-high prices for these grains as well.  The R&S piece continues:

  “The World Bank has estimated that in 2001, 2.7 billion people in the world were living on the equivalent of less than $2 a day; to them, even marginal increases in the cost of staple grains could be devastating. Filling the 25-gallon tank of an SUV with pure ethanol requires over 450 pounds of corn -- which contains enough calories to feed one person for a year. By putting pressure on global supplies of edible crops, the surge in ethanol production will translate into higher prices for both processed and staple foods around the world. Biofuels have tied oil and food prices together in ways that could profoundly upset the relationships between food producers, consumers, and nations in the years ahead, with potentially devastating implications for … global poverty”

   It has been claimed that farmers would profit from the high prices and money would flow into the economies of agricultural countries, but has been countered, e.g., in David Moberg’s In These Times article “Biofuels:  Promise or Peril?” by the argument that large corporate fuel farmers would buy up scarce land and force peasants to abandon their farms.

   The R&S paper goes on to underline the fact that in large economies, it has become common for the government to subsidize both the feedstock industry (corn, sugar cane oilseed etc) and the processing industry - alcohol or biodiesel, and to give legislative incentives for their use. In the U.S. in 2005, there were direct corn subsidies of almost $9B, and a recent flood of tax credits grants and loans to the ethanol industry.  Currently there is a direct subsidy of 51 cents per gallon to ethanol blenders.

    In Europe, the EU is actively subsidizing both ethanol from sugar beets and wheat and biodiesel from oilseeds.  It aims to obtain about 6% of its motor fuels from plants by 2010 and 10 % by 2020.

   Brazil in the 1970’s reacted to fluctuating oil prices by mandating the development of and use of sugar-based ethanol and subsidized advances in processing technology.  In 2005, the U.S. and Brazil each produced about 45% of the world’s ethanol (9.6 bg), the U.S. mostly from corn, Brazil from sugar.  The government there has since the 1970’s offered incentives, set technical standards, and invested in supporting technologies and market promotion.  And, in southeast Asia, large tracts of tropical forest and peat bogs are being burned, [releasing large amounts of CO2 ] to be replaced by oil palms for diesel.

   The upward pressure on food prices due converting food acreage to fuel crops is also causing price rises in dairy, beef, pork and poultry.  And the speculators are not sitting idly by: 

“Hedge funds are making huge bets on corn and the bull market unleashed by ethanol. The biofuel mania is commandeering grain stocks with a disregard for the obvious consequences.”  The ethanol industry with all of this momentum is still enjoying a 54-cent-a-gallon protective tariff against cheaper imports of the cheaper and more efficient sugar-based form exported by Brazil. On the other hand, if somehow oil prices should decline (at least temporarily) and the ethanol bubble should burst, food prices would collapse and there will be tremendous pressure for a bailout, from the people that made billions from the bubbl,.  Archer Daniels Midland, being the most prominent.

   But by far the most devastating impact of growing food to make alcohol will fall on the people living in food-scarce areas - the double threat of continued rises in oil prices and food prices.  One example is in sub-SaharanAfrica, where cassava provides a third of the caloric needs for 200 million people.  If cassava turns into a cash crop for the alcohol industry, the income will enrich the multinationals as usual and starvation will become even more widespread.      Estimating that for every 1% increase in the real price of staple foods, the number of food-insecure people in the world would rise by over 16 million, and assuming food prices increases projected by the International Food Policy Research Institute, in Washington, D.C., the authors estimate that by 2025 there would be an additional 600 million hungry people worldwide. 

   If the U.S. were to go all-out and use the entire existing corn crop to make ethanol, it is estimated that only 12% of the gasoline use could be replaced, a result that could hardly bring about energy independence.  [and note also that the energy input - usually in the form of fossil fuels - to make the stuff is roughly equal, with present technology, to the energy ouput from burning it ] In addition, there are serious ecological costs to be incurred by the large uses of fertilizers and pesticides and the erosional soil loss and water pollution caused by row crop monoculture. 

   The authors conclude that the costs of this rush to produce ethanol from food crops far outweigh the benefits and that the subsidies should go rather to developing more efficient processing  so that  the source could be cellulose from grasses and agricultural waste, and to developing conservation and alternative sources of energy. 

   However, another recommendation, relying on sugar-based ethanol imported from tropical countries, although it may be some eight times as energy-efficient to produce as the corn-based version, flies in the face of the environmental objections raised by the authors against the use of corn, and doesn’t address the question of energy independence, nor the political and social questions raised by giving incentives to tropical countries to convert cropland to sugar monoculture. The landless workers movment in Brazil released a statement on Feb 28, “Full Tanks at the Cost of Empty Stomachs: The Expansion of the Sugarcane Industry in Latin America” at a forum involving social movements also in Bolivia, Costa Rica, Colombia, Guatemala, and the Dominican Republic.  The opening of the document places the sugar cane economy in its colonial perspective:

The current model of production of bioenergy is sustained by the same elements that have always caused the oppression of our peoples: appropriation of territory, of natural resources, and the labor force.


Historically the sugar industry served as an instrument to maintain colonialism in our countries and the creation of dominant classes that have controlled, through today, large extensions of land, the industrial process, and commercialization. This sector is based on latifundio ownership, on the overexploitation of labor (including slave labor) and the appropriation of public resources. This sector was created upon intensive and extensive monocropping, provoking concentration of land, profit, and wealth.


The sugarcane industry was one of the main agricultural activities developed in the colonies. It allowed sectors that controlled production and commercializaction to continue accumulating capital and with this contribute to the development of capitalism in Europe.

  The historical connection among sugar, colonialism and slavery was underlined a month later by Fidel in his second Granma piece and recently, on April 29, the result of a new study of Brazilian cane-cutters appeared in the Folha of São Paulo and was the subject of an editorial.  The surge in demand  to feed a rapidly growing export sector and consequent pressures to increase worker productivity have been such that a cane-cutter can work no more than 10 to 12 years before succumbing to severe physical deterioration.  The slaves of the 19th century were luckier – they lasted 15 to 20 years.

Runge and Senauer conclude with the following recommendations: “Rather than promoting more mandates, tax breaks, and subsidies for biofuels, the U.S. government should make a major commitment to substantially increasing energy efficiency in vehicles, homes, and factories; promoting alternative sources of energy, such as solar and wind power; and investing in research to improve agricultural productivity and raise the efficiency of fuels derived from cellulose. Washington's fixation on corn-based ethanol has distorted the national agenda and diverted its attention from developing a broad and balanced strategy”.  Let’s not forget to add public transportation - mentioned nowhere in the article, nor the enormous waste of energy in war.


Military Getting Worried about Climate Change

Military Sharpens Focus on Climate Change;
A Decline in Resources Is Projected to Cause
Increasing Instability Overseas

By Juliet Eilperin; - published inWashington Post Sunday, April 15, 2007

The U.S. military is increasingly focused on a potential national security threat: climate change.

Just last month the U.S. Army War College funded a two-day conference at the Triangle Institute for Security Studies titled "National Security and the Threat of Climate Change" And on April 17, a group of 11 retired senior generals release a report saying that global warming "presents significant national security challenges to the United States," which it must address or face serious consequences.

he 63-page report -- which is being released a day before the U.N. Security Council holds its first-ever briefing on climate change -- lays out a detailed case for how global warming could destabilize vulnerable states in Africa and Asia and drive a flood of migrants to richer countries. It focuses on how climate change "can act as a threat multiplier for instability in some of the most volatile regions of the world," in part by causing water shortages and damaging food production.

The study's authors, along with several other national security experts, confirmed last week that the military has begun studying possible future impacts of global warming with new intensity.

"It's only in the last six months that climate change itself has surfaced as a term that's commonly recognized as having security implications," said Kent H. Butts, a professor of political military strategy at the War College's Center for Strategic Leadership. Butts added that when he meets with military leaders to discuss how to tackle terrorism and regional instability, "Each time they're saying, 'This is getting worse because of changes in the climate.' "

Commissioned by the Center for Naval Analyses, a government-funded think tank, the report boasts a list of contributors that includes eight retired four-star generals and three three-stars. Many have significant technological expertise, and some, such as Admiral T. Joseph Lopez, are close to Vice President Cheney. Others, including Gen. Anthony C. Zinni, have criticized President Bush in recent years.

The Army's former chief of staff, Gen. Gordon R. Sullivan, who is one of the authors, noted he had been "a little bit of a skeptic" when the study group began meeting in September. But, after being briefed by top climate scientists and observing changes in his native New England, Sullivan said he was now convinced that global warming presents a grave challenge to the country's military preparedness.

"The trends are not good, and if I just sat around in my former life as a soldier, if I just waited around for someone to walk in and say, 'This is with a hundred percent certainty,' I'd be waiting forever," he said.

Part of the sense of urgency, the generals said in interviews last week, stems from the fact that changing climatic conditions will make it harder for weak nation-states to address their citizens' basic needs. The report notes, for example, that 40 percent of the world's population gets at least half its drinking water from the summer melt of mountain glaciers that are rapidly disappearing.

"Many developing nations do not have the government and social infrastructures in place to cope with the type of stressors that could be brought about by global climate change," the report states. "When a government can no longer deliver services to its people, ensure domestic order, and protect the nation's borders from invasion, conditions are ripe for turmoil, extremism and terrorism to fill the vacuum."

The study states that conflicts in regions such as Darfur and Somalia stemmed initially from a lack of resources, something that will only worsen with global warming. Climate change is different from traditional military threats, according to report author Vice Adm. Richard H. Truly, because it's not like "some hot spot we're trying to handle."

"It's going to happen to every country and every person in the whole world at the same time," Truly said.

The report also notes that some military bases probably will be compromised by climate change. Diego Garcia, an atoll in the southern Indian Ocean that U.S. and British forces use as a logistic hub for their Middle East operations, lies just a few feet above sea level. "Although the consequences to military readiness are not insurmountable, the loss of some forward bases would require longer range lift and strike capabilities and would increase the military's energy needs," the study says.

The military has contemplated the implications of climate change before: In 2004 it released a study of possible catastrophic global warming that was commissioned by Andrew Marshall, who directs the Pentagon's Office of Net Assessment; four years earlier the Defense Department issued a report titled "Climate Change, Energy Efficiency and Ozone Protection."

Pentagon and Army officials declined repeated requests for interviews last week. But several former officers involved in the study who maintain contacts inside the Defense Department said several branches of the military are examining how to cope with climate change. Sullivan said he plans to talk to military officials about his group's report, and he expects they'll be sympathetic to his message. "I don't think this is a hard sell," he said.

A Cure Worse Than the Disease I, by John Kelly

When the associate director of the FDA's Office of Drug Safety, Dr. David Graham, reported in August 2004 that Vioxx caused 56,000 cardiovascular deaths, Merck dismissed his report and issued a press release in which it "strongly disagreed" with his conclusions. The title of the press release was: Merck Stands Behind the Efficacy, Overall Safety and Cardiovascular Safety of Vioxx.

Secret Merck memos and e-mails reveal that Graham was only the latest in a long line of medical researchers subject to attack by Merck in its worldwide campaign to discredit anyone who even questioned the safety of Vioxx and to distort and manipulate data about Vioxx. At the same time, Merck spent millions, wooing doctors and researchers to produce studies supporting the safety of Vioxx as well as to prescribe it for their patients. On the other side, Merck carried out a campaign to "neutralize" doctors who supported and prescribed rival drugs such as Pfizer's Celebrex and Bextra.

Only weeks after Graham's report, Merck itself withdrew Vioxx from the market because patients taking it in an on-going cancer study were experiencing twice as many heart attacks as those taking a placebo. Merck claimed it was acting on the side of extreme caution. In fact, the secret memo and e-mails show that Merck officials knew in 1997 that Vioxx was a serious cardiovascular threat before it sought FDA approval, and its own study confirmed this threat in 1999, the year the FDA approved Vioxx for sale.

"Prior to approval of Vioxx, a study was performed by Merck [which] found nearly a 7-fold increase in heart attack risk with low doses of Vioxx," wrote Dr. David Graham in the February 2005 issue of Lancet. Merck and the FDA acted out of "ruthless, short-sighted and irresponsible self-interest," added Lancet editor Dr. Richard Horton in the same issue. Horton also revealed that the FDA had done everything possible to try to prevent publication of Graham's article.

The FDA also was aware of Vioxx's cardiovascular risks before it gave its approval, and many studies confirmed this risk. During the ensuing years Vioxx was a worldwide, multi-billion dollar bestseller. Dr. Curt Furberg of the Wake Forest University Medical Center and Dr. Garret Fitzgerald of the University of Pennsylvania Medical Center estimate that 50 patients a day were dying at this time from Vioxx and other drugs in its category. All with the FDA's awareness.

Not only did the FDA fail to take any action against Vioxx, but also its specially convened advisory panel recommended that Vioxx be allowed to return to the market in February 2005, only four months after Merck itself had withdrawn it. The panel also voted that the equally dangerous drugs, Celebrex, Bextra, and Mobic be allowed to continue to be sold.

After a tremendous outcry, the FDA ordered Pfizer to withdraw Bextra in April 2005, but Celebrex and Mobic continue to be sold. It was revealed afterwards that ten of the 32 panel members who endorsed continued marketing of Vioxx, Celebrex, and Bextra have served as consultants for Merck and Pfizer. If the 10 advisers had not voted, the panel would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The ten advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return. Of the 30 votes cast by the ten advisers on whether Celebrex, Bextra, and Vioxx should continue to be marketed, 28 favored the drugs. Overall, the advisors with financial ties to the drug companies were 10 times more likely to favor the drugs. Dr. Alistair Wood, an associate dean at Vanderbilt University and the panel's chairman reported that the FDA had not revealed the financial conflicts of the panel's participants.

In December 2005, Dr. Graham testified before Congress "that the FDA as currently configured is incapable of protecting Americans from another Vioxx... the scientific standards the FDA applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market".

" A recent internal survey of FDA scientists -- which was originally suppressed -- confirmed Graham's opinion that the FDA as currently configured is not capable of protecting Americans from another Vioxx. The survey found that 50% of the scientists felt they are not provided sufficient time to conduct in-depth, science-based reviews of drugs scheduled for release to the public. This was clearly the case with Vioxx whose clinical tests for approval were too short because its harmful effects do not appear until some 18 months after its use. More than a third of the scientists said they were not confident of the FDA's ability to assess the safety of a drug no matter how much time it had. The same survey found that 18% of agency scientists reported that they are "pressured to approve or recommend approval for a new drug application despite reservations about the safety, efficacy, or quality of the drug." And twenty-one percent felt that the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely. FDA reviewers were also skeptical of the agency's ability to regulate drugs once they are on the market.

Another key deficiency of the FDA is its abysmally inadequate monitoring and regulating of drugs and medical devices once they have been approved for sale. William Schultz, former deputy commissioner for policy at the FDA, recently wrote: "The FDA's legal authority under federal law to require companies to conduct post-market studies of approved drugs is unclear. Moreover, the agency has never been given resources that would be necessary to keep track of adverse reactions that are reported for drugs."

The numbers tell the story. According to Dr. Bruce Psaty: "In the office of new drugs, more than 1,000 employees work to review a few dozen new drugs a year. In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market." Dr. Janet Woodcock, acting deputy commissioner for operations of the FDA, told Congress recently that for years she has had to take money from travel and furniture budgets to pay for a bare-bones system to track side effects that her supervisors and Congress failed to adequately finance. Indeed, in 2000, she helped write a proposal to spend $150 million on a tracking system that never won Congressional approval.

Republican Senator Richard Burr described the FDA's monitoring system as a "1950's model for registry that we have never changed to reflect not only [what] technology can do but what physicians have time to do." Dr. Psaty added that the FDA's structure is "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a postmarketing center."

In 2004, there were 357,392 adverse drug reactions reported to the FDA which was more than double the 1995 figure and more than four times the 1990 figure. In 2002, there was one adverse drug reaction to 16,300 prescriptions. In 2003, there was one adverse drug reaction to 9,000 prescriptions. From 1994 to 2003, adverse reactions jumped 145% while prescriptions increased 59%. So the increase in number of prescriptions cannot account for the surge in adverse drug reactions. The FDA itself says there are more than 100,000 deaths annually due to adverse drug reactions and estimates that about 390,000 adverse reactions will be reported in 2005. At the same time, it cautions that the actual number is likely to be 10 to 100 times higher because of underreporting.

On top of this, 100,000 Americans die each year from hospital errors and hundreds of thousands more are injured. In addition, 90,000 Americans die each year from infections they contact while in a hospital for other problems, and an additional 1.9 million patients incur infections not resulting in death. .

"The system is broken," says Dr Wayne Ray, Professor of Preventive Medicine at Vanderbilt University in Nashville, Tennessee.

A Cure Worse Than the Disease II, by John Kelly

The American public was shocked in 1999 when the Institute of Medicine revealed that between 44,000 to 98,000 people die in U.S. hospitals each year because of preventable mistakes. The errors ranged from operating on a wrong limb to spreading infection from dirty hands. Hospital errors are the eighth leading cause of death in the U.S., claiming more lives than AIDS, automobile accidents, or breast cancer. A recent poll of some 2,000 adults found that one-third of those surveyed said either they or a family member had experienced a medical error. The poll was conducted by the Kaiser Family Foundation, the Harvard School of Public Health and the federal Agency for Healthcare Research and Quality and also found that more than half of those surveyed are dissatisfied with the quality of health care, and 92 percent said reporting of medical errors should be mandatory. Currently, such figures are not available to the public and tightly held by the medical community.

Then in 2000, the U.S. Centers for Disease Control and Prevention (CDC) revealed that 90,000 patients die each year from infections they contract while in the hospital for other health problems. Indeed, more Americans die from hospital acquired infections than from auto accidents and homicides combined. An additional 1.9 million patients get an infection that does not cause death, but depending on the type of infection, these patients spend from one to 30 extra days in the hospital getting treated.

Increasingly, the infections that spread in hospital settings are resistant to common antibiotics, and these resistant strains have begun to spread from the hospitals into communities. A 2002 Chicago Tribune investigation found that at least 200 people in Illinois died of drug-resistant infections that they contracted at home or work, infections rarely found outside of hospitals five years ago.

In 1997, doctors found the first methicillim resistant staph infection (MRSA), common in hospitals, in a patient who had not had any contact with a hospital, and the CDC has since confirmed other cases.. more recently, the CDC reported the spread of MRSA among people in competitive sports, prisoners, and others. In 2004, the leading U.S. hospital accreditation organization, Joint Commission on Accreditation of Healthcare Organizations (JCAHO) chastised hospitals for underreporting deaths due to hospital-acquired infections. Since JCAHO implemented reporting of "sentinel events" (death or serious injury) in 1996, only 10 infection-related reports had been reviewed for the entire U.S. "Numerous high profile media reports of incidences of patient death resulting from hospital-acquired infection indicate that such cases are seriously underreported to JCAHO," the organization wrote in 2003.

Reports to JCAHO are voluntary, and where hospitals do report, the information is typically held in secret. The JCAHO information is only reported to the public in aggregate form, so a patient would have no way of knowing beforehand the status of his or her hospital. The CDC launched a confidential voluntary reporting program in 1970. But by 2004, only 315 of the country's 4,900 hospitals had joined. The program gives hospitals a standardized way to measure infection rates and compare their own infection rate with the average of all the hospitals in the program. Participating hospitals together reduced their infection rates significantly in the 1990s -- proving that hospital infections can be prevented. But patients and employers cannot distinguish the best from the worst rates, and for thousands of non-participating hospitals, virtually no information exists about infections or infection control programs.

The public was again stunned a few years later when it was disclosed that Bayer's cholesterol-lowering drug, Baycol had been withdrawn because it causes a rare muscle disease that was responsible for at least 100 deaths and untold thousands of serious injuries.

But nothing prepared the American public for the bombshell dropped by Dr David Graham who testified before Congress that Merck & Co.'s Vioxx had caused 88,000 to 139,000 heart attacks and strokes and that 30 to 40 percent of these victims died. Graham, who is associate director of the FDA's Office of Drug Safety added that the cardiovascular risks of taking Vioxx were comparable to the dangers of smoking, high blood pressure, and diabetes.. A recent study published in the Archives of Internal Medicine based on data from more than 45,000 people in 19 studies found that Vioxx does raise blood pressure, and Merck itself found that Vioxx causess heart attacks. Graham said also that Vioxx should have been pulled from the market years ago, and that the FDA's handling of Vioxx had been the most distressing episode of his 20-year career and a "profound regulatory failure." "I would argue that the FDA as currently configured is incapable of protecting Americans from another Vioxx," he added. "The scientific standards the FDA applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market."

Merck & Co, which manufactures Vioxx withdrew it from the market in September 2004 after its own clinical trials showed that patients taking Vioxx were experiencing twice as many heart attacks and strokes as patients taking a placebo. But Graham as well as Stanford University COX-2 expert Gurkipal Singh and University of Washington drug safety expert Bruce M. Psaly testified that there had been studies indicating cardiovascular problems with Vioxx as far back as the 1990s which were ignored by Merck and the FDA.

In the early 1990s, Merck was facing the loss of patent protection for its top-selling drugs and was searching for a new money maker. The goal was to replace other painkillers with Vioxx, but this would be difficult if patients believed that by choosing Vioxx, they would be foregoing potential heart benefits from drugs such as aspirin. A November 21, 1996 Merck memo shows that Merck decided it needed first of all to conduct a trial showing that Vioxx was gentler on the stomach than older painkillers such as aspirin. But to do this, the patients taking Vioxx could not take aspirin. In such a trial, however, "there is a substantial chance that significantly higher rates" of cardiovascular problems would be seen in the Vioxx group, said the memo. A similar view was expressed in a February 25, 1997 e-mail by Merck official Briggs Morrison who argued that unless patients in the Vioxx group also got aspirin, "you will thrombotic events (blood clots) and kill drug." Alise Reicin, now a Merck vice president for clinical research, also noted that the "possibility of increased CV (cardiovascular) is of great concern" in such a study.

So from the very beginning, Merck knew Vioxx was a cardiovascular threat. But it was determined to get Vioxx on the market. In 1999, Merck started a 5,000-person trial called Vigor -- for the Vioxx Gastrointestinal Outcomes Research study -- to prove the drug's gastrointestinal benefits. In March 2000, the study's results showed that patients taking Vioxx suffered fewer gastrointestinal problems than those taking naproxen but significantly more blood-clot-related problems. Precisely the sort of result anticipated in the internal memos and e-mails. The heart attack rate in the Vioxx group was five times as high as the naproxen group. The difference was so high that Dr. Scolnick, the Merck research chief at the time, acknowledged that it couldn't come solely from naproxen's heart protective effect but a risk inherent in Vioxx. In a March 9, 2000 e-mail, he wrote that the cardiovascular events "are clearly there… It is a shame but it is a low incidence and it is mechanism based (in Vioxx) as we worried it was."

But in a news release that same month, Merck offered no hint of Scolnick's conclusion that the difference in rates of cardiovascular problems was inherent in Vioxx that went beyond the protective heart benefits of other painkillers. Merck said the Vigor trial results were "consistent with" naproxen's favorable effects, implying that this explained why Vioxx did not do as well. The next month Merck issued another press release entitled: "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx." While ackowledging the Vigor results, it claimed that other trials and data had shown "NO DIFFERENCE in the incidence of cardiovascular events" between Vioxx and a placebo or between Vioxx and older painkillers.

In November 2000, the Vigor results were published in an article in the New England Journal of Medicine by Merck employees and consultants. The article all but said that Vioxx was totally safe for patients with healthy hearts, but it left out vital information about other serious cardiovascular complications such as strokes or blood clots. John Abramson, a family doctor and clinical instructor at Harvard Medical School, studied the same Vigor data. He concluded that even those without a history of heart trouble, doubled their risk of developing a cardiovascular problem by taking Vioxx instead of naproxen. In February 2001, the FDA agreed with Abramson's analysis.

FDA officials wanted to highlight the cardiovascular risk prominently on Vioxx's label but caved in to Merck's demands. The new label released in April 2002 listed the good news about fewer upset stomachs first. Then it added two unclear tables about heart attacks and strokes. Even after Dr. David Graham presented his findings in August 2004 showing that Vioxx correlated with a tripled risk of heart attack or sudden cardiac death, Merck stuck to the line it had kept since 2000. It issued a press release entitled: "Merck stands behind the efficacy, overall safety and cardiovascular safety of Vioxx," and "strongly disagreed" with Graham's conclusions, dismissing them as a retrospective analysis.

Meanwhile, Merck was conducting a massive advertising campaign and bashing at any and all critics. In one Merck-sponsored presentation, a doctor stated that the Vigor trial showed that naproxen was "a wonderful drug" for reducing the risk of heart problems, not that there was anything wrong with Vioxx. Such statements, the FDA told Merck in a September 17, 2001 letter, "minimized the potentially serious cardiovascular findings" of Vigor. But Merck was undeterred by the FDA and lashed out at researchers critical of Vioxx. Gurkirpal Singh of Stanford University, who gave lectures sponsored by Merck, pressed Merck repeatedly for more cardiovascular safety data on Vioxx. When Merck refused, Dr. Singh added a slide to his presentation that showed a man -- representing the missing data-- hiding under a blanket. Merck immediately cancelled all their sponsorship. In October 2000, a Merck official, Louis Sherwood, called James Fries, a Stanford medical professor, to complain that Singh's lectures were "irresponsibly anti-Merck and specifically anti-Vioxx." According to Fries, Sherwood further "suggested that if this continued, Dr. Singh would 'flame out' and there would be consequences for myself and for Stanford." Fries also reported that researchers at several other top medical schools complained about "a consistent pattern of intimidation of investigators by Merck" on Vioxx.

Dr. Lee Simon, a rheumatologist at Beth Israel Deaconess Medical Center in Boston who had worked with Merck, said that when he publicly mentioned that Vioxx might be associated with high blood pressure and swelling, Sherwood called him and one of his superiors at the hospital to complain that Dr. Simon's lectures were slanted against Vioxx. "I was shocked that there was a phone call like that. The company was attempting to suppress a discussion about this data."

M. Thomas Stillman, a professor at the University of Minnesota, also got a call from Sherwood after lecturing about the risks of high blood pressure and swelling from Vioxx. "We had a very direct conversation," said Stillman, "that I wouldn't call friendly. It had a tone to me of, 'You better be careful of what you're saying.' I thought that was inappropriate." His contract with Merck ended right after the phone call.

In August 2001, researchers at the Cleveland Clinic published an article in th e Journal of the American Medical Association about the cardiovascular risks of Vioxx. Before the article was published, Merck's Alise Reicin and other officials contacted the authors, arguing that "they didn't think there was a problem with the drug," according to Steven Nissen, one of the authors. Merck also asked the journal to run a rebuttal which it refused.

In the summer of 2002, Merck officials sent a "rectification" for Dr. Joan-Ramon Laporte to publish regarding an article he edited criticizing Merck's handling of Vioxx. He refused, and after Merck approached him twice more, it filed suit in a Spanish court against Laporte and his institute, Catalan Institute of Pharmacology, which had published the article. In January 2004, a judge ruled that Laporte's publication accurately reflected the debate about the cardiovascular risks of Vioxx and ordered Merck to pay all court costs.

In March 2004, Laporte was scheduled to be the featured speaker at an annual update on the pharmaceutical world for some 1,000 Spanish physicians. Merck had helped pay for the meeting for the previous eight years. It contacted the organizer, Dr. Ramon Morera Castell, and told him that the company "preferred" that Laporte was taken off the program. After Morera refused, Merck withdrew its financing of $140,000. Though there was any specific threat, "the message was clear," says Dr. Morera.

Britain was the first country outside the United States to approve the sale of Vioxx in 1999 leading to some 10 million prescriptions and 400,000 patients. Initial estimates were that there were 7,150 adverse reactions and some 2,000 deaths caused by Vioxx in Britain. But British safety expert Professor Andrew Herxheimer of the UK Cochrane Center in Oxford says the numbers are much higher because of underreporting under Britain's "yellow card" system. Under this system, doctors are supposed to report adverse reactions and deaths to the Medicines and Healthcare Products Regulatory Agency. One survey found that only 16% of doctors had ever sent a yellow card, and another found that 80% of the reports were filed by 7% of doctors. Herxheimer believes only 5% of medical problems are reported under the yellow card system.

"In a huge number of cases, the benefits of these new drugs just wasn't worth the risk," says Herxheimer. "People say time is a great healer, but you never get over it," said Maureen Watt, of Bargoed, South Wales, whose husband, Alexander, died of a heart attack at the age of 58 while taking Vioxx. "In my heart I know that tablet killed him." The European Drug Safety Agency is conducting an urgent safety review of all COX-2 inhibitors, which have a combined global sale of $10 billion. Last month, the UK Medicines and Health Care Products Regulatory Agency advised all patients still taking Vioxx.

Lawsuits have been filed against Merck in Britain under the Consumer Protection Act which covers injuries caused by defective products. Manufacturers of defective products have a defense if they can show they could not have known about the fault. But a February report in the Lancet showed that Merck knew as early as 2000 that Vioxx was causing thousands of heart attacks and strokes. "Prior to approval of Vioxx, a study was performed by Merck [which] found nearly a 7-fold increase in heart attack risk with low doses of Vioxx," wrote Dr. David Graham. Merck and FDA acted out of "ruthless, short-sighted and irresponsible self-interest," added Lancet editor Dr. Richard Horton in the same issue. Horton also revealed that the FDA had done everything possible to try to prevent publication of Graham's article.

It was also revealed that Iressa which is manufactured by Britain's AstraZeneca and had been rapidly approved by the FDA for lung cancer had failed to prolong lives in a large clinical trial. Iressa was approved in May 2003 based on small clinical trials without placebo controls that showed it shrunk tumors in about 10 percent of patients. AstraZeneca then did a follow-up study to see if it prolonged lives, a more meaningful measure than tumor shrinkage. In December 2004, it was disclosed that Iressa did not prolong life anymore than a placebo.

Public Citizen, a U.S. consumer group, has filed a petition calling for the removal of Iressa from the market. "If this drug is not taken off the market on these ground, it will make an absolute mockery of the FDA's accelerated approval program," said Dr. Peter Lurie, the group's deputy director for health research. Under the accelerated approval program, drugs are approved on the basis of preliminary data for serious and life-threatening diseases. The drugs are then supposed to be subject to further studies to confirm that they provide a meaningful benefit.

But in many cases such studies are not done. Professor of Medicine, Charles Bennett of Northwestern University reports that follow-up studies had been done in only 9 out of 26 accelerated approvals for cancer drugs, and there were eight examples of serious side effects discovered after the drugs were on the market. For example, Tsabri, a drug for multiple sclerosis, caused rare brain infections in two patients, one of whom died, only weeks after it had been placed on the market

While expressing skepticism, the FDA allowed Iressa to continue on the market at least until June, 2005. Dr. Otis W. Brawley, a member of the FDA panel reviewing the drug, said that perhaps the drug should not have been approved until it was better understood who could benefit. "The development of this drug has been mishandled," he said. "It's been mishandled by AstraZeneca. It's been mishandled by this committee."

Public Citizen has also petitioned the FDA to ban another drug manufactured by AstraZeneca, Crestor, the popular new cholesterol-lowering drug. According to Dr. Sidney Wolfe, within months of it coming on the market in September 2003, Crestor was linked to 117 cases of muscle damage known as rhabdomyolysis, 41 of which resulted in fatal kidney failure. Overall, the rate of serious muscle damage from Crestor was six times higher than with similar medicines. The FDA has refused to ban Crestor which has failed to receive approval for sale in Germany, Norway, and Spain. Wolfe called the FDA's decision "yet another example of the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs."

Adderal, another British-manufactured drug, also caused deaths within months of its approval for marketing. Made by the Shire Pharmaceutical Group as a hyperactivity drug, it was found to cause 20 sudden deaths, including 12 children. The FDA has taken no action. Worse, before Canada suspended Adderal, the FDA asked it not to do so because it could not handle another "drug safety crisis," according to Republican Senator Charles Grassley, chairman of the Senate Finance Committee.More than 700,000 Americans use Adderal and its extended release counterpart Adderal XR, and Shire sold $759 million of Adderal products in the U.S. in 2004 and $10 million in Canada. Senator Grassley wrote to the FDA that reports given to his staff suggested that the FDA was not acting with scientific integrity. "Unfortunately, such allegations raise additional concerns about the culture at the FDA."

When Vioxx was pulled off the market, sales of Germany's Boehringer Ingelheim's Mobic went up 177% with sales of more than $1 billion in 2004, up from $593 million in 2003. At the same time, Mobic's price shot up 77 percent since 2002 for its 15 milligram pill to $4.61 and 38 percent for its 7.5 pill to $3.26. At the same time, Mobic was revealed as a greater risk of heart attacks than either Vioxx or Celebrex in a huge study by David Graham and other scientists outside the FDA. They analyzed data culled from California's Medicaid program of more than 15,000 heart attack patients, making it the largest study to date of such risks. They found the statistical risk of heart attack was 137% for Mobic, compared to 132% for Vioxx and 109% for Celebrex.

"We found an increased risk," said Graham. "Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx, and any possible heart attack risk is important as more patients take the drug." Dr. Sidney Wolfe, director of the Health Research Group in Washington, D.C. has reported that Mobic is no more effective than older non-steroidal anti-inflammatory drugs that are "much less expensive." "The most generous thing I can say is that this is exploitation of thepublic," Wolfe added.

In December 2004, federal researchers suspended a study of Aleve on 2,500 patients because it produced a 50% increase in heart attacks or strokes among patients taking Aleve compared with those taking placebos. For Germany's Bayer, the warnings about Aleve came just as it was putting the shadow of Baycol behind it. In 2001, Bayer had to pull Baycol, its cholesterol-lowering drug, from the market after it had been linked to 100 deaths worldwide. Since that recall, Bayer has been fighting lawsuits. It has settled 2,895 such suits with 7,169 still pending.

Vioxx is a member of a class of drugs known as COX-2 inhibitors which ease swelling and pain by reducing the COX-2 enzymes normally found in inflamed areas of the body. Merck & claims that all COX-2 inhibitors, such as Vioxx and Pfizer's Inc.'s Celebrex and Bextra increase cardiovascular problems in patients. Studies "strongly suggest" that the entire class of COX-2 elevates the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories, recently told a panel of FDA advisers. A recent study in the Archives of Internal Medicine reported further that COX-2 drugs have been prescribed primarily to patients who do not need them. According to researchers at the University of Chicago and Stanford University, almost two-thirds of the COX-2 drugs prescribed from 1999 to 2002 went to patients with a low or very low risk of gastrointestinal complications. COX-2 drugs were initially intended for a small minority of patients at real risk of fatal gastrointestinal effects. Yet, the growth of COX-2 use over time was primarily among patients least likely to benefit.

There were 357,392 adverse drug reactions reported to the FDA which was more than double the 1995 figure and more than four times the 1990 figure. In 2002, there was one adverse drug reaction to 16,300 prescriptions. In 2003, there was one adverse drug reaction to 9,000 prescriptions. From 1994 to 2003, adverse reactions jumped 145% while prescriptions increased 59%. So the increase in number of prescriptions cannot account for the surge in adverse drug reactions. The FDA itself says there are more than 100,000 deaths annually due to adverse drug reactions and estimated that about 390,000 adverse reactions would be reported in 2005. At the same time, it cautions that the actual number would be likely to be 10 to 100 times higher because of underreporting.

"We launch into overuse of these drugs when we don't know their effects," says Dr. Brian Strom, University of Pennsylvania public health and preventive medicine professor "We're the guinea pigs in the sense of extensive population exposure," said Dr Marcus Reideng, professor of pharmacology, medicine and public health at Cornell University Medical School in NYC "If you don't want to be a guinea pig, don't take them for the first couple of years after they've been approved. It's a common teaching in clinical pharmacology that it's never good to be the first person to use a new drug," Sean Hennessey, University of Pennsylvania professor of pharmacology and epidemiology.

By 2001, Vioxx was the number one prescription drug problem in the FDA's adverse effects reporting system but no action was taken, which underscores the inadequacy of the FDA's control and response after a drug is marketed. Maintaining drug safety while approving more drugs, according to FDA's Steve Galson, "means that we have to have a robust post-approval program" to detect problems once drugs are on the market. "That's not what the FDA has. The system is broken," says Dr Wayne Ray, professor of preventive medicine at Vanderbilt U in Nashville.

A recent internal survey of FDA scientists found that more than 66 % lacked confidence in the FDA's ability to monitor drugs once they are marketed. Another such survey -- which was originally suppressed -- confirmed Graham's opinion that the FDA as currently configured is not capable of protecting Americans from another Vioxx. The survey found that 50% of the scientists felt they are not provided sufficient time to conduct in-depth, science-based reviews of drugs scheduled for release to the public. This was clearly the case with Vioxx whose clinical tests for approval were too short because its harmful effects do not appear until some 18 months after its use. More than a third of the scientists said they were not confident of the FDA's ability to assess the safety of a drug no matter how much time it had. The same survey found that 18% of agency scientists reported that they are "pressured to approve or recommend approval for a new drug application despite reservations about the safety, efficacy, or quality of the drug." And twenty-one percent felt that the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely. FDA reviewers were also skeptical of the agency's ability to regulate drugs once they are on the market, FDA director Steven K. Galston has acknowledged problems but described them as much more limited. Yet, the FDA has requested the Institute of Medicine to investigate its system for assessing drug safety.

The man who ran the FDA during this time period, Lester M. Crawford, was named FDA Commissioner in 2005. The Biotechnology Industry Organization (BIO) warmly welcomed Crawford's appointment saying he has done a "remarkable job" as acting commissioner. "This nomination seems the right signal to patients and consumers, that there will be vision and leadership in the agency," added the BIO.

In 1999, Merck's Vioxx was beaten to the market by Pfizer's Celebrex, so Merck set out to "neutralize" its opposition and buy up doctors to support Vioxx according to internal, confidential Merck documents, e-mails, memoranda, and spreadsheets.. That year, a Merck executive took Dr. Roy Altman, a nationally-known rheumatologist, to dinner in Miami and asked him what it would take to win his support for Vioxx. "Show me the money," said Altman according to a Merck memo of the meeting. Specifically, $25,000 for a clinical trial of Vioxx which Merck provided.

In the "neutralize" documents, written by a Merck marketing executive, company officials identified dozens of influential but "problem" physicians whom Meck believed had either a negative view of Merck or Vioxx or were active boosters of Celebrex. So Merck set out to offer them funding for clinical trials, consultantships, and grants. "Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics," the marketing official wrote in an e-mail. And a standardized form requesting payments to doctors read "Expected Outcome/Return on Investment."

One physician on the list was Dr. Robert Ettlinger, a rheumatologist in Tacoma, Washington. A Merck document recommended that Dr. Ettinger be giving more paid speeches, be invited to more meetings and be asked to do more drug trials. "He is participating in a number of clinical trials," the Merck memo notes. "Keep him busy." In bold letters beneath his name was the word "neutralized."

Another physician on the list was rheumatologist Dr. Max Hamburger of Melville, New York. He headed a large consortium of doctors in New York who, by the time Vioxx went on the market, were "high-volume prescribers and huge adopters of Celebrex." At the time, Dr. Hamburger was approaching drug companies to subsidize retreats for his group during which the physicians would put together guidelines on what drugs to prescribe. "Companies that provide funding will receive preferred status with its members and those that do not will have trouble accessing" the group, a Merck memo stated. "Price tag is $25,000." On the "neutralize" list, Dr. Hamburger was described as having been "turned around," and the word "advocate" appears.

In 1999, Merck also gave $25,000 to the West Coast Sports Medicine Foundation to "be competitive with Searle (which manufactured Celebrex at the time)." In a form requesting the payment, the Merck representative listed the "Expected Outcome/Return on Investment" as "51 percent share of the COX-2 market in 2000." Merck also attempted to counter moves by Pfizer and monitored its competitors' activities, regularly compiling digests of instances in which physicians speaking on behalf of Celebrex made statements it viewed as misleading or false. Many of those internal complaints claimed that some researchers were inflating Celebrx's benefits while exaggerating Vioxx's side effects.

The Merck documents also show that it hid or denied evidence for years that Vioxx caused heart attacks. E-mails show that Merck officials clearly knew about the risks of heart attacks and strokes. A March 9, 2000 e-mail from Merck research director Edward Scolnick to colleagues conceded an elevated risk of heart attack and stroke was "clearly there." However, Merck continued to try to discredit academic researchers critical of Vioxx. One training document from Merck listed potentially difficult questions about Vioxx and stated in capital letters, "DODGE!"

Graham also named four other FDA-approved drugs which should be withdrawn from the market or more sharply restricted because of dangerous side effects. These are: Astra- Zeneca's Crestor which poses risks of kidney failure and a rare muscle disease; Abbott Laboratories' Meridia which is of little use and causes cardiovascular side effects; Roche's Accutane which can cause birth defects if used by pregnant women; Pfizer's Bextra which carries cardiovascular risks similar to Vioxx; and, GlaxoSmithKline's Servent which increases the risk of dying of asthma.

Another key deficiency of the FDA is its abysmally-inadequate monitoring and regulating of drugs and medical devices once they have been approved for sale. William Schultz, former deputy commissioner for policy at the FDA, recently wrote: "The FDA's legal authority under federal law to require companies to conduct post-market studies of approved drugs is unclear. Moreover, the agency has never been given resources that would be necessary to keep track of adverse reactions that are reported for drugs."

The numbers tell the story. According to Dr. Bruce Psaty: "In the office of new drugs, more than 1,000 employees work to review a few dozen new drugs a year. In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market." Dr. Janet Woodcock, acting deputy commissioner for operations of the FDA, told Congress recently that for years she has had to take money from travel and furniture budgets to pay for a bare-bones system to track side effects that her supervisors and Congress failed to adequately finance. Indeed, in 2000, she helped write a proposal to spend $150 million on a tracking system that never won Congressional approval.

Republican Senator Richard Burr described the FDA's monitoring system as a "1950's model for registry that we have never changed to reflect not only technology can do but what physicians have time to do." Dr. Psaty added that the FDA's structure is "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a postmarketing center."

Graham's contention that the FDA is incapable of protecting the American public has now been confirmed in spades. Incredibly, an FDA advisory panel has now recommended that Vioxx be returned to the marketplace, and that Pfizer be allowed to continue selling Celebrex and Bextra. This despite the fact that Merck itself withdrew Vioxx and had admitted that there are alternatives with fewer safety concerns. Merck officials had even testified before the panel that all COX-2 drugs such as Vioxx, Celebrex, and Bextra increase cardiovascular problems in patients, and the panel agreed unanimously that all COX-2 inhibitor drugs "significantly increase" the risk of heart attacks and strokes. As chairman Alastair Wood stated before the vote: "We've seen four, maybe five studies that showed a significant cardiovascular hazard" for this class of drugs. "It's important to recognize this is a far larger safety signal than seen for other withdrawn drugs." Earlier Wood had stated that, "The data are very compelling, Vioxx is substantially worse than the others, and I can't see any reason to keep it on the market."

"This news is not good news," said Dr. Mark Frederick, professor of internal medicine at the University of Michigan School of Medicine. "COX-2 users who started to scrutinize this class of drugs after September 30, 2004 (when Merck withdrewn Vioxx) should under no means flock back to them."

"There's politics mixed with science mixed with consumer demand," added Dr. Jason Theodosakis, assistant professor at the University of Arizona College of Medicine and author of The Arthritis Cure. "These drugs should be used as the last line of therapy in the treatment of osteoarthritis, and people want to use them as the first line." Theosakis also pointed out that there is increasing evidence of cartilage loss with these drugs. "If this is true," he said, "this is like cholesterol-lowering drugs causing more heart attacks or birth control pills raising fertility." He feel that placing black warnings on the labels serve no purpose. "The checks and balances they feel are already taken care of because the FDA has allowed it to be on the market."

Celebrex was approved even though a large study published in the New England Journal of Medicine only two days before the panel's hearings, using data from Pfizer itself, revealed that patients taking Celebrex had more than three times as many heart attacks as those given a placebo. Researchers found that patients taking 400 milligrams of Celebrex were 2.5 times as likely to have a heart attack or stroke as the group taking a placebo. For patients taking 800 milligrams a day, the risk was 3.4 times as great or 340%.

A January 2004 study published in Circulation, also based on Pfizer's own data, reported that patients who had had heart bypass surgery and were taking Pfizer's Bextra and another experimental COX-2 inhibitor were three times more likely to have strokes and heart attacks than patients taking a placebo. A second study found that when mice that are genetically prone to hardening of the arteries were treated with COX-2 drugs and an aspirin substitute, their condition worsened rather than improving, as researchers had anticipated. In the mice study, it was found that deposits of artery-blocking plaque in mice became dangerously unstable after they were given a COX-2 drug, "We were amazed," said researcher Karine Egan of the University of Pennsylvania, "Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, make it more likely to rupture and activate clotting, causing heart attack and stroke."

Lead researcher Garret A, Fitzgerald of the University of Pennsylvania said the two studies led him to conclude that the entire class of COX-2 drugs poses serious risks. Fitzgerald also said that an upcoming clinical trial proposed by Pfizer to test whether Celebrex may help patients with heart disease should not go forward. "The clear emergence of a cardiovascular hazard from COX-2 inhibitors in patients," Fitzgerald told the Washington Post (18Jan05), "the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex, is, at best, ill-advised."

In a letter to the New England Journal of Medicine, three researchers recommended that doctors stop prescribing Bextra. "We believe the doubts raised about the safety of [Bextra] constitute a potential imminent hazard to public health and thus require action," wrote the three Vanderbilt University School of Medicine researchers. The FDA required an urgent "black box" warning on the Bextra label, but the researchers said this was not enough.

At the hearings of the FDA's advisory panel in February 2005, Dr. Graham testified that "There really doesn't appear to be a need for COX-2 drugs," Graham also challenged claims made by Merck both before and after the company pulled Vioxx. A study concluded that patients were far more likely to suffer from heart problems if they used Vioxx instead of naproxen, a drug sold as Aleve. Yet Merck attributed the difference not to heart ailments caused by Vioxx but instead to cardiac protection offered by naproxen. "None of them provides credible evidence of a protective effect. Naproxen is not cardio-protective," said Graham

Graham added that: "50 % of our (cardiac) cases occurred within two to three months of starting the drug (Vioxx). Nobody in our study was on it for more than 15 months." Vioxx, he said, increased the risk of heart attacks which occur in one of every 50 older males by five times and, therefore, put a huge number of people in danger. There is "no comparison" between the problems caused by previously withdrawn drugs and those triggered by Vioxx.

Both Merck and Pfizer had taken advantage of the FDA's "fast-track" approval process when rushing their drugs onto the market. This approval process is supposed to be only for drugs to treat life-threatening diseases. Graham said long-term studies are few . "I think that they are incredibly expensive. Companies don't want to do them: there's not an incentive to do them. [And] the fact is, they're not requiring them."

One panel member asked a Pfizer researcher if she would take Bextra. Dr, Karen Seibert declined to answer. Dr. Vibeke Strand, an arthritis specialist from Stanford who consults for Pfizer then stepped to the microphone. "Would I recommend that a patient with high cardiovascular risk take these products?," she asked. "I think the answer would be no." Pfizer insisted it had no evidence that Celebrex or Bextra caused heart problems.

Pfizer has since disclosed that it had, at the time of those statements, studies showing heart problems among patients taking Celebrex or Bexta. In December 2004, the NIH announced that a very large trial had found that Celebrex more than tripled the risk of heart problems.

Dr Ned Braunstein, senior director at Merck research labs, said cardiovascular risks seen in Vioxx are shared by "other drugs in the class." These include Celebrex, Bextra, Prexige, made by Novartis, and Arcoxia, an experimental drug from Merck which is trying to obtain FDA approval.

Dr. Kenneth Verburg, a vice-president at Pfizer , gave a lengthy presentation about the safety of Celebrx and Bextra. Dr. Curt Furberg responded: "I'm troubled by some inconsistencies that I have found in the briefing document from Pfizer." Furberg suggested that all of Pfizer's mistakes seemed to benefit the company. "So I wonder how much trust can we put in these presentations." Pfizer said it would check its numbers.

Dr Alistair Wood of Vanderbilt University, chairman of the panel, criticized Verburg's talk for its exclusion of the results of some trials that found increased risk of heart problems for Celebrex. Wood added that Pfizer's presentation did not "pass the laugh test." Dr. Byron Cryer of the University of Texas Southwestern Medical Center, described part of the Pfizer presentation as "misleading." Verburg responded: "Point taken."

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, dismissed Pfizer's explanation that Celebrex appeared to cause more cardiovacular problems than naproxen because naproxen prevents heart attacks. He noted that aspirin reduced the risk of heart attacks by about 20%, a fraction of the suggested protection of naproxen. "Naproxen would have to be far better than aspirin" at preventing heart problems for this explanation to make sense, Nissen said. "This story about naproxen doesn't stand up to any kind of scientific rigor."

Dr. Garret Fitzgerald said all drugs in the COX-2 class caused heart problems ."It seems to me most rational people would accept a class-based mechanism, as they did for efficacy." Two speakers presented data showing that Celebrex, known generically as celecoxib, was no better at inhibiting the COX-2 enzyme than diclofenac, also known as Voitaren, and might even be slightly worst.. Diclofenac is now sold as a generic drug for pennies a pill, and is one of the most widely used pain medications in the world. Celebrex can often cost $3 a pill.

Many Vioxx users have switched to Celebrex which Pfizer aggressively advertised as not posing the same risks as Vioxx. Celebrex has been one of Pfizer's biggest moneymakers, bringing in $1.9 billion in sales in 2004. At the advisory board hearings, Pfizer officials did not mention their own findings. Rather they all but denied that Celebrex increased the risk of heart attacks and strokes and suggested that the evidence linking Bextra to such risks was shaky and irrelevant.

Celebrex was originally touted as an alternative to other pain killed which cause ulcers and other gastric problems. In the summer of 2000, Pharmacia (which then made Celebrex) researchers sent the Journal of the American Medical Association data from a six-month study of more than 8,000 patients showing that Celebrex caused a much lower rate of stomach and intestinal ulcers than two older arthritic medicines , diclofenac and ibupropen. The journal published the findings, and Dr M. Michael Wolfe and a colleague wrote an accompanying editorial favorable about Celebrex.

In February 2001, Wolfe was given the complete data from the study. "We were flabbergasted," said Wolfe. It turned out that the study had lasted a year, But Pharmacia researchers had reported only the first six months' data which were favorable to Celebrex. During the second six months of the study, almost all of the patients who developed ulcer complications were Celebrex users, and when all of the data were considered, Celebrex's safety advantages disappeared.

"I am furious, I wrote the editorial. I looked like a fool," said Wolfe, a Boston University gastroenterologist. "But all I had available to me was the data presented in the article." JAMA's editor, Catherine D. DeAngelis, said the journal's editors also were not told about the missing data. "I am disheartened to hear that they had those data at the time that they submitted the manuscript to us, " she said. "We are functioning on a level of trust that was, perhaps, broken."

After reviewing the full study, the FDA's arthritis advisory committee concluded that Celebrex offers no proven safety advantage over older drugs in reducing the risk of ulcer complications. Meanwhile the JAMA article and editorial contributed to Celebrex's sudden, huge increase in sales. "When the JAMA article comes out and confirms the hype, that probably has more impact than our labeling does," admitted Robert J. Temple, then-director of medical policy at the FDA's Center for Drug Evaluation and Research

After the February 2005 advisory panel's decisions, Merck shares surged $3.76, or 13 percent., to close at $32.61 on the New York stock Exchange, and Pfizer shares gained $1.74, or 6.9 percent, to finish at $26.80. The panel's decision was also a boon to Merck which is facing hundreds of lawsuits from patients and their survivors.

The panel recommended that strict warnings be placed on the drugs, but with little ability on the part of the FDA to control drugs once they are marketed, these warnings can be meaningless especially with intense advertising and publicizing of the panel's decisions. The panel also concluded that drug makers wishing to market future pain pills should compare their experimental drugs with it in trials, including at least 10,000 patients over two years. Only then would the drugs be proved to be safe, they said. There is no reason to believe drug makers will ever conduct such trials. On top of this, the FDA still cannot conduct independent clinical trials, nor can it demand that companies do so. Yet without such trials the FDA will not have better information about drugs than it does now, even if it has better ways to publish its data.

Dr John Jenkins, director of the FDA's Office of New Drugs, said that if Merck & Co. wants to reintroduce Vioxx, "we'll welcome them to come talk to us about the various paths forward." It was revealed afterwards that ten of the 32 panel members who endorsed continued marketing of Vioxx, Celebrex, and Bextra have served as consultants for Merck and Pfizer. If the 10 advisers had not voted, the panel would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The ten advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return. Of the 30 votes cast by the ten advisers on whether Celebrex, Bextra, and Vioxx should continue to be marketed, 28 favored the drugs. Overall, the advisors with financial ties to the drug companies were 10 times more likely to favor the drugs. Dr. Alistair Wood, an associate dean at Vanderbilt University and the panel's chairman reported that the FDA had not revealed the financial conflicts of the panel's participants.

Panel member Dr. Curt Furberg, an epidemiologist at Wake Forest University, who has no ties to the drug companies, said he was "uncomfortable with the Pfizer-friendly undertone" and the meetings and felt that Pfizer may have played a role in setting that tone. He added that clinicians often wanted access to therapies without understanding the devastating public health consequences of their prescribing decisions. Furthermore, Celebrex, Bextra, and Vioxx have never been proven in clinical trials to cure pain any better than ibupropen or more than a dozen other, other pain pills. "Fifty patients a day probably die from those drugs, and who is speaking for them?," Dr. Furberg summed up. "There is a sense that things are broken," said

Bruce Psaty, a physician-researcher at the University of Washington and co-author of an editorial criticizing the FDA and drug makers in the latest New England Journal of Medicine. "There's been a studied inattention to safety during the last decade."

"The FDA dangerously fell down on the job," said Sidney Wolfe who also faulted Pfizer for not disclosing negative results from a study until recently. "The whole system needs to be looked at," said Sheldon Krimsky, a Tufts University professor whose book, "Science in the Private Interest" documents conflicts of interest between regulators and pharmaceutical representatives. "Until we have a firewall between the manufacturers of drugs and the people who test them, we're going to continue to see these problems, regardless of putting more people in the FDA or trying to be more transparent."

"Physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured," wrote Psaty and Wake Forest University physician-researcher Curt Furberg in the New England Journal of Medicine. "Indeed, the integrity of the American drug-safety system has been questioned."

"No drug is ever brought to market without being an experiment on the public," said Krimsky of Tufts. "The real issue is that we have to pay more attention to adverse events. We have to be serious about looking hard for them."


The CIA, the Irradiation of Brains and the Dirty Bomb - a History Lesson - by John Kelly

       "Did CIA Consider Developing Radiological Weapons of Mass Destruction?    
      "Yes. One of CIA's early missions was to create secret paramilitary forces that could harass the rear of a Soviet advance into Western Europe ..."
      "Did CIA Analysts believe the Soviets would wage radiological warfare?"
                - CIA Officer Michael Warner Memorandum for the Record, February 14, 1995

On April 10, 1953, CIA Director Allen Dulles told a Princeton alumni audience that the Soviet Union was conducting "brain warfare" of the most devious kind. "The Soviets," said Dulles, "are now using brain-perversion techniques as one of their main weapons in prosecuting the Cold War. Some of these techniques are so subtle and so abhorrent to o

Usually when Dulles accused the Soviets of conducting an operation or program, the CIA was doing the same, or worse. Brain warfare was no exception. In this case, the Soviets were not researching brain warfare or radiation warfare, and some twenty years later, then-CIA Director Stansfield Turner described the CIA's program as "abhorrent."

Around the time of Dulles' speech, a CIA researcher was recommending the use of radioisotopes to identify a drug which would produce a "chemical lobotomy": "A non-toxic drug may be found, by radioactive tracer techniques, that will be attracted to such an area (of the brain), and so produce a taming that can last for some time." The same researcher proposed studying the amygdaloid nucleus of the brain for control and manipulation purposes wrote the researcher, by a current passed brain by operation."At present," wrote the researcher, "this brain center can be stimulated by a current passed through wires inserted through the brain by operation. "Such a procedure is obviously useless to this project; but ultrasonics or other means of radiant energy may yet be improved or modified so that a cross-fire'(with X-rays) arrangement could be focussed on a selected small region in the brain without affecting the surrounding areas. "The Amygdaloid nucleus is interesting because it has been stimulated in humans (as in first paragraph above); producing fear or anger. Monkeys' amygdaloids have been removed, producing tameness. "Temporary inhibition of this region (possibly of others) should tame humans."

Elsewhere, under the heading of "Radiant Energy," the researcher wrote that: "It is also possible that some newer field of radiant energy, some atomic particles, could be aimed at sleep centers in the brain, or at brain centers that inhibit the waking state. Sudden sleeping might be produced in this way, with an unwitting subject if the apparatus were worked from the other room. "This reporter admits that he has not found a hypothetical 'sleep ray' in the literature. He believes it either is, or will be, there. It would be so valuable that more searching is highly recommended. Certainly there are sleep centers in the brain."

At this time, the late Dr. Charles Geschickter, in conjunction with the National Institutes of Health, was exposing monkeys to radiation in the form of radar, for the CIA, which was looking for a technique to secretly render someone unconscious. Geschickter late testified that "if you got into too deep a sleep, you injured the heat center of the brain the way you cook meat, and there was a borderline there that made it dangerous." Geschickter also experimented on patients at the Georgeton University Medical Center which he had turned into a "hospital safehouse," according to the CIA.

CIA officers also met at this time with the late Dr. Webb Haymaker of the Armed Forces Institute of Pathology concerning the use of radiation to affect "emotional centers in the brain or elsewhere in the neryous system." It is not known what came of this meeting, but Haymaker went on to pioneer the use of Boron Neutron Capture Therapy wherein a beam of neutrons are shot at the brain where they are captured by the boron resulting in a tiny atomic explosion. The theory was that this explosion would only destroy tumors where the boron concentrated. However, the vast majority of patients had their brains fried, like Geschickter's monkeys, and died shortly thereafter. Haymaker, who co-authored a book with the notorious Nazi scientist, Hubertus Strughold, also conducted human radiation experients. In one such experiment, a 43-year-old comatose man received eight injections to the brain of radioactive tritiated thymidine over a six month period with the last injection being given four hours before he died. Obviously, there was no informed consent nor was there any benefit to the patient or future patients.

Actually, three years before Dulles' speech, the CIA proposed the use of a radiological weapon known as "The Thing.." In January 1950, Boris T. Pash proposed "the formulation of doctrine and policy, the evolving of operational techniques, the making of plans, and the preparation of projects for the conduct of Biological, Chemical and Radiological operations" with the following objectives.

  1. Selecting the targets and establishing their priority.
  2. Determining suitable agents and methods operationally feasible for use against the selected targets.
  3. Compiling of data pertinent to the development execution of projects relating to these targets.
  4. With the assistance of established channels, developing sources and maintaining liaison with agencies, installations, and/or specialists possessing the specific knowledge, data, or materials necessary for the effective planning of BC & R operations.

Pash was a man of action who usually got what he wanted. He would not have hesitated to use radiological weapons. During World War II, he was the chief counterintelligence officer on the Manhattan Project which built the first atomic bomb. Also during the war, he directed the Alsos Mission which captured Nazi radiation and chemical warfare scientists. In addition, Pash's forces seized more than 70,000 tons of uranium ore and radium products. The radium was eventually used in making U.S. atomic weapons.

After the war, Pash served as the Army's representative for Operation Bloodstone which recruited rightwing emigres and Nazi collaborators for use by the CIA which was represented on the Bloodstone team by John S. Earman, Jr. According to Pentagon documents, Operation Bloodstone's "special operations ... include clandestine warfare, subversion, sabotage and assassination."

In March 1949, Pash was assigned by the Army to the OPC division of the CIA where he headed a five-member unit known as PB/7. According to its written charter, "PB/7 will be responsible for assassinations, kidnapping, and such other functions as from time to time may be given it ... by higher authority."

In 1949, a CIA proposal for assassination weapons included the use of X-rays. "Another possibility," stated the proposal, "would be the exposure of the entire individual to X-ray. When the whole body is exposed, a relatively small amount of radiation is sufficient to produce effects that would lead to death within a few weeks, and it is highly probable that sporadic deaths of this kind would be considered as due to blood dyscrysias. As little as 800 r. could do it."

In 1976, the Church Committee reported that Pash had been specifically delegated responsibility for planning the agency's assassinations, kidnappings, and similar "wet work. Obviously, Colonel Pash would not have winced a the idea of zapping someone with a radiation ray gun out of Darth Vader.

Pash worked with the "Father of Dirty Tricks," Frank Wisner, then assistant director of the CIA's Office of Policy Coordination (OPC). A few months after Pash's proposal, Wisner wrote that the "OPC is at present engaged in covert unconventional activity on a limited scale," and for that reason "wanted to make use of the latest scientific and technological advances to modernize the field of clandestine unconventional warfare ... We are particularly interested in the possibilities of BW, CW and RW (biological, chemical, and radiological warfare)," including the application of "nuclear energy."

"These proposals moved a step closer to implementation," according to a CIA memo, "when CIA officials subsequently tried to interest the military and the Atomic Energy Commission (AEC) in developing nuclear and radiation weapons suitable for use by guerrillas or saboteurs."

While the Pentagon was not interested, the AEC was. So,"[I]n October 1951, Acting DCI Allen Dulles asked AEC Chairman Gordon Dean to meet with Joseph Frank about the feasibility of 'research, development or adaptation of atomic weapons and radiological warfare materials that would be suitable and appropriate for employment by clandestine means.'"

Dean met with Frank, and in March 1952, the AEC told Frank Wisner that a nuclear weapon could be built to CIA specifications but at "appalling costs and only with the approval of higher authority. CIA Director Walter B. Smith promised Wisner that he would consider raising the matterat the proper levels if he specified "in the clearest and most convincing terms the strategic or tactical value of our proposed use of The Thing."

The CIA claims that nothing came of these proposals. But,in 1954, shortly after Dulles' speech, CIA deputy chief of the Southeastern European Division, Christian M. Freer, presented Wisner's successor, Richard Helms, with a full--scale plan for the use of radiological weapons, including their use in Vietnam on behalf of the French. Author Richard Rhodes recently revealed that in 1954 the U.S. Joint Chiefs of Staff had approved the use of nuclear weapons against the Vietnamese fighting the French at Diem Binh Phu, but the plan was vetoed by President Eisenhower.Freer's plan* was as follows.

  1. It is suggested that consideration be given to the development of a radiological weapon which, it is hoped, would make profitable use of substantial quantities of radioactive waste materials -- which now constitute a considerable disposal problem -- to neutralize or interdict enemy activity in localized areas for relatively short periods wi thout simultaneously causing substantial loss of life and the destruction of property.
  2. In exploring this idea, the writer had gained the impression that:
    • the present concept of radiological warfare is along the lines of developing only lethal weapons; no thought has apparently been given to the possibility of developing a weapon of this kind, or for the purposes proposed below; and
    • the technical problems could probably be worked out provided that a safe means could be evolved for handling the radioactive materials in concentrated form or in large quantity.
  3. To this end it is suggested that it may be possible to disseminate quantities of radioactive by-product materials (in the form of dust, mist or otherwise) sufficient to cause short-term illness on the part of persons in the immediate area and incapacitate them for a limited time without, however, being lethal. By virtue of the relatively short 'life time' of the incapacitating radioactivity level, occupation of the area, by friendly forces should be possible before local defenders were capable of offering serious resistance.
  4. In amplification of the above, and in light of the indications of an abnormal Soviet sensitivity to radioactive contamination, several applications of such a weapon appear reasonable. These include employment along the lines of a rolling barrage; employment in conjunction with appropriate psychological warfare measures; and paramilitary exploitation. Thus, for example, if such a weapon were used to effect a rolling barrage, an entire front might be conveniently sterilized of enemy potential, in successive depths, permitting a frontal advance over an extended area. As a psychological weapon the employment of light dosage contamination might be combined with radio broadcasts and warning leaflets designed to reduce to a minimum civilian and even military resistance; such psychological warfare measures might on the one hand emphasize that use of this relatively benign weapon reflected the humanitarian concern of the United States to avoid needless loss of life and property and on the other stress that full recovery would depend upon complete inactivity, in the absence of which sterility, prolonged illness and possibly death would ensue. In paramilitary employment a wide diversification of uses is suggested including the contamination of warehousing or storage areas, preliminary softening-up operations to reduce the defensive capabilities of well-defended areas, and the introduction of confusion into closely integrated defenses. Obviously, the contamination of food and water supplies as an end result is included in the above potential use.
  5. The logistics problem involved in the use of such weapons might be complex because of the short life of the materials employed; however, this problem might well be counter-balanced by ease of packaging and of delivery resulting from the smaller concentration of radioactivity required.
  6. The potential of such a weapon is obviously not only in military terms of overruning selected resistance points at a minimum loss in casualties to the attacking force and in the preservation of the physical assets in the area (which both our military forces and the local civilian population could use to good advantage) but also from the important humanitarian and psychological standpoint of waging war without causing the widespread destruction of life and property attendant upon the use of lethal weapons of whatever kind. It would also appear that such a weapon might be used to advantage defensively in fighting delaying actions or in such battles as the one in Diem Bien Phu, where a protective ring might have been thrown around the town to prevent the attacking forces from approaching beyond a certain perimeter.

       [*Source: MEMORANDUM FOR: DD/P, THROUGH: C/SE C/OP, SUBJECT: Suggestions for New Radiological Warfare Development, DC/SE 28 October 1954.]

Freer's plan had come with the recommendation of the CIA's Nuclear Energy Division, and he had presented his plan to Helms "for your information and any further action you deem appropriate." Shortly thereafter, Helms approved a large project, supported by the AEC, for the research and development of "covert biological, chemical and radiological warfare" techniques at the Georgetown University Medical Center in Washington , D. C. under the direction of Dr. Charles Geschickter. As suggested by the AEC with regard to "The Thing," this project had the approval of the highest authority, the Presidential Foreign Intelligence Advisory Board, and the AEC initially pledged $500,000 for the project.

The CIA would have us believe that all of this came to nought even though millions of dollars went to Geschickter who conducted human radiation experiments and the development of horrendous techniques for attacking the Central Nervous System and rendering someone unconscious.

As late as 1972, the CIA's Project Often was attempting to develop covert techniques to induce strokes and heart attacks, and it is currently conducting brain research at the Human Brain Research Laboratory and elsewhere. The key question, of course, is: Why is a secret police and paramilitary agency allowed to conduct such research.

The Green Scare and Operation Backfire

by Peter Caplan - partly edited from June, 2006 National Lawyers Guild statement

In 2004, the federal government launched Operation Backfire, a wide-scale investigation of environmental and animal rights activists. It used paid informants and conducted warrantless spying on a range of organizations. Since then, numerous individuals around the country have been arrested and charged with arson, destruction of property and conspiracy in the government's attempts to target the Earth Liberation Front (ELF) and the Animal Liberation Front (ALF). Others were subpoenaed to testify before grand juries. Some were charged with the use of "destructive devices," one count of which carries a mandatory 30-year sentence-two counts call for mandatory life in prison. The government is over-charging people with offenses that carry severe sanctions to force them to accept guilty pleas for a lower sentence or to intimidate them into turning state's evidence. The government is misusing destructive device charges and engaging in selective prosecution. For example, in the SHAC7 (Stop Huntington Animal Cruelty) case the government in 2004 prosecuted the administrators of a website, charging them with 'conspiracy' to violate the Animal Enterprise Protection Act, an industry-specific statute that provides harsher sentences for those protesting animal-related businesses than say those protesting women's health clinics. The Animal Enterprise Protection Act is a clear violation of the First Amendment, as it makes certain types of political speech illegal. Three of the SHAC7 defendants were found guilty only of conspiracy, a charge that is rarely prosecuted without a substantive offense connected to it. "In the past few years, the Guild has witnessed a disturbing trend of targeting protesters engaged in dissent, and in imposing draconian sentences for expressing such dissent. Life sentences for property damage offenses where the actor has no intent to harm an individual are simply unconstitutional-the punishment does not fit the crime," said Heidi Boghosian, Executive Director of the National Lawyers Guild. The FBI rates ALF and ELF as the number one domestic terrorist threat, calling eco-sabotage the government's top domestic terrorism priority. The State Department's definition of terrorism is: "premeditated politically motivated violence perpetrated against non-combatants." The expanded definition of domestic terrorism in the Patriot Act punishes a person who commits a dangerous criminal act intended to "intimidate or coerce a civilian population." The Guild is greatly concerned about the use of the word terrorism because it obfuscates issues about the evidence and the ability to fairly evaluate the merits of the case. The National Lawyers Guild has established a hotline, 888-NLG-ECOLAW, for individuals arrested or subpoenaed for offenses related to environmental or animal activism. The Guild held a symposium, "The Green Scare: What Lawyers Need to Know," at Cardozo Law School in New York last June. Update: In December of 2006, six suspects were arrested by the FBI and jailed in Oregon as part of Operation Backfire and charged with various ecotage crimes. Two weeks later, one of the detainees, William Rodgers, 40, committed suicide in his prison cell.

The next month saw the extradition of out-of-state defendants in the case, and a Jan 20 press conference in which (soon-to-be-ex- ?)Attorney General Alberto Gonzalez referred to the defendants as terrorists and a DOJ press release headlined "11 Indicted on Domestic Terrorism Charges." However, "terrorism" was not mentioned once in the 83-page indictment, nor were any of the defendants charged under domestic terrorism statutes.[ref] Since then seven of the defendants have been released, and the remaining four are scheduled forsentencing in early June. For updates, go to and


Books of Interest

  • Alfred W. McCoy, A Question of Torture: CIA Interrogation, from the Cold War to the War on Terror (New York: Henry Holt, 2006). "Uncovers the deep disturbing roots of Abu Graib and Guantanamo and shows that these abuses are the product of a long-standing covert program of interrogation.".
  • Collapse: How Societies Choose to Fail or Succeed, Jared Diamond
  • - yada yada
  • A Peoples History of Science: Miners, Midwives, and "Low Mechanicks" (Nation Books - Paperback), by Clifford D Connor
  • - looks at the "production and propagation of science [by] anonymous masses of humble people..."