Aftermath News

Associated Press | May 11, 2008

By KEVIN FREKING

WASHINGTON - Families claiming that a mercury-based preservative in vaccines triggers autism will challenge mainstream medicine Monday as they take their case to a federal court.

They seek vindication and financial redress from a government fund that helps people injured by shots.

Two 10-year-old boys from Portland, Ore., will serve as the test cases that determine whether the children and their families should be compensated. Attorneys for the boys will attempt to show the boys were happy, healthy and developing normally. But, after being exposed to vaccines with thimerosal, they began to regress and show symptoms of autism.

Thimerosal has been removed in recent years from standard childhood vaccines, except the flu shot. In 2004, a committee with the Institute of Medicine concluded there was no credible evidence that vaccines containing thimerosal caused autism.

Overall, nearly 4,900 families have filed claims with the U.S. Court of Claims alleging that vaccines caused autism and other neurological problems in their children. Lawyers for the families will present three different theories of how vaccines caused autism.

The case beginning Monday focuses on the second of those theories: that thimerosal-containing vaccines alone cause autism. Lawyers for the petitioning families said they will present evidence that injections with thimerosal deposit a form of mercury in the brain. That mercury excites certain brain cells that stay chronically activated trying to get rid of the intrusion.

“In some kids, there’s enough of it that it sets off this chronic neuroinflammatory pattern that can lead to regressive autism,” said attorney Mike Williams.

In the end, the families’ attorneys hope to convince a special master of the U.S. Court of Claims that thimerosal belongs on the list of causes for the inflammation that leads to regressive autism.

To win, the attorneys for the two boys, William Mead and Jordan King, will have to show that it”s more likely than not that the vaccine actually caused the injury.

Many members of the medical community are skeptical of the families’ claims. They worry that the claims about the dangers of vaccines could cause some people to forgo vaccines that prevent illness.

“I think that what’s so endearing to me about the anti-vaccine people is they’re perfectly willing to go from one hypothesis to the next without a backward glance,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Autism is a developmental disability that typically appears during the first three years of life and affects a person’s ability to communicate and interact with others. Dr. Andrew Gerber, a psychiatrists, said that medical experts don’t have a comprehensive understanding of what causes autism, but they do know there is a strong hereditary component.

Toxins from the environment could play a role, but currently, data does not support that they do, Gerber said.

Arguments are scheduled to go on throughout the month. A final decision could take several more months to occur. Claims that are successful would result in compensation taking into account lost earnings after age 18 and up to $250,000 for pain and suffering.

The families or the federal government can also appeal the decision of the special master to the Court of Federal Claims or to a federal appeals court.

While there have been about 5,000 claims relating to autism, there have been fewer than 3,000 claims for all other vaccines.

Old-Thinker News | May 4, 2008

By Daniel Taylor

In July of 1994 the U.S. Army War College Strategic Studies Institute (SSI) produced the paper titled Revolution In Military Affairs And Conflict Short Of War that uncannily forecasted the future in a “hypothetical future history” written in the year 2010.

Computer generated insurgents claim responsibility for attacks that U.S. forces carry out, pharmaceutical drugs are used as a part of national security strategy, “attitude shaping campaigns” are directed against the American people, traditional boundaries between military and law enforcement are abolished, subliminal conditioning is used in combination with propaganda, and bioelectric tags are implanted in citizens. By 2010 the revolutionaries’ goals were met.

All of this will likely sound eerily familiar to followers of current events, or for that matter anyone who lived to see the events of September 11th 2001, its resulting wars, and its truly “revolutionary” effects in the reorganization of government and law. The Bush administration’s signature legislation, the Patriot Act, has infringed on multiple sections of the Bill of Rights and Constitution. Posse Comitatus, which has protected Americans from the military engaging in domestic law enforcement since 1807 was reversed when the John Warner National Defense Authorization Act for Fiscal Year 2007 was passed last year.

The Neoconservatives reign in the United States holds striking similarities to the scenario outlined in the 1994 SSI report. Interestingly, the document clearly stated that, “Saddam Hussein’s Iraq or the other Third World caricatures of the Soviet Union are perfect opponents for a RMA-type [Revolution in Military Affairs] military.”

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The medications have side effects which accelerate mental decline, triple the risk of stroke, and double the chances of premature death.

Telegraph | Apr 28, 2008

Ministers should step in to stop inappropriate prescriptions of powerful antipsychotic drugs for Alzheimer’s patients, an influential group of MPs said today.

Up to 105,000 people with dementia in Britain are wrongly being treated with the drugs, which are used to control behavioural symptoms such as aggression, they claim. Research has shown that the medications have side effects which can accelerate mental decline, triple the risk of stroke, and double the chances of premature death.

They are intended for psychotic patients suffering from delusions, paranoia and hallucinations. Yet the drugs continue to be used as a first resort to address the challenging behaviour of people suffering from Alzheimer’s disease and other types of dementia, according to the MPs. A report from the all-party parliamentary group (APPG) on dementia demanded Government action on the problem and urged the National Institute for Health and Clinical Excellence (Nice), the health watchdog, to carry out a review.

The report, A Last Resort, points out that no audit or regulation of such prescriptions exists. Jeremy Wright, the group’s chairman, said: “Antipsychotics can double risk of death and triple the risk of stroke in people with dementia, (can) heavily sedate them, and (can) accelerate cognitive decline.

“The Government must end this needless abuse. Safeguards must be put in place to ensure antipsychotics are always a last resort. We need to include families in decisions, give people with dementia regular reviews, and equip care staff with specialist training.”

The inquiry was told that 150,000 people with dementia were prescribed antipsychotic drugs in British care facilities. Psychiatric experts said 70 per cent of these prescriptions were inappropriate.

Neil Hunt, the chief executive of the Alzheimer’s Society, said more than 70 per cent of dementia patients exhibited challenging behaviour.

“More often than not this is an expression of unmet need, not a symptom of dementia, and there is no excuse for reaching for the medicine cabinet,” he said.

Seattle Times | Apr 15, 2008

By Kyung M. Song

The maker of the controversial arthritis drug Vioxx knew of dangers associated with it for as many as three years before a massive nationwide recall, but withheld the information from federal officials and played down the number of deaths associated with the pain medication, according to an analysis published today by University of Washington professors.

The article, which appears today in the prominent Journal of the American Medical Association (JAMA), contends that Merck, which pulled Vioxx from the market in 2004, knew internally as early as 2001 that people at risk of Alzheimer’s disease who were enrolled in two Vioxx clinical trials were dying at three times the rate of those taking a placebo.

The article, which examined previously secret Merck documents, contends the company switched calculations to minimize the number of deaths.

A Merck attorney, Jim Fitzpatrick of New York, countered today that the company disclosed all its clinical results thoroughly and that “we completely disagree” with allegations that Merck misrepresented its findings.

The article is one of two papers in this week’s issue of JAMA investigating the clash of corporate interests and scientific integrity involving Vioxx, the subject of the most expensive drug recall in history.

In an accompanying editorial, JAMA’s top editors call for “drastic actions” against corporate manipulation of clinical research and the practice of ghostwriting medical articles by unnamed authors on corporate payroll. It argues that researchers, regulators and even editors of medical journals such as JAMA are complicit. It singled out doctors who lend their names as authors on research papers for money for behavior “that is unprofessional and demeaning to the medical profession.”

Both the article by UW professors and the companion paper on hidden authorship of articles on clinical trials rely on documents disclosed through some of the 27,000 Vioxx lawsuits against Merck. In November, the New Jersey company agreed to settle a majority of those suits for $4.85 billion without admitting guilt.

The co-author of the UW paper, Richard Kronmal, professor of statistics at UW, is a paid expert witness for Vioxx plaintiffs. The lead author is Bruce Psaty, UW professor of medicine.

Vioxx is a prescription arthritis drug and painkiller that was promoted as a gentler alternative to other drugs such as aspirin. Merck withdrew it in September 2004 after disclosing that a study found it doubled the risk of heart attacks and strokes.

But information was available well before 2004 that showed that Vioxx posed serious potential harm to subjects in clinical trials. As early as June 2000, unpublished data submitted to the Food and Drug Administration showed that taking Vioxx significantly raised the rate of heart attacks and strokes, as well as edema and hypertension, according to subsequent analysis by independent researchers.

Some of the same early evidence prompted pharmacists from Seattle’s Group Health Cooperative to decide against adding Vioxx to its formulary. As a result, Group Health has never covered Vioxx for its members, said Jim Carlson, the co-op’s director of pharmacy.

In the latest JAMA article, the UW researchers compared internal Merck memos about two Vioxx studies involving patients at risk of dementia against information the company submitted to the FDA and published later in two clinical papers.

In April 2001, a Merck statistician concluded that 34 people in the Vioxx groups had died, compared with 12 in the two placebo groups. But in its submissions to the FDA three months later, Merck used different methods to reduce the mortality risk, coming up with 29 deaths among Vioxx takers and 17 in the placebo groups.

Merck apparently did this in part by omitting some of the deaths that occurred after the subjects had stopped taking the drug, said Psaty.

“They were not being forthright,” he said in an interview today. “They minimized the appearance of risk.”

Related

Merck Masked Vioxx Risk, Hired Study Ghostwriters

AP | Mar 12, 2008

By MARIA CHENG

LONDON - As doctors struggle to eradicate polio worldwide, one of their biggest problems is persuading parents to vaccinate their children. In Belgium, authorities are resorting to an extreme measure: prison sentences.

Two sets of parents in Belgium were recently handed five month prison terms for failing to vaccinate their children against polio. Each parent was also fined 4,100 euros ($8,000).

“It’s a pretty extraordinary case,” said Dr. Ross Upshur, director of the Joint Centre for Bioethics at the University of Toronto.

“The Belgians have a right to take some action against the parents, given the seriousness of polio, but the question is, is a prison sentence disproportionate?”

The parents can still avoid prison — their sentences were delayed to give them a chance to vaccinate their children. But if that deadline also passes without their children receiving the injections, the parents could be put behind bars.

Because of privacy laws, Belgian officials would not talk specifically about the case, such as why the parents refused the vaccine or how much longer they have to vaccinate their children.

The polio vaccine is the only one required by Belgian law. Exceptions are granted only if parents can prove their children might have a bad physical reaction to the vaccine.

“Polio is a very serious disease and has caused great suffering in the past,” said Dr. Victor Lusayu, head of Belgium’s international vaccine centre. “The discovery of the vaccine has eliminated polio from Europe and it is simply the law in Belgium that you have to be vaccinated. … At the end of the day, the law must be respected.”

Some ethicists back the hardline Belgian stance.

“Nobody has the right to unfettered liberty, and people do not have a right to endanger their kids,” said John Harris, a professor of bioethics at the University of Manchester.

“The parents in this case do not have any rights they can appeal to. They have obligations they are not fulfilling.”

Aside from Belgium, only France makes polio vaccinations mandatory by law. In the United States, children must be vaccinated against many diseases including polio, but most states allow children to opt out if their parents have religious or “philosophical” objections.

In the U.S. state of Maryland, prosecutors and school officials in one county threatened truancy charges against parents who failed to vaccinate their children. The measure sharply reduced the number of unvaccinated children although nobody has been charged.

The only other case of mandatory polio vaccines is during the Muslim yearly Hajj pilgrimage in Saudi Arabia. Pilgrims from polio-endemic countries — Afghanistan, India, Nigeria and Pakistan — must prove they have been vaccinated. Saudi officials even give them an extra dose upon arrival at the airport.

Since the polio virus can live in the human body for weeks, it jumps borders easily. That makes health officials even in developed countries nervous, since the threat of an outbreak remains as long as the virus is circulating anywhere.

Polio is a highly infectious disease spread through water that mainly strikes children under five. Initial symptoms include fever, headaches, vomiting, stiffness in the neck and fatigue. The polio virus invades the body’s nervous system and can lead to irreversible paralysis within hours. In extreme cases, children can die when their breathing muscles are immobilized.

Incidence has dropped by 99 percent since the World Health Organization and partners began their eradication effort in 1988. But the virus is still entrenched in Afghanistan, India, Nigeria and Pakistan, and occasionally pops up elsewhere.

For developed countries, imported polio cases could cause chaos in the health system, warned Dr. Steve Cochi, an immunization expert at the United States’ Centers for Disease Control and Prevention.

He said that unlike other medical problems, in which rejecting treatment only affects the individual, refusing a vaccine for a transmissible disease like polio puts others at risk as well.

“Most of the time, polio outbreaks do spill into the general population,” Cochi said.

Ethicists argue that people who refuse vaccinations are taking advantage of everyone else who has been vaccinated. Once the majority of a population is vaccinated, there are few susceptible people the disease can infect, thus lowering the odds of an outbreak.

People who refuse to be vaccinated are “free riders,” Harris said. “They can only afford to refuse the vaccine because they are surrounded by people who have fulfilled their obligations to the community.”

Health officials doubt that Belgium’s strategy will be useful to countries still battling polio.

“It is up to individual countries to decide their own policies, but we do not feel that imprisonment would help,” said Dr. David Heymann, WHO’s top polio official.

AP | Mar 16, 2008

By MARTHA MENDOZA

Test it, study it, figure out how to clean it — but still drink it. That’s the range of reactions raining down from community leaders, utilities, environmental groups and policy makers in reaction to an Associated Press investigation that documented the presence of pharmaceuticals in major portions of the nation’s drinking water supplies.

“There is no wisdom in avoidance. There is wisdom in addressing this problem. I’m not suggesting that people be hysterical and overreact. There’s a responsible way to deal with this — and collectively we can do it,” said Washington-based environmental lawyer George Mannina.

A five-month-long inquiry by the AP National Investigative Team found that many communities do not test for the presence of drugs in drinking water, and those that do often fail to tell customers that they have found trace amounts of medications, including antibiotics, anti-convulsants, mood stabilizers and sex hormones. The stories also detailed the growing concerns among scientists that such pollution is adversely affecting wildlife and may be threatening human health.

As a result, Senate hearings have been scheduled, and there have been calls for federal solutions. But officials in many cities say they aren’t going to wait for guidance from Washington to begin testing.

Pharmaceutical industry officials said they would launch a new initiative Monday with the U.S. Fish and Wildlife Service focused on telling Americans how to safely dispose of unused medicines.

The subject of pharmaceuticals in drinking water also will be discussed this week when 7,000 scientists and regulators from 45 countries gather in Seattle for the annual meeting of the Society of Toxicology. “The public has a right to know the answers to these questions,” said Dr. George Corcoran, the organization’s president.

“The AP story has really put the spotlight on it, and it is going to lead to a pickup in the pace,” he said. “People are going to start putting money into studying this now, instead of a few years from now, and we’ll get the answers sooner than we would have otherwise.”

Environmental leaders said some answers are easy.

“It’s basic. We need to test, tell and protect health,” said Richard Wiles, executive director of the Washington-based Environmental Working Group.

Wiles said the Environmental Protection Agency needs to widely expand the list of contaminants that utilities are required to test for. That list currently contains no pharmaceuticals. He also said government agencies and water providers that don’t disclose test results “are taking away people’s right to know, hiding the fact that there are contaminants in the water. We don’t think they have that right. It’s hubris, it’s arrogance and it’s self-serving,” said Wiles.

As part of its effort, the AP surveyed 62 metropolitan areas and 52 smaller cities, reporting on positive test results in 24 major cities, serving 41 million Americans. Since release of the AP investigation, other communities and researchers have been disclosing previously unreleased local results, positive or negative.

In Yuma, Ariz., for example, city spokesman Dave Nash said four pharmaceuticals — an antibiotic, an anti-convulsant, an anti-bacterial and caffeine — have been detected in that city’s drinking water. In Denver, where the AP had reported undisclosed antibiotics had been detected, a Colorado State University professor involved in water screening there e-mailed the names of 12 specific drugs that had been detected.

Officials at many utilities said that without federal regulations, they didn’t see a need to screen their water for trace amounts of pharmaceuticals. But others have now decided to test, including Scottsdale and Phoenix in Arizona, Palm Beach County in Florida, Chicago and Springfield, Ill., Bozeman, Mont., Fargo, N.D.; Danville, Va.; and a group of four sewer partners in the Olympia, Wash., region.

“We read the AP story and made a determination that we should test our water and be transparent, just let the people know what we find. I’m confident we have safe and clean drinking water,” said Phoenix Mayor Phil Gordon.

Officials in Freeport, Ill., one of the smaller cities surveyed, said they plan to work with the state EPA to test the area’s drinking water for pharmaceuticals. Mayor George Gaulrapp said he is looking to the state agency for standards, regulations and testing procedures for that city’s water, which comes from a deep well.

In some places, residents learned that the rivers and lakes that feed their drinking water treatment plants have already been tested, or that tests are under way.

In Marin County, California, officials said repeated tests in their watershed for pharmaceuticals have come back clean. In Massachusetts, the state Department of Environmental Protection announced a program to screen rivers, streams and reservoirs for pharmaceuticals.

Dozens of newspaper editorials called for testing in communities where water is not being screened and the release of any test results.

“The first, and least expensive, step is to let the sunshine in: Water utilities that currently test for pharmaceuticals should make that information freely available to their customers, along with more information on the potential impacts of drugs in the water supply,” read an editorial in the Daytona Beach News-Journal.

The Fort Worth Star-Telegram has filed an open records request for a copy of a study conducted on the city’s water after the mayor refused to give the AP and the newspaper the name of a pharmaceutical detected in the drinking water. City officials say publishing that information could jeopardize public safety, citing post-Sept. 11 security concerns. A Texas attorney general’s opinion is being sought on possible release of the information.

The Milwaukee Journal Sentinel urged readers to take responsibility as well.

“It’s a problem in which the average person has both a stake and a role in the solution,” read a Journal Sentinel editorial. “He or she can do something as simple as not flushing unused medications down the toilet or into the drain.”

And the Pittsburgh Post-Gazette observed that “given the national scope of the problem, a strong leadership role for the federal government suggests itself in areas such as testing and upgrading water treatment plants. So it is discouraging to note that the Bush administration in its 2009 budget proposal cut $10 million from the water monitoring and research program.”

While the local responses are encouraging, Lisa Rainwater, policy director of Riverkeeper, a New York-based environmental group, said the EPA should step aside and let the National Academy of Sciences or the General Accounting Office study the impacts on humans and wildlife.

“Frankly, the EPA has failed the American public for doing far too little for far too long,” she said.

At least one local water official is putting part of his faith in another quarter. Wayne Livingston of the Oxford Water Works in Alabama said he has confidence in the existing treatment system. But he said his agency probably will test for pharmaceuticals now, although he doubts anything will turn up because the water is pumped from underground.

“The good Lord filters it,” he said. “But this is something we should keep an eye on.”

Associated Press | Mar 9, 2008

Heightening worries among scientists of long-term consequences to human health.

By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD

A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows.

To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe.

But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health.

In the course of a five-month inquiry, the AP discovered that drugs have been detected in the drinking water supplies of 24 major metropolitan areas — from Southern California to Northern New Jersey, from Detroit to Louisville, Ky.

Water providers rarely disclose results of pharmaceutical screenings, unless pressed, the AP found. For example, the head of a group representing major California suppliers said the public “doesn’t know how to interpret the information” and might be unduly alarmed.

How do the drugs get into the water?

People take pills. Their bodies absorb some of the medication, but the rest of it passes through and is flushed down the toilet. The wastewater is treated before it is discharged into reservoirs, rivers or lakes. Then, some of the water is cleansed again at drinking water treatment plants and piped to consumers. But most treatments do not remove all drug residue.

And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife.

“We recognize it is a growing concern and we’re taking it very seriously,” said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency.

Members of the AP National Investigative Team reviewed hundreds of scientific reports, analyzed federal drinking water databases, visited environmental study sites and treatment plants and interviewed more than 230 officials, academics and scientists. They also surveyed the nation’s 50 largest cities and a dozen other major water providers, as well as smaller community water providers in all 50 states.

Here are some of the key test results obtained by the AP:

_Officials in Philadelphia said testing there discovered 56 pharmaceuticals or byproducts in treated drinking water, including medicines for pain, infection, high cholesterol, asthma, epilepsy, mental illness and heart problems. Sixty-three pharmaceuticals or byproducts were found in the city’s watersheds.

_Anti-epileptic and anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.

_Researchers at the U.S. Geological Survey analyzed a Passaic Valley Water Commission drinking water treatment plant, which serves 850,000 people in Northern New Jersey, and found a metabolized angina medicine and the mood-stabilizing carbamazepine in drinking water.

_A sex hormone was detected in San Francisco’s drinking water.

_The drinking water for Washington, D.C., and surrounding areas tested positive for six pharmaceuticals.

_Three medications, including an antibiotic, were found in drinking water supplied to Tucson, Ariz.

The situation is undoubtedly worse than suggested by the positive test results in the major population centers documented by the AP.

The federal government doesn’t require any testing and hasn’t set safety limits for drugs in water. Of the 62 major water providers contacted, the drinking water for only 28 was tested. Among the 34 that haven’t: Houston, Chicago, Miami, Baltimore, Phoenix, Boston and New York City’s Department of Environmental Protection, which delivers water to 9 million people.

Some providers screen only for one or two pharmaceuticals, leaving open the possibility that others are present.

The AP’s investigation also indicates that watersheds, the natural sources of most of the nation’s water supply, also are contaminated. Tests were conducted in the watersheds of 35 of the 62 major providers surveyed by the AP, and pharmaceuticals were detected in 28.

Yet officials in six of those 28 metropolitan areas said they did not go on to test their drinking water — Fairfax, Va.; Montgomery County in Maryland; Omaha, Neb.; Oklahoma City; Santa Clara, Calif., and New York City.

The New York state health department and the USGS tested the source of the city’s water, upstate. They found trace concentrations of heart medicine, infection fighters, estrogen, anti-convulsants, a mood stabilizer and a tranquilizer.

City water officials declined repeated requests for an interview. In a statement, they insisted that “New York City’s drinking water continues to meet all federal and state regulations regarding drinking water quality in the watershed and the distribution system” — regulations that do not address trace pharmaceuticals.

In several cases, officials at municipal or regional water providers told the AP that pharmaceuticals had not been detected, but the AP obtained the results of tests conducted by independent researchers that showed otherwise. For example, water department officials in New Orleans said their water had not been tested for pharmaceuticals, but a Tulane University researcher and his students have published a study that found the pain reliever naproxen, the sex hormone estrone and the anti-cholesterol drug byproduct clofibric acid in treated drinking water.

Of the 28 major metropolitan areas where tests were performed on drinking water supplies, only Albuquerque; Austin, Texas; and Virginia Beach, Va.; said tests were negative. The drinking water in Dallas has been tested, but officials are awaiting results. Arlington, Texas, acknowledged that traces of a pharmaceutical were detected in its drinking water but cited post-9/11 security concerns in refusing to identify the drug.

The AP also contacted 52 small water providers — one in each state, and two each in Missouri and Texas — that serve communities with populations around 25,000. All but one said their drinking water had not been screened for pharmaceuticals; officials in Emporia, Kan., refused to answer AP’s questions, also citing post-9/11 issues.

Rural consumers who draw water from their own wells aren’t in the clear either, experts say.

The Stroud Water Research Center, in Avondale, Pa., has measured water samples from New York City’s upstate watershed for caffeine, a common contaminant that scientists often look for as a possible signal for the presence of other pharmaceuticals. Though more caffeine was detected at suburban sites, researcher Anthony Aufdenkampe was struck by the relatively high levels even in less populated areas.

He suspects it escapes from failed septic tanks, maybe with other drugs. “Septic systems are essentially small treatment plants that are essentially unmanaged and therefore tend to fail,” Aufdenkampe said.

Even users of bottled water and home filtration systems don’t necessarily avoid exposure. Bottlers, some of which simply repackage tap water, do not typically treat or test for pharmaceuticals, according to the industry’s main trade group. The same goes for the makers of home filtration systems.

Contamination is not confined to the United States. More than 100 different pharmaceuticals have been detected in lakes, rivers, reservoirs and streams throughout the world. Studies have detected pharmaceuticals in waters throughout Asia, Australia, Canada and Europe — even in Swiss lakes and the North Sea.

For example, in Canada, a study of 20 Ontario drinking water treatment plants by a national research institute found nine different drugs in water samples. Japanese health officials in December called for human health impact studies after detecting prescription drugs in drinking water at seven different sites.

Telegraph | Jan 13, 2008

By Richard Gray

Britain’s tap water should be monitored for powerful medicines after traces of cancer and psychiatric drugs were detected in samples, a report has warned.

Trace levels of bleomycin, a cancer chemotherapy drug, and diazepam, a sedative, have been found during tests on drinking water, the report reveals.

While the levels are considered too low to pose a direct risk to health, doctors have expressed concern about exposing pregnant women to drugs that could harm an unborn child.

The report, compiled for the DWI by the consultants Watts and Crane Associates, recommends that drinking water should be monitored for hazardous drugs.

The report states: “The observed concentrations of pharmaceuticals in raw waste water indicate that the major source of pharmaceuticals to the environment is via sewage treatment works effluent.

“Drinking water treatment works use a wider and technically more advanced range of processes, but again these are not specifically designed to remove pharmaceuticals and several compounds have been reported in drinking water.”

But it adds: “Even in the worst-case situation, there is no significant risk to health from the intake of pharmaceuticals via drinking water.”

Sue Pennison, from the DWI, said: “The recommendations are now being considered and this may include conducting testing on drinking water.”

The report comes as a separate study by environmental scientists has warned that toxic chemotherapy drugs used to treat cancer patients are being washed into Britain’s rivers. They, too, have called for testing of tap water to ensure there is no risk to people.

The study, carried out at the Centre for Ecology and Hydrology in Wallingford, Oxfordshire, examined the risks posed by chemotherapy drugs that escape into the environment through sewage.

The researchers estimated that an adult drinking more than three pints of water a day would receive a weekly dose of between 300 and 30,000 times lower than recommended safety levels.

They warn that a developing foetus would also be exposed to the drugs in the womb.

Andrew Johnson, the scientist who led the Wallingford study, said: “In the foetus, which is rapidly growing and comparatively tiny, the dose would be relatively higher and any damage to its cells could be far more serious.

“There is not evidence to show that drinking water treatment removes all these drugs, so while we are not wanting to alarm people, it would be foolish to assume there is no risk.”

news.com.au | Jan 5, 2008

THE ground-breaking Australian-developed vaccine that prevents cervical cancer is gaining a reputation as the most painful childhood shot, US health experts say.

The Gardasil vaccine is touted as an important new protection against a sexually transmitted virus that causes cervical and vaginal cancer.

In recent months, experts have noted reports of pain and fainting from the shot.

During its first year of use, reports of girls fainting from vaccinations climbed, but it is not clear whether the pain of the vaccine was the reason.

“This vaccine stings a lot,” said Patsy Stinchfield, an infectious disease expert at Children’s Hospitals and Clinics of Minnesota.

It sure does, said 18-year-old Lauren Fant.

She said other shots tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in.

“It burns,” she said.

While many say the pain is short-lived, some say driving or sleeping on the injected arm is uncomfortable for up to a day after.

Officials at Merck & Co, which makes the vaccine, attributes it partly to the virus-like particles in the shot.

Studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.

US health officials have noticed a rise in reports of vaccine-associated fainting in girls.

From 2002-04 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on to the market in 2006.

However it is not clear if Gardasil’s sting is related to the increase.

Dr Barbara Slade, an immunisation safety specialist at the US Centres for Disease Control and Prevention, said a three-dose vaccine for adolescents would be expected to prompt some fainting.

Gardasil is the first vaccine focusing on the human papilloma virus, HPV. The Food and Drug Administration approved it for females aged 9 to 26.

Preliminary studies indicate only 10 to 20 per cent have received at least one dose.

Atlanta pediatrician Dr Andy Andrews said he did not believe the shot’s “ouch” had diminished demand.

“A lot of the older teens are coming in themselves, without a parent. So they themselves are motivated to come back in,” Dr Andrews said.

For related articles on Gardasil click here

In 2002, the drug maker, Purdue Pharma of Stamford, Conn., hired Mr. Giuliani and his consulting firm, Giuliani Partners, to help stem the controversy about OxyContin.

New York Times | Dec 28, 2007

By BARRY MEIER and ERIC LIPTON

In western Virginia, far from the limelight, United States Attorney John L. Brownlee found himself on the telephone last year with a political and legal superstar, Rudolph W. Giuliani.

For years, Mr. Brownlee and his small team had been building a case that the maker of the painkiller OxyContin had misled the public when it claimed the drug was less prone to abuse than competing narcotics. The drug was believed to be a factor in hundreds of deaths involving its abuse.

Mr. Giuliani, celebrated for his stewardship of New York City after 9/11, soon told the prosecutors they were wrong.

In 2002, the drug maker, Purdue Pharma of Stamford, Conn., hired Mr. Giuliani and his consulting firm, Giuliani Partners, to help stem the controversy about OxyContin. Among Mr. Giuliani’s missions was the job of convincing public officials that they could trust Purdue because they could trust him.

So it was no small success when, after the call, Mr. Brownlee did what many people might have done when confronted with such celebrity: He went out and bought a copy of Mr. Giuliani’s book, “Leadership.”

“I wanted to be prepared for my meetings with him,” Mr. Brownlee said in a recent interview.

Over the past few weeks, Mr. Giuliani’s consulting business has received increasing scrutiny, at times forcing him to defend his business as he campaigns for the Republican presidential nomination.

But his work for Purdue, the company’s first and longest-running client, provides a window into how he used his standing as an eminent lawyer, a Republican insider and a national celebrity to aid a controversial client and build a business fortune.

A former top federal prosecutor, Mr. Giuliani participated in two meetings between Purdue officials and the head of the Drug Enforcement Administration, the agency investigating the company. Giuliani Partners took on the job of monitoring security improvements at company facilities making OxyContin, an issue of concern to the D.E.A.

As a celebrity, Mr. Giuliani helped the company win several public relations battles, playing a role in an effort by Purdue to persuade an influential Pennsylvania congressman, Curt Weldon, not to blame it for OxyContin abuse.

Despite these efforts, Purdue suffered a crushing defeat in May at the hands of Mr. Brownlee when the company and three top executives pleaded guilty to criminal charges.

Mr. Giuliani, who declined to discuss his work for Purdue for this article, has refused to talk in detail about his firm’s clients. He has said that he is no longer involved in the day-to-day management of the firm, which still represents Purdue.

Giuliani Partners would not say how much Purdue had paid it, but one consultant to the drug maker estimated that Mr. Giuliani’s firm had, in some years, earned several million dollars from the account.

“Everything I did with Giuliani Partners has been totally legal, totally ethical,” Mr. Giuliani recently told The Associated Press. “There’s nothing for me to explain about it. We’ve acted honorably, decently.”

In the OxyContin case, Mr. Giuliani’s supporters suggest that as a cancer survivor himself, he was driven by a noble goal: to keep the company’s proven pain reliever available to the widest circle of sufferers.

“I understand the pain and distress that accompanies illness,” Mr. Giuliani said at the time. “I know that proper medications are necessary for people to treat their sickness and improve their quality of life.”

To drive OxyContin’s sales, Purdue, beginning in 1996, set in motion what D.E.A. officials described as perhaps the most aggressive promotional campaign for a high-powered narcotic ever undertaken. It promoted the drug not only to pain specialists, but to family doctors with little experience in treating serious pain or recognizing drug abuse.

As a result of the expanded access, critics charged, OxyContin wound up in the high schools and street corners of rural America where curious teenagers crushed the pill, defeating the time-release formula, and ended up addicts, or in some cases, dead.

Dennis Lee, the Virginia state prosecutor for Tazewell County, an area hard hit by OxyContin abuse, said he was stunned several years ago to learn that Mr. Giuliani was working for Purdue. He had a favorable impression of Mr. Giuliani, he said, and a poor opinion of the company, which he said had played down and dissembled about its drug’s problem.

“I was shocked,” Mr. Lee said, “that he would basically become a mouthpiece for Purdue.”

Denials and Lobbying

Giuliani Partners served clients with a range of needs. The firm helped large accounting firms fight computer hackers and promoted Nextel’s efforts to expand its access to public airwaves. But some of the 55-person firm’s clients, like Purdue Pharma, were facing more difficult legal and public relations problems.

There were, for instance, the backers of a planned natural gas terminal in Long Island Sound who were facing stiff environmental opposition. Another client was a former cocaine smuggler hoping to win federal contracts for a computer system to track down terrorists.

On the business of these clients and others, Giuliani Partners carved out a lucrative niche in corporate consulting, crisis management and security.

In the process, Mr. Giuliani, a Brooklyn native whose legal career had largely been spent in government, became a corporate trouble-shooter with homes in the Hamptons and on the Upper East Side. According to financial disclosure forms filed in May, his net worth was more than $30 million.

The crisis that brought Purdue to Mr. Giuliani in 2002 involved OxyContin, a time-released form of the narcotic oxycodone, which had turned into a blockbuster product with annual sales of more than $1 billion.

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