Showing posts with label Pharmaceuticals. Show all posts
Showing posts with label Pharmaceuticals. Show all posts

Thursday, April 30, 2009

Swine Flu Scare

Critical Alert: The Swine Flu Pandemic – Fact or Fiction?
(Article from Mercola.com 4/30/09)

American health officials declared a public health emergency as cases of swine flu were confirmed in the U.S. Health officials across the world fear this could be the leading edge of a global pandemic emerging from Mexico, where seven people are confirmed dead as a result of the new virus.

On Wednesday April 29th, the World Health Organization (WHO) raised its pandemic alert level to five on its six-level threat scale,1 which means they"ve determined that the virus is capable of human-to-human transmission. The initial outbreaks across North America reveal an infection already traveling at higher velocity than did the last official pandemic strain, the 1968 Hong Kong flu.


Phase 5 had never been declared since the warning system was introduced in 2005 in response to the avian influenza crisis. Phase 6 means a pandemic is under way. WHO now openly states it is not possible to contain the spread of this infection and recommends mitigation measures, not restricting travel or closing borders.

However, a pandemic does not necessarily mean what you think it does, it is NOT black-plague carts being hauled through the streets piled high with dead bodies. Nor does it mean flesh eating zombies wandering the streets feeding on the living. All a pandemic means is that a new infectious disease is spreading throughout the world.


The number of fatalities, and suspected and confirmed cases across the world change depending on the source, so your best bet -- if you want the latest numbers -- is to use Google Maps" Swine Flu Tracker.

Several nations have imposed travel bans, or made plans to quarantine air travelers2 that present symptoms of the swine flu, such as:

Fever of more than 100
Coughing
Runny nose and/or sore throat
Joint aches
Severe headache
Vomiting and/or diarrhea
Lethargy
Lack of appetite
Top global flu experts are trying to predict how dangerous the new swine flu strain will be, as it became clear that they had little information about Mexico"s outbreak. It is as yet unclear how many cases occurred in the month or so before the outbreak was detected. It"s also unknown whether the virus was mutating to be more lethal, or less.




Much Fear Mongering Being Promoted

I suspect you have likely been alarmed by the media"s coverage of the swine flu scare. It has a noticeable subplot - preparing you for draconian measures to combat a future pandemic as well as forcing you to accept the idea of mandatory vaccinations.

On April 27, Time magazine published an article which discusses how dozens died and hundreds were injured from vaccines as a result of the 1976 swine flu fiasco, when the Ford administration attempted to use the infection of soldiers at Fort Dix as a pretext for a mass vaccination of the entire country.

Despite acknowledging that the 1976 farce was an example of “how not to handle a flu outbreak”, the article still introduces the notion that officials “may soon have to consider whether to institute draconian measures to combat the disease”.

Fortunately some respectable journalists recognize this and are seeking to spread a voice of reason to the fear that is being promoted in the majority of the media





WHO and CDC Pandemic Preparedness Seriously Broken


The pandemic warning system has failed as it simply doesn"t exist, even in North America and Europe. To improve the system, massive new investments in surveillance, scientific and regulatory infrastructure, basic public health, and global access to common sense interventions like vitamin D optimization are required.

According to the Washington Post, the CDC did not learn about the outbreak until six days after Mexico had begun to impose emergency measures. There should be no excuses. The paradox of this swine flu panic is that, while totally unexpected, it was accurately predicted. Six years ago, Science dedicated a major story to evidence that "after years of stability, the North American swine flu virus has jumped onto an evolutionary fasttrack".

However, maybe this is precisely what public health authorities desire.




This is NOT the First Swine Flu Panic


My guess is that you can expect to see a lot of panic over this issue in the near future. But the key is to remain calm -- this isn"t the first time the public has been warned about swine flu. The last time was in 1976, right before I entered medical school and I remember it very clearly. It resulted in the massive swine flu vaccine campaign.

Do you happen to recall the result of this massive campaign?

Within a few months, claims totaling $1.3 billion had been filed by victims who had suffered paralysis from the vaccine. The vaccine was also blamed for 25 deaths.

However, several hundred people developed crippling Guillain-Barré Syndrome after they were injected with the swine flu vaccine. Even healthy 20-year-olds ended up as paraplegics.

And the swine flu pandemic itself? It never materialized.




More People Died From the Swine Flu Vaccine than Swine Flu!

It is very difficult to forecast a pandemic, and a rash response can be extremely damaging.

To put things into perspective, malaria kills 3,000 people EVERY DAY, and it"s considered "a health problem"... But of course, there are no fancy vaccines for malaria that can rake in billions of dollars in a short amount of time.

One Australian news source,3 for example, states that even a mild swine flu epidemic could lead to the deaths of 1.4 million people and would reduce economic growth by nearly $5 trillion dollars.

Give me a break, if this doesn"t sound like the outlandish cries of the pandemic bird-flu I don"t know what does. Do you remember when President Bush said two million Americans would die as a result of the bird flu?

In 2005, in 2006, 2007, and again in 2008, those fears were exposed as little more than a cruel hoax, designed to instill fear, and line the pocketbooks of various individuals and industry. I became so convinced by the evidence AGAINST the possibility of a bird flu pandemic that I wrote a New York Times bestselling book, The Bird Flu Hoax, all about the massive fraud involved with the epidemic that never happened..




What is the Swine Flu?

Regular swine flu is a contagious respiratory disease, caused by a type-A influenza virus that affects pigs. The current strain, A(H1N1), is a new variation of an H1N1 virus -- which causes seasonal flu outbreaks in humans -- that also contains genetic material of bird and pig versions of the flu.

Interestingly enough, this version has never before been seen in neither human nor animal, which I will discuss a bit later.

This does sound bad. But not so fast. There are a few reasons to not rush to conclusions that this is the deadly pandemic we"ve been told would occur in the near future (as if anyone could predict it without having some sort of inside knowledge).




Why a True Bird- or Swine Flu Pandemic is HIGHLY Unlikely
While in my opinion it is highly likely factory farming is responsible for producing this viral strain, I believe there is still no cause for concern.


You may not know this, but all H1N1 flu"s are descendants of the 1918 pandemic strain. The reason why the flu shot may or may not work, however, from year to year, is due to mutations. Therefore, there"s no vaccine available for this current hybrid flu strain, and naturally, this is feeding the fear that millions of people will die before a vaccine can be made.

However, let me remind you of one very important fact here.

Just a couple of months ago, scientists concluded that the 1918 flu pandemic that killed between 50-100 million people worldwide in a matter of 18 months -- which all these worst case scenarios are built upon -- was NOT due to the flu itself!4

Instead, they discovered the real culprit was strep infections.

People with influenza often get what is known as a "superinfection" with a bacterial agent. In 1918 it appears to have been Streptococcus pneumoniae.

Since strep is much easier to treat than the flu using modern medicine, a new pandemic would likely be much less dire than it was in the early 20th century, the researchers concluded.

Others, such as evolutionary biologist Paul Ewald,5 claim that a pandemic of this sort simply cannot happen, because in order for it to occur, the world has to change. Not the virus itself, but the world.

In a previous interview for Esquire magazine, in which he discusses the possibility of a bird flu pandemic, he states:

"They think that if a virus mutates, it"s an evolutionary event. Well, the virus is mutating because that is what viruses and other pathogens do. But evolution is not just random mutation. It is random mutation coupled with natural selection; it is a battle for competitive advantage among different strains generated by random mutation.

For bird flu to evolve into a human pandemic, the strain that finds a home in humanity has to be a strain that is both highly virulent and highly transmissible. Deadliness has to translate somehow into popularity; H5N1 has to find a way to kill or immobilize its human hosts, and still find other hosts to infect. Usually that doesn"t happen."

Ewald goes on to explain that evolution in general is all about trade-offs, and in the evolution of infections the trade-off is between virulence and transmissibility.

What this means is that in order for a "bird flu" or "swine flu" to turn into a human pandemic, it has to find an environment that favors both deadly virulence and ease of transmission.

People living in squalor on the Western Front at the end of World War I generated such an environment, from which the epidemic of 1918 could arise.

Likewise, crowded chicken farms, slaughterhouses, and jam-packed markets of eastern Asia provide another such environment, and that environment gave rise to the bird flu -- a pathogen that both kills and spreads, in birds, but not in humans.

Says Ewald:

"We know that H5N1 is well adapted to birds. We also know that it has a hard time becoming a virus that can move from person to person. It has a hard time without our doing anything. But we can make it harder. We can make sure it has no human population in which to evolve transmissibility. There is no need to rely on the mass extermination of chickens. There is no need to stockpile vaccines for everyone.

By vaccinating just the people most at risk -- the people who work with chickens and the caregivers -- we can prevent it from becoming transmissible among humans. Then it doesn"t matter what it does in chickens."

Please remember that, despite the fantastic headlines and projections of MILLIONS of deaths, the H5N1 bird flu virus killed a mere 257 people worldwide since late 2003. As unfortunate as those deaths are, 257 deaths worldwide from any disease, over the course of five years, simply does not constitute an emergency worthy of much attention, let alone fear!

Honestly, your risk of being killed by a lightning strike in the last five years was about 2,300 percent higher than your risk of contracting and dying from the bird flu.6 I"m not kidding! In just one year (2004), more than 1,170 people died from lighting strikes, worldwide.7

So please, as the numbers of confirmed swine flu cases are released, keep a level head and don"t let fear run away with your brains.





So is the Swine Flu Getting More or Less Dangerous?

On Sunday, April 26, The Independent reported that more than 1,000 people had contracted the swine flu virus in Mexico, 8 but by the afternoon that same day, Mexican President Calderon declared that more than two-thirds of the 1,300 thought to have contracted the disease had been given a clean bill of health and sent home.9

Additionally, the number of actual confirmed cases appears to be far lower than reported in many media outlets, leading me to believe that many reporters are interchanging the terms "suspected cases" and "confirmed cases."

Interestingly Mexico is the ONLY country in the world where someone has actually died from this disease.Mexico has reported 159 fatalities in flu-like cases in recent days, seven of which have been confirmed as swine flu. Another 19 patients have been confirmed as having swine flu but surviving. Although some insiders at WHO believe these numbers are seriously inflated and could be as low as single digits.


By contrast, the United States has had 91 confirmed cases, five hospitalizations and no deaths from US Citizens. On April 29th CNN reported the first swine fatality in the US, however this was actually a child from Mexico that died in Texas.
According to the World Health Organization"s Epidemic and Pandemic Alert and Response site; as of April 27, there are:

91 laboratory confirmed cases in U.S. -- 0 deaths (reported by CDC as of April 30)
26 confirmed cases in Mexico -- 7 deaths
6 confirmed cases in Canada -- 0 deaths
1 confirmed case in Spain -- 0 deaths
Additionally, nearly all suspected new cases have been reported as mild.

Personally, I am highly skeptical. It simply doesn"t add up to a real pandemic.

But it does raise serious questions about where this brand new, never before seen virus came from, especially since it cannot be contracted from eating pork products, and has never before been seen in pigs, and contains traits from the bird flu -- and which, so far, only seems to respond to Tamiflu. Are we just that lucky, or... what?




Your Fear Will Make Some People VERY Rich in Today"s Crumbling Economy

According to the Associated Press at least one financial analyst estimates up to $388 million worth of Tamiflu sales in the near future10 -- and that"s without a pandemic outbreak.

More than half a dozen pharmaceutical companies, including Gilead Sciences Inc., Roche, GlaxoSmithKline and other companies with a stake in flu treatments and detection, have seen a rise in their shares in a matter of days, and will likely see revenue boosts if the swine flu outbreak continues to spread.

As soon as Homeland Security declared a health emergency, 25 percent -- about 12 million doses -- of Tamiflu and Relenza treatment courses were released from the nation"s stockpile. However, beware that the declaration also allows unapproved tests and drugs to be administered to children. Many health- and government officials are more than willing to take that chance with your life, and the life of your child. But are you?

Remember, Tamiflu went through some rough times not too long ago, as the dangers of this drug came to light when, in 2007, the FDA finally began investigating some 1,800 adverse event reports related to the drug. Common side effects of Tamiflu include:


Nausea
Vomiting
Diarrhea
Headache
Dizziness
Fatigue
Cough
All in all, the very symptoms you"re trying to avoid.

More serious symptoms included convulsions, delirium or delusions, and 14 deaths in children and teens as a result of neuropsychiatric problems and brain infections (which led Japan to ban Tamiflu for children in 2007). And that"s for a drug that, when used as directed, only reduces the duration of influenza symptoms by 1 to 1 ½ days, according to the official data.

But making matters worse, some patients with influenza are at HIGHER risk for secondary bacterial infections when on Tamiflu. And secondary bacterial infections, as I mentioned earlier, was likely the REAL cause of the mass fatalities during the 1918 pandemic!




Where did This Mysterious New Animal-Human Flu Strain Come From?

Alongside the fear-mongering headlines, I"ve also seen increasing numbers of reports questioning the true nature of this virus. And rightfully so.

Could a mixed animal-human mutant like this occur naturally? And if not, who made it, and how was it released?

Not one to dabble too deep in conspiracy theories, I don"t have to strain very hard to find actual facts to support the notion that this may not be a natural mutation, and that those who stand to gain have the wherewithal to pull off such a stunt.

Just last month I reported on the story that the American pharmaceutical company Baxter was under investigation for distributing the deadly avian flu virus to 18 different countries as part of a seasonal flu vaccine shipment. Czech reporters were probing to see if it may have been part of a deliberate attempt to start a pandemic; as such a "mistake" would be virtually impossible under the security protocols of that virus.

The H5N1 virus on its own is not very airborne. However, when combined with seasonal flu viruses, which are more easily spread, the effect could be a potent, airborne, deadly, biological weapon. If this batch of live bird flu and seasonal flu viruses had reached the public, it could have resulted in dire consequences.

There is a name for this mixing of viruses; it"s called "reassortment," and it is one of two ways pandemic viruses are created in the lab. Some scientists say the most recent global outbreak -- the 1977 Russian flu -- was started by a virus created and leaked from a laboratory.

Another example of the less sterling integrity of Big Pharma is the case of Bayer, who sold millions of dollars worth of an injectable blood-clotting medicine to Asian, Latin American, and some European countries in the mid-1980s, even though they knew it was tainted with the AIDS virus.

So while it is morally unthinkable that a drug company would knowingly contaminate flu vaccines with a deadly flu virus such as the bird- or swine flu, it is certainly not impossible. It has already happened more than once.

But there seems to be no repercussions or hard feelings when industry oversteps the boundaries of morality and integrity and enters the arena of obscenity. Because, lo and behold, which company has been chosen to head up efforts, along with WHO, to produce a vaccine against the Mexican swine flu?

Baxter!11 Despite the fact that ink has barely dried on the investigative reports from their should-be-criminal "mistake" against humanity.

According to other sources,12 a top scientist for the United Nations, who has examined the outbreak of the deadly Ebola virus in Africa, as well as HIV/AIDS victims, has concluded that the current swine flu virus possesses certain transmission "vectors" that suggest the new strain has been genetically-manufactured as a military biological warfare weapon.

The UN expert believes that Ebola, HIV/AIDS, and the current A-H1N1 swine flu virus are biological warfare agents.

In addition, Army criminal investigators are looking into the possibility that disease samples are missing from biolabs at Fort Detrick -- the same Army research lab from which the 2001 anthrax strain was released, according to a recent article in the Fredrick News Post.13 In February, the top biodefense lab halted all its research into Ebola, anthrax, plague, and other diseases known as "select agents," after they discovered virus samples that weren"t listed in its inventory and might have been switched with something else.




Factory Farming Maybe Source of Swine Flu

Another theory as to the cause of Swine Flu might be factory farming. In the United States, pigs travel coast to coast. They can be bred in North Carolina, fattened in the corn belt of Iowa, and slaughtered in California.

While this may reduce short-term costs for the pork industry, the highly contagious nature of diseases like influenza (perhaps made further infectious by the stresses of transport) needs to be considered when calculating the true cost of long-distance live animal transport.

The majority of U.S. pig farms now confine more than 5,000 animals each. With a group of 5,000 animals, if a novel virus shows up it will have more opportunity to replicate and potentially spread than in a group of 100 pigs on a small farm.

With massive concentrations of farm animals within which to mutate, these new swine flu viruses in North America seem to be on an evolutionary fast track, jumping and reassorting between species at an unprecedented rate.




Should You Accept a Flu Vaccine -- Just to be Safe?


As stated in the New York Times14 and elsewhere, flu experts have no idea whether the current seasonal flu vaccine would offer any protection whatsoever against this exotic mutant, and it will take months to create a new one.

But let me tell you, getting vaccinated now would not only offer no protection and potentially cause great harm, it would most likely be loaded with toxic mercury which is used as a preservative in most flu vaccines..

I"ve written extensively about the numerous dangers (and ineffectiveness) of flu vaccines, and why I do not recommend them to anyone. So no matter what you hear -- even if it comes from your doctor -- don"t get a regular flu shot. They rarely work against seasonal flu...and certainly can"t offer protection against a never-before- seen strain.

Currently, the antiviral drugs Tamiflu and Relenza are the only drugs that appear effective against the (human flu) H1N1 virus, and I strongly believe taking Tamiflu to protect yourself against this new virus could be a serious mistake -- for all the reasons I already mentioned above.

But in addition to the dangerous side effects of Tamiflu, there is also growing evidence of resistance against the drug. In February, the pre-publication and preliminary findings journal called Nature Precedings published a paper on this concern, stating15:

The dramatic rise of oseltamivir [Tamiflu] resistance in the H1N1 serotype in the 2007/2008 season and the fixing of H274Y in the 2008/2009 season has raised concerns regarding individuals at risk for seasonal influenza, as well as development of similar resistance in the H5N1 serotype [bird flu].

Previously, oseltamivir resistance produced changes in H1N1 and H3N2 at multiple positions in treated patients. In contrast, the recently reported resistance involved patients who had not recently taken oseltamivir.

It"s one more reason not to bother with this potentially dangerous drug.

And, once a specific swine flu drug is created, you can be sure that it has not had the time to be tested in clinical trials to determine safety and effectiveness, which puts us right back where I started this article -- with a potential repeat of the last dangerous swine flu vaccine, which destroyed the lives of hundreds of people.

Topping the whole mess off, of course, is the fact that if the new vaccine turns out to be a killer, the pharmaceutical companies responsible are immune from lawsuits -- something I"ve also warned about before on numerous occasions.

Unfortunately, those prospects won"t stop the governments of the world from mandating the vaccine -- a scenario I hope we can all avoid.





How to Protect Yourself Without Dangerous Drugs and Vaccinations

For now, my point is that there are always going to be threats of flu pandemics, real or created, and there will always be potentially toxic vaccines that are peddled as the solution. But you can break free of that whole drug-solution trap by following some natural health principles.
I have not caught a flu in over two decades, and you can avoid it too, without getting vaccinated, by following these simple guidelines, which will keep your immune system in optimal working order so that you"re far less likely to acquire the infection to begin with.

Optimize your vitamin D levels. As I"ve previously reported, optimizing your vitamin D levels is one of the absolute best strategies for avoiding infections of ALL kinds, and vitamin D deficiency is likely the TRUE culprit behind the seasonality of the flu -- not the flu virus itself.
This is probably the single most important and least expensive action you can take. I would STRONGLY urge you to have your vitamin D level monitored to confirm your levels are therapeutic at 50-70 ng.ml and done by a reliable vitamin D lab like Lab Corp.


For those of you in the US we hope to launch a vitamin D testing service through Lab Corp that allows you to have your vitamin D levels checked at your local blood drawing facility, and relatively inexpensively. We hope to offer this service by June 2009.

If you are coming down with flu like symptoms and have not been on vitamin D you can take doses of 50,000 units a day for three days to treat the acute infection. Some researchers like Dr. Cannell, believe the dose could even be as high as 1000 units per pound of body weight for three days.

However, most of Dr. Cannell"s work was with seasonal and not pandemic flu. If your body has never been exposed to the antigens there is chance that the vitamin D might not work. However the best bet is to maintain healthy levels of vitamin D around 60 ng/ml.

BUT to keep this in perspective the regular flu, not the swine flu, has killed 13,000 in the US since January. But there is strong support that these types of figures are grossly exaggerated to increase vaccine sales. However, the fact remains that the regular flu at this point in time is FAR more dangerous than the swine flu and were you worried about the regular flu before the media started talking this up?


Avoid Sugar and Processed Foods. Sugar decreases the function of your immune system almost immediately, and as you likely know, a strong immune system is key to fighting off viruses and other illness. Be aware that sugar is present in foods you may not suspect, like ketchup and fruit juice.


Get Enough Rest. Just like it becomes harder for you to get your daily tasks done if you"re tired, if your body is overly fatigued it will be harder for it to fight the flu. Be sure to check out my article Guide to a Good Night"s Sleep for some great tips to help you get quality rest.


Have Effective Tools to Address Stress . We all face some stress every day, but if stress becomes overwhelming then your body will be less able to fight off the flu and other illness.

If you feel that stress is taking a toll on your health, consider using an energy psychology tool such as the Emotional Freedom Technique (EFT), which is remarkably effective in relieving stress associated with all kinds of events, from work to family to trauma. You can check out my free, 25-page EFT manual for some guidelines on how to perform EFT.


Exercise. When you exercise, you increase your circulation and your blood flow throughout your body. The components of your immune system are also better circulated, which means your immune system has a better chance of finding an illness before it spreads. You can review my exercise guidelines for some great tips on how to get started.


Take a good source of animal based omega-3 fats like Krill Oil. Increase your intake of healthy and essential fats like the omega-3 found in krill oil, which is crucial for maintaining health. It is also vitally important to avoid damaged omega-6 oils that are trans fats and in processed foods as it will seriously damage your immune response.


Wash Your Hands. Washing your hands will decrease your likelihood of spreading a virus to your nose, mouth or other people. Be sure you don"t use antibacterial soap for this -- antibacterial soaps are completely unnecessary, and they cause far more harm than good. Instead, identify a simple chemical-free soap that you can switch your family to.


Eat Garlic Regularly. Garlic works like a broad-spectrum antibiotic against bacteria, virus, and protozoa in the body. And unlike with antibiotics, no resistance can be built up so it is an absolutely safe product to use. However, if you are allergic or don"t enjoy garlic it would be best to avoid as it will likely cause more harm than good.

Avoid Hospitals and Vaccines In this particular case, I"d also recommend you stay away from hospitals unless you"re having an emergency, as hospitals are prime breeding grounds for infections of all kinds, and could be one of the likeliest places you could be exposed to this new bug. Vaccines will not be available for six months at the minimum but when available they will be ineffective and can lead to crippling paralysis like Guillain-Barré Syndrome just as it did in the 70s.



References

1 World Health Organization, Epidemic and Pandemic Alert Response, Current WHO Phase of Pandemic Alert, http://www.who.int/csr/disease/avian_influenza/phase/en/index.html

2 Welt Online, April 28, 2009, http://www.welt.de/english-news/article3625539/Asian-countries-take-measures-against-outbreak.html

3 News.com.au, April 27, 2009, http://www.news.com.au/story/0,23599,25392380-2,00.html

4 Emerging Infectious Diseases February 2009; 15(2):346-7, http://www.ncbi.nlm.nih.gov/sites/entrez?orig_db=PubMed&db=pubmed&cmd=Search&term="Emerging%20infectious%20diseases"[Jour]%20AND%202009[pdat]%20AND%20Klugman[author]

5 Esquire, April 26, 2009, http://www.esquire.com/features/best-n-brightest-2005/ESQ1205B&BEWALD_244?src=digg

6 CDC, Lightning-Associated Deaths 1980-1995, http://wonder.cdc.gov/wonder/PrevGuid/m0052833/m0052833.asp

7 NationMaster.com, Mortality--Lighting, http://www.nationmaster.com/red/pie/mor_vic_of_lig-mortality-victim-of-lightning

8 The Independent, April 26, 2009, http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/pandemic-fears-as-flu-kills-68-1674368.html

9 Reuters, April 26, 2009, http://www.reuters.com/article/topNews/idUSTRE53P23920090426

10 Associated Press, April 27, 2009, http://www.google.com/hostednews/ap/article/ALeqM5hceWV2_Cu7yoSvw9iNYZ90-qnCyQD97R2FVG3

11 Infowars.net, April 27, 2009, http://www.infowars.net/articles/april2009/270409Baxter.htm

12 Online Journal, April 27, 2009 http://onlinejournal.com/artman/publish/article_4631.shtml

13 FredrickNewsPost.com, April 22, 2009, http://www.fredericknewspost.com/sections/news/display.htm?StoryID=89293

14 The New York Times, April 26, 2009, http://www.nytimes.com/2009/04/27/world/27flu.html?_r=3&pagewanted=1

15 Nature Precedings, hdl:10101/npre.2009.2832.1, Emergence and Fixing of Antiviral Resistance in Influenza A Via Recombination and Hitch Hiking, Henry L. Niman, http://precedings.nature.com/documents/2832/version/1

Monday, April 20, 2009

Pharma-Waste Tainting Our Water

AP IMPACT: Tons of released drugs taint US water
Monday, April 20, 2009 By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
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U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water _ contamination the federal government has consistently overlooked, according to an Associated Press investigation.
Hundreds of active pharmaceutical ingredients are used in a variety of manufacturing, including drugmaking: For example, lithium is used to make ceramics and treat bipolar disorder; nitroglycerin is a heart drug and also used in explosives; copper shows up in everything from pipes to contraceptives.
Federal and industry officials say they don't know the extent to which pharmaceuticals are released by U.S. manufacturers because no one tracks them _ as drugs. But a close analysis of 20 years of federal records found that, in fact, the government unintentionally keeps data on a few, allowing a glimpse of the pharmaceuticals coming from factories.
As part of its ongoing PharmaWater investigation about trace concentrations of pharmaceuticals in drinking water, AP identified 22 compounds that show up on two lists: the EPA monitors them as industrial chemicals that are released into rivers, lakes and other bodies of water under federal pollution laws, while the Food and Drug Administration classifies them as active pharmaceutical ingredients.
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The data don't show precisely how much of the 271 million pounds comes from drugmakers versus other manufacturers; also, the figure is a massive undercount because of the limited federal government tracking.
To date, drugmakers have dismissed the suggestion that their manufacturing contributes significantly to what's being found in water. Federal drug and water regulators agree.
But some researchers say the lack of required testing amounts to a 'don't ask, don't tell' policy about whether drugmakers are contributing to water pollution.
"It doesn't pass the straight-face test to say pharmaceutical manufacturers are not emitting any of the compounds they're creating," said Kyla Bennett, who spent 10 years as an EPA enforcement officer before becoming an ecologist and environmental attorney.
Pilot studies in the U.S. and abroad are now confirming those doubts.
Last year, the AP reported that trace amounts of a wide range of pharmaceuticals _ including antibiotics, anti-convulsants, mood stabilizers and sex hormones _ have been found in American drinking water supplies. Including recent findings in Dallas, Cleveland and Maryland's Prince George's and Montgomery counties, pharmaceuticals have been detected in the drinking water of at least 51 million Americans.
Most cities and water providers still do not test. Some scientists say that wherever researchers look, they will find pharma-tainted water.
Consumers are considered the biggest contributors to the contamination. We consume drugs, then excrete what our bodies don't absorb. Other times, we flush unused drugs down toilets. The AP also found that an estimated 250 million pounds of pharmaceuticals and contaminated packaging are thrown away each year by hospitals and long-term care facilities.
Researchers have found that even extremely diluted concentrations of drugs harm fish, frogs and other aquatic species. Also, researchers report that human cells fail to grow normally in the laboratory when exposed to trace concentrations of certain drugs. Some scientists say they are increasingly concerned that the consumption of combinations of many drugs, even in small amounts, could harm humans over decades.
Utilities say the water is safe. Scientists, doctors and the EPA say there are no confirmed human risks associated with consuming minute concentrations of drugs. But those experts also agree that dangers cannot be ruled out, especially given the emerging research.
___
Two common industrial chemicals that are also pharmaceuticals _ the antiseptics phenol and hydrogen peroxide _ account for 92 percent of the 271 million pounds identified as coming from drugmakers and other manufacturers. Both can be toxic and both are considered to be ubiquitous in the environment.
However, the list of 22 includes other troubling releases of chemicals that can be used to make drugs and other products: 8 million pounds of the skin bleaching cream hydroquinone, 3 million pounds of nicotine compounds that can be used in quit-smoking patches, 10,000 pounds of the antibiotic tetracycline hydrochloride. Others include treatments for head lice and worms.
Residues are often released into the environment when manufacturing equipment is cleaned.
A small fraction of pharmaceuticals also leach out of landfills where they are dumped. Pharmaceuticals released onto land include the chemo agent fluorouracil, the epilepsy medicine phenytoin and the sedative pentobarbital sodium. The overall amount may be considerable, given the volume of what has been buried _ 572 million pounds of the 22 monitored drugs since 1988.
In one case, government data shows that in Columbus, Ohio, pharmaceutical maker Boehringer Ingelheim Roxane Inc. discharged an estimated 2,285 pounds of lithium carbonate _ which is considered slightly toxic to aquatic invertebrates and freshwater fish _ to a local wastewater treatment plant between 1995 and 2006. Company spokeswoman Marybeth C. McGuire said the pharmaceutical plant, which uses lithium to make drugs for bipolar disorder, has violated no laws or regulations. McGuire said all the lithium discharged, an annual average of 190 pounds, was lost when residues stuck to mixing equipment were washed down the drain.
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Pharmaceutical company officials point out that active ingredients represent profits, so there's a huge incentive not to let any escape. They also say extremely strict manufacturing regulations _ albeit aimed at other chemicals _ help prevent leakage, and that whatever traces may get away are handled by onsite wastewater treatment.
"Manufacturers have to be in compliance with all relevant environmental laws," said Alan Goldhammer, a scientist and vice president at the industry trade group Pharmaceutical Research and Manufacturers of America.
Goldhammer conceded some drug residues could be released in wastewater, but stressed "it would not cause any environmental issues because it was not a toxic substance at the level that it was being released at."
Several big drugmakers were asked this simple question: Have you tested wastewater from your plants to find out whether any active pharmaceuticals are escaping, and if so what have you found?
No drugmaker answered directly.
"Based on research that we have reviewed from the past 20 years, pharmaceutical manufacturing facilities are not a significant source of pharmaceuticals that contribute to environmental risk," GlaxoSmithKline said in a statement.
AstraZeneca spokeswoman Kate Klemas said the company's manufacturing processes "are designed to avoid, or otherwise minimize the loss of product to the environment" and thus "ensure that any residual losses of pharmaceuticals to the environment that do occur are at levels that would be unlikely to pose a threat to human health or the environment."
One major manufacturer, Pfizer Inc., acknowledged that it tested some of its wastewater _ but outside the United States.
The company's director of hazard communication and environmental toxicology, Frank Mastrocco, said Pfizer has sampled effluent from some of its foreign drug factories. Without disclosing details, he said the results left Pfizer "confident that the current controls and processes in place at these facilities are adequately protective of human health and the environment."
It's not just the industry that isn't testing.
FDA spokesman Christopher Kelly noted that his agency is not responsible for what comes out on the waste end of drug factories. At the EPA, acting assistant administrator for water Mike Shapiro _ whose agency's Web site says pharmaceutical releases from manufacturing are "well defined and controlled" _ did not mention factories as a source of pharmaceutical pollution when asked by the AP how drugs get into drinking water.
"Pharmaceuticals get into water in many ways," he said in a written statement. "It's commonly believed the majority come from human and animal excretion. A portion also comes from flushing unused drugs down the toilet or drain; a practice EPA generally discourages."
His position echoes that of a line of federal drug and water regulators as well as drugmakers, who concluded in the 1990s _ before highly sensitive tests now used had been developed _ that manufacturing is not a meaningful source of pharmaceuticals in the environment.
Pharmaceutical makers typically are excused from having to submit an environmental review for new products, and the FDA has never rejected a drug application based on potential environmental impact. Also at play are pressures not to delay potentially lifesaving drugs. What's more, because the EPA hasn't concluded at what level, if any, pharmaceuticals are bad for the environment or harmful to people, drugmakers almost never have to report the release of pharmaceuticals they produce.
"The government could get a national snapshot of the water if they chose to," said Jennifer Sass, a senior scientist for the Natural Resources Defense Council, "and it seems logical that we would want to find out what's coming out of these plants."
Ajit Ghorpade, an environmental engineer who worked for several major pharmaceutical companies before his current job helping run a wastewater treatment plant, said drugmakers have no impetus to take measurements that the government doesn't require.
"Obviously nobody wants to spend the time or their dime to prove this," he said. "It's like asking me why I don't drive a hybrid car? Why should I? It's not required."
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After contacting the nation's leading drugmakers and filing public records requests, the AP found two federal agencies that have tested.
Both the EPA and the U.S. Geological Survey have studies under way comparing sewage at treatment plants that receive wastewater from drugmaking factories against sewage at treatment plants that do not.
Preliminary USGS results, slated for publication later this year, show that treated wastewater from sewage plants serving drug factories had significantly more medicine residues. Data from the EPA study show a disproportionate concentration in wastewater of an antibiotic that a major Michigan factory was producing at the time the samples were taken.
Meanwhile, other researchers recorded concentrations of codeine in the southern reaches of the Delaware River that were at least 10 times higher than the rest of the river.
The scientists from the Delaware River Basin Commission won't have to look far when they try to track down potential sources later this year. One mile from the sampling site, just off shore of Pennsville, N.J., there's a pipe that spits out treated wastewater from a municipal plant. The plant accepts sewage from a pharmaceutical factory owned by Siegfried Ltd. The factory makes codeine.
"We have implemented programs to not only reduce the volume of waste materials generated but to minimize the amount of pharmaceutical ingredients in the water," said Siegfried spokeswoman Rita van Eck.
Another codeine plant, run by Johnson & Johnson subsidiary Noramco Inc., is about seven miles away. A Noramco spokesman acknowledged that the Wilmington, Del., factory had voluntarily tested its wastewater and found codeine in trace concentrations thousands of times greater than what was found in the Delaware River. "The amounts of codeine we measured in the wastewater, prior to releasing it to the City of Wilmington, are not considered to be hazardous to the environment," said a company spokesman.
In another instance, equipment-cleaning water sent down the drain of an Upsher-Smith Laboratories, Inc. factory in Denver consistently contains traces of warfarin, a blood thinner, according to results obtained under a public records act request. Officials at the company and the Denver Metro Wastewater Reclamation District said they believe the concentrations are safe.
Warfarin, which also is a common rat poison and pesticide, is so effective at inhibiting growth of aquatic plants and animals it's actually deliberately introduced to clean plants and tiny aquatic animals from ballast water of ships.
"With regard to wastewater management we are subject to a variety of federal, state and local regulation and oversight," said Joel Green, Upsher-Smith's vice president and general counsel. "And we work hard to maintain systems to promote compliance."
Baylor University professor Bryan Brooks, who has published more than a dozen studies related to pharmaceuticals in the environment, said assurances that drugmakers run clean shops are not enough.
"I have no reason to believe them or not believe them," he said. "We don't have peer-reviewed studies to support or not support their claims."
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Associated Press Writer Don Mitchell in Denver contributed to this report.
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