Statin's...Recipe for disaster

Dr. Graveline has an interesting background that makes him particularly suited to speak on the topic of statin drugs. He's a medical doctor with 23 years of experience whose health was seriously damaged by a statin drug. His personal questions brought him out of retirement to investigate statins, which he's been doing for the past 10 years.

As a former astronaut, he would get annual physicals at the Johnson Space Center in Houston. In 1999 his cholesterol hit 280 and he was given a prescription for Lipitor.

"When they suggested Lipitor (10 mg), I went along with it because I had no reason to be particularly worried about statin drugs," he says. "I had used it a year or so before my retirement, but I wasn't a big user."

However, it quickly became apparent that something was seriously wrong.

"It was six weeks later when I experienced my first episode of what was later diagnosed as transient global amnesia," Dr. Graveline says.

"This is an unusual form of amnesia wherein you immediately, without the slightest warning, are unable to formulate new memory and you can no longer communicate. Not because you cannot talk, but you can't remember the last syllable that was spoken to you. So nothing you say is relevant anymore. In addition, you have a retrograde loss of memory, sometimes decades into the past."

He "woke up" about six hours later in the office of a neurologist, who gave him the diagnosis: transient global amnesia. He quit taking the Lipitor despite the reassurances from his doctors that the drug was not of concern, and that it was just a coincidence.

He had no relapses during the remainder of the year, but his cholesterol was still around 280 at his next physical. He was again urged to take Lipitor, and he relented.

"I admit I was concerned, but I had talked to maybe 30 doctors and a few pharmacologists during the interval," Dr. Graveline says. "They all said "statins don't do that." So I allowed myself to go back on statins but this time I took just 5 mg.

…[E]ight weeks later, I had my second, and my worst episode. In this one, I was a 13-year-old high school student for 12 hours... This is what convinced me, when I finally woke up, that something was wrong with the statin drugs. And yet, the doctors were, for years after that, still saying that this was just a remarkable coincidence.

This took me out of retirement and I've been actively involved in researching statin drugs ever since."

Statin Drugs: Not Nearly as Safe as You're Told

Dr. Graveline has since published a book about his discoveries called Lipitor: Thief of Memory.

"In trying to reach an explanation, I called Joe Graedon and asked him if he had ever heard of any unusual reactions associated with statins," Dr. Graveline says of his initial investigations.

He was directed to the statin effects study by Beatrice Golomb in San Diego, California, and his story was also published in a syndicated newspaper column. Within weeks, the web site he had created received reports of 22 cases of transient global amnesia, along with hundreds of cases of cognitive damage. At present, over 2,000 cases of transient global amnesia associated with the use of statins have been reported to FDA's MedWatch.

But cognitive problems are not the only harmful aspect of these drugs. Other serious adverse reactions include:

• Personality changes / mood disorders
• Muscle problems, polyneuropathy (nerve damage in the hands and feet), and rhabdomyolysis (a serious degenerative muscle tissue condition)
• Sexual dysfunction
• Immune suppression
• Pancreas or liver dysfunction, including a potential increase in liver enzymes
• Cataracts

According to Dr. Graveline, a form of Lou Gehrig's disease or ALS may also be a side effect, although the US FDA is resistant to accept the link found by their Swedish counterpart, and has so far refused to issue a warning.

"The World Health Organization (WHO) reported on this in July 2007 when Ralph Edwards, who directs the Vigibase in Sweden (the equivalent of the US MedWatch), reported ALS-like conditions in statin users worldwide," Dr. Graveline says.

He has since forwarded hundreds of cases to MedWatch, but the FDA still has not been moved to act, and doctors are therefore unaware of the connection between this deadly disease and statin use.

"[W]e have anecdotal evidence that if you stop the statin drug early enough, some of these cases regress. That's why we thought it was important that FDA issue a warning, but they haven't," Dr. Graveline says.

Today, all of these adverse effects, including the cognitive problems Dr. Graveline warned about 10 years ago, are supported by published research. MedWatch has received about 80,000 reports of adverse events related to statin drugs, and remember, only an estimated one to 10 percent of side effects are ever reported, so the true scope of statins' adverse effects are still greatly underestimated.

For a more in-depth explanation of how statins damage your mitochondria and DNA, resulting in a variety of health problems, please listen to the interview in its entirety or read through the transcript as he discusses far more than I can include here.

How Statins Harm Your Brain Function

As is often the case with pharmaceutical drugs, the side effects end up teaching us new things about how the human body works. When statins first hit the market, conventional medicine was unaware of the importance of cholesterol for proper brain function. Now, researchers believe that statins' adverse effects on cognition are due to cholesterol insufficiency.

Research also began to emerge in 2001 showing the importance of cholesterol in the formation of memories.

"Then we have… dolichols," Dr. Graveline says. "[W]hen a statin is used, it blocks the mevalonate pathway to get at cholesterol inhibition. It works very beautifully. But in so doing, it blocks CoQ10, dolichols, as well as other major biochemicals…

[D]olichol is one that most doctors have never even heard of before, but it just so happens that dolichols are almost as important as CoQ10 and cholesterol in cell processing."

In fact, dolichols are vital to a number of cellular processes, including:

• Glycoprotein synthesis
• Cell identification
• Cell communication
• Immunodefense
• Neurohormone formation

Dr. Graveline goes on to explain that dolichols influence all the hormones involved with your mental condition, including your emotions and moods. And if you do not have sufficient dolichol, your entire process of neurohormone production will be altered—with potentially devastating results.

"[T]here are thousands of reports of aggressiveness and hostility, increased sensitivity, paranoia, depression and homicidal ideation," Dr. Graveline says.

There are also numerous reports of suicide.

"This whole range of what I call personality- or emotion and behavioral responses have to do with the dolichol deficiency brought on by the mevalonate blockade," Dr. Graveline explains.

"It's not just something that occurs in an occasional person… You know we're all the same and yet we're all different… You give one medicine to 10 people and if you're really lucky, in six of them it will do what it's supposed to do. That's the way it is with this. I expect there are some people that won't get any effects of dolichol suppression because they have alternative pathways. The same thing probably holds for CoQ10."

That said, it's important to realize that your brain also requires cholesterol in order for memory formation to function normally. In essence, statins suppress a number of vital elements for proper brain functioning, including cholesterol, antioxidants and co-factors like CoQ10, and dolichol.

At the same time, statins also create mitochondrial DNA and cellular damage, including in your brain.

Your brain uses glial cells as factories for producing its own cholesterol on demand. Unfortunately, glial cells are affected by statins in the same way as your liver cells, or any other cell in our body. So if you take a statin, you're also harming your glial cells and when they cease to function normally, that on-demand cholesterol capability also ceases and your brain can no longer function properly.

The Importance of CoQ10 or, if You're Over 40, Ubiquinol

It's now clear that if you take statin drugs without taking CoQ10, your health is at serious risk as statin drugs deplete your body of this essential co-enzyme. As your body gets more and more depleted of CoQ10, you may suffer from fatigue, muscle weakness and soreness, and eventually heart failure. Coenzyme Q10 is also very important in the process of neutralizing free radicals.

So when your CoQ10 is depleted, you enter a vicious cycle of increased free radicals, loss of cellular energy, and damaged mitochondrial DNA.

Unfortunately, the majority of people who take statins are unaware of their need for CoQ10, and physicians rarely advise their patients to take this supplement along with their statin—at least in the United States. It's also important to supplement right from the start. According to Dr. Graveline, once the mitochondrial damage and mutations are formed they cannot be reversed—no matter how much CoQ10 you take.

So early intervention is key. (Dr. Graveline goes into further detail of how CoQ10 offers protection against mitochondrial DNA damage in this interview, so for more information, please listen to it in its entirety.)If you decide to take a CoQ10 supplement and are over the age of 40, it's important to choose the reduced version, called ubiquinol.

Ubiquinol is a FAR more effective form—I personally take 1-3 a day as it has far-ranging health benefits. Dr. Graveline concurs with this recommendation.

As for dosage, Dr. Graveline makes the following recommendation:

• If you have symptoms of statin damage such as muscle pain, take anywhere from 200 to 500 mg
• If you just want to use it preventively, 200 mg or less should be sufficient

There's also evidence that CoQ10/ubiquinol is beneficial for Parkinson's disease and Alzheimer's disease, and even cancer, and that large doses may be justified in those cases as well.

In addition, CoQ10 is believed to play an important role in preventing premature aging in general by preventing telomere shortening, which can slow or potentially even reverse the aging process. This is just one of the additional benefits of CoQ10, and one of the reasons why I take ubiquinol daily even though I've never been on a statin drug.

There are no reported side effects of CoQ10 supplementation, and neither I nor Dr. Graveline have ever heard of anyone overdosing on it. The only drawback is cost.

However, if you're taking ubiquinol, here's some cost-saving information for you.

Certified reduced ubiquinol is only manufactured by one company in the entire world, a Japanese company called Kaneca. They own the patent. So, as long as it's certified ubiquinol, you can buy the cheapest brand you can find, because they're all the same.

Other Valuable Antioxidants for Optimal Health—Especially if You're Taking a Statin

CoQ10, or preferably the reduced version, ubiquinol, is at the top of the list of important supplements when you're taking a statin drug. But there are also other antioxidants and nutrients that can be helpful. For example, selenium is also seriously inhibited by statin drugs, and selenium, along with magnesium, are commonly involved as co-factors in a variety of biological functions.

Other important nutrients include:

• Vitamin C
• Vitamin D
• Vitamin E—An emerging form of vitamin E called tocotrienol is 50 times more powerful than tocopherol, which has been used for the past 60 years. It also helps produce cholesterol and has other biochemical advantages
• Alpha-lipoic acid
• L-carnitine—which helps metabolize fats properly. Since about 70 percent of your muscles' energy comes from fats, it's important to have the ability to metabolize them. INSERT LINE BREAK According to Dr. Graveline: "If you take L-carnitine and find that you suddenly feel much better, then you've just proven you need it for the rest of your life because you're one of those people who have a dysfunction in this capability; you don't have the means to properly burn fats at our muscle level… naturally you would then get weak when exercising. So it's useful for making a diagnosis. If nothing happens after three months of a good dose, then I would say you can forget about L-carnitine."

The Sad Truth: Even Your Doctor has Been Mislead About Cholesterol

That said, aside from taking CoQ10 if you're on a statin, your diet really should be your primary source of nutrients. (For vitamin D, you'd ideally get it from sun exposure.) Supplements are just that; supplemental to an otherwise healthy diet.

"I think that when you have a statin associated muscle or nerve or even brain dysfunction, this is where you've got to go because that's where the trouble is," Dr. Graveline agrees.

"[I]f it's cholesterol inhibition, you just eat more eggs… I can't believe I went 17 years and never ate an egg. I can't believe how gullible I was. I was this young medical doctor; I marched to that band of the cholesterol-causation people… I did everything I was supposed to do, and it was all wrong. I can't believe that I was led astray, maybe for 25 years of my practice! It's so bad to have to look back and realize you've been treating cardiovascular disease erroneously because you were doing what you were asked to do.The sad truth is that cholesterol, our supposed enemy for 35 years, has nothing to do with cardiovascular disease. it is the most important biochemical in your body.

… We all listened to what amounts to brainwashing. The brainwashing that we got from 1955 on, to just recently… They have liberalized the diet stuff recently though, so people are back to eating eggs and drinking whole milk and eating butter. I went around recommending margarine for so long, and margarine is what's causing disease—butter is what's helping to cure it. It's incredible!"

This is true for the majority of our conventional medical professionals. They simply do not know better… which is all the more reason to arm yourself with the information you need to take control of your own health. Shunning statin drugs and addressing your lifestyle is theway to go if you have high cholesterol. For more information, please see my statin index page which includes a plethora of free guidance and clear advice.

More Information

Dr. Graveline covers a lot of information in this interview, so I highly recommend you listen to the entire interview, or read through the transcript. You can also find more information on his web site: www.SpaceDoc.net .

Dr. Graveline's site serves both as a tool for reporting statin complications, and a database of adverse effects, which are then forwarded to the appropriate agencies.

Scientists find host of antibiotic-eating germs

By Julie SteenhuysenThu Apr 3, 5:48 PM ET

Several strains of bacteria in the soil can make a meal of the world's most potent antibiotics, researchers said on Thursday, in a startling finding that illustrates the extent to which these germ-fighting drugs are losing the war against superbugs.

A study of soil microbes taken from 11 sites uncovered bacteria that could withstand antibiotics 50 times stronger than the standard for bacterial resistance.

"It certainly was very surprising to us," said George Church, a geneticist at Harvard Medical School in Boston, whose research appears in the journal Science.

"Many bacteria in many different soil isolates can not only tolerate antibiotics, they can actually live on them as their sole source of nutrition," Church said in an audio interview on the journal's Web site.

Other researchers have found antibiotic-eating strains of bacteria, but Church's study is among the most systematic. It offers more clues about why bacteria quickly develop resistance to antibiotics, and why drug companies must constantly develop new antibiotics to defeat them.

Church's team initially set out to find organisms in the soil that remove toxins from cellulose, the material that gives plants structure. They took samples from a variety of sites, including a cornfield fertilized by manure from cows that were fed antibiotics.

Microbes taken from these soil samples could easily defeat toxins from cellulose, which they expected. Then the researchers tested the microbes against antibiotics, something they thought would be toxic.

"We were expecting them to grow on cellulose and we weren't expecting them to grow on antibiotics," Church said.

Surprised by how easily the microbes devoured the antibiotics, Church and colleagues did a broader test, exposing hundreds of microbes to 18 antibiotics representing most of the major classes of naturally occurring and synthetic antibiotics, including penicillin and the widely prescribed antibiotic ciprofloxacin.

"We could find ... bacteria that could grow on almost all of them," depending on the bacteria and the source of the soil, Church said.

The bacteria were not known to attack humans, but some were close relatives, such as members of the Burkholderia cepacia complex, a group of bacteria that infect people with cystic fibrosis, and Serratia marcescens, which can cause blood infections in people with compromised immune systems.

Church said the finding underscores the extent to which bacteria have developed resistance to antibiotics, a process that started almost as soon as penicillin was introduced in the 1940s. Overuse and misuse of antibiotics have since fueled the rise of drug-resistant superbugs.

"This is yet another way of looking at resistance," Church said of the study. He said the microbes he found may be using a new way to disarm the antibiotics, but it may take some time to figure that out.

One antibiotic resistant infection, caused by a strain known as methicillin-resistant Staphylococcus aureus, or MRSA, is blamed for killing 19,000 people in the United States in 2005.

Area Tap Water Has Traces of Medicines

Tests Find 6 Drugs, Caffeine in D.C., Va.

By Carol D. Leonnig
Washington Post Staff Writer
Monday, March 10, 2008; B01

The Washington area's drinking water contains trace amounts of six commonly used drugs that typically turn up in wastewater and cannot be filtered out by most treatment systems.

The pharmaceuticals -- an anti-seizure medication, two anti-inflammatory drugs, two kinds of antibiotics and a common disinfectant -- were found in very small concentrations in the water supply that serves more than 1 million people in the District, Arlington County, Falls Church and parts of Fairfax County. But scientists say the health effects of long-term exposure to such drugs are not known.

Pharmaceuticals, along with trace amounts of caffeine, were found in the drinking water supplies of 24 of 28 U.S. metropolitan areas tested. The findings were revealed as part of the first federal research on pharmaceuticals in water supplies, and those results are detailed in an investigative report by the Associated Press set to be published today.

In addition to caffeine, the drugs found in water treated by the Washington Aqueduct include the well-known pain medications ibuprofen and naproxen, commonly found in Aleve. But there were also some lesser-known drugs: carbamazepine, an anti-convulsive to reduce epileptic seizures and a mood stabilizer for treating bipolar disorders; sulfamethoxazole, an antibiotic that can be used for humans and animals in treating urinary tract and other infections; and monensin, an antibiotic typically given to cattle. In addition, the study uncovered traces of triclocarban, a disinfectant used in antibacterial soaps.

That the drugs were found so commonly nationwide highlights an emerging water dilemma that the public rarely considers. The drugs we use for ourselves and animals are being flushed directly into wastewater, which then becomes a drinking water source downstream. However, most wastewater and drinking water treatment systems, including Washington's, are incapable of removing those drugs.

And although the chemicals pose no immediate health threat in the water, the health effects of drinking these drug compounds over a long period is largely unstudied. Some scientists said there is probably little human health risk; others fear chronic exposure could alter immune responses or interfere with adolescents' developing hormone systems.

Washington's water regulators and utility officials say they are not alarmed by the findings because the drugs are found at such low levels -- parts per trillion, a tiny fraction of the amount in a medical dose. But they do view these "emerging contaminants" with concern.

"What concerns me is we're finding pharmaceuticals in the river that we rely upon for drinking water," said Thomas P. Jacobus, general manager of the Washington Aqueduct. "If we can't get them out, we have to find a way to neutralize them if we find there's a health effect from them."

Jacobus said the aqueduct leadership will recommend in the next few months likely upgrades for water treatment to deal with an array of newly identified and increasing contaminants in the water. The aqueduct uses chlorine, which kills a wide group of bacteria and breaks down some chemicals but cannot disrupt pharmaceuticals. Studies show ozone water treatment is the most effective in zapping such drugs.

The U.S. Geological Survey and the U.S. Department of Agriculture have been screening Washington's and other cities' water supplies for pharmaceuticals in the first research project on pharmaceuticals in the water. The Washington Aqueduct, an arm of the U.S. Army Corps of Engineers, does not regularly screen for caffeine or pharmaceuticals, nor do most water utilities.

The drugs discovered in testing over the past two years typically get into the water supply because they pass through a user's body and are flushed downstream. The U.S. Environmental Protection Agency is studying some pharmaceuticals for their impact on public health but has not set safety standards for any of the drugs.

"We recognize it is a growing concern, and we're taking it very seriously," Benjamin H. Grumbles, the EPA's assistant administrator for water, said of the drugs' presence.

There is no clear evidence of a human health threat from such low levels of pharmaceuticals. But scientists warn that, because there has been very little study of the long-term or synergistic effects of this kind of drug exposure, water providers and regulators need to exercise caution. Although experts agree that aquatic life are most at risk from exposure to the drugs in rivers and streams, researchers are concerned about what they don't know about human health effects.

In other findings from its reporting, the AP said officials in Montgomery County and Fairfax have found numerous pharmaceuticals in their environmental watersheds but do not test their drinking water supplies for the same chemical compounds.

Nationwide, the AP reported that researchers found anti-depressants, antacids, synthetic hormones from birth control pills, and many other human and animal medicines in the water. In San Francisco, tests found a sex hormone. In New York, the water tested positive for heart medicines and a prescription tranquilizer.

The Associated Press contributed to this report.

America: The Land of the Drugged

With the story breaking last week about the trainer ratting out all of the players doing steroids, I thought it was time to revisit an article I wrote back in 2005.


National Pastimes, Steroids and Media Circuses

Last week congress was engaged in one of its favorite past times; grandstanding. A congressional panel heard testimony from current and former professional baseball players including Mark McGwire and Sammy Sosa. The biggest buzz-making item to come out of the testimony was Mark McGwire’s refusal to answer the question of whether or not he had taken steroids. His unwillingness to answer the question has fueled speculation that he was in fact taking steroids while chasing Maris’ home run record and his reputation has predictably suffered as a result.

Several observations can be drawn from the hearings that really illustrate the sort of illusory world that Americans live in today. To begin with, the whole circus sideshow was instigated by a book written by former slugger Jose Canseco. Canseco outs a number of player, including McGwire, as taking steroids when he was still in the game. Not surprisingly, Canseco has become the target of much condemnation from managers, owners and players alike, one of which is Curt Schilling.

Schilling has been an outspoken critic of steroids for a number of years; even implying in the past that steroid use in baseball is “rampant”. In last Thursday’s testimony Schilling called Canseco, whose book corroborates Schillings views on steroids, a liar. This is the conundrum that the issue of drugs creates in United States. When an outspoken critic of steroid use brands the one person who openly admits to using steroids as a liar, we begin to see the quandary this issue causes.

The issue, in a broader sense, isn’t solely about steroids; it is about American’s acceptance of certain drugs and their opposition to others. It is a kind of built-in hypocrisy that seems to come with being an American. McGwire’s public conscience wrestling seemed to show a man who was not desirous of being a liar, while struggling with the knowledge that if he did tell the truth, he would be branded a cheat; a dilemma seemingly not shared by his contemporaries. However, the worst hypocrites in this spectacle are the shameless congress members pretending to be the protectors of old-fashioned American values while at the same time accepting enormous amounts of money from the pharmaceutical industry, an industry that shamelessly advertises their drugs even after many are known to be harmful to people’s health.

Americans are bombarded daily with advertisements from the pharmaceutical companies that encourage all manner of drugs to enhance their performance. You cannot watch television for more than ten minutes without being subjected to commercials hocking male sexual arousal pills, like Viagra and Cialis. Schools across the country have become defacto pharmacies dispensing drugs likes Ritalin and adderall to our nation’s children to enhance their concentration. Celexa, Lexapro, Prozac and Zoloft, just to name a few, are now household words. These are all drugs, we are told, that supposedly enhance the quality of our lives and all of these drugs have the full backing and support of the government and Congress especially.

The message that is being sent is clear, it is not only proper to ingest drugs to enhance performance but it is absolutely encouraged. However, when it comes to athletes using drugs to enhance their performance we are supposed to be incredulous that they would even entertain such an idea. What absurdity! Why on earth would anyone be shocked by the revelation that athletes use steroids? Drug use is ingrained in our culture, it is inescapable. We are the most medicated society on earth and yet we still feign outrage that athletes use steroids.

These are classic symptoms of the American psyche’s need to present itself as steadfastly moral while at the same time giving a wink and a nod to behavior we supposedly don’t tolerate. This is America’s real, national past time

OxyContin Maker, 3 Execs Fined $634.5M

Purdue Pharma, 3 Executives Ordered to Pay $634.5M Fine for Misleading Public About OxyContin ABINGDON, Va. (AP) -- Purdue Pharma L.P., the maker of OxyContin, and three of its executives were ordered Friday to pay a $634.5 million fine for misleading the public about the painkiller's risk of addiction.

U.S. District Judge James Jones levied the fine on Purdue, its top lawyer and former president and former chief medical officer after a hearing that lasted about three-and-a-half hours. The hearing included statements by numerous people who said their lives were changed forever by addiction to OxyContin, a trade name for a long-acting form of the painkiller oxycodone.

Designed to be swallowed whole and digested over 12 hours, the pills can produce a heroin-like high if crushed and then swallowed, snorted or injected.

From 1996 to 2001, the number of oxycodone-related deaths nationwide increased fivefold while the annual number of OxyContin prescriptions increased nearly 20-fold, according to a report by the U.S. Drug Enforcement Administration. In 2002, the DEA said the drug caused 146 deaths and contributed to another 318.

Purdue, its top lawyer and former president and former chief medical officer pleaded guilty in May to claiming to doctors that OxyContin was less addictive and less subject to abuse than other pain medications. The sentencing Friday ends the national case.

Michael Friedman, who retired in June as Purdue's president, general counsel Howard Udell and former chief medical officer Paul Goldenheim each pleaded guilty to a misdemeanor count of misbranding the drug. Of the total fine, $34.5 million was levied on those three.

Jones placed the company on probation for five years and each of the executives on probation for three years. He also ordered the three to perform 400 hours of community service related to prevention of prescription drug abuse.

Former New York City Mayor Rudolph Giuliani played a central role in negotiating on behalf of Purdue with federal prosecutors, but Jones said "I completely reject" suggestions that political influence resulted in a lesser punishment for Purdue.

Many of the nearly 20 speakers called for jail terms for Friedman, Udell and Goldenheim, saying the fines were a small price for the devastation to lives from OxyContin addiction.

"Money can't buy all the lives that are lost," said Robert Palmisano, 23, who said he was addicted to OxyContin for four years but has been off the drug for 17 months.

Attorneys for the three executives said giving them criminal convictions was punishment enough, and noted they were charged because of their job titles, not because they themselves promoted OxyContin as a drug with little addiction potential.

"They are not here today because of any acts of misconduct on their part," defense attorney Howard Shapiro said. "They are good men."

The speakers, many of whose children died after trying the drug only once, disagreed.

"I feel you are legal drug users, nothing more than a large corporate drug cartel," Lee Nuss of Palm Coast, Fla., said as she addressed the Purdue Pharma contingent.

Nuss held up a stone urn slightly larger than a pill bottle that she said contained her 18-year-old son's ashes.

Attorneys for both sides acknowledged the pain of those who had lost loved ones, but urged Jones to accept the plea agreement.

"By pleading guilty they acknowledged that doing nothing was not good enough," Assistant U.S. Attorney Randy Ramseyer said. "We cannot bring those people back. It's not something this case can do."

Dillie Walker and his wife Joyce of Bay City, Mich., testified on behalf of Purdue that OxyContin has enabled them to function again despite chronic pain.

"I don't get high from it. It goes straight to my pain," Dillie Walker said.

But Kenny Keith of Roanoke said it took very little time for him to get addicted after he was prescribed OxyContin.

"The withdrawals were worse than the pain I was having," he said.

Jones said he would have preferred to have the plea agreements call for spending money on education of those at risk of drug abuse and treatment of those who are addicted to OxyContin. But Jones said he would not reject the agreement.

"Many young people mistakenly believe today that prescription drugs are safer than other drugs," Jones said.

The fines are to be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program and individuals who had sued the company. About $5 million will go toward a six-year company program to monitor compliance with the agreement.

Survivors of the victims want the Food and Drug Administration to reclassify OxyContin for use only for severe pain. The drug currently can be prescribed for moderate pain.

Purdue, based in Stamford, Conn., has said it accepted responsibility for its employees' actions and has put in place training and monitoring programs to ensure overpromotion of OxyContin doesn't happen again. But officials objected to any ties between the plea agreement and abuse of the drug.

The coal-mining region of southwest Virginia where the sentencing took place has had a number of oxycodone-related deaths -- 119 from 2003 through 2005, according to the state medical examiner's office.

Senate blocks bid to allow prescription drug imports, a victory for drug companies

By Andrew Bridges

ASSOCIATED PRESS

3:59 p.m. May 7, 2007

WASHINGTON – Prescription drug prices in the United States probably will remain among the highest in the world.

Overseas, brand-name prescription drugs can cost two-thirds less than they do in the United States. In many industrialized countries, prices are lower because they are either controlled or partially controlled by government regulation.

Lawmakers have pushed for years to allow drug imports, saying they would drive down prices in the U.S. Experts disagree by just how much, however.

Consumers won't have a chance to find out. The Senate on Monday killed a bid to allow competition from lower-priced imports.

In a triumph for the pharmaceutical industry, the Senate, on a 49-40 vote, neutralized the latest push to allow drug imports. The measure required the administration to certify the safety and effectiveness of imported drugs before they can be brought into the country. That's something officials have said they cannot do.

“Well, once again the big drug companies have proved that they are the most powerful and best financed lobby in Washington,” said Sen. David Vitter, a Louisiana Republican.

The vote nullified a second amendment, later passed on a voice vote, that would legalize the importation of prescription drugs manufactured in Canada, Australia, Europe, Japan and New Zealand.

Sen. Bernie Sanders, I-Vt., called the certification amendment, introduced by Sen. Thad Cochran, R-Miss., a “poison pill” for the drug-imports legislation. Sen. Byron Dorgan, D-N.D., acknowledged it nullified his bid to allow the purchase of drugs abroad.

“This is a setback for us. But the drug industry is one of the strongest industries in this town,” Dorgan said.

Sen. Mike Enzi, a Wyoming Republican, said the requirement for a safety certification was essential to protect the public.

“Under both Democratic and Republican administrations, secretaries of Health and Human Services have declined to certify that foreign drugs – like those allowed under the Dorgan Foreign Drug Act – are safe for American consumers. They realized, as I do, that close enough isn't good enough,” Enzi said.

The maneuvering occurred on broader legislation to renew the FDA's ability to collect fees from the drug industry to defray the cost of reviewing new drugs. Lawmakers have seized on the bill to overhaul the agency, including its handling of drug-safety issues highlighted in the wake of the withdrawal of the painkiller Vioxx.

Advocates of drug importation have argued for years that an existing ban is more a protection for the drug industry than a safety issue.

Dorgan held out Lipitor, saying 90 doses of the cholesterol drug cost $321 in the U.S. – about twice the cost in Canada.

The idea of allowing prescription drug imports enjoys broad popular support. However, lower prices overseas would not automatically translate into large savings for domestic consumers, according to a 2004 study by the Congressional Budget Office.

The study found that allowing drug imports from a broad set of countries would cut U.S. drug spending by $40 billion over 10 years, about a 1 percent savings. It said foreign governments could limit drug exports to protect their own domestic supplies, and that U.S. drug companies could respond to an importation bill by increasing prices abroad.

The pharmaceutical industry vehemently opposes allowing drug imports, arguing that they could leave the nation vulnerable to dangerous counterfeits.

Similar drug-import legislation is pending in the House.

Guess the Coca isn't out of the cola after all...

Bolivians want Coke to drop the 'Coca'

The Associated Press
Published on: 03/15/07

La Paz, Bolivia — Coca-Cola should drop the name of Bolivia's "sacred leaf" from its trademark soda, according to a resolution passed by a commission of coca industry representatives advising the assembly rewriting the Andean country's constitution.

During a three-day gathering in Sucre, 255 miles southeast of La Paz, more than 400 coca growers, traders, and politicians from Bolivia's coca-growing regions also called for the United Nations to decriminalize the leaf in its natural form and for its image to be included in Bolivia's national seal.

Though not directly affiliated with the Bolivian government, the commission is the latest step in a national effort spearheaded by President Evo Morales to rehabilitate the image of plant revered in the Andes for millenia but better known internationally as the base ingredient of cocaine.

Officials at Atlanta-based Coca-Cola released a statement Thursday saying their trademark is "the most valuable and recognized brand in the world" and is protected under Bolivian law.

Coca-Cola dropped cocaine from its ingredients a century ago, although the soda maker's secret formula still calls for a cocaine-free coca extract produced by the New Jersey-based Stepan Chemical. The company imports about 55 tons of coca leaves each year from Peru, according to the Peruvian state-run coca company Enaco.

Boy Kills 5 at Mall in Utah

SALT LAKE CITY — The 18-year-old gunman who opened fire on shoppers in a mall, killing five and wounding four others before police fatally shot him, was armed with several rounds of ammunition and was carrying two guns, authorities said Tuesday.

How many days will elapse before we find out the kid was on some form of pychotropic drugs?

A Capitol Hill Mystery: Who Aided Drug Maker?

Published on Friday, November 29, 2002 by the New York Times

by Sheryl Gay Stolberg

WASHINGTON, Nov. 28 — Lobbyists for Eli Lilly & Company, the pharmaceutical giant, did not have much luck when they made the rounds on Capitol Hill earlier this year, seeking protection from lawsuits over a preservative in vaccines. Senator Bill Frist, Republican of Tennessee, tucked a provision into a bill that went nowhere. When lawmakers rebuffed a request to slip language into domestic security legislation, a Lilly spokesman said, the company gave up. Now, in a Washington whodunit worthy of Agatha Christie, the provision has been resurrected and become law, as part of the domestic security legislation signed on Monday by President Bush. Yet in a city where politicians have perfected the art of claiming credit for deeds large and small, not a single member of Congress — or the Bush administration — will admit to being the author of the Lilly rider. "It's turning into one of Washington's most interesting parlor games," said Dave Lemmon, spokesman for Senator Debbie Stabenow, Democrat of Michigan, who has promised to introduce legislation to repeal the provision. "There's a lot of guessing, a lot of speculation as to who did this." The provision forces lawsuits over the preservative, developed by Eli Lilly and called thimerosal, into a special "vaccine court." It may result in the dismissal of thousands of cases filed by parents who contend that mercury in thimerosal has poisoned their children, causing autism and other neurological ailments. Among them are Joseph and Theresa Counter of Plano, Tex., devoted Republicans whose party allegiance has run smack into family ties. The Counters' 6-year-old son, Joseph Alexander, was normal and healthy until he was 2, they say. Then he took an unexplained downward slide. Today, the boy struggles with words. He cannot zip his pants, snap buttons or tie his shoes. His parents say tests eventually showed that he had mercury poisoning, which they attribute to vaccines. They sued last year. "I know that our legislative system can be very, very messy at times," said Mr. Counter, a political consultant, who with his wife has spent many thousands of dollars on medical care and therapy for their son. "But for them to attempt this, in the dead of night? It disgusts me. This morning, I am ashamed to be a Republican." With lawmakers now scattered across the country, Washington is rife with speculation about who is responsible for aiding Lilly, a major Republican donor. During the 2002 election cycle, the company gave more money to political candidates, $1.6 million, than any other pharmaceutical company, with 79 percent of it going to Republicans, according to the Center for Responsive Politics, a nonprofit research group that monitors campaign finances. Critics of the provision, mainly Democrats and trial lawyers, are quick to point out that the White House has close ties to Lilly. The first president Bush sat on the Lilly board in the late 1970's. The White House budget director, Mitchell E. Daniels Jr., is a former Lilly executive. The company's chairman and chief executive, Sidney Taurel, was appointed in June by President Bush to serve on a presidential council that will advise Mr. Bush on domestic security. The White House, however, has said that it did not ask Congress for the provision. Rob Smith, a spokesman for Lilly, said that the company's lobbyists "made absolutely no contact with Mitch or anyone in his office about this," and that Mr. Taurel "did not at any time ask" for any favors. "It's a mystery to us how it got in there," Mr. Smith said of the provision. Senator Frist has said it is a mystery to him as well. As the Senate's only doctor, he sought to include the provision in legislation that would promote the availability of vaccines. But the vaccine bill is stalled; Senator Edward M. Kennedy, the Massachusetts Democrat who is chairman of the Senate health committee, opposes it. Mr. Frist's spokesman said he did not seek to have the provision included in the domestic security bill. On Capitol Hill, Congressional aides-turned-detectives have traced the emergence of the provision to the Veterans Day weekend. Flush from their party's victories on Election Day, and with a mandate from President Bush to pass a domestic security bill, Republican negotiators in the House and Senate holed up for three days in the Capitol to hammer out the details, said Richard Diamond, spokesman for the retiring House majority leader, Representative Dick Armey of Texas. One aide said the language mysteriously appeared in the House version of the bill in entirely different type than the rest of the measure, as though someone had clipped it out of Mr. Frist's legislation and simply pasted it in. Mr. Diamond said all the negotiators supported the move, but would not say who was responsible. "If you want to give somebody credit for it," he said, "Mr. Armey takes ultimate credit. It's his bill. We are happy to wrap ourselves around it, but Mr. Armey is not a doctor, like Senator Frist. He's the source of the language." Whether thimerosal is truly harmful is the subject of intense scientific controversy. Earlier this year, the National Academy of Sciences issued a report saying there was no scientific evidence either to prove or disprove a link between thimerosal and brain disorders like autism. But the academy did find that such a link was "biologically plausible," and so it urged pharmaceutical companies to eliminate thimerosal, which has already been removed from many vaccines, as quickly as possible. The Lilly rider closes a loophole in a 1986 law that requires victims to file claims with the vaccine court, which awards payments from a taxpayer-financed compensation fund, before going to civil court. But the law covered only vaccines themselves, not their ingredients, which meant people like the Counters could sue ingredient manufacturers like Lilly directly. While Washington debates the origins of the provision, families are fuming. Some say the government fund will do them no good, because they have missed the statute of limitations — three years from the date symptoms first appear — for filing claims. Scott and Laura Bono of Durham, N.C., say that while their son Jackson, now 13, showed symptoms similar to autism six or seven years ago, it was not until August 2000 that they learned he had mercury poisoning. They filed suit just the other day. Aware of the controversy, lawmakers in both parties have pledged to alter the thimerosal rider, but are arguing about how to do so. While many Democrats want it repealed, Republicans have suggested that they may simply alter the language to apply to future cases only. "I'll believe it when I see it," said Mr. Waters, the Counters' lawyer. In the meantime, Mr. Smith, the Lilly spokesman, said his company would soon go to court to seek dismissal of the suits. That news made Theresa Counter cry. "It just makes me sick," she said. "I cannot tell you how devastating it is to think that we might have to start all over." Copyright The New York Times Company