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A TINY puppy has been savaged to death in front of its shocked owner while they walked near a popular children's play area.
Helpless seven-month-old Toy Poodle, Benji, had his neck bitten by a larger Mastiff-type dog at Bourne Valley, Poole, and died within minutes.
Owner Ian Gallanders, who was walking Benji and Sharday, a Labrador, when the attack unfolded said: "It could easily have happened to a small child."
He said: "It was so fast, this large tan dog just pinned him down and bit his neck. It was shocking, he was savaged and killed. There was nothing I could do. Benji didn't have a chance."
Mr Gallanders, aged 45, a hotel night manager, was walking his dogs during a lunchtime.
Benji had already encountered the tan Mastiff-type dog, being walked by two women with a young child. The larger dog started behaving boisterously, said Mr Gallanders, so he called Benji back.
"All of a sudden the dog pinned Benji down and grabbed his neck.
"I had my hands around its jaws and the woman was pulling it back, but everything happened too fast. Benji died in a couple of minutes."
Mr Gallanders, of Shillingstone Gardens, Poole, said the woman – who desperately tried pulling the dogs apart – also offered to help in the aftermath.
"She had the decency to come back to my address and leave her details. She seemed shocked as well and told me the dog wasn't hers but she'd been walking it for a friend. She also said she now had concerns about it being around her children."
After the Daily Echo contacted the woman, she and the owner were so distressed they both declined to comment.
However, we understand the owner of the Mastiff-type dog was so horrified by what transpired he has since had his dog put to sleep.
Vet Henry Feilden, of Branksome's Poole Road Veterinary Surgery, dealt with Benji and Mr Gallanders in the aftermath.
He said: "This wasn't a case of playing too hard. This dog was grabbed by the neck with intent.
"That intent was to kill."
"Something has to be done to combat the problem"
VETERINARY surgeon Henry Feilden believes something must be done to combat dog attacks across the conurbation.
He said: "The reality is that most sensible veterinary surgeons would agree that the instances of dogs being killed, dog on dog, owners being bitten, dog on humans, are happening all the time.
"It is a complex problem, there are all sorts of ramifications including infringement of human rights when people take dogs on walks – aren't they entitled to have a dog off the lead without a muzzle?
"If we had rabies in this country the government could enforce muzzles, leads, micro-chipping, almost overnight.
"But, thankfully, we don't have rabies – but for that reason we have lots of freedoms enabling people to do what they want, even if it is completely irresponsible.
"Suppose we put local bylaws in place and they started gradually?
"Suppose we said every dog needs to be on a lead in public places? How would we enforce this?
"My answer would be, let's just get the law in place now, lets be sensible, we can look at enforcement later.
"We could, here in Dorset, set an example to the rest of the country."


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Coldest winter in 500 years was described in New Scientist, 7 February 2009, p46 which reported that on January 6, 1709 the temperature plummeted from Scandinavia to Italy - from Czechoslovakia to the west coast of France, and everything turned to ice. The sea, lakes and rivers froze, and the soil froze to a depth of a metre or more. Livestock died in their barns, chicken's combs froze and fell off, trees exploded and travellers froze to death on the roads.
Off Italy's west coast, sailors aboard English men-of-war died from the cold. One of England's most meticulous meteorological observers William Derham wrote, "I believe the Frost was greater (if not more universal also) than any other within the Memory of Man". 1709 holds the record as the coldest European winter of the past half-millennium. It was the climax of a period known as the "Little Ice Age" which began in the 14th Century AD and extended to the 19th Century AD.
No-one really knows what caused the extreme cold but it seems the sun's output was low, and there were some large volcanic eruptions 1707 and 1708, including Mt Vesuvius, Mt Santorini and Mt Fuji that would have sent large amounts of dust into the atmosphere. Dennis Wheeler, a climatologist at the University of Sunderland, UK, is working with the E.U.'s Millennium Project, which aims to reconstruct the past 1000 years of Europe's climate. Wheeler is using records of wind and weather from the Royal Navy. So far he has found some unexpected results. Cold weather in Europe usually results from freezing winds blowing in from Siberia in the east, but Wheeler found a predominance of southerly and westerly winds and many storms - conditions that normally bring milder weather. Wheeler commented: "This combination of cold, storms and westerlies suggests some other mechanism was responsible for that winter." He went on to say: "We need to explain the natural variation in climate over past centuries so that we can tease apart all those factors that contribute to climate change. But before we can do that we need to nail down those changes in detail. Climate doesn't behave consistently and warmer and colder, drier and wetter periods can't always be explained by the same mechanisms."
Editorial Comment:The Little Ice Age was preceded by a period known as the "Medieval Warm Period", which was warmer than the current warm period, but no-one was driving cars or generating electricity then. We do need to understand the natural variations in climate, but we also need to have the humility to admit that there are many forces at work that we cannot control (or tax), such as volcanoes, wind, sunspots, and God. We should then get on with being good stewards of the things God gave us dominion over, and put our trust in the Creator who can control these greater forces. (Ref. weather, environment, history)
Evidence News 8 April 2009

subset: commoncrawl


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Christmas is COMING! Is anybody excited for that? So do you guys have anything you want for Christmas? Or what are you gonna do for Christmas?
Cause what I'm doing for Christmas is going to my friend's house for his birthday. This is kinda weird cause he says that if his birthday is on December, then he's gonna have a double times Super awesome Christmas gifts. The last time I went there to my friend's birthday party is when all my friends there that he invited played with the super awesome game called Call Of Duty: Black Ops with him.
Also, my wish list for Christmas is:
1. Star Fox for 3DS
2. Mario Cart 7
3. Super Mario 3D Land
4. The Legend of Zelda: Skyward Sword
5. Lord of the Rings: Aragorn's Quest
6. Twilight Breaking Dawn: The Score
7. Twilight OST Deluxe version
8. Breaking Dawn's Movie Companion Book


text: To get from Cantù a Nicastro by train you can catch one of the 4 trains that everyday travel between Milano Porta Garibaldi and Salerno, the closest station to the city. The first train to Salerno leaves from Milano Porta Garibaldi at 15:12 and the last train departs at 23:17. The trip by train from Milano Porta Garibaldi to Salerno last on average 06:12 travelling with high-speed trains (Frecciarossa or Italotreno) If you choose a local train the trip lasts on average 10:33 hours. On Wanderio you can compare all schedules, fares and railway companies to Salerno and book the best itinerary starting from Milano Porta Garibaldi.


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Sting's first album in a decade arriving this fall
Listen to Sting on iHeartRadio
It's been a decade since Sting has had new music in stores. But "The New York Times" says the hiatus will end this fall with the arrival of The Last Ship. The studio project features songs the former Police frontman wrote for his proposed Broadway musical, and some tracks are included in the show.
The album shares its name with the musical, which is based on Sting's 1991 album The Soul Cages. The theatrical production was inspired by the rocker's upbringing in Newcastle, England, a once thriving shipbuilding center that went into decline in the 1970s. The musical tells the story of a shipbuliding family that is suddenly facing uncertain times when the shipyard closes.
The The Last Ship CD is the first collection of new, original material from Sting since 2003's Sacred Love. The album is slated to be released on September 24th.
Sting is currently on the road. The next stop on his "Back To Bass" tour is coming up in Denver, Colorado tonight.
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News & Events
The Importation of Drugs into the United States
Statement of
William K. Hubbard
Senior Associate Commissioner for Policy, Planning, and Legislation
Food and Drug Administration
the Subcommittee on Health
House Committee on Energy and Commerce
July 25, 2002
Mr. Chairman and Members of the Committee, I am William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation at the U.S. Food and Drug Administration (FDA or the Agency). I appreciate the opportunity to discuss our mutual concerns related to the importation of drugs into the United States. This topic encompasses a range of issues, including the importation by individuals of prescription drugs through the mail or in person; the purchase of drugs from foreign sources over the Internet; and the potential introduction of counterfeit drugs into the U.S. drug supply.
FDA is also concerned about legislative initiatives that, while intended to provide drug price relief to consumers, would severely damage the system of drug regulation that has come to be known as the "gold standard" for drug safety throughout the world. Last month, speaking at a biotechnology summit in Canada, Secretary Thompson said "Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. In light of the anthrax attacks of last fall, that's a risk we simply cannot take."
Under the Federal Food, Drug, and Cosmetic (FD&C) Act, unapproved, misbranded, and adulterated drugs are prohibited from importation into the United States. In general, all drugs imported by individuals fall into one of these prohibited categories. This includes drugs that are foreign versions of FDA-approved medications, and drugs that are dispensed without a prescription. In addition, under the Act, FDA-approved drugs that are manufactured in the U.S. and exported may not be reimported by anyone other than the manufacturer.
The volume of prescription drugs for personal use imported through the mail has increased dramatically in recent years. According to testimony by the U.S. Customs Service (Customs) before the House Government Reform Committee in May 2000, seizures of parcels containing scheduled or controlled substances at international mail facilities increased by 450 percent in FY 1999, primarily due to drug sales over the Internet. FDA estimates that approximately two million parcels containing FDA-regulated products for personal use enter the U.S. each year through international mail facilities. This estimate is based on an extrapolation of data obtained during a pilot project conducted at the international mail facility in Carson, California, which is discussed in more detail below.
At mail facilities, Customs officials identify parcels that may violate the FD&C Act for FDA examination. FDA inspectors then determine if these products should or should not be permitted to enter the country. If detained, FDA must issue a notice to the addressee describing the potential Federal violation and provide the individual with an opportunity to respond and provide reasons why the drug parcel should be allowed entry. If the addressee does not respond or provides an inadequate response, FDA will give the parcel back to Customs to have it returned to the exporter. Due to the requirements for notice and an opportunity to respond, the detention and further processing of mail parcels consumes large amounts of FDA resources. In addition, considerable storage space is needed to hold the large number of detained parcels until replies are received from the addressees.
Recent advertisements in U.S. newspapers and magazines claim that Congress has made the personal importation of drugs a legal practice. Other advertisements and certain Internet sites state that personal importation of up to a 90-day supply of prescription medications is legal. Neither of these claims is true. As we will discuss in more detail below, we are seeing an increasing number of Canadian pharmacies and U.S. intermediaries marketing prescription drug products directly to U.S. citizens, in violation of state pharmacy laws and the FD&C Act.
From a public health standpoint, importing prescription drugs for personal use is a potentially dangerous practice. FDA and the public have no assurance that unapproved products are effective or safe, or have been produced under U.S. good manufacturing practices. FDA cannot assure the public that re-imported drugs made in the U.S. have been stored under proper conditions or that they are even the real product, because the Agency does not regulate foreign distributors or pharmacies. Therefore, unapproved drugs and re-imported approved medications may be contaminated, subpotent, superpotent, or counterfeit. In addition, some websites based outside the U.S. offer to dispense prescription drugs without a prescription by a licensed practitioner or a physical examination, bypassing the traditional doctor-patient relationship. As a result, patients may receive inappropriate medications due to misdiagnoses, they may fail to receive appropriate medications or other medical care, or they may take a product that could be harmful, or fatal, if taken in combination with other medicines they might be taking.
Personal Importation Policy
Under FDA's personal importation policy, as described in guidance to the Agency's field personnel, FDA inspectors may exercise enforcement discretion in limited circumstances to permit the importation of certain unapproved prescription medication for personal use.
First adopted in 1954, the policy was last modified in 1988 in response to concerns that certain potentially effective treatments for AIDS patients were not available in the U.S. but were available in other countries. The Agency expanded the guidance for humanitarian purposes to allow individuals suffering from serious medical conditions to acquire medical treatments legally available in foreign countries but not approved in the U.S.
The policy is articulated in guidance to FDA field personnel and is not a license for individuals to import unapproved, and therefore illegal, drugs for personal use into the United States. Because the policy does not apply to medications that are already available in the U.S., even if sold under the same name, only a very few drug products available from foreign sources, especially Canada and Mexico, meet the personal importation criteria.
The current personal importation policy permits the exercise of enforcement discretion to allow entry of an unapproved prescription drug only if the intended use is for a serious condition for which effective treatment may not be available domestically; the product is considered not to represent an unreasonable risk; the product is for personal use; there is no known commercialization or promotion to U.S. residents by those involved in the distribution of the product; and the individual seeking to import the product affirms in writing that it is for the patient's own use and provides the name and address of the U.S. licensed doctor responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
FDA's personal importation policy, as written, is difficult to implement with respect to mail shipments of drugs. This is due, at least in part, to the difficulty faced by Customs or FDA inspectors, or even health care practitioners, in identifying a medicine simply by its appearance or its labeling, which may falsely identify a product. From a practical standpoint, FDA inspectors cannot visually examine drug products contained in a mailed parcel and accurately determine their identity or the degree of risk posed to the individual who will receive these drugs. Also, largely due to the advent of Internet sites selling prescription drugs from all points around the globe, the volume of parcels containing prescription drugs has increased dramatically, beyond the ability of Customs and FDA staff to efficiently process.
Due to the huge volume of drug parcels entering the U.S. through the international mail and courier services, the requirements for notice and hearing, and our limited resources, it is difficult for FDA to detain and refuse mail imports for personal use. As a consequence, tens of thousands of parcels that FDA does not review are eventually released by Customs and sent on to their addressees, even though the products contained in these parcels may violate the FD&C Act and pose a health risk to consumers. We do not believe this is an acceptable public health outcome.
In early 2001, FDA and Customs conducted a survey of imported drug products entering the U.S. through the Carson City, California, mail facility (the Carson pilot). The purpose of the Carson pilot was to provide a means for examining incoming mail shipments of pharmaceutical products over a specified time frame to identify both the volume and the types of drug products entering the U.S. We also wanted to better assess the level of effort and human resources required to handle drug importations at a mail facility, and to better understand the public health implications these importations may have for U.S. consumers.
The Carson pilot ran for a five-week period, with FDA inspectors present for 40 hours per week, a much higher staffing level than is normally possible. Although Customs took a baseline sample which indicated they could have set aside for FDA review an estimated total of 16,500 international packages (650 packages per day), FDA was able to examine only 1,908 packages during the five-week pilot, or an average of 381 packages per week. Unexamined packages were sent on to the addressees. Of the 1,908 packages examined by FDA, 721 parcels originating in 19 countries were detained and the addressees notified that the products appeared to be unapproved for use in the U.S., misbranded and/or a drug requiring a doctor's prescription.
Analysis of the Carson Pilot Drug Parcels
FDA's Center for Drug Evaluation and Research (CDER) reviewed listings of the products detained during the Carson pilot to define better the nature of the risk to public health from the types of products coming into the U.S. through personal importation. CDER's review demonstrates that there are serious public health risks associated with many of the 721 drug shipments (composed of 197 different drugs) detained at Carson. There are primarily two types of risks that consumers of these drugs would face. The first risk arises when consumers take drugs of unknown origin or quality. Second is the very significant risk associated with taking many of these drugs without first obtaining a physician's prescription and without the continued oversight of the physician.
In general, FDA has no information to establish where these drugs were actually manufactured and whether current Good Manufacturing Practice requirements were followed. There is also no assurance that the drugs were packaged and stored under appropriate conditions to avoid degradation or contamination. Approximately eight percent of the shipments contained drugs that could not be identified because they contained no labeling; some of these contain only foreign language labeling. Most of these drug shipments were contained in plastic bags; one shipment contained drugs taped between magazine pages.
Several drugs do not appear to correspond with any FDA-approved drugs and the risks are therefore difficult to assess. One drug had been reviewed for FDA approval but was denied approval due to cardiac abnormalities and because its efficacy could not be demonstrated. Several shipments contained three drugs that were once approved by FDA but have been withdrawn from the market based on serious safety concerns.
The vast majority of the shipments were identified as containing prescription drugs, which by definition have a degree of toxicity and/or risk associated with them such that they are not safe for use except under the supervision of a licensed health care practitioner (Title 21, U.S.C. section 353(b)). We believe that very few foreign Internet sellers require a prescription from a practitioner licensed in the U.S. before dispensing drugs to U.S. residents. Moreover, after detention notices were issued to the intended recipients of the 721 drug shipments, fewer than four percent responded with evidence of prescriptions or that a physician would provide oversight of the use of the drugs purchased from abroad.
A number of controlled substances were identified, including lorazepam, codeine sulfate, loperamide, chlordiazepoxide, chloral hydrate, and diphenoxylate. These drugs have the potential for abuse, addiction or life-threatening overdose. A physician's prescription and oversight are essential for managing these risks. Additionally, drugs having potentially serious adverse side effects including diabetes, hypertension and serious infection were included in the Carson shipments, as were many drugs with serious contraindications and/or possible drug or food interactions for which physician oversight is essential.
Many of the drugs identified in the Carson pilot are intended to treat conditions that only physicians can properly diagnose. Consumers who bypass physician diagnosis and prescribing may be exposing themselves to risks and toxicities that cannot be justified by offsetting benefits. For example, almost ten percent of the shipments were for antibiotics, despite the fact that consumers are generally not able to diagnose whether their symptoms are caused by bacterial or viral infections. Several drugs listed are potent steroids, which are generally prescribed for conditions that are not self-diagnosable.
Based on these observations, FDA believes that the type of drugs that are coming into the country for personal use, as demonstrated by the Carson pilot, pose substantial risks to the public health.
Based on a survey conducted in early 2000 by FDA's Office of Criminal Investigations (OCI) and a subsequent study by the General Accounting Office, there appears to be roughly 300 to 400 Internet sites selling prescription drugs to consumers, with approximately half located domestically and half located outside the U.S. FDA has long taken the position that consumers are exposed to a number of risks when they purchase drugs from Internet sites that are not operated by pharmacies licensed and operating within state pharmacy law or sites that dispense foreign drugs. These outlets may dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use. FDA cannot provide consumers with any assurance that these products were manufactured under current good manufacturing practice standards. Taking an unsafe or inappropriate medication puts consumers at risk for dangerous drug interactions and other serious health consequences.
Internet sites that provide prescription drugs by having consumers fill out a questionnaire rather than seeing a doctor can pose serious health risks. A questionnaire generally does not provide sufficient information for a healthcare professional to determine if that drug is appropriate or safe to use, if another treatment is more appropriate, or if the consumer has an underlying medical condition where using that drug may be harmful. Finally, it must be noted that in the case of foreign based web sites, if consumers have an adverse drug reaction or any other problem they have little or no recourse because the physical location or operator of the "pharmacy" often is not known or the seller is beyond the consumers' reach. FDA has no ability to take effective action against these foreign operators on behalf of U.S. citizens.
Over the last twelve to eighteen months, FDA has noticed a proliferation of websites that offer drugs purportedly from Canada directly to U.S. consumers. As noted earlier, a number of these websites claim that drug sales from Canadian pharmacies directly to U.S. consumers are legal. This is false. Some websites purport to offer "U.S. approved" drugs, however, it is highly unlikely that the drugs are in fact approved by FDA. Some web sites are actually ordering services that take orders from consumers that are then fulfilled by supposed Canadian pharmacies. However, under state law, these ordering services are likely participating in the practice of pharmacy without a license to do so.
A number of Canadian drug websites and U.S. ordering services indicate that the Canadian drugs are dispensed pursuant to existing prescriptions that are rewritten by a Canadian doctor in order to comply with Canadian law. However, the dispensing of medication on a prescription written by a physician who has not seen the patient or conducted a physical exam is generally contrary to state medical practice standards. Additionally, Dr. Henry Haddad of the Canadian Medical Association has said that under the Canadian Code of Ethics, physicians have a responsibility to do a history, physical exam and discuss the risks and benefits of the medication with the patient. He went on to say that the approval of prescriptions for patients they have not seen "Is something Canadian physicians should not be doing" (Associated Press, 6/26/02).
Some of these sellers have become so emboldened that they have solicited state Medicaid programs to import drugs from Canada. One Canadian pharmacy recently sent packages of prescription drugs to more than 500 U.S. consumers in a single shipment. Another boasted that since it added Internet sales to its local pharmacy a year ago, the store has gained about 100,000 U.S. customers. An ordering service based in Florida has announced plans to open 500 storefront shops nationwide within three years (Orlando Sentinel, 6/3/02).
Some recent criminal cases indicate the seriousness of the risks to public health that confront regulators with regard to Internet drug sales, but also illustrate the progress that is beginning to be made in combating this problem.
Norfolk Men's Clinic
On February 16, 2002, a federal jury in Alabama convicted Anton Pusztai and Anita Yates of charges arising out of the operation of the online pharmacy that illegally sold prescription drugs over the Internet to consumers. On June 18, Pusztai and Yates were sentenced respectively to over 15 years and 6.5 years of incarceration. Pusztai, an Australian citizen, and Yates, a resident of Clanton, Alabama, were convicted of conspiracy to commit violations of the FD&C Act, conspiracy to commit money laundering, mail fraud, dispensing misbranded drugs, and operating a drug repackaging facility not registered with FDA. From fall 1998 to the summer of 2000, the defendants operated a website called Viagra.au.com, also known as Norfolk Men's Clinic, and related sites, that sold Viagra, Xenical, Celebrex, Propecia, and Claritin-D to consumers.
In September 1999, OCI received information regarding the Norfolk Men's Clinic and the website. Based on this information, several covert purchases were made via the Internet. Search warrants were executed in October 1999 that resulted in the seizure of prescription drugs along with numerous business records. Additional covert purchases were made from part of the Internet operation in West Virginia. Based on these purchases and numerous interviews, several individuals were indicted. In addition to defendants Pusztai and Yates, the president of a prescription drug wholesaler located in Miami, Florida, and the company itself, pled guilty to distributing midbranded drugs and to obstruction of justice. In conjunction with the indictment, a second search warrant was executed in Clanton, Alabama along with two search warrants in West Virginia. While most of the drugs sold in this operation were domestic product, some appeared to have originated in New Zealand.
Medications Express
On June 7, 2001, Gerald Bevins was convicted in U.S. District Court for the Southern District of California of conspiracy to defraud the U.S. and commit offenses against the U.S. by introducing misbranded drugs into interstate commerce and smuggling. On September 4, 2001, Bevins was sentenced to serve twenty-four months in prison. The case was initiated on information received from Customs concerning an Internet web site called Medications Express. Bevins sold Mexican prescription pharmaceuticals from this website and claimed that no doctor's prescription was necessary. He continued to sell Mexican prescription pharmaceuticals through the mail from Sun City, California, even after discontinuing the Medications Express web site. Bevins, his wife and daughter, would receive orders via mail, travel to Tijuana, Mexico to purchase the pharmaceuticals, and smuggle them back into the U.S. The three packaged the pharmaceuticals into commercial courier boxes and shipped them to customers around the U.S. The drugs supplied by Bevins were labeled in Spanish and included Ritalin, Valium, Rivotril, and steroids.
Canadian Drug Store, Inc.
On May 14 of this year, the Ontario College of Pharmacists, a Canadian government agency, filed charges under Ontario law against The Canadian Drug Store Inc. for unlawfully operating an unlicensed pharmacy and using an un-registered pharmacist in filling prescriptions for U.S. residents. The College also filed charges against a licensed pharmacist, pharmacy, and physician in Ontario for helping to facilitate the delivery of prescription and non-prescription drugs to U.S. residents. A drug wholesaler was charged with supplying medications to a non-licensed pharmacy.
According to a statement released by the College, "There are many websites selling prescription and non-prescription medicines that have not been accredited as legitimate pharmacies by pharmacy regulators in either Canada or the U.S. The public needs to know that some websites presenting themselves as online "pharmacies" or "drugstores" may be operating without a pharmacy license and dispensing prescriptions without the oversight of a licensed pharmacist."
Total Remedy / Prescription Center II
According to news accounts, a Los Angeles pharmacy and two pharmacists were assessed penalties of almost $90 million in a state Board of Pharmacy proceeding this past May for filling more than 3,500 illegal prescriptions over the Internet. The case was under a new law enacted in 2001 that creates a requirement in California to fill prescription pursuant to a "good-faith medical examination." The Internet site concentrated on filling prescriptions for "lifestyle" drugs such as Viagra and Propecia (Associated Press, 5/29/02).
Pillbox Pharmacy
In March of this year, a Texas pharmacist, three doctors, two corporations and an individual were charged in a federal indictment alleging that they conspired to illegally dispense drugs in connection with an Internet pharmacy operation. The indictment charged one pharmacist, three physicians and two corporations, the S&H Script Shop and the Pillbox Medical Center, with conspiring to illegally dispense controlled substances and commit money laundering. According to the indictment, between January 1, 2000, and June 12, 2001, the defendants grossed more than $7.7 million from the Internet sales of just two drugs alone. The indictment alleges the doctors would issue prescriptions without establishing a patient history, performing a mental or physical exam, using appropriate diagnostic or laboratory testing, or providing any means to monitor medication response. The charges were the result of an 18-month investigation by FDA, the DEA and the Internal Revenue Service, working with the U.S. attorney's office. In April, the pharmacist and two corporations pled guilty to illegally dispensing controlled substances, and agreed to forfeit $1 million.
Other Enforcement Activity
To date, OCI has initiated 296 Internet drug investigations with each case involving a variable number of websites from one to 25 or more. These cases originated from multiple sources including interception at mail facilities, web based research, consumer complaints, and a variety of others. OCI has effected 112 Internet-related drug arrests and obtained 72 convictions. OCI currently has 101 open Internet drug investigations.
Currently, FDA has 90 sites under active review for possible regulatory or civil action. Warning letters have been sent to 55 domestic online sellers. Additionally, FDA has sent 137 "cyber letters" to operators of Internet sites in many countries, including Canada, that offer to sell online prescription drugs or unapproved drugs. These sites may be engaged in illegal activity such as offering to sell prescription drugs to U.S. citizens without valid (or in some cases without any) prescriptions. Cyber letters are sent over the Internet to the suspect websites to warn the operators that they may be engaged in illegal activities, and inform them of the laws that govern prescription drug sales in the U.S. Cyber letters have a deterrent effect and FDA has seen positive results from using them. FDA also sends copies of its cyber letters to the home governments of targeted websites when the locations can be identified. Follow-up depends on the ability and willingness of the foreign regulatory bodies to investigate and take actions against website operators who are illegally shipping drugs to other countries.
In cooperation with the Department of Justice (DOJ), FDA has obtained five preliminary injunctions against the sale of illegal products, including one product marketed as a weight-loss aid containing a potent thyroid hormone which could cause heart attacks or strokes, and an unapproved cancer therapy. Additionally, 15 product seizures, 11 product recalls, and the voluntary destruction of 18 violative products have been achieved, generally pertaining to unapproved new drug products including gamma hydroxybutyric acid, gamma butyrolactone, Triax, 1,4 butanediol, and laetrile. Forty-five foreign shippers have been placed on Detention Without Physical Examination and added to Import Alert 66-57 for targeting sales of unapproved new drug products to the U.S.
FDA is aware that a number of U.S. citizens travel to other countries to purchase medications at a lower cost. However, many prescription drugs available from foreign sources are either unapproved foreign versions of FDA-approved drugs or products for which there is no U.S. approved counterpart. In either case, these products are unapproved drugs prohibited from importation by section 505 of the FD&C Act. In FDA's experience, many drugs obtained from foreign sources that purport to be the same as U.S. approved prescription drugs are of unknown quality. FDA cannot provide adequate assurance to the American public that the drug products they purchase in other countries are the same products approved by FDA.
FDA is developing a program to better warn U.S. citizens about these dangers and the potential risks to their health when purchasing such drugs. We have begun to provide brochures to consumers crossing U.S. borders to make such purchases and are installing posters at borders stations warning of the dangers inherent in purchasing drugs outside the U.S.
Within the last two years, FDA has conducted three surveys at U.S. borders to gather data on drug products carried by individuals entering the U.S. While these border surveys involve land traffic rather than mail importation, the results show some similarities to the findings from the Carson mail pilot, but also some significant differences.
Southwest Border Survey (August 2000)
A survey of prescription drugs being brought by pedestrians into the U.S. at eight ports of entry along the 2,000 mile border with Mexico was conducted by FDA's Southwest Import District (SWID) with the assistance of other agencies. The survey looked at activity during four hours on a Saturday (August 12, 2000) at eight border ports in California, Arizona, and Texas. The purpose of the survey was to determine what specific types of products are being imported, and who is importing these products. The data collected from over 600 interviews indicated that the most common importers of prescription drugs were older male Caucasians with prescriptions from the U.S., bringing back primarily antibiotics or pain relievers for their own use. Prescriptions were held by 63 percent of the persons interviewed (59 percent U.S. prescriptions and 41 percent Mexican). The most common drugs and their indications that were purchased in Mexico during the survey were as follows: Amoxicillin (antibiotic), Glucophage (diabetes), Premarin (estrogen), Dolo Neurobion (vitamin supplement), Vioxx (inflamation), Retin-A (acne), Tafil (anxiety), Celebrex (arthritis), Penicillin (antibiotic), Viagra (impotence), and Carisoprodol (analgesic). While many of these products are already available as FDA-approved drugs in the U.S., some are unapproved for sale in this country.
Canadian Border Survey
On January 6, 2001, in cooperation with Customs, FDA conducted a survey to obtain a snapshot of prescription drug products being brought into the U.S. from Canada via passenger vehicles. During the eight-hour survey at three ports of entry in New York, Michigan and Washington, a total of 10,374 passenger vehicles and 58 buses crossed into the U.S. Of these, 33 passenger vehicles (35 individuals) were referred by Customs to be interviewed. These individuals brought in a total of 47 containers of drug products from Canada. The types of products included pain medicines -- primarily A-222 (a combination of acetaminophen, caffeine, and codeine) or similar products. The indicated reason for import was that the products were available over-the-counter (OTC) in Canada and cost less than in the U.S. The next largest group of products was herbal products, with the reason for importation being that the products were not available in the U.S. Other products included Tobradex (antibiotic/ steroid opthalmic for individuals having laser eye surgery); Claritin and Allegra (allergies) purchased OTC in Canada; Sibelium capsules (calcium channel blocker); and a variety of OTC products sold in Canada and not available in the U.S. Some of these drugs are unapproved foreign versions of FDA-approved drugs, although some approved for sale as prescription drugs in the U.S. are sold as over-the-counter medications in Canada.
Southwest Border Survey (April 2001)
On April 11, 2001, FDA, Customs, and other agencies conducted a survey of prescription drugs being brought into the U.S. at seven ports of entry along the U.S./Mexican border. This survey coincided with both Easter vacations, college spring break and the end of the snowbird season, when tourists from Northern states visiting along the Southern border return home. During the four hour survey, a total of 586 persons brought in a total of 1,120 drugs. Approximately 56 percent had a prescription for the medicines (61 percent were U.S. prescriptions, 39 percent were Mexican). The most common drugs purchased in Mexico were: Amoxicillin (antibiotic), Premarin (estrogen), Claritine (allergy), Terramicinia (antibiotic), Ampicillin (antibiotic), Ibuprofen (analgesic), Penicillin (antibiotic), Vioxx (inflammation), Tafil (anxiety), Dolo Neuorobian (vitamin supplement), Glucophage (diabetes), Celebrex (arthritis), Naproxen (analgesic), Retin-A (acne), Ventolin (pulmonary disease), and Valium (controlled substance/ nervous system depressant). As in the earlier survey, many of these products are already available as FDA-approved drugs in the U.S., while some are unapproved for sale in this country.
Controlled Substances
Although we do not know, nor is it possible to clearly determine, the amount of controlled substances brought into the U.S. purportedly for personal use, it is likely that such medicines are frequently imported for resale and pose a public health risk. The Agency has been working with both Customs and DEA to streamline and clarify Federal import policies specifically related to the importation of controlled substances.
FDA continues to believe that the quality of drugs in this country is high, and that the public can continue to have confidence that the drugs sold in the U.S. market are authentic. The Agency, however, takes very seriously any allegations or information regarding the counterfeiting or adulteration of drug products. As the drug manufacturing and distribution system has become more global in nature, the challenge of protecting against counterfeit, adulterated or substandard drugs has become more difficult. We are concerned about a spate of drug counterfeiting and tampering cases that have occurred in recent months, and we believe these incidents caution against any weakening of the current regulatory system.
The manner in which FDA handles these types of counterfeit and tampering incidents are driven by two primary goals that are often, but not always, complementary. First and foremost, FDA works with consumers, manufacturers, wholesalers, distributors, state agencies and others in order to determine the composition of the unsuitable product and the extent to which it has been introduced into the distribution chain, and we use this information do whatever is necessary to protect the public health. Second, OCI, with the support and cooperation of other FDA components and other law enforcement agencies, attempts to bring the perpetrators of criminal acts to justice. It must be noted, however, that the need to publicize the existence of a counterfeit or adulterated product in order to alert professionals and the public to potential dangers may compromise the successful conduct of criminal investigations.
Regular FDA district field investigators often work closely with OCI special agents in these cases. They follow up at specific wholesalers, distributors, hospitals or pharmacies identified as having received counterfeit product to conduct tracebacks on particular lots and to determine sources, quantities involved and the distribution of product to retail outlets. The FDA's Forensic Chemistry Center (FCC) and/or the drug and biologic review divisions provide field personnel with the labeling and packaging of authentic product for comparison with counterfeit product. FDA also posts information to its MedWatch site to inform consumers and health care professionals about safety concerns related to counterfeited or tampered products.
OCI opened 55 counterfeit drug cases from October 1998 through June 2002. During that time we have made 26 arrests with 20 convictions. We have seen a gradual increase in the incidence of finished dosage form counterfeit activity over the last few years. So far this year we have 16 cases opened, 12 arrests, and seven convictions. Eight of these arrests and five convictions are attributable to the latest eight counterfeit drug appearances.
The current focus on drug counterfeiting and the public perception of a more dramatic increase in counterfeit drug activity is due to the fact that the latest several counterfeits have appeared in the wholesale market and received wider distribution than has been the case historically. This is due to the existence of an illicit wholesale drug diversion network that has grown up around tiered pricing and economic fraud.
This system consists of criminal middlemen who knowingly solicit closed door pharmacies, such as a hospital or nursing home supplier, to over-order certain drugs based on fraudulent demand. The drugs are then sold into the wholesale drug diversion network. The diverter typically offers a 25 percent kickback to the closed door pharmacy and diverts the excess drugs into the illicit wholesale diversion system. This system depends on the diverter maintaining confidentiality for the closed door pharmacy since the pharmacy would lose its preferred pricing should the manufacturer discover the fraudulent arrangement. False pedigrees are the hallmark of the system as each wholesaler passing the drugs on to the next faces being "cut out" if the subsequent buyer knows the identity of his supplier's source. It is easy to see how this system of "willful blindness" facilitates the entry of counterfeit and otherwise unsafe drugs into the marketplace. Unfortunately these illegal schemes net huge profits. From October 1998 to June 2002, OCI opened 255 Prescription Drug Marketing Act diversion cases, executing 464 arrests and resulting in 337 convictions, with fines and forfeitures totaling approximately $32 million.
The following examples of counterfeit drug products and tampering incidents may help to illustrate the types of activity we have recently encountered.
Serostim (somatropin (rDNA origin) for injection), Serono Laboratories
In late 2000 and early 2001, FDA became aware of consumer complaints about adverse effects and a recall at the distributor level of Serostim. FDA enforcement personnel and criminal investigators became involved and engaged FDA field offices nationwide, which included investigative follow-up at other distributors and the manufacturer. In January 2001, Serono issued a press release regarding the apparent counterfeiting of one particular lot. An additional press release and Dear Health Care Professional letter were issued by the company in May 2001, regarding a second lot.
In May 2002, Serono became aware that counterfeit Serostim displaying a fake lot number had been distributed. Preliminary information indicates that the counterfeit product may have been distributed via the Internet. Laboratory analysis by FDA shows that the product contains no active ingredient, and it has been determined that the product did not originate from Serono. On May 16, Serono issued a letter advising Serostim handlers to be aware of the counterfeit lot even though it has not shown up in normal distribution channels.
Neupogen (filgrastim), Amgen, Inc.
In the spring of 2001, based on observations by a distributor about product appearance, Amgen analyzed a suspect lot and determined that the vials contained only saline solution. Investigation by the company and FDA revealed that the lot did not display a legitimate Neupogen lot number, but one that had been assigned to a lot of Epogen, another Amgen product. The FCC performed additional analysis. In May 2001, Amgen issued 17,000 Dear Health Care Professional letters nationwide informing patients, physicians, pharmacies and wholesalers about the counterfeiting of Neupogen. Later that month, Amgen reported to FDA on product with four lot additional numbers having wrong expiration dates, indicating either counterfeit lot numbers or that expiration dates were changed to make them more saleable by extending dates. In June, Amgen updated its Dear Health Care Professional letter with information on additional confirmed and suspected counterfeit lots.
Epogen (epoetin alfa), Amgen, Inc.
In May 2002, FDA, state regulators and Amgen became aware that potential counterfeit Epogen may be in commerce. Amgen analysis indicated that a counterfeit product labeled as Epogen 40,000 U/ml vials with a particular lot number contained a clear liquid having active ingredient approximately 20 times lower than expected. Samples of the authentic product as well as the counterfeit product were sent to FCC for analysis. On May 8, Amgen issued a letter advising health care professionals about the counterfeit Epogen and describing the differences between authentic and counterfeit packaging so that physicians can identify the authentic product. Further investigation revealed that a major wholesale distributor was holding approximately 1,600 cartons of counterfeit product. The majority of this counterfeit product was tracked back to a wholesaler located in the western U.S. On May 24, Amgen issued a second advisory letter to warn health care professionals that two additional counterfeit lots of Epogen were discovered.
Combivir (lamivudine plus zidovudine), GlaxoSmithKline
In the spring of 2002, GlaxoSmithKline (GSK) received four complaints that bottles containing 60 tablets of Combivir were being replaced with Ziagen tablets. In addition, the firm determined that counterfeit Combivir labels were placed on authentic bottles of Ziagen tablets. Both medicines are used as part of a combination regimen to treat HIV infection. A GSK health hazard evaluation of this situation determined that if an individual takes the wrong tablet and is sensitive to abacavir sulfate (Ziagen), a potentially life threatening hypersensitivity reaction could occur. GSK has stated that the incidents appear to be isolated and limited in scope, and no injuries or adverse reactions have been reported. However, in May, distributors were advised to initiate recall to their customers. GSK also issued a press release to alert patients, pharmacists and physicians to watch for third party tampering that incorrectly labels Ziagen as Combivir.
Zyprexa (olanzapine), Eli Lilly & Co.
In the winter and spring of 2002, Eli Lilly received complaints from four pharmacies in four states that the product Zyprexa had been removed and replaced with white tablets labeled as aspirin. Zypreza is indicated for the treatment of schizophrenia and acute bipolar mania. The tampering situations occurred in two strengths and in three different lots. The company determined that the tablets from two of the complainants were non-Lilly tablets and looked the same in both complaints. FDA has determined the manufacturing source of the white tablet marked as aspirin and is continuing to investigate. On May 4, Lilly issued a press release and Dear Health Care Professional letter concerning the tampering situation. The company stated in their press release that these incidents appeared to be isolated and limited in scope.
Procrit (epoetin alfa), Amgen/Ortho Biotech
In May 2002, based on requests from state health authorities, Amgen obtained and analyzed samples of 40K vials of Procrit from a certain wholesale distributor. The analysis indicated that a counterfeit drug product labeled as Procrit 40,000 U/ml vials with a certain lot number contains a clear liquid having active ingredients approximately 20 times lower than expected. Samples of the authentic product as well as the counterfeit product were sent to FCC for further analysis. Investigators are continuing following up at wholesalers and distributors identified as receiving the counterfeit product. One major wholesale distributor was found to be holding approximately 339 cartons of counterfeit product. In June, Ortho Biotech issued a Dear Health Care Professional letter and press release which details the differences between authentic and counterfeit packaging so that physicians can be certain they have the authentic product.
In addition to the above cases, OCI has made a number of recent arrests relating to counterfeit AIDS and cancer drugs, as described below.
Serostim, (somatropin (rDNA origin) for injection), Serono Laboratories
In November 2000, Nicholas Hanson was arrested by a task force of OCI, U.S. Postal Inspection Service, and Iowa State Police on charges of conducting an ongoing criminal enterprise. Hanson was the leader of a small group that counterfeited Serostim. He imported the human growth hormone through the Internet from China, via Express Mail. At the same time, Jeremy Gansen was arrested by the same task force and charged with conducting an ongoing criminal enterprise related to the misbranding and distribution of human growth hormone and steroids. Gansen assisted Nicholas Hanson in the counterfeiting of Serostim.
Nutropin AQ (somatropin (rDNA origin) for injection), Genentech
In July 2001, an individual was arrested in Texas by OCI and subsequently indicted in August 2001 by a Federal Grand Jury. He was charged with counterfeiting Nutropin, trafficking in counterfeit goods and controlled substances violations. He subsequently plead guilty to counterfeiting Nutropin and distributing controlled substances. In December 2001, a second individual was indicted by a Federal Grand Jury in Texas for counterfeiting the above Nutropin, conspiracy to defraud the FDA, aiding and abetting and controlled substances violations. He is a fugitive and a provisional international arrest warrant is being sought for his arrest. He will be extradited to the U.S. In April 2002, two additional individuals involved in the distribution of counterfeit Nutropin were arrested by OCI and DEA for selling heroin to an undercover agent. Finally, in May 2002, a fifth individual was arrested by OCI for selling counterfeit Nutropin, and he subsequently plead guilty to the charge.
FDA remains strongly concerned about any possibility that counterfeit or otherwise unsafe drugs may find their way into the American drug supply. We will remain vigilant as we refine and improve the programs and procedures that we use to ensure the availability of safe medications for consumers. We also believe that proposals that have been put forth in Congress to allow either the reimportation of drugs by persons other than the original manufacturer, or to allow consumers to import drugs for their own personal use, will provide additional avenues for unscrupulous individuals to place counterfeit, substandard or otherwise dangerous drug products into U.S. commerce and into citizens' medicine cabinets, as discussed below.
Currently, new drugs marketed in the United States must be approved by FDA based on demonstrated safety and efficacy; they must be produced in manufacturing plants inspected and operated in conformance with FDA's current Good Manufacturing Practice (GMP) requirements; and their shipment and storage must be properly documented and subject to inspection. This "closed" regulatory system has been very successful in preventing unapproved, adulterated or misbranded drug products from entering the U.S. stream of commerce. Legislation that would establish other distribution routes for drug products, particularly where those routes routinely transverse a U.S. border, creates a wide inlet for counterfeit drugs and other dangerous products that can be injurious to the public health and a threat to the security of our nation's drug supply.
Although a number of bills have been introduced that would facilitate the importation of foreign drugs, FDA has looked most closely at S. 2244, which has been the subject of recent activity on the floor of the U.S. Senate. This bill, introduced by Senator Dorgan and others, and its companion bill in the House, H.R. 4616, introduced by Rep. Sanders, would create two new pathways for drugs to enter the U.S. outside of the current drug regulation system that, while not perfect, has a remarkable record of protecting the public from contaminated, ineffective, or counterfeit drugs. Of particular concern are the provisions for allowing individuals to import drugs directly from Canadian pharmacies. This would greatly exacerbate the growing problem of the hundreds of websites purporting to sell legitimate medications that are in fact selling unapproved or otherwise dangerous drugs to Americans. These personal importation provisions are so broad that they will over-ride existing statutes that allow FDA to refuse entry to prescription drugs from Canada if they are believed to be unsafe, ineffective, adulterated, contaminated or counterfeit.
Throwing the door open to drugs purchased by individuals directly from Canadian sellers will encourage unscrupulous individuals to devise schemes using Canada as a transshipment point for dangerous products from all points around the globe. Web sites touting the availability of supposedly legal drugs from Canada will spring up in large numbers, duping consumers that will have no way of knowing that the drugs may be illegal, counterfeit or contaminated.
S. 2244 and H.R. 4616 would create a second route for transporting drugs into the U.S. outside of the existing regulatory system. The bill would allow pharmacists and wholesalers to purchase drugs from Canadian sellers over which U.S. authorities (FDA or others) have no jurisdiction or control. Because the bill requires that the drugs comply with sections 501, 502 and 505 of the Act, it may be found, in practice, that for the bill to have its intended effect, U.S. manufacturers would have to sell drug products manufactured, labeled and intended solely for the U.S. market to Canadian distributors, specifically for re-sale to the U.S. As a practical matter, meeting these requirements would be very difficult, and it is unlikely that Canadian sellers and U.S. importers would be willing to endure them. Additionally, it is not clear as to how FDA could ensure that drugs reimported under this proposal would in fact comply with those sections of the Act, because the Agency has no practical ability to regulate or inspect Canadian facilities.
The bill attempts to ensure the safety of the drugs under 804(b) by requiring testing for authenticity. Unfortunately, authenticity can rarely be established solely through chemical analysis. That can only be assured by the multiple layers of safeguards that are built into the FDA's oversight system in which drug approval, regulation, inspections and surveillance tracks drugs over their entire life cycle. The testing required by the bill would not protect against the threat of counterfeit drugs because no random sampling plan can protect against such criminal conduct. The threat of counterfeits does not depend on the integrity of the product itself, but on the integrity of those handling it. Since counterfeits can easily be commingled with authentic product, either by the case, by the bottle, or by the pill, there is no sampling or testing protocol sufficient to protect against the grave public harm they pose.
In addition, the bill would require drug manufacturers to disseminate their drug formulations and chemical fingerprints to potentially thousands of pharmacies and wholesalers. This information, currently protected as trade secret, could be worth millions of dollars, per drug, on the black market. Counterfeiters could obtain drug formulations and learn how to make their fake drugs look real and survive chemical analysis. Notwithstanding these very real safety concerns, it is questionable as to whether the bill would achieve the goal of bringing cheaper pharmaceutical products to U.S. consumers. Any cost savings that might be generated may well be absorbed by the fees charged by exporters, wholesalers, pharmacists and testing labs.
We would also like to recognize that the Administration is continuing to review this legislation and may have further comments. Finally, FDA notes that we will continue to offer our expertise and advice to the Congress, as we have in the past, in exploring any additional proposals which may be offered to address the drug pricing issue, including those involving reimportation.
Mr. Chairman, FDA remains concerned about any possibility that unsafe drugs may find their way into the American drug supply. We will remain vigilant as we refine and improve the programs and procedures that we use to ensure the availability of safe medications for consumers. We appreciate the Committee's interest in assuring that the American public has access to safe and affordable medicines and we look forward to working with you in furtherance of this goal. Thank you again for the opportunity to participate in today's hearing. I will be happy to answer any questions.


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FlyAnglers OnLine
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Yesterday evening I flyfished a small river and an adjacent pit. In addition to Largemouth Bass, Crappie, Green Sunfish and Bluegills, I landed both Smallmouth Bass and Smallmouth Buffalo.
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Ankeny, Iowa
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ByNeil Shah
A roundup of economic news from around the Web.
-Fiscal-Cliff Can: Matt Yglesias says it's already too late for Obama and the Republicans to sidestep the so-called fiscal cliff. "My understanding of the calendar is that we're basically out of time already. To enact a big tax and spending bill, you'd first need agreement among the principals. Then aides would have to write it up in more precise legal language, and it'd have to be scored and sold to key members of Congress. That's really a 'deal before Christmas if you want to be finished by the New Year' scenario and we're not there." So, what can happen over the next few days once Obama and Congress return to their seats? "Democrats and Republicans can talk about what bills they might like to pass in January." Another possibility is that Obama and Boehner ask Congress for a few more weeks to hammer things out. However, "liberals will probably feel … that any mini-kick [of the fiscal-cliff can] disadvantages them. Given how close we are to locking the new baseline into place, and given the extent to which the GOP is already taking the blame for there being no deal, it looks pretty tempting from that perspective to just start negotiating anew on January 2."
-Housing's Shadow: Wall Street Journal reporter Nick Timiraos explains why the 3.4 million properties in the U.S. headed toward foreclosure–the so-called "shadow" inventory–won't snuff out this year's nascent housing-market recovery. For starters, the size of this shadow has shrunk from a peak of 4.7 million in 2009. Inventories of new and previously-owned homes are unusually low. Demand for homes has picked up. And "hearty investor appetites for foreclosed properties have trimmed the backlog and reduced the discount at which foreclosures sell. In September, foreclosures sold for around 7.7% less than traditional home sales, down from a 24% discount three years ago." In other words, even if there's a bunch of "shadow" inventory, it won't weigh on prices as much. One warning though: "The shadow does pose a threat to some markets. States such as New York, New Jersey and Florida, where banks have struggled to meet court-administered foreclosure processes, have larger backlogs … Arizona and California, by contrast, have less restrictive foreclosure processes and have cleared more bad debt."
-Gun Insurance: The Economist notes that a new idea for gun control is making the rounds: Mandatory fire-arm insurance laws. Owners of firearms could pay liability insurance, the same way Americans have to get car insurance. Ideally, the private-insurance market would distinguish between potentially violent and probably non-violent gun-owners. A 80-year-old grandmother might pay a low insurance rate, while a young adult in an inner city would pay more, the thinking goes. Nouriel Roubini just tweeted in favor of this, while Forbes.com and Slate have offered thoughts. Of course, 100k or 250k of insurance may not seem like enough to compensate for a loss of life, but the Economist notes, "it's a lot better than nothing."


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text: Home Gallery Print (image) Rocky Chocolate Biscuits Mt. Rocky 6 Rocky Chocolate Biscuits: Mt. Rocky 6 A mountain of chocolatey goodness. Published on Apr 10, 2012 Editor's Pick Chocolate seems to be advertising's favorite new medium, as we've seen in recent efforts like this, this and this. Mother introduces the latest tasty campaign to the bunch with Mt. Rocky, a fantastical chocolate-infused experience for Fox's Biscuits brand Rocky Chocolate. The agency teamed with food artists Bompas & Parr, known for their fabulous jelly spectacles, to create Mt. Rocky, the first chocolate-scented climbing wall, which debuted today at the U.K.'s Alton Towers Resort. The challenges invites visitors to ascend a chocolate scented boulder, crawl through a biscuit crumb grotto and finally, climb up a 10-meter tall chocolate cliff featuring a waterfall of chocolate that flows at 70,000 liters per hour. The entire installation will be covered with paint that is filled with micro-encapsulated chocolate aroma molecules--so passersby will be able to smell it from half a mile away. The installation is open daily from 10 a.m. to 6.p.m through Sunday, April 15th. See more images of the installation to the right, and more info at facebook.com/liverocky. Rate this Ad You must be registered to rate the ad. Please Login or Register Now About CreditsDateApr 10, 2012Agency:Mother LondonClient:Rocky Chocolate BiscuitsCreative:MotherPlanner:MotherAgency Producer:MotherProduction Company:Bompas & ParrProducer:Bompas & ParrMedia Agency:MediacomPR Agency:Cow PR Tagsinstallation CategoryAmbient!OOH Latest Creativity News on Ad Age Anomaly Adds Two Partners, TBWA London Has a New CCO, We Are Unlimited Bolsters Creative Team Hear Our New Tagline Podcast: Engineering Creativity With Shannon Boodram and More Yahoo Asserts 'OG' Fantasy Sports Status in New Campaign Related work Rocky Chocolate Biscuits: Mt. Rocky 8 Mother London Rocky Chocolate Biscuits: Mt. Rocky 3 Mother London Rocky Chocolate Biscuits: Mt. Rocky 7 Mother London


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• ethereal •
Pronunciation: ee-thi-ree-êl • Hear it!
Part of Speech: Adjective
Meaning: 1. Flimsy, wispy, airy, floating along the edge of existence. 2. (Chemistry) Related to ether.
Notes: This charming word is the adjective from ether, which to the ancient Greeks was the crystal clear upper air breathed by the gods on Mount Olympus. That is where the sense of "airiness" originated. This word may be used adverbially with the usual suffix, ethereally. The quality it represents is ethereality. While this word's sound and meaning are beautiful as they are, I think the poetic—and now archaic—spelling, æthereal, gives it a more angelic and, well, ethereal appearance.
In Play: Spirits are the most likely creatures to be ethereal: "Charlene? She just swished through the house like an ethereal spirit on a mission without speaking to anyone." Untouchable objects are also ethereal: "Sidney Couch putters around an ethereal garden of images and ideas he has created in his mind and has very little contact with the real world." (I can understand Sidney.)
Word History: Ether comes to English from Greek aither "pure upper air breathed by the gods on Olympus". This word, interestingly enough, is a noun from the verb aithein "to ignite, light, set on fire". The connection would seem to be either the ethereality of fire or the fact that fires were kept in the temples of the gods. This is suggested by a Latin word of the same origin, aedis "temple, building", a word at the bottom of Latin aedificium, which came to English, via French, as edifice. (We owe Jacob Rossignuolo of Melbourne, Australija, much more than an ethereal expression of our gratitude for suggesting today's misty Good Word.)


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Jeff - from Medina, OH
The sides of the cake are baking too fast. Use the Bake-even strips to keep the sides cooler and you'll get more even baking. You can also try baking the cake at 25 degrees lower temperature for a longer length of time.
You can expect some doming and this can be rectified by leveling the cake after it has baked and cooled.


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Moderator: mikenz66
mikenz66 wrote: SN 47.19 PTS: S v 168 CDB ii 1648
Sedaka Sutta: At Sedaka 1: The Acrobat
translated from the Pali by Thanissaro Bhikkhu
http://www.accesstoinsight.org/tipitaka ... .than.html
danieLion wrote:Reverend Analayo's lecture on this sutta and it's Agama (Chinese) parallel:
Protecting Oneself and Protecting Others Through Mindfulness
or download here
Sedaka-sutta SN 47.19 wrote:[Student:] You protect yourself, teacher, and I'll protect
myself. Thus, each self-guarded and self-
protected, we will display our skills, collect our
fee, and get down safely from the bamboo pole.'
That's the method there," the Blessed One said.
"It's just as the apprentice Medakathālikā said
to the teacher.
Saṃyukta-āgama n. 619 wrote:[Student:] Instead, we should each take care to protect
ourselves. [Like this] we will put on a show and
gain much wealth. We will be physically at ease
and yet I will get down safely.'
The teacher of acrobatics said: 'As you said, we
will take care to protect ourselves, this is
correct and is also the meaning of what I said'."
I have heard that on one occasion the Blessed One was staying near Rajagaha on Vulture's Peak Mountain, in the Boar's Cave. Then LongNails [Dighanakha] the wanderer went to the Blessed One ...
http://www.accesstoinsight.org/tipitaka ... .than.html
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sttttttopppp talkinnngg!
i like this one alot
is it really that hard to post at least one dope picture?
and wiserism chill out your shit is wack. definately doesnt belong in this thread thats for damn sure.
but this does
This guy's pretty dope.
Oops this is a thread for paper work isn't it?
Monsters Doing Coke
Big B.A.D Rots
Stolen picture, Big Mora97, from Tallinn, Estonia.
Thought I'd save that thread a little bit, so much talk on this page. If you want to battle, argue and whatever use pm's.
Last edited by Spark391; 04-28-2009 at 03:13 PM.
i dont normally like that style but that page is so fucking sick i just busted 3 nuts and had a heart attack
You can buy this but it costs $500.
that mora double pager is orgasmic
Smashtrash.net <--- That Ironlak style made me think of this site I used to visit a few years back.
Last edited by JonLester#31; 05-05-2009 at 05:27 PM.
"And for all the people who give me the respect I deserve at least some people still know what quality fuckin' vandalism is all about. Keeping all the toys, bitches and snitches in check."
were can i go to get inspiration
Few pages back....."(Duh?
The Fallen..
Ok i want to send out a book who wants it first?piece it then send it to the next person? Anyone up?
BEDAROCINK.WEEBLY.COM or find me on FACEBOOK under the name "TED BEDAROC"... anyone in nor cal get at me for any and all graff supplies...
yo ill hit ur book up.
Anyone else on here down for the book pass along pm me with your address and ill get em out to you...
BEDAROCINK.WEEBLY.COM or find me on FACEBOOK under the name "TED BEDAROC"... anyone in nor cal get at me for any and all graff supplies...
Slor GBAK


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Message Board
Cynthia Riggs Message Board
Talk about the novels, new and used books that Riggs has written!
Author Riggs's Book Reviews
Jack In the Pulpit
Dunne, June 2004, 22.95, 208 pp. ISBN 0312330111 Ninety two years old Victoria Trumbull is as spry as a person half her age and her mental faculties are probably sounder than most of those in their fourties. Her granddaughter Elizabeth is living with her after escaping her abusive husband Lockwood who unknown to them is on Martha's Vineyard. He watches his ex-wife and is waiting for the right time to �talk� to her. When the women find out he i...
The Cemetery Yew
Dunne, Sep 2003, 22.95, 208 pp. ISBN: 0312321260 The Nortons want to relocate the remains of a cousin from her burial spot under the Martha's Vineyard cemetery's yew tree to a plot in Milwaukee. However, the gravediggers find no remains when they inter the dirt at the location. Ninety-two year old Victoria Trumbull comes by just as the diggers give up assuming that the exhuming should have been somewhere else. Rumors say otherwise. Not long...
The Cranefly Orchid Murders
St. Martins, May 2002, 23.95, 272 pp. ISBN 0312301456 Victoria Trumbull is a spry ninety-two year old woman who lives on Martha's Vineyard year round. She has more energy than most people half her age, goes hiking, writes poetry and reads to the residents of the retirement home. One of Victoria's neighbors, Phoebe Eldridge, has just sold her home and land to another Martha's Vineland resident, Harry Ness. While hiking Victoria discov...
The Paperwhite Narcissus
Dunne, May 2005, 22.95, 224 pp. ISBN 0312339836 On Martha's Vineyard, ninety two year old Victoria Trumbull is fired from her job at the Island Enquirer where she has been writing the West Tisbury column for over a half a century. Publisher Colley Jameson feels he can get someone to work the section cheaper. Shortly thereafter, he gets a fake obituary notice that he believes Victoria sent to him but she denies it vehemently. Instead the nonage...


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UPDATED: Fox News Corrects False Report On Elizabeth Warren's Book
In a National Review blog post, Katrina Trinko falsely accused Massachusetts Senate candidate Elizabeth Warren of plagiarism. She alleged that Warren lifted passages for her 2005 book All Your Worth, which she co-wrote with her daughter Amelia Warren Tyagi, from another book:
Trinko has since deleted that blog post and published a correction [1]:
I took down my earlier post on Elizabeth Warren plagiarizing from the book Getting On the Money Track. On Amazon.com, the Warren book All Your Worth is listed as having been published January 9, 2006. As it turns out, that is the paperback publication date; the hardback book was published in March 2005. As such, it appears that Getting on the Money Track (published in October 2005) plagiarized from All Your Worth, not the other way around.
I apologize for the error.
On Fox News' flagship news program, Special Report, guest host Shannon Bream repeated National Review's false report:
Will Special Report issue a correction on Monday?
UPDATE: Inexplicably, Breitbart.com put up a post [2] echoing the false accusation of plagiarism against Warren -- more than an hour after Trinko had a pulled down her post and issued a correction, which the Breitbart post itself links to:
UPDATE 2: Breitbart has corrected its post, replacing the original content with an editor's note and the text of Trinko's correction:
UPDATE 3: Fox News' Bret Baier addressed the report by his own show from last Friday that accused Elizabeth Warren of plagiarism. Baier stated that the National Review author that originally made the accusation "has since apologized, saying she confused the publications dates, and so Warren was actually the victim of plagiarism and not the other way around."
- Posted In
- Government [3], The Senate [4]
- Network/Outlet
- Fox News Channel [5], National Review Online [6]
- Person
- Shannon Bream [7], Katrina Trinko [8]
- Show/Publication
- Special Report with Bret Baier [9]
- Stories/Interests
- 2012 Elections [10]


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Instant Room: 10 Designers Share How to Get Their Look
Dress your bed in all white for the summer. It's like floating on a cloud. In this dreamy white Hamptons bedroom decorated by Noel Jeffrey, the bed is upholstered in Christopher Hyland fabric and flanked by a pair of night tables that came with the house. Bed linens from Frette.
Paint your bedroom closet a favorite color, like designer Jeannette Whitson did in her Nashville, Tennessee, house. Instead of the usual chrome rods and white backdrop, Whitson gave her closet a more luxurious look by painting it Benjamin Moore's Blue Dusk and hanging her clothes on unlacquered brass rods.
11 Ways to Maximize a Small Space


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Billabong Surf With A Pro Kandui Resort: Day 9
Once again, it's been an amazing trip to Kandui Resort in the Mentawais. A bunch of the campers got the best waves of their lives,, and everyone's surfing improved over the course of ten days with the assistance of Dave Rastovich and Shane Dorian.
The crew spilt up into two groups today, one going to Bankvaults and another headed to a spot that shall remain nameless. The nameless spot was a slurpy little left that had a nice tube on take off followed up by a bash-friendly wall. Aside from two feral dudes, we were the only one on it. We shared tube after tube, with the goofyfooters applying the arm-drag technique to slow down and get into the barrel. The campers follower Rasta and Dorian's advice and scored!
Meanwhile at Bankvaults, it "wasn't that good," according to initial reports. The photos proved otherwise (see above from the day 9 gallery). We're now posted up in the bar recounting the epic waves ridden the new friends made. The trip was just capped off with an epic session at Four Bobs with eight of us out there (including the film crew who worked their asses off on this trip) sharing waves and heckling each other relentlessly.
Terima Kasih to Kandui Resort, Billabong, Dave and Shane, Paul from Perth, Margi the best bartender in the world, Josh Harper from Billabong Camps, Soja the ripper, Matt Beauchesne, Ryan Young, Laidi the fish killer, Anthony Marcotti, Jenny, and the coolest guy in the world, All Day Ray Wilcoxen. See you all next year!
Go to Kandui Resort's Web site
Follow Kandui Resort on Facebook


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Pasadena Standoff Over
PASADENA (CNS) - A knife-wielding man who holed up with a 10-month-old baby girl inside a Pasadena motel room was taken into custody this morning after being swarmed by officers who feared for the child's safety, police said.
The drama played out at the Lincoln Motel in the 1500 block of Lincoln Avenue, where officers were called around 12:45 a.m. to investigate a report of a man acting strangely and arguing with a female, according to Pasadena police.
Two officers spotted the suspect on the west side of the property and when the suspect saw them, he retreated into one of the motel rooms, said Pasadena police Lt. Jason Clawson.
As more units arrived, an officer looked through the motel room window and saw the suspect, later identified as 32-year-old Steven Flowers of Pasadena, holding the infant in one arm and a knife in his other hand, Clawson said.
Officers surrounded the room and at one point, the sergeant in command saw Flowers holding the child at knifepoint, police allege.
The sergeant quickly assembled an entry team, with some officers assigned less-lethal devices and one assigned ``lethal coverage'' in case Flowers attempted to harm the child, Clawson said.
One officer, a trained negotiator, began talking with Flowers and convinced him to place the knife on the floor, but the suspect still refused to surrender, Clawson said.
Officers then entered the room using a pass key. Flowers, who Clawson said was ``aggressive, belligerent and appeared paranoid'' retreated into a corner and appeared to be squeezing the child.
Following a pre-arranged rescue plan, the officers recovered the child and subdued Flowers, taking him into custody, Clawson said.
Both Flowers and the child were taken to a hospital for evaluation. Flowers was later released and booked at the Pasadena police jail, Clawson said.
He was being held at the Inmate Reception Center in downtown Los Angeles in lieu of $100,000 bail, according to sheriff's online booking records.
The child, who was unharmed, was placed into the custody of the county Department of Children and Family Services, Clawson said.
Posted by Amy King


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COLTON -- A 52-year-old Chino prison corrections officer was in critical condition Friday with a gunshot wound to the head, and his alleged assailants - one recently on parole from the prison - were in custody after a nighttime assault at a gas station that would have killed him if it wasn't for the quick action of police, authorities said.
When officers arrived at the Shell gas station in the 2700 block of Iowa Avenue shortly before 9 p.m. Thursday night, they found the 26-year correctional officer with a wound so serious that police didn't want to wait for paramedics.
The off-duty California Department of Corrections and Rehabilitation officer at California Institution for Men had apparently been shot while pumping gas. "The patrol officers picked up the downed officer, loaded him into their patrol unit and raced him to the emergency room at Arrowhead Regional Medical Center," said police spokesman Ray Mendez. "He's currently in critical but stable condition in the critical care unit. "
The shooters fled. But police received information on them and their silver Dodge Durango.
About three hours later, Riverside police spotted an SUV pulling into a Burger King drive-thru matching the one described by Colton police and approached the driver.
The driver jumped out of the SUV and ran, but was captured. A second man was also detained, though it was unclear whether he was in the vehicle with the driver or captured at another location.
Christopher Marquez, 24, and Anthony Gomez Jr., 31, both of Riverside, and who allegedly have gang ties, were booked into Central Detention Center in San Bernardino on suspicion of attempted murder and conspiracy.
They were each being held in lieu of $1 million bail.
A motive in the shooting was not released by police, and state officials declined to comment on whether the officer knew the suspects through his job at California Institution for Men, where Gomez was housed during his prison term.
According to court records, Gomez was sentenced to 11 years in prison in 2001 for a robbery and assault with a deadly weapon that occurred in July 2000.
The judge ordered him sent to the Chino prison.
But he was put on parole in March 2012.
State officials declined to identify the officer for his protection, but the Secretary of the California Department of Corrections and Rehabilitation, Jeff Beard, issued a statement Friday saying thoughts and prayers were with the officer and with his family.
"Our hearts are heavy after learning two people tried to murder one of our correctional officers in Colton last night," Beard said. "The Colton Police Department is investigating this tragic incident and we are thankful they immediately transported the officer to the hospital. Their quick actions saved his life. "
A personal blog belonging to a correctional officer posted a memo said to be from California Institution for Women Warden Tamara Kabban-Miller. It offered prayers for the man and stated that he was in uniform and had stopped at the gas station on his way from work.
"Again, I know you will keep (the officer) in your thoughts for his recovery as our correctional family mourns this tragic shooting," it said.


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Miley Cyrus to host & perform on 'SNL' October 5th
Listen to Miley Cyrus on iHeartRadio
Miley Cyrus has landed a major gig for the weekend before her album release.
NBC announced on Monday that the controversial former Disney star will be serving as both host and musical guest on the October 5th episode of "Saturday Night Live." Her much-anticipated album Bangerz drops the following Tuesday.
It will be Miley's first time pulling double-duty on the sketch show, but she has appeared as host once before back in 2011. The singer took to Twitter to confirm the news just before releasing her racy new video for "Wrecking Ball."
HOSTING & PERFORMING ON SNL OCTOBER 5TH ❤ #bangerz— Miley Ray Cyrus (@MileyCyrus) September 9, 2013
Photo Credit Getty Images


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Mines biomedical researcher receives Boettcher Foundation grant
GOLDEN, Colo., June 30, 2010 – Keith Neeves, Colorado School of Mines assistant professor of chemical engineering, was one of six researchers to be awarded a $250,000 grant by the Boettcher Foundation for the advancement of biomedical research.
The grant, part of the Webb-Waring Biomedical Research Program, will allow Neeves to focus on studying the role of blood flow in the formation of blood clots.
Karen Gilbert, Public Relations Specialist / 303-273-3541 / firstname.lastname@example.com
Marsha Williams, Director of Integrated Marketing Communications / 303-273-3326 / firstname.lastname@example.com


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You are here:
Letter From Dr. Stephen I. Katz: Making the Case for NIH
Office of Science Policy, Planning and Communications
Communications and Public Liaison Branch (CPLB)
Anita Linde, M.P.P.
Nancy Garrick, Ph.D.
Deputy Director—CPLB
Trish Reynolds, R.N., M.S.
Media Liaison
Letter From Dr. Stephen I. Katz: Making the Case for NIH
Dear Colleagues:
The NIH, the largest source of funding for medical research in the world, is the driving force behind many of the health advances we benefit from every day. Yet, in a recent Research!America survey, only nine percent of respondents correctly identified the NIH as the agency that funds most of the medical research paid for by U.S. taxpayers. Many are also unaware that most of the NIH budget, greater than 80 percent, goes outside the agency to universities and scientific institutions throughout the country.
To strengthen communications regarding the impact of NIH research, efforts are underway to present a unified and cohesive NIH identity. Earlier this year, the NIH adopted a new logo as the "visual mark" for the agency. It is only the fourth logo to be used by the NIH in its 125-year history.
The agency has also developed a new website — The Impact of NIH Research — that includes a toolbox with fact sheets, reports, slide sets, and other resources to help all of us better communicate the value of NIH-supported research.
Last week, NIAMS grantees received our biannual reminder
We live in an age of unprecedented scientific opportunity to improve the Nations health. Thank you for helping us to fulfill our commitment to inform the American public about the vital role of the NIH and biomedical research.
Stephen I. Katz, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health


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GastroparesisGastroparesis diabeticorum; Delayed gastric emptying
Gastroparesis is a condition that reduces the ability of the stomach to empty its contents. It does not involvea blockage (obstruction).
The exact cause of gastroparesis is unknown.It may be caused by a disruption of nerve signals to the stomach. The condition is a common complication of diabetes. It can also followsome surgeries.
Risk factors for gastroparesis include:
- Diabetes
- Gastrectomy (surgery to remove part of the stomach)
- Systemic sclerosis
- Use of medication that blocks certain nerve signals (anticholinergic medication)
- Abdominal distention
- Hypoglycemia (in people with diabetes)
- Nausea
- Premature abdominal fullness after meals
- Weight loss without trying
- Vomiting
Exams and Tests
- Esophagogastroduodenoscopy (EGD)
- Gastric emptying study (using isotope labeling)
- Upper GI series
People with diabetes should always control their blood sugar levels. Better control of blood sugar levels may improve symptoms of gastroparesis. Eating small meals and soft foods may also help relieve some symptoms.
Medicatines that may help include:
- Cholinergic drugs, which act on acetylcholine nerve receptors
- Erythromycin
- Metoclopramide, a medicine that helps empty the stomach
- Serotonin antagonist drugs, which act on serotonin receptors
Other treatments may include:
- Botulinum toxin (Botox) injected into the outlet of the stomach (pylorus)
- Surgical procedure that creates an opening between the stomach and small intestine to allow food to move through the digestive tract more easily (gastroenterostomy)
Outlook (Prognosis)
Many treatments seem to provide only temporary benefit.
Possible Complications
Ongoing nausea and vomiting may cause:
- Dehydration
- Electrolyte imbalances
- Malnutrition
People with diabetes may have serious complications from poor blood sugar control.
When to Contact a Medical Professional
Changes inyour diet may help control symptoms. Call your health care provider if symptoms continue or if you have new symptoms.
Koch KL. Gastric neuromuscular function and neuromuscular disorders. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 9th ed. Philadelphia, Pa: Saunders Elsevier;2010:chap 48.
Review Date: 10/8/2012
Reviewed By: George F. Longstreth, MD, Department of Gastroenterology, Kaiser Permanente Medical Care Program, San Diego, California. Also reviewed by A.D.A.M. Health Solutions, Ebix, Inc., Editorial Team: David Zieve, MD, MHA, David R. Eltz, and Stephanie Slon.


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WATCH: Is there more than one version of TLC's 'Creep' video?
Let's take a trip back to the '90s. Fans of TLC can now check out a newly unearthed video for their 1994 hit "Creep."
According to Digitalspy.com, the new video - which recently appeared online - is one of three different music videos that were recorded for the track. Apparently, the group wasn't sure how they wanted the video to look.
The previously unseen footage shows the trio busting their dance moves in the street, as opposed to the official video, in which TLC performs the same dance in what looks like a film set. The new video ends with a dedication to the late Lisa "Left Eye" Lopes, who passed away in 2002.
"Creep" appears on TLC's second album "CrazySexyCool." The track peaked at number one on the Billboard Hot 100 chart.
Check out the new video that has surfaced online:
Official video from their YouTube account:
Photo Credit Getty Images