A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.

The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.

But since then, Big Pharma has been satisfying the steady desires of U. S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.

From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.

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EDITOR'S NOTE — Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the second of a two-part series.

___

Unlike other prescription drugs, HGH may be prescribed only for specific uses. U. S. sales are limited by law to treat a rare growth defect in children and a handful of uncommon conditions like short bowel syndrome or Prader-Willi syndrome, a congenital disease that causes reduced muscle tone and a lack of hormones in sex glands.

The AP analysis, supplemented by interviews with experts, shows too many sales and too many prescriptions for the number of people known to be suffering from those ailments. At least half of last year's sales likely went to patients not legally allowed to get the drug. And U. S. pharmacies processed nearly double the expected number of prescriptions.

Peddled as an elixir of life capable of turning middle-aged bodies into lean machines, HGH — a synthesized form of the growth hormone made naturally by the human pituitary gland — winds up in the eager hands of affluent, aging users who hope to slow or even reverse the aging process.

Experts say these folks don't need the drug, and may be harmed by it. The supposed fountain-of-youth medicine can cause enlargement of breast tissue, carpal tunnel syndrome and swelling of hands and feet. Ironically, it also can contribute to aging ailments like heart disease and Type 2 diabetes.

Others in the medical establishment also are taking a fat piece of the profits — doctors who fudge prescriptions, as well as pharmacists and distributors who are content to look the other way. HGH also is sold directly without prescriptions, as new-age snake oil, to patients at anti-aging clinics that operate more like automated drug mills.

Years of raids, sports scandals and media attention haven't stopped major drugmakers from selling a whopping $1.4 billion worth of HGH in the U. S. last year. That's more than industry-wide annual gross sales for penicillin or prescription allergy medicine. Anti-aging HGH regimens vary greatly, with a yearly cost typically ranging from $6,000 to $12,000 for three to six self-injections per week.

Across the U. S., the medication is often dispensed through prescriptions based on improper diagnoses, carefully crafted to exploit wiggle room in the law restricting use of HGH, the AP found.

HGH is often promoted on the Internet with the same kind of before-and-after photos found in miracle diet ads, along with wildly hyped claims of rapid muscle growth, loss of fat, greater vigor, and other exaggerated benefits to adults far beyond their physical prime. Sales also are driven by the personal endorsement of celebrities such as actress Suzanne Somers.

Pharmacies that once risked prosecution for using unauthorized, foreign HGH — improperly labeled as raw pharmaceutical ingredients and smuggled across the border — now simply dispense name brands, often for the same banned uses. And usually with impunity.

Eight companies have been granted permission to market HGH by the U. S. Food and Drug Administration, which reviews the benefits and risks of new drug products. By contrast, three companies are approved for the diabetes drug insulin.

The No. 1 maker, Roche subsidiary Genentech, had nearly $400 million in HGH sales in the U. S. last year, up an inflation-adjusted two-thirds from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively, according to IMS Health. Pfizer now gets more revenue from its HGH brand, Genotropin, than from Zoloft, its well-known depression medicine that lost patent protection.

On their face, the numbers make no sense to the recognized hormone doctors known as endocrinologists who provide legitimate HGH treatment to a small number of patients.

Endocrinologists estimate there are fewer than 45,000 U. S. patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get three months' worth of HGH at a time, according to doctors and distributors.

Yet U. S. pharmacies last year supplied almost twice that much HGH — 340,000 orders — according to AP's analysis of IMS Health data.

While doctors say more than 90 percent of legitimate patients are children with stunted growth, 40 percent of 442 U. S. side-effect cases tied to HGH over the last year involved people age 18 or older, according to an AP analysis of FDA data. The average adult's age in those cases was 53, far beyond the prime age for sports. The oldest patients were in their 80s.

Some of these medical records even give explicit hints of use to combat aging, justifying treatment with reasons like fatigue, bone thinning and "off-label," which means treatment of an unapproved condition. In other cases, the drug was used "for an unknown indication," meaning that the reason for treatment wasn't clear.

Even Medicare, the government health program for older Americans, allowed 22,169 HGH prescriptions in 2010, a five-year increase of 78 percent, according to data released by the Centers for Medicare and Medicaid Services in response to an AP public records request. And nearly half the increase came in one year: 2007.

"There's no question: a lot gets out," said hormone specialist Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients.

And those figures don't include HGH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.

The AP approached every U. S.-authorized manufacturer to ask what efforts they make to market responsibly and prevent abuse. Only one HGH supplier, Novo Nordisk, agreed to an interview.

"We're doing our level best to make sure that the right patients are getting the right medicine at the right time," said company spokesman Ken Inchausti.

He said the company is aware of the abuse issue. He said if patients apply for assistance from the company's patient-support hub, prescriptions will be flagged for review if they are missing the most rigorous test or an endocrinologist's signature. He said the company won't sell HGH directly to doctors accused of bad practices and does not deal with anti-aging clinics.

Representatives of other FDA-approved HGH makers insist they do not encourage use by bodybuilders or athletes or wealthy baby boomers trying to recapture their youth. But some said they are largely powerless to control who uses their medications or why.

"Lilly cannot restrict the actions of distributors, pharmacies or doctors," Eli Lilly spokeswoman Kelley Murphy said in a written statement.

That argument doesn't fly for critics like Dr. Peter Rost, a retired Pfizer executive who filed a whistleblower lawsuit over the HGH marketing practices of Pharmacia, which later merged with Pfizer. He said drug companies are simply looking the other way and betting that their profits will eclipse the cost of any fines.

They view it as "good business," he said.

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PEDDLED ON INTERNET

Type "human growth hormone" into any Internet search engine, and it will spit back countless websites with overblown promises of smoother skin, better sex, weight loss and even renewed body organs.

Any doctor who actually prescribes the drug for those purposes is taking a legal risk.

FDA regulations ban the sale of HGH as an anti-aging drug. In fact, since 1990, prescribing it for things like weight loss and strength conditioning has been punishable by 5 to 10 years in prison.

Such marketing claims are routinely made at hormone clinics like Palm Beach Life Extension, whose owners are among 13 people now awaiting trial on federal charges in Florida in a steroids and HGH distribution case brought last year.

"Grow YOUNG with Us!" screamed a banner on the company's now-defunct website, which advertised that HGH can reduce body fat, improve vision, strengthen the immune system, aid kidney function, lower blood pressure and enhance memory and mood.

The clinic arranged to have its clients' prescriptions filled at Treasure Coast Pharmacy, in Jensen Beach, Fla.

In 2009, the FBI recorded a phone call between the pharmacy's owner, Peter Del Toro, and a doctor in Elkton, Md., who was cooperating with agents after being implicated in a related steroid-distribution case.

Their talk, documented in a court filing, illustrates how things often work in the networks of pharmacies and clinics that drive HGH sales.

Patients submitted a medical history form by mail and took a blood test. But in most instances, the indictment said, the evaluation was a sham: One doctor was charged with giving a clinic a pad of blank, signed prescriptions to save him the chore of signing off on each diagnosis. He got $50 for every drug order bearing his name, the indictment said.

Dr. Rodney Baltazar, the Maryland physician cooperating with the FBI, sometimes consulted briefly with patients via webcam. But he made it clear in the call that those evaluations were perfunctory at best.

Baltazar was a gynecologist, not an endocrinologist. He said he knew "a little bit" about HGH and testosterone, which are often prescribed in tandem, but he relied largely on clinic salespeople to set doses.

The pharmacist coached the doctor: Keep detailed medical charts documenting that patients are taking the drug for at least some kind of health problem, just in case the U. S. Drug Enforcement Administration ever came calling.

"Because somebody questions you, you want to be able to say, 'Here, look at his chart. You know, he's got fatigue. He's got, you know, a decreased sex drive. He's got increased body fat. He has some -- some slight depression, probably.' Whatever his signs and symptoms are."

None of these conditions is a legal reason to prescribe HGH. But the pharmacist said that most investigators will be satisfied and move on "because there's guys that are just selling stuff basically like a boiler room."

Del Toro was arrested along with 12 other people in September 2011 on charges that they distributed steroids and human growth hormone to people who had no legitimate medical need. He is awaiting trial. His lawyer declined to comment. Baltazar was sentenced to six months in prison for involvement in steroid distribution schemes.

At the height of the crackdown in 2007, the federal government went after Pfizer in a case involving anti-aging clinics. The company paid $34.7 million in fines to settle the case — 11 percent of the company's annual revenue from the drug.

___

TROUBLED HISTORY

Blockbuster U. S. sales of HGH represent the latest frustration in 25 years of government efforts to control abuse of the growth drug made infamous by sports scandals.

First marketed in 1985 for children with stunted growth, HGH was soon misappropriated by adults intent on exploiting its modest muscle- and bone-building qualities. Congress limited HGH distribution to the handful of rare conditions in an extraordinary 1990 law, overriding the generally unrestricted right of doctors to prescribe medicines as they see fit.

Despite the law, illicit HGH spread around the sports world in the 1990s, making deep inroads into bodybuilding, college athletics, and professional leagues from baseball to cycling. The even larger banned market among older adults has flourished more recently.

For years, cheaper supplies from unauthorized foreign factories, particularly in China, fed the market via direct and Internet sales that sidestepped the medical establishment.

Though such shipments were banned under other law, the imports initially attracted little attention because they were usually labeled as raw pharmaceutical ingredients, which compounding pharmacies are allowed to bring into the country.

That flow began to be curtailed in 2006, when U. S. drug authorities stepped up efforts to block shipments at the border.

A handful of pharmacies across the country were hit with criminal charges over their handling of HGH. Federal prosecutors charged China's biggest HGH maker, GeneScience Pharmaceutical, with illegally distributing its Jintropin brand in the U. S. The company's CEO pleaded guilty in 2010.

With illicit supplies crimped, many pharmacies stopped selling unauthorized HGH. But tens of thousands of adult abusers began buying pricey U. S.-approved HGH that remained available in abundant supply, the AP found in its analysis of sales data.

Thus, pushed by a powerful demand, sales of U. S.-approved brands have swelled far beyond expected levels for a drug approved in just a handful of rare conditions.

Dr. Robert Marcus, a retired hormone specialist who left HGH manufacturer Eli Lilly and Co. in 2008, said that company was bent on stopping foreign counterfeits, not on cutting off abusers. "That's where their major level of frustration was — pharmaceutical fraud — rather than focusing on people who were using growth hormone illegitimately," he said.

Dr. Jim Meehan, of Tulsa, Okla., who has used HGH to treat aging problems and sports injuries, said the federal clampdown "never seemed to affect my patients and their ability to get Omnitrope, Tev-Tropin" and other government-approved brands.

The big drug companies have applauded the foreign crackdown and urged the government to do even more to combat sales of fake or fraudulently labeled HGH. In 2004, Bruce Kuhlik, speaking for the Pharmaceutical Research and Manufacturers of America, told a federal task force that unauthorized drug importation "is inherently unsafe" and industry representatives used Chinese HGH imports as their poster child.

In 2007, as the HGH embargo gained momentum, authorized makers picked up 41 percent more HGH orders, raising their annual total from 245,000 to 345,000, according to the analysis of the IMS Health data. Similarly, most of the drug's sales boom happened in the first two years of the crackdown, with 46 percent inflation-adjusted growth in yearly sales to $1.1 billion.

Steve Kleppe, of Scottsdale, Ariz., a restaurant entrepreneur who has taken HGH for almost 15 years to keep feeling young, said he noticed a price jump of about 25 percent after the block on imports. He now buys HGH directly from a doctor at an annual cost of about $8,000 for himself and the same amount for his wife.

Despite higher prices, the business has expanded in recent years largely on the strength of sales to healthy adults who can afford to indulge their hope of retaining youthful vigor.

___

GROWING OLD

Many older patients go for HGH treatment to scores of anti-aging practices and clinics heavily concentrated in retirement states like Florida, Nevada, Arizona and California.

These sites are affiliated with hundreds of doctors who are rarely endocrinologists. Instead, many tout certification by the American Board of Anti-Aging and Regenerative Medicine, though the medical establishment does not recognize the group's bona fides.

The clinics offer personalized programs of "age management" to business executives, affluent retirees, and other patients of means, sometimes coupled with the amenities of a vacation resort.

The clinics insist there are few, if any, side effects from HGH. Mainstream medical authorities say otherwise.

A 2007 review of 31 medical studies showed swelling in half of HGH patients, with joint pain or diabetes in more than a fifth. A French study of about 7,000 people who took HGH as children found a 30 percent higher risk of death from causes like bone tumors and stroke, stirring a health advisory from U. S. authorities.

For proof that the drug works, marketers turn to images like the memorable one of pot-bellied septuagenarian Dr. Jeffry Life, supposedly transformed into a ripped hulk of himself by his own program available at the upscale Las Vegas-based Cenegenics Elite Health. (He declined to be interviewed.)

These promoters of HGH say there is a connection between the drop-off in growth hormone levels through adulthood and the physical decline that begins in late middle age. Replace the hormone, they say, and the aging process slows.

"It's an easy ruse. People equate hormones with youth," said Dr. Tom Perls, a leading industry critic who does aging research at Boston University. "It's a marketing dream come true."

Some scientific studies of HGH have found modest benefits: some muscle and bone building, as well as limited fat loss, but nothing like the claims of the anti-aging industry. And some of the value credited to HGH may instead come from testosterone, which is routinely provided with HGH by anti-aging doctors and sports suppliers.

Endocrinologists say it's natural for the body to produce less growth hormone as people age beyond their early 20s, because they aren't growing anymore. Only a tiny number of adults with extraordinarily low HGH levels — perhaps several thousand of them — are believed to suffer real deficiencies that can properly be treated with the hormone.

Still, anti-aging doctors routinely diagnose otherwise healthy middle-aged people with an HGH deficiency, simply because their levels are lower than in young adults. "Basically anyone going through midlife," can benefit from the drug, declared one prescriber, Dr. Howard Elkin, of Whittier, Calif., who has himself competed as a bodybuilder.

Dr. Kenneth Knott, of Marietta, Ga., said HGH helps his older patients feel "more vibrant" and look "more alive."

Like many anti-aging doctors, he diagnoses patients by testing for a blood component called insulin growth factor, which is indirectly tied to HGH. Endocrinologists use a more authoritative test that stimulates the pituitary gland to make HGH itself. Nearly all insurers insist on this stimulation testing, and that's why clinic patients almost always pay for HGH out of their own pockets.

Bob Vitols, a 50-year-old lab assistant at a veterinary medicine company in Lincoln, Neb., is a rare exception. His unusually generous health plan isn't allowed to challenge a doctor's prescription.

Four years ago, Vitols began feeling run down. So he Googled his symptoms on the Internet, decided he had a hormone deficiency, and sought out a clinic.

One doctor put him on testosterone replacement therapy. A second clinic added HGH after diagnosing him with osteopenia, a mild bone thinning common in aging adults. It is not, however, a condition that can properly be treated with HGH.

Despite the diagnosis, the treatments — which can cost $10,000 per year — have been covered by his health insurance, he said. He takes Genotropin, the HGH made by Pfizer. His prescriptions are filled via mail order by CVS Caremark Corp., one of the largest dispensers of prescription drugs in the U. S.

Vitols said the drug changed his life: his mood is better, and he isn't burning out every day at 2 p.m. "I feel like I could walk outside and just walk through a fence — and come out fine on the other side," he said.

His experiences with the drug haven't all been positive, though. Vitols said he initially developed elevated liver enzymes and went to a specialist, who told him to stop taking hormones immediately.

Instead, Vitols said, he adjusted his dosage, and the problem disappeared.

He also dumped the specialist:

"I could tell he was against hormones right at the start," Vitols said.

___

Associated Press Writer David Caruso reported from New York and AP National Writer Jeff Donn reported from Plymouth, Mass. AP Writer Troy Thibodeaux provided data analysis assistance from New Orleans.

___

AP's interactive on the HGH investigation: http://hosted.ap.org/interactives/2012/hgh

___

The AP National Investigative Team can be reached at investigate(at)ap.org

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  2. Without limiting clause 11.1, by posting or submitting Contributed Material , you are giving the Publisher, and its affiliates, agents and third party contractors the right to display or publish such Contributed Material on the Site and its affiliated publications (either in the form submitted or in the form of a derivative or adapted work), to store such content, and to distribute such content and use such content for promotional and marketing purposes. Without limiting the generality of the foregoing, with respect to any video submissions to the Publisher made by you from time to time, you understand and agree that (unless you and the Publisher agree otherwise) the Publisher may, or may permit users to compile, re‑edit, adapt or modify your video submission, or create derivative works therefrom, either on a stand‑alone basis or in combination with other video submissions, and (unless you and the Publisher agree otherwise) you shall have no rights with respect thereto and the Publisher or our licensees shall be free to display and publish the same (as so compiled, re‑edited, adapted, modified or derived) for any period.

  3. You shall be solely responsible for your own Contributed Material and the consequences of posting or publishing the Contributed Material. Without limiting clause 11.3, in connection with each of your Contributed Materials, you affirm, represent, and/or warrant that: (I) you own or have the necessary licenses, rights, consents, and permissions to use and authorize the Publisher to use all patent, trademark, trade secret, copyright or other intellectual property or proprietary rights in and to any and all such Contributed Material to enable inclusion and use of such Contributed Material in the manner contemplated by the Publisher and these Terms and Conditions; and (II) you have the written consent, release, and/or permission of each and every identifiable individual person in such Contributed Material to use the name or likeness of each and every such identifiable individual person to enable inclusion and use of such Contributed Material in the manner contemplated by the Publisher and these Terms and Conditions; and (III) the Contributed Materials and their use do not infringe any intellectual property rights or other rights of any person. In furtherance of the foregoing, you agree that you will not submit Material that is copyrighted, protected by trade secret or otherwise subject to third party proprietary rights, including privacy and publicity rights, unless you are the owner of such rights or have permission from their rightful owner to post the material and to grant the Publisher all of the rights granted herein. Publisher reserves the right to remove or not publish Contributed Material without prior notice. You understand that when you submit Material in any form to the Publisher, the Publisher may authorize such content to be distributed or syndicated to or published on other related branded environments.

  4. You may download and view or print a copy of Material on this Site for personal, non‑commercial use provided you do not modify the Material in any way (including any copyright notice). All rights not expressly granted under these terms of use are reserved by the Publisher. Unless expressly stated otherwise, you are not permitted to copy, or republish anything you find on the Site without the copyright or trademark owners' permission.

  5. All trade marks and logos that appear on the Site are owned by either the Publisher or its related bodies corporate or their licensors. Other trademarks may be displayed on the Site from time to time. These may belong to third parties. Nothing displayed on the Site should be construed as granting any license or right of use of any logo, trademark or masthead displayed on the Site, without the express written permission of the relevant owner.

Third party websites, content links, advertising and activities

  1. The Site may feature or display links and pointers to websites operated by third parties on the Site. Such websites do not form part of the Site and are not under the Publisher's control. The Publisher does not accept any responsibility in connection with any such website. If you link to any such websites, you leave the Site entirely at your own risk. The appearance of those links on this site does not indicate any relationship between the Publisher and that third party or any endorsement by the Publisher of that third party, its site or the products or services which it is advertising on this Site. The Site may include third party content which is subject to that third party's terms and conditions of use. Nothing on the Site should be construed as granting any license or right for you to use that content. You must not link to the Site from any other website (or otherwise authorize any other person to link from a third party website to the Site) without the Publisher's prior written consent.

  2. The Site may feature or display third party advertising. By featuring or displaying such advertising, the Publisher does not in any way represent that the Publisher recommends or endorses the relevant advertiser, its products or services. If you contact a third party using functionality provided on the Site, including via e‑mail, the Publisher does not accept any responsibility for any communications or transactions between you and the relevant third party.

  3. From time to time, the Publisher may promote, advertise, or sponsor functions, events, offers, competitions or other activities that may be conducted offline and may be conducted by third parties. These activities may be subject to separate terms and conditions. You participate in any such activities entirely at your own risk. The Publisher does not accept any responsibility in connection with your participation in activities conducted by any third party.

Liability and Idemnity

  1. To the extent permitted by law, you use the Site at your sole risk. The Publisher does not warrant that the Site will be uninterrupted or error‑free. There may be delays, omissions, interruptions, and inaccuracies in the news, information or other Material available through the Site. To the extent permitted by law the Publisher excludes all warranties, representations, conditions and guarantees, whether express, implied or statutory, including, without limitation, those of merchantability or fitness for a particular purpose, with respect to the Site or any Materials or goods that are available or sold through the Site. The Publisher does not exclude any statutory or implied warranty, condition or guarantee that it is prohibited by law to exclude under applicable law of any jurisdiction. The Publisher does not make any representations, nor does the Publisher endorse the accuracy, completeness, timeliness or reliability of any advice, opinion, statement or other material or database supplied, uploaded or distributed on the Site or available through links on the Site. The Publisher reserves the right to correct any errors or omissions on the Site. Although the Publisher intends to take reasonable steps to prevent the introduction of viruses, worms, ‘trojan horses' or other destructive material to the Site, the Publisher does not guarantee or warrant that the Site or Material that may be downloaded from the Site do not contain such destructive features. To the extent permitted by law, the Publisher is not liable for any loss, damage or harm attributable to such features. If you rely on the Site and any Material available through the Site you do so solely at your own risk. The Publisher does not warrant the accuracy of the Material on the Site, and the Material is provided to you “as is” and on an “as available” basis and on the condition that you undertake all responsibility for assessing the accuracy of the Material and rely on it at your own risk. You recognize that the Site may contain various combinations of text, images, audiovisual productions, opinions, statements, facts, articles, market data, stock quotes or other information created by the Publisher or by third parties. Such Material, including market data, is for your reference only and should not be relied upon by you for tax or investment advice and it does not advocate the purchase or sale of any security or investment.

  2. The Publisher does not necessarily hold the opinions expressed by Material contributors. Opinions and other statements expressed by Users and third parties (e.g., bloggers) are theirs alone, not opinions of the Publisher. Material created by third parties is the sole responsibility of the third parties and its accuracy and completeness are not endorsed or guaranteed. You acknowledge that by providing you with the ability to view and distribute Material through the Site, the Publisher is not undertaking any obligation or liability relating to the Material. The Publisher and its affiliates, successors, assigns, employees, agents, directors, officers and shareholders do not undertake or assume any duty to monitor the Site for inappropriate or unlawful content. To the extent permitted by law, the Publisher and its affiliates, successors, assigns, employees, agents, directors, officers and shareholders assume no responsibility or liability which may arise from the Material thereof, including, but not limited to, claims for defamation, libel, slander, infringement, invasion of privacy and publicity rights, obscenity, pornography, profanity, fraud, or misrepresentation. Notwithstanding the foregoing, the Publisher reserves the right to block or remove communications, postings or Materials at any time in its sole discretion.

  3. To the extent permitted by law, the Publisher will have no responsibility or liability in relation to any loss or damage that you incur, including damage to your software or hardware, arising from your use of or access to this Site.

  4. The Publisher does not warrant that functions contained in the Site content, such as hyperlinks, will be uninterrupted or error free, that defects will be corrected or that the Publisher or the server that makes it available, are free of viruses or bugs.

  5. The Publisher may be legally compelled to disclose certain Information. You agree that in the event the Publisher receives a subpoena issued by a court or from a law enforcement or government agency, the Publisher shall comply with such subpoenas without your consent or prior notice to you and may disclose your IP address, username, name, IP location or other information in response thereto.

  6. Subject to clause 30, to the extent permitted by law, the Publisher and its affiliates, and their respective members, directors, officers, managers, employees, shareholders, agents and licensors are not liable for incidental, indirect, consequential, special, punitive, or exemplary loss or damages of any kind, including, without limitation, lost revenues or profits, loss of business, opportunity or goodwill, or loss of data, arising in any way in connection with this Site or Material on the Site, the use of (or inability to use) the Site or Material, or the Conditions, whether in contract, tort (including negligence), in equity, under statue or otherwise, including but not limited to any claim, loss or injury based on errors, omissions, interruptions or other inaccuracies in the Site, or as a result of breach of any warranty or other term or condition of the Conditions. To the extent permitted by law and subject to clause 30, the Publisher's liability shall be limited to the amount you paid, if any, for use of the Site.

  7. You will be responsible for any harm the Publisher suffers as a result of your violation of these Terms and Conditions or any breach by you of your representations and warranties. You agree to indemnify and hold harmless the Publisher and its affiliates, and their respective members, directors, officers, managers, employees, shareholders, agents, and licensors, from and against all losses, expenses, damages and costs, including reasonable attorneys' fees, resulting from any violation by you of the Conditions or any breach by you of your representations and warranties thereunder. The Publisher reserves the right to take over the exclusive defense of any claim for which the Publisher is entitled to indemnification under this Section 29. In such event, you shall provide the Publisher with such cooperation as is reasonably requested by the Publisher.

  8. To the extent that the Publisher's liability for breach of any implied or statutory warranty, condition or guarantee, cannot be excluded by law, to the extent permitted by law the Publisher's liability will be limited, at the Publisher's option, to:

    1. in the case of services supplied or offered by the Publisher:

      1. the supply of the services again; or

      2. the payment of the cost of having the services supplied again; and

    2. in the case of goods supplied or offered by the Publisher:

      1. the replacement of the goods or the supply of equivalent goods;

      2. the repair of the goods;

      3. the payment of the cost of having the goods replaced; or

      4. the payment of the cost of having the goods repaired.

  9. If a jurisdiction does not allow the exclusion or limitation of liability in accordance with clause 30 but allows a limitation of a certain maximum extent then liability is limited to that extent.

No reliance, other Users

  1. Except where expressly stated otherwise, Material on the Site is provided as general information only. It is not intended as advice and must not be relied upon as such. You should make your own inquiries and take independent advice tailored to your specific circumstances prior to making any decisions. To the extent permitted by law, the Publisher will not be liable for loss resulting from any action or decision by you in reliance on the Material on the Site.

  2. You acknowledge that the Publisher is not responsible for, and accepts no liability in relation to, any other User's use of, access to or conduct in connection with the Site in any circumstance.

Termination

  1. In the event of termination of your access to the Site you must immediately cease accessing and using the Site and Materials on the Site and (at Publisher's option) return any (hard or electronic) copies of such Materials to the Publisher or destroy any copies within your control or possession. All licences granted by you and all disclaimers, indemnities and exclusion and limitations of liability set out in the Conditions will survive termination.

Severability

  1. If any provision of the Conditions is deemed invalid by a court of competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of the Conditions, which shall remain in full force and effect.

No waiver

  1. No waiver of any term of the Conditions shall be deemed a further or continuing waiver of such term or any other term. Any failure to assert any right under the Conditions shall not constitute a waiver of such right.

Affirmation regarding age

  1. By using the Site, you affirm that you are 18 years or over or otherwise possess legal parental or guardian consent.

Applicable Law

  1. These Conditions shall be construed in accordance with and governed by the laws of the Isle of Man. You consent to the exclusive jurisdiction of the courts in the Isle of Man to determine any matter or dispute which arises under the Conditions.

Definitions

  1. In these terms and conditions:

    1. "Material" means text, illustrations, photos, audio, video, or any combination of these or other content, information, data or material.

Publishing Services International Limited Privacy Policy

1. Privacy

The Publisher recognizes the importance of protecting the privacy of its customers. For the purposes of this Privacy Policy, "customers" includes visitors to the Site, subscribers to and users of the Publisher's services, purchasers of its products and advertising customers. This privacy policy is intended to inform you about the personal information that is collected from you when you visit the Site, and in the other circumstances described under the heading "Collection of personal information" below, how this information may be used and disclosed, how you can control the use and disclosure of your information, how your information is protected, and how you can access that information. The Publisher may, from time to time, review and update this Privacy Policy, including taking account of new or amended laws, new technology and/or changes to its operations. This Privacy Policy applies only in respect of the Site. This Privacy Policy does not apply to information collected through any other website (other than by or on behalf of the Publisher in the circumstances described under the heading "Collection of personal information" below) or to the practices of companies that the Publisher does not control. Please note that the Site may contain links to other websites. For example, if you click on an advertisement on the Site and link to another website, then this Privacy Policy will not apply to any information collected on that website. The Publisher is not responsible for the privacy practices of other websites, and the Publisher recommends that you read the privacy policies of each website that you visit. All personal information held by the Publisher will be governed by the most recently updated Privacy Policy.

2. Collection of personal information

The Publisher collects personal information when the Publisher provides its services to you. When you visit and interact with the Site, certain information may be collected automatically, including:

  • your computer's Internet Protocol (IP) address;
  • your browser type and operating system;
  • the web pages you were visiting immediately before and after you came to the Site;
  • activities within community discussions;
  • web pages and advertisements that you view, and links that you click on, within the Site;
  • your bandwidth speed and information about the software programs that are installed on your computer;
  • aggregated data about email click‑through rates and user video viewing;
  • standard server log information; and
  • information collected through HTML cookies, Flash cookies, web beacons, and similar technologies.

The Publisher usually collects personal information directly from you, although sometimes the Publisher may use agents or service providers to do this for the Publisher. The Publisher may also acquire lists from other sources, both from other companies and from other public documents. This may include advertisers, mailing lists, recruitment agencies, contractors and business partners. The Publisher may also access information about you from third‑party sources and platforms (such as social networking sites, databases, online marketing firms, and ad targeting firms), including:

  • if you access third‑party social networking services (such as Facebook Connect or Twitter) through the Site, your username and connection lists for those services;
  • demographic data, such as age range, gender, and interests;
  • advertisement interaction and viewing data, such as ad click‑through rates and information about how many times you viewed a particular ad; and
  • unique identifiers, including mobile device identification numbers, that can identify the physical location of such devices in accordance with applicable law.

Please note that the Site may combine the information that we collect with information that the Publisher may obtain from third‑party sources. The Publisher may collect your personal information when you request or acquire a product or service from the Publisher, register with the Publisher as a member (including user name and password and contact information such as name, email address, postal address, phone number, and mobile number), provide a product or service to the Publisher, complete a survey or questionnaire, enter a competition or event, contribute in a fundraising event, participate in one of the Publisher's services (including blogs, forums, community discussions and other interactive features), search queries conducted on the Site, or when you communicate with the Publisher by e‑mail, telephone, or in writing.

The Publisher usually collects personal information such as your name, address, telephone number, and in some instances, your financial details, including your credit card information, in addition to the other specific types of information described above. The Publisher also collects information about you that is not personal information. For example, the Publisher may collect data relating to your activity on its websites (including IP addresses) via tracking technologies such as cookies, or the Publisher may collect information from you in response to a survey.

As a general rule the Publisher does not collect sensitive information, however it reserves the right to do so. If the Publisher does, it will usually be for the purposes of providing its goods or services and if the law requires the Publisher to, the Publisher will seek your consent to collect it.

If you do not provide the Publisher with information described above, the Publisher may not be able to its services to you.

If, at any time, you provide personal information about someone other than yourself, you warrant that you have that person's consent to provide such information for the purpose specified.

If you are located outside of the Isle of Man, please note that personal information provided by you or otherwise collected as described above will be transferred to the Isle of Man.

3. Use of personal information

The Publisher uses personal information to provide its services (which may include the display of personalised content and advertising) to you, to fulfil administrative functions associated with these services, for example billing, to enter into contracts with you or third parties and for marketing and client relationship purposes. The Publisher also generally uses personal information to report statistics, analyse trends, diagnose problems and target and improve the quality of its products and services. By accessing the Site, you agree that the Publisher may use your personal information for the purposes and by the means described in this Privacy Policy, and you agree that the Publisher may use your mobile number to send you promotions, notifications, or other services. In order to provide readers with free access to content, the Publisher displays advertisements on the Site, many of which are targeted based on information about you. For example, using information collected through cookies, web beacons, and other sources, the Publisher may use demographic data or information about your online activities or interests to display targeted advertising that may be relevant to your preferences. Through this process, advertisers reach Site visitors who are most interested in their products, and you see advertising for products or services in which you may be interested. Third‑party advertisers and advertising platforms also may serve targeted ads on the Site. Please remember that the information practices of third‑party advertisers or platforms collecting data on our Site are not covered by this privacy policy. The Publisher may also use the information that it collects to prevent illegal activities, to enforce the Site's Terms and Conditions, and to otherwise protect its rights and the rights of its users. In addition to the uses identified above, the Publisher may use the information that it collects for any other purposes disclosed to you at the time it collects your information or pursuant to your consent. Where your personal information is contained within an advertisement which the Publisher publishes for you, the Publisher may also use your information for publication of that same advertisement in other media, in accordance with the terms and conditions of the initial publication. The Publisher may also use your personal information to assist the Publisher in improving its products and services and to let you know about goods, services, or promotions which may interest you.

4. Disclosure to and use by Third Parties

The Publisher values your privacy, and shares information about its users only under certain circumstances. The Publisher may share your information with other companies which are related to the Publisher. The Publisher may disclose your information to its service providers and contractors from time to time to help the Publisher to provide and market its goods and services to you. The Publisher may also share your information with third parties who provide prizes for competitions or reader offers. If the Publisher does this, the Publisher generally requires these parties to protect your information in the same way as the Publisher does.

The Publisher will make information about you available to other companies, applications, or people in the circumstances listed below:

  • The Publisher may share aggregated information or information that does not directly identify you with third parties to help the Publisher develop content, services, and advertising that the Publisher hopes you will find of interest. Please note that the Publisher does not share contact information with third parties that advertise on the Site.
  • The Publisher may employ third parties to perform Site‑related services, including database management, maintenance services, analytics, marketing, data processing, and email and text message distribution. These third parties have access to your information only to perform these tasks on the Publisher's behalf.
  • If you choose to engage in public activities on the site, such as posting comments on community message boards, any information you submit can be read, collected, or used by others. Please exercise caution when deciding to disclose any personal information in public activities or submissions.
  • The Publisher may share information about you in the event that the Site is acquired by or merged with another company or a similar corporate transaction takes place. However, the Site will notify you by placing a prominent notice on the Site or sending a notice to the primary email address specified in your account before your information is transferred and becomes subject to a different privacy policy.
  • The Publisher may share information about you to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety or other rights and interests of any person, violations of the Site's Terms and Conditions, or as otherwise required by law.
  • The Publisher may share information about you to respond to subpoenas, search warrants, judicial proceedings, court orders, legal process, or other law enforcement measures, to establish or exercise our legal rights, or to defend against legal claims.
  • In addition to the scenarios identified above, the Publisher may share information about you for any other purposes disclosed to you at the time the Publisher collects your information or pursuant to your consent.

Please note that third parties may independently collect data about you, including your IP address and information about the websites you visit and the links you click, through cookies, clicks on links, or other means when you visit or view ads on the Site.

To customize your experience on the Site and to simplify the Site's registration process, the Publisher provides you with the opportunity to access or interact with third‑party services, such as Facebook and Twitter. When you connect to the Site through these third‑party services, the Publisher may share information about you with these third‑party service providers and they may share data about you with the Publisher. When you allow the Publisher to access your data through a third‑party service to create a Site profile, the Publisher may use this data for several purposes, including:

  • For example, if you connect to the Site via a service with a public friend list, like Twitter, the Publisher may check to see if any people you follow on Twitter are also Site members. If the Publisher finds a match, the Publisher will replicate your Twitter relationship with those members, setting them to be fans, followers, or friends on the Publisher Site.
  • For example, if you connect via a service that has a private contact list (like Google and Yahoo!), the Publisher checks for people in your contacts who are Site members and suggest that you become a fan of these users.
  • When users share content with their friends, the Publisher may use friend lists from third‑party services to create a list of contacts to whom you may choose to send the email message.
  • For example, the Publisher may use friend lists from a third‑party service to create a list of contacts to whom you may choose to send an invitation to view an interactive slideshow.
  • When you are connected via a third‑party service, the Publisher may access certain account information, such as your profile picture, what stories are popular in your network, and what your friends are saying about certain articles or blog posts, in order to enhance and personalize your experience on the Site.

In addition, if you connect to a Facebook account, your experience on the Site may be personalized. For example, you may automatically see what stories are popular in your network, and what your friends are saying about particular stories. Please note that you may disconnect third party accounts at any time.

Please remember that the Publisher does not control the privacy practices of these third‑party services. The Publisher encourages you to read the privacy policies of all third‑party service providers. You can deactivate your account at any time by visiting the preferences page for your profile. When you deactivate your account, your user profile will be disabled, but your public comments will remain on the site. The Site has no responsibility to take down, remove, or edit any of your public activities or any submissions that are a result of your public activities. If you opt out of these technologies, you will continue to see advertising displayed on the Site, but the advertising may not be targeted to your interests. Please remember that the Publisher does not have access to, or control over, advertisers' or service providers' cookies, and the information practices of third parties are not covered by this privacy policy.

5. Use of Aggregate Data

The Publisher may collect and use certain non‑personal information (e.g., the identity of your Internet browser, the type of operating system you use, your IP address and the domain name of your Internet service provider) to optimise its goods and services (which may include the display of personalised content and advertising) including the Publisher's web pages for your computer. The Publisher may use personally identifiable information in aggregate form to improve its goods and services including its web sites and make them more responsive to the needs of its customers. This statistical compilation and analysis of information may also be used by the Publisher or provided to others as a summary report for marketing, advertising or research purposes.

6. Security

The Publisher strives to ensure the security, integrity and privacy of personal information of its customers. The Publisher may hold your information in either electronic or hard copy form. The Publisher uses a variety of physical and electronic security measures including restricting physical access to its offices and firewalls and secure databases to keep personal information secure from misuse, loss or unauthorized use or disclosure. Unfortunately, no data transmission over the Internet can be guaranteed to be totally secure. The Publisher limits access to contact information about you to employees or service providers who the Publisher believes reasonably need to come into contact with that information to provide products or services to you or in order to do their jobs, and subject to section 4 of this Privacy Policy. The Publisher also has adopted commercially reasonable technical, physical, and administrative procedures to help protect information about you from loss, misuse, and alteration. Personal information is destroyed or de‑identified when no longer needed. Please note that no data transmission or storage can be guaranteed to be 100% secure. The Publisher wants you to feel confident using the Site, but the Publisher cannot ensure or warrant the security of any information you transmit to the Publisher.

7. Access to Personal Information

You have a right to request access to personal information the Publisher holds about you. Where the Publisher holds personal information that you are entitled to access, the Publisher will endeavour to provide you with suitable means of accessing it (e.g. by emailing or mailing it to you). If the Publisher denies access in some circumstances, the Publisher will tell you why. To request access, please contact the Publisher's privacy officer as set out at the end of this document. If you believe that personal information the Publisher holds about you is incorrect, incomplete or inaccurate, then you may request amendment of it. The Publisher will consider if the information requires amendment. If the Publisher does not agree that there are grounds for amendment then the Publisher will add a note to the personal information stating that you disagree with it.

8. Public Information

Any information posted on bulletin boards and/or communicated in chat areas becomes public information. While the Publisher strives to protect and respect your privacy, the Publisher cannot guarantee the security of any information you disclose in a chat room or bulletin board.

9. Cookies

Cookies are data that a Web site transfers to an individual's hard drive for record‑keeping purposes. Cookies can facilitate a user's ongoing access to and use of a site. They allow the Publisher to track usage patterns and to compile data that can help the Publisher improve its content and target advertising. If you do not want information collected through the use of Cookies, there is a simple procedure in most browsers that allows you to deny or accept the Cookie feature. But you should note that Cookies may be necessary to provide you with features such as merchandise transactions or registered services.

10. Online Links to Third Party and Co‑Branded Sites

The Publisher may establish relationships with business partners that allow visitors to the Publisher's web sites to link directly to sites operated by these partners. Some of these sites may be "co‑branded" with the Publisher's logo - however, these sites may not be operated or maintained by or on behalf of the Publisher. These sites may collect personal information from you that may be shared with the Publisher. This Privacy Statement will apply to any personal information the Publisher obtains in this manner. The Publisher is not responsible for the content or practices of web sites operated by third parties that are linked to the Publisher's sites. These links are meant for the user's convenience only. Links to third party sites do not constitute sponsorship, endorsement or approval by the Publisher of the content, policies or practices of those third party sites. Once you have left the Publisher's site via such a link, you should check the applicable privacy policy of the third party site.

11. What else you should know about privacy on the Internet

Remember to close your browser when you have finished your user session. This is to ensure that others cannot access your personal information and correspondence if you share a computer with someone else or are using a computer in a public place like a library or Internet cafe. You as an individual are responsible for the security of and access to your own computer. Whenever you voluntarily disclose personal information over the Internet this information can be collected and used by others. In short, if you post personal information in publicly accessible online forums, you may receive unsolicited messages from other parties in return. Ultimately, you are solely responsible for maintaining the secrecy of your username and passwords and any account information. Please be careful and responsible whenever you are using the Internet. The Publisher does not knowingly collect personal information from children under 13. If the Publisher learns that it has collected any personal information from a child under the age of 13 without verifiable parental consent, the Publisher will delete that information from its database as quickly as possible. If you believe that the Publisher may have collected information from a child under 13, please contact the Publisher at privacy@publishingservicesinternational.im.

12. For further information

Please contact our Privacy Officer to ask for access to your information or if you have a complaint concerning your information privacy or if you would like more information about our approach to privacy at privacy@publishingservicesinternational.im.

13. Changes to the privacy policy

The Publisher reserves the right to update this Privacy Policy at any time to reflect changes in the Publisher's practices and service offerings. The Publisher will use it best endeavours to update the Privacy Policy on the Site, however it does not warrant that it will post these updates immediately.

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