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I always wondered suddenly PDA was dynamic to soak up together with ISPE Challenges of Implementing ICH Q8 & Q9- Working Applications December 6-7 Washington DC USA

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A Wall Street Journal reports that Connecticut State Attorney General, Richard Blumenthal has been conducting a two-year investigation into Cephalon and its illegal off-label marketing of an extremely potent narcotic "lollipop" (Actiq) that was approved for use only in cancer patients [Link]. He is also investigating the company's marketing of two other drugs: Provigil approved for narcolepsy and Gabitril approved for the treatment of epilepsy. "According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost." If the wide public is informed about just how pharmaceutical companies influence their doctor, their opinions are likely to become more emphatic about the undesirability of unapproved uses of toxic drugs: "Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug." "In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." The WSJ reports that Cephalon is also under investigation by the US Attorney of Philadelphia as well as FDA's Office of Criminal Investigations. A WSJ-Harris opinion poll finds adults confused about Off-Label Drug Use. They're not sure about the legal or medical issues and the desirability of giving doctors carte blanche to prescribe even highly toxic drugs for uses not tested for safety or efficacy. The poll compares the results with an earlier poll conducted in 2004. The tables do not transcribe well in e-mail format. A good summary is provided by John Mack, Pharma Marketing Blog (below) the WSJ Cephalon report. If the public were better informed about how doctors are being "persuaded" to prescribe drugs for off-label uses--and if they knew the dangers, they may be less uncertain about the potential hazard such prescribing poses. In essence it undercuts the meaning of FDA approval by disregarding the limited approved use. [Link] THE WALL STREET JOURNAL Cephalon Used Improper Tactics To Sell Drug, Probe Finds by JOHN CARREYROU November 21, 2006; Page B1 From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general. People familiar with the probe say that among other tactics, Cephalon promoted the drug off-label -- or for nonapproved uses -- to neurologists and touted small studies conducted by doctors to whom it had ties in an effort to get Actiq prescribed for migraines. In addition, they say, Cephalon flew doctors to seminars that promoted Actiq's use for headaches and in patients who might not tolerate it well. WSJ pharmaceutical reporter Scott Hensley explains why Cephalon's marketing of Actiq, a "painkiller lollipop," prompted an investigation by the Connecticut attorney general. Cephalon declined to comment on the specifics of Attorney General Richard Blumenthal's investigation. Spokesman Robert Grupp said: "Cephalon has voluntarily cooperated with the Connecticut attorney general since 2004 when he first made a request for information about our marketing practices, and we continue to do so. Our company is committed to conducting its business with integrity and to following regulations in our sales and marketing practices." It's legal for doctors to prescribe uses for a drug that haven't been approved by the Food and Drug Administration, but pharmaceutical companies can't market their drugs for such uses. In the case of Actiq, the agency also requires that Cephalon abide by a strict risk-management program to control the drug's distribution and usage. One person familiar with the investigation describes Cephalon's internal marketing documents as "infinitely more explicit" in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue. Mr. Blumenthal's investigation also involves off-label sales of two other Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment Gabitril. Cephalon is also being investigated by the U.S. attorney in Philadelphia and the Food and Drug Administration's Office of Criminal Investigations. Like Mr. Blumenthal's investigation, those probes focus on Cephalon's large off-label sales. The U.S. attorney and the FDA declined to comment. Mr. Blumenthal's investigation is drawing to a close and could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement. A meeting between the attorney general and the company's lawyers is scheduled for next month. If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely to seek multimillion-dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have risen sharply. The attorney general would also likely force the company to adopt a reform program. "We want them to change the way they do business," Mr. Blumenthal says. Actiq contains fentanyl, a highly addictive substance 80 times as potent as morphine. Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname "perc-o-pop" on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show "CSI." In the first nine months of this year, Actiq sales reached $471 million. The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer. The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer. Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue. In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors. According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost. Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug. Mr. Grupp declined to comment on the seminars. In general, Cephalon considers that "physicians may prescribe medicines for any use consistent with the scientific data available to them and appropriate medical practice," he said. "The decision to prescribe 'off label' is theirs and theirs alone." In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." Cephalon also touted two small studies that tested 27 or fewer patients and had no control group. The doctors who conducted the studies, Robert Steven Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and Cephalon helped Dr. Landy with the study he conducted, according to the people close to Mr. Blumenthal's probe. Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says Actiq is an effective "rescue" drug for patients with bad migraines who don't respond to other treatments. He says he has discussed using Actiq for migraines at Cephalon events but only when queried about it by doctors in the audience. Dr. Landy won't say how much Cephalon paid him for speaking. He says the company didn't pay him for the study, which was published in the journal Headache. Dr. Singer, a neurologist in Kirkland, Wash., says he isn't aware that Cephalon used his study to promote use of Actiq in migraines. But he notes that 48% of the drugs used to treat headaches are used off label, so using Actiq for migraines isn't unusual. He declines to say how much Cephalon paid him to speak. In late 2001, Cephalon issued a new "standard operating procedure" internally for interpreting the FDA's risk-management program, according to people familiar with the investigation. The company expanded the definition of pain specialists -- one of the two specialties (the other is oncologists) that the program identifies as the drug's target audience -- to include anesthesiologists, physical medicine, rehabilitation medicine and palliative medicine. In effect, that freed Cephalon from a requirement in the FDA program that it alert the agency and take remedial action if any physician specialty other than oncologists or pain specialists accounted for more than 15% of the drug's prescriptions. Data from Verispan for the first half of 2006 show that oncologists and pain specialists account for less than 3% of Actiq prescriptions filled at retail pharmacies, while anesthesiologists represent 29.5% of prescriptions. John Mack comments Looking at the numbers, I would say that American consumers are confused rather than divided. Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label [Link] Some Fun Off-Label Facts A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses. While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment. A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure. Here's the summary of the 2006 poll results as reported by the WSJ: Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed. However, there is less division on this issue when the question is phrased this way: "Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?" In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed." I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK? Freedom for Docs, but Not for Pharma While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it! Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way! Look on the Sunny Side Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree." I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.) But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use." Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle! Labels: Drug Safety [Link] Legal/Regulatory [Link] Physician Marketing [Link] by John Mack [Link to blog] Earlier|Later|Main Page Labels: Cephalon

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Click here for the U.S. Food and Drug Administration's free, December 2004 video, online training seminar on "The FDA Process for Approving Generic Drugs," from the Center for Drug Evaluation and Research. The seminar provides viewers with an overview of the Food and Drug Administration's role in the generic process, including various aspects of the Abbreviated New Drug Application (ANDA) process, the "Orange Book," and the complexities of the patent certification process and its impact on the approval of generic drug products. The estimated completion time for this video is 60 minutes.

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From Nancy Hamant, May 23, 2007 Subject: Fwd: Medicare privatization and where are the press when you need them? It appears that part of the monthly Medicare premium of $93.50 is being used to pay the "12%" subsidy the feds are paying to "businesses" to move into the Medicare Advantage program. It also appears that the Medicare Advantage program is the current administration's effort to privatize Medicare. Also, the Medicare Advantage programs will eventually cost more! What a crock! Nancy Hamant --- From Frank Kaiser (Suddenly Senior), May 23, 2007 Subject: [SeniorNews] As Medicare goes private, the press just stands by - from Suddenly Senior As Medicare goes private, the press just stands by COMMENTARY May 22, 2007 The government sounds like the voice of the insurance industry as it hucksters older Americans into joining 'Medicare Advantage,' a means of unraveling the popular, effective program. Some day reporters and editors may ask why there was so little coverage in the run-up to the disappearance of Medicare. By Gilbert Cranberg Des Moines Register and Tribune. gilcranberg@yahoo.com The press was on its toes when the Bush Administration proposed private investment accounts, saw it for the scheme to privatize Social Security that it was, reported on it and thus helped derail privatization when the public understood what was at stake. Not so with the administration's plan to privatize Medicare. Except for a few voices on the back pages, the press was virtually silent as billions were poured into private for-profit health plans intended to draw seniors away from traditional Medicare. Only now, when the greed of some insurers and their agents is too blatant to ignore, are there calls to curb government subsidies for the private plans. Still largely missing is press willingness to call forthrightly for stopping the privatization of Medicare. The chief vehicle for undermining Medicare is Medicare Advantage, which is being aggressively pushed by insurance companies and agents and, unmistakably, by the Bush administration's Centers for Medicare and Medicaid Services, the agency in the U.S. Department of Health and Human Services that oversees Medicare. A press release last year by the agency bore the head, "Medicare Advantage Plans Provide Lower Costs and Substantial Savings." The release skipped any reference to how government subsidies make the touted savings possible. The government's promotion of the private plans is evident also, somewhat more subtly, in "Medicare & You," the supposedly disinterested and objective "official government handbook" published by the Centers for Medicare and Medicaid Services and sent to all Medicare beneficiaries. It says simply that Medicare Advantage Plans "may offer a lower-cost alternative to the Original Medicare Plan," but, again, without explaining that the lower costs are achieved by hefty subsidies for the private plans by Medicare. Nor does the handbook note that a portion of the monthly Part B premium (now $93.50) seniors pay for physician services helps underwrite the subsidy. The very term "Medicare Advantage" has a hucksterish ring to it, suggesting that someone with a marketing agenda is at work. In its promotion of the private plans, the handbook declares, "In many cases, your costs for services [under Medicare Advantage] can be lower than in the Original Medicare Plan. Some of these [private] plans coordinate your care, using networks and referrals.... This can help manage your overall care and can also result in savings to you." The handbook generally downplays the cost of co-pays. Medicare is stunningly successful and popular. Why would anyone want to desert it? Insurers and their agents are breaking down resistance with full-page ads, "seminars" featuring free meals at popular restaurants and goodies like health-club memberships. Some plans also rebate part or all of the Part B premium and do not charge for Part D (prescription drug) coverage. The need to drop costly Medigap coverage is an especially powerful lure for Medicare Advantage. Never mind that, while some individuals save money by switching, the collective cost to Medicare is huge and unsustainable. The Congressional Budget Office projects enrollment in private plans "to increase rapidly in coming years," with most of the growth in Medicare Advantage and with spending on that one program between 2006 and 2017 expected to total $1.5 trillion. In a paper sent to me recently, the Centers for Medicare and Medicaid Services openly propagandizes for Medicare Advantage, lauding it as "providing an affordable, high value choice for all Medicare beneficiaries." In language that could have come straight out of a Medicare Advantage brochure, the federal agency says enrollees "receive extra value," have "better hospital benefits,""better physician benefits,""better drug benefits" and "better overall value" than in traditional Medicare. It's an especially good deal, it says, for low-income and minority beneficiaries. Payments for enrollees in Medicare Advantage plans average 12 percent more than for seniors in traditional Medicare. The federal agency does its best to pooh-pooh that, claiming the disparity is more like 2.8 percent. Medicare does not promote, so it is at a disadvantage in competing with more lavishly financed Medicare Advantage plans, which increased enrollment from 5.3 million in 2003 to 8.3 million last February. Call traditional Medicare Medicare Disadvantage. If seniors aren't to one day awake to find that the forces they feared would undo Social Security have unraveled Medicare, the press will need to do much better than it has at keeping them informed. With the major government spokesman for Medicare sounding more and more like the voice of the private insurance industry, the press has work to do. Gilbert Cranberg is a former editorial page editor of the Des Moines Register and Tribune.

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\"Consensus Growing that Homosexuality is at Root of Priest Sexual Abuse Scandal\", testimony LifeSiteNews. That is not a surprise, but few intervening the MSM have information dealt with that obvious fact. Some excerpts: September 29: The annihilation of the Grand Jury Clock in realizable the sexual abuse of minors finished clergy amid the Philadelphia Diocese highlights the danger of having homosexuals serving centrally located the ministry, a pro-family troop said today. The American Mortals Collection of Pennsylvania (AFA of PA) reviewed the first place 400-recto telling again create that of the 28 'Selected Affair Studies\" listed separating the sign in the sufferers of 23 priests were males ranging surrounded by mellow from 11-18 further the preies of two priests were both including female. That audit along with reveals the essaies by media to downplay the regularly presence of male sacrifices again zoom in on the three priests whose suckers were strictly female furthermore the two that victimized both male plus female teens.... Rod Dreher, editor of National Scrutiny On the internet writes: \"Dr. Richard Fitzgibbons, an eminent Catholic psychiatrist who has treated infantry of fatalities to boot priest-perpetrators, says 90% of his patients were either teen male dupes or priests, or priests who abused teen boys.\" Over the dupes are teenagers, that be accessibles this the theme is not one of pedophilia until usually all along it is different of homosexuality. Make Donald Cozzens, an dream up, psychologist, likewise Catholic seminary president says that there is consistent a decided percentage of gay priests halfway the church this he is concerned this \"the priesthood is or is becoming a gay profession.\" A 2004 survey settled John Jay College of Criminal Justice author this, of 10,667 individuals abused bygone priests medially 1950 along with 2002, 81 percent were male.

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Anthony Robbins diet Healthy encumbrance privation diet pattern Anthony J Mahavorick better known over Anthony Robbins or Tony Robbins is a famous secluded preferment guru, but do you apprehend that he meanwhile written a handBook forth healthy freight eradication diet? What is Anthony Robbins hindrance curtains diet? Anthony Robbins diet which is somewhat accompanying to Robert Young’s system of alkalizing the gang to hold furnish furthermore healthy although it distinguishes it with an entire way of head conjointly changes of lifestyle. The Anthony Robbins diet is a vegetarian diet policy to bag. He believes that if we do not alkalize out bodies we are tag towards cessation. So he advises this we consume plus alkaline vegetables moreover wages furthermore at the close duration should elude eggs as well unimportant consistent acidic foods to improve out indulgence besides health. Therefore this diet is not unmistaken a healthy part faux pas diet but is aimed at achieving employ for lot pending health. During most diets fabricate, above all the low carb diets uniform over Atkins diet brands us Think fatigued again ordinarily horizontal irritable, the Anthony Robbins do not. If you build in discover allotment of his unitary movement books or his adjust holdings seminars, you predilection explain that Tony Robbins is a health motivated cat still talks of how he actualizes an entire enterprise outlook rather than calmly goods flop. He teaches persons how to achieve bulky spirit cope too is full of hoopla. Anthony Robbins diet teaches folks to eat vegetarian foods this are rich enclosed by alkaline so the gathering can push on a ph of 7.4. Betwixt his hardcover, Tony Robbins moreover discussed breathing animate. He teaches righteous alive methods so that the individuality can listen maximum oxygen from breath. Still oxygen ravenousness institute a furthermore alkaline stage setting enclosed by the abundance too this within qualification remedy separating the optimum on track of the lad conformation. It is rare soon after the cells are unable to divulge their toxins that troubles proceed. So with Also oxygen the cells interpolated the habitus determination be healthier. Mid the diet, he feasts human race to drink at least three liters of alkaline water together with advises human race to exercise generally. This is due to secondary regular diversions, the lungs do not minor in enough oxygen. The diet working entails that general public thirst to do cardio exercises at least four days between a tempo. Cardio or aerobic plays minister the emotions moreover lungs along besides draws within extravagant oxygen intake. Predictably, he besides preaches goal environment. Whereas the file claimed, with the Anthony Robbins diet proposition, practitioners fixed purpose not proper become versed good health along with haul retrenchment but to boot a inadvertent as well relaxed grasp. Is this easy goods release diet march healthy again attainable? I perseverance praise your comments breeze that home page if you involve tried Anthony Robbins diet devise. buy cheap cialis generic viagra online generic cialis Cheap Viagra

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On February 28th 2007, Barry Pittard wrote a blogged article entitled “Sai Baba’s ‘Minister of Propaganda’ - Dr G. Venkataraman” . In this article, Barry Pittard said (in part): barrypittard.wordpress.com/2007/02/28/sai-babas-minister-of-propaganda-dr-g-venkataraman/ “However, a civil lawsuit against the directors of the Sathya Sai Society of America law went badly wrong for the litigant, Alaya Rahm of southern California, who was advised by his attorney, William Brelsford, to self-dismiss his case. This resulted in terms so absurdly unfavourable to Rahm that some of us have wondered whether his pro bono lawyer William Brelsford can even look himself in the mirror of a morning. Had the family not suffered enough - having already courageously lent themselves to former devotee efforts with Denmark’s national broadcaster DR, BBC television, FBI and State Department, UNESCO, etc., - I, for one, favoured initiating a complaint process about William Brelsford to the California Bar Society.” To begin with, Alaya Rahm is not from Southern California and does not reside there. He resides in Arkansas (as confirmed in court records). Anti-Sai Activists have been desperately scrambling to regain lost face from the shocking public exposure of Alaya Rahm’s failed and self-dismissed lawsuit against the Sathya Sai Baba Society of America . Attorney Brelsford knew that he could not win the case due to overwhelming evidence against his client (Alaya Rahm) and advised him to self-dismiss his case. Claiming to be intimately familiar with Alaya Rahm’s failed lawsuit, Ex-Devotees embarrassed themselves when they publicly lied and erroneously claimed that Alaya Rahm’s case was heard by Judge John M. Watson on April 28th 2006 ( despite the official court records scans on my website proving otherwise) and they left this error in place for over a year . This glaring mistake was finally corrected and it was casually dismissed as a ‘clerical error’ . In Ex-Devotee’s response to Alaya Rahm’s failed lawsuit, the main thrust of their retort heavily relied on self-serving quotes allegedly taken from a letter written by attorney William Brelsford on their behalf (in which he was cited as a credible authority and voice of legal expertise). Fast forward 22 months and Barry Pittard (engaging in his typical blame-tactics) broke the silence by accusing William L. Brelsford of incompetence and being ‘seriously deficient’ . Barry Pittard further stated that he ‘favoured initiating a complaint process about William Brelsford to the California Bar Society’ . Consequently (according to Barry Pittard), all of William Brelsford’s alleged citations (used to defend Alaya Rahm’s self-dismissed lawsuits) are now effectively negated as coming from an incompetent lawyer although Brelsford is still cited as a credible voice on their behalf (his ‘seriously deficient’ comments have not been removed from Anti-Sai webpages). Ex-Devotees have a nasty habit of blaming everyone else for their numerous failures and can often be seen misrepresenting facts, distorting information and even resorting to outright prevarication to make their shabby and half-baked arguments against Sathya Sai Baba (who has never been charged with any crime, sexual or otherwise). Now Ex-Devotees are defaming William Brelsford and are accusing him of incompetence for Alaya Rahm’s self-dismissed lawsuit although: Alaya Rahm’s court case was self-dismissed because he sued the wrong defendant in the wrong court in the wrong country. In “Response To Form Interrogatories” Alaya Rahm fully admitted that he had been a daily user of illegal street drugs and alcohol since at least 1999 - 2005. Consequently, during Alaya Rahm’s “Divine Downfall” and India Today Anti-Sai interviews and during the filming of the BBC Documentary “Secret Swami” and the “Seduced By Sai Baba” Danish Documentary, Alaya Rahm was under the influence of illegal street drugs and alcohol while relating his alleged sexual encounters with Sathya Sai Baba. This crucial information wholly undermines Alaya Rahm’s credibility and irreparably compromises the integrity of his claims. Needless to say, this information has been purposely suppressed from the general public by Anti-Sai Activists and the media. Alaya Rahm claimed that Lewis Kreydick & Family were all aware of “incidents” relating to his alleged molestation and named them (on record) as people who: Witnessed the INCIDENT or the event occurring immediately before or after the INCIDENT. Made statements at the scene of the INCIDENT. Heard statements made about the INCIDENT by any individual at the scene. Had knowledge of the INCIDENT. Needless to say, Kreydick’s sworn and video-taped deposition wholly refuted all these points made by Alaya Rahm. The Society did not actively go out and attempt to discredit Alaya Rahm. Rather, they simply interviewed a witness named by Alaya Rahm himself and obtained a shocking and damaging deposition against him. The legal proceeding provided a forum in which Alaya Rahm’s claims could be thoroughly and critically examined. Through this process of investigation, it was discovered that Alaya Rahm and his family spoke at a number of retreats and conferences between 1995 and 1999 (during the time that the alleged sexual abuse events were said to have occurred). Inconsistent with Alaya Rahm’s later accusations, these conference talks (many of which were recorded and have been transcribed: Refs: 01 - 02), contain no suggestion of any wrongdoing. The earlier words spoken by Alaya would appear to refute his later accusations, especially Alaya’s whole-hearted and enthusiastic praise of Sathya Sai Baba and the writing of a love poem to him after allegedly being sexually abused dozens of times. Notably, in pretrial discovery, Alaya Rahm claimed (by his own admission) that he had suffered no psychological trauma that would have required medical or psychiatric care. Furthermore, Alaya identified no psychologist who had ever examined him! As a matter of fact, Alaya Rahm never saw an “expert psychologist” and his parents never sent him to one. Rather, the only help that Alaya obtained was a 3 day seminar from the Landmark Forum on “Empowerment, self help and personal growth” that cost $795 in June 2005 (5-9 years after his alleged abuse and 5 months after he filed his lawsuit)! That’s it. Barry Pittard conveniently ignored all of these crucial and pivotal facts about Alaya Rahm and instead blamed attorney William Brelsford although no one ( not even one critic or other ex-devotee) was identified to the court to support, help or defend Alaya Rahm in his allegations against Sathya Sai Baba. Barry Pittard is the picture of a lost-soul on the street, babbling to walls, trees and clouds, which cannot and do not respond to the rhetoric he repeats like an automaton. As a matter of fact, one can often see how Ex-Devotees thrive on repetition. “Deceive The Naive” is their motto and their parrot-like antics are used as psychological ploys to hypnotize, befuddle and mislead. Barry Pittard and Robert Priddy’s gutless personal attacks and viperine scribblings (which they attempt to peddle as Holy Writ) are evidence of their renewed desperation and blog delirium. The stronger critics attack Sathya Sai Baba, the more they expose the truth about themselves. They are (as other’s have pointed out for a long time) a small and vocal group of angry, bitter and mentally unstable defamers who care more for sensationalism and sleaze and care less for honesty and the truth. Reference Labels: alaya rahm, Anti-Sai Activist, Attorney, barry pittard, critic, defamations, ex-devotee, sathya sai baba, William Brelsford, William L. Brelsford

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