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Ghostbusting in Paxil Birth Defect Litigation PDF Print E-mail
(3 votes, average 5.00 out of 5)
Written by Evelyn Pringle   
Wednesday, 03 March 2010 16:31

ghostwritingA month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, "Glaxo Used Ghostwriting Program to Promote Paxil," in reporting on a program called "CASPPER," which allowed doctors to "take credit for medical journal articles mainly written by company consultants."

"Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work," the Associated Press said on August 19, 2009. "Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective."

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: "Paxil Product Management has budgeted for 50 articles for 2000."

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The family was award $2.5 million.

Ghostwriting 101

The world-renowned neuropsychopharmacologist from the UK, Dr David Healy, testified as an expert witness for the plaintiffs in the Kilker trial.

While testifying, Healy explained the process of ghostwriting to the jury. He said ghostwriting probably began seriously in the 1980s. "It's where an article appears under the name of usually a fairly distinguished person in the field," he testified.

Last Updated on Wednesday, 03 March 2010 16:58
Patient Survival Improved with CoQ10 and Antioxidants PDF Print E-mail
(10 votes, average 4.70 out of 5)
Written by Roman Bystrianyk   
Friday, 26 February 2010 13:20

antioxidantsFree radicals are atoms or groups of atoms with an unpaired number of electrons that are created in our bodies when oxygen interacts with molecules. These highly reactive radicals can then begin a chain reaction causing damage. The main hazard comes from the damage free radicals can do when they react with the cell's DNA or membrane and this injury may eventually lead to cancer. Antioxidants stabilize free radicals and may prevent some of the damage free radicals may otherwise cause.

A recent study in The Journal of International Medical Research examined 41 patients with end-stage cancer who were put on a supplemental nutritional treatment protocol. End-stage is considered the last phase of a disease and has replaced the somewhat less bleak term of terminal. The patients included in the study had solid tumors some of which were in the breast, brain, lungs, kidneys, pancreas, ovaries, and skin and who were also diagnosed with distant metastases. The authors explain the basis of the study as follows:

"Reactive oxygen species are able to activate all stages of carcinogenesis [creation of cancer]. Simplified, this process can be regarded as a continuous growth and accumulation of mutations in a cellular clone. If combinations of antioxidants have a preventive effect, it would seem possible that they would also retard the process at a later stage, i.e. when the cancer is apparent."

"There are several putative [commonly accepted] mechanisms for the potential anticancer effect of antioxidants. Most important among these are possible effects on cytokines, and inflammation, modulation of the expression of the tumour suppressor gene p53, inhibition of mutations, and inhibition of tumour angiogenesis [formation of blood vessels to the tumor]."

Last Updated on Friday, 26 February 2010 13:36
Menomune - One Mother's Harrowing Experience with the Meningitis Vaccine PDF Print E-mail
(74 votes, average 4.39 out of 5)
Written by Virginia Young   
Saturday, 20 February 2010 03:07
marie2Well another Super Bowl has come and gone. People rushed the grocery stores in preparation for the big day. I ran up to the store just as the game was starting for a few more ingredients I needed for dinner. No surprise the place was empty. Other than staff only three customers were there at a time when the place should have been hopping, and I was one of them.

Chips, dips, beer were all purchased and the fans were snug in their living rooms with friends and family anxiously glued to the television sets. In all honesty watching the Super Bowl, while once an item on my to do list, has taken a back seat to something more important. For the last nine years Super Bowl Sunday has been a reminder to me to give thanks for my life and those who are special to me because nine years ago on Super Bowl Sunday my little girl fought for her life while the rest of the world watched football.

In 2001 news reports revealed several students had died from meningitis. Kelsey Seybold, a large clinic system located in Houston Texas, opened up clinics all around the Houston area. Every night we turned on the television to see reporters at these sites. Long lines of people were waiting their turn for the Menomune vaccine. We continued to hear reports of meningitis in the local schools. A teacherʼs husband had contracted it and it was not known whether or not he would live. Parents started pulling their children from class to take them to the doctor for the new vaccine.

I believed my children had reacted to their childhood immunizations although I could not find a physician to agree. Regardless, I was not clamoring for more. Then rumors spread of possible cases just a mile from our home. My husband was growing more concerned as his pregnant patients came into contact with the bug through friends and family. He called the Department of Health to inquire about the vaccine. He was told it was absolutely safe and he could use it in his pregnant patients.

Last Updated on Saturday, 20 February 2010 15:35
Paxil Birth Defect Litigation - First Trial A Bust For Glaxo PDF Print E-mail
(5 votes, average 5.00 out of 5)
Written by Evelyn Pringle   
Monday, 15 February 2010 23:49

pharmacynightGlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The jury awarded the family $2.5 million in compensatory damages.

Last Updated on Tuesday, 16 February 2010 00:03
A Medical Doctors' Open Letter Opposing the McCain Sponsored Dietary Supplement Safety Act (DSSA) PDF Print E-mail
(33 votes, average 4.64 out of 5)
Written by Nicholas J. Gonzalez, M.D.   
Monday, 08 February 2010 00:01
supplementsintrashDear Senator McCain:

Though I am a resident of New York, not Arizona, I suggest that someone in your staff read my letter very carefully as I believe you are unwittingly sponsoring a bill with potentially onerous consequences, one that might if I read the information about it properly, lead to the death of hundreds of my patients fighting advanced, terminal cancer. I do not think, if I am correct in my interpretation, that you would want their death on your conscience.

As some background, I am a registered Republican, and in the past have donated many thousands to Republican causes including your re-election, even when it became clear to me the Party, including you, had strayed significantly from its mission of limited government, deficit reduction, and ultimately, protection of individual liberty. In terms of my professional activities, I am a former journalist (Time Inc), currently a physician and cancer researcher, who educated at three Ivy League schools (Brown undergraduate, Columbia post grad, Cornell for medical school). I finished a fellowship in cancer immunology under Robert A. Good, for ten years President of Sloan-Kettering, and the most published author in the history of medicine. Under Dr. Good's direction, 29 years ago I began researching the use of diet, nutrients, and proteolytic enzymes against advanced cancer.

Last Updated on Monday, 08 February 2010 11:44
Academic Bias and Fraud: The cases of bone marrow transplantation for breast cancer, and HIV-nevirapine. PDF Print E-mail
(21 votes, average 4.86 out of 5)
Written by Nicholas J. Gonzalez, M.D.   
Friday, 05 February 2010 03:25

nihFrom 1998 to 2005, my colleague Dr. Linda Isaacs and I worked closely with physicians and scientists from Columbia University, the National Cancer Institute (NCI), and the National Center for Complementary and Alternative Medicine (NCCAM), developing and pursuing a formal clinical trial comparing our nutritional approach to chemotherapy in patients diagnosed with inoperable pancreatic cancer. When the project first began we were excited by, and grateful for, this opportunity to have our therapy tested under what we hoped would be rigorous academic supervision. In a personal sense, the project represented the culmination of nearly 15 long years of our own research efforts, and our battles to have our therapy properly evaluated and eventually mainstreamed. We also hoped that in a more global sense, our particular clinical trial would help usher in a new era of cooperation between mainstream academic institutions, and serious alternative practitioners with promising new treatments. Indeed, in those long ago days as the project first began, we truly believed that the endless and fruitless war between mainstream medicine and more alternative approaches might finally be coming to an end, to everyone's benefit.

From the outset, the project generated praise and enthusiasm in the alternative press, as well as considerable interest in more mainstream venues such as the New Yorker Magazine,(1) but also some dismissive attacks. At times, we both felt we were in the middle of a firestorm. Nonetheless, whatever the obstacles we were determined to soldier on, prove to the scientific community the seriousness of our research efforts, and show once and for all that a treatment developed outside the academic world could come under scrutiny and be vindicated.

Last Updated on Sunday, 07 February 2010 19:13
More Hospitalized from NSAID Bleeding than All American War Casualties PDF Print E-mail
(28 votes, average 4.64 out of 5)
Written by Roman Bystrianyk   
Sunday, 10 January 2010 16:00
cemeteryNonsteroidal anti-inflammatory drugs, often referred to as NSAIDS, are assumed to be well tolerated and are widely used as a therapy for common inflammation. Everyone is familiar with these types of drugs with millions using them for pain relief. They range from over the counter aspirin and ibuprofen to a whole host of prescription brands. These pharmaceuticals constitute one of the most widely used class of drugs in the world.

Common over the counter names include: ibuprofen (Advil®), naproxen (Aleve®), and aspirin (Bayer®). Perscription brands include: celecoxib (Celebrex®), diclofenac (Voltaren®), etodolac (Lodine®), fenoprefen (Nalfon®), indomethacin (Indocin®), ketoprofen (Orudis®, Oruvail®), ketoralac (Toradol®), oxaprozin (Daypro®), nabumetone (Relafen®), sulindac (Clinoril®), tolmetin (Tolectin®), and rofecoxib (Vioxx®).

NSAIDs are often called nonsteroidal because they are not steroids. Steroids affect inflammation by suppressing part of the immune system, which is the body's natural healing response to trauma. Instead NSAID drugs mainly inhibit the body's ability to synthesize prostaglandins. Prostaglandins are a family of hormone-like chemicals, some of which are made in response to cell injury.

The July 1998 issue of The American Journal of Medicine stated the following:

"Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated."

Last Updated on Tuesday, 23 February 2010 00:51
Thimerosal: A vaccine ingredient’s toxic legacy PDF Print E-mail
(20 votes, average 4.80 out of 5)
Written by Roman Bystrianyk   
Wednesday, 30 December 2009 02:28
thimerosalmsdsdiamondApril, 1948 an article is published in the journal Pediatrics:

"Inspection of the records of the Children's Hospital for the past ten years has disclosed 15 instances in which children developed acute cerebral symptoms within a period of hours after the administration of pertussis vaccine. The children varied between 5 and 18 months in age and, in so far as it is possible to judge children of this age range, were developing normally according to histories supplied by their parents. None had convulsions previously."

"Twelve of the children were boys and three were girls, a sex difference also encountered in relation to other substances, such as lead, causing gross injury to the developing nervous system. At inoculation time, the children varied in age between 5 and 18 months. Developmental data were obtained in detail on all but two of the children, whose mothers simply stated that they had developed normally. Reference to the case histories showed that such objective activities such as sitting, walking, and talking had appeared in many of the children prior to the inoculations; and the regressions or failure of further development occurred after the encephalopathies [Any disease or symptoms of disease referable to disorders of the brain] in several instances. In so far as it was possible to judge none of the children were defective prior to their acute illness."

"In common with many other biologic materials used parenterally [not by mouth], an important risk of encephalopathy attends the use of prophylactic pertussis vaccine. The mechanism whereby the encephalopathy is produced is not elucidated by the present study. The universal use of such vaccine is warranted only if it can be shown to be effective in preventing encephalopathy or death from pertussis itself in large groups of children. If avoidance of the inconvenience of the average attack of pertussis is all that is expected, the risk seems considerable. Efforts to diminish the hazard by modification of the vaccine or new methods of administration seem indicated."

Last Updated on Wednesday, 30 December 2009 11:58
Historic Data Shows Vaccines Not Key in Declines in Death from Disease PDF Print E-mail
(57 votes, average 4.02 out of 5)
Written by Roman Bystrianyk   
Monday, 14 December 2009 02:04

measlesdeclineMany of us have a picture of the 1800s that has been colored by a myriad of filters that have led us to a nostalgic and romantic view of that era. We picture a time where gentleman callers came to call upon a well-dressed lady in a finely furnished parlor. We imagine a time where people leisurely drifted down a river on a paddle wheel riverboat while sipping mint juleps and a time of more elegant travel aboard a steam train traveling through the countryside. We picture an elegant woman dressed in a long flowing gown leaving a sleek horse drawn carriage with the aid of a well-dressed man in a top hat. We think of those times where life was simple, ordered, in a near utopian world free of the many woes that plague modern society.

But if we remove those filters and cast a more objective light upon that time a different view emerges. Now imagine a world where workplaces had no health, safety, or minimum wage laws. It was a time where people put in 12 to 16 hours a day at the most tedious menial labor. Imagine bands of children roaming the streets out of control because their parents are laboring long days. Picture the city of New York surrounded not by suburbs, but by rings of smoldering garbage dumps and shantytowns. Imagine cities where hogs, horses, and dogs and their refuse were commonplace in the streets. Many infectious diseases were rampant throughout the world and in particular in the larger cities. This is not a description of the Third World, but was a large portion of America and other western cities only a century or so ago.

Last Updated on Monday, 14 December 2009 11:47
The Hidden Dangers Of Pre-Menopausal Mammography PDF Print E-mail
(1 vote, average 5.00 out of 5)
Written by Samuel S. Epstein, MD   
Friday, 04 December 2009 15:24

womanWomen have been and remain assured that radiation exposure from pre-menopausal mammography is trivial, and similar to that from a routine chest x-ray, about 1/1000th of a rad (radiation absorbed dose). However, the practice of taking two mammograms for each breast results in 500 times greater radiation exposure of half a rad, focused on each breast, rather than on the entire chest. Thus, pre-menopausal women undergoing annual routine mammography over a ten-year period are exposed to a total of about 5 rads for each breast. This approximates to the very high radiation whole body exposure of women one mile away from where the atom bombs were dropped in Japan.

This information is not new. Furthermore, as recognized by the prestigious National Academy of Science in 1972, the pre-menopausal breast is highly sensitive to radiation, each rad exposure increasing the risk of breast cancer by one percent. This results in a cumulative 10 percent increased risk of breast cancer over ten years of pre-menopausal mammography. This warning was subsequently emphasized in my 1978 The Politics of Cancer, "Whatever you may be told, refuse routine mammograms, especially if you are pre-menopausal. The x-ray may increase your chances of getting cancer."
This warning against premenopausal mammography was further detailed in a 2001 scientific article, "The Dangers and Unreliability of Mammography: Breast Self Examination As A Safe Effective and Practical Alternative," published in the prestigious International Journal of Services. This was co-authored by Dr. Rosalie Bertell, a leading international expert on the dangers of radiation, the late Barbara Seaman, founder and leader of the women's breast cancer movement, and myself.

Last Updated on Friday, 04 December 2009 15:37
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