20 Oct – The Ohio medical board concluded that pain physician William D. Leak had performed “unnecessary” nerve tests on 20 patients and subjected some to “an excessive number of invasive procedures,” including injections of agents that destroy nerve tissue.  Yet the finding, posted on the board’s public website, didn’t prevent Eli Lilly and Co. from using him Continue reading ‘Disgraced Docs Push Drugs for Big Pharma’

Dr. Ossi came to the hastily arranged gathering of health officials and academics expecting to talk to them about his company’s research into anti-viral drugs and flu vaccine. But the health experts clustered around a handful of tables were not interested in hearing about the science behind such products. They had much more pressing concerns. Continue reading ‘How Vaccines Became Big Business’

In another case of doctors selling out to the pharmaceutical industry, the Guardian reports that Dr Richard Eastell is being tried in front of a medical council for allowing his name to be put on a study of the osteoporosis drug Actonel.

Doctors have been agreeing to be named as authors on studies written by employees of the pharmaceutical industry, giving greater credibility to medical research, according to new evidence.

The Guardian has learned that one of Britain’s leading bone specialists is facing disciplinary action over accusations that he was involved in “ghost writing”.

The wider phenomenon has come to light through documents disclosed in the US courts which have revealed a culture in which doctors agree to “author” studies written by employees of drug firms. The doctors may have some input but do not have access to all the evidence from the drug trial on which the paper’s conclusions are based, the documents showed.

The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study’s conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures.

Experts believe the practice is widespread in Britain. In another alleged example, a consultant cardiologist claims an expert listed as an author on a medical paper died before the research began. Peter Wilmshurst, a heart specialist at the Royal Shrewsbury hospital, is involved in a dispute over a study which he helped design, which involved the insertion of a device to close a hole in the heart.

He claims the manufacturers refused him access to data and he had concerns about the accuracy of the paper, so he refused to sign it off and is not listed as an author. One of those who is named, Wilmshurst said, is a true ghost author. Anthony Rickards, a cardiologist, was involved in preliminary discussions but died before the research was conducted.

The company which sponsored the research, the US firm NMT Medical, is suing Wilmshurst for remarks in a lecture that he made about outcomes in the trial, which were published on a medical journal website. A UK charity, HealthWatch, has launched a fund to support Wilmshurst, who was in 2003 a recipient of its award for challenging misconduct in academic medical research.

The US documents show that Wyeth, one of the biggest companies involved, employed a medical writing agency with the purpose of getting favourable studies about its HRT drug Prempro into prestigious medical journals.

The agency dreamed up ideas for papers about the benefits of the drugs and then wrote an outline and even a first draft before offering it to a doctor who might agree to have his name attached as the author. Although the doctor would see drafts and revisions, critics say that control of the content and message were in the agency’s hands. The memos and emails show that many busy academics signed their approval to the finished paper.

Many of the documents are records of planning meetings, where agency staff list articles that will be written, suggesting possible authors and targeting journals. Concern about ghostwriting caused the UK-based open-access journal PloS Medicine, part of the Public Library of Science, to intervene in a court case brought by women who claim they were harmed by the HRT drug. PloS Medicine, with the New York Times, argued that the public should know what was going on. A US judge agreed to place the documents in the public domain.

Ginny Barbour, editor in chief of PloS Medicine, said she was taken aback by the systematic approach of the agency. “I found these documents quite shocking,” she said. “They lay out in a very methodical and detailed way how publication was planned. “Other documents released through US court action show that GlaxoSmithKline employed a ghostwriting programme named Caspper in which doctors could take credit for medical journal articles written by the company’s consultants.

The project was aimed at boosting the US sales of an antidepressant called paroxetine, which goes by the brand name Paxil in the US and Seroxat in the UK.

Caspper stood for Case Study Publication for Peer Review. It enabled doctors with positive experiences of Paxil to get into medical journals. A busy doctor could sit back and let a medical writing agency paid by GSK do all their work, from the first draft to getting it accepted for publication by a journal.

The medical writing agency would prepare drafts using whatever material the doctor sent them and create figures and tables. These would go to the doctor for approval. “The author ensures accuracy of material, updates references, supplies missing information, etc,” says the leaflet. Eventually the doctor would complete a sign-off form and the agency would send the paper for publication.

Caspper came to light when internal GlaxoSmithKline documents were released in court action in the US brought by the legal firm Baum Hedlund on behalf of patients who claim they were harmed by Paxil. GSK says the programme was discontinued some years ago and that the names of medical writers were included on any published papers.

But Caspper shows there was no dividing line at the time between science and marketing – the leaflet states its purpose is to “strengthen the product positioning and overcome competitive issues”. Doctors and medical journals became part of a promotional campaign, aimed at selling more drugs.

The disciplinary move in the Eastell case comes after he admitted that a statement he signed declaring that all six authors had access to all the statistical data was wrong.

In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: “In the original paper one of the authors, a statistician working for P & G, Ian Barton, had full access to all the data.” The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company.

The letter, published in 2007, also acknowledged flaws in the study. A later ndependent analysis of the data “identified some errors and poor practice”, he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck.

Eastell’s paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else.

Eastell’s colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped, Eastell said he was concerned that persistent requests might damage the
relationship they had with the company. Eastell is said to have told him: “The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.” .

Tim Kendall, joint director of the National Collaborating Centre for Mental Health, says the problem is the close relationship between doctors and the industry. “Some doctors don’t seem to see the relationship … as problematic.”

A study of 4,000 physicians found that 96% received money from drug companies, and yet “the majority did not see it as a conflict of interest”, he said.

“I do think there needs to be a national debate in this country about the interpenetration of medicine and the pharmaceutical industry.”

Ghost writing was one manifestation of a bigger problem which he believed was the institutional bias of doctors who work closely with and for drug companies. “In mental health 85% of all published trials are funded by the drug industry,” he said. Allowing for the unsuccessful trials the industry does not publish, the figure is probably nearer 95%, he said.

Studies have shown that drug company-funded trials are five times more likely to come out with a positive result for the drug than independent trials.

The GMC is criticised by doctors like Wilmshurst and Blumsohn for failing to take a tougher line against doctors involved in dubious research practices.

Jane O’Brien, head of standards and ethics, said that their research guidance specified the importance of honesty in the attribution of authorship. “We would see that as an important issue. If somebody’s name is on something it gives research a credibility that it wouldn’t otherwise have. If somebody had not been involved, we would see that as misleading people as to the credibility of the research.”

She added that the GMC felt it important to play a role in ensuring good conduct in research. About a year ago, she said, they took soundings of bodies that regulate and support research, such as the Medical Research Council, asking whether the GMC should be involved. “The response was yes, because we are the people who can strike doctors off in the end.”

Eastell declined to discuss the hearing. “I do not wish to comment on the case. The proceedings have yet to commence,” he told the Guardian in an email. A spokesperson from the University of Sheffield, where Eastell is professor of bone metabolism, said they were aware of the investigation. “We will be informed by the GMC of any outcome and cannot comment further until we receive this.”

Until last year, I was a strong supporter of the pharmaceutical industry. When Merck was sued (Vioxx), I blamed the lawyers for filing frivolous lawsuits against drug makers who, I then believed, were the innovative champions in Humanity’s fight against disease.

I dismissed stories about “big pharma” as fast as I heard them. The notion that scientists would deliberately poison patients for profit, or that the US Government would fund medical doctors like Robert Gallo after he violated his Hippocratic Oath was preposterous. As much as I like Ralph Fiennes, I refused to see a movie as unbelievable as The Constant Gardener.

So when the physicians and nurses at Semmelweis Society International (SSI) asked me to investigate allegations that UC Professor Peter Duesberg had killed millions in Africa, I expected to complete my task within days. With almost thirty years of investigative experience, I figured that a few Google searches would resolve the questions, one way or the other.

Little did I know that the allegations issued by James Murtagh MD, Kevin Kuritzky, and Richard Jefferys would consume thousands of hours of my time or expose me to the ugly underbelly of the pharmaceutical industry and its chicken-ranch relationship with America’s most prestigious universities.

While the evidence I discovered now suggests that millions may have been poisoned and murdered, I’ve found that Dr. Duesberg more closely resembles Moshe the Beadle than his pharmaceutically-funded accusers – who now appear to have far more in common with Phillip Morris than Louis Pasteur.

Since the release of my preliminary report (PDF) in July 2008, filmmaker Brent Leung completed his documentary and investigative reporter Celia Farber, who was also targeted, has filed suit against her accusers in the New York Supreme Court.

My report established the two sides of the dispute:

• One side, (commonly referred to as truthers, goons, and troofers) is comprised of the beneficiaries of millions of dollars in pharmaceutical funding. Truthers insist that HIV attacks cells and causes AIDS.
• The other side, (called rethinkers, denialists, and skeptics) question whether anyone has ever proved that HIV attacks cells and causes AIDS. These individuals rely mostly on private donations and represent a tiny fraction of what truthers receive from the pharmaceutical industry.

After examining both sides, the evidence now indicates that:

1. All HIV/AIDS research is based upon Dr. Gallo’s unproven assumption that HIV attacks cells and causes AIDS;
2. The National Institutes of Health (NIH) spends $206,906 per AIDS death (compared to $13,365 per Diabetes death, $12,000 per prostate disease, $9,000 for Parkinson’s disease and $9,000 for Alzheimer’s disease), even though AIDS has never been a leading cause of death in the United States or Africa;
3. Except for rare individuals like US Senator Charles Grassley and Rep. John Dingell, the US Congress, Food and Drug Administration (FDA) and the National Institutes of Health (NIH) and Centers for Disease Control (CDC) appear to share many of the same organizational flaws that the SEC, FBI, Fannie Mae, Freddie Mac, and the Treasury exhibited before the 2008 financial.

New Evidence

Although the toxic effects of HIV treatments are well documented, I was still confused by HIV+ patients who reported that, after years of treatment, many became ill within two weeks of discontinuing their medication. If HIV didn’t kill cells or cause AIDS, why were patients getting sick when they interrupted their drug regimen?

Although patients like Karri Stokely attributed her four-month post-drug illness to “the shock of no longer being on toxic drugs,” I didn’t accept it. Toxins don’t ordinarily make someone sicker when stopped – addictive drugs do that. If someone takes regular doses of arsenic for six months, there is no evidence that their sudden abstinence would cause anything but a recovery. Conversely, addicts (and those who know them) understand the distress that comes with abstinence from coffee, tobacco, and harder drugs like alcohol, cannabis, opiates, meth or cocaine. The degree of withdrawal depends upon factors that include the addict’s health, dosage, resistance, the intoxicant, and how the drugs are metabolized.

But while post-HIV drug symptoms sounded suspiciously like addiction withdrawal, I found little more than a mild warning (404) of the “potential for additive central nervous system effects when SUSTIVA is used concomitantly with alcohol or psychoactive drugs.” Nothing alluded to intoxicating properties of the drug itself.

When I met Karri Stokely last week, she explained her medical history, her two-month recovery from a post-operative infection, and various tests that eventually led to her HIV+ diagnosis in June 1996 when she began her treatment. (more)

Karri reported that she was initially prescribed Combivir and Crixivan until 2001, when her doctor detected signs of liver damage and switched from Crixivan to Sustiva. After that, Karri took Combivir and Sustiva as prescribed until April 2007, when she discovered Dr. Duesberg’s questions about AIDS research. After studying the information on Rethinking AIDS and Virus Myth, she abruptly stopped her medication.

At first, Karri detected no adverse symptoms. During the second week, however, she noticed increasing symptoms of fatigue, exhaustion, depression, insomnia, body aches, and a significant loss of appetite. During the next month, she developed an extreme sensitivity to pain when touched, even when lying in bed or eating. Visits to the toilet and tub were difficult and, as the weeks passed, her weight dropped from her normal 135 to 114 (she’s 5-8). Karri also experienced night sweats and often noticed a thin green/yellow coating on her tongue. Most notably, her throat was sore and she possessed an almost continuous and unquenchable thirst.

“I felt as if my system was shutting down,” she said.

Karri’s decline continued from April through August 2007, when her symptoms began to subside. She returned to her clinic for another blood test in August and, when the lab results returned a week later, the nurse called Karri in a panic: “Your lab tests are way off! You didn’t stop taking your drugs, did you?”

The nurse became more alarmed when Karri admitted that she’d been off the drugs for four months.

Nurse Nancy asked, “Why would you do such a thing? Do you know what happened to your lab work?

“No.”

“Do you even want to know what your lab work says?”

“Yes.”

“Your T-Cell count dropped to 97 (from 200s) and viral load to 135,000! Are you coming in?”

A week later, Dr. Van Hook crossed his arms and scowled at Karri. “Why would you do this?”

Karri asked him, “Did you know there is another view of HIV, that it might not cause AIDS?”

“No,” said the doctor.

“Do you want to know?”

“No, Karri, I don’t want to know. You’ve done a very stupid thing and you will be dead very soon.”

Karri Stokely didn’t die and, during the next two years, her symptoms disappeared entirely.

After listening to Karri’s story and comparing notes with other reports, I noted similarities between Karri’s symptoms and known withdrawal syndromes, including those of antidepressants. I also found reports that HIV drugs were being crushed and smoked by addicts in Africa:

The children do not know where they are and they stop making sense.

The research, production, and distribution of this class of drugs is not without controversy. Japanese researchers recently reported antidepressant (SSRI) users “who developed increased feelings of hostility or anxiety, and have even committed sudden acts of violence against others.” (Other SSRI stories indexed here.) Texas psychiatrist Karen Wagner MD was recently exposed for failing to disclose a $160,000 payment from GlaxoSmithKline while understating the dangers of Paxil for children.

Many of these known SSRI withdrawal reactions are consistent with Karri’s post-Sustiva experience.

As for Nurse Nancy’s report of Karri’s erratic T-Cell counts and viral loads, numerous clinical studies show a direct connection between the stress of withdrawal (cocaine and heroin) and decreases in immune function for up to two years. Those reports show a direct correlation between addiction, withdrawal, and the human immune system (white blood cells, T-cells, and viral loads) regardless of whether HIV is present or not. But because AIDS experts and testing rely on T-cells and viral loads to establish HIV infection, it’s hard to understand how the experts know the difference between HIV infections and physiological changes due to illicit drug use. This would also explain why active and former drug addicts are frequently identified as HIV carriers.

The revelation that Sustiva is not reported to be an extremely addictive psychotropic drug is disturbing. After speaking with patients like Karri who interrupted their prescriptions, it now appears that abstinence from so-called “ARVs” like Sustiva results not in an increased risk of AIDS but, instead, precipitates the onset of a painful and violent withdrawal syndrome not dissimilar to withdrawal from cocaine, heroin, methamphetamines, and alcohol. Unfortunately for patients like Karri, AIDS clinicians typically mischaracterize the withdrawal syndrome as a manifestation of AIDS that will soon kill them. Unless given further information, care, and nurturing, most patients are physically and emotionally unprepared to contradict their white-coated physicians. Once the drug is re-administered, however, the “AIDS symptoms” disappear in ways not unlike junkies who inject a long-awaited dose of heroin.

Conclusion

It is not known how many AIDS medications are addictive or why; nor have I established whether the pharmaceutical industry unintentionally or deliberately marketed addictive drugs for the purpose of misleading otherwise uninfected individuals. But if a retired cop can identify Sustiva’s addictive properties, it’s hard to understand how the GlaxoSmithKline’s PhDs could have missed so much evidence.

Intentional or not, by marketing this class of drugs (MAOIs and SSRIs) as “AIDS medications,” the pharmaceutical industry has built into its HIV cocktails a mechanism that punishes HIV patients when they interrupt their drug use.

Karri’s cocktail contained two drugs – a deadly poison (AZT) that kills and a highly addictive drug that makes patients feel cheerful, more optimistic, and more physically active.

At $419/mo, a patient (or taxpayers) would pay $5,028 a year for Sustiva alone. Multiplied by the alleged HIV+ US population of 1,185,000, receipts could total $6 billion/year. Multiplied by the estimated global HIV+ population, GlaxoSmithKline could generate $100 billion in sales and tax deductions annually.

Despite these facts, no one can seriously believe that a pharmaceutical company would deliberately poison and addict millions of homosexuals, drug users, and illiterate Africans for $100 billion dollars a year. No, that’s out of the question. Of course they wouldn’t.

But if the pharmaceutical industry knows that Sustiva and/or other HIV drugs are addictive, it would also explain the hysterical attacks by so-called AIDS researchers who, instead of delivering proof that HIV attacks cells and causes AIDS, attack individuals like Karri Stokely who have the temerity to ignore the results of HIV tests that prove nothing.

While the Harrison Act of 1914 prohibits the distribution of addictive drugs to perpetuate addiction, the evidence suggests that GlaxoSmithKline has circumvented the spirit of this law by delivering intoxicants, other than opiates and coca, to millions by classifying them as HIV treatments.

Karri Stokely is one of many former HIV patients who have kicked the habit and now live a happy, healthy and drug-free life. I look forward to the day when politicians jump start the agencies that are supposed to be looking out for the most vulnerable in the US, Europe, and Africa.

Smoking the pills has a hallucinogenic and relaxing effect.