What Did They Prescribe Lil Peep?


“…”I suffer from depression and some days I wake up and I’m like, ‘F***, I wish I didn’t wake up’. That was part of why I moved to California, trying to get away from the place that was doing that to me, and the people I was around.

“I realised it was just myself – it’s a chemical imbalance in my brain,” he added at the time.”

http://www.mirror.co.uk/3am/celebrity-news/lil-peep-autopsy-results-11534849

 

Lil Peep was an American rapper who overdosed on Wednesday night, November 15, at age 21. Prescription drugs such as Xanax were mentioned a lot in his lyrics and his songs contain numerous references to drugs, prescription drugs in particular. It’s sad to see a life cut short at 21, but Lil Peep is representative of the generation who psychiatry has overdosed and over-diagnosed. His death is one of many.

In one article- from Pitch-Fork- Lil Peep mentions that his ‘mental illness’ is all down to a ‘chemical imbalance’. It’s hard to believe that the drug company created- chemical imbalance theory- is still doing the rounds. A tech savvy millennial like Lil Peep would have only needed to do a quick google search to see that the chemical imbalance theory has long been debunked, and even psychiatrists are backing away from it now. Nevertheless, it seems that the the allure of this myth to those looking for a chemical cure to their despair is as potent as ever. This, of course, means tons of business for the drug companies and their psychiatric puppets… and much harm to patients.

It will be interesting to see what psychiatric drugs were prescribed to this talented young man, and in what way did they contribute to deleting his young life and potential.

RIP Lil Peep…

http://people.com/music/lil-peep-dead-possible-xanax-overdose/

 

Based on information [police] were told and evidence that was found in the tour bus, they had evidence of a possible drug overdose, most likely from Xanax,” Sgt. Dugan says, adding that an official cause of death will be released by the medical examiner after toxicology reports. “Based on evidence, there was drug paraphernalia found inside the bus and some narcotics.”

https://soundcloud.com/antidepressants/another

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…Mark’s blood contained high levels of the antidepressant drug paroxetine …


Another Paroxetine Death..

.. if SSRI’s like Paroxetine are so effective then why do people keep killing themselves on these drugs?

 


 

http://www.bathchronicle.co.uk/news/bath-news/coroner-finds-mark-hagan-51-640231#ICID=sharebar_twitter

 

Coroner finds Mark Hagan, 51, drowned in River Avon in Bathampton

His body was discovered lodged in the river shallows near a pub in July

A 51-year-old Bath man whose body was found in the River Avon in Bathampton died by drowning, a coroner has found.

Mark Richard Hagan, of London Road West, was pulled from the river near the Bathampton Mill pub on the morning of July 19.

An inquest into his death heard his body was discovered in the river shallows by a dog walker at about 7.30am.

A large man with a shaven head, Mr Hagan had been reported missing by his mother earlier that day.

His body was later identified by Isobel Rathbone, the vicar of the Church of St John The Baptist in Batheaston, who had known him and his mother for about two years.

The inquest at Avon Coroner’s Court heard that Mr Hagan was a single carer who lived with his mother.

Mr Hagan’s body was discovered in the river by the Bathampton Mill pub

He was socially isolated, had learning disabilities, dyslexia and was taking medication for anxiety and depression.

He was also overweight, had high blood pressure, sleep apnoea, swollen legs and was prone to leg ulcers.

Evidence from witnesses read out in court described how Mr Hagan’s mental health had deteriorated after the deaths of his father and sister at the end of 2016 and the recent diagnosis of his mother with cancer.

According to his brother, James Hagan, Mark had lived with his sister and parents as a “close unit” for nearly 30 years and the death of their father, in particular, had had a “major impact on Mark”.

The inquest was heard at Avon Coroners Court in Flax Bourton

James said Mark had become “fixated” on the condition of his legs and had said “life wouldn’t be worth living” if he lost his leg.

He had also told his mother he wished “God would take him”, according to James.

A post mortem found pathology “consistent with drowning”. Mark’s blood contained high levels of the antidepressant drug paroxetine but the concentration was not so high as to cause “serious toxicity”.

The dose of the drug had been raised to 40mg after he began “obsessing about his legs” and became anxious about his future after his mother was diagnosed with throat cancer.

Police at Bathampton Mill
Police at Bathampton Mill (Image: Artur Lesniak)

His former GP, Dr Charles Berrisford at Number 18 Surgery, said the last time he saw Mr Hagan on July 12 his patient was anxious but showed no signs of depression and he had “no cause for concern”.

His new GP, Dr Jim Hogg at Batheaston Medical Centre, made a similar observation upon meeting Mr Hagan for the first time when he visited the surgery on July 14.

No note was left by the deceased.

Reading her finding of death by drowning, assistant coroner Myfanwy Buckeridge noted the GPs’ remarks and the observation from James Hagan that his brother “struggled to make decisions by himself”.

She also noted there was no evidence of how Mr Hagan came to be in the river.

“I cannot rule out that the death was the result of a tragic accident,” Ms Buckeridge said.

No witnesses or friends or family of the deceased attended the inquest.

If you have been affected by this article, or are concerned about someone or need help yourself, please contact the Samaritans on 116 123.

What Did They Prescribe George Michael?


“….Georgiou dismissed claims Michael was taking Class A drugs before his death, insisting he had ‘stopped all the naughty stuff’.

He told The Times: ‘He was on antidepressants but he wasn’t doing drugs any more. 

‘He had swapped drugs for drink but he was doing better. The craziest thing is that when we were 20, 21 he used to say he’d die young….”


As 2016 came to a close, the death of singer George Michael made headline news across the world. Post-mortem results have been- thus far- inconclusive. However similar to the other celebrity deaths in recent times, it seems a lot of these cases usually involve multiple uses of prescriptions drugs over long periods of time – something termed- Polypharmacy.

George Michael’s erratic behavior has been well documented over the years, as has his experiences of depression, and anti-depressants too…

“…Chawla said the singer – who had used prescription medication to deal with his anxiety, depression and insomnia over a long period – had attempted to wean himself off drugs in March this year. He had some success, but later found “the feelings of anxiety and insomnia appeared to have redoubled”…”

He told police after his arrest:

“I’m so ashamed of it. It is so ridiculously dangerous and that is why I have stayed away from them [the antidepressants], even though I still have insomnia and I had some anxiety.” He had only started taking the drug recently, he said, adding: “They are a recent thing, and it’s taken me a whole week to fuck up again.”

https://www.theguardian.com/music/2010/sep/14/george-michael-sentenced-jail-drug-crash

“…He went on a diet of Prozac and cannabis. The Prozac made his head even worse, he says. “At first you’re flying about, snapping at people one minute, really happy the next, and I made some disastrous business decisions,” he said….

http://brosiacom.blogspot.ie/2005/12/george-michaels-depression-story.html

The Press and the public, still largely seem to think, that just because medication for depression is available for prescription that it must be safe. The fact that anti-depressants legally prescribed (by a doctor) gives these drugs an aura of legitimacy which illegal drugs don’t have.

However, often prescribed drugs (such as SSRI- anti-depressants, Benzos, etc) can induce horrific side effects and withdrawal symptoms, and they can also be just  as dangerous as any illegal drugs (if not more so- in some instances).

The polypharmacy induced deaths and shortened life-spans of celebrities highlights the generally dangerous and irresponsible prescribing habits of many doctors. Of course medication induced deaths, injury, disability and shortened lifespans/quality of life etc – has been happening to the general public, as well, for decades.

Robert Whitakers ‘Anatomy of an epidemic’ is essential reading in this regard.

In Whitakers award winning book- he describes how psychiatric patients’ lives are considerably blighted by the drugs they are prescribed…

It will be interesting to see what they have been prescribing George Michael all these years..

Unfortunately it’s likely his death is linked to the polypharmacy prescribing habits of many celebrity doctors nowadays..

Heath ledger

Amy Winehouse

Prince

Carrie Fisher

And the rest…

All had very poor health ‘care’ outcomes and treatment (in particular from the psychiatric profession)

Even though they were very wealthy and had access to the best orthodox ‘medicine’ , their deaths are still linked to the drugs they were prescribed…

Perhaps ‘orthodox’ medicine has been poisoning us all for far too long?

RIP George..

What’s the truth about Glaxo’s Infanrix hexa vaccine and sudden death among babies?


more on this story to follow in the coming days…

 

https://autismoevaccini.files.wordpress.com/2012/12/vaccin-dc3a9cc3a8s.pdf

 

http://www.inquisitr.com/1751130/doctor-claims-that-hexavalent-infanrix-vaccine-causes-sudden-death-of-babies-anti-vaccination-advocates-question-why-report-was-confidential/

 

January 15, 2015

‘Doctor Claims That Hexavalent Infanrix Vaccine Causes Sudden Death Of Babies,’ Anti-Vaccination Advocates Question Why Report Was Confidential

One doctor says there is a strong link between the Infanrix hexa vaccine and cases of sudden death among babies. The manufacturer of the hexavalent Infanrix vaccine, GlaxoSmithKline (GSK), disclosed required information in a confidential report to the regulatory authority. In that report, which has been made public per orders by Italian Court of Justice Nicola Di Leo, according to the India Medical Times, the deaths of 72 babies took place within 20 days of getting the Infanrix hexa jab. Di Leo ordered the documents released during an autism-related hearing.

Infanrix vaccination generally follows a schedule of injections at three, five, and eleven-months of age, according to a paper published in Human Vaccines and Immunotherapeutics, which stated that the vaccine was first licensed in 2000 and that the vaccine has demonstrated a decade of safety.

Dr. Jacob Puliyel, head of pediatrics at St. Stephens Hospital in Delhi, linked to the previously confidential documents on Infanrix and commented on the Human Vaccines and Immunotherapeutics’s article where it appears in the U.S. National Institute of Health’s library. The pediatrics head called attention to what he believes is a strong correlation between sudden death and Infanrix when he wrote that “if one analyzes the data looking at deaths in first 10 days after administration of vaccine and compares it to the deaths in the next 10 days, it is clear that 97% of deaths (65 deaths) in the infants below 1 year, occur in the first 10 days and 3% (2 deaths) occur in the next 10 days.”

“Had the deaths been coincidental SIDS deaths unrelated to vaccination, the numbers of deaths in the two 10 day periods should have been the same.”

Puliyel went on to write that Infanrix hexa may have been to blame for at least 69 babies’ deaths during the reporting period alone. He states that 69 of the deaths during the reporting window were investigated thoroughly and occurred within three weeks of vaccination with Infanrix and the ages of the babies varied.

image: http://cdn.inquisitr.com/wp-content/uploads/2015/01/Infanrix-hexa-death-vaccine-by-day-chart.jpg

Did the hexavalent Infanrix vaccine cause sudden death?

Rather than compounding the total deaths each day, as in the documents found online, the pediatrics doctor suggests we examine how many more deaths happened right after the vaccine was given compared to as the days went by. He said this demonstrates a link between the vaccination event and the sudden deaths.

“The data is conclusive. It is very clear and there is no room for argument,” a child safety advocate from Child Health Safety wrote just hours after Puliyel made his analysis public.

“And the analysis is simple. Anyone can understand it. The very plain data the document contains proves the matter without any doubt whatsoever.”

Claims on social media based on the doctor’s published comment are snowballing.

The doctor who analyzed the data did not state that there was no room for argument, though. He did not brazenly state that the hexavalent Infanrix vaccine causes sudden death in babies.

Puliyel stated that he published his commentary “to put it up for open review by the scientific community, on account of its urgency, as this is a matter that involves the lives of children and there is a continuing risk to children.” Puliyel notes that the “decelerating incremental-deaths” support the theory of a clear relationship between deaths labelled as sudden death and “the vaccination episode.” The vaccination episode includes many variables besides just Infanrix vaccination itself.

Puliyel noted a correlation between deaths and the combination vaccine Infanrix. Puliyel has been clear before, such as in his letter to the Guardian, that he believes combination vaccines are possibly dangerous and far too expensive.

“India is a country where 50% of the population, do not receive the 6 basic vaccines against diphtheria, whooping cough, tetanus (DPT), polio, tuberculosis and measles. The incremental cost of complete immunization with these vaccines is less than US $0.75 (Rupees 30) per child. Again today, I had the heart wrenching experience of explaining to a mother about the death of her 8 year old girl with diphtheria. Both the mother and my Registrar at the bed-side were distraught. 2 week ago we had another death from the same disease. The push to include expensive new vaccines must be viewed in this context. The ‘pentavalent vaccine’ that is being canvassed, on its own, will increase cost of DPT immunization twenty-fold [2]. It is not about lives lost in poor countries – it is all about the cash register. These organizations and their sponsors have profit margins to protect. Ethics is not a major issue with them.”

The previously classified Infanrix document listed extensive details about the safety of Infanrix, and the sudden death cases were just a fraction of the issues addressed. In one of the tables, many other events were reported. These events may or may not have been caused by the Infanrix vaccine, but were disclosed to the regulatory authority. They include nearly one hundred cases of pertussis, a couple dozen cases of meningitis, 28 cases of bacterial pneumonia, about 20 cases of encephalitis, and about one hundred cases of children suddenly staring off since the launch of the vaccine in 2000. Below are some of the more frequently reported events listed within the document. Only events listed as serious were included in the graph.

image: http://cdn.inquisitr.com/wp-content/uploads/2015/01/infanrix-hexa-vaccine-death-reactions.jpg
Infanrix hexa vaccine is given for vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type b and is being linked to infant death by a pediatric doctor who is concerned about combination vaccines. Other events were also disclosed in a a document that can now be found online.

Not all events reported can be definitively linked to Infanrix. Conversely, a great deal of events never get reported. GSK noted that as of the 2011 report, somewhere between 18 million and 73 million children were vaccinated with Infanrix, demonstrating just how infrequently side effects are reported after the vaccination. The year following the report, there was a recall on six batches of Infanrix, but that was issued out of an abundance of caution.

Some speculate that Infanrix is incredibly safe, but that Prevnar 13 administered with Infanrix might up the risks of a reaction, according to an article in LeSoir. That should come as no surprise though, given that GSK freely admits to increased reports of events following vaccination with both Prevnar and Infanrix in its prescribing literature.

Within the previously confidential document, a contraindication to vaccination with Infanrix noted is a hypersensitivity to any of the active substances or to any of Infanrix’s excipients or residues, including lactose, polysorbate 20 and 80, glycine, formaldehyde, neomycin sulphate and polymyxin B sulphate. Reports of anaphylaxis are calculated, using information disclosed in the document to the regulatory authority, to be as rare as only four in every ten million doses. According to the statistics within the document, even if the doctor from Delhi’s fears are spot on, the risk of sudden death, while existent, would also be exceptionally rare after vaccination with the hexavalent Infanrix vaccine.

This article has been corrected. In the original article, the anonymous Child Health Safety writer was described as an anti-vaccine advocate. The website’s official stance is that there is no actual anti-vaccine movement, just a movement for health safety.

Read more at http://www.inquisitr.com/1751130/doctor-claims-that-hexavalent-infanrix-vaccine-causes-sudden-death-of-babies-anti-vaccination-advocates-question-why-report-was-confidential/#CX7OaIc56RSASugf.99

 

 

Is GSK’s Migraine Drug – Imitrex- Dangerous And Deadly?


I took GSK’s Seroxat (Paxil) Drug for over 3 years in my twenties and I’m lucky that I lived to tell the tale. The side effects from Seroxat are horrendous, and GSK suppressed them from public view for years. It took 4 BBC documentaries and much public outcry before GSK would admit to any problems at all with Seroxat. GSK still sell it, they still profit off it, even though it has harmed so many people.

GSK’s Avandia drug was also embroiled in controversy a few years ago with links to thousands of heart attacks, and their Pandemrix drug has been linked to Narcolepsy for quite some time. Their Myodil dye product has crippled, maimed and harmed patients for years too, with many still just coming out of the woodwork. In recent posts on this blog about Myodil, I regularly receive comments from people who were injected with the Dye decades ago, and they are still crippled from it. Many of these people will have no hope of justice for their pain and suffering, because GSK are often too powerful to tackle, particularly if one individual tries on their own. These are essentially forgotten victims of GSK’s fraudulent behavior.

From taking Seroxat, I know that GSK are capable of releasing extremely dangerous drugs and chemicals on to the market. I wouldn’t trust any of their drugs or products as safe or effective. However GSK have dozens of products on the market which are potentially harming people. One of the drugs listed in GSK whistle-blower Greg Thorpe’s 2012 Department of Justice complaint was GSK’s migraine drug- Imitrex.

The following article on Imitrex (from 1995) makes for disturbing reading:


Migraine Killer

Imitrex, a popular new drug for treating migraines, has been associated with hundreds of life-threatening problems and deaths. So why do the FDA and Glaxo, the drug’s manufacturer, both claim that it’s safe?

 

The Food and Drug Administration, sometimes criticized in past years for being too cozy with corporations, has lately come under attack for exactly the opposite failing. A powerful bloc of critics in industry and the Republican Congress is pushing to overhaul the FDA, claiming the agency is too tough on drug companies, unnecessarily inhibiting innovation and delaying the approval of new drugs and medical devices.

Leading the charge is Speaker of the House Newt Gingrich, who has labeled the FDA the “number one job-killer” in the country, and called its head, David Kessler, “a bully and a thug.” Gingrich’s Progress & Freedom Foundation has announced a radical plan to privatize much of the FDA’s oversight of drugs and medical devices. Not surprisingly, the foundation has financial backing from some of the biggest names in the pharmaceutical industry, including Bristol-Myers Squibb Co., Eli Lilly & Co., and Marion Merrell Dow. Glaxo, manufacturer of Imitrex (see main story), has also given an undisclosed amount to the foundation, in addition to contributions of approximately $325,000 to the Republican Party and Republican candidates (including $4,000 to Gingrich) in the last election alone. As a whole, the drug industry contributed more than $1.6 million to the Republican Party in the 1993-94 election cycle.

If enacted, the Progress & Freedom Foundation’s plan will place responsibility for drug development, testing, and review in the hands of private firms hired by the drug companies themselves, while retaining a weakened FDA to rubber-stamp their recommendations. Additionally, the plan limits the liability of drug companies that place dangerous drugs on the market. An interim report on the foundation’s study was released in June; the final version is due out later this fall.

Under the plan, government-licensed firms called DCBs –drug (or device) certifying bodies–would be retained by drug companies to develop, test, and review new products. According to the proposal, “competition between firms would inevitably produce a lower-cost, faster, and higher-quality development and approval process.”

FDA spokesperson Jim O’Hara offers an alternative view: “What this report proposes is dismantling many of the safeguards that protect the public from drugs and devices that are unsafe or just don’t work. This is basically a proposal that says public health and safety are commodities for the marketplace.”

Though drug testing and review would be privatized under the plan, the FDA would still exist and would theoretically have final say on new products. However, the report states there would be “a strong presumption that private certification decisions would not be overturned without substantial cause.” Further, the FDA would not be authorized to request additional testing or data, and it would “have to exercise its veto within a fixed time period (e.g., 90 days) after which the drug would automatically receive FDA approval.”

The Progress & Freedom Foundation plan also limits the liability of drug companies should a patient be injured or killed by a dangerous drug or medical device. According to the proposal, a victim could not sue for punitive damages if the manufacturer of the product could show that it had met regulatory standards–however weakened–during development and testing.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, says the plan to limit corporate liability is “hypocrisy at the very least.”

Even some in the drug industry believe the Progress & Freedom Foundation’s proposal goes too far. Steve Berchem of the Pharmaceutical Research and Manufacturers of America says that while some drug reviews can be handled by the private sector, it would be a mistake to weaken the FDA’s authority over product approvals. “We need an FDA that maintains public confidence,” Berchem says.

Nonetheless, the political writing on the wall is clear. Earlier this year, the FDA announced steps to reform itself, including the creation of a pilot program to allow private companies to review some medical devices. But this compromise isn’t going to satisfy the hard-liners. Progress & Freedom Foundation spokesperson Rick O’Donnell says the FDA proposals “don’t actually hit at the heart of the systemic problems that our plan is addressing.”

As the battle to reshape the FDA heats up in the coming months, the Progress & Freedom Foundation will coordinate its efforts with those of other heavily funded right-wing attacks. But look for Newt and Company to draw their proposals directly from the foundation’s plan.

Despite the medical risks posed by Imitrex injection, you are not required to take the medication in the presence of your doctor. Imitrex can be administered at home, at your workplace, or at any other location by using an “autoinjector,” a futuristic-looking plastic injector that contains a prefilled syringe of Imitrex and requires only the push of a button to release the medicine into the bloodstream.

The autoinjector looks so neat, in fact, that a picture of it was featured in the hip, new technology magazine Wired. “I thought it was a wild-looking device,” says David Jacobs, editor of Wired’s “Fetish” section, where the magazine promoted the product under the heading “Kill Migranes”–spelling error and all. Jacobs discovered Imitrex when a Wired employee who suffers from migraines brought her autoinjector to work. “You have to have an eye for things that just stand out,” Jacobs says. “I look for diamonds in the rough.”

Unfortunately for readers of Wired, the magazine editors didn’t look beyond Glaxo’s nifty packaging job. The autoinjector contains a six-milligram dose of Imitrex, which has been associated with heart attacks, strokes, and other health problems. Glaxo also recommends a second injection as soon as one hour after the first if the migraine symptoms come back. And although the company suggests that the first injection be given in a doctor’s office, that decision is left to the doctor’s discretion. –Andrea Buffa

On the morning of Feb. 4, 1994, Dianne Riley joked nervously with her husband and one of her four children about a dream she’d had the night before in which someone had died. This wasn’t a pleasant way to begin the day, because once before Riley had actually forecast a death in this manner.

To make matters worse, Riley had a miserable headache. For five days running, the 41-year-old assistant manager for a Ramada Inn in Kansas City, Mo., had felt the pain in her head build to the point where she would be overpowered by nausea.

Later that morning, Riley had an appointment with Dr. Samuel Ho, a specialist in internal medicine. He diagnosed migraine, a slowly developing headache with throbbing pain that is usually felt on only one side of the head. The condition is believed to affect between 15 and 25 million Americans, mostly women.

Ho recommended Riley try Imitrex, the brand name for sumatriptan succinate, a heavily marketed new drug for migraines. At 12:25 p.m., Riley was given a six-milligram injection of the drug. Within minutes, she began to sweat, vomit, and experience chest pains.

Technicians managed to hook her up to an electrocardiograph and quickly discovered that she had an abnormal heart rhythm. They called 911.

An emergency team reached Ho’s clinic at 12:56 p.m., and transported Riley to St. Luke’s Northland Hospital where she arrived with resuscitation efforts in progress. At 1:58 p.m., a doctor pronounced Riley dead. An autopsy performed the

next day indicates Riley’s cause of death was “a result of adverse effect of Imitrex.”

On April 15, two months after Dianne Riley’s death, her family filed a lawsuit in the Circuit Court of Jackson County, Mo., charging that Glaxo, the British-based manufacturer of Imitrex, had been aware that the drug could cause serious harm or even death. The lawsuit accuses the multinational and its Cerenex division in North Carolina of not adequately labeling Imitrex and not disclosing the drug’s true risks, “in order to collect substantially higher profits.” Glaxo will not comment on the lawsuit because it is under litigation. The case, still in the legal discovery phase, is expected to go to trial sometime in 1996.

Dr. Vincent Di Maio, one of the country’s leading forensic pathologists and editor of the American Journal of Forensic Medicine and Pathology, intends to testify on the Rileys’ behalf. He says he has examined all the microscopic slides of tissues and organs from the Riley autopsy and has no doubt that its conclusion was correct. Although Dianne Riley had some risk factors for heart disease (e.g., smoking, family history of heart disease), Di Maio says her heart and coronary arteries were healthy; the heart attack that killed her was precipitated by Imitrex.

“It is a very complete autopsy,” Di Maio says. “This is a simple case where a young woman took Imitrex, started to react to it badly, developed an irregular heartbeat, and died. The autopsy shows clearly that there was no evidence of hardening of her arteries, no evidence of infection, no evidence of an enlarged heart, no evidence of stroke, no evidence of meningitis or encephalitis, no evidence of a blood clot, no evidence of lung disease, no evidence of asthma or allergic reaction, no evidence whatsoever of disease. If there is no other cause of death, by deductive reasoning she died of a coronary vasospasm following the use of Imitrex.”

Imitrex, a top-line Glaxo drug, is used by more than two million people worldwide. The drug’s sales in fiscal year 1993-94 were $365 million. Both of those numbers are likely to increase when the tablet version of the drug becomes available on the U.S. prescription market this month.

To date, the Food and Drug Administration has received 3,526 voluntary reports of possible side effects, ranging from mild to severe, associated with the use of Imitrex. Included are reports of 83 deaths and at least 273 life-threatening complications.

Earlier this year, Glaxo became the world’s largest pharmaceutical company when it bought Wellcome, another British multinational. Glaxo and Wellcome sold a combined $11.6 billion worth of products last year, to fight everything from asthma and ulcers to heart disorders, infections, and migraines.

In the high-stakes pursuit of competitive advantage, drug giants like Glaxo must sometimes spend hundreds of millions of dollars to develop new drugs. To see returns on these investments, companies push hard to get the drugs through the regulatory approval process and promote them vigorously when they are first released. Glaxo’s push of Imitrex was no exception.

The history of Imitrex goes all the way back to 1972, when Glaxo launched a research program to develop a new migraine drug. The company’s goal was to find a chemical that could narrow swollen blood vessels in the head, thereby stopping the pain of migraine headaches. But it was also important that the drug not narrow or squeeze blood vessels in the heart, because this could cause spasm in those vessels and trigger a heart attack.

More than a decade passed before Glaxo scientists came up with Imitrex. The drug mimicked serotonin, a chemical produced naturally in the body. Serotonin contracts blood vessels by acting on their cells via the gateways or “receptors” known as 5HT. Glaxo researchers thought that Imitrex would affect only the type of 5HT receptor known as 5HT-1, which they believed was rarely found in heart vessels, and therefore the drug would not cause heart spasm.

Glaxo believed it had a blockbuster drug in the making, one with a potential market of hundreds of millions of dollars.

Looking back, however, some fundamental research data contradicted the presumption that 5HT-1 receptors were generally absent from heart vessels. In one small laboratory study, Glaxo researchers found that Imitrex caused small contractions in coronary artery samples from explanted human hearts, indicating the presence of 5HT-1 receptors in heart vessels. An independent study also supported this hypothesis by demonstrating that Imitrex could cause temporary narrowing in the coronary arteries of patients with or without signs of heart disease.

Glaxo, however, emphasized other research that supported Imitrex’s safety. Specifically, one Glaxo study showed that Imitrex did not affect the cardiovascular systems of dogs, indicating that 5HT-1 receptors were not present in the dogs’ heart vessels and suggesting that this might be true for human beings as well. The company also assured regulatory agencies that the drug was safe because its heart-monitoring tests during clinical trials showed that very few patients suffered heart disturbances.

Strong indications that these assurances were hollow first surfaced in Canada.

On Dec. 20, 1991, Dr. Michele Brill-Edwards, then the assistant director of the Bureau of Human Prescription Drugs at Health and Welfare Canada, wrote a memo to the bureau’s assistant director of operations, Peter Jeffs, expressing her suspicion that Glaxo was pressuring one of her reviewers to move faster on getting approval for Imitrex.

After Brill-Edwards reviewed the file herself, she believed that there were potential problems with Imitrex. She was particularly concerned that Glaxo had only thin documentation to show that Imitrex was not a danger to heart vessels.

Brill-Edwards also wondered about Imitrex’s recommended dosage of six milligrams. Glaxo studies had shown that a one-milligram dose was enough for some patients and three milligrams worked for up to 60 percent of patients. Only an additional 10 to 20 percent benefited from the six-milligram dose. Yet contrary to standard medical practice, which recommends tailoring dosage to a patient’s needs, Glaxo recommended six milligrams for everyone. (A Glaxo spokesperson told Mother Jones that the company chose the six-milligram dose as “the best balance between efficacy and safety.”)

For more than two weeks, Brill-Edwards (who is under orders not to discuss Imitrex with the media) raised concerns within her bureau about Imitrex’s safety, and questioned Glaxo’s efforts to expedite the drug’s approval. In a Jan. 7, 1992 memo, she described the situation to her boss, Dr. Claire Franklin, then the director of the Bureau of Human Prescription Drugs:

At 5:15 p.m. [Jan. 6], Ms. Gita Lingam, [then the] head of regulatory affairs for Glaxo, telephoned.a Threatening remarks were made courteously. Ms. Lingam noted that Mr. Randall Chase [then a senior vice president of Glaxo Canada] intends to take the matter “to a higher level” if there are further delays. Legal action was intimated.a

[T]he product monograph remains less than adequate in its characterization of safe usage of this valuable new product. My recommendation is that the clinical division should be required to remedy the deficiencies in the product monograph.–This action should be undertaken notwithstanding substantial pressure to the contrary from the manufacturer.

The deficiencies in the monograph were not remedied. On Jan. 16, 1992, nine days after Brill-Edwards wrote her memo, Glaxo announced that it would construct a $70 million manufacturing facility in Canada, promising more jobs and research spending.

Four days later, on Jan. 20, senior managers at Health and Welfare Canada approved Imitrex.

The next month, when Glaxo launched its promotional campaign for Imitrex in Canada, it claimed the drug “works only on the painfully swollen blood vessels in the head.” The labeling for Imitrex, however, recommended that people with serious heart problems shouldn’t be prescribed the drug, indicating that Glaxo was, in fact, aware of its potential effect on heart vessels.

But when reports began to file in at Health and Welfare about side effects following an injection of Imitrex, Glaxo officials took the public position that these reactions were rare and unexplainable. As of July 1992, Health and Welfare had received only 20 voluntary reports of adverse side effects associated with the use of Imitrex, including severe chest pain and breathing difficulties. But by November, an additional 70 reports had been filed, again including chest symptoms. That month, Health and Welfare and Glaxo quietly cooperated in rewording the product labeling. The new labeling advised doctors to take a careful medical history to avoid prescribing Imitrex to anyone with heart disease.

Meanwhile, in Britain (where Imitrex had been available since 1991), a new chapter in the drug’s story had begun. A case report was published in May of 1992 in the British Medical Journal concerning a 47-year-old man with no sign of heart disease who developed severe chest pain after injections of Imitrex. Further tests with the patient showed that within six minutes of receiving a shot, his heart vessels began constricting. A month after this case was reported, the U.K. Committee on Safety of Medicines, Britain’s drug regulatory group, reported that Imitrex could cause heart vessels to constrict.

Glaxo, however, continued to maintain that severe side effects were rare, and that those patients who suffered heart-related complications must have had some underlying heart problem.

In the United States, the FDA had the advantage of looking at several months’ worth of cases of side effects associated with Imitrex in Canada, Britain, and the Netherlands before deciding whether to approve the drug for the American market. Dr. Paul Leber, chief of the FDA’s Division of Neuropharmacological Drug Products, clearly struggled with the decision. In an August 1992 memo to Dr. Robert Temple, director of one of the FDA’s three Offices for Drug Evaluations, Leber questioned the value of Imitrex, writing that its benefit was difficult to determine because of the absence of comparisons with alternative treatments (such as painkillers, anti-inflammatory drugs, narcotics, and medications derived from a common fungus). “It is particularly difficult to get a clear view,” Leber wrote, “because the product has been promoted worldwide with considerable vigor. Indeed, one expert has privately communicated his belief that the utility and advantages of Imitrex have been considerably inflated.”

Four months later, with Imitrex on the verge of approval, Leber voiced deep concerns about the drug’s safety, particularly for patients who might have undiagnosed heart conditions. In another memo to Temple, dated Dec. 28, 1992, Leber wrote that if the drug is “widely used once marketed, a sizable number of patients with significant, but unrecognized, coronary vessel disease will be inadvertently exposed.a If this occurs, it is probable, if not certain, that some of these individuals will suffer serious harm, even death, following their use of Imitrex injection. In fact, postmarketing reports from countries in which Imitrex is available indicate that such events have already occurred.”

But despite this danger, Leber didn’t want to stop FDA approval of Imitrex. “What counts more?” he wrote. “The rights of millions of otherwise healthy migraineurs to have access to an effective and, for them, safe treatment, or the rights of those who may be inadvertently injured by its marketing?–If there are to be potent drugs like [Imitrex]–society must be willing to tolerate the injury they will cause to some proportion of those who use them.”

The FDA approved Imitrex for sale the next day.

As part of its Imitrex information package to the press, the FDA stated that “people with underlying heart disease should not take the drug because of its potential to cause constriction of coronary arteries.” As a precautionary measure, the agency also recommended that doctors consider giving the first injection in their office to patients who might have underlying coronary heart disease.

But the drug’s labeling included no recommendation to doctors to exclude patients whom they only suspected could be at risk for underlying heart disease. And there was no recommendation for how to treat patients who seemed to be suffering a negative reaction.

Imitrex’s reputation as a breakthrough migraine treatment was largely made in the initial burst of promotion upon its release. It wasn’t until August 1994a20 months after the drug’s approval–that the FDA and Glaxo cooperated in making the first significant labeling change for Imitrex. By this time, the number of reported deaths possibly related to Imitrex had grown to at least 33. A new section was added to the Imitrex label. Titled “Drug-Associated Fatalities,” it discloses that some of the reported deaths had occurred within a few hours of Imitrex’s use and that the drug’s “specific contribution–to most of these deaths cannot be determined.” The death of Dianne Riley is noted, though not by name, among them. (The notation, however, does not mention that Riley’s autopsy showed her to be free of heart disease. Instead, it lists her risk factors for heart disease–“positive family history, postmenopausal woman, and smoking”–implying that she might have had heart disease.) The FDA also asked Glaxo to send out what is known as a “Dear Doctor” letter, to inform physicians of the labeling change.

Three months later, there was a second major relabeling and another Dear Doctor letter. Glaxo now emphasized that Imitrex should only be used when a doctor had clearly established that a patient was suffering from migraine. The drug was not intended for any other kind of headache. The new labeling also recommended that Imitrex “not be given to patients in whom unrecognized coronary artery disease is likely without a prior evaluation for underlying cardiovascular disease.” These patients include postmenopausal women, males over 40, and those with risk factors for heart disease, such as high blood pressure, high blood cholesterol, obesity, diabetes, smoking, or strong family history of heart disease.

Of course, even a patient who does not fit these categories might have undiagnosed heart disease and thus could be at risk for serious Imitrex-related complications. According to Dr. Robert Vogel, head of the division of cardiology at the University of Maryland Hospital, the problem is compounded by the fact that there is no such thing as “insignificant” coronary disease. “So-called insignificant coronary disease can be lethal,” he says.

The most disturbing possibility is that Imitrex may also affect healthy hearts. Glaxo has consistently maintained that in cases like the one described in the British Medical Journal, some early coronary disease must have been present, even if it was never detected. But what does it mean to claim that someone had incipient (Continued on page 70) (Continued from page 31) heart disease if, as in Riley’s case, the patient was outwardly healthy and the disease could not be detected, even by an autopsy? And if the disease is undetectable, how can doctors rule out patients for Imitrex use?

Concerns that Imitrex might trigger heart attacks are not Glaxo’s only problem. Recent research suggests that coronary spasm, such as that apparently caused by Imitrex, can gradually damage heart vessels over the long term. There is also concern that the drug may induce strokes in some patients.

Speaking before an audience of doctors and at least one Glaxo representative in October 1994, Health and Welfare Canada’s Brill-Edwards discussed the potential long-term risks of Imitrex use. She pointed to animal research showing that if coronary arteries are regularly constricted, hemorrhaging in the endothelial tissues will occur and over time may promote clogging of the arteries, increasing the chance of a heart attack. “So, we could be dealing with a scenario where we are giving the drug thinking everything is fine and not realizing that, over years, the risk of atherosclerosis is increasing. We are not even looking for it or monitoring for it.”

To date, the FDA has also received reports of at least 31 strokes (damage to the brain due to interruption of the blood supply) and an additional 53 cases associated with stroke or with conditions that can lead up to stroke.

A lawsuit in Travis County, Texas, is currently in the discovery phase and scheduled for trial this October. On Sept. 1, 1993, shortly after injecting herself with Imitrex, Donna Sue Currie, a dental assistant, suffered a stroke that left her disabled. Her lawyer, Jay Winckler, says the discovery process has revealed other cases of Imitrex-associated stroke known to Glaxo, but he won’t say how many because the case is in litigation.

Dr. K.M.A. Welch, a migraine and stroke specialist affiliated with the Henry Ford Health Sciences Center in Detroit, Mich., confirms that strokes have been reported in association with Imitrex. Welch points out, however, that establishing a causal relationship is tricky, because anyone who suffers from a migraine already has a significantly greater risk of having a stroke. “It is often difficult,” he says, “to determine whether the drug or the migraine itself caused the stroke.” But he adds, “Because Imitrex is a vasoconstrictor, it may well play some role in tipping the balance.”

The FDA’s effort to balance Imitrex’s benefits and risks has two major flaws. First, there is insufficient data to show that Imitrex is more effective than other treatments. More importantly, the FDA, along with Glaxo, has failed to provide potential patients with enough information to make an informed choice about a drug that may pose serious health risks.

According to Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, a watchdog agency in Washington, D.C., “Imitrex is clearly a drug of last resort, to be used only when everything else fails.”

But that is neither the way Glaxo marketed Imitrex, nor the way the FDA and other regulatory agencies have recommended it. Had Dianne Riley known the risks, she might have decided against taking Imitrex. Had she first been prescribed another migraine treatment, it might have done the job. Had the labeling recommended that her doctor have nitroglycerin on hand in case of heart attack, Dianne Riley might still be alive.

Such a failure on the part of the FDA does not bode well at a time when the agency is under attack for being too tough on drug companies (see sidebar, page 28). If the anti-regulatory assaults of drug industry lobbyists and congressional Republicans result in further downgrading of the FDA’s ability to ensure drug safety, more patients like Dianne Riley may die.

Robert Temple, the FDA bureaucrat responsible for clearing Imitrex for the U.S. market, maintains that, thus far, the drug has been safe. He confirms, however, that there is “theoretical concern about Imitrex’s causing spasm of coronary arteries–[leading] to chest pain and, if prolonged, to a heart attack.”

Temple concedes that doctors might be advised to give nitroglycerin to patients who appear to be suffering heart-related reactions. But he says there was no real need to add this information to the label, because “we thought everyone would know that,” and it might cause “undue alarm.”

Moreover, Temple admits that doctors often cannot determine which patients will suffer heart-related complications, because it is not practical to give them advanced medical tests–and even these might not turn up incipient heart disease. Asked if this means that taking Imitrex is basically a crapshoot, he replies, “Realistically, there is not much you can do about it.”

Dr. Donna Gutterman, Glaxo’s director of medical affairs in the Central Nervous System Division, agrees: “It can be extremely difficult to work up a patient for heart disease.” But she claims that Glaxo cannot be expected to provide doctors with a series of instructions on how best to weed out patients potentially at risk, because the company believes “the physician is in the best position to evaluate the patient.”

Gutterman also confirms that although “it’s difficult to tease apart what might be happening” when a stroke occurs, Imitrex might in theory contribute. She points out that a stroke produces vasoconstriction and “the addition of Imitrex, which is a vasoconstrictor, can worsen the bleeding going on.”

Meanwhile, a universe away from the offices of regulatory agencies and multinationals, Dianne Riley’s husband Lionel remembers her as “a people’s person.” He says that after her death, “a part of me was just taken away.” Daughter Natousha Murray, 25, is furious at Glaxo for running TV commercials that show a woman her mother’s age walking in the park and feeling good because of the company’s new treatment for migraine. “My mother can’t walk in the park and play with her grandchildren,” she says. “It’s sickening to see this commercial.”

Nicholas Regush is an investigative reporter and television producer living in Montreal.

RIP Gavin Clark


http://judecalverttoulmin.blogspot.ie/2007/05/gavin-clark-singer-songwriter-guitarist.html

“Gavin Clark: I’m not sure how to answer this without sounding like a nut. I’ve had bouts of depression and panic attacks since my early 20s and had the usual addictions to booze and drugs that go hand in hand with mental illness. I can’t escape it and have almost learnt to accept it, it’s part of me. My songs are a reflection of the world as i see it, and the world as I see it is often dark but not hell. I’m filled with hope sometimes I think but mostly it’s dark with the odd shaft of light.”

I’ve just watched a documentary called ‘The Living Room‘ by director Shane Meadows about his friend, and collaborator, the recently deceased musician Gavin Clark. Shane Meadows is an English director whose groundbreaking film (and subsequent series), This Is England,  is one of the finest works of British film making of recent times, for those of you that haven’t seen it, check it out.

Gavin’s music features in much of Shane Meadows works, and some of it can be seen in the recent documentary by Meadows about Gavin’s struggle to perform live.

Gavin’s long struggle with depression and anxiety can be clearly seen half-way through the documentary when he attempts for the first time to play his music to an audience in his living room. As with all of Meadows work, this documentary is both poignant and moving. Anyone who has ever struggled with depression and anxiety would be able to identify with Gavin’s struggles and inner demons- themes which he also explored in his music.

Sadly, Gavin passed away at the age of 46 in February of this year. It is unknown whether Gavin took his own life or what the exact cause of death was, but it seems (considering Gavin’s long battle with anxiety and depression) that it may have been a suicide. It’s also unknown whether Gavin was treated by a psychiatrist at the time, or whether he was on SSRI’s or other psychiatric drugs…

RIP Gavin..

Footballer Ian Redford’s Suicide and Seroxat…


Interesting to note that when he was prescribed Seroxat after suffering a panic attack, he then began to lose his grip on reality. Seroxat is notorious for increasing agitation, akathisia and anxiety, which can then lead to suicide. Ian Redford was found dead in a woods near his home, and it seems Seroxat was involved. The articles don’t say how long he was on Seroxat for – or if he was withdrawing at his time of death, I guess we will have to wait for the results of the inquest to find out more… but at this stage it looks like yet another tragic SSRI (Seroxat-Paxil) induced Suicide…

http://www.independent.co.uk/sport/football/news-and-comment/ian-herbert-ian-redfords-recent-autobiography-revealed-in-sobering-detail-how-the-end-of-his-playing-career-let-his-demons-flourish-now-he-is-dead-9167442.html

The signs of Redford’s mental disintegration came when his playing career was petering out in a wretched second season at St Johnstone. He and his wife had taken their daughter, Natalie, to the cinema in Perth when the first of what he would later realise was a panic attack – “terrifying” – forced him to leave the auditorium.

“His description of that afternoon has overtures of Eadie’s testimony, and after being prescribed the antidepressant Seroxat, Redford felt he was losing all grip on reality.”

http://www.dailyrecord.co.uk/news/scottish-news/tributes-pour-former-rangers-dundee-3010109

Tributes pour in for former Rangers and Dundee United star Ian Redford who was found dead in woods near his home

RANGERS and Dundee United hero Ian Redford was found dead in woods yesterday, aged just 53.

Police said the tragedy was not being treated as suspicious.

Father-of-three Ian was discovered in Shewalton Woods in Irvine, Ayrshire, a few miles from his home in Saltcoats.

Former Ibrox team-mate Sandy Jardine led the tributes last night. He said: “Ian was a great athlete and a very good professional. But most of all, he was just a really nice lad.”

Ian is survived by wife Janine and children Ian jnr, Gavin and Natalie. The family were too upset to comment last night.

A family friend said: “This has come as a real shock. The first I heard about it was when it flashed up on the TV. We’re absolutely stunned.

“Things haven’t been easy for the family in the last wee while. They have moved about a bit.

“They are a close family. I just can’t imagine how the kids will be feeling.”

Classy midfielder Ian became the most expensive player ever sold by one Scottish club to another when Rangers bought him from Dundee for £210,000 in 1980.

He won three League Cups and one Scottish Cup at Ibrox before moving to Dundee United in 1985.

There, he played a major role in United’s famous run to the 1987 UEFA Cup final, starring in the quarter-final triumph over Barcelona before scoring the clinching goal in a 2-0 second leg semi-final victory over Borussia Mönchengladbach.

Legendary United goalie Hamish McAlpine said of his death: “It’s absolutely terrible news – one of those things you can’t believe when you hear it.

“Nobody really knows what Ian was going through. My thoughts go out to his family first and foremost.

“Ian was such a nice lad. He just came in every day and trained hard then went away to get on with his life.”

Another United hero, Eamonn Bannon, said: “Ian was a great guy and a fantastic asset for Dundee United. My thoughts and sympathies are with his wife and children.”

SNS GroupIn action for Dundee United against Barcelona in 1987 Uefa Cup quarter final
In action for Dundee United against Barcelona in 1987 Uefa Cup quarter final

Tommy McLean, who played with Ian at Rangers, said: “He was a really nice, quiet lad off the park, quite reserved.

“When my brother Jim asked about signing him for United, I had no hesitation in recommending him.”

Ian also played for Ipswich and St Johnstone and managed Brechin City before a final taste of glory as a player with Raith Rovers, where he helped win the League Cup in 1994.

Starks Park team-mate Gordon Dalziel said: “Ian was a terrific lad, brilliant with the young players.

“He always took time to help people and pass on his experience.

“You can sum people up by what other people say about them and I never heard a bad word said about Ian.”

Football was often an escape for Ian – from a childhood tragedy that haunted him throughout his life.

He grew up on a Perthshire farm with parents Douglas and Elizabeth, little brother Dougie and sister Jill.

But Dougie fell ill with leukaemia. And Ian, who was only seven at the time, never fully got over his death.

In his autobiography Raindrops Keep Falling On My Head, serialised in the Record, he wrote: “It was a total,
unforgettable nightmare.

“There was guilt, because when Douglas was alive I treated him like a normal brother. I would regularly say things like, ‘When will Dougie be better, mum?’”

The strain of caring for Dougie took its toll on his parents. Ian said his once-happy dad became withdrawn and reclusive, while his mother turned to alcohol to try to numb the pain.

SNS GroupPlaying for Rangers
Playing for Rangers

Ian got home from a school football match in December 1972 to be told Dougie had hours to live.

He recalled: “I bolted from the kitchen, threw myself on the bed and sobbed my heart out. My life felt like it had just imploded with the shock of it all.”

Even at the end of his career, Ian was struggling to come to terms with Dougie’s loss.

He spoke to a sports psychologist about it to try to deal with his feelings of guilt – and he and Jill visited Dougie’s grave in Kinclaven, Perthshire, every December.

Ian admitted that, at the start of his football career, he “lacked self-esteem as a person, rather than as a player”. He added: “The football gave me an escape. It gave me the buzz.”

He also confessed that he struggled with the pressure of being Rangers’ record signing.

He said: “My frustrations led to me feeling depressed and I was drinking to blot everything out – but it solved nothing.

“It was a vicious downward spiral. Looking back, I can see I was very depressed.”

Ian got to the top in football despite a childhood illness that left him deaf in one ear and led doctors to advise him to avoid contact sports.

After retiring, he briefly worked as an agent, then in golf tourism.

A gifted golfer, he spoke of his dream of joining the seniors tour aged 51. Ian jnr is a professional.

Police said: “At around 11.15am, police received a report of a man’s body being found in a wooded area near Long Drive in Irvine.

“Inquiries are continuing. A post-mortem examination will be carried out in due course to establish the exact cause of death.”

Man dies after incident at GSK Waterford pharmaceutical plant


http://www.thejournal.ie/man-dies-incident-1279704-Jan2014/

Man dies after incident at Waterford pharmaceutical plant

The man at first thought to be a worker was actually a member of the public.

2 hours ago 23,076 Views  9 Comments

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Image: Lewis Whyld/PA Wire

AN INVESTIGATION IS underway after a man died following an incident on the grounds of the GlaxoSmithKline plant in Dungarvan, Co. Waterford this afternoon.

The death was at first believed to be the result of a workplace accident at the pharmaceutical plant but it has since been confirmed that the man was a member of the public.

The incident happened about 3pm this afternoon with the man subsequently taken to Waterford Regional Hospital by ambulance where he was subsequently pronounced dead.

A spokesperson for GSK said that gardaí had attended the scene and that the Health and Safety Authority has been notified.

The incident is currently under investigation and the company has extended its sympathies to the family of the deceased.

Husband Shoots Wife : Expert Says SSRI’s contributed to “out of control behavior”…


Antidepressants may have contributed to a killer’s loss of control when he shot his wife, a court has heard.

Citalopram, Dr Herzheimer said, was a drug closely linked to the controversial medication Seroxat, which has been blamed for sudden changes in behaviour in some users.

http://www.bbc.co.uk/news/uk-england-devon-18771406

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