CELEXA: Youth in India Dies During Clinical Trial

Paragraph 10 reads: “Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram [Celexa] by the Sun Pharma Advanced Research Centre in Vadodara. ”

http://www.himalmag.com/Bodies-for-hire;-The-outsourcing-of-clinical-trials_nw3213.html

Bodies for hire; The outsourcing of clinical trials August 2009
By: Sandhya Srinivasan

Medical testing by Western countries is having a staggering impact on India, if only we were to care to pay attention. And the government’s own policies are encouraging this.

Karen Haydock
In November 2008, the Hindustan Times’ LiveMint broke the story of an infant in Bangalore having died after being administered a vaccine in a drugs trial. The Drugs Controller-General of India (DCGI), Dr Surinder Singh, halted the testing, reportedly the first time that the office of the DCGI had taken such action. The trial, for a new pneumonia vaccine, was being conducted by a Hyderabad-based contracted research organisation, GVK Biotech, for the US-based multinational Wyeth Pharmaceuticals. The infant had been recruited from St. John’s Medical College, a reputed private medical institution in Bangalore.

GVK’s spokesperson claimed that the vaccine had nothing to do with the death, as the child had received an approved and widely used vaccine – not the experimental product. However, the DCGI’s investigation revealed that the infant had a heart condition, and that the trial had been meant to be conducted only on healthy babies. According to C M Gulhati, editor of the Monthly Index of Medical Specialities, India and a Delhi-based expert on clinical-trial regulations, the investigation revealed a number of other irregularities as well: the informed-consent document had not been signed before the child was recruited; and the St John’s ethics committee had not been properly constituted, as it was not chaired by an external member to ensure independent functioning.

Yet the infant’s death was not an aberration. In December 2008, 25-year-old K Surender, of Hyderabad, died in a ‘bioequivalence’ trial of a blood-pressure drug, felodipine. Bioequivalence trials test generic versions of drugs to ensure that they are as effective as the original, and involve administering the drug and then monitoring the individual through blood tests and other investigations. These tests are conducted on healthy people who are paid for their participation. The Hyderabad trial also happened to be run by GVK Biotech, which subsequently issued a statement that Surender had simultaneously been part of many bioequivalence studies, with GVK as well as other contracted research organisations. This multiple trial participation could have accounted for his death, argued the company.

Such an explanation is unconvincing. If Surender had taken part in many trials, it would only have been for the money, which would amount to an inducement according to national and international ethical guidelines for research – an inducement that might have made him overlook the risks of the trials. And, in any case, why did the company let him take part in the felodipine trial when it was aware that he had taken part in many others? The answer to this question lies in the compulsions of the global pharmaceutical industry. The GVK trials are among the increasing number of international clinical trials that are taking place in India – and the concerns that they raise will come up increasingly frequently in the future. The reports of various government and private bodies put the potential of the clinical-trial industry into billions of dollars, though the method of calculating these numbers is not available. One market-research company, Frost and Sullivan, reportedly estimates a USD two billion turnover by 2010.

Marcin Bondarowicz
The growth of the outsourced clinical-trial industry in India followed changes in the law in January 2005 that encourage clinical research in India. The most important of these was an amendment to the Drugs and Cosmetics Rules, permitting clinical trials in India to be carried out at the same time that they are done in other countries, rather than waiting until the results of drug trials in other countries were made public. Previously, this ‘phase lag’ had ensured that India was of no interest to big pharmaceutical companies to test their drugs. At that time, Phase II trials were permitted in India only after the results of a Phase III trial abroad were declared. And Phase I trials of foreign drugs were simply not permitted. (Phase I or safety trials are done on healthy ‘volunteers’, Phase II trials look at the drug’s safety and effectiveness on patients, and Phase III trials also look at safety and effectiveness, but in large numbers of patients.) It should be noted, though, that an exception was made for drugs deemed of importance to India. While the Drugs and Cosmetics Rules do not specify, such drugs would probably include the HIV vaccine.

This changed in January 2005, and India is now prominently on the radar screen of the international pharmaceutical industry in terms of clinical trials, given its vast population of potential trial subjects. As of today, the bulk of clinical trials are still located in rich countries. To illustrate, as of 19 July 2009, the US government clinical-trial database lists a total of 76,018 trials, of which 44,758 have sites in North America and 17,878 have sites in Europe – accounting for the bulk of trials. In contrast, only 1021 clinical trials have sites in India, in addition to 122 in Pakistan, 61 in Bangladesh and 12 each in Nepal and Sri Lanka.

However, the number of trials in India is growing fast. Figures given by the DCGI’s office show that the number of newly approved trials every year went from 100 in 2005, when the new rules kicked in, to about 500 in 2008. What is of concern here is that many of the trials that come to countries such as India are likely to be those rejected as unethical in Western countries. As trials shift to countries such as India, there has been an international debate on ethical concerns of the outsourcing boom. This debate has been partly responsible for amendments in the World Medical Association’s Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects” in 1996, 2000 and in October 2008. Drug regulators in Europe and the US require that clinical trials submitted to them adhere to the Declaration.

Some of these changes have dealt with placebos or ‘sugar pills’. The October 2008 revision took a strong stance against the use of a placebo in a trial when a treatment exists. Clinical trials compare the effect of an experimental drug to an existing drug. If there is no drug for the condition, the experimental drug may be compared to a placebo. Using a placebo when a treatment exists deprives the trial participant of effective treatment. The ethical guidelines of the Indian Council of Medical Research and the World Medical Association’s Declaration of Helsinki both forbid the use of a placebo when an effective treatment exists, with certain specific exceptions. While both of these documents have been a bit ambiguous in the past, the 2008 revision of the Helsinki Declaration is clear: placebos can be used only when absolutely methodologically necessary, and when the risk to the participant is low. This revision was reportedly preceded by behind-the-scenes lobbying by the drug industry to permit greater use of placebo controls.

In the same month that the revised Declaration was announced, the US Food and Drug Administration (FDA) amended its own requirements for clinical trials. While placebos are rarely necessary, regulatory bodies such as the FDA require placebo-controlled trials to give marketing approval to new drugs. Yet as of October 2008, trials conducted for FDA approval no longer had to adhere to the Declaration of Helsinki – an internationally accepted document, but not binding unless incorporated into national regulations. The FDA would continue to require placebo controls, and no one was going to tell them otherwise.

Concerns about the ethics of clinical trials do not exist merely in the realm of speculation. The GVK exposés are not unusual. An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable. It is reported that Surender, who died in the Hyderabad felodipine trial, was one of a number of Dalit students being recruited for clinical trials in that city. Likewise, some years ago, a 22-year-old Adivasi youth died in a bioequivalence trial of the antidepressant citalopram by the Sun Pharma Advanced Research Centre in Vadodara.

Certain types of trials are more likely to be conducted in India and other countries where regulatory and monitoring mechanisms are weak, or regulators are too willing to please drug companies. The use of placebos is a good example, as it is not difficult to conduct placebo trials in India. In 2005-06, Indian patients with schizophrenia were taken off their regular medication and given either a new, ‘extended-release’ formulation of an approved drug (quetiapine, marketed by AstraZeneca) or a placebo, to compare the time it took for people in each group to have a relapse attack of schizophrenia. The trial was conducted by a Contract Research Organisation (CRO) called Quintiles, in India as well as a number of countries in Eastern Europe. One patient (not in India) who was on the placebo committed suicide. Experts are unanimous in their view that a placebo was methodologically unnecessary in that trial, as the new formulation could have been compared to the existing ‘immediate-release’ drug. But the European regulators required a placebo-controlled trial, noted Irene Schipper and Francis Weyzig of the Dutch research organisation Centre for Research on Multinational Corporations, in a 2008 report. They also argued that placebo-controlled trials for severe conditions, which put the participants at greater risk, are more likely to be conducted in developing countries.

Trials in government hospitals in India can also be of special concern. In one trial, 290 people who had been hospitalised because they were having a severe attack of acute mania were given either a drug (risperidone, marketed by Johnson & Johnson) or a placebo. The idea, of course, was to examine how many people recovered with the drug, and how many with the placebo. This subjected seriously ill people to harm. The majority of patients in this India-only trial, also conducted by Quintiles, were recruited from government hospitals where, according to the principal investigator of the trial, the most seriously ill patients could be found. It is also where patients can be recruited easily, because trial participation ensures a hospital bed and free, quality treatment.

Another concern about trials in government hospitals is that they are conducted on poor people who may have no access to the drugs tested on them after the trial is over. In August 2008, the media reported that 49 children died in 42 clinical trials that were conducted over two and a half years in the Department of Paediatrics at the All India Institute of Medical Sciences (AIIMS) in Delhi. An investigation ordered by the National Human Rights Commission concluded that the trials were conducted properly: the children in the trials were seriously ill, and all the deaths occurred because of the serious illnesses, not the treatments. However, the committee’s report left many questions unanswered. What, for instance, was the purpose of these trials? Would they help other poor children in India?

One of these trials tested the blood-pressure drug valsartan, supplied by its manufacturer Novartis. Paediatric hypertension is indeed a serious condition, but companies conduct paediatric trials for various reasons, including to get information for the benefit of doctors who prescribe the drug to children. Another reason is because the US FDA extends a drug’s exclusive marketing rights when it is tested on children; this provision is meant to encourage research on children who are otherwise prescribed drugs based on the results of research on adults. However, companies also use this clause to maximise their profits. Another trial was linked to gene-activated human glucocerebrosidase, a treatment for Gaucher’s disease, a serious genetic condition in which a fatty substance (lipid) gets deposited in cells and specific organs. The drug for this trial was provided by the US-based Shire Human Genetic Therapies. Will the drug be made available in India once it is proved effective? Both the Helsinki Declaration and the ICMR’s guidelines emphasise that a community on which a drug is tested should have access to the drugs, if proven effective, once the trial is over. Unfortunately, this is rarely the case. Although all of the new drugs being tested in India will indeed be available in India, this will be at prices unaffordable to the very people who agree to have them tested on their bodies.

More generally, but of no less concern, AIIMS has stated that the trials did not “target” children from poor backgrounds. But there is no need to target poor people at AIIMS – they constitute the majority of patients at this government referral hospital. The simple fact is that the vast majority of people seeking care at the AIIMS centre would be there because they cannot afford treatment elsewhere.

Body market
The pharmaceutical industry depends on constantly getting new drugs into the market. New drugs include new uses for old drugs (a cancer drug that can also be used for infertility?) or ‘improved’ or ‘me-too’ versions of older drugs (all those antacids, blood-pressure and cholesterol-lowering drugs, anti-depressants or antibiotics). These drugs must be tested on human beings before they can go into the market. Permission has to be obtained, patients have to be recruited, trials carried out and the results filed – all at top speed, because time is money.

This is where the Contract Research Organisation – the CRO, such as GVK Biotech referred to earlier – steps in. The CRO undertakes all aspects of the process involved in getting regulatory clearance: getting the necessary permissions, tying up with doctors and hospitals to recruit patients on whom the drugs are to be tested, analysing the data that emerges from the trials, monitoring the trial to make sure that the information collected meets standards, putting together reports and even ghostwriting articles for publication in medical journals. Of course, the most important aspects of all this is the recruitment of patients. The best place to recruit patients for, say, a diabetes-drug trial, is a country with a large diabetic population. And diabetics who have not received treatment make better trial subjects, as the results of drugs tested on them will not be ‘contaminated’ with the results of drugs that they have already used.

Clinical trials in developing countries depend not only on physical infrastructure – hospitals and laboratories – and trained human power. They also depend on drug companies getting access to bodies on which they can test their drugs. So, CROs in India market Indian bodies. In a 2006 advertisement on their website (which has since been removed), a CRO named Igate advertised the ‘India advantage’ as “40 million asthmatics, about 34 million diabetics, 8-10 million people HIV positive, 8 million epileptic patients, 3 million cancer patients.”

CROs in India all claim to have ‘access’ to patients with various health problems for which drugs can be tested. For instance, a research group called Veeda claims to have “access to vast patient populations and has specific expertise in recruiting patients with cardiovascular disease, oncology, diabetes, renal disease”. The CRO Quintiles India once boasted that, for a paediatric-flu-vaccine trial, it recruited 201 one- to three-year-olds from three sites in India in just six days. What kind of network does Quintiles have, and what kind of influence does it have with the medical profession, that it can round up 200 children and convince their parents to let them get an experimental flu shot – all in just six days flat?

It seems that at least some of this is able to take place through wilful misinformation. Spectrum Clinical Research specialises in recruiting patients, collecting patients through networks of private clinics, hospitals, specialists and family physicians. It also runs ‘awareness campaigns’ – for instance, a “white ribbon initiative” on osteoporosis, co-organised with the women’s magazine Femina of the Times of India stable, collected data on 2000 patients with osteoporosis. Another campaign, this time to “defeat diabetes”, collected data on 1000 patients with diabetes. In these ways, people who think they are joining patient-support groups are actually being tracked so they can potentially be put on a trial.

Behind a veil
Other than the boasts of CROs, there is little information available on the hundreds of clinical trials being conducted in India. This is despite the evidence that many of these trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; that trial subjects could be put at risk; that subjects often have not given their informed consent to participate; that they might be provided care that is of lower quality than if they had been recruited for a trial in the West; that injuries during a trial might not be investigated thoroughly, and that those injured may not receive treatment of the highest standard, or even compensation; and that drugs that are tested are often too expensive for people who need them in India.

The only institution to have direct power over the conduct of a trial is the ethics committee (EC). Research institutions appoint their own institutional ethics committee to conduct an ethics review of all research proposals from within the institution. Independent or freelance ethics committees undertake ethics review for a fee, from anyone who applies – usually the CRO or drug company who coordinates the trial at a number of small nursing homes or private clinics, which don’t have their own ethics committee. The EC is a collection of specialists from various fields who review trial documents, including the trial design, the manner in which subjects are recruited, the patient information sheet and the informed-consent form, and approve or reject the application. These committees also have the authority to investigate a trial, and even to stop it if they feel that something is not right.

Ethicist Amar Jesani points out that ethics committees have a lot of power, as the DCGI requires that all trials be passed by such an appointed group. In fact, the DCGI only requires approval by an ethics committee, since it does not monitor the actual conduct of the trial – it does not check that informed consent is taken, that the investigators do their job correctly, that subjects are not harmed, and so on. Thus, says Jesani, it is the ethics committee, not the DCGI, that is the real regulator of clinical trials.

Yet the effectiveness of an ethics committee depends entirely on the setting in which it functions. Important factors, for instance, include the institution that funds the committee’s work or that determines its level of independence, the training of its members, and their competence in terms of doing a proper ethics review. Likewise ‘independent’ or freelance ethics committees are more accountable to the companies that pay for their services. Even the patient information sheet and informed-consent document are treated as confidential documents by the ethics committee – and, of course, the trial’s sponsor. These contain the information on the purpose of the trial, its risks and benefits, and an assurance that a patient’s treatment will not be jeopardised by refusal to participate, or withdrawal from a trial. There is nothing here of proprietary value – on the contrary, everything in these documents is of public interest, and they should be available to the public. Ethics committees are also often poorly educated in their responsibilities.

The reports of people dying in trials are likely to be merely the tip of the proverbial iceberg. And many more are likely to suffer an injury related to the trial drug, injuries that require treatment and that could result in temporary or permanent disability. Indian guidelines require that trial participants be compensated for injuries suffered during research. However, a study by Urmila Thatte and others in a 2009 issue of the UK-based Journal of Medical Ethics found that many trial investigators as well as ethics committee members are not even aware of this requirement. The guidelines of trial sponsors – such as drug companies – provide for medical treatment of any participant who suffers a trial-related injury, or reimbursement of their medical costs. However, Thatte and her colleagues found that none of the companies sponsoring trials, or ethics committees reviewing their trials, had a policy of compensation for trial-related disability or death. Yet for ethics committees to be a law unto themselves is hardly surprising, given the overall environment of lax regulation and monitoring.

Now, the FDA’s decision to do away with the Declaration of Helsinki will create a dilemma for the DCGI. If CROs in India are to follow the FDA requirements – such as using a placebo even when it is not absolutely necessary, and when it might put subjects at risk – they will be violating Indian regulations, which require that the Declaration of Helsinki be followed. The latest revision of the Declaration is quite clear that the placebo may be used in very few circumstances. At the moment, however, the DCGI’s record – permitting a number of unethical trials – suggests that his office places greater value on the potential financial returns of clinical trial outsourcing than on protecting the people who take part in drug trials in India.

Sandhya Srinivasan is a Bombay-based journalist specialising in public health and development issues. She is executive editor of the Indian Journal of Medical Ethics.

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DEPRESSION MED: Suicide Attempt: Story on The Gap: Australia

Paragraph 11 reads: “Years later, Mr Ritchie encouraged a ‘‘nervous and confused’’ woman, sitting on a ledge, shoes by her side, to follow him home. Over tea and toast, she revealed she was unhappy with medication she had been prescribed for depression. Mr Ritchie’s wife suggested she seek a second opinion. ‘‘A couple of months later she came up the path with a bottle of French champagne. We later got a Christmas card from her, and a postcard. It said ‘I’ll never forget your important intervention in my life. I am well’.’’

http://www.smh.com.au/national/an-angel-walking-among-us-at-the-gap-20090731-e4f2.html

An angel walking among us at The Gap

’’People will always come here. I don’t think it will ever stop’’ … Don Ritchie. Photo: Marco del Grande

Kate Benson Medical Reporter
August 1, 2009

HE IS the watchman of The Gap. A former life insurance salesman who in 45 years has officially rescued about 160 people intent on jumping from the cliffs at Watsons Bay, mostly from Gap Park, opposite his home high on Old South Head Road. Unofficially, that figure is closer to 400.

Some, at his urging, quietly gathered their shoes and wallets, neatly laid out on the rocks, and followed him home for breakfast. Others, tragically, struggled as he grabbed at their clothes before they slipped over the edge.

Still others later sent tokens of thanks, a magnum of champagne or an anonymous drawing slipped into his letter box, labelling him ‘‘an angel walking among us’’.

Don Ritchie, 82, spends much of his time reading newspapers, books and scanning the glistening expanse of ocean laid out before him. His days of climbing fences are gone and he admits some relief that most visitors now carry mobile phones and are quick to contact the police if they see a lone figure standing too close to the edge, too deep in contemplation.

For its part, Woollahra Council has been campaigning for $2.5 million to install higher fences, motion-sensitive lights, emergency phones and closed-circuit television cameras, but Mr Ritchie is ambivalent.

‘‘People will always come here. I don’t think it will ever stop,’’ he says, with a shrug.

Some deaths have been recorded in his diary, others are eternally etched in his mind.

One summer evening he spotted a young man perched on a thin ledge, beyond the fence.

‘‘I went over and I tried to talk to him, asking him questions about where he was from. He wouldn’t talk much, just kept looking straight ahead. I was talking to him for about half an hour … thinking I was making headway. I said ‘why don’t you come over for a cup of tea, or a

beer, if you’d like one?’ He said ‘no’ and stepped straight off the side … his hat blew up and I caught it in my hand.’’ Later, Mr Ritchie discovered the 19-year-old had grown up next door, playing with his grandchildren.

Years later, Mr Ritchie encouraged a ‘‘nervous and confused’’ woman, sitting on a ledge, shoes by her side, to follow him home. Over tea and toast, she revealed she was unhappy with medication she had been prescribed for depression. Mr Ritchie’s wife suggested she seek a second opinion. ‘‘A couple of months later she came up the path with a bottle of French champagne. We later got a Christmas card from her, and a postcard. It said ‘I’ll never forget your important intervention in my life. I am well’.’’

Despite his bravery and compassion, Mr Ritchie has steered clear of the limelight. He was awarded a Medal of the Order of Australia in 2006 for his services to suicide prevention but is all too aware that any publicity attracts more depressed and disturbed people.

In the weeks after the Channel 10 newsreader Charmaine Dragun jumped to her death outside his house in November 2007, Mr Ritchie’s wife is adamant six more followed.

‘‘But what do you do? Not talk about it?’’ he asks. ‘‘It’s the truth. It’s what goes on here.’’

It has long been a haunting dichotomy for rescuers, families and media. To speak out in a bid to have the area made safer, risking more people becoming aware of it, or to keep quiet, letting the deaths go on.

But for an anti-suicide campaigner, Dianne Gaddin, whose daughter Tracy jumped from The Gap in 2005, the answer is easy. If the issue is not aired, the problem will never be solved.

She has written four letters in the past month to the Prime Minister, Kevin Rudd, urging him to act. While her pleas go unanswered, her desperation balloons. She knows Mr Ritchie will not be standing guard forever.

‘‘Sometimes just a smile and a greeting is all it takes to change the mind of the would-be suicider. I don’t believe people want to die, but living is just too hard. To me, Don is a guardian angel.’’

Lifeline: 131 114; Salvo Crisis Line 93312000; Beyond Blue 1300224 636.

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ANTIDEPRESSANT & ALCOHOL: In Pink Pajamas Woman Slashes Neighbor’s Tires: UK

Third paragraph from the end reads: “Stephen Constantine, defending, said: ‘Ms Fergus suffers from depression and this offending was a result of combining drink with her prescribed medication’.”

http://www.sunderlandecho.com/news/Easington-tyreslasher-wore-pink-pyjamas.5509772.jp

Easington tyre-slasher wore pink pyjamas
Published Date:
30 July 2009
By Rob Freeth

A drunken woman dressed herself in pink pyjamas before going out at the dead of night to slash car tyres.

Joanne Fergus did not know the owners of the vehicles she damaged, Durham Crown Court heard.

Fergus, 25, of Glenhurst Road, Easington Village, admitted three charges of criminal damage on January 23 this year.

She has no previous convictions, but has police caustions for a public order offence and possessing a small quantity of amphetamine, and she received a penalty notice for being drunk and disorderly.

Judge Esmond Faulks sentenced Fergus to a nine-month supervision order, and ordered her to pay £282 compensation.

“You slashed the tyres of cars belonging to neighbours who had done nothing to you,” the judge told Fergus.

“It was a disgraceful thing to do and I hope you are ashamed of yourself.”

“A neighbour in Easington saw a figure crouched down beside a Jaguar car,” said David Wilkinson, prosecuting.

“He then saw a flash of metal, which was later confirmed to be a kitchen knife.

“The neighbour was able to tell police the person with the knife was a woman dressed in pink pyjamas.

“Officers cruised around the immediate area and the only house with a downstairs light on belonged to Fergus.

“She was wearing the pink pyjamas when she answered the door.”

The court heard Fergus admitted she had been out slashing tyres, but could not say why she had done it.

“She had been drinking and was upset due to an argument with her boyfriend,” added Mr Wilkinson.

“One tyre on the Jaguar was found to be slashed, as well as two tyres on a Peugeot, and another two tyres on a Vauxhall Astra.”

Stephen Constantine, defending, said: “Ms Fergus suffers from depression and this offending was a result of combining drink with her prescribed medication.

“The incident was also borne out of a domestic argument with her boyfriend at the time.

“She can pay compensation, although her income from benefits is £120 a week, from which she has to look after herself and her young daughter.”

* Last Updated: 30 July 2009 12:44 PM
* Source: n/a
* Location: Sunderland

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ANTIDEPESSANTS: Death: 21 Year Old: Florida

Paragraph 20 reads: “Mr. Mott was discharged July 14. He went home with three prescriptions to treat depression, his family said ­ and a companion.”

Paragraphs 27 through 29 read: “In the wake of his death, his family searches for answers. Kathy Mott said she does not believe her son relapsed. She wonders if the antidepressants played a role in his death.”

“Now she wants others to be careful.”

“‘Just because it’s prescription drugs, doesn’t mean you can’t OD,’ she said.”

http://www.tampabay.com/news/obituaries/article1023489.ece

Track star Matthew Mott had started rehab
By Andrew Meacham, Times Staff Writer
In Print: Friday, July 31, 2009
[LARA CERRI | Times]

ST. PETERSBURG ­ At a gathering held in his honor Wednesday at Northeast High School, Matthew Mott’s family and peers recalled the good times.

A former teammate showed off a large pink stuffed bunny rabbit, the unofficial mascot of the Northeast High track team, led by Mr. Mott and his twin brother, Jonathan. Others reminisced about late-night scavenger hunts and mud-wrestling in Mr. Mott’s back yard.

But it wasn’t good times that brought more than 140 people to Northeast’s cafeteria Wednesday ­ it was an unexpected death. Mr. Mott died of unknown causes early July 23, nine days after leaving an addiction treatment center. He was 22.

Mr. Mott literally ran through most of his life, competing with and against his brother. The brothers anchored a previously unremarkable Northeast track team, each earning second-team all-county honors in 2005. The next year, they helped take Northeast to its first state finals in more than two decades.

They trained together, worked out together. Jonathan won many races just a second or so ahead of Matthew, though sometimes it was the other way around.

“I don’t think they were competing against anybody else,” said Patty Parker, the boys’ aunt. “The competition was between those two.”

The boys took separate paths after their graduation in 2006. Jonathan Mott got a full track scholarship to Webber International University, where he remains.

Matthew Mott did not get the same offer. He enrolled in the Orlando Culinary Academy.

In the fall of 2006, after less than two weeks at the school, he called his aunt.

“He called in a panic,” said Parker, 40. He didn’t like it there, she said. Parker and her husband drove Mr. Mott back to St. Petersburg.

It is around this same time that friends began noticing changes in Mr. Mott’s behavior. Suddenly, the happy-go-lucky man with bleached blond locks had grown quieter, more reserved.

“He was the most upbeat, happy person,” said Ian Upson, 21. “He was always saying, ‘Let’s do this’ or ‘Let’s do that.’ Afterward, he just wanted to sit back and do nothing.”

Some of his friends and family members knew that Mr. Mott was taking the painkiller OxyContin. But they, like everyone else, were powerless to stop him.

“If you were around him, you knew,” said older brother Sam Mott.

Mr. Mott got a series of cooking jobs at places like the Don CeSar, the TradeWinds, Bascom’s Chop House and Derby Lane, his family said.

“He lost all of those jobs due to his addiction,” said his mother, Kathy Mott, 53.

With less money to buy OxyContin illegally, Mr. Mott resorted to Coricidin Cough and Cold medicine ­ or “Triple C” ­ an over-the-counter antihistamine that can be used as an intoxicant.

In June, Mr. Mott told his family he had had enough. His mother entered him in Fairwinds Treatment Center in Clearwater.

During a family visit to the facility, Mr. Mott seemed to have improved. He had gained weight. He was his old, animated self.

Mr. Mott was discharged July 14. He went home with three prescriptions to treat depression, his family said  and a companion.

Mr. Mott had met Genny Perry in treatment, and the two had formed an attraction. Perry and Mr. Mott lived with Kathy Mott. The two went to 12-step meetings together and separately.

Mr. Mott had gone to an AA meeting the night of July 22, then talked to his AA sponsor, his mother said. They stayed close to home the rest of the evening, Perry said, and fell asleep together at 3:30 a.m.

She awoke at 4 a.m. sensing something was wrong.

“He felt sweaty,” said Perry, 32.

Mr. Mott was snoring ­something he did not normally do, his mother said. Foam bubbled around his lips, his mother and Perry said.

Paramedics were unable to revive him, and he died at 4:40 a.m.

In the wake of his death, his family searches for answers. Kathy Mott said she does not believe her son relapsed. She wonders if the antidepressants played a role in his death.

Now she wants others to be careful.

“Just because it’s prescription drugs, doesn’t mean you can’t OD,” she said.

Learning the cause of death could take months, as the Pinellas County medical examiner awaits toxicology results.

At his celebration service Wednesday, family and friends spoke of Mr. Mott’s zest for life. A friend strummed a ukulele and sang a song. A priest extolled the value of Mr. Mott’s life and called it complete.

The audience listened in respectful silence.

Andrew Meacham can be reached at (727) 892-2248 or ameacham@sptimes.com.

.Biography

Matthew

David Mott

Born: Feb. 20, 1987.

Died: July 23, 2009.

Survivors: brothers, Jonathan and Sam; parents, Kathy and Sam; aunts, Patty Parker and Barbara DuFault; extended family.

[Last modified: Jul 30, 2009 10:29 PM]

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PROZAC: Man Hallucinates for Two Weeks: U.S.A.

Paragraphs 2 and 3 read: “I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

http://www.clusterflock.org/2009/08/dear-clusterflock-have-you-ever-hallucinated.html

August 1, 2009

Dear Clusterflock: Have you ever hallucinated?

I had a bout of hallucinations about 10 years ago. I was suffering quite badly with depression and had been on anti-depressants for years. Then came along Prozac®. The doc thought they would be good so off I went!

The three stages of my hallucinations always happened at night and in bed. I had always been asleep for a while and was awakened by the goings on. They happened in quite quick succession, perhaps over the space of two weeks, then stopped.

1. I woke violently as a tiger jumped from sitting above the bedroom door, onto my pillow and then jumped up onto a shelf (which didn’t exist in reality) above the bed. I woke my wife, quite calmly pointed out said tiger, but was told to return to sleep as there wasn’t one. He only appeared once.

2. I woke to see a man standing in the doorway of the bedroom — that would have been about 4 feet from me. He didn’t scare me. I came around slowly to see him standing there. I don’t remember colour — I do remember him being an Abe Lincoln type ­ stovepipe hat, and a beard. He wasn’t moving. I woke my wife and asked her quite calmly if she could see the man stood in the corner ­ she could not. I lay there for a while looking at him, closing my eyes and opening them. He stayed for a while and then left.

He returned for quite a few nights. He was always in the same place, always in monochrome and he never spoke. Unfortunately, I never spoke to him.

3. I woke one night. I was lying on my back, and as I looked up at the ceiling it was alive with a sea of frogs ­ all moving as one. I again woke my wife ­ just for the reality check. They stayed until I closed my eyes, say 20 minutes, then disappeared.

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ANTIDEPRESSANT: Man Threatens to Shoot Self: In Stand-Off with Police: …

Paragraph three reads: “She said he is taking medication to combat depression and that he had been drinking. The unnamed man allegedly told his wife he would resist if police responded, according to a news release.”

SSRI Stories Note: The Physicians Desk Reference states that antidepressants can cause a craving for alcohol and alcohol abuse. Also, the liver cannot metabolize the antidepressant and the alcohol simultaneously, thus leading to higher levels of both alcohol and the antidepressant in the human body.

http://www.lehighvalleylive.com/hunterdon-county/express-times/index.ssf/2009/08/armed_raritan_township_man_thr.html

Armed Raritan Township man threatens to shoot himself, engages in hour-long standoff with police

by Express-Times staff
Monday August 03, 2009, 6:55 AM
Officials in Raritan Township spent more than an hour Sunday urging an apparently suicidal man to put down his weapons and surrender peacefully.

Raritan Township police were called to a single-family home in the township about 3:30 p.m. after a woman reported her husband had locked himself in the bedroom and was threatening to shoot himself. The woman told police her husband had several guns in the house and that at least two — a pistol and a rifle — were in the bedroom with him.

She said he is taking medication to combat depression and that he had been drinking. The unnamed man allegedly told his wife he would resist if police responded, according to a news release.

Police set up a safe perimeter around the house, evacuated neighboring homes and blocked off the road. Officers called the man, with the assistance of his brother. After an hour on the phone with him, he agreed to surrender. Police recovered two handguns and a rifle from the home.

The man was taken to Hunterdon County Medical Center for an evaluation. Charges against him are pending.

The Hunterdon County Prosecutor’s Office, Flemington-Raritan First Aid and Rescue Squad and Raritan Township Department of Public Works assisted township police.

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DEPRESSION MED: Violence: Man Beats Up Frail Neighbor: England

Fourth paragraph from the end reads: “Rod Hunt, in mitigation, said his client had been mixing alcohol with anti-depressant tablets, which had made him turn violent.”

Paragraphs four & five read: “In a letter to the court, Mr Hodgson described Summersgill as a decent man and said the brutal assault was out-of-character.”

“The pair were friends at the time, and Summersgill and his partner, Heather Barnett, acted as carers for their neighbour.”

Paragraphs seven & eight read: “Paul Newcombe, prosecuting, said that without warning, Summersgill turned to his housebound friend and said he would kill him.”

“He then grabbed him by the throat and squeezed tightly as he pushed him onto a bed in his front room.”

SSRI Stories Note: The Physicians Desk Reference states that antidepressants can cause a craving for alcohol and alcohol abuse. Also, the liver cannot metabolize the antidepressant and the alcohol simultaneously, thus leading to higher levels of both alcohol and the antidepressant in the human body.

http://www.thenorthernecho.co.uk/news/4515923.Man_jailed_for_threats_to_kill_frail_neighbour/

Man jailed for threats to kill frail neighbour
1:06pm Tuesday 28th July 2009

By Neil Hunter »

A DRUNK who throttled a wheelchair- bound neighbour after threatening to kill him was yesterday jailed for four years.

Paul Summersgill left the frail pensioner on the floor of his home and stole his mobile phone and spectacles before fleeing.

Teesside Crown Court heard that Bernard Hodgson, 65, blacked out during the attack, which left him covered in wounds and bruises.

In a letter to the court, Mr Hodgson described Summersgill as a decent man and said the brutal assault was out-of-character.

The pair were friends at the time, and Summersgill and his partner, Heather Barnett, acted as carers for their neighbour.

On the day of the attack, April 9, Summersgill had been at Mr Hodgson’s home watching television and drinking his beer.

Paul Newcombe, prosecuting, said that without warning, Summersgill turned to his housebound friend and said he would kill him.

He then grabbed him by the throat and squeezed tightly as he pushed him onto a bed in his front room.

On the brink of consciousness, Mr Hodgson then had his face pushed into a pillow.

Summersgill then loosened his grip and took the phone and glasses.

After a short time, Summersgill threw a chair at Mr Hodgson, knocking him to the floor.

Mr Newcombe said: “He then straddled him, using his knees on the victim’s shoulders to pin him to the floor. He again put his hands around the victim’s throat, strangling him and striking him repeatedly across the face.”

Rod Hunt, in mitigation, said his client had been mixing alcohol with anti-depressant tablets, which had made him turn violent.

Summersgill, 34, of The Bungalows, Grangetown, Middlesbrough, admitted wounding with intent to cause grievous bodily harm.

The court heard that last year he throttled his girlfriend, now pregnant, until she lost consciousness.

Judge Tony Briggs, who described Mr Hodgson’s supportive letter as “unusual and extremely generous”, said: “It was a nasty, vicious attack and custody is inevitable.”

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DEPRESSION MED: Suicide: 14 year old girl: Ohio

Paragraphs 13 and 14 read: “After his daughter’s death, Weidlich went through a long bewildering search into why it happened.”

“She’d been on medication and in therapy for depression, but seemed to be responding.”

http://www.mansfieldnewsjournal.com/article/20090729/NEWS01/907290321/1002/NEWS01

Speaker confronts teen suicide, depression
By LINDA MARTZ • News Journal • July 29, 2009

MANSFIELD — James Weidlich is finally comfortable telling strangers about his daughter’s suicide.Advertisement

The family discovered 14-year-old Savannah after she hung herself at home July 15, 2004, after battles with depression.

Weidlich, who once ran a landscaping and contracting business, says this year he committed to a full-time mission to open up public discussion of suicide.

It’s a topic many people find difficult to address, but Weidlich argues people should talk about it. “The cost of promoting the human comfort level is that people are dying,” he said.

“There is a huge amount of secrecy and denial. We have done a really good job of scaring people out of talking about their own mental health,” he said.

Weidlich, of Cambridge, brought his Families on Fire Mental Health Reality Crusade to Citichurch last week.

This Friday, Saturday and Sunday, he’ll offer free public talks at the Quality Inn on Ohio 97, near Bellville.

Weidlich described his daughter as a good kid and an athlete. “My daughter had a very inspiring personality and a sense of humor. Yet she had an illness that took her life.”

Young people come under tremendous pressure, he said. “It is a war zone for children, in our schools, on our playgrounds, in our streets.”

Weidlich believes adults must take responsibility for spotting the signs a young person is contemplating suicide. He also believes adults must take action.

“I never want a parent to say, ‘Just get over it’ or ‘I went through the same thing you’re going through, and I got over it. Just toughen up,’ ” he said.

Severe depression is a physical illness, like diabetes or heart disease, he said. It should be discussed openly and swiftly treated.

After his daughter’s death, Weidlich went through a long bewildering search into why it happened.

She’d been on medication and in therapy for depression, but seemed to be responding.

Weidlich, a single father, eventually found clues that indicated Savannah hadn’t been doing as well as he thought. He doesn’t want others to miss signs or ignore reality.

“That moment, on that night, in our house, is something that you do not want to experience,” he said.

Now, from a “Families on Fire” camper, he spreads his message. He strikes up conversations about suicide in coffee shops and churches statewide. Making ends meet is difficult given his mission, but he’s sticking to it.

“Depression-related suicide is the number one killer of our children. You absolutely have no excuse not to come and learn something.”

lmartz@nncogannett.com

419-521-7729

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ANTIDEPRESSANTS: Mother Kills Daughter’s Rapist: Spain

First paragraph reads: “A MUM who killed her daughter’s rapist by throwing petrol over him and setting him alight has been jailed for nine years. Maria del Carmen Garcia Espinosa’s daughter Veronica was raped by a man from their home town, Benejuzar, in 1998 when she was just 13. Veronica’s mother has been in counselling and on anti-depressants ever since. But in June 2005, the rapist was on weekend leave from prison, where he was serving a nine-year sentence, and Maria del Carmen saw him in the family’s local bar.”

http://www.euroweeklynews.com/2009073061426/news/costa-blanca/jail-for-mum-who-killed-her-daughters-rapist.html

Thu, 30 July 16:33 2009

Jail for mum who killed her daughter’s rapist

BENEJUZAR

The deceased ‘provoked and intimidated’ the mother, who had been depressed since the rape

A MUM who killed her daughter’s rapist by throwing petrol over him and setting him alight has been jailed for nine years. Maria del Carmen Garcia Espinosa’s daughter Veronica was raped by a man from their home town, Benejuzar, in 1998 when she was just 13. Veronica’s mother has been in counselling and on anti-depressants ever since. But in June 2005, the rapist was on weekend leave from prison, where he was serving a nine-year sentence, and Maria del Carmen saw him in the family’s local bar.

The bar was next to the stop where Veronica caught her bus every day, leading her mother to believe his presence in the area was aimed at provoking and intimidating the family. Antonio Velasco is said to have approached Maria del Carmen and asked her how her daughter was in order to scare her. A distraught Maria del Carmen returned home and fetched a vat of petrol, a court heard. She then went back to the bar where she doused her daughter’s rapist in fuel and set him alight.

The woman was then found hours later in Alicante ‘in a disoriented state’, police say. Meanwhile, the man died in Valencia’s La Fe hospital from third-degree burns affecting 60 per cent of his body. Family members of the arrested woman say the deceased’s relatives had sold their assets to avoid having to pay compensation owed to Veronica, now 24. But Veronica’s mother has now been ordered to pay them 140,000 euros. She has also been sentenced to nine years in prison.

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ANTIDEPRESSANTS: Police Officer Dead: Shooter Dies Also: shooter was o…

Headline reads:
Coroner: “Shooter was prescribed antidepressants.”
Paragraph four reads: “The shooting left Sgt. David Kinterknecht dead, along with the suspect, Dennis Gurney, who lived at the home.”

http://www.montrosepress.com/articles/2009/07/30/news/doc4a71057ebf681398337489.txt

Injured officers face lengthy recovery

Coroner: Shooter was prescribed antidepressants

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By Katharhynn Heidelberg
Daily Press Senior Writer
Published/Last Modified on Thursday, July 30, 2009 4:11 AM MDT

MONTROSE ­ Two officers shot Saturday can expect an extensive recovery process, the chief of police said.

Montrose Police officers Larry Witte and Rodney Ragsdale were hit in the legs with shotgun blasts while responding to a domestic violence call in the Cobble Creek area.

“I think it’s going to be weeks to months before we see them back to work,” Police Chief Tom Chinn said.

The shooting left Sgt. David Kinterknecht dead, along with the suspect, Dennis Gurney, who lived at the home.

Witte was released from Montrose Memorial Hospital Tuesday, to a hero’s welcome from other officers. Ragsdale’s release from St. Mary’s Hospital in Grand Junction was expected today, Chinn said.

He said both men will need extensive rehab.

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