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WOW!! This certainly makes the connection between the use of these drugs and Bipolar Disorder obvious! But is this suppose to be a big surprise?!
From my new DVD, Bipolar, Shmypolar, Are You Really Bipolar or Misdiagnosed Due to the Use of or Abrupt Discontinuation of an Antidepressant?, let me give you a quick synopsis.
An ANTI-depressant is the opposite of a depressant and is what?
That is correct. It is a stimulant.
What is bipolar? It is a continuous series of mild seizures.
What produces seizures? STIMULANTS, like antidepressants and amphetamines – Ritalin, etc.!
Chemically inducing Bipolar Disorder to create a whole new customer base for the new and high priced atypical antipsychotics is not the least bit difficult when you start patients out on stimulant medications, like Ritalin and antidepressants. That is especially true when given to a young patient with yet growing and developing, and therefore more vulnerable, brain!
Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author: Prozac: Panacea or Pandora? Our
Serotonin Nightmare and audio: Help! I Can’t
Get Off My Antidepressant ()
Sixth sentence reads: “During the year before the new diagnosis of bipolar disorder, youths were commonly diagnosed as having depressive disorder (46.5%) or disruptive behavior disorder (36.7%) and had often filled a prescription for an antidepressant (48.5%), stimulant (33.0%), mood stabilizer (31.8%), or antipsychotic (29.1%].”
Psychiatr Serv 60:1098-1106, August 2009
© 2009 American Psychiatric Association
Mental Health Treatment Received by Youths in the Year Before and After a New Diagnosis of Bipolar Disorder
Mark Olfson, M.D., M.P.H., Stephen Crystal, Ph.D., Tobias Gerhard, Ph.D., Cecilia S. Huang, Ph.D. and Gabrielle A. Carlson, M.D.
Dr. Olfson is affiliated with the Department of Psychiatry, Columbia University, New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032 (e-mail: firstname.lastname@example.org ). Dr. Crystal and Dr. Huang are with the Institute for Health, Health Care Policy, and Aging Research, and Dr. Gerhard is with the Ernest Mario School of Pharmacy, both at Rutgers University, New Brunswick, New Jersey. Dr. Carlson is with the Department of Psychiatry and Behavioral Medicine, Stony Brook University School of Medicine, Stony Brook, New York.
OBJECTIVE: Despite a marked increase in treatment for bipolar disorder among youths, little is known about their pattern of service use. This article describes mental health service use in the year before and after a new clinical diagnosis of bipolar disorder. METHODS: Claims were reviewed between April 1, 2004, and March 31, 2005, for 1,274,726 privately insured youths (17 years and younger) who were eligible for services at least one year before and after a service claim; 2,907 youths had new diagnosis of bipolar disorder during this period. Diagnoses of other mental disorders and prescriptions filled for psychotropic drugs were assessed in the year before and after the initial diagnosis of bipolar disorder. RESULTS: The one-year rate of a new diagnosis of bipolar disorder was .23%. During the year before the new diagnosis of bipolar disorder, youths were commonly diagnosed as having depressive disorder (46.5%) or disruptive behavior disorder (36.7%) and had often filled a prescription for an antidepressant (48.5%), stimulant (33.0%), mood stabilizer (31.8%), or antipsychotic (29.1%). Most youths with a new diagnosis of bipolar disorder had only one (28.8%) or two to four (28.7%) insurance claims for bipolar disorder in the year starting with the index diagnosis. The proportion starting mood stabilizers after the index diagnosis was highest for youths with five or more insurance claims for bipolar disorder (42.1%), intermediate for those with two to four claims (24.2%), and lowest for those with one claim (13.8%). CONCLUSIONS: Most youths with a new diagnosis of bipolar disorder had recently received treatment for depressive or disruptive behavior disorders, and many had no claims listing a diagnosis of bipolar disorder after the initial diagnosis. The service pattern suggests that a diagnosis of bipolar disorder is often given tentatively to youths treated for mental disorders with overlapping symptom profiles and is subsequently reconsidered.
August 2009: This Month’s Highlights Psychiatr Serv 2009 60: 1009. [Full Text] [PDF]
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Paragraphs 6 through 9 read: “Munn lost his license to practice psychiatry in Montana in 2003, after having an ongoing sexual relationship with one of his patients. His marriage dissolved around the same time. Already being treated for depression, Munn’s condition was rediagnosed, and with the help of counseling and medicine, he rebuilt his life into one where he’s succeeding while living with a mental illness.”
“Anti-depressants didn’t help the manic side of Munn’s bipolar disorder. At times his thoughts raced. He didn’t sleep. He had grandiose ideas like how to fix the entire mental health system in the state of Montana.”
“And he believed he could do anything he wanted.”
“’I felt rules didn’t apply to me. That would be grandiosity,’ he said. ‘But they do. And that’s accepting that you have a mental illness’.”
Psychiatrist brings himself back from the brink of suicide
By JOHN HARRINGTON – Independent Record – 08/02/09
Eliza Wiley Independent Record – Nathan Munn has fought back from some very low places. Rather than ending his life, the psychiatrist chose to seek treatment for his bipolar disorder and began a new career teaching psychology courses and developing a mental health direct care program at University of Montana-Helena.
In 2003, with his career and home in very public shambles, Nathan Munn nearly committed suicide.
But rather than end his life, the psychiatrist chose not to pull the trigger one fateful night. He subsequently got treatment, including psychotherapy and medications, for his bipolar mood disorder.
Now, Munn is an instructor at the University of Montana-Helena, teaching psychology courses and developing a mental health direct care program that trains students how to be direct caregivers, counselors and other types of mental health professionals.
“I’m really thankful for my job at UM-Helena,” said Munn, 49, in a candid interview last week. “And I hope that my story can be of some inspiration along with my teaching. It’s my intention that I’m still helping in the community, but now with education as opposed to direct providing of psychiatric care.”
Munn admits somewhat nervously that his past is still “hard to talk about.” He chooses his words carefully, often pausing between sentences. He’s told his humbling story before, and maybe it’s getting a little easier but not much. Remorse hangs deep in his eyes.
Munn lost his license to practice psychiatry in Montana in 2003, after having an ongoing sexual relationship with one of his patients. His marriage dissolved around the same time. Already being treated for depression, Munn’s condition was rediagnosed, and with the help of counseling and medicine, he rebuilt his life into one where he’s succeeding while living with a mental illness.
Anti-depressants didn’t help the manic side of Munn’s bipolar disorder. At times his thoughts raced. He didn’t sleep. He had grandiose ideas like how to fix the entire mental health system in the state of Montana.
And he believed he could do anything he wanted.
“I felt rules didn’t apply to me. That would be grandiosity,” he said. “But they do. And that’s accepting that you have a mental illness.”
Mental illnesses are by no means limited to those on the fringes of society. Millions of Americans of all walks of life blue collar and white, laborers and professionals live daily with schizophrenia, depression, bipolar mood disorder and other diagnosable and treatable conditions.
Mike Larson of Dillon is director of the State Bar of Montana’s Lawyer Assistance Program, which was created in 2006 after several attorneys committed suicide in Missoula.
“Lawyers, from the first call in the morning to the last e-mail at night, are busy dealing with everyone else’s problems,” Larson said. “So what do they do when their own problems kick in?”
Larson said that from a population of 2,800 members of the bar in Montana, he takes calls from eight to 10 new clients a month, around a third of which are related to mental illness, with another third dealing with chemical dependency. He said many lawyers are reticent to call the program, either out of fear that others will learn of their treatment and their careers will suffer, or from simple denial.
“There are a lot of stereotypes out there about what mental illness is, and there’s that whole component of not wanting to be under the stigma of mental illness,” Larson said.
For Munn, day-to-day life means a regimen of a mood-stabilizing drug and an anti-depressant, acknowledgement of and taking responsibility for the mistakes he made and a resolve to move forward knowing the illness will likely be with him for the rest of his life.
“It’s not like there’s one day that you no longer have a mental illness,” he said. “On appropriate treatment, it can be in remission. And you stay on your meds and you do the psychological work necessary, and you move forward.
“I hate to say it because it sounds like it’s bragging, but it takes courage. You have to face this, you face what you did, you face having a mental illness, and you accept other aspects of your life.”
Munn doesn’t hide from his condition, and hopes that sharing his story will comfort others who find themselves in similar positions.
“One of the main things I want to say is when you have a mental illness, you have to acknowledge that that’s there, and that you have it,” he said. “I have a bipolar disorder, I am not bipolar. It is something that I have, it is not something that I am. A lot of people say, ‘I am bipolar.’ Well, what does that mean? You don’t say, ‘I am congestive heart failure. I am sinusitis.’ It’s not who you are, it’s what you have.”
Just as there are ways to characterize people living with mental illness, there are productive ways to discuss the illnesses themselves, Munn said.
“(People) talked about the dark recesses of the mind. That’s not the way to talk about it,” he said. “The term ‘dark recess’ has such a negative connotation, Dr. Jekyll and Mr. Hyde, that’s not it. They’re not dark recesses. It’s neuropathology. It’s limbic system disregulation. And it’s the cognitions, the thinking that goes along with it.
“That’s a tough thing for people to get, but I think it’s crucial for people to get that as they’re recovering from a mental illness, that our brains and our minds are the same thing. So when I have negative cognitions, when I’m thinking that people would be better off without me, that’s the psychological part.
“And that’s a key point for people, is that what you’re thinking psychologically and what your brain is doing physically, we don’t know how it’s the same function, but it is the same function. The subjective psychology that you’re feeling as a person with a mental illness, is the psychological aspect of the biological process, and yes, it is a real illness. The idea that a psychological illness is somehow not real is just absurd. That’s crazy.”
Many mental illnesses can be directly traced to chemical imbalances or other physical abnormalities in the brain. But having a mental illness can’t by itself be an excuse for any actions, good bad or otherwise.
“You don’t want to use it as an excuse to justify behaviors. You have to take accountability. Personal accountability is necessary for recovery, it just is,” he said. “It takes humility, it takes a lot of work, it takes compliance.
“I made huge mistakes. My choices were horrible. Despicable, really, is the term to use. I hurt a lot of people. I hurt patients that I had, the person herself and her family, and of course my family. I feel sorry and apologetic about that every day. Especially for my children, I feel horrible and always will.
“One of the points I would like to make is, yes, I have this bipolar disorder. To deny I do would be to deny I have a mental illness. But I also completely accept responsibility and accountability for my actions. And that’s a very important point: recovery requires personal accountability. Yes, I have a major mental illness, and yes, I am responsible for my actions. Those aren’t mutually exclusive.”
Treating a mental illness isn’t a guarantee of happiness. Life still presents challenges, and treatment gives those suffering from mental illness a better chance at facing those challenges head-on and coming out ahead.
“Life has struggles, with or without a mental illness,” Munn said. “Having your mental illness treated doesn’t mean your life is wonderful. You’re still going to have the struggles that everyone has. But you’ll also have wonderful things. I’m a grandfather. And that’s wonderful. If I had killed myself, I wouldn’t have known this joy of having a granddaughter.
“You have to accept mental health care of various types, and you need to know that it’s worth it, that treatments are available, the science is there, people do recover, illnesses do go into remission. Of all chronic illnesses to have, having a mental illness is not bad. Treatments are available, and you can live a long, good life having your mental illness treated.”
Larson of the Lawyer Assistance Program acknowledged that people need to want to treat their illnesses.
“There are a lot of people out there that still need the help that haven’t come forward or recognized they need the help,” Larson said. “Not only are they in denial that they have a problem, they’re in denial that everyone knows they have a problem.”
And even if the disease goes into remission or becomes manageable, a person must be diligent, even when things are going well.
“It’s not something you mess around with. And that’s OK,” Munn said. “Mental illnesses are chronic illnesses. People have the idea that, ‘Oh no, I’m going to be on medications for life.’ Well yeah, you are. And that’s all right, you have a chronic illness. There are a lot of chronic illnesses, not just psychiatric ones. And people who have those, like type 1 diabetes, will be on insulin. It’s accepted. So it’s a chronic illness, you accept that.”
And the more acceptance there is, across a broader swath of Montana at large, the easier it will be for people to summon the strength to get the help they need, to confront the illness, and to assume the places so many of them deserve as productive members of society.
To view the complete series on mental health care services in Montana, click here.
John Harrington: 447-4080 or email@example.com.
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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. ”
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.
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.
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.
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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WHEN ARE DOCTORS EVER GOING TO REALIZE THAT THEY CANNOT GIVE ALL OF THESE DRUGS TOGETHER?!!!!!!! THERE IS NO CLINICAL DATA TO PROVE THE SAFETY OF EVEN TWO OF THEM GIVEN IN COMBINATION!!!!!!!!!!!!!!!!!!!
Paragraphs 11 though 14 read: “To combat attention disorders and other conditions, the teen took Ritalin, Zoloft, Prozac and Adero, among other drugs, Bryce said, toting the various prescriptions with him in a pill sorter.”
“The medicine sedated Adrian for hours. He was often unresponsive and seemingly unaware of people talking to him while on the medication, Bryce said.”
“The assortment of pills ‘took a toll on him,’ he said.”
“Other times Adrian displayed anger he seemed unable to control, Bryce said. Some of it was typical teen behavior, but sometimes Adrian “blacked out” and later forgot about the episodes, Bryce said.”
Dad says, ‘There’s something wrong with him’
Father grieves for son suspected of shooting deputy.
By Matthew Pleasant
Published: Friday, July 31, 2009 at 12:24 p.m.
Last Modified: Friday, July 31, 2009 at 12:24 p.m.
BOURG To understand what happened, Bryce Broussard sifts through memories of his son.
He cries as he remembers an 18-year-old boy who struggled to read, who needed help filling out job applications and had an unpredictable and explosive temper, he said.
The same young man earned money by cutting Hope Street yards, who welded his own workout bench in school and sometimes fell asleep wearing headphones.
The teen, Adrian Broussard, is now charged with attempted first-degree murder, accused of shooting Terrebonne deputy David Bourg three times Tuesday and leaving him in critical condition.
Still reeling over the arrest, Bryce, 36, said he and his wife, Amy, plan to support his son. He finds it hard to comprehend Adrian committing the crime, he said, but recognizes the behavior problems that may have contributed to the shooting.
“He was a good kid, but there’s something wrong with him,” said Bryce, an offshore worker. “He would blow up over nothing.”
Adrian Broussard’s last steady home was 128 Hope St. in Bourg, where his father said Adrian lived for two years before moving to live with a relative in Montegut.
He struggled through school at South Terrebonne High to earn a technical-skill degree, Bryce said. Rusting in the yard is a workout bench and frames for four-wheelers all of it Adrian’s work.
Often unable to concentrate, Adrian took a slew of medications, his father said. But he never seemed more focused or content than when welding or dissembling a motor.
“He wanted to make different things that nobody else had,” Bryce said.
To combat attention disorders and other conditions, the teen took Ritalin, Zoloft, Prozac and Adero, among other drugs, Bryce said, toting the various prescriptions with him in a pill sorter.
The medicine sedated Adrian for hours. He was often unresponsive and seemingly unaware of people talking to him while on the medication, Bryce said.
The assortment of pills “took a toll on him,” he said.
Other times Adrian displayed anger he seemed unable to control, Bryce said. Some of it was typical teen behavior, but sometimes Adrian “blacked out” and later forgot about the episodes, Bryce said.
His unwieldy behavior and penchant for mechanic work followed the family to Disney World last summer, where the teen preferred to stay at the hotel rather than visit the parks, they said. When the family truck broke down, he worked on it without hesitation.
The father and son bought parts and repaired the truck in the hotel parking lot, he said.
“He helped me piece by piece, tearing it down,” he said.
Bryce said the family tried to help him find a job after graduation. The family ate at Golden Corral during one trip into Houma, and Adrian’s temper flared at servers who told him the restaurant wasn’t serving steak.
He berated the kitchen staff, telling them none knew how to cook, Bryce said. He also threw his cup in the dining room, sending drink all over surrounding tables.
“It was nothing nice,” he said.
Neighbors said the Broussard family seemed to have a troubled home life, citing fights and police visits to the trailer. Bryce and Amy Broussard said they were close despite the incidents.
“We’re not saying we’re perfect,” Amy Broussard said.
Adrian Broussard left the Hope Street trailer several months ago to stay with cousins in Montegut and only occasionally spent time with his father after that, Bryce said.
Just before midnight Tuesday, Adrian allegedly gunned down a deputy investigating reports of a suspicious person outside the Montegut Post Office.
By 1 a.m. Wednesday, deputies were at the Broussard’s trailer demanding to know where Adrian was, Bryce said. He said he spent much of the morning handcuffed inside a police cruiser that drove through Montegut in search of the teen.
The elder Broussard was charged that day with simple criminal damage to property and theft of goods over $500, according to jail records. Broussard said the arrest stemmed from outstanding warrants.
Adrian was arrested about 12 hours after the shooting when a resident found him inside an abandoned home, police have said. He is being held at the Terrebonne Parish jail in lieu of a $2 million bond on the attempted first-degree-murder charge. He is also charged with simple burglary, trespassing, possession of marijuana and illegal carrying a weapon, deputies said.
Deputies had searched for Adrian Broussard earlier Tuesday to arrest him on warrants for felony theft and criminal damage. His bond for the warrant charges is $20,000.
Deputy Bourg, a five-year veteran of the Sheriff’s Office who is married with children, remains in stable condition in the critical care unit at Terrebonne General Medical Center.
While Bryce is hoping for the best outcome for his son, he says he also hopes Bourg is able to heal.
“We are praying for a full recovery,” Bryce said. “We apologize to the family, and we’re very sorry for what happened.”
Staff Writer Matthew Pleasant can be reached at 857-2202 or firstname.lastname@example.org.
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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’.’’
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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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’.”
Easington tyre-slasher wore pink pyjamas
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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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.”
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 email@example.com.
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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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.
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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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.
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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