Mumbai- Call HELPLINE 022-24131212 for any Mental Health Issue


100 calls a day, mental health helpline a hit

Bhavika Jain, TNN May 23, 2013,

MUMBAI: Life in fast-paced Mumbai seems to be taking a toll on its citizens. In just four days after the BMC launched its mental health helpline on May 14, as many as 352 calls were received. Currently, the 24-hour helpline is receiving between 85 and 100 calls a day.

According to the initial data, one-third of the calls to the helpline was from people above the age of 50 and they had issues like depression and irritability. The second highest number of calls was from those aged between 30 and 40 , who were facing anxiety and work-related stress.

Experts say the sheer number of calls on the helpline shows that the mental health of the people in the city is falling. People are looking for a medium to vent their thoughts and this helpline aims to do just that.

Additional municipal commissioner Manisha Mhaiskar said the response has been overwhelming. The BMC will have to eventually increase the number of lines connected to the helpline, she said. “We have appointed three counsellors to work in three shifts. We have also instructed them that in case there is a very difficult case, they should suggest to the caller that he/she should take an appointment in KEM Hospital’s psychiatry outpatient department so that he/she can be given a personal counselling session,”said Mhaiskar. She said they are not insisting that the callers give out their names and personal details.

The helpline, launched by the mayor, will be operated by KEM Hospital’s psychiatric department. To call the helpline, dial: 022-24131212.

 

#India- Pay for surgeries, costly treatment with EMIs soon #healthcare


Finance

Mar 4, 2013, TNN[ Rupali Mukherjee ]

Globally, patient financing companies like Springstone and Medicard bear the cost of a patient’s treatment including surgeries, procedures and even pharma prescriptions, ranging from $2,000 to $40,000.
MUMBAI: Soon you will be able to finance the purchase of prescription medication. With healthcare costs going through the roof and exorbitantly-priced medicines making treatment inaccessible for many, companies are trying to reach out to patients and provide options of convenient monthly payments.

These companies include patient financing start-ups which will provide options so patients don’t delay expensive treatments and have access to medication through a customised repayment plan — an affordable alternative to personal loans and credit cards.

Globally, patient financing companies like Springstone and Medicard bear the cost of a patient’s treatment including surgeries, procedures and even pharma prescriptions, ranging from $2,000 to $40,000. Healthcare financing start-up Mya Health Credit will soon offer loans to patients for financing prescriptions.

Mya Health Credit’s founder Manish Menda says, “we are in talks with domestic pharma companies and will soon be rolling out the financing of pharma prescriptions over Rs 75,000 for a tenure of 12, 18 or 24 months. We will also offer financing of medical devices—used by the consumer, like hearing aids or pacemakers as their costs add up to over a lakh or so.”

Though the company is still working out the finer details, it has tied-up with Tata Finance which will provide ‘loans’ for purchasing medicines after appropriate verification checks. Hitesh Gajaria, partner KPMG, said: “This is a way of deepening the market and increasing accessibility by offering customised loans for healthcare. Patient financing is a niche area and India is a huge unserved market.”

The pay-as-you-go approach is a great model for countries like India where there is no reimbursement system and expenditure on health is largely out-of-pocket, industry experts say. In US, pharma expenses are about 8-15% of total healthcare cost while in India it may go as high as 60% in therapies. Pharma company Biogen Idec offers two critical medicines, meant for multiple sclerosis patients at half the cost, and is exploring finance options through a public-private partnership where it can part-finance the treatment, says the company’s MD Sameer Savkur.

#India-Pregnant women forced to urinate on test strips #WFTFnews #Pune


In addition, patients are handed empty sachets from pregnancy kits to collect urine samples, as gynaecology OPD doesn’t have enough workers to clean the containers generally used for the purpose.

January 28, 2013
PUNE
Anup Satphale and Swapnal Tilekar, Mid Day

Pregnant women these days have to suffer more than just labour pain at Sassoon hospital. Shortage of staff at the termination of pregnancy and antenatal care OPDs has led to expectant mothers extending a helping had to the institute authorities, albeit unwillingly.

Innovation!
MiD DAY discovered that women are being supplied with empty sachets from pregnancy kits to collect urine samples, as there aren’t enough workers to clean the containers generally used for the purpose.


File Pic

Also, patients are being asked to urinate directly on test strips, which are then handed over to lab technicians for examining sugar and albumin levels.


Matter of concern: A woman carries an empty sachet from a pregnancy kit (circled) for collecting urine sample at Sassoon hospital

Unhygienic
The matter came to light when a MiD DAY reporter visited the OPD area. A woman, who had come for urine test, told us, “I was surprised on being asked to collect my sample in a sachet. They did not have a bottle. It is quite embarrassing to take these pouches all the way to the restroom and then carry it back, with utmost caution, to the lab.”


Self-help! A woman carrying a strip to the restroom for urine test at Sassoon Hospital. This strip will then be handed to a lab technician for examining sugar and albumin levels

Many women were also being made to urinate on the test strips, in an unhygienic washroom, a few feet away from the doctor’s cabin. If the number of patients is more on a particular day, the women are forced to wait for long periods after conducting the tests. Sources said this practice is unsafe, as there is high probability of the samples getting contaminated, which may in turn result in improper diagnoses.

Elaborating on this further, one of the sources from the OPD section said “We used to provide bottles to patients to collect urine samples for various, tests but because of unavailability of workers to clean those containers, we have stopped the practice. Now, we furnish empty sachets from pregnancy kits for the purpose. Also, we have been advised to supply strips, which are used to check sugar and albumin levels, directly to patients, who are then asked to urinate on them so tests can be performed.”

1,500 Total number of beds at Sassoon General Hospital

The other side
Dr Ramesh Bhosale, HOD, gynaecology department at Sassoon hospital, said, “There is no shortage of anything in OPDs and wards. Also, directly urinating on strips will not affect the reports in any way. If that were the case, then I would have asked them to desist from using this method. However, I was not aware of the practice of using sachets for collecting samples. This may have been started by an intern or a trainee doctor.”

 

#India #Rajasthan -Cheating #tribal patients under the grab of free treatment #mustshare



A compplaint lettre to Medical Council of India

The Chairman,
Medical Council of India,
New Delhi

Dear Sir:

Please find attach a pamphlet circulated by the NIMS Medical College and Hospital
(NIMS University), Shobha Nagar, JaipurDelhi Highway, Jaipur in villages
inhabited by tribal community of Pratapgarh district of Rajasthan.

A team (perhaps not of the doctors) from this college hospital held a camp on 21st October 2012
at village Devgarh of Pratapgarh block and after initial screening asked about 80
patients to come with them to NIMS Medical College Hospital, Jaipur where they
would be provided free treatment as written in the pamphlet. All these patients
were provided free transport in two buses. After reaching at NIMS Hospital, they
were admitted and asked to sleep on beds in wards.

According to the patients, doors of the hospital were locked so that they can not escape. Nobody was given

any treatment and after two days they were again put on two buses and transported
back to village Devgarh in Pratapgarh Dt. In those two days, all these patients
received food only once and tea, a couple of times. One patient said that though
his complaint was of repeated bouts of beathlessness, but a cast with weight was
put on one of his lower limbs. While they were on beds, some people peeked into
the wards but did not come near anybody.

None of the person from the hospital explained to these poor patients from tribal community the reason for not
providing treatment. The only reason, there could be that they did not have money
and they did not fall in first 500 patients who were to be given free treatment as
mentioned in the pamphlet.

From this incident, it looks like that these patients were taken to the NIMS 
Hospital to demonstrate bed occupancy for hospital to seek some kind of 
recognition. Most patients who were taken to the NIMS hospital have given 
notorized affidavits but the local administration is in no mood to do anything. 

It is a serious matter and MCI should look into it immediately.

Thanking you.

On behalf of the duped patients
Ram Prasad meena Devgarh
Naru Meena Sovani
Kanna Meena Devgarh
Jetu Ram, Samli Pathar

Prayas, Dr narendra Gupta
8, Vijay Colony, Near Railway Station,
Chittorgarh 312 001
India
Tel : +91.1472.243788
Fax : +91.1472.250044
Cell:+91.9414110328

 

Enough is enough. Disabled people are driven to suicide because of the Government’s welfare reform


NICKY CLARK. The Independent

Thursday 4 October 2012

As a survey reveals that disabled patients have been driven to suicide due to the Government‘s fitness to work test, it’s time to fight back.

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FACT FILE
  • 20% of GPshad at least one disabled patient who had thought about suicide due to the fitness to work test
  • 65,000The number of hate crimes against disabled people last year
RELATED TOPICS

Six per cent of doctors have experienced a patient who has attempted – or committed – suicide as a result of “undergoing, or fear of undergoing” the Government’s fitness to work test.

The survey, highlighted by Exaro, the investigative website also found 14 per cent had patients who had self-harmed as a result of the test.

As I’m commenting on this, I’m so angry that the words are crashing against one another in my fury.

People are either contemplating, or actually committing suicide, because their Government, our Government, are pushing through with policies which defy all understanding.

The survey found that one in five GPs had at least one disabled patient who had thought about suicide because of the test.

There are people are dying because their elected representatives have chosen to make the welfare reform a reality.

In 2011, the Government ordered that everyone on incapacity benefit, some two million people, should be assessed.

This is just the beginning as George Osbourne set out plans for £18 billion in welfare savings by 2014-15. And yet it seems to me that disabled people are always remembered for a politician’s PR photo opportunity, but forgotten when it comes to pushing through dehumanising policy.

This is robbing disabled people of life chances and meaningful existence, but with an eye to the polls, the votes and the perceived will of the public, no one will speak out.

These men and women are choosing death because life is offering no meaningful option. They have no champion, they have no hope. So they tell their doctor. These doctors are ignored by the people paid to bring the savings, but these same doctors have made an oath to save lives.

India- Scrap outdated #Mental Health Bill- Activists


 

PLEASE  CLICK HERE AND SIGN ONLINE  PETITION TO BE SUBMITTED TO HEALTH MINISTER ON 10TH OCT

Petition health minister over inclusion of archaic psychosurgery and electro-shock treatment, which is banned in many countries #MENTALHEALTH

 

Jyoti Shelar, MUMBAI MIRROR OCT 5TH
Health Minister: Repeal of the   Draconian Mental Health Law

Posted On Friday, October 05, 2012 at 04:15:43 AM

Human rights activists are upset about a new proposed Mental Health Care bill that retains outdated and controversial treatment techniques such as electro-convulsive therapy (ECT) and psychosurgery– neurosurgical treatment for mental disorders.While many term the draft bill as ‘patient friendly’, some activists feel that the bill represents the ‘over-medicalisation’ of mental health when it should instead concentrate on the most effective therapies.

On Thursday, activists started an online petition demanding the bill be quashed. The petition letter, addressed to Health Minister Gulam Nabi Azad, demands that all rights of people with psychosocial disabilities should be covered under the recently drafted Rights of Persons with Disabilities Bill, 2012, and that the MHC Bill be given a quiet burial.

The Rights of Persons with Disabilities Bill guarantees the ‘legal capacity’ and the ‘right to choice’ of all persons with disabilities, including those with psychosocial disabilities.

“The MHC Bill, on the other hand, only looks at medicalisation of mental health issues. We are amazed that the bill retains the archaic and horrendous ECT or shock treatment, which has been banned by most countries,” said Kamayani Bali Mahabal, a lawyer and human rights activist.

According to Mahabal, the bill also retains the option of psychosurgery, which has always been controversial. “Mental health treatment needs to be more therapy-based than medicine-based,” said Mahabal.

The activists are of a view that mental health patients need community-based treatment with groups and peer support, neighborhood care systems, conflict reduction and peace building strategies, supportive counselling, addressing stigma, trauma-informed services, and a range of other alternatives.

According to Dr Sanjay Kumawat, medical superintendent of Thane Mental Hospital, the draft bill may need some modifications, but feels the demand to do away with ECT and psychosurgery is unreasonable. “ECT has proved beneficial for many patients. If ECT is performed following guidelines – using muscle relaxants and anesthesia – and is going to benefit the patient, I don’t see any harm,” said Kumawat.

Psychiatrist Dr Yusuf Matcheswalla agreed. “Patient benefit is the most important factor and I think this bill is extremely patient friendly. There are a few points that need clarity. For example, the bill says that patient’s consent is needed for any psychosurgery. However the bill does not explain if a nominee can give their consent if the patient is unable to do so,” said Matcheswalla.

Dr AK Kala, a senior psychiatrist from Ludhiana, added, “The old type of neurosurgeries, which landed patients in a vegetative state, are not performed anymore. In India, very few psychosurgeries are performed, and the bill is trying to regulate those. It states that a government committee has to approve all psychosurgeries, which is a good thing.”

 

The drugs don’t work: a modern medical scandal


The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling.
a0158-000112

Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits. 
The Guardian, Fri 21 Sep 2012 23.00 BST
Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.
But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.
It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.
I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.
Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.
In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.
Now, on to the details.
In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.
These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.
It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.
In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:
“The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”
How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.
Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.
And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.
In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.
This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in theJournal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centreand it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.
For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.
When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.
Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.
Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.
To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.
Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.
So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.
When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.
It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.
People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.
Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.
This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.
How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.
After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.
That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.
Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.
But we are more concerned with the safety and efficacy data. In 2003 theUppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.
During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.
Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.
The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.
Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.
Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.
• This is an edited extract from Bad Pharma, by Ben Goldacre, published next week by Fourth Estate at £13.99. To order a copy for £11.19, including UK mainland p&p, call 0330 333 6846, or go to guardian.co.uk/bookshop.

End of the road for mentally ill?


End of the road for mentally ill?

Arita Sarkar

Chennai, June 7, 2012, The Hindu

Patients who are not claimed by their families continue to live in the wards and are employed in the industry therapy unit

Two months ago, 26-year-old D. Sundar Raj, a patient at the Institute of Mental Health (IMH), craved for his family’s attention to such an extent that the desperation drove him to climb up the terrace of the ward and escape the premises, only to get accidentally hit by a passing lorry. This unfortunate incident sends out a strong message about the lack of social support and growing negligence of the patients at IMH.

A 206-year-old institution, IMH is the only government residential facility in the State for the mentally ill. The institute has about 1,300 patients, housed in eight wards designated for women and 12 wards for men including one for male criminal patients.

S. Ambika, a social welfare officer at IMH, said, “There are six units at IMH and on an average, every unit comprises 70-100 patients. In each unit, a maximum of ten patients get visitors on a regular basis.” In the third unit that she supervises, there are only two patients who have family members that visit occasionally.

“After the first few months, most people stop visiting their relatives admitted here. As a reminder, the families are sent postcards and letters at least once a month persuading them to visit the patients more often,” she said.

In some cases, the families give fake addresses making it difficult for the hospital officials to track them down. A 35-year-old patient, admitted at the IMH for five years, was in a similar situation recently. “After his treatment, when he was sent home with a male attendant, the address turned out to be a fake one. He was brought back here,” said Ambika.

Patients who are not claimed by their families continue to live in the wards and are employed in the industry therapy unit where they learn how to stitch uniforms and bind books.

According to the on-call psychiatrist and associate professor, V. Sabitha, “No matter what the illness may be, there is always an improvement in the condition of the patient within six to eight months. Most of them are then fit to be discharged.”

Though advised to come between 8 a.m. and 1 p.m., the families will categorically visit after working hours so as to avoid meeting the medical officer since most of them have no intention of taking their discharged family member back home, she said.

Highlighting the importance of the presence of families in the treatment of patients and discouraging the prolonged stay of a patient after treatment, Dr. Sabitha said, “After being healed, if one continues to stay in the same environment, then eventually, their condition will deteriorate.”

One-sided deal: Hospitals get but don’t give back


Hospital, Bandra

Hospital, Bandra (Photo credit: Wikipedia)

Grants, concessions and exemptions given to the hospitals far exceed the cost of free treatment they are asked to carry out

Jyoti Shelar and Lata Mishra, in Mumbaimirror

Posted On Thursday, April 26, 2012

The death of accident victim Reena Kutekar, whose husband Ram desperately hunted for a hospital that would save her life, has brought into focus how badly poor patients are treated in private medical facilities across the city.

Reena was first taken to Vile Parle’s Nanavati Hospital, where the authorities refused to take her into the ICU because Ram could not furnish the Rs 25,000 required for admission.

The story in most other hospitals in the city is alarmingly similar: though they are required by law to treat a certain number of economically backward patients, most people come away empty handed in their time of need.

The contention of the hospitals – from Jaslok to Breach Candy, from Lilavati to Hinduja – is that taking care of poor patients is a huge burden on them, and that they are asked to provide free treatment for nothing in return.

What these hospitals fail to reveal, however, is that the grants and concessions they are given by the government far exceed the cost of free treatment they are being asked to carry out. Running as charitable public trusts, their list of unaccounted-for exemptions is staggering:

1. Cheap land

If any charitable trust wants government land to build a hospital, it is charged only one-tenth of the market value in the island city, and one-twentieth of the market value in the suburbs. If the land is on lease, the price can be as low as Re 1 per square foot per year.

“Several facilities, such as Jaslok, Hinduja and Bombay Hospital, are on government land given to them on a Re 1 lease. Now they’re earning crores annually but still make excuses when it comes to treating poor patients,” said advocate Sanjeev Punalekar, who had filed a PIL on the issue in 2004.

2. Extra FSI

While the rest of the city’s commercial establishments have to make do with an Floor Space Index of 1.33 to 2, public trust hospitals get an additional FSI of up to 5.32 in the island city and up to 5 in the suburbs.

The FSI determines the height of the structure, which in turn translates into more room for patients, and more business. But the taller hospitals have hardly been of help to poor patients.

“The additional FSI and all other rebates come from the government. The rest of the money comes from patients. Ultimately, it is the government and public money that adds up to the surplus funds of hospitals,” said health activist Leni Chaudhary. “Then why not ensure that poor patients get treated?”

When contacted, Dr Pramod Lele, the CEO of the Mahim’s Hinduja Hospital, admitted that additional FSI proved beneficial in increasing the hospital’s “bed- strength”, but contented that they were asked to pay a premium for it. Not the best argument considering the demand-supply ratio of hospital rooms guarantees that this money is easily recovered.

3. Income Tax rebate

The exact rate of exemption varies from hospital to hospital, depending on how much money it makes. On average, however, 85 per cent of a public trust hospital’s income is exempt from tax. Even the remaining 15 per cent can be set aside as a corpus fund, ensuring that most hospitals have to pay no tax at all. The only catch is that anything accumulated above this 15 per cent in their account is taxable. Hospitals registered as research institutes are given similar concessions.

4. No Octroi

While Octroi rates in Maharashtra are inordinately high, hospitals are exempted from any additional tax for transporting equipment and machinery. In 2003, the BMC withdrew Octroi exemption from a few hospitals for not doing enough charity work. When contacted, a senior doctor from Lilavati hospital agreed that there had been several complaints made to the Charity Commissioner about norms being flouted, which had resulted in some rebates being pulled back for certain hospitals.

5. Duty free

All public trust hospitals are exempted from customs duty on imported machinery and medical equipment, as opposed to 10 per cent for all non-public-trust hospitals. When contacted, Customs officials said machinery and medicines from abroad were one of the most common items brought into the country. “As per the law, we clear them immediately,” an officer said.

6. Cheap Medicines

Hospitals procure generic drugs at nominal costs, and several medicines which are made available by the government under various programmes such as Tuberculosis and Malaria eradication are given to them at a fraction of the cost. However, health experts point out, that these drugs are then sold to patients at the market rate.

7. Low water and electricity rates

Despite being commercial establishments, hospitals are charged residential tariffs for water and electricity, which in itself is a huge benefit. The Residential rate for water per 1,000 litres, for example, is Rs 2.25 as opposed to Rs 38 for commercial use.

 What hospitals are supposed to do 

According to a Supreme Court judgment, charitable hospitals must admit a patient brought in an emergency and provide “essential medical facilities” until stabilisation. Transportation to a public hospital should be arranged, if necessary, and no deposit should be asked for.

Each hospital has to transfer 2 per cent of its income to an Indigent Patients Fund (IPF). The hospital has to reserve 10% of its beds for indigent patients (annual income less than Rs 25,000) who should be given free treatment.

A further 10% of its should be reserved for economically weak patients (annual income less than Rs 50,000) who should be treated at concessional rates. At the time of admission, all a patient has to provide is a certificate from the Tehsildar or a ration card or BPL card.

Disclose psychiatric info under RTI? Yes, says CIC; No, says HC


Pritha Chatterjee : New Delhi, Tue Apr 24

Do psychiatry patients have the right to access records of their treatment? While the Central Information Commission (CIC) directed a mental health hospital to provide this information to a patient, the hospital has moved court citing confidentiality.

The Delhi High Court has given the Institute of Human Behaviour and Allied Sciences (IHBAS) a stay order against disclosing the information till the next hearing in September.

The case pertains to a 32-year-old married woman. She was admitted to IHABS in April 2011 by the hospital’s mobile health unit from her Gurgaon home, after her husband approached hospital with her “symptoms”.

According to Dr Nimesh Desai, director of IHBAS, “Confidentiality of psychiatric information — which includes all information disclosed by different parties related to the patient for treatment purposes — is a very fundamental concept. It is something every psychiatrist promises his interviewees verbally. Unfortunately, till date, India does not have a legal provision regarding this. The unique nature of this information — which includes historical information of the patient, his or her recollections, fantasies, feelings, fears and preoccupations from the past as well as in the present — distinguishes it from other medical records.”

The patient was discharged after four days and has since been staying with her mother in Bhopal. After her discharge, she filed an RTI seeking “the basis for my admission, doctor’s observation, and clinical examination reports, and doctor’s observation…”

Meanwhile, the patient’s husband, too, filed an RTI application, seeking the reasons of his wife’s discharge, “without my information.”

In both cases, IHBAS authorities stated that “the information sought was provided by the patient and her husband, which is sensitive/confidential in nature.”

“The need for discretion in disclosing psychiatric information is compounded in cases like this, where there is a possible marital discord and each seeks such history to use against the other,” Dr Desai said.

The December 2011 CIC order by Information Commissioner Shailesh Gandhi stated that while the hospital was exempted from disclosing treatment records to anyone other than the patient, “these precedents are not relevant when the information is being sought by the patient herself”.

Arguing against this, in their writ before the High Court, IHBAS said, “that every party disclosed information in confidentiality to the psychiatrist and the hospital should not give it away to anyone, including the patient.”

The disclosure of information contained in psychiatry case records would discourage the patients and their relatives to furnish personal and sensitive information and they would prefer to withhold such information, which would largely affect the treatment,” the writ stated.

Meanwhile, the patient’s family said they were “exploring legal options, on this violation of the CIC order.”

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