Inhaled Insulin Afrezza Gets FDA Approval - By MikeH on June 29, 2014

Huge news, D-Friends: the new rapid-acting inhalable insulin known as Afrezza has just obtained FDA approval!

The third time’s the charm for this new formulation of inhalable insulin, the second-ever to make it through the U.S. regulatory process after Pfizer’s failed Exubera the better part of a decade ago.

On Friday, the California biotech company MannKind Corp. finally obtained regulatory clearancefor its Afrezza device. Twice before, regulators turned down Afrezza asking for more clinical study data to appease concerns about safety and effectiveness.

Now, after resubmitting Afrezza in October 2013, MannKind has finally convinced the FDA it’s ready to get into the hands of adults with diabetes!

We’re told by MannKind’s top executives that they’re working to find a pharma partner to manufacture and distribute Afrezza, and the product could be made available as soon as January, or end of the first quarter of 2015.

In the FDA news release issued on Friday, Dr. Jean-Marc Guettier of the agency’s Division of Metabolism and Endocrinology Products, states: “Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.”

Here’s the 411 on Afrezza, for those who don’t know:

Afrezza’s an ultrarapid-acting insulin in powder form that’s designed as a pre-meal insulin for adults (not yet for kids) with type 1 or type 2 diabetes. It’s aimed at post-meal blood sugar spikes, meaning used with existing insulin treatment and not meant to be a stand-alone insulin treatment.

The powdered insulin is administered via a whistle-sized inhaler called the Dreamboat, which was developed after the first FDA round and caused delays because the agency wanted more clinical studies using that new inhaler. The powder dissolves immediately when inhaled into the lungs, and the insulin’s then quickly dumped into the bloodstream to start working. Afrezza peaks within 12 to 15 minutes and is out of the system within an hour,  compared to current short-term insulins that usually take at least 20 minutes to kick in, peak at 2-3 hours, and can stay in the system for as long as five hours.

Here’s a video of how the Afrezza Dreamboat inhaler works, posted by a clinical study participant last year:

Source: YouTube

MannKind has spent years trying to gain approval for this treatment, first submitting a new drug application in May 2009. And now, Afrezza appears to be ready for primetime, having cleared the FDA.

Of course, the biggest appeal is that it requires no needles, but just a little hand-held inhaler that really does look like a whistle. The Dreamboat is meant to be thrown away after 15 days to prevent any powder buildup inside that could clog the device. Unlike traditional insulin, it needs no refrigeration, but rather is kept at room temperature. Each single-use cartridge would hold either 4 or 8 units, and by the time Afrezza is commercialized, there could be a 12-unit cartridge available.

Here’s how you might dose for it, converting current insulin injection or bolus amounts into an Afrezza-friendly inhalable dose:

From Page 4 of the MannKind Afrezza medication guide

Personally, that doesn’t seem like a lot of insulin to cover some of the meals I eat that require higher doses… I’d be going through a whole bunch of those little cartridges. So for some PWDs, this device may present a logistical challenge in terms of easily dosing the amounts we need…? But then again, this may be a good tool for knocking down stubborn high blood sugars with correction dosing.

In a phone conversation late Friday, MannKind’s president Hakan Edstrom told us the company hasn’t yet finalized any deals with potential partners in order to manufacturer and distribute Afrezza. But it’s getting close, and in talks with a number of companies to finalize a partnership as soon as possible.

Costs remain TBD (a lot depends on the potential partnership), but Edstrom says they expect prices to be in the same range as what we patients typically pay now for insulin pens in the U.S.

This approval is a HUGE development, and it’s been a long time coming, eight years since this quest began by Alfred Mann — the man who founded Minimed before it was eventually bought by Medtronic. We’ve been following the Afrezza story for years here at the ‘Mine — from the initial FDA filing days when MannKind had its initial clunkier design, to the more recent coverage on how Afrezza’s being used in Artificial Pancreas clinical trials.

So far it’s cost a whopping $1.8 billion (!) to get Afrezza to this point, and much of that money was used to pay for 60+ clinical trials that have involved 6,500 patients. Wowza!

Before last fall’s FDA resubmission, we heard MannKind boast about its Phase III clinical studieslast summer that included 500+ type 1 PWDs in the U.S. and globally, which indicated the company was poised to try its hand again with the FDA.

All that said, it’s still a bit of a surprise that Afrezza got the FDA’s approval, considering the agency’s own staff review had raised concerns about the product’s safety and effectiveness. There were initial concerns that long-term exposure of the lungs to insulin could cause lung cancer, since clinical trial data showed more cases of lung cancer among those who received Afrezza than others in control groups. But the numbers were small and far from definitive, and MannKind was required to undertake a long-term study to assess that risk.

The advisory committee that met on April 1 of this year voted 13 to 1 that Afrezza was safe and effective enough for approval as a treatment for type 1 diabetes, with the lone dissenter David Cooke voting that the risks outweighed the benefits for type 1s. He pointed to the internal FDA review that showed some patients taking Afrezza stopped treatment after developing bronchial spasms, coughing, and a decline in the functioning of their lungs. But none of those concerns came up during the voting on Afrezza for type 2 use, and the committee decided unanimously in favor with a 14-0 vote.

In approving Afrezza, the FDA has attached a number of safety, effectiveness and patient use stipulations:

• It’s not recommended for people with diabetes who smoke, nor for treating diabetic ketoacidosis (DKA).
• Afrezza is only approved for adults, not kids. However, the agency’s asking for a post-market clinical trial to evaluate the safety and use in pediatric patients.
• The FDA is requiring a Boxed Warning, advising that some people with asthma and chronic obstructive pulmonary disease (COPD) who’ve used Afrezza have experienced acute bronchospasm. As a result, those with chronic lung disease, asthma or COPD, should not use Afrezza because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
• Part of the approval requirements are a Risk Evaluation and Mitigation Strategy, which must include a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza. That’s mean to ensure that the benefits outweigh the potential risks of using Afrezza.
• Other post-market studies are required on Afrezza, such as: clinical trial to evaluate the potential risk of pulmonary malignancy with use (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function); and two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.

Edstrom told us they are planning to start pediatric trials as soon as possible, which will realistically begin sometime in mid-2015. That means Afrezza might not be approved for kids with diabetes until 2017, and that regulatory process may vary depending on what the post-market studies and adult-use experience shows in the meantime.

And despite the FDA green light, there’s no guarantee Afrezza will see commercial success or that PWDs will flock to use it. As noted, MannKind has not yet secured any pharma partners ready to sell Afrezza. But if MannKind’s earnings call in May is any indication of what’s coming soon, a potential partnership may not be far off.

From the investor point of view, many are skeptical based on the failed Exubera inhaled insulinthat has shaped much of the discussion about Afrezza over the past several years. That joint Pfizer-Sanofi product was pulled from the market in 2007 after more than a year’s worth of subpar sales — resulting in a record-breaking $2.8 billion loss for the vendors.

Of course, MannKind claims that Afrezza is significantly different, mainly because Exubera used a clunky foot-long inhaler and was linked to a higher lung cancer risk that Pfizer just couldn’t overcome.

We’ll see what the D-Community thinks now with Afrezza, especially with all the AP clinical trial attention it’s had more recently. Whether that’s enough to convince the masses is yet unclear…

Inhale the news for now, and we’ll see how long it takes for us all to exhale and turn this excitement into actual sales and widespread use.

India's lax antibiotic controls raise killer disease fears By AFP

http://www.dawn.com/news/1121298/indias-lax-antibiotic-controls-raise-killer-disease-fears

Antibiotics are displayed at a chemist's shop in India's financial capital Mumbai. Doctors and other health experts say easy access to antibiotics in India, home to 1.2 billion people, is stoking bacterial resistance to drugs, a global problem that could see long-treatable diseases become killers once again. —Photo by AFP

NEW DELHI: An Indian pharmacist swiftly pulls white boxes of powerful antibiotics from neatly stacked shelves behind him, and hands them over the counter without asking for a doctor's prescription.

Faronem and Linospan, drugs used to fight acute bacterial infections such as severe pneumonia and bronchitis, are supposed to be remedies of last resort.

Their sale is illegal without a prescription under a law introduced last year. But an AFP reporter easily bought them this week for about 700 rupees from a busy pharmacy in an upmarket New Delhi suburb.

Doctors and other health experts say such easy access to antibiotics in India, home to 1.2 billion people, is stoking bacterial resistance to drugs, a global problem that could see long-treatable diseases become killers once again.

“Growing resistance to antibiotics is a terror for the health of our people,” the country's chief drugs regulator GN Singh told AFP.

“Misuse, overuse should not happen, else there will come a time when the simplest illnesses will be hard to cure,” said Singh, the Drugs Controller General of India.

But he was “not surprised” the drugs were easy to obtain, saying cracking down on chemists and over-prescribing doctors and educating patients about the dangers of overusing them was an uphill battle.

A study published this month by Princeton University said India and other major developing countries were largely to blame for overuse of antibiotics.

India's $12.4 billion pharmaceutical industry manufactures almost a third of the world's antibiotics.

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Drug-resistant superbugs

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The country's growing middle class is increasingly popping antibiotics as a quick-fix rather than allowing their immune systems to fight common illnesses.

Doctors also wrongly prescribe antibiotics for viral infections against which they are wholly ineffective, said Sudeep Khanna, a Delhi-based gastroenterologist.

“There is often a lot of pressure from the patients because they want immediate relief and even doctors tend to over-treat in hopes that the patient will recover quickly,” Khanna told AFP.

The study called “Global Trends in Antibiotic Consumption 2000-2010” found antibiotic use worldwide had risen 36 per cent in that time period.

India emerged as the world's largest consumer, with the country's use of antibiotics growing 62 per cent over a decade, from eight billion units in 2001 to 12.9 billion units in 2010.

Experts say overuse is giving rise to dangerous drug-resistant superbugs with huge consequences for India, home to millions of poor and already sick people.

India's inadequate sanitation increases the chances of infections from drug-resistant bacteria. About half of the country's residents defecate in the open, while overflowing drains and uncovered sewers even in big cities such as Delhi spread bacteria through faeces.

“Given our high background rates of infections, antibiotic resistance has potentially more serious consequences for us than for countries that may have better sanitation and infection control,” author Ramanan Laxminarayan told AFP in an email.

Superbug NDM-1 (New Delhi metallo-beta-lactamase 1) created global panic when it was found in the Indian capital in 2010 and showed resistance even to carbapenems, a group of antibiotics often reserved as a last line of defence. For India, such superbugs also risk damaging its $1.2 billion medical tourism industry, in which swanky new hospitals offer everything from facelifts to fertility treatment at a fraction of the price of Western countries.

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No miracle solution

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The study criticised India's health system, including its policy makers for failing to adequately regulate use of antibiotics.

Regulator Singh pointed to state authorities, saying they needed to keep a tighter check on pharmacists, including threatening to cancel their licences if they handed over drugs without a prescription.

But Purva Mathur, member of a national government panel that is developing a new antibiotics policy, said slashing the use of antibiotics was “easier said than done”.

“There is no miracle solution to this, it won't stop overnight. But it's not as if the government is sitting back and doing nothing,” said Mathur, a microbiologist at the state-run All India Institute of Medical Sciences in Delhi.

The government last year banned over-the-counter sales of 46 strong antibiotics, including Faronem and Linospan and drugs to treat tuberculosis (TB), without a prescription.

India is home to 25 per cent of the world's 8.6 million TB sufferers and a growing number of multi-drug resistant TB cases.

The new policy will provide guidelines to all health officials on how best to monitor the manufacture and sale of antibiotics, keep track of prescriptions and launch public awareness programmes.

The policy is expected to be ready by December but implementation “could easily take a few more years”, said Mathur.

VM Katoch, head of the state-run Indian Council of Medical Research, said mass education campaigns for consumers about the dangers of antibiotic misuse need to be increased.

“Indians take antibiotics very casually, that's just their attitude,” he added.

GlaxoSmithKline to stop paying doctors to promote drugs

BY BEN HIRSCHLER, DECEMBER 17 2013, 13:33

http://www.bdlive.co.za/world/europe/2013/12/17/glaxosmithkline-to-stop-paying-doctors-to-promote-drugs

LONDON — GlaxoSmithKline (GSK) said on Tuesday it would stop paying doctors to promote its products through speaking engagements and end linking compensation for its sales representatives to the number of prescriptions doctors write.

It also plans to stop payments to healthcare professionals for attending medical conferences.

The initiative marks a first for the global pharmaceuticals industry and represents a bid by Britain’s biggest drug maker to get ahead of its critics, after being embroiled in a damaging corruption scandal in China this year.

The entire drugs industry has been under fire for aggressive marketing tactics in recent years and in the US many companies, including GSK, have been fined billions of dollars for improper sales tactics.

A number of other firms have taken steps to clean up their marketing practices — AstraZeneca, for example, said in 2011 it was scrapping payments for doctors to attend international congresses — but GSK’s actions go further.

"We recognise that we have an important role to play in providing doctors with information about our medicines, but this must be done clearly, transparently and without any perception of conflict of interest," CE Andrew Witty said in a statement.

The decision to stop payments to doctors for speaking about medicines during meetings with other prescribers marks a big shift for a global industry that has always relied heavily on the influence of experts in promoting products.

GSK said it aimed to implement this move and a related measure to stop paying doctors to attend medical conferences by the start of 2016.

The shift in payments to its sales representatives will be implemented faster, following a successful test-run in the US, where payments have been decoupled from the number of prescriptions generated since 2011.

The policy of ending individual sales targets will now be rolled out globally. GSK said it planned to implement the new compensation system in all countries by early 2015.

India probes kickbacks for doctors

http://www.bdlive.co.za/world/asia/2014/07/23/india-probes-kickbacks-for-doctors

NEW DELHI — India has ordered an investigation of doctors and laboratories suspected of offering kickbacks for referring patients for medical tests.

The probe follows a report on Hindi news channel News Nation TV, which showed laboratories in Delhi offering commissions as high as 50% to doctors who referred patients to their diagnostic centres.

The diagnostic market is the fastest-growing segment of India’s $74bn healthcare industry, according to consultancy PwC, with the segment forecast to grow to $17bn by 2021 from $3.4bn in 2011.

Newly appointed Health Minister Harsh Vardhan has vowed to clean up the health system, which he says is riddled with corruption, a problem that pervades public life in India.

India was ranked 94th in a list of 177 countries on Transparency International’s global corruption index last year, lower than China, SA and Brazil.

Officials at one laboratory visited by News Nation’s undercover reporters said they had kickback arrangements with 10,000 doctors, with monthly payments running into tens of thousands of rupees for some neurosurgeons who prescribe expensive tests.

Mr Vardhan wrote on his Twitter account: "Nation shamed by sting operation on doctors taking commission for referring tests. Have ordered high level probe. Ethics need of the hour." He also said doctors should treat the TV report "as a wake-up call", Mr Vardhan wrote on his Twitter account late on Monday. "Doctors should treat News Nation TV expose on commissions/kickback as a wake up call," he wrote.

In the past few weeks, leading doctors and advocacy groups in India have teamed up to try to eradicate corruption, forming anti-graft panels at hospitals and writing open letters to Mr Vardhan.

"You can’t make a difference in one day," said Balram Bhargava, a doctor who is forming a Society for Less Investigative Medicine at the All India Institute of Medical Sciences. "It has to be a gradual process," he said.

The anti-corruption debate gained momentum in India after Australian doctor David Berger wrote a column in May describing his encounters with corruption at a charitable hospital in the Himalayas.

MCI entitled to initiate proceeding against med practitioner | Business Standard News

MCI entitled to initiate proceeding against med practitioner | Business Standard News



The Madras High court bench here today ruled that not only State Medical Council but also Medical Council of India was also entitled to initiate proceedings under ethics regulations against medical practitioners. 

Justice K K Sasisdharan gave the ruling dismissing a petition by Dr S Sundarajan, a radiologist here, seeking to quash a Medical Council of India (MCI) direction to him to appear before the Ethics Committee in connection with a CBI report charging that he was only a "name lender" and never worked for Puducherry based Arupadai Veedu Medical College Hospital. 

The Judge pointed out that the CBI report proved that Sasidharan was only a "name lender". As many as 29 doctors including the petitioner were working elsewhere and they were mere name lenders for the college. 

The CBI forwarded the report to the MCI and then only the MCI had issued show cause notice asking as to why action should not be taken against him. 

Two show cause notices were issued to Sasidhran to appear before the Ethics Committee. But he failed to attend. It was clear that the petitioner was not prepared to face the ethics proceedings by the MCI, the Judge said. 

The CBI report revealed the sorry state of affairs in the medical education field. Medical practitioners who were practising elsewhere were stated to be signing in the attendance registers of various medical colleges across the state to make it appear they were actually working there, the Judge said. 

Their salaries were paid in cash and records were manipulated to make it appear that they were actually working there. Only during inspection, the medical practitioners were present. The medical colleges by hiring teachers in this manner and without giving practical and theoretical training to the medical students, were producing half-baked medical practitioners, the judge said. 

The ill equipped medical institutions were playing with the lives of the people. It was high time that the Central Government and MCI rise to the occasion and take appropriate action against all the institutions responsible for downgrading standards of medical education, the Judge said.

National shame: Why is India still abandoning her daughters?

http://www.firstpost.com/india/national-shame-why-is-india-still-abandoning-her-daughters-1630799.html

by G Pramod Kumar  Jul 24, 2014 07:15 IST

#BRICs   #Chandigarh (UT) Uttar Pradesh   #ConnectTheDots   #Delhi   #girl children   #Gujarat  #Haryana   #Himachal Pradesh   #India   #Madhya Pradesh   #Maharashtra   #Punjab  #Rajasthan   #Sex Ratio   #UN   #United Nations  

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Among the BRICS countries which recently met in Brazil, India stood out for the worst socio-economic indicators. From literacy to life expectancy, India was at the bottom of the table while claiming to be an emerging economy of the world.

On Tuesday, a new UN report has found one more reason for India to be ashamed of — its worsening child sex ratio or the ratio of girls to boys. "The sharply declining child sex ratio in India has reached emergency proportions and urgent action must be taken to alleviate this crisis," said the report published by UN Women and UNFPA. Worse still is the fact that India has been amongst the very few countries in the world, along with neighbouring Nepal and China, where the infant mortality rate for girls is worse than for boys.

Representational image. AFP

The report titled ‘Sex Ratios and Gender Biased Sex Selection: History, Debates and Future Directions,” takes a holistic view of the issue in the country within its historical context.

The study shows that the sex ratio in the country has deteriorated from from 976 girls to 1000 boys in 1961, to 927 girls in 2001; and to 918 girls in 2011, when biologically girl children are more likely to survive than boys and the country has made constant strides in other spheres of development.

Obviously, it demonstrates the skewed preference for boys over girls and the reasons could be simple abandonment of the girl children and sex selection. Interestingly, the study notes that even the planning of a family with one son and one daughter is not as simple as it appears: “even the stated preference of one son and one daughter needs to be interpreted with care – in my view families are actually ‘planning’ to have at least one son and at most one daughter,” says the author Mary John.

As Lakshmi Puri, Deputy Executive Director of UN Women and Assistant Secretary General of the UN notes, this trend of worsening child sex ratio demonstrates that the economic and social progress in the country has had minimum bearing on the status of women and daughters in our society.

Getting into the details of the sex ratio, within the historical context, the study says that the sex ratios in the country, taken as a whole in the last half century, declined slightly from 946 in 1951 to 927 in 1991. When the provisional results of census 2011 were initially released, the all india child sex ratio publicised was 914; however, the final population figures since put out by the Registrar General’s office have been upwardly revised to 918, making for a 9 point decline from 2001 compared to that of 18 points in the previous decade.

As of 2001, the worst sex ratios were to be found in the north and west (Punjab, Haryana, Himachal Pradesh, Delhi, Chandigarh (UT) Uttar Pradesh; and Gujarat, Rajasthan, Maharashtra, Madhya Pradesh). Jammu and Kashmir has been anomalous and the figures needed further probing, especially for 2011.

Comparatively, the east, south and north-east displayed better averages. In 2011, this picture has changed to reveal a new kind of difference between the worst states and the rest of India. Several states, such as Punjab, Haryana, Himachal Pradesh, Chandigarh now show small improvements from their prior low levels – but declines are now visible in large parts of India in 2011, of which states like Rajasthan and Maharashtra in the west, certain eastern states along with Andhra Pradesh in the south have significant declines. Therefore it has been speculated that while the severity of the practice of sex selection may have peaked in those regions where it was at its worst, it has now spread much more widely, if more thinly, across the country.

The solution is to address the underlying socio-economic reasons such as unequal inheritance rights, dowry, unequal socio-religious status, unpaid work, unequal pay, lack of economic opportunities for women, focus on male lineage, a culture of honour that places a greater burden of safety and protection on the parents of girls.

These factors contribute to building a society that favours sons and men, and neglects daughters and women. Unless this trend changes, India will continue to be in this pitiful condition. As Lise Grande, UN Resident Coordinator and UNDP Resident Representative in India notes, when it comes to gender biased sex selection, entire social structures including those linked to work, marriage and community need to change and the root causes of son preference, acknowledged and fought.”

Govt blacklists pharma company over wrongful labeling

http://timesofindia.indiatimes.com/City/Jaipur/Govt-blacklists-pharma-company-over-wrongful-labeling/articleshow/38945033.cms

TNN | Jul 24, 2014, 03.41 AM ISTJAIPUR: Health minister Rajendra Rathore on Wednesday announced that all medicines manufactured by a company called ?Pushkar Pharma' would be banned in the state after it had supplied injections which were labeled wrongly.

Rathore's announcement came during the question hour in the assembly, following the opposition's demand that the Himachal Pradesh-based pharmaceutical company be black-listed. He said the company had provided injections to Jodhpur MDM Government Hospital which carried labels stating ?only for use of animals'. The drug was injected to 155 patients and Congress deputy whip Govind Singh Dotasara had put forward a question regarding action taken against those found guilty in the matter.

In his reply, the minister admitted that such a case had come to light on June 21, 2014 and that it was an on-duty resident doctor who had noticed the labels. "However, the inquiry revealed that it is only a case of wrong labeling and not of administrating a wrong drug. The pharmaceutical company has also written to us saying that it does not manufacture drugs for animals at all,'' said Rathore.

Giving details about the action taken in the matter, he said pharmacists Hamid Hassan and Ganpatlal and Grade 1 nurse Chanddan Detha have been suspended. "Grade II nurse Jitendra Rathore has been transferred. The pharmacist of the counter from where the injections were issued was also transferred while notices were issued to the nursing in-charge of the wards where the injections were administered,'' he said.

However, the opposition legislators along with a few in the treasury benches demanded to know if any action had been taken against the company which had provided these medicines. Rathore said that these injections had not been procured through the centralized purchase system but were locally procured. "The license of the distributor from whom the injections were procured has also been cancelled,'' he said.

However, the opposition insisted on knowing what action had been taken against the company. Senior Congress legislator Pradhyumn Singh, supported by BJP legislator Narpat Singh Rajvi insisted that the company be black-listed. "It is a very serious matter and such errors can lead to severe medical accidents,'' said Rajvi. With the demand of action against the company mounting, Rathore announced that all drugs manufactured by the company would herewith be banned in the state.

In another query raised about the reuse of micro-tips in the blood bank of SMS Hospital, Rathore said that though a daily newspaper had claimed so, the report was found to be untrue. "An inquiry into the matter revealed that the micro-tips used for blood tests at the bank are not reused,'' he said. Giving details, he said that every year 56 lakh blood tests are done by the blood bank ? the figure for daily tests coming to 12,330. "The bank has latest and state-of-the-art equipment and no work is being done manually,'' he said.

Paracetamol used to treat acute lower back pain is no better than a dummy pill, research in the Lancet suggests.

http://www.bbc.com/news/health-28440007

The largest trial to date suggests the drug does not improve recovery time or provide greater pain relief than a placebo.

The study questions whether paracetamol should remain a first-choice drug on most national guidelines.

But experts caution anyone considering a change of medication should seek medical advice.

Continue reading the main story

“Start Quote

Paracetamol does not work for every type of pain, nor does it work for every person”

Dr Andrew MooreChurchill Hospital, Oxford

About 26 million people suffer from lower back pain each year in the UK, and it remains a leading cause of disability worldwide.

Sleep quality

Researchers studied more than 1,650 people across several primary care centres in Australia, who had experienced back pain for six weeks or less.

• A third received regular doses of paracetamol
• A third took the drug as needed
• A third were given a dummy pill (placebo) for one month

Paracetamol did not reduce the intensity of the pain, nor did it improve sleep quality. And scientists found there was no difference in recovery time for all three groups - an average of 17 days.

Lead author Dr Christopher Williams, from the University of Sydney, said: "The results suggest we need to reconsider the universal recommendation to provide paracetamol as a first-line treatment."

'Remain active'

The researchers say the mechanisms behind lower back pain may differ to those in pain felt in other conditions such as headaches, toothaches and post-surgery discomfort - where there is evidence that paracetamol can provide relief.

And as people in the trial recovered more quickly than those in some previous studies, they suggest the advice and reassurance provided during their trial may be more effective than medication.

Dr Andrew Moore, a senior researcher at the Churchill Hospital, Oxford, who was not involved in the research, told the BBC: "Paracetamol does not work for every type of pain, nor does it work for every person.

"There has been evidence emerging for some time that paracetamol does not benefit most people with chronic back pain for example.

"And I'm willing to bet in 10 years' time national guidelines will have changed."

Prof Roger Knaggs of the British Pain Society, told the BBC: "Despite how common paracetamol use is, this is a question that hasn't been studied in such a rigorous way before.

"For people who feel no benefit, there are alternative strategies. They should speak to their pharmacists or doctors and discuss any side-effects of other medication."

Prof Christine Lin, an author on the study, said: "Other ways to ease back pain include remaining as active as possible and avoiding bed rest."

Strides Arcolab gets USFDA approval for Tacrolimus capsules

MUMBAI: Pharma firm, Strides ArcolabBSE 1.10 % today announced that it has received approval from the United States Food & Drug Administration (USFDA) for marketing of Tacrolimus capsules, used as immuno-suppressant. 

"We have received approval from the USFDA for Tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg and (they) will be launched immediately," company statement said here. 

The product will be manufactured at the company's oral dosage facility at Bangalore and mark .. 

Read more at:
http://economictimes.indiatimes.com/articleshow/38932352.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

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Generic drugs – Panacea for affordable Health Care

http://www.lifescienceworld.in/highlight/generic_drugs.html

A generic drug is defined as “Any drug marketed under its chemical name without advertising “(U.S. Food & Drug Administration FDA)
A generic drug contains the same active ingredients as the original formulations of the branded name drug. Common examples are Crocin, Calpol etc.,

In most cases, generic products are available once the patent protection afforded to the original developer has expired.

Why Generic drugs are cheaper than brand name drugs

Manufacturing generic drugs are less costly as it neither involves the cost of Research, Development and invention, nor the marketing costs like advertising, as it is already in the market. The generic drug manufacturer’s only requirement is to demonstrate to the Regulators that the drug manufactured by them is as good and effective as the original brand name drug.

Are generic drugs as effective as their original brand name drugs for all patients

“For the vast majority of patients, switching is not an issue “says Aaron Kenath  , a physician and drug policy researcher at Harvard’s Brigham and Women’s hospital. However for a minority of patients who received anti-coagulant and anti-hypertension medicine for which there is a fine line between a dosage that is beneficial and one that is toxic.

Status of generic drug manufacture and usage in India,

Even though India is the second largest manufacturer of generic drugs and one of the largest exporters of generic drugs, exporting to over 200 countries including U.S., Europe, Japan and Australia, its domestic market is very small.

Why does the Government of India want to promote generic drugs

The Government of India in a major step to achieve Universal Health Coverage (UHC) has initiated a 5.4 billion dollar plan that would allow the doctor in the Public Health sector to prescribe generic drugs to patients free of cost. This move is aimed at making health care affordable to hundreds of millions of Indians and strengthening the Public Health system which is in a pathetic condition due to lack of funds and infrastructure.
The Indian Government spends just 1.2 % of GDP on the Health sector compared to 6 – 8% in developed countries like U.S., and other European countries. Primary Health Centres (PHC) in rural areas is in a pathetic condition with no basic facilities. At present, doctors in India even in the rural areas prescribe non – generic or brand name drugs, which are expensive and the patient has to buy these from medical shops as the Government Dispensaries do not have stock of the medicine.
As per the Government’s   initiative, 52% of the population will come under the cover of the free drug policy by April 2017.
The new policy would however hit the big pharma players hard, as the doctors will be allowed to prescribe only generic drugs and not the branded ones. As such the bigger pharmas will not be able to get a share of the 5.4 billion Dollar plan pie.

Why doctors in India do not prescribe generic drugs 

The doctors in India are habitual to prescribing brand name drugs and confident of its results, whereas in case of generic drugs, many doctors are not even aware of the chemical composition of the generic drug. Another reason is that India does not have a strict drug regulation policy which results in spurious drugs being passed off as generic drugs and may result in adverse effect to the patients. The doctors do not like to risk the lives of their patients and hence prescribe branded drugs even though they are expensive and unaffordable to the poor.
Unless there is a legislation to prescribe only generic drugs and also a strict drug regulation policy in place, the doctors will continue to prescribe branded drugs though they are exorbitant.
S.G.B.Rao – Life Science World

Brand vs Generic -A War?

http://www.lifescienceworld.in/brand-vs-generics-a-war.html

Brand vs Generic -A War?

There has been nothing unusual in our Government’s policies and directives aimed towards certain sectors/industries which create a lot of debates and differences of opinion.
This has been happening since long. In case of the pharma sector, earlier it was’ FDI in Indian Pharma sector’, now it is a  directive to promote’ Generic Drugs against Branded ones’.

         

More since last year, we have been hearing a lot about the word ‘generic’. The Health Ministry’s directive to all doctors in the centre and state run hospitals, to prescribe henceforth only’ generic drugs’. The Medical Council of India (MCI) has issued a circular stating every physician should prescribe drugs with ‘Generic Names’ 

‘Brand’ is the thing 
Let us look into the general fact. In India most people identify a product or commodity by a brand name. Even in the rural belt, people are aware of brand names than the commodity. The ‘brands’ have created a trust in us. Most of us ask for the brand name when it comes to buying, be it grocery or durables.       

Certain brands ( names ) have  created so much impact in the minds of people, that the brand and the product have become synonymous. When it comes to drugs (medicines) particularly the ‘Over the Counter’ (OTC), majority of patients   ask for the’ Brand’. An  average person asks for a  Crocin, Combiflam,  Amoxil, etc., In general, patients go by doctors’ prescriptions in case of scheduled drugs.  
Also, the branded medicines are there in the market for many years before the generic medicines.

The governments’ reasoning:
To make healthcare cheaper and affordability of medicines to the majority of the population who cannot otherwise afford private hospitals, clinics and branded medicines.

More than 70 percent of India's population lives in rural areas and nearly 40 percent of the population is either below the poverty line or hovering close to it. Public healthcare is the only option for millions of the rural poor who cannot afford the costly private healthcare in the country.

The Health Ministry’s directive is mainly to bring down the accelerating cost on healthcare. The majority of the people cannot afford costly branded medicines. Hence, the promotion of generic drugs  which are no different from the branded ones. So, this directive will help reduce the cost of drugs considerably and benefit people at large.

But this is not the only reason.  The government also wants to put to an end the unethical practices of the Pharma , who induce the doctors to prescribe their branded drugs over Generic drugs.

 What the doctors feel
Most of the doctors are apprehensive about the quality of generic drugs. According to a doctor in AIIMS on condition of anonymity, “there are certain generic medicines that don’t work like the branded ones ,In fact, in AIIMS, for our own use and the staff's use, certain generics are not prescribed, instead branded ones are preferred," the doctor said.

LSW LifeScienceWorld approached some experts to seek their views on this hot topic and this is what they have expressed:

This is what they say:

Dr.Narendra Saini
Hon. Secretary General, Indian Medical Association

Upon contacting IMA ((Indian Medical Association) for its views, Dr.Narendra Saini, Hon. Secretary General informed of a meeting held on 6th of February, 2013 at the IMA H.Q, New Delhi on the feasibility of Generic Drugs that was attended by the office-bearers of IMA, Drug Controller of Delhi, Director Health Services, Eminent doctors of India, representatives from pharma industry and lawyers.

Dr. Saini mentioned some of the points that were discussed. “Govt. should control the MRP of drugs, generic or branded so that benefit reaches the common man. At least the price control of MRP of all essential drugs is of paramount importance and their list should be published and revised regularly. IMA members should maintain the rational use of drugs while choosing a drug and ensure it qualifies the criteria: quality safe drug and yet affordable.

Since in our country, patients have very limited access about the information of drugs and even persons employed in chemist shops are also not qualified, proper checks and balances are essential to  ensure that patients get the best medicine on physician prescription.
The web site of Drug Controller of India should mention the names and addresses of manufacturing and marketing companies authorized by them to ensure the traceability of the product. It should also mention the MRP of drugs.”

Dr. Ganesh Mani
Cardiothorasic surgeon Indraprastha Apollo Hospitals, Delhi

The renowned Cardiothoracic Surgeon Dr.Ganesh Mani, of Indraprastha Apollo Hospitals has something novelistic to say:
“To my mind, the cost of healthcare as it appears, is to a large extent, exaggerated by "frills" of the pharmaceutical companies in:
1.Packaging & cartoning for retail use. 2. Brand promotion among physicians to get brand-loyalty for specific prescriptions.
3.Salaries  of drug representatives in large numbers to achieve personal friendships with physicians and thereby modulating their prescriptions!
4. Printing of large amount of promotion literature to act as education & reminders.
5.Organising  expensive travel to physicians to exotic locations to win their favour of loyal prescriptions as a return for memorable experiences.
6.Gifts and souvenirs with personalized inscriptions !


If these companies sell their drugs without the additional cost of their promotion as detailed above, hospitals and patients could get the same drug at a fraction of the price. These are called 'generic' medicines and have to be guaranteed by the companies for their quality and efficacy as 'equal' to their branded retail products.

The cost to the healthcare provider would reduce considerably without any compromise of quality of healthcare delivery. The savings accrued could augment the profit of the hospitals even if a portion of the savings is passed on to the patient.

I strongly recommend the use of 'generic' drugs provided there is a guarantee of the quality of the product used on the patient. Needless to add, the defaulters who compromise quality or efficacy (for profiteering) must be severely dealt with as a dis-incentive to such practices.”

Below are some of the views expressed by the industry and association personnel:

Ranga Iyer
Former Managing Director, Wyeth Ltd, immediate past President of OPPI and currently Pharma Consultant

Ranga Iyer, former Managing Director of Wyeth and immediate past president of OPPIfeels that by popularizing generic medicines, the branded medicines will not be affected. Multinational pharma companies who are producers of innovative drugs with established brands have their share of market, customers and patients.

Currently a leading pharma consultant, Ranga says, “India is a vast country with different strata of population with different demographic setup. The market is vast for all players of all class and categories.

Government wants to promote generic drugs mainly to make drugs and healthcare expenditure more affordable by a larger population who otherwise cannot afford private hospitals and branded drugs.

But the concern is that of quality. So long as the generic drug manufacturers maintain the standard of quality adhering to strict GMP rules, there should not be any worry. The government should see to it that the norms are followed to the core.

If the promotional policy of the government gathers momentum and if some of the multinationals wishes to venture into making generics, no one can stop them.

The ultimate purpose is to make healthcare cheap and affordable by all. After all medicine is a necessity and is taken with a purpose.” 

Abhay  Kumar
President-Indian Pharmacist Association

Abhay Kumar, President-Indian Pharmacist Association
The Health Ministry’s directive asking the doctors to prescribe Generic medicines is a very positive and legitimate directive as a whole. As far as the Pharmacist is considered, he/she would be the most happy to see a prescription with the generic medicine, as he will be not bounded by the "Brands" which some Physician restrict for 'not to be substitute'. This step of the GOI not only will lead to cheaper medicine to the under-deprived patients but will also encourage several other Pharmaceutical companies to market their product in Generic as well. As we all know that potency and pharmacological value of these generic drugs are as good as the branded one, there should any misconception among the common people about the "Generic medicine". So, government should also launch some awareness campaign about the efficacy of the generic drugs in addition to issuing such directive to the Physician to prescribe generic medicine.  
                
At the end we at the IPA welcome this step of Govt. of India and would request all those who stands on the other side in this regard to support this for the betterment of the common people of India, who needs this cost effective  'Generic Medicine" the most. 

Jatish Sheth 
Vice Chairman Confederation of Indian Pharmaceutical Industry (CIPI) ,
Committee member, Karnataka Drug s * Pharmaceuticals Mfgs Assoc. Director, Srusshti Pharmaceuticals

Jatish Sheth, Vice chairman, Confederation of Indian Pharmaceutical Industry (CIPI), Committee Member Karnataka Drugs &  Pharmaceutical Manufacturers Association and director, Srushti Pharmaceuticals.

“A story of Nobel Intentions but Misplaced Understanding of Realities” says Jatish Sheth,

According to him, there is a perception in the minds of the law makers (influenced by recent television programs and news items ) that if the doctors Rx generic drugs , the cost will be less .

The perception now is that there is a unholy nexus between Drs and Pharma companies to Rx a particular brand and hence if they take away this freedom from the Dr’s there will be a reduction in prices.

But there is no law to restrict the price of the end product and so in the future if the Dr Rx’s the product, it is the Chemist who will decide which company generic should be given , so the company who give the chemist the higher margin will be the one that the patient gets .

In these circumstances, the Dr or the Patient have no clue on who is the company manufacturing the product what he will be taking .

Imagine the consequences

It is a well-known fact that companies are very possessive of their Brand Names and Brand Image , Most will go out of their way to nurture and protect their brand names and hence will always ensure Quality of the product , packing etc. , Once we take away the Brand from the Rx , What is the motivation to have high quality , Companies will simply meet basic requirements and sell the product .
There is also a matter of confusion and Risk involved.

Say a Dr Rx’s Asprin 250 to a patient … Should the Chemist give Buffered Asprin , Enteric Coated Asprin or Dispersible Asprin .. ? All 3 are different in their form and use , While a Dispersible asprin is generally used for instant relief from pain , a enteric coated is usually used by long term users for blood thinning .

Imagine the consequences if one is dispensed to the other .

The same goes for Sustained release vs Instant Release products , or Capsules vs tablets , or Syrup vs Suspensions. The fact is that within the same Generic Molecule , there are various forms.

Then there is the question of the survival of the Industry and the Medical Reps who form the threads of the fabric of the Pharma Industry … Know this …

Anjarakandy, , Gaddi, Sakaldiha Chahaniya, Bhadar, Doharighat Amila, Bargadwa, Bannur, Bazarbad, Sidartha, Udayagiri, Kondapalli, , Repallie, Most of us will not recognize these names, or maybe mistake them for some mythical area seen in movies.

These actually are small towns in some remote parts of India which have 10 doctors or more and I think  each of these sees 100’s or 1000’s patients in a month.  

Today, doctors in these areas are able to treat their patients with the latest and the best medicines available only because the Medical Representative of different Pharma companies go to these towns, meet the doctors, detail the product, hand over samples for them and follow-up on their visits every month.  The doctors thus ,  can then compare the  quality of different companies , prices , availability and prescribe appropriate prescriptions to his patients when required .

The patients of these towns get same treatment for   severe infections , diabetes , or any other ailment  as someone who is treated in AIIMS and for that matter, any other prestigious Institutes in India.  

It was the Small Companies in India who’s reps first started meeting these doctors and  we called  it “ Micro Interior Working “ before recently , when the potential was seen by the larger companies and multinationals who followed and launch special “ Rapid Rural Penetration Task Force “ 

If the government moves to a Generic system of Rx , all the reps will become redundant as then it will only be a matter of Selling at the lowest price .

No company will be able to afford any investment in Marketing and this will lead to the total collapse of the Industry ( At least those who have a marketing team )

Imagine the consequences of lacs of medical reps. and the teams that go with them losing their jobs

Having said this , there is no doubt that the intentions of the Government in wanting to make available quality medicines at affordable price is commendable, but this requires some sustainable plans that will benefit all .

Already there is a National List of Essential Medicines that meet covers most of the common diseases , the government would do well to put a cap on the prices of these medicines and make them available across the country , May be companies by way of a social commitment , are made to manufacture all Essential Medicines of at least 5% of their turnover and sell to the government or market at cost , this will bring great relief to all those who need them .

As a country we hardly have brands known the world over . Brand gives visibility to a nation. USA has been able to capture the imagination of mothers all over the world with Johnson Baby Powder or Band Aid The pharmaceutical sector in India is on the verge of doing it.  Omez, Nice gel are popular brands here and abroad. We need to create more brands and with this directive of prescribing only by generic name we are losing a big opportunity as any brand has to be home grown first

Shri.  Rajesh M. Gandhi
CEO, Royal Chemist

Rajesh Gandhi, CEO, Royal Chemist:, India’s one of the oldest chemist shop in Mumbai.
If all the medicines are marketed only by generic name then one medicine will be available made by so many small as well as big companies. the customer will not be in a position to differentiate between them and although he might get them at cheaper rate but he will not be able to be confident about the manufacturing quality of the same. As big and multinational companies usually do not compromise with the quality but which also increases the cost. So they might lose the incentive to maintain the quality and go for the price reduction only. In short customer will benefit in price but suffer in quality.

This is our opinion and we feel that there should be a balance between the quality and the price.
The ultimate purpose is to make healthcare cheap and affordable by all. After all medicine is a necessity and is taken with a purpose.”

(Note: LSW has only reported the views and opinions of the above and do not either agree or disagree to their views and opinions.)

Also read: 'Generic drugs – Panacea for affordable Health Care' (http://www.lifescienceworld.in/highlight/generic_drugs.html)