WASHINGTON — A new study shows that a combination of drugs can be used in targeted therapy against a common type of lung cancer.
Lung adenocarcinomas, the most common genetic subtype of lung cancer which has long defied treatment with targeted therapies, has had its growth halted by a combination of two already-in-use drugs in laboratory and animal studies, setting the stage for clinical trials of the drugs on patients, researchers at Dana-Farber Cancer Institute in Boston, Massachusetts and other scientists report in a new study.
The study, published in the journal Cancer Discovery, describes a new tack in the treatment of lung adenocarcinomas which account for about 40 percent of all lung cancers that carry mutations in the gene KRAS.
While most efforts to target KRAS directly with drugs have not proved successful, the authors of the current study took a more circuitous approach, targeting KRAS’s accomplices, the genes that carry out its instructions rather than KRAS itself, reports Science Daily.
“About 30 percent of lung adenocarcinomas have mutations in KRAS which amount to nearly 30,000 of all patients diagnosed with lung cancer each year in the United States,” says the study’s senior author, David Barbie, MD, of the Lowe Centre for Thoracic Oncology at Dana-Farber and the Broad Institute of Harvard and Massachusetts Institute of Technology.
“That represents the single biggest subset of lung cancer patients, if grouped by the mutations within their tumour cells. Unfortunately, there has not been a reliable way of striking at the genetic mechanism that causes these cells to proliferate.”
Mutations in KRAS cause cancer cells to grow and divide in a wildly disordered way. The lack of drugs able to block KRAS safely has led investigators to look for ways of stifling its effects “downstream” by interfering with the signals it sends to other genes.
“The next step will be to take these results to the clinic where the combination can be tested on lung cancer patients,” says Wong.
“We’re in the process of developing a clinical trial. Because KRAS mutations are also common in colon and pancreatic cancer, we’re hopeful that trials will be organised for these patients as well.”
Researchers from St Jude Children’s Research Hospital in US said the drugs increased survival of mice infected with TB and were effective against drug-resistant strains of TB. The antibiotics, called spectinamides, were created by changing the chemical structure of an existing antibiotic, spectinomycin, which does not work against TB. In multiple trials of mice with both active and chronic
TB infections, researchers found that one version of the new drug – an analog known as 1599 – was as good as or better than current TB drugs at reducing levels of the bacteria in the lungs of mice.
In addition, 1599 caused no serious side effects.
“This study demonstrates how classic antibiotics derived from natural products can be redesigned to create semi-synthetic compounds to overcome drug resistance,” said corresponding author Richard Lee, a member of the St Jude Department of Chemical Biology and Therapeutics. The new class of antibiotics works against TB by disrupting the function of a part of the cell known as the ribosome, which is responsible for protein synthesis. To do that, the spectinamides bind to a particular site on ribosomes that is not shared by other TB drugs. That allows the drug to be used in combination with other medications.
For this study, researchers used an approach called structure-based design to re-engineer how spectinomycin binds to the ribosome.
To guide their design efforts, scientists used a 3-D model that provided an atomic-level view of spectinomycin bound to the tuberculosis ribosome.
The research reported on the first 20 of the more than 120 spectinomycin derivatives that have resulted from the effort. The list includes 1599 and two other analogs tested
against TB in mice, researchers said.
The three analogs not only bound the ribosome tightly, but they were more successful at avoiding a TB resistance mechanism called efflux.
The TB bacteria use efflux pumps as a strategy to remove drugs and other threats from the cell before they can work against the bacteria. Efflux pumps, however, did not protect TB against spectinamides, researchers said.
The drugs were also effective against multi-drug-resistant strains of TB growing in the laboratory. The strains had been isolated from patients with the disease.
The study is published in the journal Nature Medicine.
Cervical cancer in women is decreasing, while uterine and gall bladder cancer is on the rise at least in major metropolitan cities, suggests India’s latest cancer statistics without providing any explanation for the observed trend.
According to the population based cancer registry prepared by the Indian Council of Medical Research (ICMR), actual reported cases of cervical cancer declined between 2009 and 2011 in Bangalore, Bhopal, Chennai, Delhi and Mumbai. Decline was seen in Assam, Mizoram and Thiruvananthapuram, too. Uterine cancers, are on the rise in Bangalore, Chennai, Delhi and Mumbai in the same period. In Bangalore, the number of cases increased by 7.4 per cent between 1986 and 2009, whereas the rise was 7.3 per cent between 2005 and 2010 in Mumbai, compared to 1.7 per cent increase between 1982 and 2004.
“There is a declining trend in cervical cancer and increase in uterus and gall bladder cancer cases in some cities. We don’t know the reason yet,” said V M Katoch, director-general of ICMR. In the country, breast and cervical cancer remain the two most common cancers in women.
Among men, cancer of the lung, mouth, oesophagus and stomach are common. Cancers of the tongue, rectum, liver, lung, prostate, brain, non-Hodgkin’s lymphoma and a type of leukaemia have shown statistically significant increase.Cancer of the gall bladder in women is increasing in Chennai, Bangalore and Bhopal. In Delhi, the hike is seen in men, whereas in Mumbai, it went up both in men and women. Lung cancer among women, too, had increased in the four metros.
The new statistics come from collation of data from 28 population based cancer registries, covering 7.45 per cent of the population. As many as 250 centres contributed to the database, which was approved by ICMR’s top science advisory panel last week.
This is the third report from the ICMR registry with the addition of new sites.
Ranbaxy facilities in India are being reviewed after its US arm, Ranbaxy USA admitted to manufacturing certain drugs which didn’t follow the rules of ‘good manufacturing practices’ and were considered ‘adulterated’ under USFDA law, Health Minister Ghulam Nabi Azad said.
The Minister was replying to a query in Rajya Sabha on steps taken by the government to ensure that ‘adulterated’ drugs are not sold in India after Ranbaxy USA Inc admitted in the US District Court of Maryland to manufacturing and distribution of certain drugs not in conformity with GMP. The Drugs Controller General of India has been ordered to review facilities of Ranbaxy in the country to ascertain the quality of drugs manufactured for domestic market, he said.
Ranbaxy USA agreed to pay a whopping $500 million and pleaded guilty to three felony counts under the federal Food, Drug and Cosmetic Act (FDCA), and four felony counts of knowingly making material false statements to the Food and Drug Administration (FDA), it said.
Azad, in a written reply in Rajya Sabha, said, ‘The Drugs Controller General of India has already been ordered to review the GMP compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities.’ The Minister said the Supreme Court of India has not admitted the PIL against the company.
‘As per the US Law, any drug is considered adulterated, if it is not manufactured, processed, packed, etc in conformity with the Current Good Manufacturing Practice (CGMP) regulations of the USFDA. However, as per Drugs & Cosmetic Act & Rules, in India, manufacturing of drugs not in conformity with Good Manufacturing Practice (GMP) is viewed as non-compliance to GMP under the said Act & Rules,’ he said.
The Ranbaxy story till now…
The Ranbaxy episode started in September 2008 when the USFDA issued two Warning Letters to Ranbaxy Laboratories and import alert for generic drugs produced at two different plants. However, in June 2008, Daiichi Sankyo, a major Japanese company had procured a majority in Ranbaxy in a deal believed to be worth $4.6 billion dollar. A fortnight ago, Ranbaxy offered to pay a $500 million fine for selling adulterated drugs and pleaded guilty to seven criminal counts including fudging of data, intention to defraud and failing to report that its drug didn’t meet specifications. Since then a lot of dirty linen has been washed in public with the Japanese company accusing the Singh brothers – the former owners of Ranbaxy of concealing and misrepresenting critical information regarding the USFDA investigations. Malvinder Singh, the former Chairman however eschewed all guilt and claimed the Japanese company had mismanaged the company. He said, ‘There was no misleading… Daiichi… approached us…when they came, US FDA investigations were on. They knew about it and it was public information. So there was nothing that was hidden. Whatever they wanted and asked for was shown to them. They did a due diligence. Who would risk $5 billion without a due diligence?’
Meanwhile the Drug Controller General of India (DCGI) Dr GN Singh said that all the approvals given to Indian drugs manufactured by Ranbaxy Laboratories were in order. As per the laws, there was no indication of any company violating the Indian laws, including Ranbaxy. However, Dr Singh admitted that all matters including approvals in the past would be examined again. Dr Singh added that appropriate action would be taken and a special team would be set up to examine the case. They would send officials to the US if the situation demands it. ‘My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty,’ Dr Singh told Pharmabiz. After these events, the Indian Medical Association asked the Drugs Controller General of India (DCGI) to investigate the quality of drugs sold by Ranbaxy Laboratories in India.
The Ranbaxy issue evoked a strong response from the government which said that the country ‘has proven international quality standard capabilities’. India enjoys ‘a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds’, the statement added. It invited global importers to visit factories to ‘satisfy themselves of the quality of production of drugs’. There’s a school of thought which believes that all the complaints about generic medicines originate from Big Pharma with big brands unhappy with the growing use of cheap generics, as developed nations fight to lower healthcare costs. Also read: India vs Big Pharma
As the new prices of essential medicines fixed in accordance with the national pharmaceutical pricing policy and the Drugs Price Control Order 2013 is all set take effect from July 29, apprehension is mounting about the possible shortage of the drugs under control in the market.
In the first batch, the National Pharmaceutical Pricing Authority (NPPA) had revised the prices of 151 formulations on June 14 with a window period of 45 days for implementation by the pharmaceutical companies. Some of the drugs whose prices have been fixed are insulin, ibuprofen, metronidazole combinations, dexamethazone combinations, rifampicin combinations, carbamazepine etc.
However, many parts of the country are going to face shortage of these drugs, if the current situation is any indication. A random check with some retail outlets in the national capital region showed that many chemists had already returned the existing stocks of these drugs back to the wholesalers and to the companies for relabelling. But the drugs with new labels are yet to reach the retailers, indicating a possible shortage of many formulations.
“Some companies had asked us to sell the existing stocks with a reduced price as per the new prices. But that is not practical as we purchased them at higher prices and no clarification was made on the trade margin and other logistics,” a chemist at Ghaziabad said.
Opting less complicated route, the retailers have returned the stocks almost fully. Several chemists admitted that the new stocks with new labels were yet to reach them. “We hope, these will be available in time,” on shop-owner claimed.
The chemists are also demanding that the government should give more time to exhaust the existing stocks before implementing the new prices.
There is also allegation that the companies and the chemists together were trying to create the shortage so that higher priced alternatives could be pushed under the disguise of practical difficulties.
The Drug Controller General of India (DCGI) had already specified that he was not against the companies relabelling the existing drugs already produced, considering the practical difficulties involved.
The State Drug Controllers have been reportedly asked to ensure the availability of drugs with new prices. The task of making sure that these drugs are not sold at higher prices is with the district level drug inspectors.
According to the new pricing policy, the ceiling of prices will be done based on the simple average of the prices of all brands of that drug that have a market share of at least one per cent. The national list of essential medicines has 348 bulk drugs, which are sold as 650 formulations.– Joseph Alexander, New Delhi
The industry claims the medicine was banned suddenly without following the proper consultation process with the Drug Technical Advisory Board (DTAB) or the companies.
The industry is gathering scientific data to approach the regulator, Drugs Controller General of India (DCGI), for a review of the suspension order. If that doesn’t work, legal options could be tapped to challenge the suspension.
“We are demanding a review. A ban has to be based on science and scientific data. It has to follow a proper process and be evaluated by the DTAB and with the knowledge and consultation of the industry,” said Indian Pharmaceutical Alliance secretary general D G Shah.
He added if the government did not seek the industry’s views and review the suspension of pioglitazone, the industry body might evaluate legal options to challenge the process of imposing the ban.
Lupin, which sells pioglitazone-based combinations, said it was surprised at with the government’s decision as the drug was in use in many major markets.
“This drug is in use in most advanced markets of the world, be it the US, Japan or the UK. I believe the DCGI has invited comments and responses from the industry and it should come up for review, which would be a very welcome step,” Lupin group president, India and CIS (Commonwealth of Independent States) Shakti Chakraborty told Business Standard.
Pioglitazone is currently available in India under various brands such as Diavista by Dr Reddy’s Laboratories, Sun Pharma’s Pioglit and Pioglar by Ranbaxy Laboratories.
The drug commands a market of Rs 700 crore. According to a DCGI official, the government is likely to review its order. “The case is under consideration. We can review the order if the industry submits enough scientific evidence in favour of the drug,” said the official, who did not want to be named.
In June, the government notified suspension of manufacture and sale of pioglitazone, along with two other medicines, analgin and deanxit, in the country without specifiying reason.
Sources say it was triggered by the health ministry’s commitment to a parliamentary committee that it would immediately suspend medicines not allowed for sale in major international markets.– Business Standard
The Government is open to re-examine the case of anti-diabetes drug pioglitazone and revoke the ban if strong scientific evidences emerge in support of its safety and efficacy, Drug Controller General of India (DCGI) Dr G N Singh informed.
However, he defended the ban of the drug as per the existing system and adverse reactions, and strongly refuted the allegations that it was banned to help some other brands.
“It is not a closed case. We are open-minded in the case of pioglitazone, unlike in the case of the two other banned drugs– analgin and deanxit. Science is progressing and we are willing to re-examine the ban if the companies concerned or the scientific community come up with scientific evidence to prove its safety and efficacy,” Dr Singh told Pharmabiz.
While indicating that it was kind of ‘suspension’ of manufacturing more than the blanket ban, the DCGI said the decision to ban drug was taken as per the existing norms. “The Health Ministry had made a written commitment before the Parliamentary panel that any drug banned in more regulated countries would be banned in India also immediately. Pioglitazone is banned in developed countries like Germany and France,” he said.
Apart from this, there were also cases of adverse reports about this anti-diabetes drug under the pharmacovigilance programme in India, further strengthening the case for a ban now, the regulator revealed.
The ban of pioglitazone had raised a storm with the industry leaders questioning the step and there were also allegations that it was banned to help some other existing brands. However, the DCGI strongly denied such allegations as ‘totally baseless’.
Pioglitazone is one of the commonly-prescribed medicines. As many as 300 brands are available as single drug as well as in combinations with other drugs such as metformin and glimepiride. The sudden ban had raised protests from the industry which claimed that it was available in most of the countries across the globe.Joseph Alexander, New Delhi
Tuesday, July 02, 2013, 08:00 Hrs [IST]
“Make health your ‘new high’ in life, not drugs”. This is the theme for International day against drug and abuse and illicit trafficking this year. Every one of us wants to be fit, healthy, and live a long active life. Well, we all know that a healthy person doesn’t smoke, is at a healthy weight, exercises and eats healthy. Sounds simple, but those who have tried changing their habits know how difficult it could be. Some people decide to make drastic changes, but when they face the difficulties, they just lack motivation and give up. So it is a hard decision that one needs to make in order to make health a priority in life. The secret to healthy life is simple that is small changes lead to big results. Start today and you will have a healthy and hearty life.
Every year the United Nations’ (UN) International Day against Drug Abuse and Illicit Trafficking falls on June 26 to raise awareness of the major problem that illicit drugs represent to society. This day is supported by individuals, communities and various organizations all over the world. The aim and purpose of this day is created awareness on the harmful effects drugs and its impact on the communities and societies at large. It is an endeavor that has made many individuals and communities to take strong actions against the menace of substance abuse. As an expression of its determination to strengthen action and cooperation to achieve the goal of an international society free of drug abuse. In the words of Kofi Annan, UN Secretary-General, “Illicit drugs destroy innumerable individual lives and undermine our societies. Confronting the illicit trade in drugs and its effects remains a major challenge for the international community.”
Last year the theme was “Global Action for Healthy Communities without Drugs” is the theme of this year’s world drug campaign. According to the United Nations Office on Drugs and Crime (UNODC), nearly 200 million people are using illicit drugs such as cocaine, cannabis, hallucinogens, opiates and sedative hypnotics worldwide. The United Nations Office on Drugs and Crime (UNODC) leads the international campaign aimed at raising awareness of the major problem that illicit drugs represent to society and especially to young people. The goal is to inspire people and mobilize support for drug control. The use and abuse of illicit drugs harms individuals, families and society at large. Drugs control the body and mind of individual consumers. The drug crop and drug cartels control farmers, trafficking and crime control communities.
Teenagers and young adults are particularly vulnerable to using illicit drugs. The prevalence of drug use among young people is more than twice as high as that among the general population. At this age, peer pressure to experiment with illicit drugs can be strong and self-esteem is often low. Also, those who take drugs tend to be either misinformed or insufficiently aware of the health risks involved. According to Secretary-General Ban Ki-moon, “Our efforts to promote development and fight drugs and crime will be more effective if they are rooted in partnerships with the young, civil society, governments and the international community. Working together, we can alleviate the suffering of millions and break the hold of drugs and crime on countries, communities and families.”
According to medical sciences the habitual use of or dependence on harmful substances like liquor / alcoholic drinks, tobacco, bidis / cigarettes, drugs (for other than prescribed medical treatment) called substance abuse or addiction. As the range of addictive substances continues to expand, more and more persons particularly, in the younger age groups get addicted. There are many factors that are responsible for pushing the young as well as adults into the trap of substance abuse. These factors include peer-pressure, non-conducive family environment and stress. The risk is that many of our youth are not aware of these factors and get into these habits.
Our parents have to be considerate to children, particularly during their transition from childhood to adolescence and adulthood, when many changes occur in their physique. Adolescents are naturally curious, they are exploring new worlds, ideas, behaviors and relationships. In the process, some are exposed to drugs. Unless their environment, families, schools and friends educate them about the ill effects of using drugs, they are likely to be trapped. Drinking and smoking are the most common as well as harmful addictive actions. It is the duty and responsibility of civil societies to promote healthy life styles to avoid harmful habits.
Drinking or intake of liquor /alcohol is a very serious problem in our society today. The easiest pastime is to drink and many of our young people are lured into this menace. The youth think that it is a good pastime and also to forget worries, frustrations and other hardships of life, even though it is only temporary. If they cannot afford the standard variety, which is expensive, they go for the cheap variety. At times they drink even the poisonous things. After drinking, they lose their senses. Sometimes it results in death or permanent disability.
The use of tobacco is on the increase. Smoking is a habit which is very harmful to health, even more than drinking. Not only does it harm the smokers themselves, but also the people around them who are affected by the smoke in the atmosphere. If we respect the rights of others, then we should not smoke public places like buses, trains, markets, offices etc. Smoking is a major cause of pollution and develops deadly diseases like cancer, heart diseases, breathing problems etc. Many of our young people are not aware of the consequences of this nicotine and abuse them without restrictions.
No country or state can progress unless it pays adequate attention to the development of children and youth. A child is the future citizen of our state and the development of the state is the responsibility of every youth. Only those children and youth who grow in a healthy atmosphere can contribute to the development and strength of our state and our country. Our country has a large population of children and youth. It is our duty to make sure that they are provided with the opportunities for good health and education. During adolescence, young people experience profound physical changes, rapid growth and development, and sexual maturation, in addition to psychological and social changes. This often leads to issues with personal identity, sense of self and emotional independence. In an attempt to cope with the complex changes and challenges of development, they may engage in behaviours considered to be experimental and risky.
Addressing the positive development of young people can decrease these problems by facilitating their adoption of healthy behaviors and helping to ensure a healthy transition into adulthood. Youth development, the process of growing up and developing one’s capacities, happens no matter what we do. The challenge is to promote positive youth development and plan quality experiences with young people. Our programmes and plans have to stimulate, challenge, and encourage youth and adults as they work together to plan, conduct, and evaluate quality experiences. Whether you are a parent, teacher, volunteer, youth development professional, or teenager, this planning guide will help to work with youth. Youth development, then, is a combination of all of the people, places, supports, opportunities and services that most of us inherently understand that young people need to be happy, healthy and successful.
Supports: Motivational, emotional and strategic supports to succeed in life. The supports can take many different forms, but they must be affirming, respectful, and ongoing. The supports are most powerful when they are offered by a variety of people, such as parents and close relatives, community social networks, teachers, youth workers, employers, health providers, and peers who are involved in the lives of young people. Services: Services in such areas as education, health, employment, and juvenile justice which exhibit relevant instruction and information, challenging opportunities to express oneself, to contribute, to take on new roles, and be part of a group, and supportive adults and peers who provide respect, high standards and expectations, guidance and affirmation to young people. Our churches and other social units have to mould the youth with these visions.
Opportunities: Chances for young people to learn how to act in the world around them, to explore, express, earn, belong, and influence. Opportunities give young people the chance to test ideas and behaviors and to experiment with different roles. It is important to stress that young people, just like adults, learn best through active participation and that learning occurs in all types of settings and situations. Our educational institutions shall become the epitome of learning for life through practical knowledge.
A young person will not be able to build essential skills and competencies and be able to feel safe; cared for, valued, useful, and spiritually grounded unless their family and community provide them with the supports and opportunities they need along the way. Thus youth development is a process in which family and community must actively participate. Our body is our temple, and we need to take care of it to have a healthy life. We need to maintain it with proper care and support. Love your bodies and make sure you remain healthy. Life is beautiful and you don’t want to bog yourself down with unnecessary health problems. Today, your vital organs (kidney, heart, lungs, gall bladder, liver, stomach, intestines, etc) may be working well, but they may not be tomorrow. Don’t take your good health today for granted. Take proper care of your body. Good health isn’t just about healthy eating and exercise – it also includes having a positive mental health, healthy self-image and a healthy lifestyle because they are going to be vital in living a healthier life. On this day let us all unite together to promote good health and make our youth free of substance abuse and lead a healthy and happy life.
Fr. Joe Mariadhas
Asst. Professor and Counsellor
St. Joseph’s College
Jakhama – Nagaland