Pharma news

 The U.S. Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a contract to develop Quality by Design guidance on design space specifications.

The intention of this award is development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology. QbD is aligned with the Center for Drug Evaluation and Research’s Critical Path Initiative and Moving Manufacturing into the 21st Century to develop new manufacturing approaches that improve pharmaceutical manufacturers’ ability to assess and improve product quality.

“This brings a greater degree of science into the pharmaceutical manufacturing process; bringing in more front-end quality and less dependence on back-end inspections,” said Prabir Basu, Executive Director of NIPTE. “The framework developed through this research will be tested on a specific drug product.”

The results of this study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications. By strengthening the science-based technology through the QbD initiative, FDA is continuing to improve its regulation of new medical products by using the best management approaches, the best information technology, and the best quality systems and review processes.

This research will begin this year and is expected be ongoing through September of 2010.

About NIPTE

The National Institute of Pharmaceutical Technology and Education (NIPTE) is an independent, non-profit organization representing 11 U.S. universities that are leaders in pharmaceutical science and engineering. The member universities are Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kansas, University of Kentucky, University of Maryland - Baltimore, and the University of Minnesota. http://www.nipte.org

Source
Christy Maginn
Merritt Group on behalf of NIPTE

NIPTE

This place is organised mayhem. Toddlers scoot all round the place in plastic cars.

There’s a queue for the trampoline. The mums are taking it easier.

Some are sitting round drinking coffee, a few are feeding their newborns.

Amarjit is here with her little boy Caspar. The 22-year-old mum has another baby on the way and says it’s not easy.

“It is quite scary looking after a child. Nothing prepares you for it,” she said.

She says she wouldn’t have a clue what she’d do if her son suddenly stopped breathing.

And she’s not the only one.

Cynthia remembers the time her little boy fell down an entire flight of stairs.

Emma’s baby has serious food allergies.

She’s had to rush him to hospital three times and says it’s always terrifying.

Charlotte’s been lucky with her kids, but is still worried about this. She’s paid for a private first aid course.

She said: “We just learnt basic stuff, emergency first aid. It was very useful. A bit scary, but useful.”

At the moment, there isn’t a course like this on the NHS.

But the Royal Life Saving Society UK is going to start giving free two-hour classes in various cities.

Most of the mums here think it’s a great idea.

Sarah has three kids and thinks she could do with signing up for the sessions.

She said: “I think it would be great, especially for things like choking.

“It freaks me out that I wouldn’t get it right, and that she’d go more blue and I wouldn’t know what to do.”

But Amanda isn’t convinced that a two-hour session could really make that much difference.

“Unless you’re going to use it regularly you won’t remember it,” she said.

“When you’re panicking, and your child is ill, you just freeze, and you really need an expert.”

 Endometrial carcinoma is the most common gynecological malignancy among postmenopausal European women. Patients with high-intermediate risk endometrial cancer (based on age, tumour stage and grade) who receive no further treatment following surgery, have an approximately 20% risk of developing a locoregional recurrence, of which 75% are located in the vagina and 25% in the pelvic lymph nodes. Postoperative pelvic external beam radiotherapy (EBRT) significantly reduces the rate of locoregional recurrence to 5% at five years.

The multicentre randomised PORTEC-2 trial was initiated to investigate if vaginal brachytherapy (VBT) would be equally effective in reducing the risk of locoregional recurrence, while at the same time reducing treatment related toxicity and improving HRQL.

Between 2002-2006, 427 patients were randomised (214 to EBRT and 213 to VBT). With a median follow-up of 36 months, the vaginal recurrence rates were not significantly different between the two arms (0.9% for VBT vs. 1.9% for EBRT, p=0.97), showing that VBT is very effective in preventing vaginal recurrence. In addition, locoregional recurrence rates (4.0% for VBT vs. 2.5% for EBRT p=0.15), overall survival and relapse-free survival rates (both 90%), were not significantly different between both treatment arms.

While the efficacy of the two treatments was similar, quality of life was better after VBT. Patients receiving VBT after surgery reported significantly and clinically relevant lower levels of diarrhoea (p
As patient reported quality of life after VBT was shown to be better than after EBRT and efficacy of both treatments was similar, VBT should be the treatment of choice for patients with high-intermediate risk endometrial carcinoma.

Nout Remi et al. LUMC, Leiden, Netherlands

About ESTRO 27

ESTRO 27 (September 14th to 18th, 2008) offered an outstanding scientific programme combining lectures from eminent invited speakers, proffered papers and poster discussions, teaching lectures on a wide range of topics including clinical issues, brachytherapy, radiobiology, physics and technology as well as debates on controversial topics and clinical case discussions, a special poster reception, poster discussion sessions and electronic poster viewing.

ESTRO 27 hosted the largest European exhibition in Radiotherapy with participation from all the leading manufacturers.

ESTRO 27

ESTRO (European Society for Therapeutic Radiology and Oncology)

 US scientists working on the largest study ever to map the genetic changes involved in lung adenocarcinoma have identified 26 genes that are
frequently mutated in this most common form of lung cancer, further increasing opportunities for individualized diagnosis and treatment of the
country’s leading cause of cancer deaths.

The Tumor Sequencing Project (TSP) consortium study was funded by the National Human Genome Research Institute (NHGRI) of the National
Institutes of Health (NIH) and was the work of investigators from many research centres throughout the US and two in Germany. It is published in the
23 October print issue of the journal Nature.

Acting Director of the NHGRI, Dr Alan E Guttmacher said:

“By harnessing the power of genomic research, this pioneering work has painted the clearest and most complete portrait yet of lung cancer’s
molecular complexities.”

“This big picture perspective will help to focus our research vision and speed our efforts to develop new strategies for disarming this common and
devastating disease,” he added.

The TSP consortium’s achievement more than doubles the number of genes that were already known to be linked to lung adenocarcinoma, a deadly
form of lung cancer.

However, the study did more than identify gene mutations, it also discovered detailed gene signalling pathways involved in the development of lung
adenocarcinoma, and mapped the genetic differences among subgroups of lung cancer patients, such as between smokers and never-
smokers.

Most cancers, including lung adenocarcinoma happen because DNA changes accumulate as people age, but not much is known about the biology of
how the DNA changes lead to uncontrolled cell growth.

The TSP consortium is one of many multi-institution groups seeking to chart the complete DNA or genome map of many types of cancer.

A senior author of this paper, Dr Matthew Meyerson, who is a senior associate member of the Broad Institute of MIT and Harvard and an associate
professor at the Dana-Farber Cancer Institute and Harvard Medical School, said:

“We found lung adenocarcinoma to be very diverse from a genetic standpoint.”

Meyerson explained that the study uncovered many new targets for therapy: both in terms of oncogenes (genes that drive cancer growth) and tumor
suppressor genes (genes that prevent cancer growth).

For the study, the TSP investigators took DNA from tumor tissue donated by 188 patients with lung adenocarcinoma and matched it with DNA from
non-cancerous tissue. They purified the DNA and then sequenced it to look for mutations in 623 genes that were already suspected of being linked
to cancer.

They found 26 genes that were mutated in a significant number of the samples. Before this, scientists only knew fewer than a dozen genes to be
involved in lung adenocarcinoma.

Some of the new lung adenocarcinoma genes they found included:
Neurofibromatosis 1 (NF1). Mutations of this gene are already known to cause neurofibromatosis 1, a rare inherited disorder that involves
uncontrolled growth of nervous system tissue.

Ataxia Telengiectasia Mutated (ATM). This gene is involved in various types of leukemia and lymphoma, and in ataxia telangiectasia, a rare
inherited childhood neurological disorder.

Retinoblastoma 1 (RB1). This gene plays a role in retinoblastoma, a relatively uncommon type of childhood cancer that starts in the retina of the
eye.

Adenomatosis polyposis coli (APC). Mutations of this gene are linked to colon cancer.

Ephrin receptors A3 and A5 (EPHA3 and EPHA5), neurotrophin receptors (NTRK1 and NTRK3) and other tyrosine kinases tied to receptors
(ERBB4, KDR and FGFR4). These genes control the action of cell receptors used by a family of enzymes known as the tyrosine kinases that play a
key role in cell growth, differentiation and death, and are prime targets for new cancer treatments.

Having found the genetic mutations the TSP investigators then looked for the biological pathways they used that could be important to the
development of lung adenocarcinoma. This work is valuable for improving cancer treatment.

One example of this valuable work lies in the TSP team’s discovery that more than two thirds of the 188 tumors they investigated had at least one
mutated form of a gene that affects the mitogen-activated protein kinase (MAPK) pathway, showing it is probably an important player in the
development of lung cancer.

Such a discovery will open the way for new treatments using drugs that target the MAPK pathway. One group of similar drugs called MEK inhibitors
has already shown promising results in the treatment of colon cancer in mice.

The TSP team also found that more than 30 per cent of tumors had gene mutations that affected the mammalian target of rapamycin (mTOR)
pathway. The team believes this means that the drug rapamycin, which is used to treat organ trasplant and renal cancer patients, may have a potential
use in the treatment of lung cancer.

Among other numerous discoveries made in this study is the possibility that chemotherapy drugs currrently used to treat other cancers may be
effective in the treatment of certain types of lung cancer. This is because some of the genes activated in lung cancer are the same in other
cancers.

The TSP team also analyzed differences in genetic patterns among subgroups of lung adenocarcinoma patients. One such analysis was the
difference between smokers and never-smokers.

About 10 per cent of lung cancer patients say they have never used tobacco. In this study, the TSP investigators found that DNA samples from
smokers had significantly more gene mutations than samples from never-smokers. Some of the tumors of the smokers had as many as 49
mutations, whereas none of the never-smokers’ tumors had more than 5 mutations.

This discovery suggests more research is needed to find out what this means for the management of lung cancer. Information from other cancer
studies suggests that the more mutations present, the faster the cancer develops and the harder it is to treat.

A senior author of the paper, Dr Richard K. Wilson, who is director of the Genome Sequencing Center at Washington University School of Medicine,
St. Louis, said:

“Our findings underscore the value of systematic, large-scale studies for exploring cancer.”

“We now must move forward to apply this approach to even larger groups of samples and a wider range of cancers,” he added.

His colleague and co-author Dr Richard Gibbs, who is director of the Human Genome Sequencing Center at Baylor College of Medicine, agreed,
adding that:

“Clearly, much still remains to be discovered. We have just begun to realize the tremendous potential of large-scale, genomic studies to unravel the
many mysteries of cancer.”

Over 1 million lives, including 150,000 in the US, are lost every year throughout the world because of lung cancer, the most commonly diagnosed
form being lung adenocarcinoma. On average, only about 15 per cent of patients survive more than 5 years after diagnosis, with those who are
diagnosed early surviving the longest.

“Somatic mutations affect key pathways in lung adenocarcinoma.”
Ding, Li; Getz, Gad; Wheeler, David A; Mardis, Elaine R; McLellan, Michael D; Cibulskis, Kristian; Sougnez, Carrie; Greulich, Heidi; Muzny, Donna
M; Morgan, Margaret B; Fulton, Lucinda; Fulton, Robert S; Zhang, Qunyuan; Wendl, Michael C; Lawrence, Michael S; Larson, David E; Chen, Ken;
Dooling, David J; Sabo, Aniko; Hawes, Alicia C; Shen, Hua; Jhangiani, Shalini N; Lewis, Lora R; Hall, Otis; Zhu, Yiming; Mathew, Tittu; Ren, Yanru;
Yao, Jiqiang; Scherer, Steven E; Clerc, Kerstin; Metcalf, Ginger A; Ng, Brian; Milosavljevic, Aleksandar; Gonzalez-Garay, Manuel L; Osborne, John
R; Meyer, Rick; Shi, Xiaoqi; Tang, Yuzhu; Koboldt, Daniel C; Lin, Ling; Abbott, Rachel; Miner, Tracie L; Pohl, Craig; Fewell, Ginger; Haipek, Carrie;
Schmidt, Heather; Dunford-Shore, Brian H; Kraja, Aldi; Crosby, Seth D; Sawyer, Christopher S; Vickery, Tammi; Sander, Sacha; Robinson, Jody;
Winckler, Wendy; Baldwin, Jennifer; Chirieac, Lucian R; Dutt, Amit; Fennell, Tim; Hanna, Megan; Johnson, Bruce E; Onofrio, Robert C; Thomas,
Roman K; Tonon, Giovanni; Weir, Barbara A; Zhao, Xiaojun; Ziaugra, Liuda; Zody, Michael C; Giordano, Thomas; Orringer, Mark B; Roth, Jack A;
Spitz, Margaret R; Wistuba, Ignacio I; Ozenberger, Bradley; Good, Peter J; Chang, Andrew C; Beer, David G; Watson, Mark A; Ladanyi, Marc;
Broderick, Stephen; Yoshizawa, Akihiko; Travis, William D; Pao, William; Province, Michael A; Weinstock, George M; Varmus, Harold E; Gabriel,
Stacey B; Lander, Eric S; Gibbs, Richard A; Meyerson, Matthew; Wilson, Richard K.
Nature 455, 1069-1075 (23 October 2008)
doi:10.1038/nature07423

Click here for
Abstract.

Sources: Journal Abstract, National Human Genome Research Institute, Washington University School of Medicine.

Written by: Catharine Paddock, PhD.

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

The economy, the election, and myriad
other problems are really stressing out … pets. When humans get stressed,
often their pets take on that stress, too.

“Dogs and cats are
very good at picking up stress in people, as are birds,” James Morrisey, a
veterinarian at the College of Veterinary Medicine of Cornell University in New
York, told LiveScience.

In addition to carrying the burdens of
people, animals—especially wild creatures—have plenty of their own
to stress about. Animals will even seek out “comfort food” when
they’re all wigged out. And stress in animals, as with humans, can be a
good or a bad thing.

“In general, the more intelligent an animal is,
the more psychological stress it can undergo,” Morrisey said. “The
less you’re thinking about things, the less psychological stress you can
potentially be under.”

Animals experience stress for a variety
of reasons. A 2004 study of stress-related illness in cats found that the
biggest source of stress for domestic cats is unfriendly relationships with
other cats in the house. And a 2006 study found that dogs in shelters get
majorly stressed out by the excessive barking of the other dogs there. Prey
animals in the wild understandably fret about being eaten, and foragers worry
about finding enough food. Wild animals in captivity are often anxious about
being cooped up.

Whereas a human might respond to stress by curling
up on the couch and eating a pint of ice cream, how do animals handle the
strain? Pretty much the same way, it turns out. Rats, stressed out by being
stuck in confining tubes for 10 minutes, prefer lard and sucrose water more than
non-stressed rats.

What’s more, the effects of stress on an
animal’s body are stunningly similar to stress’s effects on humans.
In both humans and animals, stress causes the body to release adrenaline and
cortisol hormones.

These chemicals cause heart rate and respiration
to speed up, and suppress the immune system. Stress also clamps down on the
reproductive system, reducing libido and reproductive hormones.

And
in animals, as in humans, some individuals have better coping mechanisms to deal
with stress, which gives them an adaptive advantage.

Researchers at the University of Southampton are conducting a study of near-death experiences.

Some people who have experienced near-death report seeing a tunnel or bright light, while others recall looking down from the ceiling at medical staff.

BBC News website readers have been sending in their stories.

A few years ago I was knocked of my cycle at a roundabout. The next 15 minutes are missing but I was aware that the light was blindingly pure and a richer blue than I have ever seen. I was surrounded by trees in reality, but the light was astounding and there was no noise whatsoever, there were no thoughts in my head, just wanting to be in the light. Then I realised that there was a person who I believed was my guardian angel. She was so tall that she could literally touch the sky, her body went on forever. She kept repeating “don’t touch your head, don’t touch your head”. I did and suddenly pain and reality returned and I was aware of all that was going on. I was so sad because the light was gone and the guardian angel in reality was a lady who had stopped to help and she was not tall. Jane, Bracknell, Berkshire, United Kingdom

I was involved in a head-to-head car accident a year ago, which caused me to lose consciousness and black out. I was taken to the hospital and was under cardiac arrest for 14 minutes. I remember vaguely seeing myself walking through a field with my deceased brother James. It felt like only a moment before I “awoke” in which I felt extreme pain shoot up through my entire body. I have now recovered but I still keep that memory with me.Betsy Cromer, Boston, United States

I had an operation during which I was pumped with antibiotics that I was allergic to. I recall my soul slowly rising to the ceiling in the hospital and out of my body. My sisters were on either side of the bed begging the doctors to do something. As my body continued to rise a doctor gave me an injection. My soul (I believe) then began to lower itself back into my body. The following day I explained this to the doctor and he confirmed I had a near-death experience. Gary Williams, London, United Kingdom

Several days before my wife died she had a cardiac arrest from which she was recovered. She told me that she was up against the ceiling watching the medical team working to save her. She found herself reflecting that she was leaving me and her daughter and made the tremendous conscious effort to come back to stay with us. But, she said, if it happened again she might not have the strength to return. Three days later it did and she didn’t.Gerard Mulholland, Paris, France

In the early 1980s I was overcome by carbon monoxide fumes from an electricity generator. I was rushed to Winchester hospital where my life was saved by a blood gas spectrum analyser. Meanwhile, I was going through a dark tunnel with beautiful lights and flowers at the end - with wonderful organ music! I didn’t have a care in the world. Suddenly I stopped going through the tunnel and an American voice was shouting at me saying something like, “you’re not going to die you bastard - it’s not your time’! Apparently, when I woke up the young American doctor was surprised when I asked him, ‘Do all Angels have American accents?’ Rob, Bournemouth, Dorset, United Kingdom

I had a heart attack, considerable pain and discomfort. My wife called 911. They arrived, loaded me into an ambulance and proceeded to the emergency room. My memory is that about a mile from home I went to sleep and began to dream. It was quite pleasant. There was a group of people talking and interacting pleasantly. I recognised no one but there was a purple tint to everything. I “woke up” just before we arrived at the emergency room. I told the EMTs that I had been napping. I was astonished that there were contact pads on me and my shirt had been cut off. They informed me I had flatlined. I can’t describe it but what I experienced left me with a sense of peace and possibly less of a fear of dying. Larry Huffman, Newton, NC, United States

I fell off a ledge backwards and hit my head and back on a rocky ground, when I was travelling in rural Laos a few years ago. I recall vividly seeing the back of my travelling companion’s head, bending over me. And I remember feeling annoyed at him - because he didn’t seem to be doing much to assist me. Then I opened my eyes, and saw him from the ‘normal’ angle. Michele Legge, Canberra, Australia

Having worked as a nurse in a Critical Care Unit for 10 years, I have spoken with several patients directly after their near-death experiences. They all describe going down a brightly lit tunnel and experiencing complete peace and tranquillity. This is then followed by being pushed back down the tunnel again back to their bodies. One lady explained how she returned to her body, she then felt terrified for a few minutes because she could see the medical staff and got the impression they thought she was dead. Shirley Learthart, Hastings, United Kingdom

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Frustrated after twice asking a Cincinnati-based manufacturer of medical products to recall contaminated heparin, the Food and Drug Administration took the rare step Thursday of sending U.S. marshals to seize 11 lots of the blood-thinning drug.

The company, Celsus Laboratories, distributes heparin to drug and medical-device manufacturers both in the United States and internationally.

FDA testing in January found that large amounts of Chinese raw heparin imported into the United Sates were contaminated with the chemical oversulfated chondroitin sulfate. The FDA believes the substance was added to allow the product to pass tests that measure heparin levels.

Copeland Healthcare Centre opened its first location in Vancouver in 2007.
(CBC)

Two family doctors have closed up their practices and joined Calgary’s newest private medical clinic, angering some of their former patients.

The Copeman Healthcare Centre opened on Monday and among the health-care staff of about 40 people are doctors William Halliday and Cindy Mitchell.

“It’s just totally, morally wrong,” said Helena Grant, one of Halliday’s former patients. “It’s the haves and the have-nots.”

For a fee of $3,900 the first year and $2,900 every year after, patients at the Copeman Healthcare Centre get access to a range of uninsured services at the downtown centre. They also receive a specialized health plan designed by a team of doctors, nurses, registered dietitians and kinesiologists.

Chris Nedelmann, the centre’s general manager, said Halliday was forced to move his practice because the property is being annexed for the west leg of the light rail system, while Mitchell was in the process of shutting down her practice because it was no longer economically viable.

“[Mitchell] has never been a high volume physician, and as such her overheads were pretty comparable to her revenues and we were able to keep her in the public system,” he said.

‘Catering to people who are rich ‘

Two of Halliday’s former patients say that while they could afford to follow him to the Copeman Healthcare Centre, they won’t.

“Our family thought about it, but it’s wrong,” said Grant, who is losing a family doctor for the second time.

“One to the United States and now in this case. So we were kind of shocked, and I was kind of disappointed and kind of angry a little bit … he could have still probably opened an office somewhere else rather than opening up a private health-care clinic.”

Jill Rathje, her husband and two young children scrambled and successfully found a new family physician, but her father-in-law is still hunting for a new doctor to replace Halliday.

“My family, luckily, are in the position that if we wanted to we could probably afford to go there, but just in principle we are against it. I feel that it is just catering to people who are rich and it is starting to bring in two-tiered health care.”

Nedelmann said the centre is focusing on bringing home Canadian physicians who have been practising in the United States, recruiting overseas doctors and hiring physicians working in the private sector, such as for pharmaceutical companies.

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Two nursing groups are critical of the province’s decision to delay the hiring of 9,000 nurses.

The hiring announcement was made Wednesday as part of Ontario’s restraint initiative. In his economic statement, Finance Minister Dwight Duncan said the province will run a deficit of $500 million this year.

The province earlier promised to hire the nurses over four years. Now it says it will spread it over five years, saving $50 million this year.

Catherine Mayers, who sits on the board of the Registered Nurses’ Association of Ontario, says the move may have a disastrous effect.

“I think the seasoned nurses, perhaps, will leave the hospital setting a lot sooner than they would have because they’re not getting the support and they’re just being too overworked and overwhelmed,” she said.

Linda Haslam-Stroud, president of the 54,000-member Ontario Nurses’ Association, agrees and says the province needs the extra 9,000 nurses now.

“Ontario ranks second-lowest of all provinces in Canada, as far as the number of nurses we have per patient,” she said.

The province has also announced it will be deferring the addition of 50 family health teams by one year. That move is expected to save $3 million.

 An estimated 35.1 million Americans live in “food insecure” households, meaning that at some time during the previous year they were unable to obtain or were uncertain of having enough food to fulfill their basic needs. Consequently, many of those people seek aid from federal sources including the Food Stamp Program. Now, a University of Missouri poverty expert has found that, depending on the food stamp benefit amount, the emotional distress associated with food insufficiency is higher among food stamp participants.

“Our hypothesis was that participation in the Food Stamp Program would have a positive impact on participants’ mental and emotional health, but the results were not what we expected,” said Colleen Heflin, assistant professor with the MU Truman School of Public Affairs. “The results suggest the opposite - the negative mental health aspects of participating in the Food Stamp Program seem to outweigh the positive mental health aspects.”

The negative mental health effects primarily occurred during participants’ application process and transition into the program. According to Heflin, the process can be time consuming and emotionally draining. Possible negative effects on emotional health include the stigma associated with food stamp participation, association with welfare culture and difficulty meeting eligibility requirements.

Previous research has been conducted on the health consequences associated with food insufficiency. Until now, researchers had not examined the impact of the Food Stamp Program on the relationship between food insufficiency and mental health.

“We found a dosage effect - such that food-insufficient individuals who received higher amounts of food stamp benefits suffered greater emotional distress than those who received lower amounts of food stamp benefits,” Heflin said.

According to the study, further evaluation is necessary to find the direct cause for emotional distress in new food stamp participants. Heflin said that, based on the findings, modifications to the Food Stamp Program are needed to improve overall well-being among new participants. She suggests implementing a web-based application system, currently used in at least five states, that eliminates the face-to-face interview process and allows clients to choose the time and place they submit their applications. Heflin said future research will help determine the effectiveness of the web-based process.

The study, “Food Insufficiency, Food Stamp Participation and Mental Health” was published in the September issue of Social Science Quarterly. It was co-authored by James P. Ziliak from the University of Kentucky.

Source: Emily Smith

University of Missouri-Columbia