The US Food and Drug Administration has moved to address a US cancer treatment drug shortage. Not only will it permit one drug to be imported, it's also fast-tracking the approval process for another.
Both measures are intended to ensure US cancer patients have access to the drugs they need after data showed that supply issues hampered the distribution of a good 200 drugs last year.
According to doctors and other health officials, the situation has forced suppliers into putting off cancer treatment programmes or drawing on other, less-effective or more expensive drugs to plug the gap.
The imported cancer drug is Lipodox, which is used in ovarian cancer and multiple myeloma treatment when other medications have been ineffective. It shares an ingredient, doxorubicin, with Johnson & Johnson's Doxil, supplies of which are now scarce.
FDA Cancer Drug Approval
Meanwhile, the FDA has also acted against the US drug shortage by approving APP Pharmaceuticals' production of methotrexate - a cancer drug used alongside other treatments to fight childhood leukaemia.
"A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration", Doctor Margaret Hamburg - administration commissioner - confirmed in a statement. She added: "Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.
"We are making progress. There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification."
US Drug Shortages
The US drug shortages have been attributed to multiple causes including manufacturing plant closures.
Lipodox is produced by Sun Pharma Global FZE which, in a statement, described the unusual circumstances under which it had been contracted. ‘[The] temporary importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs', it wrote.
An experimental drug combination may provide “a new weapon against pancreatic cancer”, BBC News has reported.
In a search for new ways to fight the aggressive cancer, scientists combined an existing chemotherapy drug called gemcitabine with an experimental chemical called MRK003. The chemical can block the actions of a protein called "gamma secretase" that plays a range of roles in the body. To test the effect of this combination they gave the mixture to mice genetically engineered to develop pancreatic cancer. They found that that the mice survived 26 days with the combination treatment, compared with just nine days when given an inactive dummy drug. Cancer Research UK reports that a human trial of gemcitabine combined with another gamma secretase blocker are now underway.
Pancreatic cancer often has a poor prognosis as it’s usually only diagnosed at an advanced stage, by which time it is resistant to many conventional treatments. It is the fifth most common cause of cancer death in the UK, and patients with metastatic disease (where the cancer has spread survive between two and six months on average.
This animal study has reported promising results for a new form of combination therapy. However, there are limits to what can be learnt from animal tests, so the results of the current clinical trial will provide a much clearer indication of how safe or successful this regime is for treating patients.
Where did the story come from?
The study was carried out by researchers from the Cancer Research UK Cambridge Research Institute, Cambridge University and Merck Research Laboratories, USA. It was funded by the University of Cambridge and Cancer Research UK, the Li Ka Shing Foundation and Hutchison Whampoa Limited, the UK National Institute for Health Research, Cambridge Biomedical Research Centre and the collaborative research programme at Merck, a pharmaceutical company. The study was published in the peer-reviewed Journal of Experimental Medicine.
This story was covered by the BBC and Metro. The coverage was accurate and explained that the drug is part of an ongoing phase I/II clinical trial.
What kind of research was this?
This study examined the use of an experimental drug in a mouse model of pancreatic cancer and on cells grown in the laboratory. Animal models of disease provide a useful way to test what might happen if human patients were given a particular drug. Although the animal models don’t necessarily reflect what would happen in humans, they can be invaluable in exploring the properties of potential treatments. The mouse model in this research has already been used to test several pancreatic cancer drugs, with researchers finding that it accurately modelled the responses seen in patients with the condition.
This is the ideal study design for preliminary trials of new drugs. Drugs need to be well-tolerated and effective in the laboratory and in animals before trials on humans can happen.
What did the research involve?
The researchers took mice that modelled the main subtype of pancreatic cancer, called pancreatic ductal adenocarcinoma. This type accounts for around 90% of pancreatic cancer cases. The researchers wanted to test a novel drug called MRK003, a type of “inhibitor” that blocks the gamma secretase pathway. Gamma secretase is involved in a signalling pathway between cells, which is disrupted in many cancers.
To test their theory, the researchers looked at the effect of several treatment regimes involving MRK003, administering it alone or in combination with a drug called gemcitabine that is already clinically used to treat pancreatic cancer. In particular, the researchers looked at:
- the way treatment affected the expression of certain markers that are characteristic of pancreatic cancer
- the effect on mice survival
- the effect on the tumour cells
What were the basic results?
The researchers found that MRK003 could reduce the expression of certain pancreatic cancer markers. When given alone, MRK003 had no effect on the survival of pancreatic cancer model, but when given in combination with gemcitabine the median survival time of the mice was significantly increased, from nine days when given a placebo to 26 days when given MRK003 and gemcitabine in combination (p=0.002 . The researchers found that combination treatment promotes tumour cell death and suppresses tumour growth.
How did the researchers interpret the results?
The researchers concluded that this research supports the further investigation of gamma secretase inhibitors (drugs such as MRK003 in combination with gemcitabine for the treatment of patients with pancreatic ductal adenocarcinoma.
Conclusion
Patients diagnosed with pancreatic cancer can have a poor outlook, as the disease is aggressive and often advanced by the time it produces any symptoms. Despite being a relatively rare form of cancer (with around 7,800 cases diagnosed each year , it’s the fifth most common cause of cancer death in the UK. Patients with metastatic disease (where the cancer has spread have a median survival of between two and six months.
Given the current poor outlook for pancreatic cancer patients, there is a real need for new treatment options for the condition. This experimental study, although only in mice, has produced positive results for the combination therapy involving a gamma secretase inhibitor and gemcitabine. Gemcitabine is an established treatment for pancreatic cancer, but it currently attains only modest survival results.
The combination treatment was found to promote the death of tumour cells and suppress tumour growth, and increased survival time to 26 days (compared to nine days with a placebo .
These are exciting early results in an area with a clear need for better treatments. However, it will take the results of further clinical trials, such as the phase I/II clinical trial currently underway, to tell how successful or safe this regime is for treating patients.
Analysis by Bazian
Links To The Headlines
Pancreatic cancer: Trial drug MRK003 shows promise. BBC News, February 21 2012
Drugs mixture offers new hope in pancreatic cancer fight. Metro, February 21 2012
Links To Science
Cook N, Frese KK, Bapiro TE et al. Gamma secretase inhibition promotes hypoxic necrosis in mouse pancreatic ductal adenocarcinoma. The Journal of Experimental Medicine, February 20 2012
Around 400 high profile doctors, medical researchers and scientists recently joined forces to form lobby group Friends of Science in Medicine (FSM in order to have "alternative medicine" degrees removed from Australian universities.
Chiropractic, osteopathy, Chinese medicine, naturopathy, iridology, kinesiology, reflexology, homeopathy and aromatherapy are some of the courses on their blacklist.
The issue has had significant media coverage, but one question has failed to be properly answered.
Why is a group of prestigious doctors and scientists who have the backing of the most profitable industry in the world according to Fortune 500 – the pharmaceutical industry – targeting a few poorly-funded natural medicine courses?
The official line of the group is that these "alternative medicines" are making Australia look bad and "trashing" the universities' reputation. But is that really the reason? With all the countries and all the universities in the world that provide alternative medicines?
A similar move was made in the UK recently – the British will no longer be able to study certain natural medicine degrees – this does not include chiropractic or osteopathy – at publicly-funded universities from this year. Yet natural medicine has been utilised across Asia and Europe for thousands of years.
The United States and Canada are pioneers of chiropractic as we see it today, providing university courses long before they were ever offered in Australia. Also, nearly 85 per cent of US medical schools offer elective courses in alternative medicines.
According to the World Health Organisation (WHO , 80 per cent of the world's population relies on natural therapies. The figures in Australia are much the same.
So why Australia? What is FSM so worried about?
The group seems to be particularly concerned about an increase in chiropractic courses after it was announced recently that Central Queensland University would be offering a new chiropractic science degree. The move could also be partly to do with the ruling in 2010 that all chiropractors in Australia may use the title 'Doctor'.
FSM has accused what it labels as Australia's "lesser" universities that offer alternative medicine courses of "putting the public at risk".
However, this is a difficult notion to fathom when you compare the tiny number of injuries inflicted on natural medicine patients compared to the hundreds of thousands of deaths recorded each year due to medical errors.
WHO estimates that one in 10 hospital admissions leads to an adverse event while one in 300 admissions leads to death. WHO puts medical errors as among the top 10 killers in the world. According to the US's Institute of Medicine, preventable medical errors kill 98,000 people in the US alone each year and injure countless more.
One of the group's biggest complaints, according to FSM co-founder Emeritus Professor John Dwyer from the University of NSW, is that natural medicine "doesn't strive to be tested". He says that modern medicine is "totally devoted" to taking an "evidence-based approach" and "do good science and do good research into the things we do to people".
The argument that modern medicine is evidence-based as opposed to other types of medicine is an argument that is often used by medical lobbyists, and tends to be generally accepted by the public. However, according to a report by a panel of experts assembled by the prestigious Institute of Medicine, "well below half" of medical care in the US is based on or supported by adequate evidence.
According to the report, between 1993 and 2004 there was a more than 80 per cent increase in the number of medications prescribed to Americans. The panel believes this boom in pharmaceuticals is outpacing the rate at which information on their effectiveness can be generated. "If trends continue, the ability to deliver appropriate care will be strained and may be overwhelmed," the report concluded.
What FSM fails to recognise is that natural medicine courses taught at universities incorporate a much higher level of evidence-based studies, such as health science and human physiology, than if they were to be taught outside of a university.
The Australian universities that have been criticised have all defended their courses, saying they are very much evidence and science-based.
In naturopathy, for example, on top of herbal medicine and nutrition, students also learn the same things that a physiotherapist, medical doctor or nurse learn. As well as chiropractic studies, chiropractors study biology, physiology, neuroscience, anatomy and pathology, for example. These are all scientific studies.
Acting head of RMIT's Health Sciences School Dr Ray Myers has defended its programs as "evidence-based education and practice", saying clinical research of natural medicine treatments are funded by the National Health and Medical Research Council (NHMRC .
If FSM really was so worried about public safety they would not be trying to exclude natural medicine from universities where they are taught with much more of a medical focus. Graduates of these courses are much more likely to refer patients to medical doctors when necessary.
As Nick Klomp, dean of the science faculty at Charles Sturt University, points out, thousands of practitioners already provide alternative medicine and they are very much in demand. "I could ignore them or I could train them better," he said. "We actually create graduates who are much better health care providers. It's all about evidence based, science based."
The other question to ask is just how representative the group is of Australian doctors. Dr Wardle, a NHMRC Research Fellow at the University of Queensland's School of Population Health conducted a survey of every rural GP in NSW and found a third did not refer to alternative medicine providers, a third were incredibly open to it, and a third would refer patients to practitioners that they knew achieved results.
The Australian Medical Association president has withdrawn his support from the lobby group. A number of researchers and doctors have also pulled out of FSM reportedly saying they were not aware of the full picture.
Many Australian medical doctors recognise their limits and refer to natural providers when necessary. However, others continue to believe that modern medicine – which is only 100 years old – is the only way of curing pain.
Natural therapies have been used for more than 10,000 years, and so they deserve a place in society, in Australian universities, and even in modern medicine. According to Australian trauma and general surgeon Dr Valerie Malka, former director of trauma services at Westmead Hospital, while modern medicine is revolutionary when it comes to surgery, particularly in emergencies, for pretty much everything else, traditional, natural or alternative medicine is much more effective.
She says in particular, modern medicine is completely unable to treat or cure chronic illness. Rather than focusing on symptom control, natural medicines work on the body's ability to heal the cause of the illness while modern medicine suppresses the body's healing mechanism with drugs that attack the body's natural defence mechanisms, throwing the immune system out of whack.
Dr Malka believes the attack on natural medicine has more to do with the threat to modern medicine's power base as well as its "unhealthy relationship" with the "trillion-dollar pharmaceutical industry".
This is not the first time natural medicines have been attacked by the medical industry.
Alternative healthcare professionals such as chiropractors, naturopaths, and midwives have been targeted by the American Medical Association (AMA for nearly a century, in spite of a federal court injunction against the AMA in 1987 for illegally trying to create a monopoly in the healthcare market.
Up until 1983, the AMA had held that it was unethical for MDs to associate with "unscientific practitioners" and they labelled chiropractic "an unscientific cult". They also had a committee on "quackery" which challenged what it considered to be unscientific forms of healing. Five chiropractors including Chester Wilk sued the AMA, claiming that the committee was established specifically to undermine chiropractic.
Wilk won the case, with Judge Susan Getzendanner ruling that the AMA had engaged in an unlawful conspiracy in restraint of trade "to contain and eliminate the chiropractic profession," also saying that the "AMA had entered into a long history of illegal behaviour".
If you look at the history of attacks on natural healthcare providers over the last 100 years, it is difficult not to associate this attack by FSM as the latest attempt to influence the public into believing that natural medicine is, as it says, "quackery" by spreading propaganda that most of the time is simply not true.
"It's just extraordinary that such undisciplined nonsense is being taught in universities around Australia," Mr Dwyer has said.
Why does this group feel that it has the right to talk this way about natural medicines that are ages old and used by 80 per cent of people across the world?
If FSM really was concerned about patient care and safety in Australia, then perhaps it would investigate medical practices which, unfortunately, seriously injure and kill thousands of people every year, rather than target natural medicine.
Sarah Schwager is an Australian journalist currently working in South America. View her full profile
here.
In 2009, the FDA told Johnson & Johnson it could no longer sell an unsafe hip replacement in the United States. That didn’t stop the New Jersey health care giant from selling the device in other countries.
Now, the New Brunswick company faces up to $3 billion in legal and medical costs over the device, which J&J finally recalled in 2010 after evidence was revealed that it was leaving tiny, painful slivers of metal in many of those overseas patients.
Inside J&J, workers take pride in the corporation’s famous credo. Summarized, it says: Act ethically and responsibly, no matter the cost, and profits will follow.
J&J is proof that profits follow bad corporate behavior, too.
In 2010, the company earned a record $13 billion. At the same time, it paid roughly $750 million in government fines and settlements for a laundry list of wrongs. It was fined $70 million for overseas bribery, shut down a children’s drug factory for safety violations and was investigated for a “phantom” recall of tainted Motrin.
Defenders of the 1 percent insist corporations and their executives have every right to amass whatever fortunes they can in America’s free market.
But the headlines reveal that many big businesses are raking in billions without conscience. What we’re seeing is a grotesque shift in corporate values that undermines Corporate America’s image as the benevolent job creator.
Occupy Wall Street zeroed in on the enormous gap in pay between corporate executives and the so-called 99 percent. But not enough was said about the erosion of corporate citizenship and the lengths to which Big Banking, Big Pharma and Big Oil, just to name a few, will go to increase profits at the expense — even the victimization — of humanity. (See accompanying chart for some awful offenses.
We see deadly accidents in coal mines and on oil rigs as owners cut corners on worker and environmental protections; patients put at risk when pharmaceutical companies take already successful drugs and try to drive profits even higher by selling them for diseases the FDA never studied nor approved; taxpayers footing fraudulent bills as contractors look at government like a blank check, overcharging millions or more.
It is understandable for companies to pull back on their charitable works in tough times, or even trim the workforce. In the throes of the Great Recession, even companies with a social conscience often did that. Who could justify million-dollar gifts for charity when employees are being laid off?
But this is different. This is despicable behavior, and it’s widespread. If the same acts were committed by an individual, that person would likely find himself in prison. Corporations typically face only the loss of cash. Don’t worry, they’ll make more.
The U.S. Supreme Court is inching toward full personhood for corporations — see Citizens United vs. FEC, which granted them freedom of speech. Perhaps it’s time they were punished like people, too.
BY TIMOTHY W. MARTIN AND DEVLIN BARRETT
The federal government alleges Cardinal Health Inc. and CVS Caremark Corp. were aware of high-volume orders of prescription painkiller oxycodone shipped to two pharmacies in Florida, in a closely watched case probing how much responsibility companies bear for a growing drug-abuse problem.
The allegations were made in written declarations filed in federal court earlier this month by the Drug Enforcement Administration. The declarations allege that drug distributor Cardinal repeatedly overlooked escalating oxycodone orders placed by the two Central Florida pharmacies.
Summary:
Diagnoses and treats variety of diseases and injuries in general practice by performing the following duties.
Elicits and records information about patient's medical history.
Examines patient to determine general physical condition.
Orders or executes various tests, analyses, and diagnostic images to provide information on patient's condition.
Analyzes reports and findings of tests and of examination, and diagnoses condition.
Administers or prescribes treatments and drugs.
Inoculates and vaccinates patients to immunize patients from communicable diseases.
Advises patients concerning diet, hygiene, and methods for prevention of disease.
Provides prenatal care to pregnant women, delivers babies, and provides postnatal care to mother and infant.
Reports births, deaths, and outbreak of contagious diseases to governmental authorities.
Refers patients to medical specialist or other practitioner for specialized treatment.
Performs minor surgery.
Makes house and emergency calls to attend to patients unable to visit office or clinic.
Conducts physical examinations to provide information needed for admission to school, consideration for jobs, or eligibility for insurance coverage.
Job Details
| Date Posted: | 2012-02-22 |
| Job Location: | Riyadh, Saudi Arabia |
| Job Role: | Healthcare/Medical |
| Company Industry: | Pharmaceutical; Medical/Hospital; Healthcare, other |
Preferred Candidate
| Career Level: | Mid Career |
| Gender: | Male |
| Nationality: | Philippines; Saudi Arabia |
| Degree: | Bachelor's degree / higher diploma |
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"Excessive testing costs $200 billion to $250 billion (per year ," Dr. Steven Weinberger, CEO of ACP said in an interview from his office in Philadelphia. "There's an overuse of imaging studies, CT scans for lung disease, overuse of routine electrocardiograms and other cardiac tests such as stress testing."
In an article published last month in the Annals of Internal Medicine, the ACP cited 37 clinical situations where screening did not promote health and might actually hurt patients.
They included performing coronary angiography - a procedure that uses a special contrast agent and X-rays to see inside the heart's arteries - in patients with chronic, stable chest pain that is being controlled by drugs or who lack specific high-risk criteria on exercise testing.
"It's medical gluttony," said Dr. Otis Brawley, chief medical officer of the American Cancer Society.
"The ironic thing is that people are talking about rationing. We have got to think about the rational use of medicine in order to avoid rationing medicine," he said.
Erratic supplies of vitamin D drugs and the rising cost of unlicensed alternatives are wasting millions in NHS cash, GP leaders have warned.
NHS Information Centre data show the supply problem has forced GPs to prescribe expensive unlicensed medicines costing up to ?2,400.
The GPC criticised the DH for failing to help GPs increase the use of supplements, which can prevent expensive conditions such as bone disease.
Primary care prescribing costs for vitamin D have tripled since 2004 and will hit ?100m by 2013 (
GP
, 15 February . Expensive special-order vitamin D drugs are a key factor in this.
A standard course of cholecalciferol tablets to treat deficiency
costs about ?16. But the NHS spent up to ?2,400 per prescription on liquid versions in July-September 2011.
GPC negotiator Dr Chaand Nagpaul said GPs were struggling to obtain supplies of licensed vitamin D products for deficiency treatment. PCTs have repeatedly changed prescribing advice as the supply waxes and wanes, he said.
Dr Nagpaul said: 'There's a myriad of policies for obtaining products,' which has caused 'confusion' and led to higher use of specials, and called for more clarity from commissioners.
DH officials have admitted uptake of free vitamin D supplements under the Healthy Start scheme remains undersubscribed.
The UK's four CMOs recently wrote to GPs calling for more awareness of the problem and encouraging them to alert patients to the free supplements scheme.
Dr Nagpaul said: 'Many GPs received this letter, but were not (told how to implement the recommendations.' A DH spokesman said the Scientific Advisory Committee on Nutrition was reviewing advice on vitamin D.
By Stephen Robinson
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