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.
A year before recalling an artificial hip, an executive at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in “significant” numbers, requiring repeat surgeries for patients.The statements in that e-mail contrast with those made by the company in recent years about the all-metal hip. Before recalling the device amid rising failure rates in 2010, Johnson & Johnson insisted it was safe and maintained that its internal studies refuted complaints by surgeons and regulators abroad that the device was flawed. The device turned down by the F.D.A. was only sold overseas, but a companion version that was recalled at the same time by Johnson & Johnson was used in 30,000 patients in the United States.
The e-mail at issue was written in August 2009 by a vice president of a Johnson & Johnson subsidiary, DePuy Orthopaedics, just days after the F.D.A. confidentially notified the device maker that it would not approve one version of the hip for sale in this country. In the e-mail, the executive, Pamela Plouhar, explained the reasons for the agency’s decision to three other top executives, including DePuy’s president at the time, David Floyd.
Ms. Plouhar reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.
“The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk,” Ms. Plouhar wrote.
To win approval, a novel medical device like the DePuy hip must be shown to be reasonably safe and effective. One way to prove that is to show that it is at least as effective as, or not inferior to, a traditional hip implant.
In her e-mail, Ms. Plouhar said there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”
Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases overseas showed that the ASR was failing at high rates in patients after just a few years. The device also sheds metallic debris as it wears, particles that have damaged tissue in some patients or caused crippling injuries.
A DePuy spokeswoman, Mindy Tinsley, declined to respond to specific questions about the e-mail. In a statement, she said that the e-mail was “simply a notification to senior management about the F.D.A. feedback as the company appropriately continued to study data” about the implant so that it could make responsible decisions on the behalf of patients.
Last week, Andrew Ekdahl, the current president of DePuy, said in a statement issued in response to an earlier article in The New York Times that any implication that the F.D.A. had determined there were safety issues with the device was “simply untrue.”
In her 2009 e-mail, Ms. Plouhar referred to complaints about early failures of the ASR from doctors and regulators abroad. Regulators in Australia were then pressuring DePuy to withdraw the artificial hip from the market there or face having it forced off.
“This comes at a time when ASR data from national registries (Australia and UK is being closely scrutinized because of higher revision rates,” she wrote.
DePuy does not appear to have violated any laws by not publicly releasing the F.D.A. ruling, which was contained in a so-called nonapprovable letter. The F.D.A., as a matter of policy, does not release such decisions, saying that they may contain confidential business information.
But DePuy’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it and could also tarnish its reputation.
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JOB LOCATION: Based in Phnom Penh, necessary to travel.
Lake Forest-based Hospira Inc.also was given permission to expedite ingredients from its overseas factories and suppliers to ramp up production of a preservative-free version of methotrexate, a drug used to treat the most common childhood cancer, acute lymphoblastic leukemia, or ALL, and other cancers.
Preservatives in the drug can cause problems for children and for those getting high doses via injections into spinal-cord fluid as part of their cancer treatment. Adequate methotrexate supplies have been a sporadic problem since about 2008.
"I'm thrilled to relay that, 24 hours ago, we began directly shipping 31,000 vials of new product — enough to address more than a month's worth of demand — and it is being received in hundreds of our nation's hospitals and treatment centers today," Hospira Chief Executive F. Michael Ball said at a news conference in suburban Washington.
By mid-March, Hospira plans to release an additional 89,000 units of the medication "not only to meet the full market demand, but also to begin establishing safety stock to ensure patients and families never have to face this type of fear again," Ball said.
An experimental pancreatic cancer treatment combination has performed well in early trials, leading scientists to think it might be an important future drug.
While the full results of human subject tests have not yet been witnessed, the signs so far are good.
The combination of MRK003 and a chemotherapy agent has already shown it can catalyze the elimination of pancreatic cancer in mice. Now, a pool of 60 patients are involved in human-based Phase 1 and II trials taking place at the world-famous University of Cambridge, with funding supplied by Cancer Research.
Around 8,000 new pancreatic cancer diagnoses are made in the UK every 12 months. That's less than other types of cancer but, even so, the condition is vicious and, a year after being diagnosed, only 16 per cent of those in which it's developed can expect to still be alive.
New Pancreatic Cancer Treatment
With that as a starting point, developing and getting to market a new pancreatic cancer treatment drug is a key pharmaceutical goal.
MRK003 interrupts the key Notch cell signalling pathway in pancreatic cancer cells. It does the same to the cells in the linings of blood vessels that encourage the spread of pancreatic cancer and, when supplied in tandem with gemcitabine - a chemotherapy drug sold by Eli Lilly & Co as ‘Gemzar' - it delivers the cancer a powerful punch.
Pancreatic Cancer Drug Combination
Details of the pancreatic cancer drug combination work carried out so far appear in a piece published by the Journal of Experimental Medicine, in which Professor David Tuveson explains: "We've discovered why these two drugs together set off a domino effect of molecular activity to switch off cell survival processes and destroy pancreatic cancer cells."
The ongoing Cambridge pancreatic cancer drug trials are being led by Professor Duncan Jodrell who, in comments quoted by the BBC, added: "We're delighted that the results of this important research are now being evaluated in a clinical trial, to test whether this might be a new treatment approach for patients with pancreatic cancer, although it will be some time before we're able to say how successful this will be in patients."
Image copyright Hellerhoff - Courtesy Wikimedia Commons
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Definition
Program is a group of inter-related projects moving toward a common goal. Therefore a program manager should provide overall management support for the projects to ensure they all move together toward meeting that goal. The job contains all the elements of managing a project. Program manager do not typically fit into the direct chain of command for any specific project, but have more of a matrix management role. It is critical for him/her to be strong communicator and to be able to influence others in order to get things done, even when he/she has no line of authority over them. A program manager will be part of a program office that manages a portfolio of programs across the company.
Distinguishing Characteristics
1 Risk Identification:
a Experience of using facilitated workshop and other risk identification techniques to generate comprehensive project risk registers;
b Understanding of breadth of facilitation techniques for application to diverse risk management challenges (e.g. risk-based support to options-based investment decisions ;
c Strong understanding of psychological factors involved in risk identification and assessment by individuals and groups.
2 Risk Mitigation:
a Strong experience of using facilitated workshop techniques to generate structured, practical Action Plans to mitigate risks;
b Deep understanding of the behavioral issues that inhibit effective mitigation of risk, and successful track record in overcoming such problems;
c Experience of applying such techniques in complex, contractor-based environments; e.g. construction-phase activities jointly involving project main contractors etc.
Job Responsibilities:
- Provides professional program management for 2 or more complex development programs
- Facilitates the review of development projects with Senior Management, makes recommendations for action and ensures appropriate follow-up by management to achieve approved program/project objectives.
- Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes.
- If applicable, functions as a development alliance liaison helping to support development alliance management activities based on program requirements.
- Responsible for ensuring smooth transitions between action points from initiating R&D process/method analysis through product manufacturing and full life cycle management, from early to late stage development.
- Supports quarterly forecasts, manages scope, timeline and financial changes through tracking variances at the program level.
- Develop and implement goals, strategies, timelines and action plans for specific issues, campaigns, and projects.
- Establish annual and long-range organizational goals and strategic plans that support the organization’s mission and are integrated with different activities of the organization.
- Actively participate in the decision-making process involving the establishment of important permits, rules, regulations, policies, and strategic plans.
- Manages products programs, applying best practice/best suitable product development lifecycle methodologies based on the market/customer situation, by collecting data, performing analysis on the market behavior and providing recommendations to Senior Management.
Job Details
| Date Posted: | 2012-02-22 |
| Job Location: | Riyadh, Saudi Arabia |
| Job Role: | Management |
| Company Industry: | Pharmaceutical; Management |
Preferred Candidate
| Career Level: | Management |
| Gender: | Male |
| Nationality: | Philippines; Saudi Arabia |
| Degree: | Bachelor's degree / higher diploma |
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HLL Lifecare Limited, is a global provider of wide range of contraceptive, healthcare and pharma products. HLL, Mini Ratna, Schedule B Central Public Sector Enterprise under the Ministry of Health & Family Welfare is today a multi product, multi unit organization addressing various public health challenges. The company with five manufacturing units and marketing offices throughout the country is engaged in the manufacturing and marketing of a wide range of contraceptives and healthcare products. The company has also ventured into Infrastructure Development, Procurement & Consultancy Services, setting up of Life Spring Hospitals, Women's Health Pharma Division and setting up of Diagnostic Centers.
Post : Quality Manager
No of Post : One
Job Description
:
1.To implement and maintain quality systems required for NABL accredited labs.
2.To do the necessary documentation worst NABL quality audit.
3.To impart training and awareness to all the concerned staff.
Experience : 1 to 3 year
Location :
Delhi
Education :
M.Sc
-
Microbiology
, Biology, Bio-Chemistry
Contact :
Executive Name : Thomas P Abraham
Contact Company : HLL Lifecare Limited
Address : HLL Bhavan Poojappura
THIRUVANANTHAPURAM,
Kerala,India 695013
Reference Id : HLL/HR/017/2012
Deadline : 29.02.12
 |
Ever since the U.S. Food and Drug Administration (FDA decided to allow drug companies to air direct-to-consumer (DTC advertisements for prescription drugs on national television back in 1997, drug industry sales and profits have soared exponentially. Combined with... |
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.
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