Pharmageddon has been defined as, "the prospect of a world in which medicines and medicine produce more ill-health than health, and when medical progress does more harm than good".
We see the need to investigate and explore that risk and to identify the factors and features that describe it.
Pharmageddon embraces the arguments of Ivan Illich (1976) but extends his focus. He warned of the risks of medicalisation, the generally dehumanising and damaging effects of professional interventions: "the medical establishment has become a major threat to health". Beyond direct drug injury (clinical iatrogenesis), he was concerned about the ill-effects of medicine on culture and community, "the paralysis of healthy responses to suffering, impairment and death" that resulted from "the expropriation of health".
But since Illich wrote, the whole shape of medicine has changed – both the knowledge base and its applications - and the pharmaceutical industry has come to dominate the medical establishment and the thrust and ethos of drug research, regulation, prescribing, availability and use.
The values of the market increasingly count. Now the leading companies, ‘the Pharmas’, have the driving influence on lifestyle, well-being and health outcomes. Their interests and investments have a major impact on the nature and availability of drug treatments, and on the essence and conduct of medicine, worldwide.
The surge towards globalisation since the 1990s has placed the pharmaceutical industry where it is today. The Pharmas are now centred in the USA – which represents half the
global market – and mainly reflect American health values and ways of doing things. The Pharmas are also major instruments of US foreign policy, and their interests are well defended as such.
Pharmageddon stands for the lament that the state of world health represents a colossal waste of what medicine and medicines could accomplish, by structurally harnessing all the talent, energy and commitment that is there. Increasingly this is not happening, which is neither morally defensible, nor in the best interests of our future. It is damaging to the climate of health, the oxygen of community and the core of personal well-being.
Pharmageddon is marked by the contrast between over-medication and drug deprivation; it also implies a strong causal link between the two. Under-medication in poorer communities, and over-medication in richer ones, are connected as closely as obesity and malnutrition, like two sides of the same coin.
Intensive drug marketing and excessive drug consumption has produced an industry whose capacity to innovate and provide is compromised, and whose viability seems increasingly to depend on systematic exaggeration of drug benefits and suppression of evidence of risks and harm. In place of transparency, the industry has now largely taken into its own hands the role of providing information to the public and professionals, filling the air with messages about health priorities, expectations and needs. The net result is a drug supply system that starves national health and sustains global health deprivation.
Outside the major drug markets, populations suffer and die because drugs they need are completely unaffordable, because trade rules block access, and/or for lack of relevant innovation. Elsewhere, the obsession with drug treatment, health observance and disease awareness, is producing nothing like the desired effects. The USA exemplifies this trend: it is beset by diseases of affluence, most obviously by obesity, with diabetes and related complications. But in spite, and no doubt also because, of all the treatment options, fewer than one in twenty citizens manages to maintain a normal weight, eat a nutritious diet, take adequate exercise and not smoke.
For all this, the notion of Pharmageddon may still seem almost inconceivable – as did the risk and threat of Climate Change, just a few years ago. It is natural to deny risks when the misery in prospect results from so much good intent and great talent, and from the enjoyment of huge benefits, valued freedoms and countless goods. And because medicines are especially precious goods, the idea of Pharmageddon offends personal and vested interests alike.
Parallels seem to exist between health and environmental catastrophe. The issues compare to the relationship between a car journey and Climate Change: they are inextricably linked, but not remotely connected in scale or relevance in the average driver’s mind. Just as Climate Change seems inconceivable as a journey outcome, so most personal experience of medicines flatly contradicts the notion of Pharmageddon.
As clinical practitioners, or individual consumers with access to medicines, most people have seen, felt, witnessed and/or imagined their sometimes miraculous effects and results. But, to pursue the analogy, the risk of Pharmageddon is to do with the way in which all drug travel changes the climate of health, even when so many individual drug journeys seem vital or worthwhile.
Both because and in spite of all the benefits of good medicine, it seems crucial to consider whether, collectively, we are rapidly losing sight and sense of health. Increasingly it seems we are. At least we need to challenge the dominant fallacy that drugs more and more resemble magic bullets and offer ever better solutions for the main trials of life.
At the same time, we need to accept that Pharmageddon is not simply the product of malevolence, but the natural outcome of something like a ‘
conspiracy of goodwill’ – a universe driven by self interest, but dominated by a complex of corporate bodies all competing to survive. If Pharmageddon seems to beckon, it is in spite of what everyone wants, not because of it.
That also applies to the Pharmas. All might be well if their products matched promise and met genuine health needs. In fact, the Pharmas are panicked by this huge shortfall and become more predatory, gluttonous, devious and oppressive, to try to compensate for it. Health outcomes drift further and further away from mainstream thinking; excessive promotion, data suppression and falsification, secrecy, bribery, fraud and deep conflicts of interest are increasingly revealed.
The consequences go far beyond the drug disasters that make the headline news. Pharmageddon implies that we have now arrived at a tipping point where leading companies devote their main energies to marketing lifestyle products, rather than on finding ways of meeting real medical needs. The brave new world in prospect is one in which commercial imperatives trump health priorities, when Pharmas and followers systematically change our understanding and experience of what it means to be human, flattening the distinctions between cultures, degrading the clinical arsenal, and developing vast numbers of drugs, most not needed and all purporting to be best. The net result is not only therapeutic disappointment, but also crushing pressures that no public health system could ever survive.
Many people have concerns about many different flaws in the present system of pharmaceutical medicine, but what do they all add up to? Our starting point is simply that the word, Pharmageddon, may mean something important and deserves to exist, if only as a description of forest rather than trees.
The etymology seems to fit. Pharmageddon conveys the idea of a battle between health and ill-health, right and wrong and for better or worse. It also challenges the tendency to take for granted that progress in pharmaceutical medicine leads naturally to better health. Armageddon was "the great symbolic battlefield of the Apocalypse, scene of the final struggle between good and evil". Apocalypse (
– APOKALYPSIS) literally means the lifting of the veil, "a term applied to the disclosure to certain privileged persons of something hidden from the mass of humankind…" (
Wikipedia, 2007).
The time has come to lift the veil: the broader significance of the risks must be explored and revealed. If Pharmageddon is part of any future reality, we all need to know.
***
SEE ALSO:
Notes and References and
CALL FOR ABSTRACTS
A Correction Has Been Published
Perspective
The Shortage of Essential Chemotherapy Drugs in the United States
Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.
N Engl J Med 2011; 365:1653-1655
November 3, 2011
Comments open through November 9, 2011
- Article
- References
- Citing Articles (1)
- Comments (14)
For the first time in the United States, some essential chemotherapy drugs are in short supply. Most are generic drugs that have been used for years in childhood leukemia and curable cancers — vincristine, methotrexate, leucovorin, cytarabine, doxorubicin, bleomycin, and paclitaxel. 1 The shortages have caused serious concerns about safety, cost, and availability of lifesaving treatments. In a survey from the Institute for Safe Medication Practices, 25% of clinicians indicated that an error had occurred at their site because of drug shortages. Many of these errors were attributed to inexperience with alternative products — for instance, incorrect administration of levoleucovorin (Fusilev) when used as a substitute for leucovorin or use of a 1000-mg vial of cytarabine instead of the usual 500-mg one, resulting in an overdose. Most cancer centers quadruple-check drugs for accuracy, and we're unaware of any documented death of a patient with cancer such as the nine deaths in Alabama attributable to the use of locally compounded liquid nutrition because the sterile product was not available. However, it is only a matter of time.
These shortages have increased the already escalating costs of cancer care. Brand-name substitutes for generic drugs can add substantial cost. For instance, Abraxane, a protein-bound version of paclitaxel, costs 19 times as much as equally effective generic paclitaxel (see table
Average Wholesale Prices (AWPs) of Selected Oncology Drugs in Short Supply and Their Potential Alternatives. ). Since 2010, health care labor costs in the United States have increased by about $216 million because of the increased time and work required to manage drug shortages. 2 A gray market for essential drugs — an unofficial alternative market of drugs obtained by vendors outside the usual distribution networks — has grown rapidly, with unregulated vendors charging markups of up to 3000% for cancer drugs.
The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages. In addition, if a brand-name drug with a higher profit margin is available, a manufacturer may stop producing its generic. For instance, leucovorin has been available from several manufacturers since 1952. In 2008, levoleucovorin, the active l-isomer of leucovorin, was approved by the Food and Drug Administration. It was reportedly no more effective than leucovorin and 58 times as expensive, but its use grew rapidly. Eight months later, a widespread shortage of leucovorin was reported.
The second economic cause of shortages is that oncologists have less incentive to administer generics than brand-name drugs. Unlike other drugs, chemotherapeutics are bought and sold in the doctor's office — a practice that originated 40 years ago, when only oncologists would handle such toxic substances and the drugs were relatively cheap. A business model evolved in which oncologists bought low and sold high to support their practice and maximize financial margins. Oncologists buy drugs from wholesalers, mark them up, and sell them to patients (or insurers) in the office. Since medical oncology is a cognitive specialty lacking associated procedures, without drug sales, oncologists' salaries would be lower than geriatricians'. In recent decades, oncology-drug prices have skyrocketed, and today more than half the revenue of an oncology office may come from chemotherapy sales, which boost oncologists' salaries and support expanding hospital cancer centers.
Before 2003, Medicare reimbursed 95% of the average wholesale price — an unregulated price set by manufacturers — whereas oncologists paid 66 to 88% of that price and thus received $1.6 billion annually in overpayments. 3 To blunt unsustainable cost increases, the Medicare Modernization Act mandated that the Centers for Medicare and Medicaid Services (CMS) set reimbursement at the average sales price plus a 6% markup to cover practice costs. This policy has reduced not only drug payments but also demand for generics. In some cases, the reimbursement is less than the cost of administration. For instance, the price of a vial of carboplatin has fallen from $125 to $3.50, making the 6% payment trivial. So some oncologists switched to higher-margin brand-name drugs. 4 Why use paclitaxel (and receive 6% of $312) when you can use Abraxane (for 6% of $5,824)?
Now practices are struggling to treat their patients because of the unavailability of drugs. Short-term solutions include gray-market purchases, which more than half of surveyed hospitals say they've made, but that option introduces safety and quality-control issues. Pharmacists are intensively managing inventories and alerting prescribers to developing shortages and potential alternatives. Some centers now have a red–yellow–green system for quickly recognizing developing shortages and determining which patients get priority (usually those with curable cancers) when supply is limited.
Long-term, non–market-based solutions have been elusive. Proposed legislation would require manufacturers to give 3 to 6 months' notice before discontinuing a drug in order to allow others to pick up production. However, it is likely that gray-market vendors would buy the remaining inventory of such drugs and charge huge markups. Creating a national stockpile is impractical: Do we stockpile the drugs and then waste whatever is not used or stockpile the ingredients and make new batches as needed? A national health care plan with a single formulary and a central pharmacy stockpile is possible for Medicare or Veterans Affairs but unrealistic given oncologists' dependence on drug income and difficulties with timely, safe distribution.
Market solutions take one of two approaches: let the market work and accept short-term uncertainties or regulate the market more tightly. For instance, the CMS could reimburse at the average sales price plus 30%, but that wouldn't help if the drug price has fallen from $125 to $3.50 per vial. The government could set a floor for average sales prices to encourage the production of generic drugs, but that would increase the total cost of cancer drugs unless brand-name prices were reduced. Europe has fewer shortages for that reason: prices are set higher for generics so that companies will make them, but prices of brand-name drugs are often much lower than U.S. prices.
More far-reaching reforms of oncology practices and reimbursement are necessary if there is no national intervention or federal market regulation. One solution is adopting clinical pathways for which practices are paid disease-management fees that are not based on chemotherapy sales. For instance, one large oncology group has developed care pathways specifying preferred drug combinations and sequences — for example, allowing only a few first-line, mostly generic regimens for patients with non–small-cell lung cancer, as compared with the 16 possible drugs and many more combinations included in National Comprehensive Cancer Network pathways. This approach has been shown to result in equal or better survival, less use of chemotherapy near the end of life, and 35% lower costs than usual care. 5 Another solution is to pay physicians salaries, as Kaiser Permanente, Veterans Affairs, and most academic centers do, but that would reduce oncologists' earnings at a time when a 40% workforce shortage is predicted, so the effect must be monitored.
To ensure a predictable supply of generic cancer drugs, manufacturers need reasonable markets and profits, and oncologists need incentives to use generics. Standardized clinical pathways with drug choices based only on effectiveness will enable the prediction of drug needs, practices for effective management of inventory, and planning by manufacturers for adequate production. Such pathways, disease-management fees, and physician salaries would dramatically change oncologic practice, but since drug costs will increase by 4 to 6% this year alone, they are necessary. The current system not only is unsustainable but also puts oncologists in potential ethical conflict with patients, since it hides revenue information that might influence drug choices and thus affects costs and patients' copayments.
The only good news is that the drug shortages may catalyze a shift from a mostly market-based system to one that rewards the provision of high-quality cancer care at an affordable cost.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1109772) was published on October 31, 2011, and updated on November 2, 2011, at NEJM.org.
Source Information
From the Virginia Commonwealth University Health System, Richmond (M.L.G.); and the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore (T.J.S.).
Drugmakers realise they need to demonstrate the value of their new treatments to payers, but many are concerned about their ability to do so.
That is one of the key findings from a new report from the Economist Intelligence Unit, sponsored by Quintiles. The analysis, called 'The Value Challenge', is based on findings of a survey of 399 senior executives from the life sciences industry, and it states that the situation is "further complicated by a shift in the balance of power among industry stakeholders, each of which may require different evidence to be convinced of a product’s value".
The EIU report argues that the value challenge is "not just a temporary symptom of current economic conditions, but a long-term issue that is a leading concern for a majority of drug companies worldwide". Moreover, although deteriorating financial circumstances are prompting some payers —particularly governments —to focus more closely on reducing pharmaceutical spending, "the demand for proof of value has been evolving for decades".
However, many stakeholders, especially biopharma companies, "lack confidence in the industry’s ability to respond to the value challenge", the report claims. Only about one-half of survey respondents say that the pharmaceutical sector is adjusting well to increasing demands for proof of value.
All respondents are harsher about biopharmaceutical companies’ ability to demonstrate value and, among payers and regulators, only 25% are confident about the broader claims of value made by these firms. However, 68% of life sciences respondents saw the growing demand to provide value has had an important impact on their business models; 85% have made at least one change to their model for this reason, 82% to their R&D strategy, and 78% to their commercial plans.
The EIU survey also notes that biopharmaceutical companies see their market power decreasing, but others still regard them as dominant players. The report quotes Ed Pezalla, national medical director for pharmaceutical policy and strategy at US insurance major Aetna, as saying that “the industry is still making decisions about what drugs come to market and what they can charge. It is just beginning to pay attention to payer sensitivity.”
?50bn merger with Xstrata will be latest City coup for billionaires behind commodities trader
More than ?50m of World Food Programme aid to feed the starving has ended up in the hands of a London-listed commodities trader run by billionaires, despite a pledge by the United Nations agency to buy food from "very poor farmers".
Glencore International, which buys up supplies from farmers and sells them on at a profit, was the biggest single supplier of wheat to the WFP over the last eight months, the Guardian can reveal.
Glencore, which was able to operate with secrecy from its base in Baar, Switzerland, until it floated on the London stock exchange last May, is expected on Tuesday to announce a merger with mining group Xstrata to become one of the 10 biggest FTSE 100 companies with a market value of more than ?50bn.
Details of the dealings with Glencore, which controls 8% of the global wheat market, emerged a year after the head of the WFP committed to buying food from local farmers.
"Our new motto is to help people feed themselves," Josette Sheeran, the executive director of the WFP,
told China's state news agency. "When we can, we purchase our food from the very poor farmers who suffer because they are not connected to local markets."
Raj Patel, an economist expert in the global food trade and former UN employee, said it was shocking how much food aid money was "funnelling to one of the largest commodity traders".
The rising price of wheat has squeezed the incomes of millions of the world's poorest people. Many have been forced to turn to the WFP, which last year fed more than 90 million people in 73 countries.
Over the last eight months Glencore has sold wheat worth $78m (?50m) to the WFP, according to
details of contracts published on the agency's website.
In the biggest single deal, the WFP bought $22.5m of Glencore wheat in July last year to feed Ethiopians in one the worst famines in recent memory. The WFP also bought Glencore wheat, sorghum and yellow split peas for Kenya, Djibouti, Bangladesh, Sudan, North Korea and Palestine. Last month the WFP spent $10.8m on wheat for drought-stricken Djibouti.
In its latest half-year financial results Glencore, which previously attracted controversy for
environmental breaches and accusations of dealing with rogue states, including Iraq under Saddam Hussein, reported that revenue from agricultural products doubled to $8.8bn. The company said its performance had been "driven by stronger profits in grains and oil seeds" for which "prices were substantially higher in H1 [the first half of] 2011 compared to H1 2010".
The company said: "There were increased geographic arbitrage opportunities [buying commodities cheaper in order to sell them on later at a higher price] available in wheat and edible oils." It said the average wheat price of a bushel [8 gallons] of wheat increased by 60% over the previous year to $778.
A spokeswoman for the WFP said: "As a humanitarian agency that depends entirely on voluntary donations we always aim to get the most competitive price when purchasing food on the open markets. Rising food prices do have an impact on our budget and they can be driven up by any number of factors, including speculation."
Glencore said it won the WFP tenders because "we were able to offer the commodities needed at the lowest possible price".
Rob Bailey, a senior research fellow in food security at Chatham House in London, said the WFP often buys from traders such as Glencore, Cargill and Viterra, because food donations are not available and local farmers cannot provide the quantities needed. "It is concerning that the World Food Programme is left at the whim of international markets precisely when prices are high," he said.
"Such crisis periods of high volatility are also when the big traders make the most money, because they have the best information on likely supply and demand and how markets are going to evolve, allowing them to take positions in the market to turn profits."
John Hilary, the executive director of the War on Want, said: "Glencore's self-confessed speculation on grain markets last year forced up prices at a time of world shortage, driving more people into extreme hunger. The WFP needs to rethink its priorities and support local markets rather than corporate giants such as Glencore."
Patel, the author of Stuffed and Starved: Markets, Power and the Hidden Battle for the World's Food System, said: "It's a shocking amount of money to be funnelling to one of the largest commodity traders. That financial entities are now making their presence felt – and Glencore is among the most powerful of these new corporations – points to the increasing financialisation of food in the 21st century."
Glencore admitted that it bet on a rising wheat price after drought in Russia, according to investment bank UBS. "[Glencore's] agricultural team received very timely reports from Russia farm assets that growing conditions were deteriorating aggressively in the spring and summer of 2010, as the Russian drought set in … This put it in a position to make proprietary trades going long on wheat and corn," UBS said in a report to potential investors, disclosed by the Financial Times.
On 3 August 2010 the head of Glencore's Russian grain business, Yury Ognev, urged Moscow to ban grain exports, according to the UBS report. Two days later Russian authorities banned wheat exports, which forced prices up by 15% in two days.
On Monday Glencore said UBS's account of its role in the Russian grain crisis was "simply untrue. In any case, the export ban did not help our business".
A spokesman said: "We share the view that financial speculation in agricultural products markets can be harmful. Our business is physical – we produce, buy, store and blend agricultural commodities.
"We bridge the gap between harvests that last for a couple of weeks and demand which is fairly constant throughout the year.
"Because we are physical holders, we are always net sellers in the agricultural products futures markets which actually has a downward effect on the prices of agricultural products futures."
Glencore's chief executive, Ivan Glasenberg, earned the moniker "the $10 billion man" when his stake was valued at ?5.76bn at last May's flotation. Four other partners – Daniel Mate, Telis Mistakidis, Tor Peterson and Alex Beard – were also made paper billionaires. More than
$3.6bn was given to the WFP last year, with the US contributing $1.2bn and the UK ?144m.
Merger deal anticipated
Glencore is on Tuesday expected to announce plans to merge with mining group Xstrata to become one of the 10 biggest companies listed on the London stock market. It will be the latest move in Glencore's journey from secretive trading house founded by Marc Rich, a commodities traderwho was charged by US authorities with selling oil to Iran during the 1979-81 hostage crisis, to global powerhouse in the sale of commodities from copper and coal to sugar and wheat.
The largest shareholder in the combined company – dubbed Glenstrata – will be Ivan Glasenberg, Glencore's multibillionaire chief executive. But Glasenberg, who makes so much money he
indirectly funded a generous Christmas tax break for the other residents of the Swiss village where he lives, is understood to be planning to step aside to become deputy to Mick "the miner" Davis, the head of Xstrata.
Davis, already one the highest paid executives in the FTSE 100, is likely to be offered a "golden handcuffs" deal to stay at the company. A change of control clause could also see Davis collect an additional ?10.7m in long-term shares.
The deal is likely to see Glencore pay about an 8% premium to buy up the Xstrata shares it does not already own.
Sir John Bond, Xstrata's chairman and a former chair of HSBC and Vodafone, will lead the Glenstrata board, while Glencore's chairman Simon Murray, who has been attacked for his
"unbelievably primitive" views on women in business, is likely to step aside.
Tony Hayward, the former boss of BP, is likely to be appointed the senior independent director of the combined company, which will have more than 120,000 staff across five continents.
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preparing for the introduction of the new pharmacovigilance legislation in July this year. The new legislation (
Directive 2010/84/EU and
Regulation (EU) No. 1235/2010) amending existing legislation was adopted in the European Union ("EU") in December 2010. The legislation aims to promote and protect public health by strengthening the Europe-wide system for monitoring the safety and benefit-risk balance of medicines.
The new legislation is designed to strengthen the procedures for the submission of risk management plans and periodic safety update reports ("PSURs") to the EMA. Currently companies submit a risk management plan at the time of application for a marketing authorization. The plan includes information on how the medicine will be monitored for safety during its lifetime and describes risk minimization activities. PSURs provide an evaluation of the benefit-risk balance of a medicine and these are submitted at defined periods during the post-authorization phase. This month the EMA will be publishing draft good pharmacovigilance practice ("GVP") modules for both risk management plans and PSURs for consultation.
The legislation provides for a new approach to the use of post-authorization safety and efficacy studies ("PASS" / "PAES") and implementation will also begin in 2012. A PASS is a study of an authorized medicine which identifies, characterizes or quantifies a safety hazard, confirms the safety profile of the medicine, or gauges the effectiveness of risk management measures during its lifetime. A PAES aims to clarify the efficacy for a medicine on the market including efficacy in everyday medical practice. The information obtained in the studies is to support regulators in decision-making on the safety and benefit-risk profile of a medicine. Like the other GVP modules above a PASS module will also be published for public consultation in February 2012. The scientific guideline for public consultation on PAES will be published by the EMA during the year.
Several Democratic lawmakers are requesting information from two brand drugmakers and the Drug Enforcement Administration (DEA) on production quotas that may limit generic attention deficit disorder (ADD) drugs. The four leading House members accuse Shire Pharmaceuticals and Novartis of “manipulating the market” by using DEA quotas that limit the amount of a particular product to flood pharmacies with more brand than generic versions of ADD drugs.
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Most producers do not have the capacity to test for pathogens themselves and must send samples out to a lab. Results can take 2 or more days to process. For companies selling fresh meat or produce with a limited shelf life, this delay can hinder their ability to get product out before it starts to expire.
But a detection technology being developed by nanoRETE, a Michigan-based company, in conjunction with
Michigan State University, will allow producers to test their products themselves, and to do it in under an hour.
The system, called X-MARK, works by using a pathogen's antibodies to draw it out of a food sample via magnetic pull. These separated particles are then put on a biochip, which is fed into the reader, where an electric current will recognize a pathogen based on the pattern of its electrical current.
"It's simple!" explained Evangelyn Alocilja, who designed the system's nanoparticles, in a phone interview. Alocilja is a professor of biosystems and agricultural engineering at MSU and chief scientific officer of nanoRETE.
For anyone daunted by the mechanics of how the system works, it's practical application is as easy as 1, 2, 3. First, obtain a liquid sample. Juice and milk already qualify. For solid products such as fruit, swish the sample in a bag of distilled water and use the water as your sample. Next, add in the nanoparticle solution, one for each pathogen you want to detect. Finally, put the sample on a biosensor chip and insert it into the reader. Let sit for 40 minutes.
"It's truly field-based," says Alocilja. "It's on-site detection."
X-MARK is not the first detection technology to screen samples in realtime, but it is highly sensitive, detecting as few as 5 to 10 cells per milliliter as opposed to most technologies which have a threshold of 1,000 to 10,000 cells per ml. It's also faster than most products on the market, and is expected to be affordable once it goes public. Production costs for each test are under $1 each.
"The problem right now is that tests are so expensive that producers don't do a lot of testing," says Alocilja.
The system will cut down on testing costs in the short-term, but it could have an even bigger cost-saving impact in the long term by preventing contaminated food from leaving the facility, helping prevent the loss of thousands and even millions of dollars in a recall or outbreak.
"Not only are there the costs of an outbreak or recall," points out Alocilja, "but there is a negative impact on the brand."
Indeed some recalls and outbreaks result in bankruptcy for the implicated company. This does not mean that X-MARK will be a cure-all for outbreaks. Tests can only screen so many products, and a contaminated product may not be caught if it isn't among the sampled product.
Also, increased testing should not be an indicator that it's okay to slacken food safety controls earlier on in the production process.
"Testing doesn't make it safe. All testing does is tell you that a process is under control," explained Craig Wilson, Costco's Director of Food Safety, in an interview with Food Safety News last year.
The need for rapid, do-it-yourself testing is now greater than ever. As of last year, the U.S. Department of Agriculture has proposed to add 6 more strains of pathogenic E. coli to its list of banned bacteria, meaning that producers could soon be testing ground beef for these bacteria, in addition to the more well-known E. coli O157:H7. For companies who sell fresh meat and must make room to store it during testing, realtime detection is a valuable tool.
The system will also work especially well for fresh produce, says Alecilja. Fresh fruits and vegetables that don't undergo a pathogen-killing step during production or become contaminated post-production are especially dangerous since they will not likely be cooked before eating. Cantaloupes, lettuce, sprouts and tomatoes have all been responsible for multiple serious outbreaks over the past 10 years.
X-MARK technology can also be used to detect other harmful bacteria and toxins, such as tuberculosis and anthrax. For foodborne pathogens, testing can get as specific as the antibody. A more general solution will detect E. coli, whereas a specific one would isolate a specific serotype.
Alecilja says she expects the product to hit markets in about two years.
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From the GREAT STATE OF MAINE…
Fork-tender
"I just about got your sequence now. You start by rotating the plate counterclockwise…cut on the diagonal…remove unwanted elements. And now comes my favorite part: the loading of the fork. It's fascinating, the percentages you use of different vegetables to create that one…harmoniously-balanced…perfect bite."
---Jeff Bridges in The Mirror Has Two Faces
Yesterday the Maine Sunday Telegram published a
letter to the editor that captures the essence of the modern Republican party.
To set upon debunking it would be like criticizing the Mona Lisa for smirking, or Rodin's The Thinker for exposing his tuckus. This is a fork loaded up with perfect percentages of alarmism, bullshit, paranoia, untruth, fabricated fury and Fox/Limbaugh/Malkin buzzwords to create that one…inharmoniously-unbalanced…perfect bite, served up in the conservative movement's local greasy spoon on Alternate Reality Boulevard. I swear I may frame this piece of outrage art and hang it above the terlet:
His accomplishments include destroying our manned space program, ending American air superiority by discontinuing the F-22 fighter jet, defunding our military to nearly pre-World War II levels, courting ultimate defeat in Iraq and Afghanistan through premature withdrawal, humiliating and undermining our British and Israeli allies, displaying weakness to the Chinese and the Russians and bowing before anti-American tyrants … apologizing for America's legacy of spreading freedom around the world, trying to disarm Americans through government-generated "Fast and Furious"-style gun scandals, stealing our lifestyle freedom through massive federal regulation of nearly every aspect of private life, chaining the free market, smothering small businesses, retarding any return to prosperity through vindictive tax policy aimed at job creators, encouraging class hatred, letting stand without rebuke his allies' claim that all opposition to Obama is rooted in a pervasive subconscious racism, decimating America's oil industry, canceling the Keystone pipeline, and disenfranchising our control over our very own bodies through universal health care laws.
Other than that, Mrs. Lincoln, how did you like the play? And the grand finale: a false-choice swan dive from a hundred feet into a teacup:
The 2012 election is about whether voters will approve Obama's effort to fundamentally transform us, or whether we will reverse this trend and remain recognizably American. Nothing less than the soul of our nation is at stake.
Silly goose---Democrats can't steal America's soul. Republicans already called dibs on selling it to the highest bidder.
Cheers and Jeers starts below the fold... [Swoosh!!] RIGHTNOW! [Gong!!]
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When the austerity budget was revealed in June 2010 it was quickly apparent that women would bear the brunt of the new Coalition government cuts. The likely impact was analysed at the time by Yvette Cooper who
described the emergency budget as looking like “the worst for women since the creation of the welfare state”. Since then, the emerging catalogue of austerity measures: cuts to public sector, to public services, reductions in welfare measures, cuts to benefits including tax credits, have created a barren landscape for today’s women in conservative Britain.
It is easy to forget that this new reality came hard on the heels of what now seems a “golden era” which culminated in Harriet Harman’s
Equality Act 2010. We could be forgiven for thinking then that women were steadily on their way to equal pay and opportunities and to the outlawing of “unfair treatment … in the workplace and wider society”.
When public services are withdrawn or cut, it is women, as carers or mothers who commonly step in to fill the breach. Women also filled many of the low-paid public sector jobs that have been lost. Those who have hung on to their jobs experience the same career insecurity and lowering expectations as all today’s workforce. But in addition they face a stubborn gender pay gap that has hardly changed in decades. In some analyses, such as the 2010
report from the Fawcett Society with the public sector union, Unison, this remains as high as 14.9%.
The
Annual Survey of Hours and Earning published by the National Office of Statistics at the end of 2011 revealed that the official gap in 2011 had shrunk to below 10% for the first time ever are therefore of scant comfort. The figure does relate to a key statistic – median full-time hourly earnings – but it does not tell the whole story.
A problem with averages
Trying to justify cuts to the public sector, the Coalition Government argued that public sector workers receive higher average wages than those in the private sector. At the time,
UNISON pointed out that this was a ‘meaningless’ analysis which had overlooked a vital factor: a transfer of the lowest-paid jobs from public to private sector had artificially inflated the public sector average.
In the same vein, it is possible that economic crisis followed by austerity may have led to a similar distortion of averages and a consequent misleading appearance of a narrowing gender pay difference. Women hold
65% of public sector jobs and predominate in the administrative and service sectors. Since government cuts have had a greater impact in these lower-paid jobs, the women who held these jobs were more likely to be made redundant. The average pay of the women who remained in work would thus be higher, narrowing the gender gap but as a result of job losses and a rise in women’s
unemployment rate. As TUC General Secretary Brendan Barber
explained: ‘Female unemployment is already at a 23-year high, and with so many women employed in the public sector, this will only deteriorate.’
The
Fawcett Society too, has reservations about the new 2011 figure of 9.1% since it does not take into account the kind of work that women and men do. According to the Fawcett Society, 64% of the lowest-paid workers are women. Some
two thirds of workers who earn less than ?7 an hour are women. At the other extreme, the highest-paid jobs are characterised by a concentration of men. Lord Davies’s 2011 official
investigation into the barriers preventing women reaching the boardroom found that only 7.8% of FTSE 250 directorships were held by women.
This pattern of
sex segregation - broadly, men concentrated at the top end of the pay scale, women concentrated at the bottom – is the main determinant of the continuing difference in women’s and men’s pay, as Jude Brown finds in her study,
Sex Segregation and Inequality in the Modern Labour Market.
But how has this inequality persisted, 42 years since the first
Equal Pay Act? The background to this Act was nostalgically re-enacted in last year’s box-office success,
Made in Dagenham. On screen, the promise by Secretary of State Barbara Castle that the women workers at the Essex car factory would see legislation addressing the inequalities of shop floor pay was presented as a battle won, a victory for equality and justice by organised working women.
Today, equality and justice appear to be low-down on the political agenda. Coalition austerity has returned children into poverty and left skilled adults without work; cuts threaten
pensionersand deprive
disabled people of their independence. Conservative ideology scapegoats the unemployed and single mothers and reframes benefits claimants as state freeloaders. At such a time focusing on pay inequalities between men and women may look like putting principle before the urgent needs of those struggling to survive.
But with increasing numbers of families now dependent on women’s wages, it could equally be argued that the issue of gender pay disparity is all the more pertinent. Households headed by single mothers can ill afford to lose that vital 10% in their pay packets; it could be the difference between having or not having enough to eat for the week.
Solutions
Ending the gender pay gap for good has never been simply about ensuring that Ms Jones receives the same money as Mr Jones for the same job. It is about recognising the broader picture. The tough challenges are to develop progressive policies that value male and female-dominated jobs equally, and that rebalance the burden of childcare.
Jobs undertaken predominantly by women tend to be undervalued, even where they require more responsibility or skill than male-dominated jobs. ‘
Comparable worth’ is hard to prove. Is teaching as valuable as plumbing? How can secretaries show that they should be paid the same as drivers? The idea that the jobs women do - whatever they are - are less worthwhile than the jobs men do - whatever they are - appears ingrained and wages reflect this.
And there remain the perennial difficulties for working parents, seldom posed as a problem for men. As mothers, women are assumed to have other priorities; the lack of institutional
supportfor egalitarian parenting is rarely, if ever, considered. The beliefs underlying ‘
family friendly’ Conservative policies appear to centre on the welfare of families but do not address underlying problems of gender roles. As long as women are earning 10% less than men, it makes more financial sense (particularly in hard times) for mothers to take the main burden of childcare.
And yet this economic downturn may prove different from those of the past. Never before have women been so financially independent and never before have the consequences of austerity been so brazenly visited upon the less well off. The Coalition’s reported lack of success with women voters gives women an important casting vote on how a fairer world of work evolves. Any kind of gender pay gap may come to be seen as, quite simply, unacceptable.
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