Shortages of key drugs endanger patients. Free market to blame.

“Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.”  … The causes vary from drug to drug, but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.”

This is a perfect illustration of why the research, development, ownership and production of medicines must not be left in the hands of private businesses.  Drugs must be researched and produced according to our needs, not profit opportunities. Private companies must not be allowed to own patents on drugs. Despite spectacular advances in research techniques, companies’ profit-driven research has produced few significant advances.  It is virtually impossible to oversee private manufacture of medicines, and companies regard fines in response to tragic “accidents” as a cost of doing business.

Washington Post, Sunday, May 1, 2011

Shortages of key drugs endanger patients

By Rob Stein

Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.

A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.

The paucities are forcing some medical centers to ration drugs — including one urgently needed by leukemia patients — postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.

“It’s a crisis,” said Erin R. Fox, manager of the drug information service at the University of Utah, who monitors drug shortages for the American Society of Health-System Pharmacists. “Patients are at risk.”

The causes vary from drug to drug, but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.

“It seems like there were a lot of things happening with consolidations and quality issues and more things coming from overseas,” said Allen J. Vaida, executive director of the Institute for Safe Medicine Practices, a nonprofit group that helped organize a conference last fall to examine the issue. “It just reached a point where the number of shortages was slowly going up and up, and now we have a national crisis with this huge shortage of critical medications.”

While the dearth that has garnered the most public attention is — ironically — for a barbiturate that is hindering prisons trying to execute inmates, the scarcities are having a much broader impact on keeping people alive, especially in emergency rooms, oncology wards and intensive care units.

No one is systematically tracking the toll of the shortages, but reports are emerging of delayed treatments, anxious searches for desperately needed drugs, devastating injuries from mistakes and less-adequate drugs, and even possible deaths.

Federal regulators have been rushing to alleviate the shortages, sometimes helping firms resume production more quickly or approving emergency imports of supplies from overseas.

The Food and Drug Administration eased a shortage of the anesthetic propofol last year by allowing foreign importation, for example, and this year approved bringing in several other medications, including two cancer drugs.

“The types of products we’re seeing shortages of are really concerning,” said Valerie Jensen, who heads the FDA’s Drug Shortages Program. “This is affecting oncology drugs, critical-care drugs, emergency medicine drugs. We’re doing everything we can under our current authority to try to deal with this situation.”

In Congress, legislation has been introduced to address the problem. For example, a bill would require companies to notify the FDA in advance about anything that might cause a shortage and give the agency new powers to try to assuage them.

“We can’t put patients’ lives at risk simply because there’s some snafus in a process or a manufacturer decides it’s less profitable to make a certain drug,” said Sen. Amy Klobuchar (D-Minn.). “Patients deserve better than that.”

‘Very global supply chain’

Many of the shortages involve older, cheaper generic medications that are less profitable, causing many firms to stop producing them and leaving fewer sources. Most involve “sterile injectable” medications that are more complicated to produce and therefore are more prone to manufacturing problems.

In addition, drug companies increasingly rely on raw materials from other countries.

“We’ve certainly reached a very global supply chain for drug products, with the active ingredients typically made outside of the United States,” said Gordon Johnston, vice president for regulatory sciences at the Generic Pharmaceutical Association. “It could be Europe, India — some cases China. If there’s a problem at a facility in Italy or India, it leads to disruption of the drug supply in the United States.”

Some industry representatives blame part of the problem on increased oversight by the FDA, which has made drug safety a higher priority after coming under intense criticism for being too lax.

“As you know right now, FDA has taken a heightened approach towards drug safety,” said Maya Bermingham, senior assistant general counsel at the Pharmaceutical Research and Manufacturers of America. “FDA has stepped up inspections. The more you look, the more you may discover problems.”

While acknowledging that the industry needs to do a better job of coordination, some company officials said the agency should coordinate enforcement actions and drug shortage issues more closely to avoid administrative requirements that cause interruptions.

“We’re not sure how much of that is going on recently because we’ve seen more and more shortages in the industry. We think that maybe some of those coordination issues can be worked on,” said Joshua Gordon, vice president and general manager of specialty pharmaceuticals at Hospira, the largest producer of specialty generic sterile injectables.

Shortages of pre-loaded epinephrine syringes and propofol, for example, occurred when suppliers dropped out just as the FDA was demanding additional documentation, he said.

“They are very focused on taking quick and and aggressive action,” Gordon said. “We applaud the agency’s role in assuring quality, but it can slow things down significantly.”

FDA officials dispute that greater government oversight is a major factor, saying manufacturing problems were the cause of most shortages.

“There has not been a significant increase in domestic enforcement actions (seizure or injunction) for this class of products in recent years,” Jensen wrote in an e-mail.

‘Too many . . . will die’

Whatever the causes, many of the affected drugs are mainstays of medical care, such as the potent painkiller morphine, norepinephrine, which is commonly used in emergency rooms, and electrolytes, which are often given to patients in intensive care.

But shortages have been reported in many categories of drugs, including antibiotics, and drugs central to the treatment of many cancers, forcing oncologists to delay or alter carefully timed chemotherapy regimens.

“We have heard some horror stories where patients are really begging to get the drugs from other sources and where practices or institutions are forced to kind of triage patients and save the drugs for those — quote — most curable, where they have the best prognosis and using substitutes where there isn’t a cure possibility,” Michael Link, president-elect of the American Society of Clinical Oncology.

The drug cytarabine has caused the most concern and gotten the most attention because it is highly effective for treating several forms of leukemia and lymphoma but must be administered as quickly as possible, especially to patients with acute myeloid leukemia.

“With this drug they can be cured and without this drug too many of them will certainly die. That’s the simplest way to put it,” said Deborah Banker, vice president for research communication at the Leukemia & Lymphoma Society. “The disease progresses so rapidly that untreated patients can sadly die within days. There is no time for delay and no certainty of a good outcome if you can’t get a full dose.”

Many hospitals are running low, and some have run out completely. That has required many facilities to ration the drug, giving priority to those who need it most urgently.

“It’s so unbelievable,” said Mary Collins, 57, of La Crosse, Wis., whose husband, Michael, 66, had problems obtaining cytarabine to fight lymphoma. “A cancer diagnosis is a long, very, very stressful circumstance. And then to learn that a particular drug is no longer available to you and that there seems to be no formalized mechanism in place to correct it just makes it worse.”

Cytarabine’s scarcity was caused by hitches that two out of the three manufacturers hit in obtaining raw materials, as well as the discovery of crystals in some shipments.

The third manufacturer was unable to make up for the shortfall. Some of the problems have been resolved, however, and the FDA is working on importing the drug.

The shortages are forcing hospital pharmacists to juggle supplies and hunt for new sources. Many hospitals, including several contacted in the Washington area, say they are usually able to patch together solutions.

But some resort to paying inflated prices or buying from unfamiliar suppliers, increasing the risk they may be getting counterfeits.

“When it becomes clear that some drug may be in short supply or going into a shortage, what happens is sometimes there are unsavory folks — small distributors — who buy up whatever is left and sell it back at exorbitant prices,” said Roslyne Shulman, director of policy development for the American Hospital Association.

‘Panic in the pharmacy’

When shortages occur, physicians turn to less optimal alternatives or find out too late that the drug they need is unavailable. Mark Warner, president of the American Society of Anesthesiologists, described two calamities that occurred in the past year because of shortages. In one, a 16-year-old boy suffered brain damage because doctors did not have one muscle relaxer needed to treat a complication from jaw surgery.

In another, a middle-aged woman was left in a permanent vegetative state because doctors did not have the drug epinephrine after she experienced complications from heart surgery.

“These are tragic cases,” Warner said. “It’s one of those things most anesthesiologists in the country think about when they are driving to work every day. We don’t know where the shortages are and they come on very quickly. ”

Nurses and doctors responding to emergencies, meanwhile, are losing precious minutes when they must work with unfamiliar substitutes or recalculate dosages, increasing the chances of overdosing or under-dosing patients. One of the biggest problems is a shortage of syringes pre-filled with precisely measured doses.

“Grabbing the right medication out of a crash cart that’s already in a syringe is a big advantage over having to get out the syringe, get out the needle, get the medication and get the measurement right,” said Angela Gardner, an emergency medicine physician at the University of Texas Southwestern Medical Center in Dallas and immediate past president of the American College of Emergency Physicians. “Those minutes are lives.”

Many hospitals are recalibrating electronic medication delivery systems or preparing the correct doses ahead of time, especially for the emergency room, to minimize mistakes.

“We’ve been extremely fortunate using strategies in cooperation with our medical staff,” said Jay Barbaccia, head pharmacist at the Washington Hospital Center. “We’ve had a lot of panic and inconvenience but minimal, if any, impact on our ability to provide care. It makes my life miserable — the panic is in the pharmacy when we’re scrambling around to find alternatives.”

Nevertheless, a long list of errors and near-misses have been reported, including incidents in which patients required emergency care to save them.

At least two patients reportedly died from overdoses of hydromorphone they received because of a morphine shortage.

At least 19 patients were sickened and nine died in Alabama this year after being infused with a solution through their feeding tubes that was apparently contaminated with bacteria by a pharmacy using an unfamiliar ingredient because of a shortage.

The shortage occurred because the manufacturer had trouble getting the product’s packaging.

“It’s horrible. It’s something that shouldn’t have happened,” said Donald J. Mottern of Alabaster, Ala., whose 71-year-old mother was one of the victims. “We lost the matriarch of our family. The loss to our family has left each of us very hollow.”

© 2011 The Washington Post Company

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John Pilger: Empire, Obama and the Last Taboo

johnpilger.com July 9, 2009

Adapted from an address, Empire, Obama and the Last Taboo, given by John Pilger at Socialism 2009 in San Francisco on 4th July

Barack Obama is the embodiment of this “ism”. From his early political days, Obama’s unerring theme has been not “change”, the slogan of his presidential campaign, but America’s right to rule and order the world. Of the United States, he says, “we lead the world in battling immediate evils and promoting the ultimate good… We must lead by building a 21st-century military to ensure the security of our people and advance the security of all people.” And: “At moments of great peril in the past century our leaders ensured that America, by deed and by example, led and lifted the world, that we stood and fought for the freedoms sought by billions of people beyond their borders.”

Mourn on the fourth of July In an essay for the New Statesman, John Pilger argues that while liberals now celebrate America’s return to its “moral ideals”, they are silent on a venerable taboo. This is the true role of Americanism: an ideology distinguished by its myths and the denial that it exists. President Obama is its embodiment. The monsoon had woven thick skeins of mist over the central highlands of Vietnam. I was a young war correspondent, bivouacked in the village of Tuylon with a unit of US marines whose orders were to win hearts and minds. “We are here not to kill,” said the sergeant, “we are here to impart the American Way of Liberty as stated in the Pacification Handbook. This is designed to win the hearts and minds of folks, as stated on page 86.” Page 86 was headed WHAM. The sergeant’s unit was called a combined action company, which meant, he explained, “we attack these folks on Mondays and we win their hearts and minds on Tuesdays”. He was joking, though not quite. Standing in a jeep on the edge of a paddy, he had announced through a loudhailer: “Come on out, everybody. We got rice and candy and toothbrushes to give you.” Silence. Not a shadow moved. “Now listen, either you gooks come on out from wherever you are, or we’re going to come right in there and get you!” The people of Tuylon finally came out and stood in line to receive packets of Uncle Ben’s Long Grain Rice, Hershey bars, party balloons and several thousand toothbrushes. Three portable, battery-operated, yellow flush lavatories were kept for the colonel’s arrival. And when the colonel arrived that evening, the district chief was summoned and the yellow flush lavatories were unveiled. “Mr District Chief and all you folks out there,” said the colonel, “what these gifts represent is more than the sum of their parts. They carry the spirit of America. Ladies and gentlemen, there’s no place on earth like America. It’s a guiding light for me, and for you. You see, back home, we count ourselves as real lucky having the greatest democracy the world has ever known, and we want you good folks to share in our good fortune.” Thomas Jefferson, George Washington and Davy Crockett got a mention. “Beacon” was a favourite, and as he evoked John Winthrop’s “city upon a hill”, the marines clapped, and the children clapped, understanding not a word. It was a lesson in what historians call “exceptionalism”, the notion that the United States has the divine right to bring what it describes as liberty and democracy to the rest of humanity. That this merely disguised a system of domination, which Martin Luther King described, shortly before his assassination, as “the greatest purveyor of violence in the world”, was unspeakable. As the great people’s historian Howard Zinn has pointed out, Winthrop’s much-quoted description of the 17th-century Massachusetts Bay Colony as a “city upon a hill”, a place of unlimited goodness and nobility, was rarely set against the violence of the first settlers, for whom burning alive some 400 Pequot Indians was a “triumphant joy”. The countless massacres that followed, wrote Zinn, were justified by “the idea that American expansion is divinely ordained”. Not long ago, I visited the American Museum of History, part of the celebrated Smithsonian Institution in Washington, DC. One of the popular exhibitions was “The Price of Freedom: Americans at War”. It was holiday time and lines of people, including many children, shuffled reverentially through a Santa’s grotto of war and conquest where messages about their nation’s “great mission” were dispensed. These ­included tributes to the “exceptional Americans [who] saved a million lives” in Vietnam, where they were “determined to stop communist expansion”. In Iraq, other true hearts ­“employed air strikes of unprecedented precision”. What was shocking was not so much the revisionist description of two of the epic crimes of modern times as the sheer scale of omission. “History without memory,” declared Time magazine at the end of the 20th century, “confines Americans to a sort of eternal present.. They are especially weak in remembering what they did to other people, as opposed to what they did for them.” Ironically, it was Henry Luce, founder of Time, who in 1941 divined the “American century” as an American social, political and cultural “victory” over humanity and the right “to exert upon the world the full impact of our influence, for such purposes as we see fit and by such means as we see fit”. None of this is to suggest that vainglory is exclusive to the United States. The British presented their often violent domination of much of the world as the natural progress of Christian gentlemen selflessly civilising the natives, and present-day TV historians perpetuate the myths. The French still celebrate their bloody “civilising mission”. Prior to the Second World War, “imperialist” was an honoured political badge in Europe, while in the US an “age of innocence” was preferred. America was different from the Old World, said its mythologists. America was the Land of Liberty, uninterested in conquest. But what of George Washington’s call for a “rising empire” and James Madison’s “laying the foundation of a great empire”? What of slavery, the theft of Texas from Mexico, the bloody subjugation of central America, Cuba and the Philippines? An ordained national memory consigned these to the historical margins and “imperialism” was all but discredited in the United States, especially after Adolf Hitler and the fascists, with their ideas of racial and cultural superiority, had left a legacy of guilt by association. The Nazis, after all, had been proud imperialists, too, and Germany was also “exceptional”. The idea of imperialism, the word itself, was all but expunged from the American lexicon, “on the grounds that it falsely attributed immoral motives to western foreign policy”, argued one historian. Those who persisted in using it were “disreputable purveyors of agitprop” and were “inspired by the communist doctrine”, or they were “Negro intellectuals who had grievances of their own against white capitalism”. Meanwhile, the “city on the hill” remained a beacon of rapaciousness as US capital set about realising Luce’s dream and recolonising the European empires in the postwar years. This was “the march of free enterprise”. In truth, it was driven by a subsidised production boom in a country unravaged by war: a sort of socialism for the great corporations, or state capitalism, which left half the world’s wealth in American hands. The cornerstone of this new imperialism was laid in 1944 at a conference of the western allies at Bretton Woods in New Hampshire. Described as “negotiations about economic stability”, the conference marked America’s conquest of most of the world. What the American elite demanded, wrote Frederic F Clairmont in The Rise and Fall of Economic Liberalism, “was not allies but unctuous client states. What Bretton Woods bequeathed to the world was a lethal totalitarian blueprint for the carve-up of world markets.” The World Bank, the International Monetary Fund, the Asian Development Bank, the Inter-American Development Bank and the African Development Bank were established in effect as arms of the US Treasury and would design and police the new order. The US military and its clients would guard the doors of these “international” institutions, and an “invisible government” of media would secure the myths, said Edward Bernays. Bernays, described as the father of the media age, was the nephew of Sigmund Freud. “Propaganda,” he wrote, “got to be a bad word because of the Germans… so what I did was to try and find other words [such as] Public Relations.” Bernays used Freud’s theories about control of the subconscious to promote a “mass culture” designed to promote fear of official enemies and servility to consumerism. It was Bernays who, on behalf of the tobacco industry, campaigned for American women to take up smoking as an act of feminist liberation, calling cigarettes “torches of freedom”; and it was his notion of disinformation that was deployed in overthrowing governments, such as Guatemala’s democracy in 1954. Above all, the goal was to distract and deter the social democratic impulses of working people. Big business was elevated from its public reputation as a kind of mafia to that of a patriotic force. “Free enterprise” became a divinity. “By the early 1950s,” wrote Noam Chomsky, “20 million people a week were watching business-sponsored films. The entertainment industry was enlisted to the cause, portraying unions as the enemy, the outsider disrupting the ‘harmony’ of the ‘American way of life’… Every aspect of social life was targeted and permeated schools and universities, churches, even recreational programmes. By 1954, business propaganda in public schools reached half the amount spent on textbooks.” The new “ism” was Americanism, an ideology whose distinction is its denial that it is an ideology. Recently, I saw the 1957 musical Silk Stockings, starring Fred Astaire and Cyd Charisse. Between the scenes of wonderful dancing to a score by Cole Porter was a series of loyalty statements that the colonel in Vietnam might well have written. I had forgotten how crude and pervasive the propaganda was; the Soviets could never compete. An oath of loyalty to all things American became an ideological commitment to the leviathan of business: from the business of armaments and war (which consumes 42 cents in every tax dollar today) to the business of food, known as “agripower” (which receives $157bn a year in government subsidies). Barack Obama is the embodiment of this “ism”. From his early political days, Obama’s unerring theme has been not “change”, the slogan of his presidential campaign, but America’s right to rule and order the world. Of the United States, he says, “we lead the world in battling immediate evils and promoting the ultimate good… We must lead by building a 21st-century military to ensure the security of our people and advance the security of all people.” And: “At moments of great peril in the past century our leaders ensured that America, by deed and by example, led and lifted the world, that we stood and fought for the freedoms sought by billions of people beyond their borders.” Since 1945, by deed and by example, the US has overthrown 50 governments, including democracies, crushed some 30 liberation movements and supported tyrannies from Egypt to Guatemala (see William Blum’s histories). Bombing is apple pie. Having stacked his government with warmongers, Wall Street cronies and polluters from the Bush and Clinton eras, the 45th president is merely upholding tradition. The hearts and minds farce I witnessed in Vietnam is today repeated in villages in Afghanistan and, by proxy, Pakistan, which are Obama’s wars. In his acceptance speech for the 2005 Nobel Prize for Literature, Harold Pinter noted that “everyone knew that terrible crimes had been committed by the Soviet Union in the postwar period, but “US crimes in the same period have been only superficially recorded, let alone documented, let alone acknowledged, let alone recognised as crimes at all”. It is as if “It never happened. Nothing ever happened. Even while it was happening, it wasn’t happening… You have to hand it to America… masquerading as a force for universal good. It’s a brilliant, even witty, highly successful act of hypnosis.” As Obama has sent drones to kill (since January) some 700 civilians, distinguished liberals have rejoiced that America is once again a “nation of moral ideals”, as Paul Krugman wrote in the New York Times. In Britain, the elite has long seen in exceptional America an enduring place for British “influence”, albeit as servitor or puppet. The pop historian Tristram Hunt says America under Obama is a land “where miracles happen”. Justin Webb, until recently the BBC’s man in Washington, refers adoringly, rather like the colonel in Vietnam, to the “city on the hill”. Behind this façade of “intensification of feeling and degradation of significance” (Walter Lippmann), ordinary Americans are stirring perhaps as never before, as if abandoning the deity of the “American Dream” that prosperity is a guarantee with hard work and thrift.. Millions of angry emails from ordinary people have flooded Washington, expressing an outrage that the novelty of Obama has not calmed. On the contrary, those whose jobs have vanished and whose homes are repossessed see the new president rewarding crooked banks and an obese military, essentially protecting George W Bush’s turf. My guess is that a populism will emerge in the next few years, igniting a powerful force that lies beneath America’s surface and which has a proud past. It cannot be predicted which way it will go. However, from such an authentic grass-roots Americanism came women’s suffrage, the eight-hour day, graduated income tax and public ownership. In the late 19th century, the populists were betrayed by leaders who urged them to compromise and merge with the Democratic Party. In the Obama era, the familiarity of this resonates. What is most extraordinary about the United States today is the rejection and defiance, in so many attitudes, of the all-pervasive historical and contemporary propaganda of the “invisible government”. Credible polls have long confirmed that more than two-thirds of Americans hold progressive views. A majority want the government to care for those who cannot care for themselves. They would pay higher taxes to guarantee health care for everyone. They want complete nuclear disarmament; 72 per cent want the US to end its colonial wars; and so on. They are informed, subversive, even “anti-American”. I once asked a friend, the great American war correspondent and humanitarian Martha Gellhorn, to explain the term to me. “I’ll tell you what ‘anti-American’ is,” she said. “It’s what governments and their vested interests call those who honour America by objecting to war and the theft of resources and believing in all of humanity. There are millions of these anti-Americans in the United States. They are ordinary people who belong to no elite and who judge their government in moral terms, though they would call it common decency. They are not vain. They are the people with a wakeful conscience, the best of America’s citizens. They can be counted on. They were in the South with the civil rights movement, ending slavery. They were in the streets, demanding an end to the wars in Asia. Sure, they disappear from view now and then, but they are like seeds beneath the snow. I would say they are truly exceptional.”