MODELO DE BULA DO PACIENTE IDENTIFICAÇÃO DO MEDICAMENTO COVERSYL 4mg perindopril 4mg APRESENTAÇÕES: Embalagem contendo 15 ou 30 comprimidos de 4mg. USO ORAL USO ADULTO ACIMA DE 18 ANOS COMPOSIÇÃO: Cada comprimido de COVERSYL (perindopril) 4mg contém: perindopril, sal de terc-butilamina. 4,00 mg. correspondente a 3,338 mg de perindopril(DCB 06994). excipiente
Pubselect custom bookMillions for Viagra,Pennies for Diseasesof the Poor KEN SILVERSTEIN
Why are pharmaceutical companies willing to invest millions of dollars ondrugs that reduce wrinkles or that eliminate our pets’ anxiety—and not ondrugs that would eradicate life-threatening illness afflicting Third Worldpopulations? The answer is related to how global economic stratificationaffects the availability of health care—those who can pay get what they needand want from the medical institution, and those who can’t may not. Put another way, the lure of high profits encourages pharmaceutical companies to place a priority on developing “lifestyle” drugs like Viagra,Rogaine, or even antidepressants for pets over developing drugs for infectiousdiseases such as malaria or river blindness. And, as Ken Silverstein argues,until it is profitable for them to do so, pharmaceutical companies are unlikelyto change their priorities to research, develop, and introduce affordable drugsto disadvantaged populations. Almost three times as many people, most of them in tropical countries of the Third World, die of preventable, curable diseases as die of AIDS. Malaria, tuberculosis, acute lower-respiratory infections—in 1998,these claimed 6.1 million lives. People died because the drugs to treat thoseillnesses are nonexistent or are no longer effective. They died because itdoesn’t pay to keep them alive.
Only 1 percent of all new medicines brought to market by multinational pharmaceutical companies between 1975 and 1997 were designed specifi-cally to treat tropical diseases plaguing the Third World. In numbers, thatmeans thirteen out of 1,223 medications. Only four of those thirteen resultedfrom research by the industry that was designed specifically to combat trop-ical ailments. The others, according to a study by the French group Doctors “Millions for Viagra, Pennies for Diseases of the Poor” by Ken Silverstein from The Nation7/19/99. Copyright 1999 by The Nation. Reprinted by permission.
ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ Without Borders, were either updated versions of existing drugs, products ofmilitary research, accidental discoveries made during veterinary research or,in one case, a medical breakthrough in China.
Certainly, the majority of the other 1,210 new drugs help relieve suffer- ing and prevent premature death, but some of the hottest preparations, theones that, as the New York Times put it, drug companies “can’t seem to roll . . .
out fast enough,” have absolutely nothing to do with matters of life anddeath. They are what have come to be called lifestyle drugs—remedies thatmay one day free the world from the scourge of toenail fungus, obesity, bald-ness, face wrinkles and impotence. The market for each drug is worth bil-lions of dollars a year and is one of the fastest-growing product lines in theindustry.
The drug industry’s calculus in apportioning its resources is cold- blooded, but there’s no disputing that one old, fat, bald, fungus-ridden richman who can’t get it up counts for more than half a billion people who arevulnerable to malaria but too poor to buy the remedies they need.
Western interest in tropical diseases was historically linked to colonizationand war, specifically the desire to protect settlers and soldiers. Yellow feverbecame a target of biomedical research only after it began interfering withEuropean attempts to control parts of Africa. “So obvious was this deter-rence . . . that it was celebrated in song and verse by people from Sudan toSenegal,” Laurie Garrett recounts in her extraordinary book The ComingPlague. “Well into the 1980s schoolchildren in Ibo areas of Nigeria still sangthe praises of mosquitoes and the diseases they gave to French and Britishcolonialists.” US military researchers have discovered virtually all important malaria drugs. Chloroquine was synthesized in 1941 after quinine, until then theprimary drug to treat the disease, became scarce following Japan’s occupationof Indonesia. The discovery of Mefloquine, the next advance, came aboutduring the Vietnam War, in which malaria was second only to combatwounds in sending US troops to the hospital. With the end of a ground-based US military strategy came the end of innovation in malaria medicine.
The Pharmaceutical Research and Manufacturers of America (PhRMA) claimed in newspaper ads early this year that its goal is to “set every last dis-ease on the path to extinction.” Jeff Trewhitt, a PhRMA spokesman, says USdrug companies will spend $24 billion on research this year and that a num-ber of firms are looking for cures for tropical diseases. Some companies also ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ provide existing drugs free to poor countries, he says. “Our members areinvolved. There’s not an absolute void.” The void is certainly at hand. Neither PhRMA nor individual firms will reveal how much money the companies spend on any given disease—that’sproprietary information, they say—but on malaria alone, a recent survey ofthe twenty-four biggest drug companies found that not a single one maintainsan in-house research program, and only two expressed even minimal interestin primary research on the disease. “The pipeline of available drugs is almostempty,” says Dyann Wirth of the Harvard School of Public Health, who con-ducted the study. “It takes five to ten years to develop a new drug, so we couldsoon face [a strain of] malaria resistant to every drug in the world.” A 1996study presented in Cahiers Santé, a French scientific journal, found that offorty-one important medicines used to treat major tropical diseases, nonewere discovered in the nineties and all but six were discovered before 1985.
Contributing to this trend is the wave of mergers that has swept the industry over the past decade. Merck alone now controls almost 10 percentof the world market. “The bigger they grow, the more they decide that theirresearch should be focused on the most profitable diseases and conditions,”one industry watcher says. “The only thing the companies think about on adaily basis is the price of their stocks; and announcing that you’ve discovereda drug [for a tropical disease] won’t do much for your share price.” That comment came from a public health advocate, but it’s essentially seconded by industry. “A corporation with stockholders can’t stoke up a lab-oratory that will focus on Third World diseases, because it will go broke,”says Roy Vagelos, the former head of Merck. “That’s a social problem, andindustry shouldn’t be expected to solve it.” Drug companies, however, are hardly struggling to beat back the wolves of bankruptcy. The pharmaceutical sector racks up the largest legal profits ofany industry, and it is expected to grow by an average of 16 to 18 percentover the next four years, about three times more than the average for theFortune 500. Profits are especially high in the United States, which aloneamong First World nations does not control drug prices. As a result, priceshere are about twice as high as they are in the European Union and nearlyfour times higher than in Japan.
“It’s obvious that some of the industry’s surplus profits could be going into research for tropical diseases,” says a retired drug company executive,who wishes to remain anonymous. “Instead, it’s going to stockholders.” Alsoto promotion: In 1998, the industry unbuckled $10.8 billion on advertising.
ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ And to politics: In 1997, American drug companies spent $74.8 million tolobby the federal government, more than any other industry; last year theyspent nearly $12 million on campaign contributions.
Just forty-five years ago, the discovery of new drugs and pesticides led theWorld Health Organization (WHO) to predict that malaria would soon beeradicated. By 1959, Garrett writes in The Coming Plague, the Harvard Schoolof Public Health was so certain that the disease was passé that its curriculumdidn’t offer a single course on the subject.
Resistance to existing medicines—along with cutbacks in healthcare budgets, civil war and the breakdown of the state—has led to a revival ofmalaria in Africa, Latin America, Southeast Asia and, most recently, Armeniaand Tajikistan. The WHO describes the disease as a leading cause of globalsuffering and says that by “undermining the health and capacity to work ofhundreds of millions of people, it is closely linked to poverty and contributessignificantly to stunting social and economic development.” Total global expenditures for malaria research in 1993, including gov- ernment programs, came to $84 million. That’s paltry when you considerthat one B-2 bomber costs $2 billion, the equivalent of what, at current lev-els, will be spent on all malaria research over twenty years. In that period,some 40 million Africans alone will die from the disease. In the UnitedStates, the Pentagon budgets $9 million per year for malaria programs, aboutone-fifth the amount it set aside this year to supply the troops with Viagra.
For the drug companies, the meager purchasing power of malaria’s victimsleaves the disease off the radar screen. As Neil Sweig, an industry analyst atSoutheast Research Partners, puts it wearily, “It’s not worth the effort or thewhile of the large pharmaceutical companies to get involved in enormouslyexpensive research to conquer the Anopheles mosquito.” The same companies that are indifferent to malaria are enormously trou- bled by the plight of dysfunctional First World pets. John Keeling, aspokesman for the Washington, DC–based Animal Health Institute, says the“companion animal” drug market is exploding, with US sales for 1998 esti-mated at about $1 billion. On January 5, the FDA approved the use ofClomicalm, produced by Novartis, to treat dogs that suffer from separationanxiety (warning signs: barking or whining, “excessive greeting” and chew-ing on furniture). “At Last, Hope for Millions of Suffering Canines World-wide,” reads the company’s press release announcing the drug’s rollout. “Ican’t emphasize enough how dogs are suffering and that their behavior is not ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ tolerable to owners,” says Guy Tebbitt, vice president for research and devel-opment for Novartis Animal Health.
Also on January 5 the FDA gave the thumbs up to Pfizer’s Anipryl, the first drug approved for doggie Alzheimer’s. Pfizer sells a canine pain relieverand arthritis treatment as well, and late last year it announced an R&D pro-gram for medications that help pets with anxiety and dementia.
Another big player in the companion-animal field is Heska, a biotech- nology firm based in Colorado that strives to increase the “quality of life” forcats and dogs. Its products include medicines for allergies and anxiety, aswell as an antibiotic that fights periodontal disease. The company’s Web sitefeatures a “spokesdog” named Perio Pooch and, like old “shock” movies fromhigh school driver’s-ed classes, a photograph of a diseased doggie mouth todemonstrate what can happen if teeth and gums are not treated carefully. Noone wants pets to be in pain, and Heska also makes drugs for animal cancer,but it is a measure of priorities that US companies and their subsidiariesspend almost nothing on tropical diseases while, according to an industrysource, they spend about half a billion dollars for R&D on animal health.
Although “companion animal” treatments are an extreme case—that half-billion-dollar figure covers “food animals” as well, and most veterinary drugsemerge from research on human medications—consider a few examplesfrom the brave new world of human lifestyle drugs. Here, the pharmaceuti-cal companies are scrambling to eradicate: Pfizer invested vast sums to find a cure for what Bob Dole and other industry spokesman delicately refer to as “erectile dysfunction.”The company hit the jackpot with Viagra, which racked up more than $1 bil-lion in sales in its first year on the market. Two other companies, Schering-Plough and Abbott Laboratories, are already rushing out competing drugs.
The top two drugs in the field, Merck’s Propecia and Phar- macia & Upjohn’s Rogaine (the latter sold over the counter), had combinedsales of about $180 million in 1998. “Some lifestyle drugs are used for rela-tively serious problems, but even in the best cases we’re talking about very dif-ferent products from penicillin,” says the retired drug company executive. “Incases like baldness therapy, we’re not even talking about healthcare.” With the slogan “Let your feet get naked!” as its battle cry, pharmaceutical giant Novartis recently unveiled a lavish advertising cam-paign for Lamisil, a drug that promises relief for sufferers of this unsightlymalady. It’s a hot one, the war against fungus, pitting Lamisil against Janssen ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ Pharmaceutical’s Sporanox and Pfizer’s Diflucan for shares in a market esti-mated to be worth hundreds of millions of dollars a year.
Allergan earned $90 million in 1997 from sales of its “miracle” drug Botox. Injected between the eyebrows at a cost of about$1,000 for three annual treatments, Botox makes crow’s feet and wrinklesdisappear. “Every 71⁄2 seconds someone is turning 50,” a wrinkle expert toldthe Dallas Morning News in an article about Botox last year. “You’re lookingat this vast population that doesn’t want frown lines.” Meanwhile, acute lower respiratory infections go untreated, claiming about 3.5 million victims per year, overwhelmingly children in poor nations.
Such infections are third on the chart of the biggest killers in the world; thenumber of lives they take is almost half the total reaped by the number-onekiller, heart disease, which usually strikes the elderly. “The development ofnew antibiotics,” wrote drug company researcher A.J. Slater in a 1989 paperpublished in the Royal Society of Tropical Medicine and Hygiene’s Trans-actions, “is very costly and their provision to Third World countries alone cannever be financially rewarding.” In some cases, older medications thought to be unnecessary in the First World and commercially unviable in the Third have simply been pulled fromthe market. This created a crisis recently when TB re-emerged with a ven-geance in US inner cities, since not a single company was still manufactur-ing Streptomycin after mid-1991. The FDA set up a task force to deal withthe situation, but it was two years before it prodded Pfizer back into the field.
In 1990 Marion Merrell Dow (which was bought by German giant Hoechst in 1995) announced that it would manufacture Ornidyl, the firstnew medicine in forty years that was effective in treating African sleepingsickness. Despite the benign sounding name, the disease leads to coma anddeath, and kills about 40,000 people a year. Unlike earlier remedies forsleeping sickness, Ornidyl had few side effects. In field trials, it saved thelives of more than 600 patients, most of whom were near death. Yet Ornidylwas pulled from production; apparently company bean-counters determinedthat saving lives offered no return.
Because AIDS also plagues the First World, it is the one disease ravag- ing Third World countries that is the object of substantial drug companyresearch. In many African countries, AIDS has wiped out a half-century ofgains in child survival rates. In Botswana—a country that is not at war andhas a relatively stable society—life expectancy rates fell by twenty years overa period of just five. In South Africa, the Health Ministry recently issued areport saying that 1,500 of the country’s people are infected with HIV every ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ day and predicting that the annual deathrate will climb to 500,000 withinthe next decade.
Yet available treatments and research initiatives offer little hope for poor people. A year’s supply of the highly recommended multi-drug cocktail ofthree AIDS medicines costs about $15,000 a year. That’s exorbitant in anypart of the world, but prohibitive in countries like Uganda, where per capitaincome stands at $330. Moreover, different viral “families” of AIDS, with dis-tinct immunological properties, appear in different parts of the world. About85 percent of people with HIV live in the Third World, but industry researchto develop an AIDS vaccine focuses only on the First World. “Withoutresearch dedicated to the specific viral strains that are prevalent in develop-ing countries, vaccines for those countries will be very slow in coming,” saysDr. Amir Attaran, an international expert who directs the Washington-basedMalaria Project.
All the blame for the neglect of tropical diseases can’t be laid at the feet of industry. Many Third World governments invest little in healthcare, andFirst World countries have slashed both foreign aid and domestic researchprograms. Meanwhile, the US government aggressively champions the inter-ests of the drug industry abroad, a stance that often undermines healthcareneeds in developing countries.
In one case where a drug company put Third World health before profit—Merck’s manufacture of Ivermectin—governmental inertia nearlyscuttled the good deed. It was the early eighties, and a Pakistani researcherat Merck discovered that the drug, until then used only in veterinary medi-cine, performed miracles in combating river blindness disease. With onedose per year of Ivermectin, people were fully protected from river blindness,which is carried by flies and, at the time, threatened hundreds of millions ofpeople in West Africa.
Merck soon found that it would be impossible to market Ivermectin profitably, so in an unprecedented action the company decided to provide itfree of charge to the WHO. (Vagelos, then chairman of Merck, said the com-pany was worried about taking the step, “as we feared it would discouragecompanies from doing research relevant to the Third World, since they mightbe expected to follow suit.”) Even then, the program nearly failed. The WHOclaimed it didn’t have the money needed to cover distribution costs, andVagelos was unable to win financial support from the Reagan Administration.
A decade after Ivermectin’s discovery, only 3 million of 120 million people atrisk of river blindness had received the drug. During the past few years, theWHO, the World Bank and private philanthropists have finally put up the ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ money for the program, and it now appears that river blindness will becomethe second disease, after smallpox, to be eradicated.
Given the industry’s profitability, it’s clear that the companies could do farmore. It’s equally clear that they won’t unless they are forced to. The successof ACT UP* in pushing drug companies to respond to the AIDS crisis inAmerica is emblematic of how crucial but also how difficult it is to get theindustry to budge. In late 1997, a coalition of public health organizationsapproached a group of major drug companies, including Glaxo-Wellcomeand Roche, and asked them to fund a project that would dedicate itself todeveloping new treatments for major tropical diseases. Although the compa-nies would have been required to put up no more than $2 million a year,they walked away from the table. Since there’s no organized pressure—eitherfrom the grassroots or from governments—they haven’t come back. “There[were] a number of problems at the business level,” Harvey Bale, director ofthe Geneva-based International Federation of Pharmaceutical Manufacturers’Association, told Science magazine. “The cost of the project is high for somecompanies.” While the industry’s political clout currently insures against any radical government action, even minor reforms could go a long way. The retireddrug company executive points to public hospitals, which historically wereguaranteed relatively high profit margins but were obligated to provide freecare to the poor in return. There’s also the example of phone companies,which charge businesses higher rates in order to subsidize universal service.
“Society has tolerated high profit levels up until now, but society has the rightto expect something back,” he says. “Right now, it’s not getting it.” The US government already lavishly subsidizes industry research and allowscompanies to market discoveries made by the National Institute of Healthand other federal agencies. “All the government needs to do is start attachingsome strings,” says the Malaria Project’s Attaran. “If a company wants to mar-ket another billion-dollar blockbuster, fine, but in exchange it will have topush through a new malaria drug. It will cost them some money, but it’s notgoing to bankrupt them.” *Eds. Note: AIDS Coalition to Unleash Power ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ Another type of “string” would be a “reasonable pricing” provision for drugs developed at federal laboratories. By way of explanation, Attaranrecounted that the vaccine for hepatitis A was largely developed byresearchers at the Walter Reed Army Institute. At the end of the day, the gov-ernment gave the marketing rights to SmithKline Beecham and Merck. Thecurrent market for the vaccine, which sells for about $60 per person, is $300million a year. The only thing Walter Reed’s researchers got in exchange fortheir efforts was a plaque that hangs in their offices. “I’ll say one thing for thecompanies,” says Attaran. “They didn’t skimp on the plaque; it’s a nice one.
But either the companies should have paid for part of the government’sresearch, or they should have been required to sell the vaccine at a muchlower price.” At the beginning of this year, Doctors Without Borders unveiled a cam- paign calling for increased access to drugs needed in Third World countries.
The group is exploring ideas ranging from tax breaks for smaller firmsengaged in research in the field, to creative use of international trade agree-ments, to increased donations of drugs from the multinational companies.
Dr. Bernard Pécoul, an organizer of the campaign, says that differentapproaches are required for different diseases. In the case of those plaguingonly the Southern Hemisphere—sleeping sickness, for example—marketmechanisms won’t work because there simply is no market to speak of.
Hence, he suggests that if multinational firms are not willing to manufacturea given drug, they transfer the relevant technology to a Third World producerthat is.
Drugs already exist for diseases that ravage the North as well as the South—AIDS and TB, for example—but they are often too expensive forpeople in the Third World. For twenty-five years, the WHO has used fund-ing from member governments to purchase and distribute vaccines to poorcountries; Pécoul proposes a similar model for drugs for tropical diseases.
Another solution he points to: In the event of a major health emergency, stateor private producers in the South would be allowed to produce generic ver-sions of needed medications in exchange for a small royalty paid to themultinational license holder. “If we can’t change the markets, we have tohumanize them,” Pécoul says. “Drugs save lives. They can’t be treated as nor-mal products.” ᨪ MILLIONS FOR VIAGRA, PENNIES FOR DISEASES OF THE POOR ᨪ Why have drug companies focused almost exclusively on lifestyle drugs?What are some potential negative outcomes of this on the health ofpeople throughout the world? According to Silverstein, is it appropriate to put the blame solely on drugcompanies for their neglect of vaccines that would help people in ThirdWorld nations? Why, or why not? Pretend that you have ten minutes to talk to the president of a majorpharmaceutical company. What would you say to him or her aboutdeveloping treatments for tropical diseases that afflict people in ThirdWorld countries? Visit the Doctors Without Borders website (www.doctorswithoutborders.
org) and the World Health Organization website (www.who.int/home-page). What can one learn from these websites about world health prob-lems and priorities? Is what you learned consistent with the claims madeby Silverstein in this article? Explain.
WEEKLY NEWS - 24 June 2005 << More of this week's news Cedants accuse reinsurers of irrational approach to German industrial business Sharply different views on the state of the market were voiced by industrial customers, primary insurers and reinsurers during apanel discussion organised by the insurance faculty of the Cologne University of Applied Science. Hermann Jörissen, boa