Doctors, Research. Marketing and Patents
The Canadian System
The Australian PBS and Trade Agreements
This page is not an in depth analysis of the pharmaceutical industry. I have chosen simply to give some extracts from a limited range of material in my data base. The intention is to show the lines of friction that have developed between a historical and social ethos of humanitarian service and a newer more market centred competitive focus on profits and growth. I argue that this increasing friction is the consequence of changes in market philosophy over the last 20 to 30 years.
The many advances in modern medicine owe a huge debt to the pharmacology industry, to their wealth and their willingness to fund research. Over the earlier years the thrust of the business seemed to be governed by humanitarian objectives to a far greater extent than it is today. The question is why the drug giants are increasingly seen as villains rather than the more responsible citizens they once were.
That there are good reasons for this perception is clear from many analysis. In my view this is a consequence of the same forces that have swept through the rest of the health care sector. Humanitarian services operating within the marketplace typically held market views at arms length and critically examined their actions in the light of humanitarian value systems. They were also far more perceptive of community values and norms. They were more subservient to the community whose interests they served.
These same groups have now fully embraced the ideology of competitive market forces and no longer have doubts. They have lost the ability to mediate between their social role and responsibilities on the one hand, and their role in the marketplace. The latter with its emphasis on profit, cut throat competition and serial acquisitions has become an ultimate reality. The market has become their real world and the world the rest of us live in has become an anachronism. As a consequence the processes of social control have broken down. (see comments on these processes on another page)
Many of the concerns about the drug giants are beyond the scope of this web site which concentrates on the social processes underlying corporate practices in health and aged care, and on the fraud and patient care consequences. I have elected on this page to provide simply a series of extracts from the press. These serve to give an indication of the nature and extent of these conflicts, a result perhaps of the contradictions between the logic of the world of the marketplace and the world the rest of us inhabit.
Plase understand that the extracts on this web page are from a limited selection of a large volume of published material. They are intended to point to the issues and the emotions raised in the debate. They are not intended to be definitive or a detailed evaluative of the problems although some of my sentiments are reflected in the comments. With so much criticism and so much indignation I assume a large fire somewhere.
Further information can be obtained by searching the world literature. It might include the following web sites
The Great Health Grab <http://www.newint.org/issue362/keynote.htm>
Big Pharma <http://www.newint.org/issue362/contents.htm>
Much less widely publicised are the many allegations and investigations of fraud, and the unsavoury market practices employed by pharmaceutical companies, particularly in the USA. I have devoted a separate page to exploring these issues.
CLICK HERE to go to the Pharmaceutical Corporate Fraud Page
Over the last few years drug companies have seldom been far from the front pages. Their large profits and aggressive business first approach has earned them widespread condemnation. Issues of concern have included Internet marketing, direct to public marketing, deceptive marketing, excess influence on prescribing physicians, influencing research and suppressing unwanted research, exerting undue influence on authors in medical journals, and even ghost writing research papers and opinion pieces. They are accused of funding research for profitable western diseases and underfunding research for 3rd world diseases like tuberculosis, malaria and AIDS that cause many more deaths. They are accused of unreasonably pressing patent rights and high prices in poor 3rd world countries devastated by diseases like AIDS. As a consequence many millions were denied drugs to help and even cure them. The companies eventually bent before an avalanche of negative publicity and gave some ground.
The pharmaceutical giants political donations, lobbying and consequent influence are legendary. No one is more beholden to them than President George Bush. These political relationships are eflected in the manner in which governments act for the industry in international negotiations.
THE drug industry has created vast markets for products like Viagra, Celebrex and Vioxx by spending billions of dollars on consumer advertising
But to sell medicines that treat schizophrenia, the companies focus on a much smaller group of customers: state officials who oversee treatment for many people with serious mental illness. Those patients - in mental hospitals, at mental health clinics and on Medicaid - make states among the largest buyers of antipsychotic drugs.
Since the mid-1990's, a group of drug companies, led by Johnson & Johnson, has campaigned to convince state officials that a new generation of drugs - with names like Risperdal, Zyprexa and Seroquel - is superior to older and much cheaper antipsychotics like Haldol. The campaign has led a dozen states to adopt guidelines for treating schizophrenia that make it hard for doctors to prescribe anything but the new drugs. That, in turn, has helped transform the new medicines into blockbusters.
Ten drug companies chipped in to help underwrite the initial effort by Texas state officials to develop the guidelines. Then, to spread the word, Johnson & Johnson, Pfizer and possibly other companies paid for meetings around the country at which officials from various states were urged to follow the lead of Texas, according to documents and interviews that are part of a lawsuit and an investigation in Pennsylvania.
But questions have multiplied about the many ways that the drug industry tries to influence the medical information that determines its products' success or failure. Last month, for example, some senators sharply criticized the National Institutes of Health for allowing its scientists to accept consulting fees and stock options from drug and biotechnology companies. Officials of the agency said that its top-level scientists were no longer accepting such compensation.
Dr. Weiden said, industry-sponsored educational events focus on medications, while subjects like how to talk to patients to motivate them to get better fall through the cracks.
"The industry drives education right now," Dr. Weiden said. "Across the board, there has been a shifting of education toward psychopharma," meaning drug treatment. Making Drugs, Shaping the Rules The New York Times February 1, 2004
DIRECT TO CONSUMER ADVERTISING (DTCA)
DTCA (direct-to-consumer advertising) has emerged as one of the most controversial areas in the act, and debate is polarized, says Ross Duncan, a Health Canada policy adviser.
Mass-media advertising of prescription drugs is legal only in the United States and New Zealand, but pharmaceutical companies, as well as the media and advertising firms that stand to benefit, have been lobbying hard to ease restrictions in Canada and Europe.
When U.S. restrictions on DTCA were eased in 1997, spending on mass-media advertising of prescription drugs there began to soar. Looser ad rules a headache for drug plans Direct-to-consumer advertising will send costs soaring, employers warn The Globe and Mail Tuesday, September 18, 2001
Increases in the sales of the 50 drugs that were most heavily advertised to U.S. consumers accounted for almost half the $20.8 billion increase in drug spending last year, according to a study performed by The National Institute for Health Care Management Research and Educational Foundation.
The study attributed the spending increase to a boost in the number of prescriptions for the 50 drugs, and not from a rise in their price.
Only the United States and New Zealand permit advertising of prescription medicines to consumers. The advertising has grown more controversial as both the number of ads and spending on prescription drugs continue to rise. Comments about DTCA The New York Times, November 21, 2001
Mainstream public advertising of prescription drugs is having a detrimental effect on the appropriateness of treatment offered to North American patients, according to a study published in today's British Medical Journal. (see Mintzes, ML Barer, RL Kravitz, A Kazanjian, K Bassett, J Lexchin, RG Evans, R Pan, SA Marion. British Medical Journal 2 February 2002, Vol 324: 278=20) summary of report at <http://www.chspr.ubc.ca/hpru/pdf/dtca.PDF> Information from Centre for Health Services and Policy Research, University of British Columbia, Canada <http://www.chspr.ubc.ca>
One of the more successful research projects for a drug company was conducted in our hospital and was generously funded by the company selling the expensive drug to be tested. I persuaded a reluctant competitor selling a very cheap drug to provide samples for a double blind study promising to see that their interests were not unfairly compromised.
The trial got under way under the name of the expensive drug and all staff were harnessed to the effort. I ensured that the trial was conducted fairly in spite of a positive bias created by the funding and the name of the study. The results of the trial showed no difference for the two drugs other than a more convenient route of administration for the expensive drug. The results were published.
By this time everyone in the hospital knew the name of the drug and was using it. Others were told of the trial. Soon it was causing cost blowouts across the state and our hospital led the way. For the drug company it had been a brilliant start to a marketing exercise. The results of the trial which showed no additional benefit for the increased cost passed unnoticed.
Research is not always what it appears to be, and often contains a carrot for the researchers. Negative findings can be lost in the marketing.
This new Public Citizen report reveals how major U.S. drug companies and their Washington, D.C. lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), have carried out a misleading campaign to scare policy makers and the public. PhRMA's central claim is that the industry needs extraordinary profits to fund expensive, risky and innovative research and development (R&D) for new drugs. If anything is done to moderate prices or profits, R&D will suffer, and, as PhRMA's president recently claimed, "it's going to harm millions of Americans who have life-threatening conditions." But this R&D scare card - or canard - is built on myths, falsehoods and misunderstandings, all of which are made possible by the drug industry's staunch refusal to open its R&D records to congressional investigators or other independent auditors. (The authors have drawn on multiple sources to debunk the claims.) Rx R&D Myths: The Case Against The Drug Industry's R&D "Scare Card" Public Citizen July 23, 2001 <http://www.citizen.org/>
The inquiry involves Biovail's program to pay as much as $1,000 US per patient to U.S. doctors who prescribed Cardizem LA as part of a survey.
The practice, a first for Biovail, raised ethical concerns about combining sales efforts with research.
The Wall Street Journal reported last month, however, that some doctors see the incentives as a campaign to promote the drug and note that the $1,000 US maximum payment is one of the highest ever offered. U.S. government agency inquiring into Biovail's clinical, marketing practices Canadian Press August 22, 2003
Seeking to curb the growing influence of drug firms on research, the world's top medical journals announced steps on Sunday to prevent firms that fund studies from manipulating results to favor their drugs or bury studies that are unfavorable.
An editorial published by the participating journals on Monday said that "corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants or the advancement of science in general. Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation.''
The journal editors said they were spurred into action by several examples in recent years of drug companies being accused of attempting to hide findings that were not to their liking or misrepresenting such results as positive. The editorial said the use of medical studies "primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool.'' Medical Journals Act to Limit Drug Firms' Influence Reuters September 10, 2003
With big bucks shaping the industry, the emphasis shifts from drugs that cure to those that sell.
Developing countries bear a disproportionate part of the world's disease burden. But with 80 per cent of the world's population they account for only 10 per cent of global drug sales.
Take malaria, a disease which has developed several increasingly virulent drug-resistant strains and which affects up to 500 million people a year. In 2000 Glaxo Wellcome (now GlaxoSmithKline) launched the first new anti-malarial developed by a drug company in 40 years. However, it was aimed at prevention, not treatment. Its market was the estimated seven million tourists and visitors who venture into malarial regions, not the people who live in them. For meaningful research on new malaria drugs we have to look to publicly and charitably funded institutions. The great health grab New Internationalist 362 November 2003 <http://www.newint.org/issue362/keynote.htm>
The cause of death was clear: a complication from an experimental treatment for kidney inflammation using a drug made by a German company, Schering AG. (graft-versus-host disease)
Among the first to be notified was Dr. Stephen I. Katz, the senior NIH official whose institute conducted the study.
Unbeknown to the participants, Katz also was a paid consultant to Schering AG.
Katz and his institute staff could have responded to the death by stopping the study immediately. They also could have moved swiftly to warn doctors outside the NIH who were prescribing the drug for similar disorders. Either step might have threatened the market potential for Schering AG's drug. They did neither.
Two decades ago, the NIH was so distinct from industry that Margaret Heckler, secretary of Health and Human Services in the Reagan administration, could describe it as "an island of objective and pristine research, untainted by the influences of commercialization."
Today, with its senior scientists collecting paychecks and stock options from biomedical companies, the NIH is no longer an island.
Interviews and corporate and federal records obtained by the Los Angeles Times document hundreds of consulting payments to ranking NIH officials, - - - -
Schering AG paid Katz at least $170,000. Another company paid him more than $140,000 in consulting fees. It won $1.7 million in grants from his institute before going bankrupt last year.
Increasingly, outside payments to NIH scientists are being hidden from public view. Relying in part on a 1998 legal opinion, NIH officials now allow more than 94% of the agency's top-paid employees to keep their consulting income confidential.
Many of them also routinely sign confidentiality agreements with their corporate employers, putting their outside work under tight wraps.
Meanwhile, three articles written by NIH doctors and published from March 2000 through May 2001 referred to the agency's work with Fludara without mentioning the risk of graft-versus-host disease or the death in their study.
In an article published in the May 2001 issue of the journal Pharmacotherapy, the doctors, three from Katz's institute, wrote that Fludara "was well tolerated" and thanked the company for providing the drug and "analytical support." Stealth Merger: Drug Companies and Government Medical Research : Some of the National Institutes of Health's top scientists are also collecting paychecks and stock options from biomedical firms. Increasingly, such deals are kept secret. Los Angeles Times December 7, 2003
DOCTORS AND MEDICAL JOURNALS
Over the past decade, with the advent of sophisticated new computer technology, pharmaceutical manufacturers have been quietly compiling résumés on the prescribing patterns of the nation's health care professionals, many of whom have no idea that their decisions are open to commercial scrutiny.
These "prescriber profiles" are the centerpiece of an increasingly vigorous - and apparently successful - effort by drug makers to sway doctors' prescribing habits.
In describing the profiles as "a fundamental violation" of that privacy, Mr. Gostin said they also raise "an extremely important policy question, which is to what extent are health care prescribing practices influenced by commercial concerns?"
Of the $13.9 billion that the drug companies spent promoting their products last year, 87 percent, or about $12 billion, was aimed at doctors and the small group of nurse practitioners and physicians' assistants who can prescribe some medications, about one million prescribers all told. High-Tech Stealth Being Used to Sway Doctor Prescriptions The New York Times November 16, 2000
Australia (where drugs are heavily subsidised through the PBS system)
The irony is that, inevitably, a substantial amount of those taxpayer dollars is being spent by drug companies on marketing drugs to doctors in a way that many experts believe is causing doctors to prescribe excessively and inappropriately.
On many of these drug-company-sponsored lunches, dinners and special events, doctors are actually earning points towards their continuing medical education, required by the Royal College of General Practitioners. But is the information provided at these evenings always objective and appropriate? Or are many of these events just clever ways for drug companies to encourage doctors to prescribe more of their drugs?
The former drug company insider also details to Sunday the sensitive information some drug companies secretly keep on the doctors they target.
"The doctors are getting - you know - all their special little trinkets and whatever but, at the same time, data is being collected on them which I don't think they really realise exists and which I think they would resent existing."
Crucially, this research also showed that the drug information provided by drug company reps provided minimal information on product risk. It concluded the information was not considered balanced, was sometimes inaccurate, and was largely used to promote product benefits while down-playing risks.
Sunday: "But they're also paying for those free dinners, those free lunches, the car washes, the ferry rides, the free gifts, the umbrellas, the bottles of wine...We're paying for it aren't we?"
Evans: "And in every other product, you're probably doing the same thing."
As Sunday points out, what this means is that taxpayers are effectively helping pay for the very same aggressive promotion and marketing of drugs that is causing a massive blow-out in the PBS. The doctors' gravy train Sunday Chanel 9 TV (Australia) August 5, 2001
A survey of medical experts who write guidelines for treating conditions like heart disease, depression and diabetes has found that nearly 9 out of 10 have financial ties to the pharmaceutical industry, and the ties are almost never disclosed.
Financial conflicts of interest are the subject of intense debate in medicine. Pharmaceutical companies often underwrite the cost of medical conferences and hire prominent academic doctors to serve as speakers or to lead symposiums at which the companies' drugs are discussed. Study Says Clinical Guides Often Hide Ties of Doctors New York Times February 6, 2002
At least 1,000 alleged cases of corruption of doctors by large pharmaceutical firms have been cited in Germany. The companies are allegedly encouraging doctors to prescribe more expensive drug treatments.
Munich's public prosecutor spokesman Manfred Wick said the case started in 1999 when a complaint was made against the firm SmithKline Beecham Pharma GmbH on suspicion of bribery and tax evasion.
Various offices of the pharmaceutical giant were raided on May 10, 2000, in Munich as well as some of Saechsisches Serumwerk in Dresden and Hoechst Marion Roussel in Frankfurt.
But Dr. Ellis Huber, former president of the Association's Berlin branch, told Bild am Sonnag, "A third of doctors are cynical and unscrupulously oriented, a third keep to the ethical rules, and a third sway somewhere between the two. Moral principles have been mislaid in this profession. The power of the marketing people has overgrown the power of the medics and researchers." Bribery of German Docs by Drug Companies Reported Reuters Health March 11, 2003
The "murky" relationships between the world's leading pharmaceutical companies, supposedly independent medical journals and family doctors are exposed in the British Medical Journal today.
A landmark edition of the BMJ is devoted entirely to claims that patients and governments are being systematically misled over the benefits of new treatments and therapies by drugs giants.
Richard Smith, the editor of the BMJ, analysed the influence drug giants had on the medical newspapers - their shop window for prescribing doctors. Many publications rely heavily on revenue from advertisements placed by the very drugs companies they should be scrutinising - adverts Mr Smith says are often "misleading". Moreover, some companies may offer to buy advertising space on the basis that the paper runs articles favourable to their products.
Yet another study cited by the BMJ found that GPs who regularly spoke to sales representatives from drug companies were more likely to prescribe medicines unnecessarily and in contravention of guidelines. Mr Smith said: "The [drug] industry dominates health care, and most doctors have been wined and dined by it." Drug firms profit from 'murky' link with journals, study shows : Companies are misleading doctors, patients and governments to push their medicines, says a special edition of the 'BMJ' May 30, 2003 <http://news.independent.co.uk>
Free pens and pizza lunches. Sponsored conferences and compromised medical education. Courtesy golf and unaffordable holidays. Thought leaders and ghost writers. These are the trappings of doctors and drug companies being entwined in an embrace of avarice and excess, an embrace that distorts medical information and patient care. An article in this theme issue of the BMJ identifies 16 ways in which doctors are entangled with the drug industry. You can probably identify more. The issue explores the extent of this relationship, its effects on research, its influence on prescribing, and the consequences for patients. Our central argument is that doctors, drug companies, and most importantly patients would all benefit from greater distance between doctors and drug companies.
But perhaps most interesting is how the citadels of evidence based medicine can be undermined by clever companies. Silivio Garattini and others provide a guide to ethics committees on trial protocols that do more to market a drug than to advance understanding No more free lunches : Patients will benefit from doctors and drug companies disentangling British Medical Journal May 31, 2003 <http://bmj.com/content/vol326/issue7400/?etoc#TWIB>
(Dishonesty: Three days after a giant US HRT study was abandoned because of adverse findings from HRT drugs sold by Schering and others)
German gynaecologists received a fax from Professor AlexanderTeichmann, from a clinic in Aschaffenburg, southern Germany, and head of the Berufsverband's hormone commission. He wrote that "the presented data are of highly limited relevance for German circumstances."
Professor Teichmann declined to take responsibility for it. "I had never seen the information for patients before it was sent out," he said. Schering then admitted that the text had been written by the company without the involvement of Professor Teichmann or the Berufsverband. Schering uses German medical association to promote HRT 1161 BMJ VOLUME 326 31 MAY 2003
(One way to minimise adverse information is to get in with your explanations first)
Pharmaceutical giant Wyeth has admitted that it secretly briefed a number of medical societies about the results of a study into hormone replacement therapy (HRT) and dementia before they were published this week.
Normally, strictly embargoed copies of peer reviewed journal articles are distributed to news organisations several days before publication to help in the preparation of stories. However, Wyeth's briefings to medical societies happened long before embargoed copies of the article were distributed.
This week the company's public relations strategy has been to play down the significance of the findings on dementia for younger users, stressing that women in the latest study were over 65 years old. Drug company secretly briefed medical societies on HRT 1161 BMJ VOLUME 326 31 MAY 2003 bmj.com
No individual doctors should receive direct payment from commercial companies to cover travelling expenses, room and board at a conference, or compensation for their time, according to proposed guidelines from the World Medical Association.World Medical Association reviews doctors' links with drug companies BMJ 2003;326:1165 (31 May 2003)
Perhaps I shouldn't have been surprised. Caroline White, chair of the Guild of Health Writers, describes how guild members were invited to attend an "exclusive preview" of laser eye technology where they could "discuss free treatment in exchange for editorial features" (p 348). On another occasion members were invited to a conference on cancer, but places would be free only if the journalists could guarantee copy both before and after the conference. Richard Smith editor British Medical Journal <http://bmj.com/cgi/content/full/327/7410/0-g>
POLITICAL INFLUENCE AND POWER
As a result of the woefully inadequate disclosure laws, it is an insurmountable task to assess with precision the total price tag for any domestic lobbying effort in this country. But even with these obstacles, the Center's investigation reveals a remarkable lobbying campaign by special interests to affect the outcome of health care reform. According to FEC records, over $25 million was given to members of Congress from 1993 through the first quarter of 1994 by organizations with health care-related interests. Add to that the tens of millions of dollars in television, radio and newspaper advertising, plus the untold millions of dollars spent in lobbying contracts, polling, and grass-roots campaigns, and the result is the largest blitz on proposed legislation in the nation's history.
More than 40 members of Congress, their spouses, or their dependent children, held health care-related assets in 1993 while serving on committees with jurisdiction over health care legislation.
The most widely-held assets appear to be in the pharmaceutical industry -- 32 members of Congress, their spouses, or children have investments in Merck & Co.; 28 in Bristol-Myers Squibb Co.; 20 in Procter & Gamble; 17 in Johnson & Johnson; 12 in American Home Products; 12 in Glaxo; and 11 in Pfizer Anheuser Busch and Philip Morris, two other companies that have been lobbying over health care reform legislation, are also top investment choices. Inside Lobbying for Health Care Reform THE CENTER FOR PUBLIC INTEGRITY 1994
Companies that produce generic versions of brand-name drugs were in very good position to capture a greater market share under the Clinton plan. But a wave of former congressional members and staffers representing Eli Lilly and Co., Glaxo Inc., Merck and Co. Inc., Pfizer Inc., and the industry's trade group managed to convince Ways and Means Committee members to force the generics to pay a 10 percent rebate to Medicare. One aide of Sam Gibbons told The Washington Post that in order to save the rebate provision, the committee felt that it had to impose a similar demand. As one lobbyist for the generic industry put it, "For the sake of the bill, the consumer got shafted." Inside Lobbying for Health Care Reform ::: Sowing the Seeds of Doubt (Clinton's Health Plan) THE CENTER FOR PUBLIC INTEGRITY (1994) Accessed March 1997
The pharmaceutical industry gave more than $800,000 to Republican Party committees last month after the Senate voted to allow reimports of lower-priced U.S.-made drugs -- something the companies oppose.
In addition, the president of Bristol-Myers Squibb co-chaired a fund-raising dinner Wednesday for Senate Republicans. But despite the intensive lobbying effort, Congress is likely to pass the legislation.
The pharmaceutical industry also is fighting a Democratic proposal to expand Medicare, the health care program for the elderly, to cover the cost of prescription drugs.
Three drug companies -- Bristol-Myers, Eli Lilly Co. and Pharmacia Upjohn -- gave $200,000 apiece in unregulated "soft money'' donations to the National Republican Senatorial Committee last month.
"Not only are the big pharmaceutical companies spending hundreds of thousands of dollars feeding Bush running mate Dick Cheney and the Republican senators dinner, but they are feeding them millions of dollars in donations to mount a full-scale attack on Medicare and a Medicare prescription drug benefit,'' Democratic National Committee spokeswoman Jenny Backus said.
Roy said the drug donations had no impact on legislation. "What we offer is a good meal and good government,'' he said. Drug Cos. Gave $800, 000 to GOP New York Times September 27, 2000
Florida may still be poring over poll results to determine who will be the next president, but if the healthcare industry were the sole determiners over which candidate should occupy the White House, Texas Gov. George W. Bush would be the overwhelming favorite based on political contributions to his campaign. No surprise: Healthcare industry backs Bush for presidency based on political contributions Center for Responsive Politics <www.opensecrets.org.> 2000
Over the last year, the prescription drug industry has buffeted Americans with wave after wave of deceptive advertising, part of a sophisticated campaign to protect the firms' multi-billion-dollar profits. The drug lobby's goal is single-minded: avoid any kind of Medicare drug coverage that reins in skyrocketing drug costs. The campaign's effect so far has been to deny America's senior citizens and people with disabilities a Medicare prescription drug benefit.
To carry out this campaign, the drug companies' regular lobby, the Pharmaceutical Research and Manufacturers of America (PhRMA), created the innocuous-sounding Citizens for Better Medicare (CBM) to serve as its front group. Through CBM, they have budgeted at least $65 million for television advertising since July 1999. This air battle has been supplemented with radio, print and Internet ads, along with direct mail appeals from CBM and its member groups. The Truth Behind the Drug Industry's Deception of America's Seniors from Public Citizen Congress Watch Citizens for Better Medicare June 2000 < www.citizen.org>
Patients taking a controversial new drug for irritable bowel syndrome may have died because the US Food and Drug Administration (FDA) has become a "servant of the drug industry,'' the editor of The Lancet medical journal claimed in the May 19th issue.
"The FDA is not only compromised because it receives so much funding from industry but because it comes under incredible Congressional pressure to be favourable to industry. That has led to deaths.''
Horton said that GlaxoSmithKline "has failed to gather sufficient evidence to justify the safety of this product.'' He added that the company had applied pressure through private communication to senior FDA officials. "Instead of an accountable review process, one has a covert, unofficial process.'' Lancet: FDA Far Too Cozy with Drug Industry Reuters Health May 18, 2001
Washington teems with a thousand industrial lobbyists. They cluster around the band of luxury offices and expensive restaurants which stretches from the White House to the Capitol building - a two-mile axis along which money and power are constantly traded.
In this pantheon of corporate muscle, no industry wields as much power as the Pharmaceutical Research and Manufacturers Association (PhRMA), a pressure group breathtaking for its deep pockets and aggression, even by the standards of US politics.
There was a time not long ago when the corporate giants that PhRMA represents were merely the size of nations. Now, after a frenzied two-year period of pharmaceutical mega-mergers, they are behemoths which outweigh entire continents.
The combined worth of the world's top five drug companies is twice the combined GDP of all sub-Saharan Africa and their influence on the rules of world trade is many times stronger because they can bring their wealth to bear directly on the levers of western power.
In the struggle between western patent rights and the rest of the world's need for affordable medicine, the few concessions handed to the developing nations in the last year of the Clinton administration are likely to be reversed under Bush. The US government is expected to return to its customary role as a battering ram for the interests of the pharmaceutical industry and the principle of intellectual property.
The industry spent nearly 70% of its unprecedented $24.4m campaign war chest on the Republicans.
Politicians it has supported are now in key positions and it deploys 297 lobbyists - one for every two members of Congress.
It is far and away the most profitable major industry in the country.
They are also a measure of PhRMA's success in using its influence in government to fight off the threat of domestic price caps and competition from generic manufacturers producing cheap copies of its drugs.
The industry defends its hard-nosed approach by pointing to the cost of research and development (R&D) and by the high risks involved in such a pioneering field.
In fact, much of the R&D work on new drugs is government-funded.
The US companies spent more on marketing than on R&D in 1999 (the last full year figures are available) and set aside more for profits.
In September 1999, it was pointed out to the director of the NIH, Harold Varmus, that six HIV/Aids drugs, as well as anti-malarial treatments and other medicines of vital interest to developing countries, had been invented with public funds. The government therefore had the right under US law to use the drugs in public health initiatives.
There is a fast-spinning revolving door between government and the pharmaceutical industry. Mitch Daniels, the new director of the office of management and budget in the White House, was formerly the vice-president for strategy and policy at the pharmaceutical giant, Eli Lilly. Two members of the Bush transition team, Anne Marie Lynch and Bill Walters, are PhRMA members. Three others were seconded from big pharmaceutical firms.
"The PhRMA doesn't need to lobby," Democratic congressman Sherrod Brown said in a memo to staff last month. "The industry is in the White House already." Special report: George Bush's America : Industry that stalks the US corridors of power. In the second part of a series - how drug firms reach the heart of government The Guardian February 13, 2001
The battlefields are the fight against tobacco use, the movement to make affordable anti-HIV (the AIDS virus) drugs available to poor countries, and the clear links between chronic diseases and diets that are rich in fats and sugar.
In all three cases, powerful U.S. business interests are opposed to the specific scientific and health recommendations put forth by the WHO, the world's leading global health body.
During the negotiations of the anti-tobacco convention, the text of which was finalized on March 1, the United States and Germany fought against an overall ban on cigarette advertising, a key aspect of the international treaty that will be presented for adoption in May.
Given that the United States is home to the world's largest tobacco company, Philip Morris, Washington's opposition to the ban on cigarette advertising crippled the treaty at its very birth.
The United States is the only member nation of the World Trade Organization (WTO) to block, in December 2001, a multilateral initiative for access to affordable medicines by poor countries.
According to the director-general, in order to come up with long-term solutions to fight the lethal cocktail of sedentary lifestyle and a diet containing excessive fats and sugar, FAO and the WHO must work with the food industry and related companies.
But the U.S. food industry, led by the sugar producers' association, was unequivocal in its response: the report produced by FAO and the WHO misleads consumers regarding the maximum amount of sugar that should be present in the daily diet.
The upcoming World Health Assembly will be a battleground where U.S. proposals and economic interests will clash with the health policies promoted by WHO, and the new director general's agenda for the next five years will reflect the outcome of that "war." U.S. Clashes with World Health Organization Common Dreams May 01, 2003 <http://www.commondreams.org/>
In 2001, the drug industry's army of lobbyists easily outnumbered all 535 members of Congress as pharmaceutical companies employed 623 different hired guns, according to a new Public Citizen report based on newly available data. These same drug lobbyists are expected to swarm Capitol Hill next week as the House Energy and Commerce and the House Ways and Means committees begin to mark up Medicare prescription drug legislation.
That particular lobbying effort in 2001 provides a case study of the way the industry works on Capitol Hill. The biggest drug companies employed well-connected lobbyists, who played hardball with members of Congress. Then they built support for their position by funding a so-called "grassroots" coalition, run by a former drug company lobbyist, that claimed to represent sick children. Biggest Drug Companies Expand Lobbying Army in 2001 : New Report Shows Size, Strength, Connections of Drug Lobby as House Takes Up Medicare Rx Drug Legislation Public Citizen June 13, 2002 <http://www.citizen.org/congress/reform/drug_industry/contribution/articles.cfm?ID=7827>
In fact, Congress would exempt the drug industry from the kind of cost controls that are in place for virtually every other major provider of Medicare services.
Drug companies say they support covering prescription drugs under Medicare. But in the last few years, they have invested several hundred million dollars in campaign contributions, lobbying and advertising to head off price controls.
The legislation "reflects a political judgment that the pharmaceutical industry" would block "price controls or any arrangement that used the concentrated purchasing power of the government to buy prescription drugs," said Paul B. Ginsburg, president of the Center for Studying Health System Change, a private research institute.
"The obvious is that if you control prices, you pay less," said Mr. Vladeck, the former Medicare administrator. "There are some problems with it, and not all price controls work as well as others. But the pharmaceutical industry does have enough political juice to prevent any reasonable price controls."
For now, however, politicians have chosen to favor drug companies over Medicare beneficiaries, said Prof. Uwe E. Reinhardt, a health care economist at Princeton University.
"On one hand, there is the taxpayer and, in fact, patients who would benefit from having costs controlled," Dr. Reinhardt said. "But on the other hand, those people do not finance the campaigns of these legislators." RE-EXAMINING MEDICARE: Some Successful Models Ignored as Congress Works on Drug Bill New York Times September 4, 2003
In the thick of the 2000 presidential campaign, executives at Bristol-Myers Squibb, one of the nation's largest drug companies, received an urgent message: donate money to George W. Bush.
The message did not come from Republican campaign officials. It came from top Bristol-Myers executives, according to four executives who say they donated to Mr. Bush under pressure from their bosses. They said that they were urged to donate the maximum - $1,000 in their own name and $1,000 in their spouse's - and were warned that the company's chief executive would be notified if they failed to give.
Today, a Republican-controlled Congress is preparing to send a Republican president a measure with a central provision - the use of private health plans to deliver Medicare prescription drug benefits - that is tailor-made to the industry's specifications.
The story of how pharmaceutical manufacturers helped shape the Medicare drug benefit is, in part, that of a calculated decision by a lucrative industry to throw its financial weight behind one political party - with $50 million in campaign contributions over the last four years, the vast majority to Republicans. It is also the story of a dogged, mostly unseen campaign that included a small army of lobbyists in Washington and a network of industry-financed groups, which carried the drug makers' message to the public.
Throughout, the industry had a single goal: to defeat any legislation that would let Medicare negotiate steep discounts on the prices of medicines for its 40 million beneficiaries.
More important, the industry bought $50 million in TV commercials and millions more in radio, newspaper and direct-mail ads. The ads assured voters that Republican lawmakers were fighting for a Medicare drug benefit. Drug makers also gave the United States Chamber of Commerce $10 million more to run ads under its name. Months before the election, House Republicans passed a bill along the industry's preferred lines. RE-EXAMINING MEDICARE: Industry Fights to Put Imprint on Drug The New York Times September 5, 2003
PATENTS AND TRADE AGREEMENTS (see also Canada below)
South African AIDS activists picketed pharmaceutical companies in Cape Town and Gauteng on Sept 22 in a demand for affordable drugs.
The protesters demanded that the pharmaceutical industry association cut the price of zidovudine sold to the government from US$66 to $30 for a 1 month course for HIV-positive pregnant mothers; and unconditionally drop the price of essential drugs for AIDS-related diseases.
However, Barshefsky (US trade official) did not promise to remove South Africa from the list of countries providing inadequate protection for intellectual property rights although it is reported that South Africa's position could be reviewed by October. Meanwhile, the South African pharmaceutical industry has suspended legal action against the government over implementing the medicines law, which has yet to be promulgated. South Africa and USA make uneasy peace over international drug patent laws LANCET Volume 354, Number 9185 2 October 1999
However, some less-developed countries have been pressured by western governments to ban compulsory licensing and parallel imports. We focus here on Thailand, where US trade pressure has limited access to affordable treatment for patients with HIV and AIDS.
In reality few patients can afford antiretroviral treatment. The monthly price for a course of zidovudine, lamivudine, and indinavir is $US675, whereas the typical monthly wage of an office-worker is $US120.
Thailand is capable of producing good-quality cheap generic drugs, but local production has been limited by trade pressure from the US government.
The US government regards TRIPS as a minimum standard, and in bilateral discussions commonly asks for additional commitments, with threats of trade sanctions to achieve its objectives. The USA is the destination of a quarter of exports from Thailand so these threats are taken very seriously.
In 1992, under threat from the USA to limit textile imports, the Thai government passed a law to introduce product patent protection. As a safeguard, the Thai government created the Pharmaceutical Patent Review Board, which had authority to collect economic data, including the production cost of pharmaceuticals. The US Trade Representative Office objected and in 1998, under threat of increased tariffs on imports of wood products and jewellery, the Pharmaceutical Patent Review Board was disbanded and measures were taken that led to limiting of the right to issue compulsory licenses for pharmaceuticals.
Pressure from the US government has forced Thailand to limit compulsory licensing and parallel importing, both of which are rights allowed for under TRIPS and used to great extent by western governments, including the US. Other less-developed countries have been subjected to similar pressure, in particular South Africa (for a list of countries, see www.cptech.org).
An attempt to confer to WHO a role in monitoring international trade agreements was strongly opposed at the 1998 World Health Assembly: US State Department representatives threatened to withdraw WHO funding when faced with aggressive WHO support for improved access to patented medicines in less-developed countries. The adoption by unanimous consensus of the Revised Drug Strategy this year was, therefore, welcome news. Global trade and access to medicines: AIDS treatments in Thailand (from Médecins Sans Frontières) Lancet 1999; 354: 1893-95
As the first of these deadlines approaches, however, international health organisations and public-interest groups have voiced concern that the TRIPS agreement threatens the lives of millions of people by denying them life-saving drugs and medical technology.
Many pharmaceutical companies, however, take a hard line against major changes in TRIPS. For example, Pharmaceutical Research and Manufacturers of America wants to make world patent protections even tougher so that they reflect those found in fully industrialised countries. Sleep less in Seattle LANCET Editorial Volume 354, Number 9194 4 December 1999
In a speech to trade ministers attending last week's World Trade Organisation's meeting in Seattle, President Bill Clinton announced that the US government will change its current policies so that people in the world's poorest nations will have access to needed drugs. "The United States will henceforth implement its health care and trade policies in a manner that ensures that people in the poorest countries won't have to go without the medicine they so desperately need", Clinton said. US promises to help poorest nations get needed drugs LANCET Volume 354, Number 9195 11 December 1999
In the struggle between western patent rights and the rest of the world's need for affordable medicine, the few concessions handed to the developing nations in the last year of the Clinton administration are likely to be reversed under Bush. The US government is expected to return to its customary role as a battering ram for the interests of the pharmaceutical industry and the principle of intellectual property. Special report: George Bush's America : Industry that stalks the US corridors of power. In the second part of a series - how drug firms reach the heart of government The Guardian February 13, 2001
More than 40 pharmaceutical companies, many of them the world's largest and most powerful companies, will be taking the South African government to court to try to stop it enacting legislation aimed at reducing the price of medicines for South Africans.
The South African government is currently exploring changes to its Patents Act as a vehicle to import cheap generic drugs from countries such as Brazil and India. The major issue in the minds of millions watching the trial will be the HIV/AIDS epidemic, with at least 4.2 million people in South Africa carrying the virus Drug companies sue South African government over generics BMJ 2001;322:447 February 24, 2001
In South Africa a court case has begun that embodies the moral dilemmas of the age. The world's major pharmaceutical companies want to overturn a law that would get cheap life-saving drugs to Africans with AIDS. ABC Radio National 2001 programme
The Pharmaceutical Manufacturers Association and 39 of its members have lost one crucial battle inside Pretoria's High Court and a larger one outside. The industry's image has suffered irreparable damage from the case and has been portrayed as putting profits before lives in the country.
The pharmaceutical manufacturers had tried in thousands of pages of legal argument to confine the court battle to one of technical legal wording, much of this around the clause that would have allowed for parallel importing of drugs. But the judge allowed a late application by an AIDS activist group to participate in the trial.
This move, and the pressure internationally from human rights groups, has refocused the trial on the issue of making drugs for HIV and AIDS affordable to millions of South Africans who face an early death from AIDS related causes.
The Treatment Action Campaign, which lobbies for cheaper access to drugs for people living with HIV and AIDS, applied to be treated as a "friend of the court" (amicus curia). Its application was vigorously opposed by the drug companies, which claim that they are defending their constitutional rights and the rule of law.
The judge, however, accepted the argument that the action group brought a special dimension to the trial and made it clear he believed that issues around affordability of drugs for the HIV/AIDS crisis was one which needed urgent treatment. South African court battle damages drug industry's image BMJ 2001;322:635 (17 March 2001)
Oxfam and allied aid organisations have recently accused the international pharmaceutical industry of using its influence to maintain a worldwide system of intellectual property law and enforcement that is now denying the world's poor access to essential medicines and blocking progress towards health for all.
The pharmaceutical industry's critics also blame it for inadequate research investment in diseases relevant to the health of the world's poor. Editorials Poor world health and rich world wealth : Commercial companies alone can't solve the health problems of developing countries BMJ 2001;322:629-630 (17 March 2001)
The Kenya Coalition for Access to Medicines and key partners confirm the news that the WTO TRIPS Council, in Geneva, has not yet agreed on a deal that would have severely restricted access to medicines for patients in Kenya and the rest of the developing world.
Contrary to most news reports here in Kenya and around the world, developing countries are not "hailing" the agreement. Rather, coalition partners in Geneva report that poorer countries are being coerced into accepting it with strong-arm tactics in the run up to the WTO ministerial in Cancun set to start on 10 September
"From our contacts here and in Geneva, we know that Kenya and other developing countries are under tremendous pressure from the US to agree to the deal, only the US wants, before Cancun," explained Beryl Leach, a coalition member. "So far, Kenya has held its ground in negotiating for the best interests of Kenyan citizens who desperately need access to cheaper essential medicines without any further politicking and delays," she added. Kenya Coalition confirms that the life-threatening WTO deal is not 'done' PRESS RELEASE Health Action International August 23, 2003
The World Trade Organization settled its most emotive dispute when the U.S. ended its holdout and accepted a deal to allow poor countries to import cheap copies of patented drugs for killer diseases such as HIV/AIDS, malaria and tuberculosis.
U.S. pharmaceutical firms were concerned a deal to allow countries to import generic drugs would be abused by generics manufacturers and could also lead to drugs being smuggled back into rich countries.
But the aid group Oxfam said the deal would be a "disaster."
"This would be a travesty of an agreement that would no doubt be presented as wonderful thing for development," said Oxfam's head of advocacy in Geneva, Celine Charveriat. "The text contains so much red tape and so many obstacles that if it were accepted developing countries would still struggle to get access to cheap medicines and thousands of people would continue to die unnecessarily." WTO Set to Approve Generic-Drug Rules for Poor Countries Associated Press AUGUST 2003
Leukaemia patients in South Korea had taken part in trials for Novartis' new drug Glivec (also marketed as Gleevec), helping to get it approved in record time. Glivec is a genuinely life-prolonging drug. But girded by patent exclusivity, the Korean leukaemia patients found it was prohibitively priced. - - - - - - - In desperation, a group of patients who had been part of the trials in Korea decided to apply for 'compulsory licensing'. This is a World Trade Organization (WTO) provision from its warren of patenting rules which allows governments faced with a 'national emergency' or 'extreme urgency' to overrule patent rights and buy or produce a generic version of a drug.
While the South Korean Ministry of Health was considering the application, the US Secretary of Commerce sent a written threat warning against compulsory licensing of Glivec. The Korean Health Minister favoured the proposal but soon lost his job in a cabinet reshuffle. He denounced the role Big Pharma's influence had played in his dismissal. That left the patients with little option but to talk to Novartis directly - with disastrous results. Rough-handed by the police, two sustained injuries that required hospitalization.
These two dismal tales reflect Big Pharma's key obsessions - money madness, ruthless suppression of competition, an ability to bend rules to its own advantage, political clout and a contemptible disregard for the consumer. All this from an industry that takes every opportunity to crow about its noble mission to fight disease. The great health grab New Internationalist 362 November 2003 <http://www.newint.org/issue362/keynote.htm>
Canada's more limited patent requirements have been a threat to drug profits. Companies solicited strong market and international political support. They succeeded in having these wound back. Trade agreements have also put pressure on Canada's health system and the Romanow Royal Commission urged government to ensure that the Canadian Health System was protected.
(I summarised some of these findings in a paper published in Health Issues in March 2003. . . . . Download article from Health Issues Journal March 2003
Canada's lower drug prices under its universal Medicare system are admired by US citizens, many of whom slip across the border to stock up. They want the same but the drug giants see this as a threat. Other countries are eyeing the more affordable Australian and Canadian systems and the drug companies have responded by targeting them.
Drug companies and other US market interests have run very negative campaigns against the Canadian system highlighting waiting lists, standards of care etc. This has little to with Canada and a lot to do with moves in the USA to control costs by adopting a single payer health system based on the Canadian system.
The World Trade Organization says Canada's patent protection period for 66,000 different drugs, inventions and high-technology innovations is insufficient and should be lengthened.
The ruling means generic drug companies will need to wait longer to bring some of their cheaper products to market, at a cost to consumers and medicare plans of about $200-million over the next few years, according to the generic drug industry. The most prominent drug to be affected likely would be a cholesterol-reducing medication produced by Bristol Myers Squibb, whose patent is about to expire. WTO rules against Canada on patents Means longer wait for cheaper generic drugs HEATHER SCOFFIELD Parliamentary Bureau May 6, 2000
A bill supported overwhelmingly by the Legislature would set Maine (USA) drug prices here according to the much lower prices in Quebec. They are lower in Quebec because Canada, like many industrialized nations, negotiates prices with the industry, just as health-maintenance organizations do in the United States. The transaction gives manufacturers access to a market in exchange for lower prices to individuals in that market. Such exchanges are common in business, and are the basis for everything from group insurance rates to discount packages on tour buses. Price controls BANGOR DAILY NEWS (BANGOR, MAINE) April 13, 2000 Thursday
Paper by Maud Barlow (well known Canadian researcher and writer)
The Free Trade Area of the Americas (FTAA), currently being negotiated by 34 countries of the Americas, is intended by its architects to be the most far-reaching trade agreement - - - - - - - to create a new trade powerhouse with sweeping new authority over every aspect of life in Canada and the Americas.
It is also proposing to retain, and perhaps expand, the "investor-state" provisions of NAFTA, which give corporations unprecedented rights to pursue their trade interests through legally binding trade tribunals.
Combining these two powers into one agreement will give unequalled new rights to the transnational corporations of the hemisphere to compete for and even challenge every publicly funded service of its governments, including health care, education, social security, culture and environmental protection.
As well, the proposed FTAA contains new provisions on competition policy, government procurement, market access and dispute settlement that, together with the inclusion of services and investment, could remove the ability of all the governments of the Americas to create or maintain laws, standards and regulations to protect the health, safety and well-being of their citizens and the environment they share.
Once again, as in former trade agreements like NAFTA and the WTO, this free trade agreement will contain no safeguards in the body of the text to protect workers, human rights, social security or health and environmental standards. Once again civil society and the majority of citizens who want a different kind of trade agreement have been excluded from the negotiations and will be shut out of the deliberations in Quebec City in April 2001. The Free Trade Area of the Americas and the Threat to Social Programs, Environmental Sustainability and Social Justice in Canada and the Americas by Maude Barlow 2001
(The following article looks at the cheaper drug prices in countries with some sort of national bargaining system. It concludes that this does not always keep prices down. An important hidden factor is the interest of a country in enticing multinational giants to open factories or research facilities in that country. This gives Big Pharma bargaining power.)
Yet medicare, the jewel of the Canadian health-care system, is silent on drugs. Except for patients in hospitals, the national health insurance plan doesn't cover pharmaceuticals.
It is a story of power, national priorities and raw politics - of how governments, anxious to attract high-tech, high-wage pharmaceutical jobs, have let the health implications of their actions slip to second place.
- - - - - of the 29 nations that are members of this international industrial club (OECD), only four - the United States, Mexico, Turkey and Canada - lack some form of national public pharmacare scheme.
In 1969, the Liberal government of prime minister Pierre Trudeau passed a pathbreaking law to force down the prices charged by big multinational drug firms. This compulsory licensing law allowed anyone, on payment of a royalty, to make generic, or copycat, versions of patented brand-name drugs. In effect, it wiped out the monopolies the brand-name firms had been granted under patent law.
Predictably, the brand-name companies were furious.
For the next 23 years, the drug multinationals waged a fierce war against compulsory licensing until, in 1992, they finally persuaded prime minister Brian Mulroney's Conservative government to end the practice and restore their monopolies.
It is easy to demonize the multinational drug companies. In fact, it is almost irresistible. They create the products that save lives; then they haggle with the sick and dying over the price. - - - - - - - As well, the drug multinationals are among the most profitable in the world.
In 1999, for instance, Glaxco Wellcome threatened to pull investment from Britain after the government refused to place its new flu drug, Relenza, on the National Health Service list of subsidized drugs. The government reversed its decision.
In 1992, the drug giant Eli Lilly Canada Inc. threatened to cancel a planned expansion of its Scarborough manufacturing plant if the Ontario government went ahead with plans to remove Ceclor, one of the firm's high-profile anti-infectives, from the list of pharmaceuticals subsidized by the provincial drug plan. Bob Rae, Ontario premier - - - - , overruled his own experts and kept Ceclor in the drug formulary.
Meanwhile, federal Health Minister Allan Rock's department (Canada) has become so focused on the speedy approval of new drugs in order to please its brand-name "clients'' that it drew even the ire of the Senate, which, in 1999, noted there was far too much industry influence on the government.
Even worse from the brand-name companies' point of view, a national pharmacare plan might refuse to cover all new drugs - particularly those that are deemed to be simply more expensive versions of existing pharmaceuticals.
Lexchin calculates the country would actually save $650 million a year under pharmacare. In his study, A National Pharmacare Plan, published this year by the Centre for Policy Alternatives, the Toronto physician estimates pharmacare would initially increase drug consumption, as those previously unable to afford pharmaceuticals took advantage of the scheme.
Not all nations with pharmacare enjoy cheaper drugs. Willison found that even with pharmacare, France's per capita drug costs were consistently higher than those of Canada.
But perhaps Willison's most telling finding has to do with the relationship between a country's drug costs and the efforts that country makes to attract investment from the big pharmaceutical firms.
Among the seven countries Willison surveyed, New Zealand consistently had the lowest drug cost - $193 per capita in 1997.
The reason, Willison says, is not just that New Zealand has universal pharmacare. It is that the country's government, knowing the drug firms won't bother investing in such a small, faraway country, doesn't bother trying to woo them by keeping domestic pharmaceutical prices up.
The very fact that Ottawa wants Canada to be a player in this world makes it open to the blandishments - and the threats - of Big Pharma.
"Any endeavour to attract more private-sector pharmaceutical investment will increase the costs to the health system,'' he says. "The (drug) firms want extended patents, they want deregulation (of prices) and they want the (provincial) formularies opened up . . . "The side effects are almost always perverse.'' Drug wars : Medicare still doesn't cover drugs, and governments are torn between pleasing voters or the multinational pharmaceuticals. Toronto Star July 7, 2002
Lobbyists for the drug industry are stepping up spending to influence Congress, the states and even foreign governments as the debate intensifies over how to provide prescription drug benefits to the elderly, industry executives say.
Confidential budget documents from the leading pharmaceutical trade group show that it will spend millions of dollars lobbying Congress and state legislatures, fighting price controls around the world, subsidizing "like-minded organizations" and paying economists to produce op-ed articles and monographs in response to critics.
In addition, the budget sets aside $17.5 million to fight price controls and protect patent rights in foreign countries and in trade negotiations.
The PhRMA budget allocates $1 million "to change the Canadian health care system" and $450,000 to stem the flow of low-price prescription drugs from online pharmacies in Canada to customers in the United States.
The major pharmaceutical companies operate in global markets. Canada, like many industrial countries, offers health insurance to all citizens, but limits drug prices. Drug Companies Increase Spending to Lobby Congress and Governments New York Times May 31, 2003
Last week, the United States's big drug companies gave us a peek at the cards they hold when it was learned that they intend to spend $1million "to change Canada's health care system." Thanks to confidential documents by the Pharmaceutical Research and Manufacturers of America (known as PhRMA) leaked to the New York Times, we learned of industry plans to massively increase lobbying budgets so that any tinkering with drug coverage in the United States is going to bear their interests in mind.
PhRMA also aims to eliminate what it says is Canada's "subsidized" prescription drug prices. In other words, they want Canada's drug prices to be as high as those in the United States. Then Americans who've been buying drugs through Canada's multi-million dollar Internet pharmacy industry would pay premium prices no matter where they shop.
But that's not all Big Pharma wants. Their lobbyists have also been trying to dissuade members of Canada's Parliament -- such as the House of Commons' Industry, Science and Technology Committee -- from listening too closely to the generic drug industry's claims about unfair patent regulations. Generous patent protection was a gift to the pharmaceutical industry enshrined in law by the Conservative government of Brian Mulroney. It has forced generic drugs to wait a whole lot longer before becoming available. Generics typically cost 45 per cent less than brand name drugs. Don't gamble with our drug prices Globe and Mail June 23, 2003
It may come as a shock, but Canadians are apparently putting their lives on the line each time they use prescription drugs approved by Ottawa.
Or so millions of Americans in more than half the 50 states are being told in radio commercials.
A bipartisan group of members of Congress yesterday blasted the radio campaign as irresponsible scare tactics by the giant U.S. pharmaceutical industry.
In a bid to defeat legislation that would allow the "reimportation" of American-made drugs from Canada and Europe, a lobby group calling itself the Seniors Coalition is questioning the safety of Canadian and European prescription drugs.
"They have gone over the edge. They are clearly in a panic," said Bernie Sanders, an independent congressman from Vermont who was among the first to lead U.S. seniors across the border to buy cheaper Canadian drugs.
"This industry will stoop to (anything) to try to win this legislation. They will lie about anybody, they cheat, they will come into anyone's district and say whatever they have to say in order to protect their profits."
By some estimates, the reimportation of cheaper prescription drugs could save seniors $600 billion (U.S.) over 10 years, money that would come out of the big drug companies' profits. Drugs from Canada spark U.S. row : Radio ads raise doubts over safety Industry accused of scare tactics Toronto Star July 16, 2003 <http://www.thestar.com/>
Himmelstein (doctor arguing for a single payer health system in the USA) conceded that Canada's single-payer system has waiting lists for some medical services.
But the country's infant mortality rate is lower than that of the United States, its citizens' average life span is longer, and its per capita spending for health care is roughly half that of its neighbor to the south, he said. National Health Care Plan Touted The Los Angeles Times August 13, 2003
The overhead cost of operating the United States health-care system is more than three times that of running Canada's, and the gap is getting bigger, new research says.
The study, to be published today in the New England Journal of Medicine, - - - - - -. That translates to a per-person cost of $1,059 in the U.S. and $307 in Canada. Canada-U.S. gap in health care grows Globe and Mail August 21, 2003
Boston will proceed with plans to let city employees purchase prescription drugs from Canada despite a federal prohibition on importing them, Mayor Thomas Menino said Thursday after meeting with Food and Drug Administration officials.
Boston is one of a growing number of cities and states considering the illegal, cross-border importation of prescription drugs as a way to cut costs. Only Springfield, Mass., has a full program in place that allows its employees to buy the much cheaper medications from Canada, where the government controls prices. Boston to Proceed With Canada Drug Plan The New York Times December 18, 2003
Canadian doctors who co-sign the prescriptions for U.S. patients are about to be given some stark news by the national body that provides them liability insurance: If a patient gets sick or dies from the drug and you get sued, you are on your own.
However, the Canadian doctors do not see the patients and likely do not even know their medical histories. As a result, professional bodies that regulate the medical profession throughout Canada have said doctors who co-sign the prescriptions are violating ethical codes of conduct. MDs who prescribe via Internet are on their own insurer: If physicians are sued in U.S., they won't be covered: provider of liability insurance National Post January 12, 2004
While claiming the high costs of research justify their pricing, more and more of the drug giants' funding has been diverted from research to marketing which has increased steadily.
In Australia cost and efficacy are balanced by the PBS (Pharmaceutical Benefits Scheme), a body with credible scientific advisers. The PBS' success in balancing cost and benefit is widely admired across the world, even in the USA. It is used as a model by those wanting to keep down costs. It ensures that the use of drugs is skewed towards scientific evidence of benefit and cost rather than upbeat marketing. The companies resent this control, and the restriction on their right to a free market.
Companies have tried to secure greater influence in the PBS. They have succeeded in securing ministerial support in overruling the advice given by the PBAC (Pharmaceutical Benefits Advisory Committee), and in appointing members of the industry to the board. Multiple members of the committee resigned in protest at the changes made. Several members of the ministers department have since joined drug companies.
Public health lecturer at La Trobe University Dr. Ken Harvey has taken a keen interest in what was happening. He kept the issues alive by opening a website which debated the issue and brought criticisms together. He quoted from a newspaper cartoon about the minister for health, linking to the cartoon on the newspaper site. The university seized the opportunity and obtained legal opinion that this was defamatory. Instead of giving Dr. Harvey an opportunity to qualify or remove the offending comment the university closed down the entire site and charged him with serious misconduct - all without any discussion with him!
US drug giants in 2003/4 tried to further undermine the PBS and loosen its provisions during bilateral trade negotiations with the USA. The Australian government claims that it has not bowed to pressure on this unpopular issue. The small print of the trade agreement has not yet become public.
Background material about the PBS and the issues can be obtained from the following www addresses
Articles about the PBS can also be found on the web site of the Doctors Reform Society see <http://www.drs.org.au/articles.htm> and <http://www.drs.org.au/articles/2003/art17.htm>
LIMITED EXTRACTS FROM THE PRESS (note that these are incomplete and do not include denials or explanations. They are intended to show the extent and the nature of the conflicts between market, politics and community. The opposing points of view have not been given)
Macklin last week claimed multi-national pharmaceutical company Pfizer has been revealed to have used patients to apply pressure to politicians to interfere in the Pharmaceutical Benefits Advisory Committee processes. Federal Shadow Health Minister Jenny Macklin Pfizer caught using patients to subvert PBAC process. Media Release 2001
COMPERE: - - - - - -
Despite the anger, the Federal Government has decided to tough it out and appoint a drug industry lobbyist to the committee. The committee's chairman, Professor Don Birkett, says he won't serve on a committee that includes Mr Pat Clear. Until last February Mr Clear headed the drug industry's lobby group. Health Minister Michael Wooldridge spoke a short time ago to Alexandra Kirk. - - - -
MICHAEL WOOLDRIDGE: He can try and help the situation where the committee has become increasingly antagonistic with industry.
ALEXANDRA KIRK: Well don't you think it's inappropriate for a former drug company lobbyist to be advising the Government on what drugs should be on the Pharmaceutical Benefits Scheme (PBS)? Isn't that a conflict of interest?
MICHAEL WOOLDRIDGE: It's not a conflict of interest at all. He does not stand to gain personally in any way.
ALEXANDRA KIRK: But he's worked for the industry for 30 years.Interview ABC Online February 1, 2001
THE chairman of the Pharmaceutical Benefits Advisory Committee yesterday quit in disgust at a Federal Government appointment of a former industry lobbyist to the body.
Professor Don Birkett refused his reappointment as PBAC chairman after federal Health Minister Dr Michael Wooldridge ignored his demands that former pharmaceutical industry lobbyist Pat Clear be excluded from the 12-member body. Medicines chairman resigns Courier Mail Feb 2, 2001
The Federal Health Minister says there is no conflict of interest involved in the appointment of former drug industry lobbyist Pat Clear to an independent committee on drug subsidies.
The chairman and two other members of the Pharmaceutical Benefits Advisory Committee say they will resign over the appointment.
"The committee makes recommendations and decisions on large expenditures of government money on drugs which go to the parmecutical industry," he (chairman) said.
"It really couldn't operate with an an industry lobbyist sitting there when those decisions are made." Wooldridge denies conflict of interest in drug committee appointment ABC News Online February 2. 2001
The Federal Government ignored advice from the country's drug approval committee (Pharmaceutical Benefits Advisory Committee) over a new arthritic treatment, a move that has so far cost taxpayers almost $100 million dollars and raised fears of the drug industry's growing influence among government decision-makers.
For the first time ever, the Government ignored the recommendation, opting instead to take advice from its five-member Pricing Authority that includes a pharmaceutical industry representative, an investigation by The Age found. In its first five months on the PBS, Celebrex has become the fastest-growing drug ever listed in Australia, with 1,668,216 prescriptions issued between August and December last year.
Professor Birkett and at least two other former members of the PBAC, Professor David Henry, until three weeks ago chair of the PBAC's economic sub-committee, and Melbourne paediatrician Dr Sian Hughes, expressed concern that the influence of the drug industry was becoming ever more powerful.
The Age has also learnt that a key government adviser last year threatened PBAC members with a police inquiry after media reports flagging a major review of the drug-listing system.
Professor Henry has accused the Government of bowing to industry pressure by dumping him from the committee. "I was seen as an impediment to the industry's interests, namely getting their drugs on the shelves so I had to be gotten rid of," he said.
"I believe that Professor Birkett and myself were seen by the pharmaceutical industry to have presided over a process where the companies didn't get what they wanted and we, as committee chairs, were held responsible." Drug's listing costs taxpayers millions The Age February 2, 2001
Henry, along with his 11 colleagues, has for the past decade fought a David-and-Goliath battle with one of the world's most powerful and rich industries - the drug companies. A listing on the Pharmaceutical Benefits Schedule guarantees a market and enormous profits. Witness the bitter dispute in the courts over the committee's decision not to include the male impotence pill Viagra on the schedule. Pfizer, the US-based company, says the decision cost it about $50 million in revenue. Looked at another way, Australian taxpayers won't be paying dearly to help improve people's sex lives. The outcome of the company's appeal is imminent.
"I'm telling my story," he explains, "because I want Australians to realise what this industry is capable of. Their tactics are not confined to other nations, their influence is also felt right here and affects us all."
There have been three reviews of the PBAC in the past decade - all, Henry asserts, because of lobbying by the industry. "Unfortunately for the drug companies, these reviews didn't produce the results they wanted: the dismantling of our evidentiary approach.
What happened next alarmed PBAC members. One of Wooldridge's key advisers, Rachel David, who had been present when Henry and Birkett outlined their concerns to him, left the government and went to work for Pfizer.
"We were told the industry was up in arms about the committee and the minister felt there must be a problem because the drug companies were complaining so bitterly. No examples were given, just the view that there was a problem and the committee was not doing its job properly and that a major review was necessary."
Henry and Birkett argued against the review - there had, they said, already been two: one by the former Industry Commission and one by the national audit office. Both had found no major problems with the existing system and committee.
"We did start to get paranoid because we'd been reviewed twice at industry's behest, we were being sued and the minister's adviser had just gone to work for the company that was suing us - Pfizer."
The PBAC has been held up internationally as a stunning example of smart health economics in an age when governments the world over are trying to contain costs. Its emphasis is on making drug companies prove not only the safety, efficacy and quality of their product, but the cost-effectiveness over existing treatments. It was seen as a radical approach when adopted in the early 1990s.
"It's the international implications of what we do here that's got them worried," McDonald says. "Australia is the standard by which other nations judge their own processes and if markets like the US - and Al Gore was talking about it in the lead-up to the US election - and Third World nations like India and Malaysia adopt our approach, then the drug companies will really start to feel it."
"Patient support groups - that I believe are genuine - are misled by drug companies about new products. The drugs are talked up and people who are desperate want to believe there is a miracle cure around the corner.
"Being accused of killing children is always unpleasant, but that's the level to which their tactics sometimes degenerate." Too many bitter pills The Age February 2, 2001
Has the pharmaceutical industry broken the scheme which delivers Australians cheap medicines? Did the Federal Government succumb to industry pressure in dumping its own expert advisers?
These are the questions Four Corners explores in an inside account of how the Government overhauled the controversial Pharmaceutical Benefits Advisory Committee (PBAC), whose job is to advise which drugs should be publicly subsidised. Paying the Price Four Corners web site Accessed 20/2/2001
Four Corners Program by LIZ Jackson
LIZ JACKSON: Dudley Schleier made good and early links with the Government. He became one of the founding members of a new, high-powered industry working group which first met in June 1998.
The working group comprises six CEOs of drug companies, and two Cabinet ministers, the Minister for Health, Dr Michael Wooldridge, and the Minister for Industry, Senator Nick Minchin.
They have regular scheduled meetings face to face.
LIZ JACKSON: Ministerial briefing notes obtained by Four Corners make it abundantly clear that the bulk of the discussion was centred on the Pharmaceutical Benefits Scheme and the drug companies' dissatisfaction with the prices they were getting.
The meeting (of PBAC members) was with senior advisers from the office of the Minister for Health and his undersecretary Senator Grant Tambling.
PROFESSOR DON BIRKETT: The tenor of that meeting was that both Tambling and Wooldridge were under pressure from the industry.
They were being continually lobbied and continually told that there were problems with the process and with the committee.
And were worried about that and thought that if these complaints were continually coming in there must be a problem.
PROFESSOR DON BIRKETT: We were told, really, that the ministers and Tambling wished to keep themselves remote from the committee.
I think the word 'firewall' was used at one stage, which seemed quite extraordinary to us that the political level should keep itself remote from its advisory committee but that industry were in the office every day.
LIZ JACKSON: A subsequent series of articles in the 'Sydney Morning Herald' canvassed far more than just the possible review.
They included revelations that two of the Minister's advisers had gone to work, directly or indirectly, for Pfizer, and charged that Minister Wooldridge appeared to be increasingly listening to industry's concerns.
Dr Michael Wooldridge hit the roof.
He sent his chief of staff, Ken Smith, to put the fear of God about talking to the press into his expert committee.
But this was a group of medical specialists, not public servants.
The Tambling Review was never publicly released but Four Corners has a copy.
It reveals that the pharmaceutical industry had been directly lobbying the Government to get themselves a representative on the Pharmaceutical Benefits Advisory Committee.
The Tambling Review concluded, however, that this "could result in an untenable conflict of interest" and such a representative "would not appear to have any expertise that could not be covered by other sources."
PROFESSOR DON BIRKETT: That was the outcome of the Tambling Review, the Government's own review.
The Tambling Review, however, stated that all current members should serve out their terms to preserve their expertise and, indeed, pass it on.
So, no-one was worried.
The committee members continued their work, unaware that a bombshell was about to drop.
When they turned up for their regular meeting in December last year they were told that legislation would be pushed through the Senate which meant all members who'd served more than eight years would be shown the door at the end of the year.
LIZ JACKSON: Your view then was that the industry had heavied the minister?
PROFESSOR DON BIRKETT: Yes, yes -- absolutely. I don't think any of us had any doubt about that.
ALAN EVANS (for the industry): Look, I can give you an absolute guarantee, because to do otherwise would be an insult to the CEOs of the ten companies and also senior staff of the Prime Minister, because it would be basically accusing them of being liars.
The matter was not raised and nor should it have been raised and nor would it have been raised.
If anyone had even suggested raising it, I would've been saying, "Do not do that, it would be entirely improper."
LIZ JACKSON: But Four Corners has obtained a copy of the confidential background paper that was prepared for the meeting of the Bennelong Group with the Prime Minister.
It tells a different story.
It shows that the chairman of the APMA was down to attend the meeting.
It specifically lists the membership of the PBAC as an issue and reveals that, "Industry is greatly concerned about membership of the PBAC, particularly the public hostile attitude of some members and staff to industry."
The background paper says industry supports the proposed legislation that would enable the membership of the PBAC to be spilled but were concerned that changes to legislation will be held over until 2001.
LIZ JACKSON: Until Alan Evans joined last year, the Pricing Authority had been a largely administrative committee which stuck to the cost-effective limits set by the PBAC.
But with Celebrex and Vioxx, the Authority gave the companies a higher price.
The Minister, Michael Wooldridge, followed their lead.
For the first time, the pharmaceutical industry had succeeded in getting two major drugs a huge public subsidy at a price the Minister's own expert committee had said was not cost-effective.
The result is a $150 million blow-out in the PBS budget and a windfall profit for the companies, Pfizer, Merck and Pharmacia.
PROFESSOR DON BIRKETT: I really didn't have much illusions about the way the world works.
There are so many examples of just this type of event happening in other countries that I knew it was a tough world.
I didn't think it would happen in Australia, I must admit.
I thought the political will and the quality of the people in Australia were able to resist this sort of event.
But I had no illusions about the power that the industry can wield when it wishes to do so. Paying the Price: Drugs on the shelf Australian Broadcasting Corporation Four Corners February 19, 2001 <http://www.abc.net.au/4corners/stories/s246748.htm>
A La Trobe University academic faces internal charges of serious misconduct after management suspended a website for allegedly defaming federal Health Minister Michael Wooldridge over drug industry influence.
But the academic involved, school of public health lecturer Ken Harvey, says the action is intimidatory, excessive, an attack on free speech and a denial of natural justice. Dr Harvey is on stress leave from the university and could face dismissal.
On June 29 the dean of the health sciences department, Stephen Duckett, ordered the website, which is devoted to examining alleged undue pharmaceutical industry influence on the Federal Government, to be suspended after legal advice.
The offending paragraph on the site was attached to a hyperlink archiving previously published newspaper cartoons about the Wooldridge-drug industry controversy.
The paragraph read: "The aim is to explore the claim that these changes represent a hijack of the PBAC by the multinational pharmaceutical industry, aided and abetted by the current federal Health Minister, Dr Michael Wooldridge (Minister for Pfizer)." Academic faces website charge by TEVE DOW ?? where published July 10, 2001
COMMON prescription drugs would triple in price if cost controls were lifted under a US-Australia free trade agreement (FTA), a new study has warned.
US drug companies are lobbying for price controls, in place under the Pharmaceutical Benefits Scheme (PBS), to be eliminated as part of the agreement.
A study undertaken by the Australia Institute and obtained exclusively by The Sunday Telegraph warns changes to the PBS could be devastating. US trade deal may triple drug cost Murdoch Newspapers in Australia August 3, 2003 news.com.au
ELEANOR HALL: Washington has given its clearest indication yet that it would like the Australian Government to make changes to Australia's Pharmaceutical Benefits Scheme.
However, the man responsible for promoting American exports, US Under Secretary of Commerce, Grant Aldonas, admits he would like to see Australia remove its price controls on pharmaceuticals. The World Today - US Commerce official would like to see PBS change ABC TV August 13, 2003 <http://www.abc.net.au/worldtoday/content/2003/s923693.htm>
Australia's $5 billion-a-year Pharmaceutical Benefits Scheme provides subsidised drugs to consumers at affordable prices, but it is under attack from the powerful US drug company lobby because the industry claims it depresses the prices.
US President George W. Bush also raised concerns with John Howard during talks in Canberra on Thursday about the political difficulties he faces in the US over perceptions drug prices are too low in Australia.
US Trade Representative Robert Zoellick has referred to Australia's PBS as a "pharmaceutical protection system", signalling the US wants changes. Drugs threaten US trade deal The Australian October 27, 2003
RON POLLACK (Head of Families USA): Hold onto your wallet, that's my advice. What would undoubtedly happen is what's happened here in the United States, and prescription drug prices are going to skyrocket and I think increasingly people in Australia will feel that those prices are unaffordable. The World Today - Interview ABC TV 26 November , 2003 <http://www.abc.net.au/worldtoday/content/2003/s997618.htm>
If successful, the United States could use this agreement (Australia/USA free trade) as a benchmark for trade deals with other rich nations. Loosening price controls is a priority for the drug industry, which gets most of its profits in the United States and argues that prices here could be lower if other nations paid their share of the cost of developing drugs.
Drug industry executives said that provision was a sign of how badly their backers on Capitol Hill want to see trade agreements used to challenge foreign government's price-control systems, especially when Americans are flocking to Canada to buy inexpensive medicine.
"The administration is right that something has to change," he (Mark Weisbrot, co-director of the Center for Economic and Policy Research) said. "But it should be here, not in countries with an effective method to finance pharmaceuticals for their citizens."
The pharmaceutical industry disagrees. The World Trade Organization now enforces intellectual property rights, including drug patents, in large part because of industry pressure. Drug Industry Seeks to Sway Prices Overseas The New York Times November 27, 2003
CRUCIAL talks on the proposed free trade agreement are underway in Washington amid new fears that the Americans will push for a deal that will force up the price of Australian medicines.
But in a letter to President George W Bush, nine ranking Democrats have criticised America's proposals to change Australia's Pharmaceutical Benefits Scheme (PBS).
They said the American proposal appeared aimed at pushing up Australian medicine prices.
The letter by the Democrat Congress members is based on a confidential outline of America's position on the PBS. Talks start amid new PBS fears News.Com.au January 20, 2004
Welcome to the world as seen through the eyes of big drugs firms. Public pharmaceuticals programmes, by which governments drive down prescription costs by bulk-buying common medicines, are a mainstay of public health systems across the developed world. To the lunatic fringe of the pharmaceuticals lobby, they are a menace: patients under such programmes may be healthier and financially better off but (the argument goes), intangibly, they are less free.
Drugs companies contributed £10m to George Bush's election campaign in 2000 and are determined to get their money's worth out of any free trade agreement.
The likely line of attack during the trade talks will be Australia's patent laws. At present, the lifeblood of the PBS is the constant supply of low-cost generic drugs being brought on to the market; a few tweaks of intellectual property rules could banish them from existence.
The claim of global intent is no idle fear. The US drugs lobby increasingly regards public pharmaceuticals programmes, such as the PBS, the NHS's purchasing and supply agency, and Canada's provincial drug review committees, as a threat that must be conquered. War on Cheap Drugs: The big US pharmaceuticals firms are using Australia's public medicine supply scheme for target practice The Guardian January 20, 2004
A former federal health department employee is advising the US drug industry as it lobbies for changes to the Pharmaceutical Benefits Scheme under free trade negotiations, now reaching their critical final stages.
The Federal Opposition has expressed outrage that Paul Cross, the senior adviser on PBS matters to former health minister Kay Patterson (who succeeded Dr Wooldridge), is part of an American push to raise profits from US drug sales.
Mr Cross worked for the Health Department until February last year, when he quit to work for American-owned drug giant Merck Sharp and Dohme. At the time, Mr Cross said he would not be working on governmental issues.
PhRMA recently released its 2004 submission to the US National Trade Estimate Report on Foreign Trade Barriers. It said the US-Australia free trade agreement had the potential to deal with "anti-competitive practices" such as the PBS. The PBS had adopted "increasingly draconian regulatory and budgetary cost control schemes" in recent years, PhRMA said. PBS adviser lobbying for US 'a disgrace The Age January 25, 2004
Drug companies are among those health care groups which have created front "community" organisations to press and market their point of view. These groups acquire a large nominal membership, often by subterfuge. Many citizens do not know that the group is claiming them as members. They do not realise what is being done in their names. Staff and most of the funding for a public campaign are supplied by the corporate backers. These well funded organisations are able to represent themselves as large grass roots movements supporting and arguing for the corporate position, a position their "members" would not support if they knew all the facts.
Their extensive funding and access to corporate marketing services allows them to drown out genuine grass roots movements opposing company policies, and at the same time lobby politicians strongly on behalf of the public. These scams can be extremely difficult to detect but Corpwatch has publicised some of them on its web site at varying times. An increasing number of politically active US citizens seeking reform now refuse to belong to organisations, that claim to represent the public, if these organisations accept any corporate support at all. This is a particular problem in aged care where corporate chains often lend support to community groups in order to soften their image. It effectively ties the hands of the community organisation when its donor transgresses.
Flo seems such a nice old lady. She is feisty, good-humoured and worries about how other elderly Americans are getting on, especially with the high price of medicines these days. She is especially concerned that some new-fangled policy in Congress is going to put "big government in our medicine cabinet".
That remark, almost hidden among her lighthearted musings, gives away who she really works for. The series of public policy advertisements she appears in is paid for by an innocuously named group, Citizens for Better Medicare, which turns out to be the public relations arm of Pharmaceutical Research and Manufacturers of America.
The industry lobby is fighting a tooth and nail battle against a Democratic proposal to curb the ballooning price of prescription medicines.
But after the election, it is corporate America that will call in its chits, and - if recent political history is anything to go by - much of the new administration's policy will be guided by the bets placed by big business during the campaign. How big money buys big votes in US race : Gore's social agenda under assault as billions of dollars dominate 'hidden election' The Guardian October 10, 2000
"Almost all of our money to date has come from pharmaceutical companies in Canada," Pat Kelly, one of the founders of the group told Marketplace.
The Coalition is not alone. These days almost every high profile disease advocacy group relies on the financial backing of the drug industry. That has some people worried these groups may be influenced by the corporate interests that pay their bills.
Barbara Mintzes tracks how pharmaceutical companies promote their products. She says cozying up to advocacy groups is the latest trend.
No one in the public relations industry would agree to do an on-camera interview for this story. But several did tell Marketplace over the telephone that they're busy matching drug companies with patient groups.
Recent national newspaper supplements carrying the Arthritis Society's logo, extolled the virtues of two new drugs. Nowhere is it mentioned that the society gets money from the manufacturers of those products.
Another recent event held by a patients group was billed as a public information session. Two doctors urged the audience to lobby the British Columbia government to pay for an Alzheimer's drug. The audience never learned the event, which was sponsored by the Alzheimer's Society, was paid for by Pfizer - the maker of the drug the doctors said should be paid for by the BC government.
The event was organized by a public relations firm.
Wendy Armstrong of the Consumer's Association of Canada says it's becoming impossible to recognize the difference between a legitimate group and "a drug company front."
Meanwhile, The Cancer Advocacy Coalition has obtained more funding from a pharmaceutical company for a national newspaper campaign. The coalition wants politicians to spell out their commitment to cancer issues and drug approvals during the federal election. Promoting Drugs Through Patient Advocacy Groups CBC Documentary November 14, 2000
One of the biggest players in the soft money game is a group with the public-spirited title of Citizens for Better Medicare. For an organisation which commissioned an estimated $35m in advertising in the last election, Citizens for Better Medicare, maintains a remarkably small office in downtown Washington.
Citizens for Better Medicare (CBM) was founded and is funded by PhRMA and the drug industry. When it registered itself for non-profit status, CBM declared itself as a PhRMA affiliate. Before taking up his executive director position, Mr Ryan was PhRMA's marketing director. Special report: George Bush's America : Industry that stalks the US corridors of power. In the second part of a series - how drug firms reach the heart of government The Guardian February 13, 2001
A PUBLIC CITIZEN RESEARCH REPORT WHICH DESCRIBES THE PROBLEM Of FRONT ORGANISATIONS (SEE WEB SITE)
"It's time Congress listens to the America public instead of the drug industry and other powerful special interests," Kennedy said. "I applaud Public Citizen's efforts to unmask this latest fraud played on Americaâs seniors by the drug industry."
Speaking at a press conference held to unveil the report were Sens. Edward Kennedy (D-Mass.), Debbie Stabenow (D-Mich.), Charles Schumer (D-N.Y.) and Richard Durbin (D-Ill.); and Reps. Marion Berry (D-Ark.) and Janice Schakowsky (D-Ill.).New Report Unmasks United Seniors Association as Hired Gun for Drug Industry Drug Companies Appear to Have Given Seniors Group Nearly $10 Million to Push Medicare Drug Bill Favored by Industry Public Citizen July 16, 2002
United Seniors Association --- The Seniors Coalition --- The 60 Plus Association (all claim to be advocacy organisations for US seniors)
If you're like millions of other older Americans, you've seen their names many times before - either on fundraising appeals or on television spots promoting political candidates.
Three nonprofit organizations that claim to speak for older Americans are in fact heavily bankrolled by the pharmaceutical industry, an examination of tax records by the AARP Bulletin shows.
For starters, all three organizations claim to be nonpartisan, though they support - almost without exception - the campaigns and causes of one political party
Kenneth Goldstein, a political scientist at the University of Wisconsin who oversees the Wisconsin Advertising Project, says the drug industry has also emerged as unquestionably "the top-spending industry" in terms of political advertising.
But the Bulletin has learned the pharmaceutical industry quietly pulled the plug on CBM last year, just as PhRMA started channeling what it called "unrestricted educational grants" to United Seniors Association.
(CBM (Citizens for Better Medicare) - see in reports above - seems to have been sprung so is abandoned!) Pulling Strings from Afar : Drug Industry Finances Nonprofit Groups That Claim to Speak for Older Americans By Bill Hogan February 2003 <http://www.aarp.org/>
A new campaign group was launched in the UK last year called Raising Awareness of Paediatric Pneumococcal Infection and Disease (Rappid).
Less well publicised was that Rappid was set up and funded by the drug company Wyeth, which has developed a vaccine against those diseases. Drug firms profit from 'murky' link with journals, study shows : Companies are misleading doctors, patients and governments to push their medicines, says a special edition of the 'BMJ' By Maxine Frith May 30, 2003 <http://news.independent.co.uk>
Fraud by Pharmaceutical companies is addressed on another page.
CLICK HERE to go to the Pharmaceutical Corporate Fraud Page
This page created in Fenruary
2004 by Michael Wynne