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'Trading away health'
The following is the text of an address delivered by Thai AIDS Treatment Action Group director Paisan Suwannawong at the opening ceremony of the 15th International AIDS Conference which took place in Bangkok this summer. Special thanks to Paisan for his permission to reprint.
Good evening, ladies, gentlemen, and friends. Welcome to Bangkok. Sorry if I am a little nervous, but I am not used to speaking on stage; I am more experienced with speaking on the street. First, I would like to say thank you to the people who supported my invitation to speak, and thank you to the International AIDS Society because it means a lot to me to be able to speak here from the perspective of a drug user living with HIV.
I would like to tell you a little bit about myself. I grew up in one of Bangkok's biggest slums, not far from here. I saw many people using drugs, but never imagined that I would become a drug user myself. The first time I smoked marijuana, it felt like a challenge because all the public campaigns said drugs were "bad" and "dangerous." I found it wasn't true, so I continued to smoke it. Then I started smoking heroin, and became addicted without realizing it. I didn't have any money, I was feeling withdrawal symptoms, and my friend offered to share his heroin and inject me. Yes, it was scary the first time.
I got arrested at least twenty times. Most of the time, I did not have any drugs on me. The police would plant drugs on me and force me to confess, and beat me if I did not sign their document. I could not carry a needle around, because if the police arrested me the charge would be more serious.
I heard about the risk of getting HIV from sharing needles, but when you are craving heroin, you don't think about anything else. You just want to inject. I was in prison twice. The conditions were terrible and we had to stay in our cells for more than fifteen hours a day. For me, there is nothing worse than losing your rights and your freedom. I am not surprised that people use drugs and inject in prison, even if they never used or injected before. I believe that I got HIV in prison because I injected almost every day there.
Getting off drugs is not easy. Many times, I went into drug treatment just to please my family, get away from the police, or take a break because the amount of drugs I needed was getting expensive, not because I wanted to quit; and the attitudes of treatment staff only made me feel worse.
Other times, I really did want to quit. But can you imagine how it feels to leave a treatment program and go back home with nothing to do? How difficult it is to find a job and explain where you've been? My own family would watch my every move; I could see in their eyes they did not trust me. I was too embarrassed to see my friends, whose lives seemed so successful. It was so lonely. I felt I had nothing at those times. The only thing I could think of was to go back to using drugs.
Finally thirteen years ago I got off drugs. I knew I really needed help. I decided to go to a "TC," or "therapeutic community." This is how I found out how I had HIV. The test still is a requirement for entering the TC. There was no pre- or post-test counseling. In fact, my results were given to my sister—not to me.
Today, not much has changed. Drug users are still seen as morally weak and bad people. We face stigma and discrimination in society and in the health care setting. We experience constant police harassment and ineffective services. In Thailand, injecting drug users or "IDUs" are the only group whose 50% HIV prevalence has not changed in fifteen years. One third of all new HIV infections are IDU-related, and this number is increasing. Yet there has been no effective response from the government.
In a recent war on drugs in Thailand, over 2,500 people were killed extra-judicially in the first three months of the campaign. More than 50,000 people were arrested, hundreds of thousands were forced into military-run rehabilitation centers, and drug users were forced underground and away from services that were already difficult to access.
Last year, the Thai Drug Users' Network developed a proposal for a peer-driven HIV prevention, care and support intervention for injectors, and submitted it to the Global Fund. We had to bypass the country coordinating mechanism and lobby with the help of international AIDS activists to get political support for our proposal. In October, we were awarded a 1.3 million dollar grant, but we still haven't received the money. Even though the Thai government says its current policy is to treat drug users as "patients," not "criminals," it is still illegal to be a drug user. We continue to be arrested and offered the choice of prison or military-run rehabilitation centers. Is this harm reduction or harm production?
Every minute a person is infected with HIV by using a dirty needle. Globally, one in three of all new HIV infections outside of Africa is IDU-related. In fact, contaminated needles account for the largest share of new infections in Eastern Europe and Asia. The World Health Organization says drug users have an equal right to all levels of care, but in practice we are denied access to antiretroviral treatment, as well as basic prevention interventions like clean needles. Methadone is still illegal in many countries and should be included on the WHO Essential Drug List. There are many harm reduction interventions which have been proven to help IDUs stay free of HIV, including clean needles and methadone. We need these means of prevention in place now! And we need access to treatment now!
Drug users, like other politically, socially, or economically marginalized groups, are easily abused by the government and others, who exploit them for money or services. We often do not enjoy even the most basic human rights. In Thailand, this is true for sex workers, men who have sex with men, migrant workers and undocumented citizens as well.
The world we live in today is not a world of sharing but of advantage-taking, profit-seeking, and competition to "get ahead." It is a world motivated by greed and controlled by corporations, which do not recognize the value of a human being. While an elite few amass enormous wealth, basic needs are denied to many millions.
Today, many of our governments are run by these elite, who are more interested in protecting their personal investments than promoting public welfare. They invest public resources in projects whose profits go into the pockets of their friends instead of providing for the welfare of society. Governments privatize our public utilities, as well as our education and health care systems. Social welfare programs and other forms of assistance become issues of charity, not rights or entitlement. As a result, our public hospitals are overloaded and under-funded, severely compromising the availability and quality of treatment and care offered.
Of course, tackling AIDS isn't just about health care and antiretrovirals. Prevention, harm reduction, poverty reduction and decent living standards are all part of the process; but governments, like the United States, or international organizations, like the World Trade Organization (WTO), make the task much more difficult. Market-driven policies and the emphasis on "abstinence-only" have already proved to be harmful or, at best, totally useless. It is outrageous that today conservative groups, especially in the U.S., are advancing a moralistic ideology that contradicts scientific evidence about HIV prevention. Though condoms and clean needles are the most effective tool we have to prevent the transmission HIV, programs that promote them are not funded, or are de-funded.
Evidence shows that widespread access to antiretrovirals leads to huge improvements in health and quality of life, with significant reductions in health care and other costs, because of improved health and productivity among people living with HIV/AIDS and their families. The most painful experience I can think of, after living with HIV for thirteen years, is being poor and HIV-positive. Again and again, I watched many friends die in front of me, from terrible opportunistic infections, simply because they were poor and could not afford treatment. What kills us is not AIDS, but greed.
Multinational pharmaceutical companies inflate the prices of their drugs without thought for poor people. They use they wealth to influence U.S. and European government policy to ensure that intellectual property rights are weighed in their favor. Other governments say they are too worried about adherence and drug resistance to offer treatment, when the truth is they don't want to pay or suffer repercussions from their trading partners by breaking patents.
Four years ago, Thai people with HIV/AIDS asked the government to use a compulsory license for ddI, but the government was too afraid of trade and other sanctions from the U.S. Ultimately, we took Bristol Myers-Squibb to court and won the right to produce tablet-form ddI, locally. In the final judgment, the Thai Court ruled that, because patents can lead to high prices and limit access to medicines, patients have the right to sue the patent holder. This was a very important battle that we won.
But the war is not over. Recently, the Thai government entered Free Trade Agreement negotiations with the United States. We know the U.S. unilaterally pushes for intellectual property protection that is stricter than what is agreed internationally. This means that Thailand, now producing generic antiretrovirals for most who need them, will no longer be able to sustain this important program. We are demanding the Thai government refuse to trade away the health of its people by negotiating intellectual property protections for medicines.
The U.S. government and its policies affect the ability of people all over the world to enjoy their basic rights and needs. Many poor countries cannot provide basic services like health care because they have to pay back enormous debt to the U.S. and Western banks. While thousands die of AIDS everyday from lack of funds, there is unlimited funding for war. Billions of dollars are freely available for the killing and destruction in Iraq, while the Global Fund is out of money. This is because of the broken promises of rich donor countries that refuse to pay their fair share.
I have no simple solutions for achieving world peace, but I do know that the U.S. government, led by that criminal, George Bush, wages war and occupies countries like Iraq in the name of peace. The U.S. is too arrogant to listen to the United Nations, and the Thai government shows its loyalty to the U.S. by sending Thai troops to Iraq.
Four years ago, at UN General Assembly Special Session (UNGASS) on HIV/AIDS, after activists demanded an urgent response to the global AIDS treatment crisis, Kofi Annan called on all the world's governments to develop what he described as a "war chest." This became the Global Fund. At the last international AIDS conference, the World Health Organization launched its "3 by 5" initiative; yet, today, six million people are still waiting for their drugs. AIDS doesn't wait and neither do we. Faced with the abuse of power and greed of corporations, we cannot wait for our governments to act.
Governments and corporations hate activists because we know what they are up to, and we are pulling the masks of fake concern from their face to reveal their true nature. But to me, activists are to be honored. Activists are my true friends. They stand by my side when I face discrimination and injustice. They have the courage to stand up to those in power who use their positions for their own benefit. They are the ones who can help provide a way forward to fight AIDS and injustice in this world.
"Access for all" is the theme of this conference and the dream of many of us here. Yes, it's not easy to achieve in the world we live in today, but the world belongs to all of us to change.
Five years ago, doctors, nurses, and many other people told me and my friends that access to antiretrovirals was an impossible dream. Recently, Thailand announced that it would provide antiretrovirals to all who need it, starting with 50,000 people by the end of this year. Today, I urge all of us to dream of a day when our world will be filled with love, sharing and peace. And I believe that when we dream together, our dreams come true. ¤ |
| Weaning us off the dope
Just as the hand-wringing PR exercise that has become the international AIDS conference was winding down halfway across the globe, this little item hit the newsstand in the states:
July 15, 2004—Members of a government panel, which earlier this week recommended more aggressive use of statin medications for people at the highest risk of dying from heart disease, failed to disclose financial links to the companies that make the drugs.
The revised consensus guidelines were issued by none less than the American Heart Association and were drawn up by a government panel of experts in the field, convened by the NIH's own National Heart, Lung, and Blood Institute. The new rules, if sustained, would lower serum cholesterol targets to a point where 7 million more Americans would be encouraged to start taking the cholesterol lowering medications of Pfizer, Merck, BMS and AstraZeneca. (At $1,500 or so a year and 20-30% margins, we're talking an additional $2-3 billion a year in profits—with little more than the stroke of a pen.)
New York Newsday first reported the story in its Thursday edition. Eight of the nine panel members had earned money specifically from cholesterol drug makers, including Pfizer, Merck, BMS and AstraZeneca. The NIH's Dr. James Cleeman and Dr. Rose Marie Robertson, of the AHA, both said they felt financial disclosure had been covered because all but two of the authors had also served on the 2001 consensus panel—and that they had made their industry connections known then.
The summer imbroglio set familiar alarm bells sounding: foxes guarding the hen house, physicians and researchers as pharma shills. Of course, guidelines meddling is among the oldest tricks in the Big Pharma playbook. The wisest, perhaps privileged, clinicians routinely eschew such interference and hope nothing untoward will befall them for their brave and educated insolence. But the fact remains that guidelines of all guises in all specialties whack quite a wallop in establishing prescription patterns and the standard-of-care. And thus, not unlike the Swiftboat veterans' media blitz in swing electoral states, efforts to influence them suck in tens of millions of dollars a pop.
Perhaps due to an historic vigilance among AIDS activists and clinician advocates (or to its infectious nature), the field of HIV medicine has so far been spared the most egregious of these marketing-masquerading-as-medicine maneuvers. In fact, the two notable revisions to HIV's standard-of-care followed on the heels of therapeutic setbacks (results of the early vs. deferred AZT "Concorde" study, circa 1993; and the failure of the eradication hypothesis, around 1998) and resulted in retrenchment rather than new aggressivity—albeit not without sustained intervention to limit the damage.
But might that portion of the Big Pharma enthralled research and treatment establishment still be clinging onto a model of overmedicatization in order to please its generous sponsors? After all, the NIH's hallowed Principles of Antiretroviral Therapy seem immune to re-evaluation—even though the science and hypotheses on which they were based have largely been overtaken by events. "It's the virus, stupid" sprang from its en-coffined slumber on the wings of hope—whipped to frenzied cries by the medical marketers—and has since taken on a life of its own. But where the silver dagger to return it to its repose?
When otherwise patient friendly researchers and community docs self-satisfyingly state, with all the authority their years of furtive pharma hustling has bought them, before a conference crowd that "lifelong antiretroviral therapy is not really a problem (anymore) because easier to take, less toxic combos are now available or just over the horizon"; when Trizivir, Viread+Sustiva or Kaletra are considered treatment sparing "maintenance" regimens in virtually all the studies pretending to re-explore this approach (see The Irony of Bangkok); when patient advocates on federal panels sign off on (or instigate) sweeping prohibitions which diminish our treatment options and further bottleneck the progress of clinical care; we, my fellow HIVers, activists, clinicians, researchers, need to rediscover our activist rage and imagination.
The field of HIV/AIDS seems poised, once again, at a crossroads. This time, however, activism and advocacy are deafening only by their silence. While the black and white, demagogic issues such as Abbott's notorious price gouging rampage had even the bloated pharma front men crying foul, the more insidious issues—an anachronistic treatment paradigm, a research and regulatory establishment high-jacked by industry—go entirely unaddressed. It is within this context that an important voice may have serendipitously risen to stimulate our latent activist memory cells: former NEJM editor Marcia Angell via her gutsy deconstruction of (nearly) all that ails us.
Marcia Angell wasn't always a crusader. Some may remember her rather uncritical endorsement of the design and conduct of the seminal AZT study (at 1,500 mg a day; it's now dosed at 600—and 500 mg or less, outside the U.S.) when it appeared in the pages of her little journal, circa 1987. Others haven't forgiven her her tough stance against alternative medicine. But with the release of her new book late last month, "The Truth About the Drug Companies: How They Deceive Us and What We Can Do About It," Dr. Angell appears to have Goliath precariously centered within the cross hairs of a populist sling shot; her rousing philippic having transformed an otherwise mild mannered Harvard lecturer into a present day Daniel J. Goldhagen of the medical profession.
She clearly doesn't buy the Nussbaumian "good intentions" defense; instead, she lays out the evidence like an expert prosecutor—and goads us all to cease the charade. For those among us who, over the years, have come to rely on drug company beneficence for little luxuries here and there (and maybe even some extra pocket money), implementation of the Angell agenda will not be painless. Her clear and cogently articulated vision is of a reformed medical profession as much as it is a reformed pharmaceutical industry—both of which need to return to their mission, she argues, of serving the public interest.
Angell's epiphanal moment is said to have occurred in the spring of 2000 when newly required conflict-of-interest disclosures for authors exceeded the available page space. The study in question was of an antidepressant drug, nefazodone, developed by Bristol-Myers Squibb. All but one of the study investigators reported consultancy arrangements, speaking honoraria, and membership on pharma advisory boards—in most cases, with pharma companies producing similar types of drugs. Visibly frustrated, Angell referred readers to the journal's website for the complete list of pharma financial entanglements. In disgust, she penned a now legendary accompanying editorial for the issue, "Is Academic Medicine for Sale?"
If we have become inured to apocryphal tales such as that of the section chief who supplemented his income to the tune of $500,000 a year through pharma consulting gigs or the clinical trials sites paid $12,000 per patient enrolled—with a $30,000 bonus if the number reaches six, Angell's manifesto threatens to shake us from our stupor. And in a hodge-podge effort to depict the HIV KOLs and consensus makers in this regard, three extra pages of TAGline's back-to-school issue are dedicated to Dr. Angell, in support of her campaign to bring medicine back to the people and to save Big Pharma from its most egregious excesses.
Early reviewers of the names and numbers note that acceptance of financial goodies (not to mention the unquantifiable triumvirate of fame, friendship and flattery) is not in itself evidence of objectivity's loss. In fact, without exception, the half dozen or so New York City HIV docs informally queried about their advisory and lecture circuit relationships with Big Pharma were eager to point out that they moonlighted for "all the major drug companies" with HIV products expressly "to avoid any question of bias." Others note that Angell's scorched earth solution (barring anyone with pharma ties from key panel posts) would only be self-defeating. Were financial ties to drug companies an automatic disqualifier, the argument goes, there'd be only empty chairs at empty tables. (Angell disagrees.)
For the time being, the only remedy deemed workable is that of disclosure requirements—ironically, what appears to have sparked Angell's fiery exposé in the first place. But, as she is quick to point out, does the mere act of disclosing financial ties to industry then render them acceptable? In the best of all worlds, certainly not, but it looks like that's all we have for now (and what made Who Evaluates and Licenses the Drugs You're Taking of this issue possible). While the major journals and a couple of the med-ed/CME web sites are doing a reasonable job of highlighting industry ties, professional associations, the ACTG, the FDA Antiviral Advisory Committee and some less reputable treatment information providers make it difficult if not impossible to know who's writing what for whom. TAGline welcomes comments, corrections, updated disclosure and other information at tagnyc@msn.com. ¤ |
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It Wasn't Always Like This
The Truth About the Drug Companies
[excerpts]
"There used to be something faintly disreputable about really big fortunes. You could choose to do well or you could choose to do good, but most people who had a choice in the matter thought it difficult to do both. That belief was particularly strong among scientists and other intellectuals. They could choose to live a comfortable but not luxurious life in academia, or they could "sell out" to industry and do less important but more remunerative work. One of the results has been a growing pro-industry bias in medical research… and CME programs—exactly where such bias doesn't belong." (page 8)
"Many members of the FDA's eighteen advisory committees have financial connections to interested companies [see Who Evaluates and Licenses the Drugs You're Taking]. Although there are conflict-of-interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable." (page 210)
"Med ed writers and circuit speakers are often paid consultants for the drug companies. They are usually required to disclose financial ties [see Who provides you with up-to-date treatment information], and that disclosure is supposed to make it acceptable that they have them. But drug companies or their agents, the MECCs, often suggest the topic and speaker—and even put together the slides." (page 140)
"It's hard to believe that close and remunerative personal ties with drug companies do not add to the strong pro-industry bias in medical research and education. Big pharma not only controls the details of the way clinical trials are performed, but as backup, it also works to win the hearts and minds of researchers." (page 104)
"Drug companies are extremely generous to doctors in their 'education' activities… Doctors are invited to dinners in expensive restaurants or on junkets to luxurious settings to act as 'consultants' or 'advisors.' The doctors listen to speakers and provide some minimal response about how they like the company drugs or what they think of a new advertising campaign. That enables drug companies to pay doctors just for showing up [$1,000 a pop for the coveted high prescribers as of August 2004]. Participants may also receive training to serve on speakers' bureaus, so that they too can become company shills." p141
"Such gifts would trigger a red bribery alert in the mind of just about any public official or government contractor. But not, it seems, in the minds of many doctors." (page 128)
"Why do doctors pretend they believe drug companies are interested in education? (Some of them actually believe it.) The answer is: It pays. Doctors would lose the travel and entertainment and other emoluments too many of them have come to believe are entitlements to their profession. Many doctors become indignant when it is suggested that they might be swayed by all this industry largesse. But why else would drug companies put so much money into them?" (page 147)
"One of the more sobering indications of the extent to which big pharma has compromised the research community is its extensive inroads into the NIH itself. Senior NIH scientists routinely supplement their income by accepting large consulting fees and stock options from drug companies that have dealings with the institutes." (page 103)
"Congress also put the FDA on the pharmaceutical industry's payroll when, in 1992, it enacted the Prescription Drug Users Fee Act, which authorized drug companies to pay user fees to the FDA. These were to be employed to expedite the approval of drugs. They… soon accounted for half the budget of the agency's drug evaluation center. In the 2002 renewal, which was tacked on to a bioterrorism bill that swept through Congress without a murmur, the fees were increased to about $576,000 per NDA. User fees now account for about $260 million a year." (page 208)
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| Pharmaceutical Industry Revenue and Expense Breakdown, 2002 † |
| Research & Development | $31 billion |
| Marketing | $67 billion |
| Profits | $36 billion |
† Based on total worldwide sales of $217 billion.
Source: Public Citizen Congress Watch, "2002 Drug Industry Profits: Hefty Pharmaceutical Company Margins Dward Other Industries," June 2003 (cited in M Angell, 2004) | |
Pharmaceutical Industry
Marketing + Med Ed Outlays, 2001 |
| Marketing | $19.1 B |
| Free samples | $10.5 B |
| Drug reps | 5.5 |
| DTC advertising | 2.7 |
| Medical journal ads | .4 |
Medical Education and
Communications
Companies ("MECC") | $35.0 B |
| Total | $54.1 B |
| Source: U.S. General Accounting Office, October 2002 (GAO-03-177); (cited in M Angell, 2004) | |
"How to Save the Pharmaceutical Industry—And Get Our Money's Worth"
Seven broad problems:
- Too many me-too drugs and too few innovative ones.
- The FDA is too much "in thrall" of the industry it is supposed to regulate.
- Drug companies have too much control over clinical research on their own products.
- Patents and other exclusive marketing rights are too long and too elastic.
- Drug companies control medical education about their own products.
- Key information about R&D, marketing and pricing is kept secret.
- Prices are too high and too variable.
Seven broad reforms:
- Shift the emphasis from me-too to innovation.
- U.S. patent law should be enforced in its original form.
- FDA regulations should require that new drugs be compared against existing drugs (and at equivalent doses) for the same conditions (and not just against placebos).
Angell: "If I could choose only one of the reforms I am suggesting, it would be this one. This change would have multiple beneficial ripple effects. And this is the one that could be accomplished easily by congressional legislation."
- Strengthen the FDA.
- Repeal the Prescription Drug User Fee Act (or allow it to expire in 2006).
- Increase public funding for the agency.
- Exclude experts with financial ties to industry from the FDA's advisory committees.
- Create an institute to oversee clinical trials.
Angell: "I propose that an Institute for Prescription Drug Trials be established within the National Institutes of Health (NIH) to administer clinical trials of prescription drugs to ensure that clinical trials serve a genuine medical need and to see that they are properly designed, conducted, and reported."
- Curb monopoly marketing rights.
- The clock on patents should not begin ticking until the drugs come to market. Then it might have a duration of, say, six years instead of twenty years from the time the patent was filed.
- The law granting drug companies an extra six months of exclusive marketing rights for testing drugs in children should be repealed.
- The loopholes in the Hatch-Waxman Act should be closed so that exclusivity cannot be stretched out for years.
- GET BIG PHARMA OUT OF MEDICAL EDUCATION.
- Once and for all, we should clarify a simple fact: Drug companies are not providers of education—and they cannot be.
- No laws, regulations, or guidelines should be based on the idea that they are.
- The medical profession needs to take full responsibility for educating its members just as other professions do.
- There are a few simple steps to make this happen:
- Medical schools should teach students about drugs, not leave such education to industry-sponsored programs and teaching materials.
- Teaching hospitals should regard drug [.] reps just as they do other salespeople (who are not allowed to traipse around at will, promoting their wares and offering gifts and meals to medical students and doctors in training.]
- The profession needs to take responsibility for continuing medical education (CME). JUST AS THERE SHOULD BE NO PRIVATE CLINICAL RESEARCH INDUSTRY, THERE SHOULD BE NO PRIVATE MEDICAL EDUCATION INDUSTRY HIRED BY THE DRUG COMPANIES.
- Professional associations need to be self-supporting.
- Direct-to-consumer advertising should be prohibited in the United States—just as it is in other advanced countries.
- Open the "black box" of R&D and marketing costs.
- The pharmaceutical industry should be regarded as a public utility: its books should be open.
- Establish reasonable and uniform pricing.
- Drug prices should be not only transparent but reasonable and as uniform as possible for all purchasers.
- President Bush's Medicare reform bill (2003) should be repealed and replaced by a simple measure that guarantees all Medicare beneficiaries appropriate coverage of their drug costs, with government-negotiated payments to industry and a medically based formulary.
Summarized from her book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Marcia Angell, 2004) |
Camel's Nose Under the Tent
Who Evaluates and Licenses the Drugs You're Taking?
cf. M Angell, "The Hard Sell… Lures, Bribes, and Kickbacks"
Angell: "The FDA's advisory committees should not include experts with financial ties to industry. The notion that they are somehow indispensable is not credible. No one is indispensable. The truth is that experts who have deals with drug companies are being co-opted, just as the FDA is co-opted by user fees." TTATDC, p 244 |
1. Who approves your drugs?
FDA's Antiviral Advisory Committee (AVAC) membership and ties to industry: |
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Roy M. ("Trip") Gulick, MD, MPH, Chair
Consultancy fees from two pharma companies (not identified) of less than $20,000 a year; and research funding from two pharma companies (not identified) of less than $20,000 a year (per 2004 AVAC transcript). Consultancy fees from: Bristol-Myers Squibb, GlaxoSmithKline, Triangle, Trimeris; Speaking fees from: Abbott, Agouron, GlaxoSmithKline, Pharmacia-Upjohn (now part of Pfizer), Triangle. †
Tara P. Turner, Pharm. D., Executive Secretary
"Nothing to report"
Victor G. DeGruttola, Sc.D.
Pharmaceutical stock ownership totaling less than $5,000
Janet A. Englund, MD
"Nothing to report"
Courtney V. Fletcher, Pharm. D. (Consumer Rep)
Pharmaceutical stock ownership totaling less than $50,000
Princy N. Kumar, MD
Pharmaceutical stock ownership (including but not limited to Schering-Plough) totaling less than $30,000; advisory fees from Schering §
Wm. Christopher Mathews, MD
"Nothing to report"
Kenneth E. Sherman, MD, Ph.D.
Pharmaceutical stock ownership totaling less than $25,000
Lauren V. Wood, MD
"Nothing to report"
Eugene Sun, MD (nonvoting industry representative)
Employed by Abbott Laboratories; not required to make disclosures
Joel Morganroth, MD (non-voting consultant)
Not required to make disclosures
Douglas G. Fish, MD (voting consultant)
"Nothing to report"
Peter R. Kowey, MD
Consultancy and speaking fees from pharma companies totaling less than $100,000 a year.
D. Roger Illingworth, MD, Ph.D.
Consultancy and speaking fees from two pharma companies totaling less than $60,000 a year.
Rory P. Remmel, Ph.D.
"Nothing to report"
Thomas R. Tephly, MD, Ph.D.
"Nothing to report"
Ronald G. Washburn, MD
Pharmaceutical stock ownership totaling less than $150,000
Matthew Sharp (voting patient representative)
"Nothing to report"
Aggregate total disclosed: Less than $400,000 per year
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Source: DHHS/FDA/CDER transcript, Antiviral Drugs Advisory Committee (AVAC) Meeting, Tuesday, May 13, 2003. "NDA 21-567 and 21-568, ReyatazŸ (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents"; † per 2000 disclosure; § (per 11/02 documents)
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Dancing with the Devil
Who Tests (and Reports on) the Drugs You're Taking—and Formulates Your Treatment?
cf. M Angell, "The Hard Sell… Lures, Bribes, and Kickbacks"
Angell: "It is impossible to know to what extent these financial deals influence judgments about... research priorities or the interpretation of results, but they certainly are cause for concern." TTATDC, p 105
2. Who (at the NIH) tests your drugs?
ACTG HIV Research Agenda Committee (RAC) membership and ties to industry: |
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Joseph J. Eron, Jr., M.D.
Consulting arrangements with GlaxoSmithKline, Merck, Triangle, Trimeris. Research grants: GlaxoSmithKline, Merck, Abbott, Agouron, Triangle, and Trimeris.
Roy (Trip) Gulick, M.D., M.P.H.
Consultancy fees from two pharma companies (not identified) of less than $20,000 a year; and research funding from two pharma companies (not identified) of less than $20,000 a year. # Consultancy fees from: Bristol-Myers Squibb, GlaxoSmithKline, Triangle, Trimeris; Speakers bureau services for: Abbott, Agouron, GSK, Pharmacia-Upjohn (now part of Pfizer), Triangle.
Ann C. Collier, M.D.
Consulting arrangements with Merck. Research grants: Agouron, Merck, Hoffmann-La Roche, Glaxo-Wellcome, and Anor Med.
Eric S Daar, M.D.
Consulting arrangements with Abbott, Boehringer Ingelheim, GlaxoSmithKline, Gilead, Serono, ViroLogics. Speaking honoraria from: Abbott, Boehringer Ingelheim, GlaxoSmithKline, Gilead, Roche, Merck, Serono, ViroLogics, Ortho. Research grants: Abbott, Bayer, GlaxoSmithKline, Gilead, Roche, Merck, ViroLogics, Serono. †
Margaret A. Fischl, M.D.
Consultancy arrangements with and grant support (not broken out in disclosure) from: Abbott, Agouron, Bristol-Myers Squibb, DuPont, GlaxoSmithKline, Triangle.§
Richard Haubrich, M.D.
Speakers bureau member for: Agouron, GlaxoSmithKline, Trimeris, ViroLogics; Grant support from same.†
Victoria A. Johnson, M.D.
(Nothing found)
John W. Mellors, M.D.
Consultancy fees from: Agouron, Bristol-Myers Squibb, DuPont (now part of BMS), GlaxoSmithKline, Gilead, Merck, Novirio, Pharmasett, Triangle, Virco, Visible Genetics††; Grant support: BMS, Chiron, DuPont (now part of Bristol), GlaxoSmithKline, Merck.
Andrew R. Zolopa, M.D.
Consulting arrangements with Abbott, Bristol-Myers Squibb, and Merck. Research grants: Abbott, Bristol-Myers Squibb, and DuPont.†
Angell: "Increasingly, panel members and med 'educators' are required to disclose their financial ties. And that disclosure is supposed to make it acceptable that they have them." TTATDC, p140
3. Who sets your treatment guidelines?
International AIDS Society (IAS) guidelines panel membership and ties to industry: |
(U.S. based members only. Pharma ties of the six extra-U.S. panel members (Yeni, Cooper, Gatell, Gazzard, Montaner, Vella) are extensive.)
Scott Hammer, MD
Consultancy fees and grants (not broken out in disclosure): Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Roche-Trimeris, Shionogi, Shire BioChem, Tibotec-Virco, Triangle.
Charles Carpenter, MD
"None to report"
Margaret Fischl, MD
Advisory fees and grant support (not broken out in disclosure) from: Abbott, Agouron/Pfizer, Bristol-Myers Squibb, DuPont, GlaxoSmithKline, Triangle.
Martin Hirsch, MD
Consultancy and lecture fees and grant support from: Bristol-Myers Squibb, GlaxoSmithKline, Merck, Schering-Plough, Takeda, Trimeris.
David Katzenstein, MD
Stock holdings, advisory fees, speaking honoraria and grant support (not broken out in disclosure) from: Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck, ViroLogic, Visible Genetics, patent US 5,968,730 on PCR assay (October 15, 1999).
Doug Richman, MD
Consultancy arrangements with Abbott, Bristol-Myers Squibb, Chiron, Gilead, GlaxoSmithKline, Merck, Pfizer, Roche, Takeda, Triangle, ViroLogic.
Mike Saag, MD
Grant support from or served as a consultant (not broken out in disclosure) or on the speakers bureau for Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Ortho Biotech/JNJ, Pfizer/ Agouron, Pharmacia & Upjohn, Schering-Plough, Shire, TherapyEdge, Tibotec/Virco, Triangle, Trimeris, and ViroLogic.
Mauro Schecter, MD
Consultancy fees, speaking honoraria and grant support (not broken out in disclosure) from: Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck, Roche.
Melanie Thompson, MD, MPH
Consultancy and advisory fees, lecture sponsorship, speaking honoraria and grant support (not broken out in disclosure) from: Abbott, Agouron, Agouron/Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiron, DuPont, Gilead, GlaxoSmithKline, Merck, Oxo-Chemie, Roche, Serono, Triangle, Trimeris, ViroLogic.
Chip Schooley, MD
Stock holdings (options), consultancy and lecture fees, honoraria and grant support (not broken out in disclosure) from: Agouron, AnorMed, Bristol-Myers Squibb, Merck, Mojave, Pan Pacific Pharmaceuticals, Hoffmann-La Roche, Tanox Biosystems, Triangle, Vertex, ViroLogic.
Paul Volberding, MD
Consultancy fees and honoraria from: Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Merck.
† Medscape disclosures, 2001; § JAMA required disclosures from IAS guidelines panels, 2004 (IAS itself does not make this information available); # FDA AVAC transcript (see source reference on preceding page); †† per JAMA 1999
4. Who provides you with up-to-date treatment information?
Popular treatment information resources for doctors and patients-and their reliance on pharmaceutical largesse: |
[Self-test: Inquire for yourself from those resources you use most often]
Angell: "If you have a genuine firewall between the editorial and sales sides of your treatment magazine or website, you would be extremely unusual. For most journals and magazines, the pharma marketing people call the shots."
Interview, Marcia Angell, MD; September 2004
Medscape.com
Bangkok conference coverage on the site paid for by Bristol-Myers Squibb, GlaxoSmithKline, and Gilead. |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Sign-off (or assignments) for conference summaries? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
TheBody.com
Bangkok conference coverage on the site paid for by Abbott, Boehringer-Ingelheim, Gilead, GlaxoSmithKline, and Roche-Trimeris. |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Sign-off (or assignments) for conference summaries? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
| ClinicalOptions.com (and its imedoptions.com sister site) |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Sign-off (or assignments) for conference summaries ? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
hivandhepatitis.com
Grants from Abbott, Gilead, Advanced Biological Labs, Ortho Biotech, Boehringer Ingelheim, Roche Diagnostics, Bristol-Myers Squibb Virology, Roche Molecular Systems, GlaxoSmithKline, Serono, Schering-Plough. |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Sign-off (or assignments) for conference summaries ? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
aidsmap.com
Link from home page directs users to complete list of funding sources: http://www.aidsmap.com/en/about/funders.asp. Conflict-of-interest concerns are acknowledged up front, and a brief paragraph explains that the service tries to diversify its funding as much as possible. Among its many underwriters, however, figure the usual pharma companies: Abbott, BMS, Boehringer Ingelheim, Gilead, GSK, Merck, Roche, Shire. Pharma currently makes up 22% of its funding-still a hefty chunk, but the only direct quantification of pharma's involvement of all the treatment information resources surveyed. |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Sign-off (or assignments) for conference summaries ? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
HIVinsite.com
Grants from BMS, Boehringer Ingelheim, Gilead, GSK, Pfizer/Agouron, Roche, Schering Plough |
Pharma (or pharma consultant) sign-off on content? Yes __ No __
Sign-off (or assignments) for conference summaries? Yes __ No __
Pharma (or pharma consultant) selection of authors/reporters? Yes __ No __ |
Poz magazine (Poz.com)
General magazine content, while bursting with HIV drug and nutriceutical ads (and more recently, those premium drug company wrap around outside covers-and a blazing BMS scrolling banner at its web site) is said to be uninfluenced by its (sole?) reliance on pharma (and nutritional company) funds for operating revenue. Content of Poz "special supplements," however, is generally planned and written in close collaboration with the pharma sponsor of that supplement's topic. |
PRN (Physicians Research Network)
Grants from Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Roche/Trimeris. |
Pharma (or pharma consultant) sign-off on editorial content? Yes __ No __
Selection (or sign-off) on meetings' speaker selection? Yes __ No __
|
AAHIVM (AAHIVM.com)
The Los Angeles-based upstart HIV academy responsible for educating HIV clinicians (producing and distributing an annual curriculum and series of web-based CME qualifying examinations) is apparently funded via unrestricted education grants (for its HIV curriculum-and industry prepared downloadable slide sets and speakers' talking points, no less) from Abbott, BMS, Boehringer Ingelheim, Gilead, GSK, Merck, Ortho Biotech, Roche. |
Pharma (or pharma consultant) sign-off on CME content? Yes __ No __
Pharma (or pharma consultant) selection of authors/board? Yes __ No __ |
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ACT UP Again—What you can do:
Angell: "You need to know that your doctor's decisions are based solely on what is best for you. And doctors need to be weaned from their dependence on drug company largesse." TTATDC, p 262
What you can do:
⇒ When your doctor prescribes a new drug, ask her or him these questions:
- What is the evidence that this drug is better than an alternative drug or some other approach to treatment?
- Has the evidence been published in a peer-reviewed medical journal?
- Are you relying on information from drug company reps?
Insist on a straight answer and, if necessary, a reference to a journal article or a medical textbook.
- Is this drug better only because it is given at a higher dose?
- Would a cheaper drug be as effective if it were given at an equivalent dose?
Remember, there is usually no reason to think new drugs are better than olds ones. And the older the drug, the better its safety record is likely to be.
- Are the benefits worth the side effects? The expense? The risk of interactions with other drugs I take?
Every drug has side effects, and it may be better not to treat self-limited or trivial ailments.
- Is this a free sample?
- If so, is there a generic drug or an equivalent drug I can use that is cheaper when the free samples run out?
Free samples are a false economy. They are designed to get you and your doctor hooked on the newest, most expensive drugs.
- Do you have any financial ties with the company that makes this drug?
- For example, do you consult for the company?
- Other than free samples, do you receive gifts from drug companies?
- Are you being paid to put me on this drug or to enroll me in a drug company study?
- Do you make time for visits from drug company representatives?
If the answer to any of these questions is yes, you should consider changing doctors.
You need to know your doctor's decisions are based solely on what is best for you. And doctors need to be weaned from their dependence on drug company largesse.
⇒ And ask your senator and representative in Congress this question:
Do you receive campaign contributions from the pharmaceutical industry? And if so, how much?
There is no doubt that this industry largely writes its own ticket in Washington, and you have to [help] put a stop to that.
⇒ Pay no attention to direct-to-consumer ads for prescription drugs. These are meant to sell drugs—not educate consumers—and they only add to the prices you pay.
⇒ Finally, remember the admonition of the Washington Post editorial (6/9/2003,A20) to question those arguing Big Pharma's case about its sources of income. I can think of no better advice. Nowadays, even the most distinguished and apparently unbiased academics may be on the pharmaceutical industry's payroll. If they are, you need to be especially skeptical about their pronouncements.
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