In June, the New England Journal of Medicine, one of the most respected medical journals, made a startling announcement.
Price-fixing fines behind them, the firms are close to achieving a
The Pentagon's recent decision to limit anthrax vaccine shots to those
at high risk does not address the fundamental objection to the shots,
which is the lack of informed consent. The military maintains that it is
not required to seek informed consent for the vaccine because it is
currently approved by the Food and Drug Administration, and it continues
to court-martial personnel who refuse the vaccine. These servicemembers
contend that the vaccine is unsafe and that the military is not using it
in the prescribed manner.
The Pentagon announced its controversial plan to forcibly inoculate all
2.4 million troops against anthrax in 1997. Almost immediately, military
members began to protest, based in part on the revelation that
approximately 300,000 servicemembers had been given experimental drugs
without their knowledge in the Gulf War. Both during and after the Gulf
War, many military personnel experienced systemic medical problems,
which are often collectively termed Gulf War Syndrome. Seven years after
the Gulf War, the military finally admitted that it had used
experimental drugs on its personnel without their consent, and that
these drugs could be factors in the medical problems.
The FDA approved the current anthrax vaccine in 1970 primarily for
agricultural workers, but not for routine immunization on large
populations. Originally approved for a six-shot, eighteen-month
protocol, the vaccine is intended to treat cutaneous (through the skin)
anthrax, but has never been tested for inhalation anthrax, which is the
most deadly form and the most likely to occur in a combat situation.
Despite the military's assertions that very few adverse reactions have
been reported from the vaccine, the General Accounting Office found that
the Pentagon has been negligent in tracking such reactions. In fact,
many military personnel have reported adverse reactions. In 2000 the GAO
surveyed the National Guard and reserve forces given the vaccine, and 85
percent reported some reactions, with 23.8 percent reported to be
systemic. Additionally, the GAO reports that the long-term effects of
the anthrax vaccine have never been studied. In 1994 one of the Army's
top biological researchers wrote that "the current vaccine against
anthrax is unsatisfactory."
In 1996 the manufacturer BioPort submitted an application to the FDA to
amend the original anthrax vaccine license to include treatment of
inhalation anthrax as an approved use, as well as an approved reduction
in the vaccination schedule. FDA regulations specify that should an
organization desire a license change for a previously approved drug or a
modified dosing schedule, the drug essentially reverts to experimental
status. Due to a vaccine shortage, the military does not require that
personnel complete the six-shot protocol, and in some cases it has
prescribed that only two of the six required shots are necessary. So
under the current law, the military, in using the anthrax vaccine as a
prophylactic against inhalation anthrax, is basically using an
experimental drug on its own people without their consent.
In light of the Gulf War experimental drug abuses, the Pentagon's
circumvention of FDA regulations with anthrax vaccine is very
unsettling. Even after the anthrax scare post-9/11, we cannot simply
ignore the system of checks and balances for experimental drugs. In
volunteering for service, military members sacrifice much for their
country. Just as they are expected to conform to the rules of their
superiors, the Pentagon should be expected to obey the laws of the
Big Pharma tries out First World drugs on unsuspecting Third World
As corporations push new medicines, sound and affordable healthcare
A recent front-page story in the Boston Globe proclaimed that New
England leads the nation in Ritalin prescription levels. Somewhat to my
surprise, the prevalence of Ritalin ingestion was generally hailed as a
good thing--as indeed it may be in cases of children with ADHD. But to
me the most startling aspect of the Globe's analysis was the
seeming embrace in many places of Ritalin as a "performance enhancer."
Prescription rates are highest in wealthy suburbs.
While the reasons for such a statistical skewing need more exploration
than this article revealed, what I found particularly interesting was
the speculation that New Englanders have a greater investment in
academic achievement: "'Our income is higher than in other states, and
we value education,' said Gene E. Harkless, director of the family
nurse-practitioner program at the University of New Hampshire. 'We have
families that are seeking above-average children.'"
Aren't we all. (And by "all," I mean all--wouldn't it be nice if
everyone understood that those decades of lawsuits over affirmative
action and school integration meant that poor and inner-city families
also "value education" and are "seeking above- average children"?) But
Ritalin, after all, works on the body as the pharmacological equivalent
of cocaine or amphetamines. It does seem a little ironic that poor
inner-city African-Americans, who from time to time do tend to get a
little down about the mouth despite the joys of welfare reform, are so
much more likely than richer suburban whites to be incarcerated for
self-medicating with home-brewed, nonprescription cocaine derivatives.
If in white neighborhoods Ritalin is being prescribed as a psychological
"fix" no different from reading glasses or hearing aids, it's no wonder
the property values are higher. Clearly the way up for ghettos is to
sweep those drugs off the street and into the hands of drug companies
that can scientifically ladle the stuff into underprivileged young black
children. I'll bet that within a single generation, the number of
African-Americans taking Ritalin--to say nothing of Prozac and
Viagra--will equal rates among whites. Income and property values will
rise accordingly. Dopamine for the masses!
Another potential reason for the disparity is, of course, the matter of
access to medical care. Prescriptions for just about anything are likely
to be higher where people can afford to see doctors on a regular
basis--or where access to doctors is relatively greater: New England has
one of the highest concentrations of doctors in the country. But access
isn't everything. Dr. Sally Satel, a fellow at the American Enterprise
Institute, says that when she prescribes Prozac to her lucky
African-American patients, "I start at a lower dose, 5 or 10 milligrams
instead of the usual 10-to-20-milligram dose" because "blacks metabolize
antidepressants more slowly than Caucasians and Asians." Her bottom line
is that the practice of medicine should not be "colorblind" and that
race is a rough guide to "the reality" of biological differences.
Indeed, her book, PC, M.D.: How Political Correctness Is Corrupting
Medicine, is filled with broad assertions like "Asians tend to have
a greater sensitivity to narcotics" and "Caucasians are far more likely
to carry the gene mutations that cause multiple sclerosis and cystic
fibrosis." Unfortunately for her patients, Dr. Satel confuses a shifting
political designation with a biological one. Take, for example, her
statement that "many human genetic variations tend to cluster by racial
groups--that is, by people whose ancestors came from a particular
geographic region." But what we call race does not reflect geographic
ancestry with any kind of medical accuracy. While "black" or "white" may
have sociological, economic and political consequence as reflected in
how someone "looks" in the job market or "appears" while driving or
"seems" when trying to rent an apartment, race is not a biological
category. Color may have very real social significance, in other words,
but it is not the same as demographic epidemiology.
It is one thing to acknowledge that people from certain regions of
Central Europe may have a predisposition to Tay-Sachs, particularly
Ashkenazi (but not Sephardic or Middle Eastern) Jews. This is a reality
that reflects extended kinship resulting from geographic or social
isolation, not racial difference. It reflects a difference at the
mitochondrial level, yes, but certainly not a difference that can be
detected by looking at someone when they come into the examining room.
For that matter, the very term "Caucasian"--at least as Americans use
it, i.e., to mean "white"--is ridiculously unscientific. Any given one
of Dr. Satel's "Asian" patients could probably more reliably claim
affinity with the peoples of the Caucasus mountains than the English-,
Irish- and Scandinavian-descended population of which the gene pool of
"white" Americans is largely composed. In any event, a group's
predisposition to a given disease or lack of it can mislead in making
individual diagnoses--as a black friend of mine found out to his
detriment when his doctor put off doing a biopsy on a mole because
"blacks aren't prone to skin cancer."
To be fair, Dr. Satel admits that "a black American may have dark
skin--but her genes may well be a complex mix of ancestors from West
Africa, Europe and Asia." Still, she insists that racial profiling is of
use because "an imprecise clue is better than no clue at all." But let
us consider a parallel truth: A white American may have light skin, but
her genes may well be a complex mix of ancestors from West Africa,
Europe and Asia. Given the complexly libidinous history of the United
States of America, I worry that unless doctors take the time to talk to
their patients, to ask, to develop nuanced family histories or, if
circumstances warrant, to perform detailed genomic analyses, it would be
safer if they assumed that, as a matter of fact, they haven't a clue.
We live in a world where race is so buried in our language and habits of
thought that unconscious prejudgments too easily channel us into
empirical inconsistency; it is time we ceased allowing anyone, even
scientists, to rationalize that consistent inconsistency as
o, my momma called, "Why are they letting them gouge us like this?" she wanted to know. "They" are our so-called political leaders in Washington, and "them" are the drugmakers now costing her $500 a month. Nearing 87, Lillie Mabel Hightower has to take two medicines regularly, including a heart pill to keep the old ticker ticking. She tells me her pill bill goes up just about every time she refills her two prescriptions, having soared 40 percent in only two years. For someone on Social Security, the difference between $3,600 a year and $6,000 a year is a serious piece of change. "Of course I know why," she quickly added in answer to her own question: "It's the big money they give the politicians. But can't we do something? Who do I write?"
Like my mom's, the blood pressure of millions of seniors and others has reached the political boiling point because of price-gouging by big drug companies. Americans pay the highest prices in the world for prescriptions--an average of 30 percent more, for example, than Canadians pay for the exact same drugs. The companies jacked up our prices by another 17.1 percent last year while they went laughing to the bank with the highest profit margins of any industry, more than triple the average of all Fortune 500 corporations.
Political consultants in Washington recognize the explosiveness of this issue, so there has been a flurry of bills, press conferences and photo-ops by both parties, with each claiming that it cares more than the other about the problem. But, as Hemingway once advised, never mistake motion for action. No lobbying group is as well financed and well connected as the drug industry is in our capital city. It has 625 registered lobbyists on its payroll--ninety more lobbyists than there are members of Congress! The industry also liberally greases the skids of the legislative process with huge campaign donations, topping $26 million in the last election cycle. The result is that Washington postures, drug prices keep going up and seniors continue to seethe.
Still, my mother asks, "Can't we do something?" Yes.
Look to the states where citizens' groups have teamed up with legislative leaders who not only are in motion but have taken action. While Washington fiddles and faddles, twenty-six states now have some sort of program to cut drug costs, at least for the low-income elderly, and several are leading the way toward programs to take the gouge out of prescription prices for everyone.
Chellie Pingree led the charge in Maine. A small businesswoman, she was elected to the State Senate, where she took up the cause of seniors being pounded by drug prices so high that some were forced to choose between paying for essential medications or the heating bill. With the leadership of grassroots groups like the Maine People's Alliance, Consumers for Affordable Health Care and the Maine State Council of Senior Citizens, she led busloads of seniors on well-publicized trips across the Canadian border to buy their medicines; on just one trip, twenty-five seniors got prescriptions filled for $16,000 less than in the United States. Why should people have to take a six-hour bus ride to get fair prices, she asked? She answered by sponsoring the Fairer Prescription Drug Prices Act, which empowered a state pricing board to set retail prices in Maine.
Pingree's bill allowed seniors to go into any pharmacy in Maine and get the prescriptions they need at the same discounted price that Canada's government negotiates with drugmakers for its citizens. Her bill was simple, comprehensive, nonbureaucratic, effective...and it drove the big drugmakers bonkers. They dispatched their own buses to Augusta, loaded with lobbyists and money, in a frantic effort to kill the bill. In a blitz of TV and newspaper ads, the industry labeled the bill "a crazy idea" that would force the drug industry to abandon Maine. But the grassroots groups went to work, and Pingree, by now the Senate majority leader, took her bill directly to the people, holding public meetings from Madawaska to Biddeford. On April 12, 2000, her bill passed in both houses of the legislature by veto-proof margins, and the governor signed it.
Of course, the industry immediately hitched up a twenty-mule team of lawyers and rushed to federal court, but Maine's price-control law has been upheld all the way through the appeals court level and now awaits judgment at the US Supreme Court. Meanwhile, twenty-three other states, from Arizona to Wisconsin, are considering Maine's fair-pricing law, and public pressure from people like my momma is turning up the heat for national legislation.
Pingree, who is now running for the US Senate, has put the issue at the center of her campaign, vowing to bring the populist coalition behind the Maine Solution into play nationally. "There's such a disconnect between Washington and people's reality," she says. "This is more than an issue to people, it's personal outrage. Walk into any room, and it doesn't matter if the people are in overalls or suits; they've all got a story."
USAction, a network of state and local citizens' coalitions, has been a leader in developing the state proposals, and it's now working with other groups to move this public grievance from the low, slow backburner of Congress to the forefront of the progressive agenda (202-624-1730 or www.usaction.org). "This is a case where the people are miles ahead of the politicians," points out USAction's executive director, Jeff Blum, urging that progressives in Congress put forth a "fair pricing" plan that would give every senior the lowest price available on every drug. The key is not merely to provide universal coverage but to connect this to effective controls over the industry's ripoff prices. US citizens should pay no more than the average price that the drugmakers charge foreign customers in Canada, Japan, Italy and elsewhere.
If Congressional Democrats have a strategic bone left in their bodies, they'll grab this proposal and run with it, for the Lillie Mabel Hightowers are desperately looking for someone who'll stand with them against the drug profiteers. As pollster Celinda Lake reports, "This is the most powerful and intense issue of the 2002 elections, and Democrats should take the lead." If the party won't even stand up for our mommas, who'll stand up for the party?
Odds are good that on a plane or boat or bus somewhere in the world sits a refugee headed for the United States carrying the seeds of a weapon of mass destruction. The agent he unwittingly carries is insidious and lethal but slow acting, so the deaths it causes can come months or even years after it is disseminated in the population. It has the potential to overwhelm, to kill thousands, and there may be no vaccine, antidote or cure.
What is this ominous threat? An ingenious new biological weapon? No, it is a very old nemesis of humankind--tuberculosis, an infectious disease that kills more than 2 million people every year. Because the majority of them are poor and outside our borders, we don't hear much about them, but that may soon change. Tuberculosis is making a comeback and is conquering the treatments that have kept this killer at bay in the developed world. Multidrug-resistant tuberculosis--a death sentence in most developing countries--is becoming more common and is incurable in about half the cases, even in the United States.
Two numbers in the President's budget proposal stand in stark contrast to each other: $6 billion to fight bioterrorism versus $200 million to the Global Fund to Fight AIDS, Tuberculosis and Malaria. That works out to a little more than $1 billion per US anthrax death last year, as compared with $33 per global victim of the more common infectious scourges in 2001.
Re-emerging infectious diseases like malaria, HIV and tuberculosis continue their inexorable march, devastating poor countries in Africa, Asia and South America and ultimately threatening the richest countries. Either we are all protected or we are all at risk. It would be better to recognize that the developed world's inaction and callousness have allowed epidemics to flourish in the fertile soil of poverty, malnutrition and poor living conditions made worse by wars, internal displacements, repressive regimes, refugee crises, economic sanctions and huge debt payments that require poor countries to cut public services.
If we can possibly be unmoved by the staggering numbers affected by the AIDS pandemic alone (3 million dead in 2001, more than 40 million people living with HIV, 28 million of them in Africa), then perhaps we will be moved by fear. Of the world's 6 billion inhabitants, 2 billion are infected with latent tuberculosis. With adequate treatment, TB is 90 percent curable, yet only a fraction of those with the disease have access to this simple technology: a course of medications costing only $10 to $20 per patient. As a result, tuberculosis is now the world's second leading infectious killer after AIDS. Resistant tuberculosis, the result of inadequate treatment, is spreading at alarming rates in poor countries and in urban centers of rich countries. According to the World Health Organization, an eight-hour plane flight with an infected person is enough to risk getting TB.
Of all the rich countries, the United States has its head buried most deeply in the sand. It is the stingiest, spending only one cent on foreign aid for every $10 of GNP. Only $1 in $20 of the aid budget goes to health. A recent WHO report estimated that spending by industrialized countries of just 0.1 percent more of their GNPs on health aid would save 8 million lives, realize up to $500 billion a year via the economic benefits of improved health and help those in poor countries escape illness and poverty.
George W. Bush's recent pledge to increase foreign aid comes too late and with too many strings attached. The proposal doesn't start until 2004, making it largely hypothetical. The current budget keeps spending flat at about $11.6 billion. Even with the promised increase, US spending on foreign aid as a proportion of GNP will still pale in comparison with that of other developed nations. And along with this carrot comes a big stick: Only countries that continue to let corporations raid their economies through detrimental free-trade policies will be eligible.
Bioterrorism is a danger that should be taken seriously, but the current counterterrorism frenzy threatens to militarize the public health system, draining resources away from the research, surveillance systems and treatments needed for existing health problems. Already the political war profiteers have criticized the CDC's funding priorities, using the terrorist threat as cover in an attempt to advance their reactionary agenda. In a letter this past November to Health and Human Services Secretary Tommy Thompson, Republican Representatives Joseph Pitts, John Shadegg and Christopher Smith criticized the CDC for "inappropriate" actions. The Congressmen wrote that "we have grown increasingly concerned about some of the activities that the CDC is funding and promoting--activities that are highly controversial in nature, and funding that could be better used for our War on Terrorism." They specifically objected to AIDS prevention programs targeted at gay men and to a CDC website link to a conference sponsored by organizations promoting reproductive health, including abortions, for women. Bush was happy to oblige by cutting $340 million from the CDC's nonbioterrorism budget.
Just as a missile shield will not protect us from crazed men with box cutters, so mass vaccination campaigns and huge stockpiles of antibiotics will not keep us healthy in an increasingly unhealthy world. September 11 should make us more aware than ever of our shared vulnerability. Making the world safer and healthier means prevention and early treatment of disease, inside and outside our borders. It means building a healthcare system designed to keep people healthy instead of spending billions on bogymen while the real killers are on our doorstep.
Drug companies influence research; they also affect what gets published.