Copyright 2000 The New York Times Company
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July 9, 2000, Sunday, Late Edition - Final
SECTION: Section 1; Page 8; Column
1; Foreign Desk
LENGTH: 2749 words
HEADLINE: MEDICINE MERCHANTS: Patents and Patients;
As Devastating Epidemics Increase, Nations Take On Drug Companies
BYLINE: By DONALD G. McNEIL Jr.
DATELINE: ONGATA RONGAI, Kenya
BODY:
Until recently, Robert Nyantika, 30, was a
strong, straight-backed police officer fighting "shifters" -- guerrillas and
cattle thieves who make cross-border raids from Somalia. Now he is a stooped
wraith unable to focus his eyes, bathe himself or walk without help. Speaking in
a voice somewhere between a whisper and a song, he says his best memory is that
his unit never left its wounded behind.
His elder brother, Omari, has
the same philosophy. When he heard that Robert was deathly ill in a faraway
clinic, he brought him home, already gravely thin from
AIDS-related tuberculosis and diarrhea. Overworked doctors at a
public Nairobi hospital were too busy or indifferent to examine Robert for a
week, but Omari, a home health worker in a Nairobi slum, realized what was
happening: Robert had the crippling headaches and stiff neck of cryptococcal
meningitis, an AIDS complication that would blind and then kill
him within two weeks.
The cure is fluconazole, a drug patented in most
of the world by Pfizer, Inc. and commonly prescribed in America as a one-pill
cure for women's yeast infections.
In Kenya, it costs $18 per pill, a
price paid by the tiny number who can afford Nairobi's one private hospital and
escape the vagaries of a national health budget that averages $5 per citizen per
year. To live, Robert would need two pills a day for 8 weeks -- cost $1,080 --
and then one a day for the rest of his life -- $540 a month. His monthly
earnings as a police officer were $43.
Robert's cure became a tiny part
of the titanic struggle going on between pharmaceutical companies and public
health advocates over the cost of drugs like fluconazole and who has the right
to produce and market them.
A cheaper generic version of the drug was
available and made legally in Thailand, which along with South
Africa has challenged the drug companies' monopoly on their
most successful products. This, they say, is the only way to save lives from the
AIDS epidemic. The Thai generic, which costs only 60 cents a
pill, could not be brought legally to Kenya, which like many other third world
countries is only now considering whether to follow the Thai and South African
challenge to the world's pharmaceutical giants.
But Omari knew a nurse
at a foreign aid agency where doctors furious at Pfizer's
pricing policy were illegally smuggling the Thai drug into Kenya. They had
enough to save two lives. Robert's became one.
In April, when Robert
began taking the pills, he was too weak to lift his hand to his mouth, but he
still had courage, Omari said.
"He recognizes how expensive the drugs
are, and if he vomits, he throws that away," Omari said. "So he really clings
on. He fights to contain them."
By mid-June, Robert was alive and home
in this Nairobi suburb where goats graze beside row houses and turkeys stalk up
and down the dirt roads. He had survived a bout of malaria and was still
skeletal, but he could feed himself, sit up and walk with help. Asked where he
most wanted to go, he answered: "Back to my place of work." Omari, who still
helps bathe him, is slowly breaking it to Robert that this is unlikely. He is
proud that his care, connections and good luck have bought his brother a few
more months, perhaps even a few more years of life.
Setting
Prices
Big Differences And Big Profits
Fluconazole, the best
anti-fungal agent invented by modern science, is equally effective against
toenail fungus, children's oral thrush and cryptococcal meningitis. It is too
miraculous for the poor to live without and too profitable for Pfizer to give
up.
Two competing forces have intensified the battle over drugs like
fluconazole: the 1994 world treaty on intellectual property that underpins free
trade and the AIDS epidemic of the 1990's, which is devastating
whole continents too poor to pay the going rate for patented drugs.
The
public health advocates and an increasing number of third world countries say
the 1994 treaty allows them to manufacture or import much cheaper generic drugs
to avert national disaster; the drug companies argue that the costs of
developing drugs are so high that they cannot afford lower prices for the few
that become wildly successful.
Pfizer first patented fluconazole in 1982
under the name Diflucan, and it will remain patented until 2004 in the United
States and longer elsewhere. It is one of many drugs that put the drug companies
in an awkward position: They earn their largest profits when they are prescribed
for routine problems of wealthy Americans and Europeans, but they could save
millions of the very poor if available and affordable.
To protect
valuable patents, the industry has used a whole array of tactics, from
aggressive lobbying to generous giveaways of millions of doses.
Cryptococcal meningitis attacks about 9 percent of all people with
AIDS. In some countries, like Thailand, it attacks more than 20
percent. Untreated, the victims die in less than a month.
The wholesale
prices of pills are set to recoup the costs of research, which the industry says
is about $500 million per new drug, to pay for marketing, lobbying and other
overhead, and to earn the huge returns that make the pharmaceutical industry
among the world's most profitable.
Pfizer sells roughly $1 billion worth
of fluconazole a year.
Its wholesale prices vary widely around the
globe. A 1999 study by the Nobel Prize-winning agency Doctors Without Borders
found them ranging from $3.60 a pill in Thailand to over $27 in Guatemala, with
about a $10 average. Pfizer did not dispute the average, but said the range is
smaller, from $5 in Thailand to $11 in France. The wholesale price is $6.38 in
South Africa, $8.52 in Kenya and $9.78 in the United States.
With retail markups, the drug may sell for $40 a pill.
In countries that
do not honor American patents, the same drug is made by generics manufacturers.
Cipla, a major Indian drug company, offers it for 64 cents a pill; Madawa
Pharmaceuticals of Bangladesh for 41 cents, three Thai companies for between 30
and 70 cents.
Pfizer has other phenomenally profitable drugs: Lipitor,
which cuts cholesterol, Zoloft for depression and, of course, Viagra. Because it
is so wealthy, and yet keeps fluconazole prices high, Pfizer's critics call it a
pitiless corporation that lets people die rather than cut prices or relinquish
patents.
"Everyone -- senior citizens, AIDS activists
-- always accuses us of being profiteers," said Brian McGlynn, chief spokesman
for Pfizer. "And they say we'd rather give a rich white guy an erection than
help an African with AIDS.
"But we invest $4.7 billion
in research each year, and 3 out of 10 medicines never make back their
investment. And, yes, we spend a lot of money on advertising and marketing. But
we don't sell soda pop. It's an enormous transfer of knowledge from our lab
scientists to doctors, through those sales reps."
South
Africa has the world's fastest-growing AIDS
epidemic. In April, on the day that AIDS activists, unions and
religious groups were set to begin a lawsuit and picketing campaign denouncing
the company as an AIDS profiteer, Pfizer announced that it
would supply the drug free to any South African with AIDS who
could not afford it.
If the company expected thanks, it got almost none.
Act Up, the American AIDS activism group, tried to
storm Pfizer's annual meeting. By June, Doctors Without Borders, which is
campaigning for cheaper drugs, was accusing Pfizer of reneging on its promise.
It said the company had imposed a time limit on its donation and required
doctors to report back as if in a clinical trial.
Seeking
Solutions
As Disease Spreads, More Nations Act
Pfizer denied
this, saying the company will supply the drug free for life to every South
African whose doctor says he cannot afford it, and that doctors have to report
only whether their patients still take the pills and are still alive. The first
free pills will not be distributed before fall at the earliest.
In
Kenya, at a meeting in June on drug prices, officials from several African
countries wondered aloud why they could not get the same deal. Dr. Jack Watters,
Pfizer's medical director for Africa, said the giveaway might
eventually be extended to the rest of Africa. He had already
spoken with the Kenyan health authorities, he said.
"If we can make it a
success anywhere, we can in South Africa, because they have the
best infrastructure," he said. Asked what the company's limit for charity was,
he said, "I really don't know the answer.
"I tell the C.E.O.: 'We have
100,000 patients, they need 200 milligram pills, we don't know how long they'll
live . . .' It's impossible math to do. We're not planning to stop the program,
we're planning to look at it after two years."
The profits on
fluconazole and other drugs allow Pfizer to give away $120 million worth of free
drugs a year, including millions of free doses of its best-selling antibiotic,
Zithromax, to cure eye infections in central Africa and to
treat venereal disease among southern African prostitutes and mineworkers, who
are central to the spread of AIDS.
However, many third
world countries believe they cannot wait until the big pharmaceutical companies
grant them charity.
At the June conference here, held some weeks after
he had spoken to Dr. Watters, Kenya's health minister, Amukowa Anangwe, attacked
profiteering, referring specifically to fluconazole. He said afterward that
Kenya's Parliament was ready to pass a law allowing him to declare a health
emergency when an important drug is unavailable at reasonable prices. The bill
would empower him to void the drug's patent in Kenya. He could then either
import cheap generic versions or use the threat to get Pfizer to lower its
price.
More and more countries are contemplating or pursuing this path,
taken already by South Africa and Thailand.
Until the
1990's, Thai law did not allow medicines to be patented. But the country signed
the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights,
which covers all sorts of goods. Signers become members of the World Trade
Organization, an important goal for Thailand, which depends heavily on exports.
But one million Thais are infected with the AIDS virus,
and high-priced medicines, fluconazole included, were eating up the health
budget. The intellectual property laws Thailand generally defended started
working against life expectancy.
Setting U.S. Role
Once
Firms' Protector But Changing Course
Because fluconazole was on the
market before the law changed, it was unpatentable. But under American pressure,
Thailand had created a program that conferred the same market exclusivity.
Pfizer put fluconazole in it and charged $7 a capsule. When the exclusivity
expired in 1998, three Thai companies began to make cheap generic fluconazole.
Pfizer promptly dropped its price sharply in Thailand. Thai law allows the
health minister to declare an emergency and seize a drug patent. In patent law,
it is known as "compulsory licensing" -- a company is compelled
to license its secrets to a rival.
In practice, Dr. Korn Dabbarensi,
Thailand's health minister, said in an interview, seizing a patent is usually
too much legal bother; the mere threat normally gets a company to lower its
prices.
"Even though we're able to go ahead with compulsory
licensing, we've been informed by the Ministry of Trade that we have to
use W.T.O. procedures," Dr. Dabbarensi said. "So we go talk directly to the drug
companies in a 'humane' manner. Just one-to-one talking. But the bottom line for
me is -- how 'humane' are these manufacturers? They are talking to me about the
profits of their company against the lives of my people."
The 1994
global trade treaty specifically permits governments to use compulsory
licensing -- not just for drugs, but for any safeguards against crises
in public safety, war, health or environmental disasters. Such exceptions apply
only to cure domestic emergency, and some royalty must be paid to the patent
holder.
The Western pharmaceutical industry opposes compulsory
licensing, and another practice known as "parallel importing," which
let a country's drug buyers seek the cheapest price anywhere in the world. Until
recently, the drug companies' most powerful ally was the United States
government.
The United States is a signatory to the 1994 protection of
copyright worldwide, and has pressed other countries to pass patent and
copyright laws more restrictive than its own to protect American corporations
against foreign piracy.
In 1997, when South Africa
tried to pass a law allowing the health minister to ignore the Patents Act in
health crises, the United States lobbied hard against it. President Clinton
raised the issue with President Nelson Mandela, the Commerce Department put
South Africa on a watch list that is the first step toward
trade sanctions, and a bill went through Congress making all American
aid to South Africa contingent on dropping the
law.
The South African pharmaceutical industry, which included
subsidiaries of American and European companies, took the pressure much further.
It closed factories, canceled investments and took out scare ads suggesting that
babies could be hurt by counterfeit generic drugs. Its chief lobbyist, Mirryena
Deeb, threatened to cut off all new drug discoveries to South
Africa if the law passed, including AIDS
drugs, cancer drugs and antibiotics. Asked in a March 1998 interview if she was
literally threatening to let thousands of South Africans die, she reluctantly
conceded: "In so many words, yes."
The practices that the United States
and the industry were fighting so hard were legal not only under the 1994
treaty, but also under the laws of Western countries like France and Britain.
The United States, too, is a big user of compulsory
licensing, said Carlos M. Correa, an internationally recognized patent
law expert with the University of Buenos Aires. It is a common remedy in
antitrust cases and was recently considered in the Microsoft case (it would have
forced the company to license its Windows source code to rivals).
America's change of course came rather abruptly last year.
In
early 1999, the Clinton administration was still squarely against South
Africa's Medicines Control Act.
By December, the
administration said it would not object if South Africa
violated American law in seeking AIDS medications, as long as
it abided by World Trade Organization rules. Within months, it had offered the
same olive branch to the rest of Africa and to Thailand.
The catalyst was, apparently, a decision by the Philadelphia branch of
Act Up, the gay advocacy group, to take up South Africa's cause
and start heckling Vice President Al Gore, who was in the midst of his primary
campaign for the presidency. The banners saying that Mr. Gore was letting
Africans die to please American pharmaceutical companies left his campaign
chagrined. After media and campaign staff looked into the matter, the
administration did an about-face.
Without cheaper drugs, public health
advocates say, the problems of doctors like Christopher Ouma, who works in a
Nairobi public hospital where nearly 70 percent of patients have
AIDS, will never be solved.
He recently listed drugs
his hospital can never afford in sufficient quantity: Vitamins. Morphine.
Warfarin for blood clots in the bedridden. Acyclovir for blinding shingles. Any
anti-retrovirals, including the oldest, AZT. And, of course, fluconazole.
The chief killers of his AIDS patients, he said, are
tuberculosis, diarrhea, pneumonia and cryptococcal meningitis. The first three
are usually treatable. With the last, he said, "we run up against a wall"
because of the price of fluconazole.
These patients are instantly
recognizable, he says, because they moan all day. No painkiller but morphine
works for them, and it is rationed.
"They get no peace," Dr. Ouma said.
"With the intense pressure on the brain, some go blind. Most just go into a coma
and die, and by then they are in such pain that it's really a blessing."
As soon as he diagnoses cryptococcal meningitis in a patient, he says,
he dispenses advice he hates: If they want to be buried in their ancestral
village, as most Kenyans do, they should board a bus. They have only two or
three weeks to live, and the cost of refrigerated trucks ruins many families.
"Can you imagine, as a doctor, having this conversation with your
patient?" he said. "I have it once a week."
http://www.nytimes.com
GRAPHIC: Photos: Thanks
to family connections, charity and luck, Robert Nyantika, below, was able to get
a drug he could not afford to counter the effects of cryptococcal meningitis.
Because of the drug, which is unavailable to most Africans and others in third
world countries because of its cost, he has been able to return home to a
Nairobi suburb, where he is cared for by family members, including his sister,
Gladys, above, and has improved. How long he will be allowed to receive the
treatment remains unclear. (Lori Waselchuk for The New York Times); (Tyler
Hicks/Liaison, for The New York Times)
Map of Kenya shows the
location of Ongata Rongai: In Ongata Rongai, Kenya, medicine is a luxury few can
afford.
LOAD-DATE: July 9, 2000
