-Caveat Lector-
Reprinted from NewsMax.com
Investigative Report: Cipro, Part 1 – What You Don't Know Can Hurt
You
Kevin Curran, NewsMax.com
Thursday, Nov. 29, 2001
It is a simple medical equation: Anthrax exposure + Cipro = cure. Or
does it?
A NewsMax.com investigation of the reaction to the recent anthrax
episodes has found the pursuit of a treatment has opened the door for
misinformation, confusion and the protection of a major
pharmaceutical company.
Since the initial attacks, health officials have approved other drugs
for post-exposure anthrax treatment and are testing still more. These
alternate antibiotics come with their own complicating factors.
The future of anthrax treatment is murky. Federal officials, health
experts and drug companies continue to search for better methods of
handling patients exposed to anthrax.
The problems of the military's anthrax vaccine program are being
revisited. Other methods to prevent or treat anthrax are also being
tested, sometimes with bad results.
What American citizens are watching amounts to a large science
experiment, but the laboratories could be anywhere, including New
York's subway system and a small Connecticut hospital, and the guinea
pigs are human beings facing a disease virtually unknown in the
general medical community before October.
Cipro Not Benign
As anthrax fears spread, health officials initially recommended that
people with potential exposure begin taking the antibiotic known as
Cipro for 60 days.
Cipro is the trademark for ciprofloxacin hydrochloride, a drug first
approved by the FDA in 1987. It is manufactured by Bayer and was the
only drug with a specific FDA approval for treatment of post-exposure
anthrax.
As more exposures were reported, thousands rushed to their
physicians, seeking prescriptions for Cipro. Others bypassed the
normal methods and tried obtaining the drug through other sources,
including foreign pharmacies.
Now that treatments are under way, those same health officials who
recommended Cipro are receiving reports of its dark side and are
finding other drugs that may be just as effective in treating
anthrax, at a much lower cost.
The FDA's Center for Drug Education and Research warns patients that
Cipro's side effects can include disorders of the central nervous
system like dizziness, confusion and depression. It can also prompt
an allergic reaction such as breathing difficulties, swelling or
hives. Other side effects include pain, inflammation or ruptures of
tendons, colon tissue inflammation or increased sensitivity of skin
to sunlight.
Cipro is part of a group of antibiotics known as fluoroquinolones.
Other drugs in this group include levofloxacin, marketed as Levaquin,
lomefloxacin and ofloxacin.
"That drug absolutely ruined my life," said Linda Baldwin, 61, of
Oxnard, Calif. "It makes me heartsick watching people on TV grabbing
up Cipro," she told the Los Angeles Times Oct. 29, "when they're not
even sick and letting themselves in for so many adverse reactions
that their doctors may not even recognize."
Baldwin was given Cipro and another fluoroquinolone for a urinary
tract infection in 1996. She claims the drugs prevent her from
working and enjoying her grandchildren as she deals with blurred
vision, muscle pain and other side effects.
Author Stephen Fried knows first-hand the debilitating effects of
fluoroquinolones. In his 1998 book, "Bitter Pill: Inside the
Hazardous World of Legal Drugs," he discussed his wife's battle
against the effects of a single antibiotic tablet she took in 1992
for a urinary tract infection.
Fried says she was so delirious six hours after taking the pill that
she had to be taken to an emergency room. For nine years, she has
been treated for a manic-depressive illness.
Some postal workers are also wondering about the wisdom of passing
out Cipro. John Ford, 66, is a representative of the postal workers
union who frequently visited the Brentwood mail facility in
Washington, D.C.
Ford told USA Today Oct. 31 that he developed nausea, vomiting and
cramps after taking the antibiotic. "Being a reasonable person, I
thought I'd rather have this than anthrax," said Ford.
He added that side effects have required hospitalization for two of
his union members and sent a third to an emergency room.
In Florida, reports of Cipro's side effects prompted state officials
to establish a 24-hour hotline to gather information and provide
guidance. State epidemiologist Steven Wiersma told the Miami Herald
Nov. 3 that "these drugs have some pretty severe side effects, and
they shouldn't be taken lightly."
After the anthrax exposure at American Media in Boca Raton, Fla., 970
people were given 60-day Cipro prescriptions. Eighty percent of them
were still taking the drug two weeks later.
Of those, 95 patients reported itching, breathing problems, or
swelling of the face, neck or throat, or had sought medical attention
for adverse side effects. Six of them stopped taking Cipro after
going to a doctor's office or emergency room, or in two cases,
requiring hospitalization.
"The adverse events that people are reporting in Florida are no
different than what we've typically seen," CDC deputy director Julie
Gerberding told the Los Angeles Times Nov. 9.
Dr. Gerberding does not agree with those who think antibiotics have
been over-prescribed. "[W]hen we have the immediate event where
there's a case of anthrax, or a powdered envelope that proves to be
anthrax, we cannot immediately ascertain who's at risk for exposure."
Physicians Respond
At the American College of Physicians, president William Hall is also
not surprised by reports of adverse reactions. "It's not a question
of if, but when, people are going to get side effects from a broad-
spectrum antibiotic."
Hall will be carefully watching reports of these anthrax prevention
treatments. "We need to really understand what's the implication of
putting thousands of people on an antibiotic for two months. There's
never been an experience like this in the world. We have no idea what
to expect from this."
Another doctor with his eyes on the treatment is Jay Cohen, a
professor at the University of California, San Diego. Cohen recently
completed a study on the side effects of fluoroquinolones that was
supposed to be published in the December issue of The Annals of
Pharmacotherapy.
The sudden interest in these drugs prompted the journal's editors to
post the study's results on its Web site in advance of publication.
Cohen found that patients who have side effects from Cipro and its
related drugs find out quickly: 58 percent of those in his study
reported adverse events within 72 hours of taking the drug.
These effects tend to linger: 80 percent of the patients reported
severe discomfort or limited functions that lasted more than two
months. Cohen reported following one case that has lasted six years.
Not only do the effects tend to linger, they also are hard on the
patients. Only 20 percent of the patients reported mild or moderate
symptoms; 80 percent of them said the symptoms were severe.
Perhaps the most striking result of Cohen's research was the
resistance of some physicians to recognize side effects as side
effects.
Prescribing doctors "have difficulty admitting it," Cohen told
NewsMax.com. "When they see patients with side effects, they think
they are something else. The doctors are not comprehending there
could be multiple effects from one drug."
Cohen said patients rushing to their doctors for a prescription must
understand that "Cipro is not benign."
Furthermore, Cipro is the strongest broad-based antibiotic available
and Cohen felt its use should be reserved for resistant strains of
anthrax.
Cohen was happy to see the growing use of doxycycline as a post-
exposure treatment. Doxycycline is another broad-spectrum antibiotic,
but is not a member of the fluoroquinolone family. "Most doctors
think doxycycline is the way to go," Cohen said, "since it is safer
and better known."
In the immediate aftermath of the anthrax outbreaks, some people
became instant doctors. "I've been trying to hold back my own friends
and relatives who are trying to get this stuff," Dr. Stephen Baum of
New York's Beth Israel Medical Center told CBS News Oct. 26.
Prescriptions for Cipro almost tripled in the New York area, despite
requests from doctors and health officials that patients not create
personal stockpiles.
Continued tomorrow in Cipro, Part 2
Reprinted from NewsMax.com
Investigative Report: Cipro, Part 2 – A Monopoly at Any Cost
Kevin Curran, NewsMax.com
Friday, Nov. 30, 2001
Editor's note: This is part two in a series. Read part one, Cipro –
What You Don't Know Can Hurt You.
While health officials did not want Cipro in everyone's medicine
cabinet, they certainly wanted it in their warehouses. In the days
after the first anthrax attacks, Cipro became the mantra for
bureaucrats looking for a way to reassure a nervous public that
treatment was available.
With just one drug having FDA approval as a post-exposure anthrax
treatment, the U.S. government was forced to negotiate with its
manufacturer, Bayer, to obtain large quantities of Cipro.
Health and Human Services Secretary Tommy Thompson warned Bayer
executives to determine a reasonable price for the pills or he would
void their company's patent on the antibiotic. That would have
permitted another company to manufacture a generic version of the
drug.
On Oct. 24, one day after Thompson's threat, the secretary joined
Bayer President Helge Wehmeier in announcing an agreement to buy 100
million Cipro tablets for federal stockpiles. The contract included
options for 200 million additional pills if needed. Under the deal,
HHS agreed to pay 95 cents a tablet for the first 100 million, 85
cents each for the second million and 75 cents each for the last.
Before the contract, HHS paid $1.77 a pill for Cipro.
Sensing the growing pressure on doctors, the secretary added a
warning: "Widespread, unnecessary use of antibiotics can only do
harm. Antibiotics can have side effects, including a few serious side
effects in the case of the more powerful products. ... These are
important and powerful health products that need to be prescribed by
a physician."
It came as no surprise that Wehmeier was pleased with the agreement.
"Cipro has become the standard for anthrax treatment," he said at the
joint appearance with Thompson. "The men and women of Bayer are 100
percent committed to delivering this vital antibiotic to the U.S.
government on schedule."
Wehmeier and Bayer have a lot at stake in Cipro remaining the
"standard for anthrax treatment." Because the Cipro patent remains in
place, consumers do not have the option of finding a less expensive
version of the drug.
Bayer's patent on Cipro will not expire until 2003. Until then, Bayer
has a monopoly on the production and sale of ciprofloxacin
hydrochloride. Drug manufacturers are granted patent protection as a
way to help them recover their investment in research and
development.
Yet long before the anthrax scare, Bayer was facing lawsuits against
its patent on Cipro.
The consumer lawsuits under antitrust statutes in federal and state
courts claim Bayer has been paying off a generic manufacturer to
maintain their monopoly on Cipro.
In 1997, Bayer reached an out-of-court settlement with drug maker
Barr Laboratories to head off production of a generic version of
Cipro. The agreement called for Bayer to pay Barr and another company
almost $25 million to abandon their plan. Bayer has reportedly
continued to pay each company $25 million annually. Plaintiffs'
attorneys claim the deal both raised the cost of Cipro and limited
its supply on the market.
Payoff
"If Bayer hadn't paid off the generic manufacturer," lawyer Michael
Nast told the Financial Times on Oct. 26, "this [shortage] wouldn't
have happened." Nast said Bayer is operating under a section of
federal law that allows the original maker of a drug to stop the
production of generics by reaching an agreement with the first
company to challenge the patent.
A Federal Trade Commission investigation of the Bayer-Barr deal has
been under way for almost three years, but no charges have been
filed.
While the Barr challenge to Bayer precedes the anthrax scare, the
desire to obtain Cipro at a lower cost resulted in an embarrassing
situation for a senior Canadian official.
Health Minister Allan Rock at first claimed Bayer could not provide
all of the medicine he wanted for Canada's anti-anthrax inventory.
Rock placed an order with a Toronto manufacturer to produce 1 million
tablets of a generic version of the drug, despite Bayer's Canadian
patent.
Maclean's magazine reported Nov. 5 that Bayer threatened to take the
Ottawa government to court. In the end, Bayer agreed to supply the
Canadians all the Cipro they deem necessary. The Health Ministry will
pay the same price as the American HHS for the drugs. Bayer will get,
and likely destroy, any generic pills made while the dispute was
settled.
Special Treatment
U.S. authorities have also moved to protect Bayer by blocking one
common method used to obtain drugs at a lower cost. Walk across the
southwestern border into Mexico and one is bombarded by signs that
read "farmacia." Many Americans with chronic conditions obtain their
drugs from Mexican pharmacies for much less than they pay in the U.S.
But not Cipro.
On Nov. 19, a crew from KGUN-TV in Tucson traveled to Nogales,
Sonora, and obtained Cipro without a prescription from three
different pharmacies. They paid from 34 cents to $1.25 a pill. When
they returned to Nogales, Ariz., and declared they were transporting
the drug, U.S. Customs inspectors told them the pills could not enter
the country.
KGUN's Jim Osman told NewsMax.com that the port director had received
word from the FDA that Cipro was not to be taken across the border,
whether or not the patient had a U.S. prescription.
The Food and Drug Administration issued that order Nov. 14. According
to the FDA's Center for Drug Evaluation and Research, "since an
approved version of Cipro is available in the U.S., personal
importation of any unapproved version is not permitted. … FDA cannot
assure that Cipro purchased abroad is safe, effective and not a
counterfeit product."
Continued in Cipro, Part Three
> Continued tomorrow
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