Re: ~*Online WACOC News 2007 July 21*~







Women and Children of CFIDS + Men
WACOC + M

~*A comment or two*~

Happy Summer!

Welcome to all new readers and to those just catching up...

A message from FM CFIDS patient Nancy Kaiser

Part ll

HEM's was the first major double-blind clinical trial in CFS, meaning
that neither patients nor doctors knew who was getting the drug,
although a few patients later noted that clues emerged as the weeks
passed. Ampligen had a fairly distinct scent; harder to ignore was the
fact that approximately half the patients in the trial began to
improve markedly during the first twelve to fourteen weeks and those
remaining began to deteriorate.

Carter declared it to be "a study of unprecedented scope," a statement
federal scientists could hardly deny. Irrespective of the drug's
efficacy, the expansive nature of the investigations had created an
abundance of hard scientific data about the disease. For instance,
there had emerged strong evidence that interleukin-1, a substance
manufactured by the immune system in response to viral infection,
might be a marker of disease severity. Patients who received Ampligen
experienced a reduction in interleukin-1 as well as a reduction in
symptoms. In addition, in 1994, Temple University School of Medicine
biochemist Robert Suhadolnik and other clinicians and scientists who
collaborated on the trial published a study reporting that the drug
ameliorated a defective antiviral pathway common to CFS patients.

*Robert J. Suhadolnik et al., "Changes in the 2-5A Synthetase/Rnase-L
Antiviral Pathway in a Controlled Clinical Trial with Poly(I)-
Poly(C12U) in Chronic Fatigue Syndrome," In Vivo 8 (1994): 599-604.
"Poly(I)-Poly(C12U) is the molecular name for Ampligen.

Before treatment with Ampligen, the molecular indicators for damage to
this pathway were "significantly elevated" compared to those of
controls. (This finding was yet another link between CFS and AIDS;
victims of AIDS suffered an identical defect.) After treatment, these
molecular indicators were vastly improved in CFS sufferers, as they
had been in AIDS patients after Ampligen treatment, and Suhadolnik and
his co-authors noted that they corresponded with "clinical and
neuropsychological improvements."

The drug itself was not without side effects, but its toxicity was
minor compared to that of the disease. Dan Peterson hospitalized an
Ampligen recipient in the Incline Village trial after the patient
developed spinal pain, heart palpitations, and elevated liver enzymes.
The patient, Cynthia Modica-Gaines, who had been a ballet teacher at
Sacramento State University when she had fallen ill five years
earlier, pleaded to be reinstated in the trial. When, after temporary
withdrawal from Ampligen, Modica-Gaines' liver enzymes returned to
normal, Peterson acquiesced, but kept her on a half dose. She suffered
no further ill effects. In fact, she improved significantly. None of
the patients at the other sites asked to stop the trial, nor did their
doctors deem the side effects sufficient to discontinue the therapy or
even reduce the dosage for any of their patients.

Still, there was little reason to believe, at this stage, that
Ampligen was a cure, that it was universally effective, or that its
beneficial effects were equal in all sufferers. Among patients in the
first open-label pilot study who had responded well to the drug, none
had been restored to a degree of health that had allowed them to
return to their jobs. Even more problematically, among those who were
taken off the drug temporarily, for whatever reason, the disease had
become significantly worse, suggesting that to derive benefit patients
needed to be maintained on Ampligen indefinitely and that withdrawal
from the drug could actually exacerbate symptoms.

Early in August, HEM officials shipped the data to analysts at the
Food and Drug Administration in Rockville, Maryland, enabling agency
investigators to begin their review. It was the first time FDA
scientists had focused on Ampligen as a treatment for CFS. The drug
agency, in turn, sent auditors to all four sites to study the methods
by which the data was collected and to certify that all patients had
met the criteria for inclusion. HEM had demanded that patients have a
Karnofsky score no higher than 60; as a result, virtually all of the
ninety-two patients in the trial were confined to bed or to a
wheelchair when the trial began.

Until his colleagues began to analyze the data from the four-city
trial, HEM chief and Ampligen co-inventor Carter's interest in the
disease had been minimal. Now his interest was keen. CFS caused
anatomical holes to develop in its victims' brains and lowered their
IQs, among other problems; his drug restored the sufferers' IQs and
returned them to some semblance of normal functioning.

During the week of August 19, Carter held a series of meetings with
FDA staff in an attempt to persuade the government to approve use of
the drug in an even larger trial with 350 patients lasting one year.
HEM was seeking a treatment IND -- shorthand for "treatment
investigational new drug" -- exemption, one of several ways drugs
could be fast-tracked into the American marketplace. To qualify, the
manufacturer had to have already conducted phase two clinical trials
using from ten to three hundred patients, and those trials had to have
provided powerful evidence of the drug's safety and efficacy. The
agency ruled in favor of treatment INDs in cases where the drug in
question seemed "promising" and the patients for whom the drug was
intended suffered from "a serious and life-threatening disease for
which no alternative therapies [were] available." Historically, drugs
exempted in this fashion went on to win the agency's approval.

Carter made his case for Ampligen on the basis of the severity of the
illness, citing brain damage and immune system dysfunction, and what
the company believed was the drug's demonstrated ability to moderate
the disease, based on the trials completed that summer.

The new trial, he told FDA officials, would be structured as a double-
blind crossover study that would relegate 100 percent of the patients
to at least six months of saline infusions as well as six months of
Ampligen infusions. There was a significant catch: the patients
themselves would be required to pay for the phenomenally expensive
infusion cost --- approximately $25,000 a year for each patient -- in
addition to the cost of the drug -- approximately $25,000 for a half
year's supply. Simultaneously, HEM executives were consulting with
Blue Cross/Blue Shield to learn whether the company might be willing
to pay for either the infusions or the drug during the trial.

"This is going to be the first controlled drug trial among 350
millionaires in this country," Paul Cheney wryly observed. "I have no
doubt," he added, "that there are at least 350 millionaires in this
country with this disease. It's a very smart move on HEM's part. I
can't think of a better way to put pressure on the Food and Drug
Administration. The FDA has created a situation where only the rich
can get treatment, and Americans aren't going to like that."

HEM executives were discussing, too, a less expensive oral form of the
drug, but they estimated a three-to-five year development period.
Everything -- the new trial, the development of an Ampligen pill, the
formal establishment of the drug as a bona fide CFS therapy -- hung
for the moment on the FDA's appraisal of the four-city trial,
however.

With the premature end of the trial, the forty-five victims of the
disease who had received the drug were cut adrift. Many of them had
been restored from total disability to a degree of ability that had
eluded them for years, and when the Ampligen was withdrawn, they
noticed their intellectual clarity and physical strength slipping
after as few as ten days. By the third and fourth week off the drug,
patient who had been confined to wheelchairs before they entered the
trial were returned to their wheelchairs; almost everyone was again
housebound. For these patients, who had been raised momentarily out of
their zombie existence, the slide back down was excruciating. One such
sufferer told a journalist, "It's like somebody turned on a light and
I could see, and then they turned it off again." (*Kitei, p. 104)
Another compared the rapid loss of intellectual acuity to that
described in Daniel Keyes's 1966 novel Flowers for Algernon, the story
of Charly, a severely retarded man who is given brain surgery that
temporarily raises his IQ to genius level. As the surgery's good
effect wears off and his IQ falls to its previously depressed state,
he watches in horror as the accoutrements of intelligence --
discourse, society, material comforts -- drift out of reach. CFS was
among the few brain diseases that left its victims witness to their
own intellectual deterioration; withdrawal of Ampligen caused them to
experience the anguish a second time.

*Patients who had suffered a different fate, that of having a saline
solution injected into their veins two to three times a week, were
hardly better off than their counterparts who had received Ampligen
but were now without it. During the trial, four of the patients in the
placebo arm of the study -- 8 percent -- attempted suicide. HEM later
reported that "a significant number of placebo patients clinically
deteriorated during the course of the clinical test." Floyd Skloot,
the novelist, had entered the trial in Oregon under infectious disease
specialist Mark Loveless's supervision. Although Skloot eventually
divined he was a placebo recipient -- ("I knew this the way I'm told a
woman knows she's pregnant") -- he decided to "just hang in there," in
spite of the collapsing veins in his arms, because of an assumption,
common to all participants in the trial, that HEM would provide the
drug to placebo recipients, just as the company had provided the drug
indefinitely to participants in the small open-label study in Incline
Village.

In Charlotte, one of Cheney's patients, a thirty-five-year-old former
civil engineer who had been an invalid since 1988, made violent
threats when he was denied additional infusions of the drug. Cheney
hired a plainclothes policeman to stand guard in his clinic for the
next three months. Other patients talked about suicide. "Every day
now," said one, "I can't remember the day before. When you were normal
just two weeks ago, it's really a blow to be this sick."

"I don't think people appreciate the desperateness of these patients,"
Cheney said later. "To have this drug pulled from you is to watch your
IQ fall by ten points a month."

p. 513 (1991)

According to one estimate, it took twelve years and $200 million, on
average, to bring a new drug from the chemist's laboratory to the
patient. (Valery Fahey, "Waiting in Line at the FDA," In Health,
September-October 1990, p. 55) Of every five thousand compounds
tested, only five made it through the scientific and legal maze to
Food and Drug Administration approval. On September 3 HEM
Pharmaceuticals tried to speed the process along when it made formal
application to the FDA for permission to supply Ampligen to CFS
sufferers under a treatment IND, a special exemption from the agency's
normally lengthy approval routine. The agency had exactly thirty days
to respond to the request.

In the meantime, HEM's scientific advisers and its president, William
Carter, continued their analysis of the data from the completed four-
city clinical trial. So convincing were the statistics that they
discussed the possibility of presenting a paper on the trials at the
Thirty-First Interscience Conference on Antimicrobial Agents and
Chemotherapy meeting in one month in Chicago. This annual meeting was
the largest North American gathering of microbiologists, clinicians,
pharmacologists, pathologists, and other specialists interested in
infectious diseases and new drugs to treat them. Submissions were to
have been made months in advance, but Carter wondered if the news
value of the trial and its findings might persuade the organizers to
add HEM's presentation to the schedule at the eleventh hour.

p. 520 1991

Few involved in the struggle to bring Ampligen into the marketplace
failed to appreciate the larger political issue that had emerged along
with the promising results of the clinical trial. One arm of the
nation's federal health establishment, the Food and Drug
Administration, was being asked to rule on the use of a potent
antiviral drug for a disease the Centers for Disease Control and the
National Institutes of Health had dismissed for years as a psychiatric
condition. The ramifications of the FDA's decision were hardly lost on
patient advocacy groups.

"If Ampligen is approved for treatment of CFIDS," the CFIDS
Association in Charlotte had told its 25,000 members in a special
mailing that summer, "this will be a monumental step toward gaining
credibility and focusing more attention and research [italics theirs]
on CFIDS."

At the same time, Paul Cheney noted, "The FDA is really in a bind. If
the agency approves the treatment IND application, they will, in one
swoop, destroy the credibility of two government agencies."

In the case of drug approvals, the FDA's mandate was generally
straightforward. The agency was required to answer just two questions:
was the drug safe, and did it do what its manufacturer claimed it did?
On the matter of Ampligen as a therapy for CFS, however, the FDA's
decision acquired significance reaching far beyond matters of
Ampligen's safety and usefulness in the disease. Unfairly, the drug
agency's impending decision was shaping into a referendum on the
existence of the disease itself.

As the October 3 deadline for the FDA's decision neared, patients
began applying pressure on both the FDA and HEM Pharmaceuticals. An
appeal by the CFIDS Association of Charlotte to its national
membership in late June had generated a write-in campaign to members
of Congress alerting them to the recent Ampligen trial and urging
their support for increased research into treatments for CFS. While
the FDA remained mute on the subject, patient support groups and
doctors monitoring the approval process sensed that the pressure on
critical members of both houses of Congress was significant, coming
primarily in the form of constituent mail and phone calls.
Participants in the Ampligen trial were particularly desperate that
fall as they embraced the reality of their situation: should the FDA
withhold its approval, Ampligen might never again be available to
them.

Nevada patients who had participated in the Ampligen trial -- among
then a newspaper reporter, a rancher, a computer software programmer,
and a neurologist, all of whom had been disabled for several years --
turned to the state's civil courts for help when the drug was
withdrawn. Neurologist Kristine Dahl, who began to suffer from the
disease while a resident at Duke University's medical center, was the
first to hire an attorney. Soon she was joined by several co-
plaintiffs. By early fall, U.S. District Court Judge Edward C. Reed in
Reno had heard testimony from several local CFS sufferers about the
ill effects of being removed from the drug. Having heard of Dan
Peterson's patients' lawsuit against HEM, a handful of Paul Cheney's
Ampligen trial participants, among them a female Baptist minister,
decided to file suit against the firm as well. Ultimately seventeen
patients joined the suit to force HEM to continue to provide the
drug.

Officers at HEM Pharmaceuticals were hardly displeased with these
developments. A passionate display by patients might constitute enough
pressure to sway the government, and although patients looked upon the
FDA's decision as a life-or-death issue, the consequences of that
decision were equally dire for HEM. The company was struggling for its
economic survival that year. Should the agency approve HEM's
application for expanded clinical trials among chronic fatigue
syndrome patients, cash backers could be expected to flock to the
little firm.

p. 529 1991

Participants in the Ampligen trial who had joined neurologist Kristine
Dahl in her lawsuit against HEM Pharmaceuticals were provided a short-
term solution that fall: a court injunction against the company,
requiring it to provide the drug to patients for a year, or until the
legal issues could be worked out. On November 7 and December 2, U.S.
District Court Judge Edward C. Reed in Reno issued interim rulings
until the case could be tried in court. He ordered HEM to provide
Ampligen to the plaintiffs for at least twelve more months, "or until
the motion for permanent injunction is decided on the merits,
whichever comes first." He stated that the "potential harm faced by
the plaintiffs outweighed any harm to defendants that could result
from granting such an injunction." HEM's defense for removing patients
from the drug was that the government had yet to rule on its efficacy.
In addition, in the absence of federal approval for HEM's recently
proposed expanded trial, a precursor to full approval, the company had
no income with which to manufacture, distribute, and administer the
drug.

"If the new trial is approved," Cheney said, "HEM will reactivate
their compassionate care program, because they would then have money
to pay for the drug and projected large monies in the future. Maryann
Charlap feels very strongly about that. But if it's not approved," he
said, "then all bets are off. Because they'll have no income. The
proof of efficacy is not what HEM says but what the Food and Drug
Administration says. The FDA action is their litmus test. And patients
don't quite understand that little distinction. And patients could get
screwed, and the way they'll get screwed is by the FDA -- that is, the
drug did work, but the FDA didn't approve it -- and then it won't be
HEM's fault."

p. 534 1991

Chicago's McCormick Place convention center was the largest such
enterprise in the nation, its 1.6 million square feet divided between
two airplane hangar-sized halls straddling Lake Shore Drive, a ten-
minute taxi ride from the Loop. During the first week of October more
than 9,000 scientists swarmed into McCormick Place to listen to
presentations by their colleagues on subjects as diverse as the effect
of tetanus immunizations on patients suffering from AIDS and the
usefulness of topical sunscreens in preventing cold sores, a study
that happened to be written by, among others, the NIH's Stephen
Straus. One hundred and sixteen reporters and approximately fifteen
hundred pharmaceutical company representatives were monitoring the
Thirty-first Annual Interscience Conference on Antimicrobial Agents
and Chemotherapy. During their breaks, scientists roamed through the
brightly lit exhibition court where salespeople from mega-firms like
Searle, Pfizer Roerig, Lilly, Ortho-McNeil, Burroughs, Wellcome,
Bristol-Myers Squibb, and Hoechst stood in welcoming poses at booths.
A steady line of scientists awaiting complementary coffee snaked
around Abbott Labs' towering copper espresso machine.





Part ll


Less than three weeks earlier and months after the official deadline,
HEM Pharmaceuticals president William Carter had asked the committee
on presentations for an eleventh-hour consideration of his paper on
Ampligen therapy in CFS. In an exception granted to only a dozen other
late submissions among the 2,200 presentations already scheduled, the
committee added the HEM study to the agenda.

On the eve of Carter's presentation, HEM investors, scientific
consultants, potential backers, Maryann Charlap, and Carter himself
sat down to a lavish dinner in a Chicago restaurant. Spirits were
high. In less than three days the Food and Drug Administration would
be forced to meet its thirty-day deadline to rule on the company's
application for an expanded trial. In a matter of just three days,
then, a governmental green light might breathe new life into a
foundering company. Financial backers at the table knew little about
the disease itself; in many cases, their appreciation for the
phenomenon was limited to what they had read in the lay press. They
knew only that a trial had been conducted with good results. To allay
their curiosity, Carter had invited Dan Peterson and Paul Cheney to
the dinner. Carter asked the former Nevada partners to describe the
epidemic disease in detail.

The doctors quickly realized that their audience was especially
interested in hearing anecdotes about specific patients who had
experienced dramatic improvement on Ampligen. Carter drew Dan Peterson
out about Patient 00, Nancy Kaiser, who had been in a wheelchair for
nearly a decade and who was barely able to write her own name prior to
treatment with Ampligen. Now Kaiser Was close to 50 IQ points smarter,
and on her best days the former golf fanatic could play nine holes.

Carter, Cheney recalled later, "also asked us to comment about various
issues around the disease: what do we think it is, how do we think
it's transmitted, do we think it's new or old, what are holes in the
brain -- that kind of thing. There was a lot of commentary about the
brain lesions."

The malady's possible retroviral etiology was another point of
fascination for Carter's guests that evening. "Oh, yes, they were
interested," Cheney commented. "They were very concerned. Their
attitude was, 'This is incredible!' The other major issue of the
evening," Cheney continued, "was 'Be careful about exceeding the gag
order.'"

Since September 3, when HEM submitted its application to the Food and
Drug Administration for approval of expanded clinical trials, the
company had been instructed by the FDA to confine all public
commentary to the scientific data in the company's abstract. Carter
warned Cheney and Peterson in particular, who he knew would be sought
out by reporters, to avoid making claims that the drug was "safe and
efficacious" -- the sole standards by which the drug agency was
required to rule on Ampligen -- in ways that might be perceived as
advertisement.

Privately Cheney had significant reservations about the drug and was
increasingly uneasy in the face of HEM officials' excitement over the
success of the trials. The Charlotte clinician believed there were
important questions about the long-term use of the drug that had yet
to be addressed. In low doses, Ampligen stimulated the immune system;
in higher doses, it down-regulated an overactive immune system. What
if, Cheney postulated, a patient was prescribed Ampligen at a high
dose in order to down-regulate immune system activity, thus reducing
toxic levels of cytokines such as interleukins, but was later taken
off the drug. Would the patient's immune system be rendered
inoperative?

"I really think this drug could make you worse," Cheney ruminated.
"That doesn't mean the drug's not effective. And it doesn't mean that
the drug's not good. It's just that there are some pitfalls in its use
that we damn better well know about."

Cheney's theoretical musings seemed well founded, given the
testimonials of patients who had been abruptly cut off from their
Ampligen lifeline at the trial's end. More than a few sufferers
reported that they felt worse in the weeks following the trial than
they had felt at any time in their years of illness.

On the morning of October 1 several hundred scientists attended
virology session number 46 in an auditorium on Lake Michigan's shore.
William Carter, who would describe the Ampligen trial, was the morning
session's final presenter. Eyeing the diminutive, frail-seeming Carter
as he stepped to the lectern were Stephen Straus and Steven Jacobson,
the government neuroimmunologist who had helped Straus test a handful
of patient blood samples for HTLV1 and HTLV2 after the Wistar
announcement a year before. Larry Corey, the herpes expert from the
University of Washington who had published two studies promoting CFS
as a psychiatric disorder, studied the wraithlike Carter as well.
Carter commenced his rapid-fire reading of the HEM study results with
a statement that likely did little to help him with this crowd: "The
topic that we're going to discuss today," he began, "is built on the
pioneering observations of Dr. Dan Peterson and Dr. Paul Cheney, who
are in the audience today."

Carter had less than twelve minutes to present the voluminous
findings. His delivery was brusque and matter-of-fact as he started by
describing the demographics of the study subjects: their average age
was "about forty," most of them had been sick for four to six years;
nearly all were being cared for either by spouses or by professional
custodial caregivers. Carter then described patients' physical
condition upon entering the trial: "At baseline, the two groups
[placebo and treatment] were severely debilitated," according to two
standardized measurements of morbidity, the Activities Daily Living
test and the Karnofsky Performance Status. Approximately eight to
twelve weeks had passed before patients receiving Ampligen began to
diverge from the placebo group in their Activities of Daily Living
scores. By twelve to sixteen weeks, the Ampligen patients' Karnofsky
scores also began to diverge to a statistically significant degree.
Placebo patients demonstrated zero improvements. "There's less than
one chance in a thousand that this would have occurred by chance
alone," Carter said.

Even more significantly, perhaps, those patients who received the drug
did not experience "physiologic deterioration," Carter said, adding,
"which ... was seen in the placebo group."

*The history of the placebo group during the six months of the trial
was at least as revealing as that of the patients on Ampligen. Over
six months, placebo recipients, as a group, experienced an accelerated
rate of hospitalization, compared to a diminished rate in the drug-
treated group. On treadmill tests, which every patient undertook at
frequent intervals during the six months of the trial, placebo
recipients deteriorated significantly in terms of their degree of
oxygen consumption and endurance, whereas Ampligen patients improved
significantly.

Carter then said, "I should mention, by the way, that eight percent of
the patients [four people] in the placebo group attempted suicide
during the six-month observation interval, but there were no attempted
suicides reported in the drug-treated arm."

Patients on the drug improved on tests of cognitive ability, Carter
continued, but placebo patients demonstrated no statistically
significant intellectual improvement.

Before the trials, Carter added, 85 percent of all the patients had
elevated levels of human herpesvirus 6, as demonstrated by monoclonal
antibody tests. Levels of the virus's activity are "known to be
reduced" among Ampligen recipients, Carter said.

Carter concluded with the comment that, although the drug was "not
without side effects ... in no instances, to date, were any of these
side effects sufficient to discontinue therapy in patients."

In the question session afterward, Straus, Jacobsen, and Corey
dominated the floor. Straus introduced himself to Carter with the
collegiate "Straus, Bethesda." In an Edwardian show of civility, he
commended Carter for "speeding these data to us." The comment
generated a frisson of amusement in the audience, given its cynical
subtext. "You showed a lot of data, Dr. Carter," Straus said, getting
down to business. "There are several questions. One is that the rate
of hospitalizations that you seem to see indicated in this study is
surprisingly high for this population. I'm wondering what that's due
to and how representative this population is for the kind of patients
that many of us see with chronic fatigue. But in addition, you
commented on side effects of the Ampligen treatment not sufficient to
terminate therapy. But what about sufficient to unblind therapy?"

Straus' line of questioning indicated he was suspicious that the
patients' good responses had been generated by a placebo effect --
that is, an awareness that they were getting the drug. His question
ignored the fact that the HEM trial's scientists had focused not upon
patients' own sense of well-being -- as Straus did in his 1986
acyclovir trial -- but upon objective laboratory data such as viral
activity, cytokine levels, white blood cell ratios, oxygen uptake, and
so on, to measure improvement. In addition, many patients who actually
were receiving placebo got even sicker, suggesting that the normal
placebo effect noted in most double-blind trials was almost entirely
missing in this particular trial. *On the other hand, a few patients
receiving the placebo reported improvement. In fact, remarkably, two
placebo recipients joined the lawsuit against HEM, so certain were
they that they had been receiving the drug.)

Carter's unruffled elucidation of these issues silenced Straus for the
time being. But his NIH colleague, Steven Jacobson, stood to pursue
Straus's original question about the remarkable degree of debilitation
exhibited by patients in the study before starting therapy. "I was
really surprised by the low Karnofsky performance of these patients,"
Jacobson said. "I mean, it a little bit strains credulity ... to have
patients who were that sick and were able to comply and perform all
the studies -- just even coming back for follow-up, biweekly I.V.
infusions on an outpatient basis -- "

"Well, virtually all of these individuals have a custodial caregiver
who brings them to the unit," Carter responded. "As Dr. Straus
mentioned," he added, "we are not representing here that this is the
typical CFS patient. This appears to be the far end of the spectrum of
the disease."

Larry Corey stood to dispute Carter at some length about the study's
finding that 85 percent of patients had elevated levels of human
herpesvirus 6. Corey insisted that "at least in our hands, it's been
very difficult to find active viral replication of HHV6."

"Our results agree with those of Anthony Komaroff and Dan Peterson
that were published in the June 6 issue of Lancet," Carter told Corey.
"And in fact we've looked at several hundred individuals, and it looks
like the incidence of virus reactivation is not isolated to a specific
geographic region of the country. It's in your part of the country,
it's in the Southwest, the Northwest, et cetera."

Immediately after the presentation a conference press aide announced
that, due to the status of the drug at the Food and Drug
Administration, HEM would not be holding a press conference, nor would
Carter be answering questions from the press. Even so, Carter was
surrounded by reporters within moments of stepping down from the
lectern. The scientist remained mute as he advanced down the center
aisle of the auditorium toward his waiting colleagues, a throng of
bristling journalists at his elbows. Bill Jenks, HEM's Manhattan-based
public relations officer, stepped into the crowd of correspondents
from CBS, Medical World News, and other publications and struggled to
explain why Carter would be unable to talk to them. Eventually, the
reporters dispersed.

David Strayer, HEM's principal scientific adviser who had been at
Nancy Kaiser's side in Incline Village when she became the first CFS
patient to receive Ampligen, had stood quietly at the back of the
large room throughout Carter's talk. At its conclusion, he was
approached by a clinician from southern Florida who reported that his
practice was inundated with CFS sufferers and asked if some of his
most severely stricken patients might be included in the next Ampligen
trial. Strayer explained that the drug's future was in the hands of
the FDA.

For the moment, Strayer added, Ampligen's potential as a CFS therapy
occupied a high priority inside the Philadelphia company, but the FDA
would determine whether the company would continue to afford the
disease such high status. (HEM was also planning to continue testing
Ampligen in AIDS, in hepatitis B, in renal and lung cancer, and in
severe burn patients.) In addition, Strayer indicated, the fate of
patients who had received the drug in the clinical trials and now were
seeking continued infusions of the drug, whether by pressure from
civil courts or from Congress, rested with the drug agency, not with
HEM. "We could not justify continuing everybody on the drug without
some evidence that the drug was efficacious," Strayer said. "We're
still waiting for guidance from the FDA on that."

The Chicago Tribune published the Associated Press's story about the
drug trial under the benighted headline "Viral Drug Helps Fight Yuppie
Flu."

Ron Winslow, writing in the Wall Street Journal, quoted an unnamed FDA
source whose comments hinted at what the agency's action would be the
following day. "It's too early to claim that Ampligen is a dramatic
treatment for chronic fatigue syndrome," the agency spokesman said.
"The product has significant side effects that would have to be
considered against any claimed benefits." Winslow quoted Anthony
Komaroff, too, who told the reporter, "This isn't a medicine that acts
on the psyche. It acts on the body."

On the eve of the FDA's response to HEM, Paul Cheney and Dan Peterson,
independent of one another, were gloomy about the drug's prospects.
"There's not a chance the Food and Drug Administration is going to
approve this drug," Peterson said over dinner the night of Carter's
presentation. "How can they approve a drug for a disease the NIH says
doesn't exist?"

Cheney predicted the agency would "probably delay approval pending
toxicity issues, but it's just a way to delay. They don't have the
guts to kill it, because the patients will kill them. But they don't
have the guts to approve it, because Straus will kill them."

Part lll to follow


Take time to enjoy the sunsets and sunrises...

Soft hugs to all who need them!
Diana Saba
Retired Nurse
FM ME/CFIDS
Related Neurological Disorders

.