First to answer Nutcracker, prln paid East-West a $20,000 option fee and made them a working capital loan (guaranteed by a majority shareholder of East-West) of $340,000.
Harold, it sounded to me like paul was speaking of hopefully good news that will start coming out. I am hoping for the same. How much more bad news can there be? I did, however, just now discover something going on I wasn't aware of and hasn't, as far as I know, been mentioned here which may have had some influence over the past few weeks. It certainly could generated selling prln. It does, though, seem to me there are some important differences between the below mentioned product and Androvir. The Androvir study did measure viral loads and they went down. The lack of measuring viral loads in the spv-30 study and the possibility that they may have gone up seems to be the most severe criticism. Further, it does not seem like prln could be called naive in their approach having already made dramatic and innovative discoveries and advances in their ongoing CRADA work with NCI. Also, at this point prln having Alberts from Merck should be an additional advantage in dealing with the FDA. You can also see that AIDS Buyers Clubs and information groups are well-organized and reacting quickly and vigorously in defense of a product not as soundly grounded as Androvir. But what follows may have led some to sell, maybe for good reason but maybe not.
FDA Shuts Down Distribution of SPV-30 (warning letter March 5, 1997)
SPV-30 is a natural herb product extracted from an evergreen tree and
presently being used to reverse the declining level of CD4 lymphocytes in people with
asymptomatic HIV.
SPV-30 has been proven to be non-toxic and non-mutagenic. Studies of SPV-30 are being
established in major US cities. Participants receive six months of free product in exchange for
lab results every two months.
A small phase I study in France demonstrated significant rises in CD4 cell counts in
participants. However, all participants had more than 250 CD4 cells and no viral load
measurements were taken. Sally Cooper at the PWA Health Group in New York City was
concerned at the possibility of an IL-2 type situation where stimulation of CD4 population
without antiviral activity may actually increase viral load. The company that makes the product
are, according to Sally, seemingly well intentioned but a little naive about HIV pathogenesis.
SPV-30 can also now be bought from pharmacies in the city as a nutritional supplement.SPV_30 has been proven to be non-toxic and non-mutagenic. Studies of SPV-30 are being
established in major US cities. Participants receive six months of free product in exchange for
lab results every two months. A small phase I study in France demonstrated significant rises in CD4 cell counts in
participants. However, all participants had more than 250 CD4 cells and no viral load
measurements were taken. Sally Cooper at the PWA Health Group in New York City was
concerned at the possibility of an IL-2 type situation where stimulation of CD4 population
without antiviral activity may actually increase viral load. The company that makes the product
are, according to Sally, seemingly well intentioned but a little naive about HIV pathogenesis.
SPV-30 can also now be bought from pharmacies in the city as a nutritional supplement.
March 21, 1997
RE: URGENT FDA ACTION
Dear DAAIR member, activists, friends,
We are enclosing in this mailing a number of documents and we are urging you
to send them, by whatever means available to you (fax, mail and email) to the
appropriate individuals. In addition, you can make copies before you send
them and distribute them to friends, family and anyone you think will find this
issue critical.
The U.S. Food and Drug Administration has shut down the distribution of
SPV-30, a preparation from the boxwood evergreen with some moderate
efficacy in slowing progression to AIDS. Clearly, if you are someone using this
herb and are finding it beneficial, this action will outrage and frighten you. We
are working very hard to assure an uninterrupted access to SPV-30.
The FDA took this action because it claims that SPV-30 is not safe or
effective and instructions on how to use the herb are not labeled on the box
(clearly untrue). They also took the action because of the distribution of data
from the U.S. open label and preliminary results from the controlled studies in
France (which are being overseen by Dr. Luc Montagnier and partly
sponsored by the prestigious Pasteur Institute). We feel the FDA is either
ignorant of the facts or merely reinforcing a pattern of assault upon alternative
approaches.
However, this action represents a bigger threat to access to products that may
have medicinal activity such as slowing progression, lowering liver enzymes or
triglyceride levels, improving weight or minimizing diarrhea by enhancing
intestinal function. This action by the FDA is just an opening shot and ALSO
has serious ramifications for access to and distribution of balanced,
comp,ete information about these products.
Recent studies have shown a depletion in glutathione, a natural antioxidant
produced in the body, to be a marker of faster progression. The amino acid
N-acetyl-cysteine (NAC) helps improve glutathione. Will NAC become a drug?
Similarly, studies have shown people with HIV suffer losses of nutrients
shortly after infection. One study showed an important depletion of vitamin
B12. Will this vitamin become a drug? Will people be denied these possibilities
because of an inability to appropriately study them? How can poor people
obtain access to these products if they can't afford them? If doctors don't
know about them or, if they do, cannot prescribe them? If a combination of
herbs can slow progression or significantly reduce virus load--shouldn't people
have a right to that knowledge?
Part of the problem is the way the laws are set up. Not surprisingly, these laws
favor the pharmaceutical industry and its control of profits from patented
products. The FDA's bias is documented. The FDA Dietary Supplement Task
Force made recommendations to take "what steps are necessary to ensure
that the existence of dietary supplements on the market does not act as a
disincentive to drug development." A 1994 article in POZ noted that "FDA
Deputy Commissioner for Policy, David Adams, warned that if
freedom-of-choice advocates had their way, 'there could be created a class of
products to compete with approved drugs that are subject to less regulation
[which] could undercut exclusivity rights enjoyed by the holders of approved
drug applications.'" (Lederer B. The FDA's Dirty Little War, POZ, Aug-Sep, 1994;:56-59,x). These
astonishing statements by FDA officials are an indictment of a system
more interested in business and profit than human lives!
The good news is that new laws have been put forward in Congress. Some of
these issues have been clarified in the Dietary Supplements Health Education
Act which is now law. The Access to Medical Treatment Act has been
reintroduced. Another law proposes to elevate the Office of Alternative
Medicine to the status of Institute with a $198 million budget. But this still
leaves a large gray area in the law. In the attached letters, you will read about a
list of demands we are making that begin to address this area. (The promoters
of these bills are Sen. Tom Daschle (D-SD) and Peter DeFazio (D-Ore); see
end of letter for contact information.)
Too often, the arguments are framed between the stiflingly protective FDA
versus the money-grubbing supplements industry. A third voice is ignored.
That voice is those of us who actually USE supplements--herbs and
nutrients--to improve and sustain health. We want an FDA that will help to
guarantee the potency and purity of products. Who will go after true fraud.
But we also want an FDA that is not beholden solely to the interests of the
pharmaceutical industry.
THE LAWS MUST CHANGE! We MUST have a new mechanism that
facilitates the rigorous study of alternative and complementary treatments.
That mechanism should not have to undergo the greater than $200 million
costs of drug approval. And in those cases where positive results are found,
there must be a mechanism in place that allows distribution of that information
without violating labeling laws. Finally, physicians should be able to prescribe
such interventions so that people who need them may be assured access and
coverage under insurance programs, Medicaid, ADAP or other reimbursement
programs.
We are joined in this fight by David Stokes, SPV-30 US Study Coordinator,
the International Foundation for Alternative Research in AIDS, the San
Francisco Healing Alternatives Foundation, the Boston Buyer's Club, the PWA
Health Group, Being Alive Buyer's Club, Embrace Life, AIDS Treatment
Initiative, PWA Coalition of Denver and many other organizations. If your
organization wishes to officially declare your support for this initiative, please
contact DAAIR.
We urge you to join us in this fight. Our lives and health depend upon it.
Sincerely,
Fred Bingham
Director
George M. Carter
Member, ACT UP/NY
Director, Treatment Information Development
PLEASE SEND THE ENCLOSED LETTER TO THE FDA TO THE PERSON LISTED.
IN ADDITION, MAKE COPIES FOR FAXING AND/OR TO GIVE TO FRIENDS.
SEND THE LETTER ALSO TO THE FOLLOWING PEOPLE AT FDA:
PRESIDENT BILL CLINTON and VICE PRESIDENT AL GORE
(president@whitehouse.gov, vicepresident@whitehouse.gov); The White House, 1600
Pennsylvania Ave., Washington, DC 2020TEL:
DIANA AMADOR, ACTING DISTRICT DIR., TEL: 718-965-5300 EXT. 5301, FAX:
718-965-5117
RANDY WYCKOFF, Assoc. Commissioner, Office of Operations: TEL: 301-827-3320;
FAX: 301-443-3100
MICHAEL FRIEDMAN, Lead Director: TEL: 301-443-2410; FAX: 301-443-3100
RICHARD KLEIN: TEL: 301-827-4460; FAX: 301-443-4555
DONALD POHL: TEL: 301-827-4460; FAX: 301-443-4555
DAVID KESSLER: TEL: 301-443-2410; FAX: 301-443-3100
THERESA TOIGO: 301-827-4460; FAX: 301-443-4555 (Office of AIDS and Special
Health)
PLEASE ALSO FEEL FREE TO SEND THE LETTER TO YOUR
SENATOR/CONGRESSPERSON. You can call the Capital Switchboard at
1-800-962-3524 to find out who that is and their contact information. In addition, please send
it to
Rep. Peter DeFazio (D-Ore)--2134 Rayburn House Office Bldg, DC 20515; 202-225-6416;
FAX-225-0373 (pdefazio@hr.house.gov)
Sen. Tom Daschle (D-SD)-- FAX: 202-224-2047; (tom_daschle@daschle.senate.gov)
(PS: WE VIEW THE ABOVE AS "FRIENDS." DeFAZIO opposed the anti-gay-marriage
bill; Daschle and he have introduced the Access to Medical Treatment Act and the proposed
elevation of OAM to Institute of Integral Medicine.) |
