From John Hammill, President
International Advocates for Health Freedom
No matter what country you live in, please join IAHF in sending
email to President Bush and to the US Congress demanding that Bush reign in
Christine Lewis-Taylor of the FDA who is "on loan" to the (so called) World
Health Organization, where she is in charge of the (so called) "Nutrient
Assessment" workshop which in May will proceed to "fill in the blanks" on
allowable potency levels at CODEX. (If you live outside the USA, please copy
your letter to Bush to your elected officials).
There has been zero transparency in how Taylor (a Dietician and former
assistant US Delegate to the Codex Committee on Nutrition and Foods for
Special Dietary Uses) has gone about selecting the 18 people who will be making
these determinations as to what the allowable potency levels for vitamins and
minerals will be. (All applicants on our side have been rejected by Taylor
including Robert Verkerk, PhD, Exec Dir of the UK based Alliance for Natural
Health despite his having made just one of 16 submissions to WHO on this
See the NY Times article below (at end) about the rampant corruption at FDA
wherein Vioxx, Celebrex and Bextra were fraudulently approved despite
safety concerns by a panel of people which included scientists who had
worked in the past for Merck, and Pfizer, makers of these dangerous drugs.
The New York Times (February 25, 2005)
10 Voters on Panel Backing Pain Pills Had Industry Ties
By GARDINER HARRIS and ALEX BERENSON
Ten of the 32 government drug advisers who last week endorsed continued
marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have
consulted in recent years for the drugs' makers, according to disclosures in
medical journals and other public records.
If the 10 advisers had not cast their votes, the committee would have voted
12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not
return to the market. The 10 advisers with company ties voted 9 to 1 to keep
Bextra on the market and 9 to 1 for Vioxx's return.
The votes of the 10 did not substantially influence the committee's decision
on Celebrex because only one committee member voted that Celebrex should be
Eight of the 10 members said in interviews that their past relationships
with the drug companies had not influenced their votes. The two others did
respond to phone or e-mail messages.
Researchers with ties to industry commonly serve on Food and Drug
Administration advisory panels, but their presence has long been a
The agency has said it tries to balance expertise - often found among those
who have conducted clinical trials of the drugs in question or otherwise
studied them - with potential conflicts of interest.
Several of the panel members flagged with conflicts said most or all of the
money went not to themselves but to their universities or institutions.
The Center for Science in the Public Interest, an advocacy group in
Washington that maintains a large database of scientists' industry ties
disclosures in medical journals and other public documents, analyzed the
members' affiliations at the request of The New York Times.
The center has been a frequent critic of the F.D.A. and of the
pharmaceutical industry. The center's analysis may understate the industry
ties of the panel participants because some ties may not have been previously
Dr. Sheldon Krimsky, a science policy expert at Tufts University, said such
conflicts were common on F.D.A. advisory panels. The agency often conceals
these conflicts, and studies have shown that, taken as a whole, money does
influence scientific judgments, Dr. Krimsky said.
He added, "F.D.A. has to work harder to fill panels with people without
conflicts, and if they feel they have the best committee, they at least
ought to make it transparent."
A spokeswoman for the F.D.A. said no one at the agency would comment on
specific panel members' industry ties.
Before each of three meetings of the advisory board last week, an agency
secretary read a statement absolving panel members of conflicts of interest
because the committee's agenda involved "issues of broad applicability and
there are no products being approved."
The secretary also said, "The Food and Drug Administration acknowledges that
there may be potential conflicts of interest, but because of the general
nature of the discussions before the committee, these potential conflicts
But the committee took nine votes, three for each drug, on whether Celebrex,
Bextra or Vioxx hurt the heart, should continue to be marketed and, if so,
under what restrictions. These votes were deeply important to the three
companies - Merck, Pfizer and Novartis - that came before the committee.
Indeed, shares of Merck and Pfizer soared last Friday after the panel's
Ten members of the panel have worked in some capacity in recent years for
Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or
Novartis, which is applying to sell Prexige, a very similar pill discussed
by the panel, according to the public disclosures.
Of the 30 votes cast by the 10 panel members on whether Celebrex, Bextra and
Vioxx should continue to be marketed, 28 favored the drugs. Among the 66
votes cast by the remaining 22 members of the panel, just 37 favored the
crtics of the drug industry said they were not surprised that the panel's
decisions would have been different if scientists with financial ties to the
companies had recused themselves from the votes.
"My employees usually vote for me as well," said W. Mark Lanier, a lawyer in
Houston who represents people who have sued Merck after taking Vioxx and
suffering heart attacks or strokes.
Some lawyers and Wall Street analysts said last week that the panel's
decision would help to protect Merck and Pfizer from lawsuits. But juries
more skeptical of the decision after they learn about the composition of the
panel, Mr. Lanier said.
Dr. Furberg said clinicians often wanted access to therapies without
understanding the devastating public health consequences of their
decisions. Celebrex, Bextra and Vioxx have never been proved in clinical
trials to cure pain any better than ibuprofen or more than a dozen other, older
"Fifty patients a day probably die from those drugs, and who is speaking for
them?" Dr. Furberg said.
Dr. Alastair Wood, an associate dean at Vanderbilt University and the
panel's chairman, said he was disappointed that the F.D.A. failed to
disclose the financial conflicts of the panel's participants before each day's
"I'm a great believer in letting it all hang out," he said.
Still, Dr. Wood said that even with its conflicts the panel was a tough
critic of the drugs. Many of the panel members who were among the narrow
majorities approving continued marketing of Bextra and Vioxx did so only with
the stipulation that severe restrictions be imposed on their uses, he
He said he expected that the uses of the drugs would be confined to very
limited patient populations.
For Health Freedom,
John C. Hammell, President
International Advocates for Health Freedom
556 Boundary Bay Road
Point Roberts, WA 98281-8702 USA