"For almost a century, the FDA has
been the ’Good Housekeeping’ seal of approval, the Nobel Prize
and Ivory soap (99 and 44/100 percent pure) combined," writes
Park Sloper Fran Hawthorne in her latest book. "To say you
have lost faith in the FDA is like saying motherhood and apple
pie have gone rotten."
In "Inside the FDA: The Business and Politics Behind the
Drugs We Take and the Food We Eat" (Wiley, March 2005) Hawthorne,
a long-time healthcare industry reporter, delves into many issues
affecting the FDA’s operation and decision-making process, in
order to help Americans understand this powerful government agency.
"If the FDA lets us down, we are not just personally disappointed,
betrayed and angry," she writes, "we could be dead."
The U.S. Food and Drug Administration regulates more than a quarter
of the nation’s economy, setting requirements for drug labels
and nutritional information on packaged goods. And with advances
in science and technology, the scope of the FDA’s responsibilities
has been expanding to increasingly controversial issues, such
as televised drug advertisements and ethical issues like Plan
B (a morning-after emergency contraceptive pill) and stem cell
research.
So why has Hawthorne penned a book for the average Joe that discusses
in great detail the politics and inside workings of an organization
that seems far removed from his daily life?
"Every day you do something that is regulated by the FDA,"
Hawthorne told GO Brooklyn. "Everybody eats food. Everybody
takes some kind of drug or another."
It affects your daily life, she said, from popping an aspirin
to using your cell phone.
A married mother of two, Hawthorne, 53, says that she was fortunate
enough – coming from a healthy family and rarely requiring prescription
drugs aside from occasional antibiotics – not to have to worry
too much about the products the FDA oversees. Part of what compelled
Hawthorne to write this book is the wealth of her experience
and insider knowledge gained through years spent working as a
healthcare industry reporter.
Hawthorne, a Philadelphia native, works as senior contributing
editor of "Institutional Investor" and is a contributing
editor of "Chief Executive" magazines. The focus of
her coverage, spanning over 20 years, has primarily been healthcare
and business for publications such as "Fortune," "BusinessWeek"
and "Crain’s New York Business." The subject of her
previous book, "The Merck Druggernaut: The Inside Story
of a Pharmaceutical Giant" (Wiley, February 2005) also revolves
around the drug industry.
"[The] Vioxx [controversy] exploded after I turned the manuscript
in," she said, adding that she had to keep asking for it
back from her publisher to add more relevant information about
Merck’s arthritis-fighting drug that led to strokes and heart
attacks in many patients. Vioxx was taken off the market in September
2004, five years after its initial FDA approval.
The author hopes that the timely release of "Inside the
FDA," in light of the recent publicity storm the agency
has received, might help to spread awareness and understanding
of the agency’s strengths and weaknesses.
"Yes, the drug industry is powerful, but it’s not that simplistic,"
she said in regard to those who blame the FDA for succumbing
to political influences. "I hope that [the book] gives people
a better idea about the FDA."
What comes across strongly in the book is the author’s effort
to present both sides of the issues, which are divided into 15
chapters with titles ranging from "Beyond Science,"
"The First 100 Years," "How Powerful is Industry"
and "When Consumers Get Angry" to case studies like
"Chasing Cancer."
For instance, Hawthorne uses the case study titled "The
Return of Thalidomide" to exemplify the FDA’s willingness
to take risks for the benefit of medical advances. Thalidomide
is infamous for the gruesome birth defects it caused throughout
Europe, Asia and Canada when it was first released in those markets
and from which Americans were spared because the drug had not
yet been legalized here. Nevertheless, Thalidomide was approved
by the FDA in 1998 due to its potential for relieving leprosy,
AIDS and other disease symptoms.
In "The Death of Monica George," Hawthorne discusses
one of the FDA’s low points. George was in her late 60s when
her liver failed in 1998 due to then-new Rezulin, which had just
been approved by the FDA and which her doctor prescribed for
her slightly elevated blood sugar level. George’s case became
well-known and the diabetes drug was pulled from the market in
2000, after 63 deaths had been associated with it.
Although Hawthorne insists that all chapters in the book are
essential in order to understand the industry and the agency,
she places an emphasis on "A Political Pawn," "FDA
and DNA" and "The Next 100 Years," which are particularly
relevant to the pressures and criticisms the FDA faces today.
"On some things, I do take sides," she said, pointing
out the chapter, "The FDA Meets Madison Avenue," where
she talks about drug advertisements. "I think it’s outrageous
and the FDA doesn’t have a hold on it."
Hawthorne writes that, unlike with drugs themselves, the FDA
is not authorized to approve or reject drug ads before they are
released on the market. One of the major concerns of the public
are the drug ads on television, which, she said, people find
confusing and generally don’t like.
"But I let the ad people tell their side of the story,"
said Hawthorne.
When she started compiling materials for the book, Hawthorne
said she kept an open mind.
"I was starting out saying ’let me find out,’" she
said.
And what she found out is that the FDA has many limitations and
cannot always be blamed. When it comes to frivolous drugs such
as Viagra, Botox or multiple brands of the same drug, the FDA
does not have a choice but to let them on the market, she said.
And sometimes five brands are necessary, because some people
react better to certain brands than others, she explained.
Similarly, while many are criticizing manufacturers of Botox,
originally created to relieve serious eye conditions but more
commonly used today as a wrinkle-reducing injection, it turned
out that such drugs might not be "as frivolous as they seem,"
the author wrote. New data has shown that the benefits of Botox
extend beyond unlined faces to treatment of carpal tunnel syndrome,
migraines, stroke paralysis and many other health problems.
"But I do wish [the drug companies] would make priorities,"
she said. "I’d rather they do more research on cancer drugs
than Botox."
Hawthorne said that she also wishes the FDA had a strong leader.
She cited the case of Plan B, the emergency contraceptive pill
that the FDA rejected on the grounds of scientific reason, but
which the author claims was not approved because of the pressures
from the political right.
"Lester Crawford caved on that issue," said Hawthorne
of the temporary commissioner, who is nominated for the permanent
position. "I am worried about his ability to stand up to
political pressures."
The FDA, the author writes, is involved in issues from drug prices
and post-market safety tests to terrorist attacks, the American
diet and ethics.
"If the FDA merely approved a drug and ignored those other
public health issues," she writes, "it would not be
a real protector of the public health much longer."
During one of the readings the author held last month in Manhattan,
a member of the audience wanted to know whether she should take
Fosamax or Actonel – drugs used for the treatment of osteoporosis.
"I don’t prescribe drugs," Hawthorne said, reflecting
on the event a few days later. "I just want to give people
a better idea about the FDA."
"Inside the FDA: The Business and
Politics Behind the Drugs We Take and the Food We Eat" (Wiley,
March 2005) by Fran Hawthorne lists for $27.95. The book is available
at, or can be ordered through, BookCourt [163 Court St. at Dean
Street, (718) 875-3677] in Cobble Hill; A Novel Idea [8415 Third
Ave. at 84th Street, (718) 833-5115] in Bay Ridge; and Community
Bookstore of Park Slope [143 Seventh Ave. at Carroll Street,
(718) 783-3075, among other booksellers.
