Strong Medicine (39 page)

"the project we now have is timely, damned exciting, and with big

commercial possibilities; therefore we should concentrate on it."

No public fanfare was made about the Harlow opening. "The time for

fanfare," declared Sam, who had flown over for the occasion, "is when we

have something positive to show, and that isn't yet."

When would there be something positive?

"Allow me two years," Mar-tin told Sam and Celia during a relaxed private

moment. "There ought to be some progress to report by then."

After the institute's opening, Celia's visits to Britain became fewer and

shor-ter. For a while she went, as Sam's representative, to help smooth cut

initial working problems. But, mostly, Nigel Bentley seemed to be

justifying the confidence placed in him by his appointment as

administrator. From Martin, as months went by, there was no specific news

except, via Bentley, that research was continuing.

At Felding-Roth's New Jersey headquarters, Celia continued as special

assistant to the president, working on other projects Sam gave her.

It was during this period that, on the national scene, the putrescent boil

of Watergate burst. Celia and Andrew, like millions of others worldwide,

watched the parade of events nightly on television and were caught up in

the unfolding drama's fascination. Celia reminisced ab,,)ut how, a year

earlier when driving to Harlow with

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Sam, she had dismissed the first published report of a Watergate burglary as

insignificant.

Near the end of April, while tension mounted, two haughty presidential

aides--Haldeman and Ehrlichman-were thrown to the wolves by President Nixon

in an attempt to save himself Then, in October, adding to Nixon's and the

nation's misery, Vice President Agnew was ejected from office for other

corruption, unconnected with Watergate. Finally, ten months later, Nixon

himself reluctantly became the first American President to resign. As

Andrew remarked, "Whatever else history may say, at least he'll be in The

Guinness Book of Records. "

Nixon's successor promptly granted his predecessor a pardon-inadvance

against criminal prosecution and, when asked if it was all tit-for-tat

pol&cs, proclaimed, "There was no deal."

Watching and hearing the statement on TV, Celia asked Andrew, "Do you

believe that?"

"No.,'

She said emphatically, "Nor do L"

Around the same time-less significant on the larger scene, but important to

the Jordan family-Bruce, too, left home to enter prep school-the Hill

School, at Pottstown, Pennsylvania.

Through the entire period and into 1975 the fortunes of FeldingRoth, while

not spectacular, maintained an even keel. They were helped by two products

developed in the company's own laboratories-an anti-inflammatory for

rheumatoid arthritis and a betablocker called Staidpace, a medicine to slow

heartbeat and reduce blood pressure. The arthritis drug was only moderately

successfui but Staidpace proved an excellent, lifesaving product which

became widely used.

Staidpace would have contributed even more to Felding-Roth revenues had its

United States approval not been delayed by the Food and Drug Administration

for what seemed an unconscionable time-in the company's view, two years

longer than necessary.

At FDA's Washington headquarters there seemed, in the frustrated words of

Felding-Roth's research director, Vincent Lord, "an infectious

unwillingness to make a decision about anything." The opinion was echoed by

other drug firms. Reportedly, one senior FDA official exhibited proudly on

his desk a plaque with the famed promise of France's Marshal P6tain in

World War 1, "They shall not pass. " It appeared to sum up neatly the

attitude of FDA's staff to any new drug application.

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It was about this time that the phrase "drug lag"--describing the

non-availability in the United States of beneficial drugs in use else-

where-began to be used and gain attention.

Yet, always, a routine reply to any plea for faster action on new drug

approvals was: "Remember Thalidomide!"

Sam Hawthorne tackled this attitude head-on in a speech to an industry

convention. "Strong safety standards," he declared, "are necessary in the

public interest, and not long ago, too few of them existed. But pendulums

swing too far, and bureaucratic indecision has now become a national

disservice. As to critics of our industry who point back to Thalidomide,

I point forward to this: The number of Thalidomide-deformed babies is now

exceeded by the number of those who have suffered or died because

effective drugs, held back by American regulatory delays, are failing to

reach them in their time of need."

It was tough talk and the beginning of what would be a fiercely argued,

pro-and-con debate extending over many years.

At Felding-Roth, one keenly anticipated project was now on "hold.,,

The deal made by Sam for the American rights to a new French drug,

Montayne, still had not reached a point where tests for safety and

efficacy, as required by law, could begin in the United States. Thus

there was a long way to go even before a new drug application could be

made to FDA.

Montayne was a drug to combat morning sickness in pregnant women; it held

great promise, especially for working women whom it would free from a

burden that made life difficult and sometimes threatened their

employment. The drug's discoverersLaboratoires Gironde-Chimie, a

reputable house-were convinced they had something of highest quality and

safety, as shown by unusually extensive tests on animals and volunteer

humans. The tests, the Paris-based firm informed Felding-Roth, had so far

produced excellent results and no adverse side effects. Still, as the

head of Gironde-Chimic explained in a personal letter to Sam:

Because of past occurrences, and the nature fragile of this

drug, we have need of being extremely prudent. Therefore we

have decided to make a few more series of tests on different

types of animals, and also more humans. This will take a little

more of time.

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In the climate of the times, Sam agreed, the additional precautions

seemed wise. Meanwhile, Felding-Roth continued to wait for a green light

from the French before beginning their own work on Montayne.

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THREE

1975-1977

I

While Dr. Vincent Lord had some problems which were imaginary, he also had

others that were real.

One was the FDA.

The Food and Drug Administration, with headquarters just outside

Washington, D.C., represented a labyrinthine obstacle course which any

new pharmaceutical drug and its sponsors had to run before the drug was

approved for general use. Some drugs were never approved; they failed to

complete the course. And since sponsors of drugs were almost always the

companies which discovered, manufactured, and eventually sold them to the

public, the big drug firms and FDA were, more often than not, locked in

a combative state. That state ranged, according to the issue of the

moment, from intellectual-scientific skirmishing to all-out war.

As far as Vince Lord was concerned, it was war.

Part of his jot) at Felding-Roth was to deal, or supervise dealings, with

the FDA. He loathed it. He also disliked, and in some cases despised, the

people who worked there. Adding to his problem was that, to achieve

anything at all at FDA, he had either to subdue those feelings or keep

them to himself. He found both things difficult, at times impossible.

Of course, Dr. Lord was prejudiced. So were others, from other drug

firms, who dealt with FDA.

Sometimes that prejudice was justified. Sometimes not.

This was because laws and custom required the FDA to be several things

at once.

It was a guardian of the public's health, its duty to protect the

innocent from excessive avarice, incompetence, indifference, or

carelessness, all of which sins were at times committed by pharmaceutical

companies whose bottom line was profit. The reverse of that was FDA's

function as a ministering angel: the covenant to make available, with

utmost speed, those new and splendid drugs-

205

from the samc pharmaceutical companies-which lengthened life or shortened

pain.

Another agency role was to be a whipping boy for critics--drug firms,

consumer groups, journalists, authors, lawyers, lobbyists, other special

interests-who accused FDA of being either too rigid or too lenient,

depending on what camp the critics lived in. As well, the FDA was used

regularly as a political platform by self-serving and self-righteous

congressmen and senators who sought an easy way to get their names in print

and on TV.

Coupled with all this, the FDA was a bureaucratic mess-overcrowded, in

critical areas understaffed, its medical and scientific experts overworked

and underpaid.

Yet the amazing thing was, amid all these roles, hindrances, and critics,

the FDA did its job-on the whole-remarkably weU.

But without question there were glitches, and the so-called drug lag was

one of them.

Just how bad the drug lag was depended, like so much else surrounding the

FDA, on your point of view. But that it existed, even the FDA itself

conceded.

Vincent Lord suffered through an example of the drug lag during the attempt

by Felding-Roth to gain approval for United States marketing of Staidpace,

a heart and blood-pressure medicine already in use in Britain, France, West

Germany and several other countries.

The FDA required that before Staidpace could go on American drugstore

shelves and be prescribed by doctors, there must be additional, thorough,

American testing of the product's safety and efficacy. And it was a good

requirement. Nobody argued against it, including Vincent Lord and others at

Felding-Roth.

What they did protest-after all the required testing had been done

successfully, and results submitted to the FDA-was two extra years of

petty, indecisive quibbling by the government agency.

In 1972 Felding-Rotb delivered its Staidpace NDA-new drug application-to

FDA headquarters in a truck. The NDA consisted of 125,000 printed pages,

contained in 307 volumes, enough to fill a small room. All this material

was required by law and included information covering two years of U.S.

testing on animals and humans.

Although the information supplied was as complete as anyone could make it,

there was an unspoken awareness on both sides that no one at FDA could

possibly read it all. Similar amounts of mate-

206

rial were received, with great frequency, from other manufacturers seeking

approval of other drugs.

From the FDA's medical-scientific staff, a reviewer was selected to

oversee and adjudicate the Staidpace submission. He was Gideon R. Mace,

M.D., who had been with FDA a year.

Dr. Mace would be assisted by scientific specialists in the agency -that