This time David restricted himself to raising his eyebrows equivocally.
"I'm referring to the series of tests every drug is put through before it gets approval."
"Ah-I'm with you," David responded, "In the preclinical stage, you're restricted to experiments on animals."
Grudgingly, Churchward conceded, "Correct If that's satisfactory you go on to Phase One, which is merely testing for safety in a small sample of humans. In Phase Two you test for effectiveness, still using small numbers of humans. We've done all that PDM3 has gone through Phase Two and now we're ready to undertake the third phase, the extensive clinical trials. Assuming they go well-and I've no reason to think they won't-we take it in front of the FDA." He added, as if to a child, "The Food and Drug Administration."
"And when they recommend approval, we're in business?"
"And how!" murmured Leapman.
"You really believe this drug is something special?" David asked.
"Something special?" The professor hesitated, as if weighing his response. "What we have, Mr. Flexner, is the equivalent, in pharmacological terms, of the splitting of the atom."
Goosebumps formed on the backs of David's arms. In his experience, scientists weren't given to such extravagant claims.
Professor Churchward said, "PDM3 is not a protective agent It is a regenerative agent. It enables dying nerve cells to grow and regenerate. No other substance in the pharmacopoeia is capable of that."
"Brain cells regenerate?"
"Yes. Do you see the possibilities? This goes way beyond the treatment of Alzheimer's disease. We have the means of sustaining our mental ability indefinitely. There's no reason why we shouldn't make the drug available to healthy people. Young people. Men and women of forty can expect their brains to function just as efficiently when they are eighty. The drug will eliminate the process of aging."
"You mean mental aging?"
Churchward reddened. "Be reasonable. I wasn't suggesting we can make old men young again. That's a job for plastic surgery."
"So it doesn't increase life expectancy?"
He spread his hands in exasperation. "What do you want from me, Mr. Flexner?"
David told him coolly, "I'm trying to get a grasp of this discovery, Professor. If you're looking for congratulations, fine. I salute you. I also want to make sure I fully understand you."
"David, the potential is fantastic," Leapman waded in fast. "People will be capable of a longer working life if they want it. They won't be such a drain on the social budget. They can look after themselves for longer. Men and women of genius will be enabled to go on enriching the world for the rest of their lives instead of fading into senility."
"And we're ahead of the field on this?"
"There are no other runners," said Leapman.
"Some research is being done with nerve growth factor from naturally occurring brain substances," Churchward no thought fit to add, "but it's at an early stage, and of course it's organic in origin."
Leapman said, "They can't compete with a drug."
"You're quite sure we have it patented?"
"You bet we do."
"What about ADRs?" David wasn't entirely ignorant of the jargon. An ADR was an adverse drug reaction, a side effect
"As you doubtless know," said Churchward with unconcealed irony, "every drug has ADRs. It's a matter of weighing them against the benefits. PDM3 has some temporary contraindications. It produces mild headaches in some subjects, nausea and dizziness, but we also noted those effects in people receiving a placebo drug."
"To the same degree?"
"Not quite the same," he admitted. "However, a high proportion of the subjects manifested no ADRs at all."
"What proportion?"
"Up to sixty-eight percent."
The figure was meant to impress David, and it did. "What about long-term effects? I suppose it's too soon to judge."
The professor said, "There is no evidence of any lone-term ADRs."
"There wouldn't be, would there? Did you detect any ADRs in the animal tests?"
"In a few cases, slight elevations in liver enzymes."
"Isn't that a problem?"
"A problem would be putting it far too strongly. The liver has an excellent facility for regeneration, so if the dosage is monitored correctly, there is no danger."
"How do you tell, Professor?"
"By taking blood samples."
"If we want to market the drug, we can't expect people to subject themselves to blood tests," said David, realizing as he spoke that the remark was naive.
Churchward clicked his tongue and said nothing.
Leapman cleared his throat and said, "I think there's a slight confusion here."
"I'm confident that we can resolve the matter in the trials," said Churchward. "It comes down to an acceptable dosage, if that is a term we all understand."
Almost everything the professor said was laced with contempt, and David couldn't understand why. He felt inept He was sure his father would have handled this interview with less confrontation-in fact, with a mix of humor and impudence-yet Manny would still have managed to elicit the crucial facts. "Don't get me wrong," he said. "I'm just trying to cover every angle. I understand about adverse reactions. I take your point that every drug has them to a greater or lesser degree. If you want to stop a cancer, you don't care so much if your hair falls out, right? The difference is that we wouldn't be treating a disease with PDM3."
"We'd treat Alzheimer's," said Leapman.
"Yes, but the professor is talking about offering this drug to fit people."
"Hold on," said Churchward. "The first thing is that PDM3 is remarkably effective in the treatment of Alzheimer's, which was the subject of my research. We can safely go to Phase Three now."
"But you're also confident that it improves the function of the healthy brain."
"Improves, no," Churchward corrected him. "It can extend the time scale of its efficiency."
"Fine-but if we sell it to healthy people we're not balancing those ADRs, the nausea and the giddiness and the increase in liver enzymes, against a dangerous disease. We're asking them to accept risks."
"I don't accept that. Let's not talk about risks. We would eliminate risks. There might be some inconvenience or discomfort," said Churchward. "That's up to them. Plenty of popular foods and drinks produce more disagreeable symptoms than PDM3. Health products, too. You take a multivitamin and there's a chance it will give you constipation."
"So PDM3 is as safe as a vitamin tablet?"
"In the proper dosage, yes."
"It's what Manny was looking for all his life," said Leapman, spacing his words and speaking on a rising, evangelical note. "A surefire product that will take the mass market by storm."
David thought of his father. He remembered that bizarre wink in the morgue. The incident couldn't have meant anything, but it would never be erased from bis memory. "So when do we go public on this?"
"I'd say tomorrow if we want to keep Manflex afloat," said Leapman. Quick to note David's startled reaction, he added, "At this stage, we just have to announce tomorrow that we'll be hosting a conference soon to present the first studies of a new drug for Alzheimer's. That's enough to restore some confidence."
The decision couldn't be put off. Now David felt bis sweat go cold against his T-shirt He looked towards Churchward.
"That's fine by me, gentlemen," the professor said, positively fraternal. "I'm ready to publish."
"We're not going into production yet," Leapman told David in reassurance.
"Yes, but once we've made this announcement, there's no drawing back, or it'll play hell with our rating on the stock market"
"Agreed," Leapman said cheerfully.
David was still troubled. "The next step is going to require funding. Millions, probably. Clinical trials on a wide scale don't come cheap. And if we get FDA approval, we'll require massive new investment to launch this drug."