15 JUNE
At the Yamoura Pharmaceuticals office in Washington, Bob Denman spotted the Maryland postmark and the label addressed to ‘The Company Secretary, Yamoura Pharmaceuticals’. He hardly needed to open the envelope to know what the letter – on its expensive headed paper – said.
Re: Federal Food, Drug and Cosmetic Act and Related Regulations
Dear Sir/Madam,
On behalf of the Authority I am required to advise you that the Division of Drug Marketing, Advertising and Communications wishes to inquire into the advertising of claimed benefits to patients consuming SuperVerve tablets. Copies of sample advertisements are enclosed, together with text of broadcast advertisements.
In accordance with normal procedures, the inquiry will be assisted by an Advisory Committee of three suitably qualified independent medical practitioners, not, as yet, nominated. You are now required to provide the Authority with all available scientific evidence to support the advertised benefits, including expert medical reports, safety statements and clinical trial results.
We look forward to having your cooperation throughout this inquiry. Please write to the undersigned and formally acknowledge receipt of this communication.
Yours faithfully,
Maurice Chadwick,
Regulatory Review Officer
Division of Drug Marketing,
Advertising and Communications.
‘Hmmph,’ snorted Denman. Usual guff. He flattened the letter down in his scanner, saved it as SuperVerve/FDA, clicked forward, selected Yohoto’s email address and hit send.
*
At the Chess Club meeting two days later, the letter was the main item for discussion.
‘So, we are agreed, gentlemen,’ said Lumo Kinotoa. ‘We should demonstrate that we are taking the matter very seriously, but we will delay everything as best we can.’
‘Yes,’ said Dr Naga. ‘We write back with promises of our full and enthusiastic cooperation, our sincere belief that any inquiry will completely vindicate our advertising, blah, blah.’
‘No,’ said Tsan Yohoto, ‘that’s letter number two. Our first letter should thank them for their interest in our product, but point out that cephalosporin is already FDA approved.’
‘But they know that,’ said Dr Naga.
‘Of course they do,’ Tsan Yohoto smiled, ‘but it will add another two weeks to any inquiry, while they circulate our letter and someone writes a response.’ Now they all smiled.
*
PATRICK J. BROCK MEMORIAL HOSPITAL, BROOME STREET,MANHATTAN – 16 JUNE
Irene Sefton, the hospital administrator, was running her usual Monday morning review meeting with the Heads of Departments. As usual, the room was packed, with most of the doctors having to stand.
‘Okay, guys, good morning, thanks for your attendance, hope you all had a good weekend,’ she sing-songed. ‘All righty – item one, last seven days, any unusual patient events or complaints?’
After no one else volunteered anything, Dr Conrad Jones, who was sitting on the edge of a desk near the back, put his hand up.
‘One from my side, Irene,’ he said, and then looked down at the open chart on his knee. ‘Mrs Esther Wolfowitz, eighty-two years old, admitted on the eighth, suspected food poisoning, diarrhoea, vomiting, dehydration. Prescribed IV fluids and antibiotics. Slight improvement for two days on fluids. Died Saturday 3 p.m.’
‘Okay, Conrad. She was fairly elderly; why your particular concerns?’
‘Her son’s a lawyer from Connecticut. He was there when she died. Took it very badly. Got aggressive with the house doctor. Said that another person who got food poisoning from the same barbeque was hospitalised in Connecticut and discharged in good shape, three days later. Says he’s going to sue our ass.’
‘I see, thanks for alerting me. You happy with our procedures?’
‘Yeah, I’ve reviewed the file. She came in through the ER, by ambulance. Looked like a routine food poisoning. Letter from referring doctor. Responded to fluids, stool culture confirmed e-coli infection.’ He flicked through the file. ‘Temperature stayed high. She became very toxic. No response whatsoever to IV cephalosporin. Looks like she died of peritonitis.’
‘Valerie?’ the administrator enquired of the Head of ER. ‘You happy with the procedures on admission?’
‘Yes, Irene, one hundred per cent. I’ve read the notes, spoken to everyone.’
‘So, thanks for the warning. Make sure you keep your files safe. We’ll wait for the autopsy report.’ As the doctors shuffled out at the end of the meeting, Valerie Mahler walked alongside Conrad Jones.
‘That’s sad, that poor lady. Apparently, her son was shouting that she didn’t survive Auschwitz to die from food poisoning in a New York hospital. You think he’ll litigate?’
‘Nah.’ Conrad Jones shrugged. ‘He told one of the nurses that he was the one who cooked the burgers. I think he’s got enough on his mind.’
*
‘It’s not your fault, David. How were you to know? You were such a good son to her. Always visiting. Always calling.’
Sidney Wolfowitz was distraught. His sobs echoed around the kitchen as he sat hunched and red-eyed over the table. David hugged his dad tighter, tears streaming down his face.
‘C’mon, Dad. You’ve hardly eaten in two days, let’s get out. It’ll do you good.’
Sidney numbly agreed and five minutes later David still had his arm around his dad’s shoulders as they walked, teary eyed, to the nearest BurgerFantastic.
*
Dr Peter Phillips stood up to greet a new patient. ‘Hi, Ms Sheperd. Take a seat. How can I help you?’
‘Hi, doctor. Call me Cindy.’
‘Sure, Cindy.’ Smiling. ‘Are you feeling unwell?’
‘No, doctor, to be honest I’m fine. It’s just that I’ve been struggling with my weight and I could do with a little help.’
‘Okay. Do you mind if I take your blood pressure and do a few little tests?’
‘No problem.’
‘Can you please step on the scales? And I’ll check your height.’
After a few questions about Cindy’s diet and lifestyle, Dr Phillips concluded that his patient was perfectly fit and well, although perhaps a few pounds overweight.
‘You’re in good shape, Cindy. I wouldn’t be worrying. A little less fat and sugar in your diet will get that cholesterol number back into the normal range.’
‘Thanks, doctor. I’ve been hearing a lot about these SuperVerve tablets and how they can help with weight loss. Do you think I could try them?’
Peter Phillips hesitated for a moment. Yet another SuperVerve prescription. There’s far too much of this antibiotic sloshing around, and God knows how it’s supposed to help with weight loss. Still. If I don’t write the script I’ll lose a new patient. And Yamoura will move on to some other product before long. And there’s that trip to Tokyo . . .
‘Sure. I’ll give you a prescription for repeats up to six months, if you feel you need them. Always finish the course and take the tablets at regular intervals.’
Five minutes later Cindy was heading for the drug store on the corner.