Sick Money

The Truth About the Global Pharmaceutical Industry

Billy Kenber

• Publisher: Canongate Books
• Year: 2021
• ISBN:
  9781838850272
• Topic: Medicina
• Subtopic: Farmacologia

THE PHARMACEUTICAL INDUSTRY IS BROKENFrom the American hedge fund manager who drastically hiked the price of an AIDS pill to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system built to drive innovation and improve patient care has been distorted to maximise profits.In Sick Money, the investigative journalist who exposed a billion-pound British price-hiking scandal goes inside the global battle over high drug prices. From secret deals to patients forced to turn to the black market, Billy Kenber reveals how medicines have become nothing more than financial assets. He offers a diagnosis of an industry in crisis - and a prescription for how it could be fixed.

CHAPTER ONE

Apothecaries, pills and guns

It began with a stroke of fortune. An absent-minded Scottish scientist neglected to close the window in his London laboratory as he left for a month’s holiday in his country home. When he returned from Suffolk, Alexander Fleming was greeted with a collection of Petri dishes discarded from a previous experiment and waiting to be disinfected for reuse. That summer in 1928 he had been studying Staphylococcus aureus, a common bacteria which, undisturbed for several weeks, had spread across the shallow glass plates. One plate, however, was different. Here a blue-green mould had developed and at its edges the bacteria had disappeared. The substance responsible, which Fleming called ‘mould juice’, was a rare strain of the mould penicillium – he had discovered one of the world’s first antibiotics.

Fleming wrote up his findings for publication in a medical journal but he gave up on the substance he’d extracted from the mould, penicillin, after a year, unable to isolate the unstable compound and concluding that it was likely to be too toxic for clinical use anyway.¹ His discovery therefore remained undeveloped for another decade. In the meantime, the research director at German chemical company Bayer, Gerhard Domagk, had identified that a red dye, which was given the name Prontosil, cured infections caused by the bacterium streptococcus. French scientists subsequently identified the reason it was effective: a chemical in the sulphonamide group which became the basis of sulpha drugs made by dozens of pharmaceutical companies. Domagk’s breakthrough in 1932 was the most significant discovery since his compatriot Paul Ehrlich’s 1909 discovery of Salvarsan, a treatment for syphilis, and it reopened the hunt for what Ehrlich had termed ‘magic bullets’: chemicals which could target and kill microorganisms without harming the host.

In 1938, the biochemist Ernst Chain, a German Jewish emigré who had been recruited to work at the Sir William Dunn School of Pathology in Oxford, decided to join that search for compounds with antibacterial properties. He read Fleming’s earlier paper on penicillin and suggested to his supervisor, the Australian-born Howard Florey, that they try to isolate the active substance from the mould juice Fleming had captured.² They were eventually able to extract and semi-purify penicillin as a brown powder. By the spring of 1940, as war raged in Europe, it was ready to be tested on animals. Following the same procedure Domagk had used to test Prontosil, several mice were infected with a virulent bacteria and half were then injected with penicillin. The next morning, the mice that had received penicillin were still alive while the others were dead.³

Buoyed by the success of the experiment, the scientists turned their Oxford laboratory into a factory, rigging up a complicated system of baths, toilet cisterns and milk churns to produce enough penicillin for human testing.⁴ The first patient treated was Albert Alexander, a forty-three-year-old policeman with a face wound which had become badly infected.⁵ After being injected with penicillin he began to improve within hours but Florey and Chain’s supply of the drug was very small, so small in fact that they took to extracting penicillin from his urine and re-using it. After several days, they ran out of penicillin and had to stop the treatment. The policeman died a month later.⁶

Their lab couldn’t scale up production any further so it was clear that Chain and Florey needed help. The British drug industry was itself relatively small and it was struggling with wartime demands to begin manufacturing medications which had previously been the exclusive domain of German pharmaceutical companies. With little prospect of assistance from domestic firms, Florey and a colleague called Norman Heatley travelled to the United States with hopes of securing the help of American drugmakers. On July 9, 1941, they were in Washington DC visiting the US Department of Agriculture where they expected to meet a senior administrator responsible for four research laboratories. The man they sought was away on a trip, however, and in his place, serving as Acting Assistant Chief of the Bureau of Agricultural and Industrial Chemistry, was Percy Wells. As luck would have it, Wells had spent the last decade specialising in mould fermentation and so when he heard Florey explain his predicament he knew exactly where to turn. That afternoon he sent a telegram to his former colleagues who had just been relocated to the Northern Regional Research Laboratory (NRRL) in Peoria, Illinois.⁷ The reply came back the same day: ‘Suggest they visit Peoria for discussions. Laboratory in position to cooperate immediately’, the missive concluded.⁸

Florey and Heatley visited a few days later and the team in Peoria were soon put to work trying to improve the yield. The NRRL scientists rapidly made some important breakthroughs. One member of the team, Andrew Moyer, who had years of experience in growing moulds, switched out the brewer’s yeast used by the British researchers for large quantities of corn steep liquor, a change which resulted in a thirty-fold increase in production. Government scientists also experimented with switching from growing surface cultures to using deep-tank fermentation, which proved far more effective.⁹

These advances helped to persuade American manufacturers to join efforts to make the antibiotic on a mass scale. Alfred Richards, an American pharmacology professor who had been tasked with overseeing medical and scientific projects with the potential to bolster the war effort, initially struggled to convince drug companies to help. They were sceptical of their ability to produce the quantity of penicillin required for medical testing and of the risks investment would represent. Richards’ requests were twice rejected. It was only at the third time of asking, at a meeting held less than a fortnight after the Pearl Harbor attacks had brought the United States into the war, that the mood changed. Drug executives were presented with a report showing the impact the corn steep medium had made on increasing the yield. This led George Merck, the president of Merck & Co., to make the decisive move. He pledged his company’s support, saying that, ‘if these results could be confirmed in their laboratories it was possible to produce the kilo of material for Florey, and industry would do it!’¹⁰

Merck was joined by three other drug companies – Pfizer, Lederle and E.R. Squibb – in taking up the task. They struck agreements to share information and successes but scaling up production proved tough going. Six months after that December 1941 meeting, Merck had only produced enough to treat eleven patients.¹¹ Fortunately, government scientists once again came through with a critical discovery. In 1942, the Peoria team launched a search for different strains of penicillium mould in the hope that they might be able to locate one which would prove more productive than that captured by Fleming. With the help of the US military, strains were obtained from soil collected all over the world but it was one drawn from a mouldy cantaloupe melon bought in 1943 at a local market in the Illinois town where the research laboratory was based which proved to be the best.¹² It could produce as much as 100 times more penicillin than Fleming’s strain, and X-rays and UV rays were used to increase its productivity further still.¹³

By the spring of 1944, boosted by government funding, tax breaks and Pfizer’s experience with deep-tank fermentation, twenty-one factories were at work, among them a converted ice plant in Brooklyn which housed fourteen vast 7,500 gallon tanks.¹⁴ Posters on the walls of fermentation plants declared penicillin ‘the new life-saving drug’ which ‘Saves Soldiers’ Lives!’ Workers were urged on with the words: ‘Men who might have died will live . . . if YOU give this job everything you’ve got!’¹⁵ When D-Day arrived in June 1944, penicillin was in sufficient supply to save thousands of soldiers’ lives during the Normandy landings and subsequent Battle for France. By the end of the war, drug companies were producing millions of sterile packages each month, enough for it to be released for civilian use.¹⁶

* * *

Penicillin was hailed as the first ‘wonder drug’ and the successful drive to produce it on a mass scale would help to launch the modern pharmaceutical industry. For much of the preceding century, medicine had been the preserve of apothecaries and quack doctors who hawked nostrums to the unsuspecting public. These were little more than folk remedies, mixtures of herbs, alcohol, opium and cocaine packaged up and sold with evocative names and elaborate promises. Among the most popular were a ‘cure-all’ brandy-based concoction sold in Britain as Dr Samuel Solomon’s Cordial Balm of Gilead and Lydia E. Pinkman’s Vegetable Compound available in the United States as a ‘women’s tonic’.¹⁷ Another American treatment, Kopp’s Baby’s Friend, was a mixture of sugar, water and the powerful painkiller morphine, which was sold as a means of calming infants into the early part of the twentieth century.¹⁸

Those selling the ointments and powders were under no obligation to disclose what was inside; in fact this was typically a closely held trade secret, and nor was there any requirement to demonstrate that they were safe to consume or could deliver the promised benefits. By the start of the twentieth century, pressure to regulate the sale of nostrums, which, somewhat misleadingly, were known as patent medicines even though they didn’t rely on patents and often had few medicinal qualities, led to legislation on both sides of the Atlantic. In the United States, the 1906 Pure Food and Drugs Act and subsequent amendments banned medicines from being labelled with false claims, although it would take another thirty years before regulators were able to ban dangerous ingredients.

As so-called patent medicines gradually began to fall out of favour, a new type of drug company was on the rise selling ‘ethical drugs’ with products rooted in science. During the nineteenth century, advances in organic chemistry had enabled the isolation of specific active substances extracted from plants which could be purified and used as medications. These early drugs were typically compounded by pharmacists for patients as they waited in their shop but some began to see the potential of making these products on a larger scale. Among the first was Heinrich Emanuel Merck, the descendant of generations of apothecaries in the German town of Darmstadt. The expanding business he oversaw began selling morphine commercially in 1827 and by the close of the century had expanded to the United States, where pharmacists were also beginning to move into manufacturing on a larger scale.

Pfizer can trace its roots back to 1848 when it was founded by two German immigrants who opened a small chemical plant in Brooklyn. A few years later, Edward Robinson Squibb, a former naval doctor, opened a similar business nearby. Both flourished during the American Civil War from 1861 to 1865 when there was great demand for painkillers and other treatments including morphine, iodine and chloroform. In the years that followed several of the other modern pharmaceutical giants were established. Parke-Davis was founded in Detroit in 1866, a year after the war had finished. Eli Lilly, a chemist who had served as a colonel on the Union side, opened a manufacturing facility in Indianapolis in 1876 and began producing the antimalarial quinine. Abbott Laboratories began making alkaloids near Chicago in 1888, a couple of years after Upjohn had started producing drugs in Kalamazoo, Michigan.

In the same period, dye manufacturers in Germany and Switzerland were experimenting with the possible medicinal benefits of their products. These companies were some of the first to employ chemists, among them Felix Hoffmann, who in 1897, while working for the German dyemaker Bayer, then F. Bayer & Co., managed to synthesise pure acetylsalicylic acid.¹⁹ The new drug removed the stomach irritation which plagued users of salicylic acid, the most commonly available pain reliever sold by rivals. It was given the trade name aspirin and would remain one of the most widely used medications in the world more than a century later. Another of the bestselling medicines of the period was Salvarsan, the syphilis treatment discovered by Ehrlich when experimenting with chemical dyes, but most medicines were simple, purified versions of naturally-occurring substances. The discovery of new drugs remained rare. In part, this was because of the industry’s relationship with scientists and the medical establishment’s deep-seated mistrust of commercial motives. The idea of these early pharmaceutical companies carrying out scientific research was met with great scepticism if not outright horror. The intrusion of commerce into the world of science was seen as an affront to the unbridled pursuit of truth and knowledge to serve the public good.

The British Medical Research Council, the American Pharmacological Association and the French Académie Impériale de Médecine all opposed cooperation between scientists and the drug industry in the early twentieth century, and this mindset extended to the use of patents.²⁰ It was believed that scientists should not seek to prevent the flow of information and ideas by patenting something which could have medical uses. Medical researchers would frequently refuse to cooperate with clinical trials ‘merely because the products to be tested were patented’ and it wasn’t until 1950 that the British Medical Association dropped this opposition.²¹ German companies, however, took a different view.²² After developing a stable and pure form of acetylsalicylic acid in 1897, F. Bayer & Co. rushed to patent aspirin wherever possible. The company received a patent in the United States and was initially successful in Britain, too, although it was overturned a few years later after a court ruled it had previously been synthesised.

When the First World War broke out in 1914, German companies were the global leaders in the fledgling pharmaceutical industry, but the conflict forced firms in Britain, France and America to catch up. The American government passed a law which confiscated patent rights from German firms and awarded them to domestic companies. The conflict engulfing Europe meant many of the German-made chemicals needed to make important drugs were in short supply and, with necessity the mother of invention, governments tasked pharmaceutical companies with finding alternative means of creating these medicines. Burroughs Wellcome, the British firm with the most advanced scientific capabilities, came up with a substitute for the German drug Salvarsan within a year and also made versions of aspirin and a treatment for typhoid.²³

Something similar would happen during the Second World War two decades later when companies were once again forced to compensate for lost supply routes. That conflict also created demand for treatments for exotic diseases which had previously been of no significant concern to Weste...