Сергей Пузанов – Multiple Sclerosis. Everything you need to know (страница 16)
By the early 1990s, interferons were the talk of the town.
When the clinical trials for Betaseron wrapped up in 1992, MS patients were desperate for a miracle. On one side of the scales was Chiron, a small biotech firm from California; on the other was the FDA, the rigid federal regulator. Chiron’s scientists had managed to replicate interferon beta-1b using genetic engineering, but they lacked the capital to fund large-scale clinical trials, so they partnered with the pharmaceutical giant Schering AG. When the data came out, it showed a 30% reduction in the annual relapse rate, and Chiron began celebrating a victory over MS. But the boring bureaucrats at the FDA were deeply skeptical. They flagged the side effects and toxicity levels as monstrous, the surrogate endpoints as highly ambiguous, and the link between relapse reduction and actual disability progression as completely unproven. The FDA's verdict was a hard no: "Denied for accelerated approval; return to multi-year clinical trials."
What followed outside the FDA offices in Maryland looked like a civil war. MS patients joined forces with radical gay rights activists from ACT UP. In a series of DIE IN protests, hundreds of people with crutches and wheelchairs blocked the entrance to the FDA building, acting as living symbols of a bureaucracy that was killing them by withholding drugs. They chained themselves to the doors, railings, and parking gates. The police were at a total loss: arresting and dragging disabled people into paddy wagons under the glare of rolling TV cameras was a public relations nightmare. Protesters breached the perimeter, occupying waiting rooms and staging sit-ins in the hallways. Some brought literal coffins painted with the names of people who had died or become severely disabled while waiting for approval. This dramatic footage ran on every major news channel every single night. Terrified by what they saw on TV, senators and congressmen flooded the head of the FDA with calls demanding to "fix this issue immediately."
The ugliest part of this story? The protests outside the FDA were quietly bankrolled by the very companies manufacturing the interferons—Berlex and Chiron. Money was funneled to MS advocacy foundations under the guise of "educational grants" or "patient aid." These foundations, in turn, coordinated the logistics, managed patient databases, and paid for busing disabled people to the rallies in Maryland. Corporate lawyers leaked internal FDA data to the activists—flagging exactly which documents were stalled, which bureaucrats were pushing back, and which offices needed to be targeted next. Worst of all, the patients genuinely viewed the pharmaceutical companies as their allies. Amid the emotional crossfire, the world became black and white: the FDA bureaucrats were the villains standing between sick people and a life-saving miracle.
Betaseron rammed through US approval in the summer of 1993. The official press releases from the FDA and statements by its head, David Kessler, were a masterclass in political gymnastics. Publicly, the officials fiercely denied that they were bowing to the pressure of the streets; privately, they admitted that ignoring the riots was completely impossible. Publicly, they maintained that the protests hadn't lowered their safety standards; privately, they complained that the pressure was unprecedented and entirely paralyzing. Publicly, they claimed they had listened to the voice of the terminally ill; privately, they hinted the orders had come from the White House. This decision warped the FDA forever, transforming it from a closed academic registry into an agency that is forced to bow to public opinion.
By the way, the word "lottery" in this context isn't a metaphor—it was a literal draw. At the moment of Betaseron sudden registration, the US harbored about 250,000 MS patients, with roughly a third matching the criteria for the relapsing-remitting track. At launch, Berlex (the subsidiary of Schering AG handling distribution) could only manufacture enough medicine for 15,000 patients. Distributing it on a first-come, first-served basis would cause absolute riots at pharmacies. Selling it only to the ultra-wealthy would invite public destruction by enraged activists. So, Berlex hired an independent firm and launched the first-ever pharmaceutical lottery.
There were 67,000 applicants for just 15,000 available slots. More than 50,000 people walked away not with medicine, but with a waitlist number. Holding a number like 48,512 meant you wouldn't see the drug for another two or three years. This lottery single-handedly dictated the financial trajectory of the DMT market for decades to come: when you have a product with a 50,000-person waiting list, you can charge whatever the hell you want—insurance companies won't dare object. The lottery was executed right inside neurologists' offices, leaving furious doctors accusing Berlex of "playing God" and outsourcing moral responsibility to a piece of soulless software.
The end of 1993 marked the absolute peak of global hope for interferons. The scientists at the FDA could only watch in disbelief. They knew they were rubber-stamping a drug that had zero impact on the actual rate of disability progression, but they were powerless against public hysteria. Marketing had triumphed over biological reality. Under the thunderous applause of hundreds of thousands of deceived people, interferons hit the pharmacy shelves.
Interferons Beta-1b
Interferons are a family of signaling proteins naturally released by the immune system whenever a virus breaches the body. They were discovered entirely by accident in 1957 by Alick Isaacs and Jean Lindenmann at London’s National Institute for Medical Research. They stumbled upon a fascinating biological anomaly: the presence of one active viral infection blocked a second independent virus from multiplying, both in chicken embryos and lab mice. They termed this "interference"—essentially, a biological obstruction.
The very first drug approved to treat multiple sclerosis was interferon beta-1b. Marketed under the brand name Betaseron, it rammed through US registration in the summer of 1993 following the riots outside the FDA. The annual price tag was set at $9,882—an astronomical, shocking figure that broke the financial baseline of American medicine forever. The drug cost dozens of times more than any standard medication of the era, and the manufacturing deficit—which forced the therapy to be rationed via a randomized computer draw—only fed the hysteria. For comparison, the average annual salary of an American in 1993 sat at $26,362. Insurance companies were forced to engineer a brand-new coverage category called "Specialty Drugs"—prior to 1993, they had never faced a reality where a routine retail medication cost as much as a used car. Betaseron became the most expensive self-injectable drug you could take at home.
This is exactly how the era of DMTs kicked off—built on magical interferons, genetic breakthroughs, wheelchair riots, a corporate lottery, and mind-boggling prices. Betaseron's registration locked down the rules of the market for decades: from that moment on, FDA officials became terrified of MS patients. Prices continued their upward spiral: today, the annual cost of interferon therapy bounces between $80,000 and $140,000—while the median US salary sits around $62,500. The price inflation of interferons has outpaced standard economic inflation several times over, even though any manufacturing deficits vanished decades ago.
In Europe, interferon beta-1b arrived two years later under the name Betaferon. The lag occurred because on November 1, 1993, the European Union was born, and its unified drug regulator, the EMA, didn’t fire up its engines until January 1995. The application for interferon beta-1b became the first-ever high-tech drug submission managed through the new "centralized procedure." It was a high-stakes exam for the brand-new regulator: the agency desperately wanted to prove it could operate faster and more efficiently than the American FDA. Approval went through in record time—by November 1995, just 10 months after the agency opened its doors, the European Commission granted Betaferon its license. European patients, who numbered around 350,000 in 1995, were ecstatic.