Lying in bed, or staring at lines on her computer screen, Olympia’s mind often wandered over the fact that the vaccine she was working toward wouldn’t do what she said it would. It might seem to work, mostly, as measured by studies that would have the same constraints of the lab. At worst, the mutations she put into the world could open up some unanticipated pathway that made the virus deadlier than ever. Her own mother might have died because of assumptions like that: for years the hormone replacement therapy she’d been put on was the darling of epidemiology, a miracle of modern medicine that could put off the sweating of menopause, as well as diabetes, kidney failure, osteoporosis, heart attack, and other side effects associated with that disease called aging. It wasn’t long after she died that studies began to show that tens of thousands of women had been killed by the cure.
A former colleague had been so sure that the mosquitoes
he altered would eradicate dengue that he released them into the wild: an entire species, Aedes aegypti, changed forever by one overweening man, the gene drive he’d embedded into them to override evolution jumping to Anopheles gambiae mosquitos, then flesh-eating blowflies, the mutation spreading like an oil slick threatening to tar the ecological balance of an entire continent….
Despite the element of chance that was always there, Truth wins out in the end, her teachers used to claim, zealots to their faith. But to believe that, you had to believe that time was infinite, while in the meantime, if the vaccine she was chasing turned out to only work on the birds in her lab, wouldn’t the world be
better off without it?
Still…. She didn’t know it wouldn’t work. And tweaking the data wouldn’t change the result—it would just get the study to its conclusion faster. Was that being dishonest? As though in answer, she thought of the Dr. Naoki Mori papers: studies that researchers all over the world downloaded, and based their own
work on for over ten years, until someone noticed how Mori had fudged the data, relabeling slides and presenting them as different measurements because he thought that more research would just show the same thing. Or so he claimed.
What if she got caught? Well, ‘caught’ was too harsh a word: say, ‘discovered.’ No, ‘corrected’ would be more accurate.
Even if truth did win out, what good would it be to those too dead to get the news? People who might have been saved if the money and time spent on her solution went into one that actually worked, the way thousands could have been saved had Trump not pretended the Covid-19 pandemic didn't exist? Or at least hadn’t had its data ‘tweaked.’ If civilization ends before science is able to arrive at that one, unified, objective and verifiable Truth that needs no explanation because it is itself—a Möbius strip of both theory and demonstration—did that mean they would all have been wrong? The history of science a history of failed theories? A result always bestows meaning and significance upon all that comes before it.
She knew how the process worked long before she was part of it. But it was still shocking in the way that everyone knows about auto accidents, but can only understand their force, their violence, after they’ve been in one.
The success of what she did in her lab would be measured by lawyers and patent officers, and businessmen with pinkie rings instead of other biologists; her very conclusions would be co-authored by a web of venture capitalists and day traders…. The box office was the only movie review that mattered, a producer on TV once said, but he may as well have been talking about insurance adjusters, and doctors who may or may not be persuaded during the free Alaskan cruise they were given for sitting through a sales pitch to prescribe Aleve, an anti-inflammatory drug that reduces protein fragments associated with Alzheimer’s, if anti-inflammatory drugs in fact reduced protein fragments, which was unclear, and if reduced protein fragments helped with Alzheimer’s, which was even more unclear.
A circle: The old man who takes his Vioxx with his morning juice and twelve other prescriptions, orbiting the pharmacist who oversees the program run by operators who work for the mail-order house—a circle—stocked by the insurance company that has a raft of legal agreements—a circle—to buy in bulk from Big Pharma which was developing dozens of drugs—a circle—in the hopes that one would be a hit, the way a record company might back a dozen singers, knowing that it only took one to float everyone’s boat—a circle—farming out the development of one drug that they held the patent on but didn’t have the facilities to develop to a struggling biotech company that had facilities but only duds in the pipeline, this Little Pharma company that could, getting a big boost by being ‘partnered’ with Big Pharma—a circle—putting in 25% of the development cost in exchange for 5% of the profits, the deal they formed with Big Pharma—a circle—raising their stock from $32.04 to $32.84, which some investors took as their cue to cash out, and others took as a sign to jump in—a circle—a layoff-enhanced upturn in cash-on-hand making them look better on paper though they were no different in bricks, and inspiring a new spin in the revolving door of financial backers—a circle—allowing the company to start another 8-year cycle—a circle—like cicadas digging in—trying to convert an antibacterial drug that didn’t get FDA approval because too many people in the study died before the drug could take effect, clouding the data, and so causing the company to rethink their drug as a medicated anti-acne cream—a circle—a terrorist attack suddenly giving the original antibacterial drug new life—a circle—politicians looking to look like they were doing something about bioterrorism—a circle—not because they were worried about people being hurt by anthrax, that likelihood being statistically somewhere between nonexistent to less than being struck by lightning—a circle—went looking for companies to pour money into—Invest in America’s BioDefense, they called it—and they ended up with $35 million of Biodefense funding to help develop the anti-acne cream back into an antibacterial drug in defense of the nation….
“Does it work?” she’d asked.
“Depends what you mean by ‘work,’” Brian had answered.
“And ‘it,’” Sid added.
Thalidomide, the wonder drug for morning sickness, headaches, coughs, insomnia, and colds, ends up causing babies to be born without arms or legs, without ears or genitals, eyes or large intestines. Fifty years later, its maker, Grünenthal, regrets what happened, but still insists it wasn’t their fault since the drug had been approved by the best testing methods available at the time.
Truth won out, they say.
You got to take the long view, Brian said, and even if a drug turns out to not do what it claims, it can still keep labs running until they find a better solution, and what’s so bad about that?
It takes 7 to 8 years on average to bring a drug to market.
Johnson & Johnson’s Velcade, a drug that shrinks tumors at $48,000 per year per patient.
Four makers of a multiple sclerosis drug have agreed to offer a 10% discount on the annual price, now $18,000 per year per patient, if the drug didn’t work.
GlaxoSmithKline made similar agreements with two European governments though it won’t say which countries or drugs are involved.
Pfizer, which makes the best-selling cholesterol pill Lipitor and other cholesterol-lowering drugs, was asked to pay the expenses of patients who had been on the drug and still had heart attacks.
Velcade, a drug that works against bone marrow cancer, was recently dropped because, as its maker put it, it was not ‘cost effective.’
Should a drug that shrinks tumors 50% of the time be considered ‘successful’ or should 25% be considered the minimal ‘successful’ response? What if you’re in that 25%?
Dr. Diederik Stapel was found to have fabricated data for years in scientific papers he published in over 30 peer-reviewed journals, such as Science, where his data showed that a messy house can encourage its occupants to be racists.
There are so few cases of malpractice because scientific fraud is easy to perpetrate but hard to uncover. “It’s like asking how much of our money is fake money,” as one reviewer put it, “we only catch the really bad fakers, the good fakers we never catch.”
An analysis of the images published in the Journal of Cell Biology found that about 1% had been deliberately falsified, while in a confidential survey of scientists, 33.7% admitted to other questionable research practices.
The Guidant Corporation agreed to pay $195 million to settle claims for a defibrillator that used electricity to interrupt a chaotic heart rhythm after 7 patients died when the Ventak Prizm 2 Model 1861 failed to work because of faulty insulation. The company became aware of the problem in 2002 but kept shipping faulty units until a journalist posted an internal memo leaked to him about the wiring.
The science journal Nature reports a rise of 1,200% in retractions in scientific journals over the last ten years.
After Raptiva was shown to not work on AIDS, it was repackaged and sold to treat rough, red, scaly skin—until it was shown to be even better at making fatal brain infections….
Jazz Pharmaceuticals, a maker of the narcolepsy drug Xyrem—the prescription name for the street drug Gamma-Hydro-xybutyrate, or date-rape knockout drug—pleaded guilty to felony charges after having been shown to have improperly promoted the medicine for unapproved uses. Though the drug is in the same class as heroin, it has 120,000 legal patients. The company tried to widen this ‘audience’ by promoting it for unauthorized uses: depression, insomnia, and fibromyalgia, a pain disorder. Did it work for these?—Hard to say, a doctor said at their trial, since the drug was never tested for these uses. Nevertheless, a spokesman for the company claimed that this is a free speech issue, and they will be pursuing legal action against the whistleblower, a former saleswoman for Orphan Pharmaceutical, who was awarded part of the $20 million settlement.
The FDA stopped Xoma and the Harvard Medical School from using Neuprex to treat Meningococcemia, a deadly bacterial infection that afflicts children and can kill them within hours. Too many patients died after receiving the drug for the company to demonstrate that it increased survival rates so they converted it into a drug for acne.
Leading Causes of Death in U.S.:
1 Heart Disease
2 Cancer
3 Medical Error
Mediator, a drug developed for diabetes but prescribed as a slimming aid, has been linked to hundreds of patients who developed heart problems.
Dr. Hwang Woo-Suk was considered a Nobel Prize candidate after publishing in Science first his method for extracting stem cells from cloned human embryos, then, a technique for making stem cell lines from a patient’s skin cell: a method that would allow genetic engineers to make personalized cures. Two years later, someone noticed how he had fabricated his data.
Norwegian researcher Jon Sudbø still holds the record for scientific fraud: the fabrication of an entire 900-patient study ‘carried out’ over a decade, and published in the premier British journal, The Lancet.
The CDC found in tests that the antiviral drugs Amantadine and Rimantadine were ineffective 91% of the time against H3N2 influenza, the dominant strain of the season.
A commission in France found that half of all prescription drugs are worthless and/or dangerous.
The professional federation of medical industrialists denounced the doctors’ report as full of ‘confusions.’
Dong-Pyou Han, who confessed to spiking rabbit blood samples to make the results of an HIV vaccine experiment look better, has been sentenced to 57 months of prison time.
A hedge fund manager takes over a start-up, Turing Pharmaceuticals, which buys Daraprim, a drug for malaria that keeps people from going blind or dying, and raises its price from $13.50 to $750 a pill (and celebrates Trump’s victory by releasing part of a rap album he personally owned).
Days after Valeant Pharmaceuticals acquired the heart drug Isuprel from Marathon Pharmaceuticals, they raised its price 525%.
Rodelis Therapeutics buys the TB drug Cycloserine and raises the price from $500 for 30 capsules to $10,800. Because the drug works better now that they control the supply?
On the stock exchange, Big Pharma is third after Big Oil and Banking. It has bypassed diamonds with profits increasing 20% a year.
Out of a possible 130, Eli Lilly’s bestseller Alimta, a drug for lung cancer—annual revenue of $2.8 billion—scored a zero. Asked to explain why it cost each patient $9,193 a month, they replied that on average patients lived six weeks longer. What did those patients get for the money? Six weeks of suffering? Six weeks to say goodbye? Was it worth it?
When asked to comment, the FDA would only say that it was not unusual for agencies and pharmaceutical companies to evaluate ‘effectiveness’ differently.
See what I mean?