Martin Shkreli is associated with pharmaceuticals’ worst qualities, and he is remembered for his absolute disregard for the lives of the people his medications were supposed to protect. He cared for profit, and profit alone.
But what is interesting is that Shkreli was not an outlier in an otherwise reasonable health care system. Rather, he is a symptom of the American epidemic known to many as Big Pharma.
Drug Costs by the Numbers
Today, medical debt is the top reason for Americans to file for bankruptcy, and pharmaceutical drugs have earned their place in the lineup of unreasonable charges. In 2014, 4.3 billion prescriptions were filled by Americans – that’s approximately 3 prescriptions per person. All those drugs cost $374 billion.
The AARP reported in 2015 that the annual costs of commonly prescribed medications in the US is about $53,000 a year. At the time, the median U.S. household income was $52,000. So even if the average American were spending every dime they had on medications – an impossibility given the necessary expenses for food and housing – they would still be losing $1,000 per year.
Specialty drugs – those designed for rarer or more serious diseases – bring costs to a whole new level making up a third of all spending on medications. For an example, look no further than Sovaldi, a breakthrough drug that revolutionized treatment for Hepatitis C. It is effective, safe, and can be taken orally. It also costs $1,000 a day; for a 12-week treatment course, that adds up to $84,000.
The Drug Approval Process
Even as the cost of prescriptions are going up, pharmaceutical companies are trying to cut costs by reducing the amount of time it takes to bring a medication to market. Unfortunately, this has severe health and safety implications.
Basically, the faster a pharmaceutical company can bring a product to market, the more money they can make. This is especially true of new medications in the U.S., for which their makers receive a monopoly of the market during a drug’s 20-year patent. At an average of ten months long, the drug approval process is faster in the U.S. than in many other countries, but drugmakers and some policy makers want the process to move faster.
The part that takes years are the clinical trials required before a drug company can seek FDA approval. New medications must be proven safe and effective in animals first, then in humans, before an application can be submitted. Furthermore, the FDA has “fast track” and expedited review options that allow certain drugs to receive approval more quickly.
Unfortunately, these faster approvals are not risk-free, and consumers continue to suffer from shortened trial times. About one-third of new drugs approved by the FDA encounter safety issues, many of which were known by the marketers and hidden from the FDA and consumers. Even when issues are unknown, they likely would have been caught with longer and more carefully designed trials. Bad science, rushed by those who want to make money, lets safety slip through the cracks.
The Story of Pradaxa
Pradaxa, a blood thinner that can cause severe bleeding, was fast-tracked when Boehringer paid to have it placed under Priority Review. Not only did this require the FDA to provide a decision in under six months, but it also allowed Boehringer to submit only one clinical trial instead of two, as typically required.
Based on evidence from a later FDA investigation, the sole Pradaxa trial suffered from a number of problems that were only caught after the fact. In fact, the regulatory agency found issues with data at 5 out of 7 Pradaxa testing sites. Some of the mistakes were as elementary as numbers placed in wrong columns, or simply recorded inaccurately.
The trial also had issues with recording side effects. The researchers only tracked the side effects they had expected, ignoring other adverse effects that participants in the trial experienced. Furthermore, researchers only recorded side effects that occurred within six days of a dose. Bleeding risks were not mentioned in the trial’s data at all.
Initially, the FDA refused to approve Pradaxa, but the agency then reversed its decision after a closed-door meeting with Boehringer in December 2010. There was no explanation given for the change.
Within three months of approval, the FDA had received more reports of deaths and serious side effects due to Pradaxa than any other regularly monitored medication. Three years later, the FDA required a Black Box Warning for the Pradaxa, specifically calling out fatal bleeding risks. By this point, Boehringer had made hundreds of millions off of Pradaxa.
Marketing to the Doctors
While pharmaceutical companies are looking to cut costs (and increase risks) by reducing the number of clinical trials they run, they are nonetheless spending more than ever on marketing their medical products.
Two of the most prevalent places Big Pharma advertises are in medical journals and doctor’s offices. In fact, medical journals today sometimes have more adverts than editorial material. There’s a specific reason for this: You can fool a consumer into thinking your medication is the solution to their health problems, but without a prescription, there’s simply no sale.
It seems almost contradictory to have ads in medical journals, and indeed, some editors tried to remove them for the integrity of their published works. But the sad fact is that more than 97% of advertising revenue in medical journals come from Big Pharma advertising, and without them, the journals wouldn’t survive.
This gives corporations a huge amount of leverage to use to their advantage. Some drugmakers won’t agree to buy ads unless the journal includes a favorable mention of their products. In other cases, pharmaceutical companies intone that they themselves would buy more copies, sometimes hundreds to thousands, for an issue that favored them. On top of that, pharmaceutical companies fund many studies found in these journals, further inserting themselves in the editorial process by proxy of the authors.
Going a step further, drug representatives personally market medications to physicians – some even have prescription quotas for “selling” doctors on the benefits of their products. And huge budgets are used to incentivize physicians to prescribe certain medications. These incentives include everything from knick knacks like branded pens to “educational opportunities” taking place on tropical islands. In 2000, drugmakers spent $6 billion on these kickbacks, money that came, no doubt, from the high prices that people pay on a daily basis simply to stay alive.
Ignoring Approved Drug Uses
Big Pharma advertising is manipulative, but it’s not the only problem. In many cases, marketing materials embellish benefits and downplay or completely hide side effects. Some go as far as to market medications for uses they aren’t even approved for!
One prominent example is Risperdal. Despite being indicated only for schizophrenic adults, drugmaker Johnson & Johnson wanted to expand the market for the antipsychotic. So the company began to market the drug for both autistic children and elderly people with dementia – both of whom sometimes suffer from some violent tendencies similar to schizophrenics. One marketer went so far as to plan a “back to school” campaign for Risperdal, including small toys along with samples.
Risperdal wasn’t approved for these age groups for very serious reasons. Children who took the prescription entered premature puberty. Young girls could begin to lactate, and young men could began growing breasts. The drug can also cause insulin resistance, raising the risk for type 2 diabetes. If that weren’t enough, use of the medication by elderly patients was associated with increases in strokes and heart attacks, and therefore deaths. The combination of side effects, deaths and off-label marketing have lead many to file Risperdal lawsuit cases with attorneys.
The Big Pharma Lobby Engine
The pharma industry isn’t only spending money to persuade doctors – it’s also throwing tons of cash at the lawmakers and bureaucrats who regulate them.
Pharmaceutical companies have some of the most aggressive lobbyists on Capitol Hill. In the first half of 2017, Big Pharma companies spent $145 million on lobbying. They gave $4.5 million to campaigns, and spent another $28 million on ads depicting “heroic” researchers. Of the dozens of solutions to the drug price issue that have been proposed in Congress, all have been quickly struck down.
One notable example is allowing foreign drug imports, which would lower costs by allowing consumers to buy medications from outside the U.S., where they are sometimes a quarter of the price. Yet Democrats voted against the proposal, citing worries about the safety of foreign medications. That worry was specifically brought up and pushed by lobbyists for U.S. pharmaceutical companies.
Why We Still Buy
Is there a price you wouldn’t pay to save a loved one? If you’re like many Americans, the answer is a resounding no. Pharmaceutical companies know this, and they use it to their advantage. A 6,000% increase in a drug price can happen because the law allows it to, and because people will pay anything to save a life.
The system is unethical at its core, built to put the needs and safety of the consumer last. In the question of wellness or wealth, Big Pharma’s choice is clear.