Why Obama's Prescription Drug Plan Couldn't Wait
The drug shortage impacted African Americans of all incomes directly
There are not enough drugs in the nation. Either that, or there are some seriously overmedicated Americans who are running through drugs faster than companies can make them. President Obama heard the call on mass withdrawal, and this week signed an executive order addressing a shortage in critical prescription drugs, a problem for the past few years.
This latest move by Obama was part of his “we can’t wait” series, where he’s stopped asking Congress what they can do for you ("pass this jobs bill"), but what he can do for you without Congress. Last week he signed executive orders that helped homeowners, veterans in need of jobs, and college students and graduates who’ve been sinking in debt.
While those orders impacted the middle-class, vets, and young people respectively, his executive order on prescription drugs is the one that will most impact African Americans and low-income citizens. And not because these are the people most likely to use drugs, but the opposite – because they are less likely to.
And by drugs, we mean hospital-issued treatments for life-threatening illnesses such as cancer, high blood pressure, and other serious diseases. Many sick people have suffered for months because some of the top drug manufacturers have run out of drugs, and are stretched beyond their capacity to produce more to meet growing demand. At best, it’s led drug companies to flat out tell pharmacies and hospitals, “Hey, we ain’t got it.” At worst, it’s caused some companies to hoard products and drive the prices sky high.
“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” said President Obama about it.
The number of reported drug shortages in the United States nearly tripled from 61 in 2005 to a record-high 178 in 2010. The Food and Drug Administration prevented 137 drug shortages in 2011, but there are still are far too many drugs that are currently off-production. Before Obama signed the order, many pharmacies and drug companies were reporting that they would be out of essential drugs until at least 2012.
Obama's order, which isn't enforceable as law, instructs drug manufacturing companies to report shortages to the FDA much earlier for better response and planning. That’s cool for the future, but it doesn’t help people who are out of drugs today. Which is why Obama also is authorizing FDA to ease up and quicken their reviews of new drug suppliers and creators so that more product can get to hospitals faster.
“President Obama’s whole thing is about the value of government in enhancing the lives of citizens of and there are lots of things the government can do to lessen this burden on patients when drugs are in shortage,” says Dr. Ann Barbre, a pharmacist and the associate dean at the college of pharmacy in Xavier University. “Hospitals end up using other drugs that might not be the first drug of choice, but rather what is available, which may not be the best drug for” treating certain diseases like cancer.
For African Americans, who suffer from health disparities across the board when compared to other races, not having access to drugs is a matter of life or death. Black men are currently twice as likely to have new cases of stomach cancer as white men are; same for black women. Black women are 2.4 times more likely to die from stomach cancer than white women. Black men have much lower five-year cancer survival rates than white men.
Affordable access to treatments are absolutely necessary in black communities.
That affordable accessibility comes mostly in the form of generic drugs, which unfortunately are the kinds of drugs that manufacturers are mostly out of right now. Of the drugs currently out of supply, roughly 74% of them are sterile injection drugs for use in patients fighting cancer, needing anesthetics for surgery, and other emergency and life-preserving treatments. Half of those injectables today are generic prescriptions, which are the kinds most affordable for low-income patients and many minorities. The share of generics of brand name drugs in the market is rising.
But the volume of generics actually available to healthcare providers is shrinking. In the streets, when there are no drugs to buy (weed, recreational, etc.) it’s called a “drought.” Right now there is a drought among the pharmaceutical companies.
A drought, in the street sense, normally comes about because there are only a few, or in some cases one person who control the drug market. If that person or small few run out of product – because they lose their connect (distribution source), or they get arrested, or killed – then the entire system suffers, from lower-level buyers to the customers.
In the pharmaceutical industry, most of the generic injectables market is controlled by just seven manufacturers. The top three of those manufacturers hold 71% of the market, and one manufacturer produces at least 90% of the drug found in most sterile injectables. In other words, they got the block on lock.
The situation can only be resolved by allowing new suppliers in the market while the manufacturing industry increases its production capacity, which could take years.
For African Americans and poor people with cancer and other diseases, they literally can’t afford to wait. Studies have shown that black patients generally disavow drug treatment, often opting for the much more expensive, but much more immediately accessible option of the emergency room.
This is not a problem that's unique to just poor African Americans, or the uninsured in places like California where according to a UCLA study, black patients at all income levels opt for the ER over physician visits. The ER-treatment, of course, is unsustainable, though, especially when used for problems that are not actually emergencies. But when there are droughts like this, people suffering from managed illnesses may end up in the emergency room anyway if they can’t get their medicine. Lead scientist Dylan Roby figured there may be something about HMOs and the physicians they work with that creates obstacles to timely primary care for black patients.
Which is why Obama’s executive order – though just a small step in the scale of things – is a lifesaver. If black patients are being discouraged from regular care, it's only more discouraging for them to go through the motions only to find there are no medications available for them. And if emergency rooms aren't providing the best treatment for serious illnesses because of the shortages then seeking treatment becomes even more deterring.
“President Obama’s executive order that makes those drugs more available is a boon, and should definitely be looked upon as a positive thing,” says Dr. Richard Allen Williams, president of the Minority Health Institute. “Especially for minorities because the lack of availability of medicine creates healthcare disparities, which causes more minorities to suffer.”
There is some caution with Obama’s order, though, says Williams, because it allows the FDA to use “regulatory discretion” to relax drug product reviews that normally are done carefully to avoid harmful drugs from reaching the public. As it is, some of the drugs that are currently suffering shortages are because things like glass shards, metal fillings or contamination have been found in them.
At this point, it’s “weighing risks against benefits,” says Williams, who says there’s “absolutely not” an instance in FDA’s history where using this kind of discretion for expedition led to a bad drug hitting the market.
“The benefits of having drugs that might be life-saving available for people in need is greater than the risks of some downside events that could occur. We just have to watch to see what happens, but in the meantime we have to make sure enough of the essential drugs are available to the public.”