Getting it right in the battle against opioid overdose deaths

According to the Centers for Disease Control, Alabama, Tennessee and West Virginia – in that order – lead the nation in prescriptions for narcotic painkillers. Nationwide, there were close to 60,000 deaths in 2016 from drug overdoses.

How is this possible, when narcotics are strictly controlled? A popular target for blame for this problem is the pharmaceutical industry, which is often the focus of criticism. “We would not have a drug problem if manufacturers weren’t trying so hard to sell them,” the reasoning, such as it is, goes.

But making and selling drugs is what drug manufacturers do: they spend millions or billions of dollars over a decade and often longer to find the right formula to create a product that will help people suffering from a medical condition. They work to get the product through lengthy clinical trials and the stringent FDA approval process. Then, they must sell enough of that product during the patent protection period to recoup the costs of its development so the company can invest that money in another product’s development.

Also understand that drug companies do not provide addictive drugs to individuals, neither the legal users, nor the illegal users. They provide them to distributors, or directly to pharmacies, and unless someone steals them or distributes them improperly, they will contribute not one bit to a drug problem.

Far too many prescription drugs do get to users through “pill mills,” and some physicians who don’t have sufficient information about the effects of some drugs as they need may, as a result, over-prescribe them. And, obviously, these problems must be addressed.

However, a recent Daily Signal article tells us that the painkiller abuse problem is not primarily caused by prescription drug abuse and misuse, although the news we hear might convince many of us that drug companies are at fault.

The article, written by former director of the Office of National Drug Control Policy, Bill Bennett, who is also a former U.S. Secretary of Education, and Robert L. DuPont, MD, president of the Institute for Behavior and Health, explains that of the 60,000 deaths in the U.S. in 2016 from drug overdoses, 33,000 of them were opioid related.

And, they add that our news media mistakenly focus more attention on prescription drugs, instead of the illegal ones. Is that because Big Pharma is an easy and popular target?

Bennett and DuPont, in fact, say, “nearly 70 percent of our nation’s opioid deaths do not come via prescription abuse.” “The main problem today, and the growth for tomorrow,” they say, “is illegal opioids such as heroin, illegal fentanyl, and a hundred other synthetics, not legal drugs used illegally or in ways not as prescribed.”

They cite data from the Obama administration’s press office in 2015 saying that there were 33,091 opioid overdose deaths, 12,990 of which were from heroin. Another 9,580 were from synthetic opioids, mostly illegal fentanyl.

They propose a two-phased attack on the problem. First, fight harder against illegal drugs coming into the U.S. through better border enforcement to stop the drug traffic from and through Mexico, as well as working to have Mexico eliminate its poppy crops; have stricter monitoring of international mail services; and crack down on cartel activity, both here in the U.S. and at their source.

The second phase acknowledges that most money directed at the problem goes to “treatment, recovery, and urgent overdose reversal,” which they say is certainly important, but it is not enough. “We need to improve engagement in treatment, reduce dropout, and address the far too common outcome of relapse with sustained recovery—meaning no use of alcohol, marijuana, or other drugs,” by recovering addicts.

“But the main unaddressed nature of the opioid crisis,” Bennett and DuPont say, “is focus and energy on prevention.” This includes serious efforts to educate the public about what is in their medicine cabinets and how to keep those drugs out of the hands of those for whom they aren’t prescribed, and to educate the public about the dangerous nature of the drugs sold on the street. It is critical to also work to counteract the youthful use of alcohol, marijuana, tobacco and other drugs, where they say 90 percent of addictions begin.

Citing the rising death toll from illegal drugs, which they note is much greater than the crack cocaine problem in the 80s, the authors call for more effective action by political leaders, parents, the entertainment industry and health care professionals.

Looking back to the late 1970s and 1980s Bennett and DuPont recount how the nation conquered the serious drug problems of that time. “The nation rolled up its sleeves, went to work, talked about it, taught about it, and reversed it—and by 1992 we had cut drug use in half, and even more in some age groups.”

This problem is entirely preventable, and certainly can be dramatically reduced. “In sum, let us commence a strategy to stop the problems of abuse before they start,” they wrote. “It will take a nationwide effort, from the president’s bully pulpit down to local community messaging.”

Certainly, focusing on the real problem will produce positive results.

The wildly outrageous costs of pharmaceutical drug production

Drug companies – “Big Pharma,” as they are called – are targets in America. Especially with Mylan’s recent EpiPen pricing issue and earlier when Turing’s odious CEO Martin Shkreli raised the price of Daraprim by more than 55 times, from $13.50 per pill to $750 per, and his smug reaction to criticism over that questionable move. There are bad guys in all areas of life, of course, and pharmaceutical companies are no exception. Perhaps these two examples are evidence of bad players at work.

Without getting into the minutiae of either of these situations – and certainly not defending either Mylan or Turing – here is some badly needed and eye-opening information about the business of producing pharmaceuticals.

Making drugs is a business, and like other manufacturers drug producers find something people need or want and produce it. Life-saving drugs, or drugs that improve our health are valuable and needed. Drug companies spend billions of dollars over many years to develop useful, needed pharmaceutical products, improve them so that they will meet or surpass the FDA’s strict standards, and once approved market them.

In June of this year, the American Action Forum released research addressing the process of producing new drugs. The process “is extraordinarily expensive and time consuming,” the article stated. “A Tufts University study found that the average cost to bring just one drug to the market is about $2.6 billion. It takes an average of 15 years from the time a drug developer first begins testing a new formula until it is approved by the FDA. Only 1 in 1,000 drug formulas will ever enter pre-clinical testing, and of those, roughly 8 percent will ultimately receive FDA approval.”

Let’s say PharmX creates 100,000 drug formulas, but only one in a thousand, or 100 of them, gets to pre-clinical testing and only eight will receive FDA approval. PharmX will have invested on average $2.6 billion in each one of the eight. The company has to sell enough of each of those eight drugs to pay for its development, and to have enough left over to finance new research and development, and some profit.

Like other inventors, drug companies patent their products, or receive an exclusivity period. A patent is issued for 20 years from the date of filing, and drug makers usually file early in the development stage to prevent other companies from moving in on their idea. If it takes an average of 15 years to get a drug through approval and to market, the pharmaceutical company has on average only five years to sell enough of the drug to recoup the $2.6 billion in development, approval and marketing costs. At the end of the patent period and/or the exclusivity period, another drug maker might make a generic form of the drug, and sell it for a lot less.

So, when you do the math for a drug with development costs of $2.6 billion, you find that if PharmX charges a dollar a dose, it will have to sell 2.6 billion doses in five years just to break even. If PharmX charges $100 a dose, it will have to sell 26 million doses in five years, just to break even. John LaMattina, senior partner at PureTech venture capital, noted that drug development “is a high-risk, expensive, and long-term endeavor.” Classic understatement.

Another aspect of this issue is when drugs made by US companies cost more at home than they do in other countries, such as Canada. It doesn’t seem right that Canadians can buy American drugs cheaper than Americans can. But what is the drug company supposed to do when the Canadian government, or another government, wants to buy millions of dollars of its product at lower than market price when it is trying to recoup billions in costs? There are likely other drugs made by other companies that treat the same disease that these governments could buy instead, so should the drug company pass up that opportunity, leave the millions of dollars on the table, and perhaps suffer financially as a result, while a competitor sells millions of dollars of its product to these countries at a below-market price?

Another obstacle to manufacturers’ ability to recoup the cost of bringing a new drug to market is that regulations imposed by other countries, perhaps to protect one of their own companies, makes the potential market for sales smaller.

And, despite the rigorous development and testing process required to gain the FDA’s approval that the drug is safe for public use, the required warnings about potential side effects and such that go on product sheets, and the fact that drugs are prescribed by patient’s doctors, drug manufacturers still get sued by patients.

Doing business in the U.S. is a real challenge, with often burdensome and unreasonable regulations and other hurdles that must be negotiated that make producing needed and wanted products and services difficult and expensive.

The more expensive drug production is, the greater the need for high prices. While we would all like lower prices for drugs and healthcare in general, we also want to continue to have companies developing new and better drugs and medical devices.

Hillary on Drugs

Not long ago ago Democrat presidential candidate Hillary Clinton declared a war on drug prices. At a forum in Iowa she said that asking people to pay thousands of dollars for pills they need to stay alive is not how the market is supposed to work and was a sign of "bad actors making a fortune off of people's misfortune."

Indeed, a recent Kaiser Family Foundation poll showed that more than 70 percent of Americans think drug costs are unreasonable and want limitations on what drug companies can charge for medicines that treat serious illnesses.

Real events feed this sort of thinking. Turing Pharmaceuticals, for example, has come under fire for a dramatic hike in the price of Daraprim, which has been used for decades to treat toxoplasmosis and more recently to treat AIDS and cancer patients. Turing purchased a quantity of the drug along with marketing rights, and hiked the price to $750 per tablet from $13.50. Such a steep increase appears to defy reason, and to make Clinton’s case, although the economic factors involved in the price hike are not discussed when Turing is getting run through the wringer.

Clinton concludes that high prices are routinely due to price gouging, as appears to be the case with the Turing price hike. That is the populist’s first response. But she either lacks understanding of how businesses work, and in particular the realities of developing needed pharmaceutical products, or she uses this emotional response to her benefit, or perhaps both.

As reported on MedicineNet.com earlier this month, “In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet. That is, if it makes it.” And if that isn’t sobering enough: “Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds.”

Does Clinton have even a suspicion of the huge investment pharmaceutical companies have to make in the 1 drug in 5,000 that actually gets to market?

Forbes.com reported that the Eli Lilly company blog contained a post noting that “The average drug developed by a major pharmaceutical company costs at least $4 billion, and it can be as much as $11 billion.”

And Hillary Clinton thinks the cost of pills is too high? How many pills must be sold to recoup that investment? And the lower the price, the more pills have to be sold to pay for developing a drug to help people with serious health problems.

Her solution, predictably, is more involvement by the federal government, the Democrat solution to nearly everything.

However, more than a little bit of these incredibly high investments is due to the federal government. “Regulating pharmaceutical drugs to a certain extent is important to prevent dangerous medicines from being released on the market, yet the current amount of regulation is stifling competition,” according to Scott Gottlieb, a medical doctor and resident fellow at the American Enterprise Institute writing in the Wall Street Journal. “The FDA has increased the security on the manufacturing process and as a result several U.S. drug plants have closed their doors. The time intensive process of approval and the recent shutdown of plants is creating drug shortages and monopolies, causing the prices of drugs to skyrocket.”

The reality is that the cost of drugs amounts to about 10 percent of health-care spending, and the amount of health-care spending used on drugs has not changed in 50 years. That could be changing.

If Clinton is really interested in bringing down the price of drugs, she would acknowledge the role over-regulation and slow approval processes play in the price of drugs, and pledge to streamline the process instead of demonizing drug manufacturers and proposing even more government intervention.