September 9, 2002
From Inception to Ingestion:The Cost of Creating New Drugs
by
Merrill Matthews |
Publications |
IPI Ideas
PDF
The pharmaceutical industry cites studies that suggest it costs more than $800 million to move a new drug through the 10-to-12 year discovery, development and approval process. However, critics claim those estimates are artificially inflated and that the actual costs are much lower. For example, Ralph Nader’s Public Citizen released a study last year claiming that the cost of creating a new drug is only about $110 million (in 2000 dollars). And that includes the cost of failures.
Is there a way to resolve this discrepancy? Yes, by looking at aggregate research and development spending and the number of drugs finally approved.
The Drug Creation Process. The pharmaceutical industry is a high-technology — “pharmatech” — industry that pours billions of dollars annually into new, innovative drugs. But new drugs face numerous hurdles as they move from inception to ingestion — and those hurdles drive up the costs.
Scientists must first identify a chemical compound they think will help a medical condition. They then apply for a patent, which can take a couple of years before being issued. Researchers then must find a deliverable form of the drug and, in most cases, test it in animals.
If animal tests appear promising, the drug will begin moving through the human testing process, a series of three or four clinical trials that may test the drug on thousands of patients at various medical centers throughout the country, and sometimes internationally.
These trials can take six to eight years and thousands of medical personnel. There are numerous opportunities for failure. Often it isn’t until the end of the clinical trials that enough patients are involved to determine if a drug’s active ingredient is effective and if the side effects are acceptable. And the patent clock is running all the while, despite the fact that the drug isn’t yet on the market.
If patients are not responding as researchers had predicted, scientists may be able to adjust the formula, but they sometimes have to scrap the project and start over again, losing both time and the money invested.
If the drug makes it through the clinical trials and demonstrates to researchers that it is more effective than placebo (an inactive substance), the manufacturer sends the thousands of pages documenting the research to the Food and Drug Administration (FDA) for approval — a process that can also take more than two years (though there are ways to expedite it).
According to a 2001 study by economist Joseph DiMasi of the Tufts Center for the Study of Drug Development at Tufts University, for every 5,000 drugs that appear promising enough to be tested in animals, only five make it to human clinical trials and only one will actually be approved.
Case Study: A “Youth Pill.” The Wall Street Journal recently reported that Pfizer spent $71 million researching a “youth pill” intended to stimulate the pituitary gland in hopes of reversing “the physical decline that comes with aging.” Early tests on animals seemed very positive, but human trials were not as successful. Pfizer eventually and reluctantly discontinued its research. However, those costs can only be recovered through other drugs that successfully make it through the approval process.
How Much Does It Cost to Create a New Drug? Determining how much it costs to produce a new drug isn’t an easy task. Some new drugs are tested on thousands of patients. Others target diseases that afflict relatively few people. Some may go through multiple variations in either animal or human tests before the scientists get the right formula.
Moreover, the cost of a drug that actually reaches the market must incorporate the cost of those that failed — just as the price of products for sale in retail stores must reflect the cost of damaged, lost and stolen goods.
In 1991, DiMasi et al. published a paper in the Journal of Health Economics estimating that it cost about $231 million (in 1987 dollars) to take a new drug from creation to approval, including the cost of other drug failures and the interest lost had the money been invested rather than used for experiments. A few years later, the Boston Consulting Group (BCG) extrapolated the DiMasi study and concluded that it cost about $500 million to get a new drug to market.
BCG recently updated that figure. The firm interviewed about 60 scientists and executives from nearly 50 companies and academic institutions and concluded that it takes about $880 million and 15 years to get a single drug to market. And according to BCG’s report, 75 percent of that cost is drug failures.
The DiMasi study produced for the Tufts Center and released last year also weighed in with a new estimate: the average drug takes about 12 years to move through the approval process and costs $802 million per approved drug.
Another Way to Estimate Costs. Another way to estimate the cost of creating a new drug is to look at total research and development costs — a number that has been tracked for years— and divide that amount by the number of new drugs approved each year, thus yielding the average cost of a new, approved drug. For example, the research-based pharmaceutical companies spent about $26 billion on R&D in 2000, and 27 drugs were approved. Thus, it cost approximately $964 million per drug approved in 2000. [See the figure.]
The other side of your little delusion you hate to acknowledge.
Up to 70 percent of Americans are addicted to prescription drugs and pay $280 billion a year in the process. The big drug companies make more money than you ever dreamed possible by turning the American people into the most doped up people in the history of the planet. In America today, the number of people hooked on legal drugs absolutely dwarfs the number of people hooked on illegal drugs. This is particularly true when it comes to antidepressants and painkillers. I know so many people using them. They have told me that they are addicted and they don’t know what to do to stop.
Sadly, the number of people killed by legal drugs absolutely dwarfs the number of people killed by illegal drugs. Most Americans assume that if a drug is “legal” that it must be safe. However, I am not including you, my readers, in this category. Many of you have been reading my newsletters and emails and books and CD’s for decades. You already know the truth!
Most people believe that the big pharmaceutical companies and the federal government would never allow us to take anything that would hurt us, right? Sadly, the truth is that they do not really care about us. In fact, they have a fiduciary responsibility to sell us as many drugs as possible to make the highest profits. They do not really care that prescription painkillers are some of the most addictive drugs on the entire planet and that they kill more Americans each year than heroin and cocaine combined. They do not care that antidepressants are turning tens of millions of Americans into zombies and can significantly increase the chance of suicide. All the big pharmaceutical companies really care about is making as much money as they possibly can.
Here are 20 things you need to know about prescription drugs, along with my commentary:
1. According to a study conducted by the Mayo Clinic, 70 percent of Americans are on at least one prescription drug. An astounding 20 percent of all Americans are on at least five prescription drugs. I know folks that are on over a dozen. Most of them walk around in a zombie state.
When you combine the drugs with the fluoride it is no wonder most Americans don’t know what is going on in the world scene. They are content to sit in front of the idiot box for six hours a day in an alpha brain wave state, drooling on themselves while watching sports shows and drinking beer!
And do you know everything that pharmaceuticals do to enhance the cost of their drugs. You know through legislation. How they use the system go gain favor. Mostly economically. But you forget that soooooo conveniently don't you
And naturally people blame the healthcare. What about the price gouging from the pharmaceuticals?
Stupid people.
Perhaps you will answer the question.
From diagnosis to drug....do you know everything that is involved in the creation of these drugs, and their costs?
I do....so, answer My question. How much does it cost from inception to market? Do you know?