After suffering from a recurrent antibiotic-related infection for nearly a year, antibiotic stewardship is a topic near and dear to my heart. Antimicrobial resistance is a near second. Antimicrobial resistance – when bacteria become resistant to usual antibiotics – is a complex and growing problem in the U.S. Enter SB 2076, the PASTEUR Act.
Why is antimicrobial resistance a problem?
The frequent use and the misuse of antibiotics in humans and animals has fueled an increase in bacterial resistance to antibiotics. High rates of resistance to some antibiotics have occurred, such as fluoroquinolones (like Cipro) that are used to treat urinary tract infections. In some parts of the world this treatment is now ineffective in more than half of patients.
This has led the World Health Organization to publish the first ever list, in 2019, of the 12 families of bacteria that pose the greatest risk to humans. These families are resistant to antibiotics and are able to transmit their resistance abilities to other bacteria.
How bad are resistant infections in the U.S.?
More than 2.8 million antibiotic-resistant infections occur annually in the United States. More than 35,000 people die from resistant infections annually. That is one person dying from an antibiotic resistant infection every 15 minutes. Every day. Treating antibiotic resistant infections is thought to cost over 4.6 billion dollars annually. (I have a hard time digesting big numbers- that is $4,600,000,000. Ouch!) It is thought that by 2053, more people will die from antibiotic resistant infections than cancer annually.
Why is antibiotic resistance such a bad problem?
As mentioned above, resistance is caused by frequent use, overuse, and misuse of antibiotics in humans and animals. Bacteria (like viruses) want to live, and they are able to adapt to antibiotic pressure. Their mutations are then carried to further generations, and can spread from one bacterial type to another. Besides antibiotic use in medicine for humans and animals, antibiotics are widely used in animal feed. Chickens, for example, are routinely fed ciprofloxacin. Ciprofloxacin is one of our main treatment options for anthrax, besides being a common treatment for UTI as mentioned above.
The other problem is that it takes 10-15 years to discover an antibiotic substance, to test it, do clinical trials and then bring it to market. Because of the way drug development is funded, antibiotics don’t make enough money to reimburse those costs, and many developers have gone bankrupt before getting their new antibiotic on shelves. This means there are fewer new antibiotics in development. The risks of investing in the development of an antibiotic are too high for investors to take.
What is the Pasteur Act?
Named after Louis Pasteur, known as “the father of bacteriology”, the PASTEUR Act (Pioneering Antimicrobial Subscriptions To End Up surging Resistance) aims to help increase the number of new antibiotics targeting critical bacterial infections enter the market. It was introduced in 2021 by Senators Mike Bennett and Todd Young and Representatives Mike Doyle and Drew Ferguson.
What is the process of bringing an antibiotic to market?
A drug company first finds a promising substance. It obtains a patent (more on that later). It starts by doing phase 1 and phase 2 trials, looking at how the substance works and how it works in animals. Then it enters phase 3 trials, looking at safety and effectiveness in humans. At that point, if the substance shows substantial benefit and is safe, they look for an investor. This is where the problems begin: they have to develop a marketing plan and they have to plan on and scale up manufacturing capabilities. They need an infusion of cash BEFORE any of the drug is sold.
What’s the problem with that?
Imagine you are developing a drug for a chronic condition like hypertension. You have sort of a “captive audience” there – people take medications for conditions like hypertension and diabetes indefinitely. That means lots of ongoing sales. In fact, drug companies make their money on the volume of a drug sold. Contrast that to an antibiotic. Antibiotics are taken for a week or two. Sometimes a bit longer, but generally not on an ongoing basis over time. That means much less volume of product is sold. And that means less profit. There are enormous up-front costs to discover and develop a substance, and it is the profits from selling the product at volumes that reimburse the developer for those up-front costs.
Normally, pharmaceutical developers apply for a patent on their medication to enable them to be the sole producer of that medication in the U.S. This allows them a period of time to recoup their initial costs to develop their drug. Patents last around 20 years. As they are applied for at the beginning of the trial process, once a drug is being marketed there is often around 10 years left on the patent. That’s what “brand-name” refers to: the patented original medication. Once the patent expires, other companies can produce generic medications. They do not need to complete the same rigorous studies; they simply need to prove that their own formula is comparable to the brand name medication.
How does the PASTEUR Act bring more antibiotics to market?
The PASTEUR Act creates a subscription model to pay antibiotic developers to bring their tested and approved products to market, paying them on a subscription basis. It’s kind of like Netflix for antibiotics. This payment upfront allows pharmaceutical manufacturers to get paid on a regular basis for an agreed-upon volume of antibiotics. It reduces the risk of investing in antibiotic development. This would encourage innovation and ensure that antibiotics will be available to treat these resistant infections.
What else does the PASTEUR Act do?
To ensure success of its mission, the PASTEUR Act also:
- Forms a committee to identify and provide guidance for emerging resistant infections and discuss the favorable characteristics of the treatments developed.
- Defines terms of the subscription contacts to include the medication being available to patients on government health insurance plans, support of appropriate antibiotic use, and completion of post marketing studies. Contracts will be valued between $750 million and $3 billion.
- Taps into existing programs such as the CDC National Healthcare Safety Network to collect data about antibiotic use to improve appropriate antibiotic use, and reports on use and resistance data.
- May provide transitional measures such as providing smaller subscription contracts to some novel developers.
COVID has been a real eye-opener. It has taught us that we need to adapt, be prepared to take action, and that we need to anticipate. We have to be ready for the next big thing that poses to wipe us out.
Here is where YOU come in. Write your legislators and ask them to support this bill as soon as possible. Here are links to find your legislators: Find Your Members in the U.S. Congress | Congress.gov | Library of Congress It will take a few minutes to write a quick note, but it is worth your time.
I’ll make it easy for you! Look below for a sample letter – just copy it into a WORD file, then cut and paste your legislators’ info and your own. If you can tell a personal story about you or someone you know having a resistant infection such as MRSA, please enter that, too. Legislators want to know how a bill will impact their constituents. One more teensy ask – drop me a comment if you send a letter!
Join me next time for a look into sludge. We’ve all experienced it, no one likes it, and why it is a problem. See you then!
(Month) (Day) (Year)
The Honorable (First name) (Last name)
(Room Number),
Washington DC
RE: SB2076 PASTEUR Act
Dear (Representative/Senator) (Last name):
My name is (your first and last name) and I am a (family member /service provider/advocate/community member) who resides in your district.
I support the PASTEUR Act because more than 2.8 million antibiotic-resistant infections occur annually in the United States. More than 35,000 people die from resistant infections annually, with one person dying from an antibiotic resistant infection every 15 minutes every day. Treating antibiotic resistant infections is thought to cost over 4.6 billion dollars annually. It is thought that by 2053, more people will die from antibiotic resistant infections than cancer annually. Due to market dysfunction, pharmaceutical companies are not creating antibiotics to combat these serious conditions. The PASTEUR Act seeks to correct that, creating a subscription program to bring antibiotics to market to treat the most deadly infections.
If there is one thing we have learned from COVID it is that we need to anticipate and be prepared for further serious infections.
(Include a personal story. Have you or a friend or family member ever had a resistant infection? Tell your representative why the issue is important to you and how it affects you, your family member and your community.)
I am asking you to vote to enact SB 2076 The PASTEUR Act.
Sincerely,
Sign your name
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Street address
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