From the IL 10th Wrap-Up, A newsletter from Illinois 10th State Central Committeeman Keith Brin:
Is It Time We Did Drugs Differently
WRITTEN by Keith Brin
| Our government thinks we’re stupid. It’s pretty clear – especially when our Democrat overlords take the wheel – that our government thinks we are grossly uninformed to the point that we are largely unable to make educated decisions about our own lives. I make this assertion based upon a number of patently obvious points, including the Democratic Party’s own philosophy of increasing centralized authority, but for this column I’m going to focus on the FDA and pharmaceuticals.  What is the FDA, and what’s its role in drug approval The modern FDA approval system began with the Federal Food, Drug, and Cosmetic Act of 1938, passed after the Elixir Sulfanilamide tragedy. In 1937, more than 100 people, many of them children, died after a manufacturer dissolved the antibiotic sulfanilamide in diethylene glycol, a toxic chemical related to antifreeze. The next major change came with the 1962 Kefauver–Harris Amendment. Before then, companies only had to prove a drug was safe. Afterward, they also had to prove it was effective. The amendment was driven largely by the thalidomide disaster, which caused severe birth defects in thousands of children. The drug never received full U.S. approval because FDA reviewer Frances Kelsey demanded more safety data. Overall, the FDA approval system was created for a number of reasons – because drug makers know more about their products than patients, unsafe drugs can harm large numbers of people, companies can profit before risks become known, and public confidence in medicines depends on a trusted approval process. Time and cost to approve drugs While the intention behind the FDA approval system is laudable and reasonable, there is a tremendous trade-off: The resulting process takes a long time and is very costly, almost prohibitively so. Before reaching patients, a drug undergoes years of laboratory research followed by three phases of clinical trials. Phase 1 tests safety in a small group of healthy volunteers. Phase 2 evaluates effectiveness and side effects in patients. Phase 3 expands to thousands of patients at multiple sites to confirm safety and effectiveness before FDA review. The process is lengthy. Preclinical research typically takes 3–6 years, clinical trials can take another decade, and FDA review may add a year or more. It is also costly. Preclinical research can exceed $600 million, while Phases 1, 2, and 3 can cost roughly $6 million, $20 million, and more than $100 million, respectively. By the time a new drug reaches the market, it may have taken 10–15 years and cost well over $1 billion to develop. And don’t forget the risk to the pharmaceutical companies – only about 12% of drugs that enter clinical trials end up getting approved. That amounts to less than 100 new drugs approved by the FDA, per year. Is It Really Safe? Admittedly, from someone who has a graduate degree in public health and done a fair amount of work at the CDC, it’s a wild world out there for drugs. The intentions of the FDA are well founded. But even after the best of intentions, and a process so chock full of red tape that it could make Rube Goldberg blush, the FDA gets it wrong from time to time. Way more than people think. In fact, each year almost 1,300 drugs that were previously approved get pulled from the shelves after discovering issues. That means that after all the years of work and clinical trials, this system is at best just a better mousetrap on the front end for drug approval. Is It Time to Make a Change? The FDA approval system was created in response to real tragedies, at a time when information was far more restricted and largely confined to experts. I’m not sure that lack of information currently exists in the same way. Today, anyone can access studies, reviews, and firsthand experiences online. The quality varies and is… well…often only as good as the price tag to get it, but information is no longer limited to the scientific community. Drug education has also changed. Today, the problem is often too much information rather than too little. How often do we see information on a drug for allergies, that then indicates the drug may cause cancer, blindness, and your brain to melt? I get the basis for including that information. No one wants the cure to be worse than the illness, but most of us don’t pay much heed to the list of side effects and adverse events. If we did, we would never set foot in a pharmacy again. What do we do? We tend to rely on our medical practitioners to do the field work, and use their expertise, training, and professionalism to guide out decisions. That’s fair and seems reasonable. But what about promising drugs that could save lives now and are tied up in years of testing and regulatory review? We already make exceptions through programs such as emergency authorizations (as if none of us remember Covid) and compassionate use, which allow patients with serious or life-threatening illnesses to access unapproved treatments when no alternatives exist. Is it time for flexibility? Is it time to allow people to make educated decisions about their own bodies, and then live with the consequences? We do it with known drugs now. There are few people who haven’t been exposed to the dangers of smoking cigarettes – decades of warnings, drilled into our heads. Yet, cigarettes are legal. The potential consequences are real. And people can decide for themselves. Alcohol is another drug with similar scrutiny, and we know how banning that turned out. Further, many people get drugs without approval from the FDA. I don’t want to harp on pure illegality, but the last I heard heroin, crack, and a multitude of other drugs are still illegal, and still obtainable in the US. And people are using those drugs out in the open and under the tacit approval of the watchful eye of our Democrat masters in large cities across the country. Less nefariously, many drugs approved overseas remain unavailable in the United States, yet Americans often obtain them anyway through the miracle of our truly global marketplace. Peptides are a good example. These drugs enhance natural processes already occurring in the body. Semaglutide drugs like Ozempic, for instance, increase a naturally occurring gut hormone that regulates blood sugar, digestion, and appetite. Although approved for diabetes, they quickly became popular off-label for weight loss. Many other peptides are still unavailable in the US yet are easily purchased online from “gray market” vendors who sell them for “research purposes” rather than “human use”. This has been going on for more than a decade, and there is no chance the pipeline will shut. So, my question remains: With greater information, and accepting the risk, is it time to allow people to make informed decisions about what pharmaceuticals to use? I don’t mean that we should just open the spigot to everything, but on classes of drugs that are well known, have a minimal risk profile, and are studied with millions of uses around the world, should we reconsider our current approval program for a modern age? By the way, as you’re reading this, the FDA will be meeting to approve a whole batch of different peptides that have been used by people via the gray market for years, thanks to a massive push by Secretary Robert Kennedy, Jr. If not for this very specific push, these drugs would remain banned. Not to everyone, just the general public. The rich have been using them for years, and even Secretary Kennedy admitted to using them. This may not be the equivalent of the next adventure in the untamed, wild frontier, but it’s still something to think about. |
