Peter Thiel vs. This idea is embodied in Peter Thiel, the billionaire founder of Pay. Pal, who has reportedly been helping the president vet a pool of candidates to lead the Food and Drug Administration. Thiel, a libertarian iconoclast, has repeatedlymade the case that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market. Some of the FDA candidates he’s identified — including Silicon Valley’s Jim O’Neill and Balaji Srinivasan — have similarly argued that the agency should dump its requirement that drugs be proven effective before reaching the market, and that we’d be better off if the FDA operated more like a “Yelp for drugs.” In other words, bringing the same speedy and disruptive approach to medical regulation that Silicon Valley brought to the taxi and hotel industries, for example, will unlock cures — fast. But Thiel and his pals miss a very important point about developing new drugs: Manipulating biology isn’t the same as manipulating computer code. It’s much, much harder. Speeding up medical innovation will take a lot more than just stripping down the FDA — it’ll take huge leaps forward in our understanding of biochemistry and the body. Health care is also different from taxis and hotels in another key way: Consumers can’t really judge the safety and quality of medical products by themselves. It’s not the FDA that gets in the way of innovation; it’s the limits of our knowledge One of the key notions that undergirds the Peter Thiel view of the FDA is that if the agency just got rid of some of the pesky restrictions for drug approval, we’d usher in another golden age in drug development. In his 2. 8 years in the lab, Lowe has seen hundreds of thousands of compounds tested on a huge variety of drug targets, and never, not once, has he brought a drug to market. For every 5,0. 00 compounds discovered at this . Directory of New Jersey Biotech, Pharma & Life Sciences Companies.That’s a success rate of 0. Drug innovation comes from painstaking tinkering and a dash of luck. In medical research, scientists do not have that advantage, Lowe said. And unless you’ve done . I don’t know of anything that’s harder.” Biochemistry and cell biology are “like alien nanotechnology,” he added. So the real hurdle researchers facewhen it comes to finding new drugs for people isn’t overcoming a stringent regulator; it’s grappling with that “alien nanotechnology” in the lab. Cheaper, faster, but .. In one talk, he said that if we didn’t force drugmakers to prove their products are better than the others already available, we’d have more “slightly worse, but much cheaper” options to pick from.
To address this,he and other regulation skeptics typically suggest that the FDA should loosen up, or even get rid of, its efficacy requirement. Let’s step back a bit to explain how the FDA approves drugs, and the three phases of clinical testing they have to pass to get the final green light. In phase one trials, researchers test drugs for safety in a small group of healthy people, and tinker with dosing. In phase two, they test the drug in a larger group of people and make sure it delivers on its promise by monitoring how well it works against the best available therapies or a placebo. In phase three, the drug is tested on an even bigger group (up to 3,0. If the drug makes it through phase three, the data is submitted to the FDA for approval. Folks in the Thiel camp argue that removing the efficacy requirements — or abolishing phase two and three clinical trials — would give consumers more drug options. And they’re right on that point: If drugmakers only had to prove their drugs were safe, there would certainly be many more products on the market. Again, methodological constraints limit making completely. ![]() But would they be good drugs? Consider this. It wasn’t until 1. Food and Drug Administration starting asking drug companies to prove their products were bothsafe and effective before they hit the market. Until that time, there were some standards related to adulteration and labeling, but otherwise it was mostly a free- for- all. It took the infamous scandal around thalidomide, a morning- sickness medication that caused severe birth defects, to strengthen the FDA .. That means the vast majority of drugs aren’t safe or effective enough to be used — they don’t do what they were supposed to do. As Yale FDA researcher Joe Ross noted to me, “If there is no demonstration of a benefit, does it matter if we have more options?” And here’s Lowe: “The clinical failure rate is not 9. FDA are such bastards. The clinical failure rate is that high because most drugs don’t do what we thought they were going to do.” It’s precisely the clinical trial process, with scientists closely measuring efficacy, that helps weed out drugs that don’t work. Unlike hotels or taxi services, which can easily be evaluated by consumers, consumers often can’t judge whether their drugs are helping or hurting them: The effects may not be obvious or appear for a very long time. And it’s a travesty.” Supplement makers don't need to demonstrate that their products are effective or even safe before putting them on store shelves — so most supplements are unproven, and problems with quality and adulteration appear to be distressingly common. The FDA has become the fastest medical regulatory agency in the world. In the 1. 98. 0s and ’9. Congress and the FDA created several programs to speed up the development and approval process for new pharmaceuticals: the orphan drug designation, priority review, fast track, and accelerated approval. These programs were intended to push the most clinically important, innovative drugs — medicines to treat rare, serious, or life- threatening diseases — out to patients more quickly, often on the basis of more limited and less rigorous clinical trial data.“These pathways along with increased funding for FDA drug reviews from user fees enacted first in 1. Aaron Kesselheim, an associate professor of medicine at Brigham and Women’s Hospital, in an email. But research continues to show that the majority of drugs that have come onto the market offer little or no improvement over the status quo. For example, several studies have found that since the mid- 1. More worryingly, the special expedited development and approval pathways have become the rule, rather than the exception. Newer research, led by Kesselheim in the BMJ, looked at a database of all new medicines approved by the FDA between 1. FDA's expedited programs has increased by 2. Kesselheim and his colleagues also concluded that . Some even argue that if you want to bolster medical innovation, you need to look well beyond the FDA. Yale’s Ross says some of the biggest barriers occur in the world of insurance payers. If payers were making more coverage decisions — including reimbursing more effective, safer medications — based on value, that would be a huge incentive to innovate better products,” he says. Before descending on the agency, Silicon Valley types will also need a firmer grasp of the history of medical regulation and why it’s there in the first place. Peter Thiel has said, . Yale medical historian Jason Schwartz disagreed: “This assertion is at best ahistorical, if not altogether meaningless.” The famous Salk polio vaccine trial in 1. Schwartz explained. And shortly after the vaccine’s introduction, problems with its production resulted in the Cutter Incident: Vaccines with live polio virus (instead of killed virus) were administered to thousands of American children, sickening 4. Over the past half- century, we’ve seen a number of new vaccines come onto the market, including shots to prevent hepatitis B and meningococcal, which were developed without harming children. As he wrote on his blog: Today almost everyone carries in their pocket the processing power of a 1. Smartphones equipped with sensors can monitor blood pressure, perform ECGs and even analyze DNA. Other devices being developed or available include contact lens that can track glucose levels and eye pressure, devices for monitoring and analyzing gait in real time and head bands that monitor and even adjust your brain waves. And several of the FDA commissioner candidates would be well positioned to help the agency work through how to safely integrate these technologies into clinical trial research and patient care. Bush, agreed. He told us he’d like to see the FDA enable innovators to use technologies like electronic medical records, mobile phones, and remote sensing to automatically collect medical data from patients or find potential enrollees for clinical trials. Vincent De. Vita, an oncologist and former head of the National Cancer Institute, wants to see cancer centers initiate and run early- stage clinical trials instead of the status quo (which involves the agency signing off on the trials first, adding time and cost to the process). The FDA also requires researchers to test drugs separately — but a lot of cancer treatments right now involve treating patients with combination therapies — so here, too, the FDA lags the pace of oncologic drug innovation. But he also said, “I think . It’s the midlevel staff at the agency that often wields the most influence, he added. A “Yelp for drugs,” sponsored by the government, is a long way off. Did an FDA Panel Really Just Approve the First Gene Therapy Treatment? This week marked a major milestone in medicine: On Wednesday, a Food and Drug Administration panel unanimously recommended the approval of the first CAR- T therapy, a pioneering new cancer drug from Novartis that genetically engineers a patient’s own white blood cells to recognize and attack the cancer cells invading their body. The headlines were emphatic. And then, in true internet- era fashion, came the pedantry: In a world in which being “first” can mean clickier headlines, more traction and eventually even more research dollars, it’s a label that matters. It is clear that the drug—the practically unpronounceable tisagenlecleucel—is a landmark achievement. CAR- T therapy, which several other companies are also pursuing drugs for, works by extracting and isolating a patient’s T cells, genetically altering them, and then infusing them back into the patient’s body. In one key clinical trial, 8. CAR- T infusion. After one year, 7. It’s less clear, what, exactly, Novartis’ groundbreaking drug may have been the first of. The FDA, for one, defines human gene therapy vaguely as “products that introduce genetic material into a person’s DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.”The agency notes that, so far, no such product has been approved for sale in the US. On Twitter, scientists and reporters argued about whether that definition of gene therapy meant the gene itself must be the treatment—if so, CAR- T would not qualify, as it is the souped- up white blood cells that are the treatment, rather than the genes that have been added to them. The edits made do not directly correct a biological defect. Gene therapies, this camp might argue, require more editing, and CAR- T is simply a cell therapy. Others argued that anything involving genetic alteration qualified as gene therapy, which might make CAR- T the first. The agency does not have to follow that recommendation, but it typically does. It is expected to make a decision in September. Upon approval, Novartis has said it plans a slow roll- out because of serious side effects that result from the therapy, mainly making it available to only a few dozen medical establishments. The FDA’s pending decision could have big implications for other companies developing similar treatments, such as Kite Pharma and Juno Therapeutics. And big implications for patients, whether we settle on calling it gene therapy or not.
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