Comments on another article here have gone far off topic from a discussion of a potentially life-saving treatment for oxygen depletion to one about the relative merits of the FDA versus industry self-regulation or a private regulatory agency. Because the comments have expanded to the point that a new reader might be too overwhelmed to follow the conversation, I’d like to take what I think are some of the relevant pieces and address them.
Preamble: I spend a good deal of time keeping up with the issue from the point of view of medical and science professionals, reading pieces from their blogs and publicly available sections of professional journals, and checking out published research. I am not saying that the system we have in place is flawless, and the sources I just mentioned are very articulate about what those flaws are, and what the relative merits are of various alternatives and regulatory changes. Since they’re down in the trenches, I feel that their opinions are valuable, but I’d like to start by addressing some specific items brought up in the comments on the linked article.
Patrick McPike challenged the idea that government offers better protection for drug consumers with the following questions:
Because the government holds manufacturers legally responsible for adverse events and keeps a database of all events nationwide, so consumers don't have to rely on their own legal resources to contest an industry team of lawyers in order to get recourse or compensation. An individual consumer would not have the knowledge or financial resources to pursue a court case against a manufacturer, nor would he necessarily be aware that he could be covered by a collective action. By tracking all adverse events, the FDA can make a case that there is a correlation between the product and the adverse event, and take action against the manufacturer to remove the product and compensate the victims. Multiple individual lawsuits or even multiple class action suits will not accomplish this.
Because the standards, obligations, and consequences are laid out clearly in advance to manufacturers, and they know that they are legally required to meet or exceed them, and what the consequences will be if they don't. Even if they can finagle numbers to make things look like they work better than they do or have fewer adverse effects than they do, the FDA can enact consequences for doing so that an independent organization never could. See my above point about lots of lawsuits as compared to a major government ordered shutdown.
Because they also monitor manufacturing standards and waste disposal in addition to product quality as part of the whole package, instead of looking at only one facet of the process. The FDA regulates and tests products to make sure that they contain what the manufacturer says they contain, have been tested for what the manufacturer says they’ve been tested for, and that manufacturing facilities meet and maintain standards of cleanliness and quality that include disposal and cross contamination.
2) What is their incentive?
It’s their job. They do not get rewards for approving or delaying the release of a product, and they take a lot of public flak for even the slightest inattention to detail, regardless of where the flawed information might have originated. They do not get financial incentives from industry, they do not fund research. Their sole purpose is to make sure that medical and food products meet a standard of efficacy and safety, and that public health is protected as much as possible.
3) What happens if they don't approve a drug that would be useful?
More studies are done by the scientific community to provide further evidence that the drug is useful. They don’t approve it because there isn’t enough statistical significance of its efficacy in the existing research. They make exceptions for certain cases in which human trials might otherwise be unethical, but these are rare and carefully considered. Otherwise, it’s safe to say that if scientists can’t validate its usefulness, it’s not rational to consider it useful. If you look at a listing of drugs approved by the FDA, you will be able to go to a published research aggregator like PubMed and find the studies that supported the approval of each of these medications.
4) What happened if they approve a bad drug?
“Bad drug” is such a broad category that this is an inherently flawed question. A drug that works in Stage III or IV Clinical Trials has not been tested in every person who might use it, so it’s impossible to predict how an individual with a confounding health issue or possible pharmaceutical contraindication might react.
5) How would the answers change if a 3 party private firm/alliance were responsible?
Not much, as far as what gets approved and what gets denied. The biggest effect would be if private firms were enlisted by the FDA to speed up the process of review. Not only would this keep the FDA more up to date with current research, but it would make the entire application process for follow up research happen much more quickly.
Patrick also asked why a 3rd party can't do the same thing, and why *must* it be done by the government. In addition to the points above, without government regulation, these third parties would be able to accept incentives from manufacturers to give them a pass on noncompliance and take part in marketing. If they were to augment the FDA, they themselves would be subject to regulation that would help prevent this. As Douglas Goodman said, “The FDA actually trusts third-party auditors, USP, NSF, and others. . . They are devising very strict registration requirements. Also, because of workload, the FDA currently contracts with state Departments of Health to do inspections. These state agencies are not trained to the FDA standard yet they count as an FDA audit. . .The FDA could still be a clearing house of complaints, which is largely what enforcement action is based on. “
Gary W. Patterson, Jr. argued the following: “You can make 2 different mistakes."
1) Approve a drug that turns out to have unanticipated side effects resulting in many deaths.
2) Refuse approval of drug that is capable of saving many lives or relieving great distress that has no untoward effects.
If you make the first mistake- approve a thalidomide- your name will be spread over the countryside. You will be disgraced. If you make the second mistake, who will know it? The pharma company who will be dismissed as an example of greedy businessmen w/ hearts of stone. The people whose lives might have been saved will not be around to protest.”
I would like to point out that these incidents have actually improved the performance of the FDA. The thalidomide example dates back to the 1950s, and was pivotal in changes to regulations to strengthen oversight. In fact, it’s only one of the most visible cases among a huge number of adverse drug reactions that existed before the FDA enacted more restrictive standards for drug approval. What we learned from these events and others in the ensuing 60-some years has prevented untold numbers of deaths and huge amounts of human suffering.
As for the second case, again, there’s a burden of proof. If the evidence shows that it can save lives and that it shows no statistically significant dangers, the FDA is not going to prohibit its release. If the FDA is holding it back, it’s not out of some perverse kind of schadenfreude, but because its efficacy and safety is still questionable.
I would also like to point out that labeling standards would not exist without the FDA. When you pick up a prescription, you have an insert with an impressive amount of important information. In fact, it wasn’t until 2006 that this labeling was required for all medicines. Prior to this, the doctor prescribed the medicine, you took it, and the rest was left to fate. The FDA is also to thank (in a way) for the Quack Miranda Warning, which tells us that what’s in the bottle hasn’t been tested for efficacy, but that it probably won’t kill us. Additionally, a lot of FDA resources would be better spent on investigation if we required the same evidence from alternative medicine that we do of real medicine.
The FDA has booted “cancer cure” scammers out of the U.S., prosecuted sellers of dangerous, unproven treatments for untreatable and deadly diseases, and forced practitioners who make unsubstantiated claims to redact them and compensate consumers they’ve harmed. People still believe what they read on the internet, and even the FDA can’t keep up with the misinformation that harms more people percentage-wise than almost all approved treatments combined.
Maintaining health and curing disease is something that often requires a high level of expertise not generally possessed by the average person. When we self-diagnose, we’re frequently wrong, which indicates potentially fatal results from self-treatment. Unless you’re ready to get yourself a medical degree, you’re protected by the FDA much more than you’re harmed by it.