No, not the zombie-apocalypse that we narrowly missed last Friday, but the possibility of protecting off-label promotion of medical drugs as free speech.
About a week ago, American drug giant Pfizer (proud bringer of Lipitor) paid the US government more than $55 million in fines for the actions of one of its companies, Wyeth, which overstated the benefits of its drug protonix, despite warnings from the FDA.While drug companies paying for similar offences is an age-old story, a recent court ruling could deeply reduce the trust we have maintained with drug companies. According to US vs. Caronia, it was initially ruled that the defending company (Jazz Pharmaceuticals) was over exaggerating the benefits of its drug Xyrem, and thus had to pay the fines. However, a federal appeals court has overturned that statement, saying "that off-label promotion should be protected as free speech." The case will proceed to the Supreme Court, meanwhile, what will it mean for us if off-label promotion does indeed become protected?
Well, two things.
1. Loss of trust between patients and drug companies (if there was any to begin with)
2. Discourage "good science"
By allowing drug companies to have unrestricted promotion of off-label uses, our job as consumers becomes that much harder. We have to begin analyzing which uses and side effects to truly take into account, or whether they should be taken into account. Allowing off-label promotion will not only affect the way we buy drugs, but also the way we approach drug companies. Is it really necessary to add suspicion to an already uneasy relationship?
According to the journal Nature, forcing drug companies to go through the FDA-approving process encourages companies to invest in trials in order to provide truth to their off-label uses. Trying to turn off-label uses to label uses, progresses Science and Medicine development. For example, through the trials Johnson & Johnson was able to expand its drug label, for patients who have advanced prostate cancer.
Good habits lead to good science, something we can't avoid losing so that drug companies can simply make more money.
This is a really interesting topic. I think that many drug companies already advertise their products as better than they actually are off the label. I have come across many ads on the side of websites, on TV, or in magazines that boast about how good a certain weight loss drug or joint supplement is or such. Most of these ads exaggerate the benefits by not disclosing potential side-effects, or the time period the substance must be used, and the dose it must be taken in. Labels on the actual drug/supplement tend to be a little more honest because there is often a lot of fine print that people do not bother to read. As long as the main benefit is stated in slightly larger font and the directions are clear, then everything seems okay. I think it would be terrible if drug companies had more freedom with their labels. It's one thing to have deceiving advertisements, but if the label did not enclose all the information about the drug, or over stated its benefits, then many people would probably misuse the drug or get side-effects that they did not intend. While I understand that these companies want to bring in costumers, I don't think that they should be allowed to over-exaggerate on commercials either. It is important that labels have the complete truth on them (all ingredients, benefits, and potential side-effects). However, I think it is also important for ads to be truthful. Some people don't even bother to read labels. These people rely on what they heard from their doctors, friends, family, and commercials. Hence, it is important that ads keep their facts straight so people can safely use their drug or supplement if necessary. So I guess I think that freedom of speech must be controlled when it comes to medicine and substances we put in our bodies.
ReplyDeleteYeah I definitely agree. There are so many different ways of approaching this situation. You could think about it in a business way, where it might be good idea to have that protection of free speech. On the other hand, as a consumer, there's something frightening and unnerving about a lower trust relationship than before. I think it's even like the whole cigarette, do we add all the side effects or not. It's a decision where there really is no win-win situation.
DeleteFor someone who is interested in pursuing a career that deals with drug companies and medicine, it is both embarrassing and shocking that these sorts of scandals are happening. Medicine is extraordinarily powerful, in both good and bad ways, so it is very important for drug companies to stay truthful. If we allow drug companies to have more and more freedom regarding what they say about their products, we could end up getting drug descriptions that are completely false. That's terrifying, thinking about what could happen if you take a medication that isn't perfectly suitable for you.
ReplyDeleteDrug companies are vital, however there needs to be a sense of trust between the company and the patient! Like you said, this trust leads to honest practice and better science. If drug companies cannot be trusted, they need to be regulated until they become trusted.
This comment has been removed by the author.
ReplyDeleteI certainly agree that a law that regulated drug companies in their off label promotion is a good law-- but is it a fair law? In a purely economic context, in the same way our government protects the right of other businesses that sell non-medical products to exaggerate the benefits of "x" product, shouldn't medicine be treated with the same economic protection?
ReplyDeleteUndoubtedly the accuracy of information for medicine holds more weight than whether a sham wow really absorbs that much liquid-- however, isn't that all the more reason why individuals should do legwork for their education as consumers as to what the medicine actually can do, or even easier, check with their doctors or other medical professionals? Furthermore, it's off-label information- check the labels and make sure the information matches up-- although this would certainly require education of the medicine.
Maybe it doesn't start with the drug companies, maybe it starts with the individuals consuming those products.
I see your point Yang, but as a consumer can we really afford even less trust with businesses at this point? Especially when those businesses are making products that go into our body and our lives depend on that. What happens if people don't have the proper education, proper resources to do what you're suggesting? Is that really fair, as fellow human beings? I totally see the logic with your point, it's just that if we lose faith in the products that could save our lives is just sad and depressing...
DeleteYang, I very much disagree.
ReplyDeleteBut let us assume that the main concern of regulation was not the safety and health of the people, but fairness. I'd say fairness to the drug companies isn't the issue. Fairness to the consumer is a far bigger issue.
Medicine is complicated. Few people can pronounce, let alone understand the ingredients on the medicine labels. Most people aren't doctors, and don't have the time or money for medical school. So they need to trust that drugs will do what they're supposed to.
If a medicine is falsely labeled as effective against a serious illness, that could pose a large health threat to consumers.
I understand where you're coming from, but the idea of personal accountability is easier when all of the facts are readily available. I know not to drink two chocolate milkshakes per day because I know that chocolate milkshakes aren't healthy (from the taste and ingredients--chocolate milk, ice cream, sugar, etc). But a pill is practically tasteless and has dozens of ingredients I've never heard of, and going to consult my doctor costs money.
If you still don't think the law is fair, consider that maybe food (regulated by the FDA) and medicine are slightly more important to regulate because we put those things in our bodies and bad medicine or spoiled food could get people really sick, whereas a faulty sham wow just makes the mess take a little longer to clean up.