Dr. Kevin Most: Right to try and cigarettes
through Last week the House failed to pass a Bill that the Senate had passed termed “Right to Try”. You may have heard of it, in this bill patients with terminal illnesses are allowed to seek treatment with medications that have not met full FDA approval. This law is in place in 38 states in some fashion. Gov Rauner signed the bill in Aug of 2015 allowing patients in Illinois to access experimental drugs as long as they filled a few criteria. They must have a life expectancy of under two years and had been blocked from possible treatment due to the approval process by the FDA. In Illinois the bill is silent as to whether the company had to provide the medication nor do they state who would pay for the medication. Vice president pence signed a similar law while Governor of Indiana in 2015.
As this is present in 38 states an attempt is being made to make this a federal law so that patients could cross state lines or move to another state and receive the same treatment. The house bill that did not pass limited the life expectancy to a matter of months or an illness that would lead to severely premature death.
The Senate had approved a much broader version of when these medications could be used, with the definition being those with a “life threatening disease or condition”
Now most people listening to this may make a quick decision and say it should be supported, if 38 states have done this why wouldn’t we just make it a federal law. However many large groups including the American cancer Society, American Lung Association and Cystic Fibrosis Association sent letters of concern saying it is not dealing with the main barriers to experimental drugs as well as concern for patient safety. They feel the current expanded access program is safer and covers this issue much better.
The expanded access program receives requests for the use of experimental drugs on individuals in unique medical conditions, they approve close to 99% of the appeals. They receive over 1,000 requests a year. The appeals are decided within hours sometimes. Right to try advocates say this law would ease the process for obtaining permission and clear up the liability concern thus allowing more patients and doctors to participate.
This bill was fast tracked through the House with the expectation that it would receive the 2/3 rds votes needed to pass. However it fell short with a 259- 140 vote. Advocates say they will bring the bill back through the normal process where only a simple majority is needed to pass.
Many feel this may hinder the actual FDA approval process as patients who were to use this drug and found it not helpful would not add to the data being collected through the normal FDA process. Serious adverse effects would still be reported but it is unclear how this information would be used as the drug went through the normal process.
The Pharmaceutical industry is interestingly very silent on the bill and really not taking a stand either way. It may be their way to let the public share the concern with the length of time needed for a drug to be approved. It may be that if they weigh in one way or another it will impact the public perception or expectations. Think about payment, how do you charge for a drug that is not on the market yet? Make up a price? This could be a disaster for them. Also their concern that these patients may have serious adverse effects that are now associated with their test drug.
Nothing in the bill would force the pharmaceutical company from providing the drug to the patients. In some cases they have only an amount needed to actually complete the FDA approved clinical trial. As noted above setting a price could be very problematic as well.
This is not the last we have heard about this, it will be back in the House shortly and go through the regular process and be tweaked a bit I would bet.
FDA wants to knock down the amount of nicotine in cigarettes
We all know about the effects of cigarette smoking on our health. Although we all think about cigarette smoking and the effects on the lungs, it actually damages just about every organ in the body. We know it causes a lot of deaths, in fact close to 500,000 individuals die from tobacco related illnesses, including close to 150,000 from Lung cancer alone. It is the largest cause of preventable disease in the US This does not even take into consideration the simple cases of bronchitis or sinusitis caused by smoking. The health and financial impact of cigarette smoking is staggering.
Nicotine is so highly addictive, some rate the addictive properties right up there with heroin and cocaine. Nicotine when inhaled reaches the brain within seconds. The concern is now with our youth, unfortunately we still see over 3,000 teens try their first cigarette every day and a substantial portion of them will become regular smokers. They often don’t understand the impact it can make on their life in the short term as well as lifelong impacts.
Certainly we took a huge step when we took the step to outlaw smoking in enclosed public settings. That made an impact on restaurant and bar workers and has really not made an impact on the success of restaurants as was once feared.
We certainly have made advancements in getting individuals to quit smoking with therapy, patches, chewing gum, medication and even the NY resolution Cold turkey process. However we know many fall off the wagon as they are exposed to smoke and the highly addictive nature of nicotine lures them back.
These are all good ways to try to treat the addiction that causes so many health related problems, but what if we could do something to slow or stop the addiction from even occurring in the first place. The FDA announced its plans to take a big step that should impact the addictive nature of tobacco and thus improve on the dismal health outcomes we currently see.
The FDA moved last week to take the first step to reduce the amount of nicotine in cigarettes with the goal of getting the amount of nicotine to below addictive levels. The FDA would work on setting nicotine levels for cigarettes.
The results of a study published last Friday estimate that cutting nicotine levels in cigarettes could eventually knock the smoking rate down to under 2% from its current 15%. That change would result in 8 million fewer tobacco related deaths through the remainder of the century, based on that change alone, now add in the advancements that will be made in detection and treatment and years from now people will be blown away at what is occurring now.
The FDA will soon open the public comment 90 day time frame. During this time we expect many comments guiding the FDA as to what level the nicotine level should be harnessed to. No doubt Tobacco Companies will have studies that try to keep the levels higher, while health related studies will push for lower levels. Also discussed during this comment session will be how quickly should the change be made. The timing of the change has been laid out to show the impact of a slow taper over years versus an immediate sharp drop. Estimates are that 5 million people would quit smoking within the first year of nicotine limits. It also appears that the restrictions will be placed on combustible tobacco, it is unclear if the restrictions will extend to chewing tobacco.
Some concerns are being raised about illicit trade of foreign cigarettes, the concern that people will actually smoke more cigarettes as they chase the impact of nicotine. This concern has been tested and it is in fact not true, the studies have shown that individuals smoke less and are more likely to quit.
The impact of much lower tax dollars is also being raised. In Illinois a pack of cigarettes is taxed around $2 a pack so the impact would be substantial. Now think about states like New York ( $4.35) Massachusetts ($3.50) that would be a large impact for them. The lowest state tax on cigarettes? Not North Carolina where they have cities or counties named, Winston, Salem, Raleigh ,and Marlboro. The lowest tax rate on cigarettes is actually Missouri at $0.17/ pack. Remember there is a federal tax on cigarettes as well of $1.00/ pk.
In 2016 the state of Illinois received $800 million in taxes from cigarette sales, this number was expected to be higher, however an increase in the tax on cigarettes in 2012 actually impacted this number and in 2016 we saw a significant drop. If the change in nicotine has the impact many feel it could have the $800 million would shrink significantly. This is certainly not a reason to hold up the change as the impact on the public’s health far outweighs the financial impact on the state’s budget.
This change may prevent youths from becoming addicted to cigarettes and may help those who are trying to quit to quit thus making a substantial impact on their health, the health of their family as well as their personal finance.
Stay tuned as this will play out over the next few months before the final decision on how much and how fast is actually made.