On Friday 12th June, the US Senate voted in favor of a bill that gives the Food and Drug Administration the power to regulate tobacco products. President Obama (who as a Senator was a sponsor of the bill, as was John McCain) has indicated he will sign the bill into law.
Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides here.
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.
-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
– Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
– FDA also has the right to request any such industry document produced prior to the enactment of this law.
– FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
– Nicotine cannot be banned but it can be reduced to very low levels.
– FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.
Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these: Read more »
Life is short… and you never know when your time will be up. I was about to get on the train right after the one that crashed today. On a friend’s advice… I might just go buy a lottery ticket.
For more information on the crash check here. Those who want to find out if their loved ones were on the train may call 202-727-9099. Or follow #DC Metro on Twitter.
I have heard a lot of talk about ownership of medical information. Bloggers like e-Patient Dave, and Robin are strong advocates for patient ownership of their information. To be truthful, I get nervous when I hear people saying they own something I have in my possession (and I’ve blogged about this). The charts in my office are mine, right? How can I create something and have it not be mine?
I carried this unease with me into the exam room recently. Thinking about the ownership of medical information, I opened a patient chart. The vital signs were already in, and I started in on the HPI (the patient’s story as to why they are there). I do this by asking questions: When did it start? How long did it last? What did it feel like? What did you take? Did you have other symptoms with this? How bad was it? Have you ever had this before?
Hmmm…. Whose information is this?
Then I went on to the review of systems. We have the patients circle symptoms on a laminated sheet and I discuss what they circled.
“You have some chest pain?”
“Well, it was a sharp pain that happened when I coughed. Is that bad? Could it be my heart?”
We then go into a discussion about chest pain and what to look for.
I put down the information the patient has given me and think a little more. The patient’s information?
Then I get frustrated. The past medical history hasn’t been updated recently, she’s been in the hospital and most of the information about this is not in the chart. The medication list is not accurate. The information about her family, lifestyle, and habits are incomplete and I don’t know when they were last updated. I sigh, then try to fill in the gaps as best as I can by asking her questions without betraying my lack of confidence in our record.
We have a meeting of our IT team after this, and I am thinking about this encounter. We are about to roll out a patient portal where patients will be able to log onto our website securely and fill out patient demographics, request refills, and get appointments.
“What information in the record would the patient be best to be in charge of?” I ask. By being “in charge” I mean that the patients would have actual control of this information and we would read it. I tell them about my experience and frustrations and we make the following list:
Marital Status
# Children
Job/School info
Home DM monitoring, weight, BP
Address, phone, e-mail address
Family history
Then I ask, “What information in the record could the patient contribute directly to?” By this I mean that they would see the information as it is in there and be able to suggest changes or additions, but would not be able to actually change themselves. Here’s what we came up with:
Smoking, alcohol
Medication List
History of visits to other medical providers, consultant names, etc.
Review of systems prior to visit
Surgical history
We want to be able to assemble this information so that it is in a format that is readable to us and fits our needs, but the patient would have the ability to take this data information and perhaps download it to organize as they wish.
“So what information should they have access to?” I ask, referring to information they can see, download, and organize as they wish, but not add or subtract to. Here is that list:
Upcoming tests needed (Colonoscopy, etc)
Immunizations
Lab results
Visit schedule – past and present
Previous vital signs
Recommended schedule based on their diseases
Problem list?
Finally, we discuss what is our own information that the patient only has access to if they request it. This is information that either will give them too much information (our thought process and remote concerns) or even things that we don’t want them to see (suspicions about truthfulness or worse). Here is this list:
Perhaps the problem list – if it contains things like anxiety, suspected abuse, or private things the patient has told us.
The HPI often has information that is potentially sensitive. People have to feel free to tell us things, and having that information be back in the face of the patient on the Internet (albeit a secure site) goes a bit too far. Who knows if a family member can access it? What about teens? It’s just too complicated.
Part of the assessment and plan is often conjecture and reminders to ourselves to pay attention to things in the future. If a person has weight loss, we may keep cancer in the back of our minds. If a person is asking repeatedly for narcotics, we may write down suspicions that bear watching in the future. We have to have a place where we can put things down and know they are for our own eyes only.
The last list is the shortest. Yet the current state of things is that the entire chart falls into the last category. This not only leaves the patient in the dark, it makes it so we have to do a whole lot of unnecessary work that the patient would do much better at (and without costing us a dime).
I think this is the sweet spot. This is the way the medical record should be in the future. It should be a shared venture – not just between PCP and patient, but also including other providers. For care to truly move forward we have to dream about what it could be. Our office now has this as the vision for where we want to head. I know my patients will be thrilled, and I am pretty sure I’ll have a lot less frustration in the exam room.
SonoSite just released their SonoRemote for controlling the company’s M-Turbo and S Series ultrasounds during interventional procedures like joint injections or central line placements. In addition to traditional style buttons, the remote control features voice recognition and can be programmed to understand commands in any language. So now you can hold the probe in one hand and the syringe in the other, and not have to fiddle with reaching over to the unit to take snapshots or change parameters.
Like most of you, I’m continuing to watch the events unfold in Iran via Twitter and YouTube. Not surprisingly, given the escalating violence, doctors and nurses are caught in the crossfire. This video was posted on YouTube on June 16th. One woman who I’m guessing is a nurse is showing a sign that says that 8 people were martyred. Toward the end of the clip the young man (whose voice breaks down many times) is saying that he witnessed the brutal beating of women and children. He speculates that the attackers were Lebanese Hezbollah. Hat tip to Andrew Sullivan, The Daily Dish.
This story really upset me because I work with medical students at UGH (Undisclosed Government Hospital), and because I have children who are the same age as these victims. The eye witnesses reports come from medical students who hid when Iranian militia and police raided a Tehran University dormitory in the middle of the night. Hat tip to Nico Pitney of the Huffington Post. As we witness history, we will continue to witness the murder of innocent people.
“At the same time, Iran’s Interior Ministry ordered a probe into an attack late Sunday night on Tehran University students in a dormitory reported to have left several students dead and many more injured or arrested. Students say it was carried out by Islamic militia and police. Iran’s English-language Press TV said the ministry urged Tehran’s governor’s office to identify those involved. Iran’s influential speaker of parliament, Ali Larijani, condemned the attack.
Students’ Web sites reported mass resignations by Tehran University professors outraged over the incident. One medical student said he and his roommate blocked their door with furniture and hid in the closet when they heard the militia’s motorcycles approaching. He heard the militia breaking down doors, and then screams of anguish as students were dragged from their beds and beaten violently.
When he came out after the militia had left, friends and classmates lay unconscious in dorm rooms and hallways, many with chest wounds from being stabbed or bloody faces from blows to their heads, he said. The staff of the hospital where the wounded students were taken, Hazrat Rasoul Hospital, was so shocked that they went on strike for two hours, standing silently outside the gate in their white medical uniforms.”
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