I love this claim:
"...the confusion caused by the presence on the market of unregulated nicotine products viewed by the public as unsafe or ineffective may lead consumers to forgo all smoking cessation products, even those FDA has actually found to be safe and effective."
Wouldn't it be fun to get Margaret Hamberg on the stand and cross-examine her about some of this (as Harry put it) sosdd?
PLAINTIFF ATTORNEY: Now, Ms. Hamberg, there has been a lot of discussion about the smoking cessaation drugs that the FDA has "found to be safe and effective. " Isn't it true that the FDA found that verenicline, brand name Chantix, was a safe and effective drug to use for smoking cessation?
HAMBERG: Yes.
PLAINTIFF ATTORNEY: Ms. Hamberg, I'm handing you a report on a study on verenicline by the Institute for Safe Medication Practices.* Would you please read the highlighted text.
HAMBERG [Reading]: "From May 2006 through December 2007, the FDA had received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories were not mutually exclusive."
PLAINTIFF ATTORNEY: Thank you. Now isn't it true, Ms. Hamberg, that in July 2009 the FDA invited the public to use the MedWatch FDA program to report adverse events caused by electronic cigarettes?
HAMBERG: Yes.
PLAINTIFF ATTORNEY: Can you tell me how many reports of "suicidal thoughts, acts or behaviors" MedWatch has received about electronic cigarettes?
HAMBERG: None
PLAINTIFF ATTORNEY: How many cases of possible psychosis caused by electronic cigarettes have been reported to MedWatch?
HAMBERG: None
PLAINTIFF ATTORNEY: How many cases of hostility or aggression caused by electronic cigarettes have been reported to MedWatch?
HAMBERG: None
PLAINTIFF ATTORNEY: How many deaths are attributed to using an electronic cigarette?
HAMBERG: None
PLAINTIFF ATTORNEY: Ms. Hamberg, I direct your attention to the very end of the report that I handed you. Would you read that bottom line to the court?
HAMBERG [Reading]: "Published May 21, 2008 by the Institute for Safe Medication Practices."
PLAINTIFF ATTORNEY: And since receiving this report, did the FDA remove Chantix from the marketplace?
HAMBERG: No. The FDA required the manufacturer to add a "black box warning" to the package and prescribing instructions.
PLAINTIFF ATTORNEY [Sounding incredulous]: No? The product is still being marketed?
With all those serious problems, why didn't the FDA get rid of it?
HAMBERG: The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking.
PLAINTIFF ATTORNEY: So would it be fair to say, Ms. Hamberg, that the FDA believes that smoking is so detrimental to health that it is worth it for a smoker to risk the potential for suicide, psychosis, hostility, and agression?
HAMBERG: Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.**
PLAINTIFF ATTORNEY: I hear you saying that smoking is so very dangerous that if there's a product that even
might be effective, it's worth taking a risk that the smoking cessation treatment might be unsafe. So tell me, Ms. Hamberg. We've discussed the risks of taking Chantix. What would be the odds of an electronic cigarette user developing any of those problems?
HAMBERG: We have no way of knowing, because the electronic cigarettes have not been through our drug approval process.
PLAINTIFF ATTORNEY: But haven't we just established the fact that the FDA's drug approval process doesn't always guarantee that a drug is truly safe? And haven't we established that there have been no reports of serious problems by electronic cigarette users?
HAMBERG: Yes, but....
PLAINTIFF ATTORNEY: Isn't it true, Ms. Hamberg, that FDA prefers randomized clinical trials for proof that a product is safe?
HAMBERG: Yes.
PLAINTIFF ATTORNEY: And isn't it also true, Ms. Hamberg, that FDA allows drug manufacturers to exclude certain populations from participation in the trials, if the manufacturer believes including those populations might change the results? For example, weren't people with any history of depression or other mental illnesses excluded from testing Chantix.
HAMBERG: Yes, but there's a good...
PLAINTIFF ATTORNEY: Ms. Hamberg, doesn't it follow that the true measure of how safe any drug is comes when the drug is out on the market and available to just about anyone?
HAMBERG: Yes.
PLAINTIFF ATTORNEY: So, Ms. Hamberg, wouldn't you have to agree that there is a pretty clear picture that electronic cigarettes are much safer than using Chantix?
HAMBERG: No!
PLAINTIFF ATTORNEY:No? Your honor, I'm through with this witness.
NOTE: The dialog above is fiction. I made it up. I just wish it were true. Some of the facts and FDA statements are drawn from real life. See references below.
*
Strong Signal Seen on New Varenicline Risks
**
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
), and so on.
