American Woman 2

There are a number of features of the American Woman story that are emblematic. My original post said she contacted GSK and GSK replied but a closer reading of the emails makes all this less clear. I will continue the convention of referring to contact with GSK, as ultimately it would seem the company must be responsible for the handling of the event. There is probably nothing specific to GSK about this however – other companies will handle events the same way.

AW’s email (see all AW Paxil emails) “was received by one of our external websites and Glenna at CRC”. CRC usually means Customer Response Center, which at that time was for Over-the-Counter drugs. Why go this route? Well as we shall see this is a case study of the barriers a consumer has to overcome to get an adverse event reported directly to a pharmaceutical company.

The report says the initial email came in on May 31, 2001 from an external website. It is responded to by the call center within hours of being received. AW had a response on May 31, 2001 at 12:59pm, and the safety department at two minutes prior at 12:57pm. Yet, the second time AW e-mails, this time directly to the CRC on Friday, June 1 instead of through the external website (in response to the CRC’s May 31 outgoing e-mail), it takes 2 business days for CRC to take action. The CRC notifies the safety department about it on Wed, June 6, 11:32am while also notifying them that they have not responded to AW. Why the delay in forwarding the data and responding? In fact we don’t know when Glenna at CRC or their external site first received AW’s e-mail, which leaves the 15-day FDA notification up in the air.

What external website did AW contact? The Paxil website at that time did not have an e-mail submission page, but only a brochure request page that did not include a “questions/comments” line for data entry. It was simply a submission page of personal information in order to get mailed a brochure.

The Paxil website did not have a “contact us” link at the bottom of the page or instructions on how to specifically report an adverse event. Who did she e-mail then? There simply was not a way to e-mail GSK through the website. The only instruction about reporting adverse events was after many clicks in one paragraph about side effects where the consumer read this line “If you should experience any side effects, be sure to report them to your doctor”.

The company has several phone numbers. There is the Medical Information number listed in the response letter. There are also phone numbers on all the Paxil DTC ads. But it’s not clear that any connect directly to the company. Even professional journal ads whose audience is doctors did not at this time have a number that would reach the company directly. In the case of Paxil DTC adverts, the company subcontracted a call center to provide information to consumers – this is neither a medical information center, nor the GSK Customer Response Center call center, although it provides information of the type a manufacturer’s Medical Information department would provide. They can be mail-houses for brochures.

Some of the Paxil numbers have been recycled. For example, Paxil CR’s toll free number is now a program called Neevo Plus for an entirely different company, or the Paxil’s DTC numbers just ring and hang up. They do not reach the company. The advert numbers were not an internal company phone number. So if a woman like this called the numbers on the Paxil DTC ads, even if she left a voice message, it is almost certain that no one called her back as she had not reached GSK. This may have led to her efforts to email GSK and her pleas for someone to respond.

This begs a question – Do the call centers hosting prescription drug ad toll free numbers have an adverse events channel? They may not, which raises an interesting issue for FDA.

Companies now have FDA’s Medwatch reporting mechanism on their print ads and a line stating “talk to your doctor”. But whereas manufacturers have to follow up on adverse event reports they are notified of, and because of this Direct-to-Company communication from patients could lead to changes to their label’s warnings, if they find the adverse event could be caused by the drug, Medwatch does not have to follow up on incoming adverse events. Having the reports go straight to Medwatch paradoxically makes it less likely there will be action on any reported adverse events.

The message “talk to your doctor” instead of call our Medical Information Center also stops reporting of adverse events to the manufacturer. As the email to our American woman says “Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician.” Is this really saying “please don’t call us, it would cause us problems”?

Ironically, the origin of “Talk to your doctor” seems to lie in negotiations around OTC labels 1997. The FDA set up the “talk to your doctor” message to give consumers someone to talk to before taking the OTC drug. Then FDA requested OTC labels to carry a number directly to the manufacturer, for any questions after they took the OTC drug. But while this was seen as good for OTC drugs and OTCs list a toll free number directly to the manufacturer, it was never set up in this fashion for a prescription drug print ad, package insert or commercial.

The DTC ads from 1999 had 800 numbers that were not direct to the manufacturer and were not set up to report adverse events. The number offered in the AW letter is not the same as the numbers listed in any of the Paxil DTC print or TV ads. How many adverse events were not reported because consumers could not reach GSK directly and just gave up?

Since 2007 the package insert for prescription drugs mentions reporting adverse events to Medwatch and gives the manufacturer’s direct toll free number. While on the package insert, the direct manufacturer adverse event toll free number is not readily available on a prescription medication manufacturer’s website, while the Medwatch info is. The argument may be that the package insert is geared to doctors and not consumers, therefore it is more appropriate to have the manufacturer’s direct number solely in the package insert. But, given how few doctors submit adverse events that argument seems somewhat hollow.

Making reference to the Medwatch scheme, and urging patients to Talk to your Doctor makes companies look good but if in fact companies can divert patients down one or other of these routes they have an almost perfect way to hide problems. Win-win.

Ultimately we know from the correspondence a letter was sent to an address, but it is not clear it went to the woman. The zip code on the return certified letter suggests it went to Hudsonville, Michigan. The 4 digit code at the end of a zip code may mean a Post Office Box location.

The message has “other” marked off and “undeliverable” stamped, so it appears that she did not come in to pick up her mail and the post office, or whoever was holding the letter, sent it back.

The company sent a Medwatch report to FDA on this case. On this they indicate they sent one follow up letter “X1 letter unclaimed.” Yet, this woman communicated well via email. Why was she not sent an email asking for the doctor’s info? Why are GSK acting like they could not reach this woman?

The company reports “mother’s concurrent medications and medical conditions were not specified” as though she was on other meds but did not disclose specifically which ones. This is not supported by the woman’s statement which was she was on Paxil for Panic Disorder. Leaving other meds or conditions unknown means the company do not have to assign causality.

In her email, the woman said she was married in October 2000.  If this was in Hudsonville, and in Church these could be checked. The town hall may contain her marriage certificate.

Can anyone help us trace this woman?

Readers can also view my blog posts (American Woman 2) and find further information at www.davidhealy.org or visit my Facebook page.