Yaz On Trial : Yaz Birth Control Lawsuit : Info on Yasmin & Ocella Side Effects

Doctors rely on drug company representatives for information about a drug's risks and benefits. The information that the drug company provides to the doctors is supposed to be accurate and truthful. Unfortunately, as I wrote here, the representatives sometimes understate a drug’s risks, overstate its benefits, and promote the drug for uses for which it has not been approved, all in an attempt to increase sales and boost profits. The bad information leads doctors to prescribe drugs to their patients when they really shouldn't. As a result, consumers are needlessly injured.

Now the FDA is catching on. On May 11 the FDA announced that it is asking doctors to turn in drug company representatives who provide misleading information about the drugs they are promoting. The FDA is asking doctors to be on the lookout for --  an anonymously report -- the following types of drug company violations:
 

Example of Omission of Risk
You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.
This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Unapproved Use
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.
This presentation would be illegal because it promotes an off-label use.
 

Example of Overstating the Effectiveness
“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”
This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.
 

Why is the FDA asking doctors to help?  Isn't it the FDA's job to police the drug companies?   According to the FDA website:

[Our] traditional surveillance activities have been somewhat limited by [our] inability to monitor drug promotion in settings such as physician offices, local dinner programs, and promotional speaker training sessions. By raising awareness about misleading promotion and providing an easy process for reporting it, FDA can gain the valuable assistance of health care professionals in helping to decrease the number of misleading promotional messages about prescription drugs.

It's good to see that the FDA is finally catching on.  But there's an obvious problem with the program.  The doctors rely on the drug company representatives for information about the drugs.  How can they be expected to know when the information the drug company gives them is false or misleading?

• Email This
• Print
• Comments
• Trackbacks
• Share Link

The press continues to get the word out about the potential side effects of the birth control pills Yaz and Yasmin. Yesterday, a California consumer protection group called The Civil Justice Research Project reported on the status of the litigation and the claims brought by women and their families who have suffered after taking Yaz, Yasmin or Ocella. The group reported that some women have suffered strokes, pulmonary emboli and heart attacks after taking these birth control pills.

In addition to the health concerns, the group also reported on Bayer’s “aggressive advertising,” noting that the FDA found that some of the Yaz commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. Although the article acknowledged that Bayer ran a multi-million dollar corrective ad campaign, it also explains that some find those corrective ads to be “too confusing and jargon-filled to be effective.”

Two of the authors of this blog, Yaz attorneys A.J. De Bartolomeo and Mike Danko, and were also mentioned in the article for their work representing injured women in the Yaz and Yasmin lawsuits. Articles like this one really help spread the word about the potential side effects of Yaz, Yasmin and Ocella, and keep people informed about what’s happening with the lawsuits.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Lawyer2Lawyer is a legal talk show that brings together lawyers with opposing views from across the country.  On its show devoted to the growing number of Yaz lawuits, Lawyer2Lawyer interviewed Mike Danko and Professor James O'Reilly, from the University of Cincinnati College of Law.  Mike discussed the basis for the lawsuits, while Professor O'Reilly discussed the FDA's role in the drug's approval and its monitoring of Bayer's advertising.

Listen on line, or read the transcipt:

Announcer:

This is Lawyer2Lawyer, the award-winning legal podcast with J. Craig Williams and Robert Ambrogie.

West Coast meets East Coast, and yes! they are attorneys.

Bringing you the latest legal news and observations every week with the leading experts in the legal profession. Produced here on the Legal Talk Network.

Craig:
Welcome to Lawyer2Lawyer on the Legal Talk Network. Thank you for listening today. I’m Craig Williams from a very sunny California.

Bob:
And this is Bob Ambrogie from just outside of Boston, Massachusetts where I practice law and write a couple of blogs…

[sponsor information…]

Craig:
Today’s show is about Bayer Healthcare Pharmaceuticals, who is facing a growing number of lawsuits claiming that the company concealed the health risks associated with top-selling birth control pills Yaz and Yasmin.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Bayer's Yaz commercials are misleading. The FDA determined that they overstated the drug's benefits, and minimized the drug's risks (PDF). So the FDA yanked them off TV.  It also ordered Bayer to televise new commercials that set things straight.  The FDA ordered Bayer to spend $20 million doing it thinking, that way, every woman would get the word.  But did Bayer follow through?

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Earlier this year, the Food and Drug Administration (FDA), wrote a warning letter to the makers of Yaz about their advertising campaigns, which the FDA characterized as “misleading” because, among other things, many of the Yaz ads “fail[ed] to communicate any risk information” about use of the drug.

Interestingly, this was not the first time the makers of Yaz and Yasmin had received such warnings. In both 2003 and 2008, the FDA sent similar warning letters. Despite all of the FDA’s warnings, the drug manufacturers continued to use the same questionable marketing strategies to promote Yaz.

In the 2009 warning letter, the FDA told Bayer that:

...for promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

According to the FDA, these Yaz ads did not contain that important risk information. The letter warns that the manufacturers overstated both the benefits of Yaz and the conditions that Yaz was approved to treat, making the ads “incomplete and misleading."

The FDA warning letter concluded that Bayer should immediately pull the ads and discontinue the use of any other similar materials.

Even after receiving two previous warning letters from the FDA about their misleading advertisements, the makers of Yaz and Yasmin continued to use these questionable advertising practices. These ads incorrectly led some women to believe that Yaz was safer than it really is.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Have you seen the new Yaz commercial? You know, the one that begins with the main actress saying:

You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads.

It turns out that the “Yaz commercials” the actress is talking about are the very ads that were the subject of an FDA warning letter (PDF) in 2008 to Bayer (the manufacturer of Yaz and Yasmin). The FDA’s letter addressed two of Bayer’s Yaz commercials, entitled "Not Gonna Take it" and "Balloons.”

The warning letter stated that these commercials were “misleading” and “over-promised the benefits while minimizing the risks associated with Yaz.” The FDA also said that the ads were misleading because they implied that Yaz could treat PMS and “help keep skin clear.” In fact, Yaz was only approved to treat the more severe symptoms of PMDD (Premenstrual Dysphoric Disorder) and moderate acne, as opposed to more severe or less severe forms of acne..

The FDA also noted that, in addition to overstating the benefits of Yaz, Bayer also minimized the risks, which the FDA said was “particularly troubling as some of the risks being conveyed are serious, even life-threatening.”

The warning letter concluded that Bayer should stop running the ads immediately, and work on putting together a corrective campaign about the real uses and risks of Yaz that were both truthful and non-misleading.

So, it was actually in response to this warning letter that the makers of Yaz and Yasmin began to air the new commercial to “clear up” misconceptions! Check out that commercial below.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

You might have read about some of the warning letters the FDA sent to the makers of Yaz and Yasmin for misleading advertising – maybe you’ve even seen the Yaz commercial that clarifies the risks of Yaz at the FDA’s request – but did you know that the FDA has actually been warning the makers of Yaz and Yasmin about this sort of advertising since 2003?

In 2003, the FDA sent the first of three warning letters (PDF) to the manufacturer of Yasmin for its advertisements, stating that the:

TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone.

Yasmin was the first in a line of birth control pills to contain the hormone drospirenone. The FDA’s letter said that the commercial, named “Goodbye Kiss,” over-promoted the effectiveness and safety of Yasmin. Check out this excerpt from the letter:

[The] FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other [oral contraceptives] or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.

The FDA's warning letter concluded that the makers of Yasmin should remove the ad immediately and stop the use of any other similar promotional materials.

The trend of misleading advertising by the makers of Yasmin, and eventually Yaz, dates all the way back to 2003! It’s been more than five years since the FDA first called them out for minimizing the risks associated with the Yaz/Yasmin hormone drsp. Yet, despite many FDA warning letters about this issue, the makers of Yaz and Yasmin continued to use these questionable advertising practices well into 2009.

• Email This
• Print
• Comments
• Trackbacks
• Share Link