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Bloomberg’s and AP Hormone Therapy Update

The following is from a Bloomberg News and AP update on Hormone Therapy payments.  Our Firm is still in the middle of this litigation.  Pfizer purchased Wyeth about 2 years ago, which is why it is interchangeable in this article.

The AP (5 1/2, Johnson) reported that Pfizer “recorded charges totaling $472 Million as it reached agreements to settle about one-third of the lawsuits it faces” over whether hormone-replacement therapy (HRT) drugs made by its “Wyeth subsidiary caused breast cancer or other harm to women.”  In an  SEC filing “late Thursday, Pfizer said it took a $172 million charge in the first quarter to cover those agreements, plus verdicts in lawsuits it has lost.”  The pharmaceutical company also “recorded a $300 million charge in the quarter for the minimum expected costs to resolve all of the other outstanding hormone-replacement therapy actions against Pfizer and its affiliated companies.”

Bloomberg News (5/13, Feeley) reports that in February, Pfizer had “agreed to pay about $330 million to resolve 2,200 cases over the menopause drugs, according to people familiar with the accords.”  Overall, Pfizer’s “Wyeth and Upjohn units have lost eight of the fifteen Prempro [conjugated estrogens and medroxyprogesterone] cases decided by juries since trials began in 2006.”

DR Oz on Hormone Therapy

     If you are a DR Oz show watcher and you are also trying to learn more about hormone therapy options, then his opinion will matter to you. It’s not so good for Wyeth/Pfizer. Since this Firm is still in the middle of litigation regarding the hormone therapy drug, Prempro, then Dr Oz’s recent entry on hormone therapy is very relevant. I’m guessing that these Pharma companies would disagree with him.

     In response to a question to him about what to do in fighting menopausal symptoms, Dr Oz addressed what to consider, in light of the allegations that hormone therapy causes breast cancer. In response, he suggested a consideration of three things:

     1.Estrogen used alone, slightly decreased the risk of breast cancer; which suggests that the problem relating to the breast cancer increase, was  a result of combining estrogen with a combination of progesterone. (those involved in the Prempro litigation, know about this combination)

     Dr Oz’s second consideration in using hormone therapy is that it is now safer, due to previous studies. Attention was brought to the hazards of hormone therapy, when the Women’s Health Initiative began a study that included a control group. The volunteers in the control group, taking the hormone therapy, were developing cancer at  such alarming rates, that the study was halted before it was completed.  A side benefit  is that now, more are aware and alternatives are proving to be potentially safer.

     Dr Oz believes that the third consideration in using hormone therapy, is that he feels that there is mounting evidence that it can help in protecting woman from heart disease. (more evidence needs to be developed on this benefit)

     What is Dr Oz’s viewpoint on the product, Prempro, that was manufactured by Wyeth, and is now a Pfizer product. Well, I’ll let him put it in his own words:Prempro, a mix of equine estrogens (from pregnant horses) and synthetic progesterone, which we now know disrupts estrogen’s heart and breast benefits. While this combo is still prescribed (there’s been a lower-dose form since 2003), you should insist on today’s different — and much safer, in our opinion — types of estrogen and progesterone. They can lower your breast cancer risk and help your heart.

     What does Dr Oz recommend now as a product for hormone therapy:
What are the newer, safer forms? Bioidentical estrogen (estradiol) and micronized progesterone, which doesn’t block estrogen’s artery-pampering effects. We and many other doctors recommend them. If you’re already using HT, you may be taking them. They’re sold as individual drugs (Estrace, Prometrium) and combo products (Angeliq)

Business Choices

     Chuck Geschke of Adobe, tells about the presentation of technology to Xerox executives and their spouses.  The year was 1977 and printers and computer controllers,  referred to as a “mouse”,  were completely foreign.

     The spouses “loved this stuff. They sat down and played with the mouse and changed things on the screen. They hit the print button and could see the same thing on the paper, that they had just been looking at on the screen”, said Geschke. Several said, “Wow, this is really cool. This would really change an office if it had this technology”.

     The Xerox executives didn’t listen to their wives. Instead, they felt that Xerox would be moving outside of what it already did successfully. As a result, Adobe and Apple exist today.

     I titled this “Business Choices” because decisions that are made may have long lasting impact on a business, or it may have impact on the consumer. The attachments below demonstrate business impacting the health of its consumers, because of choices made. 

     Over the weekend, I watched the documentary “Casino Jack and the Unted States of Money”  It is the story of lobbyist Jack Abramoff and his actions in influencing Congress. His conviction was a house of cards to a few others being convicted,  including Congressman Robery Ney. Tom Delay also resigned from the US House of Representatives.

     The premise of the documentary was that lobbyists received money from businesses or special interests and passed it on for favorable legislation. This legislation led to a relaxation of regulations on such industries as Pharmaceutical Companies. Today, politicians are returning with the same message and not even repackaging the message.

     On Sunday, Politicol News  did a story on Wyeth and its hormone therapy drugs. Since Pfizer has bought Wyeth and the existing lawsuits relating to this medication, the article is titled “Pfizer Fights Breast Cancer Survivors in Court-2010”. It shows what happens, when a drug company can ignore testing and put products on the market, with profit in mind. It shows what happens when regulations are relaxed.  

     This weekend, I watched football and saw many NFL Players wearing pink, in support of the fight against breast cancer. On Saturday, I watched many gather, as they were part of the Susan Komen Race for the Cure, in Virginia Beach. Teams gathered, dressed in pink, as they raised money for a cure. Survivors of breast cancer were celebrated.

     I hope you will click on the news article that outlines the continuing fight of Pfizer. When business makes a bad choice, like Xerox did, it usually means that competitors benefit. When Wyeth/Pfizer made and continues to make choices, it has a long lasting impact on those fighting for a cure for breast cancer.

On the Lookout

     Maybe it is too hot to blog but I wanted to mention some “goings on” in our Pharmaceutical practice. We have an upcoming trial in Philadelphia in our hormone therapy litigation. Wyeth is listed as the defendant, but Pfizer bought them at the end of 2009. At this point, I expect that the trial will go forward. It involves one of our Virginia clients. In addition, the Philadelphia Judge will soon be ruling on combining plaintiffs in one trial. That would move the litigation forward and create less expense for each of our clients.

     We are still completing disbursements to our Vioxx clients. Under the original terms of the settlement, the disbursements are in waves, based on the type of injury that was suffered. In addition, Merck paid, subject to approval of the Judge,  of each of the costs and fees.

     That’s a quick summary of a couple of the drug litigation course of events. Of course, we are always on the look out for other possible drugs that may be causing injury. Sometimes, a prospective client will send me information of an injury that they believe was caused by some prescription. That’s why, I have titled this “On the Lookout” because I believe that people calling to report bad drugs have made our medications safer and the FDA more aware. We all benefit when people call.

                                                        

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Hormone Trial Verdict Today

Around lunchtime today, a Philadelphia jury returned a verdict against Wyeth in the Singleton v. Wyeth case. Punitive Damages are also being considered. I am going to post the Bloomberg story verbatim in this blog, since it is short and does a good summary of that verdict. In addition, there should be another verdict that will be either tomorrow or Wednesday, as both trials were going on simultaneously. Anyway, here is how the reporter for Bloomberg saw it: 

Feb. 22 (Bloomberg) — Pfizer Inc.’s Wyeth unit must pay $3.45 million to a woman who argued the company’sPrempro menopause medicine helped cause her cancer, a Philadelphia jury ruled today.

Jurors in state court deliberated about five hours over two days before finding Prempro was one of the causes of Audrey Singleton’s breast cancer. Singleton, a retired school bus driver from Chatom, Alabama, took Prempro for about seven years before developing the disease. She underwent multiple surgeries, chemotherapy and radiation, according to her lawyers.

Jurors awarded Singleton $3.25 million in damages for claims including medical expenses and pain and suffering. They awarded her husband $200,000 for loss of consortium. Jurors will hear arguments on punitive damages later today.

“We are obviously disappointed with the verdict and will evaluate all of our legal options once the court completes its work in this case,” Pfizer said in a statement. “Given that the case is continuing to the next phase, it would not be appropriate to comment any further.”

Lawyers for Singleton declined to comment until the end of the case.

The verdict is Wyeth’s seventh loss in 10 cases to have gone before juries and the fifth in a row over the drug. Former users have filed more than 8,000 complaints against Wyeth and another Pfizer unit over menopause drugs, according to a Wyeth regulatory filing last year. The drugs are still on the market.

2002 Study

More than 6 million women took the pills to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted the drugs’ links to cancer.

Until 1995, many patients combined Premarin, Wyeth’s estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Pharmacia & Upjohn unit. Wyeth combined the two hormones in Prempro.

New York-based Pfizer, the world’s largest drugmaker, completed its $68 billion purchase of Wyeth last year.

Singleton, a mother of three, began taking Prempro in August 1997. A mammogram at that time was normal, her lawyers said during the trial. She stopped taking the drug in January 2004 after her breast cancer diagnosis.

Lawyers for Pfizer argued during the trial that Singleton learned in July 2002 of the risks associated with the drug. Her prescribing physician suggested she stay on the medicine, Pfizer said.

Fake Medical Research

Imagine the following wonderful television advertisement. A friendly announcer's voice tells us that, "It has now been proven that eating chocolate increases muscle definition, causes weigh loss and, in certain circumstances has shown to regrow hair in men 55 and older." The ad then goes on to say, "new research has also shown that chocolate is the fountain of youth. Ask your doctor if chocolate is right for you".

First, as I was typing this blog, I wanted to believe this myself. In fact, I gave some thought to just hitting the publish button, to make myself feel good. However, the title of this blog is "Fake Medical Research", so you know that the ending here is not what we want. Second, this doesn't mean that chocolate doesn't have some value. I do like chocolate!  I just wish that what I am blogging below, only related to the humor or benefits of chocolate. Unfortunately, fraud is the culprit.

I post on fake research because the Associated Press has reported that federal prosecutors have announced that they have filed a health care fraud charge against a Massachusetts anesthesiologist, who reportedly used fake research data. In 21 published studies he suggested that Vioxx and Celebrex provided certain after-surgery special benefits. According to findings, Dr Scott Ruben has admitted to making up some or all of his supportive data for these studies, that were published during 2002-2007 and that the published findings had no scientific basis.

    This tale of phony research came to light last year when the hospital where he worked, found that this doctor had faked the data. At that time the Boston US attorney began looking into his conduct, as well. It was also found that during the period of these published studies, Pfizer had give Dr. Reuben five research grants, in conjunction with his published findings. Pfizer is the distributor of Celebrex.

 I blog on this for two reasons:  there is a connection to Pfizer and this law firm's hormone therapy litigation. The primary defendant in most of these lawsuits is Wyeth. In October, Wyeth was purchased by Pfizer. In the hormone therapy jury trials, the defense has called experts to testify on behalf of the drug company. I also blog on this because it shows that just because a drug company advertises benefits does not mean we shouldn't question the statements.  

Back to the fraud, an analysis of Reuben's relationship to Pfizer also shows that he was a member of the company's speakers bureau and gave talks to other colleagues about Pfizer's drugs. Despite this relationship, I didn't see any mention of Pfizer's concern over Reuben and his false data, when reading this Associated Press article. 

The FDA relies on the published data, when these drug companies seek approval. It's obvious that the advancement of science and cure is greatly effected by fraud. Plus, fraud is not the only concern when there is evidence that Celebrex and Vioxx are responsible, in certain instances, for causing death. Considering that, what responsibility does a drug company  owe when relying on such information? Is it fair that they can just keep their profits and turn a blind eye to such? Hopefully, juries will hold drug companies accountable for such actions or omissions.

Wyeth Verdicts

On October 26, a Philadelphia jury returned a punishment damage verdict in the case of Barton v. Wyeth. This, on the heels of a 3.7 million compensatory verdict that had been entered against Wyeth Pharmaceuticals, for the actual damages that Mrs Barton had suffered, from taking the Wyeth hormone therapy drug, Prempro. Because another hormone therapy trial against Wyeth was going on a few doors down in the same courthouse, the Judge sealed the punitive damage verdict until the conclusion of the other pending case.  However, as of today, that verdict has been unsealed to reveal a $75 million dollar punitive verdict.

On Friday, in the case of Kendall v. Wyeth, the jury returned a verdict of $6.3 million with Wyeth being responsible for 60% of the verdict and Upjohn Pharmaceutical, responsible for 40%. (Story) Today, the jury returned a punitive verdict to be added to the $6.3, in an amount of $16 million against wyeth and $12 million against UpJohn for a total punitive verdict of $28 million, making the sum total verdict in Kendall to be $34.3 million.

Under our hormone therapy update section, I am also providing a listing of the verdicts that have been compiled in the hormone therapy cases. (Download Jury Verdict List) As previously blogged, Wyeth has listed a "scorecard" that did not sync with this listing. However, I think that it is difficult for them to ignore the last three verdicts that have been significant findings of fault against them. In addition, I am attaching a short video (5m:15sec) that also gives a news type update that is being sent to news stations. It's true that a picture is worth a thousand words; so this video is certainly worth more.

 

The Testimony of Dr Dey

The title of the blog almost sounds like a Hollywood movie. Instead, it was one of those instances where fact seemed stranger than fiction. Dr Michael Dey was on the stand, as a witness for Wyeth Pharmaceuticals.

Earlier, Wyeth's defense counsel had filed a brief in support of its motion, that women assumed the risk of breast cancer, when they chose to take Prempro, a hormone therapy drug. The basis of this motion, in part, is that the language of the drug label had inserted the following language:  "Potential Risk".  

That has been part of Wyeth's defense. Right now, a Philadelphia jury is being asked to determine whether such language was enough warning to relieve Wyeth from responsibility, for causing breast cancer. Of course, the public has now become used to TV commercials that include so many warning symptoms, followed by "Ask your doctor if it's right for you", that these commercials have become fodder for comedians. Plus, these attached information sheets are several folded pages, in small print and almost require the skill of a neurosurgeon to unfold them.

  Notwithstanding, Dr Dey took the stand to testify about the warning. In a 2008 Press Release, he had been appointed as President of Wyeth's newly created Women's Healthcare Business Division. He has been employed by Wyeth since 1984.

Prior to the questions about the Wyeth label, Dr Dey was asked about the sales call notes of the Wyeth drug reps, that had been produced in discovery. Those notes show a huge amount of information that show doctors receiving gifts for prescription production. The jury will consider whether those gifts were incentives for prescription, I guess, or rewards for looking out for patients.

Dr Dey answered questions about such things as Champagne, wine and lavish dinners: tickets to sporting events, The Ice Capades, theater shows and the Circus; and lavish trips. According to courtroom witnesses, this seemed to throw the doctor off a bit.

Then, Dr Dey was asked about the risk of breast cancer. Like a political survey, he was asked to choose whether he would say that the effects of the drug were a) a risk of cancer; b) a potential risk; or c) No risk of cancer at all. His response on the record:

   

DR. DEY

4    A Based on what was in the label, there was a

5    potential risk.  I would have said as a scientist

6    there is a risk.

Then the Judge, presiding over the trial, decided to ask the Dr again, about his answer. The impression was that he could not believe what he had just heard:.

  

    13     THE COURT:  I

    14 asked the question, is it a risk or a

    15 potential risk?

    16     THE WITNESS:  It depends on whether you

    17 are asking me as a scientist or what's in the

    18 label.

    19     THE COURT:  Oh, I see.

    20     THE WITNESS:  As a scientist I would

    21 say there is a risk.

    22     THE COURT:  What's in the label?

    23     THE WITNESS:  The label says there is a

    24 potential risk.  As I recall.

 

It will be interesting to see how the jury reacts to this. Did the doctor decide to just be honest? Is he no longer worried about the consequence, since Pfizer has completed the purchased Wyeth? Was he still thinking about all those theater tickets and trips? I guess we will see what the jury thinks, in the next couple of days.

  

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