JOEL BIEBER'S BLOG

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.

Hormone Therapy Ruling

Yesterday I posted a quick blog on testimony of a defense expert. Wyeth (now owned by Pfizer) had called an expert to attack the medical testimony for the global hearing regarding all upcoming hormone therapy trials in Philadelphia. Since our firm has one starting in April, with the jury being selected in March, this ruling would have a direct impact on this upcoming trial.  

As set forth by a news story in "The Legal Intellligencer", Dr. Lewis A. Chodosh, a professor of cancer biology at the University of Pennsylvania, testified for the defense. Chodosh said that differential diagnosis "is the heart and soul of what it means to be a physician." But Chodosh said that the typical breast cancer has many different pathways stimulating its growth, and differential diagnosis cannot isolate which growth pathway is the cause of a patient's cancer. He said more than 95 percent of breast cancers have unknown causes.

Analyzing this drug company's defense is sometimes like eating dry cereal, it's just hard to get through. However, in the context of what they are trying to do, they keep "running out" a defense to try, to see if it might work. For several trials, they had an expert who testified that she found cancer in each of the women at trial, before any hormone therapy was taken. She found cancer, contrary to any other medical testimony or treating doctors in each case. Those juries did not find her very persuasive, so I guess, that we will continue to hear new stories as a defense. Fortunately, the Judge did not find this testimony persuasive either. 

When Opinion Ignores Reality

While sitting in the doctor's office today, I was reading the USA Today opinion page. It's amazing what sometimes becomes interesting when you are just waiting.

The opinion page is like a letter to the editor. The one that caught my attention was dealing with the recent health care bill. The author reminded that former Senator, John Edwards, had been named one of the biggest political losers of 2009. He recommended that Edwards should consider going back into the lucrative practice of law, since the health care bill had not adopted any tort reform measures regarding medical malpractice. I am sugarcoating some of the author's venom.

 This takes us back to the supposed purpose of malpractice reforms to be included in the health care bill. the reasoning was that by reducing doctor liability, it would reduce testing and "defensive medicine", which in turn would reduce medical costs.

For a blog, it would be both boring and impossible to argue logic for that position. Instead, I'll simply remind you of the argument for restricting liability for drug companies. At that time, bureaucrats and politicians were saying that drug companies needed protection from trial lawyers. Otherwise, if you did not enact caps, limits and immunity, drug companies would no longer have incentives to produce helpful medication. And, good drugs would not make it to market. As such, without these limits, would all suffer.

 Fortunately, for the safety of patients, no such immunity and limits was passed. In fact, some were even lifted. Yesterday, an interesting statistic was provided by the FDA. The number of new drugs that were cleared for market by the FDA, kept pace with 2008. This is statistical proof that the push for safety in early warnings and citations to drug companies has not affected the pipeline of medications to market.

The FDA also approved drugs known as a "first-of-kind", which shows no hesitation of drug companies in pushing their drugs forward. Again, without government intervention and the silly reasoning of politicians, the free enterprise is at work rewarding companies that produce medications safely, with appropriate warnings. Of course, drug companies don't like the extra hoops that they have to go through. So, I expect that they will continue with their illogical tort reform and their large political donations to the receptive politicians.  

Hormone Therapy Appeal Update

Both my parents worked full time jobs. So, before school age had arrived, they would drop me off at my Grandparents' house. I'd arrive early; do the requisite crying as my parents would drive off; and then I'd settle in for a day with my grandmother that might also include some farm chores.

My grandmother had probably already been up about 3 hours by the time that I arrived. The wood stove was pumping heat and she was busy peeling potatoes or getting ready for washday. No electric heat or electric washer and dryer to just turn on and leave. That's why it took a whole day, basically, to wash and roll through the ringer and then hang it up.

 I would always look forward to seeing my "Pop Pop" come back from the farm, if I hadn't gotten there early enough to go with him to feed the pigs and collect the eggs. Milking had been done long before that arrival time. He would come back for lunch. Usually, it was a pretty good spread of home grown farm food. Some good "fixins", as they say.

Anyway, I wrote those previous three paragraphs to get to what would happen after lunch. My grandmother and I would sit down to watch her "soaps". One was the long running program, "Days of Our Lives". It always started with the "Like sands through the hourglass, so are the Days of our Lives". I analogize that opening to the constant sand that is running against Wyeth and Pfizer Drug Companies.

On November 2, the US Court of Appeals for the Eighth Circuit issued its opinion in the case of Scroggin v. Wyeth.(Download Scroggin Opinion) On the lower level, a jury had awarded Ms Scroggin a verdict of $2.75 million in compensatory damages and $20 million in punitive damages against Wyeth and $8M in punitive against UpJohn. The lower level Court set aside the punitive verdicts and entered judgment on the compensatory. The Drug companies appealed the compensatory verdict and Ms Scroggin appealed the setting aside of the punitive damage verdict.

The Eighth Circuit upheld the $2.75 Million in compensatory and sent the case back to the lower level jury, to determine what amount of punitives should be entered against Wyeth. It upheld setting aside the UpJohn punitive verdict but didn't want the UpJohn evidence to have any influence on the punitive verdict against Wyeth.

 Ms Scroggin was happy that the Court was now ordering the consideration of the punishment damages against Wyeth. Amazingly, Wyeth(now owned by Pfizer) issued a press release that somehow suggested a victory in the Eighth Circuit opinion. The fact that the punitives had originally been set aside and was now going to be considered, was escaping them, apparently.

As my previous blogs have suggested, on these verdicts involving Wyeth and its hormone therapy drug Prempro, it has been amazing to watch the defense spin of the verdicts. Somehow, it seems like a bunker mentality to me. The attached link titles the Court opinion, "Hormone Therapy Victims Win Important Appeal". That's how I see that the hormone therapy litigation is proceeding.

Notwithstanding, Wyeth and Pfizer seem to be seeing it differently. That's why it makes me travel back in time, as I sat in my grandmother's living room and saw the sand running through the hourglass. Can those drug companies feel the sand escaping too?  

Pfizer Responsibility

Connie Barton developed breast cancer five years after taking Wyeth's hormone therapy drug, Prempro. That's what a Philadelphia jury said on September 25. On Friday, that same jury entered the verdict of $3.7 million against Wyeth. (Bloomberg) This same month, Pfizer "closed" on its 68 Billion dollar purchase of Wyeth. Now, Pfizer has "purchased" this verdict and what is yet to come.

Today, that same Philadelphia jury returns at 2:30 PM to enter a verdict of punitive damages. On Friday, the jury found that Wyeth was "reckless and wanton" in its sale and marketing of Prempro. While the jury has not received evidence of the Pfizer purchase, the evidence for the jury to consider is that Wyeth's net worth "is" $19.2 Billion, and based on that, the jury will consider the amount of punitive damages.

 I am always fascinated by the arguments of defense counsel and, sometimes, I wonder if they really believe what they are saying. In the current trial, following plaintiff's argument that Wyeth was not accepting responsibility for anything, defense counsel got up and announced that, "talk is cheap but where is the evidence". I wonder if Pfizer will think of the word "cheap" when the jury returns its verdict. I'm guessing that the verdict will be brought back before the end of the day. Keep your eyes on the news if it's a big one!

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.

  

April Fool Me

     I've never been a big fan of April Fool's day. I'm not one that gets a kick out of pranks. I am a big Peyton Manning fan, but when I read about him throwing quarterback, Jay Cutler, into the pool, at the Pro Bowl this year, I didn't get a kick out of it. Especially when it was revealed that it caused Cutler to lose his diabetic medicine that he was carrying.(Indy Star)   I guess that some would say that I just don't have a sense of humor about that.

     I have always said that I enjoy watching Greta Van Susteren. She's a lawyer who has done commentating on both CNN and Fox News. I even thought that when she did a good interview of Governor Sarah Palin, It appeared to me, that she had crossed over into the world of journalism. Then, I found out that she and her husband are Scientologists,(Wikipedia) and her husband, John P.Coale, has or is a legal advisor to Governor Palin. I felt like I had been fooled.

     I kid about the product, Sham Wow. I think I might have even blogged about it. However, when I read about the pitchman, Vince Shlomi, this week, who apparently got in a tussle with a hooker because he bit her tongue, I just shook my head. Then, when I did more research on this guy, I realized that once again, I guess I was fooled. However, maybe a product that starts with the name "Sham" should have alerted me.

     All this ties in to my feelings about what Drug Companies and what they submit to the FDA, for approval for their drugs. Some of the records and articles that I have now seen, makes me feel bad for those taking some of these drugs, but also thankful, that many of these drugs have been driven off the market. When I saw Justice Alito, in Wyeth v. Levine, write in his dissent, that Drug companies should not be judged by jurors, for injuries that are caused. His opinion was that such judgment should come from the scientists at the FDA. I guess I will never have the chance to ask him, but I'd like to say,"Do you think that the FDA could be fooled?"  

Doctors' Opinions on Hormone Therapy

    As a lawyer, I get to see various documents during discovery that show me some of the methods that drug companies employ, in marketing their drugs. When I blog about it, discuss it or speak on it, it appears slanted, I'm sure, because it is coming from a trial lawyer. Every now and then, I see an article that sums up actions of the drug companies that say it with a medical background.

     I am posting an article from The Wall Street Journal. In reality, it is an opinion piece. There has been alot of news about articles being "Ghost written". Wyeth recently admitted to it. Specifically, having staff write articles and then having doctors putting their names to it. The article I am posting is not ghost written. It is authored by three doctors who call it "telling the truth about hormone therapy". It's a short article, so I hope I have enticed you enough to click on the attachment and make up your own mind about what these doctors are saying about drug companies.      

Wyeth v. Levine Result!

     It should be all over the web shortly, though I doubt that Wyeth is in a hurry to broadcast it. The opinion of Wyeth v. Levine has just been reported by the US Supreme Court.  Here is the opinion

I am also posting the breakdown of the decision by the Justices:

STEVENS, J., delivered the opinion of the Court, in which KENNEDY, SOUTER, GINSBURG, and BREYER, JJ., joined. BREYER, J., filed a concurring opinion. THOMAS, J., filed an opinion concurring in the judgment. ALITO, J., filed a dissenting opinion, in which ROBERTS, C. J., and SCALIA, J., joined.

     There was some discussion that Justice Roberts would recuse himself, since he allegedly owns stock in Pfizer, who is currently in the process of buying Wyeth. Despite that, he voted against Ms. Levine's verdict against Wyeth. Notwithstanding, the majority, by a 6-3 vote, determined that federal preemption does not exist as an escape for these Drug companies. I wonder if Justice Scalia will still be on the speaking circuit to speak on strict construction of the Constitution. Apparently, he doesn't think of it that "strictly" to cause him to dissent. 

The Conduct of Wyeth

     Because the Firm is involved in Hormone Therapy Litigation, I keep a close eye on all things related to Wyeth. Certainly, the sale of Wyeth to Pfizer may impact Wyeth litigation, going forward. However, I am more interested in looking at Wyeth in the past. The following article that I am posting, from Martha Rosenberg, summarizes some of Wyeth's conduct. I am posting it without other comment. I will let the article speak for itself.

MARTHA ROSENBERG

CHICAGO

REVELATIONS of Wyeth Pharmaceuticals’ alleged pay-to-play, ghostwritten articles in medical journals brought by Sen. Charles Grassley (R.-Iowa) in December could not come at a worse time for the company, which will be bought by Pfizer.

The hormone-maker’s bellwether case, Wyeth vs. Levine, is before the Supreme Court. The case is testing whether approval of a product by a federal agency pre-empts the right of injured consumers to sue.

Wyeth tried to get a Food and Drug Administration veterinarian, Victoria Hampshire, who exposed its heartworm drug ProHeart 6, which has killed 600 dogs and sickened thousands, arrested and fired, according to USA Today. (Surprise: The drug is back on the market.) And its signature product line, the hormone drugs Prempro and Premarin, still kills.

Since 70 percent of hormone-replacement therapy (HRT) patients quit when the Women’s Health Initiative (WHI) found that the hormones caused a 26-percent increased risk of breast cancer, 29-percent increased risk of heart attack, 41-percent increased risk of stroke, and double the risk of blood clots in 2002, Wyeth has been trying to resuscitate the $3 billion-a-year HRT gravy train. But the condemning studies won’t cease.

Two years ago researchers reported that breast-cancer cases fell 7 percent and estrogen-positive breast cancer 15 percent — sparing 14,000 women — in the first year women turned their backs on HRT.

Not only could breast cancer from HRT regress or not develop in the first place in that short a period, The New York Times reported, it can also grow that quickly, according to new evidence.

New findings from the WHI presented at the San Antonio Breast Cancer Symposium in December reveal that HRT doubles the risk for breast cancer in just five years and increases the risk in just two years. Oops.

“It’s an excellent message for women: You can still diminish risk (by quitting), even if you’ve been on hormones for a long time,” Dr. Claudine Isaacs of Georgetown University’s Lombardi Comprehensive Cancer Center told the Associated Press about the new WHI interpretations.

“It’s not like smoking, where you have to wait 10 or 15 years for the risk to come down.”

When the Prempro/Premarin deception blew up in 2002, Wyeth sent out 550,000 letters “educating” doctors about the study findings. It ceased all advertising “to make sure it was consistent with new data,” Wyeth spokesperson Natalie DeVane told PR Week, not that it wasn’t in compliance anyway.

Then it sicced its ghostwriters and subsidized docs on the medical press.

Women in the WHI study were too old, too menopausal, took HRT too long, shouldn’t have had heart disease and shouldn’t have had uteruses, said the spin machine even as 4,500 cancer suits were brought against Wyeth.

One arm of the misinformation brigade was the “Council on Hormone Education,” at the University of Wisconsin School of Medicine and Public Health. “Designed to provide OB/GYNs and primary-care physicians access to the most up-to-date and fair, balanced scientific and educational information about postmenopausal hormone therapy,” according to its Web site, and funded by guess who? Wyeth.

In fact, the 64 physician council members named 44 financial ties to Wyeth. The council offered continuing medical-education credit (ACCME) for a course called Quality of Life, Menopausal Changes and Hormone Therapy, educating physicians about the “physiological effects of estrogen loss,” not in 1998, not in 2001, but in 2006! (Credit for the course is no longer available.)

The course in pharma-funded medicine was co-sponsored by the very company Senator Grassley has accused of planting pay-to-play Wyeth articles in medical journals: DesignWrite, of Princeton, N.J. And there’s more. Dr. Lila E. Nachtigall, the New York University professor and Women’s Wellness Center director whom Grassley documents suggest was recruited by Wyeth for ghostwritten articles, was on the distinguished faculty of the 2006: Quality of Life, Menopausal Changes and Hormone Therapy course

In addition to taking money from Wyeth, the University of Wisconsin reports that she was funded by Eli Lilly, Merck, Pfizer, Proctor & Gamble and Novaritis AG.

While many doctors rode the HRT gravy train, Dr. Nachtigall was an early and zealous promoter. Way back in 1985 she wrote in the Journal of Reproductive Medicine in an article cryptically titled “Is Estrogen Replacement Therapy Necessary?” that “despite continuing controversy, the risks of ERT [HRT] are now considered minimal. With individualized therapy and appropriate monitoring, ERT with progestin supplements appears to be safe and effective for the great majority of postmenopausal women.”

Not only was HRT indicated for women during and after menopause — from “menopause to death,” as former Wyeth CEO Robert Essner used to tell his reps — “it may even reduce the risk of atherosclerosis,” she wrote in the same article, adding in the journal Geriatrics in 1990, that most “studies have shown that replacing estrogen in the menopausal woman reduces cardiovascular disease.”

Dr. Nachtigall was also an early worrier about HRT dropouts and wrote that a physician explanation of risks “enhances compliance and discourages patients from discontinuing therapy because of fears of cancer or misconceptions about hormone replacement therapy,” in Obstetrics & Gynecology in 1990. So much for “no one knew” until WHI.

Dr. Nachtigall even took the cancer “problem” head on in Obstetrics & Gynecology in 1993, finding that “22-year year administration of estrogen-progestin hormone replacement therapy did not increase the incidence of breast cancer in a small group of continuously hospitalized postmenopausal women.”

Dr. Nachtigall also helped to widen the HRT revenue window with “The Symptoms of Perimenopause,” in Clinical Obstetrics & Gynecology in 1998.

Start ’em young!

Asked by The New York Times if she had rubber-stamped pharma-written articles, as Senator Grassley’s disclosures suggest, Dr. Nachtigall was annoyed. “It kind of makes me laugh that with what goes on in the Senate, the senator’s worried that something’s ghostwritten. I mean, give me a break.”

Martha Rosenberg is a Chicago-based columnist/cartoonist who writes about public health.