Press Conference on Wednesday, New Jersey-Updated 5/3

[scotty]

I'm going to be speaking at a press conference with NJPIRG on Wednesday at the State House in Trenton. NJPIRG is presenting a "report" on deceptive practices by pharma. Should be interesting! There are going to be multiple press conferences across the country.

[rdjanis]

Way to go Laurie!!

[Charlie]

Try not to hurt anyone Prisoners are OK!

[scotty]

They called me today and apologized for the short notice. Then asked if I would be comfortable speaking...DUH!!!!!!!!!!!!

[Delynbetter]

Then asked if I would be comfortable speaking...

[angels]

I didn't read the story, but today's front page of the NY Times, had a story on marred or falsified drug studies (can't remember exactly). I think there is a good chance we are nearing the point where this stuff is making headlines on a routine basis.

[scotty]

And to think that I used to dread talking in front of people... see paxil does work for "social anxiety"!!!!!!!!!!!!!!!! Once you've had a loved one affected, you'll talk to anyone, anywhere, anytime!!

[Charlie]

Originally Posted by scotty

And to think that I used to dread talking in front of people... see paxil does work for "social anxiety"!!!!!!!!!!!!!!!! Once you've had a loved one affected, you'll talk to anyone, anywhere, anytime!!

You are more right than you may ever know.

[Lilly]

Allright Laurie! Another one! Is there a place we can read or watch a telecast of it?

Good job again!
Lilly

[Delynbetter]

This may not have been what they were going for when they claimed "curing" social anxiety and such.

[scotty]

Ah, they've created a monster!!!

[ihatezaps]

Good luck, Laurie! You will do great!!!

[Homerbcool]

Laurie...you are aour ees, ears, mouth...and you will do great...looking forward to your comments..

[Delynbetter]

So what time does this happen? When should we expect a report back? Anyone hear from her today yet? Huh? Huh? Huh???

[Suze]

I'm looking forward to hearing how this went for you Laurie. Yea Laurie!!!!

[Katesmom]

I found it! Posted in Google news 34 minutes ago!

NJPIRG News Room

NJPIRG Law & Policy Statement on Turning Medicine into Snake Oil, How Drug Marketers Put Patients at Risk
Thank you for coming. I’m Abigail Caplovitz, Consumer Advocate for NJPIRG Law & Policy Center, and with me is Laurie Yorke, a registered nurse and mother of a Paxil victim. She will speak with you in a minute.

We are here today to release a new report, Turning Medicine into Snake Oil, How Pharmaceutical Marketers Put Patients at Risk,, which documents what has been coming to light in past months with the Vioxx verdicts.

Drug marketers are pushing drugs in deceptive ways that put the public at risk. Vioxx might be the poster child, but our report shows that the problem is pervasive throughout the drug industry. In the past five years, the FDA has sent 170 regulatory letters to 85 different companies calling their marketing of 150 different drugs false or misleading. So, when it comes to putting patients at risk, it seems like everyone is doing it.

The drug marketers are sending deceptive messages to both doctors and the public, and they’re doing it in every way imaginable.

Table 1 here shows that doctors received 38 different types of deceptive marketing—doctors are being targeted in their offices, in their journals, at conferences—everywhere they go.

The public gets inundated too—the letters identified 17 different types of marketing aimed at the public—but especially through broadcast media, as you can see here in table 2. It’s simply impossible to avoid deceptive drug ads.

Table 3 here shows you what kinds of deceptive messages the drug marketers are sending. We’ve grouped them into three categories: Misrepresenting risks, promoting unproven uses, making unsubstantiated claims. You can see here that doctors are targeted for far more deceptive messages than the public is.

In fact, 62% of the deceptive messages were aimed at doctors, the very people who most need accurate information. And 2/3 of the deceptive messages aimed at doctors misrepresented risks or promoted unproven uses. That’s dangerous.

Consider these two examples from the letters:

 Pharmacia promoted Celebrex for use in patients at risk of serious bleeding. Pharmacia promoted Celebrex as safe for patients taking the drug Coumadin, although the prescribing materials state that patients taking both may experience serious bleeding. The FDA explained: “minimization of this risk raises significant public health and safety concerns.” (FDA Warning Letter to Pharmacia 2-1-01)

 Cubist Pharmaceuticals promoted Cubicin for off-label use as a pneumonia treatment despite data showing it is ineffective. Cubist Pharmaceuticals used a website to promote its antibiotic Cubicin for use against the bacteria that causes community-acquired pneumonia even though Cubist knew it doesn’t work for pneumonia. The FDA’s letter noted the promotion for pneumonia “poses a significant public health risk because such practice could lead to therapeutic failure and death.” (FDA Warning Letter 8-17-04)

The deceptive marketing problem goes far beyond what you normally think of as ads. It touches the core science: clinical drug trials and the publication of reports about them.

Several of the case studies in the report—they’re all here in the center spread—illustrate this problem. In the Vioxx case study, Merck, Inc. repeatedly misrepresented the unfavorable heart risk data from the VIGOR study by promoting an unsupported but favorable hypothesis as truth, as well as flatly misstating the numbers.

In the Paxil case study, GlaxoSmithKline went further, choosing not to report four trials showing Paxil’s complete ineffectiveness in adolescents, trials that revealed Paxil use by adolescents puts them at risk of psychosis and suicide. Laurie here can talk about that more. It seems unimaginable that a company could sit on such data, but it did.

A report in the New England Journal of Medicine cited nine examples of trials where data unfavorable to the drug company sponsor were either suppressed or, the investigator believed, misrepresented in the article that was published.

But suppressing and misrepresenting clinical trial data aren’t the only deceptive marketing practice distorting the underlying science. The FDA letters reveal a more subtle and likely more pervasive type of clinical data misrepresentation: citing studies for product claims they do not support.

In the five years we studied, the FDA sent 25 companies a total of 38 Untitled and Warning Letters that involved more than 82 mis-cited studies.

Check out these examples in Table 6. My favorite is this one, from the October 2001 FDA letter to AstraZeneca. AstraZeneca produced a Detail Aid—for use by sales representatives when they talk to doctors—that claimed Zomig was effective for migraines. It cited part two of a two part study to support the migraine claim. The first part was blinded, placebo controlled and randomized—the clinical trial gold standard—and that part showed no benefit from using Zomig for migraines. Part 2 did suggest it was effective, but part 2 was open-label, uncontrolled and non-comparative, a very inferior trial design. It’s hard to see how AstraZeneca could totally disregard the scientifically sound part 1 to make the claim and cite part 2 to support it.

What is the FDA doing in the face of all this deceptive activity? Not much. Its policy is like the line Robin Williams used when talking about British police officers who don’t carry guns: STOP! Or I’ll shout stop again!

Looking here at Tables 4 and 5, you can see that the FDA is completely ineffective, because its enforcement actions don’t deter future false advertising. Table four shows how many companies received multiple letters from the FDA in the five years we studied. Pfizer is in a class by itself, the only one with double digits, here at 15. But by no means is it alone; there’s 28 companies that received multiple letters, and they accounted for two thirds of the letters. And those companies aren’t fringe outfits; they’re blue chip companies. Table 5 shows the problem isn’t just that the companies sell lots of drugs; these 26 companies received more than one letter for marketing the same drug in the same deceptive way.

This high rate of recidivism isn’t the only reason the FDA’s enforcement is ineffective. Under the FDA’s letter approach, deceptive messages reach doctors and the public. The FDA reviews advertising only after the advertising is in use, so it does not prevent deceptive messages from reaching doctors and patients. Indeed, letters can take so long to send out that the deceptive ad has fully run its course.

Also troubling, the FDA doesn’t require marketers to correct their advertising most of the time. Only 23% of the FDA letters call for corrective advertising, allowing whatever misperceptions the false ads created to remain unchallenged in three quarters of the cases.

Bottom line: An enforcement system that responds late, requires corrective advertising a quarter of the time, and experiences significant recidivism is a failure.

Making the situation even worse, the FDA only reviews a tiny fraction of drug marketing.

Clearly the problem is large and dangerous. Thankfully, New Jersey can solve the problem itself, without waiting for Congress or the FDA to act. New Jersey can act on its own, right now, to protect its citizens.

First, New Jersey can solve the problem of clinical trial data suppression and manipulation. New Jersey can create an online database of all the clinically important information from each trial about each drug sold in New Jersey. That kind of database is called a clinical trial registry, and it would be created by requiring the drug companies to submit the information to the department of health and pay a filing fee that’s big enough to pay for the registry.

Second, New Jersey can solve the enforcement problem in the situations it matters most—when the deceptive prescription drug marketing is so dangerous it creates a public health risk. To do that, New Jersey has to give doctors and the public the right to sue drug companies to stop the ads, and require corrective ads. That’s all the suits would be about—an injunction, not damages to the plaintiff. Empowering these suits would enable the people who are targeted with the deceptive messages to do something about it. There’s no way the FDA could ever eavesdrop on every meeting between a sales rep and a doctor, to make sure that what’s said is accurate. These suits would make that a non issue; if a sales force is distributing seriously false literature or making seriously false statements, a doctor could use this suit to make them stop.

Third, New Jersey can do more to publicize the FDA letters and any other evidence of deceptive marketing it receives. For example, NJ could issue an annual report highlighting the key features in every year’s letters, or perhaps create a webpage where it posts all the information it has about deceptive prescription drug marketing.

[Homerbcool]

Wow...this is good indeed...it will be interesting to find out whom attended this meeting and what type of press coverage it gets...locally I am sure it will, nationally??...and finding out what our Nurse Laurie said...

[Delynbetter]

Dang, Kim! You win for web-detective!

[scotty]

Good going Kim!! The NJPIRG website will also have the whole report up. It's long but well worth the read.
Here's a link to the full report:
http://njpirg.org/NJ.asp?id2=24023


The press conference went well. TV coverage by News12 NJ. Print coverage by the National Associated Press(this should get picked up in your area paper), Newark Star Ledger, Gannett News Group, and two others that I didn't catch where they were from.

This is what I said after the comments by Abigail that you see above.

Good Morning. My name is Laurie Yorke and I’m a nurse of 22 years. First let me address this subject from my professional view first. I have a lot of experience with Drug Reps. They have been in every hospital that I’ve worked in. You can tell who they are because they carry the doughnuts and bagels. We as nurses get a lot of drug in-services. Usually for the newest brand name drugs. They always come with food, pens, penlights, ID badge lariats and brochures. While on the surface this doesn’t sound like it would be a big influence on prescribing look at it from a patient prospective. They look to nurses for their drug education. If I’m writing out their discharge instructions with a Coreg, Paxil, or any other drug pen, am I not subliminally endorsing its use? The one specific rep that stands out in my mind was the Oxycontin rep. He would be at my floor every week with goodies and handouts. He would tell us how wonderful Oxycontin would be for our patients and how much better it was than any other drug out there. The one thing he neglected to mention was that the pain that our patients had, met none of the criteria for Oxycontin use. These were patients with short term pain who needed minimal narcotic intervention. But, yet he would persist week after week. In none of these inservices was clinical trial information presented. It was the word of the rep only. Risks are rarely mentioned
Now let me get more personal. In my 22 years of nursing I trusted the FDA to thoroughly investigate a drug before approval. It was based on this trust thatI allowed my son to take paxil in 2002 after a panic attack. I’ll admit it. I had NO idea what was wrong with him and I wanted him fixed. After being seen by an adolescent psychiarist his advice was to put Ryan on paxil for a year to get him past the raging hormones that he felt caused the attack. I researched paxil, I read the PDR, I read the drug insert and I specifically asked the psychiatrist about adverse reactions. I was given one… diarrhea for a few weeks when starting the paxil. For the first few months Ryan did well. Then we started seeing the behavioral changes/aggression creeping in. Aggression, failing grades, total indifference to life… a zombie. His dose was increased 4 times in a one year period to deal with these problems with NO mention of possible adverse reaction to paxil He had gone from an A student to failing every class. His personality was completely changed. This is when I started to wake up and realize that there was something going on. It was an article in the Star Ledger that made me realize it was the paxil. Not his psychiatrist… a newspaper.

I hit the internet and on a google search of paxil adverse effects. I found what I was looking for. My son was only one of thousands experiencing the same problems on paxil. Now I had to get him off. It was two weeks into that first wean recommended by the psychiatrist that Ryan attempted suicide twice in a 10 hour period. The first attempt we missed, he was lethargic and vomiting. The psychiatrist told me that this was normal” flu symptoms” with weaning. He woke up in a psychotic episode that lasted 4 hours and resulted in him slashing his wrists screaming that he was “born to die”. The vomiting had been from a xanax overdose. He was admitted to an adolescent psychiatric unit where they admitted to me that this was paxil withdrawal. They attempted to start Depakote as a mood stabilizer, but by this point I was NOT letting any other drug into my child. Especially another off label use drug. I now trusted NO information coming out of the drug companies.

Ryan weaned off paxil over the next 4 months with advice from strangers on the internet, which turned out to be MUCH more reliable that any information I’d received from the doctor,drug company or the FDA. While the paxil use was a horror in itself, withdrawal would be worse. Symptoms are bizarre, unpredictable and devastating. It took Ryan a full year off of paxil to start to feel normal again. He continues to have short term memory problems to this day. He has very little memory of his year on paxil.

It was during Ryan’s withdrawal that the information that GSK had suppressed the clinical trial data on children was made public. These suppressed trials resulted in the “black box warnings” for suicidality,aggression, and changes in behavior in children on ssri’s. Albeit years too late for some.
These hidden clinical trials would have given me the information I needed to make an informed decision regarding my child. I was not given that opportunity. Ryan never would have taken paxil if I knew what was in those trials.

I am not anti-drug. Far from it, I’m nurse and know that drugs have great benefits, but the public and physicians have a right to have access to ALL of the information that is known about a drug BEFORE putting it in their bodies. It’s only with complete disclosure of clinical trial data that the consumer and the physician can make in informed risk benefit decision. The public should not be forced to go to an internet website and talk to strangers to get the real story… but for now that’s where you’ll find me talking to those in withdrawal. Without that information my child and others would be dead. The FDA has failed in its regulatory duties, drug companies have failed in providing accurate and unaltered drug information, and the medical profession has failed in getting their prescribing information from a salesman.

This report covers all the information that I have discovered in the last 4 years, and it makes recommendations that if put in place will save lives of adults and children alike.

[Delynbetter]

Thank you, Laurie...for everything. Big hugs to you!

[Homerbcool]

If I Had A Webcam...you Would See My Standing Ovation...great Work Laurie...awesome Awesome Awesome!!!

[Katesmom]

Yea, Laurie!!! You are such a rock star!

[ihatezaps]

Ryan is very lucky to have a mom like you!

[Homerbcool]

Moms are the best aint they....

[scotty]

This is only the start. Following this report is legislation in NJ that encompasses every recommendation in the report. This is going to be an uphill battle, but if we get it passed(we have bipartisan support) it will be a benchmark bill for other states to follow!

This is going to be fun with NJ being pharma capitol of the US... anyone want to volunteer to start my car in the mornings???