"Pens for Pens" – GlaxoSmithKline ought to join the "Pens for Pens" program. “Blockbuster drugs like Vioxx and Celebrex get the headlines but some doctors say the real issue is something else entirely.”
That’s the report of http:/// on March2, 2005. A doctor at Columbia University is “urging his colleagues to do a quick self-examination starting with their breast pocket. Do they contain a half dozen pens from pharmaceutical sales reps?” What does a Paxil pen look like?
Doctors around the country send this pioneering doctor unmarked cardboard boxes full of drug industry pens. Then he sends back a “no free lunch” pen. Maybe the U.S Marshals who seized lots of Paxil CR should try to seize the pens. On March 4th, the New York Times, www.nytimes.com and the Associated Press, www.ap.org, reported the seizure. The AP reported: “Angered by quality-control problems it said had dragged on for more than two years, the Food and Drug Administration used armed federal marshals to seize millions of tablets of two medicines from facilities in Tennessee and Puerto Rico operated by GlaxoSmithKline, the agency said Friday.” One of the drugs was “the antidepressant Paxil CR, which had $725 million in sales last year.”
The drug industry spends billions of dollars on pens and other marketing because “There's plenty of evidence doctors are influenced by gifts and promotions” notes marketplace.org, which reports that “hundreds of doctors . . . receive substantial honoraria from drug companies to lecture about new therapies. They always flash a slide to disclose his picking up the tab for the prime rib. But does that cancel potential conflict of interest?”
Drug company representatives “bring briefcases full of free samples of new medication and few doctors bar their doors.” And this marketing technique works. “Many studies have found that doctors do prescribe more of the drugs that get promoted.”
There are better warnings now about Paxil side effects. But if you have gotten a sample from a doctor, heed this sworn testimony from an expert witness in the Tobin trial:
"Question: In order to do a detailed mental status examination you have to get the information from the patient or his family, true?"
“Answer: That's true. And not only that, you're not going to get a detailed mental examination from an internist. This is where psychiatry training will come into the picture."
The Tobin trial (the only successful trial against an SSRI maker - there have been three court trials) sparked worldwide interest, vindicated the expert witnesses who supported the family’s claims and ultimately resulted in better warnings. See the warnings outcome at http://www.msnbc.msn.com/id/4579108/. Unfortunately, there are still some samples out there in clinics, hospitals and doctors offices without the new warnings. And there are still some families who have lost loved ones because the old warning were not good enough, but those families have not understood why they lost their loved ones to suicide. So talk to your doctor. I’m not a doctor, but if you are on Paxil or have lost a loved one to suicide (or disfigurement), start asking questions. There are answers but not all the doctors have the answers.
Here’s one answer: the warnings may not have been right.
Here’s what I told the jury in Tobin, as the Paxil maker should have told the public:
“Sometimes people will have suicidal ideation. Sometimes they will have hallucinations. Sometimes they will need a sedative. So please, you internists out there who prescribe our pills, please take heed, please take heed and remember to get a detailed history and to monitor carefully and to empower the family.
Well, that's a perfectly good idea. We heard about that. Let's empower the family with the information so that the prescribing doctor can give the whole picture.
Let's go to the prescribing doctor’s office. Here he is and he says "I have examined you now, Mr. Patient. And, as to your wife, thank you so much for coming in. And I'm going to prescribe the medication. It is called Paxil. I think it will help you. It helps a lot of people. I do want to caution you about some things. For some people it causes hallucinations. For some people it causes agitation or anxiety.
Tell me, let's go through your history. Have you seen a psychiatrist? How many times? What for? What was the outcome? Have you had medications before? How did they work? Tell me about your experience on them.
[Patient’s] doctor could have been empowered by SmithKline Beecham and then the doctor could empower the family and say, "Okay, now that I have your history, I want to tell you I'm going to prescribe a sedative."
[Patient’s] doctor said: "If I had known this information, I would have handled the case differently."
I'm going to prescribe a sedative and I'm going to make certain that you monitor your husband very carefully. And I'm going to check on you, and I'm going to, and I'm going to, and I'm going to, and I'm going to," because he would have had power.”
For more about the Tobin trial, visit www.fitzgeraldlaw.com.
For more on the history of Paxil and suicide, visit www.paxilInform.com.
I argued that if the Paxil maker properly warned the doctor, he would have handled the case differently, and the doctor testified that was so:
“What does this mean? SmithKline Beecham's own witness comes in here and says an internist is not going to have enough information. So where would the internist get the information that the internist needs?
There's only one place. And that's from SmithKline Beecham.
This proves that SmithKline Beecham should have put more information in the product instructions, and in the Physician's Desk Reference, the blue book that all practicing physicians have in their office about drugs and their side effects, because an internist is not going to get the detailed information.
You have to tell the prescribing physician, the internist, and others throughout this nation, "Dr., this drug has no sedative effect. You may wish to consider giving a sedative."
The prescribing doctor who gave [the patient] the Paxil testified: ‘If I had known that, I would have handled the case differently.’
The defendant should have said: ‘Dr., you are like many general practitioners or internists and you're not going to have the information you need unless we tell you in the package insert. If you're going to prescribe the drug, and we hope you do" -- and I hope they do because it does a lot of people a lot of good -- "but if you're going to prescribe it, please sit down with your patient and get a detailed history.’
Think about it, members of the jury. We've all been to the doctor. You go in and you sit down and you answer the doctor's questions. If only SmithKlineBeecham had said, ‘Get a detailed history, you internists and general practitioners. It is very important and watch out for these things. Find out if there's been a bad reaction in the past on an SSRI.’
The prescribing doctor said, ‘If I had been given that kind of information, it would have made a difference in how I handled this case.’
And what kind of information was he talking about? He wasn't talking about [the patient] hiding something or filling out a questionnaire to minimize his condition or misleading the doctor or withholding information. He was talking about ‘If SmithKlineBeecham had told me this information, I would have handled this case differently.’ And that, members of the jury, is the crux of our case.
It is very important for me to try to clarify exactly where we stand. SmithKlineBeecham says that their product is not defective. Let's get real clear about one thing. There is nothing wrong with the Paxil pill. We're not claiming there's anything wrong with the Paxil pill. Nothing.
So why are we here? We are here because the product consists of the pill and the instructions and warnings that go along with it, and those instructions and warnings are inadequate and defective. That's why we're here.
When they say that the product is not defective and they argue the facts, they're leaving out a very important part of the picture, and that is that a product maker must foresee the uses of its product.
You don't have to take my word for this. His Honor will be giving you comprehensive instructions on product liability law. When SmithKlineBeecham says their product is not defective, they overlook the fact and the law that an inadequate or improper warning can make a product defective. Let me tell you what the jury instructions will say: A defective product can include a product which has inadequate or improper warnings.
When the defendant says their product is not defective, they overlook the fact that a manufacturer like SmithKline Beecham has an obligation to give appropriate warnings of any, any dangerous condition which is likely to be encountered, and sometimes there will be a dangerous condition.
When Paxil, a good pill, is given, and there are inadequate instructions, inadequate warnings, inadequate information given out, it becomes a defective product, not the pill itself, but because it doesn't have the proper warnings.”